Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared Savings Program Requirements; and Medicare Diabetes Prevention Program, 33950-34203 [2017-14639]
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33950
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
42 CFR Parts 405, 410, 414, 424, and
425
[CMS–1676–P]
RIN 0938–AT02
Medicare Program; Revisions to
Payment Policies Under the Physician
Fee Schedule and Other Revisions to
Part B for CY 2018; Medicare Shared
Savings Program Requirements; and
Medicare Diabetes Prevention Program
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
AGENCY:
This major proposed rule
addresses changes to the Medicare
physician fee schedule (PFS) and other
Medicare Part B payment policies.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on September 11, 2017. (See
the SUPPLEMENTARY INFORMATION section
of this final rule with comment period
for a list of provisions open for
comment.)
SUMMARY:
In commenting, please refer
to file code CMS–1676–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–1676–P, P.O. Box 8016, 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–1676–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
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ADDRESSES:
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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:
Jamie Hermansen, (410) 786–2064, for
issues related to the valuation of
anesthesia services and any physician
payment issues not identified below.
Lindsey Baldwin, (410) 786–1694,
and Emily Yoder, (410) 786–1804, for
issues related to telehealth services and
primary care.
Roberta Epps, (410) 786–4503, for
issues related to PAMA section 218(a)
policy and transition from traditional
X-ray imaging to digital radiography.
Isadora Gil, (410) 786–4532, for issues
related to the valuation of
cardiovascular services, bone marrow
services, surgical respiratory services,
dermatological procedures, and
payment rates for nonexcepted items
and services furnished by nonexcepted
off-campus provider-based departments
of a hospital.
Donta Henson, (410) 786–1947, for
issues related to ophthalmology
services.
Tourette Jackson, (410) 786–4735, for
issues related to the valuation of
musculoskeletal services, allergy and
clinical immunology services,
endocrinology services, genital surgical
services, nervous system services, INR
monitoring services, injections and
infusions, and chemotherapy services.
Ann Marshall, (410) 786–3059, for
issues related to primary care, chronic
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care management (CCM), and evaluation
and management (E/M) services.
Geri Mondowney, (410) 786–4584, for
issues related to malpractice RVUs.
Patrick Sartini, (410) 786–9252, for
issues related to the valuation of
imaging services and malpractice RVUs.
Michael Soracoe, (410) 786–6312, for
issues related to the practice expense
methodology, impacts, conversion
factor, and valuation of pathology and
surgical procedures.
Pamela West, (410) 786–2302, for
issues related to therapy services.
Corinne Axelrod, (410) 786–5620, for
issues related to rural health clinics or
federally qualified health centers.
Felicia Eggleston, (410) 786–9287, for
issues related to DME infusion drugs.
Rasheeda Johnson, (410) 786–3434,
for issues related to initial data
collection and reporting periods for the
clinical laboratory fee schedule.
Edmund Kasaitis, (410) 786–0477, for
issues related to biosimilars.
JoAnna Baldwin, (410) 786–7205, or
Sarah Fulton, (410) 786–2749, for issues
related to appropriate use criteria for
advanced diagnostic imaging services.
Alesia Hovatter, (410) 786–6861, for
issues related to PQRS.
Alexandra Mugge, (410) 786–4457, or
Elizabeth Holland, (410) 786–1309, for
issues related to the EHR incentive
program.
Rabia Khan or Terri Postma, (410)
786–8084 or ACO@cms.hhs.gov, for
issues related to the Medicare Shared
Savings Program.
Kimberly Spalding Bush, (410) 786–
3232, or Fiona Larbi, (410) 786–7224,
for issues related to Value-based
Payment Modifier and Physician
Feedback Program.
Wilbert Agbenyikey, (410) 786–4399,
for issues related to MACRA patient
relationship categories and codes.
Carlye Burd, (410) 786–1972, or
Albert Wesley, (410) 786–4204, for
issues related to diabetes prevention
program.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
II. Provisions of the Proposed Rule for PFS
A. Background
B. Determination of Practice Expense
Relative Value Units (PE RVUs)
C. Determination of Malpractice Relative
Value Units (MRVUs)
D. Medicare Telehealth Services
E. Potentially Misvalued Services Under
the PFS
F. Implementation of Reduced Payment for
Film-Based Imaging Services
G. Proposed Payment Rates Under the
Medicare PFS for Nonexcepted Items
and Services Furnished by Nonexcepted
Off-Campus Provider-Based Departments
of a Hospital
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H. Proposed Valuation of Specific Codes
I. Evaluation & Management (E/M)
Guidelines and Care Management
Services
III. Other Provisions of the Proposed Rule
A. New Care Coordination Services and
Payment for Rural Health Clinics (RHCs)
and Federally Qualified Health Centers
(FQHCs)
B. Payment for DME Infusion Drugs
C. Solicitation of Public Comments on
Initial Data Collection and Reporting
Periods for Clinical Laboratory Fee
Schedule
D. Solicitation of Public Comments on
Biosimilars
E. Appropriate Use Criteria for Advanced
Diagnostic Imaging Services
F. Physician Quality Reporting System
Criteria for Satisfactory Reporting for
Individual EPs and Group Practices for
the 2018 PQRS Payment Adjustment
G. Medicare EHR Incentive Program
H. Medicare Shared Savings Program
I. Value-Based Payment Modifier and
Physician Feedback Program
J. MACRA Patient Relationship Categories
and Codes
K. Medicare Diabetes Prevention Program
IV. Collection of Information Requirements
V. Response to Comments
VI. Regulatory Impact Analysis
Regulations Text
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Acronyms
In addition, because of the many
organizations and terms to which we
refer by acronym in this final 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)
BLS Bureau of Labor Statistics
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
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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
FSHCAA Federally Supported Health
Centers Assistance Act
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
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
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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)
PAMPA Patient Access and Medicare
Protection Act (Pub. L. 114–115)
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
PPS Prospective Payment System
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 Scale
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
TCM Transitional Care Management
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
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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 on the CMS Web site at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
PhysicianFeeSched/PFS-FederalRegulation-Notices.html. Click on the
link on the left side of the screen titled,
‘‘PFS Federal Regulations Notices’’ for a
chronological list of PFS Federal
Register and other related documents.
For the CY 2018 PFS Proposed Rule,
refer to item CMS–1676–P. Readers with
questions related to accessing any of the
Addenda or other supporting
documents referenced in this proposed
rule and posted on the CMS Web site
identified above should contact Jamie
Hermansen at (410) 786–2064.
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 2016 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
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A. Purpose
This major proposed rule proposes to
revise payment polices under the
Medicare PFS and make other policy
changes related to Medicare Part B
payment, applicable to services
furnished in CY 2018. In addition, this
proposed rule includes proposals
related to payment policy changes that
are addressed in section III. of this
proposed rule.
1. 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
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for CY 2018 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 Codes.
• Telehealth Services.
• Establishing Values for New,
Revised, and Misvalued Codes.
• Establishing Payment Rates under
the PFS for Nonexcepted Items and
Services Furnished by Nonexcepted OffCampus Provider-Based Departments of
a Hospital.
• Evaluation & Management (E/M)
Guidelines and Care Management
Services.
• Care Coordination Services and
Payment for Rural Health Clinics (RHCs)
and Federally Qualified Health Centers
(FQHCs).
• Payment for DME Infusion Drugs.
• Solicitation of Public Comments on
Initial Data Collection and Reporting
Periods for Clinical Laboratory Fee
Schedule.
• Solicitation of Public Comments on
Payment for Biosimilar Biological
Products under Section 1847A of the
Act.
• Appropriate Use Criteria for
Advanced Diagnostic Imaging Services.
• PQRS Criteria for Satisfactory
Reporting for Individual EPs and Group
Practices for the 2018 PQRS Payment
Adjustment.
• Medicare EHR Incentive Program.
• Medicare Shared Savings Program.
• Value-Based Payment Modifier and
the Physician Feedback Program.
• MACRA Patient Relationship
Categories and Codes.
• Medicare Diabetes Prevention
Program.
2. Summary of Costs and Benefits
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.
II. Provisions of the Proposed Rule for
PFS
A. Background
Since January 1, 1992, Medicare has
paid for physicians’ services under
section 1848 of the Act, ‘‘Payment for
Physicians’ Services.’’ The PFS 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
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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 Scale 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
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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 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
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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 hospital outpatient
department (HOPD)) would reflect costs
typically incurred by the facility. Thus,
payment associated with those facility
resources is not made under the PFS.
Section 212 of the Balanced Budget
Refinement Act of 1999 (Pub. L. 106–
113, enacted on November 29, 1999)
(BBRA) directed the Secretary of Health
and Human Services (the Secretary) to
establish a process under which we
accept and use, to the maximum extent
practicable and consistent with sound
data practices, data collected or
developed by entities and organizations
to supplement the data we normally
collect in determining the PE
component. On May 3, 2000, we
published the interim final rule (65 FR
25664) that set forth the criteria for the
submission of these supplemental PE
survey data. The criteria were modified
in response to comments received, and
published in the Federal Register (65
FR 65376) as part of a November 1, 2000
final rule. The PFS final rules published
in 2001 and 2003, respectively, (66 FR
55246 and 68 FR 63196) extended the
period during which we would accept
these supplemental data through March
1, 2005.
In the CY 2007 PFS final rule with
comment period (71 FR 69624), we
revised the methodology for calculating
direct PE RVUs from the top-down to
the bottom-up methodology beginning
in CY 2007. We adopted a 4-year
transition to the new PE RVUs. This
transition was completed for CY 2010.
In the CY 2010 PFS final rule with
comment period, we updated the
practice expense per hour (PE/HR) data
that are used in the calculation of PE
RVUs for most specialties (74 FR
61749). In CY 2010, we began a 4-year
transition to the new PE RVUs using the
updated PE/HR data, which was
completed for CY 2013.
c. Malpractice RVUs
Section 4505(f) of the BBA amended
section 1848(c) of the Act to require that
we implement resource-based MP RVUs
for services furnished on or after CY
2000. The resource-based MP RVUs
were implemented in the PFS final rule
with comment period published
November 2, 1999 (64 FR 59380). The
MP RVUs are based on commercial and
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physician-owned insurers’ malpractice
insurance premium data from all the
states, the District of Columbia, and
Puerto Rico. For more information on
MP RVUs, see section II.C. of this
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 5-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,
that require 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
do 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.
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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 conversion
factor (CF), which is calculated based on
a statutory formula by CMS’s Office of
the Actuary (OACT). The formula for
calculating the Medicare PFS 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
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.
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B. Determination of Proposed 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
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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
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 5 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
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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 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 use crosswalks
for specialties that did not participate in
the PPIS. These crosswalks have been
generally established through notice and
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comment rulemaking and are available
in the file called ‘‘CY 2018 PFS
Proposed Rule PE/HR’’ on the CMS Web
site under downloads for the CY 2018
PFS proposed rule at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
PhysicianFeeSched/PFS-FederalRegulation-Notices.html.
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.
mstockstill on DSK30JT082PROD with PROPOSALS2
(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
We allocate 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
incorporate the survey data described
earlier in the PE/HR discussion (see
section II.B.2.b of this proposed rule).
The general approach to developing the
indirect portion of the PE RVUs is as
follows:
• For a given service, we use the
direct portion of the PE RVUs calculated
as previously described and the average
percentage that direct costs represent of
total costs (based on survey data) across
the specialties that furnish the service to
determine an initial indirect allocator.
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, represent 25
percent of total costs for the specialties
that furnish 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 RVU of 8.00
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(2.00 is 25 percent of 8.00 and 6.00 is
75 percent of 8.00).
• Next, we add the greater of the work
RVUs or clinical labor portion of the
direct portion of the PE RVUs to this
initial indirect allocator. In our
example, if this service had a work RVU
of 4.00 and the clinical labor portion of
the direct PE RVU 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
facility setting, where Medicare makes a
separate payment to the facility for its
costs in furnishing a service, 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.
(4) Services With Technical
Components and Professional
Components
Diagnostic services are generally
comprised of two components: A
professional component (PC) and a
technical component (TC). The PC and
TC may be furnished independently or
by different providers, or they may be
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33955
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 2018
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 in
this proposed rule for individual 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, use the conversion factor to
calculate a direct PE scaling adjustment
to ensure that the aggregate pool of
direct PE costs calculated in Step 3 does
not vary from the aggregate pool of
direct PE costs for the current year.
Apply the scaling adjustment to the
direct costs for each service (as
calculated in Step 1).
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Step 5: Convert the results of Step 4
to a RVU scale for each service. To do
this, divide the results of Step 4 by the
conversion factor (CF). Note that the
actual value of the CF used in this
calculation does not influence the final
direct cost PE RVUs as long as the same
CF is used in Step 4 and Step 5.
Different CFs would result in different
direct PE scaling adjustments, but this
has no effect on the final direct cost PE
RVUs since changes in the CFs and
changes in the associated direct scaling
adjustments 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 generally use an average of the 3
most recent years of available Medicare
claims data to determine the specialty
mix assigned to each code. Prior to
implementing that policy, we used the
most recent year of available claims data
to determine the specialty mix assigned
to each code.
Under either of these approaches,
codes with low Medicare service
volume require special attention since
billing or enrollment irregularities for a
given year can result in significant
changes in specialty mix assignment.
Prior to adopting the 3-year average of
data, for low-volume services (fewer
than 100 Medicare allowed services), we
assigned the values associated with the
specialty that most frequently reported
the service in the most recent claims
data (dominant specialty). For some
time, stakeholders, including the RUC,
have requested that we use a
recommended ‘‘expected’’ specialty for
all low volume services instead of the
information contained in the claims
data. Currently, in the development of
PE RVUs we use ‘‘expected specialty’’
overrides for only several dozen services
based on several code-specific policies
we established in prior rulemaking. As
we stated in the CY 2016 final rule with
comment period (80 FR 70894), we
hoped that the 3-year average would
mitigate the need to use dominant or
expected specialty instead of the
specialty identified using claims data.
Because we incorporated CY 2015
claims data for use in the CY 2017
proposed rates, we believe that the
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finalized PE RVUs associated with the
CY 2017 PFS final rule provided a first
opportunity to determine whether
service-level overrides of claims data are
necessary.
Although we believe that the use of
the 3-year average of claims data to
determine specialty mix has led to an
improvement in the stability of PE and
MP RVUs from year to year, after
reviewing the RVUs for low volume
services, we continue to see possible
distortions and wide variability from
year to year in PE and MP RVUs for low
volume services. Several stakeholders
have suggested that CMS implement
service-level overrides based on the
expected specialty in order to determine
the specialty mix for these low volume
procedures. The RUC previously
supplied us with a list of nearly 2,000
lower volume codes and their suggested
specialty overrides. After reviewing the
finalized PE RVUs for the CY 2017 PFS
final rule, we agree that the use of
service-level overrides for low volume
services would help mitigate annual
fluctuations and provide greater
stability in the valuation of these
services. While the use of the 3-year
average of claims data to determine
specialty mix has helped to mitigate
some of the year-to-year variability for
low volume services, it has not fully
mitigated what appear to be anomalies
for many of these lower volume codes.
We are, therefore, proposing to use
the most recent year of claims data to
determine which codes are low volume
for the coming year (those that have
fewer than 100 allowed services in the
Medicare claims data). For codes that
fall into this category, instead of
assigning specialty mix based on the
specialties of the practitioners reporting
the services in the claims data, we are
proposing to instead use the expected
specialty that we identify on a list. For
CY 2018, we are proposing to use a list
that was developed based on our
medical review of the list most recently
recommended by the RUC, in addition
to our own proposed expected specialty
for certain other low-volume codes for
which we have historically used
expected specialty assignments. We
would display this list as part of the
annual set of data files we make
available as part of notice and comment
rulemaking. We propose to consider
recommendations from the RUC and
other stakeholders on changes to this
list on an annual basis.
We are also proposing to apply these
service-level overrides for both PE and
MP, rather than one or the other
category. We believe that this would
simplify the implementation of servicelevel overrides for PE and MP, and
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would also address stakeholder
concerns about the year-to-year
variability for low volume services. We
are soliciting public comment on the
proposal to use service-level overrides
to determine the specialty mix for low
volume procedures, as well as on the
proposed list of expected specialty
overrides itself, which is largely based
on the recommendations submitted by
the RUC last year. The proposed list of
expected specialty assignments for
individual low volume services is
available on our Web site under
downloads for the CY 2018 PFS
proposed rule at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html.
Services for which the specialty is
automatically assigned based on
previously finalized policies under our
established methodology (for example,
‘‘always therapy’’ services) would be
unaffected by this proposal.
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 would be allocated
using the work RVUs, and for the TC
service, indirect PEs would 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.
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• 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
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 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 proposed rule.)
Step 19: Apply the phase-in of
significant RVU reductions and its
associated adjustment. 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 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. To comply
with section 1848(c)(7) of the Act, we
adjust the PE RVUs to ensure that the
total RVUs for all services that are not
new or revised codes decrease by no
more than 19 percent, and then apply a
relativity adjustment to ensure that the
total pool of aggregate PE RVUs remains
relative to the pool of work and MP
RVUs. For a more detailed description
of the methodology for the phase-in of
significant RVU changes, we refer
readers to the CY 2016 PFS final rule
with comment period (80 FR 70927
through 70931).
(e) Setup File Information
• Specialties excluded from
ratesetting calculation: For the purposes
of calculating the PE RVUs, we exclude
certain specialties, such as certain NPPs
paid at a percentage of the PFS and lowvolume specialties, from the calculation.
These specialties are included for the
purposes of calculating the BN
adjustment. They are displayed in Table
1.
TABLE 1—SPECIALTIES EXCLUDED FROM RATESETTING CALCULATION
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Specialty code
49
50
51
52
53
54
55
56
57
58
59
60
61
73
74
87
88
89
96
......................
......................
......................
......................
......................
......................
......................
......................
......................
......................
......................
......................
......................
......................
......................
......................
......................
......................
......................
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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.
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TABLE 1—SPECIALTIES EXCLUDED FROM RATESETTING CALCULATION—Continued
Specialty code
97 ......................
A0 .....................
A1 .....................
A2 .....................
A3 .....................
A4 .....................
A5 .....................
A6 .....................
A7 .....................
B2 .....................
B3 .....................
Specialty description
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
Modifier
Description
Volume adjustment
80,81,82 ......................
AS ...............................
16% ....................................................................................
14% (85% * 16%) ..............................................................
Intraoperative portion.
Intraoperative portion.
or LT and RT .........
................................
................................
................................
................................
Assistant at Surgery ............
Assistant at Surgery—Physician Assistant.
Bilateral Surgery ..................
Multiple Procedure ...............
Reduced Services ...............
Discontinued Procedure ......
Intraoperative Care only ......
150% of work time.
Intraoperative portion.
50%.
50%.
Preoperative +
Intraoperative portion.
55 ................................
Postoperative Care only ......
62 ................................
66 ................................
Co-surgeons ........................
Team Surgeons ...................
150% ..................................................................................
50% ....................................................................................
50% ....................................................................................
50% ....................................................................................
Preoperative + Intraoperative Percentages on the payment files used by Medicare contractors to process
Medicare claims.
Postoperative Percentage on the payment files used by
Medicare contractors to process Medicare claims.
62.5% .................................................................................
33% ....................................................................................
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50
51
52
53
54
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.
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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
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Time adjustment
Postoperative portion.
50%.
33%.
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)∧ life of equipment)))) +
maintenance)
Where:
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minutes per year = maximum minutes per
year if usage were continuous (that is,
usage=1); generally 150,000 minutes.
usage = variable, see discussion in this
proposed rule.
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 in this
proposed rule.
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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 finalized in the CY
1998 PFS final rule with comment
period (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 (see 77 FR 68902
for a thorough discussion of this issue).
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). We are not
proposing any changes to these interest
rates for CY 2018. The interest rates are
listed in Table 3.
TABLE 3—SBA MAXIMUM INTEREST
RATES—Continued
Price
Useful life
>$50K ...........
7+ Years .....
Interest rate
(%)
6.00
3. Changes to Direct PE Inputs for
Specific Services
This section focuses on specific PE
inputs. The direct PE inputs are
included in the CY 2018 direct PE input
database, which is available on the CMS
Web site under downloads for the CY
2018 PFS proposed rule at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
PhysicianFeeSched/PFS-FederalRegulation-Notices.html.
(a) PE Inputs for Digital Imaging
Services
In the CY 2017 PFS final rule (81 FR
80179 through 80184), we finalized our
proposal to add a professional PACS
workstation (ED053) used for
interpretation of digital images to a
series of CPT codes and to address costs
related to the use of film that had
previously been incorporated as direct
PE inputs for these services. We
finalized the following criteria for the
inclusion of a professional PACS
workstation:
• We did not add the professional
PACS workstation to any code that
currently lacks a technical PACS
workstation (ED050) or lacks a work
RVU. We continue to believe that
procedures that do not include a
technical workstation, or do not have
physician work, would not require a
professional workstation.
• We did not add the professional
PACS workstation to add-on codes.
Because the base codes include
equipment minutes for the professional
PACS workstation, we continue to
believe it would be duplicative to add
additional equipment time for the
professional PACS workstation in the
add-on code.
• We also did not add the
professional PACS workstation to image
guidance codes where the dominant
provider is not a radiologist according to
the most recent year of claims data,
because we believe a single technical
TABLE 3—SBA MAXIMUM INTEREST
PACS workstation would be more
RATES
typical in those cases.
• We agreed with commenters that
Interest rate
because the clinical utility of the PACS
Price
Useful life
(%)
workstation is not necessarily limited to
diagnostic services, there may be
<$25K ........... <7 Years .....
7.50
$25K to $50K <7 Years .....
6.50 therapeutic codes where it would be
>$50K ........... <7 Years .....
5.50 reasonable to assume its use to be
<$25K ........... 7+ Years .....
8.00 typical. Based on information provided
$25K to $50K 7+ Years .....
7.00 by commenters and our own medical
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review, we stated that we believe that
the use of the professional PACS
workstation is typical for many of the
specific codes that were identified. We
added the workstation to many of the
therapeutic codes requested by
commenters, specifically CPT codes
listed outside the 70000 series, where
we agreed that use of the professional
PACS workstation was typical.
• For CPT codes in the 80000 and
90000 series, we expressed our concerns
about whether it is appropriate to
include the technical PACS workstation
in many of these services. PACS
workstations were created for imaging
purposes, but many of these services
that include a technical PACS
workstation do not appear to make use
of imaging. Although we did not remove
the technical PACS workstation from
these codes at that time, we did not
believe that a professional PACS
workstation should be added to these
procedures.
Prior to the publication of this CY
2018 PFS proposed rule, a stakeholder
expressed concern about our decision
not to include the professional PACS
workstation in a series of vascular
ultrasound codes that use technical
PACS workstations. The stakeholder
indicated that the vascular ultrasound
codes in question do make use of a
professional PACS workstation, and that
the dominant specialty provider
requirement (that is, that the code’s
dominant specialty provider being
diagnostic radiology) would exclude
codes for which the professional PACS
workstation is typical based on a
mistaken assumption. The stakeholder
stated that to furnish vascular
ultrasound services following the
transition from film to digital imaging,
both a technical and a professional
PACS workstation are required,
regardless of whether the practitioner
furnishing the service is a radiologist,
cardiologist, neurologist, or vascular
surgeon.
We appreciate the submission of this
additional information regarding the use
of the professional PACS workstation in
vascular ultrasound codes. Therefore,
we seek comments regarding whether or
not the use of the professional PACS
workstation would be typical in the
following list of CPT and HCPCS codes.
The codes brought to our attention by
the stakeholder are CPT codes 93880,
93882, 93886, 93888, 93890, 93892,
93893, 93922, 93923, 93924, 93925,
93926, 93930, 93931, 93965, 93970,
93971, 93975, 93976, 93978, 93979,
93980, 93981, 93990, and 76706, and
HCPCS code G0365. We will consider
information submitted in comments to
determine whether the professional
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PACS workstation should be included
as a direct PE input for these codes.
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(2) Standardization of Clinical Labor
Tasks
As we noted in the CY 2015 PFS final
rule with comment period (79 FR
67640–67641), we continue to make
improvements 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
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 simultaneously 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. Preservice Clinical Labor for 0-Day
and 10-Day Global Services
Several years ago, the RUC’s PE
Subcommittee reviewed the preservice
clinical labor times for CPT codes with
0-day and 10-day global periods. The
RUC concluded that these codes are
assumed to have no preservice clinical
staff time (standard time of 0 minutes)
unless the specialty can provide
evidence that the preservice time is
appropriate. In other words, for minor
procedures, it is assumed that there is
no clinical staff time typically spent
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preparing for the specific procedure
prior to the patient’s arrival. However,
we note that for CY 2018, 41 of the 53
reviewed codes with 0-day or 10-day
global periods include preservice
clinical labor of some kind, suggesting
that it is typical for clinical staff to
prepare for the procedure prior to the
patient’s arrival. As we review
misvalued codes, we believe that the
general adherence to values that we
have established as standards supports
relativity within the PFS. Because 77
percent of the reviewed codes for the
current calendar year deviate from the
‘‘standard,’’ we are seeking comment on
the value and appropriate application of
the standard in our review of RUC
recommendations in future rulemaking.
In reviewing the inputs included in the
direct PE inputs database, we found that
for the 1,142 total 0-day global codes,
741 of them had preservice clinical
labor of some kind (65 percent). We also
noticed a general correlation between
preservice clinical labor time and the
recent review. We are seeking comment
specifically on whether the standard
preservice clinical labor time of 0
minutes should be consistently applied
for 0-day and 10-day global codes in
future rulemaking.
b. Obtain Vital Signs Clinical Labor
The direct PE inputs for each CPT
code paid under the PFS include
minutes assigned to a series of standard
clinical labor tasks assumed to be
typical for the service in question. The
minutes assigned to each of these tasks
for each CPT code have been developed
over several decades, and what was
previously considered to be a standard
value in the review of the codes has
changed over time. Because each year
we perform a detailed review of all of
the inputs for only several hundred of
the over 7,000 CPT codes paid under the
PFS, valuation for individual services
can be influenced by shifts in review
standards over time rather than purely
based on changes in practice.
For example, we traditionally
assigned a clinical labor time of 3
minutes for the ‘‘Obtain vital signs’’
clinical labor activity, based on the
amount of time typically required to
check a patient’s vitals. Over time, that
number of minutes has increased as
codes are reviewed. For example, many
of the reviewed codes for the current CY
2018 rulemaking cycle have a
recommended clinical labor time of 5
minutes for ‘‘Obtain vital signs,’’ based
on the understanding that these services
are measuring two additional vital signs:
The patient’s height and weight. We do
not have any reason to believe that
measuring a patient’s height and weight
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is only typical for services described by
recently reviewed codes. Instead, we
believe that the review standards have
changed, perhaps in conjunction with
changes in medical practice, and that
the change in the minutes assigned for
the ‘‘Obtain vital signs’’ task for newerreviewed services is detrimental to
relativity among PFS services.
Therefore, to preserve relativity
among the PFS codes, we are proposing
to assign 5 minutes of clinical labor time
for all codes that include the ‘‘Obtain
vital signs’’ task, regardless of the date
of last review. We are proposing to
assign this 5 minutes of clinical labor
time for all codes that include at least
1 minute previously assigned to this
task. We are also proposing to update
the equipment times of the codes with
this clinical labor task accordingly to
match the changes in clinical labor time.
For codes that were not recently
reviewed and for which we lacked a
breakdown of how the equipment time
was derived from the clinical labor
tasks, we could not determine if the
equipment time included time assigned
for the ‘‘Obtain vital signs’’ task. In
these cases, we are proposing to adjust
the equipment time of any equipment
item that matched the clinical labor
time of the full service period to match
the change in the ‘‘Obtain vital signs’’
clinical labor time. The proposed list of
all codes affected by these proposed
vital signs changes to direct PE inputs
is available on the CMS Web site under
downloads for the CY 2018 PFS
proposed rule at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html.
c. Establishment of Clinical Labor
Activity Codes
Historically, the RUC has submitted a
‘‘PE worksheet’’ that details the
recommended direct PE inputs for our
use in developing PE RVUs. The format
of the PE worksheet has varied over
time and among the medical specialties
developing the recommendations. These
variations have made it difficult for both
the RUC’s development and our review
of code values for individual codes.
Beginning for the CY 2019 PFS
rulemaking cycle, we understand that
the RUC intends to mandate the use of
a new PE worksheet for purposes of
their recommendation development
process that standardizes the clinical
labor tasks and assigns them a clinical
labor activity code. We believe the
RUC’s use of the new PE worksheet in
developing and submitting
recommendations to us would, in turn,
help us to simplify and standardize the
hundreds of different clinical labor tasks
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currently listed in our direct PE
database.
To help facilitate this transition to the
new clinical labor activity codes, we
have developed a crosswalk to link the
old clinical labor tasks to the new
clinical labor activity codes. Our
crosswalk is for informational purposes
only, and would not change either the
direct PE input values or the PE RVUs
for codes. Instead, we hope that the
crosswalk would help us to translate the
sprawling, existing data set into a
condensed version that would
significantly improve the
standardization of clinical labor
recommendations and improve the
ability of commenters to identify
concerns with our proposed valuation.
For CY 2018 rulemaking, we are
displaying two versions of the Labor
Task Detail public use file: One version
with the old listing of clinical labor
tasks, and one with the same tasks as
described by the new listing of clinical
labor activity codes. These lists are
available on the CMS Web site under
downloads for the CY 2018 PFS
proposed rule at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html.
(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
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 proposed standalone
prices for each scope, and separate
prices for the video systems that are
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used with scopes. We proposed to
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
was the ‘‘video system, endoscopy
(processor, digital capture, monitor,
printer, cart)’’ equipment item (ES031),
which we proposed 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 proposed to use for
this re-pricing. We understand that
there may be other accessories
associated with the use of scopes; we
proposed 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 also proposed 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 scope video 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
proposed 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
proposed 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 planned to propose
input prices for these equipment items
through future rulemaking.
We proposed these changes only for
the reviewed codes for CY 2017 that
made use of scopes, along with updated
prices for the equipment items related to
scopes utilized by these services. But,
we did not propose to apply these
policies to codes with inputs reviewed
prior to CY 2017. We also solicited
comment on this separate pricing
structure for scopes, scope video
systems, and scope accessories, which
we could consider proposing to apply to
other codes in future rulemaking. In
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33961
response to comments, we finalized the
addition of a digital capture device to
the endoscopy video system (ES031) in
the CY 2017 PFS final rule. We finalized
our proposal to price the system at
$33,391, based on component prices of
$9,000 for the processor, $18,346 for the
digital capture device, $2,000 for the
monitor, $2,295 for the printer, and
$1,750 for the cart. We also finalized a
price of $16,843.87 for the stroboscopy
system scope accessory (ES065). We did
not finalize price increases for a series
of other scopes and scope accessories, as
the invoices submitted for these
components indicated that they are
different forms of equipment with
different product IDs and different
prices. We did not receive any data to
indicate that the equipment on the
newly submitted invoices was more
typical in its use than the equipment
that we were currently using for pricing.
We did not make further changes to
existing scope equipment in CY 2017 in
order to allow the RUC’s PE
Subcommittee the opportunity to
provide feedback. However, we believe
there was some miscommunication on
this point, as the RUC’s PE
Subcommittee workgroup that was
created to address scope systems stated
that no further action was required
following the finalization of our
proposal. We are making further
proposals to continue clarifying scope
equipment inputs, and seek comments
regarding the new set of scope
proposals. We welcome feedback from
all stakeholders, including practitioners
with direct experience in the use of
scope equipment.
We are seeking comment on several
potential categories of scope system PE
inputs. We are considering creating a
single scope equipment code for each of
the five categories detailed in this
proposed rule: (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. Under
the current classification system, there
are many different scopes in each
category depending on the medical
specialty furnishing the service and the
part of the body affected. We believe
that the variation between these scopes
is not significant enough to warrant
maintaining these distinctions, and we
believe that creating and pricing a single
scope equipment code for each category
would help provide additional clarity.
We are seeking public comment on the
merits of this potential scope
organization, as well as any pricing
information regarding these five new
scope categories.
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For CY 2018, we are proposing two
minor changes to PE inputs related to
scopes. We are proposing to add an LED
light source into the cost of the scope
video system (ES031), which would
remove the need for a separate light
source in these procedures. If this
proposal were to be finalized, we would
remove the equipment time for the
separate light source from CPT codes
that include the scope video system. We
are also proposing an increase to the
price of the scope video system of
$1,000.00 to cover the expense of
miscellaneous small equipment
associated with the system that falls
below the threshold of individual
equipment pricing as scope accessories
(such as cables, microphones, foot
pedals, etc.) We seek comments on the
inclusion of the LED light in the scope
video system, and the appropriate
pricing of the system with the inclusion
of these additional equipment items.
We anticipate adopting detailed
changes to scope systems at the code
level through rulemaking for CY 2019,
because we believe that additional
feedback from expert stakeholders will
improve the details of the proposed
changes. We are not proposing any
additional pricing changes to scope
equipment for CY 2018 due to the
proposed reorganization into a single
type of scope equipment for each of the
five scope categories. However, we
would consider updating prices for
these equipment items through the
public request process for price updates,
or based on information submitted as
part of RUC recommendations.
the service described by the add-on
procedure. We are soliciting comment
regarding the use of multiple kits during
procedures described by the base and
add-on codes to determine whether or
not this supply should be included as a
direct PE input for CPT code 36474 for
CY 2018.
(4) Clarivein Kit for Mechanochemical
Vein Ablation
In the CY 2017 PFS final rule, we
finalized work RVUs and direct PE
inputs for two new codes related to
mechanochemical vein ablation, CPT
codes 36473 and 36474. Following the
publication of the final rule,
stakeholders contacted CMS and
requested that a Clarivein kit supply
item (SA122) be added to the direct PE
inputs for CPT code 36474, the add-on
code for ablation of subsequent veins.
They stated that the Clarivein kit was
accidentally omitted from the RUC
recommendations, and that an
additional kit is necessary to perform
After finalizing the creation of
separately billable codes for moderate
sedation during the CY 2017 PFS final
rule, we received additional
recommendations to remove the oxygen
gas supply item (SD084) from a series of
CPT codes that were previously valued
with moderate sedation as an inherent
part of the procedure. Because oxygen
gas is included in the moderate sedation
pack contained within the separately
billed moderate sedation codes, we
believe that the continued inclusion of
the oxygen gas in these codes is a
duplicative supply. We are therefore
proposing to remove the oxygen gas
from the following codes (see Table 4):
(5) Removal of Oxygen From NonModerate Sedation Post-Procedure
Monitoring
TABLE 4—CY 2018 PROPOSED REMOVAL OF OXYGEN (SD084) FROM NON-MODERATE SEDATION POST-PROCEDURE
MONITORING
HCPCS
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31622
31625
31626
31627
31628
31629
31632
31633
31645
31652
31653
31654
52647
52648
90870
.........................................................................................................
.........................................................................................................
.........................................................................................................
.........................................................................................................
.........................................................................................................
.........................................................................................................
.........................................................................................................
.........................................................................................................
.........................................................................................................
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.........................................................................................................
.........................................................................................................
.........................................................................................................
.........................................................................................................
(6) Technical Corrections to Direct PE
Input Database and Supporting Files
Subsequent to the publication of the
CY 2017 PFS final rule, stakeholders
alerted us to several clerical
inconsistencies in the direct PE
database. We are proposing to correct
these inconsistencies as described in
this proposed rule and reflected in the
CY 2018 proposed direct PE input
database displayed on the CMS Web site
under downloads for the CY 2018 PFS
proposed rule at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html.
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Current
(liters)
NF/F
NF
NF
NF
NF
NF
NF
NF
NF
NF
NF
NF
NF
NF
NF
NF
....................................................
....................................................
....................................................
....................................................
....................................................
....................................................
....................................................
....................................................
....................................................
....................................................
....................................................
....................................................
....................................................
....................................................
....................................................
For CY 2018, we are proposing to
address the following inconsistencies:
• For CY 2018, we are proposing to
make direct PE changes for CPT code
96416 (Chemotherapy administration,
intravenous infusion technique;
initiation of prolonged chemotherapy
infusion (more than 8 hours), requiring
use of a portable or implantable pump)
to improve payment accuracy, in
response to a stakeholder inquiry
regarding the use of the ambulatory IV
pump equipment for this service. We
are proposing to add 6 additional
minutes of RN/OCN clinical labor
(L056A), 4 minutes for the ‘‘Review
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Cost
90
105
135
150
120
105
54
60
175
180
225
90
10
10
198
¥0.27
¥0.32
¥0.41
¥0.45
¥0.36
¥0.32
¥0.16
¥0.18
¥0.53
¥0.54
¥0.68
¥0.27
¥0.03
¥0.03
¥0.59
charts by chemo nurse regarding course
of treatment & obtain chemotherapyrelated medical hx’’ task, and 2 minutes
for the ‘‘Greet patient and provide
gowning’’ task. We are proposing to add
1 quantity of the IV infusion set supply
(SC018) and proposing to lower the
quantity from 2 to 1 of the 20 ml syringe
supply (SC053). We are proposing to
add 1800 minutes for the new
ambulatory IV pump equipment, and we
are proposing to increase the equipment
time of the medical recliner chair
(EF009) from 83 minutes to 89 minutes
to match the increase in RN/OCN
clinical labor. For CY 2018, these
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proposed direct PE changes would be
used to calculate the PE RVU for CPT
code 96416. We seek comments on these
proposed direct PE refinements.
• We propose to correct an anomaly
in the postservice work time for CPT
code 91200 (Liver elastography,
mechanically induced shear wave (e.g.,
vibration), without imaging, with
interpretation and report) by changing it
from 5 minutes to 3 minutes, which also
results in a refinement in the total work
time for the code from 18 minutes to 16
minutes.
• In the process of making updates to
our direct PE database, we discovered a
series of discrepancies between the
finalized direct PE inputs and the values
entered into the database from previous
calendar years. To reconcile these
discrepancies, we are proposing the
following direct PE refinements:
TABLE 5—DIRECT PE DATABASE DATA DISCREPANCIES AND PROPOSED CHANGES
HCPCS
Input code
Input code description
scalpel with blade, surgical (#10–20) ..............
gauze, sterile 4in x 4in (10 pack uou) .............
lidocaine 1% w-epi inj (Xylocaine w-epi) .........
Greet patient, provide gowning, ensure appropriate medical records are available.
Provide pre-service education/obtain consent
Prepare room, equipment, supplies .................
Clean room/equipment by physician staff .......
OCT Tissue-Tek ...............................................
blade, microtome .............................................
blade, surgical, super-sharp ............................
gauze, sterile 4in x 4in (10 pack uou) .............
tape, foam, elastic, 2in (Microfoam) ................
gauze, sterile 4in x 4in (10 pack uou) .............
OCT Tissue-Tek ...............................................
histology freezing spray (Freeze-It) .................
Service total costs ............................................
Service total costs ............................................
room, ultrasound, general ................................
light, exam ........................................................
Post service total costs ....................................
needle, 18–27g ................................................
Service total costs ............................................
Service total costs ............................................
Service total costs ............................................
swab, procto 16in .............................................
Service total costs ............................................
swab, procto 16in .............................................
lidocaine 1%–2% inj (Xylocaine) .....................
room, basic radiology .......................................
Service total costs ............................................
Technologist QC’s images in PACS, checking
for all images, reformats, and dose page.
table, exam ......................................................
mayo stand ......................................................
suction machine (Gomco) ................................
manometry system (computer, transducers,
catheter).
manometry accessory cable ............................
PACS Workstation Proxy .................................
EGG monitoring system ...................................
lane, screening (oph) .......................................
lane, exam (oph) ..............................................
Preservice total costs .......................................
tape, surgical paper 1in (Micropore) ................
..........
..........
..........
..........
SF033 .......
SG056 ......
SH046 ......
L037D .......
11719
11719
11719
17312
17313
17313
17313
17313
17314
17314
17315
19283
19286
19286
19286
23333
28045
32405
37765
37766
45171
45172
45172
52214
72120
72148
74230
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
L037D .......
L037D .......
L037D .......
SL097 .......
SF004 .......
SF044 .......
SG056 ......
SG088 ......
SG056 ......
SL097 .......
SL078 .......
L043A .......
L051B .......
EL015 .......
EQ168 ......
L037D .......
SC029 ......
L041B .......
L037D .......
L037D .......
SJ052 .......
L037D .......
SJ052 .......
SH047 ......
EL012 .......
L047A .......
L041B .......
91013
91013
91013
91013
..........
..........
..........
..........
EF023 .......
EF015 .......
EQ235 ......
EQ181 ......
91013
91013
91132
92227
92227
93017
95819
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11307
11311
11311
11719
..........
..........
..........
..........
..........
..........
..........
EQ339 ......
ED050 ......
EQ019 ......
EL006 .......
EL005 .......
L051A .......
SG079 ......
The proposed PE RVUs displayed in
Addendum B on our Web site were
calculated with the inputs displayed in
the CY 2018 proposed direct PE input
database.
(7) 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
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0.74
NF
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NF
NF
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NF
NF
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NF
NF
NF
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F
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1
1
8
1
0
3
10
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8
0
55
30
19
19
63
2
52
91
121
2
6
2
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47
0
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2
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54
31
20
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90
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57
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4.17
¥2.39
¥0.01
¥1.60
¥0.12
0.29
¥0.43
0.51
1.40
0.00
9.99
¥0.09
2.05
1.11
1.11
0.12
2.22
0.12
1.72
0.48
0.84
0.82
NF
NF
NF
NF
0
0
0
0
9
9
9
9
0.03
0.01
0.02
1.15
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42
0.05
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0.83
¥1.07
1.15
¥5.10
0.07
inputs through annual rulemaking,
beginning with the CY 2012 PFS
proposed rule. For CY 2018, we are
proposing the following price updates
for existing direct PE inputs.
We are proposing to update the price
of thirteen supplies and one equipment
item in response to the public
submission of invoices. For the details
of these proposed price updates, please
refer to section II.H, of this proposed
rule, Table 14: Invoices Received for
Existing Direct PE Inputs.
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We are not proposing to update the
price of the blood warmer (EQ072), the
cell separator system (EQ084), or the
photopheresor system (EQ206)
equipment items. The only pricing
information that we received for these
three equipment items was an invoice
that included a hand-written price over
redacted information. We were unable
to verify the accuracy of this invoice.
We are also not proposing to update the
price of the DNA image analyzer (ACIS)
(EP001) equipment item, due to the
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inclusion of many components on the
submitted invoice that are not part of
the price of the DNA image analyzer.
We were unable to determine which of
these components were included in the
cost of the DNA image analyzer, and
which of these components were
unrelated types of equipment. To price
these equipment items accurately, we
believe that we need additional
information. We continue to use the
current price for these equipment items
pending the submission of additional
pricing information. We welcome the
submission of updated pricing
information regarding these equipment
items through valid invoices from
commenters and other stakeholders.
We are also proposing to change the
name of the ED050 equipment from the
‘‘PACS Workstation Proxy’’ to the
‘‘Technologist PACS workstation.’’ In
the CY 2017 final rule (81 FR 80180–
80182), we finalized a policy to add a
professional PACS workstation (ED053)
to the list of approved equipment items,
and we believe that renaming ED050 to
the technologist PACS workstation
would help to alleviate potential
confusion between the two PACS
workstations.
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 RUCrecommended values for the codes. For
CY 2018, we note that some
stakeholders have submitted invoices
for new, revised, or potentially
misvalued codes after the February 10th
deadline established for code valuation
recommendations. To be included in a
given year’s proposed rule, we generally
need to receive invoices by the same
February 10th deadline. However, we
would consider invoices submitted as
public comments during the comment
period following the publication of the
proposed rule, and would consider any
invoices received after February or
outside of the public comment process
as part of our established annual process
for requests to update supply and
equipment prices.
4. Adjustment to Allocation of Indirect
PE for Some Office-Based Services
As we explain in section II.B.2.c.(2) of
this proposed rule, we allocate indirect
costs for each code 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.
Indirect expenses include
administrative labor, office expense, and
all other expenses. For PFS services
priced in both the facility and non-
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facility settings, the difference in
indirect PE RVUs between the settings
is driven by differences in direct PE
inputs for those settings since the other
allocator of indirect PE, the work RVU,
does not differ between settings. For
most services, the direct PE input costs
are higher in the nonfacility setting than
in the facility setting. As a result,
indirect PE RVUs allocated to these
services are higher in the nonfacility
setting than in the facility setting. When
direct PE inputs for a service are very
low, however, the allocation of indirect
PE RVUs is almost exclusively based on
work RVUs, which results in a very
small (or no) site of service differential
between the total PE RVUs in the
facility and nonfacility setting.
Some stakeholders have suggested
that for codes in which direct PE inputs
for a service are very low, this allocation
methodology does not allow for a site of
service differential that accurately
reflects the relative indirect costs
involved in furnishing services in
nonfacility settings. Among the services
most affected by this anomaly are the
primary therapy and counseling services
available to Medicare beneficiaries for
treatment of behavioral health
conditions, including substance use
disorders. For example, for the most
commonly reported psychotherapy
service (CPT code 90834), the difference
between the nonfacility and facility PE
RVUs is only 0.02 RVUs, which seems
unlikely to represent the difference in
relative resource costs in terms of
administrative labor, office expense, and
all other expenses incurred by the
billing practitioner for 45 minutes of
psychotherapy services when furnished
in the office setting versus the facility
setting.
We agree with these stakeholders that
the site of service differential for these
services that is produced by our PE
methodology seems unlikely to reflect
the relative resource costs for the
practitioners furnishing these services
in nonfacility settings. For example, we
believe the 0.02 RVUs, which translates
to approximately $0.72, would be
unlikely to reflect the relative
administrative labor, office rent, and
other overhead involved in furnishing
the 45 minute psychotherapy service in
a nonfacility setting. Consequently, we
believe it would be appropriate to
modify the existing methodology for
allocating indirect PE RVUs in order to
better reflect the relative indirect PE
resources involved in furnishing these
kinds of services in the nonfacility
setting.
In examining the range of services
furnished in the nonfacility setting that
are most affected by this circumstance,
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we identified HCPCS codes that
describe face-to-face services, have work
RVUs greater than zero, and are priced
in both the facility and nonfacility
setting. From among these codes, we
further selected those with the lowest
ratio between nonfacility PE RVUs and
work RVUs. We selected 0.4 as an
appropriate threshold based on several
factors, including the range of
nonfacility PE RVU to work RVU ratios
among the codes identified. Based on
these criteria, there were fewer than 50
codes that we identified with a ratio of
less than 0.4 nonfacility PE RVUs for
each work RVU, most of which are
primarily furnished by behavioral
health professionals, for a potential
modification to our indirect PE
allocation methodology.
In considering how to address the
anomaly and ensure that an appropriate
number of indirect PE RVUs are
allocated to these services in the
nonfacility setting, we looked at the
indirect, nonfacility PE RVU for the
most commonly billed physician office
visit, CPT code 99213, which is billed
by a wide range of physicians and nonphysician practitioners under the PFS.
We believe that the indirect PE costs
allocated to services reported with CPT
code 99213, including administrative
labor and office rent, would be common
for a broad range of physicians and nonphysician practitioners across the PFS.
We recognize that the services we seek
to address are primarily furnished by
behavioral health professionals who
may be unlikely to incur some of the
costs incurred by other practitioners
furnishing a broader range of medical
services. For instance, a practitioner
furnishing a broader range of primary
care services likely requires separate
office and examination room space, and
storage for disposable medical supplies
and equipment. Some costs, however,
such as those for office staff and records
maintenance, would be analogous.
We looked at the relationship between
indirect PE and work RVUs for CPT
code 99213 as a marker because that is
the most commonly and broadly
reported PFS code that describes faceto-face office-based services. We
compared the relationship between
indirect PE and work RVUs for the set
of HCPCS codes that we identified using
the criteria discussed above and found
that for the significant majority of codes,
that ratio was at least 0.4 nonfacility PE
RVUs for each work RVU. We believe
the 0.4 nonfacility PE RVUs can serve as
an appropriate marker that
appropriately reflects the relative
resources involved in furnishing these
services.
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For the fewer than 50 outlier codes
identified using the criteria above, we
believe it would be appropriate to
establish a minimum nonfacility
indirect PE RVU that would be a better
reflection the resources involved in
furnishing these services. We propose to
set the nonfacility indirect PE RVUs for
these codes using the indirect PE RVU
to work RVU ratio for the most
commonly furnished office-based, faceto-face service (CPT 99213) as a marker.
Specifically, for each of these outlier
codes, we propose to compare the ratio
between indirect PE RVUs and work
RVUs that result from the preliminary
application of the standard methodology
to the ratio for the marker code, CPT
code 99213. Our proposed change in the
methodology would then increase the
allocation of indirect PE RVUs to the
outlier codes to at least one quarter of
the difference between the two ratios.
We believe this approach reflects a
reasonable minimum allocation of
indirect PE RVUs, but we do not
currently have empirical data that
would be useful in establishing a more
precise number.
In developing the proposed PE RVUs
for CY 2018, we propose to implement
only one quarter of this proposed
minimum value for nonfacility indirect
PE for the outlier codes. We recognize
that this change in the PE methodology
could have a significant impact on the
allocation of indirect PE RVUs across all
PFS services. In making significant
changes to the PE methodology in
previous years, we have implemented
such changes using 4 year transitions,
based largely on concerns that some
specialties experience significant
payment reductions with changes in PE
relativity, and a transition period allows
for a more gradual adjustment for
affected practitioners. Under the
approach we are proposing, we estimate
that approximately $40 million, or
approximately 0.04 percent of total PFS
allowed charges, would shift within the
PE methodology for each year of the
proposed 4-year transition, including for
CY 2018. We also note that we are
proposing to exclude the codes directly
subject to this proposed change from the
misvalued code target calculation
because the proposed change is a
methodological change to address an
anomaly produced by our indirect PE
allocation process as opposed to a
change to address misvalued codes. The
PE RVUs displayed in Addendum B on
our Web site were calculated with the
one quarter of the indirect PE
adjustment factor implemented.
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C. 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 (MP) expense. As
required by section 1848(c)(2)(C)(iii) of
the Act, beginning in CY 2000, MP
RVUs are resource based. 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 is
composed of three factors: (1) Specialtylevel risk factors derived from data on
specialty-specific MP premiums
incurred by practitioners, (2) service
level risk factors derived from Medicare
claims data of the weighted average risk
factors of the specialties that furnish
each service, and (3) an intensity/
complexity of service adjustment to the
service level risk factor based on either
the higher of the work RVU or clinical
labor RVU. 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
adjusted (or scaled) 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 was
applied for the new/revised code and
source code, but the work RVU for the
new/revised code was used to adjust the
MP RVUs for risk.
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33965
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, 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. Under this approach,
for new and revised codes, we generally
assign a specialty risk factor to
individual codes based on the same
utilization assumptions we make
regarding specialty mix we use for
calculating PE RVUs and for PFS budget
neutrality. We continue to use the work
RVU or clinical labor RVU to adjust the
MP RVU for each code for intensity and
complexity. In finalizing this policy, we
stated 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.
In CY 2017, we finalized the eighth
GPCI update, which reflected updated
MP premium data. We did not propose
to use the updated MP premium data to
propose updates for CY 2017 to the
specialty risk factors used in the
calculation of MP RVUs because it was
inconsistent with the policy we
previously finalized in the CY 2016 PFS
final rule with comment period,
whereby 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.
However, we solicited comment on
whether we should consider doing so,
perhaps as early as for CY 2018, prior
to the fourth review and update of MP
RVUs that must occur no later than CY
2020. After consideration of the
comments received, we stated that we
would consider the possibility of using
the updated MP data to update the
specialty risk factors used in the
calculation of the MP RVUs prior to the
next 5-year update in future rulemaking
(81 FR 80191 through 80192). Since MP
premium data are used to update both
the MP GPCIs and the MP RVUs, going
forward we believe it would be logical
to align the update of MP premium data
used to determine the MP RVUs with
the update of the MP GPCI. Section
1848(e)(1)(C) of the Act requires us to
review and, if necessary, adjust the
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GPCIs at least every 3 years. The next
review of the GPCIs must occur by CY
2020.
We propose to use the most recent
data for the proposed MP RVUs for CY
2018 and to align the update of MP
premium data and MP GPCIs to once
every 3 years. We are seeking comment
on these proposals, and we are also
seeking comment on methodologies and
sources that we might use to improve
the next update of MP premium data.
2. Methodology for the Proposed
Revision of Resource Based Malpractice
RVUs
a. General Discussion
The proposed MP RVUs were
calculated based on updated
malpractice premium data obtained
from state insurance rate filings by a
CMS contractor. The methodology used
in calculating the proposed CY 2018
review and update of resource based MP
RVUs largely parallels the process used
in the CY 2015 update. The calculation
requires using information on specialtyspecific malpractice premiums linked to
specific services based upon the relative
risk factors of the various specialties
that furnish a particular service.
Because malpractice premiums vary by
state and specialty, the malpractice
premium information must be weighted
geographically and by specialty.
Accordingly, the proposed MP RVUs are
based upon four data sources: CY 2014
and CY 2015 malpractice premium data;
CY 2016 and 2017 Medicare payment
and utilization data; CY 2017
geographic practice cost indices (GPCIs),
and CY 2018 proposed work and
clinical labor RVUs.
Similar to the previous update, we
calculated the proposed MP RVUs using
specialty-specific malpractice premium
data because they represent the actual
expense incurred by practitioners to
obtain malpractice insurance. We
obtained malpractice premium data
exclusively from the most recently
available data published in the 2014 and
2015 Market Share Reports accessed
from the National Association of
Insurance Commissioners (NAIC) Web
site. We used information obtained from
malpractice insurance rate filings with
effective dates in 2014 and 2015. These
were the most current data available
during our data collection process. We
collected malpractice insurance
premium data from all 50 States, and
the District of Columbia, and Puerto
Rico. Rate filings were not available in
American Samoa, Guam or the Virgin
Islands. Premiums were for $1 million/
$3 million, mature, claims-made
policies (policies covering claims made,
rather than those covering services
furnished, during the policy term). A $1
million/$3 million liability limit policy
means that the most that would be paid
on any claim is $1 million and the most
that the policy would pay for claims
over the timeframe of the policy is $3
million. We made adjustments to the
premium data to reflect mandatory
surcharges for patient compensation
funds (funds to pay for any claim
beyond the statutory amount, thereby
limiting an individual physician’s
liability in cases of a large suit) in states
where participation in such funds is
mandatory.
We included premium information for
all physician and NPP specialties, and
all risk classifications available in the
collected rate filings. Although we
collected premium data from all states,
the District of Columbia, and Puerto
Rico, not all specialties had distinct
premium data in the rate filings from all
states. Additionally, for some
specialties, MP premiums were not
available from the rate filings in any
state. Therefore, for specialties for
which there were not premium data for
at least 35 states, and specialties for
which there were not distinct premium
data in the rate filings, we crosswalked
the specialty to a similar specialty,
either conceptually or by available
premium data, for which we did have
sufficient and reliable data. These
specialties and the specialty data that
we propose to use are shown in Table
6.
For example, for radiation oncology,
data were only available from 23 states,
and therefore this specialty does not
meet our 35-state threshold, which
determines whether or not a specialty is
deemed to have premium data sufficient
to construct a unique risk factor.
However, based on the 23 states’ worth
of rate filings for radiation oncology, the
resource costs for the premiums
suggests a similar, though slightly lesser
average than that of the premiums for
diagnostic radiology. We developed the
proposed MP RVUs for radiation
oncology by crosswalking the risk factor
for diagnostic radiology as a similar
specialty with similar premium data.
We are seeking comment as to the
appropriateness of this and the other
crosswalks used in developing MP
RVUs.
For the proposed CY 2018 MP RVU
update, sufficient and reliable premium
data were available for 43 specialty
types, representing over 76 percent of
allowed Medicare PFS services, which
we used to develop specialty specific
malpractice risk factors. (See Table 8 for
a list of these specialties.)
TABLE 6—PROPOSED CROSSWALK OF SPECIALTIES TO SIMILAR SPECIALTIES
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Specialty code
12
15
17
19
23
27
32
35
36
40
41
42
43
48
62
64
65
67
68
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
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Crosswalk
specialty code
Medicare specialty name
Osteopathic Manipulative Medicine .............................
Speech Language Pathology ......................................
Hospice and Palliative Care ........................................
Oral Surgery (Dentist only) ..........................................
Sports Medicine ...........................................................
Geriatric Psychiatry .....................................................
Anesthesiology Assistant .............................................
Chiropractic ..................................................................
Nuclear Medicine .........................................................
Hand Surgery ..............................................................
Optometry ....................................................................
Certified Nurse Midwife ...............................................
Certified Registered Nurse Anesthetist (CRNA) .........
Podiatry ........................................................................
Psychologist .................................................................
Audiologist ...................................................................
Physical Therapist in Private Practice .........................
Occupational Therapist in Private Practice .................
Psychologist, Clinical ...................................................
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03
03
03
24
01
26
05
03
30
20
03
16
05
07
03
03
03
03
03
Sfmt 4702
Crosswalk specialty
Allergy/Immunology.
Allergy/Immunology.
Allergy/Immunology.
Plastic and Reconstructive Surgery.
General Practice.
Psychiatry.
Anesthesiology.
Allergy/Immunology.
Diagnostic Radiology.
Orthopedic Surgery.
Allergy/Immunology.
Obstetrics & Gynecology.
Anesthesiology.
Dermatology.
Allergy/Immunology.
Allergy/Immunology.
Allergy/Immunology.
Allergy/Immunology.
Allergy/Immunology.
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33967
TABLE 6—PROPOSED CROSSWALK OF SPECIALTIES TO SIMILAR SPECIALTIES—Continued
Specialty code
76
79
80
81
85
86
89
92
94
97
98
C0
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
Peripheral Vascular Disease .......................................
Addiction Medicine ......................................................
Licensed Clinical Social Worker ..................................
Critical Care (Intensivists) ...........................................
Maxillofacial Surgery ...................................................
Neuropsychiatry ...........................................................
Certified Clinical Nurse Specialist ...............................
Radiation Oncology .....................................................
Interventional Radiology ..............................................
Physician Assistant ......................................................
Gynecological Oncology ..............................................
Sleep Medicine ............................................................
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b. Steps for Calculating Malpractice
RVUs
Calculation of the proposed MP RVUs
conceptually follows the specialtyweighted approach used in the CY 2015
final rule with comment period (79 FR
67591). The specialty-weighted
approach bases the MP RVUs for a given
service upon a weighted average of the
risk factors of all specialties furnishing
the service. This approach ensures that
all specialties furnishing a given service
are accounted for in the calculation of
the MP RVUs. The steps for calculating
the proposed MP RVUs are described
below.
Step (1): Compute a preliminary
national average premium for each
specialty.
Insurance rating area malpractice
premiums for each specialty are mapped
to the county level. The specialty
premium for each county is then
multiplied by its share of the total U.S.
population (from the U.S. Census
Bureau’s 2014 American Community
(ACS) estimates). This is in contrast to
the method used for creating national
average premiums for each specialty in
the 2015 update; in that update,
specialty premiums were weighted by
the total RVU per county, rather than by
the county share of the total U.S.
population. We refer readers to the PFS
2016 Final Rule with comment period
(80 FR 70909) for a discussion of why
we have adopted a weighting method
based on share of total U.S. population.
This calculation is then divided by the
average MP GPCI across all counties for
each specialty to yield a normalized
national average premium for each
specialty. The specialty premiums are
normalized for geographic variation so
that the locality cost differences (as
reflected by the GPCIs) would not be
counted twice. Without the geographic
variation adjustment, the cost
differences among fee schedule areas
would be reflected once under the
VerDate Sep<11>2014
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specialty code
Medicare specialty name
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77
03
03
29
24
26
01
30
30
03
02
01
Crosswalk specialty
Vascular Surgery.
Allergy/Immunology.
Allergy/Immunology.
Pulmonary Disease.
Plastic and Reconstructive Surgery.
Psychiatry.
General Practice.
Diagnostic Radiology.
Diagnostic Radiology.
Allergy/Immunology.
General Surgery.
General Practice.
methodology used to calculate the MP
RVUs and again when computing the
service specific payment amount for a
given fee schedule area.
Step (2): Determine which premium
class(es) to use within each specialty.
Some specialties had premium rates
that differed for surgery, surgery with
obstetrics, and non-surgery. These
premium classes are designed to reflect
differences in risk of professional
liability and the cost of malpractice
claims if they occur. To account for the
presence of different classes in the
malpractice premium data and the task
of mapping these premiums to
procedures, we calculated distinct risk
factors for surgical, surgical with
obstetrics, and nonsurgical procedures.
However, the availability of data by
surgery and non-surgery varied across
specialties. Consistent with the CY 2015
MP RVU update, because no single
approach accurately addressed the
variability in premium class among
specialties, we employed several
methods for calculating average
premiums by specialty. These methods
are discussed below.
(a) Substantial Data for Each Class:
For 10 out of 86 specialties, we
determined that there were sufficient
data for surgery and non-surgery
premiums, as well as sufficient
differences in rates between classes.
These specialties are listed in Table 7.
Therefore, we calculated a national
average surgical premium and nonsurgical premium. We note that, unlike
in the CY 2015 MP RVU update, for CY
2018, there were no specialties that fell
under the ‘‘unspecified dominates’’
specialty/surgery class scenario,
therefore we have omitted that surgical
class category.
(b) Major Surgery Dominates: For 9
surgical specialties, rate filings that
included non-surgical premiums were
relatively rare. For most of these
surgical specialties, the rate filings did
not include an ‘‘unspecified’’ premium.
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Fmt 4701
Sfmt 4702
When it did, the unspecified premium
was lower than the major surgery rate.
For these surgical specialties, we
calculated only a surgical premium and
used the premium for major surgery for
all procedures furnished by this
specialty.
(c) Blend All Available: For the
remaining specialties, there was wide
variation across the rate filings in terms
of whether or not premium classes were
reported and which categories were
reported. Because there was no clear
strategy for these remaining specialties,
we blended the available rate
information into one general premium
rate. For these specialties, we developed
a weighted average ‘‘blended’’ premium
at the national level, according to the
percentage of work RVUs correlated
with the premium classes within each
specialty. For example, the surgical
premiums for a given specialty were
weighted by that specialty’s work RVUs
for surgical services; the nonsurgical
premiums were weighted by the work
RVUs for non-surgical services and the
unspecified premiums were weighted
by all work RVUs for the specialty type.
The three methods for calculating
premiums by specialty type are
summarized in Table 7. (See Table 8:
‘‘Proposed Risk Factors by Specialty
Type’’ for the specialty names
associated with the specialty codes
listed in Table 7.)
TABLE 7—PROPOSED PREMIUM CALCULATION APPROACH BY SPECIALTY
TYPE
Method
Medicare specialty codes
(a) Substantial
Data for Each
Class (10).
(b) Major Surgery
Dominates (9).
01, 04, 08, 09, 13, 16, 18,
34, 72, 93.
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02, 14, 20, 24, 28, 33, 77,
78, 91.
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TABLE 7—PROPOSED PREMIUM CAL- single risk factor and applied the
CULATION APPROACH BY SPECIALTY specialty risk factor to both surgery and
non-surgery services.
TYPE—Continued
Method
Medicare specialty codes
(c) Blend all
Available (24).
03, 05, 06, 07, 10, 11, 22,
25, 26, 29, 30, 37, 38,
39, 44, 46, 50, 66, 71,
82, 83, 84, 90, 99.
Step (3): Calculate a risk factor for
each specialty.
The relative differences in national
average premiums between specialties
are expressed in our methodology as a
specialty risk factor. These risk factors
are an index calculated by dividing the
national average premium for each
specialty by the national average
premium for the specialty with the
lowest premiums for which we had
sufficient and reliable data, allergy and
immunology. For specialties with
sufficient surgical and non-surgical
premium data, we calculated both a
surgical and non-surgical risk factor. For
specialties with rate filings that
distinguished surgical premiums with
obstetrics, we calculated a separate
surgical with obstetrics risk factor. For
all other specialties we calculated a
We note that for determining the risk
factor for suppliers of TC-only services
in the CY 2015 update, we updated the
premium data for independent
diagnostic testing facilities (IDTFs) that
we used in the CY 2010 update. These
data were obtained from a survey
conducted by the Radiology Business
Management Association (RBMA) in
2009; we ultimately used these data to
calculate an updated TC specialty risk
factor. We applied the updated TC
specialty risk factor to suppliers of TConly services. In the CY 2015 final rule
with comment period (79 FR 67595),
RBMA voluntarily submitted updated
MP premium information collected from
independent diagnostic testing facilities
(IDTFs) in 2014, and requested that we
use the data for calculating the CY 2015
MP RVUs for TC services. We declined
to utilize the data and stated that we
believe further study is necessary and
we would consider this matter and
propose any changes through future
rulemaking. We believe that data for a
broader set of technical component
services are needed, and seek comment
on appropriate, comparable data sources
for such information. We also seek
comment on whether the data for IDTFs
are comparable and appropriate as a
proxy for the broader set of TC services.
We endeavor to, in the next update of
specialty risk factors, collect more data
across a broader set of the technical
component services, not just for
radiology (as is currently reflected in the
RBMA data), but data for services
performed by other non-physician
practitioners including
cytotechnologists, and cardiovascular
technologists. In the interim, for CY
2018, we propose to assign a TC risk
factor of 1.0, which corresponds to the
lowest physician specialty risk factor.
We assigned the risk factor of 1.0 to
the TC services because we do not have
comparable professional liability
premium data for the full range of
clinicians that furnish these services. In
lieu of comprehensive, comparable data,
we used 1.0 as the default minimum
risk factor, though we seek information
on the best available data sources for
use in the next update, as well as
empirical information that would
support assignment of an alternative
risk factor for these services. Table 8
shows the proposed risk factors by
specialty type.
TABLE 8—PROPOSED RISK FACTORS BY SPECIALTY TYPE
Medicare specialty name
Non-surgical
risk factor
General Practice ...............................................................................................................
General Practice w/OB .....................................................................................................
General Surgery ...............................................................................................................
Allergy/Immunology ..........................................................................................................
Otolaryngology ..................................................................................................................
Anesthesiology ..................................................................................................................
Cardiovascular Disease (Cardiology) ...............................................................................
Dermatology ......................................................................................................................
Family Practice .................................................................................................................
Family Practice w/OB .......................................................................................................
Interventional Pain Management ......................................................................................
Gastroenterology ..............................................................................................................
Internal Medicine ..............................................................................................................
Osteopathic Manipulative Medicine ..................................................................................
Neurology ..........................................................................................................................
Neurosurgery ....................................................................................................................
Speech Language Pathology ...........................................................................................
Obstetrics & Gynecology ..................................................................................................
Obstetrics & Gynecology w/OB ........................................................................................
Hospice and Palliative Care .............................................................................................
Ophthalmology ..................................................................................................................
Oral Surgery (Dentist only) ...............................................................................................
Orthopedic Surgery ...........................................................................................................
Pathology ..........................................................................................................................
Sports Medicine ................................................................................................................
Plastic and Reconstructive Surgery .................................................................................
Physical Medicine and Rehabilitation ...............................................................................
Psychiatry .........................................................................................................................
Geriatric Psychiatry ...........................................................................................................
Colorectal Surgery (Proctology) .......................................................................................
Pulmonary Disease ...........................................................................................................
Diagnostic Radiology ........................................................................................................
Anesthesiology Assistant ..................................................................................................
Thoracic Surgery ..............................................................................................................
Urology ..............................................................................................................................
1.80
........................
........................
1.00
1.53
2.58
1.90
2.77
1.67
........................
2.08
2.40
2.70
1.00
2.46
........................
1.00
1.59
........................
1.00
1.03
........................
........................
1.60
1.80
........................
1.49
1.27
1.27
........................
1.82
2.82
2.58
........................
1.66
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Specialty code
01
01
02
03
04
05
06
07
08
08
09
10
11
12
13
14
15
16
16
17
18
19
20
22
23
24
25
26
27
28
29
30
32
33
34
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
..............................
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21JYP2
Surgical risk
factor
3.72
4.30
6.75
1.00
4.08
2.58
1.90
2.77
3.74
4.31
2.97
2.40
2.70
1.00
13.02
10.66
1.00
4.52
8.67
1.00
2.16
4.93
6.22
1.60
3.72
4.93
1.49
1.27
1.27
4.19
1.82
2.82
2.58
6.06
2.97
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
33969
TABLE 8—PROPOSED RISK FACTORS BY SPECIALTY TYPE—Continued
Medicare specialty name
Non-surgical
risk factor
35 ..............................
36 ..............................
37 ..............................
38 ..............................
39 ..............................
40 ..............................
41 ..............................
42 ..............................
42 ..............................
43 ..............................
44 ..............................
46 ..............................
48 ..............................
50 ..............................
62 ..............................
64 ..............................
65 ..............................
66 ..............................
67 ..............................
68 ..............................
71 ..............................
72 ..............................
76 ..............................
77 ..............................
78 ..............................
79 ..............................
80 ..............................
81 ..............................
82 ..............................
83 ..............................
84 ..............................
85 ..............................
86 ..............................
89 ..............................
90 ..............................
91 ..............................
92 ..............................
93 ..............................
94 ..............................
97 ..............................
98 ..............................
99 ..............................
C0 .............................
mstockstill on DSK30JT082PROD with PROPOSALS2
Specialty code
Chiropractic .......................................................................................................................
Nuclear Medicine ..............................................................................................................
Pediatric Medicine ............................................................................................................
Geriatric Medicine .............................................................................................................
Nephrology ........................................................................................................................
Hand Surgery ....................................................................................................................
Optometry .........................................................................................................................
Certified Nurse Midwife ....................................................................................................
Certified Nurse Midwife w/OB ..........................................................................................
Certified Registered Nurse Anesthetist (CRNA) ..............................................................
Infectious Disease ............................................................................................................
Endocrinology ...................................................................................................................
Podiatry .............................................................................................................................
Nurse Practitioner .............................................................................................................
Psychologist ......................................................................................................................
Audiologist ........................................................................................................................
Physical Therapist in Private Practice ..............................................................................
Rheumatology ...................................................................................................................
Occupational Therapist in Private Practice ......................................................................
Psychologist, Clinical ........................................................................................................
Registered Dietitian or Nutrition Professional ..................................................................
Pain Management .............................................................................................................
Peripheral Vascular Disease ............................................................................................
Vascular Surgery ..............................................................................................................
Cardiac Surgery ................................................................................................................
Addiction Medicine ............................................................................................................
Licensed Clinical Social Worker .......................................................................................
Critical Care (Intensivists) .................................................................................................
Hematology .......................................................................................................................
Hematology-Oncology ......................................................................................................
Preventive Medicine .........................................................................................................
Maxillofacial Surgery .........................................................................................................
Neuropsychiatry ................................................................................................................
Certified Clinical Nurse Specialist ....................................................................................
Medical Oncology .............................................................................................................
Surgical Oncology .............................................................................................................
Radiation Oncology ..........................................................................................................
Emergency Medicine ........................................................................................................
Interventional Radiology ...................................................................................................
Physician Assistant ...........................................................................................................
Gynecological Oncology ...................................................................................................
Undefined Physician type .................................................................................................
Sleep Medicine .................................................................................................................
1.00
2.82
1.82
1.52
1.56
........................
1.00
1.59
........................
2.58
2.03
1.75
2.77
1.95
1.00
1.00
1.00
1.58
1.00
1.00
1.37
2.65
........................
........................
........................
1.00
1.00
1.82
1.77
1.85
1.15
........................
1.27
1.80
1.82
........................
2.82
2.29
2.82
1.95
........................
1.95
1.80
Step (4): Calculate malpractice RVUs
for each HCPCS code.
Resource-based MP RVUs were
calculated for each HCPCS code that has
work or PE RVUs. The first step was to
identify the percentage of services
furnished by each specialty for each
respective HCPCS code. This percentage
was then multiplied by each respective
specialty’s risk factor as calculated in
Step 3. The products for all specialties
for the HCPCS code were then added
together, yielding a specialty-weighted
service specific risk factor reflecting the
weighted malpractice costs across all
specialties furnishing that procedure.
The service specific risk factor was
multiplied by the greater of the work
RVU or PE clinical labor index for that
service to reflect differences in the
complexity and risk-of-service between
services.
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Low volume service codes: As we
discussed in section II.B. of this
proposed rule, we are proposing to use
a list of expected specialties instead of
the claims-based specialty mix for low
volume services in order to address
stakeholder concerns about the year to
year variability in PE and MP RVUs for
low volume services. We are soliciting
comments on the proposal to use these
service-level overrides to determine the
specialty for low volume procedures, as
well as on the list of overrides itself.
The proposed list of codes and expected
specialties is available on our Web site
under downloads for the CY 2018 PFS
proposed rule at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html. In
previous MP RVU updates, as discussed
in the CY 2015 final rule with comment
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Surgical risk
factor
1.00
2.82
1.82
1.52
1.56
6.22
1.00
4.52
8.67
2.58
2.03
1.75
2.77
1.95
1.00
1.00
1.00
1.58
1.00
1.00
1.37
3.65
6.67
6.67
6.87
1.00
1.00
1.82
1.77
1.85
1.15
4.93
1.27
3.72
1.82
4.32
2.82
5.03
2.82
1.95
6.75
1.95
3.72
period (79 FR 40354), we assigned
specialty for low volume services based
on dominant specialty. As discussed in
the CY 2012 final rule with comment
period (76 FR 73187 through 73189), we
applied an additional list of servicelevel overrides for purposes of
calculating MP RVUs for a number of
cardiothoracic surgery codes. Therefore,
we note that there are certain codes for
which we have previously applied
expected specialty overrides for
purposes of calculating MP RVUs based
on assumptions regarding low Medicare
volume. Because we are consolidating
policies for low volume service
expected specialty overrides into a
single list for PE and MP, and because
we do not believe that there is a reason
to assume different specialties for
purposes of calculating PE RVUs than
for MP RVUs for any particular code, we
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are also proposing to assign the
specialty mix solely based on the claims
data for any code that does not meet the
low volume threshold of 99 allowed
services or fewer in the previous year,
for the purposes of calculating MP
RVUs.
Given that we now annually
recalibrate MP RVUs based on claims
data, and in light of our proposed
introduction of the service-level
specialty override for low volume
services, we believe that there would no
longer be a need to apply service-level
MP crosswalks in order to assign a
specialty-mix risk factor. Contingent on
finalizing this proposal, we are also
proposing to eliminate general use of an
MP-specific specialty-mix crosswalk for
new and revised codes. However, we
would continue to consider, in
conjunction with annual
recommendations, specific
recommendations from the public and
the RUC regarding specialty mix
assignments for new and revised codes,
particularly in cases where coding
changes are expected to result in
differential reporting of services by
specialty, or where the new or revised
code is expected to be low-volume.
Absent such information, we would
derive the specialty mix assumption for
the first year for a new or revised code
from the specialty mix used for
purposes of ratesetting. In subsequent
years when claims data are available, we
would assign the specialty based on
claims data unless the service does not
exceed the low volume threshold (99 or
fewer allowed services). If the service is
low volume, we would assign the
expected specialty, establishing a new
expected specialty through rulemaking
as needed, which is consistent with our
approach for developing PE RVUs.
Step (5): Rescale for budget neutrality.
The statute requires that changes to
fee schedule RVUs must be budget
neutral. Thus, the last step is to adjust
for relativity by rescaling the proposed
MP RVUs so that the total proposed
resource based MP RVUs are equal to
the total current resource based MP
RVUs scaled by the ratio of current
aggregate MP and work RVUs. This
scaling is necessary in order to maintain
the work RVUs for individual services
from year to year while also maintaining
the overall relationship among work,
PE, and MP RVUs.
The proposed resource based MP
RVUs are shown in Addendum B,
which is available on the CMS Web site
under the downloads section of the CY
2018 PFS proposed rule at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
PhysicianFeeSched/.
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Because a different share of the
resources involved in furnishing PFS
services is reflected in each of the three
fee schedule components,
implementation of the resource based
MP RVU update will have much smaller
payment effects than implementing
updates of resource based work RVUs
and resource based PE RVUs. On
average, work represents about 50.9
percent of payment for a service under
the fee schedule, PE about 44.8 percent,
and MP about 4.3 percent. Therefore, a
25 percent change in PE RVUs or work
RVUs for a service would result in a
change in payment of about 11 to 13
percent. In contrast, a corresponding 25
percent change in MP values for a
service would yield a change in
payment of only about one percent.
Estimates of the effects on payment by
specialty type can be found in section
VI. of this proposed rule.
Additional information on our
proposed methodology for updating the
MP RVUs may be found in our
contractor’s report, ‘‘Interim Report on
Malpractice RVUs for the CY 2018 PFS
Proposed Rule,’’ which is available on
the CMS Web site under the downloads
section of the CY 2018 PFS proposed
rule located at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/
index.html.
We are seeking comments on these
proposals for calculating the MP RVUs
for CY 2018.
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 professional consultations,
office visits, office psychiatry services,
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and any additional service specified by
the Secretary, when furnished via a
telecommunications system. We first
implemented this statutory provision,
which was effective October 1, 2001, in
the CY 2002 PFS final rule with
comment period (66 FR 55246). We
established a process for annual updates
to the list of Medicare telehealth
services as required by section
1834(m)(4)(F)(ii) of the Act in the CY
2003 PFS final rule with comment
period (67 FR 79988).
As specified at § 410.78(b), we
generally require that a telehealth
service be furnished via an interactive
telecommunications system. Under
§ 410.78(a)(3), an interactive
telecommunications system is defined
as multimedia communications
equipment that includes, at a minimum,
audio and video equipment permitting
two-way, real-time interactive
communication between the patient and
distant site physician or practitioner.
Telephones, facsimile machines, and
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
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telehealth services to the Medicare
Administrative Contractors (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. For geographic qualifications, our
regulation at § 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 Federal Office of
Rural Health Policy 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 our Web site at https://
www.cms.gov/MedicareMedicareGeneral-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
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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 CY 2003
PFS final rule with comment period (67
FR 79988), we established a process for
adding services to or deleting services
from the list of Medicare telehealth
services. This process provides the
public with an ongoing opportunity to
submit requests for adding services.
Under this process, we assign any
qualifying request to make additions to
the list of telehealth services to one of
two categories. Revisions to criteria that
we use to review requests in the second
category were finalized in the CY 2012
PFS final rule with comment period (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 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 furnish
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.
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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.
The list of telehealth services,
including the proposed additions
described below, is included in the
Downloads section to this proposed rule
at https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
PhysicianFeeSched/PFS-FederalRegulation-Notices.html.
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 2017
will be considered for the CY 2019
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 our Web site at https://
www.cms.gov/Medicare/MedicareGeneral-Information/Telehealth/
index.html.
3. Submitted Requests To Add Services
to the List of Telehealth Services for CY
2018
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
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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
2016 to add various services as
Medicare telehealth services effective
for CY 2018. The following presents a
discussion of these requests, and our
proposals for additions to the CY 2018
telehealth list. Of the requests received,
we found that three services were
sufficiently similar to services currently
on the telehealth list to qualify on a
category 1 basis. Therefore, we are
proposing to add the following services
to the telehealth list on a category 1
basis for CY 2018:
• HCPCS code G0296 (Counseling
visit to discuss need for lung cancer
screening using low dose ct scan (ldct)
(service is for eligibility determination
and shared decision making))
We found that the service described
by HCPCS code G0296 is sufficiently
similar to office visits currently on the
telehealth list. We believe that all the
components of this service, which
include assessment of the patient’s risk
for lung cancer, shared decision making,
and counseling on the risks and benefits
of LDCT, can be furnished via
interactive telecommunications
technology.
• CPT codes 90839 and 90840
(Psychotherapy for crisis; first 60
minutes) and (Psychotherapy for crisis;
each additional 30 minutes (List
separately in addition to code for
primary service))
We are proposing to add CPT codes
90839 and 90840 on a Category 1 basis.
We found that these services are
sufficiently similar to the psychotherapy
services currently on the telehealth list,
even though these codes describe
patients requiring more urgent care and
psychotherapeutic interventions to
minimize the potential for psychological
trauma. However, we did identify one
specific element of the services as
described in the CPT prefatory language
that we concluded may or may not be
able to be furnished via telehealth,
depending on the circumstances of the
particular service. The CPT prefatory
language specifies that the treatment
described by these codes requires,
‘‘mobilization of resources to defuse the
crisis and restore safety.’’ In many cases,
we believe that a distant site
practitioner would have access (via
telecommunication technology,
presumably) to the resources at the
originating site that would allow for the
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kind of mobilization required to restore
safety. However, we also believe that it
would be possible that a distant site
practitioner would not have access to
such resources. Therefore we are
proposing to add the codes to the
telehealth list with the explicit
condition of payment that the distant
site practitioner be able to mobilize
resources at the originating site to
defuse the crisis and restore safety,
when applicable, when the codes are
furnished via telehealth. ‘‘Mobilization
of resources’’ is a description used in
the CPT prefatory language. We believe
the critical element of ‘‘mobilizing
resources’’ is the ability to communicate
with and inform staff at the originating
site to the extent necessary to restore
safety. We solicit comment on whether
our assumption that the remote
practitioner is able to mobilize resources
at the originating site to defuse the crisis
and restore safety is valid.
Although we did not receive specific
requests, we are also proposing to add
four additional services to the telehealth
list based on our review of services. All
four of these codes are add-on codes
that describe additional elements of
services currently on the telehealth list
and would only be considered
telehealth services when billed as an
add-on to codes already on the
telehealth list. The four codes are:
• CPT code 90785 (Interactive
complexity (List separately in addition
to the code for primary procedure))
• CPT codes 96160 and 96161
(Administration of patient-focused
health risk assessment instrument (e.g.,
health hazard appraisal) with scoring
and documentation, per standardized
instrument) and (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))
• HCPCS code G0506
(Comprehensive assessment of and care
planning for patients requiring chronic
care management services (list
separately in addition to primary
monthly care management service))
In the case of CPT codes 96160 and
96161, and HCPCS code G0506, we
recognize that these services may not
necessarily be ordinarily furnished inperson with a physician or billing
practitioner. Ordinarily, services that
are typically not considered to be faceto-face services do not need to be on the
list of Medicare telehealth services;
however, these services would only be
considered Medicare telehealth services
when billed with a base code that is also
on the telehealth list and would not be
considered Medicare telehealth services
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when billed with codes not on the
Medicare telehealth list. We believe that
by adding these services to the
telehealth list it will be administratively
easier for practitioners who report these
services in association with a visit code
that is furnished via telehealth as both
the base code and the add-on code
would be reported with the telehealth
place of service.
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 physical,
occupational, and speech therapy,
initial hospital care, and online E/M by
physician/qualified healthcare
professional to the telehealth list, or
changing the requirements for ESRD
procedure codes furnished via
telehealth, for the reasons noted in the
paragraphs that follow.
a. Physical and Occupational Therapy
and Speech-Language Pathology
Services: CPT Codes—
• CPT code 97001: Now deleted and
reported as CPT code 97161 (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.)
• CPT code 97002: Now deleted and
reported as CPT code 97162 (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)
• CPT code 97003: Now deleted and
reported as CPT code 97165
(Occupational therapy evaluation, low
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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 problemfocused 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)
• CPT code 97004: Now deleted and
reported as CPT code 97166
(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))
• CPT code 97110 (Therapeutic
procedure, 1 or more areas, each 15
minutes; therapeutic exercises to
develop strength and endurance, range
of motion and flexibility)
• CPT code 97112 (Therapeutic
procedure, 1 or more areas, each 15
minutes; neuromuscular reeducation of
movement, balance, coordination,
kinesthetic sense, posture, and/or
proprioception for sitting and/or
standing activities)
• CPT code 97116 (Therapeutic
procedure, 1 or more areas, each 15
minutes; gait training (includes stair
climbing))
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• CPT code 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)
• CPT code 97750 (Physical
performance test or measurement (e.g.,
musculoskeletal, functional capacity),
with written report, each 15 minutes)
• CPT code 97755 (Assistive
technology assessment (e.g., to restore,
augment or compensate for existing
function, optimize functional tasks and/
or maximize environmental
accessibility), direct one-on-one contact,
with written report, each 15 minutes).
• CPT 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).
• CPT code 97761 (Prosthetic
training, upper and/or lower
extremity(s), each 15 minutes).
• CPT code 97762 (Checkout for
orthotic/prosthetic use, established
patient, each 15 minutes).
In section 1834(m)(4)(E) of the Act,
the statute specifies the types of
practitioners who may furnish and bill
for Medicare telehealth services as those
practioners under section 1842(b)(18)(C)
of the Act. Physical therapists,
occupational therapists and speechlanguage pathologists are not among the
practitioners identified in section
1842(b)(18)(C) of the Act. We stated in
the CY 2017 PFS final rule (81 FR
80198) that because these services are
predominantly furnished by physical
therapists, occupational therapists and
speech-language pathologists, we did
not believe it would be appropriate to
add them to the list of telehealth
services at this time. In an ensuing
submission for 2018, the original
requester suggested that we might
propose these services to be added to
the list so that they can be furnished via
telehealth when furnished by eligible
distant site practitioners. We considered
that possibility; however, since the
majority of the codes are furnished by
therapy professionals over 90 percent of
the time, we believe that adding therapy
services to the telehealth list that
explicitly describe the services of the
kinds of professionals not included on
the statutory list of distant site
practitioners could result in confusion
about who is authorized to furnish and
bill for these services when furnished
via telehealth. We also note that several
of these services, such as CPT code
97761, require directly physically
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manipulating the beneficiary, which is
not possible to do through
telecommunications technology.
Therefore, we are not proposing to add
these codes to the list of Medicare
telehealth services.
b. Initial Hospital Care Services: CPT
Codes—
• CPT code 99221 (Initial hospital
care, per day, for the evaluation and
management of a patient, which
requires these 3 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/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
problem(s) requiring admission are of
low severity.)
• CPT code 99222 (Initial hospital
care, per day, for the evaluation and
management of a patient, which
requires these 3 key components: A
comprehensive history; A
comprehensive examination; and
Medical decision making of moderate
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 problem(s)
requiring admission are of moderate
severity.)
• CPT code 99223 (Initial hospital
care, per day, for the evaluation and
management of a patient, which
requires these 3 key components: A
comprehensive history; A
comprehensive examination; and
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 problem(s)
requiring admission are of high
severity.)
We previously considered a request to
add these codes to the telehealth list. As
we stated in the CY 2011 PFS final rule
with comment period (75 FR 73315),
while initial inpatient consultation
services are currently on the list of
approved telehealth services, there are
no services on the current list of
telehealth services that resemble initial
hospital care for an acutely ill patient by
the admitting practitioner who has
ongoing responsibility for the patient’s
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treatment during the hospital course.
Therefore, consistent with prior
rulemaking, we are not proposing initial
hospital care services be added to the
Medicare telehealth services list on a
category 1 basis.
The initial hospital care codes
describe the first visit of the
hospitalized patient by the admitting
practitioner who may or may not have
seen the patient in the decision-making
phase regarding hospitalization. Based
on the description of the services for
these codes, we believe it is critical that
the initial hospital visit by the admitting
practitioner be conducted in person to
ensure that the practitioner with
ongoing treatment responsibility
comprehensively assesses the patient’s
condition upon admission to the
hospital through a thorough in-person
examination. Additionally, the requester
submitted no additional research or
evidence that the use of a
telecommunications system to furnish
the service produces demonstrated
clinical benefit to the patient; therefore,
we also are not proposing to add initial
hospital care services to the Medicare
telehealth services list on a category 2
basis.
We note that Medicare beneficiaries
who are being treated in the hospital
setting can receive reasonable and
necessary E/M services using other
HCPCS codes that are currently on the
Medicare telehealth list including those
for subsequent hospital care, initial and
followup telehealth inpatient and
emergency department consultations, as
well as initial and followup critical care
telehealth consultations.
Therefore, we do not propose to add
the initial hospital care services to the
list of Medicare telehealth services for
CY 2018.
c. Online E/M by physician/QHP: CPT
Code—
• CPT code 99444 (Online evaluation
and management service provided by a
physician or other qualified health care
professional who may report evaluation
and management services provided to
an established patient or guardian, not
originating from a related E/M service
provided within the previous 7 days,
using the Internet or similar electronic
communications network)
As we indicated in the CY 2016 final
rule with comment period (80 FR
71061), CPT code 99444 is assigned a
status indicator of ‘‘N’’ (Non-covered
service). Under section 1834(m)(2)(A) of
the Act, Medicare pays the physician or
practitioner furnishing a telehealth
service an amount equal to the amount
that would have been paid if the service
was furnished without the use of a
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telecommunications system. Because
CPT code 99444 is currently noncovered, there would be no Medicare
payment if this service were furnished
without the use of a
telecommunications system. Because
this code is a non-covered service for
which no Medicare payment may be
made under the PFS, we do not propose
to add online E/M services to the list of
Medicare telehealth services for CY
2018.
d. Monthly Capitation Payment (MCP)
for ESRD-Related Services for Home
Dialysis, by Age: CPT Codes—
• CPT codes 90963 (End-stage renal
disease (ESRD) related services for home
dialysis per full month, for patients
younger than 2 years of age to include
monitoring for the adequacy of
nutrition, assessment of growth and
development, and counseling of
parents); 90964 (End-stage renal disease
(ESRD) related services for home
dialysis per full month, for patients 2–
11 years of age to include monitoring for
the adequacy of nutrition, assessment of
growth and development, and
counseling of parents); 90965 (End-stage
renal disease (ESRD) related services for
home dialysis per full month, for
patients 12–19 years of age to include
monitoring for the adequacy of
nutrition, assessment of growth and
development, and counseling of
parents); and 90966 (End-stage renal
disease (ESRD) related services for home
dialysis per full month, for patients 20
years of age and older)
• 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); and 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 (Endstage renal disease (ESRD) related
services for dialysis less than a full
month of service, per day; for patients
20 years of age and older).
In the CY 2004 PFS final rule (68 FR
63216), we established G-codes for
ESRD monthly capitation payments
(MCPs), which were replaced by CPT
codes in CY 2009 (73 FR 69898). The
services described by CPT codes 90963
through 90966 were added to the
Medicare telehealth list in CY 2005 (69
FR 66276) and CPT codes 90967
through 90970 were added to the
Medicare telehealth list in the CY 2017
PFS final rule (81 FR 80194); however,
we specified that the required clinical
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examination of the vascular access site
must be furnished face-to-face ‘‘hands
on’’ (without the use of an interactive
telecommunications system) by a
physician, clinical nurse specialist
(CNS), nurse practitioner (NP), or
physician assistant (PA). The American
Telemedicine Association (ATA)
submitted a new request for CY 2018
requesting that we allow telehealth
coverage of ESRD procedure codes
without in-person exam of the catheter
access site monthly. Our current policy
reflects our understanding that
evaluation of the integrity and
functionality of the access site is a
critical element of the services
described by the codes and that this
element cannot be performed via
telecommunications technology. The
requester did not submit evidence to
support the assertation that effective
examination of the access site can be
executed via telecommunications
technology. Therefore, for CY 2018, we
are not proposing any changes to the
policy requiring that the MCP
practitioner must furnish at least one
face-to-face encounter with the home
dialysis patient per month for clinical
examination of the catheter access site.
However, we are interested in more
information about current clinically
accepted care practices and to what
extent telecommunications technology
can be used to examine the access site.
We are also interested in information
about the clinical standards of care
regarding the frequency of the
evaluation of the access site.
In summary, we are proposing to add
the following codes to the list of
Medicare telehealth services beginning
in CY 2018 on a category 1 basis:
• HCPCS code G0296 (Counseling
visit to discuss need for lung cancer
screening using low dose CT scan (ldct)
(service is for eligibility determination
and shared decision making)).
• HCPCS code G0506
(Comprehensive assessment of and care
planning for patients requiring chronic
care management services (list
separately in addition to primary
monthly care management service)).
• CPT code 90785 (Interactive
complexity (List separately in addision
to the code for primary procedure)).
• CPT codes 90839 and 90840
(Psychotherapy for crisis; first 60
minutes) and (Psychotherapy for crisis;
each additional 30 minutes (List
separately in addition to code for
primary procedure)).
• CPT codes 96160 and 96161
(Administration of patient-focused
health risk assessment instrument (e.g.,
health hazard appraisal) with scoring
and documentation, per standardized
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instrument) and (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).
4. Elimination of the Required Use of
the GT Modifier on Professional Claims
Medicare has required distant site
practitioners to report one of two
longstanding HCPCS modifiers when
reporting telehealth services. Current
guidance instructs practitioners to
submit claims for telehealth services
using the appropriate CPT or HCPCS
code for the professional service along
with the telehealth modifier GT (via
interactive audio and video
telecommunications systems). For
federal telemedicine demonstration
programs in Alaska or Hawaii,
practitioners are instructed to submit
claims using the appropriate CPT or
HCPCS code for the professional service
along with the telehealth modifier GQ if
telehealth services are performed ‘‘via
an asynchronous telecommunications
system.’’ By coding and billing these
modifiers with a service code,
practitioners are certifying that both the
broad and code-specific telehealth
requirements have been met.
In the CY 2017 PFS final rule (81 FR
80201), we finalized payment policies
regarding Medicare’s use of a new Place
of Service (POS) Code describing
services furnished via telehealth. The
new POS code became effective January
1, 2017, and we believe its use is
redundant with the requirements to
apply the GT modifier for telehealth
services. We did not propose to
implement a change to the modifier
requirements during CY 2017
rulemaking because at the time of the
CY 2017 PFS proposed rule, we did not
know whether the telehealth POS code
would be made effective for January 1,
2017. However, we noted in the CY
2017 PFS final rule that, like the
modifiers, use of the telehealth POS
code certifies that the service meets the
telehealth requirements.
Because a valid POS code is required
on professional claims for all services,
and the appropriate reporting of the
telehealth POS code serves to indicate
both the provision of the service via
telehealth and certification that the
requirements have been met, we believe
that it is unnecessary to also require the
distant site practitioner report the GT
modifier on the claim. Therefore, we are
proposing to eliminate the required use
of the GT modifier on professional
claims. Because institutional claims do
not use a POS code, we propose for
distant site practitioners billing under
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CAH Method II to continue to use the
GT modifier on institutional claims. For
purposes of the federal telemedicine
demonstration programs in Alaska or
Hawaii, we propose to retain the GQ
modifier to maintain the distinction
between synchronous and asynchronous
telehealth services, as reflected in
statute.
5. Comment Solicitation on Medicare
Telehealth Services
We have received numerous requests
from stakeholders to expand access to
telehealth services. As noted above,
Medicare payment for telehealth
services is restricted by statute, which
establishes the services initially eligible
for Medicare telehealth and limits the
use of telehealth by defining both
eligible originating sites (the location of
the beneficiary) and the distant site
practitioners who may furnish and bill
for telehealth services. Originating sites
are limited both by geography and
provider setting. We have the authority
to add to the list of eligible services
based on our annual process, but cannot
change the limitations relating to
geography, patient setting, or type of
furnishing practitioner because these
requirements are specified in statute.
For CY 2018, we are seeking
information regarding ways that we
might further expand access to
telehealth services within the current
statutory authority and pay
appropriately for services that take full
advantage of communication
technologies.
6. Comment Solicitation on Remote
Patient Monitoring
In addition to the broad comment
solicitation regarding Medicare
telehealth services, we are also
specifically seeking comment on
whether to make separate payment for
CPT codes that describe remote patient
monitoring. We note that remote patient
monitoring services would generally not
be considered Medicare telehealth
services as defined under section
1834(m) of the Act. Rather, like the
interpretation by a physician of an
actual electrocardiogram or
electroencephalogram tracing that has
been transmitted electronically, these
services involve the interpretation of
medical information without a direct
interaction between the practitioner and
beneficiary. As such, they are paid
under the same conditions as in-person
physicians’ services with no additional
requirements regarding permissible
originating sites or use of the telehealth
place of service code.
We are particularly interested in
comments regarding CPT code 99091
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33975
(Collection and interpretation of
physiologic data (e.g., ECG, blood
pressure, glucose monitoring) digitally
stored and/or transmitted by the patient
and/or caregiver to the physician or
other qualified health care professional,
qualified by education, training,
licensure/regulation (when applicable)
requiring a minimum of 30 minutes of
time). This code is currently assigned a
procedure status of B (bundled). As with
many other bundled codes, we currently
assign RVUs for this code based on
existing RUC recommendations, even
though we have considered the services
described by the code to be bundled
with other services. In addition to
comments on the payment status and
valuation for this code (the RUCrecommended value, specifically) we
are seeking information about the
circumstances under which this code
might be reported for separate payment,
including how to differentiate the time
related to these services from other
services, including care management
services. For example, PFS payment for
analysis of patient-generated health data
is considered included in chronic care
management (CCM) services (CPT codes
99487, 99489, and 99490) to the extent
that this activity is medically necessary
and performed as part of CCM (see the
CY 2015 PFS final rule (79 FR 67727),
CY 2016 PFS final rule (81 FR 80244),
and the CMS FAQ available at: https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
PhysicianFeeSched/Downloads/
Payment_for_CCM_Services_FAQ.pdf.).
We also seek comment from
beneficiaries and beneficiary advocacy
organizations on the value of such
services and what protections might be
necessary to assure that beneficiaries are
properly informed that they are
receiving a remote monitoring service,
since beneficiaries would be required to
pay standard cost sharing for such
services. Finally, regarding CPT code
99091, we are seeking available
information regarding potential
utilization assumptions we might make
for the service for purposes of PFS
ratesetting, were we to make it payable
for CY 2018 or in the future; since
making such asumptions would be
necessary to implement separate
payment. We note that since the PFS is
a budget neutral system, any increase in
payment made for particular services
would result in decreases in payment
for other services, and the degree of that
decrease would depend, in large part,
on the utilization assumptions.
We are also seeking comment on other
existing codes that describe extensive
use of communications technology for
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consideration for future rulemaking,
including CPT code 99090 (Analysis of
clinical data stored in computers (e.g.,
ECGs, blood pressures, hematologic
data)). CPT code 99090 is also assigned
a procedure status of B (bundled).
However, we do not have RUC
recommended values for this service,
and therefore, currently do not assign
RVUs.
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E. Proposed 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.H. 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 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 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
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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’
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 0l 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.
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• 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
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(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 approximately 1,700
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 (76
FR 73055 through 73958), we finalized
our policy to consolidate the review of
physician work and PE at the same time,
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
(73 FR 38589), 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. 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
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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 Harvardvalued 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
our screen of high expenditure services
across specialties.
In the CY 2017 PFS final rule, we
finalized for review a list of potentially
misvalued services, which included
eight codes in the end-stage renal
disease home dialysis family (CPT codes
90963–90970). We also finalized as
potentially misvalued 19 codes
identified through our screen for 0-day
global services that are typically billed
with an evaluation and management (E/
M) service with modifier 25.
3. CY 2018 Identification and Review of
Potentially Misvalued Services
In the CY 2012 PFS final rule with
comment period (76 FR 73058), we
finalized a process for the public to
nominate potentially misvalued codes.
The public and stakeholders may
nominate potentially misvalued codes
for review by submitting the code with
supporting documentation by February
10 of each year. Supporting
documentation for codes nominated for
the annual review of potentially
misvalued codes may include the
following:
• Documentation in peer reviewed
medical literature or other reliable data
that there have been changes in
physician work due to one or more of
the following: technique, knowledge
and technology, patient population, siteof-service, length of hospital stay, and
work time.
• An anomalous relationship between
the code being proposed for review and
other codes.
• Evidence that technology has
changed physician work.
• Analysis of other data on time and
effort measures, such as operating room
logs or national and other representative
databases.
• Evidence that incorrect
assumptions were made in the previous
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valuation of the service, such as a
misleading vignette, survey, or flawed
crosswalk assumptions in a previous
evaluation.
• Prices for certain high cost supplies
or other direct PE inputs that are used
to determine PE RVUs are inaccurate
and do not reflect current information.
• Analyses of work time, work RVU,
or direct PE inputs using other data
sources (for example: Department of
Veteran Affairs (VA) National Surgical
Quality Improvement Program (NSQIP),
the Society for Thoracic Surgeons (STS)
National Database, and the Physician
Quality Reporting System (PQRS)
databases).
• National surveys of work time and
intensity from professional and
management societies and
organizations, such as hospital
associations.
We evaluate the supporting
documentation submitted with the
nominated codes and assess whether the
nominated codes appear to be
potentially misvalued codes appropriate
for review under the annual process. In
the following year’s PFS proposed rule,
we publish the list of nominated codes
and indicate whether we are proposing
each nominated code as a potentially
misvalued code. The public has the
opportunity to comment on these and
all other proposed potentially
misvalued codes. In that year’s final
rule, we finalize our list of potentially
misvalued codes.
After we issued the CY 2017 PFS final
rule, we received a nomination and
supporting documentation for one code
to be considered as potentially
misvalued. We evaluated the supporting
documentation for this nominated code
to ascertain whether the submitted
information demonstrated that the code
should be proposed as potentially
misvalued.
CPT code 27279 (Arthrodesis,
sacroiliac joint, percutaneous or
minimally invasive (indirect
visualization), with image guidance,
includes obtaining bone graft when
performed, and placement of transfixing
device) was nominated for review as a
potentially misvalued code because the
current work RVU is potentially
undervalued and stakeholders
recommend that it should be increased
to 14.23. We are proposing this code as
a potentially misvalued code. In the CY
2017 PFS final rule, we noted that some
assertions regarding appropriate values
for the dialysis vascular access codes
newly created in CY 2017 (CPT codes
36901 through 36909) did not include
data that would warrant increases to the
work RVUs. However, we urged
interested stakeholders to consider
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submitting robust data regarding costs
for these and other services (81 FR
80294). We have continued to receive
feedback from stakeholders regarding
the work valuation of these codes.
Stakeholders have expressed concerns
regarding the typical patient for these
procedures as reflected in the
information included in the RUC
recommendations for CY 2017 and the
importance of appropriate payment for
ensuring access to care for Medicare
beneficiaries. Therefore, we are seeking
additional comment and continuing to
request robust data regarding the
potentially misvalued work RVUs for
CPT codes 36901 through 36909 and
considering alternate work valuations
for CY 2018, such as the RUCrecommended work RVUs from CY
2017, or other potential values based on
submission of data through the public
comment process. We note that the RUC
recommended work RVUs for these
services are displayed in the CY 2017
PFS final rule (81 FR 80290 through
80296). We have received conflicting
information about the direct PE inputs
for CPT codes 88184 (Flow cytometry,
cell surface, cytoplasmic, or nuclear
marker, technical component only; first
marker) and 88185 (Flow cytometry, cell
surface, cytoplasmic, or nuclear marker,
technical component only; each
additional marker (List separately in
addition to code for first marker)), and
we are proposing these codes as
potentially misvalued so that they can
be reviewed again because some
stakeholders have suggested the clinical
labor and supplies that were previously
finalized are no longer accurate.
We have received information
suggesting that the work RVUs for
emergency department visits may not
appropriately reflect the full resources
involved in furnishing these services.
Specifically, stakeholders have
expressed concerns that the work RVUs
for these services have been
undervalued given the increased acuity
of the patient population and the
heterogeneity of the sites, such as
freestanding and off-campus emergency
departments, where emergency
department visits are furnished. We are,
therefore, seeking comment on whether
CPT codes 99281–99385 (Emergency
department visits for the evaluation and
management of a patient) should be
reviewed under the misvalued code
initiative.
For over a decade, CMS has
collaborated with the RUC to regularly
prioritize codes for review by using the
categories specified in the statute or as
determined appropriate. We generally
have referred to these categories as
‘‘misvalued code screens.’’ To
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supplement ongoing RUC identification
of potentially misvalued codes through
established screens, CMS regularly uses
PFS rulemaking to identify other
screens for use in identifying potentially
misvalued codes. For example, in recent
years, CMS has prioritized the following
screens:
• Codes with low work RVUs
commonly billed in multiple units per
single encounter.
• Codes with high volume and low
work RVUs.
• Codes with site-of-serviceanomalies.
• E/M codes.
• PFS high expenditure services.
• Services with standalone PE
procedure time.
• Services with anomalous time.
• Contractor Medical Director
identified potentially misvalued codes.
• Codes with higher total Medicare
payments in office than in hospital or
ASC.
• Publicly nominated potentially
misvalued codes.
• 0-day global services that are
typically billed with an evaluation and
management (E/M) service with
modifier 25.
Although we are not proposing a new
screen for CY 2018, we continue to
believe that it is important to prioritize
codes for review under the misvalued
code initiative. As a result, we are
seeking public comment on the best
approach for developing screens, as well
as what particular new screens we
might consider. We will consider these
comments for future rulemaking.
F. Payment Incentive for the Transition
From Traditional X-Ray Imaging to
Digital Radiography and Other Imaging
Services
Section 502(a)(1) of Division O, Title
V of the Consolidated Appropriations
Act of 2016 (Pub. L. 114–113) amended
section 1848(b) of the Act by
establishing a new paragraph (9) of
subsection (b). Section 1848(b)(9)(B) of
the Act provides for a 7 percent
reduction in payments for the technical
component (TC) for imaging services
made under the PFS that are X-rays
(including the technical component
portion of a global service) taken using
computed radiography technology
furnished during CYs 2018, 2019, 2020,
2021, or 2022, and for a 10 percent
reduction for the technical component
of such imaging services furnished
during CY 2023 or a subsequent year.
Computed radiography technology is
defined for purposes of this paragraph
as cassette-based imaging that utilizes
an imaging plate to create the image
involved. Section 1848(b)(9) of the Act
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also requires implementation of the
reduction in payments through
appropriate mechanisms, which can
include the use of modifiers. In
accordance with section
1848(c)(2)(B)(v)(X) of the Act, the
adjustments under section 1848(b)(9)(A)
of the Act are exempt from the budget
neutrality requirement.
We stated in the CY 2017 PFS
proposed rule that because the required
reductions in PFS payment for the TC
of imaging services (including the TC
portion of a global service) that are Xrays taken using computed radiography
technology did not apply for CY 2017,
we would address implementation of
section 1848(b)(9)(B) of the Act in future
rulemaking. Therefore, to implement the
provisions of section 1848(b)(9)(B) of
the Act relating to the payment
reduction for the TC (including the TC
portion of a global service) of X-rays
taken using computed radiography
technology during CY 2018 or
subsequent years, we are proposing to
establish a new modifier to be used on
claims for these services.
We are proposing that beginning
January 1, 2018, this modifier would be
required to be used when reporting
imaging services for which payment is
made under the PFS that are X-rays
(including the X-ray component of a
packaged service) taken using computed
radiography technology. The modifier
would be required on claims for the
technical component of the X-ray
service, including when the service is
billed globally because the PFS payment
adjustment is made to the technical
component regardless of whether it is
billed globally, or billed separately
using the TC modifier. The modifier
must be used to report the specific
services that are subject to the payment
reduction and accurate use is subject to
audit. The use of this proposed modifier
to indicate an X-ray taken using
computed radiography would result in a
7 percent reduction for CYs 2018
through 2022 and a 10 percent
reduction for CY 2023 or a subsequent
calendar year to the payments for the TC
for such imaging services furnished as
specified under section 1848(b)(9)(B) of
the Act.
G. Proposed Payment Rates Under the
Medicare Physician Fee Schedule for
Nonexcepted Items and Services
Furnished by Nonexcepted Off-Campus
Provider-Based Departments of a
Hospital
1. Background
Sections 1833(t)(1)(B)(v) and (t)(21) of
the Act require that certain items and
services furnished by certain off-campus
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provider-based departments (PBDs)
(collectively referenced here as
nonexcepted items and services
furnished by nonexcepted off-campus
PBDs) shall not be considered covered
OPD services for purposes of payment
under the OPPS, and payment for those
nonexcepted items and services
furnished on or after January 1, 2017
shall be made under the applicable
payment system. In the CY 2017 OPPS/
ASC final rule with comment period (81
FR 79713), we finalized the PFS as the
‘‘applicable payment system’’ for most
nonexcepted items and services
furnished by off-campus PBDs.
As part of that discussion, we
indicated that, in response to public
comments received on the proposed
payment policies for nonexcepted items
and services, we would issue an interim
final rule with comment period (the CY
2017 interim final rule, 81 FR 79720
through 79729) to establish payment
policies under the PFS for nonexcepted
items and services furnished on or after
January 1, 2017. In the following
paragraphs, we propose the payment
policies under the PFS for nonexcepted
items and services furnished during CY
2018. The CY 2017 interim final rule
can be found on the Internet at https://
www.gpo.gov/fdsys/pkg/FR-2016-11-14/
pdf/2016-26515.pdf. We anticipate
responding to public comments and
finalizing the CY 2017 interim final rule
in future PFS rulemaking.
2. Payment Mechanism
Coding and payment policies under
the PFS have long recognized the
differences between the portions of
services for which direct costs generally
are incurred by practitioners and the
portions of services for which direct
costs generally are incurred by facilities.
At present, the coding and RVUs
established for particular groups of
services under the PFS generally reflect
such direct cost differences. As
described in section II.B of this
proposed rule, we establish separate
nonfacility and facility RVUs for many
HCPCS codes describing particular
services paid under the PFS. For many
other services, we establish separate
RVUs for the professional component
and the technical component of the
service described by the same HCPCS
code. For other services, we establish
RVUs for the different HCPCS codes that
segregate and describe the discrete
professional and technical aspects of
particular services.
Because hospitals with nonexcepted
off-campus PBDs that furnish
nonexcepted items and services are
likely to furnish a broader range of
services than other provider or supplier
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types for which there is a separately
valued technical component under the
PFS, for CY 2017, we established a new
set of payment rates under the PFS that
reflected the relative resource costs of
furnishing the technical component of a
broad range of services to be paid under
the PFS specific to the off-campus PBD
of a hospital with packaging (bundling)
rules that are unique to the hospital
outpatient setting under the OPPS.
In principle, the coding and billing
mechanisms required to make
appropriate payment to hospitals for
nonexcepted items and services
furnished by nonexcepted off-campus
PBDs are parallel to those used to make
payment for the technical component
services for a range of supplier types
paid under the PFS. That is, payments
to hospitals are made for the technical
aspect of services, while physicians and
other practitioners report the
professional aspect of these same
services. In some cases, the entities
reporting the technical aspect of
services use the same coding that is
used by the individuals reporting the
professional services. In other cases,
different coding applies. We are
proposing to maintain this mechanism
for CY 2018.
3. Establishment of Payment Rates
Using the relativity among OPPS
payments to establish rates for the
nonexcepted items and services
furnished by nonexcepted off-campus
PBDs and billed by hospitals under the
PFS was only one aspect of establishing
the necessary relativity of these services
under the PFS more broadly. It was
necessary to estimate the relativity of
these services compared to PFS services
furnished in other settings. For CY 2017,
we used our best estimate of the more
general relativity between the technical
component of PFS services furnished in
nonexcepted off-campus PBDs and all
other PFS services furnished in other
settings using the limited information
available to us at that time. As described
in the CY 2017 interim final rule (81 FR
79722 through 79726), we estimated
that for CY 2017, scaling the OPPS
payment rates by 50 percent would
strike an appropriate balance that
avoided potentially underestimating the
relative resources involved in furnishing
services in nonexcepted off-campus
PBDs as compared to the services
furnished in other settings for which
payment was made under the PFS.
Specifically, we established site-specific
rates under the PFS for the technical
component of the broad range of
nonexcepted items and services
furnished by nonexcepted off-campus
PBDs to be paid under the PFS that was
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33979
based on the OPPS payment amount for
the same items and services, scaled
downward by 50 percent. We called this
adjustment the ‘‘PFS Relativity
Adjuster.’’ The PFS Relativity Adjuster
refers to the percentage of the OPPS
payment amount paid under the PFS for
a nonexcepted item or service to the
non-excepted off-campus PBD under
this policy.
a. Methodology for Establishing CY
2017 PFS Relativity Adjuster
In developing the CY 2017 interim
final rule, we began by analyzing
hospital outpatient claims data from
January 1 through August 26, 2016, that
contained the ‘‘PO’’ modifier signifying
that they were billed by an off-campus
department of a hospital paid under the
OPPS other than a remote location, a
satellite facility, or a dedicated
emergency department (ED). We noted
that the use of the ‘‘PO’’ modifier was
a new mandatory reporting requirement
for CY 2016. We limited our analysis to
those claims billed on the 13X Type of
Bill because those claims were used for
Medicare Part B billing under the OPPS.
We then identified the top (most
frequently billed) 25 major codes that
were billed by claim line; that is, items
and services that were separately
payable or conditionally packaged.
Specifically, we restricted our analysis
to codes with OPPS status indicators
‘‘J1’’, ‘‘J2’’, ‘‘Q1’’, ‘‘Q2’’, ‘‘Q3’’, ‘‘S’’, ‘‘T’’,
or ‘‘V’’. We did not include separately
payable drugs or biologicals in this
analysis because those drugs or
biologicals were not paid under the PFS
under the CY 2017 interim final rule. As
such, under the CY 2017 interim final
rule, the PFS Relativity Adjuster did not
apply to separately payable drugs and
biologicals furnished by a nonexcepted
PBD. Similarly, we excluded codes
assigned an OPPS status indicator ‘‘A’’
because the services described by those
codes were already paid at a rate under
a fee schedule other than the OPPS and
payment for those nonexcepted items
and services was not changed by the
rates established under the CY 2017
interim final rule. Next, for the same
major codes (or analogous codes in the
rare instance that different coding
applies under the OPPS than the PFS),
we compared the CY 2016 payment rate
under the OPPS to a CY 2016 payment
rate under the PFS attributable to the
nonprofessional relative resource costs
involved in furnishing the services.
The most frequently billed service
with the ‘‘PO’’ modifier was described
by HCPCS code G0463 (Hospital
outpatient clinic visit for assessment
and management of a patient), which is
paid under APC 5012; the total number
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of CY 2016 claim lines for that service
was approximately 6.7 million as of
August 2016. In CY 2016, the OPPS
payment rate for APC 5012 was $102.12.
Because there were multiple CPT codes
(CPT codes 99201 through 99215) used
under the PFS for billing that service, an
exact comparison between the $102.12
OPPS payment rate for APC 5012 and
the payment rate for a single CPT code
billed under the PFS was not possible.
However, for purposes of the analysis,
we examined the difference between the
nonfacility payment rates and the
facility payment rates under the PFS for
CPT codes 99213 and 99214, which
were the billing codes for a Level III and
a Level IV office visit. While we did not
have data to precisely determine the
equivalent set of PFS visit codes to use
for the comparison, we believed that,
based on the distribution of services
billed for the visit codes under the PFS
and the distribution of the visit codes
under the OPPS from the last time
period the CPT codes were used under
the OPPS in CY 2014, those two codes
provided reliable points of comparison.
For CPT code 99213, the difference
between the nonfacility payment rate
and the facility payment rate under the
PFS in CY 2016 was $21.86, which was
21 percent of the OPPS payment rate for
APC 5012 of $102.12. For CPT code
99214, the difference between the
nonfacility payment rate and the facility
payment rate under the PFS in CY 2016
was $29.02, which was 28 percent of the
OPPS payment rate for APC 5012.
However, we recognized that, due to the
more extensive packaging that occurred
under the OPPS for services provided
along with clinic visits relative to the
more limited packaging that occurred
under the PFS for office visits, those
payment rates were not entirely
comparable.
We then assessed the next 24 major
codes most frequently billed on the 13X
claim form by hospitals. We removed
HCPCS code 36591 (Collection of blood
specimen from a completely
implantable venous access device)
because, under current PFS policies, the
code is used only to pay separately
under the PFS when no other service
was on the claim. We also removed
HCPCS code G0009 (Administration of
Pneumococcal Vaccine) because there
was no payment for the code under the
PFS. For the remaining 22 major codes
most frequently billed, we estimated the
amount that would have been paid to
the physician in the office setting under
the PFS for practice expenses not
associated with the professional
component of the service. As indicated
in Table 9, this amount reflected (1) the
difference between the PFS nonfacility
payment rate and the PFS facility rate,
(2) the technical component, or (3) in
instances where payment would have
been made only to the facility or only
to the physician, the full nonfacility
rate. This estimate ranged from zero
percent to 137.8 percent of the OPPS
payment rate for a code. Overall, the
average (weighted by claim line volume
times rate) of the nonfacility payment
rate estimate for the PFS compared to
the estimate for the OPPS for the 22
remaining major codes was 45 percent.
TABLE 9—COMPARISON OF CY 2016 OPPS PAYMENT RATE TO CY 2016 PFS PAYMENT RATE FOR TOP HOSPITAL
CODES BILLED USING THE ‘‘PO’’ MODIFIER
HCPCS
code
Code description
Total claim
lines
CY 2016
OPPS
payment rate
CY 2016
applicable
PFS
technical
payment
amount
estimate
(1)
(2)
(3)
(4)
(5)
96372 ..
Injection beneath the skin or
into muscle for therapy, diagnosis, or prevention.
X-ray of chest, 2 views, front
and side.
Routine
electrocardiogram
(EKG) with tracing using at
least 12 leads.
Infusion of chemotherapy into
a vein up to 1 hour.
71020 ..
93005 ..
96413 ..
93798 ..
96375 ..
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93306 ..
77080 ..
77412 ..
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PFS estimate
(6)
338,444
$25.42
60.1
60.80
16.83
27.7
318,099
55.94
8.59
15.4
254,704
280.27
136.41
48.7
203,926
103.92
11.10
10.7
189,140
42.31
22.56
53.3
Single rate paid exclusively to
either practitioner or facility:
Full nonfacility rate.
179,840
416.80
165.77
39.8
Technical component: Full
nonfacility rate.
155,513
100.69
31.15
30.9
Technical component: Full
nonfacility rate.
137,241
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$42.31
333,203
Physician services for outpatient heart rehabilitation
with continuous EKG monitoring per session.
Injection of different drug or
substance into a vein for
therapy, diagnosis, or prevention.
Ultrasound
examination
of
heart including color-depicted blood flow rate, direction, and valve function.
Bone density measurement
using dedicated X-ray machine.
Radiation treatment delivery ....
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Col (5) as a
percent of
OPPS
194.35
267.86
137.8
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Single rate paid exclusively to
either practitioner or facility:
Full nonfacility rate.
Technical component: Full
nonfacility rate.
Technical component: Full
nonfacility rate.
Single rate paid exclusively to
either practitioner or facility:
Full nonfacility rate.
Nonfacility rate—Facility rate.
Technical component (Full
nonfacility rate) based on
weighted averages for the
following PFS codes: G6011;
G6012; G6013; and G6014.
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TABLE 9—COMPARISON OF CY 2016 OPPS PAYMENT RATE TO CY 2016 PFS PAYMENT RATE FOR TOP HOSPITAL
CODES BILLED USING THE ‘‘PO’’ MODIFIER—Continued
HCPCS
code
Code description
Total claim
lines
CY 2016
OPPS
payment rate
CY 2016
applicable
PFS
technical
payment
amount
estimate
(1)
(2)
(3)
(4)
(5)
90853 ..
96365 ..
Group psychotherapy ..............
Infusion into a vein for therapy,
prevention, or diagnosis up
to 1 hour.
Aspiration and/or injection of
large joint or joint capsule.
Removal of skin and tissue
first 20 sq cm or less.
Infusion into a vein for therapy
prevention or diagnosis additional sequential infusion up
to 1 hour.
Exercise or drug-induced heart
and blood vessel stress test
with EKG tracing and monitoring.
Radiation therapy delivery .......
123,282
122,641
69.65
173.18
0.36
69.82
0.5
40.3
Nonfacility rate—Facility rate.
Nonfacility rate—Facility rate.
106,769
223.76
13.96
6.2
Nonfacility rate—Facility rate.
99,134
225.55
54.78
24.3
Nonfacility rate—Facility rate.
98,930
42.31
30.79
72.8
Single rate paid exclusively to
either practitioner or facility:
Full nonfacility rate.
96,312
220.35
39.74
18.0
Technical component: Full
nonfacility rate.
81,925
505.51
347.30
68.7
79,242
1,108.46
412.82
37.2
76,393
347.72
220.20
63.3
71260 ..
Nuclear medicine study of vessels of heart using drugs or
exercise multiple studies.
CT scan of abdomen and pelvis with contrast.
CT scan chest with contrast ....
Technical component: Nonfacility rate for CPT code
G6015 (analogous code
used under the PFS).
Technical component: Full
nonfacility rate.
75,052
236.86
167.21
70.6
71250 ..
CT scan chest .........................
74,570
112.49
129.61
115.2
73030 ..
X-ray of shoulder, minimum of
2 views.
Psychotherapy, 45 minutes
with patient and/or family
member.
71,330
60.80
19.33
31.8
70,524
125.04
0.36
0.3
20610 ..
11042 ..
96367 ..
93017 ..
77386 ..
78452 ..
74177 ..
90834 ..
Col (5) as a
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Weighted Average (claim line volume*rate) of the PFS payment compared to OPPS payment for the 22 major
codes:
As noted with the clinic visits, we
recognized that there were limitations to
our data analysis, including that OPPS
payment rates include the costs of
packaged items or services billed with
the separately payable code, and
therefore the comparison to rates under
the PFS was not a one-to-one
comparison. Also, we included only a
limited number of services, and noted
that additional services may have
different patterns than the services
described. After considering the
payment differentials for major codes
billed by off-campus departments of
hospitals with the ‘‘PO’’ modifier and
based on the data limitations of our
analysis, we adopted, with some
exceptions noted below, a set of PFS
payment rates that were based on a 50percent PFS Relativity Adjuster to the
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OPPS payment rates (inclusive of
packaging) for nonexcepted items and
services furnished by nonexcepted offcampus PBDs in the CY 2017 interim
final rule. Generally speaking, we
arrived at the 50 percent PFS Relativity
Adjuster by examining the 45-percent
comparison noted above, the ASC
payment rate—which was roughly 55
percent of the OPPS payment rate on
average—and the payment rate
differential for the large number of
OPPS and PFS evaluation and
management services, as described
above. We recognized that the
equivalent PFS nonfacility rates may be
higher or lower on a code-specific basis
than the rates that result from applying
the overall PFS Relativity Adjuster to
the OPPS payment rates on a code
specific basis. However, we believed
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PFS estimate
Technical component: Full
nonfacility rate.
Technical component: Full
nonfacility rate.
Technical component: Full
nonfacility rate.
Technical component: Full
nonfacility rate.
Nonfacility rate—Facility rate.
45%
that, on the whole, the percentage
reduction did not underestimate the
overall relativity between the OPPS and
the PFS based on the limited data that
was available. We were concerned,
however, that the 50 percent PFS
Relativity Adjuster might overestimate
PFS nonfacility payments relative to
OPPS payments. For example, if we
were able at the time to sufficiently
estimate the effect of the packaging
differences between the OPPS and PFS,
we suspected that the equivalent
portion of PFS payments for evaluation
and management codes, and for PFS
services on average, would likely have
been less than 50 percent for the same
services. We considered the 50 percent
PFS Relativity Adjuster for CY 2017 to
be a transitional policy until such time
that we had more precise data to better
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identify and value nonexcepted items
and services furnished by nonexcepted
off-campus PBDs and billed by
hospitals.
We established several significant
exceptions to the application of the 50
percent PFS Relativity Adjuster. For
example, we did not apply the 50
percent PFS Relativity Adjuster to
services that are currently paid under
the OPPS based on payment rates from
other Medicare fee schedules (including
the PFS) on an institutional claim. The
items and services that are assigned
status indicator ‘‘A’’ in Addendum B to
the CY 2017 OPPS/ASC final rule with
comment period (available on the CMS
Web site at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/HospitalOutpatientPPS/
Hospital-Outpatient-Regulations-andNotices-Items/CMS-1656-FC.html)
continue to be reported on an
institutional claim and paid under the
PFS, the CLFS, or the Ambulance Fee
Schedule (ASC) without a payment
reduction. Similarly, drugs and
biologicals that are separately payable
under the OPPS (identified by status
indicator ‘‘G’’ or ‘‘K’’ in Addendum B to
the CY 2017 OPPS/ASC final rule with
comment period) are paid in accordance
with section 1847A of the Act (that is,
typically ASP + 6 percent), consistent
with payment rules in the physician
office setting. Drugs and biologicals that
are unconditionally packaged under the
OPPS and are not separately payable
(that is, those drugs and biologicals
assigned status indicator of ‘‘N’’ in
Addendum B to the CY 2017 OPPS/ASC
final rule with comment period) are
bundled into the PFS payment and are
not separately paid to hospitals billing
for nonexcepted items and services
furnished by nonexcepted off-campus
PBDs. The full range of exceptions and
adjustments to the otherwise applicable
OPPS payment rate that were adopted in
the new PFS site-of-service payment
rates in the CY 2017 interim final rule
can be found on the CMS Web site at
https://www.cms.gov/Medicare/
Medicare-Fee-for-Service-Payment/
HospitalOutpatientPPS/Downloads/
CMS-1656-FC-2017-OPPS-StatusIndicator.zip.
All nonexcepted items and services
furnished by nonexcepted off-campus
PBDs and billed by a hospital on an
institutional claim with modifier ‘‘PN’’
(Nonexcepted service provided at an offcampus, outpatient, provider-based
department of a hospital) are currently
paid under the PFS at the rate
established in the CY 2017 interim final
rule. Specifically, nonexcepted off
campus PBDs must report modifier
‘‘PN’’ on each UB–04 claim line to
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indicate a nonexcepted item or service,
and otherwise continue to bill as they
currently do. Further billing
instructions on the PN modifier can be
found in the January 2017 OPPS
Quarterly Update (transmittal 3685,
Change Request 9930) released
December 22, 2016, available on the
CMS Web site at https://www.cms.gov/
Regulations-and-Guidance/Guidance/
Transmittals/Downloads/R3685CP.pdf.
b. PFS Relativity Adjuster
As noted in the CY 2017 interim final
rule, we considered the CY 2017 50
percent PFS Relativity Adjuster to be a
transitional policy until such time that
we had more precise data to better
identify and value nonexcepted items
and services furnished by nonexcepted
off-campus PBDs and billed by
hospitals. At present, we do not have
more precise data than were available
when we established the PFS Relativity
Adjuster in the CY 2017 interim final
rule, and we do not anticipate having
such data until after the end of CY 2017,
at the earliest. However, in developing
a proposed policy for CY 2018, we have
continued to explore options for
modifying the calculation of the CY
2018 PFS Relativity Adjuster.
There is no consensus among
stakeholders regarding the appropriate
PFS Relativity Adjuster. Many
stakeholders have suggested that making
separate facility fee payments to
hospitals under the PFS for all services
that are separately paid under the OPPS
itself undermines site-neutral payment
because practitioners are only paid a
single combined fee for many services
when furnished in an office setting,
while there are two separate fees
(professional and facility) paid when the
service is furnished in the hospital
setting. We acknowledge that there are
many cases where single fees are paid
to practitioners for services furnished in
an office setting while fees for
comparable services when furnished in
the hospital setting are paid to both the
professional and facility entities.
However, we do not agree that this
necessarily means that overall payment
cannot be site neutral. We point out that
the sum of the professional and the
facility portions of payment for a service
furnished in a nonexcepted off-campus
PBD or in a different institutional
setting could be equivalent to a single
fee paid to the professional in the office
setting. In the case of some services, in
fact, the single payment made under the
PFS at the nonfacility rate exceeds the
sum of the separate payments Medicare
makes to the professional at the facility
rate under the PFS and to the facility
under the OPPS. We also note that there
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are many separately reportable services
under the PFS (for example, the vast
majority of services described by add-on
codes) for which separate payment is
made to physician offices but no
separate payment is made under either
the OPPS or under the site-specific PFS
payments made to hospitals billing for
nonexcepted items and services
furnished by nonexcepted off-campus
PBDs. For these reasons, we believe that
the overall total payment made for
services is more relevant to the goal of
site neutrality than the quantity of
individual payments made.
Nonetheless, we continue to recognize
and share stakeholders’ concerns
regarding the importance of equivalent
overall payment for services, regardless
of setting.
In considering the appropriate PFS
Relativity Adjuster for CY 2018, we
continue to believe that claims data
from CY 2017, which are not yet
available, are needed to guide potential
changes to our general approach. In the
absence of such data, however, we have
continued to consider the appropriate
PFS Relativity Adjuster based on the
information that is available. In the
analysis we used to establish the PFS
Relativity Adjuster for CY 2017, we
attempted to identify the appropriate
value by comparing OPPS and PFS
payment rates for services frequently
reported in PBDs and described by the
same codes under the two payment
systems. As we acknowledged in the CY
2017 interim final rule, that data
analysis did not include the most
frequently billed service furnished in
nonexcepted off-campus hospital PBDs,
outpatient visits. Outpatient visits are
reported using a single code under the
OPPS and by one of ten different codes
under the PFS.
Consistent with our previously stated
concern that the PFS Relativity Adjuster
for CY 2017 might be too small,
generally resulting in greater overall
payments to hospitals for services
furnished by nonexcepted off-campus
PBDs than would otherwise be paid
under the PFS in the non-facility
setting, we believe it is appropriate to
propose changing the PFS Relativity
Adjuster in order to ensure that
payment made to these nonexcepted
PBDs better aligns with these services
that are the most frequently furnished in
this setting.
For CY 2018, we propose to revise the
PFS Relativity Adjuster for nonexcepted
items and services furnished by
nonexcepted off-campus PBDs to be 25
percent of the OPPS payment rate. We
arrived at this proposed PFS Relativity
Adjuster by making a code-level
comparison for the service most
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commonly billed in the off-campus PBD
setting under the OPPS: A clinic visit
reported using HCPCS code G0463. In
order to determine the analogous
payment for the technical aspects of this
service under the PFS in nonfacility
settings, we compared the CY 2017
OPPS national payment rate for HCPCS
code G0463 ($102.12) to the difference
between the nonfacility and facility PFS
payment amounts under the PFS using
CY 2017 rates for the weighted average
of outpatient visits (CPT codes 99201–
99205 and CPT codes 99211–99215)
billed by physicians and other
professionals in an outpatient hospital
place of service.
This proposed 25 percent PFS
Relativity Adjuster is based solely on
the comparison for the visit services that
reflect greater than 50 percent of
services billed in off-campus PBDs. We
continue to recognize that the
comparison between the OPPS and PFS
rates for other services varies greatly,
and that there are other factors,
including the specific mix of services
furnished by non-excepted PBDs,
policies related to packaging of codes
under OPPS, and payment adjustments
like MPPRs and bundling under the PFS
that rely on empirical information about
whether or not codes are billed on the
same day, that contribute to the
differences in aggregate payment
amounts for a broader range of services.
However, for CY 2018, as for CY 2017,
we must set the PFS Relativity Adjuster
prior to studying the CY 2017 claims
data that might allow us to consider and
incorporate many more factors,
including the ones stated above. When
we established the 50 percent PFS
Relativity Adjuster for CY 2017, we
stated that we did so with the goal of
ensuring adequate payment but
remained concerned that the resulting
reduction was too small. For CY 2018,
we are focused on ensuring that we do
not overestimate the appropriate overall
payments for these services. Until we
are able to study claims data, we believe
that the comparison between PFS and
OPPS payment for the most common
services furnished in off-campus PBDs,
outpatient visits, is a better proxy than
our previous approach.
We welcome stakeholder input with
regard to this analysis and the resulting
rate. We also request comment on
whether we should adopt a different
PFS Relativity Adjuster, such as 40
percent, that represents a relative
middle ground between the CY 2017
PFS Relativity Adjuster, selected to
ensure adequate payment to hospitals
and our proposed CY 2018 PFS
Relativity Adjuster, selected to ensure
that hospitals are not paid more than
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others would be paid through the PFS
nonfacility rate. We intend to continue
to study this issue and welcome
comments regarding potential future
refinements to payment rates for nonexcepted items and services furnished
by non-excepted off-campus PBDs as we
gain more experience with these new
site-of-service PFS rates.
Finally, we note that for CY 2018, as
in recent years, the proposed annual
update to OPPS payments exceeds the
proposed annual update to PFS
payments. Because we are proposing to
make a single, across-the-board and, by
necessity, imprecise adjustment to
OPPS payment rates to establish PFS
payment rates for nonexcepted items
and services furnished by nonexcepted
off-campus PBDs, we expect that the
actual difference between OPPS and
PFS payment rates for nonexcepted
items and services furnished by
nonexcepted off-campus PBDs falls in a
range which includes our proposed PFS
Relativity Adjuster (that is, the actual
differential may differ from our
proposed PFS Relativity Adjuster). As
such, taking into account the differential
between the OPPS and PFS annual
updates by making an adjustment to the
PFS Relativity Adjuster our proposal for
CY 2018 would presume a level of
precision in our estimates that is simply
not present in our analysis. Therefore,
we will not adjust our proposal to
reflect the relative updates to PFS and
OPPS between CY 2017 and CY 2018,
and instead note that the differential
between the OPPS and PFS payment
update for CY 2018 is a factor that
suggests that the proposed PFS
Relativity Adjuster may overestimate
PFS nonfacility payment relative to
OPPS payments; in future years, we
intend to more precisely account for any
differential between these two update
factors.
c. Geographic Adjustments
For CY 2017, we established classspecific geographic practice cost indices
(GPCIs) under the PFS exclusively used
to adjust these site-specific, technical
component rates for nonexcepted items
and services furnished in nonexcepted
off-campus PBDs. These class-specific
GPCIs are parallel to the geographic
adjustments made under the OPPS
based on the hospital wage index. We
believed it was appropriate to adopt the
hospital wage index areas for purposes
of geographic adjustment because nonexcepted off-campus PBDs are still
considered to be part of a hospital, and
the PFS payments to these entities will
be limited to the subset of PFS services
furnished by hospitals. We also believed
it was appropriate, as an initial matter
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for CY 2017, to adopt the actual wage
index values for these hospitals in
addition to the wage index areas. The
PFS GPCIs that would otherwise
currently apply are not based on the
hospital wage index areas. For CY 2018,
we are proposing to continue using the
authority under section 1848(e)(1)(B) of
the Act to maintain a class-specific set
of GPCIs for these site-specific technical
component rates that are based both on
the hospital wage index areas and the
hospital wage index value themselves.
For purposes of payment to hospitals,
this means that the geographic
adjustments used under the OPPS
continue to apply.
d. Coding Consistency
For most services, the same HCPCS
codes are used to describe services paid
under both the PFS and the OPPS.
There are two notable exceptions that
describe high-volume services. The first
is the set of codes that describe
evaluation and management (E/M)
services which are reported under the
PFS using the 5 levels of CPT codes
describing new or established patient
visits (for a total of 10 codes). However,
since CY 2014, these visits have been
reported under the OPPS using the
single HCPCS code G0463 (Hospital
Outpatient Clinic Visit) (see 78 FR
75042). We are proposing to maintain
the current PFS payment rate for HCPCS
code G0463 based on the OPPS payment
rate modified by the PFS Relativity
Adjuster.
The second is a set of radiation
treatment delivery and imaging
guidance services that are reported
using different codes under the PFS and
the OPPS. CMS established HCPCS
Level II G codes to describe radiation
treatment delivery services when
furnished in the physician office setting
(see 79 FR 67666 through 67667).
However, these HCPCS G codes are not
recognized under the OPPS; rather, CPT
codes are used to describe these services
when furnished in the HOPD. Both sets
of codes were implemented for CY 2015
and were maintained for CY 2016.
Under the PFS, there is a particular
statutory provision under section
1848(c)(2)(K) of the Act that required
maintenance of the CY 2016 coding and
payment inputs for these services for CY
2017 and also for CY 2018. Accordingly,
the proposed CY 2018 PFS rates for
these services are calculated based on
the maintenance of the CY 2016 coding
and payment inputs. Because nonexcepted items and services furnished
by a nonexcepted off-campus PBD are
paid under the PFS, and we are required
to maintain the CY 2016 coding and
payment inputs for these services under
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the CY 2018 PFS, we are proposing to
maintain payment amounts for
nonexcepted items and services
furnished by a nonexcepted off-campus
PBD consistent with the payments that
would be made to other facilities under
the PFS. That is, nonexcepted offcampus PBDs submitting claims for
these nonexcepted items and services
will continue to bill the HCPCS G codes
established under the PFS to describe
radiation treatment delivery services.
Under this proposal, the nonexcepted
off-campus PBD must append modifier
PN to each applicable claim line for
these nonexcepted items and services,
even though the PFS Relativity Adjuster
will not apply. The payment amount for
these services would be set to reflect the
technical component rate for the code
under the PFS.
4. OPPS Payment Adjustments
In the CY 2017 interim final rule, we
adopted the packaging payment rates
and multiple procedure payment
reduction (MPPR) percentage that
applied under the OPPS to establish the
PFS payment rates for nonexcepted
items and services furnished by
nonexcepted off-campus PBDs and
billed by hospitals. That is, the claims
processing logic that was used for
payments under the OPPS for
comprehensive APCs (C–APCs),
conditionally and unconditionally
packaged items and services, and major
procedures, was incorporated into the
newly established PFS rates. We
continue to believe it is necessary to
incorporate the OPPS payment policies
for C–APCs, packaged items and
services, and the MPPR in order to
maintain the integrity of the PFS
Relativity Adjuster because the adjuster
is intended in part to account for the
methodological differences between the
OPPS and the PFS rates that would
otherwise apply. We also direct
interested stakeholders to related
proposed policies under the OPPS,
since prospective changes in the
applicable adjustments and policies
would generally apply to non-excepted
items and services furnished by
nonexcepted off-campus PBDs for CY
2018. We are interested in comments
regarding the applicability of particular
prospective OPPS adjustments to nonexcepted items and services.
In order to apply these OPPS payment
policies and adjustments to nonexcepted items and services, we propose
that hospitals continue to bill on an
institutional claim form that will pass
through the Outpatient Code Editor and
into the OPPS PRICER for calculation of
payment. This approach will yield data
based on claims for non-excepted items
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and services furnished by nonexcepted
off-campus PBDs, which can be used to
refine PFS payment rates for these
services in future years.
There were several OPPS payment
adjustments that we did not adopt in the
CY 2017 interim final rule, including,
but not limited to, outlier payments, the
rural sole community hospital (SCH)
adjustment, the cancer hospital
adjustments, transitional outpatient
payments, the hospital outpatient
quality reporting payment adjustment,
and the inpatient hospital deductible
cap to the cost-sharing liability for a
single hospital outpatient service. We
believed these payment adjustments
were expressly authorized for, and
should be limited to, hospitals that are
paid under the OPPS for covered OPD
services in accordance with section
1833(t) of the Act. We continue to
believe that these policies should not
apply to non-excepted items and
services furnished by nonexcepted offcampus PBDs, and are not proposing
that they apply for CY 2018.
5. Partial Hospitalization Services
With respect to partial hospitalization
programs (PHP) (intensive outpatient
psychiatric day treatment programs
furnished to patients as an alternative to
inpatient psychiatric hospitalization or
as a stepdown to shorten an inpatient
stay and transition a patient to a less
intensive level of care), section
1861(ff)(3)(A) of the Act specifies that a
PHP is a program furnished by a
hospital, to its outpatients, or by a
CMHC. In the CY 2017 OPPS/ASC
proposed rule (81 FR 45690), in the
discussion of the proposed
implementation of section 603 of Public
Law 114–74, we noted that because
CMHCs also furnish PHP services and
are ineligible to be provider-based to a
hospital, a nonexcepted off-campus PBD
would be eligible for PHP payment if
the entity enrolls and bills as a CMHC
for payment under the OPPS. We further
noted that a hospital may choose to
enroll a nonexcepted off-campus PBD as
a CMHC, provided it meets all Medicare
requirements and conditions of
participation.
Commenters expressed concern that
without a clear payment mechanism for
PHP services furnished by nonexcepted
off-campus PBDs, access to partial
hospitalization services would be
limited, and pointed out the critical role
PHPs play in the continuum of mental
health care. Many commenters believed
that Congress did not intend for partial
hospitalization services to no longer be
paid for by Medicare when such
services are furnished by nonexcepted
off-campus PBDs. Several commenters
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disagreed with the notion of enrolling as
a CMHC in order to receive payment for
PHP services. These commenters stated
that hospital-based PHPs and CMHCs
are inherently different in structure,
operation, and payment, and noted that
the conditions of participation for
hospital departments and CMHCs are
different. Several commenters requested
that CMS find a mechanism to pay
hospital-based PHPs in nonexcepted offcampus PBDs.
Because we shared the commenters’
concerns, in the CY 2017 OPPS/ASC
final rule with comment period and the
CY 2017 interim final rule (81 FR
79727), we adopted payment for partial
hospitalization items and services
furnished by nonexcepted off-campus
hospital-based PBDs under the PFS.
When billed in accordance with the CY
2017 interim final rule, these partial
hospitalization services are paid at the
CMHC per diem rate for APC 5853, for
providing three or more partial
hospitalization services per day (81 FR
79727).
In the CY 2017 OPPS/ASC proposed
rule (81 FR 45681), the CY 2017 OPPS/
ASC final rule with comment period,
and the CY 2017 interim final rule (81
FR 79727), we noted that when a
beneficiary receives outpatient services
in an off-campus department of a
hospital, the total Medicare payment for
those services is generally higher than
when those same services are provided
in a physician’s office. Similarly, when
partial hospitalization services are
provided in a hospital-based PHP,
Medicare pays more than when those
same services are provided by a CMHC.
Our rationale for adopting the CMHC
per diem rate for APC 5853 as the PFS
payment amount for nonexcepted offcampus PBDs providing PHP services is
because CMHCs are freestanding entities
that are not part of a hospital, but they
provide the same PHP services as
hospital-based PHPs (81 FR 79727). This
is similar to the differences between
freestanding entities paid under the PFS
that furnish other services also provided
by hospital-based entities. Similar to
other entities currently paid for their
technical component services under the
PFS, we believe CMHCs would typically
have lower cost structures than hospitalbased PHPs, largely due to lower
overhead costs and other indirect costs
such as administration, personnel, and
security. We believe that paying for
nonexcepted hospital-based partial
hospitalization services at the lower
CMHC per diem rate aligns with section
603 of Pubic Law 114–74, while also
preserving access to PHP services. In
addition, nonexcepted off-campus PBDs
will not be required to enroll as CMHCs
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in order to bill and be paid for providing
partial hospitalization services.
However, a nonexcepted off-campus
PBD that wishes to provide PHP
services may still enroll as a CMHC if
it chooses to do so and meets the
relevant requirements. Finally, we
recognize that because hospital-based
PHPs are providing partial
hospitalization services in the hospital
outpatient setting, they can offer
benefits that CMHCs do not have, such
as an easier patient transition to and
from inpatient care, and easier sharing
of health information between the PHP
and the inpatient staff. We are not
proposing to require these PHPs to
enroll as CMHCs but instead we are
proposing to continue to pay nonexcepted off-campus PBDs providing
PHP items and services under the PFS.
Further, we are proposing to continue to
adopt the CMHC per diem rate for APC
5853 as the PFS payment amount for
nonexcepted off-campus PBDs
providing three or more PHP services
per day in CY 2018.
6. Supervision Rules
The supervision rules that apply for
hospitals continue to apply for
nonexcepted off-campus PBDs that
furnish nonexcepted items and services.
The amendments made by section 603
of the Bipartisan Budget Act of 2015
(Pub. L. 114–74, enacted November 2,
2015) did not change the status of these
PBDs, only the status of, and payment
mechanism for, the services they
furnish. These supervision requirements
are specified in § 410.27.
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7. Beneficiary Cost-Sharing
Under the PFS, the beneficiary
copayment is generally 20 percent of the
fee schedule amount, unless there is an
applicable exception in accordance with
the statute. All cost-sharing rules that
apply under the PFS in accordance with
section 1848(g) of the Act and section
1866(a)(2)(A) of the Act continue to
apply for all nonexcepted items and
services furnished by nonexcepted offcampus PBDs, regardless of the costsharing obligation under the OPPS.
8. CY 2019 and Future Years
We continue to believe the
amendments made to the statute by
section 603 of the Bipartisan Budget Act
of 2015 intended to eliminate the
Medicare payment incentive for
hospitals to purchase physician offices,
convert them to off-campus PBDs, and
bill under the OPPS for items and
services they furnish there. Therefore,
we continue to believe the payment
policy under this provision should
ultimately equalize payment rates
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between nonexcepted off-campus PBDs
and physician offices to the greatest
extent possible, while allowing
nonexcepted off-campus PBDs to bill in
a straight-forward way for services they
furnish.
We note that a full year of claims data
regarding the mix of services reported
using the ‘‘PN’’ modifier (from CY 2017)
will first be available for use in PFS
ratesetting for CY 2019. Under the
current methodology, we would expect
to use that data in order to ensure that
Medicare payment to hospitals billing
for non-excepted items and services
furnished by nonexcepted off-campus
PBDs under the PFS would reflect the
relative resources involved in furnishing
the items and services relative to other
PFS services. We recognize that under
our current approach, the payment rates
would not be equal on a procedure-byprocedure basis, application of the PFS
Relativity Adjuster would move toward
equalizing payment rates in the
aggregate between physician offices and
nonexcepted off-campus PBDs to the
extent appropriate. Therefore, for
certain specialties, service lines, and
nonexcepted off-campus PBD types,
total Medicare payments for the same
services might be either higher or lower
when furnished by a nonexcepted offcampus PBD rather than in a physician
office.
Depending on the mix of services for
particular off-campus PBDs, we remain
concerned that such specialty-specific
patterns in payment differentials could
result in continued incentives for
hospitals to buy certain types of
physician offices and convert them to
nonexcepted off-campus PBDs; these are
the incentives we believe Congress
intended to avoid. However, continuing
a policy similar to the one we are
proposing in this proposed rule would
allow hospitals to continue billing
through a facility claim form and would
allow for continuation of the packaging
rules and cost report-based relative
payment rate determinations under
OPPS, which we believe are preferable
to using the current valuation
methodologies under the PFS that are
not well-suited for nonexcepted items
and services furnished by nonexcepted
off-campus PBDs. Therefore, for CY
2019 and for future years, we intend to
examine the claims data in order to
determine not only the appropriate PFS
Relativity Adjuster(s), but also to
determine whether additional
adjustments to the methodology are
appropriate—especially with the goal of
attaining site neutral payments to
promote a level playing field under
Medicare between physician office
settings and nonexcepted off-campus
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PBD settings, without regard to the
kinds of services furnished by particular
off-campus PBDs. We solicit comments
on potential changes to our
methodology that would better account
for these specialty-specific patterns.
H. Proposed 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.E.4 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 for a year. Then, during
the 60-day period following the
publication of the final rule, 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.
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 the CY 2017 PFS
proposed rule, the new process was
applicable to all codes, except for new
codes that describe truly new services.
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For CY 2017, we proposed new values
in the CY 2017 PFS 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 reproposed values for those codes in the
CY 2017 PFS proposed rule.
We considered public comments
received during the 60-day public
comment period for the proposed rule
before establishing final values in the
CY 2017 PFS final rule. As part of our
established process we will 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. For CY 2017, we were not aware
of any new codes that described such
wholly new services. Therefore, we did
not establish any code values on an
interim final basis.
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
reviews of recommended work RVUs
and time inputs have generally
included, but have not been limited to,
a review of information provided by the
RUC, the Health Care Professionals
Advisory Committee (HCPAC), and
other public commenters, medical
literature, and comparative databases, as
well as a comparison with other codes
within the PFS, consultation with other
physicians and health care professionals
within CMS and the federal
government, as well as Medicare claims
data. We have also assessed the
methodology and data used to develop
the recommendations submitted to us
by the RUC and other public
commenters and the rationale for the
recommendations. In the CY 2011 PFS
final rule with comment period (75 FR
73328 through 73329), we discussed a
variety of methodologies and
approaches used to develop work RVUs,
including survey data, building blocks,
crosswalks to key reference or similar
codes, and magnitude estimation (see
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the CY 2011 PFS final rule with
comment period (75 FR 73328 through
73329) 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. We have used the
building block methodology to
construct, or deconstruct, the work RVU
for a CPT code based on component
pieces of the code.
Components that we have used in the
building block approach may have
included 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 and 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 have refined 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 preservice
time packages for services typically
furnished in the facility setting (for
example: Preservice time packages
reflecting the different combinations of
straightforward or difficult procedure,
and straightforward or difficult patient).
Currently, there are three preservice
time packages for services typically
furnished in the nonfacility setting.
We 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
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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 have
believed that the RUC has not
adequately accounted for the
overlapping activities in the
recommended work RVU and/or times,
we have adjusted 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
have removed 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 have also removed a work RVU of
0.09 (4 minutes × 0.0224 IWPUT) if we
have not believed the overlap in time
had 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 had regarding the
time resources involved in furnishing
individual services. We have been
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. We are
statutorily obligated to consider both
time and intensity in establishing work
RVUs for PFS services. As explained in
the CY 2016 PFS final rule with
comment period (80 FR 70933), we
recognize that adjusting work RVUs for
changes in time is not always a
straightforward process, so we have
applied various methodologies to
identify several potential work values
for individual codes.
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We have observed that for many codes
reviewed by the RUC, recommended
work RVUs have appeared to be
incongruous with recommended
assumptions regarding the resource
costs in time. This has been 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 have begun by looking at the
change in the time in the context of the
RUC-recommended work RVU. When
the recommended work RVUs have not
appeared to account for significant
changes in time, we have employed 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 block, 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 have
sometimes used 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 have used
the recommended values as a starting
reference and then applied one of these
several methodologies to account for the
reductions in time that we believe had
not otherwise been reflected in the RUCrecommended value. When we have
believed that such changes in time have
already been accounted for in the RUC
recommendation, then we have not
made such adjustments. Likewise, we
have not arbitrarily applied time ratios
to current work RVUs to calculate
proposed work RVUs. We have used the
ratios to identify potential work RVUs
and considered these work RVUs as
potential options relative to the values
developed through other options.
We do not imply 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 have believed that, since the two
components of work are time and
intensity, absent an obvious or
explicitly stated rationale for why the
relative intensity of a given procedure
has increased, significant decreases in
time should be reflected in decreases to
work RVUs. If the RUC recommendation
had 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
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have generally used 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 stakeholders, 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; other
stakeholders have also expressed
concerns with CMS refinements to RUC
recommended values in general. In the
CY 2017 PFS final rule (81 FR 80272
through 80277) we responded in detail
to several comments that we received
regarding this issue. In the CY 2017 PFS
proposed rule, we requested comments
regarding potential alternatives to
making adjustments that would
recognize overall estimates of work in
the context of changes in the resource of
time for particular services; however,
we did not receive any specific potential
alternatives as requested.
In developing proposed values for
new, revised, and potentially misvalued
codes for CY 2018, we considered the
lack of alternative approaches to making
the adjustments, especially since many
stakeholders have routinely urged us to
propose and finalize the RUC
recommended values. We also
considered the RUC’s consistent
reassurance that these kinds of concerns
(regarding changes in time, for example)
had already been considered, and either
incorporated or dismissed, as part of the
development of their recommended
values. These have led us to shift our
approach to reviewing RUC
recommendations, especially as we
believe that the majority of practitioners
paid under the PFS, though not
necessarily those in any particular
specialty, would prefer CMS rely more
heavily on RUC recommended values in
establishing payment rates under the
PFS.
For CY 2018, we have generally
proposed RUC-recommended work
RVUs for new, revised, and potentially
misvalued codes. We are proposing
these values based on our
understanding that the RUC generally
considers the kinds of concerns we have
historically raised regarding appropriate
valuation of work RVUs. During our
review of these recommended values,
however, we identified some concerns
similar to those we have recognized in
prior years. Given the relative nature of
the PFS and our obligation to ensure
that the RVUs reflect relative resource
use, we have included descriptions of
potential approaches we might have
taken in developing work RVUs that
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differ from the RUC recommended
values. We are seeking comment on
both the RUC-recommended values as
well as the alternatives considered.
Table 10 contains a list of codes for
which we proposed work RVUs; this
includes all codes for which we
received RUC recommendations by
February 10, 2017. The proposed work
RVUs, work time and other payment
information for all proposed CY 2018
payable codes are available on the CMS
Web site under downloads for the CY
2018 PFS proposed rule at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
PhysicianFeeSched/PFS-FederalRegulation-Notices.html. Table 10 also
contains the CPT code descriptors for all
proposed, new, revised, and potentially
misvalued codes discussed in this
section.
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, and 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’s
recommendations appropriately
estimate the direct PE inputs (clinical
labor, disposable supplies, and medical
equipment) required for the typical
service, are 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
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(2) Equipment Time
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).
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
(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
across codes, as well as refinements that
are specific to particular services. Table
11 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 $0.30 or less, the
refinement has no impact on the
proposed PE RVUs. This calculation
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 11 result in changes under the
$0.30 threshold and are unlikely to
result in a change to the proposed
RVUs.
We also note that the proposed direct
PE inputs for CY 2018 are displayed in
the CY 2018 direct PE input database,
available on the CMS Web site under
the downloads for the CY 2018 PFS
proposed rule at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html. The
inputs displayed there have also been
used in developing the proposed CY
2018 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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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.
We refer readers to section II.B. of this
proposed rule for more information
regarding the collaborative work of CMS
and the RUC in improvements in
standardizing 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 2018, we
received invoices for several new
supply and equipment items. Tables 13
and 14 detail the invoices received for
new and existing items in the direct PE
database. As discussed in section II.B. of
this proposed rule, we encourage
stakeholders to review the prices
associated with these new and existing
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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 13 and 14 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
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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 did not include clinical labor
minutes assigned to the service period
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 2018 are
available on the CMS Web site under
downloads for the CY 2018 PFS
proposed rule at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html For
more information regarding the history
of the MPPR policy, we refer readers to
the CY 2014 PFS final rule (78 FR
74261–74263). For more information
regarding the history of the OPPS cap,
we refer readers to the CY 2007 PFS
final rule (71 FR 69659–69662).
4. Proposed Valuation of Specific Codes
for CY 2018
(1) Anesthesia Services for
Gastrointestinal (GI) Procedures (CPT
codes 007X1, 007X2, 008X1, 008X2, and
008X3)
In the CY 2016 PFS proposed rule (80
FR 41686), we discussed that in
reviewing Medicare claims data, a
separate anesthesia service is typically
reported more than 50 percent of the
time that various colonoscopy
procedures are reported. We discussed
that given the significant change in
relative frequency with which
anesthesia codes are reported with
colonoscopy services, we believed the
relative values of the anesthesia services
should be reexamined and proposed to
identify CPT codes 00740 (Anesth upper
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gi visualize) and 00810 (Anesth low
intestine scope) as potentially
misvalued. For CY 2018, the CPT
Editorial Panel is deleting CPT codes
00740 and 00810 and creating new
codes for anesthesia services furnished
in conjunction with and in support of
gastrointestinal endoscopic procedures:
Two codes for upper GI procedures
(007X1 and 007X2), two codes for lower
GI procedures (008X1 and 008X2), and
one code for upper and lower GI
procedures (008X3).
For CY 2018, we are proposing the
RUC-recommended base units without
refinement for CPT codes 007X1 (5.00
base units), 007X2 (6.00 base units),
008X1 (4.00 base units), 008X2 (4.00
base units) and 008X3 (5.00 base units).
We considered 3.00 base units (the 25th
percentile survey result) for CPT code
008X2 (Anesthesia for lower intestinal
endoscopic procedures, endoscope
introduced distal to duodenum;
screening colonoscopy), based on our
comparison of the surveyed postinduction anesthesia-intensity
allocation for CPT code 008X2 to codes
with similar allocations (CPT code
01382 (Anesth dx knee arthroscopy)).
We found that CPT code 01382, which
was also valued with 3.00 base units,
had similar allocations compared to the
survey results for CPT code 008X2. We
are seeking comment on our proposed
and alternative value for CPT code
008X2.
(2) Acne Surgery (CPT code 10040)
CPT code 10040 was identified as
potentially misvalued on a screen of
Harvard-valued codes with utilization
over 30,000 in CY 2014. We are
proposing the RUC-recommended work
RVU of 0.91 for CPT code 10040 and the
RUC-recommended work time values.
We considered using the current
number of 0.5 post-procedure office
visits of CPT code 99212 (Office/
outpatient visit est) rather than the RUCrecommended number of 1.0 postprocedure office visits. For CPT code
10040, the RUC states that it is a low
intensity service that can be performed
by a nurse under a physician’s
supervision, and that the average
number of office visits in the follow-up
period of acne surgery is 0.4. We are
seeking public comments regarding the
typical number of postoperative visits
for this code, considering there have
been no changes made to the code
descriptor and we have not found
evidence of changes to the typical
patient population.
We are proposing the RUCrecommended direct PE inputs for CPT
code 10040 without refinement. We
considered refinements to the clinical
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labor for ‘‘Assist physician in
performing procedure’’ from 10 minutes
to 3 minutes. CPT code 10040
previously used about one third of the
intraservice work time for this clinical
labor activity (5 minutes out of 14
minutes), and the RUC-recommended
value of 10 minutes would have
increased this to 100 percent of the
intraservice work time without rationale
for the change. We considered 3
minutes for this clinical labor activity,
which is about one third of the
intraservice work time (3 minutes out of
10 minutes) and would have maintained
the current ratio between clinical labor
time and work time.
For CY 2018, we are proposing the
RUC-recommended work RVUs and
direct PE inputs for CPT code 10040 and
are seeking comment on our proposed
and alternative values.
(3) Muscle Flaps (CPT codes 15734,
15736, 15738, 157X1, and 157X2)
CPT codes 15732 and 15736 were
identified via a screen of high level E/
M visits included in their global
periods. This screen identified that a
CPT code 99214 office visit was
included for CPT codes 15732 and
15736 but not included in the other
codes in this family. During the review
process for this family of codes, CPT
code 15732 was deleted and replaced
with two new codes, CPT codes 157X1
and 157X2, to better differentiate and
describe the work of large muscle flaps
performed on patients with head and
neck cancer depending on the site
where the service was performed.
For CY 2018, we are proposing the
RUC-recommended work RVUs for CPT
codes 15734 (a work RVU of 23.00),
15736 (a work RVU of 17.04), 15738 (a
work RVU of 19.04), 157X1 (a work
RVU of 13.50), and 157X2 (a work RVU
of 15.68). For CPT code 157X1, we
considered a work RVU of 12.03,
crosswalking to CPT code 36830
(Creation of arteriovenous fistula by
other than direct arteriovenous
anastomosis (separate procedure);
nonautogenous graft (eg, biological
collagen, thermoplastic graft)). We have
concerns because the RUCrecommended work RVU of 13.50
would represent nearly double the
intensity of CPT codes 15734 through
15738, as well as nearly double the
intensity of deleted CPT code 15732.
The RUC-recommended work RVU for
CPT code 157X1 is also based on a
direct crosswalk to CPT code 36832
(Revision, open, arteriovenous fistula;
without thrombectomy, autogenous or
nonautogenous dialysis graft (separate
procedure)), which has the same
intraservice time, but with 20 additional
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minutes of total time. We considered a
potential crosswalk to another code in
the same family, CPT code 36830,
which also shares the same intraservice
time with CPT code 157X1 but differs
by only 8 minutes of total time.
However, we seek comment on whether
the RUC recommendation is appropriate
given the significant variation in
intensity among these services.
We considered a work RVU of 14.63
for CPT code 157X2 (survey 25th
percentile), crosswalking to CPT code
36833 (Revision, open, arteriovenous
fistula; with thrombectomy, autogenous
or nonautogenous dialysis graft
(separate procedure)), which has the
same intraservice time, 1 minute of
additional total time, and a work RVU
of 14.50. We are seeking comment on
the effect that an alternative work RVU
of 14.50 would have on relativity among
the codes in this family.
We considered refining the clinical
labor time for ‘‘Check dressings &
wound/home care instructions’’ for CPT
code 157X1 from 10 minutes to 5
minutes. We are seeking comment on
the typical time input for checking
dressings, and whether removing and
replacing dressings, would typically
take place during the intraservice or
postservice period.
We are also seeking comments
regarding the use of the new ‘‘plate,
surgical, mini-compression, 4 hole’’
(SD189) supply included in CPT code
157X1, including whether use of this
supply would be typical, and if so,
whether it should be included in the
work description. We note that SD189 is
mentioned in the direct PE
recommendations, but the supply does
not appear in the work description. In
the work description, the fixation
screws are applied to the orbital rim and
lateral nasal wall, not the surgical plate.
(4) Application of Rigid Leg Cast (CPT
code 29445)
CPT code 29445 appeared on a high
growth screen of all services with total
Medicare utilization of 10,000 or more
that increased by at least 100 percent
from 2008 through 2013. This screen
also indicated that the code was last
surveyed more than 10 years previously,
and that the dominant specialty had
changed during that time.
For CY 2018, we are proposing the
RUC-recommended work RVU of 1.78
for CPT code 29445. For the direct PE
inputs, we are proposing to refine the
clinical labor time for ‘‘Check dressings
& wound/home care instructions’’ from
5 minutes to 3 minutes. We believe that
the additional 2 minutes of clinical
labor time that we are proposing to
remove would take place during the
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monitoring time following the
procedure and be accounted for in that
clinical labor time.
We also considered refining the
clinical labor time for ‘‘Remove cast’’
from 22 minutes to 11 minutes: 1
minute for room prep, 10 minutes for
assisting the physician, and 0 minutes
for the additional activities described in
the RUC recommendations, which
would have only taken place during the
initial casting. We have concerns that
the RUC-recommended clinical labor
regarding the ‘‘remove cast’’ task is
based only on an initial visit where a
new cast would be applied and 22
minutes may be an appropriate length of
time. However, the RUC
recommendations suggest that four to
twelve cast changes are common for
patients, and we are seeking comment
on whether the initial application of a
new cast would be typical for CPT code
29445. We reviewed the Medicare
claims data for CPT code 29445 and
found that three or more castings took
place for 52 percent of beneficiaries,
which suggests that three or more
castings may be the typical case. A
single casting only took place for 30
percent of services reported with CPT
code 29445.
(5) Strapping Multi-Layer Compression
(CPT codes 29580 and 29581)
The RUC reviewed CPT code 29580
since it appeared on the screen for high
expenditure services and reviewed CPT
code 29581 as part of this family of
codes. For CY 2018, the CPT Editorial
Panel is deleting two additional codes
in the family: CPT codes 29582
(Application of multi-layer compression
system; thigh and leg, including ankle
and foot, when performed) and 29583
(Application of multi-layer compression
system; upper arm and forearm).
For CY 2018, we are proposing the
RUC-recommended work RVUs for CPT
code 29580 (a work RVU of 0.55) and
CPT code 29581 (a work RVU of 0.60).
However, we are concerned about the
changes in preservice time reflected in
the specialty surveys compared to the
RUC-recommended work RVUs. For
instance, for CPT code 29580, we
considered a work RVU of 0.46,
crosswalking to CPT code 98925
(Osteopathic manipulative treatment
(OMT); 1–2 body regions involved)),
which has a work RVU of 0.46 and
shares a similar intraservice time.
Compared to the specialty survey times,
the RUC recommended a slight decrease
(9 minutes) in preservice time for CPT
code 29580, with the intraservice and
immediate postservice times remaining
unchanged.
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For CPT code 29581, we considered a
work RVU of 0.5 by using the RUCrecommended work RVU increment
between CPT codes 29580 and 29581
(+0.05), added to the work RVU we
considered for CPT code 29580 (0.46),
and crosswalking to CPT code 97597
(Debridement (eg, high pressure waterjet
with/without suction, sharp selective
debridement with scissors, scalpel and
forceps), open wound, (eg, fibrin,
devitalized epidermis and/or dermis,
exudate, debris, biofilm), including
topical application(s), wound
assessment, use of a whirlpool, when
performed and instruction(s) for
ongoing care, per session, total
wound(s) surface area; first 20 sq cm or
less)), which has similar intraservice
and total times to the RUCrecommended services times for CPT
code 29581. We are seeking comment on
whether a work RVU of 0.51 would
improve relativity among the codes in
this family.
For CY 2018, we are proposing the
RUC-recommended work RVUs for CPT
codes 29580 and 29581 and are seeking
comment on whether the alternative
values we considered would be more
appropriate.
(6) Resection Inferior Turbinate (CPT
Code 30140)
CPT code 30140 was identified as
potentially misvalued on a screen of
Harvard-valued codes with utilization
over 30,000 in CY 2014. During the
review process, the RUC re-surveyed the
code as a 0-day global period, based on
the presence of a negative intensity
value in the initial survey and highly
variable postoperative office visits.
For CY 2018, we are proposing the
RUC-recommended work RVU of 3.00
for CPT code 30140 as a 0-day global
code. We also considered a work RVU
of 2.68 for CPT code 30140 and are
seeking comment on changes in practice
patterns since the code was previously
reviewed, service times of comparable
services, and whether a work RVU of
2.68 would better maintain relativity
among similar codes. We note that the
RUC-recommended work RVU of 3.0
nearly doubles the derived intensity of
the code as currently valued. We note
that the RUC recommendations
referenced services that had similar
service times to CPT code 30140 (CPT
code 31240 (Nasal/sinus endoscopy,
surgical; with concha bullosa resection),
with a work RVU of 2.61; and CPT code
31295 (Nasal/sinus endoscopy, surgical;
with dilation of maxillary sinus ostium
(eg, balloon dilation), transnasal or via
canine fossa), with a work RVU of 2.70).
We note that the initial survey for
CPT code 30140 as a 90-day global
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resulted in a RUC-recommended work
RVU of 3.57, while the second survey
for the code as a 0-day global resulted
in a RUC-recommended work RVU of
3.00, despite the removal of two
postoperative office visits of CPT code
99212 and a half discharge visit of CPT
code 99238. These removed
postoperative visits have a total work
RVU of 2.58, which is notably higher
than the difference in the RUCrecommended work RVU between the
two surveys.
We are also proposing to create
equipment codes for three new
equipment items based on invoices
submitted with the RUC
recommendations for CPT code 30140.
We are proposing to create three new
equipment codes based on the invoices
submitted for this code family: the 2mm
reusable shaver blade (EQ383) at a price
of $790, the microdebrider handpiece
(EQ384) at a price of $4,760, and the
microdebrider console (EQ385) at a
price of $9,034.
(7) Control Nasal Hemorrhage (CPT
Codes 30901, 30903, 30905, and 30906)
For CY 2018, we are proposing the
RUC-recommended work RVUs for CPT
codes 30901 (a work RVU of 1.10),
30903 (a work RVU of 1.54), 30905 (a
work RVU of 1.97), and 30906 (a work
RVU of 2.45). We are also proposing to
use the RUC-recommended direct PE
inputs for CPT codes 30901, 30903,
30905, and 30906, with standard
refinements to the equipment times to
account for patient monitoring times.
We noted that as part of its
recommendation, the RUC informed us
that the specialty societies presented
evidence stating that the 1995
valuations for these services factored in
excessive times, specifically to account
for infection control procedures that
were necessary at that time due to the
prevalence of HIV/AIDS. The specialty
societies also noted that increased
availability and use of blood thinner
medications compared to those
available in 1995, has increased the
difficulty and intensity of these
procedures. We are seeking additional
information regarding the presumption
that the relative resource intensity of
these services, specifically, would be
affected by the commercial availability
of additional blood thinner medications.
We believe that blood thinner
medications were widely available
before 1995 when these codes were last
valued. Additionally, we seek
comments on the prevalence of HIV/
AIDS and whether the work related to
infection control procedures would be
relative across many PFS services or
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specifically related to nasal hemorrhage
control procedures.
For CPT code 30901 (Control nasal
hemorrhage, anterior, simple (limited
cautery and/or packing) any method),
we considered a work RVU of 1.00 (the
25th percentile survey result),
crosswalking to CPT code 20606 (Drain/
inj joint/bursa w/us), which has similar
service times. The median survey total
time (24 minutes) dropped by 2 minutes
(from preservice time), to 24 minutes
compared to the existing total time. The
difference in total time reflected a small
decrease in preservice time, with no
change in intraservice time (10
minutes). Among codes with similar
service times, we found only three
codes that had a higher work RVU than
the RUC-recommended value.
For CPT code 30903 (Control nasal
hemorrhage, anterior, complex
(extensive cautery and/or packing) any
method), we considered a work RVU of
1.30 (the 25th percentile survey result),
which would have been further
supported by CPT codes 36584 and
51710 which have similar service times
to the median survey results. The RUC
recommended a decreased total time of
39 minutes compared to the existing
total time (70 minutes), with
intraservice time dropping from 30 to 15
minutes.
For CPT code 30905 (Control nasal
hemorrhage, posterior, with posterior
nasal packs and/or cautery, any method;
initial), we considered a work RVU of
1.73, using the RUC-recommended work
RVU increment between CPT code
30903 and CPT code 30905 (0.43),
added to the work RVU we considered
for CPT code 30903 (1.30), and
crosswalking to CPT code 45321
(Proctosigmoidoscopy volvul), which
has similar service times. The surveyed
intraservice time dropped from 48
minutes to 20 minutes. The RUC
recommendations indicated that
surveyed service times for CPT code
30905 are longer than for CPT code
30903 since the service is performed to
control an arterial posterior bleed.
According to the specialty society,
arterial posterior bleeds are more
difficult to treat and require a more
extensive procedure in comparison to
services reported with CPT code 30903.
We considered using the RUCrecommended work RVU increment
between CPT code 30903 and CPT code
30905 (0.43), added to the work RVU we
considered for CPT code 30903 (1.30),
resulting in a work RVU of 1.73. We are
seeking comment on whether a work
RVU of 1.73 would potentially affect
relativity among the codes in this
family.
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For CPT code 30906 (Control nasal
hemorrhage, posterior, with posterior
nasal packs and/or cautery, any method;
subsequent), we considered a work RVU
of 2.21, using the RUC-recommended
work RVU increment between CPT
codes 30905 and 30906 (0.48), added to
the work RVU we considered for CPT
code 30905 (1.73), and crosswalking to
services with similar service times (CPT
codes 19281 (Perq device breast 1st
imag), 51727 (Cystometrogram w/up),
49185 (Sclerotx fluid collection), and
62305 (Myelography lumbar injection)).
The surveyed median intraservice time
dropped from 60 minutes to 30 minutes.
We are seeking comment on whether a
work RVU of 2.21 would potentially
improve relativity among the codes in
this family.
Given the RUC’s consensus for CY
2018, we are proposing the RUCrecommended work RVUs for each code
in this family and seeking comment on
whether our alternative values would be
more appropriate.
(8) Nasal Sinus Endoscopy (CPT Codes
31254, 31255, 31256, 31267, 31276,
31287, 31288, 31295, 31296, 31297,
31XX1, 31XX2, 31XX3, 31XX4, and
31XX5)
In October 2016, the CPT Editorial
Panel created five new codes (CPT
codes 31XX1, 31XX2, 31XX3, 31XX4
and 31XX5) and revised CPT codes
31238, 31254, 31255, 31276, 31287,
31288, 31296, and 31297. CPT codes
31XX2—31XX5 are newly bundled
services representing services that are
frequently reported together. CPT code
31XX1 represents a new service. The
RUC reviewed this family of codes at
their January 2017 meeting. For CY
2018, we are proposing the RUCrecommended work RVUs for all 15 CPT
codes in this family as follows: 4.27 for
CPT code 31254, 5.75 for CPT code
31255, 3.11 for CPT code 31256, 4.68 for
CPT code 31267, 6.75 for CPT code
31276, 3.50 for CPT code 31287, 4.10 for
CPT code 31288, 2.70 for CPT code
31295, 3.10 for CPT code 31296, 2.44 for
CPT code 31297, 8.00 for CPT code
31XX1, 9.00 for CPT code 31XX2, 8.00
for CPT code 31XX3, 8.48 for CPT code
31XX4, and 4.50 for CPT code 31XX5.
For CPT code 31296, we considered a
work RVU of 2.82, supported by a
crosswalk to CPT code 36901 (Intro cath
dialysis circuit) with an intraservice
time of 25 minutes and total time of 66
minutes, similar to the service times for
CPT code 31296. We are concerned
about the decrease in service time
compared to the work RVU and we seek
comment on whether or not a work RVU
of 2.82 might improve relativity with
other PFS services.
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For CPT code 31256, we considered a
work RVU of 2.80, supported by a
crosswalk to CPT code 43231
(Esophagoscopy, flexible, transoral; with
endoscopic ultrasound examination),
which has 30 minutes of intraservice
time and 81 minutes of total time,
similar to the RUC-recommended
service times. We are concerned about
the difference in total time between CPT
code 31256 and the RUC-recommended
crosswalk to CPT code 43247. CPT code
43247 has 30 minutes intraservice time
and 58 minutes total time), and CPT
code 31256 (30 minutes intraservice
time and 83 minutes total time).
For CPT code 31254, we note the
RUC’s explanation that this service is
more intense than the functional
endoscopic sinus surgery on the
maxillary or sphenoid sinuses due to
the risk of major complications such as
injury to the eye muscles, bleeding into
the eye or brain fluid leak and,
consequently, that the RUC concluded
that it should be valued higher than
either CPT code 31256 or CPT code
31287. Since CPT code 31256 has the
same total time (30 minutes) and
intraservice time (30 minutes) as CPT
code 31254, we considered whether the
incremental difference recommended by
the RUC between these two codes (work
RVU of 1.16) would reflect the intensity
of the service. We considered a work
RVU of 2.80 for CPT code 31256, and
also considered an alternative work
RVU of 3.97 for CPT code 31254.
For CPT code 31287, we considered a
work RVU of 3.19 based on the
difference between the RUCrecommended work RVU for the
maxillary sinus surgery (CPT code
31256) and the sphenoid sinus surgery
(CPT code 31287) (difference = 0.28)
added to the work RVU that we
considered for the base code (CPT code
31256, a work RVU of 2.80). We note
that the magnitude of decreases in
service times are greater than those for
the work RVU, which potentially could
affect relativity among PFS services.
For CPT code 31255, we considered a
work RVU of 5.30, based on a crosswalk
to CPT codes 36475 (Endovenous rf 1st
vein) and 36478 (Endovenous laser 1st
vein) since both of these services have
the same intraservice times, total times,
and work RVUs). We note that there are
several CPT codes with similar total and
intraservice times that have lower work
RVUs than the crosswalk to CPT code
36246 (Ins cath abd/l-ext art 2nd) noted
by the RUC, which has 45 minutes
intraservice and 96 minutes total time,
has work RVU of 5.02; CPT code 36475
(Endovenous rf 1st vein) has 94 minutes
intraservice and 94 minutes total time
and has work RVU of 5.30).
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For CPT code 31276 (Nasal/sinus
endoscopy, surgical; with frontal sinus
exploration, including removal of tissue
from frontal sinus, when performed), we
considered a work RVU of 6.30, which
is similar to other functional endoscopic
surgeries. We note that the services
reported with CPT code 31276 are the
most intense and complex of the
functional endoscopic surgeries due to
the risks of working in the narrow
confines in the frontal recess. However,
we have concerns that a crosswalk to
CPT code 52352 (Cystourethroscopy,
with ureteroscopy and/or pyeloscopy;
with removal or manipulation of
calculus (ureteral catheterization is
included)), and we seek comment on
whether the RUC-recommended
decrease in service times is appropriate
since CPT code 52352 has 20 minutes
more total time than CPT code 31276.
For CPT 31XX1 (nasal/sinus
endoscopy, surgical; with ligation of
Sphenopalatine artery), we have
concerns and seek comment regarding
the accuracy and applicability of the
surveys as the RUC indicated that the
specialty society did not use the survey
instrument that contains questions
about the number and types of visits
and that this service requires a half day
discharge day management as the
patients typically stay overnight to be
monitored for further bleeding. We seek
comment on whether inclusion of a half
day discharge day visit is typical for this
service since services assigned 0-day
global periods do not typically include
discharge visits. We considered
reducing the total time from 142
minutes to 123 minutes by removing the
half day discharge. Using the alternative
total time of 123 minutes, we found
services with similar total and
intraservice time (60 minutes) and total
time (123 minutes).
We considered a work RVU of 7.30 for
CPT code 31XX1, supported by a direct
crosswalk to CPT code 36253
(Superselective catheter placement (one
or more second order or higher renal
artery branches) renal artery and any
accessory renal artery(s) for renal
angiography, including arterial
puncture, catheterization, fluoroscopy,
contrast injection(s), image
postprocessing, permanent recording of
images, and radiological supervision
and interpretation, including pressure
gradient measurements when
performed, and flush aortogram when
performed; unilateral), since CPT code
36253 has a similar total time compared
to our alternative total time.
For CPT code 31XX3, we considered
a work RVU of 7.30, based on a
crosswalk to CPT code 36253
(Superselective catheter placement (one
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or more second order or higher renal
artery branches) renal artery and any
accessory renal artery(s) for renal
angiography, including arterial
puncture, catheterization, fluoroscopy,
contrast injection(s), image
postprocessing, permanent recording of
images, and radiological supervision
and interpretation, including pressure
gradient measurements when
performed, and flush aortogram when
performed; unilateral). We have similar
concerns regarding the service times for
this service, including the cited
reference codes, compared to the
recommended work RVU. We are
seeking comment on whether a work
RVU of 7.30 for CPT code 31XX3 would
improve consistency among the
combined CPT codes in this family.
CPT code 31XX4 is a new code
representing a combination of the
services previously described by CPT
codes 31255 and 31288. We note the
changes in overall service times
compared to other codes in this family
and other PFS services. We considered
a work RVU of 7.85 for CPT code
31XX4, crosswalking to CPT code 93461
(R&l hrt art/ventricle angio), which has
identical intraservice times. We are
seeking comment on the effect that this
alternative work RVU might have on
consistency and rank order compared to
the other bundled codes in this family.
CPT code 31XX5 represents a
combination of CPT codes 31296 and
31297. We have concerns about the use
of CPT codes 47532 and 58558, which
were used by the RUC as comparison
codes, due to differences in both
intraservice and total time compared to
the service times for CPT code 31XX5.
We considered a work RVU of 4.10 for
CPT code 31XX5, crosswalking to CPT
code 44406 (Colonoscopy w/
ultrasound), which has similar service
times.
For CY 2018, we are proposing the
RUC-recommended work RVUs for each
code in this family and are seeking
comment on our alternative values.
Regarding the recommended direct PE
inputs, we are concerned about one of
the supply items used in furnishing
services for several CPT codes in this
family:, ‘‘sinus surgery balloon
(maxillary, frontal, or sphenoid) kit’’
(SA106). In the current
recommendations, half of one kit (each
kit has sufficient supply for two sinuses)
is included in the practice expense
inputs for CPT codes 31295, 31296, and
31297. The new CPT code 31XX5 has
one full kit, reflecting a service
consisting of two sinuses, according to
the RUC’s explanation. The price of the
full kit (two sinuses) of this disposable
supply is $2599.06. Our analysis of 2016
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Medicare claims data indicates that 48
percent of the time one of the three CPT
codes (31295, 31296, and 31297) is
billed, it is reported on a claim with
either one or both of the other codes.
Ten percent of the time one of the three
CPT codes is billed, it is reported on a
claim with both of the other two codes.
Effectively, 10 percent of claims
reporting these CPT codes are being
paid for three sinuses.
We are seeking comments on the
number of units of this supply item that
are used for each service. We welcome
suggestions about improved
methodologies for identifying the
quantity of this disposable supply used
during these procedures and will
continue to monitor utilization and
reporting of these services.
In reviewing the RUC
recommendations for this family of CPT
codes, we note that CPT codes in this
family are subject to the standard
payment adjustment for multiple
surgeries. In our analysis of the claims
data, we noted that the average number
of HCPCS codes in this family reported
together on a claim line is
approximately 2.89. In addition, about
15 percent of claims have two of the
newly bundled CPT codes reported
together on a claim line. We are
concerned about the frequency with
which the nasal sinus endoscopy CPT
codes in this family are billed together.
We are seeking comments on whether
we should consider the endobase code
adjustments as a better approach to
adjusting payment for these services
instead of the current multiple
procedure reduction. For additional
information about the payment
adjustment under the special rule for
multiple endoscopic services, we refer
readers to the Medicare Claims
Processing Manual, Chapter 23
(available on the CMS Web site at
https://www.cms.gov/Regulations-andGuidance/Guidance/Manuals/
downloads/clm104c23.pdf.).
We note that in developing the
utilization crosswalk we use for
purposes of PFS ratesetting, for this
complex set of newly bundled codes, we
adopted ratios that differ significantly
from the ratios accompanying the RUC
recommendations to better account for
the reductions in overall reporting
frequency. We direct readers to the file
called ‘‘CY 2017 Analytic Crosswalk to
CY 2018’’ on the CMS Web site under
downloads for the CY 2018 PFS
proposed rule at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html.
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(9) Tracheostomy (CPT Codes 31600,
31601, 31603, 31605, and 31610)
CPT code 31600 was identified as part
of a screen of high expenditure services
with Medicare allowed charges of $10
million or more that had not been
recently reviewed. CPT codes 31601,
31603, 31605, and 31610 were added
and reviewed as part of the code family.
We are proposing the RUCrecommended work RVUs for all five
codes in this family. We are proposing
a work RVU of 5.56 for CPT code 31600,
a work RVU of 8.00 for CPT code 31601,
a work RVU of 6.00 for CPT code 31603,
a work RVU of 6.45 for CPT code 31605,
and a work RVU of 12.00 for CPT code
31610.
We considered a work RVU of 6.50 for
CPT code 31601. We seek comment on
the effect that this alternative value
would have on relativity compared to
other PFS services, especially since the
survey data does not suggest an increase
in the time required to perform the
procedure.
We considered a work RVU of 4.77 for
CPT code 31605, based on the survey
25th percentile from the combined
survey total. We also considered an
intraservice work time of 15 minutes,
based on the median intraservice work
time from the combined survey total for
CPT code 31605. We are seeking
comments on the methodology used to
determine the RUC-recommended work
RVU and intraservice work time. We are
concerned that the number of
respondents (20) is below the threshold
typically required for submission of a
survey, and the effect of using survey
results only from physicians who had
personal experience performing the
procedure (20 respondents). CPT code
31605 has a lower intraservice and total
time, but a higher work RVU than
comparable codes under the PFS. We
note that the next highest 0-day global
code with 20 minutes of intraservice
time is CPT code 16035 (Escharotomy;
initial incision) at a work RVU of 3.74.
All other 0-day global codes with a work
RVU of 6.45 or greater have at least 40
minutes of intraservice time. We are
seeking comment on the effect that an
alternative work RVU of 4.77 would
have on the relativity of this service
compared to other services in this
family of codes and compared to other
PFS services, taking into account that
CPT code 31605 describes a difficult
and dangerous life-threatening
emergency procedure.
We considered a work RVU of 6.50 for
CPT code 31610 based on a direct
crosswalk to CPT code 31601 (Incision
of windpipe). We understand that the
RUC considered the possibility of
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recommending this code be assigned a
0-day global period based on concerns
about negative derived intensity. We
share the RUC’s concerns with the
current construction of CPT code 31610,
particularly with the 242 minutes of
work time included in the postoperative
visits, which is an unusually large
amount for a procedure with only 45
minutes of intraservice time. We did not
identify any other comparable codes
under the PFS with 45 minutes of
intraservice time and more than 300
minutes of total time. We seek comment
on whether the unusual volume of
physician work time included in the
postoperative visits for CPT code 31610
contributed to the negative derived
intensity reported by the survey data.
Considering that the other codes in this
family have 0-day global periods, we
considered and are seeking comment on
whether a 0-day global period should be
assigned to CPT code 31610. Removal of
the postoperative E/M visits from CPT
code 31610 would result in an
intraservice time of 45 minutes and a
total time of 125 minutes, similar to CPT
code 31601 with 45 minutes of
intraservice time and 135 minutes of
total time.
We are proposing the RUCrecommended direct PE inputs for all
five CPT codes in this family without
refinements. As discussed earlier, we
considered a 0-day global period for
CPT code 31610, which would also have
resulted in removal of the clinical labor
associated with the postoperative E/M
visits, along with the supplies and
equipment utilized during those visits.
While we remain concerned about the
global period assigned to CPT code
31610 and the changes in service times
reflected in the specialty surveys
compared to the RUC-recommended
work RVUs, for CY 2018, we are
proposing the RUC-recommended work
RVUs and direct PE inputs for each code
in this family and are seeking comment
on our proposed and alternative values.
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(10) Bronchial Aspiration of
Tracheobronchial Tree (CPT Codes
31645 and 31646)
CPT code 31645 was identified as
potentially misvalued on a screen of
Harvard-valued codes with utilization
over 30,000 in CY 2014. CPT code
31646 was added for review as part of
the family of codes, and both were
revised to reflect recent changes in how
the services are typically performed. For
CY 2018, we are proposing the RUCrecommended work RVU of 2.88 for
CPT code 31645 and the RUCrecommended work RVU of 2.78 for
CPT code 31646.
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We considered a work RVU of 2.72 for
CPT code 31645, crosswalking to CPT
code 45347 (Sigmoidoscopy, flexible;
with placement of endoscopic stent).
We have concerns regarding the
decrease in intraservice and total time
compared to the current values (we also
believe that it is important to note how
these related codes have been affected
by the creation of separately billable
codes for moderate sedation (see CY
2017 PFS final rule (81 FR 80339)). The
RUC-recommended values CPT code
31645 higher than CPT code 31622
(Bronchoscopy, rigid or flexible,
including fluoroscopic guidance, when
performed; diagnostic, with cell
washing, when performed), which is the
base procedure for this wider group of
codes. We agree that CPT code 31645
should be valued at a higher work RVU
than CPT code 31622, however, we are
seeking comment on whether the work
of moderate sedation was inadvertently
included in the development of the
recommended work RVU. We note that
as part of the CY 2017 PFS final rule (81
FR 80339), we finalized separate
payment for moderate sedation.
Following the creation of separately
billable codes for moderate sedation,
CPT code 31622 is currently valued at
a work RVU of 2.53, not 2.78 as it was
previously valued, and we do not
believe it would be appropriate to
continue to value CPT code 31645 as
though moderate sedation was still an
inherent part of the work of this service.
As a result, we considered a direct
crosswalk to CPT code 45347, which
has the same intraservice time and 8
additional minutes of total time, at a
work RVU of 2.72.
We considered a work RVU of 2.53 for
CPT code 31646, crosswalking to CPT
code 31622 (Dx bronchoscope/wash).
The RUC recommendation for CPT code
31646 indicated that the code was
comparable to CPT code 31622, since
they share the same intraservice time
and similar total time, and that the
recommended work RVU of 2.78 for
CPT code 31646 was equal to the work
RVU of CPT code 31622 before the CY
2017 changes to reporting of moderate
sedation. We agree with the survey
participants that these two codes are
comparable to one another, but have
concerns about valuation of CPT code
31646 using a cross reference to a code
that included moderate sedation. We
considered crosswalking CPT code
31646 (Bronchoscopy reclear airway)
using the current CY 2017 valuation for
CPT code 31622 (a work RVU of 2.53).
For the direct PE inputs, we are
proposing to remove the oxygen gas
(SD084) from CPT code 31645. This
supply is included in the separately
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billable moderate sedation codes, and
we are proposing to remove the oxygen
gas as recommended by the RUC’s PE
Subcommittee as part of the removal of
oxygen from non-moderate sedation
post-procedure monitoring codes. We
are proposing to remove the equipment
time for the IV infusion pump (EQ032)
from CPT code 31645. We do not agree
that there would typically be a need for
a separate infusion pump in CPT code
31645, as the infusion pump is
contained in the separately reportable
moderate sedation codes. We are also
proposing to remove the equipment
time for the CO2 respiratory profile
monitor (EQ004) and the mobile
instrument table (EF027) from CPT code
31645. These equipment items are not
contained in the current composition of
the code, and there was no rationale
provided in the RUC recommendations
for their inclusion. As a result, we do
not believe that their use would be
typical for CPT code 31645.
We are proposing to increase the
equipment time for the flexible
bronchoscopy fiberscope (ES017) for
CPT code 31645 consistent with
standard equipment times for scopes.
We are also proposing to increase the
equipment time for the Gomco suction
machine (EQ235) and the power table
(EF031) consistent with standard
equipment times for non-highly
technical equipment.
For CY 2018, we are proposing the
RUC-recommended work RVUs for both
codes in this family and are seeking
comment on whether we should finalize
refined values consistent with the
implementation of separately billable
codes for moderate sedation.
(11) Cryoablation of Pulmonary Tumor
(CPT Codes 32998 and 32X99)
For CY 2018, the CPT Editorial Panel
modified the descriptor for CPT code
32998 (Ablation therapy for reduction or
eradication of 1 or more pulmonary
tumor(s) including pleura or chest wall
when involved by tumor extension,
percutaneous, including imaging
guidance when performed, unilateral;
radiofrequency) to include imaging
guidance. In addition, the panel deleted
Category III CPT Code 0304T and
replaced it with a new CPT code 32X99,
to describe ablation therapy for
reduction of pulmonary tumor using
cryoablation with imaging guidance. For
CY 2018, we are proposing the RUCrecommended work RVUs for CPT
codes 32998 (a work RVU of 9.03) and
32X99 (a work RVU of 9.03).
However, we have concerns about the
descriptions of the codes and the
recommended valuations assuming that
imaging guidance is inherent to the
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procedure. Based on our analysis of
claims data from 2014, existing CPT
code 32998 is currently reported with
one of the three imaging guidance codes
(CPT codes 76940, 77013, or 77022) less
than 50 percent of the time. We seek
comment on whether there is additional
information that would help explain
why the codes are being bundled
despite what is reflected in the
Medicare claims data. We considered a
work RVU of 7.69 for CPT code 32998,
that included approximately one half
the value of the imaging guidance in the
new codes that describe the work of
both the procedure and the image
guidance (that is, the sum of the current
work RVU for CPT code 32998 and onehalf of the work RVU for CPT code
77013 (the imaging guidance code most
frequently billed with CPT code 32998
according to 2014 claims data)). We
applied the same general rationale
regarding the use of imaging guidance
for new CPT code 32X99. Since the RUC
recommended identical work RVUs for
these codes, we also considered a work
RVU of 7.69 for CPT 32X99.
For CPT codes 32998 and 32X99, we
are proposing to use the RUCrecommended direct PE inputs with
standard refinements.
For CY 2018, we are proposing the
RUC-recommended work RVUs and
direct PE inputs for both codes and are
seeking comment on our proposed and
alternative values.
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(12) Artificial Heart System Procedures
(CPT Codes 339X1, 339X2, and 339X3)
For CY 2018, the CPT Editorial Panel
deleted Category III CPT Codes 0051T
through 0053T and created CPT codes
339X1, 339X2, and 339X3 to report
artificial heart system procedures. We
are proposing the RUC-recommended
work RVU of 49.00 for CPT code 339X1,
and proposing to assign contractorpriced status to CPT codes 339X2 and
339X3 as recommended by the RUC.
We considered assigning contractorpriced status for CPT code 339X1. We
have concerns regarding the accuracy of
the RUC-recommended work valuation
for CPT code 339X1, due to its low
utilization and the resulting difficulties
in finding enough practitioners with
direct experience of the procedure for
the specialty societies to survey. We
seek comment on the sufficiency of the
survey data, especially since new
technologies and those with lower
utilization are typically contractorpriced. For CY 2018, we are proposing
the RUC-recommended work RVUs for
CPT code 339X1. We are seeking
comment on alternative pricing for this
CPT code 339X1.
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We are not proposing any direct PE
inputs, as we did not receive RUCrecommended PE information for CPT
codes 339X1, 339X2, and 339X3. These
three codes will be placed on the RUC’s
new technology list and will be rereviewed by the RUC in 3 years.
(13) Endovascular Repair Procedures
(CPT Codes 34X01, 34X02, 34X03,
34X04, 34X05, 34X06, 34X07, 34X08,
34X09, 34X10, 34X11, 34X12, 34X13,
34812, 34X15, 34820, 34833, 34834,
34X19, and 34X20)
The CPT/RUC joint workgroup on
codes recommended in October 2015 to
bundle endovascular abdominal aortic
aneurysm repair (EVAR) codes together
with radiologic supervision and
interpretation codes, since these codes
were typically reported together at least
50 percent of the time. The CPT
Editorial Panel bundled these services
together in September 2016, creating 16
new codes, revising four existing codes,
and deleting 14 other codes related to
endovascular repair procedures.
We are proposing the RUCrecommended work RVUs for all 20
codes in this family. We are proposing
a work RVU of 23.71 for CPT code
34X01, a work RVU of 36.00 for CPT
code 34X02, a work RVU of 26.52 for
CPT code 34X03, a work RVU of 45.00
for CPT code 34X04, a work RVU of
29.58 for CPT code 34X05, a work RVU
of 45.00 for CPT code 34X06, a work
RVU of 22.28 for CPT code 34X07, a
work RVU of 36.50 for CPT code 34X08,
a work RVU of 6.50 for CPT code 34X09,
a work RVU of 15.00 for CPT code
34X10, a work RVU of 6.00 for CPT code
34X11, a work RVU of 12.00 for CPT
code 34X12, a work RVU of 2.50 for CPT
code 34X13, a work RVU of 4.13 for CPT
code 34812, a work RVU of 5.25 for CPT
code 34X15, a work RVU of 7.00 for CPT
code 34820, a work RVU of 8.16 for CPT
code 34833, a work RVU of 2.65 for CPT
code 34834, a work RVU of 6.00 for CPT
code 34X19, and a work RVU of 7.19 for
CPT code 34X20.
We are also proposing the RUCrecommended direct PE inputs without
refinement for all 20 codes in the
family.
We considered a work RVU of 32.00
for CPT code 34X02 based on the survey
25th percentile, and further supported
with a crosswalk to CPT code 48000
(Placement of drains, peripancreatic, for
acute pancreatitis), which has the same
intraservice time of 120 minutes and a
work RVU of 31.95. When we compared
the RUC-recommended work RVU to
similar codes valued under the PFS, we
were unable to find any 90-day global
services with 120 minutes of
intraservice time and approximately 677
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minutes of total time that had a work
RVU greater than 36.00.
We considered a work RVU of 40.00
for CPT code 34X04 based on the survey
25th percentile, crosswalking to CPT
code 33534 (Coronary artery bypass,
using arterial graft(s); 2 coronary arterial
grafts) which has a work RVU of 39.88.
CPT code 33534 has 193 minutes of
intraservice time, but a lower total time
of 717 minutes. When we compared the
RUC-recommended work RVU for CPT
code 34X04 to similar codes paid under
the PFS, we were unable to find any 90day global services with 180 minutes of
intraservice time and approximately 737
minutes of total time that had a work
RVU greater than 45.00.
We considered a work RVU of 40.00
for CPT code 34X06 based on the survey
25th percentile. CPT code 34X06 has
nearly identical time values to CPT code
34X04, with 2 fewer minutes of
intraservice time and total time, and the
RUC-recommended work RVU was the
same for both of these codes. The survey
respondents also believe that these two
codes had a comparable amount of
work, as the survey 25th percentile
work RVU is 40.00 for both codes.
We considered a work RVU of 30.00
for CPT code 34X08 based on the survey
25th percentile and seek comment on
whether a work RVU of 30.00 would
improve relativity among the codes in
this family. CPT code 34X08 has
identical intraservice and total times as
CPT code 34X02. However, we note that
the RUC-recommended work RVU of
36.50 for CPT code 34X08 is higher than
the RUC-recommended work RVU of
36.00 for CPT code 34X02. This is the
inverse of the relationship between CPT
codes 34X07 and 34X01, which describe
the same procedures in a non-emergent
state when a rupture does not take
place. CPT code 34X07 has a RUCrecommended work RVU of 22.28 while
CPT code 34X01 has a RUCrecommended work RVU of 23.71. We
seek comment on whether the RUCrecommended work RVUs would create
a rank order anomaly within the family
by reversing the relationship between
these paired codes when performed in
an emergent state. We note that if CPT
codes 34X08 and 34X02 were valued at
the survey 25th percentile, this potential
rank order anomaly disappears; in this
scenario, we considered valuing CPT
code 34X08 at a work RVU of 30.00 and
CPT code 34X02 at a work RVU of
32.00. We seek comment on whether
these alternative work values would
improve relativity with the RUCrecommended work RVUs for CPT code
34X07 (22.28) and CPT code 34X01
(23.71), with an increment of
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approximately 1.50 to 2.00 RVUs
between the two code pairs.
For the eight remaining codes that
describe endovascular access
procedures, we considered assignment
of a 0-day global period, instead of the
RUC-recommended add-on (ZZZ) global
period and subsequently adding back
the preservice and immediate
postservice work time, and increasing
the work RVU of each code accordingly
using a building block methodology. We
note that as add-on procedures, these
eight codes would not be subject to the
multiple procedure payment discount.
We are concerned that the total payment
for these services will be increasing in
the aggregate based on changes in
coding that alter MPPR adjustments,
despite the information in the surveys
that reflects a decrease in the
intraservice time required to perform
the procedures, and a decrease in their
overall intensity as compared to the
current values.
We considered a work RVU of 3.95 for
CPT code 34X13, based on the RUCrecommended work RVU of 2.50 plus an
additional 1.45 work RVUs. This
additional work results from the
addition of 38 total minutes of
preservice work time and 30 minutes of
postservice work time based on a
crosswalk to CPT code 37224
(Revascularization, endovascular, open
or percutaneous, femoral, popliteal
artery(s), unilateral; with transluminal
angioplasty) as valued by using the
building block methodology. Using the
same method, we considered a work
RVU of:
• 6.48 for CPT code 34812 based on
maintaining the current 75 minutes of
preservice work time and the current 30
minutes of postservice work time, with
a total work RVU of 2.35, added to the
RUC-recommended work RVU of 4.13;
• 7.53 for CPT code 34X15 with the
addition of 75 minutes of preservice
work time and 27 minutes of postservice
work time to match CPT code 34833;
• 9.46 for CPT code 34820 based on
maintaining the current 80 minutes of
preservice work time and the current 30
minutes of postservice work time;
• 10.44 for CPT code 34833 based on
maintaining the current 75 minutes of
preservice work time and the current 27
minutes of postservice work time;
• 5.00 for CPT code 34834 based on
maintaining the current 70 minutes of
preservice work time and the current 35
minutes of postservice work time;
• 8.35 for CPT code 34X19 with the
addition of 70 minutes of preservice
work time and 35 minutes of postservice
work time to match CPT code 34834;
and
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• 9.47 for CPT code 34X20 with the
addition of 75 minutes of preservice
work time and 27 minutes of postservice
work time to match CPT code 34833.
(14) Selective Catheter Placement (CPT
Codes 36215, 36216, 36217, and 36218)
CPT code 36215 was identified as
potentially misvalued on a screen of
Harvard-valued codes with utilization
over 30,000 in CY 2014, as well as on
a screen of high expenditure services
across specialties with Medicare
allowed charges of over $10 million.
CPT codes 36216, 36217, and 36218
were added to the family to be reviewed
together with CPT code 36215.
We are proposing the RUCrecommended work RVUs for each code
in this family as follows: A work RVU
of 4.17 for CPT code 36215, a work RVU
of 5.27 for CPT code 36216, a work RVU
of 6.29 for CPT code 36217, and a work
RVU of 1.01 for CPT code 36218.
We also considered refinements to the
intraservice work time for CPT code
36217 from 60 minutes to 50 minutes,
consistent with the RUC’s usual use of
the survey median intraservice work
time. We have concerns that the use of
the recommended survey 75th
percentile intraservice work time will
not be clinically appropriate for this
code, as the 75th percentile time was
identical for both CPT code 36216 and
36217, and therefore, the use of this
value would not preserve the
incremental, linear consistency between
the work RVU and the intraservice time
within the family.
For the direct PE inputs, we are
proposing to refine the clinical labor
time for the ‘‘Post-procedure doppler
evaluation (extremity)’’ activity from 3
minutes to 1 minute for CPT codes
36215, 36216, and 36217. We believe
that 1 minute would be more typical for
this task, as the practitioner would be
able to quickly evaluate if there was an
issue with the extremity because there
would be visual signs of arterial
insufficiency resulting from the
procedure.
We are proposing to remove the
equipment time for the mobile
instrument table (EF027) from CPT
codes 36215, 36216, and 36217. We
believe that the mobile instrument table
would be used for moderate sedation,
which was removed from these
procedures in CY 2017 (see CY 2017
PFS final rule (81 FR 80339)). While we
recognize that 180 minutes of postprocedure monitoring time remains in
these codes during which the stretcher
(EF018), IV infusion pump (EQ032), and
3-channel ECG (EQ011) would remain
in use, we do not agree that the mobile
instrument table would typically be in
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use during this period of monitoring. As
a result, we are proposing to remove this
equipment time from these three codes.
While we remain concerned about the
use of the survey 75th percentile
intraservice work time for CPT code
36217, for CY 2018, we are proposing
the RUC-recommended work RVUs for
each code in this family and seek
comment on whether our alternative
values would be more appropriate.
(15) Treatment of Incompetent Veins
(CPT Codes 36470, 36471, 364X3,
364X4, 364X5, and 364X6)
In September 2016, the CPT Editorial
Panel created four new codes to
describe the treatment of incompetent
veins, and revised existing CPT codes
36470 and 36471. These six codes were
reviewed together as part of the same
family of procedures. For CY 2018, we
are proposing the RUC-recommended
work RVU for all six codes as follows:
A work RVU of 0.75 for CPT code
36470, a work RVU of 1.50 for CPT code
36471, a work RVU of 3.50 for CPT code
364X3, and a work RVU of 1.75 for CPT
code 364X4, a work RVU of 2.35 for CPT
code 364X5, and a work RVU of 3.00 for
CPT code 364X6.
We considered a work RVU of 4.38 for
CPT code 364X3, which would have
been based on the RUC-recommended
work RVU of 3.50 plus half of the RUCrecommended work RVU of CPT code
364X4. We also considered assigning
CPT code 364X4 a status indicator of
‘‘bundled.’’ The services that would be
reported using CPT codes 364X3 and
364X4 in CY 2018, are currently
reported with unlisted CPT code 37799
(Unlisted procedure, vascular surgery).
We have concerns about the frequency
that the current services include
treatment of an initial vein (CPT code
364X3) as compared to the treatment of
initial and subsequent veins (CPT codes
364X3 and 364X4 together). It may be
more accurate to describe these services
through the use of a single code, as in
the rest of this code family, instead of
a base code and add-on code pair.
Under this potential scenario, we looked
at the RUC-recommended crosswalk and
noted that the add-on CPT code 364X4
was estimated to be billed 50 percent of
the time together with CPT code 364X3.
We therefore considered adding half of
the RUC-recommended work RVU of
CPT code 364X4 (0.88) to the RUCrecommended work RVU of CPT code
364X3 (3.50), resulting in a work RVU
of 4.38.
We are proposing to remove the 2
minutes of clinical labor for the ‘‘Setup
scope’’ (CA015) activity and add the
same 2 minutes of clinical labor for the
‘‘Prepare room, equipment and
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supplies’’ (CA013) activity for CPT
codes 364X3, 364X5, and 364X6. The
RUC-recommended materials stated that
these 2 minutes were a proxy for setting
up the ultrasound machine, and we
believe that this 2 minutes is more
accurately described by the ‘‘Prepare
room, equipment and supplies’’ (CA013)
activity code, since there is no scope
equipment utilized in these procedures.
We are proposing to maintain the
Vascular Tech (L054A) clinical labor
type for these 2 minutes. We are also
proposing to refine the clinical labor for
the ‘‘Check dressings, catheters,
wounds’’ (CA029) activity for CPT codes
36470, 36471, 364X3, 364X5, and
364X6, consistent with the standard
times for this clinical labor activity.
We are proposing to remove the six
individual 4x4 sterile gauze (SG055)
supplies and replace them with a 4x4
sterile gauze pack of 10 (SG056) for CPT
codes 36470, 36471, 364X3, 364X5, and
364X6. The pack of 10 sterile gauze is
cheaper than six individual pieces of
sterile gauze, and we do not agree that
it would be typical to pay a higher cost
for fewer supplies. We are also
proposing to create three new supply
codes in response to the invoices
submitted for this family of codes. We
are proposing to establish a price of
$1495 for the Venaseal glue (SD323)
supply, a price of $3195 for the
Varithena foam (SD324) supply, and a
price of $40 for the Varithena admin
pack (SA125) supply.
We are proposing to adjust the
equipment times for the surgical light
(EF014), the power table (EF031), and
the portable ultrasound unit (EQ250) for
CPT codes 364X3, 364X5, and 364X6
consistent with the standards for nonhighly technical equipment and to
reflect the changes in the clinical labor
described in this section of the proposed
rule.
While we remain concerned about the
creation of a base code and add-on code
pairing (CPT codes 364X3 and 364X4)
out of services that are currently
reported using an unlisted code, for CY
2018, we are proposing the RUCrecommended work RVUs for each code
in this family and are seeking comment
on whether our alternative values would
be more appropriate.
(16) Therapeutic Apheresis (CPT Codes
36511, 36512, 36513, 36514, 36516, and
36522)
CPT code 36516 was nominated as
potentially misvalued in the CY 2016
PFS proposed rule. The CPT Editorial
Panel deleted CPT code 36515 and
made revisions to CPT code 36516 to
include immunoabsorption. CPT codes
36511, 36512, 36513, 36514, and 36522
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were added to CPT code 36516 to be
reviewed together as part of the
therapeutic apheresis family.
For CY 2018, we are proposing the
RUC-recommended work RVU for all six
codes in the family as follows: A work
RVU of 2.00 for CPT code 36511, a work
RVU of 2.00 for CPT 36512, a work RVU
of 2.00 for CPT code 36513, a work RVU
of 1.81 for CPT code 36514, a work RVU
of 1.56 for CPT code 36516, and a work
RVU of 1.75 for CPT code 36522.
We are proposing to use the RUCrecommended direct PE inputs for these
codes without refinement. We
considered refining the clinical labor
time for the ‘‘Prepare room, equipment,
supplies’’ activity from 20 minutes to 10
minutes for CPT codes 36514 and
36522, and from 30 minutes to 10
minutes for CPT code 36516. We also
considered refining the clinical labor for
the ‘‘Prepare and position patient/
monitor patient/set up IV’’ activity from
15 minutes to 10 minutes for these same
three codes. In both cases, we
considered maintaining the current
clinical labor time for CPT codes 36514
and 36516, and adjusting the clinical
labor time for CPT code 36522 to match
the other two codes in the family. We
have concerns about the lack of a
rationale provided for these changes in
clinical labor time, and whether these
clinical labor tasks would typically
require this additional time.
We are proposing the RUCrecommended work RVUs and to use
the RUC-recommended direct PE inputs
for each code in this family and seeking
comment on whether our alternative
values would be more appropriate. We
are also seeking comment on whether
these procedures are creating a new
point of venous access or utilizing a
previously placed access.
(17) Insertion of Catheter (CPT Codes
36555, 36556, 36620, and 93503)
CPT code 36556 was identified as part
of a screen of high expenditure services
with Medicare allowed charges of $10
million or more that had not been
recently reviewed. CPT codes 36555,
36620, and 93503 were added for review
as part of the code family. We are
proposing the RUC-recommended work
RVUs for each code in this family as
follows: A work RVU of 1.93 for CPT
code 36555, a work RVU of 1.75 for CPT
code 36556, a work RVU of 1.00 for CPT
code 36620, and a work RVU of 2.00 for
CPT code 93503.
We are proposing to remove the
clinical labor time for the ‘‘Monitor pt.
following procedure’’ activity and the
equipment time for the 3-channel ECG
(EQ011) for CPT code 36555. CPT code
36555 no longer includes moderate
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sedation as part of the procedure (see
CY 2017 PFS final rule (81 FR 80339).
We are proposing to remove the direct
PE inputs related to moderate sedation
from CPT code 36555 as they would
now be included in the separately
reported moderate sedation services. We
are also proposing to refine the
equipment times for the exam table
(EF023) and the exam light (EQ168) to
reflect changes in the clinical labor
time.
(18) Insertion of PICC Catheter (CPT
Code 36569)
CPT code 36569 was identified as part
of a screen of high expenditure services
with Medicare allowed charges of $10
million or more that had not been
recently reviewed. For CY 2018, we are
proposing the RUC-recommended work
RVU of 1.70 for CPT code 36569.
We are proposing to remove the
equipment time for the exam table
(EF023), as this equipment item is a
component part of the radiographicfluoroscopic room (EL014) included in
CPT code 77001 (Fluoroscopic guidance
for central venous access device
placement, replacement (catheter only
or complete), or removal). Because CPT
code 36569 is typically billed together
with CPT code 77001, we believe that
the additional equipment time for the
exam table would be duplicative.
(19) Bone Marrow Aspiration (CPT
Codes 38220, 38221, 382X3, and 2093X)
CPT code 38221 was identified as part
of a screen of high expenditure services
with Medicare allowed charges of $10
million or more that had not been
recently reviewed. The descriptors for
CPT codes 38220 and 38221 were
revised to reflect changes in practice
patterns, and two new CPT codes
(382X3 and 2093X) were created to
more accurately describe new services
that are now available. For CY 2018, we
are proposing the RUC-recommended
work RVUs for each code in this family
as follows: A work RVU of 1.20 for CPT
code 38220, a work RVU of 1.28 for CPT
code 38221, a work RVU of 1.44 for CPT
code 382X3, and a work RVU of 1.16 for
CPT code 2093X.
We also received a recommendation
from the RUC to change the global
period for CPT codes 38220, 38221, and
382X3 from XXX global periods to 0-day
global periods, even though these codes
were surveyed under the XXX global
period. We agree with the
recommendation that for these three
particular codes, their services are more
accurately described when assigned 0day global periods as opposed to the
XXX global status. Therefore, we
propose to assign a 0-day global period
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to all three codes in this family. We
note, however, that we believe that
global period changes must be
addressed on an individual basis,
especially when the routine survey
methodologies rely on assumptions
regarding global periods for particular
codes. Subsequently, we are proposing
to refine the preservice work time from
15 minutes of evaluation time to 9
minutes of evaluation time, 1 minute of
positioning time, and 5 minutes of
scrub, dress, and wait time. We are
proposing these refinements to the work
times for these three codes to more
closely align with the preservice times
of other recently reviewed 0-day global
procedures, such as CPT code 30903
(Control nasal hemorrhage, anterior,
complex (extensive cautery and/or
packing) any method). We also note that
given our proposal to value CPT code
382X3, we are proposing to eliminate
payment using HCPCS code G0364 for
CY 2018 since the changes to the set of
CPT codes will now accurately describe
the services currently reported by
G0364. For CPT code 2093X, we
considered a work RVU of 1.00 based on
a direct crosswalk to CPT codes 64494
(Injection(s), diagnostic or therapeutic
agent, paravertebral facet
(zygapophyseal) joint (or nerves
innervating that joint) with image
guidance (fluoroscopy or CT), lumbar or
sacral; second level) and 64495
(Injection(s), diagnostic or therapeutic
agent, paravertebral facet
(zygapophyseal) joint (or nerves
innervating that joint) with image
guidance (fluoroscopy or CT), lumbar or
sacral; third and any additional level(s)).
CPT code 2093X is a global ZZZ add-on
code for CPT code 38220, and we are
concerned with maintaining relativity
among PFS services, considering that an
add-on code typically has significantly
less intraservice time and total time
compared to the base code. We
considered an alternative crosswalk to
CPT codes 64494 and 64495, which
share the same intraservice and total
time with CPT code 2093X and have a
work RVU of 1.00.
We are also proposing to refine the
clinical labor for ‘‘Lab Tech activities’’
from 12 minutes to 9 minutes for CPT
code 38220, from 7.5 minutes to 7
minutes for CPT code 38221, and from
12.5 minutes to 10 minutes for CPT
code 382X3. We are maintaining the
current time value for the two existing
codes, as we have no reason to believe
that the typical duration has increased
for these lab activities. We are assigning
10 minutes for CPT code 382X3 based
on the statement in the RUCrecommended materials for the direct
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PE inputs that this activity takes 0.5
minutes longer than it does in the
current version of CPT code 38220. We
are also proposing to remove the
breakout lines for the lab activities. We
believe that the breakout of activities
into numerous subactivities generally
tends to inflate the total time assigned
to clinical labor activities and results in
values that are not consistent with the
analogous times for other PFS services.
We considered refining the clinical
labor for ‘‘Provide preservice education/
obtain consent’’ for CPT codes 38220,
38221, and 382X3 from 12 minutes to 6
minutes. We have concerns regarding
whether 12 minutes would be typical
for education and consent prior to these
procedures, as much of the patient
education takes place following the
procedure, in the clinical labor activity
described under the ‘‘Check dressings &
wound/home care instructions’’
heading.
We are proposing the RUCrecommended work RVUs for each code
in this family and are seeking comment
on whether our alternative values would
be more appropriate.
(20) Esophagectomy (CPT Codes 43107,
43112, 43117, 432X5, 432X6, and
432X7)
CPT codes 432X5, 432X6, and 432X7
were created by the CPT Editorial Panel
to report esophagectomy via
laparoscopic and thoracoscopic
approaches. CPT codes 43107, 43112,
and 43117 were also reviewed as part of
the family with the three new codes.
CPT code 43112 was revised to clarify
the nature of the service being
performed. We are proposing the RUCrecommended work RVUs and work
times for all six codes in the family as
follows: A work RVU of 52.05 for CPT
code 43107, a work RVU of 62.00 for
CPT code 43112, a work RVU of 57.50
for CPT code 43117, a work RVU of
55.00 for CPT code 432X5, a work RVU
of 63.00 for CPT code 432X6, and a
work RVU of 66.42 for CPT code 432X7.
We are also proposing the RUCrecommended work times for all six
codes in this family. We considered
removing 20 minutes from the
preservice evaluation work time from all
six of the codes in this family. We have
concerns as to whether this additional
evaluation time should be included for
surgical procedures, due to the lack of
evidence indicating that it takes longer
to review outside imaging and lab
reports for surgical services than for
non-surgical services. We also
considered refining the preservice
positioning work time and the
immediate postservice work time for all
six of the codes in this family consistent
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with standard preservice and
postservice work times allocated to
other PFS services.
We have concerns about the presence
of two separate surveys conducted for
the three new codes. We note that CPT
codes 432X5, 432X6, and 432X7 were
surveyed initially in January 2016, and
then were surveyed again in October
2016 together with CPT codes 43107,
43112, and 43117 due to concerns about
the description of the typical patient in
the original vignette and a change in the
codes on the reference service list (RSL).
We note that CPT codes 432X5 and
432X6 had the same median intraservice
time on both surveys, while CPT code
432X7 had a median intraservice time
that was an hour longer on its second
survey (420 minutes) as compared to its
first survey (360 minutes). We also note
that the total survey time for CPT code
432X5 decreased from 1058 minutes in
the first survey to 972 minutes in the
second survey, while the median work
RVU increased from 50.00 to 65.00. We
do not understand how the survey
median intraservice time could increase
so significantly from the first survey to
the second survey for CPT code 432X7,
or how the surveyed times for CPT code
432X5 could be decreasing while the
work RVU was simultaneously
increasing by 15.00 work RVUs.
Based on our analysis, it appears that
the accompanying RSL is the main
difference between the two surveys; the
codes on the initial RSL had a median
work RVU of 44.18, while the codes on
the second RSL had a median work RVU
of 59.64. This increase of 15.00 work
RVUs between the two RSLs that
accompanied the surveys appears to
account for the increase in the work
RVUs for the three new codes. We are
concerned that the second survey may
have overestimated the work required to
perform these procedures, as the 25th
percentile work RVU of the second
survey is higher than the median work
RVU of the initial survey for all three
codes, despite no change in the median
intraservice work time for CPT codes
432X5 and 432X6.
Given these concerns, we considered
a work RVU of 50.00 for CPT code
432X5, a work RVU of 60.00 for CPT
code 432X6, and a work RVU of 61.00
for CPT code 432X7, by using the survey
median work RVU from the first survey
for the three new codes. For CPT codes
43107 and 43117, we considered
employing the intraservice time ratio
between the laparoscopic version of the
procedure represented by the new code
and the open version of the same
procedure represented by the existing
code.
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We considered a work RVU of 45.00
for CPT code 43107 based on the
intraservice time ratio with CPT code
432X5 and a work RVU of 55.00 for CPT
code 43117 based on the intraservice
time ratio with CPT code 432X6. CPT
code 43107 has 270 minutes of
intraservice time as compared with 300
minutes of intraservice time for CPT
code 432X5, which produces a ratio of
0.9, and when multiplied by a work
RVU of 50.00 (CPT code 432X5), results
in the proposed work RVU of 45.00. We
considered using the same methodology
for CPT codes 43117 and 432X6.
Finally, we considered a work RVU of
58.94 for CPT code 43112 based on a
direct crosswalk to CPT code 46744
(Repair of cloacal anomaly by
anorectovaginoplasty and urethroplasty,
sacroperineal approach). We note that
the intraservice time ratio when applied
to CPT codes 43112 and 432X7, the
paired McKeown esophagectomy
procedures, would have produced a
potential work RVU of 52.29, creating a
rank order anomaly within the family by
establishing a higher work RVU for CPT
code 43117 than CPT code 43112, and
are concerned with whether this is an
appropriate valuation for the code. We
are seeking comment on whether the
alternative work RVUs that we
considered may reflect the relative
difference in work more accurately
between the six codes in the family. We
note, for example, that these valuations
correct the rank order anomaly between
CPT codes 43112 and 43121 as noted in
the RUC recommendations.
We are proposing the RUCrecommended direct PE inputs for all
six codes in the family without
refinement. We considered changing the
preservice clinical labor type for all six
codes from an RN (L051) to an RN/LPN/
MTA blend (L037D). We have concerns
about whether the use of RN clinical
labor would be typical for filling out
referral forms or for scheduling space
and equipment in the facility. We also
considered removing the additional
clinical labor time for the ‘‘Additional
coordination between multiple
specialties for complex procedures (eg,
tests, meds, scheduling)’’ activity,
consistent with preservice standards for
codes with 90-day global periods. We
are concerned that this time would not
typically be included in non-surgical
procedures performed by other
specialties even when additional
coordination is required.
We are seeking comment regarding
the changes in the valuation between
the two surveys, the preservice and
immediate postservice work times, and
the RN staffing type employed for
routine preservice clinical labor.
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(21) Transurethral Electrosurgical
Resection of Prostate (CPT Code 52601)
CPT code 52601 appeared on a screen
of potentially misvalued codes which
indicated that it was performed less
than 50 percent of the time in the
inpatient setting, yet included inpatient
hospital E/M services within the global
period. For CY 2018, we are proposing
the RUC-recommended work RVU of
13.16 for CPT code 52601 and proposing
to use the RUC-recommended direct PE
inputs without refinements.
We considered a work RVU of 12.29
for CPT code 52601 based on a direct
crosswalk to CPT code 58541
(Laparoscopy, surgical, supracervical
hysterectomy, for uterus 250 g or less),
which is one of the reference codes. CPT
code 58541 may potentially be a more
accurate crosswalk for CPT code 52601
than the RUC-recommended direct
crosswalk to CPT code 29828
(Arthroscopy, shoulder, surgical; biceps
tenodesis). Although all three of these
codes share the same intraservice time
of 75 minutes, CPT code 58541 is a
closer match in terms of the total time
at only 10 minutes difference. CPT code
58541 also shares the same
postoperative office visits as CPT code
52601, a pair of CPT code 99213 office
visits, while CPT code 29828 also
contains two CPT code 99212 office
visits that are not present in the
reviewed code.
We note that if we were to use a
reverse building block methodology for
CPT code 52601 and subtract out the
value of the E/M visits being removed,
the proposed work RVU would be 11.21.
We are not proposing this work RVU,
however, because as we noted in the CY
2017 PFS final rule (81 FR 80274), 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 and building block methodologies
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. For CPT
code 52601, we are concerned as to how
the RUC-recommended derived
intensity of the procedure could be
increasing by 30 percent over the
current derived intensity, while at the
same time the typical site of service is
changing from inpatient to outpatient
status. In other words, if it is now
typical for CPT code 52601 to be
performed on an outpatient basis, then
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we would generally expect the intensity
of the procedure to be decreasing, not
increasing. We considered a work RVU
of 12.29 for CPT code 52601 based on
a direct crosswalk to CPT code 58541
(Lsh uterus 250 g or less), and seek
comment on whether this alternative
value might better reflect relativity.
(22) Peri-Prostatic Implantation of
Biodegradable Material (CPT Code
55X87)
In October 2016, the CPT Editorial
Panel deleted CPT Category III code
0438T and created a new CPT code
55X87 (Transperineal placement of
biodegradable material, peri-prostatic,
single or multiple injection(s), including
image guidance, when performed). For
CY 2018, we are proposing the RUCrecommended work RVU of 3.03 for
CPT code 55X87.
In reviewing the RUC
recommendations, we noted a decrease
in preservice time (30 minutes)
compared to the current value. In order
to account for this change in time, we
considered calculating the intraservice
time ratio between the key reference
code (CPT code 49411), which has an
intraservice time of 40 minutes, and the
RUC-recommended intraservice time
(30 minutes) and multiplying that
against the work RVU for CPT code
49411 (3.57), which would have
resulted in a work RVU of 2.68. A work
RVU of 2.68 would have been further
supported by a bracket of two crosswalk
codes, CPT code 65779 (Placement of
amniotic membrane on the ocular
surface; single layer, sutured) which has
a work RVU of 2.50 and CPT code 43252
(Esophagogastroduodenoscopy, flexible,
transoral; with optical endomicroscopy),
which has a work RVU of 2.96.
Compared with CPT code 55X87, these
codes have identical intraservice and
similar total times. We are seeking
comment on whether these alternative
values should be considered, especially
given the changes in time reflected in
the survey data.
We received invoices with pricing
information regarding two new supply
items: ‘‘endocavity balloon’’ and
‘‘biodegradeable material kit—
periprostatic’’. The invoice for
endocavity balloon was $399.00 and the
input price on the PE spreadsheet for
this supply item was noted as such. We
believe the input price noted on the PE
spreadsheet was an error, given that the
invoice noted that the price of $399.00
was for a box of ten and the specialty
society requested a single unit of this
supply item. Therefore, we are
proposing to use this information to
propose for supply item ‘‘endocavity
balloon’’ a price of $39.90. The invoice
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for the ‘‘biodegradeable material kit—
periprostatic’’ totaled $2850.00. We are
proposing to use this information to
propose for the supply item
‘‘biodegradeable material kit—
periprostatic’’ a price of $2850.00. We
also received an invoice with pricing
information regarding the new
equipment item ‘‘endocavitary US
probe’’ which totaled $16,146.00. We
are proposing to use this information to
propose for equipment item
‘‘endocavitary US probe’’, a per-minute
price of $0.0639. We question, given an
invoice price of $29,999.00 for this
existing equipment item EQ250
(portable ultrasound unit), whether this
equipment item includes probes. We are
seeking public comments related to
whether equipment item EQ250
(portable ultrasound) includes probes.
(23) Colporrhaphy With
Cystourethroscopy (CPT Codes 57240,
57250, 57260 and 57265)
In October 2015, CPT code 57240 was
identified by analysis of the Medicare
data from 2011–2013 that indicated that
services reported with CPT code 57240
were performed less than 50 percent of
the time in the inpatient setting, yet
include inpatient hospital E/M services
within the global period. The RUC
recommended that CPT codes 57240
(Anterior colporrhaphy, repair of
cystocele with or without repair of
urethrocele), 57250 (Posterior
colporrhaphy, repair of rectocele with or
without perineorrhaphy), 57260
(Combined anteroposterior
colporrhaphy), and 57265 (Combined
anteroposterior colporrhaphy; with
enterocele repair) be referred to the CPT
Editorial Panel. In September 2016, the
CPT Editorial Panel revised 57240,
57260 and 57265 to preclude separate
reporting of follow up
cystourethroscopy after colporrhaphy
(CPT code 52000).
For CY 2018, we are proposing the
RUC-recommended work RVUs for CPT
code 57240 (a work RVU of 10.08), CPT
code 57250 (a work RVU of 10.08), CPT
code 57260 (a work RVU of 13.25), and
CPT code 57265 (a work RVU of 15.00).
We note that there were changes in
service times reflected in the specialty
surveys compared to the RUCrecommended work RVUs for CPT code
57240. Specifically, we note that the
RUC recommended a 48 minute
decrease in total time, compared to the
specialty survey total time of 259
minutes. The difference in total time
reflected a decrease in preservice time
(29 minutes) and inpatient visits (0.5
visits = 19 minutes). We considered a
work RVU of 9.77 for CPT code 57240,
crosswalking to CPT code 50590
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(Lithotripsy, extracorporeal shock
wave), which has similar service times.
We are seeking comment on whether
CPT code 57250 would be a relevant
comparator for CPT code 57240, based
on the described elements of each
service and existing or surveyed service
times, compared to CPT code 57240.
We considered a work RVU of 11.47
for CPT code 57265, crosswalking to
CPT code 47563 (Laparoscopy, surgical;
cholecystectomy with cholangiography)
with similar service times. We seek
comment on how an alternative work
RVU of 11.47 for CPT code 57265 would
affect relativity among PFS services, and
on whether CPT code 57260 is a
relevant comparator for CPT code
57265, considering differences in the
described procedures and service times.
We are proposing the RUCrecommended direct PE inputs for CPT
codes 57240, 57250, 57260 and 57265
without refinements.
(24) Nerve Repair With Nerve Allograft
(CPT Codes 64910, 64911, 64X91 and
64X92)
The CPT Editorial Panel created two
new CPT Category I codes (64X91 and
64X92) to report the repair of a nerve
using a nerve allograft. CPT codes 64910
and 64911 were also reviewed as part of
this code family. CPT codes 64X91 and
64X92 will be placed on the new
technology list to be re-reviewed by the
RUC in 3 years to ensure correct
valuation and utilization assumptions.
For CY 2018, we are proposing the
RUC-recommended work RVUs for the
following codes: A work RVU of 10.52
for CPT code 64910, a work RVU of
14.00 for CPT code 64911, a work RVU
of 12.00 for CPT code 64X91, and a
work RVU of 3.00 for CPT code 64X92.
We noted a decrease in preservice
time (7 minutes) for CPT code 64910
and considered an alternate work RVU
of 10.15, crosswalking to CPT code
15120 (Split-thickness autograft, face,
scalp, eyelids, mouth, neck, ears, orbits,
genitalia, hands, feet, and/or multiple
digits; first 100 sq cm or less, or 1
percent of body area of infants and
children (except 15050)), which has
similar service times. We seek
comments on whether an alternative
work RVU of 10.15 for CPT code 64910
would better reflect relativity among
PFS services with similar service times.
For CPT code 64911 (Nerve repair;
with autogenous vein graft (includes
harvest of vein graft), each nerve)), we
considered a work RVU of 13.50,
crosswalking to CPT code 31591
(Laryngoplasty, medicalization,
unilateral), which has similar service
times. We seek comments on whether a
work RVU of 13.50 for CPT code 64911
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would better reflect relativity among
other PFS services with similar service
times.
The new coding structure for these
services increases granularity by
including add-on codes that describe
each strand of nerve repair. While we
recognize that additional granularity
may be important and useful for
purposes of data collection, the
advantages to Medicare for such
granularity for purposes of payment are
unclear, especially since we are
unaware of a payment-related reason for
such coding complexity. We considered
proposing a bundled status to the new
add-on codes and incorporating the
relative resources in furnishing the addon code (CPT code 64X92) into the base
code (CPT code 64X91) based on the
utilization assumptions that
accompanied the RUC
recommendations. The RUC estimated
that CPT code 64X91 would have 750
Medicare allowed services in CY 2018,
and that the corresponding add-on CPT
code 64X92 would have 150 Medicare
allowed services in CY 2018. Therefore,
the RUC estimates that CPT code 64X91
will be billed without add-on CPT code
64X92 for 80 percent (750/900) of the
Medicare allowed services, and that
CPT code 64X91 will be billed with
add-on CPT code time 64X92 for 20
percent (150/900) of the Medicare
allowed services in CY 2018. To account
for the additional work involved in 20
percent of the allowed services, we
added a work RVU of 0.60 (20 percent
of a work RVU of 3.00 for CPT code
64X92) to the work RVU of 12.00 for
CPT code 64X91, to get to an alternate
work RVU of 12.60 for CPT code 64X91
and increased the intraservice time by 6
minutes to account for the bundling of
services from CPT code 64X92. The
alternative work RVU of 12.60 would
have been further supported by a
crosswalk to CPT code 14301 (Adjacent
tissue transfer or rearrangement, any
area; defect 30.1 sq cm to 60.0 sq cm),
which has similar intraservice and total
times.
We are proposing the RUCrecommended direct PE inputs for CPT
codes 64910, 64911, 64X91 and 64X92
without refinements.
(25) CT Soft Tissue Neck (CPT Codes
70490, 70491, and 70492)
CPT codes 70490 and 70492 were
identified through the high expenditure
services across specialties with
Medicare allowed charges of $10
million or more screen. CPT code 70491
was also included for review as part of
this code family. For CY 2018, we are
proposing the RUC-recommended work
RVUs of 1.28 for CPT code 70490, 1.38
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for CPT code 70491, and 1.62 for CPT
code 70492.
For CPT code 70490, we considered a
work RVU of 1.07 based on a crosswalk
to CPT code 72125 (Computed
tomography, cervical spine; without
contrast material). CPT code 72125 is a
non-contrast CT service on a similar
anatomical area and has identical
intraservice and total times to those
recommended by the RUC for CPT code
70490. We also considered work RVUs
of 1.17 for CPT code 70491 and 1.41 for
CPT code 70492. We are seeking
comment on how relativity among other
CT services paid under the PFS would
be affected by applying the alternative
work RVUs described above for CPT
codes in this family.
(26) Magnetic Resonance Angiography
(MRA) Head (CPT Codes 70544, 70545,
and 70546)
CPT code 70544 was identified by a
screen of services across specialties with
Medicare allowed charges of $10
million or more. Subsequently, CPT
codes 70545 and 70546 were also
reviewed as part of this code family. We
are proposing the RUC-recommended
work RVUs of 1.20 for CPT code 70544,
1.20 for CPT code 70545, and 1.48 for
CPT code 70546.
We are also proposing the following
refinements to the RUC-recommended
direct PE inputs. For the service period
clinical labor activity ‘‘Provide
preservice education/obtain consent,’’
we are proposing 5 minutes for CPT
code 70544, 7 minutes for CPT code
70545, and 7 minutes for CPT code
70546 so that the times for this activity
are consistent with other magnetic
resonance (MR) services performed
without-contrast materials, withcontrast materials, and without-andwith contrast materials, respectively.
For the clinical labor task ‘‘Acquire
images,’’ we are proposing to use the
RUC-recommended clinical time of 26
minutes for CPT code 70544. We
considered proposing 20 minutes of
clinical time to maintain the relativity
among the three codes in this family
and for consistency with other MRA and
magnetic resonance imaging (MRI)
codes, which do not typically assign
more clinical labor time to this task for
services without contrast material than
for services with contrast material. We
seek comments as to the appropriate
time value for this clinical labor task.
(27) Magnetic Resonance Angiography
(MRA) Neck (CPT Codes 70547, 70548,
and 70549)
CPT code 70549 was identified
through a high expenditure screen. CPT
codes 70547 and 70748 were also
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reviewed as part of this family of codes.
We are proposing the RUCrecommended work RVUs of 1.20 for
CPT code 70547, 1.50 for CPT code
70548, and 1.80 for CPT code 70549.
We are also proposing several
refinements to the RUC-recommended
direct PE inputs for these services. For
the service period clinical labor activity
‘‘Provide preservice education/obtain
consent’’, we are proposing 5 minutes
for CPT code 70547, 7 minutes for CPT
code 70548, and 7 minutes for CPT code
70549 so that the times for this activity
are consistent with other MR services
performed without contrast material,
with contrast material, and without-andwith contrast material, respectively.
For the intraservice clinical labor task
acquire images, for CPT code 70547, we
are proposing to use the RUCrecommended 26 minutes. We
considered applying 20 minutes to this
clinical labor task, which would have
maintained consistency with the 20
minutes recommended by the RUC for
CPT code 70548 (the service that
includes with-contrast material). We are
concerned about the lack of evidence
that a non-contrast MRA would require
more clinical labor time than the withcontrast MRA service. We are seeking
comment as to the appropriate time
value for this clinical labor task.
(28) CT Chest (CPT Codes 71250, 71260,
and 71270)
CMS identified this code family
through the high expenditures screen.
We are proposing the RUCrecommended work RVUs of 1.16 for
CPT code 71250, 1.24 for CPT code
71260, and 1.38 for CPT code 71270.
For CPT code 71250, we considered
maintaining the CY 2017 work RVU of
1.02. We are concerned with the lack of
evidence that the physician time or
intensity of furnishing this service has
changed since it was last valued. In
addition, a comparison to other CT
codes indicates that the RUCrecommended work values could be
overvalued relative to other CT services
and compared to similar, non-contrast
CT studies such as CPT codes 72131
(Computed tomography, lumbar spine;
without contrast material) and 73700
(Computed tomography, lower
extremity; without contrast material),
both of which have work RVUs of 1.00.
For CPT code 71260, we considered
proposing a work RVU of 1.10 by
applying the RUC-recommended
increment between CPT code 71250 and
71260 (0.08) to CPT code 71260. For
CPT code 71270, we considered a work
RVU of 1.24 by applying the RUCrecommended increment between CPT
codes 71260 and 71270 (0.22) to CPT
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code 71270. In addition to maintaining
relatively among the codes in this
family, we considered further
supporting these alternative values
based on a comparison to other CT
studies, such as with-contrast material
CT studies, and without-and-with
contrast CT studies.
While we have concerns about the
RUC-recommended work RVUs for
these codes, for CY 2018, we are
proposing the RUC recommended work
RVUs for CPT code 71250, 71260, and
71270 and are seeking comment on
whether our alternative values would
improve relativity.
(29) MRI of Abdomen and Pelvis (CPT
Codes 72195, 72196, 72197, 74181,
74182, and 74183)
CPT codes 74182 and 72196 were
identified as part of the screen of high
expenditure services across specialties
with Medicare allowed charges of $10
million or more. CPT codes 74181,
74183, 72195, and 72197 were also
reviewed as part of this code family. We
are proposing the RUC-recommended
work RVUs of 1.46 for CPT code 72195,
1.73 for CPT code 72196, 2.20 for CPT
code 72197, 1.46 for CPT code 74181,
1.73 for CPT code 74182, and 2.20 for
CPT code 74183.
While we are proposing the RUCrecommended direct PE inputs, we
considered 30 minutes for clinical labor
task ‘‘Acquire images’’ for CPT codes
74181 and 74182, which appears to be
more consistent with the codes in this
family and more consistent with other
MR codes. We also note that for CPT
codes 74181 and 74182, the clinical
labor time for acquired images appears
to have been developed through a
consensus panel from the specialty
society over 15 years ago. Given that
these times are estimates based on
expert panel consensus rather than
survey data, we seek comments on
whether using a structure that matches
other MR code families would be more
appropriate to value these clinical labor
times.
(30) MRI Lower Extremity (CPT Codes
73718, 73719, and 73720)
CPT codes 73718 and 73720 were
identified as part of the screen of high
expenditure services, and CPT code
73719 was included for review as part
of the code family. We are proposing the
RUC-recommended work RVUs of 1.35
for CPT code 73718, 1.62 for CPT code
73719, and 2.15 for CPT code 73720.
We are also proposing the following
refinements to the RUC-recommended
direct PE inputs. For the service period
clinical labor activity ‘‘Provide
preservice education/obtain consent,’’
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we are proposing 5 minutes for CPT
code 73718, 7 minutes for CPT code
73719, and 7 minutes for CPT code
73720. Likewise, for the service period
task ‘‘Prepare room, equipment,
supplies,’’ we are proposing 3 minutes
for CPT code 73718, 5 minutes for CPT
code 73719, and 5 minutes for CPT code
73720. We are proposing these changes
to maintain consistency with other MR
services without contrast materials, with
contrast materials, and without-andwith contrast materials, respectively.
(31) Abdominal X-ray (CPT Codes
74022, 740X1, 740X2, and 740X3)
CPT codes 74000 (Radiologic
examination, abdomen; single
anteroposterior view) and 74022
(Radiologic examination, abdomen;
complete acute abdomen series,
including supine, erect, and/or
decubitus views, single view chest)
were identified via a high expenditure
screen. The CPT Editorial Panel created
CPT codes 740X1, 740X2, and 740X3 to
replace CPT codes 74000, 74010, and
74020. For CY 2018, we are proposing
the RUC-recommended work values for
these codes.
As part of their recommendations, the
RUC’s utilization crosswalk suggests
that 25 percent of services currently
reported with CPT code 74010 will be
reported with CPT code 740X2 and 75
percent will be reported with CPT code
740X3; and 75 percent of services
currently reported with CPT code 74020
will be reported with CPT code 740X2
and 25 percent will be reported with
CPT code 740X3. However, we did not
identify evidence or a rationale for these
assumptions. For purposes of
calculating the proposed RVUs, we used
an even distribution of services
previously reported as CPT codes 74010
and 74020 to CPT codes 740X2 and
740X3 instead of the RUCrecommended distribution because we
think that the services previously
reported with codes 74010 and 74020
will be reported in equal volume
between the code representing two
views and the code representing three
views. We seek comment on
information that would help us improve
on this distribution for purposes of
developing final RVUs, including
rationale for the distribution reflected in
the RUC’s utilization crosswalk.
(32) Angiography of Extremities (CPT
Codes 75710 and 75716)
This code family was identified
through the $10 million or more screen
of high expenditure services. We are
proposing the RUC-recommended work
RVUs of 1.75 for CPT code 75710 and
1.97 for CPT code 75716. We are also
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proposing to use the RUC-recommended
direct PE inputs for both CPT codes
75710 and 75716, with the following
refinements. For the clinical labor task
‘‘Technologist QC’s images in PACS,
checking for all images, reformats, and
dose page,’’ we are proposing
refinements consistent with the
standard clinical labor times for tasks
associated with the PACS Workstation.
We are also proposing to refine the
clinical labor by removing the 2 minutes
associated with the task ‘‘prepare room,
equipment, and supplies.’’ CPT codes
75710 and 75716, which represent
radiological supervision and
interpretation, are billed with codes that
include activities such as needle
placement and imaging, and the
‘‘prepare room, equipment, supplies,’’
activity will be accounted for with the
codes that are billed with these
interpretation codes.
(33) Ophthalmic Biometry (CPT Codes
76516, 76519, and 92136)
In the CY 2016 PFS final rule with
comment period, CMS identified CPT
codes 76519 and 92136 as potentially
misvalued on the high expenditure
screen. For CY 2018, we are proposing
the RUC-recommended work RVUs for
each code in this family as follows: A
work RVU of 0.40 for CPT code 76516,
a work RVU of 0.54 for CPT code 76519,
and a work RVU of 0.54 for CPT code
92136.
For both CPT codes 76519 and 92136,
the RUC recommended adding an
additional 8 minutes of immediate
postservice time for dictating the report
of the procedure for the medical record,
review and sign report, communicate
results to the patient, discussing lens
implant options for desired postoperative refractive result, and entering
an order for the intraocular lens
implant. We considered time and work
values that would not include the
additional 8 minutes of immediate
postservice time in either of these codes,
due to the concern that the additional
time may not reflect the typical case.
Were we to not include those 8 minutes,
each of these procedures would have a
total time of 14 minutes. We considered
applying the total time ratio (decrease
from 17 minutes to 14 minutes; ratio of
0.824) to the RUC-recommended work
RVU of 0.54, which would have resulted
in a work RVU of 0.44 for both CPT
codes 76519 and 92136. We are seeking
comment on whether these alternative
values would improve relativity.
(34) Ultrasound of Extremity (CPT
Codes 76881 and 76882)
The RUC identified CPT codes 76881
and 76882 for review of PE inputs. For
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CPT code 76881, we are proposing the
recommended inputs with refinements.
We are proposing to remove 1 minute
from the clinical labor task ‘‘Exam
documents scanned into PACS. Exam
completed in RIS system to generate
billing process and to populate images
into Radiologist work queue,’’ because
this code does not include any
equipment time for the PACS
workstation proxy or professional PACS
workstation. We note that the RUCrecommended inputs shift the general
ultrasound room from the PE inputs for
CPT code 76881 to the PE inputs for
CPT code 76882. We are proposing to
make this change, consistent with the
RUC recommendations. We are also
seeking comment on whether a portable
ultrasound unit would be a more
accurate PE input for both codes, given
that the dominant specialty for both of
these services is podiatry based on
available 2016 Medicare claims data.
However, we are proposing that these
codes would not be subject to the phasein of significant RVU reductions given
the significance of this shift of resource
costs between codes in the same family.
In the CY 2016 PFS final rule (80 FR
70927 through 70931), we finalized a
policy to identify services that are not
subject to the phase-in because they are
new or revised codes. We excluded as
new and revised codes those codes that
describe a different set of services in the
update year when compared to the
current year by virtue of changes in
other related codes or codes that are part
of a family with significant coding
revisions. Significant coding revisions
within a family of codes can change the
relationships among codes to the extent
that it changes the way that all services
in the group are reported, even if some
individual codes retain the same
number or, in some cases, the same
descriptor. Moving the general
ultrasound room input from CPT code
76881 to CPT code 76882 as
recommended by the RUC would
represent a significant shift in direct PE
due to the high cost nature of this
equipment item. As a result, these codes
describe different services in the update
year than in the current year, producing
a substantial revision in the valuation of
the coding. We are seeking comment on
this proposed application of the phasein policy.
(35) Radiation Therapy Planning (CPT
Codes 77261, 77262, and 77263)
CPT code 77263 was identified
through a screen of high expenditure
services across specialties. CPT codes
77261 and 77262 were included for
review. For CY 2018, we are proposing
the RUC-recommended work RVUs of
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1.30 for CPT code 77261, 2.00 for CPT
code 77262, and 3.14 for CPT code
77263.
However, we have concerns regarding
the RUC-recommended work RVUs
given the decreases in service times as
recommended by the RUC and reflected
in the survey data compared to the
current values. For CPT code 77263, we
considered a work RVU of 2.60 based on
a crosswalk to CPT code 96111
(Developmental testing, (includes
assessment of motor, language, social,
adaptive, and/or cognitive functioning
by standardized developmental
instruments) with interpretation and
report), which has an identical
intraservice time, and similar total time
to the RUC-recommended time values
for CPT code 77263. We are concerned
that despite a 15 minute decrease in
intraservice time, the RUC did not
recommend a work RVU decrease.
We note that the majority of the
utilization among the codes in this
family would be reported with CPT
code 77263. Therefore, we considered
using a work RVU of 2.60 for CPT code
77263 as a base for alternative
valuations for CPT codes 77261 and
77262 by applying the ratio of the
crosswalk work RVU of CPT code 96111
(Developmental test extend) to the RUCrecommended work RVU of CPT code
77263 (that is, 2.60/3.14 = 0.83) to the
RUC-recommended work RVU for CPT
code 77261 (that is, 0.83 × 1.30 = 1.08)
and CPT code 77262 (that is, 0.83 × 2.0
= 1.66), which would have resulted in
work RVUs of 1.08 for CPT code 77261
and 1.66 for CPT code 77262. We seek
comments on whether the alternative
valuation would be more appropriate for
these codes.
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(36) Pathology Consultation during
Surgery (CPT Codes 88333 and 88334)
CPT codes 88333 and 88334 were
surveyed for both work and PE for the
CY 2018 rule cycle. We are proposing
the RUC-recommended work RVU of
1.20 for CPT code 88333 and the RUCrecommended work RVU of 0.73 for
CPT code 88334. For the direct PE
inputs, we are proposing to remove the
clinical labor for the ‘‘Prepare room.
Filter and replenish stains and supplies
(including setting up grossing station
with colored stains)’’ activity from CPT
code 88333. This clinical labor is not
currently included in the direct PE
inputs for CPT code 88333, and we
continue to believe that this is a form of
indirect PE that is not individually
allocable to a particular patient for a
particular service. While we agree that
replenishing stains and supplies is a
necessary task, under the established
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methodology, it is more appropriately
classified as indirect PE.
We are proposing to refine the clinical
labor time for ‘‘Clean room/equipment
following procedure’’ activity for CPT
code 88333, consistent with the
standard clinical labor time assigned for
room cleaning when used by laboratory
services. We seek comments related to
the equipment time assigned to the
‘‘grossing station w-heavy duty
disposal’’ (EP015) for both CPT codes
88333 and 88334. Although the
recommended equipment time of 10
minutes maintains the current
equipment time assigned to the grossing
station, and we have no reason to
believe that this time is incorrect, it is
unclear to us how this equipment time
is derived.
(37) Tumor Immunohistochemistry
(CPT Codes 88360 and 88361)
CPT codes 88360 and 88361 appeared
on a high expenditure services screen
across specialties with Medicare
allowed charges of over $10 million. We
are proposing the RUC-recommended
work RVU of 0.85 for CPT code 88360
and the RUC-recommended work RVU
of 0.95 for CPT code 88361. We are
proposing to refine the clinical labor
time for the ‘‘Enter patient data,
computational prep for antibody testing,
generate and apply bar codes to slides,
and enter data for automated slide
stainer’’ activity for both codes,
consistent with the standard time for
this clinical labor activity across
different pathology services. For CPT
code 88361, we are also proposing to
remove the 1 minute of clinical labor
time from the ‘‘Performing instrument
calibration, instrument qc and start up
and shutdown’’ and the ‘‘Gate areas to
be counted by the machine’’ activities.
These clinical labor activities do not
appear in other recently reviewed
computer-assisted pathology codes. We
believe that these clinical labor
activities would not be typical for CPT
code 88361 and are already included in
the allocation of indirect PE consistent
with our established methodology.
We are proposing to remove the
clinical labor time for ‘‘Clean room/
equipment following procedure’’ for
CPT codes 88360 and 88361, as we
believe that this clinical labor is
duplicative of the 4 minutes of clinical
labor assigned to ‘‘Clean equipment and
work station in histology lab’’. We are
also proposing to remove the clinical
labor time for the ‘‘Verify results and
complete work load recording logs’’ and
the ‘‘Recycle xylene from tissue
processor and stainer’’ activities for CPT
codes 88360 and 88361. As we have
stated in previous rules, such as in the
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CY 2017 PFS final rule (81 FR 80319),
we believe these clinical labor activities
to be already included in the allocation
of indirect PE consistent with our
established methodology.
We are proposing to refine the
equipment time for the ‘‘Benchmark
ULTRA auto slide prep & E-Bar Label
system’’ (EP112) from 18 minutes to 16
minutes for both codes. The RUCrecommended equipment time of 18
minutes was an increase of 3 minutes
from the current EP112 equipment time
to incorporate the equipment time of the
‘‘E-Bar II Barcode Slide Label System’’
(EP113), which the recommended
materials have clarified is part of the
EP112 equipment item. We are
proposing to add 1 minute over the
current value of 15 minutes to the
EP112 equipment time to reach the
aforementioned 16 minutes, as we
believe that this would be more typical
for the slide labeling taking place.
For CPT code 88361, we are
proposing to maintain the current price
of $195,000.00 for the DNA image
analyzer (EP001) equipment, as the
submitted invoice contains a series of
unrelated items that have been crossed
out, making it difficult to determine the
cost of the equipment. We considered
refining the equipment time for the
DNA image analyzer from 30 minutes to
5 minutes. The equipment literature for
the DNA image analyzer states that the
machine can run 50 slides per hour, and
CPT code 88361 only requires 3 slides
per procedure. This works out to 3.6
minutes of equipment usage (3 slides
divided by 50 slides per hour multiplied
by 60 minutes in an hour), to which we
considered adding 1 minute for
preparing the slides. The resulting
figure of 4.6 minutes would then round
up to 5 minutes, which we considered
as the potential equipment time for
EP001 assigned to CPT code 88361. We
seek comments on additional pricing
information for the EP001 DNA image
analyzer equipment, specifically
invoices solely for this equipment
containing a rationale for each
component part, as well as the
appropriate equipment time typically
required for use in CPT code 88361.
(38) Cardiac Electrophysiology Device
Monitoring Services (CPT Codes 93279,
93281, 93282, 93283, 93284, 93285,
93286, 93287, 93288, 93289, 93290,
93291, 93292, 93293, 93294, 93295,
93296, 93297, 93298, and 93299)
As part of the CY 2016 PFS final rule
(80 FR 70914), several services in this
family (reported with CPT codes 93288,
93293, 93294, 93295, and 93296) were
identified as potentially misvalued
through the high expenditure by
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specialty screen. Seven of the 21
services in this family involve remote
monitoring of cardiovascular devices,
and two of these services (reported with
CPT codes 93296 and 93299) are valued
for practice expense only. For CY 2018,
we are proposing the RUCrecommended work RVUs for the 19
CPT codes in this family that are valued
with physician work as follows: 0.65 for
CPT code 93279, 0.77 for CPT code
93280, 0.85 for CPT code 93281, 0.85 for
CPT code 93282, 1.15 for CPT code
93283, 1.25 for CPT code 93284, 0.52 for
CPT code 93285, 0.30 for CPT code
93286, 0.45 for CPT code 93287, 0.43 for
CPT code 93288, 0.75 for CPT code
93289, 0.43 for CPT code 93290, 0.37 for
CPT code 93291, 0.43 for CPT code
93292, 0.31 for CPT code 93293, 0.60 for
CPT code 93294, 0.74 for CPT code
93295, 0.52 for CPT code 93297, and
0.52 for CPT code 93298.
For CPT code 93293, we considered a
work RVU of 0.91 (25th percentile
survey result) and seek comment on
whether this alternative work RVU for
this service would better maintain
relativity between single and dual lead
pacemaker systems and cardioverter
defibrillator services. We considered
reducing the work RVU for CPT code
93282 by 0.11 work RVUs and seek
comments on whether this alternative
value would better reflect relativity
between the single and dual lead
systems that exist within pacemaker
services and within cardioverter
defibrillator services. We also noted that
there is a difference of 0.10 work RVUs
between the RUC-recommended values
for CPT codes 93289 and 93282.
Therefore, we considered a
proportionate reduction for CPT code
93289 to a work RVU of 0.69. For CPT
code 93283, we considered a work RVU
of 0.91, consistent with the 25th
percentile from the survey results, and
seek comment on whether this value
would improve relativity.
As noted in this section of the
proposed rule, several of the CPT codes
(99392, 99294, 99295, 99297, and
99298) reviewed by the RUC in January
2017 involve remote monitoring
services for cardiac devices. We agree
with the RUC that these services are
difficult to value considering that the
monitoring duration (number of days
between 30 and 90) and the average
number of transmissions vary. We also
note that these codes were surveyed
twice, and in both cases the intraservice
and total times were considered by the
specialty societies to be inconsistent
with existing times. The RUC explained
that they extrapolated total and
intraservice time data for these codes
and warned against making
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comparisons. Without additional
information about the methods and
sources used for extrapolation, however,
we have no basis for assuming the
imputed values are of higher quality
and/or accuracy than those from the
survey. We do not agree, therefore, that
survey results should not be used as a
point of comparison in the context of
other factors, particularly when they are
used to support other considerations.
Although we are proposing the RUCrecommended work RVUs for each of
these CPT codes, we considered
alternative values. The RUC
recommended a work RVU of 0.31 for
CPT code 93293, which is 0.01 work
RVUs lower than the existing work RVU
for this code. We have concerns that the
amount of the reduction in the work
RVU recommended by the RUC may not
be consistent with the decrease in total
time of 7 minutes. We considered an
alternative crosswalk for CPT code
93293 (Pm phone r-strip device eval) (5
minutes intraservice time and 13
minutes total time) to CPT code 94726
(Pulm funct tst plethysmograp), which
has 5 minutes intraservice time and 15
minutes total time and a work RVU of
0.26. We seek comments our proposed
and alternative valuations for this code.
For CPT code 93294, we considered a
work RVU of 0.55, crosswalking from
CPT code 76706 (Us abdl aorta screen
aaa), and we seek comments on whether
it would better align with the RUCrecommended service times. We are
concerned that a work RVU of 0.60 may
not account for the difference between
existing service times and the RUCrecommended service times. Similarly,
the RUC recommended a work RVU for
CPT code 93294 of 0.60, which is 0.05
work RVUs less than the existing work
RVU. The total time for furnishing
services reported with CPT code 93294
decreased by 10 minutes, however, and
we believe this reduction in time may
not be appropriately reflected by a
decrease of 0.05 work RVUs. Compared
to services with similar total and
intraservice times, we identified CPT
code 76706 (Us abdl aorta screen aaa) as
potentially a more appropriate
crosswalk. CPT code 76706 has
identical intraservice and total service
times as CPT code 93294, with a work
RVU of 0.55. We seek comments on
whether our alternative value would
better reflect the time and intensity
involved in furnishing this service.
For CPT code 93295, we considered a
work RVU of 0.69, crosswalking to CPT
code 76586, which has identical
intraservice and total times compared to
CPT code 93295. We considered using
a work RVU of 0.69 to maintain the
differential between CPT code 93295
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and the work RVU we considered for
the previous code in this family (a work
RVU of 0.11 for CPT code 93295). We
are concerned about the decrease in
service time compared to the work RVU.
We note that the existing intraservice
time is 22.5 minutes, compared to the
RUC-recommended intraservice time of
10 minutes. We seek comments on
whether our alternative value would
better reflect the time and intensity
involved in furnishing this service.
For CPT code 93298, the RUC
recommended a work RVU of 0.52,
which is unchanged from the current
work RVU for this code. We are
concerned about that recommendation
given the reduction in both intraservice
and total time for this service. The
intraservice time decreased from 24 to 7
minutes, while total time decreased
from 44 to 17 minutes. We acknowledge
that the current times for this CPT code
and others in this family are
extrapolations. However, without
additional information about the
extrapolation of data from survey
results, we question whether the survey
results should be excluded from
consideration altogether. We considered
a work RVU of 0.37 for CPT code 93297,
crosswalking to CPT code 96446
(Chemotx admn prtl cavity). We also
considered a work RVU of 0.37 for CPT
code 93298 based on a crosswalk to CPT
code 96446, since the RUC indicated
that the work RVUs for CPT codes
93297 and 93298 should be the same.
We are seeking comment on our
proposed valuation and whether our
alternative valuation would be more
appropriate for this code.
We propose the RUC-recommended
direct PE inputs with the following
refinements. We propose to remove 2
minutes for ‘‘review charts’’ from CPT
codes 93279, 93281, 93282, 93283,
93284, 93285, 93286, 93287, 93288,
93289, 93290, 93291, and 93292 to
maintain relativity since it is not
typically incorporated for similar PFS
codes. We also propose removing 2
minutes for ‘‘complete diagnostic forms,
lab & X-ray requisitions’’ for the labor
category ‘‘med tech/asst’’ (L026A) for
these services because we believe the
same activity is being performed by
labor category RN/LPN/MTA (L037D).
We seek comments regarding whether
this row was included in error. Also for
the same group of CPT codes, we also
propose standard refinements for the
time for equipment items EF023 and
EQ198.
We propose to use the RUCrecommended direct practice expense
inputs and times for all other CPT codes
in this family (CPT codes 93293, 93294,
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93295, 93296, 93297, 93298, and 93299)
without refinement.
(39) Transthoracic Echocardiography
(TTE) (CPT Codes 93306, 93307, and
93308)
In the CY 2016 PFS final rule with
comment period (80 FR 70914), CMS
identified CPT code 93306 through the
high expenditures screen. Subsequently,
the RUC reviewed CPT codes 93307 and
93308, in addition to CPT code 93306 as
part of this family of codes that describe
transthoracic echocardiograms. For CY
2018, we are proposing the RUCrecommended work RVUs for CPT
codes 99306 (a work RVU of 1.50),
99307 (a work RVU of 0.92), and 99308
(a work RVU of 0.53), and proposing the
RUC-recommended direct PE inputs for
CPT codes 93306, 93307, and 93308
without refinement.
For CPT code 93306
(Echocardiography, transthoracic, realtime with image documentation (2D),
includes M-mode recording, when
performed, complete, with spectral
Doppler echocardiography, and with
color flow Doppler echocardiography),
we considered maintaining the CY 2017
work RVU of 1.30. The surveyed total
time for this code dropped slightly due
to changes in the immediate postservice
time. The median preservice and
intraservice time remained unchanged.
For CPT code 93307
(Echocardiography, transthoracic, realtime with image documentation (2D),
includes M-mode recording, when
performed, complete, without spectral
or color Doppler echocardiography), we
considered a work RVU of 0.80,
crosswalking to services with similar
service times (CPT codes 93880
(Extracranial bilat study), 93925 (Lower
extremity study), 93939, 93976
(Vascular study), and 93978 (Vascular
study)). The surveyed total time
dropped 3 minutes (from the
intraservice time) compared to the
existing service times for this code.
For CPT code 93308
(Echocardiography, transthoracic, realtime with image documentation (2D),
includes M-mode recording, when
performed, follow-up or limited study),
we considered a work RVU of 0.43,
crosswalking to CPT code 93292 (Wcd
device interrogate) based on similar
service times. The surveyed total time
dropped by 5 minutes (from the
intraservice time) compared to the
existing service times for this code.
For CY 2018, we are proposing the
RUC-recommended work RVUs for CPT
codes 93306, 93307, and 93308 and seek
comments on whether our alternative
values would better reflect the time and
intensity of these services.
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(40) Stress Transthoracic
Echocardiography (TTE) Complete (CPT
Codes 93350 and 93351)
CPT code 93351 was identified as
potentially misvalued and the RUC
reviewed CPT code 93350 as part of the
same code family. For CY 2018, we are
proposing the RUC-recommended work
RVUs for CPT codes 93350 (a work RVU
of 1.46) and 93351 (a work RVU of 1.75).
We are proposing the following
refinements to the RUC-recommended
direct PE inputs for CPT codes 93350
and 93351. For both codes, we applied
the standard formula in developing the
minutes for equipment item ED053
(professional PACS workstation), which
results in 18 minutes for CPT code
93350 and 25 minutes for CPT code
93351. We are also proposing standard
clinical labor times for providing
preservice education/obtaining consent.
We are not proposing to include clinical
labor time for the task setup scope since
there is no scope used in the procedure
and we do not agree with the RUC’s
statement that this replicates 5 minutes
in CPT code 93015 when the RN
prepares patients for 10-lead ECG. We
have found that there is no
corresponding time of 5 minutes for
setup scope in the PE inputs for CPT
code 93015. We are proposing
refinements to the equipment time for
ED050 (PACS workstation proxy) for
CPT code 93351, consistent with our
standard equipment times for PACS
Workstation Proxy.
(41) Peripheral Artery Disease (PAD)
Rehabilitation (CPT Code 93668)
We have issued a national coverage
determination (NCD) for Medicare
coverage of supervised exercise therapy
(SET) for the treatment of peripheral
artery disease (PAD). Information
regarding the NCD can be found on the
CMS Web site at https://www.cms.gov/
medicare-coverage-database/details/
nca-decision-memo.aspx?NCAId=287.
For the remainder of CY 2017, we
anticipate that CPT code 93668,
currently assigned PROCSTAT N
(noncovered service by Medicare), will
be payable before the end of CY 2017,
retroactive to the effective date of the
NCD to implement payment under the
NCD.
For CY 2018, we are proposing to
make payment for Medicare-covered
SET for the treatment of PAD, consistent
with the NCD, reported with CPT code
93668. For CPT code 93668, we are
proposing to use the most recent RUCrecommended work and direct PE
inputs. We are also seeking comment on
the coding structure and valuation
assumptions. Since the RUC has not
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reviewed CPT code 93668 since 2001,
we seek comments on the direct PE
inputs assigned to the code, which
appear in the direct PE input database.
We also note that CPT code 93668 is a
PE only code and does not include
physician work.
CPT prefatory language states that
CPT code 93668 may be separately
reported with appropriate E/M services,
including office and/or outpatient
services (CPT codes 99201 through
99215), initial hospital care (CPT codes
99221 through 99223), subsequent
hospital care (CPT codes 99231 through
99233), and critical care services (CPT
codes 99291 through 99292). Our
understanding of CPT’s prefatory
language is that these E/M codes may
only be billed when review or exam of
the patient is medically indicated and
must conform to all existing E/M
documentation requirements. E/M visit
codes should not be billed to account
for supervision of SET for the treatment
of PAD by a physician or other qualified
healthcare practitioner. We seek
comments on whether to develop
professional coding to reflect the
supervision of clinical staff, and on the
potential overlap with CPT code 99211
(Office or other outpatient visit for the
evaluation and management of an
established patient, that may not require
the presence of a physician or other
qualified health care professional.
Usually, the presenting problem(s) are
minimal. Typically, 5 minutes are spent
performing or supervising these
services.) and any distinctions between
time spent by clinical staff for CPT code
99211 and time spent by clinical staff
for CPT code 93668.
(42) Pulmonary Diagnostic Tests (CPT
Codes 94621, 946X2, and 946X3)
CPT code 94620 was identified as part
of a screen of high expenditure services
with Medicare allowed charges of $10
million or more that had not been
recently reviewed. CPT code 94621 was
added to the family for review. The CPT
Editorial Panel deleted CPT code 94620
and split it into two new codes, CPT
codes 946X2 and 946X3, to describe two
different tests commonly performed for
evaluation of dyspnea. We are
proposing the RUC-recommended work
RVUs of 1.42 for CPT code 94621, 0.70
for CPT code 946X2, and 0.48 for CPT
code 946X3.
We are proposing to refine the clinical
labor time for the ‘‘Provide preservice
education/obtain consent’’ activity from
10 minutes to 5 minutes for CPT code
94621, which is the current time
assigned for this task. While we agree
that CPT code 94621 requires additional
time above the standard for this clinical
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labor activity, we do not believe that
double the current time would be
typical for this procedure. We are also
proposing to refine the clinical labor
time for the ‘‘Prepare and position
patient/monitor patient/set up IV’’
activity from 5 minutes to 3 minutes for
the same code. The standard time for
this activity is 2 minutes, and we are
proposing a value of 3 minutes to reflect
1 minute of additional preparation time
above the standard. We believe that
additional clinical labor time used for
preparation would be included under
the 10 minutes assigned to the ‘‘Prepare
room, equipment, supplies’’ activity for
this code.
We are proposing to refine the clinical
labor time for the ‘‘Complete diagnostic
forms, lab & X-ray requisitions’’ activity,
consistent with the standard clinical
labor time for this activity. We also
propose to refine the equipment times
for CPT codes 94621 and 946X2 to
account for 1:4 patient monitoring time,
and to refine the equipment times for
CPT code 946X3 consistent with
standards for non-highly technical
equipment.
We considered refining the clinical
labor time for the ‘‘pre exercise ECG,
VC, Min Vent. Calculation’’ activity
from 27 minutes to 15 minutes for CPT
code 94621. We considered proposing
this value of 15 minutes based on
assigning 5 minutes apiece for the ECG,
the MVV, and the spirometry. We
believe that each of these three
components of this clinical labor
activity would typically take no longer
than 5 minutes based on a comparison
to the use of these tasks in other CPT
codes. We also considered refining the
clinical labor time for the ‘‘Clinical staff
performs procedure’’ activity from 55
minutes to 35 minutes for CPT code
946X2 and from 14 minutes to 12
minutes for CPT code 94621. The RUCrecommended materials for the PE
inputs state that this clinical labor task
consists of performing 5 spirometries at
9 minutes each plus 10 minutes of
exercise time for CPT code 946X2; we
believe that the spirometries typically
take 5 minutes each, which would
reduce this activity from 55 minutes to
35 minutes. For CPT code 94621, we
considered maintaining the current
value of 12 minutes due to a lack of
justification for increasing the time to 14
minutes.
While we remain concerned about the
intraservice period clinical labor times,
for CY 2018, we are proposing the RUCrecommended work RVUs for each code
in this family and seek comment on
whether our alternative clinical labor
times would better reflect the work and
times for these services.
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(43) Percutaneous Allergy Skin Tests
(CPT Code 95004)
In the CY 2016 PFS proposed rule (80
FR 41706), CPT code 95004 was
identified through the high
expenditures screen as potentially
misvalued. The RUC suggested in its
comments on the CY 2016 PFS
proposed rule (80 FR 41706), that CPT
code 95004 should be removed from the
list of potentially misvalued codes
because it has a work RVU of 0.01 and
that it would serve little purpose to
survey physician work for this code.
The RUC and CMS previously
determined that there is physician work
involved in providing this service since
the physician must interpret the test and
prepare a report. In the CY 2016 PFS
final rule with comment period (80 FR
70913), CMS reiterated an interest in the
review of work and PE for this service.
We note that our interest in stakeholder
review of a particular code should not
be considered a directive for survey
under the RUC process. We intend to
more clearly state our interests in the
future, so that under similar
circumstances, such effort need not be
undertaken based on a mistaken
impression. To reiterate, we believe that
whether or not a code should be
surveyed in response to our interest in
receiving recommendations regarding
the work RVUs should be at the RUC
and the specialties’ discretion. In many
cases, we have used recommendations
developed through means other than
surveys in developing RVUs. For
example, for many PFS services, the
direct PE inputs are the primary drivers
of overall RVUs and Medicare payment.
In most of these cases, the
recommended inputs are not derived
from survey data. In some cases,
especially for resource-intensive and
highly technical services, we have
expressed some concern about the lack
of survey or other broad-based data that
we have relied on in developing rates
across the PFS for many years.
For CY 2018, we are proposing the
RUC-recommended work RVU of 0.01
for CPT code 95004.
Regarding direct PE inputs, we are
proposing to refine the equipment times
for exam table (EF023) and mayo stand
(EF015) to 79 minutes each to account
for clinical 1:4 patient monitoring time.
We received invoices with new pricing
information for two supplies: SH101
‘‘negative control, allergy test’’ ($5.17)
and SH102 ‘‘positive control, allergy
test’’ ($26.12). Using this information,
we are proposing a price of $0.03 per
test for supply item SH101 and a price
of $0.13 per test for supply item SH102.
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(44) Continuous Glucose Monitoring
(CPT Codes 95250 and 95251)
CPT codes 95250 (Ambulatory
continuous glucose monitoring of
interstitial tissue fluid via a
subcutaneous sensor for a minimum of
72 hours; sensor placement, hook-up,
calibration of monitor, patient training,
removal of sensor, and printout of
recording) and 95251 (Ambulatory
continuous glucose monitoring of
interstitial tissue fluid via a
subcutaneous sensor for a minimum of
72 hours; interpretation and report) are
used to report the technical and
professional component for continuous
glucose monitoring. In April 2013, CPT
code 95251 was identified through the
high volume growth services screen and
subsequently this code family was
reviewed at the RUC’s October 2016
meeting.
For CY 2018, we are proposing the
RUC-recommended work RVU of 0.70
for CPT code 95251. However, we are
concerned and seek comments on
whether the 2 minutes of physician
preservice time is necessary. Since CPT
code 95251 is typically billed with an
E/M service on the same day, we believe
the 2 minutes of preservice time may be
duplicative. Furthermore, we seek
comment on whether it would be
typical for the physician to spend 2
minutes to obtain the CGM reports for
review since we believe the report
would typically be obtained by clinical
staff on behalf of the physician.
For the direct PE inputs, the RUC
submitted 19 invoices to update the
price of the medical supply item
‘‘glucose monitoring (interstitial)
sensor’’ (SD114) for CPT code 95250.
We are proposing to use these invoice
prices for the glucose monitoring
(interstitial) sensor (SD114), with an
average cost of $53.08. Therefore, we are
proposing to use the average price of
$53.08 for this supply item.
As part of our review of this service,
we obtained publicly available pricing
information for the CGM system
(EQ125). We reviewed the information
provided in a study titled, ‘‘The costeffectiveness of continuous glucose
monitoring in type 1 diabetes,’’ (Huang,
SE., O’Grady, M., Basu, A. et al.,
Diabetes Care. June 2010), which
indicated the price of CGM technology
(without sensors) from 3 different
vendors, reflective of full retail prices
with no insurer discounts, to be
$600.00, $1119.00, and $1250.00, which
equated to an average cost of $1016.00
for the CGM system. In addition, we
obtained publicly available pricing
information for two vendors. This
information indicated the price of a
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CGM system to be $1061.90 and
$1279.17, which equated to an average
cost of $1170.54. For CY 2018, we are
proposing to price supply items SD114
at $53.08 and EQ125 at $1170.54. We
seek comments on current pricing for
equipment item ‘‘continuous glucose
monitoring system’’ (EQ125).
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(45) Parent, Caregiver-Focused Health
Risk Assessment (CPT Codes 96160 and
96161)
In the CY 2017 PFS final rule (81 FR
80330), we discussed that in October
2015, the CPT Editorial Panel created
two new PE-only codes, CPT code
96160 (Administration of patient
focused health risk assessment
instrument (e.g., health hazard
appraisal) with scoring and
documentation, per standardized
instrument) and CPT code 96161
(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). We assigned an active
payment status to both codes for CY
2017 and finalized use of the RUCrecommended values for these codes.
We also assigned an add-on code status
to both of these services. As add-on
codes, CPT codes 96160 and 96161
describe additional resource
components of a broader service
furnished to the patient that are not
accounted for in the valuation of the
base code.
The RUC submitted updated
recommendations for the direct PE
inputs for CPT codes 96160 and 96161
after reviewing new specialty society
surveys. The RUC recommended 7 total
minutes of clinical staff time, and we
are proposing to adopt this number of
minutes in valuing the services. The PE
worksheet included several distinct
tasks with minutes for each; however, in
keeping with the standardization of
clinical labor tasks, we are proposing to
designate all 7 minutes under
‘‘administration, scoring, and
documenting results of completed
standardized instrument’’ rather than
dividing the minutes into the four
categories as shown in the RUC
recommendations.
(46) Chemotherapy Administration (CPT
codes 96401, 96402, 96409, and 96411)
In the CY 2016 PFS proposed rule,
CPT codes 96401 (Chemotherapy
administration, subcutaneous or
intramuscular; non-hormonal antineoplastic), 96402 (Chemotherapy
administration, subcutaneous or
intramuscular; hormonal antineoplastic), 96409 (Chemotherapy
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administration; intravenous, push
technique, single or initial substance/
drug), and 96411 (Chemotherapy
administration; intravenous, push
technique, each additional substance/
drug (List separately in addition to code
for primary procedure)) were identified
through the high expenditure services
screen across specialties with Medicare
allowed charges of over $10 million.
For CY 2018, we are proposing the
RUC-recommended work RVUs for CPT
code 96401 (a work RVU of 0.21), CPT
code 96402 (a work RVU of 0.19), CPT
code 96409 (a work RVU of 0.24) and
CPT code 96411 (a work RVU of 0.20).
For CPT code 96402, we are
proposing the RUC-recommended
equipment times with refinements for
the biohazard hood (EP016) and exam
table (EF023) from 31 minutes to 34
minutes to reflect the service period
time associated with this code. We are
proposing the RUC-recommended direct
PE inputs for CPT codes 96401, 96409,
and 96411 without refinements.
(47) Photochemotherapy (CPT Code
96910)
CPT code 96910 appeared on a high
expenditure services screen across
specialties with Medicare allowed
charges of over $10 million, which is a
PE-only code that does not have work
RVUs.We are proposing to refine the
clinical labor time for the ‘‘Provide
preservice education/obtain consent’’
from 3 minutes to 1 minute for CPT
code 96910. We believe that 1 minute
would be typical for patient education,
as CPT code 96910 is a repeat procedure
where there would not be a need to
obtain consent again. We are also
proposing to remove the 2 minutes of
clinical labor for the ‘‘Complete
diagnostic forms, lab & X-ray
requisitions’’ activity, as this item is
considered indirect PE consistent with
our established methodology. We are
also proposing to create a new supply
code (SB054) for the sauna suit, and
proposing to price at $9.99 based on the
submitted invoice. Finally, we are also
proposing to adjust the equipment times
to reflect changes in the clinical labor
for CPT code 96910.
We are proposing the RUCrecommended clinical labor time of 15
minutes for the ‘‘Prepare and position
patient/monitor patient/set up IV’’
activity, the RUC-recommended clinical
labor time of 16 minutes for the
‘‘Monitor patient during procedure’’
activity, and the RUC-recommended
clinical labor time of 15 minutes for the
‘‘Clean room/equipment by physician
staff’’ activity, but seeking additional
information regarding the rationale for
these values. Given the lack of
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explanation, we considered using the
current clinical labor time of 7 minutes
for the ‘‘Prepare and position patient/
monitor patient/set up IV’’ activity, the
current clinical labor time of 4 minutes
for the ‘‘Monitor patient during
procedure’’ activity, and the current
clinical labor time of 10 minutes for the
‘‘Clean room/equipment by physician
staff’’ activity. We seek comment on
whether maintaining the current values
would improve relativity.
We considered removing the ‘‘Single
Patient Discard Bag, 400 ml’’ (SD236)
supply and replacing it with the
‘‘biohazard specimen transport bag’’
(SM008). We are concerned about
whether the single patient discard bag is
the appropriate size for storing the
sauna suit used in this procedure, and
whether use of a biohazard specimen
transport bag would be typical. We seek
comments on our proposed and
alternative values for these direct PE
inputs.
(48) Photodynamic Therapy (CPT Codes
96567, 96X73, and 96X74)
CPT code 96567 was identified as
potentially misvalued through a CMS
screen for codes with high expenditures.
This code describes a service furnished
by clinical staff and does not include
physician work. For CY 2018, the CPT
Editorial Panel created two new codes,
CPT codes 96X73 and 96X74, to
describe photodynamic therapy by
external application of light to destroy
premalignant skin lesions, including the
physician work involved in furnishing
the service. CPT codes 96567, 96X73,
and 96X74 were reviewed during the
RUC’s January 2017 meeting.
For CY 2018, we are proposing the
RUC-recommended work RVUs for CPT
code 96X73 (a work RVU of 0.48) and
CPT code 96X74 (a work RVU of 1.01).
We are proposing the RUCrecommended PE inputs with
refinements due to inconsistencies
between the stated description of
clinical activities and the submitted
spreadsheets. First, we propose to add
assist physician clinical staff time to
CPT codes 96X73 (10 minutes) and
96X74 (16 minutes), which is equivalent
to the physician intraservice times for
these services. For both CPT codes
96X73 and 96X74, we propose a
reduction from 35 minutes to 17
minutes for clinical activity in the
postservice time, consistent with the
description of clinical work in the
summary of recommendations, which
states that the patient receives activation
of the affected area with the BLU–U
Photodynamic Therapy Illuminator for
approximately 17 minutes. For CPT
codes 96X73 and 96X74, we are
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proposing to refine equipment formulas
for two items: Power table (EF031) and
LumaCare external light with probe set
(EQ169), consistent with standards for
nonhighly technical equipment. An
explanation of the standards and
formulas for equipment related to direct
PE inputs is in the CY 2014 PFS final
rule with comment period (79 FR
67557).
We identified several vendors with
publically available prices available for
supply item LMX 4 percent cream
(SH092) for significantly less than the
existing $1.60 per gram. Based on our
research of vendors, we are proposing to
set the price of supply item SH092 to
$0.78 per gram. Other CPT codes
affected by the proposed change in the
price of supply item LMX 4 percent
cream (SH092) are: CPT code 46607
(Anoscopy; with high-resolution
magnification (HRA) (eg, colposcope,
operating microscope) and chemical
agent enhancement, with biopsy, single
or multiple), CPT code 17000
(Destruction (eg, laser surgery,
electrosurgery, cryosurgery,
chemosurgery, surgical curettement),
premalignant lesions (eg, actinic
keratoses); first lesion), CPT code 17003
(Destruction (eg, laser surgery,
electrosurgery, cryosurgery,
chemosurgery, surgical curettement),
premalignant lesions (eg, actinic
keratoses); second through 14 lesions,
each (List separately in addition to code
for first lesion)), and CPT code 17004
(Destruction (eg, laser surgery,
electrosurgery, cryosurgery,
chemosurgery, surgical curettement),
premalignant lesions (eg, actinic
keratoses), 15 or more lesions)).
In addition, the RUC forwarded an
invoice for a new supply item, safety
goggles, at $6.00 and requested three
goggles each for CPT codes 96X73 and
96X74. Because we do not have a basis
for distinguishing the requested new
goggles from the existing UV-blocking
goggles, we consider this invoice to be
an additional price point for SJ027
rather than an entirely new item. We
propose a price of $4.10 for supply item
SJ027 (the average of the two prices for
this supply item ($2.30 + $6.00)/
2=$4.10)). Other CPT codes affected by
the proposed change in the price of
supply item UV-blocking goggles
(SJ027) are: CPT code 36522
(Photopheresis, extracorporeal), CPT
code 96910 (Photochemotherapy; tar
and ultraviolet B (Goeckerman
treatment) or petrolatum and ultraviolet
B), CPT code 96912
(Photochemotherapy; psoralens and
ultraviolet A (PUVA)), and CPT code
96913 (Photochemotherapy
(Goeckerman and/or PUVA) for severe
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photoresponsive dermatoses requiring at
least 4–8 hours of care under direct
supervision of the physician (includes
application of medication and
dressings)), CPT code 96920 (Laser
treatment for inflammatory skin disease
(psoriasis); total area less than 250 sq
cm), CPT code 96921 (Laser treatment
for inflammatory skin disease
(psoriasis); 250 sq cm to 500 sq cm), and
CPT code 96922 (Laser treatment for
inflammatory skin disease (psoriasis);
over 500 sq cm). We seek comments on
our proposed PE refinements, including
our proposed supply item prices.
(49) Physical Medicine and
Rehabilitation (PM&R) (CPT Codes
97012, 97016, 97018, 97022, 97032,
97033, 97034, 97035, 97110, 97112,
97113, 97116, 97140, 97530, 97533,
97535, 97537, 97542, and HCPCS code
G0283)
In our CY 2015 PFS final rule (79 FR
67576) and CY 2016 PFS final rule (80
FR 70917), we identified a total of ten
codes through the high expenditure by
specialty screen for services primarily
furnished by physical and occupational
therapists: CPT codes 97032, 97035,
97110, 97112, 97113, 97116, 97140,
97530, 97535, and HCPCS code G0283.
An additional nine codes in this PM&R
family were identified for review by the
physical therapy (PT) and occupational
therapy (OT) specialty societies: CPT
codes 97012, 97016, 97018, 97022,
97033, 97034, 97533, 97537, and 97542.
Many of these code values had not been
reviewed since they were established in
1994, 1995 or 1998.
After review during its January 2017
meeting, the HCPAC submitted
recommendations for all 19 codes.
While the HCPAC included
recommendations for CPT code 97014,
we note that this is a code we have not
recognized for PFS payment since 2002
when we implemented our wound care
electrical stimulation policies. For
payment under the PFS, instead of CPT
code 97014, we recognize HCPCS code
G0281 for wound care electrical
stimulation and HCPCS code G0283 for
all other electrical stimulation
scenarios, when covered. For CY 2018,
we are proposing the HCPAC
recommendations for CPT code 97014,
HCPCS code G0283, and HCPCS code
G0281.
CMS considers all 19 codes as
‘‘always therapy’’ which means they are
always considered to be furnished
under a physical therapy (PT),
occupational therapy (OT), or speechlanguage pathology (SLP) plan of care
regardless of who furnishes them and
the payment amounts are counted
towards the appropriate statutory
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therapy cap—either the therapy cap for
PT and SLP services combined, or the
single therapy cap for OT services.
These always therapy codes are also
subject to the therapy MPPR.
For CY 2018, we are proposing the
HCPAC’s recommended work RVUs for
CPT codes 97012, 97016, 97018, 97022,
97032, 97033, 97533, 97034, 97035,
97110, 97112, 97113, 97116, 97140,
97530, 97533, 97535, 97537, 97542, and
G0283 (97014).
For supervised modality services
reported with CPT codes 97012, 97016,
97018, and 97022, and HCPCS code
G0283 (97014), we considered
maintaining the current values for these
codes rather than the HCPAC
recommendations. We note that the
work times recommended by the
HCPAC reflect use of the survey data
even though the HCPAC explained in its
recommendations that the survey results
were not deemed credible because of a
lack of evidence to support higher work
RVUs of each survey’s 25th percentile or
median values. We note total time
decreases among these codes ranging
from 1 to 8 minutes.
While we are proposing the HCPACrecommended work RVUs and work
times for each code in this family, we
seek comments on whether maintaining
the current times, given the HCPAC’s
lack of confidence in the survey data,
would better reflect the work times for
these services.
We are proposing to maintain the
existing CY 2017 PE inputs for all 19
codes. We note that section 1848(b)(7) of
the Act requires a 50 percent therapy
MPPR instead of the 25 percent therapy
MPPR established during CY 201l PFS
rulemaking. One of the primary
rationales for the MPPR policy
developed through the rulemaking
process was that the direct PE inputs for
these services did not fully recognize
the redundant inputs when these
services were furnished together, or in
multiple units. After reviewing the
recommended direct PE inputs, it is
evident that they were developed based
on an acknowledgement of the
efficiencies of services typically
furnished together as well as codes
billed in multiple units. Given this
assessment, we believe that were we to
use the recommended inputs to develop
the PE RVUs, the 50 percent MPPR on
the PE for these services, as required by
current law, would functionally
duplicate the payment adjustments to
account for efficiencies that had already
been addressed through code-level
valuation. Therefore, for CY 2018, we
are proposing to retain the existing CY
2017 PE inputs for these services and
seek comments on whether there is an
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alternative approach that would avoid
duplicative downward payment
adjustments while still allowing for the
direct PE inputs to be updated to better
reflect current practice.
We note that we believe that the
always therapy codes subject to the
therapy MPPR on PE are unique from
other therapeutic and diagnostic
procedure codes paid under the PFS
and subject to MPPRs. For example,
unlike most surgical services, these
‘‘always therapy’’ codes are typically
billed either with other therapy codes or
in multiple units, or both. Generally,
MPPRs are used when codes are often,
but not typically, furnished with other
particular codes. When full sets of
related codes are almost all typically
billed with other codes, or billed in
multiple units, coding and valuation
have changed to reflect these practices.
For example, new codes have been
introduced to describe combined
services or some related services are
described by add-on codes. In other
cases, the MPPR is considered in the
valuation for individual services.
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(50) Management and/or Training:
Orthotics and Prosthetics (CPT Codes
97760, 97761, and 977X1)
For CY 2018, the CPT Editorial Panel
revised the set of codes that comprise
the CPT manual’s PM&R subsection for
orthotic management and prosthetic
management at its September 2016
meeting. According to the CPT Editorial
Panel, these revisions were made at the
request of the specialty societies
representing physical and occupational
therapists to differentiate between the
initial and subsequent encounters and
to describe the ongoing management
and/or training that is involved in
subsequent encounters. These changes
include:
• Revising the code descriptors by
adding the term ‘‘initial encounter’’ to
CPT code 97760 (Orthotic(s)
management and training (including
assessment and fitting when not
otherwise reported), upper
extremity(ies), lower extremity(ies) and/
or trunk, initial orthotic(s) encounter,
each 15 minutes), and CPT code 97761
(Prosthetic(s) training, upper and/or
lower extremity(ies), initial prosthetic(s)
encounter, each 15 minutes);
• Creating a new CPT code 977X1
(Orthotic(s)/prosthetic(s) management
and/or training, upper extremity(ies),
lower extremity(ies), and/or trunk,
subsequent orthotic(s)/prosthetic(s)
encounter, each 15 minutes); and
• Deleting CPT code 97762 (checkout
for orthotic/prosthetic use, established
patient, each 15 minutes).
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Intended for the management and/or
training of patients with orthotics and/
or prosthetics, CPT codes 97760 and
97761 were previously used to report
both the initial and subsequent
encounters, that, when furnished under
the Medicare outpatient therapy
services benefit, included services
occurring during the same PT or OT
episode of care. CPT code 97762 was
used to separately report the assessment
and fitting (including any adjustments)
of an orthotic or prosthetic for an
established patient when these services
were not bundled into another code or
service. For CY 2018, CPT codes 97760
and 97761 are intended to be reported
only for the initial encounter, and CPT
code 977X1 is intended to be reported
for all other orthotic and/or prosthetic
services for an established patient that
occur on a ‘‘subsequent encounter’’ or a
different date of service from that of the
initial encounter service.
The HCPAC submitted work and PE
recommendations for CPT codes 97760,
97761, and 977X1 from their January
2017 meeting. For CY 2018, we propose
the HCPAC recommended work RVU of
0.5 for CPT code 97760, a work RVU of
0.5 for CPT code 97761, and a work
RVU of 0.48 for CPT code 977X1. We
note that for budget neutrality purposes,
the HCPAC recommendations also
included utilization crosswalks for each
of the three codes that were each
assigned a one-to-one crosswalk to the
utilization of the prior codes: All the
prior services of CPT codes 97760 and
97761 were each crosswalked to the
same newly revised codes; and, all the
utilization from CPT code 97762 was
crosswalked to the new CPT code
977X1.
For CPT code 977X1, we considered
a work RVU of 0.33, crosswalking to
CPT code 92508 (Speech/hearing
therapy), which has a similar total
therapist time (22 minutes). We are
concerned and seek comments on the
HCPAC one-to-one utilization crosswalk
recommendations for all three codes in
this family since the utilization
assumptions are potentially flawed
when viewed in the context of the new
CPT code descriptors. For instance, for
CPT code 977X1, the new descriptor
indicates that the services inherent to
CPT code 97762 (over 14,000 in 2015),
as well as the new services for
subsequent encounters previously
reported via CPT codes 97760 and
97761 will also be encompassed,
although it is difficult to estimate the
number of additional services the latter
represents. We are concerned that the
HCPAC’s valuation is inconsistent with
the submitted information regarding
how services will be reported under the
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new coding. We seek comments on our
proposed and alternative values for CPT
code 977X1. We are also interested in
receiving comments from stakeholders
and clinicians with expertise in
furnishing these orthotic management
and/or prosthetics training services
about the utilization and types of
services that would be furnished under
the new CPT coding structure,
particularly those of the newly created
CPT code 977X1 and how these services
differ from the services reported with
the predecessor CPT code 97762.
We propose to maintain the current
PE inputs for CPT codes 97760, 97761,
and 977X1, as we discussed in our
proposals for the PM&R codes discussed
above; the same therapy MPPR applies.
We are proposing the current direct PE
inputs for CPT code 97762 and for new
CPT code 977X1, though we are seeking
comment as to whether or not a
different crosswalk or other adjustment
would be appropriate given the change
in code descriptor.
We also note that these codes are
designated as always therapy, meaning
that they always represent therapy
services regardless of who furnishes
them; and that a GO or GP therapy
modifier is always required to indicate
that the services are furnished under an
OT or PT plan of care, respectively. As
always therapy, these codes are subject
to the therapy MPPR and the statutory
therapy caps.
(51) Cognitive Function Intervention
(CPT Code 97X11)
We received HCPAC
recommendations for new CPT code
97X11 that describes services currently
reported under CPT code 97532
(Development of cognitive skills to
improve attention, memory, problem
solving (includes compensatory
training), direct (one-on-one) patient
contact, each 15 minutes). CPT code
97532 is scheduled to be deleted for CY
2018 and replaced by CPT code 97X11.
The existing code is reported per 15
minutes and the new code is reported
once. Under current coding, Medicare
utilization for these services is
heterogeneous and indicates that
practitioners of different disciplines
incur significantly different resource
costs (especially in time) when
furnishing these services to Medicare
beneficiaries. As described by both the
existing and new code, the service
might be appropriately furnished both
by therapists under the outpatient
therapy (OPT) services benefit (includes
physical therapy (PT), occupational
therapy (OT) or speech-language
pathology (SLP)); and outside the
therapy benefit by physicians, certain
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NPPs, and psychologists. As an OPT
service, it can (1) be billed by
physicians, certain NPPs, or private
practice therapists including physical
therapists (PT–PPs), occupational
therapists (OT–PPs) and speechlanguage pathologists (SLP–PPs) in
private practice, or (2) be billed by
institutional providers (for example,
skilled nursing facilities, rehabilitation
agencies, outpatient hospitals, etc.)
when furnished by therapists working
for the institutional providers.
According to the HCPAC, professional
claims data indicate that CPT code
97532 was most often billed in 4 units.
The HCPAC recommended a work RVU
of 1.50 for CPT code 97X11, which is
only 3.4 times greater than the work
RVU for the predecessor code (0.44).
Assuming professional billing patterns
remain the same, the recommended
coding and valuation could result in a
significant reduction in overall
Medicare payment under the PFS.
However, our analysis of the claims
data indicates that the number of units
typically reported for the current code
suggests a significant difference in the
amount of time spent with the patient,
depending on which discipline (and
implicitly under which benefit) bills
Medicare for services described by this
single code.
Based on our review of claims data by
specialty, SLP–PPs, OT–PPs and PT–
PPs furnishing the same services under
the OPT benefit would receive overall
payment increases due simply to the
change in coding because they typically
bill for fewer than 4 units, while overall
payment for clinical psychologists
furnishing therapeutic interventions for
cognitive function would decrease
because they typically bill in units of
four or more.
We are seeking additional information
regarding the potential impact of this
coding and payment change prior to
proposing its use under the PFS. For CY
2018, we are proposing to maintain the
current coding and valuation for these
cognitive function services. If the CPT
Editorial Panel deletes the existing CPT
code for CY 2018, we would effectuate
this proposal through use of a new a Gcode, GXXX1, which would maintain
the descriptor and values from existing
CPT code 97532. Under this proposal,
new CPT code 97X11 would be given a
procedure status of ‘‘I’’ (Invalid for
Medicare).
We also note that this change in
coding and payment could have
significant impact for payment to
Medicare institutions for OPT services.
Under section 1834(k) of the Act, when
reported by Medicare institutional
providers, OPT services are paid at PFS
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non-facility payment rates. Institutional
claims data for CPT code 97532 when
furnished by the three therapist
disciplines show a much higher
utilization overall than that for
professional claims but significantly
fewer 15 minute units reported. This
suggests that professionals generally
spend significantly less time with
patients in the institutional setting. Use
of the new CPT code could therefore
result in significant additional
expenditure to the Medicare program, as
well as other payers, including
Medicaid programs, based on the
change in coding alone.
obtained publically available pricing
information from two vendors. The
pricing from one vendor indicated the
price for a box of 24 of supply item
SJ055 item (INR test strip) to be $150.00,
which equated to a unit price of $6.25.
Pricing from a second vendor indicated
the price of a box of 48 of the supply
item SJ055 to be $233.00, which equated
to a unit price of $5.06. The average
price of these two unit prices is $5.66.
Therefore, we are proposing to reprice SJ055 from $21.86 to $5.66 for
CPT code 993X1. We are seeking public
comments on current pricing for the INR
test strip supply.
(52) INR Monitoring (CPT Codes 993X1
and 993X2)
In October 2015, AMA staff assembled
a list of all services with total Medicare
utilization of 10,000 or more that have
increased by at least 100 percent from
2008 through 2013 and these services
were identified on that list. The RUC
recommended that HCPCS codes G0248,
G0249 and G0250, which describe
related INR monitoring services, be
referred to the CPT Editorial Panel to
create Category I codes to describe these
services. For CY 2018, the CPT Editorial
Panel is deleting CPT codes 99363 and
99364 and creating new CPT codes
993X1 (Patient/caregiver training for
initiation of home INR monitoring
under the direction of a physician or
other qualified health care professional,
including face-to-face, use and care of
the INR monitor, obtaining blood
sample, instructions for reporting home
INR test results, and documentation of
patient’s/caregiver’s ability to perform
testing and report results) and 993X2
(Anticoagulant management for a
patient taking warfarin, must include
review and interpretation of a new
home, office, or lab International
Normalized Ratio (INR) test result,
patient instructions, dosage adjustment
(as needed), and scheduling of
additional test(s) when performed). CPT
code 993X1 is a technical componentonly code. With the creation CPT codes
993X1 and 993X2, the RUC
recommended that CMS delete HCPCS
codes G0248, G0249 and G0250.
For CPT code 993X2, we are
proposing the RUC-recommended work
RVU of 0.18. Because HCPCS codes
G0248, G0249 and G0250 are used to
report related services under a national
coverage determination, we do not
intend to delete the G-codes.
In reviewing the recommended PE
inputs for these services, we obtained
updated invoices for prices for
particular items. We are proposing to
use the invoices to update the price of
the supply ‘‘INR test strip’’ (SJ055). We
(53) Psychiatric Collaborative Care
Management Services (CPT Codes
994X1, 994X2, 994X3, and HCPCS Code
G0507)
In the CY 2017 PFS final rule (81 FR
80230), we established separate
payment for three services (HCPCS
codes G0502, G0503, and G0504) under
the psychiatric collaborative care model
that paralleled CPT codes that were
being created to report these services as
well as a G-code for general behavioral
health integration (BHI) services
(HCPCS code G0507).
For CY 2018, the CPT Editorial Panel
is creating CPT codes 994X1, 994X2,
994X3, and 99XX5 to describe these
services. We are proposing the RUCrecommended work RVUs for each of
these services, which are identical to the
current values for HCPCS codes G0502,
G0503, G0504, and G0507.
We are proposing the RUCrecommended PE inputs, with one
refinement. The RUC-recommended
values included clinical labor inputs in
the facility setting, but we are not
proposing to include these minutes in
developing the facility PE RVUs.
Were we to develop facility PE RVUs
for these services that included clinical
staff time, when a practitioner working
in a provider-based department of a
hospital was furnishing these services,
both the professional and the hospital
would be paid for the same clinical
labor costs. We presume that this aspect
of the RUC’s recommendation reflects
the circumstance where the patient
receiving the services spends a
significant period of time in a facility
setting, but the billing practitioner is
nonetheless incurring the cost
associated with the non-face-to-face
clinical staff time over the course of a
month. We recognize that the binary site
of service differential may not recognize
the different models of this kind of care
and may not be appropriate in some
cases. We seek comments on how to
best address this valuation issue for
these and other monthly care
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management services. We could
consider a range of options for future
rulemaking, including allowing separate
billing for the professional, technical,
and global components of these services
to allow practitioners to bill the
component of the service they furnish.
We stated in the CY 2017 PFS final
rule (81 FR 80236) that the general BHI
code (CPT code 99XX5) may be used to
report a range of models of BHI services
and that we expected this code to be
refined over time as we receive more
information about other BHI models in
use. We remain interested in how this
code is being used and look forward to
hearing from stakeholders regarding its
use in reporting different models of BHI
services. Additionally, we have received
inquiries from stakeholders about
whether or not professionals who
cannot report E/M services to Medicare
might nonetheless serve as a primary
hub for BHI services. For example,
stakeholders have suggested that a
clinical psychologist might serve as the
primary practitioner that integrates
medical care and psychiatric expertise.
For purposes of future rulemaking, we
are seeking comment on the
circumstances under which this model
of care is happening and whether
additional coding would be needed to
accurately describe and value other
models of care.
(54) Hyperbaric Oxygen Therapy
(HCPCS Code G0277)
In the CY 2016 PFS final rule (80 FR
71005), we discussed the CY 2015
valuation of hyperbaric oxygen therapy
services (79 FR 67677). Prior to CY
2015, CPT code 99183 was used to
report both the professional attendance
and supervision, and the costs
associated with treatment delivery were
included in the nonfacility direct PE
inputs for the code. We created HCPCS
code G0277 to be used to report the
treatment delivery separately, consistent
with the OPPS coding mechanism, to
allow the use of the same coding
structure across settings. In establishing
interim final direct PE inputs for HCPCS
code G0277, we used the RUCrecommended direct PE inputs for CPT
code 99183, which assumed a 120minute treatment interval and adjusted
them to align with the 30-minute
treatment interval of HCPCS code
G0277. We observed that the quantity of
oxygen increased significantly relative
to the previous inputs for CPT code
99183.
To better understand why the oxygen
supply increased, we reviewed the
instruction manual for the Sechrist
Model 3600E Hyperbaric Chamber,
which was the model noted on the
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invoice that was included with the RUC
recommendations for use in pricing the
capital equipment. The instruction
manual for the Sechrist 3600E model
provided guidance regarding the
quantity of oxygen to be used in
furnishing the service described by
HCPCS code G0277. Based on our
review at that time, we determined that
12,000 liters, rather than 47,000 liters,
was the typical number of units for the
oxygen gas. Therefore, in aligning the
direct PE inputs as described in this
section of the proposed rule, we first
adjusted the units of oxygen to 12,000
liters for the recommended 120 minute
time, and subsequently adjusted it to
align with the 30-minute G-code by
dividing by 4. We stated that we agreed
that an initial high purge flow rate is
needed to reach maximum pressure/O2;
however, we still had not seen data that
demonstrated the need to continue the
high purge flow rate throughout the
entire session. According to the
manufacturer’s instruction manual for
this model, ‘‘once the nitrogen has been
purged from the chamber and the
internal oxygen concentration has
exceeded 95 percent, high flows are no
longer needed to maintain the patient’s
saturation level.’’ The manual also
stated that ‘‘the plateau purge flow can
be set to 80 liters per minute (lpm).’’ We
calculated that 13 minutes at 400 lpm
plus 120 minutes at 80 lpm equals
14,800 liters of oxygen. We stated that
based on information in the
manufacturer’s manual that was
publicly available at the time, we
believed that this represented the
typical usage for a 120-minute
treatment. That amount represented an
increase from the interim final amount
of 12,000 liters. We aligned this total
oxygen requirement to the 30-minute Gcode by dividing 14,800 liters of oxygen
by 4 and stated we were updating the
direct PE inputs to 3,700 liters of oxygen
for HCPCS code G0277.
For CY 2018, we received requests
from stakeholders to update the direct
PE inputs for HCPCS code G0277. In the
CY 2016 PFS final rule (80 FR 71005),
we explained that we had previously
established values for this service based
on information suggesting that the
Sechrist Model 3600E Hyperbaric
Chamber was typically used in
furnishing the service in the non-facility
setting. As we noted in that rule, we
established the amount of oxygen used
in furnishing the service based on use
of the equipment item described as part
of the RUC recommendation, instead of
the RUC-recommended amount of
oxygen, which appeared to be based on
use of a different equipment product,
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the Sechrist Model 3200. Based on
information received from stakeholders,
we are proposing to update both the
equipment item and the amount of
oxygen so that the amount of oxygen
conforms to the RUC-recommended
value of 47,600 liters of oxygen, which
we divided by 4 to conform to the 30minute service period for HCPCS code
G0277, and that the equipment item is
consistent with that recommendation.
The proposed direct PE inputs for
HCPCS code G0277 are displayed in the
proposed CY 2018 direct PE input
database, available on the CMS Web site
under the downloads for the CY 2018
PFS proposed rule at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
PhysicianFeeSched/PFS-FederalRegulation-Notices.html.
We are also proposing to exclude this
change in direct PE inputs from
calculation of the misvalued code target
since we view this proposed change as
a refinement of a single
recommendation over several years.
Since the initial recommendation (79 FR
67677) was undertaken in a year
without the misvalued code target, we
believe it would be consistent with our
previously established policy (80 FR
70923) to exclude this change from the
calculation. We note that this change
would represent an increase from the
current PE RVUs for this service.
(55) Physician Coding for Insertion and
Removal of Subdermal Drug Implants
for the Treatment of Opioid Addiction
(HCPCS Codes GDDD1, GDDD2, and
GDDD3)
We met with representatives from the
American Society of Addiction
Medicine (ASAM) in April 2016 to
discuss the possibility of making
separate payment for insertion and
removal of buprenorphine
hydrochloride, formulated as a 4-rod, 80
mg, long-acting subdermal drug implant
for the treatment of opioid addiction.
There are existing CPT codes that
broadly describe the insertion and
removal of non-biodegradable drug
delivery implants (CPT codes 11981
through 11983). However, ASAM
contended that the resources associated
with the administration of this
particular drug are greater than that of
other drug delivery implants, stating
that the physician must insert four rods
using a newly designed applicator and
obturator and use a specially designed
clamp to remove the four rods, which in
some cases requires careful shaving of
tissue that has attached to the rods
during the 6-month period that the rods
have been inserted. They noted that
these procedures can have unique
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challenges associated with treating
patients with opioid addiction, who
often have complications and/or comorbidities. They also noted that the
FDA has recognized the complexity of
the technology and patient needs by
establishing regulatory standards to
adhere to the protocol and imposing
special training requirements on
physicians. ASAM indicated that they
would pursue an application to the CPT
Editorial Panel for new CPT codes.
ASAM informed CMS that the CPT
Editorial Panel did not approve their
application; therefore, they repeated
their request that CMS establish
separate payment for the insertion,
removal, and removal with reinsertion
of the buprenorphine subdermal
implants.
To improve payment accuracy, for CY
2018, we are proposing to make separate
payment for the insertion, removal, and
removal with reinsertion of
Buprenorphine subdermal implants
using HCPCS G codes:
• HCPCS code GDDD1: Insertion,
non-biodegradable drug delivery
implants, 4 or more.
• HCPCS code GDDD2: Removal,
non-biodegradable drug delivery
implants, 4 or more.
• HCPCS code GDDD3: Removal with
reinsertion, non-biodegradable drug
delivery implants, 4 or more.
For HCPCS code GDDD1, ASAM
states that performing the procedure
according to the FDA-required Risk
Evaluation and Mitigation Strategies
(REMS) program takes approximately
23–25 minutes for the a physician who
is not a trainer/proctor for this
procedure. They state that in developing
crosswalk recommendations for
physician work values, they used a total
time of 35–40 minutes, which is based
on a preservice time of 10 minutes, an
intraservice time of 20–25 minutes, and
a postservice time of 5 minutes. Based
on ASAM’s recommendations, we are
proposing a work RVU of 1.82 for
HCPCS code GDDD1, which is
supported by a direct crosswalk to CPT
code 64644 (Chemodenervation of one
extremity; 5 or more muscles).
For HCPCS code GDDD2, ASAM
states that data from physicians who
perform this procedure indicated that it
takes approximately 15–20 additional
minutes compared to the insertion
procedure (HCPCS code GDDD1) based
on the FDA-required REMS program for
removal of the implant. They note that
this procedure is of a higher intensity
compared to CPT code 11982 as this
service requires identification and
removal of multiple subdermal
implants. They state that in developing
crosswalk recommendations for
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physician work values, they used a total
time of 45–60 minutes, which is based
on a preservice time of 10 minutes, an
intraservice time of 30–45 minutes, and
a postservice time of 5 minutes. Based
on ASAM’s recommendations, we are
proposing a work RVU of 2.10 for
HCPCS code GDDD2, which is
supported by a direct crosswalk to CPT
code 96922 (Laser treatment for
inflammatory skin disease (psoriasis);
over 500 sq cm).
For HCPCS code GDDD3, ASAM
indicated that there is minimal
consolidation of effort since the removal
of the implants from one arm is
followed by insertion of a new set of
implants in the contralateral arm.
Physician data from those who have
performed this procedure indicated that
it takes approximately 70 minutes of
total intra-service time. They state that
in developing crosswalk
recommendations for physician work
values, they assumed a preservice
evaluation time of 10 minutes (7
minutes for removal and 3 minutes for
insertion), positioning of 4 minutes (2
minutes for each arm), and wait time of
2 minutes (1 minute for each arm). They
state that using the multiple surgical
procedure rule, they calculated an
intraservice time of 40–58 minutes
based on 100 percent of the intraservice
time for HCPCS code GDDD2 (30–45
minutes) and 50 percent of the
intraservice time for HCPCS code
GDDD1 (0.5 × (20 – 25) = 10 – 13). They
used a postservice time of 8 minutes
based on 100 percent of the postservice
time for the removal arm and 50 percent
of the postservice time for the insertion
arm, equaling a total time of 58–76
minutes. Based on ASAM’s
recommendations, we are proposing a
work RVU of 3.55 for HCPCS code
GDDD3, which is supported by a direct
crosswalk to CPT code 31628
(Bronchoscopy, rigid or flexible,
including fluoroscopic guidance, when
performed; with transbronchial lung
biopsy(s), single lobe).
We are proposing to use the direct PE
inputs requested by ASAM for HCPCS
codes GDDD1, GDDD2, and GDDD3,
which are reflected in the Direct PE
Inputs public use files for clinical labor,
supplies, and equipment, available on
the CMS Web site at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
PhysicianFeeSched/.
In addition to seeking comment on
the proposal to make separate payment
for these services using HCPCS G codes,
we are also seeking comment on the
appropriateness and accuracy of our
proposed work RVUs and direct PE
inputs.
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(56) Superficial Radiation Treatment
Planning and Management (HCPCS
Code GRRR1)
In the CY 2015 PFS final rule with
comment period (79 FR 67666 through
67667), we noted that changes to the
CPT prefatory language limited the
codes that could be reported when
describing services associated with
superficial radiation treatment (SRT)
delivery, described by CPT code 77401
(radiation treatment delivery, superficial
and/or ortho voltage, per day). The
changes effectively meant that many
other related services were bundled
with CPT code 77401, instead of being
separately reported. For example, CPT
guidance clarified that certain codes
used to describe clinical treatment
planning, treatment devices, isodose
planning, physics consultation, and
radiation treatment management cannot
be reported when furnished in
association with superficial radiation
treatment. Stakeholders stated that these
changes to the CPT prefatory language
prohibited them from billing Medicare
for codes that were previously
frequently billed in addition to CPT
code 77401. We solicited comments as
to whether the coding for SRT allowed
for accurate reporting of the associated
services.
In the CY 2016 PFS final rule with
comment period (80 FR 70955), we
noted that the RUC did not review the
inputs for superficial radiation therapy
procedures, and therefore, did not
assess whether changes in its valuation
were appropriate in light of the
bundling of associated services. In
addition, we solicited recommendations
from stakeholders regarding whether or
not it would be appropriate to add
physician work for this service, even
though physician work is not included
in other radiation treatment services. As
commenters were not in agreement as to
whether the service should be valued
with physician work, we introduced the
possibility of creating a HCPCS G code
to describe total work associated with
the course of treatment for these
services.
The 2016 National Correct Coding
Initiative (NCCI) Policy Manual for
Medicare Services states that radiation
oncology services may not be separately
reported with E/M codes. While this
edit is no longer active, stakeholders
have stated that MACs have denied
claims for E/M services associated with
SRT based on the NCCI policy manual
language. According to stakeholders, the
bundling of services associated with
SRT, as well as the confusion regarding
the appropriate use of E/M coding to
report associated physician work, means
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that practitioners are not being
accurately paid for planning and
treatment management associated with
furnishing SRT.
In recognition of these concerns, we
are proposing to make separate payment
for the professional planning and
management associated with SRT using
HCPCS code GRRR1 (Superficial
radiation treatment planning and
management related services, including
but not limited to, when performed,
clinical treatment planning (for
example, 77261, 77262, 77263),
therapeutic radiology simulation-aided
field setting (for example, 77280, 77285,
77290, 77293), basic radiation dosimetry
calculation (for example, 77300),
treatment devices (for example, 77332,
77333, 77334), isodose planning (for
example, 77306, 77307, 77316, 77317,
77318), radiation treatment management
(for example, 77427, 77431, 77432,
77435, 77469, 77470, 77499), and
associated evaluation and management
per course of treatment). We intend for
this code to describe the range of
professional services associated with a
course of SRT, including services
similar to those not otherwise separately
reportable under CPT guidance and the
NCCI manual.
To value this code, we are including
the physician work and work time
associated with radiation managementrelated services that we think would be
typical for a course of SRT treatment.
These services include: CPT code 77261
(Therapeutic radiology treatment
planning; simple), CPT code 77280
(Therapeutic radiology simulation-aided
field setting; simple), CPT code 77300
(Basic radiation dosimetry calculation,
central axis depth dose calculation,
TDF, NSD, gap calculation, off axis
factor, tissue inhomogeneity factors,
calculation of non-ionizing radiation
surface and depth dose, as required
during course of treatment, only when
prescribed by the treating physician),
CPT code 77306 (Teletherapy isodose
plan; simple (1 or 2 unmodified ports
directed to a single area of interest),
includes basic dosimetry calculation(s)),
CPT code 77332 (Treatment devices,
design and construction; simple (simple
block, simple bolus)), and CPT code
77427 (Radiation treatment
management, 5 treatments). Therefore,
for CY 2018, we are proposing a work
RVU of 7.93 for HCPCS code GRRR1.
To develop the proposed direct PE
inputs for this code, we are proposing
to use the RUC-recommended direct PE
inputs from the aforementioned codes
with several adjustments. We are
proposing to apply the staff type ‘‘RN/
LPN/MTA’’ for all of the clinical labor
inputs for this code because we believe
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that the typical office performing SRT
will be staffed with this labor type,
rather than with another clinical labor
type such as radiation therapists, and
we seek comments as to the
appropriateness of the staff type ‘‘RN/
LPN/MTA’’ for this SRT-related service.
Some stakeholders have suggested that
many services related to SRT are
personally performed by the billing
practitioner rather than by clinical staff.
We are proposing to remove the
supply items ‘‘gown, patient’’ and
‘‘pillow case’’ that are associated with
CPT code 77280, as these items are
included in the minimum multispecialty visit pack that is associated
with CPT code 77427. We are not
proposing to include the equipment
items ‘‘radiation virtual simulation
system,’’ ‘‘room, CT’’ and ‘‘PACS
Workstation Proxy’’ that are associated
with CPT code 77280, as we do not
believe that a typical office furnishing
SRT uses this kind of equipment.
Instead, we are including additional
time for the capital equipment used in
delivering SRT in the proposed direct
PE inputs. For ‘‘radiation dose therapy
plan,’’ we are proposing to apply the
clinical labor time that is associated
with CPT code 77300 to HCPCS code
GRRR1 for purposes of developing a
proposed value, but we seek comments
as to whether the clinical staff would
typically perform the radiation dose
therapy planning for this service, or if
the physician would perform this and/
or other tasks, and, in the case of the
latter, what the appropriate physician
time would be. Likewise, we are
soliciting comment as to whether the
clinical labor associated with the
teletherapy isodose plan would be
performed by the physician. We are
proposing to assign 14 minutes each to
the equipment items ‘‘radiation therapy
dosimetry software (Argus QC)’’,
‘‘computer workstation’’, and ‘‘3D
teletherapy treatment planning’’ as these
are the times assigned to these
equipment items for CPT code 77300.
We are not proposing to include
inputs related to radiation physics
consultation, described by CPT code
77336, as we think that a typical course
of SRT would not require this service,
and the typical practitioner providing
SRT would not be performing physics
consultation, and we are seeking
comment as to whether inputs
associated with this code or other inputs
used in furnishing analogous services
should be included. We are not
proposing to include the post-operative
office visits included in the valuation of
CPT code 77427, as we do not believe
that a typical course of SRT will require
post-operative visits; however, we are
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34013
seeking comment regarding the amount
of face-to-face time typically spent by
the practitioner with the patient for
radiation treatment management
associated with SRT.
As discussed in the CY 2016 PFS final
rule (80 FR 70924 through 70927), in the
case of new codes that describe services
that were previously included in the
payment for other codes, we finalized
the policy that these new codes are
excluded from the misvalued code
target when they were previously
bundled into a set of broadly reported
E/M codes and services that include E/
M visits. We noted that we did not
believe that the change to separate
payment for these kinds of services
should be counted as increases that are
included in calculating ‘‘net reductions’’
in expenditure attributable to
adjustments for misvalued codes.
Therefore, we are proposing to exclude
HCPCS code GRRR1 from the misvalued
code target.
(57) Payment Accuracy for Prolonged
Preventive Services (HCPCS Codes
GYYY1 and GYYY2)
Most services paid under the PFS are
coded to reflect differential resource
costs associated with different levels of
care. However, this level of granularity
is not applied evenly across the PFS.
For example, there are far fewer
Evaluation and Management (E/M) visit
codes than there are codes that describe
procedures. While not a comprehensive
solution to address the differential
resource costs of certain E/M visits,
prolonged services codes can be used to
report medically necessary E/M visits
that require additional amounts of time.
Like E/M visit codes, many of the
Medicare-covered preventive services
codes describe a service that has an
atypically broad range of potential
resource costs, including differential
amounts of time required to furnish
services. However, unlike for most E/M
visit codes, there are not prolonged
services codes that apply to Medicarecovered preventive services.
Some stakeholders have expressed
concerns to CMS that there is no coding
mechanism for practitioners to report
the additional time sometimes required
to appropriately furnish care to a patient
receiving a Medicare-covered preventive
service. We note that Medicare covers a
broad range of preventive services, such
as a ‘‘Welcome to Medicare Preventive
Visit’’, yearly wellness visits, cancer
screenings, and many types of
counseling. Medicare beneficiary
coinsurance and deductible payments
are not applicable for certain Medicarecovered preventive services. Additional
information about preventive services
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Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
covered under Medicare, including
whether beneficiary coinsurance or
deductible apply, is available on the
CMS Web site at https://www.cms.gov/
Medicare/Prevention/PrevntionGenInfo/
Downloads/MPS-QuickReferenceChart1TextOnly.pdf. To more accurately
reflect the differential resource costs
when additional time is required to
furnish a Medicare-covered preventive
service, we are proposing to make
payment for prolonged preventive
services using two new HCPCS G codes
that could be billed along with the
Medicare-covered preventive service
codes, when a clinician provides a
prolonged Medicare-covered preventive
service.
• GYYY1: Prolonged preventive
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 30 minutes (List
separately in addition to code for
preventive service)), and
• GYYY2: Prolonged preventive
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; each additional 30
minutes (List separately in addition to
code for preventive service)). These
proposed services (HCPCS codes
GYYY1 and GYYY2) are only permitted
to be billed with Medicare-covered
preventive services. Beneficiary
coinsurance and deductible would not
be applicable for HCPCS codes GYYY1
and GYYY2 because the codes can only
be reported to describe prolonged
portions of services where beneficiary
coinsurance and deductible are not
applicable.
We are proposing to use prolonged
services codes in 30-minute increments
instead of the 60-minute increments that
apply for the parallel office/outpatient
prolonged services codes, since some
Medicare-covered preventive services
have a shorter duration than E/M visits.
For purposes of valuation for both
initial and additional 30 minute codes,
we are proposing to use one half of the
current work RVUs and direct PE inputs
for CPT code 99354 (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 (List separately in
addition to code for office or other
outpatient Evaluation and Management
or psychotherapy service)). CPT code
99354 has a total time of 60 minutes and
a work RVU of 2.33. Therefore, we are
proposing a work RVU of 1.17 and 30
minutes of total work time for HCPCS
codes GYYY1 and GYYY2. We are
proposing to use one half of the direct
PE inputs for CPT code 99354, which
results in a proposal of 7 minutes of
clinical labor type L037D (RN/LPN/
MTA) and 15 minutes for equipment
type EF031 (table, power) for HCPCS
code GYYY1 and HCPCS code GYYY2
as the best reflection of typical direct PE
costs. We understand that these specific
clinical labor and equipment types may
be functioning as proxy inputs for some
Medicare-covered preventive services.
As described in this section of the
rule, we propose that HCPCS codes
GYYY1 and GYYY2 be billed for
prolonged preventive services beyond
the typical service time of the primary
procedure. For preventive services with
both physician work and practice
expense, we are considering the typical
service time of the primary procedure to
be the intraservice work time used for
the purposes of ratesetting. For
Medicare-covered preventive services
with no face-to-face physician work, the
typical time is the service period
clinical staff time that best represents
the face-to-face time with the patient.
The counted time requirements (derived
from the typical times assumed for
ratesetting) for all eligible companion
Medicare-covered preventive services
are available in the file called ‘‘CY 2018
Preventive Services Billed with
Prolonged Preventives Code’’ on the
CMS Web site under downloads for the
CY 2018 PFS proposed rule at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
PhysicianFeeSched/PFS-FederalRegulation-Notices.html.
TABLE 10—PROPOSED CY 2018 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES
Current
work
RVU
HCPCS
Descriptor
007X1 .........
Anesthesia for upper gastrointestinal endoscopic procedures, endoscope introduced proximal to
duodenum; not otherwise specified.
Anesthesia for upper gastrointestinal endoscopic procedures, endoscope introduced proximal to
duodenum; endoscopic retrograde cholangiopancreatography (ERCP).
Anesthesia for lower intestinal endoscopic procedures, endoscope introduced distal to duodenum;
not otherwise specified.
Anesthesia for lower intestinal endoscopic procedures, endoscope introduced distal to duodenum;
screening colonoscopy.
Anesthesia for combined upper and lower gastrointestinal endoscopic procedures, endoscope introduced both proximal to and distal to the duodenum.
Acne surgery (e.g., marsupialization, opening or removal of multiple milia, comedones, cysts,
pustules).
Muscle, myocutaneous, or fasciocutaneous flap; trunk ......................................................................
Muscle, myocutaneous, or fasciocutaneous flap; upper extremity .....................................................
Muscle, myocutaneous, or fasciocutaneous flap; lower extremity ......................................................
Midface flap (i.e., zygomaticofacial flap) with preservation of vascular pedicle(s) .............................
Muscle, myocutaneous, or fasciocutaneous flap; head and neck with named vascular pedicle (i.e.,
buccinators, genioglossus, temporalis, masseter, sternocleidomastoid, levator scapulae).
Preparation of tumor cavity with placement of a radiation therapy applicator for intraoperative radiation therapy (IORT) concurrent with partial mastectomy.
Mastectomy, simple, complete ............................................................................................................
Bone marrow aspiration for bone grafting, spine surgery only, through separate skin or fascial incision.
Application of rigid total contact leg cast ............................................................................................
Strapping; Unna boot ..........................................................................................................................
Application of multi-layer compression system; leg (below knee), including ankle and foot ..............
Submucous resection inferior turbinate, partial or complete, any method .........................................
Control nasal hemorrhage, anterior, simple (limited cautery and/or packing) any method ................
Control nasal hemorrhage, anterior, complex (extensive cautery and/or packing) any method ........
Control nasal hemorrhage, posterior, with posterior nasal packs and/or cautery, any method; initial
007X2 .........
008X1 .........
008X2 .........
008X3 .........
10040 ..........
15734 ..........
15736 ..........
15738 ..........
157X1 .........
157X2 .........
mstockstill on DSK30JT082PROD with PROPOSALS2
192X1 .........
19303 ..........
2093X .........
29445
29580
29581
30140
30901
30903
30905
..........
..........
..........
..........
..........
..........
..........
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E:\FR\FM\21JYP2.SGM
RUC
work
RVU
CMS
work
RVU
CMS time
refinement
NEW
0.00
0.00
No.
NEW
0.00
0.00
No.
NEW
0.00
0.00
No.
NEW
0.00
0.00
No.
NEW
0.00
0.00
No.
1.21
0.91
0.91
No.
19.86
17.04
19.04
NEW
NEW
23.00
17.04
19.04
13.50
15.68
23.00
17.04
19.04
13.50
15.68
No.
No.
No.
No.
No.
NEW
3.00
3.00
No.
15.85
NEW
15.00
1.16
15.00
1.16
No.
No.
1.78
0.55
0.25
3.57
1.10
1.54
1.97
1.78
0.55
0.60
3.00
1.10
1.54
1.97
1.78
0.55
0.60
3.00
1.10
1.54
1.97
No.
No.
No.
No.
No.
No.
No.
21JYP2
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TABLE 10—PROPOSED CY 2018 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued
Current
work
RVU
HCPCS
Descriptor
30906 ..........
Control nasal hemorrhage, posterior, with posterior nasal packs and/or cautery, any method; subsequent.
Nasal/sinus endoscopy, surgical; with ligation of sphenopalatine artery ............................................
Nasal/sinus endoscopy, surgical with ethmoidectomy; total (anterior and posterior), including frontal sinus exploration, with removal of tissue from frontal sinus, when performed.
Nasal/sinus endoscopy, surgical with ethmoidectomy; total (anterior and posterior), including
sphenoidotomy.
Nasal/sinus endoscopy, surgical with ethmoidectomy; total (anterior and posterior), including
sphenoidotomy, with removal of tissue from the sphenoid sinus.
Nasal/sinus endoscopy, surgical; with dilation of frontal and sphenoid sinus ostia (e.g., balloon dilation).
Nasal/sinus endoscopy, surgical with ethmoidectomy; partial (anterior) ............................................
Nasal/sinus endoscopy, surgical with ethmoidectomy; total (anterior and posterior) .........................
Nasal/sinus endoscopy, surgical, with maxillary antrostomy ..............................................................
Nasal/sinus endoscopy, surgical, with maxillary antrostomy; with removal of tissue from maxillary
sinus.
Nasal/sinus endoscopy, surgical, with frontal sinus exploration, including removal of tissue from
frontal sinus, when performed.
Nasal/sinus endoscopy, surgical, with sphenoidotomy .......................................................................
Nasal/sinus endoscopy, surgical, with sphenoidotomy; with removal of tissue from the sphenoid
sinus.
Nasal/sinus endoscopy, surgical; with dilation of maxillary sinus ostium (e.g., balloon dilation),
transnasal or canine fossa.
Nasal/sinus endoscopy, surgical; with dilation of frontal sinus ostium (e.g., balloon dilation) ...........
Nasal/sinus endoscopy, surgical; with dilation of sphenoid sinus ostium (e.g., balloon dilation) .......
Tracheostomy, planned (separate procedure) ....................................................................................
Tracheostomy, planned (separate procedure); younger than 2 years ...............................................
Tracheostomy, emergency procedure; transtracheal ..........................................................................
Tracheostomy, emergency procedure; cricothyroid membrane ..........................................................
Tracheostomy, fenestration procedure with skin flaps ........................................................................
Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed with therapeutic
aspiration of tracheobronchial tree, initial.
Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when performed with therapeutic
aspiration of tracheobronchial tree, subsequent, same hospital stay.
Ablation therapy for reduction or eradication of 1 or more pulmonary tumor(s) including pleura or
chest wall when involved by tumor extension, percutaneous, including imaging guidance when
performed, unilateral; radiofrequency.
Ablation therapy for reduction or eradication of 1 or more pulmonary tumor(s) including pleura or
chest wall when involved by tumor extension, percutaneous, including imaging guidance when
performed, unilateral; cryoablation.
Implantation of a total replacement heart system (artificial heart) with recipient cardiectomy ...........
Removal and replacement of total replacement heart system (artificial heart) ..................................
Removal of a total replacement heart system (artificial heart) for heart transplantation ....................
Open femoral artery exposure for delivery of endovascular prosthesis by groin incision, unilateral
Open iliac artery exposure for delivery of endovascular prosthesis or iliac occlusion by abdominal
or retroperitoneal incision, unilateral.
Open iliac artery exposure with creation of conduit for delivery of endovascular prosthesis or for
establishment of cardiopulmonary bypass, by abdominal or retroperitoneal incision, unilateral.
Open brachial artery exposure for delivery of endovascular prosthesis unilateral .............................
Endovascular repair of infrarenal aorta by deployment of an aorto-aortic tube endograft including
pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, all endograft extension(s) placed in the aorta from the
level of the renal arteries to the aortic bifurcation, and all angioplasty/stenting performed from
the level of the renal arteries to the aortic bifurcation; for other than rupture (e.g., for aneurysm,
pseudoaneurysm, dissection, penetrating ulcer).
Endovascular repair of infrarenal aorta by deployment of an aorto-aortic tube endograft including
pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, all endograft extension(s) placed in the aorta from the
level of the renal arteries to the aortic bifurcation, and all angioplasty/stenting performed from
the level of the renal arteries to the aortic bifurcation; for rupture including temporary aortic and/
or iliac balloon occlusion when performed (e.g., for aneurysm, pseudoaneurysm, dissection,
penetrating ulcer, traumatic disruption).
Endovascular repair of infrarenal aorta and/or iliac artery(ies) by deployment of an aorto-uniiliac
endograft including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, all endograft extension(s)
placed in the aorta from the level of the renal arteries to the iliac bifurcation, and all angioplasty/
stenting performed from the level of the renal arteries to the iliac bifurcation; for other than rupture (e.g., for aneurysm, pseudoaneurysm, dissection, penetrating ulcer).
Endovascular repair of infrarenal aorta and/or iliac artery(ies) by deployment of an aorto-uniiliac
endograft including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, all endograft extension(s)
placed in the aorta from the level of the renal arteries to the iliac bifurcation, and all angioplasty/
stenting performed from the level of the renal arteries to the iliac bifurcation; for rupture including temporary aortic and/or iliac balloon occlusion when performed (e.g., for aneurysm,
pseudoaneurysm, dissection, penetrating ulcer, traumatic disruption).
31XX1 .........
31XX2 .........
31XX3 .........
31XX4 .........
31XX5 .........
31254
31255
31256
31267
..........
..........
..........
..........
31276 ..........
31287 ..........
31288 ..........
31295 ..........
31296
31297
31600
31601
31603
31605
31610
31645
..........
..........
..........
..........
..........
..........
..........
..........
31646 ..........
32998 ..........
32X99 .........
339X1 .........
339X2 .........
339X3 .........
34812 ..........
34820 ..........
34833 ..........
34834 ..........
34X01 .........
34X02 .........
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34X03 .........
34X04 .........
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E:\FR\FM\21JYP2.SGM
RUC
work
RVU
CMS
work
RVU
CMS time
refinement
2.45
2.45
2.45
No.
NEW
NEW
8.00
9.00
8.00
9.00
No.
No.
NEW
8.00
8.00
No.
NEW
8.48
8.48
No.
NEW
4.50
4.50
No.
4.64
6.95
3.29
5.45
4.27
5.75
3.11
4.68
4.27
5.75
3.11
4.68
No.
No.
No.
No.
8.84
6.75
6.75
No.
3.91
4.57
3.50
4.10
3.50
4.10
No.
No.
2.70
2.70
2.70
No.
3.29
2.64
7.17
4.44
4.14
3.57
9.38
2.91
3.10
2.44
5.56
8.00
6.00
6.45
12.00
2.88
3.10
2.44
5.56
8.00
6.00
6.45
12.00
2.88
No.
No.
No.
No.
No.
No.
No.
No.
2.47
2.78
2.78
No.
5.68
9.03
9.03
No.
NEW
9.03
9.03
No.
NEW
NEW
NEW
6.74
9.74
49.00
C
C
4.13
7.00
49.00
C
C
4.13
7.00
No.
No.
No.
No.
No.
11.98
8.16
8.16
No.
5.34
NEW
2.65
23.71
2.65
23.71
No.
No.
NEW
36.00
36.00
No.
NEW
26.52
26.52
No.
NEW
45.00
45.00
No.
21JYP2
34016
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 10—PROPOSED CY 2018 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued
Current
work
RVU
HCPCS
Descriptor
34X05 .........
Endovascular repair of infrarenal aorta and/or iliac artery(ies) by deployment of an aorto-biiliac
endograft including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, all endograft extension(s)
placed in the aorta from the level of the renal arteries to the iliac bifurcation, and all angioplasty/
stenting performed from the level of the renal arteries to the iliac bifurcation; for other than rupture (e.g., for aneurysm, pseudoaneurysm, dissection, penetrating ulcer).
Endovascular repair of infrarenal aorta and/or iliac artery(ies) by deployment of an aorto-biiliac
endograft including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological supervision and interpretation, all endograft extension(s)
placed in the aorta from the level of the renal arteries to the iliac bifurcation, and all angioplasty/
stenting performed from the level of the renal arteries to the iliac bifurcation; for rupture including temporary aortic and/or iliac balloon occlusion when performed (e.g., for aneurysm,
pseudoaneurysm, dissection, penetrating ulcer, traumatic disruption).
Endovascular repair of iliac artery by deployment of an ilio-iliac tube endograft including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological
supervision and interpretation, and all endograft extension(s) proximally to the aortic bifurcation
and distally to the iliac bifurcation, and treatment zone angioplasty/stenting when performed,
unilateral; for other than rupture (e.g., for aneurysm, pseudoaneurysm, dissection, arteriovenous
malformation).
Endovascular repair of iliac artery by deployment of an ilio-iliac tube endograft including pre-procedure sizing and device selection, all nonselective catheterization(s), all associated radiological
supervision and interpretation, and all endograft extension(s) proximally to the aortic bifurcation
and distally to the iliac bifurcation, and treatment zone angioplasty/stenting when performed,
unilateral; for rupture including temporary aortic and/or iliac balloon occlusion when performed
(e.g., for aneurysm, pseudoaneurysm, dissection, arteriovenous malformation, traumatic disruption).
Placement of extension prosthesis(es) distal to the common iliac artery(ies) or proximal to the
renal artery(ies) for endovascular repair of infrarenal abdominal aortic or iliac aneurysm, false
aneurysm, dissection, penetrating ulcer, including pre-procedure sizing and device selection, all
nonselective catheterization(s), all associated radiological supervision and interpretation, and
treatment zone angioplasty/stenting when performed, per vessel treated.
Delayed placement of distal or proximal extension prosthesis for endovascular repair of infrarenal
abdominal aortic or iliac aneurysm, false aneurysm, dissection, endoleak, or endograft migration, including pre-procedure sizing and device selection, all nonselective catheterization(s), all
associated radiological supervision and interpretation, and treatment zone angioplasty/stenting
when performed; initial vessel treated.
Delayed placement of distal or proximal extension prosthesis for endovascular repair of infrarenal
abdominal aortic or iliac aneurysm, false aneurysm, dissection, endoleak, or endograft migration, including pre-procedure sizing and device selection, all nonselective catheterization(s), all
associated radiological supervision and interpretation, and treatment zone angioplasty/stenting
when performed; each additional vessel treated.
Transcatheter delivery of enhanced fixation device(s) to the endograft (e.g., anchor, screw, tack)
and all associated radiological supervision and interpretation.
Percutaneous access and closure of femoral artery for delivery of endograft through a large
sheath (12 French or larger), including ultrasound guidance, when performed, unilateral.
Open femoral artery exposure with creation of conduit for delivery of endovascular prosthesis or
for establishment of cardiopulmonary bypass, by groin incision, unilateral.
Open axillary/subclavian artery exposure for delivery of endovascular prosthesis by infraclavicular
or supraclavicular incision, unilateral.
Open axillary/subclavian artery exposure with creation of conduit for delivery of endovascular
prosthesis or for establishment of cardiopulmonary bypass, by infraclavicular or supraclavicular
incision, unilateral.
Selective catheter placement, arterial system; each first order thoracic or brachiocephalic branch,
within a vascular family.
Selective catheter placement, arterial system; initial second order thoracic or brachiocephalic
branch, within a vascular family.
Selective catheter placement, arterial system; initial third order or more selective thoracic or
brachiocephalic branch, within a vascular family.
Selective catheter placement, arterial system; additional second order, third order, and beyond,
thoracic or brachiocephalic branch, within a vascular family.
Injection of sclerosant; single incompetent vein (other than telangiectasia) ......................................
Injection of sclerosant; multiple incompetent veins (other than telangiectasia), same leg .................
Endovenous ablation therapy of incompetent vein, extremity, by transcatheter delivery of a chemical adhesive (e.g., cyanoacrylate) remote from the access site, inclusive of all imaging guidance and monitoring, percutaneous; first vein treated.
Endovenous ablation therapy of incompetent vein, extremity, by transcatheter delivery of a chemical adhesive (e.g., cyanoacrylate) remote from the access site, inclusive of all imaging guidance and monitoring, percutaneous; subsequent vein(s) treated in a single extremity, each
through separate access sites.
Injection of non-compounded foam sclerosant with ultrasound compression maneuvers to guide
dispersion of the injectate, inclusive of all imaging guidance and monitoring; single incompetent
extremity truncal vein (e.g., great saphenous vein, accessory saphenous vein).
Injection of non-compounded foam sclerosant with ultrasound compression maneuvers to guide
dispersion of the injectate, inclusive of all imaging guidance and monitoring; multiple incompetent truncal veins (e.g., great saphenous vein, accessory saphenous vein), same leg.
Therapeutic apheresis; for white blood cells .......................................................................................
Therapeutic apheresis; for red blood cells ..........................................................................................
Therapeutic apheresis; for platelets ....................................................................................................
Therapeutic apheresis; for plasma pheresis .......................................................................................
34X06 .........
34X07 .........
34X08 .........
34X09 .........
34X10 .........
34X11 .........
34X12 .........
34X13 .........
34X15 .........
34X19 .........
34X20 .........
36215 ..........
36216 ..........
36217 ..........
36218 ..........
36470 ..........
36471 ..........
364X3 .........
mstockstill on DSK30JT082PROD with PROPOSALS2
364X4 .........
364X5 .........
364X6 .........
36511
36512
36513
36514
..........
..........
..........
..........
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RUC
work
RVU
CMS
work
RVU
CMS time
refinement
NEW
29.58
29.58
No.
NEW
45.00
45.00
No.
NEW
22.28
22.28
No.
NEW
36.50
36.50
No.
NEW
6.50
6.50
No.
NEW
15.00
15.00
No.
NEW
6.00
6.00
No.
NEW
12.00
12.00
No.
NEW
2.50
2.50
No.
NEW
5.25
5.25
No.
NEW
6.00
6.00
No.
NEW
7.19
7.19
No.
4.67
4.17
4.17
No.
5.27
5.27
5.27
No.
6.29
6.29
6.29
No.
1.01
1.01
1.01
No.
1.10
1.65
NEW
0.75
1.50
3.50
0.75
1.50
3.50
No.
No.
No.
NEW
1.75
1.75
No.
NEW
2.35
2.35
No.
NEW
3.00
3.00
No.
1.74
1.74
1.74
1.74
2.00
2.00
2.00
1.81
2.00
2.00
2.00
1.81
No.
No.
No.
No.
21JYP2
34017
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 10—PROPOSED CY 2018 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued
Current
work
RVU
HCPCS
Descriptor
36516 ..........
Therapeutic apheresis; with extracorporeal selective adsorption or selective filtration and plasma
reinfusion.
Photopheresis, extracorporeal .............................................................................................................
Insertion of non-tunneled centrally inserted central venous catheter; younger than 5 years of age
Insertion of non-tunneled centrally inserted central venous catheter; age 5 years or older ..............
Insertion of peripherally inserted central venous catheter (PICC), without subcutaneous port or
pump; age 5 years or older.
Arterial catheterization or cannulation for sampling, monitoring or transfusion (separate procedure); percutaneous.
Diagnostic bone marrow; aspiration(s) ................................................................................................
Diagnostic bone marrow; biopsy(ies) ..................................................................................................
Diagnostic bone marrow; biopsy(ies) and aspiration(s) ......................................................................
Laparoscopy, surgical; with bilateral total pelvic lymphadenectomy and peri-aortic lymph node
sampling peritoneal washings, peritoneal biopsy(s), omentectomy, and diaphragmatic washings,
including biopsy(s) when performed.
Total or near total esophagectomy, without thoracotomy; with pharyngogastrostomy or cervical
esophagogastrostomy, with or without pyloroplasty (transhiatal).
Total or near total esophagectomy, with thoracotomy; with pharyngogastrostomy or cervical
esophagogastrostomy, with or without pyloroplasty (i.e., McKeown esophagectomy, or triincisional esophagectomy).
Partial esophagectomy, distal two-thirds, with thoracotomy and separate abdominal incision, with
or without proximal gastrectomy; with thoracic esophagogastrostomy, with or without pyloroplasty (Ivor Lewis).
Esophagectomy, total or near total, with laparoscopic mobilization of the abdominal and mediastinal esophagus and proximal gastrectomy, with laparoscopic pyloric drainage procedure if
performed, with open cervical pharyngogastrostomy or esophagogastrostomy (i.e., laparoscopic
transhiatal esophagectomy).
Esophagectomy, distal two-thirds, with laparoscopic mobilization of the abdominal and lower mediastinal esophagus and proximal gastrectomy, with laparoscopic pyloric drainage procedure if
performed, with separate thoracoscopic mobilization of the middle and upper mediastinal
esophagus
and
thoracic
esophagogastrostomy
(i.e.,
laparoscopic
thoracoscopic
esophagectomy, Ivor Lewis esophagectomy).
Esophagectomy, total or near total, with thoracoscopic mobilization of the upper, middle, and
lower mediastinal esophagus, with separate laparoscopic proximal gastrectomy, with
laparoscopic pyloric drainage procedure if performed, with open cervical pharyngogastrostomy
or esophagogastrostomy (i.e., thoracoscopic, laparoscopic and cervical incision
esophagectomy, McKeown esophagectomy, tri-incisional esophagectomy).
Measurement of post-voiding residual urine and/or bladder capacity by ultrasound, non-imaging ...
Transurethral electrosurgical resection of prostate, including control of postoperative bleeding,
complete (vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or dilation, and internal urethrotomy are included).
Transperineal placement of biodegradable material, peri-prostatic, single or multiple injection(s),
including image guidance, when performed.
Anterior colporrhaphy, repair of cystocele with or without repair of urethrocele, including
cystourethroscopy, when performed.
Posterior colporrhaphy, repair of rectocele with or without perineorrhaphy .......................................
Combined anteroposterior colporrhaphy, including cystourethroscopy, when performed ..................
Combined anteroposterior colporrhaphy, including cystourethroscopy, when performed; with
enterocele repair.
Laparoscopy, surgical, total hysterectomy; with or without salpingo-oophorectomy, unilateral or bilateral, with resection of malignancy (tumor debulking), with omentectomy.
Injection, anesthetic agent; suprascapular nerve ................................................................................
Percutaneous implantation of neurostimulator electrode array; cranial nerve ....................................
Percutaneous implantation of neurostimulator electrode array; peripheral nerve (excludes sacral
nerve).
Nerve repair; with synthetic conduit or vein allograft (e.g., nerve tube), each nerve .........................
Nerve repair; with autogenous vein graft (includes harvest of vein graft), each nerve ......................
Nerve repair; with nerve allograft, each nerve, first strand (cable) .....................................................
Nerve repair; with nerve allograft, each additional strand ..................................................................
Correction of trichiasis; epilation, by forceps only ..............................................................................
Computed tomography, soft tissue neck; without contrast material ...................................................
Computed tomography, soft tissue neck; with contrast material(s) ....................................................
Computed tomography, soft tissue neck; without contrast material followed by contrast material(s)
and further sections.
Magnetic resonance angiography, head; without contrast material(s) ...............................................
Magnetic resonance angiography, head; with contrast material(s) ....................................................
Magnetic resonance angiography, head; without contrast material(s), followed by contrast material(s) and further sequences.
Magnetic resonance angiography, neck; without contrast material(s) ................................................
Magnetic resonance angiography, neck; with contrast material(s) .....................................................
Magnetic resonance angiography, neck; without contrast material(s), followed by contrast material(s) and further sequences.
Radiologic examination, chest; single view .........................................................................................
Radiologic examination, chest; 2 views ..............................................................................................
Radiologic examination, chest; 3 views ..............................................................................................
Radiologic examination, chest; 4 or more views ................................................................................
Radiologic examination, ribs, unilateral; 2 views ................................................................................
Radiologic examination, ribs, unilateral; including posteroanterior chest, minimum of 3 views .........
Radiologic examination, ribs, bilateral; 3 views ..................................................................................
Radiologic examination, ribs, bilateral; including posteroanterior chest, minimum of 4 views ...........
36522
36555
36556
36569
..........
..........
..........
..........
36620 ..........
38220 ..........
38221 ..........
382X3 .........
3857X .........
43107 ..........
43112 ..........
43117 ..........
432X5 .........
432X6 .........
432X7 .........
51798 ..........
52601 ..........
55X87 .........
57240 ..........
57250 ..........
57260 ..........
57265 ..........
5857X .........
64418 ..........
64553 ..........
64555 ..........
64910 ..........
64911 ..........
64X91 .........
64X92 .........
67820 ..........
70490 ..........
70491 ..........
70492 ..........
mstockstill on DSK30JT082PROD with PROPOSALS2
70544 ..........
70545 ..........
70546 ..........
70547 ..........
70548 ..........
70549 ..........
710X1 .........
710X2 .........
710X3 .........
710X4 .........
71100 ..........
71101 ..........
71110 ..........
71111 ..........
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RUC
work
RVU
CMS
work
RVU
CMS time
refinement
1.22
1.56
1.56
No.
1.67
2.43
2.50
1.82
1.75
1.93
1.75
1.70
1.75
1.93
1.75
1.70
No.
No.
No.
No.
1.15
1.00
1.00
No.
1.08
1.37
NEW
NEW
1.20
1.28
1.44
20.00
1.20
1.28
1.44
20.00
Yes.
Yes.
Yes.
No.
44.18
52.05
52.05
No.
47.48
62.00
62.00
No.
43.65
57.50
57.50
No.
NEW
55.00
55.00
No
NEW
63.00
63.00
No.
NEW
66.42
66.42
No.
0.00
15.26
0.00
13.16
0.00
13.16
No.
No.
NEW
3.03
3.03
No.
11.50
10.08
10.08
No.
11.50
14.44
15.94
10.08
13.25
15.00
10.08
13.25
15.00
No.
No.
No.
NEW
32.60
32.60
No.
1.32
2.36
2.32
1.10
6.13
5.76
1.10
6.13
5.76
No.
No
No.
11.39
14.39
NEW
NEW
0.71
1.28
1.38
1.45
10.52
14.00
12.00
3.00
0.32
1.28
1.38
1.62
10.52
14.00
12.00
3.00
0.32
1.28
1.38
1.62
No.
No
No.
No.
No.
No.
No.
No.
1.20
1.20
1.80
1.20
1.20
1.48
1.20
1.20
1.48
No.
No.
No.
1.20
1.20
1.80
1.20
1.50
1.80
1.20
1.50
1.80
No.
No.
No.
NEW
NEW
NEW
NEW
0.22
0.27
0.27
0.32
0.18
0.22
0.27
0.31
0.22
0.27
0.29
0.32
0.18
0.22
0.27
0.31
0.22
0.27
0.29
0.32
No.
No.
No.
No.
No.
No.
No.
No.
21JYP2
34018
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 10—PROPOSED CY 2018 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued
Current
work
RVU
HCPCS
Descriptor
71250 ..........
71260 ..........
71270 ..........
Computed tomography, thorax; without contrast material ..................................................................
Computed tomography, thorax; with contrast material(s) ...................................................................
Computed tomography, thorax; without contrast material, followed by contrast material(s) and further sections.
Magnetic resonance (e.g., proton) imaging, pelvis; without contrast material(s) ...............................
Magnetic resonance (e.g., proton) imaging, pelvis; with contrast material(s) ....................................
Magnetic resonance (e.g., proton) imaging, pelvis; without contrast material(s), followed by contrast material(s) and further sequences.
Radiologic examination, wrist; 2 views ...............................................................................................
Radiologic examination, wrist; complete, minimum of 3 views ...........................................................
Radiologic examination, hand; 2 views ...............................................................................................
Radiologic examination, hand; minimum of 3 views ...........................................................................
Radiologic examination, finger(s), minimum of 2 views ......................................................................
Magnetic resonance (e.g., proton) imaging, lower extremity other than joint; without contrast material(s).
Magnetic resonance (e.g., proton) imaging, lower extremity other than joint; with contrast material(s).
Magnetic resonance (e.g., proton) imaging, lower extremity other than joint; without contrast material(s), followed by contrast material(s) and further sequences.
Radiologic examination, abdomen; complete acute abdomen series, including supine, erect, and/
or decubitus views, single view chest.
Radiologic examination, abdomen; 1 view ..........................................................................................
Radiologic examination, abdomen; 2 views ........................................................................................
Radiologic examination, abdomen; 3 or more views ..........................................................................
Magnetic resonance (e.g., proton) imaging, abdomen; without contrast material(s) ..........................
Magnetic resonance (e.g., proton) imaging, abdomen; with contrast material(s) ...............................
Magnetic resonance (e.g., proton) imaging, abdomen; without contrast material(s), followed by
with contrast material(s) and further sequences.
Computed tomographic angiography, abdominal aorta and bilateral iliofemoral lower extremity runoff, with contrast material(s), including noncontrast images, if performed, and image
postprocessing.
Angiography, extremity, unilateral, radiological supervision and interpretation ..................................
Angiography, extremity, bilateral, radiological supervision and interpretation ....................................
Ophthalmic ultrasound, diagnostic; B-scan and quantitative A-scan performed during the same patient encounter.
Ophthalmic ultrasound, diagnostic; quantitative A-scan only .............................................................
Ophthalmic ultrasound, diagnostic; B-scan (with or without superimposed non-quantitative A-scan)
Ophthalmic biometry by ultrasound echography, A-scan ...................................................................
Ophthalmic biometry by ultrasound echography, A-scan; with intraocular lens power calculation ....
Ultrasound, extremity, nonvascular, real-time with image documentation; complete .........................
Ultrasound, extremity, nonvascular, real-time with image documentation; limited, anatomic specific
Therapeutic radiology treatment planning; simple ..............................................................................
Therapeutic radiology treatment planning; intermediate .....................................................................
Therapeutic radiology treatment planning; complex ...........................................................................
Bone and/or joint imaging; limited area ..............................................................................................
Bone and/or joint imaging; multiple areas ...........................................................................................
Bone and/or joint imaging; whole body ...............................................................................................
Pathology consultation during surgery; cytologic examination (e.g., touch prep, squash prep), initial site.
Pathology consultation during surgery; cytologic examination (e.g., touch prep, squash prep),
each additional site.
Morphometric analysis, tumor immunohistochemistry (e.g., Her-2/neu, estrogen receptor/progesterone receptor), quantitative or semiquantitative, per specimen, each single antibody stain
procedure; manual.
Morphometric analysis, tumor immunohistochemistry (e.g., Her-2/neu, estrogen receptor/progesterone receptor), quantitative or semiquantitative, per specimen, each single antibody stain
procedure; using computer-assisted technology.
Ophthalmic biometry by partial coherence interferometry with intraocular lens power calculation ....
Programming device evaluation (in person) with iterative adjustment of the implantable device to
test the function of the device and select optimal permanent programmed values with analysis,
review and report by a physician or other qualified health care professional; single lead pacemaker system.
Programming device evaluation (in person) with iterative adjustment of the implantable device to
test the function of the device and select optimal permanent programmed values with analysis,
review and report by a physician or other qualified health care professional; dual lead pacemaker system.
Programming device evaluation (in person) with iterative adjustment of the implantable device to
test the function of the device and select optimal permanent programmed values with analysis,
review and report by a physician or other qualified health care professional; multiple lead pacemaker system.
Programming device evaluation (in person) with iterative adjustment of the implantable device to
test the function of the device and select optimal permanent programmed values with analysis,
review and report by a physician or other qualified health care professional; single lead
transvenous implantable defibrillator system.
Programming device evaluation (in person) with iterative adjustment of the implantable device to
test the function of the device and select optimal permanent programmed values with analysis,
review and report by a physician or other qualified health care professional; dual lead
transvenous implantable defibrillator system.
72195 ..........
72196 ..........
72197 ..........
73100
73110
73120
73130
73140
73718
..........
..........
..........
..........
..........
..........
73719 ..........
73720 ..........
74022 ..........
740X1 .........
740X2 .........
740X3 .........
74181 ..........
74182 ..........
74183 ..........
75635 ..........
75710 ..........
75716 ..........
76510 ..........
76511
76512
76516
76519
76881
76882
77261
77262
77263
78300
78305
78306
88333
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
88334 ..........
88360 ..........
88361 ..........
92136 ..........
93279 ..........
93280 ..........
mstockstill on DSK30JT082PROD with PROPOSALS2
93281 ..........
93282 ..........
93283 ..........
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RUC
work
RVU
CMS
work
RVU
CMS time
refinement
1.02
1.24
1.38
1.16
1.24
1.38
1.16
1.24
1.38
No.
No.
No.
1.46
1.73
2.26
1.46
1.73
2.20
1.46
1.73
2.20
No.
No.
No.
0.16
0.17
0.16
0.17
0.13
1.35
0.16
0.17
0.16
0.17
0.13
1.35
0.16
0.17
0.16
0.17
0.13
1.35
No.
No.
No.
No.
No.
No.
1.62
1.62
1.62
No.
2.15
2.15
2.15
No.
0.32
0.32
0.32
No.
NEW
NEW
NEW
1.46
1.73
2.26
0.18
0.23
0.27
1.46
1.73
2.20
0.18
0.23
0.27
1.46
1.73
2.20
No.
No.
No.
No.
No.
No.
2.40
2.40
2.40
No.
1.14
1.31
1.55
1.75
1.97
0.70
1.75
1.97
0.70
No.
No.
No.
0.94
0.94
0.54
0.54
0.63
0.49
1.39
2.11
3.14
0.62
0.83
0.86
1.20
0.64
0.56
0.40
0.54
0.63
0.49
1.30
2.00
3.14
0.62
0.83
0.86
1.20
0.64
0.56
0.40
0.54
0.63
0.49
1.30
2.00
3.14
0.62
0.83
0.86
1.20
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
0.73
0.73
0.73
No.
1.10
0.85
0.85
No.
1.18
0.95
0.95
No.
0.54
0.65
0.54
0.65
0.54
0.65
No.
No.
0.77
0.77
0.77
No.
0.90
0.85
0.85
No.
0.85
0.85
0.85
No.
1.15
1.15
1.15
No.
21JYP2
34019
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 10—PROPOSED CY 2018 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued
Current
work
RVU
HCPCS
Descriptor
93284 ..........
Programming device evaluation (in person) with iterative adjustment of the implantable device to
test the function of the device and select optimal permanent programmed values with analysis,
review and report by a physician or other qualified health care professional; multiple lead
transvenous implantable defibrillator system.
Programming device evaluation (in person) with iterative adjustment of the implantable device to
test the function of the device and select optimal permanent programmed values with analysis,
review and report by a physician or other qualified health care professional; implantable loop recorder system.
Peri-procedural device evaluation (in person) and programming of device system parameters before or after a surgery, procedure, or test with analysis, review and report by a physician or
other qualified health care professional; single, dual, or multiple lead pacemaker system.
Peri-procedural device evaluation (in person) and programming of device system parameters before or after a surgery, procedure, or test with analysis, review and report by a physician or
other qualified health care professional; single, dual, or multiple lead implantable defibrillator
system.
Interrogation device evaluation (in person) with analysis, review and report by a physician or other
qualified health care professional, includes connection, recording and disconnection per patient
encounter; single, dual, or multiple lead pacemaker system.
Interrogation device evaluation (in person) with analysis, review and report by a physician or other
qualified health care professional, includes connection, recording and disconnection per patient
encounter; single, dual, or multiple lead transvenous implantable defibrillator system, including
analysis of heart rhythm derived data elements.
Interrogation device evaluation (in person) with analysis, review and report by a physician or other
qualified health care professional, includes connection, recording and disconnection per patient
encounter; implantable cardiovascular monitor system, including analysis of 1 or more recorded
physiologic cardiovascular data elements from all internal and external sensors.
Interrogation device evaluation (in person) with analysis, review and report by a physician or other
qualified health care professional, includes connection, recording and disconnection per patient
encounter; implantable loop recorder system, including heart rhythm derived data analysis.
Interrogation device evaluation (in person) with analysis, review and report by a physician or other
qualified health care professional, includes connection, recording and disconnection per patient
encounter; wearable defibrillator system.
Transtelephonic rhythm strip pacemaker evaluation(s) single, dual, or multiple lead pacemaker
system, includes recording with and without magnet application with analysis, review and report(s) by a physician or other qualified health care professional, up to 90 days.
Interrogation device evaluation(s) (remote), up to 90 days; single, dual, or multiple lead pacemaker system with interim analysis, review(s) and report(s) by a physician or other qualified
health care professional.
Interrogation device evaluation(s) (remote), up to 90 days; single, dual, or multiple lead
implantable defibrillator system with interim analysis, review(s) and report(s) by a physician or
other qualified health care professional.
Interrogation device evaluation(s) (remote), up to 90 days; single, dual, or multiple lead pacemaker system or implantable defibrillator system, remote data acquisition(s), receipt of transmissions and technician review, technical support and distribution of results.
Interrogation device evaluation(s), (remote) up to 30 days; implantable cardiovascular monitor
system, including analysis of 1 or more recorded physiologic cardiovascular data elements from
all internal and external sensors, analysis, review(s) and report(s) by a physician or other qualified health care professional.
Interrogation device evaluation(s), (remote) up to 30 days; implantable loop recorder system, including analysis of recorded heart rhythm data, analysis, review(s) and report(s) by a physician
or other qualified health care professional.
Interrogation device evaluation(s), (remote) up to 30 days; implantable cardiovascular monitor
system or implantable loop recorder system, remote data acquisition(s), receipt of transmissions
and technician review, technical support and distribution of results.
Echocardiography, transthoracic, real-time with image documentation (2D), includes M-mode recording, when performed, complete, with spectral Doppler echocardiography, and with color
flow Doppler echocardiography.
Echocardiography, transthoracic, real-time with image documentation (2D), includes M-mode recording, when performed, complete, without spectral or color Doppler echocardiography.
Echocardiography, transthoracic, real-time with image documentation (2D), includes M-mode recording, when performed, follow-up or limited study.
Echocardiography, transthoracic, real-time with image documentation (2D), includes M-mode recording, when performed, during rest and cardiovascular stress test using treadmill, bicycle exercise and/or pharmacologically induced stress, with interpretation and report.
Echocardiography, transthoracic, real-time with image documentation (2D), includes M-mode recording, when performed, during rest and cardiovascular stress test using treadmill, bicycle exercise and/or pharmacologically induced stress, with interpretation and report; including performance of continuous electrocardiographic monitoring, with supervision by a physician or
other qualified health care professional.
Insertion and placement of flow directed catheter (e.g., Swan-Ganz) for monitoring purposes ........
Intracardiac electrophysiologic 3-dimensional mapping ......................................................................
Peripheral arterial disease (PAD) rehabilitation, per session .............................................................
Cardiopulmonary exercise testing, including measurements of minute ventilation, CO2 production,
O2 uptake, and electrocardiographic recordings.
Exercise test for bronchospasm, including pre- and post-spirometry and pulse oximetry .................
Pulmonary stress testing (e.g., 6-minute walk test), including measurement of heart rate, oximetry,
and oxygen titration, when performed.
Percutaneous tests (scratch, puncture, prick) with allergenic extracts, immediate type reaction, including test interpretation and report, specify number of tests.
93285 ..........
93286 ..........
93287 ..........
93288 ..........
93289 ..........
93290 ..........
93291 ..........
93292 ..........
93293 ..........
93294 ..........
93295 ..........
93296 ..........
93297 ..........
93298 ..........
93299 ..........
93306 ..........
93307 ..........
93308 ..........
93350 ..........
mstockstill on DSK30JT082PROD with PROPOSALS2
93351 ..........
93503
93613
93668
94621
..........
..........
..........
..........
946X2 .........
946X3 .........
95004 ..........
VerDate Sep<11>2014
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E:\FR\FM\21JYP2.SGM
RUC
work
RVU
CMS
work
RVU
CMS time
refinement
1.25
1.25
1.25
No.
0.52
0.52
0.52
No.
0.30
0.30
0.30
No.
0.45
0.45
0.45
No.
0.43
0.43
0.43
No.
0.92
0.75
0.75
No.
0.43
0.43
0.43
No.
0.43
0.37
0.37
No.
0.43
0.43
0.43
No.
0.32
0.31
0.31
No.
0.65
0.60
0.60
No.
1.29
0.74
0.74
No.
0.00
0.00
0.00
No.
0.52
0.52
0.52
No.
0.52
0.52
0.52
No.
0.00
0.00
0.00
No.
1.30
1.50
1.50
No.
0.92
0.92
0.92
No.
0.53
0.53
0.53
No.
1.46
1.46
1.46
No.
1.75
1.75
1.75
No.
2.91
6.99
N
1.42
2.00
5.23
0.00
1.42
2.00
5.23
0.00
1.42
No.
No.
No.
No.
NEW
NEW
0.70
0.48
0.70
0.48
No.
No.
0.01
0.01
0.01
No.
21JYP2
34020
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 10—PROPOSED CY 2018 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued
Current
work
RVU
HCPCS
Descriptor
95250 ..........
Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for
a minimum of 72 hours; sensor placement, hook-up, calibration of monitor, patient training, removal of sensor, and printout of recording.
Ambulatory continuous glucose monitoring of interstitial tissue fluid via a subcutaneous sensor for
a minimum of 72 hours; interpretation and report.
Visual evoked potential (VEP) testing central nervous system except glaucoma, checkerboard or
flash, with interpretation and report.
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.
Intravenous infusion, hydration; initial, 31 minutes to 1 hour .............................................................
Intravenous infusion, hydration; each additional hour ........................................................................
Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or
intramuscular.
Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); intravenous push,
single or initial substance/drug.
Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); each additional sequential intravenous push of a new substance/drug.
Application of on-body injector (includes cannula insertion) for timed subcutaneous injection .........
Chemotherapy administration, subcutaneous or intramuscular; non-hormonal anti-neoplastic .........
Chemotherapy administration, subcutaneous or intramuscular; hormonal anti-neoplastic ................
Chemotherapy administration; intravenous, push technique, single or initial substance/drug ...........
Chemotherapy administration; intravenous, push technique, each additional substance/drug ..........
Photochemotherapy; tar and ultraviolet B (Goeckerman treatment) or petrolatum and ultraviolet B
Photodynamic therapy by external application of light to destroy premalignant lesions of the skin
and adjacent mucosa with application and illumination/activation of photosensitizing drug(s), per
day.
Debridement of premalignant hyperkeratotic lesion(s) (i.e., targeted curettage, abrasion) followed
with photodynamic therapy by external application of light to destroy premalignant lesions of the
skin and adjacent mucosa with application and illumination/activation of photosensitizing
drug(s), per day.
Application of a modality to 1 or more areas; traction, mechanical ....................................................
Application of a modality to 1 or more areas; electrical stimulation (unattended) ..............................
Application of a modality to 1 or more areas; vasopneumatic devices ..............................................
Application of a modality to 1 or more areas; paraffin bath ................................................................
Application of a modality to 1 or more areas; whirlpool ......................................................................
Application of a modality to 1 or more areas; electrical stimulation (manual), each 15 minutes .......
Application of a modality to 1 or more areas; iontophoresis, each 15 minutes .................................
Application of a modality to 1 or more areas; contrast baths, each 15 minutes ................................
Application of a modality to 1 or more areas; ultrasound, each 15 minutes ......................................
Therapeutic procedure, 1 or more areas, each 15 minutes; therapeutic exercises to develop
strength and endurance, range of motion and flexibility.
Therapeutic procedure, 1 or more areas, each 15 minutes; neuromuscular reeducation of movement, balance, coordination, kinesthetic sense, posture, and/or proprioception for sitting and/or
standing activities.
Therapeutic procedure, 1 or more areas, each 15 minutes; aquatic therapy with therapeutic exercises.
Therapeutic procedure, 1 or more areas, each 15 minutes; gait training (includes stair climbing) ...
Manual therapy techniques (e.g., mobilization/manipulation, manual lymphatic drainage, manual
traction), 1 or more regions, each 15 minutes.
Therapeutic activities, direct (one-on-one) patient contact (use of dynamic activities to improve
functional performance), each 15 minutes.
Sensory integrative techniques to enhance sensory processing and promote adaptive responses
to environmental demands, direct (one-on-one) patient contact, each 15 minutes.
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.
Community/work reintegration training (e.g., shopping, transportation, money management, avocational activities and/or work environment/modification analysis, work task analysis, use of assistive technology device/adaptive equipment), direct one-on-one contact, each 15 minutes.
Wheelchair management (e.g., assessment, fitting, training), each 15 minutes ................................
Orthotic(s) management and training (including assessment and fitting when not otherwise reported), upper extremity(ies), lower extremity(ies) and/or trunk, initial orthotic(s) encounter, each
15 minutes.
Prosthetic(s) training, upper and/or lower extremity(ies), initial prosthetic(s) encounter, each 15
minutes.
Orthotic(s)/prosthetic(s) management and/or training, upper extremity(ies), lower extremity(ies),
and/or trunk, subsequent orthotic(s)/prosthetic(s) encounter, each 15 minutes.
Therapeutic interventions that focus on cognitive function (e.g., attention, memory, reasoning, executive function, problem solving, and/or pragmatic functioning) and compensatory strategies to
manage the performance of an activity (e.g., managing time or schedules, initiating, organizing
and sequencing tasks, direct (one-on-one) patient contact (do not report 97X11 in conjunction
with 0364T, 0365T, 0368T, 0369T) (report 97X11 only once per day).
Patient/caregiver training for initiation of home INR monitoring under the direction of a physician
or other qualified health care professional, including face-to-face, use and care of the INR monitor, obtaining blood sample, instructions for reporting home INR test results, and documentation of patient’s/caregiver’s ability to perform testing and report results.
95251 ..........
95930 ..........
96160 ..........
96161 ..........
96360 ..........
96361 ..........
96372 ..........
96374 ..........
96375 ..........
96377 ..........
96401 ..........
96402 ..........
96409 ..........
96411 ..........
96910 ..........
96X73 .........
96X74 .........
97012
97014
97016
97018
97022
97032
97033
97034
97035
97110
..........
..........
..........
..........
..........
..........
..........
..........
..........
..........
97112 ..........
97113 ..........
97116 ..........
97140 ..........
97530 ..........
97533 ..........
97535 ..........
97537 ..........
97542 ..........
97760 ..........
mstockstill on DSK30JT082PROD with PROPOSALS2
97761 ..........
977X1 .........
97X11 .........
993X1 .........
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E:\FR\FM\21JYP2.SGM
RUC
work
RVU
CMS
work
RVU
CMS time
refinement
0.00
0.00
0.00
No.
0.85
0.70
0.70
No.
0.35
0.35
0.35
No.
0.00
0.00
0.00
No.
0.00
0.00
0.00
No.
0.17
0.09
0.17
0.17
0.09
0.17
0.17
0.09
0.17
No.
No.
No.
0.18
0.18
0.18
No.
0.10
0.10
0.10
No.
0.00
0.21
0.19
0.24
0.20
0.00
NEW
0.17
0.21
0.19
0.24
0.20
0.00
0.48
0.17
0.21
0.19
0.24
0.20
0.00
0.48
No.
No.
No.
No.
No.
No.
No.
NEW
1.01
1.01
No.
0.25
0.18
0.18
0.06
0.17
0.25
0.26
0.21
0.21
0.45
0.25
0.18
0.18
0.06
0.17
0.25
0.26
0.21
0.21
0.45
0.25
0.18
0.18
0.06
0.17
0.25
0.26
0.21
0.21
0.45
No.
No.
No.
No.
No.
No.
No.
No.
No.
No.
0.45
0.50
0.50
No.
0.44
0.48
0.48
No.
0.40
0.43
0.45
0.43
0.45
0.43
No.
No.
0.44
0.44
0.44
No.
0.44
0.48
0.48
No.
0.45
0.45
0.45
No.
0.45
0.48
0.48
No.
0.45
0.45
0.48
0.50
0.48
0.50
No.
No.
0.45
0.50
0.50
No.
NEW
0.48
0.48
No.
NEW
1.50
I
NEW
0.00
0.00
21JYP2
Yes.
No.
34021
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 10—PROPOSED CY 2018 WORK RVUS FOR NEW, REVISED AND POTENTIALLY MISVALUED CODES—Continued
Current
work
RVU
HCPCS
Descriptor
993X2 .........
Anticoagulant management for a patient taking warfarin, must include review and interpretation of
a new home, office, or lab International No.rmalized Ratio (INR) test result, patient instructions,
dosage adjustment (as needed), and scheduling of additional test(s) when performed.
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, 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.
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.
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.
Assessment of and care planning for a patient with cognitive impairment, requiring an independent historian, in the office or other outpatient, home or domiciliary or rest home, with all of
the following required elements: Cognition-focused evaluation including a pertinent history and
examination; Medical decision making of moderate or high complexity; Functional assessment
(e.g., Basic and Instrumental Activities of Daily Living), including decision-making capacity; Use
of standardized instruments for staging of dementia (e.g., Functional Assessment Staging Test
[FAST], Clinical Dementia Rating [CDR]); Medication reconciliation and review for high-risk
medications; Evaluation for neuropsychiatric and behavioral symptoms, including depression, including use of standardized screening instrument(s); Evaluation of safety (e.g., home), including
motor vehicle operation; Identification of caregiver(s), caregiver knowledge, caregiver needs,
social supports, and the willingness of caregiver to take on caregiving tasks; Development, updating or revision, or review of an Advance Care Plan; Creation of a written care plan, including
initial plans to address any neuropsychiatric symptoms, neuro-cognitive symptoms, functional
limitations, and referral to community resources as needed (e.g., rehabilitation services, adult
day programs, support groups) shared with the patient and/or caregiver with initial education
and support. Typically, 50 minutes are spent face-to-face with the patient and/or family or caregiver.
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, per calendar month,
with the following required elements: Initial assessment or follow-up monitoring, including the
use of applicable validated rating scales; Behavioral health care planning in relation to behavioral/psychiatric health problems, including revision for patients who are not progressing or
whose status changes; Facilitating and coordinating treatment such as psychotherapy,
pharmacotherapy, counseling and/or psychiatric consultation; and Continuity of care with a designated member of the care team.
Electrical stimulation (unattended), to one or more areas for indication(s) other than wound care,
as part of a therapy plan of care.
Insertion, non-biodegradable drug delivery implants, 4 or more ........................................................
Removal, non-biodegradable drug deliver implants, 4 or more ..........................................................
Removal with reinsertion, non-biodegradable drug delivery implants, 4 or more ..............................
Superficial radiation treatment planning and management related services, including but not limited to, when performed, clinical treatment planning (e.g., 77261, 77262, 77263), therapeutic radiology simulation-aided field setting (e.g., 77280, 77285, 77290, 77293), basic radiation dosimetry calculation (e.g., 77300), treatment devices (e.g., 77332, 77333, 77334), isodose planning
(e.g., 77306, 77307, 77316, 77317, 77318), radiation treatment management (e.g., 77427,
77431, 77432, 77435, 77469, 77470, 77499), and associated evaluation and management per
course of treatment.
Therapeutic interventions that focus on cognitive function (e.g., attention, memory, reasoning, executive function, problem solving, and/or pragmatic functioning) and compensatory strategies to
manage the performance of an activity (e.g., managing time or schedules, initiating, organizing
and sequencing tasks, direct (one-on-one) patient contact.
Prolonged preventive service(s), initial 30 minutes ............................................................................
Prolonged preventive service(s), first 30 minutes ...............................................................................
994X1 .........
994X2 .........
994X3 .........
99XX3 .........
99XX5 .........
G0283 .........
mstockstill on DSK30JT082PROD with PROPOSALS2
GDDD1
GDDD2
GDDD3
GRRR1
.......
.......
.......
.......
GXXX1 ........
GYYY1 ........
GYYY2 ........
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E:\FR\FM\21JYP2.SGM
RUC
work
RVU
CMS
work
RVU
CMS time
refinement
NEW
0.18
0.18
No.
NEW
1.70
1.70
No.
NEW
1.53
1.53
No.
NEW
0.82
0.82
No.
NEW
3.44
3.44
No.
NEW
0.61
0.61
No.
0.18
0.18
0.18
No.
NEW
NEW
NEW
NEW
1.82
2.10
3.55
7.93
No.
No.
No.
No.
NEW
0.44
No.
NEW
NEW
1.17
1.17
No.
No.
21JYP2
34022
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
Mdfc flap w/
prsrv vasc
pedcl.
ED050
Technologist
PACS
workstation.
NF
..........................
115
117
157X1 .......
Mdfc flap w/
prsrv vasc
pedcl.
EF014
light, surgical ....
NF
..........................
115
117
157X1 .......
Mdfc flap w/
prsrv vasc
pedcl.
EF031
table, power .....
NF
..........................
115
117
157X1 .......
Mdfc flap w/
prsrv vasc
pedcl.
EQ011
ECG, 3-channel
(with SpO2,
NIBP, temp,
resp).
NF
..........................
115
117
157X1 .......
Mdfc flap w/
prsrv vasc
pedcl.
EQ110
electrocauteryhyfrecator, up
to 45 watts.
NF
..........................
115
117
157X1 .......
Mdfc flap w/
prsrv vasc
pedcl.
EQ138
instrument pack,
medium
($1500 and
up).
NF
..........................
127
129
157X1 .......
Mdfc flap w/
prsrv vasc
pedcl.
L038A
COMT/COT/RN/
CST.
NF
Obtain vital
signs.
3
5
29445 .......
Apply rigid leg
cast.
EF031
table, power .....
NF
..........................
69
67
29445 .......
Apply rigid leg
cast.
EQ080
cast cart ...........
NF
..........................
69
67
29445 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
157X1 .......
Apply rigid leg
cast.
EQ168
light, exam .......
NF
..........................
69
67
29445 .......
Apply rigid leg
cast.
L037D
RN/LPN/MTA ...
NF
Check
dressings &
wound/home
care instructions/coordinate office
visits/prescriptions.
5
3
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E:\FR\FM\21JYP2.SGM
21JYP2
Comment
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
L1: Refined time
to standard
for this clinical
labor task.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
L1: Refined time
to standard
for this clinical
labor task.
Direct costs
change
(in dollars)
$0.04
0.02
0.03
0.03
0.01
0.01
0.76
¥0.03
¥0.02
¥0.01
¥0.74
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
34023
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
Application of
paste boot.
EF023
table, exam ......
NF
..........................
35
34
29580 .......
Application of
paste boot.
EQ168
light, exam .......
NF
..........................
35
34
29580 .......
Application of
paste boot.
L037D
RN/LPN/MTA ...
NF
2
Apply multlay
comprs lwr
leg.
EF023
table, exam ......
NF
Provide preservice education/obtain
consent.
..........................
3
29581 .......
37
36
29581 .......
Apply multlay
comprs lwr
leg.
EQ168
light, exam .......
NF
..........................
37
36
29581 .......
Apply multlay
comprs lwr
leg.
L037D
RN/LPN/MTA ...
NF
2
Resect inferior
turbinate.
EF008
chair with headrest, exam,
reclining.
NF
Provide preservice education/obtain
consent.
..........................
3
30140 .......
98
100
30140 .......
Resect inferior
turbinate.
EQ137
instrument pack,
basic ($500–
$1499).
NF
..........................
102
104
30140 .......
Resect inferior
turbinate.
EQ170
light, fiberoptic
headlight wsource.
NF
..........................
98
100
30140 .......
Resect inferior
turbinate.
EQ234
suction and
pressure cabinet, ENT
(SMR).
NF
..........................
98
100
30140 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
29580 .......
Resect inferior
turbinate.
EQ383
reusable shaver
blade, 2mm.
NF
..........................
102
104
VerDate Sep<11>2014
00:24 Jul 21, 2017
Jkt 241001
PO 00000
Frm 00075
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
L1: Refined time
to standard
for this clinical
labor task.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
L1: Refined time
to standard
for this clinical
labor task.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
Direct costs
change
(in dollars)
0.00
0.00
¥0.37
0.00
0.00
¥0.37
0.02
0.00
0.02
0.02
0.01
34024
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
Resect inferior
turbinate.
EQ384
Microdebrider
handpiece.
NF
..........................
98
100
30140 .......
Resect inferior
turbinate.
EQ385
Microdebrider
console.
NF
..........................
98
100
30140 .......
Resect inferior
turbinate.
L037D
RN/LPN/MTA ...
NF
Obtain vital
signs.
3
5
30901 .......
Control of nosebleed.
EF008
chair with headrest, exam,
reclining.
NF
..........................
22
26
30901 .......
Control of nosebleed.
EQ137
instrument pack,
basic ($500–
$1499).
NF
..........................
29
33
30901 .......
Control of nosebleed.
EQ170
light, fiberoptic
headlight wsource.
NF
..........................
22
26
30901 .......
Control of nosebleed.
EQ234
suction and
pressure cabinet, ENT
(SMR).
NF
..........................
22
26
30903 .......
Control of nosebleed.
EF008
chair with headrest, exam,
reclining.
NF
..........................
27
31
30903 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
30140 .......
Control of nosebleed.
EQ110
electrocauteryhyfrecator, up
to 45 watts.
NF
..........................
27
31
30903 .......
Control of nosebleed.
EQ137
instrument pack,
basic ($500–
$1499).
NF
..........................
34
38
VerDate Sep<11>2014
00:24 Jul 21, 2017
Jkt 241001
PO 00000
Frm 00076
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
L1: Refined time
to standard
for this clinical
labor task.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E5: Refined
equipment
time to conform to established policies
for surgical instrument
packs.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E5: Refined
equipment
time to conform to established policies
for surgical instrument
packs.
Direct costs
change
(in dollars)
0.03
0.06
0.74
0.04
0.01
0.03
0.04
0.04
0.01
0.01
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
34025
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
RUC
recommendation
or current
value
(min or qty)
CMS
refinement
(min or qty)
Control of nosebleed.
EQ170
light, fiberoptic
headlight wsource.
NF
..........................
27
31
30903 .......
Control of nosebleed.
EQ234
suction and
pressure cabinet, ENT
(SMR).
NF
..........................
27
31
30905 .......
Control of nosebleed.
EF008
chair with headrest, exam,
reclining.
NF
..........................
32
62
30905 .......
Control of nosebleed.
EQ110
electrocauteryhyfrecator, up
to 45 watts.
NF
..........................
32
62
30905 .......
Control of nosebleed.
EQ137
instrument pack,
basic ($500–
1499).
NF
..........................
39
69
30905 .......
Control of nosebleed.
EQ170
light, fiberoptic
headlight wsource.
NF
..........................
32
62
30905 .......
Control of nosebleed.
EQ234
suction and
pressure cabinet, ENT
(SMR).
NF
..........................
32
62
30906 .......
Repeat control
of nosebleed.
EF008
chair with headrest, exam,
reclining.
NF
..........................
42
72
30906 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
30903 .......
Repeat control
of nosebleed.
EQ110
electrocauteryhyfrecator, up
to 45 watts.
NF
..........................
42
72
00:24 Jul 21, 2017
Jkt 241001
Input code
description
Labor activity
(where
applicable)
HCPCS code
description
VerDate Sep<11>2014
Input
code
Nonfacility
(NF)/
Facility
(F)
HCPCS
code
PO 00000
Frm 00077
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E5: Refined
equipment
time to conform to established policies
for surgical instrument
packs.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
Direct costs
change
(in dollars)
0.03
0.04
0.32
0.08
0.07
0.24
0.28
0.32
0.08
34026
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
RUC
recommendation
or current
value
(min or qty)
CMS
refinement
(min or qty)
Repeat control
of nosebleed.
EQ137
instrument pack,
basic ($500–
$1499).
NF
..........................
49
79
30906 .......
Repeat control
of nosebleed.
EQ170
light, fiberoptic
headlight wsource.
NF
..........................
42
72
30906 .......
Repeat control
of nosebleed.
EQ234
suction and
pressure cabinet, ENT
(SMR).
NF
..........................
42
72
31254 .......
Nsl/sins ndsc w/
prtl ethmdct.
EF008
chair with headrest, exam,
reclining.
NF
..........................
47
52
31254 .......
Nsl/sins ndsc w/
prtl ethmdct.
EF015
mayo stand ......
NF
..........................
47
52
31254 .......
Nsl/sins ndsc w/
prtl ethmdct.
EQ138
instrument pack,
medium
($1500 and
up).
NF
..........................
59
64
31254 .......
Nsl/sins ndsc w/
prtl ethmdct.
EQ167
light source,
xenon.
NF
..........................
47
52
31254 .......
Nsl/sins ndsc w/
prtl ethmdct.
EQ170
light, fiberoptic
headlight wsource.
NF
..........................
47
52
31254 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
30906 .......
Nsl/sins ndsc w/
prtl ethmdct.
EQ234
suction and
pressure cabinet, ENT
(SMR).
NF
..........................
47
52
00:24 Jul 21, 2017
Jkt 241001
Input code
description
Labor activity
(where
applicable)
HCPCS code
description
VerDate Sep<11>2014
Input
code
Nonfacility
(NF)/
Facility
(F)
HCPCS
code
PO 00000
Frm 00078
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
E5: Refined
equipment
time to conform to established policies
for surgical instrument
packs.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E5: Refined
equipment
time to conform to established policies
for surgical instrument
packs.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
Direct costs
change
(in dollars)
0.07
0.24
0.28
0.05
0.01
0.03
0.14
0.04
0.05
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
34027
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
RUC
recommendation
or current
value
(min or qty)
CMS
refinement
(min or qty)
Nsl/sins ndsc w/
prtl ethmdct.
EQ383
reusable shaver
blade, 2mm.
NF
..........................
47
52
31254 .......
Nsl/sins ndsc w/
prtl ethmdct.
EQ384
Microdebrider
handpiece.
NF
..........................
47
52
31254 .......
Nsl/sins ndsc w/
prtl ethmdct.
EQ385
Microdebrider
console.
NF
..........................
47
52
31254 .......
Nsl/sins ndsc w/
prtl ethmdct.
ES005
endoscope disinfector, rigid
or fiberoptic,
w-cart.
NF
..........................
37
51
31254 .......
Nsl/sins ndsc w/
prtl ethmdct.
ES031
video system,
endoscopy
(processor,
digital capture, monitor,
printer, cart).
NF
..........................
47
44
31254 .......
Nsl/sins ndsc w/
prtl ethmdct.
ES040
PROXY endoscope, rigid,
sinoscopy (0
degrees).
NF
..........................
37
51
31254 .......
Nsl/sins ndsc w/
prtl ethmdct.
L037D
RN/LPN/MTA ...
NF
0
Nsl/sins ndsc w/
prtl ethmdct.
L037D
RN/LPN/MTA ...
NF
Complete preservice diagnostic and referral forms.
Obtain vital
signs.
3
31254 .......
3
5
31254 .......
Nsl/sins ndsc w/
prtl ethmdct.
L037D
RN/LPN/MTA ...
NF
0
Nsl/sins ndsc w/
prtl ethmdct.
L037D
RN/LPN/MTA ...
NF
3
0
31295 .......
Sinus endo w/
balloon dil.
EF008
chair with headrest, exam,
reclining.
NF
Provide preservice education/obtain
consent.
Complete preprocedure
phone calls
and prescription.
..........................
3
31254 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
31254 .......
37
42
31295 .......
Sinus endo w/
balloon dil.
EF015
mayo stand ......
NF
..........................
37
42
00:24 Jul 21, 2017
Jkt 241001
Input code
description
Labor activity
(where
applicable)
HCPCS code
description
VerDate Sep<11>2014
Input
code
Nonfacility
(NF)/
Facility
(F)
HCPCS
code
PO 00000
Frm 00079
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E4: Refined
equipment
time to conform to established policies
for scopes.
E19: Refined
equipment
time to conform to established policies
for scope accessories.
E4: Refined
equipment
time to conform to established policies
for scopes.
L1: Refined time
to standard
for this clinical
labor task.
L1: Refined time
to standard
for this clinical
labor task.
L1: Refined time
to standard
for this clinical
labor task.
L1: Refined time
to standard
for this clinical
labor task.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
Direct costs
change
(in dollars)
0.02
0.06
0.15
0.85
¥0.39
0.11
¥1.11
0.74
¥1.11
¥1.11
0.05
0.01
34028
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
Sinus endo w/
balloon dil.
EQ138
instrument pack,
medium
($1500 and
up).
NF
..........................
49
54
31295 .......
Sinus endo w/
balloon dil.
EQ167
light source,
xenon.
NF
..........................
37
42
31295 .......
Sinus endo w/
balloon dil.
EQ170
light, fiberoptic
headlight wsource.
NF
..........................
37
42
31295 .......
Sinus endo w/
balloon dil.
EQ234
suction and
pressure cabinet, ENT
(SMR).
NF
..........................
37
42
31295 .......
Sinus endo w/
balloon dil.
EQ383
reusable shaver
blade, 2mm.
NF
..........................
37
42
31295 .......
Sinus endo w/
balloon dil.
EQ384
Microdebrider
handpiece.
NF
..........................
37
42
31295 .......
Sinus endo w/
balloon dil.
EQ385
Microdebrider
console.
NF
..........................
37
42
31295 .......
Sinus endo w/
balloon dil.
ES005
endoscope disinfector, rigid
or fiberoptic,
w-cart.
NF
..........................
27
41
31295 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
31295 .......
Sinus endo w/
balloon dil.
ES031
video system,
endoscopy
(processor,
digital capture, monitor,
printer, cart).
NF
..........................
37
34
31295 .......
Sinus endo w/
balloon dil.
ES040
PROXY endoscope, rigid,
sinoscopy (0
degrees).
NF
..........................
27
41
VerDate Sep<11>2014
00:24 Jul 21, 2017
Jkt 241001
PO 00000
Frm 00080
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
E5: Refined
equipment
time to conform to established policies
for surgical instrument
packs.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E4: Refined
equipment
time to conform to established policies
for scopes.
E19: Refined
equipment
time to conform to established policies
for scope accessories.
E4: Refined
equipment
time to conform to established policies
for scopes.
Direct costs
change
(in dollars)
0.03
0.14
0.04
0.05
0.02
0.06
0.15
0.85
¥0.39
0.11
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
34029
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
Sinus endo w/
balloon dil.
L037D
RN/LPN/MTA ...
NF
31295 .......
Sinus endo w/
balloon dil.
L037D
RN/LPN/MTA ...
NF
31295 .......
Sinus endo w/
balloon dil.
L037D
RN/LPN/MTA ...
NF
31295 .......
Sinus endo w/
balloon dil.
L037D
RN/LPN/MTA ...
NF
31296 .......
Sinus endo w/
balloon dil.
EF008
chair with headrest, exam,
reclining.
31296 .......
Sinus endo w/
balloon dil.
EF015
31296 .......
Sinus endo w/
balloon dil.
31296 .......
CMS
refinement
(min or qty)
Provide preservice education/obtain
consent.
Complete preprocedure
phone calls
and prescription.
Obtain vital
signs.
3
0
3
0
3
5
3
0
NF
Complete preservice diagnostic and referral forms.
..........................
40
45
mayo stand ......
NF
..........................
40
45
EQ138
instrument pack,
medium
($1500 and
up).
NF
..........................
52
57
Sinus endo w/
balloon dil.
EQ167
light source,
xenon.
NF
..........................
40
45
31296 .......
Sinus endo w/
balloon dil.
EQ170
light, fiberoptic
headlight wsource.
NF
..........................
40
45
31296 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
31295 .......
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
Sinus endo w/
balloon dil.
EQ234
suction and
pressure cabinet, ENT
(SMR).
NF
..........................
40
45
31296 .......
Sinus endo w/
balloon dil.
EQ383
reusable shaver
blade, 2mm.
NF
..........................
40
45
VerDate Sep<11>2014
00:24 Jul 21, 2017
Jkt 241001
PO 00000
Frm 00081
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
Direct costs
change
(in dollars)
L1: Refined time
to standard
for this clinical
labor task.
L1: Refined time
to standard
for this clinical
labor task.
¥1.11
L1: Refined time
to standard
for this clinical
labor task.
L1: Refined time
to standard
for this clinical
labor task.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E5: Refined
equipment
time to conform to established policies
for surgical instrument
packs.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
0.74
¥1.11
¥1.11
0.05
0.01
0.03
0.14
0.04
0.05
0.02
34030
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
Sinus endo w/
balloon dil.
EQ384
Microdebrider
handpiece.
NF
..........................
40
45
31296 .......
Sinus endo w/
balloon dil.
EQ385
Microdebrider
console.
NF
..........................
40
45
31296 .......
Sinus endo w/
balloon dil.
ES005
endoscope disinfector, rigid
or fiberoptic,
w-cart.
NF
..........................
32
44
31296 .......
Sinus endo w/
balloon dil.
ES031
video system,
endoscopy
(processor,
digital capture, monitor,
printer, cart).
NF
..........................
40
37
31296 .......
Sinus endo w/
balloon dil.
ES040
PROXY endoscope, rigid,
sinoscopy (0
degrees).
NF
..........................
32
44
31296 .......
Sinus endo w/
balloon dil.
L037D
RN/LPN/MTA ...
NF
0
Sinus endo w/
balloon dil.
L037D
RN/LPN/MTA ...
NF
3
0
31296 .......
Sinus endo w/
balloon dil.
L037D
RN/LPN/MTA ...
NF
Complete preservice diagnostic and referral forms.
Provide preservice education/obtain
consent.
Obtain vital
signs.
3
31296 .......
3
5
31296 .......
Sinus endo w/
balloon dil.
L037D
RN/LPN/MTA ...
NF
31297 .......
Sinus endo w/
balloon dil.
EF008
chair with headrest, exam,
reclining.
31297 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
31296 .......
Sinus endo w/
balloon dil.
EF015
31297 .......
Sinus endo w/
balloon dil.
EQ138
VerDate Sep<11>2014
00:24 Jul 21, 2017
Jkt 241001
3
0
NF
Complete preprocedure
phone calls
and prescription.
..........................
37
42
mayo stand ......
NF
..........................
37
42
instrument pack,
medium
($1500 and
up).
NF
..........................
49
54
PO 00000
Frm 00082
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E4: Refined
equipment
time to conform to established policies
for scopes.
E19: Refined
equipment
time to conform to established policies
for scope accessories.
E4: Refined
equipment
time to conform to established policies
for scopes.
L1: Refined time
to standard
for this clinical
labor task.
L1: Refined time
to standard
for this clinical
labor task.
L1: Refined time
to standard
for this clinical
labor task.
L1: Refined time
to standard
for this clinical
labor task.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E5: Refined
equipment
time to conform to established policies
for surgical instrument
packs.
Direct costs
change
(in dollars)
0.06
0.15
0.73
¥0.39
0.09
¥1.11
¥1.11
0.74
¥1.11
0.05
0.01
0.03
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
34031
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
Sinus endo w/
balloon dil.
EQ167
light source,
xenon.
NF
..........................
37
42
31297 .......
Sinus endo w/
balloon dil.
EQ170
light, fiberoptic
headlight wsource.
NF
..........................
37
42
31297 .......
Sinus endo w/
balloon dil.
EQ234
suction and
pressure cabinet, ENT
(SMR).
NF
..........................
37
42
31297 .......
Sinus endo w/
balloon dil.
EQ383
reusable shaver
blade, 2mm.
NF
..........................
37
42
31297 .......
Sinus endo w/
balloon dil.
EQ384
Microdebrider
handpiece.
NF
..........................
37
42
31297 .......
Sinus endo w/
balloon dil.
EQ385
Microdebrider
console.
NF
..........................
37
42
31297 .......
Sinus endo w/
balloon dil.
ES005
endoscope disinfector, rigid
or fiberoptic,
w-cart.
NF
..........................
27
41
31297 .......
Sinus endo w/
balloon dil.
ES031
video system,
endoscopy
(processor,
digital capture, monitor,
printer, cart).
NF
..........................
37
34
31297 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
31297 .......
Sinus endo w/
balloon dil.
ES040
PROXY endoscope, rigid,
sinoscopy (0
degrees).
NF
..........................
27
41
31297 .......
Sinus endo w/
balloon dil.
L037D
RN/LPN/MTA ...
NF
Obtain vital
signs.
3
5
31297 .......
Sinus endo w/
balloon dil.
L037D
RN/LPN/MTA ...
NF
Complete preprocedure
phone calls
and prescription.
3
0
VerDate Sep<11>2014
00:24 Jul 21, 2017
Jkt 241001
PO 00000
Frm 00083
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E4: Refined
equipment
time to conform to established policies
for scopes.
E19: Refined
equipment
time to conform to established policies
for scope accessories.
E4: Refined
equipment
time to conform to established policies
for scopes.
L1: Refined time
to standard
for this clinical
labor task.
L1: Refined time
to standard
for this clinical
labor task.
Direct costs
change
(in dollars)
0.14
0.04
0.05
0.02
0.06
0.15
0.85
¥0.39
0.11
0.74
¥1.11
34032
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
31297 .......
Sinus endo w/
balloon dil.
L037D
RN/LPN/MTA ...
NF
31297 .......
Sinus endo w/
balloon dil.
L037D
RN/LPN/MTA ...
NF
31645 .......
Brnchsc w/ther
aspir 1st.
Brnchsc w/ther
aspir 1st.
EF027
table, instrument, mobile.
table, power .....
Brnchsc w/ther
aspir 1st.
Brnchsc w/ther
aspir 1st.
Brnchsc w/ther
aspir 1st.
EQ004
31645 .......
Brnchsc w/ther
aspir 1st.
ES017
fiberscope, flexible, bronchoscopy.
31645 .......
Brnchsc w/ther
aspir 1st.
ES031
31645 .......
Brnchsc w/ther
aspir 1st.
Nsl/sins ndsc w/
sins dilat.
31XX5 .......
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
3
0
3
0
57
0
..........................
57
58
..........................
57
0
..........................
57
0
..........................
57
58
NF
..........................
72
82
video system,
endoscopy
(processor,
digital capture, monitor,
printer, cart).
NF
..........................
42
55
SD084
gas, oxygen .....
NF
..........................
175
0
EF008
chair with headrest, exam,
reclining.
NF
..........................
59
64
Nsl/sins ndsc w/
sins dilat.
EF015
mayo stand ......
NF
..........................
59
64
31XX5 .......
Nsl/sins ndsc w/
sins dilat.
EQ138
instrument pack,
medium
($1500 and
up).
NF
..........................
71
76
31XX5 .......
Nsl/sins ndsc w/
sins dilat.
EQ167
light source,
xenon.
NF
..........................
59
64
31645 .......
31645 .......
31645 .......
31645 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
31XX5 .......
VerDate Sep<11>2014
EF031
EQ032
EQ235
00:24 Jul 21, 2017
Jkt 241001
NF
Complete preservice diagnostic and referral forms.
Provide preservice education/obtain
consent.
..........................
NF
CO2 respiratory NF
profile monitor.
IV infusion
NF
pump.
suction machine NF
(Gomco).
CMS
refinement
(min or qty)
PO 00000
Frm 00084
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
L1: Refined time
to standard
for this clinical
labor task.
L1: Refined time
to standard
for this clinical
labor task.
G1: See preamble text.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
G1: See preamble text.
G1: See preamble text.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E4: Refined
equipment
time to conform to established policies
for scopes.
E19: Refined
equipment
time to conform to established policies
for scope accessories.
G1: See preamble text.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E5: Refined
equipment
time to conform to established policies
for surgical instrument
packs.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
Direct costs
change
(in dollars)
¥1.11
¥1.11
¥0.08
0.02
¥1.47
¥0.36
0.00
0.82
1.68
¥0.53
0.05
0.01
0.03
0.14
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
34033
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
RUC
recommendation
or current
value
(min or qty)
CMS
refinement
(min or qty)
Nsl/sins ndsc w/
sins dilat.
EQ170
light, fiberoptic
headlight wsource.
NF
..........................
59
64
31XX5 .......
Nsl/sins ndsc w/
sins dilat.
EQ234
suction and
pressure cabinet, ENT
(SMR).
NF
..........................
59
64
31XX5 .......
Nsl/sins ndsc w/
sins dilat.
EQ383
reusable shaver
blade, 2mm.
NF
..........................
59
64
31XX5 .......
Nsl/sins ndsc w/
sins dilat.
EQ384
Microdebrider
handpiece.
NF
..........................
59
64
31XX5 .......
Nsl/sins ndsc w/
sins dilat.
EQ385
Microdebrider
console.
NF
..........................
59
64
31XX5 .......
Nsl/sins ndsc w/
sins dilat.
ES005
endoscope disinfector, rigid
or fiberoptic,
w-cart.
NF
..........................
57
73
31XX5 .......
Nsl/sins ndsc w/
sins dilat.
ES031
video system,
endoscopy
(processor,
digital capture, monitor,
printer, cart).
NF
..........................
59
56
31XX5 .......
Nsl/sins ndsc w/
sins dilat.
ES040
PROXY endoscope, rigid,
sinoscopy (0
degrees).
NF
..........................
57
73
31XX5 .......
Nsl/sins ndsc w/
sins dilat.
L037D
RN/LPN/MTA ...
NF
0
Nsl/sins ndsc w/
sins dilat.
L037D
RN/LPN/MTA ...
NF
3
0
31XX5 .......
Nsl/sins ndsc w/
sins dilat.
L037D
RN/LPN/MTA ...
NF
3
0
31XX5 .......
Nsl/sins ndsc w/
sins dilat.
L037D
RN/LPN/MTA ...
NF
Complete preservice diagnostic and referral forms.
Provide preservice education/obtain
consent.
Complete preprocedure
phone calls
and prescription.
Obtain vital
signs.
3
31XX5 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
31XX5 .......
3
5
00:24 Jul 21, 2017
Jkt 241001
Input code
description
Labor activity
(where
applicable)
HCPCS code
description
VerDate Sep<11>2014
Input
code
Nonfacility
(NF)/
Facility
(F)
HCPCS
code
PO 00000
Frm 00085
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E4: Refined
equipment
time to conform to established policies
for scopes.
E19: Refined
equipment
time to conform to established policies
for scope accessories.
E4: Refined
equipment
time to conform to established policies
for scopes.
L1: Refined time
to standard
for this clinical
labor task.
L1: Refined time
to standard
for this clinical
labor task.
L1: Refined time
to standard
for this clinical
labor task.
L1: Refined time
to standard
for this clinical
labor task.
Direct costs
change
(in dollars)
0.04
0.05
0.02
0.06
0.15
0.97
¥0.39
0.12
¥1.11
¥1.11
¥1.11
0.74
34034
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
RUC
recommendation
or current
value
(min or qty)
CMS
refinement
(min or qty)
Ablate pulm
tumor perq rf.
ED050
Technologist
PACS
workstation.
NF
..........................
133
112
32998 .......
Ablate pulm
tumor perq rf.
EL007
room, CT ..........
NF
..........................
98
96
32998 .......
Ablate pulm
tumor perq rf.
EQ168
light, exam .......
NF
..........................
98
107
32998 .......
Ablate pulm
tumor perq rf.
EQ214
radiofrequency
generator
(NEURO).
NF
..........................
98
96
32X99 .......
Ablate pulm
tumor perq
crybl.
ED050
Technologist
PACS
workstation.
NF
..........................
138
117
32X99 .......
Ablate pulm
tumor perq
crybl.
EL007
room, CT ..........
NF
..........................
103
101
32X99 .......
Ablate pulm
tumor perq
crybl.
EQ168
light, exam .......
NF
..........................
103
112
32X99 .......
Ablate pulm
tumor perq
crybl.
EQ302
cryosurgery system (for tumor
ablation).
NF
..........................
103
101
36215 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
32998 .......
Place catheter
in artery.
ED050
Technologist
PACS
workstation.
NF
..........................
61
59
36215 .......
Place catheter
in artery.
EF027
table, instrument, mobile.
NF
..........................
180
0
00:24 Jul 21, 2017
Jkt 241001
Input code
description
Labor activity
(where
applicable)
HCPCS code
description
VerDate Sep<11>2014
Input
code
Nonfacility
(NF)/
Facility
(F)
HCPCS
code
PO 00000
Frm 00086
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
E2: Refined
equipment
time to conform to established policies
for highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E2: Refined
equipment
time to conform to established policies
for highly
technical
equipment.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
E2: Refined
equipment
time to conform to established policies
for highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E2: Refined
equipment
time to conform to established policies
for highly
technical
equipment.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
G1: See preamble text.
Direct costs
change
(in dollars)
¥0.46
¥9.73
0.04
¥0.25
¥0.46
¥9.73
0.04
¥0.19
¥0.04
¥0.25
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
34035
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
36215 .......
Place catheter
in artery.
L037D
RN/LPN/MTA ...
NF
36216 .......
Place catheter
in artery.
ED050
Technologist
PACS
workstation.
36216 .......
Place catheter
in artery.
Place catheter
in artery.
EF027
36217 .......
Place catheter
in artery.
36217 .......
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
3
1
NF
Other Clinical
Activity—
specify: Postprocedure
doppler evaluation (extremity).
..........................
76
74
table, instrument, mobile.
RN/LPN/MTA ...
NF
..........................
180
0
NF
3
1
ED050
Technologist
PACS
workstation.
NF
Other Clinical
Activity—
specify: Postprocedure
doppler evaluation (extremity).
..........................
91
89
Place catheter
in artery.
Place catheter
in artery.
EF027
NF
..........................
180
0
L037D
table, instrument, mobile.
RN/LPN/MTA ...
NF
3
1
Place catheter
in artery.
Njx sclrsnt 1
incmptnt vein.
L037D
RN/LPN/MTA ...
NF
Other Clinical
Activity—
specify: Postprocedure
doppler evaluation (extremity).
Circulator (25%)
12
15
L037D
RN/LPN/MTA ...
NF
Obtain vital
signs.
3
5
36470 .......
Njx sclrsnt 1
incmptnt vein.
L037D
RN/LPN/MTA ...
NF
5
3
36470 .......
Njx sclrsnt 1
incmptnt vein.
SG055
gauze, sterile
4in x 4in.
NF
Check
dressings,
catheters,
wounds.
..........................
6
0
36470 .......
Njx sclrsnt 1
incmptnt vein.
SG056
gauze, sterile
4in x 4in (10
pack uou).
NF
..........................
0
1
36471 .......
Njx sclrsnt mlt
incmptnt vn.
L037D
RN/LPN/MTA ...
NF
Obtain vital
signs.
3
5
36471 .......
Njx sclrsnt mlt
incmptnt vn.
L037D
RN/LPN/MTA ...
NF
5
3
36471 .......
Njx sclrsnt mlt
incmptnt vn.
SG055
gauze, sterile
4in x 4in.
NF
Check
dressings,
catheters,
wounds.
..........................
6
0
36471 .......
Njx sclrsnt mlt
incmptnt vn.
SG056
gauze, sterile
4in x 4in (10
pack uou).
NF
..........................
0
1
36216 .......
36217 .......
36217 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
36470 .......
VerDate Sep<11>2014
L037D
00:24 Jul 21, 2017
Jkt 241001
PO 00000
Frm 00087
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
Direct costs
change
(in dollars)
G1: See preamble text.
¥0.74
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
G1: See preamble text.
G1: See preamble text.
¥0.04
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
G1: See preamble text.
G1: See preamble text.
¥0.04
G1: See preamble text.
L1: Refined time
to standard
for this clinical
labor task.
L1: Refined time
to standard
for this clinical
labor task.
S7: Supply item
replaced by
another item;
see preamble
SG056.
S8: Supply item
replaces another item;
see preamble
SG055.
L1: Refined time
to standard
for this clinical
labor task.
L1: Refined time
to standard
for this clinical
labor task.
S7: Supply item
replaced by
another item;
see preamble
SG056.
S8: Supply item
replaces another item;
see preamble
SG055.
¥0.25
¥0.74
¥0.25
¥0.74
1.11
0.74
¥0.74
¥0.95
0.80
0.74
¥0.74
¥0.95
0.80
34036
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
Comment
¥0.05
364X3 .......
Endoven ther
chem adhes
1st.
EF014
light, surgical ....
NF
..........................
58
53
364X3 .......
Endoven ther
chem adhes
1st.
EF031
table, power .....
NF
..........................
58
53
364X3 .......
Endoven ther
chem adhes
1st.
EQ250
ultrasound unit,
portable.
NF
..........................
58
53
364X3 .......
Endoven ther
chem adhes
1st.
L037D
RN/LPN/MTA ...
NF
5
3
364X3 .......
Endoven ther
chem adhes
1st.
L037D
RN/LPN/MTA ...
NF
Check
dressings,
catheters,
wounds.
Obtain vital
signs.
3
5
364X3 .......
Endoven ther
chem adhes
1st.
Endoven ther
chem adhes
1st.
Endoven ther
chem adhes
1st.
L054A
Vascular Technologist.
NF
0
2
L054A
Vascular Technologist.
NF
2
0
G1: See preamble text.
¥1.08
SG055
gauze, sterile
4in x 4in.
NF
Prepare room,
equipment
and supplies.
Setup scope
(nonfacility
setting only).
..........................
6
0
¥0.95
364X3 .......
Endoven ther
chem adhes
1st.
SG056
gauze, sterile
4in x 4in (10
pack uou).
NF
..........................
0
1
364X5 .......
Njx noncmpnd
sclrsnt 1 vein.
EF014
light, surgical ....
NF
..........................
48
43
364X5 .......
Njx noncmpnd
sclrsnt 1 vein.
EF031
table, power .....
NF
..........................
48
43
364X5 .......
Njx noncmpnd
sclrsnt 1 vein.
EQ250
ultrasound unit,
portable.
NF
..........................
48
43
364X5 .......
Njx noncmpnd
sclrsnt 1 vein.
L037D
RN/LPN/MTA ...
NF
Check
dressings,
catheters,
wounds.
5
3
S7: Supply item
replaced by
another item;
see preamble
SG056.
S8: Supply item
replaces another item;
see preamble
SG055.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
L1: Refined time
to standard
for this clinical
labor task.
364X3 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
364X3 .......
VerDate Sep<11>2014
00:24 Jul 21, 2017
Jkt 241001
PO 00000
Frm 00088
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
L1: Refined time
to standard
for this clinical
labor task.
L1: Refined time
to standard
for this clinical
labor task.
G1: See preamble text.
Direct costs
change
(in dollars)
¥0.08
¥0.58
¥0.74
0.74
1.08
0.80
¥0.05
¥0.08
¥0.58
¥0.74
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
34037
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
RUC
recommendation
or current
value
(min or qty)
CMS
refinement
(min or qty)
Njx noncmpnd
sclrsnt 1 vein.
L037D
RN/LPN/MTA ...
NF
Obtain vital
signs.
3
5
364X5 .......
Njx noncmpnd
sclrsnt 1 vein.
L054A
Vascular Technologist.
NF
0
Njx noncmpnd
sclrsnt 1 vein.
L054A
Vascular Technologist.
NF
0
2
G1: See preamble text.
364X5 .......
Njx noncmpnd
sclrsnt 1 vein.
SG055
gauze, sterile
4in x 4in.
NF
Setup scope
(nonfacility
setting only).
Prepare room,
equipment
and supplies.
..........................
2
364X5 .......
6
0
364X5 .......
Njx noncmpnd
sclrsnt 1 vein.
SG056
gauze, sterile
4in x 4in (10
pack uou).
NF
..........................
0
1
364X6 .......
Njx noncmpnd
sclrsnt mlt vn.
EF014
light, surgical ....
NF
..........................
58
53
364X6 .......
Njx noncmpnd
sclrsnt mlt vn.
EF031
table, power .....
NF
..........................
58
53
364X6 .......
Njx noncmpnd
sclrsnt mlt vn.
EQ250
ultrasound unit,
portable.
NF
..........................
58
53
364X6 .......
Njx noncmpnd
sclrsnt mlt vn.
L037D
RN/LPN/MTA ...
NF
Obtain vital
signs.
3
5
364X6 .......
Njx noncmpnd
sclrsnt mlt vn.
L037D
RN/LPN/MTA ...
NF
3
Njx noncmpnd
sclrsnt mlt vn.
L054A
Vascular Technologist.
NF
2
0
S7: Supply item
replaced by
another item;
see preamble
SG056.
S8: Supply item
replaces another item;
see preamble
SG055.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
L1: Refined time
to standard
for this clinical
labor task.
L1: Refined time
to standard
for this clinical
labor task.
G1: See preamble text.
364X6 .......
Njx noncmpnd
sclrsnt mlt vn.
L054A
Vascular Technologist.
NF
0
2
G1: See preamble text.
364X6 .......
Njx noncmpnd
sclrsnt mlt vn.
SG055
gauze, sterile
4in x 4in.
NF
Check
dressings,
catheters,
wounds.
Setup scope
(nonfacility
setting only).
Prepare room,
equipment
and supplies.
..........................
5
364X6 .......
6
0
364X6 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
364X5 .......
Njx noncmpnd
sclrsnt mlt vn.
SG056
gauze, sterile
4in x 4in (10
pack uou).
NF
..........................
0
1
36555 .......
Insert non-tunnel cv cath.
EF023
table, exam ......
NF
..........................
68
38
S7: Supply item
replaced by
another item;
see preamble
SG056.
S8: Supply item
replaces another item;
see preamble
SG055.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
00:24 Jul 21, 2017
Jkt 241001
Input code
description
Labor activity
(where
applicable)
HCPCS code
description
VerDate Sep<11>2014
Input
code
Nonfacility
(NF)/
Facility
(F)
HCPCS
code
PO 00000
Frm 00089
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
L1: Refined time
to standard
for this clinical
labor task.
G1: See preamble text.
Direct costs
change
(in dollars)
0.74
¥1.08
1.08
¥0.95
0.80
¥0.05
¥0.08
¥0.58
0.74
¥0.74
¥1.08
1.08
¥0.95
0.80
¥0.09
34038
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Insert non-tunnel cv cath.
EQ011
36555 .......
Insert non-tunnel cv cath.
36555 .......
Nonfacility
(NF)/
Facility
(F)
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
NF
..........................
68
0
EQ168
ECG, 3-channel
(with SpO2,
NIBP, temp,
resp).
light, exam .......
NF
..........................
68
38
Insert non-tunnel cv cath.
L037D
RN/LPN/MTA ...
NF
Monitor pt. following procedure/check
tubes, monitors, drains,
multitasking
1:4.
7.5
0
36569 .......
Insert picc cath
EF023
table, exam ......
NF
..........................
30
0
36569 .......
Insert picc cath
EQ168
light, exam .......
NF
..........................
30
32
36569 .......
Insert picc cath
L037D
RN/LPN/MTA ...
NF
Obtain vital
signs.
3
5
38220 .......
Dx bone marrow aspirations.
EF023
table, exam ......
NF
..........................
84
82
38220 .......
Dx bone marrow aspirations.
L033A
Lab Technician
NF
9
Dx bone marrow biopsies.
EF023
table, exam ......
NF
Other Clinical
Activity—
specify:Lab
Tech activities.
..........................
12
38221 .......
83
82
38221 .......
Dx bone marrow biopsies.
L033A
Lab Technician
NF
7
Dx bone marrow bx &
aspir.
EF023
table, exam ......
NF
Other Clinical
Activity—
specify:Lab
Tech activities.
..........................
7.5
382X3 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
36555 .......
Input code
description
95
92
382X3 .......
Dx bone marrow bx &
aspir.
L033A
Lab Technician
NF
12.5
10
55X87 .......
Tprnl plmt
biodegrdabl
matrl.
EF031
table, power .....
NF
Other Clinical
Activity—
specify:Lab
Tech activities.
..........................
63
65
VerDate Sep<11>2014
00:24 Jul 21, 2017
Jkt 241001
PO 00000
Frm 00090
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
Direct costs
change
(in dollars)
G1: See preamble text.
¥0.95
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
L11: Removed
clinical labor
associated
with moderate
sedation;
moderate sedation not
typical for this
procedure.
G1: See preamble text.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
L1: Refined time
to standard
for this clinical
labor task.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
G1: See preamble text.
¥0.13
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
G1: See preamble text.
0.00
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
G1: See preamble text.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
¥2.78
¥0.09
0.01
0.74
¥0.01
¥0.99
¥0.17
¥0.01
¥0.83
0.03
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
34039
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
55X87 .......
Tprnl plmt
biodegrdabl
matrl.
EQ250
ultrasound unit,
portable.
NF
..........................
48
50
55X87 .......
Tprnl plmt
biodegrdabl
matrl.
EQ386
Endocavitary
US probe.
NF
..........................
48
50
55X87 .......
Tprnl plmt
biodegrdabl
matrl.
ER061
stepper, stabilizer, template (for
brachytherapy
treatment).
NF
..........................
48
50
55X87 .......
Tprnl plmt
biodegrdabl
matrl.
ER062
stirrups (for
brachytherapy
table).
NF
..........................
48
50
55X87 .......
Tprnl plmt
biodegrdabl
matrl.
L037D
RN/LPN/MTA ...
NF
Obtain vital
signs.
3
5
5857X .......
Laps tot hyst
resj mal.
EQ168
light, exam .......
F
..........................
142
125
5857X .......
Laps tot hyst
resj mal.
Revise eyelashes.
Revise eyelashes.
SA051
pack, pelvic
exam.
lane, screening
(oph).
COMT/COT/RN/
CST.
F
..........................
4
3
NF
..........................
11
5
F
Coordinate presurgery services.
3
0
67820 .......
Revise eyelashes.
L038A
COMT/COT/RN/
CST.
F
3
0
67820 .......
Revise eyelashes.
L038A
COMT/COT/RN/
CST.
F
3
0
67820 .......
Revise eyelashes.
L038A
COMT/COT/RN/
CST.
F
3
0
67820 .......
Revise eyelashes.
L038A
COMT/COT/RN/
CST.
F
3
0
70544 .......
Mr angiography
head w/o dye.
ED050
Technologist
PACS
workstation.
NF
Provide preservice education/obtain
consent.
Schedule space
and equipment in facility.
Complete preservice diagnostic and referral forms.
Follow-up
phone calls
and prescriptions.
..........................
72
69
70544 .......
Mr angiography
head w/o dye.
ED053
Professional
PACS
Workstation.
NF
..........................
17
15
67820 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
67820 .......
VerDate Sep<11>2014
EL006
L038A
00:24 Jul 21, 2017
Jkt 241001
PO 00000
Frm 00091
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
L1: Refined time
to standard
for this clinical
labor task.
E7: Refined
equipment
time to conform to office
visit duration.
G1: See preamble text.
G1: See preamble text.
L1: Refined time
to standard
for this clinical
labor task.
L1: Refined time
to standard
for this clinical
labor task.
L1: Refined time
to standard
for this clinical
labor task.
L1: Refined time
to standard
for this clinical
labor task.
L1: Refined time
to standard
for this clinical
labor task.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
Direct costs
change
(in dollars)
0.23
0.13
0.12
0.02
0.74
¥0.07
¥1.17
¥0.54
¥1.14
¥1.14
¥1.14
¥1.14
¥1.14
¥0.07
¥0.12
34040
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
RUC
recommendation
or current
value
(min or qty)
CMS
refinement
(min or qty)
Mr angiography
head w/o dye.
EL008
room, MR .........
NF
..........................
39
38
70544 .......
Mr angiography
head w/o dye.
L047A
MRI Technologist.
NF
3
Mr angiography
head w/o dye.
L047A
MRI Technologist.
NF
7
5
70545 .......
Mr angiography
head w/dye.
ED050
Technologist
PACS
workstation.
NF
Technologist
QCs images
in PACS,
checking all
images, reformats, and
dose page.
Provide preservice education/obtain
consent.
..........................
4
70544 .......
75
74
70545 .......
Mr angiography
head w/dye.
ED053
Professional
PACS
Workstation.
NF
..........................
17
15
70545 .......
Mr angiography
head w/dye.
EL008
room, MR .........
NF
..........................
37
36
70545 .......
Mr angiography
head w/dye.
L047A
MRI Technologist.
NF
3
Mr angiography
head w/dye.
L047A
MRI Technologist.
NF
Technologist
QCs images
in PACS,
checking all
images, reformats, and
dose page.
Obtain vital
signs.
4
70545 .......
3
5
70545 .......
Mr angiography
head w/dye.
L047A
MRI Technologist.
NF
7
Mr angiograph
head w/o&w/
dye.
ED050
Technologist
PACS
workstation.
NF
Provide preservice education/obtain
consent.
..........................
9
70546 .......
116
115
70546 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
70544 .......
Mr angiograph
head w/o&w/
dye.
ED053
Professional
PACS
Workstation.
NF
..........................
20
18
70546 .......
Mr angiograph
head w/o&w/
dye.
EL008
room, MR .........
NF
..........................
58
57
00:24 Jul 21, 2017
Jkt 241001
Input code
description
Labor activity
(where
applicable)
HCPCS code
description
VerDate Sep<11>2014
Input
code
Nonfacility
(NF)/
Facility
(F)
HCPCS
code
PO 00000
Frm 00092
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
L1: Refined time
to standard
for this clinical
labor task.
Direct costs
change
(in dollars)
¥3.38
¥0.47
G1: See preamble text.
¥0.94
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
L1: Refined time
to standard
for this clinical
labor task.
¥0.02
L1: Refined time
to standard
for this clinical
labor task.
G1: See preamble text.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
¥0.12
¥3.38
¥0.47
0.94
¥0.94
¥0.02
¥0.12
¥3.38
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
34041
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
Mr angiograph
head w/o&w/
dye.
L047A
MRI Technologist.
NF
Obtain vital
signs.
3
5
70546 .......
Mr angiograph
head w/o&w/
dye.
L047A
MRI Technologist.
NF
3
Mr angiograph
head w/o&w/
dye.
L047A
MRI Technologist.
NF
9
7
70547 .......
Mr angiography
neck w/o dye.
ED050
Technologist
PACS
workstation.
NF
Technologist
QCs images
in PACS,
checking all
images, reformats, and
dose page.
Provide preservice education/obtain
consent.
..........................
4
70546 .......
72
69
70547 .......
Mr angiography
neck w/o dye.
ED053
Professional
PACS
Workstation.
NF
..........................
17
15
70547 .......
Mr angiography
neck w/o dye.
EL008
room, MR .........
NF
..........................
39
38
70547 .......
Mr angiography
neck w/o dye.
L047A
MRI Technologist.
NF
3
Mr angiography
neck w/o dye.
L047A
MRI Technologist.
NF
7
5
70548 .......
Mr angiography
neck w/dye.
ED050
Technologist
PACS
workstation.
NF
Technologist
QCs images
in PACS,
checking all
images, reformats, and
dose page.
Provide preservice education/obtain
consent.
..........................
4
70547 .......
75
74
70548 .......
Mr angiography
neck w/dye.
ED053
Professional
PACS
Workstation.
NF
..........................
20
18
70548 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
70546 .......
Mr angiography
neck w/dye.
EL008
room, MR .........
NF
..........................
37
36
70548 .......
Mr angiography
neck w/dye.
L047A
MRI Technologist.
NF
Technologist
QCs images
in PACS,
checking all
images, reformats, and
dose page.
4
3
VerDate Sep<11>2014
00:24 Jul 21, 2017
Jkt 241001
PO 00000
Frm 00093
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
L1: Refined time
to standard
for this clinical
labor task.
L1: Refined time
to standard
for this clinical
labor task.
Direct costs
change
(in dollars)
0.94
¥0.47
G1: See preamble text.
¥0.94
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
L1: Refined time
to standard
for this clinical
labor task.
¥0.07
¥0.12
¥3.38
¥0.47
G1: See preamble text.
¥0.94
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
L1: Refined time
to standard
for this clinical
labor task.
¥0.02
¥0.12
¥3.38
¥0.47
34042
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
HCPCS
code
HCPCS code
description
70548 .......
Mr angiography
neck w/dye.
L047A
MRI Technologist.
NF
70548 .......
Mr angiography
neck w/dye.
L047A
MRI Technologist.
NF
70549 .......
Mr angiograph
neck w/o&w/
dye.
ED050
Technologist
PACS
workstation.
NF
70549 .......
Mr angiograph
neck w/o&w/
dye.
ED053
Professional
PACS
Workstation.
70549 .......
Mr angiograph
neck w/o&w/
dye.
EL008
70549 .......
Mr angiograph
neck w/o&w/
dye.
70549 .......
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
Comment
Direct costs
change
(in dollars)
¥0.94
7
G1: See preamble text.
3
5
..........................
116
115
NF
..........................
25
23
room, MR .........
NF
..........................
58
57
L047A
MRI Technologist.
NF
Obtain vital
signs.
3
5
Mr angiograph
neck w/o&w/
dye.
L047A
MRI Technologist.
NF
9
7
Mr angiograph
neck w/o&w/
dye.
L047A
MRI Technologist.
NF
4
3
L1: Refined time
to standard
for this clinical
labor task.
¥0.47
71250 .......
Ct thorax w/o
dye.
ED053
Professional
PACS
Workstation.
NF
Provide preservice education/obtain
consent.
Technologist
QCs images
in PACS,
checking all
images, reformats, and
dose page.
..........................
L1: Refined time
to standard
for this clinical
labor task.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
L1: Refined time
to standard
for this clinical
labor task.
G1: See preamble text.
70549 .......
20
18
Ct thorax w/dye
ED053
Professional
PACS
Workstation.
NF
..........................
21
19
71270 .......
Ct thorax w/o &
w/dye.
ED053
Professional
PACS
Workstation.
NF
..........................
25
23
72195 .......
Mri pelvis w/o
dye.
ED053
Professional
PACS
Workstation.
NF
..........................
25
23
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
¥0.12
71260 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
9
VerDate Sep<11>2014
00:24 Jul 21, 2017
Jkt 241001
PO 00000
Frm 00094
Provide preservice education/obtain
consent.
Obtain vital
signs.
CMS
refinement
(min or qty)
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
0.94
¥0.02
¥0.12
¥3.38
0.94
¥0.94
¥0.12
¥0.12
¥0.12
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
34043
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
RUC
recommendation
or current
value
(min or qty)
CMS
refinement
(min or qty)
72196 .......
Mri pelvis w/dye
ED050
Technologist
PACS
workstation.
NF
..........................
64
66
72196 .......
Mri pelvis w/dye
ED053
Professional
PACS
Workstation.
NF
..........................
30
28
72196 .......
Mri pelvis w/dye
L047A
MRI Technologist.
NF
Obtain vital
signs.
3
5
72197 .......
Mri pelvis w/o &
w/dye.
ED050
Technologist
PACS
workstation.
NF
..........................
79
81
72197 .......
Mri pelvis w/o &
w/dye.
ED053
Professional
PACS
Workstation.
NF
..........................
32
30
72197 .......
Mri pelvis w/o &
w/dye.
L047A
MRI Technologist.
NF
Obtain vital
signs.
3
5
73718 .......
Mri lower extremity w/o
dye.
ED050
Technologist
PACS
workstation.
NF
..........................
55
53
73718 .......
Mri lower extremity w/o
dye.
ED053
Professional
PACS
Workstation.
NF
..........................
20
18
73718 .......
Mri lower extremity w/o
dye.
EL008
room, MR .........
NF
..........................
44
42
73718 .......
Mri lower extremity w/o
dye.
Mri lower extremity w/dye.
L047A
MRI Technologist.
NF
5
3
ED050
Technologist
PACS
workstation.
NF
Prepare room,
equipment,
supplies.
..........................
62
64
Mri lower extremity w/dye.
ED053
Professional
PACS
Workstation.
NF
..........................
25
23
mstockstill on DSK30JT082PROD with PROPOSALS2
73719 .......
VerDate Sep<11>2014
00:24 Jul 21, 2017
Jkt 241001
Input code
description
Labor activity
(where
applicable)
HCPCS code
description
73719 .......
Input
code
Nonfacility
(NF)/
Facility
(F)
HCPCS
code
PO 00000
Frm 00095
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
L1: Refined time
to standard
for this clinical
labor task.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
L1: Refined time
to standard
for this clinical
labor task.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
G1: See preamble text.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
Direct costs
change
(in dollars)
0.04
¥0.12
0.94
0.04
¥0.12
0.94
¥0.04
¥0.12
¥6.76
¥0.94
0.04
¥0.12
34044
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
HCPCS
code
HCPCS code
description
73719 .......
Mri lower extremity w/dye.
EL008
room, MR .........
NF
..........................
73719 .......
Mri lower extremity w/dye.
L047A
MRI Technologist.
NF
73719 .......
Mri lower extremity w/dye.
L047A
MRI Technologist.
NF
73719 .......
Mri lower extremity w/dye.
L047A
MRI Technologist.
NF
Provide preservice education/obtain
consent.
Prepare room,
equipment,
supplies.
Obtain vital
signs.
73720 .......
Mri lwr extremity
w/o&w/dye.
ED050
Technologist
PACS
workstation.
NF
73720 .......
Mri lwr extremity
w/o&w/dye.
ED053
Professional
PACS
Workstation.
73720 .......
Mri lwr extremity
w/o&w/dye.
EL008
73720 .......
Mri lwr extremity
w/o&w/dye.
73720 .......
CMS
refinement
(min or qty)
Comment
Direct costs
change
(in dollars)
¥6.76
5
G1: See preamble text.
¥0.94
3
5
..........................
77
79
NF
..........................
29
27
room, MR .........
NF
..........................
63
61
L047A
MRI Technologist.
NF
7
5
Mri lwr extremity
w/o&w/dye.
L047A
MRI Technologist.
NF
5
7
G1: See preamble text.
0.94
Mri lwr extremity
w/o&w/dye.
L047A
MRI Technologist.
NF
Prepare room,
equipment,
supplies.
Provide preservice education/obtain
consent.
Obtain vital
signs.
L1: Refined time
to standard
for this clinical
labor task.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
G1: See preamble text.
73720 .......
3
5
Mri abdomen w/
o dye.
ED053
Professional
PACS
Workstation.
NF
..........................
25
23
74182 .......
Mri abdomen w/
dye.
ED050
Technologist
PACS
workstation.
NF
..........................
74
76
74182 .......
Mri abdomen w/
dye.
ED053
Professional
PACS
Workstation.
NF
..........................
30
28
74182 .......
Mri abdomen w/
dye.
L047A
MRI Technologist.
NF
Obtain vital
signs.
3
5
L1: Refined time
to standard
for this clinical
labor task.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
L1: Refined time
to standard
for this clinical
labor task.
0.94
74181 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
G1: See preamble text.
VerDate Sep<11>2014
00:24 Jul 21, 2017
Jkt 241001
PO 00000
Frm 00096
Fmt 4701
Sfmt 4702
48
46
5
7
7
E:\FR\FM\21JYP2.SGM
21JYP2
0.94
0.94
0.04
¥0.12
¥6.76
¥0.94
¥0.12
0.04
¥0.12
0.94
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
34045
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
RUC
recommendation
or current
value
(min or qty)
CMS
refinement
(min or qty)
Mri abdomen w/
o & w/dye.
ED050
Technologist
PACS
workstation.
NF
..........................
79
81
74183 .......
Mri abdomen w/
o & w/dye.
ED053
Professional
PACS
Workstation.
NF
..........................
35
33
74183 .......
Mri abdomen w/
o & w/dye.
L047A
MRI Technologist.
NF
Obtain vital
signs.
3
5
75635 .......
Ct angio abdominal arteries.
ED050
Technologist
PACS
workstation.
NF
..........................
119
124
75635 .......
Ct angio abdominal arteries.
ED053
Professional
PACS
Workstation.
NF
..........................
49
44
75635 .......
Ct angio abdominal arteries.
EL007
room, CT ..........
NF
..........................
71
70
75635 .......
Ct angio abdominal arteries.
L046A
CT Technologist
NF
3
Artery x-rays
arm/leg.
ED050
Technologist
PACS
workstation.
NF
Technologist
QCs images
in PACS,
checking all
images, reformats, and
dose page.
..........................
4
75710 .......
52
49
75710 .......
Artery x-rays
arm/leg.
ED053
Professional
PACS
Workstation.
NF
..........................
55
48
75710 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
74183 .......
Artery x-rays
arm/leg.
L041B
Radiologic
Technologist.
NF
4
3
75710 .......
Artery x-rays
arm/leg.
L041B
Radiologic
Technologist.
NF
2
0
75716 .......
Artery x-rays
arms/legs.
ED050
Technologist
PACS
workstation.
NF
Technologist
QCs images
in PACS,
checking all
images, reformats, and
dose page.
Prepare room,
equipment,
supplies.
..........................
62
59
00:24 Jul 21, 2017
Jkt 241001
Input code
description
Labor activity
(where
applicable)
HCPCS code
description
VerDate Sep<11>2014
Input
code
Nonfacility
(NF)/
Facility
(F)
HCPCS
code
PO 00000
Frm 00097
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
L1: Refined time
to standard
for this clinical
labor task.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
L1: Refined time
to standard
for this clinical
labor task.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
L1: Refined time
to standard
for this clinical
labor task.
Direct costs
change
(in dollars)
0.04
¥0.12
0.94
0.11
¥0.29
¥2.70
¥0.46
¥0.07
¥0.41
¥0.41
G1: See preamble text.
¥0.82
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
¥0.07
34046
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
Direct costs
change
(in dollars)
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
G1: See preamble text.
¥0.41
3
L1: Refined time
to standard
for this clinical
labor task.
¥0.41
8
7
¥0.02
..........................
8
7
1
0
NF
Exam document
scanned into
PACS. Exam
completed in
RIS system to
generate billing process
and to populate images
into Radiologist work
queue.
..........................
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
G1: See preamble text.
15
13
Professional
PACS
Workstation.
NF
..........................
15
13
ED053
Professional
PACS
Workstation.
NF
..........................
78
13
Intraop cyto
L033A
path consult 1.
Lab Technician
NF
Prepare room.
Filter and replenish stains
and supplies.
(including
OCT blocks,
set up
grossing station with colored stains).
10
0
75716 .......
Artery x-rays
arms/legs.
ED053
Professional
PACS
Workstation.
NF
..........................
65
58
75716 .......
Artery x-rays
arms/legs.
L041B
Radiologic
Technologist.
NF
0
Artery x-rays
arms/legs.
L041B
Radiologic
Technologist.
NF
4
76881 .......
Us xtr non-vasc
complete.
EF031
table, power .....
NF
Prepare room,
equipment,
supplies.
Technologist
QCs images
in PACS,
checking all
images, reformats, and
dose page.
..........................
2
75716 .......
76881 .......
Us xtr non-vasc
complete.
EQ250
ultrasound unit,
portable.
NF
76881 .......
Us xtr non-vasc
complete.
L026A
Medical/Technical Assistant.
NF
78300 .......
Bone imaging
limited area.
ED053
Professional
PACS
Workstation.
78305 .......
Bone imaging
ED053
multiple areas.
78306 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
Comment
Bone imaging
whole body.
88333 .......
VerDate Sep<11>2014
00:24 Jul 21, 2017
Jkt 241001
PO 00000
Frm 00098
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
G6: Indirect
Practice Expense input
and/or not individually allocable to a
particular patient for a particular service.
¥0.82
¥0.12
¥0.26
¥0.12
¥0.12
¥3.76
¥3.30
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
34047
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
Intraop cyto
L037B
path consult 1.
Histotechnologist.
NF
88360 .......
Tumor
immunohistochem/manual.
EP112
Tumor
immunohistochem/manual.
L033A
Benchmark
ULTRA automated slide
preparation
system.
Lab Technician
NF
88360 .......
NF
88360 .......
Tumor
immunohistochem/manual.
L037B
Histotechnologist.
NF
88360 .......
Tumor
immunohistochem/manual.
L037B
Histotechnologist.
NF
88360 .......
Tumor
immunohistochem/manual.
L037B
Histotechnologist.
NF
88361 .......
Tumor
immunohistochem/comput.
EP112
Tumor
immunohistochem/comput.
L033A
Benchmark
ULTRA automated slide
preparation
system.
Lab Technician
NF
88361 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
88333 .......
VerDate Sep<11>2014
00:24 Jul 21, 2017
Jkt 241001
PO 00000
NF
Frm 00099
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
Clean room/
equipment following procedure (including any equipment maintenance that
must be done
after the procedure).
..........................
CMS
refinement
(min or qty)
5
1
18
16
Recycle xylene
from tissue
processor and
stainer.
1
0
Clean room/
equipment following procedure (including any equipment maintenance that
must be done
after the procedure).
Verify results
and complete
work load recording logs.
1
0
1
0
Enter patient
data, computational
prep for antibody testing,
generate and
apply bar
codes to
slides, and
enter data for
automated
slide stainer.
..........................
5
1
18
16
1
0
Recycle xylene
from tissue
processor and
stainer.
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
Direct costs
change
(in dollars)
L1: Refined time
to standard
for this clinical
labor task.
¥1.48
G1: See preamble text.
¥1.14
G6: Indirect
Practice Expense input
and/or not individually allocable to a
particular patient for a particular service.
L2: Clinical
labor task redundant with
clinical labor
task Clean
equipment
and work station in histology lab.
¥0.33
G6: Indirect
Practice Expense input
and/or not individually allocable to a
particular patient for a particular service.
L1: Refined time
to standard
for this clinical
labor task.
¥0.37
¥0.37
¥1.48
G1: See preamble text.
¥1.14
G6: Indirect
Practice Expense input
and/or not individually allocable to a
particular patient for a particular service.
¥0.33
34048
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
RUC
recommendation
or current
value
(min or qty)
CMS
refinement
(min or qty)
88361 .......
Tumor
immunohistochem/comput.
L037B
Histotechnologist.
NF
Verify results
and complete
work load recording logs.
1
0
88361 .......
Tumor
immunohistochem/comput.
L037B
Histotechnologist.
NF
1
0
88361 .......
Tumor
immunohistochem/comput.
Tumor
immunohistochem/comput.
L037B
Histotechnologist.
NF
1
L037B
Histotechnologist.
NF
88361 .......
Tumor
immunohistochem/comput.
L037B
Histotechnologist.
NF
93279 .......
Pm device progr
eval sngl.
EF023
table, exam ......
NF
Performing instrument calibration, instrument qc
and start up
and shutdown..
Gate areas to
be counted by
the machine.
Enter patient
data, computational
prep for antibody testing,
generate and
apply bar
codes to
slides, and
enter data for
automated
slide stainer.
Clean room/
equipment following procedure (including any equipment maintenance that
must be done
after the procedure).
..........................
93279 .......
Pm device progr
eval sngl.
EQ198
pacemaker follow-up system (incl software and
hardware)
(Paceart).
NF
..........................
93279 .......
Pm device progr
eval sngl.
L026A
Medical/Technical Assistant.
NF
93279 .......
Pm device progr
eval sngl.
L037D
RN/LPN/MTA ...
NF
93280 .......
Pm device progr
eval dual.
EF023
table, exam ......
NF
mstockstill on DSK30JT082PROD with PROPOSALS2
VerDate Sep<11>2014
00:24 Jul 21, 2017
Jkt 241001
Input code
description
Labor activity
(where
applicable)
HCPCS code
description
88361 .......
Input
code
Nonfacility
(NF)/
Facility
(F)
HCPCS
code
PO 00000
Frm 00100
Comment
Direct costs
change
(in dollars)
G6: Indirect
Practice Expense input
and/or not individually allocable to a
particular patient for a particular service.
G1: See preamble text.
¥0.37
0
G1: See preamble text.
¥0.37
5
1
L1: Refined time
to standard
for this clinical
labor task.
¥1.48
1
0
L2: Clinical
labor task redundant with
clinical labor
task Clean
equipment
and work station in histology lab.
¥0.37
33
26
¥0.02
33
26
Complete diagnostic forms,
lab, X-ray
requisitions.
2
0
Other Clinical
Activity—
specify: Review charts.
..........................
2
0
38
31
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
L2: Clinical
labor task redundant with
clinical labor
task L037D.
L1: Refined time
to standard
for this clinical
labor task.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
¥0.37
¥0.53
¥0.52
¥0.74
¥0.02
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
34049
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
HCPCS
code
HCPCS code
description
93280 .......
Pm device progr
eval dual.
EQ198
pacemaker follow-up system (incl software and
hardware)
(Paceart).
NF
..........................
93280 .......
Pm device progr
eval dual.
L026A
Medical/Technical Assistant.
NF
93280 .......
Pm device progr
eval dual.
L037D
RN/LPN/MTA ...
NF
93281 .......
Pm device progr
eval multi.
EF023
table, exam ......
93281 .......
Pm device progr
eval multi.
EQ198
93281 .......
Pm device progr
eval multi.
93281 .......
CMS
refinement
(min or qty)
31
Complete diagnostic forms,
lab, X-ray
requisitions.
2
0
2
0
NF
Other Clinical
Activity—
specify: Review charts.
..........................
39
31
pacemaker follow-up system (incl software and
hardware)
(Paceart).
NF
..........................
39
31
L026A
Medical/Technical Assistant.
NF
Complete diagnostic forms,
lab, X-ray
requisitions.
2
0
Pm device progr
eval multi.
L037D
RN/LPN/MTA ...
NF
0
Pm device progr
eval multi.
L037D
RN/LPN/MTA ...
NF
Other Clinical
Activity—
specify: Review charts.
Assist physician
in performing
procedure.
2
93281 .......
16
15
93282 .......
Prgrmg eval
implantable
dfb.
EF023
table, exam ......
NF
..........................
35
28
93282 .......
Prgrmg eval
implantable
dfb.
EQ198
pacemaker follow-up system (incl software and
hardware)
(Paceart).
NF
..........................
35
28
93282 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
38
Prgrmg eval
implantable
dfb.
L026A
Medical/Technical Assistant.
NF
Complete diagnostic forms,
lab, X-ray
requisitions.
2
0
93282 .......
Prgrmg eval
implantable
dfb.
L037D
RN/LPN/MTA ...
NF
Other Clinical
Activity—
specify: Review charts.
2
0
VerDate Sep<11>2014
00:24 Jul 21, 2017
Jkt 241001
PO 00000
Frm 00101
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
L2: Clinical
labor task redundant with
clinical labor
task L037D.
L1: Refined time
to standard
for this clinical
labor task.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
L2: Clinical
labor task redundant with
clinical labor
task L037D.
L1: Refined time
to standard
for this clinical
labor task.
L15: Refined
clinical labor
time to match
intraservice
work time.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
L2: Clinical
labor task redundant with
clinical labor
task L037D.
L1: Refined time
to standard
for this clinical
labor task.
Direct costs
change
(in dollars)
¥0.53
¥0.52
¥0.74
¥0.02
¥0.61
¥0.52
¥0.74
¥0.37
¥0.02
¥0.53
¥0.52
¥0.74
34050
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
Prgrmg eval
implantable
dfb.
EF023
table, exam ......
NF
..........................
38
31
93283 .......
Prgrmg eval
implantable
dfb.
EQ198
pacemaker follow-up system (incl software and
hardware)
(Paceart).
NF
..........................
38
31
93283 .......
Prgrmg eval
implantable
dfb.
L026A
Medical/Technical Assistant.
NF
Complete diagnostic forms,
lab, X-ray
requisitions.
2
0
93283 .......
Prgrmg eval
implantable
dfb.
L037D
RN/LPN/MTA ...
NF
0
Prgrmg eval
implantable
dfb.
EF023
table, exam ......
NF
Other Clinical
Activity—
specify: Review charts.
..........................
2
93284 .......
40.5
33.5
93284 .......
Prgrmg eval
implantable
dfb.
EQ198
pacemaker follow-up system (incl software and
hardware)
(Paceart).
NF
..........................
40.5
33.5
93284 .......
Prgrmg eval
implantable
dfb.
L026A
Medical/Technical Assistant.
NF
Complete diagnostic forms,
lab, X-ray
requisitions.
2
0
93284 .......
Prgrmg eval
implantable
dfb.
L037D
RN/LPN/MTA ...
NF
0
Ilr device eval
progr.
EF023
table, exam ......
NF
Other Clinical
Activity—
specify: Review charts.
..........................
2
93285 .......
30
25
93285 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
93283 .......
Ilr device eval
progr.
EQ198
pacemaker follow-up system (incl software and
hardware)
(Paceart).
NF
..........................
30
25
93285 .......
Ilr device eval
progr.
L026A
Medical/Technical Assistant.
NF
Complete diagnostic forms,
lab, X-ray
requisitions.
1
0
93285 .......
Ilr device eval
progr.
L037D
RN/LPN/MTA ...
NF
Other Clinical
Activity—
specify: Review charts.
2
0
VerDate Sep<11>2014
00:24 Jul 21, 2017
Jkt 241001
PO 00000
Frm 00102
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
L2: Clinical
labor task redundant with
clinical labor
task L037D.
L1: Refined time
to standard
for this clinical
labor task.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
L2: Clinical
labor task redundant with
clinical labor
task L037D.
L1: Refined time
to standard
for this clinical
labor task.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
L2: Clinical
labor task redundant with
clinical labor
task L037D.
L1: Refined time
to standard
for this clinical
labor task.
Direct costs
change
(in dollars)
¥0.02
¥0.53
¥0.52
¥0.74
¥0.02
¥0.53
¥0.52
¥0.74
¥0.01
¥0.38
¥0.26
¥0.74
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
34051
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
RUC
recommendation
or current
value
(min or qty)
CMS
refinement
(min or qty)
Peri-px pacemaker device
evl.
EF023
table, exam ......
NF
..........................
27
20
93286 .......
Peri-px pacemaker device
evl.
EQ198
pacemaker follow-up system (incl software and
hardware)
(Paceart).
NF
..........................
27
20
93286 .......
Peri-px pacemaker device
evl.
L026A
Medical/Technical Assistant.
NF
Complete diagnostic forms,
lab, X-ray
requisitions.
2
0
93286 .......
Peri-px pacemaker device
evl.
L037D
RN/LPN/MTA ...
NF
0
Peri-px device
eval & prgr.
EF023
table, exam ......
NF
Other Clinical
Activity—
specify: Review charts.
..........................
2
93287 .......
27
20
93287 .......
Peri-px device
eval & prgr.
EQ198
pacemaker follow-up system (incl software and
hardware)
(Paceart).
NF
..........................
27
20
93287 .......
Peri-px device
eval & prgr.
L026A
Medical/Technical Assistant.
NF
Complete diagnostic forms,
lab, X-ray
requisitions.
2
0
93287 .......
Peri-px device
eval & prgr.
L037D
RN/LPN/MTA ...
NF
0
Pm device eval
in person.
EF023
table, exam ......
NF
Other Clinical
Activity—
specify: Review charts.
..........................
2
93288 .......
33
26
93288 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
93286 .......
Pm device eval
in person.
EQ198
pacemaker follow-up system (incl software and
hardware)
(Paceart).
NF
..........................
33
26
93288 .......
Pm device eval
in person.
L026A
Medical/Technical Assistant.
NF
Complete diagnostic forms,
lab, X-ray
requisitions.
2
0
93288 .......
Pm device eval
in person.
L037D
RN/LPN/MTA ...
NF
Other Clinical
Activity—
specify: Review charts.
2
0
00:24 Jul 21, 2017
Jkt 241001
Input code
description
Labor activity
(where
applicable)
HCPCS code
description
VerDate Sep<11>2014
Input
code
Nonfacility
(NF)/
Facility
(F)
HCPCS
code
PO 00000
Frm 00103
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
L2: Clinical
labor task redundant with
clinical labor
task L037D.
L1: Refined time
to standard
for this clinical
labor task.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
L2: Clinical
labor task redundant with
clinical labor
task L037D.
L1: Refined time
to standard
for this clinical
labor task.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
L2: Clinical
labor task redundant with
clinical labor
task L037D.
L1: Refined time
to standard
for this clinical
labor task.
Direct costs
change
(in dollars)
¥0.02
¥0.53
¥0.52
¥0.74
¥0.02
¥0.53
¥0.52
¥0.74
¥0.02
¥0.53
¥0.52
¥0.74
34052
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
Interrog device
eval heart.
EF023
table, exam ......
NF
..........................
33
26
93289 .......
Interrog device
eval heart.
EQ198
pacemaker follow-up system (incl software and
hardware)
(Paceart).
NF
..........................
33
26
93289 .......
Interrog device
eval heart.
L026A
Medical/Technical Assistant.
NF
Complete diagnostic forms,
lab, X-ray
requisitions.
2
0
93289 .......
Interrog device
eval heart.
L037D
RN/LPN/MTA ...
NF
0
Icm device eval
EF023
table, exam ......
NF
Other Clinical
Activity—
specify: Review charts.
..........................
2
93290 .......
28
24
93290 .......
Icm device eval
EQ198
pacemaker follow-up system (incl software and
hardware)
(Paceart).
NF
..........................
28
24
93290 .......
Icm device eval
L026A
Medical/Technical Assistant.
NF
Complete diagnostic forms,
lab, X-ray
requisitions.
1
0
93290 .......
Icm device eval
L037D
RN/LPN/MTA ...
NF
0
Ilr device interrogate.
EF023
table, exam ......
NF
Other Clinical
Activity—
specify: Review charts.
..........................
2
93291 .......
27
22
93291 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
93289 .......
Ilr device interrogate.
EQ198
pacemaker follow-up system (incl software and
hardware)
(Paceart).
NF
..........................
27
22
93291 .......
Ilr device interrogate.
L026A
Medical/Technical Assistant.
NF
Complete diagnostic forms,
lab, X-ray
requisitions.
1
0
93291 .......
Ilr device interrogate.
L037D
RN/LPN/MTA ...
NF
Other Clinical
Activity—
specify: Review charts.
2
0
VerDate Sep<11>2014
00:24 Jul 21, 2017
Jkt 241001
PO 00000
Frm 00104
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
L2: Clinical
labor task redundant with
clinical labor
task L037D.
L1: Refined time
to standard
for this clinical
labor task.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
L2: Clinical
labor task redundant with
clinical labor
task L037D.
L1: Refined time
to standard
for this clinical
labor task.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
L2: Clinical
labor task redundant with
clinical labor
task L037D.
L1: Refined time
to standard
for this clinical
labor task.
Direct costs
change
(in dollars)
¥0.02
¥0.53
¥0.52
¥0.74
¥0.01
¥0.30
¥0.26
¥0.74
¥0.01
¥0.38
¥0.26
¥0.74
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
34053
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
Wcd device interrogate.
EF023
table, exam ......
NF
..........................
30
25
93292 .......
Wcd device interrogate.
EQ198
pacemaker follow-up system (incl software and
hardware)
(Paceart).
NF
..........................
30
25
93292 .......
Wcd device interrogate.
L026A
Medical/Technical Assistant.
NF
Complete diagnostic forms,
lab, X-ray
requisitions.
1
0
93292 .......
Wcd device interrogate.
L037D
RN/LPN/MTA ...
NF
0
Stress tte only ..
ED053
Professional
PACS
Workstation.
NF
Other Clinical
Activity—
specify: Review charts.
..........................
2
93350 .......
20
18
93351 .......
Stress tte complete.
ED050
Technologist
PACS
workstation.
NF
..........................
104
114
93351 .......
Stress tte complete.
ED053
Professional
PACS
Workstation.
NF
..........................
30
25
93351 .......
Stress tte complete.
EQ078
cardiac monitor
w-treadmill
(12-lead PCbased ECG).
NF
..........................
104
91
93351 .......
Stress tte complete.
L037D
RN/LPN/MTA ...
NF
Obtain vital
signs.
3
5
93351 .......
Stress tte complete.
L037D
RN/LPN/MTA ...
NF
2
Stress tte complete.
L051A
RN ....................
NF
5
0
94621 .......
Cardiopulm exercise testing.
EQ042
Vmax 29c
(cardio-pulm
stress test
equip, treadmill, computer
system).
NF
Provide preservice education/obtain
consent.
Setup scope
(non facility
setting only).
..........................
3
93351 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
93292 .......
127
115
VerDate Sep<11>2014
00:24 Jul 21, 2017
Jkt 241001
PO 00000
Frm 00105
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
Comment
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
L2: Clinical
labor task redundant with
clinical labor
task L037D.
L1: Refined time
to standard
for this clinical
labor task.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
E18: Refined
equipment
time to conform to established policies
for PACS
Workstations.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
L1: Refined time
to standard
for this clinical
labor task.
L1: Refined time
to standard
for this clinical
labor task.
G1: See preamble text.
E6: Refined
equipment
time to conform to established policies
for equipment
with 4x monitoring time.
Direct costs
change
(in dollars)
¥0.01
¥0.38
¥0.26
¥0.74
¥0.12
0.22
¥0.29
¥0.49
0.74
¥0.37
¥2.55
¥1.98
34054
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
HCPCS
code
HCPCS code
description
94621 .......
Cardiopulm exercise testing.
EQ211
pulse oximeter
w-printer.
NF
..........................
127
115
94621 .......
Cardiopulm exercise testing.
L047C
RN/Respiratory
Therapist.
NF
5
3
94621 .......
Cardiopulm exercise testing.
L047C
RN/Respiratory
Therapist.
NF
10
94621 .......
Cardiopulm exercise testing.
L047C
RN/Respiratory
Therapist.
NF
946X2 .......
Exercise tst
brncspsm.
EQ043
Vmax 29s
(spirometry
testing equip,
computer system).
NF
Prepare and position pt/monitor pt/set up
IV.
Provide preservice education/obtain
consent.
Complete diagnostic forms,
lab, X-ray
requisitions.
..........................
946X2 .......
Exercise tst
brncspsm.
EQ078
cardiac monitor
w-treadmill
(12-lead PCbased ECG).
NF
946X2 .......
Exercise tst
brncspsm.
EQ211
pulse oximeter
w-printer.
946X2 .......
Exercise tst
brncspsm.
L047C
946X3 .......
Pulmonary
stress testing.
946X3 .......
Comment
Direct costs
change
(in dollars)
¥0.05
5
G1: See preamble text.
¥2.35
5
3
87
83
..........................
87
83
NF
..........................
87
83
RN/Respiratory
Therapist.
NF
4
3
EQ211
pulse oximeter
w-printer.
NF
Complete diagnostic forms,
lab, X-ray
requisitions.
..........................
17
15
Pulmonary
stress testing.
L047C
RN/Respiratory
Therapist.
NF
Percut allergy
skin tests.
EF015
mayo stand ......
95004 .......
Percut allergy
skin tests.
EF023
table, exam ......
L1: Refined time
to standard
for this clinical
labor task.
E6: Refined
equipment
time to conform to established policies
for equipment
with 4x monitoring time.
E6: Refined
equipment
time to conform to established policies
for equipment
with 4x monitoring time.
E6: Refined
equipment
time to conform to established policies
for equipment
with 4x monitoring time.
L1: Refined time
to standard
for this clinical
labor task.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
L1: Refined time
to standard
for this clinical
labor task.
E6: Refined
equipment
time to conform to established policies
for equipment
with 4x monitoring time.
E6: Refined
equipment
time to conform to established policies
for equipment
with 4x monitoring time.
¥0.94
95004 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
E6: Refined
equipment
time to conform to established policies
for equipment
with 4x monitoring time.
G1: See preamble text.
VerDate Sep<11>2014
00:24 Jul 21, 2017
Jkt 241001
PO 00000
2
3
NF
Complete diagnostic forms,
lab, X-ray
requisitions.
..........................
1.28
1.58
NF
..........................
1.28
1.58
Frm 00106
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E:\FR\FM\21JYP2.SGM
21JYP2
¥0.94
¥0.31
¥0.15
¥0.02
¥0.47
¥0.01
0.47
0.00
0.00
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34055
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
Pt-focused hlth
risk assmt.
L026A
Medical/Technical Assistant.
NF
96160 .......
Pt-focused hlth
risk assmt.
L026A
Medical/Technical Assistant.
NF
96160 .......
Pt-focused hlth
risk assmt.
L026A
Medical/Technical Assistant.
NF
96160 .......
Pt-focused hlth
risk assmt.
L026A
Medical/Technical Assistant.
NF
96160 .......
Pt-focused hlth
risk assmt.
L026A
Medical/Technical Assistant.
NF
96161 .......
Caregiver health
risk assmt.
L026A
Medical/Technical Assistant.
NF
96161 .......
Caregiver health
risk assmt.
L026A
Medical/Technical Assistant.
NF
96161 .......
Caregiver health
risk assmt.
L026A
Medical/Technical Assistant.
NF
96161 .......
Caregiver health
risk assmt.
L026A
Medical/Technical Assistant.
NF
96161 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
96160 .......
Caregiver health
risk assmt.
L026A
Medical/Technical Assistant.
NF
96360 .......
Hydration iv infusion init.
EF023
table, exam ......
NF
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RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
Explain purpose
of assessment to patient/caregiver
and answer
questions.
Remain in exam
room with patient/caregiver
exclusive to
completion of
assessment.
Collate and
score data
elements on
assessment
in advance of
physician
exam.
Scan assessment or enter
data elements
and total
score into
electronic
health record.
Administration,
scoring, and
documenting
results of
completed
standardized
instrument.
Explain purpose
of assessment to patient/caregiver
and answer
questions.
Remain in exam
room with patient/caregiver
exclusive to
completion of
assessment.
Collate and
score data
elements on
assessment
in advance of
physician
exam.
Scan assessment or enter
data elements
and total
score into
electronic
health record.
Administration,
scoring, and
documenting
results of
completed
standardized
instrument.
..........................
Fmt 4701
Sfmt 4702
CMS
refinement
(min or qty)
Comment
Direct costs
change
(in dollars)
2
0
G1: See preamble text.
¥0.52
2
0
G1: See preamble text.
¥0.52
1
0
G1: See preamble text.
¥0.26
2
0
G1: See preamble text.
¥0.52
0
7
G1: See preamble text.
1.82
2
0
G1: See preamble text.
¥0.52
2
0
G1: See preamble text.
¥0.52
1
0
G1: See preamble text.
¥0.26
2
0
G1: See preamble text.
¥0.52
0
7
G1: See preamble text.
1.82
16
24
E6: Refined
equipment
time to conform to established policies
for equipment
with 4x monitoring time.
0.02
E:\FR\FM\21JYP2.SGM
21JYP2
34056
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
Hydration iv infusion init.
EQ032
IV infusion
pump.
NF
..........................
96360 .......
Hydration iv infusion init.
L056A
RN/OCN ...........
NF
96361 .......
Hydrate iv infusion add-on.
EF023
table, exam ......
96361 .......
Hydrate iv infusion add-on.
EQ032
96361 .......
Hydrate iv infusion add-on.
96372 .......
16
24
Obtain vital
signs.
3
5
NF
..........................
7
9
IV infusion
pump.
NF
..........................
7
9
L056A
RN/OCN ...........
NF
Obtain vital
signs.
3
5
Ther/proph/diag
inj sc/im.
EF023
table, exam ......
NF
..........................
12
9
96372 .......
Ther/proph/diag
inj sc/im.
EQ189
otoscope-ophthalmoscope
(wall unit).
NF
..........................
12
9
96372 .......
Ther/proph/diag
inj sc/im.
L037D
RN/LPN/MTA ...
NF
Complete medical record
documentation.
1
0
96372 .......
Ther/proph/diag
inj sc/im.
L037D
RN/LPN/MTA ...
NF
Document lot
number and
expiration
date.
1
0
96372 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
96360 .......
CMS
refinement
(min or qty)
Ther/proph/diag
inj sc/im.
L037D
RN/LPN/MTA ...
NF
Clean room/
equipment by
physician staff.
1
0
96374 .......
Ther/proph/diag
inj iv push.
EF023
table, exam ......
NF
..........................
23
31
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21JYP2
Comment
E6: Refined
equipment
time to conform to established policies
for equipment
with 4x monitoring time.
L1: Refined time
to standard
for this clinical
labor task.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
L1: Refined time
to standard
for this clinical
labor task.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
G6: Indirect
Practice Expense input
and/or not individually allocable to a
particular patient for a particular service.
L3: Refined clinical labor time
to conform
with identical
labor activity
in other codes
in the family.
G8: Input removed; code
is typically
billed with an
E/M or other
evaluation
service.
E6: Refined
equipment
time to conform to established policies
for equipment
with 4x monitoring time.
Direct costs
change
(in dollars)
0.05
1.58
0.01
0.01
1.58
¥0.01
¥0.01
¥0.37
¥0.37
¥0.37
0.02
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
34057
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
HCPCS
code
HCPCS code
description
96374 .......
Ther/proph/diag
inj iv push.
EQ189
otoscope-ophthalmoscope
(wall unit).
NF
..........................
96374 .......
Ther/proph/diag
inj iv push.
L056A
RN/OCN ...........
NF
Complete medical record
documentation.
96375 .......
Tx/pro/dx inj
new drug
addon.
EF023
table, exam ......
NF
96375 .......
Tx/pro/dx inj
new drug
addon.
EQ189
otoscope-ophthalmoscope
(wall unit).
96375 .......
Tx/pro/dx inj
new drug
addon.
L056A
96377 .......
Applicaton onbody injector.
96377 .......
CMS
refinement
(min or qty)
31
1
0
..........................
12
17
NF
..........................
12
17
RN/OCN ...........
NF
Complete medical record
documentation.
1
0
EF023
table, exam ......
NF
..........................
12
11
Applicaton onbody injector.
EQ189
otoscope-ophthalmoscope
(wall unit).
NF
..........................
12
11
96377 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
23
Applicaton onbody injector.
L056A
RN/OCN ...........
NF
Complete medical record
documentation.
1
0
96910 .......
Photochemothe- EF023
rapy with uv-b.
table, exam ......
NF
..........................
67
65
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21JYP2
Comment
E6: Refined
equipment
time to conform to established policies
for equipment
with 4x monitoring time.
G6: Indirect
Practice Expense input
and/or not individually allocable to a
particular patient for a particular service.
E6: Refined
equipment
time to conform to established policies
for equipment
with 4x monitoring time.
E6: Refined
equipment
time to conform to established policies
for equipment
with 4x monitoring time.
G6: Indirect
Practice Expense input
and/or not individually allocable to a
particular patient for a particular service.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
G6: Indirect
Practice Expense input
and/or not individually allocable to a
particular patient for a particular service.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
Direct costs
change
(in dollars)
0.01
¥0.79
0.01
0.01
¥0.79
0.00
0.00
¥0.79
¥0.01
34058
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TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
Photochemothe- EQ168
rapy with uv-b.
light, exam .......
NF
..........................
67
65
96910 .......
Photochemothe- EQ204
rapy with uv-b.
phototherapy
unit, handfoot, UVA–
UVB.
NF
..........................
67
65
96910 .......
Photochemothe- EQ205
rapy with uv-b.
phototherapy
unit, whole
body, UVA–
UVB.
NF
..........................
67
65
96910 .......
Photochemothe- L037D
rapy with uv-b.
RN/LPN/MTA ...
NF
Complete diagnostic forms,
lab & X-ray
requisitions,
and documentation.
2
0
96910 .......
Photochemothe- L037D
rapy with uv-b.
RN/LPN/MTA ...
NF
1
Photochemothe- L037D
rapy with uv-b.
RN/LPN/MTA ...
NF
Provide preservice education/obtain
consent.
Obtain vital
signs.
3
96910 .......
3
5
96X73 .......
Pdt dstr prmlg
les phys/qhp.
EF031
table, power .....
NF
..........................
230
52
96X73 .......
Pdt dstr prmlg
les phys/qhp.
EQ169
light, external
PDT, w-probe
set
(LumaCare).
NF
..........................
20
52
96X73 .......
Pdt dstr prmlg
les phys/qhp.
L037D
RN/LPN/MTA ...
NF
Obtain vital
signs.
3
5
96X73 .......
Pdt dstr prmlg
les phys/qhp.
SJ027
goggles, uvblocking.
NF
..........................
0
3
96X74 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
96910 .......
Dbrdmt prmlg
les w/pdt.
EF031
table, power .....
NF
..........................
232
54
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21JYP2
Comment
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
E15: Refined
equipment
time to conform to
changes in
clinical labor
time.
G6: Indirect
Practice Expense input
and/or not individually allocable to a
particular patient for a particular service.
G1: See preamble text.
L1: Refined time
to standard
for this clinical
labor task.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
L1: Refined time
to standard
for this clinical
labor task.
S8: Supply item
replaces another item;
see preamble.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
Direct costs
change
(in dollars)
¥0.01
¥0.01
¥0.07
¥0.74
¥0.74
0.74
¥2.91
1.12
0.74
12.30
¥2.91
34059
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TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
Comment
96X74 .......
Dbrdmt prmlg
les w/pdt.
EQ168
light, exam .......
NF
..........................
52
54
96X74 .......
Dbrdmt prmlg
les w/pdt.
EQ169
light, external
PDT, w-probe
set
(LumaCare).
NF
..........................
20
54
96X74 .......
Dbrdmt prmlg
les w/pdt.
L037D
RN/LPN/MTA ...
NF
Obtain vital
signs.
3
5
96X74 .......
Dbrdmt prmlg
les w/pdt.
SJ027
goggles, uvblocking.
NF
..........................
0
3
97012 .......
Mechanical traction therapy.
EQ241
NF
..........................
13
15
97012 .......
Mechanical traction therapy.
L023A
traction system
(hi-low table,
digital unit,
accessories).
Physical Therapy Aide.
NF
1
2
G1: See preamble text.
97012 .......
Mechanical traction therapy.
Mechanical traction therapy.
L023A
Physical Therapy Aide.
Physical Therapy Aide.
NF
Clean room/
equipment by
physician staff.
Assist therapist
2
0
0
1
97012 .......
Mechanical traction therapy.
L023A
Physical Therapy Aide.
NF
1
97012 .......
Mechanical traction therapy.
Mechanical traction therapy.
L023A
Physical Therapy Aide.
Physical Therapy Assistant.
NF
Mechanical traction therapy.
Mechanical traction therapy.
Mechanical traction therapy.
Mechanical traction therapy.
L039B
Physical Therapy Assistant.
gloves, nonsterile.
gown, patient ...
NF
Other clinical
Activity—
specify: posttreatment assistance.
Prepare room,
equipment,
supplies.
Prepare and position patient.
Check
dressings &
wound/home
care instructions/coordinate office
visits/prescriptions.
Assist therapist
G1: See
amble
G1: See
amble
NF
97012 .......
Mechanical traction therapy.
SK082
97012 .......
Mechanical traction therapy.
SM012
97014 .......
Electric stimulation therapy.
Electric stimulation therapy.
EF028
97014 .......
Electric stimulation therapy.
L023A
97014 .......
Electric stimulation therapy.
L023A
97012 .......
97012 .......
97012 .......
97012 .......
97012 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
97012 .......
97014 .......
VerDate Sep<11>2014
L023A
L039B
SB022
SB026
SG039
EQ116
00:24 Jul 21, 2017
Jkt 241001
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
E1: Refined
equipment
time to conform to established policies
for non-highly
technical
equipment.
L1: Refined time
to standard
for this clinical
labor task.
S8: Supply item
replaces another item;
see preamble.
G1: See preamble text.
Direct costs
change
(in dollars)
0.01
1.19
0.74
12.30
0.03
0.23
pretext.
pretext.
¥0.46
0
G1: See preamble text.
¥0.23
1
0
1
pretext.
pretext.
¥0.23
0
G1: See
amble
G1: See
amble
0
5
1
0
NF
..........................
1
0
dressing, 5in x
9in (ABDCombine).
towel, paper
(Bounty) (per
sheet).
disinfectant
spray
(Transeptic).
table, mat, hi-lo,
6 x 8 platform.
electrotherapy
stimulator,
high volt, 2
channel.
Physical Therapy Aide.
NF
..........................
0
1
pretext.
pretext.
pretext.
pretext.
1.95
..........................
G1: See
amble
G1: See
amble
G1: See
amble
G1: See
amble
NF
..........................
2
0
G1: See preamble text.
¥0.01
NF
..........................
2
0
G1: See preamble text.
¥0.06
NF
..........................
10
15
NF
..........................
10
15
NF
1
Physical Therapy Aide.
NF
Prepare room,
equipment,
supplies.
Assist therapist
2
PO 00000
NF
NF
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0.39
¥0.08
¥0.53
0.27
pretext.
pretext.
0.05
0
G1: See preamble text.
¥0.23
0
21JYP2
G1: See
amble
G1: See
amble
0.23
G1: See preamble text.
¥0.46
0.03
34060
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TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS code
description
97014 .......
Electric stimulation therapy.
L023A
Physical Therapy Aide.
NF
97014 .......
Electric stimulation therapy.
L023A
Physical Therapy Aide.
NF
97014 .......
Electric stimulation therapy.
Electric stimulation therapy.
Electric stimulation therapy.
L023A
Physical Therapy Aide.
Physical Therapy Assistant.
Physical Therapy Assistant.
NF
Electric stimulation therapy.
Electric stimulation therapy.
Electric stimulation therapy.
Electric stimulation therapy.
SB026
gown, patient ...
SJ024
electrolyte coupling gel.
razor .................
97014 .......
Electric stimulation therapy.
SM012
97016 .......
Vasopneumatic
device therapy.
Vasopneumatic
device therapy.
Vasopneumatic
device therapy.
EF028
Vasopneumatic
device therapy.
Vasopneumatic
device therapy.
Vasopneumatic
device therapy.
Vasopneumatic
device therapy.
Vasopneumatic
device therapy.
Vasopneumatic
device therapy.
Vasopneumatic
device therapy.
Vasopneumatic
device therapy.
Paraffin bath
therapy.
97014 .......
97014 .......
97014 .......
97014 .......
97014 .......
97014 .......
97016 .......
97016 .......
97016 .......
97016 .......
97016 .......
97016 .......
97016 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
97016 .......
97016 .......
97016 .......
97018 .......
VerDate Sep<11>2014
Input
code
L039B
L039B
Input code
description
Nonfacility
(NF)/
Facility
(F)
HCPCS
code
NF
Clean room/
equipment by
physician staff.
Other clinical
Activity—
specify: posttreatment assistance.
Prepare and position patient.
Assist therapist
CMS
refinement
(min or qty)
Comment
Direct costs
change
(in dollars)
1
2
G1: See preamble text.
0.23
0
1
G1: See preamble text.
0.23
1
0
3
pretext.
pretext.
pretext.
¥0.23
0
G1: See
amble
G1: See
amble
G1: See
amble
G1: See
amble
G1: See
amble
G1: See
amble
G1: See
amble
pretext.
pretext.
pretext.
pretext.
¥0.53
1.17
0
1
NF
Check
dressings &
wound/home
care instructions/coordinate office
visits/prescriptions.
..........................
1
0
NF
..........................
0
1
NF
..........................
0
1
towel, paper
NF
(Bounty) (per
sheet).
disinfectant
NF
spray
(Transeptic).
table, mat, hi-lo, NF
6 x 8 platform.
..........................
1
0
..........................
1
0
G1: See preamble text.
¥0.03
..........................
11
20
G1: See preamble text.
0.09
vasopneumatic
compression
system.
Physical Therapy Aide.
NF
..........................
11
20
G1: See preamble text.
0.02
NF
0
2
G1: See preamble text.
0.46
L023A
Physical Therapy Aide.
NF
1
0
G1: See preamble text.
¥0.23
L023A
Physical Therapy Aide.
NF
1
2
G1: See preamble text.
0.23
L023A
Physical Therapy Aide.
NF
Other clinical
Activity—
specify: posttreatment assistance.
Prepare room,
equipment,
supplies.
Clean room/
equipment by
physician staff.
Prepare and position patient.
1
0
G1: See preamble text.
¥0.23
L023A
Physical Therapy Aide.
NF
Assist therapist
2
0
G1: See preamble text.
¥0.46
L039B
Physical Therapy Assistant.
NF
Assist therapist
0
10
G1: See preamble text.
3.90
L039B
Physical Therapy Assistant.
NF
0
5
G1: See preamble text.
1.95
L039B
Physical Therapy Assistant.
NF
Check
dressings &
wound/home
care instructions/coordinate office
visits/prescriptions.
Obtain vital
signs.
0
2
G1: See preamble text.
0.78
SB026
gown, patient ...
NF
..........................
1
0
G1: See preamble text.
¥0.53
EQ200
paraffin bath,
hand-foot (institutional).
NF
..........................
11
15
G1: See preamble text.
0.03
SK068
SK082
EQ263
L023A
00:24 Jul 21, 2017
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PO 00000
NF
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
Frm 00112
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
0.39
0.02
0.39
¥0.01
34061
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
97018 .......
Paraffin bath
therapy.
L023A
Physical Therapy Aide.
NF
97018 .......
Paraffin bath
therapy.
L023A
Physical Therapy Aide.
NF
97018 .......
Paraffin bath
therapy.
L023A
Physical Therapy Aide.
NF
97018 .......
Paraffin bath
therapy.
Paraffin bath
therapy.
Paraffin bath
therapy.
L023A
Physical Therapy Aide.
Physical Therapy Aide.
Physical Therapy Assistant.
NF
Paraffin bath
therapy.
Paraffin bath
therapy.
L039B
Whirlpool therapy.
Whirlpool therapy.
EF012
Whirlpool therapy.
Whirlpool therapy.
Whirlpool therapy.
L023A
Physical Therapy Assistant.
pack, minimum
multi-specialty
visit.
lift, hydraulic,
chair.
whirlpool, lo-boy
tank (whole
body).
Physical Therapy Aide.
Physical Therapy Aide.
Physical Therapy Aide.
Whirlpool therapy.
Whirlpool therapy.
L039B
Physical Therapy Assistant.
Physical Therapy Assistant.
NF
Whirlpool
apy.
Whirlpool
apy.
Whirlpool
apy.
Whirlpool
apy.
Whirlpool
apy.
Whirlpool
apy.
Whirlpool
apy.
ther-
SB022
ther-
SB024
gloves, nonsterile.
gloves, sterile ...
ther-
SB033
ther-
SG017
ther-
SG027
ther-
SG055
ther-
SG079
97018 .......
97018 .......
97018 .......
97018 .......
97022 .......
97022 .......
97022 .......
97022 .......
97022 .......
97022 .......
97022 .......
97022 .......
97022 .......
97022 .......
97022 .......
97022 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
97022 .......
97022 .......
97022 .......
97032 .......
97032 .......
Whirlpool therapy.
Electrical stimulation.
Electrical stimulation.
VerDate Sep<11>2014
L023A
L039B
SA048
EF036
L023A
L023A
L039B
SJ046
EF028
EQ116
00:24 Jul 21, 2017
Jkt 241001
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
Comment
Direct costs
change
(in dollars)
1
3
G1: See preamble text.
0.46
0
1
G1: See preamble text.
0.23
1
2
G1: See preamble text.
0.23
2
0
1
3
0
1
pretext.
pretext.
pretext.
¥0.46
NF
Prepare and position patient.
Check
dressings &
wound/home
care instructions/coordinate office
visits/prescriptions.
Assist therapist
G1: See
amble
G1: See
amble
G1: See
amble
0
5
..........................
0
0.5
pretext.
pretext.
1.95
NF
G1: See
amble
G1: See
amble
NF
..........................
26
4
..........................
26
24
pretext.
pretext.
¥0.28
NF
G1: See
amble
G1: See
amble
NF
Prepare and position patient.
Assist therapist
2
3
2
0
Other clinical
Activity—
specify: posttreatment assistance.
Assist therapist
0
3
G1: See
amble
G1: See
amble
G1: See
amble
pretext.
pretext.
pretext.
0
5
0
1
pretext.
pretext.
1.95
NF
Check
dressings &
wound/home
care instructions/coordinate office
visits/prescriptions.
..........................
G1: See
amble
G1: See
amble
1
0
..........................
0
1
mask, surgical ..
NF
..........................
0
1
bandage, Kling,
non-sterile 2in.
cast, stockinette
4in.
gauze, sterile
4in x 4in.
tape, surgical
paper 1in
(Micropore).
silver nitrate applicator.
table, mat, hi-lo,
6 x 8 platform.
electrotherapy
stimulator,
high volt, 2
channel.
NF
..........................
0
1
NF
..........................
0
1
NF
..........................
0
5
NF
..........................
0
12
pretext.
pretext.
pretext.
pretext.
pretext.
pretext.
pretext.
¥0.08
NF
G1: See
amble
G1: See
amble
G1: See
amble
G1: See
amble
G1: See
amble
G1: See
amble
G1: See
amble
NF
..........................
0
1
..........................
18
15
NF
..........................
18
15
pretext.
pretext.
pretext.
0.07
NF
G1: See
amble
G1: See
amble
G1: See
amble
PO 00000
NF
NF
NF
NF
NF
Frm 00113
Prepare room,
equipment,
supplies.
Other clinical
Activity—
specify: posttreatment assistance.
Clean room/
equipment by
physician staff.
Assist therapist
CMS
refinement
(min or qty)
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
0.46
0.39
0.57
¥0.02
0.23
¥0.46
0.69
0.39
0.84
0.20
0.36
0.46
0.80
0.02
¥0.03
¥0.02
34062
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
HCPCS
code
HCPCS code
description
97032 .......
Electrical stimulation.
L023A
Physical Therapy Aide.
NF
97032 .......
Electrical stimulation.
Electrical stimulation.
L023A
Physical Therapy Aide.
Physical Therapy Aide.
NF
97032 .......
Electrical stimulation.
L023A
Physical Therapy Aide.
NF
97032 .......
Electrical stimulation.
Electrical stimulation.
L039B
Physical Therapy Assistant.
Physical Therapy Assistant.
NF
Electrical stimulation.
Electrical stimulation.
Electrical stimulation.
SB022
gloves, nonsterile.
gown, patient ...
97032 .......
Electrical stimulation.
SG079
97032 .......
Electrical
lation.
Electrical
lation.
Electrical
lation.
Electrical
lation.
stimu-
SJ020
stimu-
SJ053
stimu-
SK068
stimu-
SK082
97032 .......
Electrical stimulation.
SM012
97033 .......
Electric current
therapy.
Electric current
therapy.
Electric current
therapy.
EF028
97033 .......
Electric current
therapy.
97033 .......
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
Comment
Direct costs
change
(in dollars)
1
0
G1: See preamble text.
¥0.23
1
0
1
pretext.
pretext.
¥0.23
0
G1: See
amble
G1: See
amble
1
2
G1: See preamble text.
0.23
0
3
0
1
pretext.
pretext.
1.17
NF
Check
dressings &
wound/home
care instructions/coordinate office
visits/prescriptions.
..........................
G1: See
amble
G1: See
amble
1
0
..........................
1
0
electrode, electrical stimulation.
tape, surgical
paper 1in
(Micropore).
electrode conductive gel.
swab-pad, alcohol.
razor .................
NF
..........................
0
2
pretext.
pretext.
pretext.
¥0.08
NF
G1: See
amble
G1: See
amble
G1: See
amble
NF
..........................
0
6
G1: See preamble text.
0.01
NF
..........................
0
5
0.08
NF
..........................
1
2
NF
..........................
0
1
towel, paper
(Bounty) (per
sheet).
disinfectant
spray
(Transeptic).
table, mat, hi-lo,
6 x 8 platform.
iontophoresis
machine.
Physical Therapy Aide.
NF
..........................
1
0
G1: See
amble
G1: See
amble
G1: See
amble
G1: See
amble
NF
..........................
1
0
NF
..........................
20
15
NF
..........................
20
15
NF
0
1
L023A
Physical Therapy Aide.
NF
2
Electric current
therapy.
L023A
Physical Therapy Aide.
NF
97033 .......
Electric current
therapy.
L039B
Physical Therapy Assistant.
NF
97033 .......
Electric current
therapy.
Electric current
therapy.
Contrast bath
therapy.
SG055
gauze, sterile
4in x 4in.
razor .................
NF
Other clinical
Activity—
specify: posttreatment assistance.
Prepare room,
equipment,
supplies.
Clean room/
equipment by
physician staff.
Other Clinical
Activity—
specify: Obtain measurements.
..........................
NF
L023A
Physical Therapy Aide.
NF
97034 .......
Contrast bath
therapy.
L023A
Physical Therapy Aide.
NF
97034 .......
Contrast bath
therapy.
L023A
Physical Therapy Aide.
NF
97032 .......
97032 .......
97032 .......
97032 .......
97032 .......
97032 .......
97032 .......
97032 .......
97033 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
97033 .......
97033 .......
97034 .......
VerDate Sep<11>2014
L023A
L039B
SB026
SD055
EQ141
L023A
SK068
00:24 Jul 21, 2017
Jkt 241001
PO 00000
NF
NF
Frm 00114
Prepare room,
equipment,
supplies.
Prepare and position patient.
Other clinical
Activity—
specify: posttreatment assistance.
Clean room/
equipment by
physician staff.
Assist therapist
pretext.
pretext.
pretext.
pretext.
0.23
0.39
¥0.53
2.62
0.01
0.39
¥0.01
G1: See preamble text.
¥0.03
G1: See
amble
G1: See
amble
G1: See
amble
pretext.
pretext.
pretext.
¥0.05
3
G1: See preamble text.
0.23
1
3
G1: See preamble text.
0.46
0
1
G1: See preamble text.
0.39
0
1
0
1
Clean room/
equipment by
physician staff.
Prepare room,
equipment,
supplies.
Prepare and position patient.
2
5
pretext.
pretext.
pretext.
0.16
..........................
G1: See
amble
G1: See
amble
G1: See
amble
2
3
G1: See preamble text.
0.23
1
2
G1: See preamble text.
0.23
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
¥0.01
0.23
0.39
0.69
34063
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
97034 .......
HCPCS code
description
Input
code
Contrast bath
therapy.
Contrast bath
therapy.
L039B
Contrast bath
therapy.
Contrast bath
therapy.
Ultrasound therapy.
Ultrasound therapy.
Ultrasound therapy.
Ultrasound therapy.
SB022
97035 .......
Ultrasound therapy.
97035 .......
Ultrasound
apy.
Ultrasound
apy.
Ultrasound
apy.
Ultrasound
apy.
Ultrasound
apy.
Input code
description
Nonfacility
(NF)/
Facility
(F)
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
Comment
Direct costs
change
(in dollars)
Physical Therapy Assistant.
Physical Therapy Assistant.
NF
Assist therapist
0
3
NF
0
3
gloves, nonsterile.
gown, patient ...
NF
Check
dressings &
wound/home
care instructions/coordinate office
visits/prescriptions.
..........................
1
0
NF
..........................
1
0
table, mat, hi-lo,
6 x 8 platform.
ultrasound unit,
therapeutic.
Physical Therapy Aide.
Physical Therapy Aide.
NF
..........................
16
15
NF
..........................
16
8
NF
1
0
1
0
L023A
Physical Therapy Aide.
NF
0
1
G1: See preamble text.
0.23
ther-
L039B
NF
0
3
SB022
NF
..........................
1
0
ther-
SB026
NF
..........................
1
0
ther-
SJ024
NF
..........................
0
1
ther-
SJ062
NF
..........................
30
0
97035 .......
Ultrasound therapy.
SK082
NF
..........................
1
0
G1: See preamble text.
¥0.01
97035 .......
Ultrasound therapy.
SM012
NF
..........................
1
0
G1: See preamble text.
¥0.03
97110 .......
Therapeutic exercises.
Therapeutic exercises.
EF028
NF
..........................
22
10
..........................
22
8
pretext.
pretext.
¥0.12
NF
G1: See
amble
G1: See
amble
Therapeutic exercises.
Therapeutic exercises.
Therapeutic exercises.
EQ129
electrolyte coupling gel.
ultrasound
transmission
gel.
towel, paper
(Bounty) (per
sheet).
disinfectant
spray
(Transeptic).
table, mat, hi-lo,
6 x 8 platform.
exercise equipment (treadmill, bike,
stepper, UBE,
pulleys, balance board).
hydrocollator,
cold.
hydrocollator,
hot.
Physical Therapy Aide.
G1: See
amble
G1: See
amble
G1: See
amble
G1: See
amble
G1: See
amble
1.17
ther-
Physical Therapy Assistant.
gloves, nonsterile.
gown, patient ...
Prepare and position patient.
Prepare room,
equipment,
supplies.
Other clinical
Activity—
specify: posttreatment assistance.
Assist therapist
NF
..........................
0
4
..........................
0
4
NF
0
1
97110 .......
Therapeutic exercises.
L023A
Physical Therapy Aide.
NF
1
0
G1: See preamble text.
¥0.23
97110 .......
Therapeutic exercises.
Therapeutic exercises.
Therapeutic exercises.
L023A
Physical Therapy Aide.
Physical Therapy Aide.
Physical Therapy Aide.
NF
Other clinical
Activity—
specify: posttreatment assistance.
Prepare room,
equipment,
supplies.
Prepare and position patient.
Assist therapist
pretext.
pretext.
pretext.
0.02
NF
G1: See
amble
G1: See
amble
G1: See
amble
1
0
¥0.23
5
0
Other Clinical
Activity—
specify:
Verify/Coordinate availability of resources/
equipment.
0
1.5
G1: See
amble
G1: See
amble
G1: See
amble
97034 .......
97034 .......
97034 .......
97035 .......
97035 .......
97035 .......
97035 .......
97035 .......
97035 .......
97035 .......
97035 .......
97110 .......
97110 .......
97110 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
97110 .......
97110 .......
97110 .......
VerDate Sep<11>2014
L039B
SB026
EF028
EQ251
L023A
L023A
EQ118
EQ130
L023A
L023A
L023A
00:24 Jul 21, 2017
Jkt 241001
PO 00000
NF
NF
NF
Frm 00115
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
G1: See
amble
G1: See
amble
pretext.
pretext.
1.17
G1: See
amble
G1: See
amble
G1: See
amble
G1: See
amble
G1: See
amble
G1: See
amble
pretext.
pretext.
pretext.
pretext.
pretext.
pretext.
¥0.08
pretext.
pretext.
pretext.
pretext.
pretext.
pretext.
pretext.
pretext.
1.17
¥0.53
¥0.01
¥0.03
¥0.23
¥0.23
¥0.08
¥0.53
0.02
¥0.39
¥0.40
0.01
0.23
¥1.15
0.35
34064
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS code
description
97110 .......
Therapeutic exercises.
L039B
Physical Therapy Assistant.
NF
97110 .......
Therapeutic exercises.
L039B
Physical Therapy Assistant.
NF
97110 .......
Therapeutic exercises.
Therapeutic exercises.
L039B
Physical Therapy Assistant.
Physical Therapy Assistant.
NF
97110 .......
Therapeutic exercises.
L039B
Physical Therapy Assistant.
NF
97110 .......
Therapeutic exercises.
SA048
97110 .......
Therapeutic exercises.
Therapeutic exercises.
SB022
97110 .......
Therapeutic exercises.
SM012
97112 .......
Neuromuscular
reeducation.
Neuromuscular
reeducation.
EF028
97112 .......
Neuromuscular
reeducation.
EQ118
97112 .......
Neuromuscular
reeducation.
EQ201
97112 .......
Neuromuscular
reeducation.
L023A
pack, minimum
multi-specialty
visit.
gloves, nonsterile.
towel, paper
(Bounty) (per
sheet).
disinfectant
spray
(Transeptic).
table, mat, hi-lo,
6 x 8 platform.
balance assessment-retraining system
(Balance
Master).
exercise equipment (treadmill, bike,
stepper, UBE,
pulleys, balance board).
parallel bars,
platform
mounted.
Physical Therapy Aide.
97112 .......
Neuromuscular
reeducation.
Neuromuscular
reeducation.
Neuromuscular
reeducation.
L023A
Physical Therapy Aide.
Physical Therapy Aide.
Physical Therapy Aide.
NF
Neuromuscular
reeducation.
L023A
Physical Therapy Aide.
NF
97110 .......
97110 .......
97112 .......
97112 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
97112 .......
97112 .......
VerDate Sep<11>2014
Input
code
L039B
SK082
EQ068
L023A
L023A
00:24 Jul 21, 2017
Jkt 241001
Input code
description
Nonfacility
(NF)/
Facility
(F)
HCPCS
code
PO 00000
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
Comment
Direct costs
change
(in dollars)
Check
dressings &
wound/home
care instructions/coordinate office
visits/prescriptions.
Other Clinical
Activity—
specify: Obtain measurements.
Assist therapist
1.5
2.5
G1: See preamble text.
0.39
0
1.5
G1: See preamble text.
0.59
2.5
7.5
0
1
pretext.
pretext.
1.95
0
1.5
G1: See preamble text.
0.59
NF
Other Clinical
Activity—
specify: Conduct phone
calls/call in
prescriptions.
Other Clinical
Activity—
specify: Review/read
documentation, plan of
care, treatment goals.
..........................
G1: See
amble
G1: See
amble
0
0.5
G1: See preamble text.
0.57
NF
..........................
1
0
NF
..........................
4
0
NF
..........................
5
0
NF
..........................
22
10
NF
..........................
22
15
NF
..........................
22
NF
..........................
NF
NF
NF
NF
Frm 00116
G1: See
amble
G1: See
amble
pretext.
pretext.
0.39
¥0.08
¥0.03
G1: See preamble text.
¥0.14
G1: See
amble
G1: See
amble
pretext.
pretext.
¥0.12
15
G1: See preamble text.
¥0.20
22
5
G1: See preamble text.
¥0.06
Prepare room,
equipment,
supplies.
Prepare and position patient.
Assist therapist
1
0
G1: See preamble text.
¥0.23
1
0
0
Other clinical
Activity—
specify: posttreatment assistance.
Other Clinical
Activity—
specify:
Verify/Coordinate availability of resources/
equipment.
0
1
pretext.
pretext.
pretext.
¥0.23
5
G1: See
amble
G1: See
amble
G1: See
amble
0
1.5
G1: See preamble text.
0.35
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
¥0.37
¥1.15
0.23
34065
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
97112 .......
Neuromuscular
reeducation.
L039B
Physical Therapy Assistant.
NF
97112 .......
Neuromuscular
reeducation.
L039B
Physical Therapy Assistant.
NF
97112 .......
Neuromuscular
reeducation.
Neuromuscular
reeducation.
L039B
Physical Therapy Assistant.
Physical Therapy Assistant.
NF
97112 .......
Neuromuscular
reeducation.
L039B
Physical Therapy Assistant.
NF
97112 .......
Neuromuscular
reeducation.
SA048
97112 .......
Neuromuscular
reeducation.
Neuromuscular
reeducation.
SB022
97112 .......
Neuromuscular
reeducation.
SM012
97113 .......
Aquatic therapy/
exercises.
Aquatic therapy/
exercises.
Aquatic therapy/
exercises.
Aquatic therapy/
exercises.
Aquatic therapy/
exercises.
EF012
pack, minimum
multi-specialty
visit.
gloves, nonsterile.
towel, paper
(Bounty) (per
sheet).
disinfectant
spray
(Transeptic).
lift, hydraulic,
chair.
aquatic therapy
pool.
kit, aquatic exercise.
pool cleaner .....
L023A
97113 .......
Aquatic therapy/
exercises.
97113 .......
97112 .......
L039B
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
Comment
Direct costs
change
(in dollars)
Check
dressings &
wound/home
care instructions/coordinate office
visits/prescriptions.
Other Clinical
Activity—
specify: Review/read
documentation, plan of
care, treatment goals.
Assist therapist
1.5
2.5
G1: See preamble text.
0.39
0
1.5
G1: See preamble text.
0.59
2.5
7.5
0
1
pretext.
pretext.
1.95
0
1.5
G1: See preamble text.
0.59
NF
Other Clinical
Activity—
specify: Conduct phone
calls/call in
prescriptions.
Other Clinical
Activity—
specify: Obtain measurements.
..........................
G1: See
amble
G1: See
amble
0
0.5
G1: See preamble text.
0.57
NF
..........................
1
0
NF
..........................
4
0
NF
..........................
5
NF
..........................
NF
NF
0.39
pretext.
pretext.
¥0.08
0
G1: See preamble text.
¥0.14
0
4
..........................
30
15
NF
..........................
30
10
NF
..........................
0
15
Physical Therapy Aide.
NF
2
0
L023A
Physical Therapy Aide.
NF
0
1.5
G1: See preamble text.
0.35
Aquatic therapy/
exercises.
L023A
Physical Therapy Aide.
NF
2
3
G1: See preamble text.
0.23
97113 .......
Aquatic therapy/
exercises.
L023A
Physical Therapy Aide.
NF
2
1.5
G1: See preamble text.
¥0.12
97113 .......
Aquatic therapy/
exercises.
Aquatic therapy/
exercises.
L023A
Physical Therapy Aide.
Physical Therapy Aide.
NF
Prepare room,
equipment,
supplies.
Other Clinical
Activity—
specify:
Verify/Coordinate availability of resources/
equipment.
Other clinical
Activity—
specify: posttreatment assistance.
Greet patient,
provide
gowning, ensure appropriate medical
records are
available.
Prepare and position patient.
Clean room/
equipment by
physician staff.
G1: See
amble
G1: See
amble
G1: See
amble
G1: See
amble
G1: See
amble
3
1.5
¥0.35
2
1
G1: See
amble
G1: See
amble
97112 .......
97113 .......
97113 .......
97113 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
97113 .......
97113 .......
VerDate Sep<11>2014
SK082
EQ050
EQ145
EQ207
L023A
00:24 Jul 21, 2017
Jkt 241001
PO 00000
NF
Frm 00117
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
G1: See
amble
G1: See
amble
pretext.
pretext.
pretext.
pretext.
pretext.
pretext.
pretext.
¥0.03
0.05
¥1.15
¥0.03
0.05
¥0.46
¥0.23
34066
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
97113 .......
Aquatic therapy/
exercises.
Aquatic therapy/
exercises.
L023A
Aquatic therapy/
exercises.
Aquatic therapy/
exercises.
L039B
97113 .......
Aquatic therapy/
exercises.
97113 .......
97113 .......
Input code
description
Nonfacility
(NF)/
Facility
(F)
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
pretext.
pretext.
¥3.45
G1: See
amble
G1: See
amble
pretext.
pretext.
¥0.39
1.5
G1: See preamble text.
0.59
0
1
G1: See preamble text.
0.39
2
7.5
0
0.5
pretext.
pretext.
2.15
..........................
G1: See
amble
G1: See
amble
NF
..........................
1
0
..........................
0
1
pretext.
pretext.
¥0.08
NF
G1: See
amble
G1: See
amble
NF
..........................
4
0
G1: See preamble text.
¥0.03
NF
..........................
0
10
culture swab
system
(Culturette).
disinfectant
spray
(Transeptic).
table, mat, hi-lo,
6 x 8 platform.
kit, ambulation ..
NF
..........................
0
1
NF
..........................
5
0
G1: See preamble text.
¥0.14
NF
..........................
22
0
..........................
0
15
parallel bars,
platform
mounted.
stairs, ambulation training.
treadmill ...........
NF
..........................
22
10
pretext.
pretext.
pretext.
¥0.22
NF
G1: See
amble
G1: See
amble
G1: See
amble
NF
..........................
22
5
..........................
22
0
L023A
Physical Therapy Aide.
NF
0
1
Gait training
therapy.
L023A
Physical Therapy Aide.
NF
1
0
G1: See preamble text.
¥0.23
Gait training
therapy.
Gait training
therapy.
L023A
Physical Therapy Aide.
Physical Therapy Aide.
NF
Other clinical
Activity—
specify: posttreatment assistance.
Prepare room,
equipment,
supplies.
Prepare and position patient.
Assist therapist
pretext.
pretext.
pretext.
¥0.03
NF
G1: See
amble
G1: See
amble
G1: See
amble
1
0
¥0.23
5
0
G1: See
amble
G1: See
amble
NF
Assist therapist
15
0
NF
2
2.5
Physical Therapy Assistant.
Physical Therapy Assistant.
NF
2
1
0
1.5
L039B
Physical Therapy Assistant.
NF
0
Aquatic therapy/
exercises.
L039B
Physical Therapy Assistant.
NF
Aquatic therapy/
exercises.
Aquatic therapy/
exercises.
L039B
NF
NF
Aquatic therapy/
exercises.
Aquatic therapy/
exercises.
SB022
97113 .......
Aquatic therapy/
exercises.
SK082
97113 .......
Aquatic therapy/
exercises.
Aquatic therapy/
exercises.
SL032
Physical Therapy Assistant.
pack, minimum
multi-specialty
visit.
gloves, nonsterile.
swimsuit, female for
hydrotherapy.
towel, paper
(Bounty) (per
sheet).
culture media ...
Check
dressings &
wound/home
care instructions/coordinate office
visits/prescriptions.
Obtain vital
signs.
Other Clinical
Activity—
specify: Review/read
documentation, plan of
care, treatment goals.
Other Clinical
Activity—
specify: Obtain measurements.
Other Clinical
Activity—
specify: Conduct phone
calls/call in
prescriptions.
Assist therapist
97113 .......
Aquatic therapy/
exercises.
SM012
97116 .......
Gait training
therapy.
Gait training
therapy.
Gait training
therapy.
EF028
Gait training
therapy.
Gait training
therapy.
Gait training
therapy.
EQ231
97116 .......
97116 .......
97113 .......
97113 .......
97113 .......
97113 .......
97113 .......
97113 .......
97116 .......
97116 .......
97116 .......
97116 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
97116 .......
97116 .......
Direct costs
change
(in dollars)
G1: See
amble
G1: See
amble
Physical Therapy Aide.
Physical Therapy Assistant.
97113 .......
Comment
VerDate Sep<11>2014
L039B
L039B
SA048
SB041
SL033
EQ144
EQ201
EQ243
L023A
00:24 Jul 21, 2017
Jkt 241001
PO 00000
NF
NF
Frm 00118
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
G1: See
amble
G1: See
amble
pretext.
pretext.
pretext.
pretext.
0.20
0.59
0.57
6.87
0.13
0.87
0.03
¥0.04
¥0.29
0.23
¥1.15
34067
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
97116 .......
Gait training
therapy.
L023A
Physical Therapy Aide.
NF
97116 .......
Gait training
therapy.
Gait training
therapy.
L039B
Physical Therapy Assistant.
Physical Therapy Assistant.
NF
97116 .......
Gait training
therapy.
L039B
Physical Therapy Assistant.
NF
97116 .......
Gait training
therapy.
L039B
Physical Therapy Assistant.
NF
97116 .......
Gait training
therapy.
L039B
Physical Therapy Assistant.
NF
97116 .......
Gait training
therapy.
SA048
97116 .......
Gait training
therapy.
Gait training
therapy.
Gait training
therapy.
SB022
97116 .......
Gait training
therapy.
SM012
97116 .......
Gait training
therapy.
Manual therapy
1/> regions.
SM021
97140 .......
Manual therapy
1/> regions.
L023A
pack, minimum
multi-specialty
visit.
gloves, nonsterile.
Thera-bands
(6in width).
towel, paper
(Bounty) (per
sheet).
disinfectant
spray
(Transeptic).
sanitizing clothwipe (patient).
table,
mobolizationmanipulation
(Lloyd’s).
Physical Therapy Aide.
97140 .......
Manual therapy
1/> regions.
L023A
Physical Therapy Aide.
NF
97140 .......
Manual therapy
1/> regions.
Manual therapy
1/> regions.
L023A
Physical Therapy Aide.
Physical Therapy Aide.
NF
Manual therapy
1/> regions.
L023A
Physical Therapy Aide.
NF
97116 .......
97116 .......
97116 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
97140 .......
97140 .......
97140 .......
VerDate Sep<11>2014
L039B
SJ056
SK082
EF029
L023A
00:24 Jul 21, 2017
Jkt 241001
PO 00000
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
Other Clinical
Activity—
specify:
Verify/Coordinate availability of resources/
equipment.
Assist therapist
CMS
refinement
(min or qty)
Comment
Direct costs
change
(in dollars)
0
1.5
G1: See preamble text.
0.35
2.5
7.5
1.5
2.5
pretext.
pretext.
1.95
0
1.5
G1: See preamble text.
0.59
0
1
G1: See preamble text.
0.39
0
1.5
G1: See preamble text.
0.59
NF
Check
dressings &
wound/home
care instructions/coordinate office
visits/prescriptions.
Other Clinical
Activity—
specify: Review/read
documentation, plan of
care, treatment goals.
Other Clinical
Activity—
specify: Conduct phone
calls/call in
prescriptions.
Other Clinical
Activity—
specify: Obtain measurements.
..........................
G1: See
amble
G1: See
amble
0
0.5
G1: See preamble text.
0.57
NF
..........................
1
0
NF
..........................
1.5
0
NF
..........................
4
0
NF
..........................
5
NF
..........................
NF
NF
NF
NF
Frm 00119
0.39
pretext.
pretext.
pretext.
¥0.08
0
G1: See preamble text.
¥0.14
0
1
..........................
22
15
G1: See
amble
G1: See
amble
Prepare room,
equipment,
supplies.
Other Clinical
Activity—
specify:
Verify/Coordinate availability of resources/
equipment.
Prepare and position patient.
Other clinical
Activity—
specify: posttreatment assistance.
Assist therapist
1
0
G1: See preamble text.
¥0.23
0
1.5
G1: See preamble text.
0.35
1
0
0
1
5
0
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
G1: See
amble
G1: See
amble
G1: See
amble
pretext.
pretext.
¥0.90
¥0.03
0.04
¥0.13
pretext.
pretext.
¥0.23
G1: See preamble text.
¥1.15
G1: See
amble
G1: See
amble
0.23
34068
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS code
description
97140 .......
Manual therapy
1/> regions.
L039B
Physical Therapy Assistant.
NF
97140 .......
Manual therapy
1/> regions.
L039B
Physical Therapy Assistant.
NF
97140 .......
Manual therapy
1/> regions.
L039B
Physical Therapy Assistant.
NF
97140 .......
Manual therapy
1/> regions.
L039B
Physical Therapy Assistant.
NF
97140 .......
Manual therapy
1/> regions.
Manual therapy
1/> regions.
L039B
Manual therapy
1/> regions.
Manual therapy
1/> regions.
Manual therapy
1/> regions.
SB022
97140 .......
Manual therapy
1/> regions.
SM012
97530 .......
Therapeutic activities.
EL003
97530 .......
Therapeutic activities.
EQ219
97530 .......
Therapeutic activities.
EQ267
97530 .......
Therapeutic activities.
Therapeutic activities.
Therapeutic activities.
L023A
Physical Therapy Assistant.
pack, minimum
multi-specialty
visit.
gloves, nonsterile.
lotion, massage,
unscented.
towel, paper
(Bounty) (per
sheet).
disinfectant
spray
(Transeptic).
environmental
module—the
workshop.
rehab and testing system
(BTE primus).
work samples,
small tools
(Valpar 1).
Physical Therapy Aide.
Physical Therapy Aide.
Physical Therapy Aide.
97530 .......
Therapeutic activities.
L023A
Physical Therapy Aide.
NF
97530 .......
Therapeutic activities.
L023A
Physical Therapy Aide.
NF
97530 .......
Therapeutic activities.
L039B
Physical Therapy Assistant.
NF
97140 .......
97140 .......
97140 .......
97140 .......
97530 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
97530 .......
VerDate Sep<11>2014
Input
code
SA048
SK046
SK082
L023A
L023A
00:24 Jul 21, 2017
Jkt 241001
Input code
description
Nonfacility
(NF)/
Facility
(F)
HCPCS
code
PO 00000
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
NF
Other Clinical
Activity—
specify: Conduct phone
calls/call in
prescriptions.
Other Clinical
Activity—
specify: Obtain measurements.
Other Clinical
Activity—
specify: Review/read
documentation, plan of
care, treatment goals.
Check
dressings &
wound/home
care instructions/coordinate office
visits/prescriptions.
Assist therapist
NF
CMS
refinement
(min or qty)
Comment
Direct costs
change
(in dollars)
0
1
G1: See preamble text.
0.39
0
1.5
G1: See preamble text.
0.59
0
1.5
G1: See preamble text.
0.59
1.5
2.5
G1: See preamble text.
0.39
2.5
7.5
0
0.5
pretext.
pretext.
1.95
..........................
G1: See
amble
G1: See
amble
NF
..........................
1
0
..........................
2
0.5
NF
..........................
4
0
pretext.
pretext.
pretext.
¥0.08
NF
G1: See
amble
G1: See
amble
G1: See
amble
NF
..........................
5
0
G1: See preamble text.
¥0.14
NF
..........................
22
12
G1: See preamble text.
¥0.50
NF
..........................
22
4
G1: See preamble text.
¥3.20
NF
..........................
22
12
G1: See preamble text.
¥0.06
NF
Prepare and position patient.
Assist therapist
1
0
0
0
1.5
pretext.
pretext.
pretext.
¥0.23
3.75
G1: See
amble
G1: See
amble
G1: See
amble
0
1
G1: See preamble text.
0.23
1
1.5
G1: See preamble text.
0.12
3.75
7.5
G1: See preamble text.
1.46
NF
NF
Frm 00120
Other Clinical
Activity—
specify:
Verify/Coordinate availability of resources/
equipment.
Other clinical
Activity—
specify: posttreatment assistance.
Prepare room,
equipment,
supplies.
Assist therapist
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
0.57
¥0.24
¥0.03
¥0.86
0.35
34069
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS code
description
97530 .......
Therapeutic activities.
L039B
Physical Therapy Assistant.
NF
97530 .......
Therapeutic activities.
L039B
Physical Therapy Assistant.
NF
97530 .......
Therapeutic activities.
Therapeutic activities.
SB022
97530 .......
Therapeutic activities.
SM012
97533 .......
Sensory integration.
EQ224
97533 .......
Sensory integration.
EQ225
97533 .......
Sensory integration.
Sensory integration.
L023A
gloves, nonsterile.
towel, paper
(Bounty) (per
sheet).
disinfectant
spray
(Transeptic).
sensory integration equip
(eg, ball pit,
glider, trampoline, ramp).
sensory integration equipment, suspension system.
Physical Therapy Aide.
Physical Therapy Aide.
Sensory integration.
Sensory integration.
L023A
Physical Therapy Aide.
Physical Therapy Aide.
NF
Sensory integration.
Sensory integration.
L023A
Physical Therapy Aide.
Physical Therapy Aide.
NF
97533 .......
Sensory integration.
L023A
Physical Therapy Aide.
NF
97533 .......
Sensory integration.
Sensory integration.
Sensory integration.
L039B
Physical Therapy Assistant.
Physical Therapy Assistant.
Physical Therapy Assistant.
NF
97530 .......
97533 .......
97533 .......
97533 .......
97533 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
97533 .......
97533 .......
97533 .......
VerDate Sep<11>2014
Input
code
SK082
L023A
L023A
L023A
L039B
L039B
00:24 Jul 21, 2017
Jkt 241001
Input code
description
Nonfacility
(NF)/
Facility
(F)
HCPCS
code
PO 00000
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
Comment
Direct costs
change
(in dollars)
0
1.5
G1: See preamble text.
0.59
1.5
2.5
G1: See preamble text.
0.39
NF
Other Clinical
Activity—
specify: Review/read
documentation, plan of
care, treatment goals.
Check
dressings &
wound/home
care instructions/coordinate office
visits/prescriptions.
..........................
1
0
NF
..........................
4
0
NF
..........................
5
NF
..........................
NF
NF
NF
NF
NF
NF
NF
Frm 00121
pretext.
pretext.
¥0.08
0
G1: See preamble text.
¥0.14
22
15
G1: See preamble text.
¥0.06
..........................
22
15
G1: See preamble text.
¥0.05
Obtain vital
signs.
Other Clinical
Activity—
specify:
Verify/Coordinate availability of resources/
equipment.
Assist therapist
0
1
0
1.5
0
7.5
Prepare room,
equipment,
supplies.
Prepare and position patient.
Other clinical
Activity—
specify: posttreatment assistance.
Check
dressings &
wound/home
care instructions/coordinate office
visits/prescriptions.
Obtain vital
signs.
Assist therapist
1
1.5
1
0
0
1
0
2.5
1
0
7.5
0
1.5
0
Check
dressings &
wound/home
care instructions/coordinate office
visits/prescriptions.
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
G1: See
amble
G1: See
amble
¥0.03
G1: See
amble
G1: See
amble
pretext.
pretext.
0.23
G1: See
amble
G1: See
amble
pretext.
pretext.
1.73
G1: See
amble
G1: See
amble
pretext.
pretext.
¥0.23
G1: See preamble text.
0.58
G1: See
amble
G1: See
amble
G1: See
amble
pretext.
pretext.
pretext.
0.35
0.12
0.23
¥0.39
¥2.93
¥0.59
34070
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
HCPCS
code
HCPCS code
description
97533 .......
Sensory integration.
L039B
Physical Therapy Assistant.
NF
97533 .......
Sensory integration.
Sensory integration.
SJ053
97533 .......
Sensory integration.
SM012
97535 .......
Self care
mngment
training.
Self care
mngment
training.
Self care
mngment
training.
EL002
swab-pad, alcohol.
towel, paper
(Bounty) (per
sheet).
disinfectant
spray
(Transeptic).
environmental
module—
kitchen.
kit, ADL ............
L023A
Self care
mngment
training.
Self care
mngment
training.
Self care
mngment
training.
97535 .......
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
Comment
Direct costs
change
(in dollars)
0
1.5
NF
Other Clinical
Activity—
specify: Review/read
documentation, plan of
care, treatment goals.
..........................
0
3
NF
..........................
4
0
NF
..........................
5
0
G1: See preamble text.
¥0.14
NF
..........................
22
12
G1: See preamble text.
¥1.15
NF
..........................
22
16
G1: See preamble text.
¥0.01
Physical Therapy Aide.
NF
0
1.5
G1: See preamble text.
0.35
L023A
Physical Therapy Aide.
NF
1
1.5
G1: See preamble text.
0.12
L023A
Physical Therapy Aide.
NF
Other Clinical
Activity—
specify:
Verify/Coordinate availability of resources/
equipment.
Prepare room,
equipment,
supplies.
Prepare and position patient.
1
0
G1: See preamble text.
¥0.23
L023A
Physical Therapy Aide.
NF
0
1
G1: See preamble text.
0.23
Self care
mngment
training.
L039B
Physical Therapy Assistant.
NF
1.5
2.5
G1: See preamble text.
0.39
97535 .......
Self care
mngment
training.
L039B
Physical Therapy Assistant.
NF
0
1.5
G1: See preamble text.
0.59
97535 .......
Self care
mngment
training.
Self care
mngment
training.
Self care
mngment
training.
Self care
mngment
training.
Self care
mngment
training.
Self care
mngment
training.
SB022
gloves, nonsterile.
NF
Other clinical
Activity—
specify: posttreatment assistance.
Check
dressings &
wound/home
care instructions/coordinate office
visits/prescriptions.
Other Clinical
Activity—
specify: Review/read
documentation, plan of
care, treatment goals.
..........................
1
0
G1: See preamble text.
¥0.08
SK009
bath soap (one
bar uou).
NF
..........................
0
0.5
G1: See preamble text.
0.34
SK080
toothbrush ........
NF
..........................
0
1
G1: See preamble text.
0.81
SK081
toothpaste ........
NF
..........................
0
0.25
G1: See preamble text.
0.12
SK082
towel, paper
(Bounty) (per
sheet).
disinfectant
spray
(Transeptic).
NF
..........................
4
0
G1: See preamble text.
¥0.03
NF
..........................
5
0
G1: See preamble text.
¥0.14
97533 .......
97535 .......
97535 .......
97535 .......
97535 .......
97535 .......
97535 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
97535 .......
97535 .......
97535 .......
97535 .......
VerDate Sep<11>2014
SK082
EQ143
SM012
00:24 Jul 21, 2017
Jkt 241001
PO 00000
Frm 00122
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
G1: See preamble text.
0.59
G1: See
amble
G1: See
amble
0.04
pretext.
pretext.
¥0.03
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
34071
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
97535 .......
Self care
mngment
training.
SM013
97537 .......
Community/
work reintegration.
Community/
work reintegration.
Community/
work reintegration.
Community/
work reintegration.
EL001
Input code
description
Nonfacility
(NF)/
Facility
(F)
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
Comment
Direct costs
change
(in dollars)
disinfectant, surface
(Envirocide,
Sanizide).
environmental
module—car.
NF
..........................
0
2
G1: See preamble text.
0.33
NF
..........................
22
8
G1: See preamble text.
¥1.01
EQ147
kit, ergonomic
(office).
NF
..........................
22
8
G1: See preamble text.
¥0.08
L023A
Physical Therapy Aide.
NF
1
1.5
G1: See preamble text.
0.12
L023A
Physical Therapy Aide.
NF
0
1
G1: See preamble text.
0.23
Community/
work reintegration.
Community/
work reintegration.
L023A
Physical Therapy Aide.
NF
Prepare room,
equipment,
supplies.
Other clinical
Activity—
specify: posttreatment assistance.
Prepare and position patient.
1
0
G1: See preamble text.
¥0.23
L023A
Physical Therapy Aide.
NF
0
1.5
G1: See preamble text.
0.35
97537 .......
Community/
work reintegration.
L039B
Physical Therapy Assistant.
NF
1.5
2.5
G1: See preamble text.
0.39
97537 .......
Community/
work reintegration.
L039B
Physical Therapy Assistant.
NF
0
1.5
G1: See preamble text.
0.59
97537 .......
Community/
work reintegration.
Community/
work reintegration.
Community/
work reintegration.
Wheelchair
mngment
training.
Wheelchair
mngment
training.
Wheelchair
mngment
training.
SB022
gloves, nonsterile.
NF
Other Clinical
Activity—
specify:
Verify/Coordinate availability of resources/
equipment.
Check
dressings &
wound/home
care instructions/coordinate office
visits/prescriptions.
Other Clinical
Activity—
specify: Review/read
documentation, plan of
care, treatment goals.
..........................
1
0
G1: See preamble text.
¥0.08
SK082
towel, paper
(Bounty) (per
sheet).
disinfectant
spray
(Transeptic).
environmental
module—
kitchen.
Physical Therapy Aide.
NF
..........................
4
0
G1: See preamble text.
¥0.03
NF
..........................
5
0
G1: See preamble text.
¥0.14
NF
..........................
22
8
G1: See preamble text.
¥1.61
NF
1
1.5
G1: See preamble text.
0.12
L023A
Physical Therapy Aide.
NF
0
1
G1: See preamble text.
0.23
Wheelchair
mngment
training.
Wheelchair
mngment
training.
L023A
Physical Therapy Aide.
NF
Prepare room,
equipment,
supplies.
Other clinical
Activity—
specify: posttreatment assistance.
Prepare and position patient.
1
0
G1: See preamble text.
¥0.23
L023A
Physical Therapy Aide.
NF
3.75
0
G1: See preamble text.
¥0.86
97537 .......
97537 .......
97537 .......
97537 .......
97537 .......
97537 .......
97537 .......
97542 .......
97542 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
97542 .......
97542 .......
97542 .......
VerDate Sep<11>2014
SM012
EL002
L023A
00:24 Jul 21, 2017
Jkt 241001
PO 00000
Frm 00123
Assist therapist
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
34072
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
97542 .......
Wheelchair
mngment
training.
L023A
Physical Therapy Aide.
NF
97542 .......
Wheelchair
mngment
training.
L039B
Physical Therapy Assistant.
NF
97542 .......
Wheelchair
mngment
training.
L039B
Physical Therapy Assistant.
NF
97542 .......
Wheelchair
mngment
training.
Wheelchair
mngment
training.
Wheelchair
mngment
training.
Wheelchair
mngment
training.
Orthotic
mgmt&trainj
1st enc.
Orthotic
mgmt&trainj
1st enc.
Orthotic
mgmt&trainj
1st enc.
Orthotic
mgmt&trainj
1st enc.
L039B
Physical Therapy Assistant.
SB022
SK082
Orthotic
mgmt&trainj
1st enc.
Orthotic
mgmt&trainj
1st enc.
L023A
97760 .......
NF
Other Clinical
Activity—
specify:
Verify/Coordinate availability of resources/
equipment.
Check
dressings &
wound/home
care instructions/coordinate office
visits/prescriptions.
Other Clinical
Activity—
specify: Review/read
documentation, plan of
care, treatment goals.
Assist therapist
gloves, nonsterile.
NF
towel, paper
(Bounty) (per
sheet).
disinfectant
spray
(Transeptic).
cart-workbench,
orthotic, mobile.
table, treatment,
hi-lo.
CMS
refinement
(min or qty)
Comment
Direct costs
change
(in dollars)
0
1.5
G1: See preamble text.
0.35
1.5
2.5
G1: See preamble text.
0.39
0
1.5
G1: See preamble text.
0.59
3.75
7.5
G1: See preamble text.
1.46
..........................
1
0
G1: See preamble text.
¥0.08
NF
..........................
4
0
G1: See preamble text.
¥0.03
NF
..........................
5
0
G1: See preamble text.
¥0.14
NF
..........................
27
10
G1: See preamble text.
¥0.03
NF
..........................
27
10
G1: See preamble text.
¥0.09
rehab and testing system
(BTE primus).
water bath, thermoplastic
softener (20in
x 12in).
Physical Therapy Aide.
NF
..........................
27
5
G1: See preamble text.
¥3.91
NF
..........................
27
10
G1: See preamble text.
¥0.04
NF
Assist therapist
5
0
G1: See preamble text.
¥1.15
L023A
Physical Therapy Aide.
NF
0
1.5
G1: See preamble text.
0.35
Orthotic
mgmt&trainj
1st enc.
L023A
Physical Therapy Aide.
NF
0
1
G1: See preamble text.
0.23
97760 .......
Orthotic
mgmt&trainj
1st enc.
L023A
Physical Therapy Aide.
NF
2
1.5
G1: See preamble text.
¥0.12
97760 .......
Orthotic
mgmt&trainj
1st enc.
L023A
Physical Therapy Aide.
NF
Other Clinical
Activity—
specify:
Verify/Coordinate availability of resources/
equipment.
Other clinical
Activity—
specify: posttreatment assistance.
Greet patient,
provide
gowning, ensure appropriate medical
records are
available.
Clean room/
equipment by
physician staff.
2
1
G1: See preamble text.
¥0.23
97542 .......
97542 .......
97542 .......
97760 .......
97760 .......
97760 .......
97760 .......
97760 .......
97760 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
VerDate Sep<11>2014
SM012
EF005
EF033
EQ219
ER064
00:24 Jul 21, 2017
Jkt 241001
PO 00000
Frm 00124
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
34073
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
97760 .......
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
¥0.12
2
0
G1: See preamble text.
¥0.46
2.5
7.5
G1: See preamble text.
1.95
Obtain vital
signs.
2
1
G1: See preamble text.
¥0.39
0
1.5
G1: See preamble text.
0.59
2
2.5
G1: See preamble text.
0.20
2
0
G1: See preamble text.
¥0.78
NF
Other Clinical
Activity—
specify: Review/read
documentation, plan of
care, treatment goals.
Check
dressings &
wound/home
care instructions/coordinate office
visits/prescriptions.
Conduct phone
calls/call in
prescriptions.
..........................
5
7.5
G1: See preamble text.
1.06
NF
..........................
4
0
G1: See preamble text.
¥0.03
NF
..........................
85
128
G1: See preamble text.
0.56
disinfectant
NF
spray
(Transeptic).
table, mat, hi-lo, NF
6 x 8 platform.
balance board .. NF
..........................
5
0
G1: See preamble text.
¥0.14
..........................
27
5
27
4
parallel bars,
platform
mounted.
stairs, ambulation training.
treadmill ...........
NF
..........................
27
4
pretext.
pretext.
pretext.
¥0.22
..........................
G1: See
amble
G1: See
amble
G1: See
amble
NF
..........................
27
3
..........................
27
3
L023A
Physical Therapy Aide.
NF
2
1.5
Prosthetic trainj
1st enc.
L023A
Physical Therapy Aide.
NF
2
0
G1: See preamble text.
¥0.46
Prosthetic trainj
1st enc.
Prosthetic trainj
1st enc.
L023A
Physical Therapy Aide.
Physical Therapy Aide.
NF
Greet patient,
provide
gowning, ensure appropriate medical
records are
available.
Prepare room,
equipment,
supplies.
Prepare and position patient.
Other Clinical
Activity—
specify:
Verify/Coordinate availability of resources/
equipment.
pretext.
pretext.
pretext.
¥0.04
NF
G1: See
amble
G1: See
amble
G1: See
amble
2
0
¥0.46
0
1.5
G1: See
amble
G1: See
amble
NF
L023A
Physical Therapy Aide.
NF
L039B
Physical Therapy Assistant.
NF
Assist therapist
L039B
Physical Therapy Assistant.
NF
L039B
Physical Therapy Assistant.
NF
97760 .......
Orthotic
mgmt&trainj
1st enc.
L039B
Physical Therapy Assistant.
NF
97760 .......
Orthotic
mgmt&trainj
1st enc.
Orthotic
mgmt&trainj
1st enc.
Orthotic
mgmt&trainj
1st enc.
Orthotic
mgmt&trainj
1st enc.
Orthotic
mgmt&trainj
1st enc.
Prosthetic trainj
1st enc.
Prosthetic trainj
1st enc.
Prosthetic trainj
1st enc.
L039B
Physical Therapy Assistant.
NF
SH035
fluori-methane
(cold spray).
SK082
towel, paper
(Bounty) (per
sheet).
water, distilled ..
Prosthetic trainj
1st enc.
Prosthetic trainj
1st enc.
Prosthetic trainj
1st enc.
EQ231
97761 .......
97761 .......
97760 .......
97760 .......
97760 .......
97760 .......
97760 .......
97761 .......
97761 .......
97761 .......
97761 .......
97761 .......
97761 .......
97761 .......
Direct costs
change
(in dollars)
G1: See preamble text.
Physical Therapy Aide.
97760 .......
Comment
1.5
L023A
97760 .......
CMS
refinement
(min or qty)
2
Orthotic
mgmt&trainj
1st enc.
Orthotic
mgmt&trainj
1st enc.
Orthotic
mgmt&trainj
1st enc.
Orthotic
mgmt&trainj
1st enc.
Orthotic
mgmt&trainj
1st enc.
97760 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
VerDate Sep<11>2014
SK087
SM012
EF028
EQ069
EQ201
EQ243
L023A
00:24 Jul 21, 2017
Jkt 241001
PO 00000
NF
Frm 00125
Prepare room,
equipment,
supplies.
Prepare and position patient.
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
pretext.
pretext.
¥0.03
¥0.09
¥0.32
¥0.12
0.35
34074
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS code
description
97761 .......
Prosthetic trainj
1st enc.
L023A
Physical Therapy Aide.
NF
97761 .......
Prosthetic trainj
1st enc.
Prosthetic trainj
1st enc.
L023A
Physical Therapy Aide.
Physical Therapy Aide.
NF
97761 .......
Prosthetic trainj
1st enc.
L039B
Physical Therapy Assistant.
NF
97761 .......
Prosthetic trainj
1st enc.
Prosthetic trainj
1st enc.
Prosthetic trainj
1st enc.
L039B
Physical Therapy Assistant.
Physical Therapy Assistant.
Physical Therapy Assistant.
NF
97761 .......
Prosthetic trainj
1st enc.
L039B
Physical Therapy Assistant.
NF
97761 .......
Prosthetic trainj
1st enc.
L039B
Physical Therapy Assistant.
NF
97761 .......
Prosthetic trainj
1st enc.
L039B
Physical Therapy Assistant.
NF
97761 .......
Prosthetic trainj
1st enc.
Prosthetic trainj
1st enc.
Prosthetic trainj
1st enc.
Prosthetic trainj
1st enc.
SB026
gown, patient ...
SG027
97761 .......
Prosthetic trainj
1st enc.
SM012
977X1 .......
Orthc/prostc
mgmt sbsq
enc.
Orthc/prostc
mgmt sbsq
enc.
Orthc/prostc
mgmt sbsq
enc.
EF005
Orthc/prostc
mgmt sbsq
enc.
L023A
97761 .......
97761 .......
97761 .......
97761 .......
97761 .......
97761 .......
977X1 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
977X1 .......
977X1 .......
VerDate Sep<11>2014
Input
code
L023A
L039B
L039B
SG058
SK082
EF033
ER064
00:24 Jul 21, 2017
Jkt 241001
Input code
description
Nonfacility
(NF)/
Facility
(F)
HCPCS
code
NF
NF
Other clinical
Activity—
specify: posttreatment assistance.
Assist therapist
CMS
refinement
(min or qty)
Comment
0
G1: See preamble text.
10
Clean room/
equipment by
physician staff.
Other Clinical
Activity—
specify: Obtain measurements.
Obtain vital
signs.
Assist therapist
1
0
2
1
G1: See
amble
G1: See
amble
0
1.5
2
1
5
7.5
0
1.5
0
Direct costs
change
(in dollars)
0.23
pretext.
pretext.
¥2.30
G1: See preamble text.
0.59
¥0.23
pretext.
pretext.
pretext.
¥0.39
1
G1: See preamble text.
0.39
2
0
G1: See preamble text.
¥0.78
G1: See preamble text.
0.20
G1: See
amble
G1: See
amble
G1: See
amble
0.98
2
2.5
NF
Other Clinical
Activity—
specify: Review/read
documentation, plan of
care, treatment goals.
Other Clinical
Activity—
specify: Conduct phone
calls/call in
prescriptions.
Conduct phone
calls/call in
prescriptions.
Check
dressings &
wound/home
care instructions/coordinate office
visits/prescriptions.
..........................
0.75
0
cast, stockinette
4in.
moleskin 9in
width.
towel, paper
(Bounty) (per
sheet).
disinfectant
spray
(Transeptic).
cart-workbench,
orthotic, mobile.
table, treatment,
hi-lo.
NF
..........................
0.3
1
NF
..........................
0.2
0.33
NF
..........................
4
0
NF
..........................
5
0
G1: See preamble text.
¥0.14
NF
..........................
27
10
G1: See preamble text.
¥0.03
NF
..........................
27
16
G1: See preamble text.
¥0.06
water bath, thermoplastic
softener (20in
x 12in).
Physical Therapy Aide.
NF
..........................
27
10
G1: See preamble text.
¥0.04
NF
Other clinical
Activity—
specify: posttreatment assistance.
0
1
G1: See preamble text.
0.23
PO 00000
NF
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
Frm 00126
Fmt 4701
Sfmt 4702
E:\FR\FM\21JYP2.SGM
21JYP2
G1: See
amble
G1: See
amble
G1: See
amble
G1: See
amble
pretext.
pretext.
pretext.
pretext.
0.59
¥0.40
0.32
0.45
¥0.03
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
34075
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
977X1 .......
Orthc/prostc
mgmt sbsq
enc.
L023A
Physical Therapy Aide.
NF
977X1 .......
Orthc/prostc
mgmt sbsq
enc.
Orthc/prostc
mgmt sbsq
enc.
L023A
Physical Therapy Aide.
NF
L023A
Physical Therapy Aide.
NF
Orthc/prostc
mgmt sbsq
enc.
Orthc/prostc
mgmt sbsq
enc.
Orthc/prostc
mgmt sbsq
enc.
Orthc/prostc
mgmt sbsq
enc.
L023A
Physical Therapy Aide.
NF
L023A
Physical Therapy Aide.
NF
L023A
Physical Therapy Aide.
NF
L039B
Physical Therapy Assistant.
NF
Orthc/prostc
mgmt sbsq
enc.
Orthc/prostc
mgmt sbsq
enc.
L039B
Physical Therapy Assistant.
NF
L039B
Physical Therapy Assistant.
NF
Orthc/prostc
mgmt sbsq
enc.
Orthc/prostc
mgmt sbsq
enc.
Orthc/prostc
mgmt sbsq
enc.
Orthc/prostc
mgmt sbsq
enc.
Orthc/prostc
mgmt sbsq
enc.
Orthc/prostc
mgmt sbsq
enc.
Orthc/prostc
mgmt sbsq
enc.
Orthc/prostc
mgmt sbsq
enc.
Orthc/prostc
mgmt sbsq
enc.
Orthc/prostc
mgmt sbsq
enc.
L039B
Physical Therapy Assistant.
SA048
977X1 .......
977X1 .......
977X1 .......
977X1 .......
977X1 .......
977X1 .......
977X1 .......
977X1 .......
977X1 .......
977X1 .......
977X1 .......
977X1 .......
977X1 .......
mstockstill on DSK30JT082PROD with PROPOSALS2
977X1 .......
977X1 .......
977X1 .......
977X1 .......
VerDate Sep<11>2014
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
CMS
refinement
(min or qty)
Comment
Direct costs
change
(in dollars)
Greet patient,
provide
gowning, ensure appropriate medical
records are
available.
Clean room/
equipment by
physician staff.
Other Clinical
Activity—
specify:
Verify/Coordinate availability of resources/
equipment.
Assist therapist
2
1.5
G1: See preamble text.
¥0.12
2
1
G1: See preamble text.
¥0.23
0
1.5
G1: See preamble text.
0.35
5
0
G1: See preamble text.
¥1.15
Prepare room,
equipment,
supplies.
Prepare and position patient.
2
1.5
G1: See preamble text.
¥0.12
2
0
G1: See preamble text.
¥0.46
Other Clinical
Activity—
specify: Review/read
documentation, plan of
care, treatment goals.
Obtain vital
signs.
0
1.5
G1: See preamble text.
0.59
2
1
G1: See preamble text.
¥0.39
2
2.5
G1: See preamble text.
0.20
NF
Check
dressings &
wound/home
care instructions/coordinate office
visits/prescriptions.
Assist therapist
2.5
7.5
G1: See preamble text.
1.95
pack, minimum
multi-specialty
visit.
cast, stockinette
4in.
NF
..........................
0.5
1
G1: See preamble text.
0.57
NF
..........................
0.4
0.5
G1: See preamble text.
0.05
SG058
moleskin 9in
width.
NF
..........................
0.7
1
G1: See preamble text.
1.04
SG060
outrigger line ....
NF
..........................
7
50
G1: See preamble text.
3.91
SG061
outrigger post ...
NF
..........................
3
4
G1: See preamble text.
0.40
SH035
fluori-methane
(cold spray).
NF
..........................
5
7.5
G1: See preamble text.
1.06
SJ047
splint straps 1in
NF
..........................
0.7
1
G1: See preamble text.
0.39
SJ048
splint straps 2in
NF
..........................
1.3
2
G1: See preamble text.
1.07
SK071
rubber bands,
non-sterile.
NF
..........................
4
6
G1: See preamble text.
0.04
SG027
00:24 Jul 21, 2017
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E:\FR\FM\21JYP2.SGM
21JYP2
34076
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 11—CY 2018 PROPOSED CODES WITH DIRECT PE INPUT RECOMMENDATIONS WITH REFINEMENTS—Continued
HCPCS
code
977X1 .......
977X1 .......
977X1 .......
97X11 .......
97X11 .......
97X11 .......
97X11 .......
994X1 .......
994X1 .......
994X2 .......
994X2 .......
994X3 .......
994X3 .......
HCPCS code
description
Input
code
Input code
description
Nonfacility
(NF)/
Facility
(F)
0
G1: See preamble text.
¥0.03
NF
..........................
85
128
G1: See preamble text.
0.56
disinfectant
NF
spray
(Transeptic).
notebook (Dell
NF
Latitute D600).
..........................
5
0
G1: See preamble text.
¥0.14
..........................
60
0
G1: See preamble text.
¥0.52
EF027
table, instrument, mobile.
NF
..........................
60
5
G1: See preamble text.
¥0.08
L023A
Physical Therapy Aide.
NF
0
12
G1: See preamble text.
2.76
SK057
paper, laser
printing (each
sheet).
One Couch and
Two Chairs.
Behavioral
Health Care
Manager.
NF
Assist physician
in performing
procedure.
..........................
10
0
G1: See preamble text.
¥0.05
F
..........................
38
0
¥0.15
F
85
0
EF042
One Couch and
Two Chairs.
F
Other clinical
Activity—
specify:
994X1 and
994X3.
..........................
G1: See
amble
G1: See
amble
27
0
G1: See preamble text.
¥0.11
L057B
Behavioral
Health Care
Manager.
F
60
0
G1: See preamble text.
¥34.20
EF042
One Couch and
Two Chairs.
Behavioral
Health Care
Manager.
F
Other clinical
Activity—
specify:
994X2.
..........................
13.5
0
30
0
G1: See
amble
G1: See
amble
20
0
G1: See preamble text.
¥11.40
20
0
G1: See preamble text.
¥11.40
Sbsq psyc
collab care
mgmt.
Sbsq psyc
collab care
mgmt.
1st/sbsq psyc
collab care.
1st/sbsq psyc
collab care.
SK087
SM012
ED038
EF042
L057B
L057B
F
Behavioral
Health Care
Manager.
F
G0507 .......
Care manage
serv minimum
20.
Behavioral
Health Care
Manager.
F
L057B
TABLE 12—CY 2018 PROPOSED
CODES WITH DIRECT PE INPUT
RECOMMENDATIONS WITHOUT RE-
mstockstill on DSK30JT082PROD with PROPOSALS2
HCPCS
code
Description
Anes upr gi ndsc px nos.
Anes upr gi ndsc px ercp.
Anes lwr intst ndsc nos.
Anes lwr intst scr colsc.
Anes upr lwr gi hdsc px.
Acne surgery.
Muscle-skin graft trunk.
Muscle-skin graft arm.
Muscle-skin graft leg.
Musc myoq/fscq flp h&n pedcl.
Mast simple complete.
Nsl/sins ndsc w/tot ethmdct.
Exploration maxillary sinus.
Endoscopy maxillary sinus.
00:24 Jul 21, 2017
Jkt 241001
Other clinical
Activity—
specify:
994X1 and
994X3.
Other clinical
Activity—
specify:
G0507.
Other clinical
Activity—
specify:
G0507.
TABLE 12—CY 2018 PROPOSED
CODES WITH DIRECT PE INPUT
RECOMMENDATIONS WITHOUT REFINEMENT—Continued
FINEMENT
VerDate Sep<11>2014
Direct costs
change
(in dollars)
4
towel, paper
(Bounty) (per
sheet).
water, distilled ..
Care mgmt svc
L057B
bhvl hlth cond.
....
....
....
....
....
.....
.....
.....
.....
....
.....
.....
.....
.....
Comment
..........................
SK082
99XX5 .......
007X1
007X2
008X1
008X2
008X3
10040
15734
15736
15738
157X2
19303
31255
31256
31267
CMS
refinement
(min or qty)
NF
Orthc/prostc
mgmt sbsq
enc.
Orthc/prostc
mgmt sbsq
enc.
Orthc/prostc
mgmt sbsq
enc.
Ther ivntj w/
focus cog
funcj.
Ther ivntj w/
focus cog
funcj.
Ther ivntj w/
focus cog
funcj.
Ther ivntj w/
focus cog
funcj.
1st psyc collab
care mgmt.
1st psyc collab
care mgmt.
HCPCS
code
RUC
recommendation
or current
value
(min or qty)
Labor activity
(where
applicable)
31276 .....
31287 .....
31288 .....
31600 .....
31601 .....
31603 .....
31610 .....
31646 .....
31XX1 ....
31XX2 ....
31XX3 ....
31XX4 ....
34812 .....
34820 .....
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Frm 00128
Description
Nsl/sins ndsc frnt tiss rmvl.
Nasal/sinus endoscopy surg.
Nasal/sinus endoscopy surg.
Incision of windpipe.
Incision of windpipe.
Incision of windpipe.
Incision of windpipe.
Brnchsc w/ther aspir sbsq.
Nsl/sins ndsc w/artery lig.
Nsl/sins ndsc total.
Nsl/sins ndsc tot w/sphendt.
Nsl/sins ndsc sphn tiss rmvl.
Opn fem art expos.
Opn ilac art expos.
Fmt 4701
Sfmt 4702
pretext.
pretext.
pretext.
pretext.
¥48.45
¥0.05
¥17.10
TABLE 12—CY 2018 PROPOSED
CODES WITH DIRECT PE INPUT
RECOMMENDATIONS WITHOUT REFINEMENT—Continued
HCPCS
code
34833
34834
34X01
34X02
34X03
34X04
34X05
34X06
34X07
34X08
34X09
34X10
34X11
34X12
E:\FR\FM\21JYP2.SGM
.....
.....
....
....
....
....
....
....
....
....
....
....
....
....
21JYP2
Description
Opn ilac art expos cndt crtj.
Opn brach art expos.
Evasc rpr a-ao ndgft.
Evasc rpr a-ao ndgft rpt.
Evasc rpr a-unilac ndgft.
Evasc rpr a-unilac ndgft rpt.
Evac rpr a-biiliac ndgft.
Evasc rpr a-biiliac rpt.
Evasc rpr ilio-iliac ndgft.
Evasc rpr ilio-iliac rpt.
Plmt xtn prosth evasc rpr.
Dlyd plmt xtn prosth 1st vsl.
Dlyd plmt xtn prosth ea addl.
Tcat dlvr enhncd fixj dev.
34077
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 12—CY 2018 PROPOSED
CODES WITH DIRECT PE INPUT
RECOMMENDATIONS WITHOUT REFINEMENT—Continued
HCPCS
code
34X13
34X15
34X19
34X20
36218
364X4
36514
36516
36522
36556
3857X
43107
43112
43117
432X5
432X6
432X7
51798
52601
57240
57250
57260
57265
64418
64553
....
....
....
....
.....
....
.....
.....
.....
.....
....
.....
.....
.....
....
....
....
.....
.....
.....
.....
.....
.....
.....
.....
TABLE 12—CY 2018 PROPOSED
CODES WITH DIRECT PE INPUT
RECOMMENDATIONS WITHOUT REFINEMENT—Continued
HCPCS
code
Description
Perq access & clsr fem art.
Opn fem art expos cndt crtj.
Opn ax/subcla art expos.
Opn ax/subcla art expos cndt.
Place catheter in artery.
Endoven ther chem adhes sbsq.
Apheresis plasma.
Apheresis immunoads slctv.
Photopheresis.
Insert non-tunnel cv cath.
Laps pelvic lymphadec.
Removal of esophagus.
Esphg tot w/thrcm.
Partial removal of esophagus.
Esphg tot w/laps moblj.
Esphg dstl 2⁄3 w/laps moblj.
Esphg tot thrsc moblj.
Us urine capacity measure.
Prostatectomy (turp).
Anterior colporrhaphy.
Repair rectum & vagina.
Cmbn ant pst colprhy.
Cmbn ap colprhy w/ntrcl rpr.
N block inj suprascapular.
Implant neuroelectrodes.
64555
64910
64911
64X91
70490
70491
70492
710X1
710X2
710X3
710X4
71100
71101
71110
71111
73100
73110
73120
73130
73140
74022
740X1
740X2
740X3
76510
.....
.....
.....
....
.....
.....
.....
....
....
....
....
.....
.....
.....
.....
.....
.....
.....
.....
.....
.....
....
....
....
.....
TABLE 12—CY 2018 PROPOSED
CODES WITH DIRECT PE INPUT
RECOMMENDATIONS WITHOUT REFINEMENT—Continued
HCPCS
code
Description
Implant neuroelectrodes.
Nerve repair w/allograft.
Neurorraphy w/vein autograft.
Nrv rpr w/nrv algrft 1st.
Ct soft tissue neck w/o dye.
Ct soft tissue neck w/dye.
Ct sft tsue nck w/o & w/dye.
X-ray exam chest 1 view.
X-ray exam chest 2 views.
X-ray exam chest 3 views.
X-ray exam chest 4+ views.
X-ray exam ribs uni 2 views.
X-ray exam unilat ribs/chest.
X-ray exam ribs bil 3 views.
X-ray exam ribs/chest4/> vws.
X-ray exam of wrist.
X-ray exam of wrist.
X-ray exam of hand.
X-ray exam of hand.
X-ray exam of finger(s).
X-ray exam series abdomen.
X-ray exam abdomen 1 view.
X-ray exam abdomen 2 views.
X-ray exam abdomen 3+ views.
Ophth us b & quant a.
76511 .....
76512 .....
76516 .....
76519 .....
76882 .....
88334 .....
92136 .....
93293 .....
93296 .....
93299 .....
93306 .....
93307 .....
93308 .....
95250 .....
95930 .....
96401 .....
96402 .....
96409 .....
96411 .....
96567 .....
993X1 ....
993X2 ....
99XX3 ....
GXXX1 ...
Description
Ophth us quant a only.
Ophth us b w/non-quant a.
Echo exam of eye.
Echo exam of eye.
Us xtr non-vasc lmtd.
Intraop cyto path consult 2.
Ophthalmic biometry.
Pm phone r-strip device eval.
Pm/icd remote tech serv.
Icm/ilr remote tech serv.
Tte w/doppler complete.
Tte w/o doppler complete.
Tte f-up or lmtd.
Glucose monitoring cont.
Visual ep test cns w/i&r.
Chemo anti-neopl sq/im.
Chemo hormon antineopl sq/im.
Chemo iv push sngl drug.
Chemo iv push addl drug.
Pdt dstr prmlg les skn.
Pt/caregiver trainj home inr.
Anticoag mgmt pt warfarin.
Assmt & care pln pt cog imp.
Cognitive skills development.
TABLE 13—CY 2018 PROPOSED RULE—INVOICES RECEIVED FOR NEW DIRECT PE INPUTS
CMS code
Average price
EQ383 ..........................................................................................................................................
SD322 ..........................................................................................................................................
EQ384 ..........................................................................................................................................
EQ385 ..........................................................................................................................................
SD323 ..........................................................................................................................................
SD324 ..........................................................................................................................................
SA125 ..........................................................................................................................................
SD328 ..........................................................................................................................................
SD325 ..........................................................................................................................................
SA126 ..........................................................................................................................................
EQ386 ..........................................................................................................................................
SA124 ..........................................................................................................................................
SJ092 ...........................................................................................................................................
SJ093 ...........................................................................................................................................
SB054 ..........................................................................................................................................
790.00
25.00
4,760.00
9,034.00
1,495.00
3,195.00
40.00
353.64
39.90
2,850.00
16,146.00
2.35
8.44
0.19
9.99
Estimated
non-facility
allowed
services for
HCPCS codes
using this item
Number of
invoices
1
1
1
1
1
2
2
1
1
3
1
2
209
5
1
39,006
3,435
39,006
39,006
387
1550
1550
41
4
4
4
421,539
9,931,981
9,931,981
387,359
mstockstill on DSK30JT082PROD with PROPOSALS2
TABLE 14—CY 2018 PROPOSED RULE—INVOICES RECEIVED FOR EXISTING DIRECT PE INPUTS
CPT/HCPCS codes
17000, 17003, 17004,
46607, 96567,
96X73, 96X74.
20982, 32998, 50592
VerDate Sep<11>2014
CMS
code
Item name
Current price
Updated price
Percent
change
Estimated
non-facility
allowed
services for
HCPCS codes
using this item
Number of
invoices
LMX 4% anesthetic
cream.
SH092
1.60
0.78
¥51
1
23,584,412
probe, radiofrequency, 3 array
(StarBurstSDE).
SD109
353.64
2233.00
531
1
2,972
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34078
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 14—CY 2018 PROPOSED RULE—INVOICES RECEIVED FOR EXISTING DIRECT PE INPUTS—Continued
CMS
code
Number of
invoices
Item name
30140, 30901, 30903,
30905, 30906,
31231, 31237,
31238, 43197,
43198.
36514 ........................
Atomizer tips (disposable).
SL464
0.00
2.66
........................
1
625,876
tubing set, plasma
exchange.
ACD–A anticoagulant
kit, apheresis treatment.
kit, photopheresis
procedure.
goggles, uv-blocking
SC085
173.33
273.66
58
1
1,237
SJ071
SA072
6.58
140.00
7.10
243.33
8
74
1
1
2,517
22
SA024
858.00
1598.00
86
1
25
SJ027
2.30
4.1
78
1
697,047
Antibody Estrogen
Receptor
monoclonal.
negative control, allergy test.
positive control, allergy test.
sensor, glucose monitoring (interstitial).
glucose continuous
monitoring system.
test strip, INR ...........
SL493
14.00
14.47
3
3
209,384
SH101
5.08
5.17
2
2
10,036,050
SH102
17.28
26.12
51
6
10,036,050
SD114
29.50
53.08
80
19
26,205
EQ125
2465.00
1170.54
¥53
5
26,205
SJ055
21.88
5.66
¥74
2
1,265,540
36522, 96567, 96910,
96912, 96913,
96920, 96921,
96922, 96X73,
96X74.
88360, 88361 ............
95004, 95017, 95018
95004, 95017, 95018
95250 ........................
95250 ........................
mstockstill on DSK30JT082PROD with PROPOSALS2
993X1, G0249 ...........
I. Evaluation & Management (E/M)
Guidelines and Care Management
Services
In recent years, we have sought to
recognize significant changes in health
care practice, especially innovations in
the active management and ongoing care
of chronically ill patients. We have been
engaged in an ongoing incremental
effort to identify gaps in appropriate
coding and payment for care
management/coordination, cognitive
services and primary care within the
PFS. This has included working with
the CPT Editorial Panel (CPT) to
develop and value (or revalue) the
following service codes:
• Transitional care management
(TCM) services (2013).
• Chronic care management services
(CCM) (2015, 2017).
• Behavioral health integration (BHI)
services (2017).
• Assessment/care planning services
for cognitive impairment (2017).
• Prolonged E/M services without
direct patient contact (2017).
In response to public feedback
regarding the initial implementation of
TCM and CCM, in the CY 2017 PFS
final rule (81 FR 80225 through 80256),
we finalized significant administrative
VerDate Sep<11>2014
00:24 Jul 21, 2017
Jkt 241001
Updated price
Percent
change
CPT/HCPCS codes
36514, 36516 ............
none (formerly in deleted code 36515).
36522 ........................
Current price
Estimated
non-facility
allowed
services for
HCPCS codes
using this item
burden reduction for CCM and focused
on limiting as much as possible the
ways in which Medicare’s rules differed
from the CPT guidance that generally
applies for all payers. We also worked
with the CPT Editorial Panel and other
stakeholders to develop coding and
improve payment accuracy for BHI,
cognitive impairment assessment/
management, and prolonged services. In
the CY 2017 PFS final rule (81 FR
80255), we also reiterated our
commitment to addressing disparities
for individuals with disabilities and
advancing health equity, and noted that
we will continue to explore
improvements in payment accuracy for
services furnished to individuals with
disabilities. We look forward to
continued work with stakeholders to
ensure that the coding and valuation of
these services accurately reflects the
resource costs involved in furnishing
these services. We are soliciting public
comments on ways we might further
reduce administrative burden for these
and similar services under the PFS.
1. E/M Guidelines
a. Background
Most physicians and other billing
practitioners bill patient visits to the
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PFS under a relatively generic set of
codes that distinguish level of
complexity, site of care, and in some
cases between new or established
patients. These codes are called
Evaluation and Management (E/M) visit
codes. For example, there are generally
three levels of hospital and nursing
facility inpatient E/M visit codes, and
five levels of office or hospital
outpatient E/M visit codes, that vary
based on complexity. The latter also
distinguish whether or not the patient is
new to the billing practitioner.
Billing practitioners must maintain
information in the medical record to
document that they have reported the
appropriate level of E/M visit code.
CMS maintains guidelines that specify
the kind of information that is required
to support Medicare payment for each
level. According to these documentation
guidelines, there are three key
components to selecting the appropriate
level:
• History of Present Illness (HPI or
History);
• Physical Examination (Exam); and
• Medical Decision Making (MDM).
There are two versions of the
documentation guidelines, commonly
referenced based on the year of their
E:\FR\FM\21JYP2.SGM
21JYP2
mstockstill on DSK30JT082PROD with PROPOSALS2
Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
release (the ‘‘1995’’ and ‘‘1997’’
guidelines), available under downloads
on the CMS Web site at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
PhysicianFeeSched/. The
most substantial differences between the
two sets of guidelines pertain to
requirements for the physical exam. The
two versions have a slight difference in
requirements for documenting the
history, and no difference in
requirements for MDM. In documenting
a given E/M service, practitioners must
use one version of the guidelines or the
other, with one exception related to
extended histories (see the Evaluation
and Management Services guide
available on the CMS Web site at
https://www.cms.gov/Outreach-andEducation/Medicare-Learning-NetworkMLN/MLNProducts/Downloads/evalmgmt-serv-guide-ICN006764.pdf). These
guidelines are very similar to guidelines
within the CPT codebook for E/M visits.
We provide an example of how the
guidelines distinguish between level 2
and level 3 visits in Table 15.
Stakeholders have long maintained
that both the 1995 and 1997 guidelines
are administratively burdensome and
outdated with respect to the practice of
medicine, stating that they are too
complex, ambiguous, and that they fail
to distinguish meaningful differences
among code levels. In general, we agree
that there may be unnecessary burden
with these guidelines and that they are
potentially outdated, and believe this is
especially true for the requirements for
the history and the physical exam. The
guidelines have not been updated to
account for significant changes in
technology, especially electronic health
record (EHR) use, which presents
challenges for data and program
integrity and potential upcoding given
the frequently automated selection of
code level.
While CMS conducts few audits on
E/M visits relative to the volume of PFS
services they comprise, we have
repeatedly heard from practitioners that
compliance with the guidelines is a
source of significant audit vulnerability
and administrative burden. Our prior
attempts to revise the guidelines met
with a lack of stakeholder consensus
and support, which contributed to the
current policy that allows practitioners
to use either the 1995 guidelines or 1997
guidelines, resulting in further
complexity in determining or selecting
the applicable requirements.
b. E/M Guidelines Public Comment
Solicitation
We continue to agree with
stakeholders that the E/M
VerDate Sep<11>2014
00:24 Jul 21, 2017
Jkt 241001
documentation guidelines should be
substantially revised. We believe that a
comprehensive reform of E/M
documentation guidelines would
require a multi-year, collaborative effort
among stakeholders. We believe that
revised guidelines could both reduce
clinical burden and improve
documentation in a way that would be
more effective in clinical workflows and
care coordination. We also think
updated E/M guidelines coupled with
technological advancements in voice
recognition, natural language processing
and user-centered design of EHRs could
improve documentation for patient care
while also meeting requirements for
billing and population health
management. We recognize that
achieving the goal of reduced clinician
burden and improved, meaningful
documentation for patient care will
require both updated E/M guidelines, as
well as changes in technology, clinician
documentation practices and workflow.
We are seeking input from a broad array
of stakeholders, including patient
advocates, on the specific changes we
should undertake to reform the
guidelines, reduce the associated
burden, and better align E/M coding and
documentation with the current practice
of medicine. We are specifically seeking
comment on how we might focus on
initial changes to the guidelines for the
history and physical exam because we
believe documentation for these
elements may be more significantly
outdated, and that differences in MDM
are likely the most important factors in
distinctions between visits of different
levels. We are also specifically seeking
comment on whether it would be
appropriate to remove our
documentation requirements for the
history and physical exam for all E/M
visits at all levels. We believe medical
decision-making and time are the more
significant factors in distinguishing visit
levels, and that the need for extended
histories and exams is being replaced by
population-based screening and
intervention, at least for some
specialties. In addition, an increase in
the utilization of EHRs, and to some
extent, shared health information via
EHRs, may have changed the character
of extended patient histories since the
guidelines were established. As long as
a history and physical exam are
documented and generally consistent
with complexity of MDM, there may no
longer be a need for us to maintain such
detailed specifications for what must be
performed and documented for the
history and physical exam (for example,
which and how many body systems are
involved). We are seeking comment on
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whether clinicians and other
stakeholders believe removing the
documentation requirements for the
history and physical exam would be a
good approach.
While we believe MDM guidelines
may also need to be updated, we believe
in the nearer term it may be possible to
eliminate the current focus on details of
history and physical exam, and allow
MDM and/or time to serve as the key
determinant of E/M visit level. We are
seeking public comment on this
approach. We are also seeking comment
on how such reforms may differentially
affect physicians and practitioners of
different specialties, including primary
care clinicians, and how we could or
should account for such effects as we
examine this issue. We note, however,
that there may still be clinical or legal
reasons for individual practitioners to
document an extended history or
physical exam (for example, where there
are negative findings for certain body
systems in support of differential
diagnosis). We are additionally seeking
comment on whether CMS should leave
it largely to the discretion of individual
practitioners to what degree they should
perform and document the history and
physical exam. We also welcome
comments on specific ideas that
stakeholders may have on how to
update MDM guidelines to foster
appropriate documentation for patient
care commensurate with the level of
patient complexity, while avoiding
burdensome documentation
requirements and/or inappropriate
upcoding.
We note that through letters,
meetings, public comment letters in past
rulemaking cycles, and other avenues,
we have heard from many stakeholders
that the E/M code set itself is outdated
and needs to be revised. For example,
some stakeholders recommend an
extensive research effort to revise and
revalue E/M services, especially
physician work inputs (see 81 FR
46200). In prior rulemaking cycles, we
acknowledged the limitations of the
current E/M code set and agree that the
structure of the underlying code set and
its valuation relative to other PFS
services are also important issues that
we expect to continue to explore,
though we are immediately focused on
revision of the current E/M guidelines
in order to reduce unnecessary
administrative burden.
2. Care Management Public Comment
Solicitation
We continue to be interested in the
ongoing work of the medical community
and other stakeholders to refine the set
of codes used to describe care
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management services. In section II.H.,
we are proposing to adopt CPT codes for
CY 2018 to replace the G-codes we
established for several of the care
management services finalized last year.
We are committed to continued work
further reduce burden on reporting
practitioners for care management
services, including through stronger
alignment between CMS requirements
and CPT guidance for existing and
potential new codes.
with stakeholders on necessary
refinements to the code set, especially
describing the professional work
involved in caring for complex patients
in other clinical contexts. We are
seeking comment on ways we might
TABLE 15—KEY COMPONENT DOCUMENTATION REQUIREMENTS FOR LEVEL 2 VS 3 EVALUATION & MANAGEMENT (E/M)
VISIT
Key component †
Level 2 (1995)
Level 3 (1995)
Level 2 (1997)
History (History of Present
Illness or HPI).
Review of Systems (ROS)
n/a.
No change from 1995 .......
No change from 1995.
Physical Examination
(Exam).
A limited examination of
the affected body area
or organ system.
Problem Pertinent ROS:
inquires about the system directly related to
the problem(s) identified
in the HPI.
A limited examination of
the affected body area
or organ system and
other symptomatic or related organ system(s).
General multi-system
exam: Performance and
documentation of one to
five elements in one or
more organ system(s) or
body area(s).
Single organ system
exam: Performance and
documentation of one to
five elements.
General multi-system
exam: Performance and
documentation of at
least six elements in one
or more organ system(s)
or body area(s).
Single organ system
exam: Performance and
documentation of at
least six elements.
Medical Decision Making
(MDM)
Straightforward:
1. Minimal
2. Minimal or no data
review
3. Minimal risk
Low complexity:
1. Limited
2. Limited data review
3. Low risk
Level 3 (1997)
No change from 1995.
Measured by: *
1. Problem—Number
of diagnoses/treatment options
2. Data—Amount and/
or complexity of
data to be reviewed
3. Risk—Risk of complications and/or
morbidity or mortality
* Two of three met or exceeded.
† For certain settings and patient types, each of these three key components must be met or exceeded (for example, new patients; initial hospital visits). For others, only two of the three key components must be met or exceeded (for example, established patients, subsequent hospital
or other visits).
III. Other Provisions of the Proposed
Rule
A. New Care Coordination Services and
Payment for Rural Health Clinics
(RHCs) and Federally-Qualified Health
Centers (FQHCs)
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1. Overview
We have been engaged in a multi-year
examination of coordinated and
collaborative care services in
professional settings, and as a result
established codes and separate payment
in the Physician Fee Schedule (PFS) to
separately recognize and pay for these
important services. As part of this
initiative, the CY 2016 PFS proposed
rule (80 FR 41708) solicited public
comments on (1) improving payment for
the professional work of care
management services; (2) establishing
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separate payment for collaborative care,
particularly inter-professional
consultation between primary care
physicians, psychiatrists, and other
practitioners; and (3) assessing whether
current PFS payment for Chronic Care
Management (CCM) services is adequate
and whether the administrative burden
associated with furnishing and billing
these services should be reduced.
As a result of the comments we
received in response to our request, we
established in the PFS separate payment
for complex CCM services, and
temporary codes to make separate
payment for general behavioral health
integration (BHI) services and a
psychiatric collaborative care model
(CoCM). We established four G codes to
describe BHI and psychiatric CoCM
services and stated that we would
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consider whether to adopt and establish
values for any associated new CPT
codes being developed under our
standard process once those codes are
active. The separate payment for
complex CCM services, general BHI, and
psychiatric CoCM services were
finalized in the CY 2017 PFS final rule
(81 FR 80225) beginning January 1,
2017, for practitioners billing under the
PFS. Based on these payments and
codes, we are proposing revisions to the
CCM payment for RHCs and FQHCs,
and proposing requirements and
payment for general BHI and psychiatric
CoCM services furnished in RHCs and
FQHCs, beginning on January 1, 2018.
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2. Background
a. RHC and FQHC Payment
Methodologies
RHC and FQHC visits are face-to-face
encounters between a patient and one or
more RHC or FQHC practitioners during
which time one or more RHC or FQHC
qualifying services are furnished. RHC
and FQHC practitioners are physicians,
nurse practitioners (NPs), physician
assistants (PA), certified nurse
midwives (CNMs), clinical
psychologists, and clinical social
workers, and under certain conditions,
a registered nurse or licensed practical
nurse furnishing care to a homebound
RHC or FQHC patient. A Transitional
Care Management (TCM) service can
also be an RHC or FQHC visit, and a
Diabetes Self-Management Training
(DSMT) service or a Medical Nutrition
Therapy (MNT) service furnished by a
certified DSMT or MNT provider may
also be an FQHC visit. Only medicallynecessary medical, mental health, or
qualified preventive health services that
require the skill level of an RHC or
FQHC practitioner are RHC or FQHC
billable visits. Services furnished by
auxiliary personnel (for example,
nurses, medical assistants, or other
clinical personnel acting under the
supervision of the RHC or FQHC
practitioner) are considered incident to
the visit and are included in the pervisit payment.
RHCs are paid an all-inclusive rate
(AIR) for medically necessary medical
and mental health services and qualified
preventive health services furnished on
the same day (with some exceptions). In
general, the A/B Medicare
Administrative Contractor (MAC)
calculates the AIR for each RHC by
dividing total allowable costs by the
total number of visits for all patients.
Productivity, payment limits, and other
factors are also considered in the
calculation. Allowable costs must be
reasonable and necessary and may
include practitioner compensation,
overhead, equipment, space, supplies,
personnel, and other costs incident to
the delivery of RHC services. The AIR
is subject to a payment limit, except for
certain provider-based RHCs that have
an exception to the payment limit.
FQHCs were paid under the same AIR
methodology until October 1, 2014,
when, in accordance with section
1834(o) of the Act (as added by section
10501(i)(3) of the Affordable Care Act),
they began to transition to an FQHC PPS
system in which they are paid based on
the lesser of the FQHC PPS rate or their
actual charges. The FQHC PPS rate is
adjusted for geographic differences in
the cost of services by the FQHC PPS
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geographic adjustment factor (GAF). The
rate is increased by 34 percent when an
FQHC furnishes care to a patient that is
new to the FQHC, or to a beneficiary
receiving an Initial Preventive Physical
Examination (IPPE) or has an Annual
Wellness Visit (AWV).
Both the RHC AIR and FQHC PPS
payment rates were designed to reflect
the cost of all services and supplies that
an RHC or FQHC furnishes to a patient
in a single day. The rates are not
adjusted for the complexity of the
patient health care needs, the length of
the visit, or the number or type of
practitioners involved in the patient’s
care.
b. Current CCM Requirements and
Payment for RHCs and FQHCs
In the CY 2016 PFS final rule with
comment period (80 FR 71080), 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. The requirement that
RHC or FQHC services be furnished
face-to-face was waived for CCM
services.
In the CY 2017 PFS final rule (81 FR
80256), we finalized revisions to the
CCM requirements for RHCs and
FQHCs. Specifically, we revised
§ 405.2413(a)(5) and § 405.2415(a)(5) to
state that services and supplies
furnished incident to CCM and TCM
services can be furnished under general
supervision of an RHC or FQHC
practitioner, 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.
We also revised requirements pertaining
to the provision of CCM services,
consistent with the same revisions for
practitioners billing under the PFS to
reduce the burden of furnishing these
services and promote beneficiary access
to these services. These revisions were
effective beginning on January 1, 2017,
and included:
• Revising the requirement that CCM
be initiated during a comprehensive
evaluation and management (E/M),
AWV, or IPPE visit, to require a
separately billable initiating visit only
for new patients or patients that have
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34081
not had an E/M, AWV, or IPPE visit
within the previous year;
• Revising the requirement that CCM
services be available 24/7 with an RHC
or FQHC practitioner who has access to
the patient’s electronic care plan, to
allow 24/7 access to auxiliary personnel
with a means to make contact with an
RHC or FQHC practitioner;
• Removing the restriction on faxing
information, and no longer requiring
that care plan information be available
on a 24/7 basis;
• Removing the requirement that
clinical summaries must be formatted
according to certified EHR technology,
and instead requiring that the RHC or
FQHC create, exchange, and transmit
continuity of care document(s) in a
timely manner with other practitioners
and providers;
• Removing the description of the
format of the care plan that is given to
the patient or caregiver; and
• Revising the requirement that RHCs
and FQHCs obtain a written agreement
that the elements of CCM were
discussed, to allowing this information
to be documented in the medical record.
In the CY 2017 PFS final rule, we
stated that although CCM is typically
associated with primary care conditions,
patient eligibility is determined by the
RHC or FQHC practitioner, and mental
health conditions are not excluded. We
invited comments on whether an
additional code specifically for mental
health conditions is necessary for RHCs
and FQHCs that want to include
beneficiaries with mental health
conditions in their CCM services. We
received a few comments regarding
mental health services in RHCs and
FQHCs and appreciate the information
that was provided.
The CCM payment rate for RHCs and
FQHCs is set annually based on the PFS
national non-facility payment rate, and
is paid when CPT code 99490 is billed
alone or with other payable services on
an RHC or FQHC claim. The 2017 rate
for RHCs and FQHCs is $42.71 for 20
minutes or more of CCM services. This
is the only RHC and FQHC service that
is paid in this manner, and RHCs and
FQHCs are not currently authorized to
be paid for any other CCM or other care
management codes. Also, RHCs and
FQHCs cannot bill for CCM services for
a beneficiary during the same service
period as billing for TCM or any other
program that provides additional
payment for care management services
(outside of the RHC AIR or FQHC PPS
payment) for the same beneficiary.
Additional information on CCM
requirements is available on the CMS
Care Management Web page at https://
www.cms.gov/Medicare/Medicare-Fee-
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for-Service-Payment/
PhysicianFeeSched/CareManagement.html and on the CMS RHC
and FQHC Web pages at https://
www.cms.gov/Center/Provider-Type/
Rural-Health-Clinics-Center.html and
https://www.cms.gov/Center/ProviderType/Federally-Qualified-HealthCenters-FQHC-Center.html.
c. Payment for Care Management Codes
under the PFS
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CCM Services (CPT Code 99487 and
CPT Code 99489)
As we stated in the CY 2017 PFS final
rule (81 FR 80244), the initial claims
data for CCM services billed under the
PFS showed that although utilization
was increasing steadily, use of CPT code
99490 was still relatively low, and
interviews with practitioners indicated
that many believed that they were
exceeding the 20-minute time threshold
for billing this code. To pay as
accurately as possible and to encourage
access to CCM services, the CY 2017
PFS final rule established separate
payment for two additional CCM codes,
CPT code 99487 and CPT code 99489,
effective beginning on January 1, 2017,
for practitioners billing under the PFS.
These codes are for complex CCM
services that reflect additional clinical
staff time, more extensive care planning,
and higher complexity of the patient.
CPT code 99487 is for complex CCM
services. It requires multiple (two or
more) chronic conditions expected to
last at least 12 months, or until the
death of the patient; chronic conditions
that 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; and 60 minutes of clinical staff
time directed by a physician or other
qualified health care professional, per
calendar month.
CPT code 99489 is for each additional
30 minutes of clinical staff time directed
by a physician or other qualified health
care professional, per calendar month.
Practitioners paid under the PFS can
bill either complex (CPT code 99487
and CPT code 99489) or non-complex
(CPT code 99490) CCM services during
a given service period, and can submit
only one professional claim for CCM
services for that service period.
General BHI Services (HCPCS Code
G0507)
The types of chronic conditions that
are eligible for CCM services are not
specified and could include chronic
mental health or behavioral health
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conditions or chronic cognitive
disorders as long as the CCM
requirements are met. However, because
not all behavioral health issues fit into
the CCM model, and Medicare
beneficiaries with behavioral health
conditions often require extensive care
management discussions, informationsharing, and planning between a
primary care practitioner and a
behavioral health specialist, the CY
2017 PFS final rule established HCPCS
code G0507 for 20 minutes or more of
general BHI services. Payment for this
code was effective beginning on January
1, 2017, for practitioners billing under
the PFS.
BHI is a team-based, collaborative
approach to care that focuses on
integrative treatment of patients with
primary care and mental or behavioral
health conditions. As finalized in the
CY 2017 PFS final rule, requirements for
this code include an initial assessment
or follow-up monitoring (including the
use of applicable validated rating
scales); behavioral health care planning
in relation to behavioral/psychiatric
health problems (including revision for
patients who are not progressing or
whose status changes); facilitating and
coordinating treatment such as
psychotherapy, pharmacotherapy,
counseling and/or psychiatric
consultation; and continuity of care
with a designated member of the care
team.
Psychiatric CoCM Services (HCPCS
codes G0502, G0503, and G0504)
Psychiatric CoCM is a specific model
of care provided by a primary care team
consisting of a primary care provider
and a health care manager who works in
collaboration with a psychiatric
consultant. As finalized in the CY 2017
PFS final rule, we provide Medicare
payment for psychiatric CoCM services
to practitioners billing under the PFS
when these services are directed by a
treating physician or other qualified
health care professional. We also
finalized that the treating physician or
other qualified health care professional
directs the behavioral health care
manager, who must be an individual
with formal education or specialized
training in behavioral health, including
social work, nursing, or psychology,
working under the oversight and
direction of the physician or qualified
health care professional. We finalized
that a psychiatric consultant must be a
medical professional trained in
psychiatry and qualified to prescribe the
full range of medications. Finally,
psychiatric CoCM services may be
furnished to beneficiaries with any
psychiatric or behavioral health
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condition(s) and may include substance
use disorders. The three psychiatric
CoCM codes established in the CY 2017
PFS final rule were G0502, G0503, and
G0504.
HCPCS code G0502 is for 70 minutes
or more of initial psychiatric CoCM
services 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. Required
elements include: outreach to and
treatment of a patient as 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 of the patient
into a registry and tracking patient
follow-up and progress using the
registry (with appropriate
documentation), 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.
HCPCS code G0503 is for 60 minutes
of subsequent psychiatric CoCM
services in a subsequent month and
includes: 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.
HCPCS code G0504 is for each
additional 30 minutes of initial or
subsequent psychiatric CoCM services
in a calendar month.
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3. Proposed Care Management
Requirements and Payment for RHCs
and FQHCs
To ensure that RHC and FQHC
patients have access to new care
management services in a manner
consistent with the RHC and FQHC per
diem payment methodologies, we are
proposing the establishment of two new
G codes for use by RHCs and FQHCs.
The first new G code, GCCC1, would be
a General Care Management code for
RHCs and FQHCs, with the payment
amount set at the average of the national
non-facility PFS payment rates for CCM
codes 99490 and 99487 and general BHI
code G0507. The second new G code for
RHCs and FQHCs, GCCC2, would be a
Psychiatric CoCM code,with the
payment amount set at the average of
the national non-facility PFS payment
rates for psychiatric CoCM codes G0502
and G0503. The following is a detailed
discussion of our proposal, as well as
alternatives that we considered.
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a. Proposed Establishment of a General
Care Management Code for RHCs and
FQHCs
The RHC AIR and the FQHC PPS rate,
which include all costs associated with
an RHC or FQHC visit, are based on the
RHC’s and FQHC’s costs. Although
many RHCs and FQHCs have always
provided some coordination of care
within and outside their facilities, the
type of structured care management
services that are now billable under the
PFS are generally not included in the
RHC AIR or the FQHC PPS rate. Because
CCM services are not required to be
face-to-face encounters, and do not
require the skill level of an RHC or
FQHC practitioner, they do not meet the
requirements for an RHC or FQHC
billable visit. In addition, RHC and
FQHC services cannot be separately
billed to the PFS. Therefore, in the CY
2016 PFS final rule with comment
period, we established payment for
CCM services at the PFS national nonfacility rate when CPT code 99490 is
billed alone or with other payable
services on an RHC or FQHC claim to
pay for the costs of CCM services that
are not already captured in the RHC AIR
or the FQHC PPS payment.
When CCM services were first
established for RHCs and FQHCs, CPT
code 99490 was the only CCM code that
was billable under the PFS. Now that
there are additional codes for more
complex CCM services and for general
BHI and psychiatric CoCM services, we
believe it is necessary to revise our
payment approach for payment of care
management services.
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RHCs and FQHCs are paid per-visit
rates that are not adjusted based on the
complexity of a service or the time spent
furnishing services, and the payment
rate is not designed to be equal to the
payment under the PFS for a specific
service. We sought to develop a
methodology for payment of care
management services that is consistent
with the RHC and FQHC payment
principles of bundling services and not
paying for services based on time
increments. We also sought to develop
a methodology that would support the
provision of care management services
without creating additional reporting
burdens, while promoting beneficiary
access to comprehensive CCM and BHI
services furnished by RHCs and FQHCs.
Therefore, effective for services
furnished on or after January 1, 2018,
we are proposing to create General Care
Management code GCCC1 for RHCs and
FQHCs, with the payment amount set at
the average of the 3 national non-facility
PFS payment rates for the CCM and
general BHI codes and updated annually
based on the PFS amounts. The 3 codes
are:
• CPT 99490—20 minutes or more of
CCM services
• CPT 99487—at least 60 minutes of
complex CCM services
• HCPCS G0507—20 minutes or more
of BHI services
RHCs and FQHCs could bill the new
General Care Management code when
the requirements for any of these 3
codes (CPT codes 99490, 99487, or
HCPCS code G0507) are met. The
General Care Management code would
be billed alone or in addition to other
services furnished during the RHC or
FQHC visit. This code could only be
billed once per month per beneficiary,
and could not be billed if other care
management services (such as TCM or
home health care supervision) are billed
for the same time period. We note that
CPT 99489 is an add-on code when CPT
99487 is furnished, and is therefore not
included as RHCs and FQHCs are not
paid for additional time once the
minimum requirements have been met.
As previously noted, the program
requirements for RHCs and FQHCs
furnishing CCM services were
established in the CY 2016 PFS final
rule with comment period (80 FR
71080) and revised in the CY 2017 PFS
final rule (81 FR 80256). We are not
proposing any changes to these
requirements at this time.
BHI refers to care management
services that integrate behavioral health
services with primary care and other
clinical services. To bill for this service
using the proposed General Care
Management Code for RHCs and
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34083
FQHCs, 20 minutes or more of clinical
staff time, directed by an RHC or FQHC
practitioner, must be furnished per
calendar month. We are proposing the
following requirements for RHCs and
FQHCs furnishing BHI services:
• Initiating Visit: An E/M, AWV, or
IPPE visit with an RHC or FQHC
primary care practitioner (physician,
NP, PA, or CNM) occurring no more
than one-year prior to commencing BHI
services. This could be the same
initiating visit that is used for initiating
CCM services, and would be billed
separately as an RHC or FQHC visit (if
the RHC or FQHC has not already billed
for this visit).
• Beneficiary Consent:
Documentation in the medical record
that the beneficiary has consented to
receive BHI services, given permission
to consult with relevant specialists as
needed, and been informed that there
may be beneficiary cost-sharing,
including deductible and coinsurance
amounts as applicable, for both inperson and non-face-to-face services
that are provided. The beneficiary
consent process would also include
informing the patient that only one
practitioner/facility can furnish and be
paid for these services during a calendar
month, and that the patient can stop
care coordination services at any time
(effective at the end of the calendar
month). This could be obtained at the
same time that beneficiary consent is
obtained for CCM services.
• Billing Requirements: At least 20
minutes of care management services
per calendar month, furnished under
the direction of the RHC or FQHC
primary care physician, NP, PA, or
CNM, and furnished by an RHC or
FQHC practitioner, or by clinical
personnel under general supervision.
These are the same billing requirements
as for CCM services. If both CCM and
BHI services are furnished in the same
month, the time would be combined
and billed as one under the new care
coordination code.
• Patient Eligibility: One or more new
or pre-existing behavioral health or
psychiatric conditions being treated by
the RHC or FQHC primary care
practitioner, including substance use
disorders, that, in the clinical judgment
of the RHC or FQHC primary care
practitioner, warrants BHI services.
• Required Service Elements: An
initial assessment or follow-up
monitoring, including the use of
applicable validated rating scales;
behavioral health care planning in
relation to behavioral/psychiatric health
problems, including revision for
patients who are not progressing or
whose status changes; facilitating and
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coordinating treatment such as
psychotherapy, pharmacotherapy,
counseling and/or psychiatric
consultation; and continuity of care
with a designated member of the care
team.
Both CCM and general BHI services
are intended to provide a structured and
coordinated approach to care
management that is not typically
included in the RHC’s AIR or the FQHC
PPS payment methodology. Care
management services are directed by the
RHC or FQHC primary care practitioner,
who remains involved through ongoing
oversight, management, collaboration
and reassessment, while care
management services are typically
furnished in a non-face-to-face setting
primarily by a non-RHC or FQHC
practitioner working under general
supervision requirements. Time spent
by administrative or clerical staff cannot
be counted towards the time required to
bill these services.
Table 16 compares the requirements
for CCM and general BHI services. We
believe that even though there are some
differences in the requirements of CCM
and general BHI, bundling them
together will help to promote integrated
care management services for Medicare
beneficiaries who have either or both
primary care and behavioral health
needs. It will also result in the least
amount of reporting burden for RHCs
and FQHCs because once the 20-minute
threshold is met for either CCM or
general BHI, reporting and tracking of
additional time increments is not
required.
If this policy had been adopted for CY
2017, the payment amount for General
Care Management for RHCs and FQHCs
would have been approximately $61
(CPT 99490 at $42.71, + CPT 99487 at
$93.67, + G0507 at $47.73 = $184.11/3
= $61.37). This is more than is the CY
2017 PFS national non-facility rates for
CPT code 99490 and HCPCS code
G0507, and less than the PFS national
non-facility rate for CPT code 99487. We
believe that this bundling methodology
is consistent with the RHC and FQHC
payment methodology of averaging costs
to determine a payment rate rather than
paying for each individual service.
TABLE 16—COMPARISON OF PROPOSED CCM AND GENERAL BHI REQUIREMENTS FOR RHCS AND FQHCS
Requirements
CCM (CPT codes 99490 and 99487)
Initiating Visit ........................
An E/M, AWV, or IPPE visit occurring no more than
one-year prior to commencing care coordination services.
Furnished by a primary care physician, NP, PA, or
CNM.
Billed as an RHC/FQHC visit ..........................................
Obtained during or after initiating visit and before provision of care coordination services by RHC or FQHC
practitioner or clinical staff.
Written or verbal, documented in the medical record ....
Includes information: .......................................................
• On the availability of care coordination services and
applicable cost-sharing;
• That only one practitioner can furnish and be paid for
care coordination services during a calendar month;
• That the patient has right to stop care coordination
services at any time (effective at the end of the calendar month); and
• That the patient has given permission to consult with
relevant specialists.
At least 20 minutes of care coordination services per
calendar month that is:
• Furnished under the direction of the RHC or FQHC
primary care physician, NP, PA, or CNM; and
• Furnished by an RHC or FQHC practitioner, or by
clinical personnel under general supervision.
Multiple (two or more) chronic conditions expected to
last at least 12 months, or until the death of the patient, and place the patient at significant risk of death,
acute exacerbation/decompensation, or functional decline.
Beneficiary Consent .............
Billing Requirements ............
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Patient Eligibility ...................
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General BHI (proposed) (HCPCS code G0507)
Same.
Same.
Same.
Same.
Same.
Same.
Same.
Any behavioral health or psychiatric condition being
treated by the RHC or FQHC primary care practitioner, including substance use disorders, that, in the
clinical judgment of the RHC or FQHC practitioner,
warrants BHI services.
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34085
TABLE 16—COMPARISON OF PROPOSED CCM AND GENERAL BHI REQUIREMENTS FOR RHCS AND FQHCS—Continued
Requirements
Requirement Service Elements.
mstockstill on DSK30JT082PROD with PROPOSALS2
CY 2017 PFS Non-Facility
Payment.
RHC/FQHC Payment for
new General Care Management G code.
CCM (CPT codes 99490 and 99487)
General BHI (proposed) (HCPCS code G0507)
Includes:
• Structured recording of patient health information
using Certified EHR Technology and includes demographics, problems, medications, and medication allergies that inform the care plan, care coordination,
and ongoing clinical care;
• 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, and continuity of care with a designated
member of the care team with whom the patient is
able to schedule successive routine appointments;
• Comprehensive care management including systematic assessment of the patient’s medical, functional,
and psychosocial needs; system-based approaches
to ensure timely receipt of all recommended preventive care services; medication reconciliation with review of adherence and potential interactions; and
oversight of patient self-management of medications;
• Comprehensive care plan including the creation, revision, and/or monitoring of an electronic 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 with particular
focus on the chronic conditions being managed;
• Care plan information made available electronically
(including fax) in a timely manner within and outside
the RHC or FQHC as appropriate and a copy of the
plan of care given to the patient and/or caregiver;
• 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; timely creation and exchange/transmit
continuity of care document(s) with other practitioners
and providers;
• Coordination with home- and community-based clinical service providers, and documentation of communication to and from home- and community-based
providers regarding the patient’s psychosocial needs
and functional deficits in the patient’s medical record;
and
• Enhanced opportunities for the patient and any caregiver to communicate with the practitioner regarding
the patient’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.
CPT 99490—$42.71 .......................................................
CPT 99487—$93.67 .......................................................
Current: $42.71 ...............................................................
Proposed: Average of CPT codes 99490, 99487 and
G0507 (If using the 2017 payment amounts, this
would be $61.37).
Includes:
• Initial assessment or follow-up monitoring, including
the use of applicable validated rating scales;
• Behavioral health care planning in relation to behavioral/psychiatric health problems, including revision
for patients who are not progressing or whose status
changes;
• Facilitating and coordinating treatment (such as psychotherapy, pharmacotherapy, counseling and/or
psychiatric consultation); and
• Continuity of care with a designated member of the
care team.
We expect that utilization of care
coordination services will continue to
increase as more health care practices,
including RHCs and FQHCs, implement
these services. Because the separate
payments for the complex CCM codes
have only been implemented this year
for practitioners billing under the PFS,
we do not have adequate data to
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G0507—$47.73.
Current: N/A
Proposed: Average of CPT codes 99490, 99487 and
G0507 (If using the 2017 payment amounts, this
would be $61.37).
determine the frequency of billing for
CCM codes CPT codes 99487 by
practitioners billing under the PFS
compared with CPT code 99490.
Although billing practices may vary
between physician offices and RHCs
and FQHCs (and within and between
RHCs and FQHCs), we believe that
utilization patterns under the PFS can
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provide a reasonable proxy for
utilization practices in RHCs and
FQHCs of care coordination utilization.
If the PFS data starts to show definitive
trends in billing certain CCM and BHI
codes, or if data becomes available that
provides information on the extent of
these services in RHCs and FQHCs, we
may consider using a weighted average
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in determining the payment rate in the
future. Similarly, if the proposal to
create a new care management code for
RHCs and FQHCs is finalized, and any
additional care management codes
become available on the PFS, we would
review the new codes to determine if
they should also be factored into the
RHC and FQHC General Care
Management Code. Any changes would
be undertaken through future
rulemaking.
mstockstill on DSK30JT082PROD with PROPOSALS2
b. Proposed Establishment of a
Psychiatric CoCM Code for RHCs and
FQHCs
Psychiatric CoCM is a defined model
of care that integrates primary health
care services with care management
support for patients receiving behavioral
health treatment, and includes regular
psychiatric inter-specialty consultation
with the primary care team, particularly
regarding patients whose conditions are
not improving. We recognize that the
requirements of this model may be
challenging for some RHCs and FQHCs,
especially those who have difficulty
maintaining adequate primary care and
mental health staffing in rural and or
underserved areas. For those RHCs and
FQHCs that choose to offer these
services, we believe this model may be
particularly helpful, especially for
patients with primary care and mental
health conditions who have not
benefited from standard treatment.
Effective for services furnished on or
after January 1, 2018, we are proposing
to create a psychiatric CoCM code for
RHCs and FQHCs, GCCC2, with the
payment amount set at the average of
the 2 national non-facility PFS payment
rates for CoCM codes, to be updated
annually based on the PFS amounts.
The 2 codes are:
• G0502—70 minutes or more of
initial psychiatric CoCM services
• G0503—60 minutes or more of
subsequent psychiatric CoCM services
RHCs and FQHCs could bill the new
psychiatric CoCM code when the
requirements for any of these 2 codes
(G0502 or G0503) are met. The
psychiatric CoCM code would be billed
alone or in addition to other services
furnished during the RHC or FQHC
visit. To prevent duplication of
payment, this code could only be billed
once per month per beneficiary, and
could not be billed if other care
management services, including the
proposed General Care Management
code, are billed for the same time
period. We note that G0504 is an addon code when G0503 is furnished and
is therefore not included as RHCs and
FQHCs are not paid for additional time
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once the minimum requirements have
been met.
If this policy had been adopted for CY
2017, the payment amount for
psychiatric CoCM for RHCs and FQHCs
would have been approximately $134.58
(G0502 at $142.84 + G0503 at $126.33
= $269.17/2 = $134.58).
All care management services,
including psychiatric CoCM, require a
separately billable initiating visit (E/M,
AWV, or IPPE) for new patients or
beneficiaries not seen within 1 year
prior to commencement of care
management services. Prior to
commencement of psychiatric CoCM
services, the beneficiary must provide
consent for this service, including
permission to consult with a psychiatric
consultant and relevant specialists.
Advance consent must also include
information on cost sharing for both
face-to-face and non-face-to-face
services, and acceptance of these
requirements must be documented in
the medical record.
Patients with mental health,
behavioral health, or psychiatric
conditions, including substance use
disorders, who are being treated by an
RHC or FQHC practitioner, may be
eligible for psychiatric CoCM services,
as determined by the RHC or FQHC
practitioner. Psychiatric CoCM services,
like CCM and general BHI services, are
intended to provide a structured and
coordinated approach to care
management that is not typically
included in the RHC’s AIR or the FQHC
PPS payment methodology.
The psychiatric CoCM team must
include the RHC or FQHC practitioner,
a behavioral health manager, and a
psychiatric consultant. Proposed
specific requirements of the psychiatric
CoCM team are as follows:
Psychiatric CoCM Team—RHC or FQHC
Practitioner
For psychiatric CoCM, the RHC or
FQHC practitioner may be a primary
care physician, NP, PA, or CNM. The
psychiatric CoCM requirements of the
RHC or FQHC practitioner are to:
• Direct the behavioral health care
manager and any other clinical staff;
• Oversee the beneficiary’s care,
including prescribing medications,
providing treatments for medical
conditions, and making referrals to
specialty care when needed; and
• Remain involved through ongoing
oversight, management, collaboration
and reassessment.
Psychiatric CoCM Team—Behavioral
Health Care Manager
For psychiatric CoCM, the behavioral
health care manager is a designated
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individual with formal education or
specialized training in behavioral health
such as social work, nursing, or
psychology. A behavioral health care
manager in an RHC or FQHC would be
expected to have a minimum of a
bachelor’s degree in a behavioral health
field (such as in clinical social work or
psychology), or be a clinician with
behavioral health training, including
RNs and LPNs. The behavioral health
care manager furnishes both face-to-face
and non-face-to-face services under the
general supervision of the RHC or FQHC
practitioner and may be employed by or
working under contract to the RHC or
FQHC. The psychiatric CoCM
requirements of the behavioral health
care manager are:
• Providing assessment and care
management services, including the
administration of validated rating
scales; behavioral health care planning
in relation to behavioral/psychiatric
health problems, including revision for
patients who are not progressing or
whose status changes; provision of brief
psychosocial interventions; ongoing
collaboration with the RHC or FQHC
practitioner; maintenance of the
registry; acting in consultation with the
psychiatric consultant;
• Being available to provide services
face-to-face with the beneficiary; having
a continuous relationship with the
patient and a collaborative, integrated
relationship with the rest of the care
team; and
• Being available to contact the
patient outside of regular RHC or FQHC
hours as necessary to conduct the
behavioral health care manager’s duties.
Psychiatric CoCM Team—Psychiatric
Consultant
For CoCM, a psychiatric consultant is
a medical professional trained in
psychiatry and qualified to prescribe the
full range of medications. The
psychiatric consultant is not required to
be on site or to have direct contact with
the patient and does not prescribe
medications or furnish treatment to the
beneficiary directly. The CoCM
requirements of the psychiatric
consultant are:
• Participating in regular reviews of
the clinical status of patients receiving
psychiatric CoCM services;
• Advising the RHC or FQHC
practitioner regarding diagnosis and
options for resolving issues with
beneficiary adherence and tolerance of
behavioral health treatment; making
adjustments to behavioral health
treatment for beneficiaries who are not
progressing; managing any negative
interactions between beneficiaries’
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behavioral health and medical
treatments; and
• Facilitating referral for direct
provision of psychiatric care when
clinically indicated.
RHCs and FQHCs could bill the new
psychiatric CoCM code, GCCC2, when
the requirements for HCPCS code G0502
or G0503 are met. This code could only
be billed once per month per
beneficiary, and could not be billed if
other care management services,
including the General Care Management
code GCCC1, are billed for the same
time period.
As with the proposed General Care
Management code GCCC1, we would
monitor PFS data to determine if a
weighted average would be more
appropriate in determining the
psychiatric CoCM payment rate for
RHCs and FQHCs, and whether any
additional codes that may be added to
the PFS in the future should also be
34087
factored into the RHC and FQHC
psychiatric CoCM code. Any changes
would be done through future
rulemaking.
Table 17 compares the requirements
for general BHI, which would be billed
using the proposed General Care
Management code GCCC1, and
psychiatric CoCM services, which
would be billed using the proposed
psychiatric CoCM code, GCCC2.
TABLE 17—COMPARISON OF PROPOSED GENERAL BHI AND PSYCHIATRIC COCM REQUIREMENTS FOR RHCS AND
FQHCS
Requirements
General BHI (proposed)
(HCPCS code G0507)
Initiating Visit ........................
An E/M, AWV, or IPPE visit occurring no more than
one-year prior to commencing care coordination services.
Furnished by a primary care physician, NP, PA, or
CNM.
Billed as an RHC or FQHC visit .....................................
Obtained during or after initiating visit and before provision of care coordination services by RHC or FQHC
practitioner or clinical staff.
Written or verbal, documented in the medical record ....
Includes information:
• On the availability of care coordination services and
applicable cost-sharing;
• That only one entity can furnish and be paid for care
coordination services during a calendar month;
• That the patient has the right to stop care coordination services at any time (effective at the end of the
calendar month); and
• That the patient has given permission to consult with
relevant specialists.
At least 20 minutes of care management services per
calendar month that is:
• Furnished under the direction of the RHC or FQHC
primary care physician, NP, PA, or CNM; and
• Furnished by an RHC or FQHC practitioner, or by
clinical personnel under general supervision.
Beneficiary Consent .............
Billing Requirements ............
Patient Eligibility ...................
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Requirement Elements ........
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Psychiatric CoCM (proposed)
(HCPCS code G0502 and G0503)
Any mental, behavioral health, or psychiatric condition
being treated by the RHC or FQHC primary care
practitioner, including substance use disorders, that,
in the clinical judgment of the RHC or FQHC practitioner, warrants BHI services.
Includes:
• Initial assessment or follow-up monitoring, including
the use of applicable validated rating scales
• Behavioral health care planning in relation to behavioral/psychiatric health problems, including revision
for patients who are not progressing or whose status
changes
• Facilitating and coordinating treatment (such as psychotherapy, pharmacotherapy, counseling and/or
psychiatric consultation) Continuity of care with a
designated member of the care team
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Same.
Same.
Same.
Same.
Same.
Same.
At least 70 minutes in the first calendar month, and at
least 60 minutes in subsequent calendar months of
psychiatric CoCM services that is:
• Furnished under the direction of the RHC or FQHC
primary care practitioner; and
• Furnished by an RHC or FQHC practitioner or behavioral health care manager under general supervision.
Same.
Includes:
RHC or FQHC primary care practitioner:
• Direct the behavioral health care manager or clinical
staff;
• Oversee the beneficiary’s care, including prescribing
medications, providing treatments for medical conditions, and making referrals to specialty care when
needed; and
• Remain involved through ongoing oversight, management, collaboration and reassessment
Behavioral Health Care Manager:
• Provide assessment and care management services,
including the administration of validated rating scales;
behavioral health care planning in relation to behavioral/psychiatric health problems, including revision
for patients who are not progressing or whose status
changes; provision of brief psychosocial interventions; ongoing collaboration with the RHC or FQHC
practitioner; maintenance of the registry; acting in
consultation with the psychiatric consultant;
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TABLE 17—COMPARISON OF PROPOSED GENERAL BHI AND PSYCHIATRIC COCM REQUIREMENTS FOR RHCS AND
FQHCS—Continued
General BHI (proposed)
(HCPCS code G0507)
Requirements
Cy 2017 PFS Non-Facility
Payment.
RHC/FQHC Payment for
New Psychiatric CoCM G
Code.
G0507—$47.73 ...............................................................
Current: N/A ....................................................................
Proposed: Average of CPT codes 99490, 99487, and
G0507. (If using the 2017 payment amounts, this
would be $61.37)
mstockstill on DSK30JT082PROD with PROPOSALS2
c. Other Options Considered
We considered allowing RHCs and
FQHCs to bill for the complex CCM
codes, the BHI code, and the psychiatric
CoCM codes by allowing the individual
CPT or HCPCS codes to be added to an
RHC or FQHC claim, in the same
manner as we currently allow CPT code
99490 to be added to a claim. We do not
believe this approach is in the best
interest of RHCs and FQHCs. There are
now 5 separate care management codes
that are applicable to RHCs and FQHCs,
and more codes could be added in the
future as we learn more about the
benefits of non-face-to-face care
management services. Each of these
codes has specific time increments that
must be tracked and reported for
payment under the PFS. We believe that
bundling the CCM and BHI codes and
the psychiatric CoCM codes into 2 G
codes is more consistent with the RHC
and FQHC payment methodology of
averaging actual costs to determine a
payment rate and not paying for services
based on time increments. It also
requires less record keeping,
monitoring, and coding expertise, while
maintaining the same quality of care
standards.
We also considered bundling all 5
codes together into one G code, or
developing 3 G codes—one for the CCM
codes, one for the BHI code, and one for
the psychiatric CoCM codes. We did not
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Psychiatric CoCM (proposed)
(HCPCS code G0502 and G0503)
Jkt 241001
• Be available to provide services face-to-face with the
beneficiary; having a continuous relationship with the
patient and a collaborative, integrated relationship
with the rest of the care team; and
• Be available to contact the patient outside of regular
RHC or FQHC hours as necessary to conduct the
behavioral health care manager’s duties.
Psychiatric Consultant:
• Participate in regular reviews of the clinical status of
patients receiving CoCM services;
• Advise the RHC or FQHC practitioner regarding diagnosis, options for resolving issues with beneficiary
adherence and tolerance of behavioral health treatment; making adjustments to behavioral health treatment for beneficiaries who are not progressing; managing any negative interactions between beneficiaries’ behavioral health and medical treatments;
and
• Facilitate referral for direct provision of psychiatric
care when clinically indicated.
G0502—$142.84.
G0503—$126.33.
Current: N/A
Proposed: Average of HCPCS codes G0502 and
G0503. (If using the 2017 payment amounts, this
would be $134.58).
choose either of these approaches
because CCM and BHI are similar
services that complement each other,
and bundling them together is
consistent with an integrated approach
to care with reduced reporting
requirements. We also believe that
psychiatric CoCM is different enough
from both CCM and BHI in its
requirements, particularly in staffing
and required services, that it warrants a
separate G code. We believe that our
proposal of creating 2 new G codes to
encompass the 5 care management
codes is the best option for RHCs and
FQHCs now and in the future if new
care management codes are developed.
We welcome comments on the proposal.
4. Implementation
RHCs and FQHCs are familiar with
billing G codes. If this proposal is
finalized as proposed, RHCs and FQHCs
would continue to receive payment for
CCM when CPT code 99490 is billed
alone or with other payable services on
an RHC or FQHC claim until December
31, 2017. Beginning on January 1, 2018,
we propose that RHCs and FQHCs
would use the new General Care
Management G code GCCC1 when
billing for CCM or general BHI services,
and the new psychiatric CoCM G code
GCCC2 when billing for psychiatric
CoCM services, either alone or with
other payable services on an RHC or
FQHC claim. Claims submitted using
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CPT 99490 on January 1, 2018, or after,
will not be paid.
Both the current RHC and FQHC
payment rate for CCM, and the proposed
RHC and FQHC payment rates for
General Care Management and
Psychiatric CoCM codes, are based on
the PFS national non-facility rates. The
PFS rates are updated annually, and the
new G codes for RHCs and FQHCs
would be updated accordingly and
finalized when the PFS rates are
finalized for the year. No geographic
adjustment would be applied to the
General Care Management or Psychiatric
CoCM G codes. RHCs and FQHCs are
required to submit claims for RHC and
FQHC services on an institutional claim
(electronically per the HIPAA compliant
ANSI X12 837I or the Form CMS 1450,
also known as the UB–04,) and are not
authorized to bill RHC or FQHC services
separately to the PFS. Specific
information on billing and claims
processing for the new G codes will be
provided when the policy is finalized.
We note that in section X of this
proposed rule, G0502, G0503, and
G0507 are proposed to be replaced by
new CPT codes. Corresponding changes
would be made for RHCs and FQHCs
when the new CPT codes become
available.
5. Regulatory Changes
As previously noted, § 405.2413(a)(5)
and § 405.2415(a)(5) was revised
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effective January 1, 2017, to state that
services and supplies furnished incident
to CCM and TCM services can be
furnished under general supervision of
an RHC or FQHC practitioner,
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. We propose to further
revise § 405.2413(a)(5) and
§ 405.2415(a)(5) to state that services
and supplies incident to the services of
a physician, NP, PA, or CNM are
furnished under the direct supervision
of a physician, NP, PA, or CNM, except
for TCM, General Care Management,
and Psychiatric CoCM services, which
can be furnished under general
supervision of a physician, NP, PA, or
CNM when these services or supplies
are furnished by auxiliary personnel, as
defined in § 410.26(a)(1).
B. Part B Drug Payment: Infusion Drugs
Furnished Through an Item of Durable
Medical Equipment (DME)
Section 303(c) of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (Pub.
L. 108–173, enacted on December 8,
2003) revised the payment methodology
for most Medicare-covered Part B drugs
and biologicals by adding section 1847A
to the Act, which established a new
average sales price (ASP) drug payment
methodology beginning January 1, 2005.
However, section 303(b) of the MMA
specified payments for certain drugs
using methodologies other than the ASP
pricing methodology. Specifically,
section 303(b) of the MMA added
section 1842(o)(1)(D)(i) of the Act that
required that an infusion drug furnished
through an item of DME covered under
section 1861(n) of the Act be paid 95
percent of the average wholesale price
(AWP) for that drug in effect on October
1, 2003.
Section 5004(a) of the 21st Century
Cures Act (Cures Act) (Pub. L. 114–255,
enacted on December 13, 2016) revised
sections 1842(o)(1)(C) and (D) of the
Act, changing the payment methodology
for DME infusion drugs from being
based on AWP to the methodologies in
sections 1847, 1847A, 1847B, or
1881(b)(13) of the Act, as the case may
be for the drug or biological. To
implement the pricing changes required
by section 5004(a) of Cures Act, which
modifies the payment for DME infusion
drugs to the amount under section
1847A of the Act (ASP payment
methodology), by the statutorily
mandated effective date of January 1,
2017, we incorporated the ASP-based
infusion drug payment amounts into the
January 2017 quarterly ASP drug pricing
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files and instructed claims processing
contractors to use the updated payment
limits for DME infusion drugs.
To conform regulations with the new
payment requirements in section
5004(a) of the Cures Act as they pertain
to section 1847A of the Act, we propose
revising § 414.904(e)(2). Currently, this
describes an exception to ASP-based
payments and requires pricing DME
infusion drugs at 95 percent of the 2003
AWP. Consistent with section 5004(a) of
the Cures Act, the proposed revision
limits the exception to infusion drugs
furnished before January 1, 2017. In
addition, we propose at § 414.904(e)(2)
to delete the phrase ‘‘and is not updated
in 2006.’’ We believe this language is
not relevant since there was no update
for pricing DME infusion drugs in 2006,
and the proposed revision will serve to
simplify the language. Effective January
1, 2017, payment limits for these drugs
are determined under section 1847A of
the Act.
C. Solicitation of Public Comments on
Initial Data Collection and Reporting
Periods for Clinical Laboratory Fee
Schedule
1. Background on Medicare Clinical
Diagnostic Laboratory Tests Payment
System Final Rule
In the final rule published in the June
23, 2016 Federal Register (81 FR 41036)
entitled, ‘‘Medicare Program; Medicare
Clinical Diagnostic Laboratory Tests
Payment System,’’ we implemented the
requirements of section 1834A of the
Act, which requires extensive revisions
to the Medicare payment, coding, and
coverage for clinical diagnostic
laboratory tests (CDLTs) paid under the
Clinical Laboratory Fee Schedule
(CLFS).
Under the CLFS final rule, reporting
entities are required to report to CMS
certain applicable information for their
component applicable laboratories. The
applicable information includes, for
each CDLT furnished during a data
collection period, the specific HCPCS
code associated with the test, each
private payor rate for which final
payment has been made, and the
associated volume of tests performed
corresponding to each private payor
rate. In general, the payment amount for
a test on the CLFS furnished on or after
January 1, 2018, will be equal to the
weighted median of private payor rates
determined for the test, based on the
applicable information that is collected
during a data collection period and
reported to us during a data reporting
period.
In the CLFS final rule, we established
a data collection period that is the 6
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months from January 1 through June 30
during which applicable information is
collected and that precedes the data
collection period. We established a data
reporting period that is the 3-month
period, January 1 through March 31,
during which a reporting entity reports
applicable information to CMS and that
follows the preceding data collection
period. The first data collection period
was January 1, 2016 through June 30,
2016. The first data reporting period
was January 1, 2017 through March 31,
2017. This 6-month data collection
period and 3-month data reporting
period schedule will be repeated every
3 years for CDLTs that are not advanced
diagnostic laboratory tests (ADLTs), and
every year for ADLTS that are not new
ADLTs.
For the first data reporting period,
industry feedback suggested that many
reporting entities would not be able to
submit a complete set of applicable
information to us by the March 31, 2017
deadline, and that entities required
additional time to review collected data,
address any issues identified during
such review, and compile the data into
our required reporting format. As a
result, on March 30, 2017, we
announced that we would exercise
enforcement discretion until May 30,
2017, with respect to the data reporting
period for reporting applicable
information under the Medicare CLFS
and the application of the Secretary’s
potential assessment of civil monetary
penalties for failure to report applicable
information.1 The enforcement
discretion applied to entities that were
subject to the data reporting
requirements adopted in the CLFS final
rule (81 FR 41036). We noted in the
announcement that the 60-day
enforcement discretion period was the
maximum amount of time we could
permit to still have sufficient time to
calculate the CLFS payment rates
scheduled to go into effect on January 1,
2018.
The announcement stated that the
enforcement discretion period would
not prevent reporting entities prepared
to report applicable information from
doing so before May 30, 2017. We
explained in the announcement that we
were committed to the successful
implementation of the new private
payor rate-based CLFS and looked
forward to working with the laboratory
industry to ensure accurate payment
rates. Over the coming months, we will
be analyzing the applicable information
we received, holding our Annual
1 https://www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/ClinicalLabFeeSched/
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Laboratory Public Meeting, meeting
with the Advisory Panel for Clinical
Diagnostic Laboratory tests, and posting
preliminary payment rates.
2. Solicitation of Public Comments on
Medicare Clinical Diagnostic Laboratory
Tests Payment System Initial Data
Collection and Reporting Periods
To better understand the applicable
laboratories’ experiences with the data
reporting, data collection, and other
compliance requirements for the first
data collection and reporting periods,
we are interested in public comments
from applicable laboratories and
reporting entities on the following
questions:
• Was the CMS data reporting system
easy to use? Please describe your overall
experience with navigating the CMS
data reporting system. For example,
describe the aspects of the CMS data
reporting system that worked well for
your reporting entity and/or any
problems the reporting entity
experienced with submitting applicable
information to us.
• Did the applicable laboratory (or its
reporting entity) request and receive
assistance from our Help Desk regarding
the CMS data reporting system? Please
describe your experience with receiving
assistance.
• Did the applicable laboratory (or its
reporting entity) request and receive
assistance from the CMS CLFS Inquiries
Mailbox regarding policy questions?
Please describe your experience with
receiving assistance.
• Did the applicable laboratory (or its
reporting entity) use the subregulatory
guidance on data reporting provided on
the CMS CLFS Web site? 2 If so, was the
information presented useful?
• Was the information that the
applicable laboratory was required to
report readily available in the applicable
laboratory’s record systems?
• Did the reporting entity have a
manual, automated, or semi-automated
remittance process for data reporting?
• If the reporting entity used a
manual or semi-automated remittance
process for data reporting, what
percentage of the process was manual?
• How much time (hours) was
required to assemble and report
applicable information to CMS?
• Is there any other information that
will inform us regarding the reporting,
recordkeeping, and other compliance
requirements from the first data
collection and reporting periods?
We believe that industry feedback on
these issues will help inform us
2 https://www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/ClinicalLabFeeSched/PAMARegulations.html.
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regarding potential refinements to the
private payor rate-based CLFS for future
data collection and reporting periods.
We welcome comments on these
questions from the public.
D. Payment for Biosimilar Biological
Products Under Section 1847A of the
Act
In the CY 2016 Physician Fee
Schedule (PFS) final rule with comment
period, we finalized a proposal to
amend the regulation text at § 414.904(j)
to make clear that the payment amount
for a biosimilar biological product is
based on the ASP of all NDCs assigned
to the biosimilar biological products
included within the same billing and
payment code (80 FR 71096 through
71101, November 16, 2015 Federal
Register). In general, this means that
products that rely on a common
reference product’s biologics license
application are grouped into the same
payment calculation for determining a
single ASP payment limit and that a
single HCPCS code is used for such
biosimilar products. The regulation
went into effect on January 1, 2016.
The comments received on the rule
revealed that stakeholders had varying
opinions about payment for biosimilar
biological products under Part B. The
commenters included individuals,
pharmaceutical manufacturers, patient
advocate groups, providers, insurers,
and members of Congress. A number of
commenters opposed a single payment
amount for all biosimilars that rely on
a common reference product. Most of
these commenters believed that the
proposed regulation would decrease
incentives for biosimilar development
and that grouping payment for
biosimilar biological products is
inconsistent with the statute. Some
commenters also expressed concerns
that prescribers’ choices will be limited,
that tracking or pharmacovigilance
activities will be impaired, and that
innovation and product development
will be harmed, leading to market
consolidation and increased costs for
biosimilar biological products. Many
commenters who opposed our proposal
suggested that we determine a payment
amount for each biosimilar biological
product. These stakeholders have
expressed concerns that the finalized
policy restricts and threatens the
viability of their business models and
expressed support for a market-based
solution. Some of these stakeholders
believe that determining a payment for
each biosimilar product by using
individual HCPCS codes, would drive
and reward innovators producing
potential cost savings, of at least 10–15
percent compared to the reference
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biologic ASP, necessary for biosimilar
products to compete with the reference
biological.
However, some commenters
supported our proposed regulation,
stating that the potential marketplace for
biosimilar biological products is large
and it is less risky than the marketplace
for reference biologicals. Commenters
also expressed concern that separate
payment for each biosimilar biological
product would result in less
competition among manufacturers,
which in turn could lead to higher
payment amounts for Medicare and
beneficiaries. Some commenters stated
that separate billing codes could be
perceived as a type of price protection
and could artificially increase prices for
biosimilars. Commenters who supported
the proposed regulation suggested that
we remain mindful of our policy as the
biosimilar biological product
marketplace evolves. Several
commenters requested that policy
decisions be delayed while issues such
as naming conventions and
interchangeability standards are
finalized by the FDA.
As CMS expected, since the
regulation was finalized, the biosimilar
product marketplace has continued to
grow, and several biosimilar biological
products that are paid under Part B have
been licensed, including one product
that we expect will share a HCPCS code
with another biosimilar biological
product. Over the next year or so, we
anticipate that several more biosimilar
biological products will be licensed for
use in the United States and that during
the following years, the marketplace
will continue to grow steadily. We also
anticipate that biological products will
continue to be heavily utilized in Part
B. At the same time, we are aware of
concerns that current policy may
discourage development of new
biosimilars and other innovation in this
area potentially resulting in higher costs
over time due to a lack of competition
in the market place.
In the 2016 PFS final rule, we stated
that it is desirable to have fair
reimbursement in a healthy marketplace
that encourages product development
(80 FR 71101). CMS seeks to promote
innovation, to provide more options to
patients and physicians, and
competition to drive prices down,
recognizing that even though these two
goals may be difficult to achieve
concurrently, to delink them would be
counterproductive.
Although we believe that the United
States biosimilar biological product
marketplace is still in an early phase
(because only a few products are on the
market), we are interested in assessing
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the effects of Medicare payment policy
on this important portion of the Part B
drug marketplace at this time,
particularly for fostering a robust, and
competitive marketplace and
encouraging the innovation that is
necessary to bring these products to the
marketplace. It is essential to take a
measured approach that considers all
options given the significant federal
spending by Medicare on Part B drugs,
the effect of payment policies on
program sustainability for taxpayers,
health care affordability and access for
beneficiaries, and the considerable
investment the biosimilar industry is
making in the nascent market. Failure to
do so could potentially restrict
innovation in the marketplace, increase
costs to the American taxpayer, and
limit treatment options. With that in
mind, it is CMS’s goal to further
investigate a solution that allows market
forces to provide a robust and
comprehensive selection of choices for
patients at a fair price. Additionally, we
are interested in better understanding if
and how the innate differences in
biological products and their current
regulatory environment should be
reflected in Medicare payment policy
for biosimilars, particularly as it relates
to biosimilars that are licensed for fewer
than all indications for which the
reference product is licensed or
situations where different biosimilars
may be licensed for different subsets of
indications for which the reference
product is licensed.
Thus, we are requesting comments
regarding our Medicare Part B
biosimilar biological product payment
policy. This comment solicitation is
seeking new or updated information on
the effects of the current biosimilar
payment policy that is based on
experience with the United States
marketplace. We are particularly
interested in obtaining material, such as
market analyses or research articles that
provide data and insight into the current
economics of the biosimilar market
place. This includes patient, plan, and
manufacturer data both domestic and,
where applicable, from European
markets that may be more established
than, and provide insight for, the
current United States’ market.
We also seek data to demonstrate how
individual HCPCS codes could impact
the biosimilar market, including
innovation, the number of biosimilar
products introduced to the market,
patient access, and drug spending.
Finally, we also seek comment
regarding other novel payment policies
that would foster competition, increase
access, and drive cost savings in the
biological product marketplace. These
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solutions may include legislation,
demonstrations, and administrative
options. Please note that this is a
solicitation for comments on this issue
for future consideration. We are not
making a proposal to change the
existing payment policy in this
proposed rule.
requests public feedback on details
regarding how AUC consultation
information must be included on the
Medicare claim. To further this iterative
process of implementation, we also
discuss briefly the potential for
alignment with other Medicare quality
programs.
E. Appropriate Use Criteria for
Advanced Diagnostic Imaging Services
Section 218(b) of the Protecting
Access to Medicare Act (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 (80 FR 70886), we established
an evidence-based process and
transparency requirements for the
development of AUC, defined providerled entities (PLEs) and established the
process by which PLEs may become
qualified to develop, modify or endorse
AUC. The first list of qualified PLEs was
posted on the CMS Web site at the end
of June 2016 at which time their AUC
libraries became specified applicable
AUC for purposes of section
1834(q)(2)(A) of the Act. The CY 2017
PFS final rule addressed the second
component of this program,
specification of qualified clinical
decision support mechanisms (CDSMs).
In that rule (81 FR 80170), we defined
CDSM, identified the requirements
CDSMs must meet for qualification
including an opportunity for
preliminary qualification for
mechanisms still working toward full
adherence, and established a process by
which CDSMs may become qualified.
We also defined applicable payment
systems under this program, specified
the first list of priority clinical areas and
identified exceptions to the
requirements that ordering professionals
consult specified applicable AUC when
ordering applicable imaging services.
The first list of qualified CDSMs will be
posted on the CMS Web site in
conjunction with this proposed rule.
This rule proposes the start date of the
Medicare AUC program for advanced
diagnostic imaging services. It is on and
after this date that ordering
professionals must consult specified
applicable AUC using a qualified CDSM
when ordering applicable imaging
services and furnishing professionals
must report consultation information on
the Medicare claim. This rule also
proposes to modify the policy related to
significant hardship exceptions and
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 is 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 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 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 descriptions of
clinical decision support 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/policyresearchers-implementers/clinicaldecision-support-cds), within health IT
applications, a CDSM is a functionality
that provides persons involved in care
processes with general and personspecific information, intelligently
filtered and organized, at appropriate
times, to enhance health and health
care.
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2. 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
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directs the Secretary to establish a new
program to promote the use of AUC.
Section 1834(q)(4) of the Act requires
ordering professionals to consult with a
qualified CDSM for applicable imaging
services 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.
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3. Discussion of Statutory Requirements
There are four major components of
the AUC program under section 1834(q)
of the Act, and each component has its
own implementation date: (1)
Establishment of AUC by November 15,
2015 (section 1834(q)(2) of the Act); (2)
identification of mechanisms for
consultation with AUC by April 1, 2016
(section 1834(q)(3) of the Act); (3) AUC
consultation by ordering professionals,
and reporting on AUC consultation by
furnishing professionals by January 1,
2017 (section 1834(q)(4) of the Act); and
(4) annual identification of outlier
ordering professionals for services
furnished after January 1, 2017 (section
1834(q)(5) of the Act). As we will
discuss later in this preamble and in
prior PFS rules, we did not identify
mechanisms for consultation by April 1,
2016. Therefore, we did not require
ordering professionals to consult
CDSMs or furnishing professionals to
report information on the consultation
by the January 1, 2017 date.
a. Establishment of AUC
In the CY 2016 PFS final rule with
comment period, we addressed the first
component of the Medicare AUC
program 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
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
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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.
In the same rule we established a
timeline and process under
§ 414.94(c)(2) for PLEs to apply to
become qualified. Consistent with this
timeline the first list of qualified PLEs
was published at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/AppropriateUse-Criteria-Program/PLE.html (OMB
Control Number 0938–1288).
b. Mechanism for AUC Consultation
In the CY 2017 PFS final rule, we
addressed the second major component
of the Medicare AUC program—the
specification of qualified CDSMs for use
by ordering professionals for
consultation with specified applicable
AUC under section 1834(q)(3) of the
Act, along with relevant aspects of the
definitions under section 1834(q)(1) of
the Act. This included defining the term
CDSM and finalizing functionality
requirements of mechanisms, upon
which qualification is based, as
provided in section 1834(q)(3)(B) of the
Act and in the CY 2017 PFS final rule.
We included an opportunity for
mechanisms still working toward full
adherence to these requirements to
receive preliminary qualification during
the preliminary qualification period that
begins June 30, 2017, and ends when
the AUC consulting and reporting
requirements become effective. The
preliminarily qualified CDSMs must
meet all requirements by that time. We
defined CDSM 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.
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.
In the CY 2017 PFS final rule we
established a timeline and process in
§ 414.94(g)(2) for CDSM developers to
apply to have their CDSMs qualified.
Consistent with this timeline, the first
list of qualified CDSMs will be posted
on the CMS Web site https://
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www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Appropriate-Use-CriteriaProgram/CDSM.html in conjunction
with this proposed rule (OMB Control
Number 0938–1315).
c. AUC Consultation and Reporting
The third major component of the
Medicare 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. Since a list of qualified
CDSMs was not available by January 1,
2017, we did not require ordering
professionals to meet the consultation
requirement by that date.
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. In the CY 2017 PFS final rule,
we identified the circumstances specific
to ordering professionals under which
consulting and reporting requirements
are not required. These include orders
for applicable imaging services: (1) For
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; and (3) by ordering
professionals who are granted a
significant hardship exception to the
Medicare EHR Incentive Program
payment adjustment for that year under
42 CFR 495.102(d)(4), except for those
granted such an exception under
§ 495.102(d)(4)(iv)(C). We propose
changes to the significant hardship
exception later in this preamble.
Section 1834(q)(4)(D) of the Act
specifies that the applicable payment
systems for the AUC consultation and
reporting requirements, and, in the CY
2017 PFS final rule we defined them as:
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(1) The physician fee schedule
established under section 1848(b) of the
Act; (2) the prospective payment system
for hospital outpatient department
services under section 1833(t) of the
Act; and (3) the ambulatory surgical
center payment system under section
1833(i) of the Act.
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d. Identification of Outliers
The fourth component of the
Medicare 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.
Given that we are proposing a program
start date of January 1, 2019, we
anticipate that implementation of the
prior authorization component would
be delayed. We expect to discuss details
around outlier calculations and prior
authorization in the CY 2019 PFS
proposed rule. However, we did finalize
in the CY 2017 PFS final rule the first
list of priority clinical areas to guide
identification of outlier ordering
professionals as follows:
• Coronary artery disease (suspected
or diagnosed).
• Suspected pulmonary embolism.
• Headache (traumatic and nontraumatic).
• Hip pain.
• Low back pain.
• Shoulder pain (to include suspected
rotator cuff injury).
• Cancer of the lung (primary or
metastatic, suspected or diagnosed).
• Cervical or neck pain.
As established in § 414.94(e)(4) of our
regulations, priority clinical areas may
be used in the identification of outlier
ordering professionals. By starting to
identify these areas now, we believe
ordering professionals will have the
opportunity to become familiar with
AUC within identified priority clinical
areas prior to Medicare claims for those
services being part of the input for
calculating outlier ordering
professionals.
We are not including proposals to
expand or modify the list of priority
clinical areas in this rule.
4. Proposals for Continuing
Implementation
We propose to amend § 414.94 of our
regulations, ‘‘Appropriate Use Criteria
for Certain Imaging Services,’’ to reflect
the following proposals.
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a. Consultation by Ordering Professional
and Reporting by Furnishing
Professional
We are proposing that ordering
professionals must consult specified
applicable AUC through qualified
CDSMs for applicable imaging services
furnished in an applicable setting, paid
for under an applicable payment system
and ordered on or after January 1, 2019.
This proposed effective date for the
consulting and reporting requirements
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. Although there will be another
rulemaking cycle next year before the
consulting and reporting requirement is
effective as proposed on January 1,
2019, we are establishing this date
through rulemaking this year because
the agency expects practitioners and
other stakeholders to begin preparing
themselves to report on that date and, in
response to public comment and
stakeholder feedback, we want to ensure
all impacted parties have sufficient time
to prepare to meet the requirements of
this program.
After proposing the timeline and
process for qualification of CDSMs in
the CY 2017 PFS proposed rule (81 FR
46392), we anticipated that furnishing
professionals may begin reporting as
early as January 1, 2018. However, we
received comments that these timelines
did not allow enough time to address
the needs of different stakeholder
groups. Some commenters requested
that CMS delay the timeline and process
to give practitioners sufficient time to
obtain a qualified CDSM. Other
commenters cited insufficient time for
CDSMs to incorporate requirements
between the release of the final CDSM
requirements and January 1, 2018, and
requested that CMS fully implement the
program at a later date. Additionally, in
the CY 2017 PFS final rule (81 FR
80411) we discussed commenters’
recommendations that CMS develop
and launch an educational campaign,
including a Town Hall meeting. Some
commenters requesting additional time
suggested that, for purposes of both
CDSM vendor readiness and
practitioner readiness, consulting and
reporting requirements should not go
into effect for an additional 12–18
months after the initial list of CMS
qualified CDSMs is posted.
By proposing the consulting and
reporting requirements begin on January
1, 2019 we believe that we are allowing
needed time for education and outreach
efforts, time for practitioners and
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34093
stakeholders to prepare, and time for
CDSMs to continue current strides in
being more user-friendly and less
burdensome. We note that the statute
required publication of qualified CDSMs
by April 1, 2016, and required AUC
consultation and reporting by January 1,
2017; therefore, our proposal
substantially lags the statutory
requirements. As noted above and in
previous rulemaking, a delay in the
statutory timeline is necessary to
maximize the opportunity for public
comment and stakeholder engagement,
also a statutory requirement, and allows
for adequate advance notice to
practitioners, beneficiaries, AUC
developers, and CDSM developers.
Consistent with section 1834(q)(4)(B)
of the Act, we are also proposing that
furnishing professionals report the
following information on Medicare
claims for applicable imaging services,
furnished in an applicable setting, paid
for under an applicable payment system
as defined in § 414.94(b), and ordered
on or after January 1, 2019: (1) Which
qualified CDSM was consulted by the
ordering professional; (2) whether the
service ordered would adhere to
specified applicable AUC, would not
adhere to specified applicable AUC, or
whether specified applicable AUC were
not applicable to the service ordered;
and (3) the NPI of the ordering
professional (if different from the
furnishing 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 remind readers as required under
§ 414.94(g)(1)(iii) that qualified CDSMs
must make available, at a minimum,
AUC that reasonably address common
and important clinical scenarios within
all priority clinical areas. As discussed
in the CY 2017 PFS final rule (81 FR
80170), the current list of priority
clinical areas represents about 40
percent of advanced diagnostic imaging
services paid for by Medicare in 2014.
We also remind readers that consistent
with section 1834(q)(4)(A) of the Act,
ordering professionals must consult
AUC for every advanced diagnostic
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imaging service ordered. While section
218(b) of the PAMA allows qualified
CDSMs to return a response of ‘‘not
applicable’’ if a qualified CDSM does
not contain specified applicable AUC
for the service ordered, we expect these
situations to be limited in scope and
number, and to decrease over time. The
‘‘not applicable’’ responses should
decrease as qualified PLEs continue to
build out their AUC libraries and
qualified CDSMs update their content
and potentially collaborate with more
qualified PLEs so as to make available
highly comprehensive tools.
Section 1834(q)(4)(B) requires that
payment may only be made if the claim
for the service includes the specific
information discussed in this proposed
rule. This information, to the extent
feasible, is required across claim types
(including both the furnishing
professional and facility claims) and
across all three applicable payment
systems (PFS, hospital outpatient
prospective payment system and
ambulatory surgical center payment
system). In other words, we would
expect this information to be included
on the practitioner claim that includes
the professional component of the
imaging service and on the hospital
outpatient claim for the technical
component of the imaging service.
Claims for services for which payment
is not made under the three identified
payment systems would not be required
to include consultation related
information.
To implement this requirement we
propose to establish a series of HCPCS
level 3 codes. These G-codes would
describe the specific CDSM that was
used by the ordering professional.
Ultimately there would be one G-code
for every qualified CDSM with the code
description including the name of the
CDSM. However, because the claims
processing system can only recognize
new codes quarterly, we may not be able
to update the G-code descriptors
simultaneously with the announcement
of any new qualified CDSMs which is
expected to occur in June of each year.
To ensure that there is a code available
to immediately describe newly qualified
CDSMs, we propose to establish a
generic G-code that would be used to
report that a qualified CDSM was
consulted, but would not identify a
specific qualified CDSM; clinicians
would only be permitted to use this
code if a more specific named code did
not yet exist for that clinician’s CDSM.
Furnishing professionals would report
this code temporarily until a specific Gcode describing the newly qualified
CDSM by name becomes available. We
also propose to establish a G-code to
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identify circumstances where there was
no AUC consultation through a
qualified CDSM. The description of this
code would indicate that a qualified
CDSM was not consulted by the
ordering professional.
G-codes would be a line-item on both
practitioner claims and facility claims.
We would expect that one AUC
consulatation G-code would be reported
for every advanced diagnostic imaging
service on the claim. If there are two
codes billed for advanced imaging
services on the claim then we would
expect two G-codes. Each G-code would
be expected, on the same claim line, to
contain at least one new HCPCS
modifier. We propose to develop a
series of modifiers to provide necessary
information as to whether, when a
CDSM is used to consult AUC: (1) The
imaging service would adhere to the
applicable appropriate use criteria; (2)
the imaging service would not adhere to
such criteria; or (3) such criteria were
not applicable to the imaging service
ordered. We propose to create
additional modifiers to describe
situations where an exception applies
and a qualified CDSM was not used to
consult AUC: (1) The imaging service
was ordered for a patient with an
emergency medical condition or (2) the
ordering professional has a significant
hardship exception. Based on this
proposal we specifically seek comments
on any additional HCPCS modifiers that
might be needed to separately identify
allowable scenarios for which a
qualified CDSM was not consulted by
the ordering professional.
The proposed AUC consultation and
reporting start date of January 1, 2019 is
expected to allow adequate time for us
to operationalize the claims-based
procedures and systems changes needed
to accomplish the processing of
Medicare claims with AUC consultation
information.
There are aspects of the AUC program
that are novel and complex for the CMS
claims processing system and for
ordering and furnishing professionals.
An AUC consultation by an ordering
professional has never before been
required by fee-for-service Medicare
with such a broad application (all
professionals ordering advanced
diagnostic tests). Additional
considerations for the complex
communication of AUC consultation
information from the ordering
professional to the furnishing
professional and facility that must
include that information when billing
for the service are warranted. Their
billing systems will need to translate the
AUC consultation information onto
Medicare claims in the form of G-codes
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and HCPCS modifiers. These processes
are new for many professionals, and
there are many areas for potential error.
For these reasons an educational and
operations testing period is needed.
During this period, ordering
professionals would consult AUC and
furnishing professionals would report
AUC consultation information on the
claim, but we would continue to pay
claims whether or not they correctly
include such information. This
educational period allows professionals
to actively participate in the program
while avoiding claims denials during
the learning curve. It also gives us an
opportunity to make any needed claims
processing adjustments before payments
are impacted.
We believe it is preferable to begin
implementation using a single year
educational and operations testing
period, rather than possibly further
delaying the start-date of the program.
We do not expect to continue this
educational and operations testing
period beyond the first year of the AUC
program.
We look forward to receiving public
comments on all aspects of our
proposal, and specifically, comments
related to whether the program should
be delayed beyond the proposed start
date of January 1, 2019. Although our
proposal is based in part on comments
received in prior rulemaking cycles, it is
important to receive comments that help
us understand the current readiness of
stakeholders. In addition, we have
proposed that the program begin with
an educational and operations testing
period and are interested in comments
regarding how long, if longer than one
year, such a period should be available.
We expect a voluntary reporting
period to be available ahead of January
1, 2019 and anticipate such a period
will begin July 2018. The timing for this
opportunity for voluntary reporting is
dependent on the readiness of the
Medicare claims system to accept and
process claims that include AUC
consultation information. When the
voluntary period becomes available we
will make announcements through our
educational channels such as the CMS
Web site and listservs. It is important to
note that the proposed educational and
operations testing period beginning
January 1, 2019, is separate from the
anticipated voluntary reporting period
that we expect to allow before January
1, 2019. During the voluntary reporting
period, AUC consultation and reporting
are not required. However, for
applicable imaging services ordered on
and after January 1, 2019, consulting
specified applicable AUC and reporting
consultation information on the
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Medicare claim would be required for
all ordering and furnishing
professionals, respectively.
b. Alignment With Other Medicare
Quality Programs
The CY 2017 Merit-based Incentive
Payment System and Alternative
Payment Model final rule with comment
period (Quality Payment Program final
rule) (81 FR 77008) finalized policies to
improve physician and other clinician
payments by changing the way
Medicare incorporates quality
measurement into payments and
developing new policies to address and
incentivize participation in Advanced
Alternative Payment Models (APMs).
We expect the Quality Payment Program
to evolve over multiple years and to
continue iterating on these policies. To
this end, the AUC program has the
potential to provide new opportunities
to improve care delivery by supporting
and rewarding clinicians as they find
new ways to engage patients, families
and caregivers as well as improving care
coordination and patient health
management.
Therefore, we have proposed in the
CY 2018 Quality Payment Program
proposed rule to develop a direct tie
between MIPS and the AUC program
(See CY 2018 Quality Payment Program
Proposed Rule (82 FR 30010) published
in the June 30, 2017 Federal Register).
In that rule, we proposed to give MIPS
credit to ordering professionals for
consulting AUC using a qualified CDSM
as a high-weight improvement activity
for the performance period beginning
January 1, 2018 (82 FR 30484). We
believe this will incentivize early use of
qualified CDSMs to consult AUC by
motivated eligible clinicians looking to
improve patient care and to better
prepare themselves for the AUC
program. Although the AUC program
would not officially begin until January
1, 2019, we are able to support this
proposed improvement activity because
the first qualified CDSMs will be
announced in conjunction with this
proposed rule; therefore, ordering
professionals will be able to begin
consulting AUC using those tools.
We are also considering how the AUC
program could serve to support a quality
measure under the MIPS quality
performance category and seek feedback
from the public regarding feasibility and
value of pursuing this idea further.
c. Significant Hardship Exceptions to
Consulting and Reporting Requirements
We are proposing to modify
§ 414.94(i)(3) of our regulations to
reflect the sunsetting of the payment
adjustments under the Medicare EHR
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Incentive Program and to substitute an
alignment with the advancing care
information performance category of
MIPS. The categories that we included
in the CY 2017 PFS final rule for
purposes of the AUC program
significant hardship exceptions were the
following from § 495.102(d)(4):
• Insufficient Internet Connectivity
(as specified in § 495.102(d)(4)(i)).
• Practicing for less than 2 years (as
specified in § 495.102(d)(4)(ii)).
• Extreme and Uncontrollable
Circumstances (as specified in
§ 495.102(d)(4)(iii)).
• Lack of Control over the
Availability of CEHRT (as specified in
§ 495.102(d)(4)(iv)(A)).
• Lack of Face-to-Face Patient
Interaction (as specified in
§ 495.102(d)(4)(iv)(B)).
In addition, in the CY 2017 Quality
Payment Program final rule, we
finalized a policy (81 FR 77240–77243)
to reweight the advancing care
information performance category to
zero in the MIPS final score for the year
for MIPS eligible clinicians who meet
the criteria in one of the above listed
categories of § 495.102(d)(4), with the
exception of the category for clinicians
practicing for less than 2 years. Under
section 1848(q)(1)(C)(v) of the Act,
eligible clinicians who first enroll in
Medicare during the performance period
for a year and have not previously
submitted claims under Medicare are
not considered MIPS eligible clinicians,
and thus are excluded from MIPS. We
believe it is likely that many clinicians
who have been practicing for less than
2 years would be excluded from MIPS
on the basis that they are new Medicareenrolled MIPS eligible clinicians as
defined in § 414.1305. Because these
clinicians are not MIPS eligible
clinicians, they would never meet the
criteria for re-weighting of their MIPS
advancing care information performance
category for the year. Therefore, to
implement a hardship exception for
purposes of the AUC program that is
both operationally consistent and
administratively efficient, we propose to
remove as a criterion for a significant
hardship exception for the AUC
program the criterion specified in
§ 495.102(d)(4)(ii) of our regulations for
those practicing for less than 2 years.
We propose to keep the remaining listed
categories including insufficient
internet connectivity, extreme and
uncontrollable circumstances, lack of
control over availability of CEHRT and
lack of face-to-face patient interaction.
We note that section 1843(q)(4)(C)(iii) of
the Act only allows the ordering
professional to seek a significant
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34095
hardship exception, not the furnishing
professional.
As such, we propose to amend the
AUC significant hardship exception
regulation to specify that ordering
professionals who are granted reweighting of the advancing care
information performance category to
zero percent of the final score for the
year under MIPS per § 414.1380(c)(2)
due to circumstances that include the
criteria listed in § 495.102(d)(4)(i), (iii),
(iv)(A) and (iv)(B) would be excepted
from the AUC consultation requirement
during the same year that the reweighting applies for purposes of the
MIPS payment adjustment.
There will be scenarios when a
clinician’s experience of a significant
hardship or extraordinary circumstance
does not align with the prospective
identification of these ordering
professionals with reference to MIPS
criteria and processes. However, we
believe the prospective identification
process allows us to apply exceptions in
real-time for claims submitted for
advanced imaging services. There are
timing differences between the MIPS
and the AUC program (the MIPS
payment adjustment year is based on
performance in a prior year while the
Medicare AUC program requires realtime AUC consultation and claimsbased reporting). In addition to the
timing, there will be instances when a
clinician who is not a MIPS eligible
clinician will need to seek a significant
hardship exception to the Medicare
AUC program. To accommodate these
two separate scenarios, we propose to
establish a process to identify ordering
professionals in need of a significant
hardship exception to the Medicare
AUC program requirements that is
outside the MIPS re-weighting process.
For purposes of these scenarios, we
propose to use the criteria for clinicians
seeking an AUC significant hardship
exception described under
§ 495.102(d)(4) to include (i), (iii),
(iv)(A) and (iv)(B) of our regulations. We
propose these criteria to align with the
criteria used under MIPS for reweighting under the advancing care
information performance category, and
to provide predictability and
consistency to the determination of
significant hardship. We further propose
that a significant hardship exception
from the Medicare AUC program
requirements would be granted for no
longer than 12 months, and that we
could establish an exception for a
shorter period where warranted by the
circumstances.
Therefore we propose that ordering
professionals who have not received a
re-weighting to zero for the MIPS
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advancing care information performance
category for the year, but experience one
of the circumstances described in
§ 495.102(d)(4) to include (i), (iii),
(iv)(A) and (iv)(B), may be granted an
AUC significant hardship exception for
no longer than one year. We expect to
provide further information on this
execption process in future rulemaking.
In addition to the proposals above, we
invite the public to comment on
additional circumstances for which it
may be appropriate for an ordering
professional to be granted a significant
hardship exception under the AUC
program.
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5. Summary
Section 1834(q) of the Act includes
rapid timelines for establishing a
Medicare AUC program for advanced
diagnostic imaging services. The impact
of this program is extensive as it will
apply to every physician or other
practitioner who orders or furnishes
advanced diagnostic imaging services
(for example, magnetic resonance
imaging (MRI), computer tomography
(CT) or positron emission tomography
(PET)). 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. Stakeholders have
expressed concern that program
requirements may inadvertently
encourage physicians to order imaging
services that they do not believe are
right for their patients. The goal of
evidence-based AUC is to assist
clinicians in ordering the most
appropriate imaging service for their
patients’ specific clinical scenarios.
However, to ensure we are
implementing the program effectively,
we are asking for public comment on
such potential unintended
consequences. Additionally, as we
continue to develop the AUC program,
we continue to engage a variety of
stakeholders interested in participating
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in the development of AUC. We seek
comment about how we can continue to
engage interested participants,
consistent with statutory requirements
at section 1834(q) of the Act, in
developing AUC in a transparent and
scientifically robust manner. We are
particularly interested in how qualified
PLEs develop or modify AUC in
collaboration with non-PLE entities and
what additional challenges such entities
might face.
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 propose to
continue a stepwise approach, adopted
through notice and comment
rulemaking. We propose policies to
implement the third component of the
AUC program—the consulting and
reporting requirements and the effective
date on which these requirements
would begin. Under this proposal,
ordering professionals must begin
consulting specified applicable AUC
through qualified CDSMs for applicable
imaging services ordered on and after
January 1, 2019, and furnishing
professionals must begin reporting AUC
consultation information on Medicare
claims for advanced diagnostic imaging
services for which payment is made
under an applicable payment system as
defined in § 414.94(b) and ordered on or
after January 1, 2019.
We also propose modifications to the
significant hardship exception to better
align these exceptions under the AUC
program with those under existing
quality programs.
In summary, we are proposing
requirements necessary to implement
the third component of the AUC
program. We invite the public to submit
comments on these proposals.
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F. Physician Quality Reporting System
(PQRS) Criteria for Satisfactory
Reporting for Individual EPs and Group
Practices for the 2018 PQRS Payment
Adjustment
1. Background
Section 1848(a)(8) of the Act provides
that for covered professional services
furnished by an EP during each of 2015
through 2018, if the EP does not
satisfactorily report data on quality
measures for covered professional
services for the reporting period for the
year, the PFS amount for services
furnished by such professional during
the year (including the PFS amount for
purposes of determining a payment
based on such amount) shall be equal to
the applicable percent of the PFS
amount that would otherwise apply to
such services. For 2016 through 2018,
the applicable percent is 98.0 percent.
Thus, individual EPs and group
practices who did not satisfactorily
report data on quality measures for the
CY 2016 reporting period are subject to
a downward payment adjustment of 2.0
percent to the PFS payment amount for
covered professional services they
furnish in 2018.
2. Previously Finalized Satisfactory
Reporting Criteria for Individual EPs
and Group Practices for the 2018 PQRS
Payment Adjustment
We previously finalized the
satisfactory reporting criteria for
individual EPs and group practices for
the CY 2016 reporting period to avoid
the 2018 PQRS payment adjustment in
the CY 2016 PFS final rule (80 FR 71140
through 71250) at § 414.90(j)(8) and (9)
and § 414.90(k)(5).
Table 18 summarizes the previously
finalized satisfactory reporting criteria
for individual EPs at § 414.90(j)(8) and
§ 414.90(k)(5).
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TABLE 18—SUMMARY OF REQUIREMENTS FOR THE 2018 PQRS PAYMENT ADJUSTMENT: INDIVIDUAL REPORTING CRITERIA
FOR THE SATISFACTORY REPORTING OF QUALITY MEASURES DATA VIA CLAIMS, QUALIFIED REGISTRY, AND ELECTRONIC HEALTH RECORDS (EHRS) AND SATISFACTORY PARTICIPATION CRITERIA IN QUALIFIED CLINICAL DATA REGISTRIES (QCDRS)
Measure type
Reporting mechanism
Satisfactory reporting/satisfactory participation criteria
12-month (Jan 1–Dec 31,
2016).
Individual Measures ..........
Claims ................................
12-month (Jan 1–Dec 31,
2016).
Individual Measures ..........
Qualified Registry ..............
12-month (Jan 1–Dec 31,
2016).
Individual Measures ..........
Direct EHR Product or
EHR Data Submission
Vendor Product.
12-month (Jan 1–Dec 31,
2016).
Measures Groups ..............
Qualified Registry ..............
12-month (Jan 1–Dec 31,
2016).
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Reporting period
Individual PQRS measures
and/or non-PQRS measures reportable via a
QCDR.
QCDR ................................
Report at least 9 measures, covering at least 3 of the
National Quality Strategy (NQS) domains AND report each measure for at least 50 percent of the
EP’s Medicare Part B Fee-for-Service (FFS) patients seen during the reporting period to which the
measure applies. Of the measures reported, if the
EP sees at least 1 Medicare patient in a face-toface encounter, the EP will report on at least 1
measure contained in the PQRS cross-cutting
measure set. If less than 9 measures apply to the
EP, the EP would report on each measure that is
applicable), AND report each measure for at least
50 percent of the Medicare Part B FFS patients
seen during the reporting period to which the measure applies. Measures with a 0 percent performance
rate would not be counted.
Report at least 9 measures, covering at least 3 of the
NQS domains AND report each measure for at least
50 percent of the EP’s Medicare Part B FFS patients seen during the reporting period to which the
measure applies. Of the measures reported, if the
EP sees at least 1 Medicare patient in a face-toface encounter, the EP will report on at least 1
measure contained in the PQRS cross-cutting
measure set. If less than 9 measures apply to the
EP, the EP would report on each measure that is
applicable, AND report each measure for at least 50
percent of the Medicare Part B FFS patients seen
during the reporting period to which the measure
applies. Measures with a 0 percent performance
rate would not be counted.
Report 9 measures covering at least 3 of the NQS domains. If an EP’s direct EHR product or EHR data
submission vendor product does not contain patient
data for at least 9 measures covering at least 3 domains, then the EP would be required to report all
of the measures for which there is Medicare patient
data. An EP would be required to report on at least
1 measure for which there is Medicare patient data.
Report at least 1 measures group AND report each
measures group for at least 20 patients, the majority
(11 patients) of which are required to be Medicare
Part B FFS patients. Measures groups containing a
measure with a 0 percent performance rate will not
be counted.
Report at least 9 measures available for reporting
under a QCDR covering at least 3 of the NQS domains, AND report each measure for at least 50
percent of the EP’s patients. Of these measures,
the EP would report on at least 2 outcome measures, OR, if 2 outcomes measures are not available,
report on at least 1 outcome measures and at least
1 of the following types of measures—resource use,
patient experience of care, efficiency/appropriate
use, or patient safety.
Table 19 summarizes the previously
finalized satisfactory reporting criteria
for group practices via the group
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practice reporting option (GPRO) at
§ 414.90(j)(9) and § 414.90(k)(5).
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TABLE 19—SUMMARY OF REQUIREMENTS FOR THE 2018 PQRS PAYMENT ADJUSTMENT: GROUP PRACTICE REPORTING
CRITERIA FOR SATISFACTORY REPORTING OF QUALITY MEASURES DATA VIA THE GPRO
Reporting
period
Measure type
Group practice size
Reporting
mechanism
Satisfactory reporting criteria
Report on all measures included in the web interface; AND
populate data fields for the first 248 consecutively ranked
and assigned beneficiaries in the order in which they appear in the group’s sample for each module or preventive
care measure. If the pool of eligible assigned beneficiaries is less than 248, then the group practice must report on 100 percent of assigned beneficiaries. In other
words, we understand that, in some instances, the sampling methodology we provide will not be able to assign at
least 248 patients on which a group practice may report,
particularly those group practices on the smaller end of
the range of 25–99 EPs. If the group practice is assigned
less than 248 Medicare beneficiaries, then the group
practice must report on 100 percent of its assigned beneficiaries. A group practice must report on at least 1 measure for which there is Medicare patient data.
The group practice must have all CAHPS for PQRS survey
measures reported on its behalf via a CMS-certified survey vendor. In addition, the group practice must report on
all measures included in the Web Interface; AND populate data fields for the first 248 consecutively ranked and
assigned beneficiaries in the order in which they appear
in the group’s sample for each module or preventive care
measure. If the pool of eligible assigned beneficiaries is
less than 248, then the group practice must report on 100
percent of assigned beneficiaries. A group practice will be
required to report on at least 1 measure for which there is
Medicare patient data.
Please note that, if the CAHPS for PQRS survey is applicable to a group practice who reports quality measures via
the Web Interface, the group practice must administer the
CAHPS for PQRS survey in addition to reporting the Web
Interface measures.
Report at least 9 measures, covering at least 3 of the NQS
domains. Of these measures, if a group practice sees at
least 1 Medicare patient in a face-to-face encounter, the
group practice would report on at least 1 measure in the
PQRS cross-cutting measure set. If less than 9 measures
covering at least 3 NQS domains apply to the group practice, the group practice would report on each measure
that is applicable to the group practice, AND report each
measure for at least 50 percent of the group’s Medicare
Part B FFS patients seen during the reporting period to
which the measure applies. Measures with a 0 percent
performance rate would not be counted.
The group practice must have all CAHPS for PQRS survey
measures reported on its behalf via a CMS-certified survey vendor, and report at least 6 additional measures,
outside of the CAHPS for PQRS survey, covering at least
2 of the NQS domains using the qualified registry. If less
than 6 measures apply to the group practice, the group
practice must report on each measure that is applicable
to the group practice. Of the additional measures that
must be reported in conjunction with reporting the CAHPS
for PQRS survey measures, if any EP in the group practice sees at least 1 Medicare patient in a face-to-face encounter, the group practice must report on at least 1
measure in the PQRS cross-cutting measure set.
Report 9 measures covering at least 3 domains. If the
group practice’s direct EHR product or EHR data submission vendor product does not contain patient data for at
least 9 measures covering at least 3 domains, then the
group practice must report all of the measures for which
there is Medicare patient data. A group practice must report on at least 1 measure for which there is Medicare
patient data.
25–99 EPs; 100+ EPs (if
Consumer Assessment of
Healthcare Providers and
Systems (CAHPS) for
PQRS does not apply).
Individual
GPRO
Measures in
the Web
Interface.
Web Interface
12-month (Jan
1–Dec 31,
2016).
25–99 EPs that elect CAHPS
for PQRS; 100+ EPs (if
CAHPS for PQRS applies).
Individual
GPRO
Measures in
the Web
Interface +
CAHPS for
PQRS.
Web Interface
+ CMS-Certified Survey
Vendor.
12-month (Jan
1–Dec 31,
2016).
2–99 EPs; 100+ EPs (if
CAHPS for PQRS does not
apply).
Individual
Measures.
Qualified Registry.
12-month (Jan
1–Dec 31,
2016).
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12-month (Jan
1–Dec 1,
2016).
2–99 EPs that elect CAHPS
for PQRS; 100+ EPs (if
CAHPS for PQRS applies).
Individual
Measures +
CAHPS for
PQRS.
Qualified Registry + CMSCertified
Survey Vendor.
12-month (Jan
1–Dec 31,
2016).
2–99 EPs; 100+ EPs (if
CAHPS for PQRS does not
apply).
Individual
Measures.
Direct EHR
Product or
EHR Data
Submission
Vendor
Product.
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Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
34099
TABLE 19—SUMMARY OF REQUIREMENTS FOR THE 2018 PQRS PAYMENT ADJUSTMENT: GROUP PRACTICE REPORTING
CRITERIA FOR SATISFACTORY REPORTING OF QUALITY MEASURES DATA VIA THE GPRO—Continued
Reporting
period
Group practice size
Measure type
Reporting
mechanism
Satisfactory reporting criteria
12-month (Jan
1–Dec 31,
2016).
2–99 EPs that elect CAHPS
for PQRS; 100+ EPs (if
CAHPS for PQRS applies).
Individual
Measures +
CAHPS for
PQRS.
Direct EHR
Product or
EHR Data
Submission
Vendor
Product +
CMS-Certified Survey
Vendor.
12-month (Jan
1–Dec 31,
2016).
2+ EPs ...................................
Individual
PQRS
measures
and/or nonPQRS
measures
reportable
via a QCDR.
QCDR ............
The group practice must have all CAHPS for PQRS survey
measures reported on its behalf via a CMS-certified survey vendor, and report at least 6 additional measures,
outside of CAHPS for PQRS, covering at least 2 of the
NQS domains using the direct EHR product or EHR data
submission vendor product. If less than 6 measures apply
to the group practice, the group practice must report all of
the measures for which there is Medicare patient data. Of
the additional 6 measures that must be reported in conjunction with reporting the CAHPS for PQRS survey
measures, a group practice would be required to report
on at least 1 measure for which there is Medicare patient
data.
Report at least 9 measures available for reporting under a
QCDR covering at least 3 of the NQS domains, AND report each measure for at least 50 percent of the group
practice’s patients. Of these measures, the group practice
would report on at least 2 outcome measures, OR, if 2
outcomes measures are not available, report on at least 1
outcome measures and at least 1 of the following types of
measures—resource use, patient experience of care, efficiency/appropriate use, or patient safety.
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3. Proposed Modifications to the
Satisfactory Reporting Criteria for
Individual EPs and Group Practices for
the 2018 PQRS Payment Adjustment
Since we finalized these
requirements, we have heard from
stakeholders that EPs have had
difficulty with the previously finalized
satisfactory reporting criteria for the CY
2016 reporting period, which is the final
reporting period for the PQRS.
Specifically, we have heard from
stakeholders through written
communications to CMS that EPs have
found the requirements complex, and
had difficulty in understanding the
requirements to be a satisfactory
reporter for PQRS. Stakeholders have
also requested that the requirements for
the CY 2016 reporting period be aligned
with those of the Quality Payment
Program, specifically the Merit-based
Incentive Payment System (MIPS). In
particular, we have heard requests to
lower the previously finalized
requirement from 9 measures across 3
NQS domains, where applicable, to only
6 measures with no domain requirement
associated with these measures. While
the PQRS and the MIPS are separate
programs, we understand that
stakeholders would like to see greater
continuity between the final year of the
PQRS and the beginning of the MIPS.
The final reporting period for the
PQRS was CY 2016. The Quality
Payment Program, authorized by the
Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA),
consolidates and replaces three existing
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programs (the Medicare EHR Incentive
Program for EPs, the PQRS, and the
Value-Based Payment Modifier (VM)).
There are two ways eligible clinicians
can participate in this program: (1)
Through the MIPS; and (2) through
Advanced Alternative Payment Models
(APMs). The initial performance period
for the MIPS began on January 1, 2017.
Under MIPS, there are four connected
pillars that affect how MIPS eligible
clinicians will be paid by Medicare:
Quality; Improvement Activities;
Advancing Care Information; and Cost.
For more information on the Quality
Payment Program, see https://
qpp.cms.gov/.
While we understand that the data
submission period for the CY 2016
reporting period has already ended and
that all data that has been submitted to
CMS is based on the previously
finalized satisfactory reporting criteria
for the CY 2016 reporting period, we are
revisiting our previously finalized
policy because we want individual EPs
and groups to be assessed for purposes
of the 2018 PQRS payment adjustment
based on satisfactory reporting criteria
that are simpler, more understandable,
and more consistent with the beginning
of MIPS. We believe that such criteria
will help clinicians more accurately
gauge their readiness for the beginning
of MIPS and transition into the Quality
Payment Program successfully.
Additionally, we want to be responsive
to the concerns of the clinician
community. Therefore, while we are not
proposing to collect any additional data
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for the CY 2016 reporting period, we are
proposing to modify the criteria we
would apply to the data already
submitted for the CY 2016 reporting
period to determine whether an
individual EP or group practice has
satisfactorily reported for purposes of
avoiding the 2018 PQRS payment
adjustment. Specifically, we are
proposing to revise the previously
finalized satisfactory reporting criteria
for the CY 2016 reporting period to
lower the requirement from 9 measures
across 3 NQS domains, where
applicable, to only 6 measures with no
domain or cross-cutting measure
requirement. For individual EPs, this
would apply to the following reporting
mechanisms: claims, qualified registry
(except for measures groups), QCDR,
direct EHR product and EHR data
submissions vendor product. This
proposal would not affect the criteria
used to determine whether an
individual EP or group practice has
satisfactorily reported for purposes of
avoiding the 2017 PQRS payment
adjustment, with the exception of the
criteria applicable to individual EPs and
group practices reporting using the
secondary reporting period established
under § 414.90(j)(1)(ii) for the 2017
PQRS payment adjustment (hereinafter
referred to as the ‘‘ACO Secondary
Reporting Period’’), as discussed in
section III.F.4. of this proposed rule.
Table 20 summarizes our proposed
modifications to the previously
finalized satisfactory reporting criteria
for individual EPs to avoid the 2018
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Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
PQRS payment adjustment, based on
data previously submitted for the CY
2016 reporting period. We are not
proposing to collect any additional data
for the CY 2016 reporting period, as the
data submission period for the CY 2016
reporting period has already ended. As
summarized in Table 20, the NQS
domain requirement would no longer
apply. No changes are being proposed
for the measures groups criteria.
Additionally, we are also proposing
that individual EPs and group practices
reporting via claims or qualified
registry, as applicable, would no longer
be required to report a cross-cutting
measure and that individual EPs and
group practices reporting via QCDR
would no longer be required to report an
outcome or ‘‘high priority’’ measure
(that is, for purposes of PQRS, a
resource use, patient experience of care,
efficiency/appropriate use, or patient
safety measure). We note that what is
considered to be a ‘‘high-priority’’
measure in PQRS is different from what
is considered a ‘‘high-priority’’ measure
in MIPS, and we are not proposing to
align this requirement with MIPS for the
last year of PQRS as this could cause
confusion. While certain MIPS eligible
clinicians are required to report at least
one outcome or other high-priority
measure (see § 414.1335(a)(1)(i)), we are
also not aligning with that requirement
because, while we agree that outcome
and high-priority measures are valuable
for reporting, we want to revise the
satisfactory reporting criteria for the last
year of PQRS to be less complex for
individual EPs and groups to
understand.
Lastly, where we are proposing to
lower the requirement to only 6
measures, if less than 6 measures apply
to the individual EP or group practice,
each measure that is applicable would
need to have been reported. We define
‘‘applicable’’ to mean measures relevant
to a particular individual EP’s or group
practice’s services or care rendered. As
previously finalized, individual EPs and
group practices would continue to be
subject to the measure application
validity (MAV) process (80 FR 71140
through 71145). The MAV process seeks
to identify clinically similar measures
and creates clusters of measures that can
be reported if one of the measures in the
cluster is reported. We would maintain
the requirement that each required
measure be reported for at least 50
percent of the individual EP’s or group
practice’s patients to which the measure
applies.
TABLE 20—SUMMARY OF PROPOSED MODIFICATIONS TO THE REQUIREMENTS FOR THE 2018 PQRS PAYMENT ADJUSTMENT: INDIVIDUAL REPORTING CRITERIA FOR THE SATISFACTORY REPORTING OF QUALITY MEASURES DATA VIA
CLAIMS, QUALIFIED REGISTRY, AND EHRS AND SATISFACTORY PARTICIPATION CRITERION IN QCDRS
Measure type
Reporting mechanism
Proposed satisfactory reporting criteria
12-month (Jan 1– ................
Dec 31, 2016) ......................
Individual Measures ..........
Claims ................................
12-month (Jan 1– ................
Dec 31, 2016) ......................
Individual Measures ..........
Qualified Registry ..............
12-month (Jan 1– ................
Dec 31, 2016) ......................
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Reporting
period
Individual Measures ..........
Direct EHR Product or
EHR Data Submission
Vendor Product.
12-month (Jan 1– ................
Dec 31, 2016) ......................
12-month (Jan 1– ................
Dec 31, 2016) ......................
Measures Groups ..............
Qualified Registry ..............
Report at least 6 measures, AND report each measure for at least 50 percent of the EP’s Medicare Part
B FFS patients seen during the reporting period to
which the measure applies. If less than 6 measures
apply to the EP, the EP must report on each measure that is applicable, AND report each measure for
at least 50 percent of the Medicare Part B FFS patients seen during the reporting period to which the
measure applies. Measures with a 0 percent performance rate will not be counted (unless they are
inverse measures where a lower rate reflects better
performance).
Report at least 6 measures, AND report each measure for at least 50 percent of the EP’s Medicare Part
B FFS patients seen during the reporting period to
which the measure applies. If less than 6 measures
apply to the EP, the EP must report on each measure that is applicable, AND report each measure for
at least 50 percent of the Medicare Part B FFS patients seen during the reporting period to which the
measure applies. Measures with a 0 percent performance rate will not be counted (unless they are
inverse measures where a lower rate reflects better
performance).
Report at least 6 measures. If an EP’s direct EHR
product or EHR data submission vendor product
does not contain patient data for at least 6 measures, then the EP must report all of the measures
for which there is Medicare patient data. An EP
must report on at least 1 measure for which there is
Medicare patient data.
No proposed changes.
Individual ...........................
PQRS measures and/or
non-PQRS measures reportable via a QCDR.
QCDR ................................
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Report at least 6 measures available for reporting
under a QCDR AND report each measure for at
least 50 percent of the EP’s patients seen during
the reporting period to which the measure applies. If
less than 6 measures apply to the EP, the EP must
report on each measure that is applicable, AND report each measure for at least 50 percent of the
EP’s patients.
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Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
Accordingly, we are proposing to
revise § 414.90(j)(8) and (k)(5) consistent
with our proposals above. We believe
these proposals will result in fewer
individual EPs being subject to the 2018
PQRS payment adjustment, and will
impose no additional burden on
individual EPs because this data has
already been submitted to CMS. We
request comment on these proposals.
As discussed above, while we are not
proposing to collect any additional data
for the CY 2016 reporting period, we are
proposing to modify the satisfactory
reporting criteria for the CY 2016
reporting period for purposes of the
2018 PQRS payment adjustment.
Specifically, we are proposing to lower
the requirement from 9 measures across
3 NQS domains, where applicable, to
only 6 measures with no domain or
cross-cutting measure requirement. For
group practices, this would apply to the
following reporting mechanisms:
Qualified registry; QCDR; direct EHR
product; and EHR data submissions
vendor product. This proposal would
not affect the criteria used to determine
whether an individual EP or group
practice has satisfactorily reported for
purposes of avoiding the 2017 PQRS
payment adjustment, with the exception
of the criteria applicable to individual
EPs and group practices reporting using
the ACO Secondary Reporting Period, as
discussed in section III.F.4. of this
proposed rule.
Table 21 summarizes our proposed
modifications to the previously
finalized satisfactory reporting criteria
for group practices to avoid the 2018
PQRS payment adjustment, based on
data previously submitted for the CY
2016 reporting period. We are not
proposing to collect any additional data
for the CY 2016 reporting period, as the
data submission period for the CY 2016
reporting period has already ended. As
summarized in Table 21, the NQS
domain requirement would no longer
apply. No changes are being proposed
for the Web Interface criteria.
Additionally, as discussed above, we
are proposing that individual EPs and
group practices reporting via claims and
qualified registry, as applicable, would
no longer be required to report a crosscutting measure and that individual EPs
and group practices reporting via QCDR
would no longer be required to report an
outcome or high priority measure. We
note that what is considered to be a
‘‘high-priority’’ measure in PQRS is
different from what is considered a
‘‘high-priority’’ measure in MIPS, and
are not proposing to align this
requirement with MIPS for the last year
of PQRS as this could cause confusion.
While certain MIPS eligible clinicians
are required to report at least one
outcome or other high-priority measure
(see § 414.1335(a)(1)(i)), we are also not
aligning with that requirement because,
while we agree that outcome and highpriority measures are valuable for
reporting, we want to revise the
satisfactory reporting criteria for the last
year of PQRS to be less complex for
individual EPs and groups.
Where we are proposing to lower the
requirement to only 6 measures, if less
than 6 measures apply to the individual
EP or group practice, each measure that
is applicable would need to have been
reported. We define ‘‘applicable’’ to
mean measures relevant to a particular
34101
individual EP’s or group practice’s
services or care rendered. As previously
finalized, individual EPs and group
practices would continue to be subject
to the MAV process (80 FR 71140
through 71145). The MAV process seeks
to identify clinically similar measures
and creates clusters of measures that can
be reported if one of the measures in the
cluster is reported. We would maintain
the requirement that each required
measure be reported for at least 50
percent of the individual EP’s or group
practice’s patients to which the measure
applies.
Lastly, for purposes of the 2018 PQRS
payment adjustment, § 414.90(j)(9)(viii)
currently provides that if the CAHPS for
PQRS survey is applicable to the
practice, group practices comprised of
100 or more eligible professionals that
register to participate in the GPRO must
administer the CAHPS for PQRS survey,
regardless of the GPRO reporting
mechanism selected. For the reasons
discussed above, we are proposing to
revise § 414.90(j)(9)(viii) to provide that
such group practices may administer the
CAHPS for PQRS survey, regardless of
the GPRO reporting mechanism
selected, but are not required to do so.
This change would be consistent with
the data submission criteria for the
MIPS quality performance category,
under which groups may voluntarily
elect to participate in the CAHPS for
MIPS survey (see § 414.1335(a)(3)(i)). As
summarized in Table 21, the previously
finalized satisfactory reporting criteria
for group practices administering the
CAHPS for PQRS survey would
continue to apply to group practices that
elected to administer the survey.
TABLE 21—SUMMARY OF PROPOSED MODIFICATIONS TO THE REQUIREMENTS FOR THE 2018 PQRS PAYMENT ADJUSTMENT: GROUP PRACTICE REPORTING CRITERIA FOR SATISFACTORY REPORTING OF QUALITY MEASURES DATA VIA
THE GPRO
Reporting
mechanism
Group practice size 3
Measure type
12-month (Jan 1–Dec
31,2016).
12-month (Jan 1–Dec
31,2016).
25+ EPs .......................
12-month (Jan 1–Dec
31,2016).
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Reporting period
2+ EPs .........................
Individual GPRO Measures in the
Web Interface.
Individual GPRO Measures in the
Web Interface+ CAHPS for
PQRS.
Individual Measures ........................
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25+ EPs that elect
CAHPS for PQRS.
00:24 Jul 21, 2017
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Proposed satisfactory reporting criteria
Web Interface ..............
No proposed changes.
Web Interface + CMSCertified Survey Vendor..
Qualified Registry .........
No proposed changes.
Sfmt 4702
E:\FR\FM\21JYP2.SGM
Report at least 6 measures AND report each
measure for at least 50 percent of the
group’s Medicare Part B FFS patients seen
during the reporting period to which the
measure applies. If less than 6 measures
apply to the group, the group practice must
report on each measure that is applicable,
AND report each measure for at least 50 percent of the Medicare Part B FFS patients
seen during the reporting period to which the
measure applies. Measures with a 0 percent
performance rate will not be counted (unless
they are inverse measures where a lower
rate reflects better performance).
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Federal Register / Vol. 82, No. 139 / Friday, July 21, 2017 / Proposed Rules
TABLE 21—SUMMARY OF PROPOSED MODIFICATIONS TO THE REQUIREMENTS FOR THE 2018 PQRS PAYMENT ADJUSTMENT: GROUP PRACTICE REPORTING CRITERIA FOR SATISFACTORY REPORTING OF QUALITY MEASURES DATA VIA
THE GPRO—Continued
Reporting period
Group practice size 3
Reporting
mechanism
Measure type
Measures+CAHPS
Proposed satisfactory reporting criteria
12-month (Jan 1–Dec
31,2016).
2+ EPs that elect
CAHPS for PQRS.
Individual
PQRS.
for
Qualified
Registry+CMS-Certified Survey Vendor.
12-month (Jan 1–Dec
31,2016)..
2+ EPs .........................
Individual Measures ........................
Direct EHR Product or
EHR Data Submission Vendor Product.
12-month (Jan 1–Dec
31,2016)..
2+ EPs that elect
CAHPS for PQRS.
Individual
PQRS.
Direct EHR Productor
EHR Data Submission Vendor
Product+CMS-Certified Survey Vendor.
12-month (Jan 1–Dec
31,2016).
2+ EPs .........................
Individual PQRS measures and/or
non-PQRS measures reportable
via a QCDR.
Measures+CAHPS
for
QCDR ..........................
The group practice must have all CAHPS for
PQRS survey measures reported on its behalf via a CMS-certified survey vendor. In addition, the group practice must report at least
3 additional measures using the qualified registry AND report each measure for at least 50
percent of the group’s Medicare Part B FFS
patients seen during the reporting period to
which the measure applies. If less than 3
measures apply to the group practice, the
group practice must report on each measure
that is applicable, AND report each measure
for at least 50 percent of the Medicare Part B
FFS patients seen during the reporting period
to which the measure applies. Measures with
a 0 percent performance rate will not be
counted (unless they are inverse measures
where a lower rate reflects better performance).
Report 6 measures. If the group practice’s direct EHR product or EHR data submission
vendor product does not contain patient data
for at least 6 measures, then the group practice must report all of the measures for which
there is Medicare patient data. A group practice must report on at least 1 measure for
which there is Medicare patient data.
The group practice must have all CAHPS for
PQRS survey measures reported on its behalf via a CMS-certified survey vendor. In addition, the group practice must report at least
3 additional measures using the direct EHR
product or EHR data submission vendor
product. If less than 3 measures apply to the
group practice, the group practice must report all of the measures for which there is patient data. Of the additional 3 measures that
must be reported in conjunction with reporting the CAHPS for PQRS survey measures,
a group practice must report on at least 1
measure for which there is Medicare patient
data.
Report at least 6 measures available for reporting under a QCDR AND report each measure
for at least 50 percent of the group practice’s
patients seen during the reporting period to
which the measure applies. If less than 6
measures apply to the group practice, the
group practice must report on each measure
that is applicable, AND report each measure
for at least 50 percent of the group practice’s
patients.
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3 Please note that the group practice size descriptions have been revised for greater consistency with our proposal to make the CAHPS for
PQRS survey voluntary.
Accordingly, we are proposing to
revise § 414.90(j)(9) and (k)(5) consistent
with our proposals above. We believe
these proposals will result in fewer
group practices being subject to the
2018 PQRS payment adjustment, and
will impose no additional burden on
group practices because this data has
already been submitted to CMS. We
request comment on these proposals.
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4. Accountable Care Organization (ACO)
Participants Who Report PQRS Quality
Measures Separately During the
Secondary Reporting Period
As discussed in the CY 2017 PFS final
rule (81 FR 80441 through 80445),
individual EPs and group practices who
bill under the TIN of an ACO
participant may report separately from
the ACO, if the ACO failed to report on
behalf of such individual EPs or group
practices for the applicable reporting
period, during the CY 2016 reporting
period for purposes of the 2017 and
2018 PQRS payment adjustments, as
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Sfmt 4702
applicable. Please note that, in
accordance with our previously
established policies for the ACO
Secondary Reporting Period, our
proposed modifications to the
satisfactory reporting criteria for
individual EPs and group practices for
the CY 2016 reporting period would
apply to such individual EPs and group
practices for purposes of the 2017 PQRS
payment adjustment. This proposal
would not affect the 2017 PQRS
payment adjustment for any other
individual EP or group practice.
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5. Physician Compare Downloadable
Database—Addition of Value Modifier
(VM) Data
We previously finalized in the CY
2016 PFS final rule (80 FR 71129
through 71130) a decision to publicly
report three data points for the 2018 VM
based on 2016 data in the Physician
Compare downloadable file in late 2017:
• 2018 VM quality tiers for cost and
quality, based on the 2016 data, noting
if the EP or group is high, low, or
average on cost and quality per the VM.
• A notation of the payment
adjustment received based on the cost
and quality tiers—upward, downward,
or neutral—for each EP or group.
• An indication if the EP or group
was eligible to but did not report quality
measures to CMS for CY 2016 under
PQRS.
In light of the proposals to change the
2016 reporting criteria to avoid the 2018
payment adjustment for PQRS (see
section III.F. of this proposed rule) and
subsequent VM proposed policies to
hold all physician groups and solo
practitioners who met minimum quality
reporting requirements harmless from
downward payment adjustments for
performance under quality-tiering for
the last year of the program (see section
III.I. of this proposed rule), and because
the proposed policies for PQRS and VM
in this rule would change the nature of
how the PQRS data will be used under
the VM, we are now proposing not to
report this data specific to the VM.
Given the fact that VM data would be
available for posting in the Physician
Compare downloadable database for
only one year and the VM data may not
reflect an EP or group’s actual
performance or payment adjustment
given they could have chosen to report
fewer measures, we believe that
proceeding with the posting of this data
could be confusing for the public.
Additionally, we have created other
VM data files intended to promote
transparency. For each VM performance
year, we will publish a Public Use File
(PUF) that contains VM performance
results of de-identified practices.
Supporting documentation for each PUF
that contains the field name, length,
type, label, description, and notes for
each variable included in the PUF. The
Value Modifier program years 2015 and
2016 (performance year 2013 and 2014)
are currently available at https://
www.cms.gov/Research-Statistics-Dataand-Systems/Statistics-Trends-andReports/VMPUF/Value-ModifierPUF.html. In addition, three Research
Identifiable Files (RIFs) for Value
Modifier program years 2015 and 2016
(performance year 2013 and 2014) are
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00:24 Jul 21, 2017
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available through the Research Data
Assistance Center (ResDAC) and will be
made available for each program year.
These files include a practice-level, an
NPI-practice level, and a beneficiarylevel file, as described at: https://
www.resdac.org/news/cms-creates-setrif-data-files-support-value-basedpayment-modifier-program/2017/06.
All other previously finalized policies
related to 2016 PQRS data available for
public reporting on Physician Compare
in late 2017 remain unchanged (80 FR
71116 through 71132). Appreciating
this, we believe the best course of action
is to not move forward with publicly
reporting this VM data for 2016. All data
required to be reported by law will
remain available for public reporting as
previously finalized (80 FR 71116
through 71132). For more information
on the public reporting policies
previously finalized and proposed for
MIPS, we refer readers to the 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 77390 through 77399) and
Medicare Program; CY 2018 Updates to
the Quality Payment Program (82 FR
30163 through 30170), respectively. We
request comment on this proposal and
specifically, if we were to release this
data, how it could be used by the
public.
G. Clinical Quality Measurement for
Eligible Professionals Participating in
the Electronic Health Record (EHR)
Incentive Program for 2016
1. Background
Sections 1848(o), 1853(l) and (m),
1886(n), and 1814(l) of the Act provide
the statutory basis for the Medicare
incentive payments made to eligible
professionals (EPs), Medicare Advantage
(MA) organizations (for certain
qualifying EPs and hospitals),
subsection (d) hospitals, and critical
access hospitals (CAHs) that
demonstrate meaningful use of certified
electronic health record (EHR)
technology (CEHRT). Sections
1848(a)(7), 1853(l) and (m),
1886(b)(3)(B), and 1814(l) of the Act also
establish downward adjustments to
Medicare payments, beginning with
calendar or fiscal year (FY) 2015, for
EPs, MA organizations, subsection (d)
hospitals, and CAHs that are not
meaningful users of CEHRT for certain
associated reporting periods. Sections
1903(a)(3)(F) and 1903(t) of the Act
provide the statutory basis for the
Medicaid incentive payments made to
EPs and eligible hospitals for the
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34103
adoption, implementation, upgrade, and
meaningful use of CEHRT. We have
implemented these statutory provisions
in prior rulemakings to establish the
Medicare and Medicaid EHR Incentive
Programs.
Under these statutory provisions and
the regulations at 42 CFR 495.4, one of
the requirements of being a meaningful
EHR user is successfully reporting the
clinical quality measures selected by
CMS to CMS or the states, as applicable,
in the form and manner specified by
CMS or the states, as applicable. Section
1848(o)(2)(B)(iii) of the Act requires that
in selecting clinical quality measures
(CQMs) for EPs to report under the EHR
Incentive Program, and in establishing
the form and manner of reporting, the
Secretary shall seek to avoid redundant
or duplicative reporting otherwise
required, including reporting under
section 1848(k)(2)(C) of the Act (the
Physician Quality Reporting System).
As such, we have taken steps to
establish alignments among various
quality reporting and payment programs
that include the submission of CQMs.
2. Clinical Quality Measure (CQM)
Requirements for Meaningful Use in
2016
Under sections 1848(o)(2)(A)(iii) and
1903(t)(6)(C)(i)(II) of the Act and the
definition of ‘‘meaningful EHR user’’ at
§ 495.4, EPs must report on CQMs
selected by CMS using CEHRT, as part
of being a meaningful EHR user under
the Medicare and Medicaid EHR
Incentive Programs. In the final rule
titled ‘‘Medicare and Medicaid
Programs; Electronic Health Record
Incentive Program—Stage 3 and
Modifications to Meaningful Use in
2015 Through 2017,’’ we finalized the
options for CQM submission for EPs in
the Medicare EHR Incentive Program in
2016 as follows (80 FR 62888 through
62889):
• EP Options for Medicare EHR
Incentive Program Participation (single
program Participation—EHR Incentive
Program only):
++ Option 1: Attest to CQMs through
the EHR Registration & Attestation
System.
++ Option 2: Electronically report
CQMs through Physician Quality
Reporting System (PQRS) Portal.
• EP Options for Electronic Reporting
for Multiple Programs (for example:
EHR Incentive Program plus PQRS
participation):
++ Option 1: Report individual EP’s
CQMs through PQRS Portal.
++ Option 2: Report group’s CQMs
through PQRS Portal.
(NOTE: Under option 2, this may
include an EP reporting using the group
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reporting option, either electronically
using QRDA, or via the GPRO Web
Interface.)
For the Medicaid EHR Incentive
Program, we specified (80 FR 62888)
that states would continue to be
responsible for determining whether
and how electronic reporting of CQMs
would occur, or if they wish to allow
reporting through attestation. Any
changes that states make to their CQM
reporting methods must be submitted
through the state Medicaid Health IT
Plan (SMHP) process for our review and
approval prior to being implemented.
We maintained a requirement that EPs
report 9 CQMs covering at least 3 NQS
domains (80 FR 62888 through 62889).
This requirement was established in the
final rule titled ‘‘Medicare and Medicaid
Programs; Electronic Health Record
Incentive Program—Stage 2’’ (77 FR
54058).
We also continued (80 FR 62888
through 62889) our existing policy that
under Medicare, healthcare providers in
any year of participation for the EHR
Incentive Program for 2015 through
2017 may electronically report CQM
data using the options previously
outlined for electronic reporting either
for single program participation in the
Medicare EHR Incentive Program, or for
participation in multiple programs if the
requirements of the aligned quality
program are also met.
We noted that an EHR certified for
CQMs under the 2014 Edition
certification criteria does not need to be
recertified each time it is updated to a
more recent version of the eCQMs (80
FR 62889).
3. CQM Requirements for EPs and
Groups Under the Medicare EHR
Incentive Program in 2016
As we discussed in section III.F. in
this proposed rule, since we finalized
these requirements, we have heard from
stakeholders through written
communications that EPs and groups
have found the previously finalized
reporting criteria for the CY 2016
reporting period to be complex and had
difficulty in understanding the
requirements to be a satisfactory
reporter, and these same EPs and groups
subsequently requested that the CQM
reporting requirements for EPs and
groups participating in the Medicare
EHR Incentive Program in 2016 who
chose to report CQMs electronically
through the Physician Quality Reporting
System (PQRS) Portal be aligned with
those of the Quality Payment Program,
specifically the Merit-based Incentive
Payment System (MIPS).
Therefore, while we are not proposing
to collect any additional data for 2016,
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we are proposing to change the
reporting criteria for EPs and groups
who chose to electronically report
CQMs through the PQRS Portal for
purposes of the Medicare EHR Incentive
Program. Specifically, we are proposing
to change the reporting criteria from 9
CQMs covering at least 3 NQS domains
to 6 CQMs with no domain requirement.
We are proposing this change so that the
reporting criteria for the Medicare EHR
Incentive Program would be in
alignment with the modified
requirement that we are proposing for
the final PQRS reporting period (2016)
in section III.F. of this proposed rule, as
well as the transition year of the Quality
Payment Program. We are proposing
that an EP or group who satisfies the
proposed reporting criteria may qualify
for the 2016 incentive payment under
section 1848(o) of the Act and may
avoid the downward payment
adjustment in 2017 and/or 2018 under
section 1848(a)(7)(A) of the Act,
depending on the EP or group’s
applicable EHR reporting period for the
payment adjustment year. This
proposed change would help maintain
alignment with PQRS per the
requirement under section
1848(o)(2)(B)(iii) of the Act for the
Secretary to seek to avoid redundant or
duplicative reporting otherwise
required, including reporting under
section 1848(k)(2)(C) of the Act (the
PQRS). We are not proposing to change
the previously finalized requirements
for CQM reporting in 2016 for eligible
hospitals and CAHs; or the previously
finalized requirements for EPs who
chose to report CQMs through
attestation in 2016 for the Medicare EHR
Incentive Program (80 FR 62888). Our
reasoning for not proposing to change
the eligible hospital or CAH
requirements for CQM reporting is
because the changes proposed for PQRS
in section III.F. of this proposed rule
and the policies established for the
transition year of the Quality Payment
Program would only affect clinicians
and groups, and therefore, there is no
reason to propose changes to the
established policy for eligible hospitals
or CAHs. We are not proposing to
change the requirements for EPs who
reported CQMs through attestation
because those who attested were
successful, therefore we believe there is
no need to change the requirement.
Additionally, the Registration and
Attestation portal is scheduled to sunset
as of October 1, 2017 before this final
rule is published.
Lastly, we are also not proposing to
change the previously finalized
requirements for 2016 for EPs
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participating in the Medicaid EHR
Incentive Program. We have already
proposed in ‘‘Medicare Program;
Hospital Inpatient Prospective Payment
Systems for Acute Care Hospitals and
the Long-Term Care Hospital
Prospective Payment System and
Proposed Policy Changes and Fiscal
Year 2018 Rates; Quality Reporting
Requirements for Specific Providers;
Medicare and Medicaid Electronic
Health Record (EHR) Incentive Program
Requirements for Eligible Hospitals,
Critical Access Hospitals, and Eligible
Professionals; Provider-Based Status of
Indian Health Service and Tribal
Facilities and Organizations; Costs
Reporting and Provider Requirements;
Agreement Termination Notices’’ that,
for 2017, Medicaid EPs would be
required to report on any six CQMs that
are relevant to the EP’s scope of practice
(82 FR 20135). In proposing that change,
we indicated that it is our intention to
align CQM requirements for Medicaid
EPs with requirements under the
Medicare quality improvement
programs, to the extent practicable.
However, we believe that due to the
timing of when any changes we might
propose for 2016 through this
rulemaking would take effect (if
finalized), the benefits of proposing to
extend the policy proposed for Medicare
EPs for 2016 to Medicaid EPs for 2016
would not be realized, and the burden
on states to implement such a policy
would be significant. There is no
negative payment adjustment for not
participating in the Medicaid EHR
Incentive Program, so it is likely that
applying the proposed policy for
Medicare EPs to Medicaid EPs for 2016
would benefit Medicaid EPs only if they
are able to submit new data to states for
a Medicaid EHR incentive payment for
2016. Because we anticipate that most
states will have completed processing
and paying 2016 Medicaid EHR
incentive payments by the time such a
proposal (if finalized) would take effect,
we believe that applying this change to
the Medicaid EHR Incentive Program for
2016 would significantly burden states.
We seek comment on our assessment of
the difficulty states might face
implementing this policy for 2016 for
Medicaid EPs, and on the number of
Medicaid EPs who might benefit if we
instead decided to apply this policy in
the Medicaid EHR Incentive Program for
2016, to the extent that doing so would
be legally permissible.
H. Medicare Shared Savings Program
Under section 1899 of the Act, we
established the Medicare Shared
Savings Program (Shared Savings
Program) to facilitate coordination and
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cooperation among health care
providers to improve the quality of care
for Medicare Fee-For-Service (FFS)
beneficiaries and reduce the rate of
growth in expenditures under Medicare
Parts A and B. 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 Program;
Medicare Shared Savings Program:
Accountable Care Organizations; Final
Rule (76 FR 67802) (hereinafter referred
to as the ‘‘November 2011 final rule’’)).
A subsequent major update to the
program rules appeared in the June 9,
2015 Federal Register (Medicare
Program; Medicare Shared Savings
Program: Accountable Care
Organizations; Final Rule (80 FR 32692)
(hereinafter referred to as the ‘‘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) (hereinafter
referred to as the ‘‘June 2016 final
rule’’)). We have also made use of the
annual calendar year (CY) Physician Fee
Schedule (PFS) rules to address quality
reporting and certain other issues. In
addition, in the CY 2017 Quality
Payment Program final rule (81 FR
77255 through 77256), we finalized
policies related to quality performance
category scoring for Merit-Based
Incentive Payment System (MIPS)
eligible clinicians that participate in the
Shared Savings Program. In that final
rule, we adopted an APM scoring
standard that reduces burden for eligible
clinicians that participate in Shared
Savings Program ACOs by using the
same quality data reported by the ACO
using the the CMS web interface for
purposes of the Shared Savings Program
to score the MIPS quality performance
category for these eligible clinicians.
In this CY 2018 PFS proposed rule,
we propose further refinements to the
Shared Savings Program rules. This rule
includes two proposed modifications to
the Shared Savings Program beneficiary
assignment methodology: (1) Revisions
to the assignment methodology under
42 CFR part 425, subpart E to reflect the
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requirement under section 17007 of the
21st Century Cures Act (Pub. L. 114–
255, December 13, 2016), that for
performance years beginning on or after
January 1, 2019, the Secretary determine
an appropriate method to assign
Medicare FFS beneficiaries to an ACO
based on their utilization of services
furnished by rural health clinics (RHCs)
or federally qualified health centers
(FQHCs), and (2) addition of new
chronic care management and BHI
service codes to our definition of
primary care services. In addition, we
propose to revise the methodology used
in our quality validation audits and the
manner in which the results of these
audits may be used to adjust an ACO’s
sharing rate. We also propose to reserve
the discretion to redesignate a measure
reported through the CMS web interface
as pay-for-reporting when substantive
changes are made to the measure under
the Quality Payment Program.
We also address proposals intended to
reduce application burden for
stakeholders by reducing certain
documentation submission
requirements included in the initial
Shared Savings Program application and
the application for use of the skilled
nursing facility (SNF) 3-Day Rule
Waiver. We also propose to establish
specific procedures to address situations
where a Taxpayer Identification Number
(TIN) that is an ACO participant in more
than one ACO begins to submit claims
for services used in the beneficiary
assignment process and becomes out of
compliance with the ‘‘exclusivity’’
requirement in § 425.306(b)(2). Finally,
we propose that, for performance year
2018 and subsequent years, we would
only include individually beneficiary
identifiable payments made under a
demonstration, pilot or time limited
program that are final and not subject to
further reconciliation in financial
calculations related to establishing and
updating benchmarks and determining
performance year expenditures under
the Shared Savings Program.
1. Modifications to the Shared Savings
Program Beneficiary Assignment
Methodology
a. Assignment of Beneficiaries to ACOs
That Include RHCs and/or FQHCs
(1) Background
(a) General Shared Savings Program
Assignment Methodology
As originally enacted in the
Affordable Care Act, section 1899(c) of
the Act requires us to assign FFS
beneficiaries to an ACO participating in
the Shared Savings Program based on
the beneficiary’s utilization of primary
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34105
care services rendered by physicians
participating in the ACO. Medicare FFS
beneficiaries do not enroll in the Shared
Savings Program or with a particular
ACO, and they retain the right to seek
Medicare-covered services from any
Medicare-enrolled provider or supplier
of their choosing. Furthermore, 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
during a prior 12 month period (the
‘‘assignment window’’) furnished by
physicians and certain nonphysician
practitioners that are ACO professionals
in the ACO determines the beneficiary’s
assignment to an ACO under the Shared
Savings Program.
The regulations governing the
assignment methodology under the
Shared Savings Program are in part 425,
subpart E. Consistent with the statutory
requirement to base assignment on the
utilization of primary care services
furnished by physicians who are ACO
professionals, a beneficiary is eligible
for assignment to an ACO under
§ 425.402 if the beneficiary had at least
one primary care service during the
applicable assignment window
furnished by a physician who is an ACO
professional in the ACO and who is a
primary care physician as defined under
§ 425.20 or has one of the primary
specialty designations specified in
§ 425.402(c). This initial process for
determining whether a beneficiary is
eligible for assignment is referred to as
the assignment ‘‘pre-step’’. Under the
first step of the assignment process, a
beneficiary who is eligible for
assignment to the ACO will be assigned
to the ACO if the allowed charges for
primary care services furnished to the
beneficiary during the assignment
window by all primary care physicians
who are ACO professionals and nonphysician ACO professionals in the
ACO are greater than the allowed
charges for such services provided
during the assignment window 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 billing
TIN. The second step of the assignment
process considers the remainder of
beneficiaries who have received at least
one primary care service during the
assignment window from an ACO
physician who is a primary care
physician as defined under § 425.20 or
who has one of the primary specialty
designations specified in § 425.402(c),
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but have received no primary care
services during the assignment window
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 during the assignment
window 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 during the assignment
window by physicians with such
specialty designations who are ACO
professionals in another ACO or who
are not affiliated with any ACO and are
identified by a Medicare-enrolled billing
TIN. Thus, the assignment methodology
simultaneously maintains the statutory
requirement to focus on physician
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.
(b) Retrospective vs Prospective
Assignment
As discussed in detail in the
November 2011 final rule we finalized
a claims-based hybrid approach (called
preliminary prospective assignment
with retrospective reconciliation) for
assigning beneficiaries to an ACO (76
FR 67851 through 67870), which is
currently applicable to ACOs
participating under Track 1 or Track 2
of the Shared Savings Program. Under
this approach, beneficiaries are
preliminarily assigned to an ACO at the
beginning of a performance year and
quarterly thereafter during the
performance year, but the final
beneficiary assignment is determined
after 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 during the performance year
with the ACO’s desire to know in
advance about beneficiaries who have
chosen to receive such services from
practitioners participating in the ACO in
the past and who are likely to continue
to choose to receive such services
during the performance year. Knowing
in advance which beneficiaries are
likely to receive a plurality of their
primary care from ACO practitioners
during the performance year gives ACOs
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greater opportunities to proactively
impact the quality and cost of care for
beneficiaries who may be assigned to
the ACO at the end of the performance
year.
In the June 2015 final rule, and in
response to stakeholders’ suggestions,
we implemented an option for ACOs to
participate in a new two-sided
performance-based risk track, Track 3
(80 FR 32771 through 32781). Under
Track 3, beneficiaries are prospectively
assigned to the ACO at the beginning of
the performance year using the same
two-step methodology described
previously, based on where the
beneficiaries have chosen to receive a
plurality of their primary care services
during a 12-month assignment window
offset from the calendar year that
reflects the most recent 12 months for
which data are available prior to the
start of the performance year. The ACO
is held accountable for beneficiaries
who are prospectively assigned to it for
the performance year. Under limited
circumstances, a beneficiary may be
excluded from the prospective
assignment list during or after the
performance year. For example, a
beneficiary will be excluded from the
prospective assignment list if the
beneficiary enrolls in Medicare
Advantage during the performance year
or no longer lives in the United States
or U.S. territories and possessions,
based on the most recent available data
regarding the beneficiary’s residence at
the end of the performance year. A
beneficiary is not excluded from the
ACO’s prospective assignment list
during the performance year or at the
time of reconciliation for most other
reasons, such as if 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 during the
performance year or at the time of
reconciliation even if they chose to
receive a plurality of their primary care
during the performance year from ACO
professionals participating in the ACO
and were not previously identified on
the prospective assignment list. 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
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effectively improve care for specific FFS
beneficiaries rather than for all FFS
beneficiaries. We note, however, that
such certainty is limited because
prospectively assigned beneficiaries
who meet the exclusion criteria
specified in § 425.401(b) during the
performance year will not be assigned to
the ACO at the end of the year; further,
as noted, beneficiaries remain free
under FFS Medicare to choose the
healthcare providers from whom they
receive services.
Finally, in the CY 2017 Physician Fee
Schedule final rule (81 FR 80501
through 80510), we further enhanced
the claims-based beneficiary assignment
methodology by finalizing a policy to
incorporate data gathered directly from
beneficiaries who designate a ‘‘main
doctor’’ they believe is responsible for
coordinating their overall care.
Beginning in performance year 2017,
beneficiaries may designate a provider
or supplier as responsible for
coordinating their overall care using
MyMedicare.gov, a secure, online,
patient portal. Notwithstanding the
assignment methodology in
§ 425.402(b), beneficiaries who
designate an ACO professional whose
services are used in assignment as
responsible for their overall care will be
prospectively assigned to the ACO in
which that ACO professional
participates, provided the beneficiary
meets the eligibility criteria established
at § 425.401(a) and has had at least one
primary care service during the
assignment window with an ACO
professional in the ACO who is a
primary care physician or a physician
with one of the primary specialty
designations included in § 425.402(c).
Such beneficiaries will be added
prospectively to the ACO’s list of
assigned beneficiaries for the
subsequent performance year.
(c) Special Assignment Conditions for
RHCs and FQHCs
RHCs and FQHCs are facilities that
furnish services that are typically
furnished in an outpatient clinic setting.
Prior to October 1, 2014, FQHCs were
paid an all-inclusive rate (AIR) per visit
for qualified primary and preventive
health services furnished to Medicare
beneficiaries. On October 1, 2014,
FQHCs began to transition to a new
FQHC prospective payment system
(PPS). FQHCs were required to use
HCPCS coding on all their claims
starting on January 1, 2011, to inform
the development of the PPS and for
limited other purposes, and are now
required to use HCPCS coding for
payment purposes under the FQHC PPS.
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RHCs are paid an AIR per visit for
qualified primary and preventive health
services furnished to Medicare
beneficiaries. Prior to April 1, 2016,
RHCs were required to report HCPCS
codes for a few services, such as certain
preventive services eligible for a waiver
of the deductible and/or coinsurance,
services subject to frequency limits, and
services eligible for payments in
addition to the AIR. Effective April 1,
2016, all RHCs are required to report the
appropriate HCPCS code for each
service furnished during the visit, along
with the appropriate revenue code (For
additional background, please see the
CMS Web site at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/FQHCPPS/Downloads/RHCReporting-FAQs.pdf).
As we noted in the November 2011
final rule, RHC and FQHC claims
contain very limited information
concerning the individual practitioner,
or even the type of health professional
(for example, physician, PA, or NP) who
provided the service because this
information is not necessary to
determine payment rates for services in
RHCs and FQHCs s (76 FR 67858
through 67861). Therefore, unlike
physician fee schedule claims, there is
no direct way for us to determine if a
claim was for a service furnished by a
physician at the RHC or FQHC.
In spite of the difference in claims
billing, based on detailed comments
from some RHC and FQHC
representatives, in the November 2011
final rule, we established a process that
allows primary care services furnished
in RHCs and FQHCs to be considered in
the assignment process for any ACO that
includes an RHC or FQHC as an ACO
participant. This process is set forth in
§ 425.404. We assign beneficiaries to
ACOs that include RHCs or FQHCs as
ACO participants in a manner generally
consistent with how we assign
beneficiaries to other ACOs based on
primary care services performed by
certain physicians and non-physician
practitioners who are ACO professionals
in the ACO, as described previously.
However, to address the requirement
under section 1899(c) of the Act that
beneficiaries be assigned to an ACO
based on their use of primary care
services furnished by physicians, we
require ACOs that include RHCs or
FQHCs to identify, through an
attestation, the physicians that directly
provide patient primary care services in
their ACO participant RHCs or FQHCs
(see §§ 425.204(c)(5)(iii) and 425.404(a)).
We use the combination of the RHC or
FQHC ACO participant TIN (and
another unique identifier, such as a
CCN, where appropriate) and the NPIs
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of the RHC or FQHC physicians
provided to us through the attestation
process to identify those beneficiaries
who received a primary care service
from a physician in the RHC or FQHC
and who are therefore eligible to be
assigned to the ACO as provided under
§ 425.402(b)(1), which we refer to as the
assignment ‘‘pre-step’’. Then, we assign
those beneficiaries to the ACO, using
the step-wise assignment methodology
under § 425.402(b), if they received the
plurality of their primary care services,
as determined based on allowed charges
for the HCPCS codes and revenue center
codes included in the definition of
primary care services at § 425.20, from
ACO professionals in the ACO.
The special procedures that we have
established for using RHC and FQHC
services in the assignment methodology
are discussed in detail in the June 2015
final rule (80 FR 32755 through 32756).
RHC and FQHC services are billed on an
institutional claim form and require
special handling to incorporate them
into the beneficiary assignment process.
For RHCs and FQHCs that are ACO
participants, we treat an RHC or FQHC
service reported on an institutional
claim as a primary care service
performed by a primary care physician
if the claim includes a HCPCS or
revenue center code that is included in
the definition of a primary care service
at § 425.20 and the service was
furnished by a physician who was
identified as directly providing primary
care services on the attestation provided
under § 425.404(a). All such physicians
are considered primary care physicians
for purposes of the assignment
methodology and no specialty code is
required for these claims. If the claim is
for a primary care service furnished by
someone other than a physician listed
on the attestation, we treat the service
as a primary care service furnished by
a non-physician ACO professional. As a
result, all primary care services
furnished by an ACO professional in an
RHC or FQHC to a beneficiary eligible
for assignment to the ACO are
considered in step 1 of the assignment
methodology. Finally, for RHCs and
FQHCs that are not ACO participants,
we assume a primary care physician
performed all primary care services so
that all primary care services furnished
by non-ACO RHCs/FQHCs are
considered in step 1 of the assignment
methodology. We believe this approach
helps to ensure that we do not disrupt
established relationships between
beneficiaries and their caregivers in
non-ACO participant RHCs and FQHCs
by inappropriately assigning
beneficiaries to ACOs that are not
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34107
primarily responsible for coordinating
their overall care.
We developed and implemented these
regulatory and operational policies to
facilitate full participation of rural
providers, including RHCs and FQHCs,
in the Shared Savings Program, within
the statutory requirements for the
program. In general, stakeholders have
been appreciative of our policies to
include rural providers and suppliers in
the Shared Savings Program. However,
some stakeholders have expressed
concerns that the special conditions
required for us to consider RHC and
FQHC institutional claims in beneficiary
assignment are burdensome and
discourage ACOs from including RHCs
and FQHCs as ACO participants in the
Shared Savings Program. Stakeholders
have commented that the requirement
for ACOs that include an RHC or FQHC
as an ACO participant to provide an
attestation identifying ACO
professionals who are physicians who
directly furnish primary care services at
the RHC or FQHC is particularly
burdensome. In addition, due to the
operational complexities of collecting
identifying information about ACO
participants, screening them for
program integrity and other potential
issues, and incorporating claims data for
approved ACO participants into
beneficiary assignment and financial
calculations, we have implemented a
policy that limits the addition of entities
to the ACO participant list, absent
unusual circumstances, to an annual
basis. The limitation also applies to
changes to the attestation to identify
additional physicians who directly
furnish primary care services at an ACO
participant RHC or FQHC. In contrast,
when a new ACO professional begins
billing for primary care services under
the TIN of an ACO participant that is
not an RHC or FQHC, those services will
be considered for purposes of
assignment in the current performance
year. As a result, there are a number of
unique burdens and anomalies in the
way in which RHC and FQHC
institutional claims are used for
purposes of assignment under the
Shared Savings Program. First, as noted
by stakeholders, the required attestation
process for submitting physician
identifiers requires more effort to ensure
the accuracy of the ACO participant list
(including the attestation that includes
the physician identifiers) than the level
of effort required for ACOs that do not
include RHCs and FQHCs. Second, we
have recognized that the required
attestation process for submitting
physician identifiers is also prone to
error because some RHCs and FQHCs
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(particularly rural FQHCs) have
multiple locations with potentially
hundreds of NPIs to report which, in
turn, increases the likelihood that ACOs
that include RHCs or FQHCs as ACO
participants will make inadvertent
clerical errors, such as transposing
digits, in submitting the required
information. Errors that are not
identified and corrected by the specified
deadline for additions to the ACO
participant list may result in fewer
claims being considered for purposes of
assignment under the Shared Savings
Program than would otherwise occur.
(2) Proposals
Section 17007 of the 21st Century
Cures Act, amended section 1899(c) of
the Act (42 U.S.C. 1395jjj(c)) to require
the Secretary to assign beneficiaries to
ACOs participating in the Shared
Savings Program based not only on their
utilization of primary care services
furnished by physicians but also on
their utilization of services furnished by
RHCs and FQHCs, effective for
performance years beginning on or after
January 1, 2019. The statute provides
the Secretary with broad discretion to
determine how to incorporate services
provided by RHCs and FQHCs into the
Shared Savings Program beneficiary
assignment methodology.
We believe that the 21st Century
Cures Act provides the Secretary with
broad discretion to revise the
assignment methodology to address the
concerns expressed by certain
stakeholders regarding the burdens
placed on ACOs that include RHCs and
FQHCs as ACO participants, as
described above. Section 17007 of the
21st Century Cures Act provides that for
performance years beginning on or after
January 1, 2019, Medicare services
furnished in an FQHC or RHC should be
considered in beneficiary assignment for
the Shared Savings Program, as may be
determined by the Secretary.
Accordingly, in implementing section
17007 of the 21st Century Cures Act, we
believe it would be appropriate to
reduce operational burdens for ACOs
that include RHCs or FQHCs as ACO
participants and bring greater
consistency to the operational method
of using claims to assign beneficiaries to
ACOs. In order to promote participation
of RHCs and FQHCs under the Shared
Savings Program, we propose to remove
the burdensome attestation requirement
and instead treat a service reported on
an RHC or FQHC institutional claim as
a primary care service furnished by a
primary care physician. Consistent with
the 21st Century Cures Act, under this
proposal: (1) The requirement for an
attestation identifying physicians who
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directly provide primary care services in
each RHC or FQHC that is an ACO
participant and/or ACO provider/
supplier in the ACO would be removed;
(2) all RHC and FQHC claims would be
used to establish beneficiary eligibility
to be assigned to the ACO (pre-step);
and (3) all RHC and FQHC claims would
be included in step 1. We would note
that in considering all services billed
under the TIN of the ACO participant
RHC or FQHC, we would include
services that do not meet the definition
of primary care services, and such
services would not be limited to those
provided by a primary care physician,
as defined under program rules. This
means that under the proposal, a
beneficiary could be furnished services
in an RHC and FQHC only by a nurse
practitioner, physician assistant, clinical
nurse specialist, or any other
practitioner in an RHC and FQHC and
still be eligible for assignment to the
ACO.
More specifically, we are proposing
the following changes to our
regulations: (1) Remove
§ 425.204(c)(5)(iii) in its entirety; (2)
revise § 425.404; and (3) make
conforming changes to the definition of
primary care physician found at
§ 425.20. Under our proposal, for
performance year 2019 and subsequent
performance years, ACOs with ACO
participants that are RHCs and FQHCs
would no longer be required to submit
NPIs or other identifying information for
physicians who directly provide
primary care services in the ACO
participant RHCs and FQHCs as
indicated in § 425.204(c)(5)(iii)(A) and
§ 425.404(a). Therefore we propose to
remove § 425.204(c)(5)(iii) in its
entirety. Additionally, we propose
revisions to § 425.402 and § 425.404 to
reflect that for performance year 2019
and subsequent performance years, we
would assign beneficiaries to ACOs
based on services furnished in RHCs or
FQHCs consistent with the general
assignment methodology in § 425.402,
by treating a service reported on an RHC
or FQHC institutional claim in the same
way as a primary care service performed
by a primary care physician. We also
propose to remove revenue center codes
from the definition of primary care
services (§ 425.20) for performance year
2019 and subsequent performance years
because all RHC and FQHC services will
be used for purposes of assignment for
benchmark and performance years;
therefore, we believe it is appropriate to
modify our definition of primary care
services for performance year 2019 and
subsequent years to no longer include
revenue center codes. Additionally, we
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note that the requirement for an
attestation under § 425.404 is also
referenced in the definition of primary
care physician at § 425.20; accordingly,
we propose to make a conforming
revision to that definition to remove the
reference to the attestation requirement
for performance year 2019 and
subsequent years.
Consistent with how we have
implemented other changes to the
assignment methodology (see, for
example, 80 FR 32757 through 32758),
we propose to adjust all ACO
benchmarks at the start of the first
performance year in which the new
assignment rules are applied so that the
ACO benchmarks reflect the use of the
same assignment rules as will apply in
the performance year. Also consistent
with how we have implemented
previous changes to the Shared Savings
Program assignment methodology, we
would use the new methodology each
time assignment is determined for
purposes of performance year 2019,
including using the new methodology in
late CY 2018 to determine the eligibility
of ACOs wishing to enter into or renew
a participation agreement beginning
January 1, 2019. Under the Shared
Savings Program, ACOs must have and
maintain at least 5,000 assigned
beneficiaries.
We believe this proposal would
reduce administrative burden for ACOs
that include RHCs or FQHCs as ACO
participants and support our policy goal
of assigning beneficiaries to the entity
that is primarily responsible for the
beneficiary’s overall care. That is,
including all services furnished by
RHCs or FQHCs to establish beneficiary
eligibility to be assigned to an ACO (prestep) and in the stepwise assignment
methodology should help to ensure that
a beneficiary is assigned to an ACO
when the ACO participants in that ACO
are providing the plurality of care for
that beneficiary and thus the ACO
should be accountable for the patient’s
overall care.
We welcome comments on our
proposal to: (1) Remove
§ 425.204(c)(5)(iii) and modify § 425.402
and § 425.404, for performance year
2019 and subsequent performance years,
to eliminate the requirement for ACOs
that include an RHC or FQHC as an
ACO participant to provide an
attestation identifying physicians who
directly provide primary care services in
each RHC or FQHC that is an ACO
participant and/or ACO provider/
supplier in the ACO, and make
conforming changes to the definition of
primary care physician at § 425.20; and
(2) for performance year 2019 and
subsequent performance years, to: (a)
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Use all claims submitted by RHCs and
FQHCs in the ‘‘pre-step’’ of the
assignment methodology under
§ 425.402 to determine whether a
beneficiary is eligible for assignment to
an ACO participating in the Shared
Savings Program, (b) treat a service
reported on an RHC or FQHC claim as
if it were a primary care service
performed by a primary care physician,
and (c) remove revenue center codes
from the definition of primary care
services.
We recognize the unique needs and
challenges of rural and underserved
communities and the important role
played by providers and suppliers
serving these communities in assuring
access to primary health care. RHCs,
FQHCs, and other providers furnishing
care in rural and underserved
communities play an important role in
the nation’s health care delivery system
by serving as safety net providers of
primary care and other health care
services, and we believe these proposed
changes will enhance their ability to
participate in the Shared Savings
Program.
We also invite suggestions on how we
might further support participation of
RHCs and FQHCs in the Shared Savings
Program.
b. Revisions to the Definition of Primary
Care Services
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(1) Background
Section 1899(c) of the Act requires the
Secretary to assign beneficiaries to an
ACO ‘‘based on their utilization of
primary care services’’ provided by a
physician. However, the statute does not
specify which kinds of services may be
considered primary care services for this
purpose, nor the amount of those
services that would be an appropriate
basis for making assignments. In this
section of this proposed rule, we
summarize how we currently identify
the appropriate primary care services on
which we base assignment. In addition,
we propose a revision to our current
policies for defining primary care
services for purposes of beneficiary
assignment, consistent with our
statement in the November 2011 final
rule (76 FR 67853), that we intended to
monitor this issue and would consider
making changes to the definition of
primary care services to add or delete
HCPCS codes used to identify primary
care services, if there were sufficient
evidence that revisions were warranted.
We currently define primary care
services for purposes of the Shared
Savings Program in § 425.20 as the set
of services identified by the following
HCPCS/CPT codes: 99201 through
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99215, 99304 through 99318 (excluding
claims including the POS 31 modifier),
99319 through 99340, 99341 through
99350, 99495, 99496, 99490, the
Welcome to Medicare visit (G0402), and
the annual wellness visits (G0438 and
G0439). In addition, we have
established a cross-walk for these codes
to certain revenue center codes used by
FQHCs (for services furnished prior to
January 1, 2011) and RHCs so that their
services can be included in the
beneficiary assignment process. Lastly,
we include G0463 for services furnished
in electing teaching amendment (ETA)
hospitals.
In the November 2011 final rule (76
FR 67853), we established the initial list
of codes that we considered to
constitute primary care services for
several reasons. First, we believed the
listed codes represented a reasonable
approximation of the kinds of services
that are described by the statutory
language which refers to assignment of
‘‘Medicare fee-for-service beneficiaries
to an ACO based on their utilization of
primary care services’’ furnished by
physicians. In addition, we selected this
list to be largely consistent with the
definition of primary care services in
section 5501 of the Affordable Care Act.
That section establishes the Primary
Care Incentive Payment Program to
expand access to primary care services,
and thus its definition of primary care
services provides a compelling
precedent for adopting a similar list of
codes for purposes of the beneficiary
assignment process under the Shared
Savings Program. We slightly expanded
the list of codes found in section 5501
of the Affordable Care Act to include the
Welcome to Medicare visit (HCPCS code
G0402) and the annual wellness visits
(HCPCS codes G0438 and G0439) as
primary care services for purposes of the
Shared Savings Program. These codes
clearly represent primary care services
frequently received by Medicare
beneficiaries, and in the absence of the
special G codes the services provided
during these visits would be described
by one or more of the regular office visit
codes that are included in the list under
Section 5501 of the Affordable Care Act.
In the June 2015 final rule (80 FR
32746 through 32748), we expanded the
definition of primary care services to
include two transitional care
management (TCM) codes (CPT codes
99495 and 99496), and one chronic care
management (CCM) code, (CPT 99490).
As discussed in the final rule, the TCM
codes were established to pay a patient’s
physician or practitioner to coordinate
the patient’s care in the 30 days
following a hospital or skilled nursing
facility (SNF) stay. Including these
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34109
codes in the definition of primary care
services reflects our belief that the work
of community physicians and
practitioners in managing a patient’s
care following discharge from a hospital
or nursing facility to ensure better
continuity of care for these patients and
help reduce avoidable readmissions is a
key aspect of primary care.
In the CY 2017 PFS Final Rule, we
finalized a separate payment for three
additional CCM service codes, CPT
codes 99487 and 99489 (see 81 FR
80251), and an additional add-on code
G0506 (see 81 FR 80245), to support
care management for the most complex
and time-consuming cases of
beneficiaries with multiple chronic
conditions. These codes are used to
report complex CCM services furnished
to patients with multiple (two or more)
chronic conditions. CCM services
generally include regular development
and revision of a plan of care,
communication with other treating
health professionals, and medication
management. We explained in the CY
2017 PFS final rule that we believe the
addition of the complex CCM codes will
retain elements of the CCM service that
are characteristic of the changes in
medical practice toward advanced
primary care, while eliminating
redundancy, simplifying provision of
the services, and improving access to
the services. Additional explanation of
required elements for billing CCM
services can be found in the CY 2017
PFS Final Rule (81 FR 80243 through
80251).
Finally, in the 2017 PFS final rule (81
FR 80230 through 80243), we finalized
a policy to make separate payments to
physicians and non-physician
practitioners for behavioral health
integration (BHI) services they furnish
to beneficiaries over a calendar month
service period using four new Medicare
Part B billing codes. Three of these BHI
codes (G0502, G0503, G0504) are used
to bill for monthly services furnished
using the Psychiatric Collaborative Care
Model (CoCM), an approach to BHI
shown to improve outcomes in multiple
studies. CoCM is a model of BHI that
enhances ‘‘usual’’ primary care by
adding two key services: Care
management support for patients
receiving behavioral health treatment;
and regular psychiatric inter-specialty
consultation to the primary care team,
particularly regarding patients whose
conditions are not improving. The
fourth BHI service code (G0507) is used
to bill monthly services furnished using
BHI models of care other than CoCM
that similarly include ‘‘core’’ service
elements such as systematic assessment
and monitoring, care plan revision for
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patients whose condition is not
improving adequately, and a continuous
relationship with a designated care team
member. The BHI service codes may be
billed by the treating practitioner.
Physicians billing for these services
would typically be primary care
physicians, but may be of another
specialty such as cardiology or
oncology. Non-physician practitioners
(PAs, NPs, CNSs, or CNMs), may also
bill for these services.
(2) Proposals
As discussed above, we previously
finalized the inclusion of CCM code
99490 in the definition of primary care
services for the Shared Savings Program.
For the same reason that we included
CCM code 99490, we believe that it
would be also be appropriate to include
the complex CCM service codes 99487,
99489, and G0506 in the definition of
primary care services and to utilize
these codes in the beneficiary
assignment methodology under the
Shared Savings Program beginning in
2018 for performance year 2019 and
subsequent years. These three
additional CCM codes reflect the
changes in medical practice toward
advanced primary care and differ from
each other only in the amount of
clinical staff service time provided; the
complexity of medical decision-making
as defined in the Evaluation and
Management 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).
In addition, we believe that it would
be also be appropriate to include the
four BHI codes G0502, G0503, G0504
and G0507 in the definition of primary
care services and to utilize these codes
in the beneficiary assignment
methodology under the Shared Savings
Program beginning in 2018 for
performance year 2019 and subsequent
years. These BHI codes reflect important
enhancements in primary care to
support improvement and integration of
care provided for patients receiving
behavioral health treatment. As
discussed above, the BHI service codes
may be billed by the treating
practitioner (a physician and/or nonphysician practitioner (PA, NP, CNS,
CNM)). Physicians billing for these
services would typically be primary care
physicians, but may be of another
specialty such as cardiology or
oncology. (See fact sheet available on
our Web site at https://www.cms.gov/
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Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/
Downloads/Behavioral-HealthIntegration-Fact-Sheet.pdf.)
Therefore, we propose to revise the
definition of primary care services
currently located in § 425.20 to include
three additional CCM service codes
99487, 99489, and G0506, and four BHI
service codes G0502, G0503, G0504 and
G0507, beginning in 2018 for
performance year 2019 and subsequent
performance years and to include these
codes when performing beneficiary
assignment under § 425.402. In
addition, we propose to move the list of
service codes currently listed in the
definition in § 425.20 to § 425.400(c).
We believe § 425.400, which specifies
general requirements related to the
assignment methodology and currently
contains a cross-reference at
§ 425.400(c) to the definition of primary
care services under § 425.20, is the more
appropriate place to specify the
particular primary care codes that will
be considered in the assignment
methodology. We also propose to
reorganize the list of service codes,
grouping HCPCS codes, G codes, and
revenue center codes together,
respectively, by relevant performance
year(s). We seek comments on this
proposal. In addition, we seek
comments as to whether there are any
additional existing HCPCS/CPT codes,
that we should consider adding to the
definition of primary care services in
future rulemaking for purposes of
assignment of beneficiaries to ACOs
under the Shared Savings Program.
We also propose to remove paragraph
(3) from the definition of primary care
services. Paragraph (3) indicates that we
will include additional codes
designated by us as primary care
services, including new HCPCS/CPT
and revenue center codes and any
subsequently modified or replacement
codes for the HCPCS/CPT and revenue
center codes identified in the definition.
We finalized this policy in the June
2015 final rule (80 FR 32746),
explaining that it was intended to
promote flexibility for the Shared
Savings Program and allow us to
respond more quickly to HCPCS/CPT
coding changes made in the annual PFS
rulemaking process. We now believe
this paragraph which directs CMS to
respond to HCPCS/CPT coding changes
though rulemaking is unnecessary
because we always have the flexibility
to propose, through the annual PFS
rulemaking (or other rulemaking for the
Shared Savings Program), to make
changes to the definition of primary care
services to reflect HCPCS/CPT coding
changes made elsewhere in the same
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PFS rulemaking or in a previous PFS
final rule. We therefore believe it would
be reasonable to remove this paragraph
rather than move it to subpart E under
part 425 along with the other paragraphs
making up the definition of primary
care services.
2. ACO Quality Reporting
a. Changes to the Quality Measure Set
Used in Establishing the Quality
Performance Standard
(1) Background
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 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. We designate the
quality performance standard that will
apply for each performance year. The
quality performance standard is the
overall standard the ACO must meet in
order to be eligible for shared savings.
In the November 2011 final rule (76
FR 67973), we initially established a
quality performance standard consisting
of 33 measures across 4 domains (see
§ 425.502(d)), including patient
experience of care, care coordination/
patient safety, preventive health, and atrisk population and a methodology for
scoring the measures submitted by
ACOs (see § 425.502(e)). Quality
measures are submitted by the ACO
through the CMS web interface,
calculated by us 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. To
qualify for shared savings (see
§§ 425.604(c), 425.606(c), and
425.610(c)), an ACO must meet or
exceed its minimum savings rate, meet
the minimum quality performance
standards established under § 425.502,
and otherwise maintain its eligibility to
participate in the Shared Savings
Program. For example, under the
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regulation at § 425.604(d), an ACO
participating in the Shared Savings
Program under Track 1 that meets all
the requirements for receiving shared
savings payments will receive a shared
savings payment of 50 percent of all
savings under the updated benchmark
(up to the performance payment limit).
Since the November 2011 Shared
Savings Program final rule, we have
continued to review the quality
measures used for the Shared Savings
Program to ensure that they are up to
date with current clinical practice and
are aligned with the CMS web interface
reporting for PQRS, and most recently,
with reporting requirements under the
Quality Payment Program. Through the
annual rulemaking for the PFS we have
reviewed and updated the quality
measures reported by ACOs through the
CMS web interface, including adding
new measures and retiring measures
that were redundant or no longer met
the goals for group reporting, and
ensuring that the ACO CMS web
interface reported measures align with
the measures reported through the CMS
web interface by group practices in
other CMS initiatives such as PQRS and
the Quality Payment Program. The
quality measure set currently includes
31 quality measures (see Tables 42 and
43 at 81 FR 80488 and 80489). To avoid
confusion and duplication of
rulemaking, and reduce provider
burden, we also finalized a policy in the
2017 PFS final rule that future changes
to the CMS web interface measure will
be made through rulemaking for the
Quality Payment Program and will be
applicable to ACO quality reporting
under the Shared Savings Program (81
FR 80499 and 80500). Under the APM
scoring standard finalized in the CY
2017 Quality Payment Program final
rule (81 FR 77255 through 77256),
measures reported by Shared Savings
Program ACOs through the CMS web
interface will also be used to determine
the Merit-Based Incentive Payment
System (MIPS) quality performance
category score for eligible clinicians
participating in a Shared Savings
Program ACO in 2017.
When scoring ACO quality
performance in the Shared Savings
Program, we designate a performance
benchmark and minimum attainment
level for each measure. 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 the measure will receive points
on a sliding scale based on the level of
performance. We update the quality
performance benchmarks every 2 years.
For the first performance year of an
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ACO’s first agreement period, we define
the quality performance standard at the
level of complete and accurate reporting
for all quality measures. During
subsequent performance years of the
ACO’s first agreement period, the
quality performance standard is phased
in such that the ACO must continue to
report all measures but the ACO will be
assessed on performance based on the
quality performance benchmark and
minimum attainment level for certain
measures that are designated a pay for
performance. The quality performance
standard that applies to an ACO’s final
year in its first agreement period also
applies for each performance year of an
ACO’s subsequent agreement period. A
newly introduced measure is set at the
level of complete and accurate reporting
for the first 2 reporting periods the
measure is required. For subsequent
reporting periods, the quality
performance standard for the measure
will be assessed according to the phasein schedule for the measure. Pay for
reporting measures are worth 2 points
each for complete and accurate
reporting, whereas pay for performance
measures are worth 0–2 points based on
ACO performance compared to the
established benchmark. The EHR
measure (ACO–11), however, is doubleweighted and ACOs can earn up to 4
points based on their performance on
this measure.
Additionally, as discussed in the CY
2016 PFS final rule with comment
period (see 80 FR 71269), occasionally
issues arise with measures that cause us
to reevaluate whether it is appropriate
to hold an ACO accountable for
performance on a measure. For instance,
in the CY 2015 PFS final rule with
comment period we retired measures
that were no longer consistent with
updated clinical guidelines for
cholesterol targets, but we were unable
to finalize retirement of the measures for
the 2014 reporting year due to the
timing of the guideline updates and
rulemaking cycle. Because these
measures did not align with updated
clinicial guidance, in February 2015, we
issued an update to the guidance
document on the Medicare Shared
Savings Program Quality Measure
Benchmarks for the 2014 Reporting Year
that maintained these measures,
including the Diabetes Composite
measure, as pay for reporting for the
2014 reporting year. In order to address
such issues in the future, we finalized
a policy in the CY 2016 PFS final rule
with comment period (80 FR 71269)
under which we reserve the right to
maintain a measure as pay for reporting
or revert a pay for performance measure
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to pay for reporting when the measure
owner determines the measure no
longer aligns with clinical practice or
continued application of the measure
may result in patient harm (see
§ 425.502(a)(5)).
(2) Proposals
As previously noted in the
background section, we finalized a
policy that future changes to the CMS
web interface measures will be adopted
through rulemaking for the Quality
Payment Program and will be applicable
to ACO quality reporting under the
Shared Savings Program (81 FR 80501).
We also note that, as discussed in the
CY 2017 Quality Payment Program final
rule with comment period (81 FR
77136), section 1848(q)(2)(D)(i)(II) of the
Act requires the Secretary to update the
final list of quality measures from the
previous year (and publish an updated
list in the Federal Register) annually.
Updates may include the removal of
quality measures the addition of new
quality measures, and the exclusion of
existing quality measures that the
Secretary determines have gone through
substantive changes. In the CY 2017
Quality Payment Program final rule
with comment period, we indicated that
in the future we would use rulemaking
for the MIPS program to address
substantive changes to measures (81 FR
77143). On June 20, 2017, HHS issued
a proposed rule that includes a number
of proposals to revise certain policies
under the Quality Payment Program for
CY 2018, including a proposal to make
substantive changes to several measures
reported through the CMS web
interface. For example, substantive
changes are proposed for the way ACO–
17 Tobacco Use: Screening and
Cessation Intervention measure rate is
calculated via the CMS web interface
(see Table E, 82 FR 30469). This
measure was originally developed as a
two-part measure: The first part of the
measure assessed whether a patient had
been screened for tobacco use within
the past 24 months; the second part of
the measure assessed whether those
who had been screened and identified
as tobacco users in the first part of the
measure also received tobacco cessation
intervention (either counseling and/or
pharmacotherapy). To date, the two
parts of the measure have been
combined into a single performance
rate. We have identified two notable
limitations with this approach,
including (1) the performance rate does
not show the difference in performance
with respect to how well clinicians
adhere to performing tobacco use
screenings and how well clinicians
follow the guidelines to provide tobacco
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cessation interventions, and (2) the
measure is topped out, meaning it
continuously shows a high performance
rate. The changes to the measure
proposed in the CY 2018 Quality
Payment Program proposed rule would
not modify the sampling methodology
or the data reported into the CMS web
interface. The proposed changes would
simply revise the measure specifications
to measure the percent of tobacco users
that received cessation counseling;
instead of measuring a combined
performance rate for beneficiaries that
were screened for tobacco use and for
the subset of beneficiaries that are
tobacco users that received tobacco
cessation counseling.
Substantive changes to other CMS
web interface measures are also
proposed. A substantive change is
proposed to the Influenza Immunization
measure (ACO–14), however, the
changes apply only to the Registry and
EHR data submission methods and not
the CMS web interface reporting method
(82 FR 30472). Finally, a substantive
change is proposed for the Body Mass
Index Screening and Follow-Up Plan
(ACO–16); specifically, the frequency of
documenting BMI will change from 6 to
12 months (82 FR 30471).
Consistent with how we have
addressed previous changes to
measures, we reviewed the proposed
substantive changes to the CMS web
interface measures proposed in the CY
2018 Quality Payment Program
proposed rule to assess whether the
changes, if finalized, would warrant a
change in how the measures are used to
assess ACO performance under the
Shared Savings Program. As part of this
review, we considered whether the
proposed substantive changes might
raise sampling issues or require that we
recalculate the measure benchmarks for
purposes of the Shared Savings
Program. Based on our preliminary
review of the Quality Payment Program
proposals, we believe the proposed
‘‘substantive’’ changes to the CMS web
interface measures would not require
that we revert these measures to pay for
reporting for the 2018 performance year.
The Quality Payment Program proposals
do not appear to modify the current
structure and reporting of the measures
for which substantive changes are
proposed; rather, in the case of the
Tobacco Use: Screening and Cessation
Intervention measure, the proposed
change would only modify the way the
data are manipulated and calculated
after the data are submitted. Similarly,
we do not believe that the proposed
substantive change to the BMI measure
to change the frequency of reporting
would impact an ACO’s ability to
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perform well compared to the
established benchmark for this measure.
Finally, the substantive change to the
Influenza Immunization measure does
not apply to the CMS web interface
reporting method. Therefore, we believe
that we will have the data necessary
from past submission periods to
calculate appropriate benchmarks that
could be used to assess ACO
performance for the CMS web interface
measures under consideration for
performance year 2018 and subsequent
years. Additionally, the recalculation of
the benchmark coincides with the
biannual timing of the benchmark
updates. Therefore, if the proposed
changes to the measures are finalized
under the Quality Payment Program, we
do not believe it would be necessary or
appropriate, to revert the measures to
pay for reporting under the Shared
Savings Program. Instead, we believe it
would be appropriate under the Shared
Savings Program to: (1) Update the
measure specifications through
subregulatory guidance in order to
continue to align the measures with the
measure specifications used under the
Quality Payment Program and Million
Hearts initiative, and (2) retain the
current phase-in schedule for the
measures rather than redesignating any
of the measures as pay for reporting.
Because the particular substantive
changes that are proposed in the CY
2018 Quality Payment Program
proposed rule do not appear to change
the information that must be collected
for these measures (which makes it
possible for us to use data submitted
previously to determine prior
performance under the new measure
rate, and therefore calculate an
appropriate prospective quality
benchmark), we do not believe any
changes to the measures’ phase-in
schedules are necessary. However, the
statutory directive under the Quality
Payment Program to address substantive
changes to measures in rulemaking and
the proposals in the CY 2018 Quality
Payment Program proposed rule to
address substantive changes to certain
web interface measures have caused us
to evaluate what recourse we might
have in the future under the Shared
Savings Program rules to modify a
measure’s phase-in in instances where a
substantive change to the measure
makes it inappropriate to hold ACOs
accountable for performance on a
measure that has been substantively
modified. We anticipate that there could
be future substantive changes to the
CMS web interface measures made
under the Quality Payment Program that
would give us reason to redesignate a
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measure as pay-for-reporting under the
Shared Savings Program. Currently,
although the Shared Savings Program
rules afford flexibility to redesignate a
measure as pay for reporting whem the
measure owner determines the measure
no longer aligns with clinical practice or
causes patient harm, there is no
discretion to modify how we assess
CMS web interface measures in the
event substantive changes are made to
those measures under the Quality
Payment Program that make it
inappropriate to hold ACOs accountable
for performance on the measure. Given
the timing of the Quality Payment
Program proposals in relationship to the
timing for when the quality performance
benchmarks must be established under
the Shared Savings Program, it may in
some cases be necessary to have
flexibility to designate a pay for
performance measure as pay for
reporting just before or following the
start of a performance year outside of
the formal rulemaking process,
consistent with the way in which we
have redesignated measures in the past
when measure owners have made
changes after the start of a performance
year. Accordingly, we believe it would
be appropriate to modify the Shared
Savings Program regulations to provide
additional flexibility to address
substantive changes to CMS web
interface measures that are made under
the Quality Payment Program and to
continue to facilitate alignment of
measures with the Quality Payment
Program and other CMS initiatives.
We are therefore proposing to modify
§ 425.502(a)(5) to include the right for
CMS to redesignate a measure as payfor-reporting when a substantive change
to a CMS web interface measure is made
under the Quality Payment Program.
This proposed revision would
supplement CMS’s existing discretion to
redesignate a measure as pay-forreporting when the measure owner
determines the measure no longer aligns
with clinical practice or causes patient
harm. Specifically, we are proposing to
revise the regulation at § 425.502(a)(5) to
reserve CMS’s right to redesignate CMS
web interface measures that have
undergone a substantive change as
determined under the Quality Payment
Program to pay-for-reporting status.
Such measures would not necessarily be
automatically redesignated as pay for
reporting when a substantive change
occurs (for example, as indicated
previously, we do not believe the
currently proposed substantive changes
present an impediment to holding ACOs
accountable for performance on these
measures in performance year 2018 and
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subsequent years); however, in the
future, substantive changes made to
CMS web interface measures under the
Quality Payment Program (such as when
the substantive change to a measure
results in an issue with sampling,
calculating performance, or the
calculating the quality benchmark) may
make it inappropriate to hold an ACO
accountable for performance on the
measure for the time needed for CMS to
obtain the information necessary to
calculate a quality benchmark for the
substantively changed measure in
advance of a performance year and/or
until ACOs gain experience reporting
the measure, as substantively changed.
Although we expect to conduct at least
a preliminary assessment of any
substantive changes to the CMS web
interface measures as part of the annual
PFS rulemaking in order to determine
whether any change to the phase in
schedule for a measure is warranted,
because we cannot always anticipate the
types of substantive changes that may be
finalized under the Quality Payment
Program or the effect of those changes
on our ability to calculate performance
on the measure, this proposal would
provide us with additional flexibility to
redesignate existing measures
undergoing a substantive change as payfor-reporting on a measure by measure
basis. We believe this additional
flexibility would enable us to more
appropriately assess ACO quality
performance, by ensuring that ACOs are
not held accountable for performance on
a measure when substantive changes to
that measure affect our ability to assess
performance on that measure
appropriately. Otherwise, ACOs could
be inappropriately held accountable for
performance on such measures until
such time as we could undertake
rulemaking to modify the phase-in
schedule for the measure. As with
redesignations that occur when the
measure owner determines the measure
no longer aligns with clinical practice or
causes patient harm, redesignations that
occur due to substantive changes to a
measure would be communicated to
ACOs as soon as possible through
operational documents and other typical
methods we use to communicate with
ACOs. We invite comments on this
proposal.
b. Further Refining 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 quality measure data
ACOs enter into the web interface (76
FR 67893 through 67894). We believe
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that the data validation process
implicitly incentivizes ACOs to keep
organized and up-to-date medical
records and is necessary to protect
against gaming. 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)
and involved a process under which we
selected a subset of web interface
measures and a random sample of 30
confirmed and completely reported
beneficiaries for each measure in the
subset. The ACO was required to
provide medical records to support the
data reported in the web interface for
those beneficiaries. A measure-specific
audit performance rate was then
calculated using a multi-phased audit
process. If at the conclusion of the third
phase there was a discrepancy greater
than 10 percent between the quality
data reported and the medical records
provided during the audit, the ACO was
not given credit for meeting the quality
target for any measure(s) for which the
mismatch rate existed.
In the CY 2017 PFS final rule (81 FR
80489 through 80492), we revisited the
quality validation audit process and
finalized several significant changes as
a result of our experience in conducting
audits and in an effort to increase the
statistical rigor of the audit methodology
while streamlining audit operations. We
expressed our intent to align the quality
measures validation audit used in the
Shared Savings Program more closely
with other CMS quality program audits,
including those performed in the
Physician Quality Reporting Program
and the Hospital Inpatient and
Outpatient Quality Reporting programs.
We therefore finalized four
improvements to our audit process that
addressed 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.
Specifically, we finalized a policy under
which we will audit enough medical
records to achieve a 90 percent
confidence interval; conduct the audit
in a single phase; and calculate an
overall audit performance rate. If at the
conclusion of the audit process the
overall match rate between the quality
data reported and the medical records
provided by the ACO is less than 90
percent, absent unusual circumstances,
we will adjust the ACO’s overall quality
score proportional to the ACO’s audit
performance. The audit-adjusted quality
score is calculated by multiplying the
ACO’s overall quality score by the
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ACO’s overall audit 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 would be 60 percent. The
audit-adjusted quality score is the
quality score that will be 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. We note that under
the revised audit methodology, our
intent was to continue to audit a subset
of ACOs, which we would identify by
looking for data anomalies such as high
skip rates, although we have flexibility
to randomly select ACOs or specific
measures for audit as we have done in
the past.
We also finalized a new requirement
at § 425.500(e)(3) that an 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 our approval. In the CAP,
the ACO would be required to explain
the reasons for the low audit match rate
and how it plans to improve the
accuracy of its quality reporting in the
future. In addition, we noted that we
maintain 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 indicated that
we would begin applying these policies
to the quality validation audits
beginning in 2017 with the quality
validation audits of quality reporting for
the 2016 performance year.
(2) Proposals
Since publication of the CY 2017 PFS
final rule, we have gained additional
experience with the quality validation
audits, and have performed additional
analyses related to these audits. Our
analysis of the 2016 quality measure
validation audit results for Shared
Savings Program ACOs indicates that
the average match rate of ACOs audited
in calendar year 2016 was 72 percent
and the median performance was 80
percent. Typically, during the audit, we
review medical record documentation
and work with ACOs to better
understand the mismatch between what
was reported and what was documented
and have determined through our
analyses that ACOs continue to
experience challenges in understanding
certain aspects of the measure
specifications, coordinating collection
of information across many different
providers and practices, and satisfying
the requirements for supporting
documentation. Many of these errors are
not indicative of poor quality of care but
rather reflect minor errors in process or
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in understanding measure requirements.
For instance, we have identified errors
by individuals abstracting data from the
medical record. In one case, a medical
record abstractor incorrectly
misinterpreted the less than symbol (<)
in the quality measure specifications for
the ACO–31 Heart Failure: Beta Blocker
Therapy for Left Ventricular Systolic
Dysfunction and ACO–33 AngiotensinConverting Enzyme (ACE) Inhibitor or
Angiotensin Receptor Blocker (ARB)
Therapy, and therefore, abstracted the
data incorrectly for reporting.
Under our newly finalized singlephase approach to quality validation
audits, minor errors are more likely to
affect the final audit results and impact
the calculation of shared savings or
shared losses when the overall match
rate is below 90 percent. Additionally,
we note that the match rate threshold
under the Hospital Inpatient Quality
Reporting (HIQR) Program is 75 percent.
The HIQR validates data submitted by
hospitals, which are entities that
generally have more experience with
quality reporting, greater health record
accessibility and integration, and a
longer history of validation of quality
data submitted to CMS.
In light of our analyses of the 2016
quality measure validation audit results,
we believe it is appropriate to consider
making additional modifications to our
quality validation audit process. First,
we are concerned that the 90 percent
match rate adopted in CY 2017 PFS
final rule may be too high and could
inappropriately penalize ACOs that
make quality data reporting errors that
are unrelated to care quality. In the early
years of phasing in this new audit
methodology, we believe that the match
rate should instead be based on actual
ACO experience in order to focus on
holding ACOs accountable for clinically
related mismatches in reporting quality
measures as they continue to gain
experience with how to measure, report
and improve quality under the program.
We believe that basing the audit match
rate threshold on actual validation audit
results would strike an appropriate
balance between ensuring the accuracy
of ACO quality reporting while not
unduly penalizing ACOs for minor
quality reporting errors that are not
necessarily indicative of poor quality
care. Accordingly, we believe it would
be appropriate to set the audit match
rate threshold based on the median
match rate (80 percent) for ACOs
audited in calendar year 2016 rather
than an alternative approach such as the
mean match rate because the median
match rate would be less affected by
data outliers. Therefore, we are
proposing to revise § 425.500(e)(2) to
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indicate that if an ACO has a match rate
below 80 percent, absent unusual
circumstances, we would adjust the
ACO’s overall quality score proportional
to the ACO’s audit performance.
Second, we propose to amend the
method by which we adjust an ACO’s
overall quality score to reflect the ACO’s
audit performance. Specifically, we
propose to revise the methodology
described in the 2017 PFS final rule (81
FR 80490) under which the auditadjusted quality score is calculated by
multiplying the ACO’s overall quality
score by the ACO’s audit match rate.
Instead, we propose that for each
percentage point difference between the
ACO’s match rate and the match rate
considered passing the audit, the ACO’s
overall quality score would be adjusted
downward by 1 percent. That is, if we
finalize the proposal to establish an 80
percent match rate as the threshold for
passing the quality validation audit, and
the ACO’s match rate is 75 percent, then
under this proposal we would adjust the
ACO’s overall quality score downward
by 5 percent. To illustrate, assuming a
match rate threshold of 80 percent, an
ACO with an overall quality score of 90
percent would have an audit-adjusted
quality score of 85.50 percent, that is,
(90¥[.05×90]) = 85.50.
Finally, we propose a conforming
change to § 425.500(e)(3) to reflect the
80 percent threshold such that if at the
conclusion of the audit process CMS
determines there is an audit match rate
of less than 80 percent, the ACO may be
required to submit a CAP.
We believe that over time, as ACOs
become more experienced with quality
reporting requirements, improve their
quality reporting processes and become
better clinically integrated, quality
validation audit results that show a
significant mismatch between the
information reported and the underlying
medical records will more consistently
reflect meaningful, clinically related
quality reporting errors for which ACOs
should be held accountable. In addition,
because the audit process involves the
exchange of information regarding
medical record review and
communication between ACOs and us,
the audit process, itself, provides
additional education on the quality
measures and quality reporting.
Accordingly, we will periodically
review the audit match threshold and
seek to increase the match rate over
time. We may also consider requiring a
higher match rate for ACOs that have
been in the program longer. Therefore,
we anticipate that we will continue to
closely monitor quality validation audit
results and the reasons for mismatches
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and, over time, seek to increase the
audit match rate threshold.
Although at this time we are
proposing the change the audit match
rate threshold to 80 percent, we also
seek comment on an alternative
approach we considered to address the
quality validation audit match rate and
the resulting impact on an ACO’s
overall quality score.
Consistent with the approach used
under the HIQR program, we considered
revising § 425.500(e)(2) to provide that
we would adjust the ACO’s overall
quality score if an ACO has a match rate
below 75 percent. We did not propose
this approach because the results of the
Quality Measures Validation Audits
conducted on Shared Savings Program
ACOs in calendar year 2016 yielded a
median match rate of 80 percent,
suggesting that a match rate of 75
percent would be too low.
We invite comment on the proposed
refinements to the process used to
validate ACO quality data reporting and
to adjust an ACO’s overall quality score
to reflect the ACO’s audit performance,
and on the alternative that was
considered, but not proposed.
3. Reducing Shared Savings Program
Application Burden
a. SNF 3-Day Rule Waiver Application
Requirement That ACOs Report Their
Financial Relationships
(1) 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
3 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,
32808), we provided ACOs participating
in Track 3 with additional flexibility to
attempt to increase quality and decrease
costs by allowing these ACOs to apply
for a waiver of the SNF 3-day rule to
permit their prospectively assigned
beneficiaries to receive coverage for
inpatient SNF care without a prior 3-day
inpatient hospital stay when they are
admitted to a ‘‘SNF affiliate,’’ that is, a
SNF with which the ACO has executed
a SNF affiliate agreement, and certain
additional eligibility criteria are met
(see § 425.612(a)(1)). Waivers are
effective upon our notification to the
ACO 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
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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 (and as
provided in § 425.612(a)(1)(iv) for
certain other beneficiaries), who receive
otherwise covered post-hospital
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 SNF services furnished to a
particular beneficiary are eligible for
payment under the SNF 3-day rule
waiver 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)), so it will be
clearer to a Track 3 ACO and its SNF
affiliates 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 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 that
ACOs, ACO providers/suppliers, SNF
affiliates, and beneficiaries must meet
for SNF services to be covered under the
SNF 3-day rule waiver under the Shared
Savings Program. All ACOs electing to
participate in Track 3 are offered the
opportunity to apply for a waiver of the
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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.
The program rules for a waiver of the
SNF 3-day rule are under § 425.612 and
are discussed in detail in the 2015 final
rule (80 FR 32804 through 32806).
To qualify to use the SNF 3-day rule
waiver, ACOs must submit a SNF 3-Day
Rule Waiver application that includes
supplemental information sufficient to
demonstrate that the ACO has 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.
Required application materials include
but are not limited to the following:
• Narratives describing how the ACO
plans to implement the waiver.
Narratives must include a
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 health care 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.
• A list of SNFs with which the ACO
will partner along with executed written
SNF affiliate agreements between the
ACO and each listed SNF. The
agreements must include elements
determined by CMS including but not
limited to the following:
++ Agreement to comply with the
requirements and conditions of the
Shared Savings Program.
++ The effective dates of the SNF
affiliate agreement.
++ Agreement to implement and
comply with the ACO’s beneficiary
evaluation and admission plan and care
management plan.
++ Agreement to validate the
eligibility of a beneficiary to receive
covered SNF services in accordance
with the waiver prior to admission.
++ Remedial processes and penalties
that will apply for non-compliance.
• Documentation demonstrating that
each SNF included on the submitted list
of SNF affiliates has an overall rating of
3 or higher under the CMS 5-star
Quality Rating System as reported on
CMS’s Nursing Home Compare Web
site.
In addition, § 425.612(b)(3) provides
that we will evaluate the information
submitted with the ACO’s application
for the SNF 3-day rule waiver and any
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supplemental information submitted in
response to a CMS request for
information to determine whether the
ACO’s waiver request satisfies the
requirements of § 425.612(a)(1). The
effective date and termination date of
the waiver are determined in
accordance with § 425.612(c). Section
425.612(d) provides for monitoring of
the use of the waiver and termination of
the waiver, and includes a requirement
that ACOs that have been approved for
the SNF 3-day rule waiver post their
approval to use the waiver as part of
public reporting under § 425.308. If our
monitoring of an ACO’s use of the
waiver reveals misuse of the waiver, we
may revoke the ACO’s approval to use
the waiver. Additionally, we may
revoke an ACO’s approval to use a
waiver if the ACO does not successfully
meet the quality performance standard
or we identify another program integrity
issue affecting the ACO’s use of the
waiver.
To be eligible to receive covered
services under the SNF 3-day rule
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 in
§ 425.612(a)(1)(ii).
We noted in the 2015 final rule 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 (80 FR
32806). We indicated that in the event
we determined that changes were
necessary, we would propose these
changes through future rulemaking.
Subsequently, based on initial
experiences with the SNF 3-day rule
waiver under the Pioneer ACO Model
and Next Generation ACO Model, we
proposed and finalized additional SNF
3-day rule waiver beneficiary
protections under § 425.612(a)(1)(iv)
and (v). (See the CY 2017 PFS final rule
(81 FR 80510 through 80515)).
We began accepting SNF 3-Day Rule
Waiver applications in the summer of
2016 and approved 26 Track 3 ACOs to
begin using the SNF 3-day rule waiver
under the Shared Savings Program
effective January 1, 2017.
(2) Proposal
As discussed in this proposed rule,
the SNF 3-day rule waiver requirements
are primarily based on criteria
previously developed under the Pioneer
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ACO Model. As a result of our recent
experience implementing the waiver in
the Next Generation ACO Model and the
Shared Savings Program, we believe that
the rules governing use of the SNF 3-day
rule waiver are generally reasonable.
However, based on our initial
experiences in reviewing SNF 3-Day
Rule Waiver applications, we believe
there are two requirements, in
particular, that impose an unnecessary
burden on applicants, without a
sufficient benefit to the administration
of the Shared Savings Program to justify
the burden.
First, the requirement under
§ 425.612(a)(1)(i)(A)(4) that ACOs
submit, as part of their application for
the SNF 3-day rule waiver, a narrative
describing any financial relationships
that exist between the ACO, SNF
affiliates, and acute care hospitals is
burdensome for ACOs and CMS. As
explained in the 2015 final rule (81 FR
32806), the SNF 3-day rule waiver only
provides for coverage of SNF services
that meet all applicable requirements
except the requirement for a prior 3-day
inpatient stay. The waiver does not
protect financial or other arrangements
between or among ACOs, ACO
participants, ACOs providers/suppliers,
or other individuals or entities
providing services to Medicare
beneficiaries from liability under the
fraud and abuse laws or any other
applicable laws (§ 425.612(e)(1)). The
Shared Savings Program regulations do
not prohibit ACOs or SNFs from having
financial arrangements with acute care
hospitals, nor do they require such
arrangements. Therefore, we have found
that the narratives are not useful to us
for purposes of determining whether to
approve a waiver request. Based on our
experience with the implementation of
SNF 3-day rule waivers, we are
proposing to remove the requirement at
§ 425.612(a)(1)(i)(A)(4) under which
ACOs applying for the SNF 3-day rule
waiver must submit a narrative
describing any financial relationships
between the ACO, SNF affiliate, and
acute care hospitals. Removing this
requirement would not only reduce
burden for ACOs applying for the
waiver but would also enable us to
devote our application review resources
to a rigorous review of other, more
relevant application elements. Focusing
our resources on the review of the
information that is most directly
relevant to determining an ACO’s
capacity to manage beneficiaries who
are admitted to a SNF without a prior
3-day inpatient hospital stay, along with
ongoing oversight and program
compliance monitoring of the use of the
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waiver by approved ACOs (as described
in section III.G.3.a.(1) of this proposed
rule), would also allow us to more
efficiently use our resources to ensure
that the SNF 3-day rule waiver is being
used appropriately and to address any
potential concerns about use of the
waiver. Although we do not believe it is
necessary for ACOs to submit separate
narratives describing their financial
relationships for purposes of the SNF 3day rule waiver, we note that under the
Shared Savings Program rules, ACOs,
ACO participants, ACO providers/
suppliers, and other individuals or
entities performing functions or services
related to ACO activities, including SNF
affiliates, must maintain and give us
access to certain documents and
information related to items including
financial arrangements related to ACO
activities (§ 425.314(b)(1)). We continue
to retain broad discretion under
§ 425.316 to audit ACOs, ACO
participants, and ACO providers/
suppliers for compliance with program
rules, and the program rules also make
it clear that waivers under § 425.612 do
not protect financial or other
arrangements between or among ACOs,
ACO participants, ACO providers/
suppliers, or other individuals or
entities providing services to Medicare
beneficiaries from liability under the
fraud and abuse laws or any other
applicable laws (§ 425.612(e)).
Second, we believe that the
requirement under § 425.612(a)(1)(i)(C)
that ACOs submit documentation
demonstrating that each SNF included
on their list of SNF affiliates has an
overall rating of 3 or higher under the
CMS 5-star Quality Rating System is
unnecessarily burdensome. In order to
meet this requirement, ACOs typically
submit a screen shot from the CMS
Nursing Home Compare Web site or
other Nursing Home Compare
information that reflects the star rating
for each listed SNF. The submission of
this documentation by the ACO does
not add value to our review and
approval of SNFs included on the
ACO’s SNF affiliate list. Instead, we
obtain the information directly from our
Web site during the application review
process. In this way, we insure that the
most current information is used during
the application review process. We also
periodically monitor this information
after an ACO has been approved to use
the waiver because SNF affiliates are
required to maintain an overall rating of
3 stars or higher, under
§ 425.612(a)(1)(iii)(A). Because we are
able to obtain the required information
directly from the CMS Nursing Home
Compare Web site, the additional
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documentation submitted by the ACO as
part of its application does not add
value to our ability to review and
approve SNF affiliates. Accordingly, we
are proposing to eliminate this
documentation submission requirement
by removing § 425.612(a)(1)(i)(C). We
note that we are not proposing to
remove or modify the requirement in
§ 425.612(a)(1)(iii)(A) that SNF affiliates
must have and maintain an overall
rating of 3 or higher under the CMS 5star Quality Rating System in order to
remain eligible to partner with the ACO
for purposes of the SNF 3-day rule
waiver. The requirement for SNF
affiliates to have and maintain a 3-star
or higher rating is retained.
Furthermore, as part of the application
process, we intend to continue to verify
that the ACO has met all requirements
related to the SNF 3-day rule waiver,
but we believe that the burdensome and
duplicative submission of CMS 5-star
Quality Rating System documentation is
not necessary to ensure compliance
with the requirement that the ACO’s
SNF affiliates have a star rating of 3 or
more.
We welcome comments on our
proposal to remove
§ 425.612(a)(1)(i)(A)(4) which requires
SNF 3-Day Rule Waiver applicants to
submit a narrative describing any
financial relationships that exist
between the ACO, SNF affiliate, and
acute care hospitals. We further
welcome comments on our proposal to
remove § 425.612(a)(1)(i)(C) which
requires waiver applicants to submit
documentation demonstrating that each
SNF affiliate on their SNF affiliate list
has an overall rating of 3 or higher
under the CMS 5-star Quality Rating
System. We also welcome other
suggestions on how we might further
decrease the burden for ACOs
requesting approval to use the SNF 3day rule waiver, without compromising
our ability to ensure that ACOs and
their SNF affiliates have the capacity to
identify and manage beneficiaries
receiving covered SNF services
pursuant to the waiver. We may
consider any such suggestions in future
rulemaking.
b. Modifications to the Shared Savings
Program Initial Application
(1) Background
In order to participate in the Shared
Savings Program, organizations must
meet certain eligibility requirements,
including the statutory requirement to
define processes to promote evidencebased medicine and patient engagement,
report on quality and cost measures, and
coordinate care. Additionally, the ACO
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must demonstrate it meets patientcenteredness criteria specified by the
Secretary, such as the use of patient and
caregiver assessments or the use of
individualized care plans. We discussed
and finalized details for ACO eligibility
criteria, including the four required
processes and patient-centeredness
criteria, in the November 2011 final rule
(76 FR 67826 and 67827) and made
updates to them in the June 2015 final
rule (80 FR 32722 through 32725).
Section 425.204(c)(1) articulates the
supporting documents and materials an
ACO must submit to demonstrate that
the ACO satisfies the eligibility
requirements to participate in the
Shared Savings Program.
To obtain a determination regarding
whether an ACO meets the requirements
to participate in the Shared Savings
Program, a prospective ACO must
submit a complete application in the
form and manner required by us by the
deadline established by us
(§ 425.202(a)(1)). The content of the
application is outlined at § 425.204.
Section 425.204(c) states that as part of
the application, and upon request
thereafter, an ACO must submit to us
certain supporting documentation to
demonstrate that the ACO satisfies the
requirements of the Shared Savings
Program. Supporting documentation in
this section includes:
• Documents (for example, ACO
participant agreements, agreements with
ACO providers/suppliers, employment
contracts, and operating policies)
sufficient to describe the ACO
participants’ and ACO providers’/
suppliers’ rights and obligations in and
representation by the ACO, and how the
opportunity to receive shared savings or
other financial arrangements will
encourage ACO participants and ACO
providers/suppliers to adhere to the
quality assurance and improvement
program and evidence-based clinical
guidelines.
• A description, or documents
sufficient to describe, how the ACO will
implement the required processes and
patient-centeredness criteria under
§ 425.112, including descriptions of the
remedial processes and penalties
(including the potential for expulsion)
that will apply if an ACO participant or
an ACO provider/supplier fails to
comply with and implement these
processes.
• Materials documenting the ACO’s
organization and management structure,
including an organizational chart, a list
of committees (including names of
committee members) and their
structures, and job descriptions for
senior administrative and clinical
leaders.
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• Evidence that the ACO’s governing
body is an identifiable body, represents
a mechanism for shared governance for
ACO participants, is composed of
representatives of its ACO participants;
and is at least 75 percent controlled by
its ACO participants.
• Evidence that the governing body
includes a Medicare beneficiary
representative(s) served by the ACO
who does not have a conflict of interest
with the ACO, and who has no
immediate family member with a
conflict of interest with the ACO.
• A copy of the ACO’s compliance
plan or documentation describing the
plan that will be put in place at the time
the participation agreement with CMS
becomes effective. Additionally,
§ 425.204(d) states that as part of the
application to participate in the Shared
Savings Program, an ACO must describe
the following:
++ How it plans to use shared savings
payments, including the criteria it plans
to employ for distributing shared
savings among its ACO participants and
ACO providers/suppliers.
++ How the proposed plan will
achieve the specific goals of the Shared
Savings Program.
++ How the proposed plan will
achieve the general aims of better care
for individuals, better health for
populations, and lower growth in
expenditures.
Section 425.204(c)(1)(ii) includes a
reference to the required processes and
patient centeredness criteria under
§ 425.112. Of note, § 425.112(b)(4)(ii)
requires that, as part of its application,
an ACO must submit a description of its
individualized care program, along with
a sample individual care plan, that
explains how the ACO’s program is
used to promote improved outcomes for,
at a minimum, its high risk and multiple
chronic condition patients
(§ 425.112(b)(4)(ii)(A)). The ACO must
also, as part of its application, describe
additional target populations that would
benefit from individualized care plans
(§ 425.112(b)(4)(ii)(B)) and describe how
it will encourage and promote the use
of enabling technologies for improving
care coordination for beneficiaries
(§ 425.112(b)(4)(ii)(C)). Finally, as part
of its application, the ACO must
describe how it intends to partner with
long-term and post-acute care providers,
both inside and outside the ACO, to
improve care coordination for its
assigned beneficiaries
(§ 425.112(b)(4)(ii)(D)).
Once an applicant has submitted the
information required under § 425.204,
we evaluate it to determine whether the
applicant satisfies the Shared Savings
Program requirements. We notify ACO
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applicants during the application
review process when information is
missing or when supplemental
documentation or other information is
necessary to make a determination on
the ACO’s application and provide
opportunities for the ACO to submit the
requested additional information for
review. At the end of the application
review process, we approve or deny the
application and notify the ACO of our
determination.
(2) Proposals
In conducting Shared Savings
Program application reviews, we have
found that many of the document
submission requirements in
§ 425.204(c)(1) substantially increase
application and review burden without
lending significant value to our review
of an organization’s application to
confirm that the ACO meets the
eligibility requirements for participation
in the Shared Savings Program. We
believe it would meet program needs
and reduce applicant burden if we were
to revise § 425.204(c)(1) to remove the
requirement to submit supporting
documents or narratives and instead
provide that we may request these
materials if additional information is
needed in order to fully assess the
ACO’s application before making a
decision to approve or deny the
application.
To illustrate, as discussed in this
proposed rule, we require under
§ 425.204(c)(1)(ii), as part of the
application process, that the ACO
submit documentation addressing the
required processes and patient
centeredness criteria under § 425.112.
This requirement is addressed in the
Medicare Shared Savings Program
Initial Application (see application on
the CMS Web site at https://
www.cms.gov/medicare/medicare-feefor-service-payment/
sharedsavingsprogram/
application.html) through the
requirement that an applicant ACO
submit narratives describing how it will
define, establish, implement, evaluate,
and periodically update each process. In
these narratives, the ACO must also
describe certain additional details
regarding the required processes:
• Process to promote evidence-based
medicine. The ACO must describe how
it will:
++ Encourage the use of protocols
grounded in evidence-based medicine
in the case of diagnoses with significant
potential for the ACO to achieve quality
improvements, while taking into
account the circumstances of individual
beneficiaries; and
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++ Use the internal assessments of
this process to continuously improve
the ACO’s care practices.
• Process to promote beneficiary
engagement. The ACO must describe
how it will:
++ Evaluate the health needs of its
assigned beneficiary population
(including consideration of diversity in
its patient population) and develop a
plan to address the needs of its
population;
++ Communicate clinical knowledge/
evidence-based medicine to
beneficiaries in a way they can
understand;
++ Engage beneficiaries in shared
decision-making in ways that consider
beneficiaries’ unique needs, preferences,
values and priorities;
++ Establish written standards for
beneficiary access and communication
as well as a process for beneficiaries to
access their medical records; and
++ Use the internal assessments of
this process to continuously improve
the ACO’s care practices.
• Process to internally report quality
and cost metrics. The ACO must
describe how:
++ The ACO will use these results to
improve care and service over time; and
++ The ACO will use the internal
assessments of this process to
continuously improve the ACO’s care
practices.
• Process to promote coordination of
care. The ACO must describe:
++ The ACO’s methods and processes
to coordinate care throughout an
episode of care and during care
transitions, such as discharge from a
hospital or transfer of care from a
primary care physician to a specialist
(both inside and outside the ACO).
++ The ACO’s individualized care
program, along with a sample
individual care plan, and explain how
the ACO uses this program to promote
improved outcomes for, at a minimum,
high-risk and multiple chroniccondition patients.
++ How individual care plans take
into account the community resources
available to beneficiaries.
++ Additional target populations that
would benefit from individualized care
plans.
++ How the ACO will use the
internal assessments of this process to
continuously improve the ACO’s care
practices.
++ How the ACO will encourage and
promote use of enabling technologies for
improving care coordination for
beneficiaries.
++ How the ACO intends to partner
with long-term and post-acute care
providers, both inside and outside of the
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ACO, to improve care coordination for
their assigned beneficiaries.
As a result of our experience in
reviewing these narratives, we have
determined that while they can be
helpful to verify that the ACO has
established the required processes and
defined patient-centeredness criteria
prior to its entry into the Shared Savings
Program, the specific details of the
processes the ACO has established are
not particularly important or relevant
for purposes of assessing whether the
ACO is eligible to participate in the
program. In fact, ACOs have indicated
that their initial plans for the processes
required under § 425.112 as articulated
in their program application often
change as a result of obtaining
additional information about their ACO
participants’ and ACO providers/
suppliers’ processes and gaining
additional experience during
implementation of the processes. We
believe such improvements to ACO
processes based on program experience
are reasonable to expect and should be
encouraged. First, under § 425.112(b),
ACOs are required to evaluate and
periodically update each process and as
they do so, initially implemented
processes will necessarily change to
accommodate lessons learned.
Moreover, once the ACO begins to
request claims information and other
CMS data and to incorporate this
information into its operations, the ACO
may discover that certain assumptions it
made at the time of application should
be adjusted to maximally improve the
quality of care or cost efficiencies for the
ACO’s assigned population. In rare
instances, particularly in the early days
of the program before stakeholders fully
understood the implications of program
participation, we found review of such
narratives useful to understand the level
of an ACO’s readiness for participation
in the Shared Savings Program.
However, such narratives have not been
particularly useful in determining if the
ACO meets the requirements for
participation in the Shared Savings
Program. In a vast majority of cases, we
now believe it is sufficient that the ACO
certify at the time of application that it
has defined the required processes and
patient centeredness criteria consistent
with the requirements specified in
section § 425.112. Therefore, we believe
it would reduce burden for ACOs,
without compromising our ability to
determine whether an ACO meets the
criteria for participation in the Shared
Savings Program, to require that the
ACO certify that it meets the
requirements in § 425.112, and only
submit a narrative or other
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documentation describing how the ACO
will implement the required processes
and patient-centeredness criteria upon
our request. Further, we do not
anticipate that this change would have
a significant effect on beneficiaries
receiving services from ACO providers/
suppliers because as noted earlier, we
anticipate that ACOs would update each
process as they gain experience and, as
they do so, initially implemented
processes that might have been reflected
in the narrative or other supporting
documentation submitted with their
application would necessarily change to
accommodate lessons learned.
Similarly, as part of the application
process, the Shared Savings Program
regulations require the ACO to submit
materials documenting the ACO’s
organization and management structure,
including an organizational chart, a list
of committees (including names of
committee members) and their
structures, and job descriptions for
senior administrative and clinical
leaders (§ 425.204(c)(1)(iii)). While we
have found the organizational chart
useful for purposes of our review and
approval of an ACO’s application, and
we anticipate continuing to request this
chart from many applicants, we have
found that further detail including lists
of committees and job descriptions for
senior administrative and clinical
leaders have not added particular value
to our review and approval of
applications. Moreover, the receipt of
such materials as part of the ACO’s
application has not significantly
impacted our ability to determine
whether the ACO meets the
requirements regarding leadership and
management in § 425.108. We believe,
on balance, that our need for such
detailed information from all applicants
is outweighed by our desire to reduce
application burden. In particular
circumstances where additional
information would aid our review, we
believe our need for such detailed
information can be reasonably met by
requiring applicants to submit such
materials upon our request. As a result,
we believe it would be less burdensome
for us to require ACO applicants to
certify that, for example, they meet the
leadership and management
requirements found at § 425.108 rather
than requiring all ACO applicants to
submit detailed materials (such as job
descriptions) or narratives about the
ACO’s committees and leadership.
While we do not anticipate having to
routinely request such materials to
supplement our review and approval of
ACO applications to participate in the
Shared Savings Program, we believe it is
important to retain the discretion to do
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so in limited cases where such detail
could be useful. Therefore, we propose
to make revisions to our application
requirements as discussed in this
section. We would note that in cases
where an ACO is requested to submit
additional material for review in
conjunction with its application, and we
find that the material is inconsistent
with program requirements, then we
may deny the ACO’s application.
Similarly, if we discover the
inconsistency after the ACO has already
been approved to participate in the
program, the ACO may be subject to the
pre-termination actions set forth in
§ 425.216, termination under § 425.218,
or both.
Additionally, we do not believe it is
necessary for ACO applicants to submit
narratives describing how they would
distribute shared savings payments or
how the proposed plan would achieve
the specific goals of the Shared Savings
Program and the general aims of better
care for individuals, better health for
populations, and lower growth in
expenditures, as required by
§ 425.204(d). Based on our experience,
such narratives have not been useful in
determining if the ACO meets
requirements for participation in the
program or whether an ACO’s
application should be approved. We
believe it would be more useful to us
and less burdensome for ACOs if we
were instead to require that, an ACO, as
part of its application to participate in
the Shared Savings Program, certify that
it has a method and plan to receive
shared savings payments and to
distribute those payments to its ACO
participants and ACO providers/
suppliers, as required by the statute. We
note, however, that we continue to
believe it is useful to stakeholders to
know how various ACOs have chosen to
use or distribute the shared savings they
earn. Therefore, in the interest of
transparency, we will continue to
require ACOs to publicly report
information on their dedicated Web
pages about their shared savings and
shared losses, including information
about the total proportion of shared
savings invested in infrastructure,
redesigned care processes, and other
resources to support the three-part aim
goals of better health for populations,
better care for individuals, and lower
growth in expenditures, including the
proportion distributed among ACO
participants, as required under
§ 425.308(b)(4).
In light of our experience with the
review of the documentation submitted
as part of the ACO’s initial application,
we are proposing several modifications
to our requirements for document
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submission. Under this proposal, we
would retain all requirements related to
ACO eligibility criteria and public
reporting, as currently specified under
the Shared Savings Program regulations.
However, in order to reduce application
burden without compromising our
ability to evaluate applications
effectively for compliance with Shared
Savings Program requirements, we
propose to modify certain sections of
our regulations that require ACOs to
submit supporting materials and
documentation at the time of
application. Instead of requiring
submission of certain materials,
narratives, or supporting
documentation, as discussed in this
section, we propose to require ACOs to
certify that they meet the applicable
eligibility and documentation
requirements as specified under our
program rules. At the same time, while
we are interested in reducing burden,
we recognize that there have been
instances when the review of supporting
documentation and/or narratives has
been helpful in making a determination
about an ACO’s eligibility for
participation in the program. Therefore,
although we are proposing to eliminate
the general requirement that ACOs
submit certain documentation as part of
their initial application to participate in
the Shared Savings Program, we
propose to retain the right to request the
submission of supporting materials and
documentation in cases when such
additional information would be useful
in making a determination regarding the
ACO’s application. We believe that this
proposed modification to the
regulations governing ACO applications
would introduce additional flexibility
that would reduce the level of burden
inherent in the Shared Savings Program
application process while also ensuring
we are still able to appropriately
evaluate an ACO’s eligibility for
program participation.
Accordingly, in order to reduce
application burden while retaining
flexibility to obtain additional
documentation when necessary to
determine ACO eligibility and
compliance with program rules, we
propose to remove the requirements in
§§ 425.204(c)(1) and (d), 425.112(a)(3)(i)
and (ii), and 425.112(b)(4)(ii) for the
submission of certain specified
documents and narratives as part of an
ACO’s application to participate in the
Shared Savings Program. Specifically,
we propose to revise paragraph
§ 425.204(c)(1) to require an ACO, as
part of its application, to certify that it
satisfies the Shared Savings Program
requirements and to submit, upon CMS
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34119
request, supporting materials (including
narratives) and documentation
demonstrating that the ACO satisfies
program requirements indicated in
proposed revised § 425.204(c).
Additionally, we propose to revise
§ 425.204(d) to indicate that the ACO
must certify, as part of its application to
participate in the Shared Savings
Program, that it has a mechanism and
plan to receive and use payments for
shared savings, including criteria for
distributing shared savings among its
ACO participants and ACO providers/
suppliers. We also propose to make a
conforming change to remove
paragraphs (d)(1) through (3) of
§ 425.204, which relate to the
submission of narratives related to the
ACO’s use of shared savings payments.
This proposal does not include a
requirement that the ACO submit
information regarding its mechanism
and plan for receiving and using shared
savings upon request. We do not intend
to request this information as part of the
application process because in our
experience, how an ACO intends to use
or distribute shared savings has not
been a relevant consideration during
any application cycle to determine
whether the ACO has met the eligibility
requirements to participate in the
Shared Savings Program. However, we
note that we continue to believe that
information on how an ACO uses and
distributes its shared savings is useful
for the public, and therefore ACOs will
continue to be required to publicly
report this information under
§ 425.308(b)(4)(ii).
We also propose similar changes to
the requirements in § 425.112(a)(3)(i),
(a)(3)(ii), and (b)(4)(ii) to remove
reference to the submission of narratives
to explain or describe how the ACO will
implement the required elements of the
ACO’s care processes and patientcenteredness criteria. ACOs must still
implement these care processes and
adopt a focus on patient-centeredness,
however, they will no longer need to
submit descriptions of how they will
satisfy these requirements as part of
their initial application. We note,
however, that ACOs may still be
required to submit upon request a
description or documentation sufficient
to describe how the ACO will
implement the required processes and
patient-centeredness criteria found at
§ 425.112 because under the proposed
revisions to § 425.204(c)(1)(ii), CMS
would retain the discretion to request
such documentation from the ACO at
any time.
In summary, we believe these
modifications to the application
requirements will significantly reduce
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the burden of applying to participate in
the Shared Savings Program without
reducing our ability to ensure that
applicants meet the established
eligibility requirements. Rather than
requiring every applicant to submit
detailed supporting documents or
narratives for all of these requirements,
we would instead request supporting
documents or narratives only if
additional information is needed in
order to fully assess an ACO’s
application before making a decision to
approve or deny the application.
Further, we do not anticipate that the
proposed modifications to our
application requirements would have
any effect on beneficiaries receiving care
from providers and suppliers
participating in the Shared Saving
Program, nor do we believe that the
proposed changes would affect our
program integrity efforts, because we
would retain discretion to request such
information (and more targeted and
appropriate information) as needed. We
seek comment on these proposals and
on additional ways to reduce burden in
the application process.
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4. Addressing Compliance With ACO
Participant TIN Exclusivity
Requirement
a. Background
Under the Shared Savings Program,
ACO participant TINs are not required
to be exclusive to one Shared Savings
Program ACO unless the TIN submits
claims for primary care services used to
determine the ACO’s assigned
population (§ 425.306(b)). The purpose
behind this requirement is to ensure
that we are able to assign a unique set
of beneficiaries to each ACO
participating in the Shared Savings
Program. Therefore, as part of the
Shared Savings Program application
process and upon an ACO’s request to
add an ACO participant TIN, we check
the TIN against all other Shared Savings
Program ACO participant lists. If the
TIN appears on the ACO participant list
one or more other ACOs, the TIN is
considered to be ‘‘overlapping.’’ We
then determine whether the overlap is
permissible under our program rules. If
the overlap is not permissible (because
the TIN has a history of billing for
primary care services used in our
assignment methodology) then we
require the ACO that is seeking to add
the TIN to its ACO participant list to
rectify the overlap by the deadline we
have established for making changes to
the next performance year’s ACO
participant list. If the overlap is
permissible (because the TIN does not
have a history of billing for primary care
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services used in our assignment
methodology) then the ACO participant
TIN can be approved to be an ACO
participant in more than one ACO for
the performance year. Each time we run
the assignment algorithm during the
course of the performance year, we
monitor overlaps to ensure that the
overlaps continue to be in compliance
with § 425.306(b).
In a few instances, as a result of our
monitoring, we have discovered that
ACO participant TINs that had been
approved to participate in multiple
ACOs subsequently began billing for
primary care services used in
assignment during a benchmark or
performance year. For example, for
performance year 2016, we identified
four TINs that were initially permitted
to overlap and participate in more than
one ACO because they had not
previously billed Medicare for primary
care services used in our assignment
methodology. At some point during the
performance year, however, the TINs
began billing Medicare for primary care
services that are used to assign
beneficiaries to the ACO (including
claims for services furnished during the
performance year, but submitted during
the three-month claims runout for the
performance year). This can occur, for
example, if a single specialty practice
made up of physician specialty types
not used in assignment (for example, a
practice of ophthalmologists) hires a
nurse practitioner who then begins
billing Medicare under the billing TIN
of the ACO participant for primary care
services as defined under the Shared
Savings Program rules. Thus, the ACO
participant TIN would be used to bill
Medicare for primary care services
furnished by a practitioner used in our
assignment methodology (the nurse
practitioner) and would therefore trigger
our requirement under § 425.306(b)(2)
that the ACO participant TIN be
exclusive to a single Shared Savings
Program ACO. Although our program
rules permit us to take compliance
action against ACOs for violations of
Shared Savings Program requirements,
they do not specifically address what
compliance actions we would impose
on ACOs in instances where an ACO
participant falls out of compliance with
§ 425.306(b)(2) during a benchmark or
performance year or when noncompliance with § 425.306(b)(2) is
discovered during the 3-month claims
runout for a benchmark or performance
year. Moreover, the program rules do
not address what modifications to our
assignment methodology could be made
to account for this overlap. In the case
of the four overlapping TINs discovered
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during the 2016 performance year, we
notified the respective ACOs of the
overlap and the ACO participant TINs
were required to terminate their
participation in the ACO of their choice.
As a result, each ACO from which the
TINs terminated was required to
recertify its ACO participant list for the
2016 performance year. Depending on
the timing of recertification, such
changes to an ACO participant list may
also require us to recalculate
performance year beneficiary
assignment and financial benchmarks.
For example, if a TIN, that was
previously allowed to appear on more
than one ACO participant list, hires a
nurse practitioner who begins billing
primary care claims in the month of
December for the ACO’s third
benchmark year, we would discover the
now impermissible overlap when we
begin creating the historical benchmark
reports after the 3-month claims runout.
We would contact the ACOs involved,
each ACO would contact the TIN and
ask the TIN to select the ACO it wishes
to remain aligned with. The ACO not
selected would be asked to remove the
TIN from its ACO Participant List and
recertify the list. As a result of the
recertification of the list, the ACO’s
assigned population would need to be
redetermined and calculation of its
benchmark would be delayed. We are
therefore concerned about the
uncertainty the current process (which
includes recertification of ACO
participant lists, recalculation of
assignment, and resulting delay of
calculations for the benchmark or
performance year) could introduce for
ACOs that may have little influence
over or knowledge of ACO participant
TIN billing practices.
We believe it is important for ACOs,
ACO participants, and ACO providers/
suppliers to have updated and accurate
information regarding their
participation status in the Shared
Savings Program. For example,
participation in a Shared Savings
Program ACO has implications for ACO
providers/suppliers under the new
Quality Payment Program (see 81 FR
80496 through 80501). The Quality
Payment Program replaces a patchwork
system of Medicare programs with a
flexible system that allows eligible
clinicians to choose from two paths that
link payments to quality: The MeritBased Incentive Payment System (MIPS)
and participation in Advanced
Alternative Payment Models (APMs).
The Quality Payment Program, through
MIPS and the APM incentive, will
impact eligible clinicians’ payments
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beginning in payment year 2019 based
on 2017 reporting.
Under the CY 2017 Quality Payment
Program final rule with comment
period, eligible clinicians participating
in Advanced APMs (including Tracks 2
and 3 under the Shared Savings
Program) may become Qualifying APM
Participants and receive a 5 percent
APM Incentive Payment if they have a
sufficient percentage of payments for
Part B covered professional services, or
a sufficient percentage of Medicare
patients that are attributable to services
furnished through an Advanced APM
for a year. In addition to earning a 5
percent APM Incentive Payment,
Qualifying APM Participants are not
subject to the MIPS reporting
requirements and payment adjustment
for the year. As a result, revisions to
ACO participant lists that occur midyear or following the end of a
benchmark or performance year could
have widespread implications not only
for the ACO but also for its ACO
providers/suppliers under the Quality
Payment Program.
b. Proposals
As participation in the Shared
Savings Program grows and more ACOs
and ACO participants join the program,
we believe the overlap situation
described previously is likely to become
more common. We also believe that
changes to our program rules regarding
the claims that will be considered in
assigning FFS beneficiaries to an ACO
(specifically, the policy finalized in the
June 2015 final rule to exclude services
furnished by several physician specialty
types from the assignment methodology)
may result in a greater number of
permissible ACO participant TIN
overlaps (see 80 FR 32753 and 32754).
As a result, we anticipate there could
also be an increased number of cases
where ACO participant TINs with
initially permissible overlaps could
become out of compliance with the
requirement at § 425.306(b)(2) that an
ACO participant TIN be exclusive to a
single Shared Savings Program ACO if
the TIN bills for primary care services
that are used to assign beneficiaries to
the ACO. This could occur, for example,
if a group practice that initially includes
only physician specialty types whose
services are excluded from the
assignment methodology were to
subsequently employ a non-physician
practitioner who bills for primary care
services. We believe these types of
practice arrangements are becoming
increasingly common.
We therefore believe it is necessary to
streamline our approach to handling
such situations in order to reduce the
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burden and uncertainty for ACOs when
changes in ACO participant billing
practices result in an ACO participant
falling out of compliance with the
exclusivity requirement at
§ 425.306(b)(2). Rather than the current
policy under which an ACO may be
required to remove an overlapping ACO
participant and recertify its ACO
participant list for the performance year
(thus necessitating redetermination of
beneficiary assignment and delays in or
revisions to benchmark or performance
year calculations), we believe it would
be less disruptive for ACOs if we were
to permit overlapping TINs that begin
billing for services used in assignment
during a benchmark or performance
year (including claims for services
furnished during the benchmark of
performance year, but submitted during
the 3-month claims runout) to remain
on the ACO participant lists for all
affected ACOs for the remainder of the
performance year in which we
determine that an overlap exists. For
example, assume that, based on an
analysis of claims for services furnished
in performance year 2018, we were to
identify an impermissibly overlapping
TIN in January 2019 after the ACO
participant lists for performance year
2019 had already been certified. Under
this proposal, the TIN would be able to
remain on the ACO participant lists of
all affected ACOs for the 2018
performance year as well as the
remainder of performance year 2019. In
order to ensure that the TIN overlap
does not inadvertently result in
assignment of the same beneficiaries to
multiple ACOs, we would simply
exclude any claims for services
furnished by the overlapping TIN from
the assignment methodology when
conducting final beneficiary assignment
for any benchmark or performance year
in which the TIN bills Medicare for
services used in our assignment
methodology. The affected ACOs would
be required to resolve the overlap prior
to recertification of their ACO
participant lists for the subsequent
performance year. If the overlap remains
unresolved when the ACOs certify their
ACO participant lists for the next
performance year, we would remove the
TIN from the ACO participant lists of all
ACOs seeking to include the TIN, in
accordance with our current policy for
resolving overlaps. For example, in the
hypothetical case above, if the overlap
were to remain unresolved when the
ACOs certify their ACO participant lists
for performance year 2020, we would
remove the TIN from the ACO
participant lists for all ACOs seeking to
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34121
include the TIN as an ACO participant
for performance year 2020.
We therefore propose to modify our
program rules in § 425.306 and subpart
E of part 425 to address this issue. We
propose to modify § 425.306(b) to
indicate that if, during a benchmark or
performance year (including the 3month claims run out period for such
benchmark or performance year), an
ACO participant that participates in
more than one ACO begins billing for
services that would be used in
assignment, we would not consider any
services billed through that TIN during
the relevant performance year when
performing beneficiary assignment for
the applicable benchmark or
performance year. As part of this
proposed modification, we would also
eliminate the references to ‘‘primary
care’’ when describing the services used
to determine the ACO’s assigned
beneficiary population in order to
conform with our proposal to
implement section 17007 of the 21st
Century Cures Act under which we
would consider all services furnished in
FQHCs and RHCs in the assignment
methodology as primary care services
starting in the 2019 performance year. In
addition, the ACOs in which the
overlapping TIN is an ACO participant
may be subject to compliance action (as
provided under § 425.216) or
termination under § 425.218.
Compliance actions may include
requiring each ACO that includes the
TIN as an ACO participant to submit a
corrective action plan explaining how
the ACO plans to work with the
overlapping ACO participant to resolve
the overlap for the next performance
year. If the overlap remains unresolved
by the date specified by us in our
request for a corrective action plan, we
would remove the overlapping ACO
participant TIN from the ACO
participant list of each ACO for the
subsequent performance year.
We also propose to revise our general
assignment methodology at
§ 425.400(a)(1) to add new paragraph
(a)(1)(iii) to indicate that when we
determine final assignment after the end
of each benchmark or performance year,
we will exclude claims for services
furnished during the benchmark or
performance year by an ACO participant
that participates in more than one ACO.
We believe that this policy will ensure
a uniquely assigned beneficiary
population for each ACO and prevent
the same beneficiaries from being
included in determining benchmark or
performance year expenditures for more
than one ACO.
We believe that implementing this
proposed process would improve ACO
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and ACO participant understanding of
our policies and requirements regarding
ACO participant overlaps while also
reducing burden for ACOs that currently
must recertify ACO participant lists and
may be subject to retrospective
modifications or delays in assignment
and other dependent benchmark or
performance year calculations. We also
note that this policy allows us to
preserve the flexibility that is currently
extended to ACO participants that do
not bill for services used in assignment,
while recognizing the possibility for
mid-year changes in care and billing
practices by these ACO participants.
Additionally, ACO participant TINs and
the eligible clinicians that bill through
those TINs would be provided greater
certainty regarding whether they qualify
as participating in an APM or Advanced
APM for a performance year. Under this
proposed policy, an ACO participant
would know for the entire performance
year with certainty that it is
participating in a particular APM entity.
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5. Treatment of Individually Beneficiary
Identifiable Payments Made Under a
Demonstration, Pilot, or Time Limited
Program
a. Background
Under section 1899(d) of Act, ACOs
participating in the Shared Savings
Program are accountable for the total
Parts A and B costs for the Medicare feefor-service beneficiaries assigned to the
ACO. Therefore, we include all
payments made from the Medicare Trust
Fund for Parts A and B services
furnished to assigned Medicare FFS
beneficiaries, including individually
beneficiary identifiable non-claims
based payments made under a
demonstration, pilot or time limited
program, when computing average per
capita Medicare expenditures for an
ACO during both the benchmark period
and performance years. We believe it is
appropriate to take into account nonclaims based payments from a
demonstration, pilot, or time limited
program in Medicare Shared Savings
Program financial calculations to ensure
that the final shared savings payments
that are made to ACOs are accurate and
reflect all Parts A and B expenditures
for the ACO’s assigned beneficiaries. We
also review individually beneficiary
identifiable payments made under a
demonstration, pilot, or time-limited
program as part of our efforts to ensure
there is no duplication of payments for
beneficiaries that may be assigned to
both the Shared Savings Program and
other Innovation Center models. This
general policy of considering
individually beneficiary identifiable
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non-claims based payments made under
a demonstration, pilot or time limited
program was initially established in the
2011 final rule implementing the Shared
Savings Program (76 FR 67915) for:
• Establishing, adjusting, and
updating the benchmark for an ACO’s
first agreement period under
§ 425.602(a)(1)(ii),
• Calculation of savings under the
one-sided model (Track 1) at
§ 425.604(a)(6)(ii), and
• Calculation of shared savings and
losses under Track 2 at
§ 425.606(a)(6)(ii).
This policy has also been included in
subsequent program modifications to
the program for:
• Resetting, adjusting, and updating
the benchmark for a subsequent
agreement period under
§§ 425.603(c)(1)(ii) and 425.603(e)(2)(ii),
and
• Calculation of shared savings and
losses under Track 3 at
§ 425.610(a)(6)(ii).
More specifically, in addition to
Medicare Parts A and B claims, we
include non-claims based individually
beneficiary identifiable payments when
performing financial calculations for the
Shared Savings Program, including
setting the preliminary and final
benchmarks, updating the financial
benchmark at the time of reconciliation
and calculating performance year
expenditures. We internally track nonclaims based beneficiary identifiable
payments (that is, payments made
outside the Medicare fee-for-service
claims system) through a separate CMS
system that receives and stores these
non-claims based payments made from
the Medicare Trust Funds under a
demonstration, pilot or time limited
program. The non-claims based
payments are loaded into the separate
system at various points in time,
depending on the terms of payment
under each specific demonstration, pilot
or time limited program. The amounts
that are reflected in this separate system
include interim payment amounts that
are subject to final reconciliation and
may not reflect the actual final
payments to the provider or site. For
example, the Bundled Payments for
Care Improvement (BPCI) initiative is
comprised of four broadly defined
models of care, which link payments for
the multiple services beneficiaries
receive during an episode of care. (See
the CMS Web site at https://
innovation.cms.gov/initiatives/bundledpayments/). Under the retrospective
BPCI payment models, Medicare
continues to make fee-for-service (FFS)
payments for the Part A and Part B
services furnished to a beneficiary
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during an episode; but, the total Part A
and Part B expenditures for the episode
are later reconciled against a bundled
payment amount (the target price)
determined by CMS. A payment or
recoupment amount is determined by
comparing the aggregate expenditures to
the target price. Interim payment and
recoupment amounts are calculated
quarterly but it is only after the BPCI
claims run out period that the final
reconciliation can be performed and the
final expenditure amount is known. In
contrast, under certain other
demonstrations, pilots, or time limited
programs only final non-claims based
payment data are loaded into the
system. For example, under the
Community-based Care Transitions
Program (CCTP), the participating
community-based organizations were
paid an all-inclusive rate per eligible
discharge. This final non-claims based
payment was then loaded into the
system and was not subject to
subsequent reconciliations.
To date, when we perform ACO
benchmarking and financial
calculations under the Shared Savings
Program, we have included (in addition
to all Medicare Parts A and B claims) all
non-claims based beneficiary
identifiable payments for the applicable
benchmark or performance year that are
included in the separate CMS system,
including any payments made during
the benchmark or performance year’s 3months claims run-out period. This
means that to date we have included
some interim payments made under a
demonstration, pilot or time limited
program that will undergo subsequent
reconciliation to determine the final
payment amount in the calculation of
historical benchmarks and performance
year expenditures. However, because
the various demonstrations, pilots or
time limited programs may have
different operational schedules to the
Shared Savings Program, it is not
possible for us to include all interim
and final beneficiary identifiable
payments made under these initiatives
in benchmarking and financial
reconciliation calculations for the
Shared Savings Program; and, as a
result, these calculations have excluded
some interim and final non-claims
based beneficiary identifiable payments
made under certain demonstrations,
pilots or time limited programs. For
example, because of the timing and
availability of BPCI non-claims based
payment amounts, to date we have
included only up to two quarters of
interim payment data for BPCI in ACO
benchmarking and financial
reconciliation calculations for the
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Shared Savings Program and no final
payment amounts.
To date, non-claims based
individually beneficiary identifiable
payments represent a relatively minor
proportion of an ACO’s total Part A and
B beneficiary expenditure amounts as
determined under the Shared Savings
Program (mean of 0.09 percent overall
impact of ACO non-claims based
payments on total per capita
expenditures and a mean of 137 personyears in an ACO’s assigned beneficiary
population with a non-claims based
payment during the year; minimum
-0.72 percent, 0 person-years; maximum
1.24 percent, 1,865 person-years). For
the demonstrations, pilots or time
limited programs that include interim
and final reconciliations, the impact of
including the non-claims based
payments could be positive or negative
for an ACO for a given performance
year. Additionally, a preliminary
analysis suggests that interim payments
made under select demonstrations,
pilots or time-limited program fluctuate
on a quarterly basis. An examination of
trends in total per capita non-claims
based payments in 2016 quarterly
program reports across 416 Track 1 and
2 ACOs found a mean decline of 14
percent from Quarter 1 to Quarter 2,
followed by a mean increase of 144
percent from Quarter 2 to Quarter 3, and
a mean increase of 742 percent from
Quarter 3 to Quarter 4. Quarterly trends
for individual ACOs also tended to
fluctuate. Per capita amounts in this
analysis were based on those ACOs with
at least one non-claims based payment
in each quarterly report period. Almost
half of the ACOs in the analysis (201 out
of 416) had at least one quarter in 2016
with a net negative per capita payment
across all beneficiaries with at least one
non-claims based payment and at least
one quarter with a net positive per
capita payment. A review of non-claims
based payments incorporated in PY
2017 preliminary historical benchmarks
also found similar swings between
negative and positive amounts, with
roughly one third of ACOs receiving a
benchmark (156 of 480) having at least
one benchmark year with a net negative
per capita payment across all
beneficiaries with at least one nonclaims based payment and at least one
benchmark year with a net positive per
capita payment.
These fluctuations in the non-claims
based payments for certain initiatives
like BPCI have generated stakeholder
concern. Further, stakeholders note that
the impact of including interim
payments in financial calculations may
become greater in the future, given the
increasingly widespread interest in
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participation in alternative payment
models and the growing number of such
models being tested through the CMS
Innovation Center. Stakeholders have
therefore suggested that we should
revise our policies to clarify that only
final non-claims based payments made
within the 3 months claims run out
period under a demonstration, pilot or
time limited program will be included
in the calculation of an ACO’s
benchmark and performance year
expenditures.
b. Proposals
Our preliminary analysis, as
discussed in the background section,
suggests that interim non-claims based
payments (that is, payments that are
subject to reconciliation at a later date)
made under a demonstration, pilot, or
time limited program can fluctuate
significantly from quarter to quarter and
may not reflect the actual final
reconciled payment amount. Thus, we
agree with the stakeholders who have
suggested that only final non-claims
based payments made under a
demonstration, pilot or time limited
program should be included in financial
calculations related to benchmarks and
performance year expenditures under
the Shared Savings Program. We believe
this would be a reasonable approach to
determining Parts A and B expenditures
for assigned beneficiaries for both
benchmark and performance years given
the uncertain impact on ACOs’ financial
calculations of including interim
payments that will be subsequently
revised to reflect the final reconciled
payment amounts. We also agree that
use of interim payments made under a
demonstration, pilot or time limited
program could have an increasingly
large effect on ACO benchmarks and
performance year expenditure
calculations in the future given
widespread stakeholder interest in
participating in alternative payment
models and CMS interest in testing and
expanding additional payment models
that may lead to higher quality and
more coordinated care at a lower cost to
Medicare.
Therefore, we are proposing to revise
the applicable regulations to make clear
that we would include only final
individually beneficiary identifiable
payments made under a demonstration,
pilot or time limited program in
financial calculations related to
establishing and updating benchmarks
and determining performance year
expenditures under the Shared Savings
Program. We propose that this policy
would be applied to calculations that
are necessary to determine ACO
performance for the 2018 performance
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34123
year and subsequent performance years.
For ACOs that are in the middle of an
agreement period when this revised
policy takes effect, we would adjust the
benchmarks for these ACOs at the start
of the 2018 performance year and each
subsequent performance year so that the
benchmark for the ACO reflects the use
of the same payment information that
would apply in expenditure
calculations for the performance year.
More specifically, we propose to modify
our regulations at §§ 425.602(a)(1)(ii),
425.603(c)(1)(ii), and 425.603(e)(2)(ii) to
add new provisions to indicate that, (1)
when establishing benchmarks for
agreement periods before 2018, we will
include all individually beneficiary
identifiable payments, including interim
payments, made under a demonstration,
pilot, or time limited program, (2) for
agreement periods beginning in 2018
and subsequent years, we would only
include individually beneficiary
identifiable payments made under a
demonstration, pilot or time limited
program that are final and not subject to
further reconciliation, and (3) For the
2018 performance year and subsequent
performance years in agreement periods
beginning in 2015, 2016 and 2017, the
benchmark would be adjusted to reflect
only individually beneficiary
identifiable final payments made under
a demonstration, pilot or time limited
program. Additionally, we propose to
add new §§ 425.604(a)(6)(ii)(A),
425.606(a)(6)(ii)(A) and
425.610(a)(6)(ii)(A) indicating that when
calculating expenditures for
performance years before 2018, we will
include all individually beneficiary
identifiable payments, including interim
payments, made under a demonstration,
pilot, or time limited program. We also
propose to add new
§§ 425.604(a)(6)(ii)(B),
425.606(a)(6)(ii)(B) and
425.610(a)(6)(ii)(B) indicating that when
calculating expenditures for
performance year 2018 and subsequent
performance years, we would only
include individually beneficiary
identifiable payments made under a
demonstration, pilot or time limited
program that are final and not subject to
further reconciliation. To be consistent
with our treatment of claims-based
payments, such final payments would
have to be available in the separate CMS
system by the end of the 3-month claims
run out period.
We invite comments on this proposal.
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I. Value-Based Payment Modifier and
Physician Feedback Program
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1. Overview
Section 1848(p) of the Act requires
the establishment of a value-based
payment modifier (VM) that applies 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 programs continue
our 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 Medicare
Access and CHIP Reauthorization Act of
2015 (MACRA) (Pub. L. 114–10) 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
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Medicare PFS for physicians in groups
of 10 or more EPs. Then, in the CY 2015
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 non-physician 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.
In the CY 2016 PFS final rule with
comment period (80 FR 71288 to
71291), we finalized that we would
apply the following adjustments to
payments, for items and services
furnished under the Medicare PFS in
CY 2018, to physicians, PAs, NPs, CNSs,
and CRNAs in groups with 10 or more
EPs and at least one physician:
• Negative 4 percent (¥4.0 percent)
for those that fall into Category 2,
meaning that they did not meet the
criteria to avoid the 2018 PQRS
payment adjustment.
• Negative 4 percent (¥4.0 percent)
under the quality-tiering methodology
for those classified as low quality/high
cost and negative 2 percent (¥2.0
percent) for those classified as either
low quality/average cost or average
quality/high cost.
• An upward adjustment of four
times an adjustment factor (+4.0x) under
the quality-tiering methodology for
those classified as high quality/low cost
and two times an adjustment factor
(+2.0x) for those classified as either
average quality/low cost or high quality/
average cost.
We finalized that we would apply the
following adjustments to payments, for
items and services furnished under the
Medicare PFS in CY 2018, to physician
solo practitioners and physicians, PAs,
NPs, CNSs, and CRNAs in groups with
2 to 9 EPs and at least one physician:
• Negative 2 percent (¥2.0 percent)
to those that fall into Category 2,
meaning that they did not meet the
criteria to avoid the 2018 PQRS
payment adjustment.
• Negative 2 percent (¥2.0 percent)
under the quality tiering methodology
for those classified as low quality/high
cost and negative 1 percent (-1.0
percent) for those classified as either
low quality/average cost or average
quality/high cost.
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• An upward adjustment of two times
an adjustment factor (+2.0x) under the
quality-tiering methodology for those
classified as high quality/low cost and
one times an adjustment factor (+1.0x),
for those classified as either average
quality/low cost or high quality/average
cost.
We finalized that we would apply the
following adjustments to payments, for
items and services furnished under the
Medicare PFS in CY 2018, to nonphysician solo practitioners who are
PAs, NPs, CNSs, and CRNAs and to
PAs, NPs, CNSs, and CRNAs in groups
comprised solely of non-physician EPs:
• Negative 2 percent (¥2.0 percent)
for those who fall in Category 2,
meaning that they did not meet the
criteria to avoid the 2018 PQRS
payment adjustment.
• No downward adjustments under
the quality-tiering methodology in CY
2018.
• An upward adjustment of two times
an adjustment factor (+2x) under the
quality-tiering methodology, for those
classified as high quality/low cost and
one times an adjustment factor (+1.0x)
for those classified as either average
quality/low cost or high quality/average
cost.
In the CY 2017 PFS final rule with
comment period (81 FR 80520–80524),
we finalized the following, with regard
to Medicare Shared Savings Program
ACO participant TINs whose ACO did
not successfully report quality data on
behalf of its EPs for purposes of PQRS
as required by the Shared Savings
Program under § 425.504 for the CY
2017 and CY 2018 PQRS payment
adjustments:
• For the CY 2017 VM payment
adjustment period, we will use the data
reported to the PQRS by the EPs under
the ACO participant TIN (as a group or
as individuals) outside of the ACO
during the secondary PQRS reporting
period in 2016 to determine whether the
TIN would fall in Category 1 or Category
2 under the VM.
• We will apply the two-category
approach finalized for the CY 2017 VM
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.
• We will 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, groups
that meet the criteria to avoid the PQRS
payment adjustment for CY 2018 as a
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group or by having at least 50 percent
of the group’s EPs meet the criteria to
avoid the PQRS payment adjustment for
CY 2018 as individuals, based on data
submitted outside the ACO and during
the secondary PQRS reporting period in
2016, will be included in Category 1 for
the CY 2017 VM. In addition, solo
practitioners that meet the criteria to
avoid the PQRS payment adjustment for
CY 2018 as individuals, based on data
submitted outside the ACO and during
the secondary PQRS reporting period in
2016, will be included in Category 1 for
the CY 2017 VM. For these groups and
solo practitioners in Category 1, we will
classify their quality composite as
‘‘average quality,’’ and as established in
the CY 2015 PFS final rule with
comment period (79 FR 67943), we will
classify their cost composite as ‘‘average
cost.’’ Category 2 will 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. We note that
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.
For the CY 2018 payment adjustment
period, 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 or by having at least 50
percent of the group’s EPs meet the
criteria to avoid the PQRS payment
adjustment for CY 2018 as individuals
by reporting quality data to PQRS
outside of the ACO, then they will 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, then they
will also be included in Category 1. We
will 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 is
classified as ‘‘average cost.’’
3. Provisions of This Proposed Rule
As a general summary, we are
proposing the following modifications
to the VM policies for the CY 2018
payment adjustment period:
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• Reduce the automatic downward
adjustment for groups and solo
practitioners in Category 2 (those who
do not meet the criteria to avoid the
2018 PQRS payment adjustment as
individual solo practitioners, as a group
practice, or groups that have at least 50
percent of the group’s EPs meet the
criteria as individuals) to negative 2
percent (¥2.0 percent) for groups with
10 or more EPs and at least one
physician, and negative 1 percent (¥1.0
percent) for groups with between 2 to 9
EPs, physician solo practitioners, and
for groups and solo practitioners that
consist only of non-physician EPs.
• Hold all groups and solo
practitioners who are in Category 1
(those who meet the criteria to avoid the
2018 PQRS payment adjustment as
individual solo practitioners, as a group
practice, or groups that have at least 50
percent of the group’s EPs meet the
criteria as individuals) harmless from
downward payment adjustments under
quality tiering for the last year of the
program.
• To provide a smoother transition to
the MIPS and to align incentives across
all groups and solo practitioners, reduce
the maximum upward adjustment under
the quality-tiering methodology to two
times an adjustment factor (+2.0x) for
groups with 10 or more EPs. This is the
same maximum upward adjustment
under the quality-tiering methodology
that we finalized and will maintain for
groups with between 2 to 9 EPs,
physician solo practitioners, and for
groups and solo practitioners that
consist only of non-physician EPs.
a. Approach to Setting the VM
Adjustment Based on PQRS
Participation
Section 1848(p)(4)(B)(iii)(II) of the Act
requires the Secretary to apply the VM
to items and services furnished under
the PFS beginning not later than January
1, 2017, for all physicians and groups of
physicians. Therefore, as mentioned in
this proposed rule, in the CY 2016 PFS
final rule with comment period (80 FR
71277 through 71279), we established
that for the CY 2018 payment
adjustment period, the VM will apply to
non-physician EPs who are PAs, NPs,
CNSs, and CRNAs in groups with 2 or
more EPs and to PAs, NPs, CNSs, and
CRNAs who are solo practitioners.
In the CY 2016 PFS final rule with
comment period (80 FR 71280), we
adopted a two-category approach for the
CY 2018 VM based on participation in
the PQRS by groups and solo
practitioners. For the purposes of the CY
2018 VM, Category 1 includes the
following groups and solo practitioners:
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34125
(1) Groups that meet the criteria to
avoid the CY 2018 PQRS payment
adjustment as a group practice
participating in the PQRS GPRO;
(2) Groups that have at least 50
percent of the group’s EPs meet the
criteria to avoid the PQRS payment
adjustment for CY 2018 as individuals;
(3) Solo practitioners that meet the
criteria to avoid the CY 2018 PQRS
payment adjustment as individuals; and
(4) Groups and solo practitioners that
meet the criteria to avoid the CY 2018
PQRS payment adjustment through
participation in a Shared Savings
Program ACO, if the ACO in which they
participate successfully reports quality
data as required by the Shared Savings
Program.
Category 2 includes those groups and
solo practitioners that are subject to the
CY 2018 VM payment adjustment and
do not fall within Category 1. Groups in
Category 1 have been eligible to receive
upward, neutral, or downward
adjustments under our quality tiering
methodology, and groups and solo
practitioners in Category 2 receive an
automatic downward adjustment under
the VM.
As noted in this proposed rule, 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 MIPS that shall apply to payments
for items and services furnished on or
after January 1, 2019. In the interest of
program alignment and providing a
smooth transition between the VM and
MIPS, as well as aligning with the
proposed changes to the policies for
satisfactory reporting under the final
year of PQRS, modifications to the CY
2018 VM payment adjustments are
proposed and described in section III.F.
of this proposed rule. We are not
proposing any change to our existing
policy that TINs that avoid the
downward payment adjustment under
PQRS (either as a group practice
participating in the PQRS GPRO or
through the individual participation of
at least 50 percent of the group’s EPs, or
as a solo practitioner) will be considered
Category 1 under the VM. These TINs
therefore will avoid an automatic
downward adjustment under the VM.
b. Payment Adjustment Amount
In this section, we are proposing
modifications to the VM policies for the
CY 2018 payment adjustment period. As
discussed in greater detail below, we are
proposing these modifications based on
our general policy goals of better
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alignment and ensuring a smooth
transition from the final year of the VM
(2018) to the first year of MIPS (2019)
as well as continuing to align the VM
with the policies established for the
PQRS.
To maintain stability in the payment
adjustment amounts applicable under
the VM as we transition to the MIPS in
2019, we maintained generally the same
VM payment adjustment amounts from
the CY 2017 payment adjustment period
to the CY 2018 payment adjustment
period (80 FR 71288 through 71291).
Under our existing policy (80 FR
71290), the estimated funds derived
from the application of the downward
adjustments to groups and solo
practitioners in Category 1 and Category
2 are available to all groups and solo
practitioners eligible for upward
adjustments under the VM. The upward
payment adjustment factor (the ‘‘x’’
factor) is determined after the
performance period has ended based on
the aggregate amount of downward
payment adjustments. Despite our
efforts to ensure a smooth transition
from the VM to the MIPS, the 2017 VM
adjustment factor has resulted in
payment adjustments for some groups
and solo practitioners that are
significantly higher than the maximum
upward adjustment under the MIPS,
which will apply to payments starting
in 2019, after the sunset of the VM in
2018. The magnitude of the 2017 VM
adjustment factor is due in large part to
the number of physician practices
failing to satisfy the criteria to avoid the
PQRS payment adjustment (Category 2).
Furthermore, we believe it is likely that
many physician practices that fail to
meet these criteria and as a result are in
Category 2 and are subject to automatic
downward adjustments under the 2018
VM will be excluded from MIPS in
2019, due to the low-volume threshold.
For example, as noted in the 2015 PQRS
Experience Report, CMS foundthat,
based on historical data, the
participation rate for practices falling
below the low volume threshold ‘‘low
volume’’ (< $30k charges OR <100
beneficiaries) would be approximately
60 percent. Based on historical data, the
participation rate among practices
falling above the low volume threshold
(>= $30k charges AND >=100
beneficiaries) would be approximately
80 percent.
The 2017 VM adjustment factor is
15.48 percent, which is similar to the
2016 VM adjustment factor of 15.92
percent. We would expect, absent any
policy change, that the 2018 VM
adjustment factor would be similar or
higher. The 2018 VM adjustment factor
could potentially be higher than the
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2017 VM adjustment factor, because
non-physician EPs who will be subject
to the 2018 VM may be less familiar
with quality reporting and may fail to
meet the criteria to avoid the CY 2018
PQRS payment adjustment, which
would result in a greater number of
groups and solo practitioners in
Category 2. In addition, groups with 2–
9 EPs and solo practitioner physicians
will no longer be held harmless from
downward adjustments under the
quality-tiering methodology in the CY
2018 payment adjustment period.
In section III.F. of this proposed rule,
we are proposing to change certain
policies for the 2018 PQRS payment
adjustment. We discuss the implications
of these proposed changes for PQRS
with regard to the VM in greater detail
below.
• Quality-Tiering for groups and solo
practitioners in Category 1: As noted in
section III.F. of this proposed rule, we
are proposing to change the reporting
criteria for the 2018 PQRS payment
adjustment. We are proposing to lower
the number of measures required and to
eliminate the requirement for reporting
across a number of domains. We
recognize that some groups and solo
practitioners may have reported
differently under PQRS if the PQRS
reporting criteria had been established
prior to the reporting period. For
example, it is possible that groups and
solo practitioners may have selected
fewer or different PQRS measures to
report or may have chosen to report
through a different PQRS reporting
mechanism, which could have resulted
in a higher quality composite score
under the VM. Based on these
implications for the VM, we are
proposing to hold all groups and solo
practitioners in Category 1 harmless
from downward adjustments under the
quality-tiering methodology in the CY
2018 payment adjustment period. This
proposal would apply to groups and
solo practitioners who would have
otherwise received downward
adjustments based on their quality
composite score and/or cost composite
score. A group or solo practitioner that
is classified as ‘‘high cost’’ based on
their cost composite score potentially
could have reported differently under
the PQRS and received a quality
composite score that would be classified
as ‘‘high quality,’’ if the PQRS reporting
criteria proposed in section III.F. of this
proposed rule had been established
prior to the reporting period. A high
quality/high cost classification would
have resulted in a neutral adjustment
under the VM in 2018.
In contrast to the existing policy for
2018 where only non-physician solo
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practitioners and groups comprised
solely of non-physician EPs would be
held harmless from downward
adjustments under quality-tiering, this
proposed policy would mean that all
groups and solo practitioners that meet
the criteria to avoid the 2018 PQRS
payment adjustment would receive
either a neutral or upward adjustment
based on performance.
We also propose to reduce the
maximum upward adjustment under the
quality-tiering methodology in CY 2018
from four times an adjustment factor
(+4.0x) to two times an adjustment
factor (+2.0x) for those classified as high
quality/low cost and from two times an
adjustment factor (+2.0x) to one times
an adjustment factor (+1.0x), for those
classified as either average quality/low
cost or high quality/average cost. This
proposal would align the upward
adjustments for groups with ten or more
eligible professionals with the existing
policy for smaller groups and solo
practitioners, as well as groups
comprised solely of non-physician EPs
(80 FR 71290). We are proposing this
change based on our concern that the
2018 VM adjustment factor (the ‘‘x’’
factor used to determine upward
adjustments) could potentially be higher
than the 2017 VM adjustment factor, as
discussed above. Lowering the
maximum upward adjustment in 2018
would mitigate the effect of a high
adjustment factor and ensure a smoother
transition from the VM adjustment in
2018 to the MIPS adjustment in 2019.
We welcome public comment on this
proposal.
We are not proposing any change to
the existing policy (80 FR 71291) that
groups and solo practitioners that are
eligible for upward adjustments under
the quality-tiering methodology and
have average beneficiary risk score that
is in the top 25 percent of all beneficiary
risk scores will earn an additional
upward adjustment of one times an
adjustment factor (+1x). We are also not
proposing any change to the existing
policy (81 FR 80520 through 80524) (a)
for the CY 2017 payment adjustment
period for groups and solo practitioners
that would be in Category 1 as a result
of meeting the proposed reduced PQRS
reporting criteria (see section III.F. of
this proposed rule) outside of their
Shared Savings Program ACO during
the secondary PQRS reporting period in
2016 or (b) for the CY 2018 payment
adjustment period for groups and solo
practitioners that would be Category 1
as a result of reporting outside of their
Shared Savings Program ACO because
their ACO failed to successfully report
on their behalf to avoid the PQRS
payment adjustment. As stated
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previously, under the existing policy,
these groups and solo practitioners in
Category 1 would be classified as
‘‘average quality’’ and ‘‘average cost’’ for
purposes of the CY 2017 VM.
Tables 22 through 24 illustrate how
the proposed policies differ from the
existing policies for each group size and
composition.
TABLE 22—CURRENT AND PROPOSED CY 2018 VM AMOUNTS UNDER THE QUALITY-TIERING APPROACH FOR PHYSICIANS,
NPS, PAS, CNSS, & CRNAS IN GROUPS OF PHYSICIANS WITH 10+ EPS
Cost/quality
Low quality
Current
(%)
VM Payment adjustment
Low Cost ..................................................
Average Cost ...........................................
High Cost .................................................
Average quality
Proposed
(%)
+0.0
¥2.0
¥4.0
Current
+0.0
+0.0
+0.0
High quality
Proposed
+2.0x*
+0.0%
¥2.0%
+1.0x*
+0.0%
+0.0%
Current
Proposed
+4.0x*
+2.0x*
+0.0%
+2.0x*
+1.0x*
+0.0%
* Under existing policy, these groups are eligible for an additional +1.0x if their average beneficiary risk score is in the top 25 percent of all
beneficiary risk scores, where ‘x’ represents the upward payment adjustment factor.
TABLE 23—CURRENT AND PROPOSED CY 2018 VM AMOUNTS UNDER THE QUALITY-TIERING APPROACH FOR PHYSICIANS,
PAS, NPS, CNSS, & CRNAS IN GROUPS OF PHYSICIANS WITH 2–9 EPS AND PHYSICIAN SOLO PRACTITIONERS
Cost/quality
Low quality
Current
(%)
VM Payment adjustment
Low Cost ..................................................
Average Cost ...........................................
High Cost .................................................
Average quality
Proposed
(%)
+0.0
¥1.0
¥2.0
Current
+0.0
+0.0
+0.0
High quality
Proposed
+1.0x*
+0.0%
¥1.0%
+1.0x*
+0.0%
+0.0%
Current
Proposed
+2.0x*
+1.0x*
+0.0%
+2.0x*
+1.0x*
+0.0%
* Under existing policy, these groups and solo practitioners are eligible for an additional +1.0x if their average beneficiary risk score is in the
top 25 percent of all beneficiary risk scores, where ‘x’ represents the upward payment adjustment factor.
TABLE 24—CURRENT AND PROPOSED CY 2018 VM AMOUNTS UNDER THE QUALITY-TIERING APPROACH FOR PAS, NPS,
CNSS, & CRNAS WHO ARE SOLO PRACTITIONERS OR IN GROUPS CONSISTING OF NON-PHYSICIAN EPS ONLY
Cost/quality
Low quality
Current
(%)
VM Payment adjustment
Low Cost ..................................................
Average Cost ...........................................
High Cost .................................................
Average quality
Proposed
(%)
+0.0
+0.0
+0.0
Current
+0.0
+0.0
+0.0
High quality
Proposed
+1.0x*
+0.0%
+0.0%
+1.0x*
+0.0%
+0.0%
Current
+2.0x*
+1.0x*
+0.0%
Proposed
+2.0x*
+1.0x*
+0.0%
* Under existing policy, these groups and solo practitioners are eligible for an additional +1.0x if their average beneficiary risk score is in the
top 25 percent of all beneficiary risk scores, where ‘x’ represents the upward payment adjustment factor.
Table 25 displays the proposed 2018
VM adjustments under the qualitytiering methodology, for groups and solo
practitioners in Category 1. Under the
proposed policies, groups of any size
and composition would be subject to the
same upward adjustments under quality
tiering and would be held harmless
from any downward adjustments based
on performance.
TABLE 25—PROPOSED CY 2018 VM AMOUNTS UNDER THE QUALITY-TIERING APPROACH FOR PHYSICIANS, PAS, NPS,
CNSS, AND CRNAS WHO ARE SOLO PRACTITIONERS AND THOSE IN GROUPS OF ANY SIZE
Low quality
(%)
Cost/quality
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Low cost .......................................................................................................................................
Average cost ................................................................................................................................
High cost ......................................................................................................................................
+0.0
+0.0
+0.0
Average
quality
+1.0x*
+0.0%
+0.0%
High quality
+2.0x*
+1.0x*
+0.0%
* Under existing policy, these groups and solo practitioners are eligible for an additional +1.0x if their average beneficiary risk score is in the
top 25 percent of all beneficiary risk scores, where ‘x’ represents the upward payment adjustment factor.
• Automatic Downward Adjustments
for groups and solo practitioners in
Category 2. Under existing policy, the
total maximum downward adjustment
in 2018 under the PQRS and VM
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programs combined is negative 6
percent (¥6.0 percent), while the
maximum downward adjustment under
MIPS in 2019 is negative 4 percent
(¥4.0 percent). In order to ensure a
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smoother transition to the downward
payment adjustments under MIPS, we
are proposing to reduce the amount of
the automatic downward adjustments
applied to payments for TINs
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categorized as Category 2 (those that do
not avoid the PQRS payment adjustment
as individual solo practitioners, as a
group practice, or as a group that has at
least 50 percent of the group’s EPs meet
the criteria to avoid the payment
adjustment as individuals).
For physicians, PAs, NPs, CNSs, and
CRNAs in groups with 10 or more EPs
and at least one physician, we propose
to reduce the automatic downward VM
adjustment from negative 4 percent
(¥4.0 percent) to negative 2 percent
(¥2.0 percent) for those that fall in
Category 2, meaning they did not meet
the criteria to avoid the 2018 PQRS
payment adjustment. We welcome
public comment on this proposal.
For physician, PA, NP, CNS, and
CRNA solo practitioners; physicians,
PAs, NPs, CNSs, and CRNAs in groups
with 2 to 9 EPs; and for PAs, NPs, CNSs,
and CRNAs who are in groups
comprised solely of non-physician EPs,
we propose to reduce the automatic
downward VM adjustment from
negative 2 percent (¥2.0 percent) to
negative 1 percent (¥1.0 percent) for
those that fall in Category 2. We
welcome public comment on this
proposal.
Section 1848(p) of the Act does not
specify the amount of payment that
should be subject to the adjustment for
the VM; however, section 1848(p)(4)(C)
of the Act requires the VM be
implemented in a budget neutral
manner. In the past, under the VM, we
have achieved budget neutrality by
increasing payments for some groups
and solo practitioners based on high
performance and decreasing them for
others based on low performance or
failing to meet the criteria to avoid the
PQRS payment adjustment as a group or
as individuals. Under the proposals
discussed above for the CY 2018
payment adjustment period, we would
not decrease payments to groups and
solo practitioners based on performance
under the quality-tiering methodology,
provided that they are classified as
Category 1 under the VM (meaning that
they meet the criteria to avoid the CY
2018 PQRS payment adjustment as
individual solo practitioners, as a group
practice, or as a group that has at least
50 percent of the group’s EPs meet the
criteria). We would continue to decrease
payments to groups and solo
practitioners in Category 2 (meaning
that they did not meet the criteria to
avoid the CY 2018 PQRS payment
adjustment as individual solo
practitioners, as a group practice, or as
a group that has at least 50 percent of
the group’s EPs meet the criteria).
Regardless of the proposals discussed
above for the CY 2018 payment
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adjustment period, the aggregate
expected amount of Medicare spending
in any given year for physician and nonphysician EP services paid under the
Medicare PFS will not change as a result
of the application of the VM. As
discussed above, because the VM must
be implemented in a budget neutral
manner, the amount available for
upward adjustments for high performers
would decrease under our proposals. In
other words, groups and solo
practitioners that performed well on
cost and quality would receive a smaller
increase in payment. For this reason, we
seek comment on whether we have
appropriately balanced the interests of
high and low-performing groups and
solo practitioners through this proposed
change to the policy.
We propose to make conforming
revisions to §§ 414.1270, and
414.1275(c)(4) and (d)(3) to reflect the
proposals described in this section. We
seek public comment on these proposed
changes to the regulation text.
J. MACRA Patient Relationship
Categories and Codes
1. Development of Patient Relationship
Categories and Codes To Improve
Identification of Physician-Patient
Relationship
a. Overview
The Quality Payment Program (QPP)
aims to improve health outcomes,
promote smarter spending, minimize
burden of participation, and provide
fairness and transparency in operations.
These aims are centered on improving
beneficiary outcomes and engaging
patients through patient-centered
policies, and enhancing clinician
experience through flexible and
transparent program design and
interactions with easy-to-use program
tools.
The Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA)
(Pub. L. 114–10) was enacted on April
16, 2015. Section 101(f) of MACRA
amended section 1848 of the Act to
create a new subsection (r) entitled
Collaborating with the Physician,
Practitioner, and Other Stakeholder
Communities to Improve Resource Use
Measurement. Section 1848(r)(2) of the
Act requires the development of care
episode and patient condition groups,
and classification codes for such groups.
To facilitate the attribution of patients
and episodes to one or more clinicians,
section 1848(r)(3) of the Act requires the
development of patient relationship
categories and codes that define and
distinguish the relationship and
responsibility of a physician or
applicable practitioner with a patient at
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the time of furnishing an item or
service. The categories shall include
different relationships of the clinician to
the patient and reflect various types of
responsibility for and frequency of
furnishing care. Pursuant to section
1848(r)(3)(C) of the Act, we posted a
draft list of patient relationship
categories in April 2016 and solicited
public comment on the categories and
the policy principles that were used in
developing them.4 In December 2016,
we solicited additional comment on
potential modifications to these
categories based on comments received
previously, as well as a method to
operationalize the coding of these
categories on the Medicare claim.5
2. Operational List of Patient
Relationship Categories
Based on the public comments
received and consultation with
stakeholders and experts regarding the
draft list of patient relationship
categories posted in April 2016 and the
list of modified patient relationship
categories posted in December 2016, we
posted the operational list of patient
relationship categories on May 17, 2017,
pursuant to section 1848(r)(3)(E) of the
Act, which is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Value-Based-Programs/
MACRA-MIPS-and-APMs/CMS-PatientRelationship-Categories-and-Codes.pdf.
The patient relationship categories on
the operational list are the following:
• Continuous/Broad Services.
• Continuous/Focused Services.
• Episodic/Broad services.
• Episodic/Focused Services.
• Only as Ordered by Another
Clinician.
3. Subsequent Revisions
Section 1848(r)(3)(F) of the Act
requires that after the posting of the
operational list of patient relationship
categories and codes, not later than
November 1st of each year (beginning
with 2018), the Secretary shall, through
rulemaking, make revisions to the
operational list of patient relationship
categories and codes as the Secretary
determines appropriate. The revisions
may be based on experience, new
information and input from
stakeholders. In preparation for
4 https://www.cms.gov/Medicare/QualityInitiatives-Patient-Assessment-Instruments/ValueBased-Programs/MACRA-MIPS-and-APMs/PatientRelationship-Categories-and-Codes.pdf (assessed
04/26/2017).
5 https://www.cms.gov/Medicare/QualityInitiatives-Patient-Assessment-Instruments/ValueBased-Programs/MACRA-MIPS-and-APMs/PatientRelationship-Categories-and-Codes-PostingFINAL.pdf.
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potential subsequent revisions by
November 1, 2018, we seek comment on
the operational list of patient
relationship categories available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Value-Based-Programs/
MACRA-MIPS-and-APMs/CMS-PatientRelationship-Categories-and-Codes.pdf.
4. Reporting of Patient Relationship
Codes Using Modifiers
Section 1848(r)(4) of the Act requires
that claims submitted for items and
services furnished by a physician or
applicable practitioner on or after
January 1, 2018, shall, as determined
appropriate by the Secretary, include
the applicable codes established for care
episode groups, patient condition
groups, and patient relationship
categories under sections 1848(r)(2) and
(3) of the Act, as well as the NPI of the
ordering physician or applicable
practitioner (if different from the billing
physician or applicable practitioner).
Applicable practitioners are defined in
section 1848(r)(9)(B) of the Act as a
physician assistant, nurse practitioner,
and clinical nurse specialist (as such
terms are defined in section
1861(aa)(5)), and a certified registered
nurse anesthetist (as defined in section
1861(bb)(2)), and beginning January 1,
2019, such other eligible professionals
(as defined in subsection (k)(3)(B)) as
specified by the Secretary.
We have been planning for the use of
procedure code modifiers for the
reporting of patient relationships codes
on Medicare claims. In December 2016,
as described above, when we solicited
comments on the potential
modifications to the patient relationship
categories, we also sought comment on
the use of Level II Healthcare Common
Procedure Coding System (HCPCS)
Modifiers for the patient relationship
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codes. Public comments indicated that
Current Procedural Terminology (CPT)
Modifiers would be the best way to
operationalize the reporting of patient
relationship codes.6
We worked with the American
Medical Association’s (AMA) CPT
Editorial Panel, which is responsible for
maintaining the CPT code set. We
submitted an application for the CPT
modifiers for reporting of the patient
relationship codes. The CPT Editorial
Panel, at their June 2017 meeting
determined that AMA would not
include the modifiers in the CPT code
set, pending future finalization of the
modifiers by CMS, whereby CMS
publishes the modifiers as Level II
HCPCS Modifiers. Therefore, we are
proposing the Level II HCPCS Modifiers
in Table 26 as the patient relationship
codes, which we would add to the
operational list if we adopt them in the
final rule.
TABLE 26—PROPOSED PATIENT RELATIONSHIP HCPCS MODIFIERS AND CATEGORIES
Proposed
HCPCS
modifier
No.
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1x
2x
3x
4x
5x
.....................................................
.....................................................
.....................................................
.....................................................
.....................................................
Patient relationship categories
X1
X2
X3
X4
X5
Continuous/broad services
Continuous/focused services
Episodic/broad services
Episodic/focused services
Only as ordered by another clinician
We are proposing that Medicare
claims submitted for items and services
furnished by a physician or applicable
practitioner on or after January 1, 2018,
should include the applicable HCPCS
modifiers in Table 26, as well as the NPI
of the ordering physician or applicable
practitioner (if different from the billing
physician or applicable practitioner).
We anticipate there will be a learning
curve with the use of the modifiers to
report patient relationships, and believe
that time would be needed to work with
clinicians to ensure they gain
experience in using these modifiers.
Therefore, for at least an initial period
while clinicians gain familiarity, we are
proposing that the HCPCS modifiers
may be voluntarily reported on
Medicare claims, and the use and
selection of the modifiers would not be
a condition of payment. Claims would
be paid regardless of whether and how
the modifiers are included. We would
work with clinicians to educate them
about the proper use of the modifiers.
The use of modifiers to report patient
relationships would not change the
meaning of the procedure codes used to
report items and services and guidelines
associated with use of such procedure
codes. The modifiers would also not be
tied or related to intensity of services
(evaluation and management services).
Finally, we note that, while we may
work with clinicians to explore
incorporating these codes into the QPP
in future years, the measures we have
proposed and finalized to date, those we
have proposed for 2018, and those we
are currently developing for future
rulemaking for the MIPS performance
categories do not require patient
relationship codes to properly measure
clinicians’ quality and resource use in
the Medicare program.
We solicit comment on our proposal
for voluntary reporting of the proposed
HCPCS modifiers on claims submitted
for items and services furnished by a
physician or applicable practitioner on
or after January 1, 2018 and on the
proposed list of HCPCS modifiers in
Table 26. We seek comments on our
intention to resubmit these patient
relationship modifiers to AMA for
future consideration into the CPT
modifier code set.
6 The CMS Level II HCPCS Coding Workgroup
meets regularly (generally monthly) to consider
requests for new HCPCS codes and modifiers.
Information on the code request and approval
process is available at https://www.cms.gov/
Medicare/Coding/MedHCPCSGenInfo/
(assessed 04/26/2017).
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K. Proposed Changes to the Medicare
Diabetes Prevention Program (MDPP)
Expanded Model
1. Background
a. Authority for and Establishment of
the MDPP Expanded Model
In the November 15, 2016 Federal
Register, we issued a final rule to
implement aspects of the Medicare
Diabetes Prevention Program (MDPP)
expanded model (81 FR 80459 through
80475 and 80552 through 80558) as part
of the CY 2017 PFS final rule.
Section 1115A(c) of the Act provides
the Secretary with the authority to
expand, through rulemaking (including
implementation on a nationwide basis),
the duration and scope of a model that
is being tested under section 1115A(b)
of the Act if certain determinations
specified in the Act are made, taking
into account the evaluation of the model
under section 1115A(b)(4) of the Act.
The MDPP expanded model is an
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expansion of CMS’ Center for Medicare
and Medicaid Innovation’s (Innovation
Center) Diabetes Prevention Program
(DPP) model test under the authority of
section 1115A of the Act. The Secretary
expanded the DPP model test in
duration and scope under the authority
of section 1115A(c) of the Act. For
further information on the DPP model
test, and the associated National DPP
administered by the Centers for Disease
Control and Prevention (CDC), we refer
readers to the CY 2017 PFS final rule
and the following Web sites: https://
Innovation.cms.gov/initiatives/HealthCare-Innovation-Awards/ and https://
www.cdc.gov/diabetes/prevention/
index.html .
The aim of the MDPP expanded
model is to continue to test a method of
prevention of the onset of type 2
diabetes among Medicare beneficiaries
with an indication of prediabetes as
defined by the MDPP beneficiary
eligibility criteria (finalized at
§ 410.79(c)(1)). Services available
through the MDPP expanded model are
MDPP services furnished in community
and health care settings by coaches,
such as trained community health
workers or health professionals. We
have designated services under the
MDPP expanded model to be covered as
additional preventive services under
Medicare, as defined in section
1861(ddd) of the Act.
For a detailed discussion of the DPP
model test and the development of
aspects of the MDPP expanded model,
we refer readers to the July 15, 2016
MDPP proposed rule (‘‘Proposed
Expansion of the Diabetes Prevention
Program (DPP) Model’’) (81 FR 46413
through 46418), and the CY 2017 PFS
final rule (81 FR 80459 through 80475).
In the CY 2017 PFS final rule, we
responded to and incorporated certain
suggestions from the public comments
we received that were within the scope
of the MDPP proposals presented in the
July 15, 2016 MDPP proposed rule. We
indicated in that final rule (81 FR
80459) that the MDPP expanded model
would be implemented through at least
two rounds of rulemaking. In the CY
2017 PFS final rule, we finalized MDPP
policies that will enable CDCrecognized organizations to prepare for
enrollment, including finalizing the
framework for the MDPP expanded
model, details of the MDPP expanded
model (codified at § 410.79(a) and (b)),
beneficiary eligibility criteria (codified
at § 410.79(c) and (d)), supplier
eligibility criteria and supplier
enrollment requirements (codified at
§ 424.59, proposed in this rule to be
redesignated as § 424.205). We also
identified several issues, including
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some issues raised by commenters that
we deferred to future rulemaking. The
proposals in this proposed rule address
a number of issues raised by the public
in response to the July 15, 2016 MDPP
proposed rule. We also are making
additional proposals to implement the
MDPP expanded model.
b. Summary of Provisions Finalized
2017 PFS Final Rule
In the CY 2017 PFS final rule (81 FR
80465 through 80468), we finalized the
structure of MDPP services. We
provided that the MDPP core benefit
consists of at least 16 weekly core
sessions over months 1 through 6 and at
least 6 monthly core maintenance
sessions over months 7 through 12,
furnished regardless of weight loss
(§ 410.79(b) and (c)(2)). We also
finalized that Medicare will cover
ongoing maintenance sessions after the
12-month core set of MDPP services if
beneficiaries achieve and maintain the
required minimum weight loss of 5
percent. In section III.K.2.b. of this
proposed rule, we are proposing to
further revise the structure of MDPP
services as a 3-year service period,
generally contingent upon a
beneficiary’s attainment of two
performance goals: achievement and
maintenance of weight loss and
attendance at a certain number of MDPP
sessions.
As used in this proposed rule, the
term ‘‘MDPP services period’’ refers to
the time period in which MDPP services
are furnished under the MDPP
expanded model over a minimum of 12
consecutive months and a maximum of
36 consecutive months from the date of
the first core session the beneficiary
attends. We use the term ‘‘set of MDPP
services’’ to include the entirety of
MDPP services available under the
MDPP expanded model, including core
sessions, core maintenance sessions,
and, subject to paragraph § 410.79(c)(3),
ongoing maintenance sessions offered
over the course of the MDPP services
period. For purposes of this proposed
rule and the expanded model, MDPP
services would be covered under the
‘‘additional preventive services’’ benefit
category under section 1861(ddd)(1) of
the Act and paid through the Medicare
Part B Trust Fund. As indicated in the
CY 2017 PFS, we intended to begin
supplier enrollment before MDPP
services became available, and we
finalized an expanded model start date
of January 1, 2018.
In this proposed rule, we propose a
new start date for the furnishing of
MDPP services within the expanded
model of April 1, 2018. That is, MDPP
suppliers will not be able to furnish
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MDPP services, or to receive payment
for these services, prior to April 1, 2018.
We note that if finalized as part of the
CY 2018 PFS, the supplier enrollment
and compliance policies will become
effective on January 1, 2018. This
change to delay the furnishing of MDPP
services would allow time for
organizations to enroll in Medicare
before they begin furnishing and billing
for MDPP services.
In the CY 2017 PFS final rule (81 FR
80459), we described a possible
payment structure for MDPP services,
but deferred full development of the
payment structure to future rulemaking.
In section III.K.2.d. of this proposed
rule, we discuss our proposed payment
structure for MDPP services. This
proposal takes into consideration the
significant number of public comments
we received in response to the possible
payment structure we described in the
July 15, 2016 MDPP proposed rule. We
also are proposing payment policies for
instances in which an MDPP beneficiary
switches MDPP suppliers.
In the CY 2017 PFS final rule (81 FR
80471 through 80474), we required
CDC-recognized organizations that will
bill Medicare for MDPP services to
enroll in Medicare as MDPP suppliers.
We also finalized the requirements for
coaches furnishing MDPP services. We
finalized policies regarding CDC
Diabetes Prevention Recognition
Program (DPRP) full recognition for
MDPP suppliers and we indicated an
intention to propose policies in future
rulemaking regarding whether a DPP
organization without full CDC
recognition could enroll as an MDPP
supplier. We are proposing an interim
MDPP preliminary recognition standard
in section III.K.2.e. of this proposed
rule. Also, in this section of this
proposed rule, we are proposing
revisions to the supplier eligibility and
enrollment requirements, including
establishment of standards and
implementation of appropriate program
integrity safeguards. In section III.K.2.f.
of this proposed rule, we are proposing
policies related to MDPP beneficiary
engagement incentives furnished by
MDPP suppliers.
In the CY 2017 PFS final rule (81 FR
80459), we deferred establishing
policies related to organizations
delivering ‘‘virtual’’ DPP services, where
services are not furnished in person. In
section III.K.3. of this proposed rule, we
explain that the MDPP expanded model
covers in-person MDPP services (other
than ad hoc virtual make-up sessions
discussed in section III.K.2.c.iv.(3) of
this proposed rule), and thus, explain
why we are not currently making any
proposals related to MDPP services
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furnished 100 percent virtual and state
that we are considering a separate
model under CMS’s Innovation Center
authority to test and evaluate virtual
DPP services.
2. Proposed Policy Changes
a. Proposed Changes to Effective Date of
MDPP Services
In the CY 2017 PFS final rule, we
established at § 410.79(a) that MDPP
services would be available on January
1, 2018. We are proposing to change
§ 410.79(a) to state that MDPP services
would be available on April 1, 2018. We
are proposing this change because we
want to ensure that MDPP suppliers
have sufficient time to enroll in
Medicare after the effective date of the
CY 2018 PFS final rule.
Therefore, beneficiaries will not be
able to receive MDPP services
immediately on January 1, 2018 due to
the time needed for supplier enrollment.
For this reason, we are proposing April
1, 2018 as the expanded model start
date, which we believe allows a
sufficient amount of time (90 days) for
eligible suppliers to enroll in Medicare
before furnishing and billing for MDPP
services. Subject to this proposed
change, the following regulatory
provisions, if finalized, would be
effective April 1, 2018: § 414.84 related
to payment for MDPP services; and
§ 424.210 related to beneficiary
engagement incentives. All other
sections, if finalized, will be effective on
January 1, 2018, including the policies
proposed in section III.K.2.e. related to
supplier enrollment and compliance.
We seek comment on this new
expanded model start date and whether
90 days is a sufficient amount of time
for organizations to enroll in Medicare
and prepare to furnish and bill for
MDPP services.
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b. Proposed Changes to the Set of MDPP
Services
In the CY 2017 PFS final rule, we
established the parameters of MDPP
services. The policies and terms
proposed in this proposed rule seek to
clarify, build on, and at times change
these previously finalized policies. In
particular, we propose to refine and add
terms related to the different aspects of
‘‘MDPP services.’’ In this proposed rule,
we propose to slightly refine the term
‘‘MDPP services’’ to refer to structured
health behavior change sessions that are
furnished under the MDPP expanded
model with the goal of preventing
diabetes among Medicare beneficiaries
with prediabetes, and that follow a CDCapproved curriculum (proposed
§ 410.79(b)). The sessions provide
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practical training in long-term dietary
change, increased physical activity, and
problem-solving strategies for
overcoming challenges to maintaining
weight loss and a healthy lifestyle.
In the preamble to the CY 2017 PFS
final rule, we referenced the set of
MDPP services covered under the
expanded model as the ‘‘MDPP benefit.’’
In this proposed rule, we propose to
update this terminology. In cases where
we would have previously referred to
the term ‘‘benefit’’ to describe the entire
set of MDPP sessions covered under the
MDPP model, we propose to use the
phrase ‘‘set of MDPP services.’’ ‘‘Set of
MDPP services’’ means the series of
MDPP sessions, composed of core
sessions, core maintenance sessions,
and ongoing maintenance sessions,
offered over the course of the MDPP
services period (proposed § 410.79(b)).
In cases where we would have
previously used the term ‘‘benefit’’ to
describe a period of time, we propose to
refer to the ‘‘MDPP services period.’’
The MDPP services period means the
time period, beginning on the date an
MDPP beneficiary attends his or her first
core session, over which the set of
MDPP services is furnished to the MDPP
beneficiary, to include the core services
period described in paragraph
§ 410.79(c)(2)(i) and, subject to
paragraph § 410.79(c)(3), one or more
ongoing maintenance session intervals
during the ongoing services period
described in paragraph § 410.79(c)(2)(ii)
(proposed § 410.79(b)). The duration of
the MDPP services period is discussed
further in section III.K.2.c.iv. of this
proposed rule. As noted throughout this
section, the term ‘‘benefit’’ would no
longer be used. We propose to remove
the term ‘‘MDPP core benefit’’ from the
list of definitions.
In the CY 2017 PFS final rule, we
included a definition for ‘‘core sessions’’
that referred to the set of core sessions
covered under the MDPP expanded
model. We propose to revise the
definition for ‘‘core sessions,’’ and
instead define the singular ‘‘core
session’’ as an MDPP service that is
furnished by an MDPP supplier to an
MDPP beneficiary during months 1
through 6 of the MDPP services period,
is approximately 1 hour in length, and
adheres to a CDC-approved DPP
curriculum for core sessions (proposed
§ 410.79(b)). We believe that having a
definition for the individual core
session would be more uniform with
other MDPP definitions, which are
defined in the singular form. We
propose to revise the definition of ‘‘core
maintenance session’’ as an MDPP
service that is furnished by an MDPP
supplier to an MDPP beneficiary during
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a core maintenance session interval, is
approximately 1 hour in length, and
adheres to a CDC-approved DPP
curriculum for maintenance sessions
(under proposed revised § 410.79(b)).
We propose to revise the definition of
an ‘‘ongoing maintenance session’’ as an
MDPP service that is furnished by an
MDPP supplier to an MDPP beneficiary
during an ongoing maintenance session
interval; is approximately 1 hour in
length and adheres to a CDC-approved
DPP curriculum for maintenance
sessions (proposed revised § 410.79(b)).
The proposed time period over which
MDPP suppliers offer ongoing
maintenance sessions, which differs
from our previously finalized policy, is
discussed in section III.K.2.b.i. of this
proposed rule.
We propose to add a definition for
‘‘MDPP session,’’ which means a core
session, a core maintenance session, or
an ongoing maintenance session
(proposed § 410.79(b)).
We invite public comments on these
proposals.
i. Ongoing Maintenance Session Time
Limit
In the CY 2017 PFS final rule, we
finalized that ‘‘MDPP eligible
beneficiaries,’’ a term we now propose
to remove and replace with ‘‘MDPP
beneficiary,’’ as described further in
section III.K.2.c. of this proposed rule,
would have Medicare coverage for
ongoing maintenance sessions for an
unspecified length of time, provided
that they maintained the required
minimum weight loss, which is 5
percent weight loss from baseline. Based
on public comments indicating the
limited administrative and operational
capability of many MDPP suppliers to
provide ongoing maintenance sessions
for an individual indefinitely (81 FR
80468), we stated our intent to propose
a limit on the number or duration of
ongoing maintenance sessions to be
covered in the set of MDPP services,
although we did not finalize a policy
that would do so.
In this rule, we propose a 2-year limit
on Medicare coverage for ongoing
maintenance sessions (proposed
§ 410.79(c)(2)(ii)). The CMS Chief
Actuary noted in the certification of the
expansion of the DPP model test that
continued participation in a type 2
diabetes DPP after 3 years has generally
been untested. In addition, a DPP
clinical trial conducted by the National
Institutes of Health from 1996 to 2001
followed participants in a DPP for 3
years and found that, at the end of the
study, diabetes incidence was reduced
by 58 percent in the group that received
a DPP lifestyle intervention when
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compared to the placebo group.7 Based
on the lack of evidence about DPP
services beyond 3 years and evidence of
positive effects from DPP participation
for 3 years, in this proposed rule, we
propose a total MDPP services period of
up to 3 years (consisting of 1 year of
core sessions and core maintenance
sessions, followed by up to 2 years of
ongoing maintenance sessions,
(proposed § 410.79(b)).
We considered alternatives to this
proposal, such as limiting Medicare
coverage for ongoing maintenance
sessions to 1 year, which would limit
the total MDPP services period to 2
years. Because the CDC DPRP does not
require organizations to offer ongoing
maintenance sessions, we also
considered not covering ongoing
maintenance sessions altogether, which
would limit the total MDPP services
period to 1 year. However, we believe
that beneficiaries can benefit from
maintenance sessions beyond the 6
months of core maintenance sessions
because weight loss is difficult to
achieve and can be even more difficult
to sustain. We believe that the behavior
changes necessary to sustain weight loss
will be more deeply ingrained through
beneficiary participation in ongoing
maintenance sessions. Existing evidence
also supports the effectiveness of
participation in a DPP through 3 years.
We did not consider alternatives that
would extend Medicare coverage for
ongoing maintenance sessions beyond 2
years, and therefore, create an MDPP
services period that would last longer
than 3 years. Therefore, we propose to
continue to include ongoing
maintenance sessions, but with a limit
of up to 2 years. As stated earlier, we
believe there is not enough evidence
available to support the effectiveness of
participation in a DPP beyond 3 years.
We also believe, based on public
comments received in response to the
July 15, 2016 MDPP proposed rule, that
many suppliers have limited
administrative and operational capacity
to offer MDPP ongoing maintenance
sessions indefinitely to all MDPP
beneficiaries who maintain eligibility.
As noted in section III.K.2.e.iv.4 of this
proposed rule, an example of a capacity
limit could include a situation where an
MDPP supplier has met its class size
maximum and therefore could not
accept additional beneficiaries. We are
inviting public comments on our
proposal and the alternatives we
considered.
7 Available at https://www.nejm.org/doi/full/
10.1056/NEJMoa012512.
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ii. MDPP Services Period Clarifications
At § 410.79(b), we propose to remove
the existing definition of ‘‘maintenance
session bundle,’’ and to establish new
definitions for ‘‘core maintenance
session interval,’’ and ‘‘ongoing
maintenance session interval,’’ which
we believe will more directly reflect the
structure of the set of MDPP services, as
well as support the proposed policies in
this proposed rule. Through these
proposed definition changes, we are
seeking to clarify the differences
between the two types of intervals. We
propose to define ‘‘core maintenance
session interval’’ as one of the two
consecutive 3-month time periods
during months 7 through 12 of the
MDPP services period, during which an
MDPP supplier offers an MDPP
beneficiary at least one core
maintenance session per month. We
propose to define ‘‘ongoing maintenance
session interval’’ as one of the up to
eight consecutive 3-month time periods
during the ongoing services period
described in paragraph § 410.79(c)(2)(ii),
during which an MDPP supplier offers
at least one ongoing maintenance
session to an MDPP beneficiary per
month.
We are making the proposal to use the
term ‘‘interval’’ instead of ‘‘bundle’’
because the proposed performance
payments are tied to attendance and
weight loss performance goals and, in
aggregate, constitute the payment to
MDPP suppliers for furnishing MDPP
services during the MDPP services
period, but they do not provide specific
payments for a particular subset of
sessions. Therefore, we believe that the
term ‘‘bundle’’ is not appropriate for
describing performance payments for
these time intervals. The proposed new
terms allow us to more appropriately
describe the relationship of the
performance payments to the specific
time periods where performance is
measured. Furthermore, we propose to
define ‘‘make-up session’’ as a core
session, a core maintenance session, or
an ongoing maintenance session
furnished to an MDPP beneficiary when
the MDPP beneficiary misses a regularly
scheduled core session, core
maintenance session, or ongoing
maintenance session (proposed at
§ 410.79(b)). We propose to define
‘‘virtual make-up session’’ as a make-up
session that is not furnished in person
and that is furnished in a manner
consistent with the DPRP standards for
virtual sessions (proposed § 410.79(b)).
Policies describing the parameters of
make-up sessions and virtual make-up
sessions are described further in section
III.K.2.c.iv.(3).
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We propose an additional term that
helps describe key aspects of the MDPP
expanded model: ‘‘Performance goal.’’
This term refers to an attendance or
weight loss goal that an MDPP
beneficiary must achieve during the
MDPP services period for an MDPP
supplier to be paid a performance
payment (proposed § 414.84(a)).
Because we propose this term that more
broadly speaks to the performance goals
of this expanded model, we propose to
remove the definition of ‘‘maintenance
of weight loss.’’ We also propose to
move the definition of ‘‘coach’’ from
§ 410.79(b) to § 424.205(a) (we propose
in section III.K.2.e to redesignate
§ 424.59, Requirements for Medicare
Diabetes Prevention Program suppliers
to § 424.205). We propose to revise the
definition of ‘‘MDPP supplier’’ to mean
an entity that is enrolled in Medicare to
furnish MDPP services as provided in
§ 424.59 (proposed to be redesignated as
§ 424.205).
We invite public comments on these
proposals.
c. Proposed Changes Related to
Beneficiary Eligibility
In the CY 2017 PFS final rule, we
established the eligibility criteria for
Medicare beneficiaries to have coverage
of the set of MDPP services, codified at
§§ 410.79(c)(1) and 410.79(d),
respectively. We previously finalized
that an individual who met these
criteria would be referred as an ‘‘MDPP
eligible beneficiary.’’ However, in this
proposed rule, we propose to remove
this term, and instead, add the
definition of ‘‘MDPP beneficiary’’ to
mean a Medicare beneficiary who meets
the criteria specified in paragraph
§ 410.79(c)(1)(i), who has initiated the
MDPP services period by attending the
first core session, and for whom the
MDPP services period has not ended as
specified in paragraph § 410.79(c)(3)
(proposed § 410.79(b)). We believe that
this revised definition will provide
more clarity about when a beneficiary
qualifies to receive MDPP services. We
propose to remove the definition of
‘‘MDPP eligible beneficiary’’ to avoid
confusion between the two definitions,
and we propose conforming changes to
§ 410.79 to remove the term ‘‘MDPP
eligible beneficiary’’ and use the term
‘‘MDPP beneficiary’’ in its place, where
appropriate.
In the CY 2017 PFS final rule (81 FR
80470), we specified at § 410.79(c)(1)
that Medicare beneficiaries are eligible
for MDPP services if they meet all of the
following criteria:
• Are enrolled in Medicare Part B.
• Have, as of the date of attendance
at the first core session, a body mass
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index (BMI) of at least 25 if not selfidentified as Asian or a BMI of at least
23 if self-identified as Asian (please see
our discussion of BMI parameters in the
CY 2017 PFS final rule at 81 FR 80468).
• 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).
• Have no previous diagnosis of type
1 or type 2 diabetes (other than
gestational diabetes).
• Do not have end-stage renal disease
(ESRD).
In this proposed rule, we propose
changes to these eligibility criteria at
§ 410.79(c)(1) to clarify the eligibility
limitations related to previous type 1 or
type 2 diabetes diagnosis (described
further in section III.K.2.c.ii. of this
proposed rule), move and edit the
regulation text that specifies that each
beneficiary can only receive the set of
MDPP services once in their lifetime
(described further in section III.K.2.c.iii.
of this proposed rule), and make
editorial changes so that the provisions
are specific to an individual beneficiary.
We also are taking this opportunity to
clarify some of these eligibility criteria.
i. Clarifying MDPP Eligibility Criteria
Related to Gestational Diabetes and EndStage Renal Disease (ESRD)
We note that we are not excluding
beneficiaries with a prior history of
gestational diabetes from eligibility for
MDPP services, while beneficiaries with
a prior history of a diagnosis of type 1
or type 2 diabetes are ineligible. The
eligibility criteria are intended to
identify a beneficiary at high risk for the
development of type 2 diabetes in an
individual that has not been diagnosed
with type 1 or type 2 diabetes.
Gestational diabetes is a condition that
develops during pregnancy and
typically resolves after delivery,
although an individual with a history of
gestational diabetes is at increased risk
of subsequent type 2 diabetes
development and may benefit from the
set of MDPP services. Because of the
clinical differences between gestational
diabetes and type 1 or type 2 diabetes,
we determined that it was appropriate
not to exclude a beneficiary with a prior
history of gestational diabetes from
eligibility for MDPP services.
We also are clarifying that a
beneficiary who is diagnosed with ESRD
after having begun receiving MDPP
services would lose eligibility. We do
not believe MDPP services are
appropriate for beneficiaries with ESRD
because beneficiaries with ESRD require
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dialysis, and the nutrition requirements
for individuals on dialysis are very
specific and therefore MDPP curriculum
will not apply.8 We believe that a
beneficiary receiving MDPP services
who develops ESRD will be best suited
by ceasing to receive MDPP services and
receiving attention by other health care
professionals specifically suited to
address his or her condition.
Additionally, individuals with ESRD
were not included in the DPP model
test. Suppliers can use the online
HIPAA Eligibility Transaction System
(HETS) to verify if a beneficiary has
ESRD by checking his or her eligibility
status as a Part B or ESRD Medicare
beneficiary. Suppliers can find more
information on this system at https://
www.cms.gov/hetshelp/. We recognize
that some Medicare beneficiaries may
have other serious conditions, such as
heart disease or cancer, and therefore
may also have specific dietary
requirements. We recommend that
beneficiaries with complex dietary
needs consult their health care provider
as to whether they should participate in
MDPP.
In summary, a beneficiary must
maintain Medicare Part B coverage and
not have ESRD throughout the duration
of the MDPP services period to remain
eligible to receive coverage for MDPP
services. In conjunction with our
proposal in this proposed rule related to
diabetes diagnosis (explained further in
section III.K.2.c.ii. of this proposed
rule), a beneficiary must meet the
eligibility requirements related to
prediabetes and diabetes (including
BMI, blood test results, and no diagnosis
of diabetes other than gestational
diabetes) as of the date of attendance at
the first core session.
We invite public comments on these
proposals.
ii. Diabetes Diagnosis During the MDPP
Services Period
In the CY 2017 PFS final rule, we
finalized that to be eligible for coverage
for the set of MDPP services, a Medicare
beneficiary must have prediabetes, as
shown through a qualifying BMI and
blood test results, and must have no
8 WE Mitch, ‘‘Beneficial responses to modified
diets in treating patients with chronic kidney
disease,’’ Kidney International Supplements April,
94 (2005): S133–5, https://www.ncbi.nlm.nih.gov/
pubmed/15752230. J Rysz et al., ‘‘The Effect of Diet
on the Survival of Patients with Chronic Kidney
Disease,’’ Nutrients 9, no. 5 (2017): E495, https://
www.ncbi.nlm.nih.gov/pubmed/28505087. ME
Chen et al., ‘‘Correlations of dietary energy and
protein intakes with renal function impairment in
chronic kidney disease patients with or without
diabetes,’’ The Kaohsiung Journal of Medical
Sciences 33, no. 5 (2017):252–259, https://
www.ncbi.nlm.nih.gov/pubmed/28433072.
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34133
previous diagnosis of type 1 or type 2
diabetes (other than gestational
diabetes). We received public comments
in response to the July 15, 2016 MDPP
proposed rule that asked whether a
beneficiary would remain eligible for
the set of MDPP services if the
beneficiary developed diabetes during
the MDPP services period. In the CY
2017 PFS final rule, we deferred action
in response to these public comments
and are now addressing them in this
proposed rule.
We propose that the diabetes
diagnosis exclusion applies only at the
time of the first core session (that is, if
a beneficiary develops diabetes during
the MDPP services period, it would not
affect the beneficiary’s eligibility to
continue receiving MDPP services).
Specifically, we propose to revise the
eligibility requirements for MDPP
services to state that a beneficiary has,
as of the date of attendance at the first
core session, no previous diagnosis of
diabetes, other than gestational diabetes
(proposed § 410.79(c)(1)(i)(E)). This
proposed policy is based in part on the
fact that the DPP model test, which
demonstrated cost savings, did not
exclude from the model individuals
who developed diabetes. Additionally,
whereas suppliers can check HETS to
verify a beneficiary’s ESRD status fairly
easily, we believe requiring a supplier to
reassess other beneficiary eligibility
criteria such as diabetes status and
blood test results, and subsequently
removing those who no longer meet the
eligibility criteria is impractical and
unduly burdensome.
Alternatively, we considered deeming
any beneficiary who develops diabetes
during the MDPP services period to be
ineligible to continue to receive
coverage for MDPP services because
these services are intended to be
preventive. If a beneficiary progresses to
type 2 diabetes, other treatment options,
such as Diabetes Self-Management
Training (DSMT), may be more
appropriate than services that seek to
prevent a condition the beneficiary
already has. However, it is important to
note that the receipt of MDPP services
does not preclude a beneficiary from
accessing other treatments for diabetes
during the time period that the
beneficiary is covered for MDPP
services. An MDPP beneficiary who
ultimately also receives DSMT at some
time during the MDPP services period
because he or she develops diabetes
after beginning the set of MDPP services
will receive different types of
information and training. For example,
a beneficiary receiving DSMT furnished
by certified diabetes educators acquires
knowledge for self-care and life style
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changes including blood sugar
monitoring, insulin usage, medication
management, and crisis management. In
contrast, MDPP services are furnished
by trained coaches who teach patients
with prediabetes how to lower their risk
of progressing to type 2 diabetes with
methods that do not include medication
or other interventions for patients
diagnosed with diabetes. Despite some
common elements, the interventions for
the MDPP expanded model and the
DSMT benefit target different
populations and furnish different
services.
We are seeking public comments on
our proposal and whether individuals
who develop diabetes during the MDPP
services period should continue to be
eligible for coverage of MDPP services
for the full duration of the MDPP
services period.
iii. Once-Per-Lifetime Set of Services
In the CY 2017 PFS final rule, we
specified that coverage for the set of
core MDPP services is available only
once per lifetime for each MDPP
beneficiary (codified at § 410.79(d)(1)).
In this rule, we propose to delete
§ 410.79(d)(1) and move this provision
to proposed § 410.79(c)(1)(i)(B) to place
it with other MDPP beneficiary
eligibility criteria. We also propose to
edit this provision to specify that
coverage for the full set of MDPP
services, inclusive of ongoing
maintenance sessions as opposed to
only core MDPP services, is available
only once per lifetime per MDPP
beneficiary. Now that we propose to
limit the ongoing services period to 2
years, we believe that this proposed
revision is necessary to clarify that
coverage for the entire set of MDPP
services is subject to this limitation—
otherwise, the once-per-lifetime
limitation has no practical effect
because an MDPP beneficiary could
continue to attend ongoing maintenance
sessions long after the MDPP beneficiary
has completed the core services period.
In addition, for the reasons stated
previously, we do not have evidence to
support coverage of MDPP services for
more than 3 years. We also are clarifying
that the once-per-lifetime coverage limit
applies to a beneficiary who receives a
set of MDPP services under the MDPP
model expansion. This limitation would
not apply to beneficiaries who
participated in a DPP as part of the DPP
model test unless they receive the set of
MDPP services under the MDPP
expanded model. We invite public
comments on our proposal.
In the CY 2017 PFS final rule, we
stated that beneficiaries could selfreport to MDPP suppliers that they had
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not previously received MDPP services.
We recognize that self-reported
information may not be the most
reliable source for MDPP suppliers to
use before submitting claims for MDPP
beneficiaries, and there is a risk that
information that is inaccurately selfreported could result in the denial of
payments for MDPP services. We are
considering ways MDPP suppliers
would be able to reliably verify if a
beneficiary has received coverage of
MDPP services from another supplier,
such as through a standardized tracker
described in section III.K.2.d.v of this
proposed rule, and we are seeking
public comments on any additional
ways MDPP suppliers could access this
information. We intend to provide
administrative guidance on any
resources to assist MDPP suppliers in
identifying beneficiaries’ previous
receipt of covered MDPP sessions, as
appropriate.
iv. Eligibility Throughout the MDPP
Services Period
In the CY 2017 PFS final rule, we
specified the minimum number and
frequency of sessions that MDPP
suppliers must offer to MDPP
beneficiaries (codified at
§§ 410.79(c)(2)(i) and 410.79(c)(2)(ii)).
We finalized that MDPP suppliers must
furnish ongoing maintenance session
intervals to MDPP eligible beneficiaries
who have maintained 5 percent weight
loss from their baseline weight as
measured during the previous
maintenance session interval. As
defined at § 410.79(b), ‘‘baseline
weight’’ is the MDPP beneficiary’s body
weight recorded during that
beneficiary’s first core session.
However, because in this proposed
rule we propose to tie payment for
MDPP services to the beneficiary’s
achievement of performance goals, we
propose additional changes to tie the
beneficiary’s eligibility for continued
coverage of ongoing maintenance
session intervals to his or her
achievement of performance goals,
namely requiring a minimum level of
attendance. Because our proposed
policies for payment and coverage differ
somewhat, we are addressing them
separately below.
(1) MDPP Services Period
As discussed in section III.K.2.b. of
this proposed rule, we propose to revise
§ 410.79(c)(2), which describes MDPP
services periods, to specify that the
MDPP services period means the time
period, beginning on the date an MDPP
beneficiary attends his or her first core
session, over which the set of MDPP
services is furnished to the MDPP
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beneficiary, to include the core services
period described in paragraph
§ 410.79(c)(2)(i) and, subject to
paragraph § 410.79(c)(3), one or more
ongoing maintenance session intervals
during the ongoing services period
described in paragraph § 410.79(c)(2)(ii).
We propose to revise § 410.79(c)(2) to
specify that there are two service
periods in which Medicare will cover
MDPP services for a beneficiary: The
core services period; and the ongoing
services period. Together these would
make up the MDPP services period. The
core services period is the first 12
months of the MDPP services period,
and consists of core sessions and core
maintenance sessions. There are 16 core
sessions that are offered at least a week
apart in months 1 through 6, beginning
on the date of attendance at the first
core session. Core maintenance sessions
are offered at least once per month in
months 7 through 12 of the core services
period. We propose to move the
requirements for MDPP suppliers to
offer these services to § 424.205(d)(9)
because they are more appropriately
included among other requirements for
MDPP suppliers. Consistent with our
policies finalized in the CY 2017 PFS
final rule, we do not condition coverage
for the core services period upon weight
loss or attendance. Medicare will pay
for the set of core MDPP services,
regardless of how many sessions the
beneficiary attends and regardless of his
or her weight loss. However, we note
that an MDPP beneficiary must attend at
least one core session to initiate the
MDPP services period.
These proposals would align with
CDC’s 1-year curriculum, divided into
two 6-month periods. We recognize that
framing the MDPP services period in
terms of months may cause some
confusion because the CDC terminology
uses weeks. However, we believe that
framing the MDPP services period in
months would better align with our
proposed payment structure. We did not
make eligibility for the core
maintenance sessions contingent upon
an attendance-based performance goal;
because the CDC DPP curriculum covers
12 months of sessions, we believe that
coverage for the 12 months of the core
services period should be available to
all MDPP beneficiaries, regardless of
attendance. The 12-month CDC DPP
curriculum is based on evidence from
the original DPP randomized clinical
trial, and the curriculum used in that
trial, which achieved a 58 percent
reduction in type 2 diabetes risk (with
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71 percent reduction in those over age
60).9
As discussed in section III.K.2.e.iv.4
of this proposed rule, MDPP suppliers
must offer a minimum of 16 core
sessions, no more frequently than once
each week, in months 1 through 6, and
at least 1 core maintenance session each
month in months 7 through 12 of the
core services period. However, some
MDPP suppliers may choose to furnish
more than the minimum number of
sessions, and these proposed coverage
parameters would allow beneficiaries to
receive more than the minimum number
of sessions if the MDPP supplier elects
to furnish them.
We invite public comments on our
proposals.
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(2) Ongoing Services Period
As discussed in section III.K.2.b.i. of
this proposed rule, we propose to revise
§ 410.79(c)(2)(ii) to clarify that the
ongoing services period consists of up to
eight 3-month ongoing maintenance
session intervals offered during months
13 through 36 of the MDPP services
period. Medicare’s coverage of the
ongoing services period is subject to
limitations proposed subsequently in
this section.
(a) Eligibility for the Ongoing Services
Period
Our existing regulations at § 410.79(b)
affirm that Medicare will cover MDPP
services in the first 12 months of the
MDPP services period, without regards
to a beneficiary’s achievement of
performance goals, whereas
§ 410.79(d)(2) specifies that, for
coverage of ongoing maintenance
sessions, the beneficiary must have
achieved weight loss of 5 percent from
his or her baseline weight. In this
proposed rule, we propose to delete
§ 410.79(d)(2) and move this provision
to § 410.79(c)(1) with other MDPP
beneficiary eligibility criteria. We also
propose to add paragraph (c)(1)(ii) to
§ 410.79 to specify that beneficiaries
must also attend at least one in-person
core maintenance session in months 10
through 12 of the MDPP services period
and achieve or maintain required
minimum weight loss at a minimum of
one in-person session during the final
core maintenance session interval to be
eligible for coverage of the first ongoing
maintenance session interval. We
9 WC Knowler et al., ‘‘Reduction in the incidence
of type 2 diabetes with lifestyle intervention or
metformin,’’ New England Journal of Medicine 346,
6 (2002): 393–403, https://www.ncbi.nlm.nih.gov/
pubmed/11832527. The Diabetes Prevention
Program (DPP) Research Group, ‘‘The Diabetes
Prevention Program,’’ Diabetes Care 25, 12 (2002):
2165–2171, https://care.diabetesjournals.org/
content/25/12/2165.long.
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propose to establish that a beneficiary
must attend at least one in-person core
maintenance session in months 10
through 12 of the MDPP services period
because, as stated in the CY 2017 PFS
final rule, an MDPP beneficiary must
achieve at least 5 percent weight loss
from baseline at least once during the
previous maintenance session interval
to have coverage of an ongoing
maintenance session.
Because we propose that weight
measurements used for determining
beneficiary eligibility for coverage or
supplier payment must be taken in
person by an MDPP supplier at an
MDPP core maintenance or ongoing
maintenance session (proposed
§ 410.79(c)(1)(iv)), a beneficiary must
attend at least one in-person core
maintenance session during months 10
through 12 to have his or her weight
measured to determine whether he or
she qualifies for coverage of the first
ongoing maintenance session interval.
We believe that in-person measurements
are the most feasible method for weight
ascertainment at this time for services
where the beneficiary would have
regular in-person sessions with the
MDPP supplier. We believe that selfreported weight loss is not reliable for
the purposes of determining continued
coverage of MDPP services for a
beneficiary. We invite public comments
on these proposals.
(b) Eligibility for Ongoing Maintenance
Session Intervals 2 Through 8
In addition to achieving weight loss
performance goals, as previously
finalized in the CY 2017 PFS final rule,
we propose that beneficiaries must also
meet an attendance-related performance
goal in order for Medicare to cover
ongoing maintenance session intervals.
We propose to add paragraph (c)(1)(iii)
to § 410.79 to specify that for coverage
of ongoing maintenance session
intervals 2 through 8, an MDPP
beneficiary must attend at least 3
ongoing maintenance sessions during
the previous ongoing maintenance
session interval, in addition to
maintaining 5 percent weight loss from
baseline at least once during the
previous ongoing maintenance session
interval.
We believe that adding an attendancerelated performance goal during the
ongoing services period is important
because it will provide an incentive to
keep MDPP beneficiaries engaged after
the core services period. MDPP
beneficiaries who meet the specified
attendance and weight loss goals will
have Medicare coverage of ongoing
maintenance sessions, which are a part
of the set of MDPP services, but not a
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34135
part of the CDC DPP curriculum. We
believe that the subsequent attendance
goal requirements during ongoing
maintenance session intervals will
motivate beneficiaries to take on more
individual responsibility for their
behavior changes over time because
coverage of these services is dependent
upon their attendance and achievement
and maintenance of weight loss.
In addition, this proposed policy
closely aligns with our proposed policy
for supplier payment for ongoing
maintenance session intervals. As
described further in section
III.K.2.d.iii.5. of this proposed rule, we
propose that a supplier would be paid
for furnishing an ongoing maintenance
session interval only if the MDPP
beneficiary both attended three sessions,
as well as maintained a 5 percent weight
loss from baseline measured at least
once in that interval. However, in light
of our proposal to pay MDPP suppliers
upon the beneficiary’s attendance of
three ongoing maintenance sessions (in
addition to maintaining at least a 5
percent weight loss), we believe that we
similarly need to have attendance goals
for beneficiaries to continue to have
coverage of ongoing maintenance
sessions. Without requiring attendance,
an MDPP beneficiary who maintained 5
percent weight loss but only attended
two ongoing maintenance sessions in an
ongoing maintenance session interval
would be eligible for coverage of
ongoing maintenance sessions, but the
supplier would not receive payment for
furnishing that ongoing maintenance
session interval. In effect, the MDPP
supplier could be required to furnish up
to 24 months of MDPP services without
payment. For this reason, we propose to
require beneficiaries to attend all three
sessions within an ongoing maintenance
session interval to have coverage of the
subsequent interval.
We considered an alternative where a
beneficiary would have continued
coverage of ongoing maintenance
session intervals if he or she attends at
least one in-person ongoing
maintenance session during an ongoing
maintenance session interval, as long as
that beneficiary maintained at least 5
percent weight loss from baseline at
least once during that interval.
However, we do not believe that this
alternative would align with our
proposed supplier payment
requirements for ongoing maintenance
sessions discussed in section
III.K.2.d.iii.5 of this proposed rule,
which would require suppliers to
furnish, and the beneficiary to attend,
all three sessions of the ongoing
maintenance session interval for the
supplier to receive payment for that
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interval. We are inviting public
comments on our proposal and the
alternative we considered.
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(c) Limitations on the Set of MDPP
Services
In this proposed rule, we propose to
add § 410.79(c)(3) to specify that
coverage of the MDPP services period
would end upon completion of the core
services period for a beneficiary that is
not eligible for the first ongoing
maintenance session interval as
proposed under § 410.79(c)(1)(ii); that
is, if the beneficiary does not attend at
least one in-person core maintenance
session during the second core
maintenance session interval and/or
does not achieve the required minimum
weight loss during this interval. For any
beneficiary who is eligible for at least
one ongoing maintenance sessions
interval, but who does not meet the
requirements for coverage of a
subsequent interval based on failure to
meet attendance or weight loss goals
proposed at § 410.79(c)(1)(iii), the
beneficiary’s coverage of the set of
MDPP services would end upon
completion of his or her current ongoing
maintenance session interval. It is
important to note that proposed
performance payments, discussed in
section III.K.2.d.iii.5. of this proposed
rule, would be tied to the achievement
of the same performance goals a
beneficiary must meet to have coverage
for the ongoing maintenance session
intervals. Therefore, if an MDPP
beneficiary does not meet weight loss or
attendance goals to access the
subsequent ongoing maintenance
session interval, the supplier will not
receive payment for that ongoing
maintenance session interval or any
subsequent performance payments
related to that beneficiary.
We are inviting public comments on
these proposed policies.
(d) Beneficiaries Who Change MDPP
Suppliers During the MDPP Services
Period
In the CY 2017 PFS final rule, we
indicated that a beneficiary may change
MDPP suppliers at any time. However,
we deferred to future rulemaking
specific policies to address coverage of
and payment for MDPP services when
beneficiaries change MDPP suppliers. In
this proposed rule, we are clarifying that
a beneficiary may change MDPP
suppliers at any time during his or her
MDPP services period, subject to
beneficiary eligibility requirements.
Based on evidence from the CDC DPRP,
we believe that the instances of
beneficiaries changing MDPP suppliers
will be relatively infrequent. However,
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we intend to monitor how often
beneficiaries change MDPP suppliers, as
well as MDPP suppliers’ billing patterns
to detect any aberrant billing patterns
suggestive of fraudulent or
discriminatory practices. Payment
policies related to when a beneficiary
changes MDPP suppliers are discussed
in section III.K.2.d.v.
(3) Make-Up Sessions
(a) General Requirements
In this proposed rule, we propose at
§ 410.79(d)(1) that suppliers may offer
make-up sessions to an MDPP
beneficiary who missed a regularly
scheduled session. As defined at
proposed § 410.79(b), ‘‘make-up
session’’ means a core session, core
maintenance session, or ongoing
maintenance session furnished to an
MDPP beneficiary when the MDPP
beneficiary misses a regularly scheduled
core session, core maintenance session,
or ongoing maintenance session. Makeup sessions may be delivered in person
or virtually, although virtual make-up
sessions are subject to additional
requirements proposed in this rule (and
the term ‘‘virtual make-up session’’ is
separately defined). We propose the
availability of make-up sessions to be
consistent with CDC’s DPRP standards
and to ensure that MDPP beneficiaries
have the opportunity to receive the full
DPRP curriculum, even if they are
unable to attend a particular regularly
scheduled MDPP session.
We propose that the curriculum
delivered during a make-up session
must address the same CDC-approved
DPP curriculum topic as the session that
the beneficiary missed (proposed
§ 410.79(d)(1)(i)). To be consistent with
CDC’s proposed 2018 DPRP standards,
we propose that the MDPP supplier may
furnish to the beneficiary a maximum of
one make-up session on the same day as
a regularly scheduled session (proposed
§ 410.79(d)(1)(ii)) and the MDPP
supplier may furnish to the beneficiary
a maximum of one make-up session per
week (proposed § 410.79(d)(1)(iii)).
(b) Virtual Make-Up Sessions
There is a growing area of research
examining the effectiveness of DPP
delivered virtually. CDC began
recognizing Virtual DPP organizations
in 2015 and emerging evidence suggests
that virtual delivery of DPP services can
show similarly successful participant
weight loss and health benefits to DPP
delivered in other settings, including
among Medicare-age participants.10
10 See, for example: F Chen et al., ‘‘Clinical and
Economic Impact of a Digital, Remotely-Delivered
Intensive Behavioral Counseling Program on
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Since CDC’s DPRP standards permit
virtual make-up sessions, and we
recognize that MDPP beneficiaries may
encounter situations where they are
unable to attend in-person make-up
sessions, we propose to allow MDPP
suppliers to offer a limited number of
virtual make-up sessions (proposed
§ 410.79(d)(2)). As proposed in
§ 410.79(b), ‘‘virtual make-up session’’
means a make-up session that is not
furnished in person and that is
furnished in a manner consistent with
the DPRP standards for virtual sessions.
All requirements proposed in
§ 410.79(d)(1) apply to virtual make-up
sessions. In addition, we propose that
virtual make-up sessions are subject to
additional requirements.
First, as indicated by the applicable
definition, virtual make-up sessions
must be furnished in a manner
consistent with CDC’s DPRP standards
for virtual sessions (proposed
§ 410.79(d)(2)(i)). To align with CDC’s
DPRP standards, virtual make-up
sessions refer to any modality, or
method of furnishing MDPP services,
that is not in person. This includes, but
is not limited to:
(1) Furnishing services online where
the behavior change program is
furnished 100 percent online, with
participants accessing course resources
and a coach via a computer, laptop,
tablet, smart phone, or other device with
Internet access. This modality requires
that the MDPP beneficiary have an
Internet connection to participate in all
aspects of the virtual make-up session;
(2) Furnishing services online with
other means of support by a coach (for
example, telecommunications, video
conferencing). This modality requires
that the MDPP beneficiary have an
Internet connection for some aspects of
the virtual make-up session, but not all;
and
(3) Distance learning, where a coach
is present in one location and
participants are calling, videoconferencing, or otherwise using
telecommunications technology to
access the coach from another location.
Medicare Beneficiaries at Risk for Diabetes and
Cardiovascular Disease.’’ PLoS ONE 11, 10 (2016),
https://doi.org/10.1371/journal.pone.0163627. W
Su et al., ‘‘Return on Investment for Digital
Behavioral Counseling in Patients With Prediabetes
and Cardiovascular Disease.’’ Preventing Chronic
Disease 13 (2016), https://dx.doi.org/10.5888/
pcd13.150357. J Ma et al., ‘‘Translating the Diabetes
Prevention Program lifestyle intervention for weight
loss into primary care: A randomized trial.’’ JAMA
Intern Med. 173, 2 (2013): 113–21, https://
www.ncbi.nlm.nih.gov/pubmed/23229846. CS
Sepah et al., ‘‘Translating the diabetes prevention
program into an online social network: Validation
against CDC standards.’’ The Diabetes Educator 40,
4 (2014): 435–443, https://www.ncbi.nlm.nih.gov/
pubmed/24723130.
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This modality does not require that the
MDPP beneficiary have an Internet
connection for any of the aspects of the
virtual make-up session.
By defining MDPP virtual make-up
sessions as being consistent with CDC’s
DPRP standards for virtual sessions, we
allow our definition to change over time
as such standards are updated.
Second, a supplier may only offer
virtual make-up sessions based on an
individual MDPP beneficiary’s request
(proposed § 410.79(d)(2)(ii)). A supplier
may not cancel a regularly scheduled
MDPP session and offer the session to
all MDPP beneficiaries virtually.
However, the supplier may cancel a
regularly scheduled MDPP session and
offer the session to all MDPP
beneficiaries in person. We believe that
this is necessary to ensure that the
MDPP expanded model remains a
model predominantly delivered in
person. Individual beneficiary needs
may be accommodated, but suppliers
should not use virtual make-up sessions
as a means to move toward virtuallydelivered MDPP sessions more
generally.
Third, to further ensure that MDPP
services are largely provided in-person,
we propose at § 410.79(d)(2)(iii) that a
supplier may offer: (a) No more than 4
virtual make-up sessions within the core
services period to an MDPP beneficiary,
of which no more than 2 virtual makeup sessions may be core maintenance
sessions; and (b) no more than 3 virtual
make-up sessions that are ongoing
maintenance sessions to an MDPP
beneficiary during any rolling 12-month
time period. At § 410.79(d)(3), we
propose that these same limitations on
the number of virtual make-up sessions
also apply for the purposes of
determining whether a beneficiary has
attended a sufficient number of MDPP
sessions in order to be eligible for
ongoing maintenance sessions
(proposed § 410.79(c)(1)) and for
assessing whether a beneficiary has met
the attendance-related performance
goals used to determine whether an
MDPP supplier is eligible to receive a
performance payment (proposed
§ 414.84(b)). The limitation on the
number of make-up sessions is not
applicable to in-person make-up
sessions.
We assume not all suppliers will have
the ability to offer virtual make-up
sessions, and we are not requiring
suppliers to offer virtual make-up
sessions. Conversely, an MDPP supplier
could offer only virtual make-up
sessions and no in-person make up
sessions if the supplier chooses as long
as the proposed limits for these sessions
are not exceeded. We believe that
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allowing fewer than these proposed
number of virtual make-up sessions will
make it difficult for suppliers to meet
DPRP standards, and therefore remain
enrolled as an eligible MDPP supplier.
However, the DPP model test only
offered in-person sessions (no virtual
sessions) and therefore the MDPP
expanded model is intended to
predominantly offer services in person.
Allowing more than the proposed
number of virtual make-up sessions
would not support an evaluation of an
in-person MDPP curriculum. We seek
comment on our proposals and
specifically on the proposed limitations
on virtual make-up sessions.
We considered the following
alternatives to this proposal. We
considered not allowing any make-up
sessions to be furnished virtually.
However, we believe that this would
place undue restrictions on MDPP
suppliers who are willing and would
like to offer virtual make-up sessions to
MDPP beneficiaries, particularly if these
are offered to other DPP participants
who are not Medicare beneficiaries.
We also considered allowing an
MDPP supplier to furnish between one
and three sessions within the core
services period and either one or two
ongoing maintenance sessions each year
as virtual make-up sessions per MDPP
beneficiary. However, we believe that
allowing fewer sessions to be furnished
as virtual make-up sessions than
proposed would not provide sufficient
flexibility for MDPP suppliers to meet
CDC’s DPRP standards, which require
organizations to meet attendance
requirements for their panel of
participants. Organizations may struggle
to meet DPRP attendance requirements
without the flexibility to provide virtual
make-up sessions.
We also considered permitting
suppliers to offer any number of virtual
make-up sessions, and for attendance at
any number of virtual make-up sessions
to count toward attendance goals.
However, as stated previously, since the
DPP model test only offered DPP
services in person, the MDPP expanded
model is intended to predominantly
offer MDPP sessions in person as well.
Therefore we believe that it is important
to limit the number of virtual make-up
sessions so that MDPP beneficiaries are
predominantly receiving MDPP sessions
in person.
We propose that the payment policies
detailed in section III.K.2.d. of this
proposed rule apply to virtual make-up
sessions. Specifically, as indicated in
sections III.K.2.c.1.iv. and
III.K.2.d.iii.10.b. of this proposed rule,
weight measurements used for the
purposes of determining the
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achievement or maintenance of weight
loss for weight loss performance
payments, or for determining eligibility
for coverage of ongoing maintenance
sessions, would be required to be taken
at an in-person session, not during a
virtual make-up session. We are seeking
public comments on these proposals
and the alternatives considered.
d. Payment for MDPP Services
i. MDPP Payment Discussion in Prior
Rulemaking
In the July 15, 2016 MDPP proposed
rule (81 FR 46415 through 46416), we
discussed a potential MDPP payment
structure and the associated payment
amounts and sought information from
the public to inform future MDPP
proposals. We received a number of
public comments on these topics and
have considered this information in the
development of our proposals for the
MDPP payment structure, payment
amounts, and related issues discussed
in this section.
ii. Conceptual Framework for Payment
for MDPP Services
In this proposed rule, we are
proposing to pay for the set of MDPP
services through a performance-based
payment methodology that makes
periodic performance payments to
MDPP suppliers during the MDPP
services period. The aggregate of all
performance payments constitutes the
total performance-based payment
amount for the set of MDPP services. As
discussed in detail throughout this
section, we are proposing a maximum
total performance payment amount per
beneficiary for the set of MDPP services
of $810. Performance payments would
be made to MDPP suppliers periodically
during the course of a beneficiary’s
MDPP services period based upon a
number of factors, including the
beneficiary’s completion of a specified
number of MDPP sessions and the
achievement of the required minimum
weight loss that is associated with a
reduced incidence of type 2 diabetes,
rather than individual payments being
made upon the furnishing of any service
as is typical of payment in the
traditional Medicare program.
The aggregate amount of the
performance payments proposed in this
section would equal the total
performance-based payment amount for
the set of MDPP services during the
MDPP services period, including core
sessions, core maintenance sessions,
and ongoing maintenance sessions.
Even though these performance
payments would be made periodically
and in amounts that would not be
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evenly distributed across the course of
sessions furnished during the MDPP
services period, payment for each
session would be included in the total
performance-based payment amount.
For example, the proposed performance
payment of $25 that would be paid to
MDPP suppliers upon furnishing the
first MDPP core session is relatively
large on a per-session basis compared to
other attendance-based performance
payments (as calculated on a per-session
basis) ranging from approximately $3 to
$20 made during the MDPP services
period. However, the performance
payment for the first core session would
make payment for some of the MDPP
supplier resources used in furnishing
the first session, as well as make a
partial prospective payment attributable
to the MDPP supplier furnishing
subsequent sessions.
Once the required minimum weight
loss is achieved and the 12-month core
services period, described at proposed
§ 410.79(c)(2)(i), concludes, we would
make additional 3-month interval
performance payments for ongoing
maintenance sessions when the required
minimum weight loss is maintained,
whereas no additional interval
performance payments would be made
for ongoing maintenance sessions if the
required minimum weight loss is not
maintained. Finally, when a beneficiary
achieves a significant percentage of
weight loss, specifically a level of 5
percent (the required minimum weight
loss) or 9 percent, we are proposing to
make additional performance payments
to the MDPP supplier. This proposal
would provide performance payments
in addition to the performance
payments we may have already made
for the previous MDPP sessions
furnished to the beneficiary because
those sessions resulted in the
beneficiary achieving the weight loss
performance goal.
In total, based on our consultation
with DPP providers holding commercial
contracts, review of information related
to DPP providers that currently hold or
are in the process of obtaining CDC
recognition, and comments received on
the discussion of the payment structure
and payment amounts for the set of
MDPP services included in the July 15,
2016 MDPP proposed rule (81 FR 46415
through 46416), we believe the
proposed performance-based payment
methodology would pay MDPP
suppliers appropriately for the resources
used in furnishing MDPP services
throughout the MDPP services period.
We note that we sought public comment
on the payment structure and payment
amounts for the set of MDPP services in
the July 15, 2016 MDPP proposed rule,
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and we have used the information
provided by commenters in developing
the proposed performance-based
payments included in this proposed
rule.
In this performance-based payment
structure, it is important to note that a
beneficiary’s performance goals are not
considered in the same way for
beneficiary coverage and supplier
payment during each specific period
within the MDPP services period.
During the core services period, a
beneficiary would not be required to
achieve attendance and/or weight loss
performance goals for coverage of MDPP
services, although a beneficiary would
be required to achieve specified
performance goals for an MDPP supplier
to receive performance payments during
this period. In contrast, achieving
performance goals would be required for
both coverage of MDPP services and
performance payments during the
ongoing services period.
For example, a supplier is required to
offer a minimum of 16 core sessions
during the core services period
according to § 410.79(c)(2)(i) but a
beneficiary would not need to achieve
an attendance or weight loss
performance goal to be eligible for
coverage of core maintenance sessions.
However, MDPP supplier performance
payments during the core services
period would be based on the
beneficiary’s achievement of attendance
and/or weight loss performance goals.
During the ongoing services period,
achievement of performance goals
would affect both coverage and supplier
payment. We note that a beneficiary
would need to attend at least 1 core
session to initiate the core services
period, and attend at least 1 core
maintenance session during the final
core maintenance session interval to
determine whether he or she has
achieved the required minimum weight
loss to have coverage of ongoing
maintenance sessions. Because we are
proposing in section III.K.2.d.iii.4 of this
proposed rule to make a performance
payment for core maintenance sessions
only when the beneficiary attends at
least 3 sessions within a 3-month
interval, it is possible that an MDPP
supplier would not be paid a separate
performance payment for the second
core maintenance session interval, but
the beneficiary would still have
coverage of the first ongoing
maintenance session interval. This
would occur if the beneficiary attended
only 1 or 2 core maintenance sessions
during the second core maintenance
session interval and achieved or
maintained the required minimum
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weight loss as measured at 1 of those 2
sessions.
iii. Performance Payments for MDPP
Services
(1) Overview of Public Comments on
Discussion of Payment for MDPP
Services in Prior Rulemaking
In addition to requests for
clarification on certain details of the
payment structure, such as the timing of
beneficiary achievement of weight loss,
which are addressed subsequently in
this section, commenters on the
discussion of payment for MDPP
services in the July 15, 2016 MDPP
proposed rule (81 FR 46415 through
46416) expressed a variety of
perspectives on the performance-based
payment methodology presented in that
proposed rule. In general, commenters
urged us to set payment amounts that
are sufficient to ensure MDPP supplier
participation.
Several commenters recommended
that a sustainable payment rate structure
should mirror performance-based
payment models in the existing
employer marketplace. A number of
commenters requested that we not tie
Medicare payment to weight loss or that
we make separate weight loss and
attendance payments; that we tie
payment to aggregate, rather than
individual, beneficiary weight loss; or
that we tie payment to other factors
besides or in addition to weight loss.
Other commenters urged us to provide
payment based on sessions furnished by
MDPP suppliers rather than basing
payment on an individual beneficiary’s
success, arguing that the payment
structure presented would not be a
sustainable model for MDPP suppliers
that would expend resources furnishing
sessions but would have little influence
over beneficiaries’ achievement of
attendance and/or weight loss
performance goals.
Several commenters requested that we
provide information on how the
payment rates included in the
discussion were determined. Some
commenters expressed concern that the
magnitude of MDPP payments was not
consistent with payments for other
similar services.
A number of commenters urged that
higher payments be made at the
beginning of the MDPP services period
to cover program start-up costs, that we
decrease supplier financial risk by
providing sufficient payment for
beneficiaries who do not achieve weight
loss performance goals, and that we
implement risk-stratification of
payments to reduce the risk of MDPP
suppliers preferentially seeking to
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furnish MDPP services to low-risk
beneficiaries most likely to achieve
weight loss and avoiding high-risk
beneficiaries. In addition, several
commenters requested that we update
the payment rates annually for inflation
and the increasing costs experienced by
MDPP suppliers.
As discussed in this section, the
proposed MDPP payment structure is
generally similar to that which was
discussed in the July 15, 2016 MDPP
proposed rule (81 FR 46415 through
46416). However, the proposed
performance payment amounts for core
sessions, core maintenance session 3month intervals, and ongoing
maintenance session 3-month intervals
differ somewhat based on our
consideration of the comments received
in response to the July 15, 2016 MDPP
proposed rule in the context of our
policy goal to prioritize the achievement
and maintenance of the required
minimum weight loss that is associated
with a reduction in the incidence of
type 2 diabetes. In this proposed rule,
we are proposing a payment structure
for MDPP services that is performancebased in relation to two meaningful
performance goals.
First, the proposed payment structure
values beneficiary weight loss most
significantly. Weight loss is a key
indicator of success among individuals
enrolled in a DPP due to the strong
association between weight loss and
reduction in the risk of type 2
diabetes.11 Second, the proposed
payment structure values beneficiary
attendance because, in the DPP model
test, session attendance was associated
with greater weight loss. According to
the second year independent evaluation
of the DPP model test, those
beneficiaries who attended at least 1
core session lost an average of 7.6
pounds, while beneficiaries who
attended at least 4 core sessions lost an
average of 9 pounds. Body mass index
was reduced from 32.9 to 31.5 among
Medicare beneficiaries who attended at
least 4 core sessions.12
In addition to weight loss, we
considered linking other criteria such as
hemoglobin A1c level to MDPP
11 RF Hamman et al., ‘‘Effects of Weight Loss with
Lifestyle Intervention on Risk of Diabetes,’’ Diabetes
Care 29, no. 9 (2006): 2102–2107.
12 Hinnant L, Razi S, Lewis R, Sun A, Alva M,
Hoerger T, Jacobs S, Halpern M. Evaluation of the
Health Care Innovation Awards: Community
Resource Planning, Prevention, and Monitoring,
Annual Report 2015. Awardee-Level Findings:
YMCA of the USA; 2016. Table 17. Average/
Frequencies Health Outcomes of all Participants
through Q11, p. 36. RTI Project Number
0212790.010.001.004, Contract HHSM–500–2010–
00021I. Sponsored by the Centers for Medicare &
Medicaid Services.
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performance payments, or using
aggregate instead of individual weight
loss for MDPP payments. However, the
MDPP expanded model was determined
to meet the statutory requirements for
expansion based on the DPP model test,
which demonstrated that weight loss
was associated with reductions in
Medicare expenditures. Although
elevated hemoglobin A1c levels were
included as part of the beneficiary
eligibility criteria in the DPP model test,
hemoglobin A1c levels were not
evaluated post-intervention in that
model. Therefore, we are not proposing
to use hemoglobin A1c blood values in
the performance-based payment
methodology for MDPP services. The
use of hemoglobin A1c blood values in
the MDPP payment methodology would
have incorporated changes in values for
which there was no evidence that could
be used to support the determination
that the MDPP expanded model meets
the statutory requirements for
expansion. We further note that the CDC
does not require post-MDPP services
hemoglobin A1c blood values to be
determined as part of its 2015 DPRP
standards, and we aim to align with the
CDC DPRP standards as much as
possible. While 5 percent weight loss is
considered a performance measure for
DPRP recognition, the CDC does not
examine pre-post DPP differences in
hemoglobin A1c as part of its DPRP
standards.
The proposed MDPP payment
structure incentivizes MDPP suppliers
to prioritize the achievement and
maintenance of beneficiary weight loss
by furnishing MDPP services, and
provides a balance between
performance-based payments related to
weight loss and session attendance. We
do not believe that it would be
appropriate for payment to be tied to
attendance alone because weight loss is
more directly associated with a
reduction in the incidence of type 2
diabetes than attendance at MDPP
sessions. We further believe that the
proposed performance-based payment
structure based on individual
beneficiary success, rather than average
weight loss across all MDPP
beneficiaries who receive MDPP
services from an MDPP supplier,
maximizes the focus of MDPP suppliers
on the achievement of the performance
goals for all beneficiaries, including
those beneficiaries who experience
challenges with achieving attendance
and/or weight loss performance goals.
Therefore, we do not believe it would be
appropriate to use aggregate beneficiary
information (that is, average weight loss)
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34139
in the proposed performance-based
payment methodology.
(2) Overall Approach To Setting
Performance Payment Amounts
We are proposing to establish the
rules governing payment for MDPP
services at new § 414.84. We note that
as discussed in section III.K.2.a. of this
proposed rule, we are proposing that
MDPP services may be furnished and
payment made under the MDPP
expanded model starting April 1, 2018.
Therefore, we are proposing that the
effective date of § 414.84 would be April
1, 2018. Only MDPP services furnished
on or after April 1, 2018, would be
eligible for payment when all
requirements for billing for performance
payments for those services are met.
At proposed § 414.84(a)(1), we are
proposing to define ‘‘performance goal’’
as an attendance or weight loss goal that
an MDPP beneficiary must achieve for
an MDPP supplier to be paid a
performance payment. We are proposing
to define ‘‘performance payment’’ as a
payment to an MDPP supplier for
furnishing certain MDPP services when
an MDPP beneficiary achieves the
applicable performance goal. These
definitions are used in our proposals for
payment of MDPP services.
To align with the once-per-lifetime
policy, we are proposing at § 414.84(b)
that each performance payment made
based on attendance of a specified
number of core sessions, for a specific
3-month core maintenance or ongoing
maintenance interval during the MDPP
services period, or for achieving a
weight loss performance goal, is made
only once per MDPP beneficiary.
(a) Total Amount and Distribution of
Performance Payments Across the Set of
MDPP Services
As displayed in Table 27, we are
proposing a maximum total
performance payment amount per
beneficiary for the set of MDPP services
of $810. This amount is the aggregate of
the maximum performance payments
for core sessions, core maintenance
sessions, and ongoing maintenance
sessions furnished to MDPP
beneficiaries who achieve weight loss of
at least 9 percent over the 36 months of
the MDPP services period. This
performance payment amount would be
made for a minimum of 46 MDPP
sessions required to be offered to the
beneficiary in the set of MDPP services.
Although CMS would make
performance payments to MDPP
suppliers at intervals throughout the
MDPP services period in varying
amounts, payment for each session
furnished would be included in the total
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performance payment amount a
supplier was paid for the set of MDPP
services.
While we are not proposing that
payment for MDPP services utilize a feefor-service payment methodology, we
note that, estimated on a per-session
basis, the maximum MDPP payment
amount for achievement of all the
performance goals would equate to
approximately $18 per session. For
comparison, Medicare pays under the
PFS approximately $10 (excluding
physician work and malpractice) for
CPT code 98962 (Education and training
for patient self-management by a
qualified, nonphysician health care
professional using a standardized
curriculum, face-to-face with the patient
(could include caregiver/family) each 30
minutes; 5–8 patients), a service that
may bear some resemblance to an MDPP
session furnished by an MDPP supplier,
although an MDPP session would be
furnished by a coach (not necessarily a
health care professional), has a duration
of 1 hour, and has no explicit limitation
on group size.
However, this estimated per-session
MDPP payment amount would result
only from the furnishing of MDPP
services to those beneficiaries who
achieve the highest attendance and
weight loss performance goals under the
proposed performance-based payment
methodology for MDPP services. For
beneficiaries who do not achieve the
highest performance goals, the
estimated per-session MDPP payment
amount would generally be significantly
lower, with the amount based upon the
actual attendance and weight loss
performance of the beneficiary. The
differences between the estimated
MDPP per-session payment amounts
and between the MDPP and PFS
payment amounts result from the
proposed performance-based
methodology for MDPP services. We
note that under the PFS payments are
based on suppliers’ relative resources
used to furnish services. On the other
hand, we believe that that the estimated
per-session MDPP payment amounts
under our proposal for beneficiaries
who achieve specified attendance and
weight loss performance goals are
appropriate in the context of a
performance-based payment
methodology for the set of MDPP
services that differs from the
methodology used under the PFS.
Finally, we note that there are also
some administrative costs that MDPP
suppliers would bear to enroll in
Medicare and ensure compliance with
the requirements for furnishing MDPP
services. The total MDPP performance
payment across all Medicare
beneficiaries would provide some
payment for the resources that would be
used by MDPP suppliers to meet the
administrative requirements for
furnishing MDPP services.
In terms of the proposed distribution
of the maximum total performance
payment amount for MDPP services
across the types of performance
payments, as discussed in detail in
sections III.K.2.d.iii.(3) and (4) of this
proposed rule and displayed in Table
27, we are proposing that, for those
beneficiaries achieving the highest core
services period performance goals,
approximately 13 percent of the
maximum of $810 would be paid for
attendance at core sessions during the
initial 6 months of the core services
period, while approximately 15 percent
would be paid for core maintenance
sessions during months 7 to 12 of the
core services period. We believe that
payment of a similar percentage of the
maximum total performance payment
amount during the initial 6 months of
the core services period for beneficiaries
who meet attendance performance goals
and during months 7 to 12 for
beneficiaries who meet both weight loss
and attendance performance goals is
appropriate to balance performance
payment for attendance and weight loss
throughout the core services period.
In addition, as discussed in detail in
section III.K.2.d.iii.(5) of this proposed
rule, we are proposing that
approximately 49 percent of the
maximum of $810 would be paid for
ongoing maintenance sessions over a 24month period, or 24.5 percent per each
12-month period, for those beneficiaries
who maintain the required minimum
weight loss. The focus of ongoing
maintenance sessions is on maintenance
of weight loss that has already been
achieved, and there would typically be
an established relationship between the
MDPP supplier and the MDPP
beneficiary during the ongoing services
period. Therefore, the totality of MDPP
sessions furnished during this 24-month
period would result in a slightly lower
performance payment per 12-month
period than the totality of those sessions
furnished when the required minimum
weight loss is achieved during the 12
months of the core services period,
when 28 percent of the maximum total
performance payment amount would be
paid.
Finally, due to the importance of
weight loss as a meaningful outcome of
MDPP services because of its association
with a reduction in the incidence of
type 2 diabetes, as discussed in detail in
section III.K.2.d.iii.(6) of this proposed
rule, we are proposing that 23 percent
of the maximum total performance
payment amount would be paid for
weight loss performance payments to
provide additional payments for MDPP
sessions that are effective (that is, lead
to specified percentages of weight loss).
We note that, in the DPP model test,
44.7 percent of participants achieved 5
percent weight loss, which under our
proposal would result in a weight loss
performance payment of approximately
20 percent of the maximum total
performance payment amount.13
Moreover, according to estimates from
CDC’s DPRP, approximately 12 percent
of program participants attending at
least 2 sessions achieved 9 percent or
greater weight loss.14
Table 27 summarizes the proposed
maximum total amount and distribution
of performance payments for the set of
MDPP services.
TABLE 27—PROPOSED MAXIMUM TOTAL AMOUNT AND DISTRIBUTION OF PERFORMANCE PAYMENTS FOR THE SET OF
MDPP SERVICES
Maximum performance
payment for achieving
attendance and/or weight-loss
performance goals
($)
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Type of performance payment
Core sessions ......................................................................................................
Core maintenance session intervals ...................................................................
Ongoing maintenance session intervals ..............................................................
13 National Council of Young Men’s Christian
Associations, Measurement and Monitoring Report.
CMS Health Care Innovation Awards, Round One,
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105
120
400
Sixteenth Quarterly Reporting Period (16QR), April,
May, and June 2016.
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Percentage of maximum total
performance payment
14 CDC’s Diabetes Prevention Recognition
Program dataset as of March 1, 2017.
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TABLE 27—PROPOSED MAXIMUM TOTAL AMOUNT AND DISTRIBUTION OF PERFORMANCE PAYMENTS FOR THE SET OF
MDPP SERVICES—Continued
Maximum performance
payment for achieving
attendance and/or weight-loss
performance goals
($)
Type of performance payment
Percentage of maximum total
performance payment
Weight loss ..........................................................................................................
185
23
Total performance payment .........................................................................
810
100
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We are inviting public comments on
our proposals for the maximum total
performance payment amount and the
distribution of performance payments
for MDPP services across the set of
MDPP services.
(b) Payment Considerations Related to
Coverage of MDPP Services for
Beneficiaries With Social Risk Factors
We understand that social risk factors
such as income, education, race and
ethnicity, employment, disability,
community resources, and social
support play a major role in health. The
Office of the Assistant Secretary for
Planning and Evaluation (ASPE) and the
National Academies of Sciences,
Engineering, and Medicine recently
released reports on the issue of
accounting for social risk factors in CMS
programs.15 16 We have previously
sought public comment on accounting
for social risk factors in CMS programs,
primarily on the topics of quality
measurement and reporting, such as in
the Request for Information Regarding
Implementation of the Merit-Based
Incentive Payment System, Promotion
of Alternative Payment Models, and
Incentive Payments for Participation in
Eligible Alternative Payment Models
published in the October 1, 2015
Federal Register (80 FR 59105, 59109,
59110, and 59113).
In the CY 2017 PFS final rule (81 FR
80466), we acknowledged commenters’
concerns regarding the potential
unintended consequences if the MDPP
expanded model were to result in lowincome or other disadvantaged
populations having less access to
ongoing maintenance sessions due to
their failure to achieve or maintain the
weight loss performance goal required
for coverage of these sessions. In
addition, through listening sessions,
stakeholders have provided us with
anecdotal information suggesting that
racial and ethnic minorities and low
15 Available at https://aspe.hhs.gov/sites/default/
files/pdf/253971/ASPESESRTCfull.pdf.
16 Available at https://nationalacademies.org/
hmd/Reports.aspx?filters=inmeta:activity=
Committee+on+Accounting+for+SES+in+Medicare+
Payment+Programs.
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socioeconomic status populations lose
about 1 percent less weight, on average,
than higher socioeconomic groups and
non-Hispanic whites.
We are proposing an MDPP payment
structure for the set of MDPP services
that is similar to the structure presented
in the July 15, 2016 MDPP proposed
rule (81 FR 46416), where performance
payments are tied to attendance at
MDPP sessions and/or weight loss.
Based on information provided to us by
stakeholders, we acknowledge that tying
performance payment to a specific
threshold of weight loss and/or
attendance may make achieving the
performance goals required for the
highest performance payments and
beneficiary eligibility for coverage of
ongoing maintenance sessions more
challenging for MDPP suppliers
furnishing services to individuals with
social risk factors. We note that our
proposal for beneficiary engagement
incentives as discussed in section
III.K.2.f. of this proposed rule would
provide MDPP suppliers with the
flexibility under certain conditions to
furnish in-kind patient engagement
incentives, such as transportation, to
support beneficiaries in achieving the
MDPP expanded model performance
goals, including session attendance and
weight loss. We expect these beneficiary
engagement incentives may be helpful
to MDPP suppliers furnishing services
to beneficiaries, including those with
social risk factors that could increase
their risk of not achieving the MDPP
performance goals.
We are not proposing to risk-adjust
MDPP payments for social risk factors or
to adopt additional special payment
policies to specifically encourage MDPP
suppliers to furnish sessions to
beneficiaries with social risk factors
because, for the MDPP expanded model,
we do not believe that such approaches
are necessary to ensure access to MDPP
services for all beneficiaries. This is
because we believe that the proposed
performance goals upon which the
performance payments for the set of
MDPP services would be based, as well
as the payment policies that recognize
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that weight loss is a gradual process that
may occur slowly over the 12 months of
the core services period, should allow
MDPP suppliers sufficient time to work
with all eligible beneficiaries, including
beneficiaries with social risk factors,
toward achieving the attendance and
weight loss performance goals of the
MDPP expanded model. However, we
may consider proposing additional
payment policies for the MDPP
expanded model in the future.
We are requesting comments about
social risk factors in the context of the
set of MDPP services that could inform
any future considerations of additional
payment policies for the MDPP
expanded model. We also are inviting
public comments on other types of
strategies that we could utilize
throughout the testing of the MDPP
expanded model to assist MDPP
suppliers in providing robust access to
MDPP services for beneficiaries with
social risk factors, such as learning
activities to share best practices among
MDPP suppliers in providing the set of
MDPP services.
(3) Performance Payments for Core
Sessions
The payment structure presented in
the July 15, 2016 MDPP proposed rule
(81 FR 46415 through 46416) would
have made attendance-based payments
of $25 for the first core session, $50 for
4 total core sessions, and $100 for 9 total
core sessions. Based on our
consideration of information provided
in the public comments on that
proposed rule and our increased
emphasis in the performance payments
on the achievement and maintenance of
the required minimum weight loss as
the outcome of MDPP services, our
proposal for the attendance-based
performance payments for 4 and 9 core
sessions differs from these payment
amounts.
We are proposing that an MDPP
supplier would be paid a $25
performance payment the first time it
furnishes an MDPP session to an MDPP
beneficiary as displayed in Table 28.
This performance payment would be
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available once per beneficiary for the
beneficiary’s first core session.
We are proposing that an MDPP
supplier would be paid the performance
payment upon furnishing the first core
session to a beneficiary who initiates the
MDPP services period, regardless of
whether the MDPP supplier qualifies for
any of the additional performance
payments for that beneficiary. As we are
proposing in the sections that follow,
additional performance payments
would depend upon the beneficiary’s
achievement of the performance goals
for attendance and/or weight loss. We
believe that making the first
performance payment based on
beneficiary attendance at the first core
session is appropriate because the
MDPP supplier would use significant
resources to furnish the first session,
including collecting administrative
information on the beneficiary who is
not already known to the supplier,
regardless of whether the beneficiary
goes on to receive further MDPP
services from that supplier.
On a per-session basis, the
performance payment for the first MDPP
core session would be the highest
performance payment amount for any
core session during the core services
period. Of note, the first core session
performance payment also provides
some payment for MDPP supplier
activities to encourage the beneficiary’s
attendance at additional core sessions
following the first session. Such
supplier activities could include
sending electronic messages or making
reminder phone calls about upcoming
sessions or providing transportation to
the next session under the beneficiary
engagement incentives policy proposed
in section III.K.2.f. of this proposed rule.
It is only through attendance at the first
core session with an MDPP supplier that
a beneficiary initiates the MDPP
services period and has the potential to
achieve weight loss through receiving
MDPP services.
Further, we are proposing that
suppliers would be paid a performance
payment for the interval (which we are
referring to in this proposed rule as an
‘‘interval performance payment’’ to
distinguish it from other performance
payments, such as the performance
payment upon an MDPP beneficiary’s
achievement of the required minimum
weight loss, that do not require
attendance at multiple sessions) upon a
beneficiary’s attendance at 4 total core
sessions, and again upon a beneficiary’s
attendance at 9 total core sessions—that
is, attendance of 5 more core sessions
after having attended his or her first 4.
We are proposing an interval
performance payment of $30 upon a
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beneficiary attending 4 core sessions
and an interval performance payment of
$50 upon a beneficiary attending 9 core
sessions as displayed in Table 28.
Although an MDPP supplier must offer
at least 16 core sessions to a beneficiary
during the initial 6 month of the MDPP
core services period, we are not
proposing any other interval
performance payment for the core
sessions after the performance payment
for attendance at 9 core sessions. We
note that while these proposed payment
amounts are somewhat lower than the
payment amounts for these milestones
presented in the July 15, 2016 MDPP
proposed rule (81 FR 46415 through
46416), they follow a similar pattern of
a higher payment amount associated
with attendance at a larger cumulative
number of core sessions to provide a
significant financial incentive for MDPP
suppliers to encourage MDPP
beneficiary attendance at core sessions
in the first 6 months of the core services
period.
On a per-session basis, the payments
for attendance at 4 total core sessions
and 9 total core sessions would be
approximately $10 and $4 to $10,
respectively, depending upon the
number of sessions attended by the
beneficiary beyond the 9 required for
the second interval performance
payment up to the maximum of 16 core
sessions that must be offered to the
beneficiary by the MDPP supplier
during the initial 6 months of the MDPP
core services period. Because the
performance payments for core sessions
would be based solely on the
achievement of attendance performance
goals, we believe these per-session
performance payment amounts that are
lower than the proposed performance
payment amount for the first core
session are still appropriate because we
expect that fewer MDPP supplier
resources would be used to furnish
sessions to beneficiaries with whom the
MDPP supplier has an established
relationship. The per-session payment
amounts for core sessions are set based
on attendance at these sessions, which
is associated with ultimate achievement
of the required minimum weight loss.
We are proposing to make the first
interval performance payment for core
sessions when the beneficiary has
attended 4 core sessions for the
following reasons. First, beneficiary
attendance at 4 core sessions was a
significant attendance milestone in the
evaluation of the DPP model test, which
provided evidence that meeting this
milestone is tied to weight loss
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outcomes.17 According to the second
year independent evaluation of the DPP
model test, those beneficiaries who
attended at least 1 core session lost an
average of 7.6 pounds while
beneficiaries who attended at least 4
core sessions lost an average of 9
pounds. BMI was reduced from 32.9 to
31.5 among Medicare beneficiaries who
attended at least 4 core sessions.
Second, in examining CDC’s DPRP
participant trend data, we found that a
higher percentage of participants drop
out after 3 core sessions as compared to
those who drop out after 4 core sessions,
meaning that if a beneficiary completes
the 4th core session, he or she is more
likely to remain in the DPP for the 12month program.18 Therefore, we believe
making the first interval performance
payment after beneficiary attendance at
4 core sessions would be appropriate.
We are proposing to make the second
interval performance payment when the
beneficiary has attended 9 core sessions
because attending a higher amount of
sessions in the initial 6 months of the
MDPP core services period, beginning at
session 9, has been shown to greatly
improve weight loss outcomes.
Specifically, according to CDC data,
there is a 125 percent increase in weight
loss comparing beneficiaries who attend
4 to 8 sessions (1.6 percent weight loss
on average) and beneficiaries who
attend 9 to 16 sessions (3.6 percent
weight loss on average).19 Therefore, we
believe that attendance at 9 sessions
reflects clinically meaningful
attendance at core sessions and would
provide an incentive to MDPP suppliers
to encourage beneficiaries to continue
into the second 6 months of the MDPP
core services period, which is when the
5 percent weight loss from baseline is
usually achieved or exceeded.
Additionally, 9 is the number of core
sessions, on average, that a participant
must attend in CDC’s National DPP in
the first 6 months for a CDC-recognized
organization to achieve full CDC
recognition.
MDPP suppliers would be paid these
performance payments when
beneficiaries achieve these core session
17 Hinnant L, Razi S, Lewis R, Sun A, Alva M,
Hoerger T, Jacobs S, Halpern M. Evaluation of the
Health Care Innovation Awards: Community
Resource Planning, Prevention, and Monitoring,
Annual Report 2015. Awardee-Level Findings:
YMCA of the USA; 2016. Table 17. Average/
Frequencies Health Outcomes of all Participants
through Q11, p. 36. RTI Project Number
0212790.010.001.004, Contract HHSM–500–2010–
00021I. Sponsored by the Centers for Medicare &
Medicaid Services.
18 CDC’s Diabetes Prevention Recognition
Program dataset as of March 1, 2017.
19 CDC’s Diabetes Prevention Recognition
Program dataset as of February 28, 2017.
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attendance performance goals,
regardless of weight loss. Although we
are proposing to base performance
payments during the MDPP services
period substantially on weight loss,
which is directly associated with a
significant decrease in the incidence of
type 2 diabetes, we recognize that
weight loss is a gradual process and that
MDPP suppliers utilize resources to
furnish MDPP services during the
period of time when the beneficiary is
losing weight. Therefore, we are
proposing that performance payments
for beneficiary attendance at core
sessions during the first 6 months of the
core services period be based on
attendance only. The maximum total
performance payment to MDPP
suppliers for furnishing MDPP core
sessions would be $105 per beneficiary,
as displayed in Table 28.
attendance early in a beneficiary’s
participation with the MDPP supplier,
considering that MDPP suppliers would
be paid an initial $25 performance
payment for the first core session
attended by the beneficiary and would
then be paid performance payments for
beneficiary attendance of up to 9 core
sessions, regardless of weight loss. We
believe that increasing the initial
payments for attendance at MDPP
sessions would shift the nature of the
payment for the set of MDPP services
from a performance-based structure
based on a balance of attendance and
weight loss considerations toward a
payment structure that is based on
attendance at each session furnished.
The proposed attendance-based
performance payments for MDPP core
sessions are included at proposed
§ 414.84(b)(1), (2), and (3). We are
inviting public comments on these
proposals. We also are inviting public
comments on the alternative considered.
TABLE 28—PROPOSED ATTENDANCEBASED PERFORMANCE PAYMENTS
(4) Performance Payments for Core
FOR MDPP CORE SESSIONS
Maintenance Session Intervals
We are proposing that performance
payments for core maintenance sessions
Performance goal
would be tied to the beneficiary’s
achievement of attendance and weight
loss performance goals during a core
maintenance session interval. A core
1st core session attended
(performance payment) .....
25 maintenance session interval, as we are
proposing to define it at § 410.79(b),
4 total core sessions atmeans one of the two consecutive 3tended (interval performance payment) ..................
30 month time periods during months 7
9 total core sessions atthrough 12 of the MDPP services period,
tended (interval performduring which an MDPP supplier offers
ance payment) ..................
50 at least one core maintenance session
Maximum total performance
per month to an MDPP beneficiary.
payment for core sessions
105
The payment structure presented in
the July 15, 2016 MDPP proposed rule
We considered alternatives to this
(81 FR 46415 through 46416) would
proposed payment structure for core
have required the MDPP beneficiary to
sessions, such as making higher
attend 3 core maintenance sessions and
payments for attendance at the earlier
achieve or maintain a minimum 5
sessions to provide MDPP suppliers
percent weight loss for a $45 payment
with additional funds for the resources
to be made to an MDPP supplier for the
necessary for start-up of the MDPP
core maintenance session interval. If 5
expanded model. Although we
percent weight loss was not achieved or
understand that there are some up-front maintained during the core maintenance
supplier costs associated with
session interval, no separate
implementing the MDPP expanded
performance payment would be made.
model, we believe these costs would
MDPP suppliers would still have been
disproportionately be related to start-up required to offer (and furnish if the
and not generally be ongoing costs
beneficiary attended) MDPP services
borne by the MDPP supplier. In
during core maintenance intervals to
addition, because we expect that many
beneficiaries regardless of weight loss.
MDPP suppliers are currently offering
Based on our consideration of
DPPs through contracts with
information provided in the public
commercial payers, MDPP suppliers
comments on that proposed rule and
may be able to minimize start-up costs
our increased emphasis in the
by relying on their relevant experience
performance payments on the
with offering other DPPs. Finally, we
achievement and maintenance of the
believe that our proposal for payment of required minimum weight loss as the
MDPP core sessions already includes
outcome of MDPP services, our proposal
substantial payment for session
for the performance payments for core
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performance
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beneficiary
($)
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maintenance sessions differs from the
payment amounts included in the July
15, 2016 MDPP proposed rule (81 FR
46415 through 46416).
For the MDPP expanded model, we
are proposing performance payments
amounts for core maintenance session
intervals that value achievement of both
session attendance and the required
minimum weight loss, with an emphasis
on achieving the weight loss
performance goal. We are proposing that
an MDPP supplier would be paid a
performance payment for a core
maintenance session interval if a
beneficiary achieves the performance
goal of attending at least 3 core
maintenance sessions during the
interval. The specific performance
payment amount would be determined
by whether the beneficiary has also
achieved or maintained the required
minimum weight loss within the
interval. The achievement or
maintenance of the required minimum
weight loss within the 3-month core
maintenance session interval would be
determined based on a measurement
taken in-person during any 1 session
within that 3-month interval. We are
proposing that MDPP suppliers would
be paid a performance payment for no
more than two core maintenance session
intervals for each MDPP beneficiary.
As discussed previously, we
recognize that weight loss is a process
that may still be ongoing for some
beneficiaries during the final months of
the core services period. According to
an analysis of participant data from
CDC’s DPRP, the longer a participant
remains in the lifestyle change program,
the greater his or her average weight loss
achieved.20 Findings indicate that it
takes an average of 17 DPP sessions
attended to exceed the required
minimum weight loss, and the 9 percent
or greater weight loss goal is more likely
to be achieved upon attending 19
sessions on average. This average
number of sessions exceeds the 16 core
sessions that must be offered to the
MDPP beneficiary during the first 6
months of the MDPP services period
and emphasizes the importance of core
maintenance sessions to achievement of
meaningful weight loss goals.
Of further note, the National DPP’s
core maintenance sessions were
developed based on results from the
original 2002 DPP Randomized Control
Trial and CDC’s DPRP standards were
developed with this science in mind.21
20 CDC’s Diabetes Prevention Recognition
Program dataset as of March 1, 2017.
21 Available at https://www.niddk.nih.gov/aboutniddk/research-areas/diabetes/diabetes-preventionprogram-dpp/Documents/DPP_508.pdf.
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Core maintenance sessions are integral
for the expected reduction in the
incidence of type 2 diabetes to be
experienced by MDPP beneficiaries.
These findings were recently confirmed
in a literature review on combined diet
and physical activity programs to
prevent type 2 diabetes conducted by
the Community Preventive Services
Task Force that reiterated the year-long
intensity and duration of the National
DPP.22
Therefore, we believe that providing
no performance payment to MDPP
suppliers for furnishing core
maintenance sessions to beneficiaries
who have not achieved the required
minimum weight loss prior to or during
months 7 to 12 of the core services
period could reduce the opportunity for
MDPP beneficiaries to achieve the
weight loss performance goal. Such a
payment methodology could reduce the
likelihood that MDPP suppliers would
continue to work to engage beneficiaries
in the weight loss process if those
beneficiaries had not achieved the
required minimum weight loss after
completion of the initial 6 months of the
MDPP core services period. We note
that, as finalized in the CY 2017 PFS
final rule (81 FR 80459), suppliers must
offer a minimum of 1 core maintenance
session per month in months 7 to 12 of
the core services period to eligible
beneficiaries, regardless of the
beneficiary’s weight loss. We believe
that it is possible for some beneficiaries
to have achieved the required minimum
weight loss performance goal by the
time the core sessions have been
completed, and we want to incentivize
MDPP suppliers to work toward the
weight loss performance goal in that
timeframe. However, we believe that it
is also appropriate to place some value
on achieving attendance performance
goals alone through performance
payments for core maintenance session
intervals so that MDPP suppliers
continue to work to engage all
beneficiaries in striving to achieve the
required minimum weight loss
performance goal.
As discussed in section
III.K.2.d.iii.(2)(a) of this proposed rule,
we are proposing that the maximum
total performance payment for MDPP
core maintenance sessions would be
$120 for beneficiaries who achieve both
the attendance and weight loss
performance goals during months 7 to
12 of the core services period.
Specifically, we are proposing to pay
MDPP suppliers $60 for a core
maintenance session interval if a
beneficiary attends 3 sessions and
achieves or maintains the required
minimum weight loss during that
interval, and to pay MDPP suppliers $10
for a core maintenance session interval
if the beneficiary attends 3 sessions but
does not achieve or maintain the
required minimum weight loss during
that core maintenance session interval.
As compared to the payment amounts
with and without achievement or
maintenance of the required minimum
weight loss that were presented for core
maintenance session intervals in the
July 15, 2016 MDPP proposed rule (81
FR 46415 through 46416), these
payment amounts are both higher. As
discussed previously in this section, we
believe it is appropriate in months 7 to
12 of the core services period to provide
some performance payment for
achievement of attendance performance
goals even if the required minimum
weight loss is not achieved, in order to
provide the greatest opportunity for
beneficiaries to achieve the required
minimum weight loss over the full core
services period. In addition, we are
proposing a higher payment amount for
core maintenance session intervals with
achievement or maintenance of the
required minimum weight loss to
recognize that achievement and
maintenance of the required minimum
weight loss are necessary for the
reduced incidence of type 2 diabetes
and to encourage MDPP suppliers to
work to engage beneficiaries in
achieving weight loss and sustaining
their weight loss over time.
Proposed performance payments for
the core maintenance session intervals
are displayed in Table 29. On a persession basis, these payments would be
approximately $20 and $3, respectively.
While both of these payment amounts
provide payment to MDPP suppliers for
the resources involved with furnishing
core maintenance sessions, we believe
the relatively high per-session
performance payment of $20 in
comparison to the per-session
performance payment amounts for core
sessions is appropriate due to the
achievement or maintenance of both the
required minimum weight loss and
beneficiary attendance at core
maintenance sessions, as compared to
core sessions where the performance
payment is based solely on attendance.
On the other hand, we believe that the
relatively low per-session payment
amount in our core maintenance session
interval performance payment proposal
for core maintenance sessions for those
beneficiaries who do not achieve the
weight loss performance goal, while
providing some performance payment
for attendance at core maintenance
sessions by beneficiaries still working to
achieve the required minimum weight
loss, is appropriate because these
sessions have not yet resulted in those
beneficiaries achieving the weight loss
performance goal.
TABLE 29—PROPOSED PERFORMANCE PAYMENTS FOR CORE MAINTENANCE SESSION INTERVALS
Performance payment per
beneficiary
(with achievement or
maintenance of required
minimum weight loss)
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Performance goal
3 sessions attended in first core maintenance session interval (months 7–9 of
the MDPP core services period) ......................................................................
3 sessions attended in second core maintenance session interval (months
10–12 of the MDPP core services period) ......................................................
Maximum total performance payment for core maintenance session intervals
(two consecutive 3-month intervals over months 7–12 of the MDPP core
services period) ................................................................................................
Performance Payment per
beneficiary
(without achievement or
maintenance of required
minimum weight loss)
$60
$10
60
10
120
20
22 Available at https://
www.thecommunityguide.org/diabetes/
combineddietandpa.html.
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The proposed core maintenance
session interval performance payments
for core maintenance sessions are
included at proposed § 414.84(b)(4). We
are inviting public comments on these
proposals.
(5) Performance Payments for Ongoing
Maintenance Session Intervals
Similar to our proposal for the
payment of core maintenance session
intervals described previously, we are
proposing to make performance
payments to MDPP suppliers for 3month ongoing maintenance session
intervals. This payment would be made
when suppliers furnish ongoing
maintenance sessions during the 24
months of the ongoing services period
after the 12-month MDPP core services
period ends. We are proposing that an
MDPP supplier would be paid a
performance payment for an ongoing
maintenance session interval if an
MDPP beneficiary achieves the
performance goals of attending at least
3 ongoing maintenance sessions and
maintaining the required minimum
weight loss from baseline measured in
person during a session at least once
within that interval. Under this
proposal, an MDPP supplier would not
be paid a performance payment unless
the beneficiary has achieved these both
of these performance goals within that
3-month interval. An ongoing
maintenance session interval, as we are
proposing to define it at § 410.79(b),
means one of the up to eight
consecutive 3-month time periods
during the ongoing services period,
during which an MDPP supplier offers
at least one ongoing maintenance
session to an MDPP beneficiary per
month.
The payment structure presented in
the July 15, 2016 MDPP proposed rule
(81 FR 46415 through 46416) would
have required the MDPP beneficiary to
attend 3 ongoing maintenance sessions
and maintain the required minimum
weight loss for a $45 payment to be
made to an MDPP supplier for the
ongoing maintenance session interval.
Based on our consideration of
information provided in the public
comments on that proposed rule and
our increased emphasis in the
performance payments on the
achievement and maintenance of weight
loss as the outcome of MDPP services,
our proposal for the performance
payment for ongoing maintenance
session intervals differs from that
payment amount.
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We are proposing that MDPP
suppliers could be paid up to 8
performance payments of $50 each for
ongoing maintenance session intervals.
Just like the other proposals for
performance payments, we are
proposing this payment in CY 2018
dollars to ensure consistency in
calendar year dollars among
performance payments for a given
calendar year. However, we note that no
ongoing maintenance session interval
payments, available only for intervals in
the ongoing services period during
months 13 through 36 of an MDPP
beneficiary’s MDPP services period,
would be made in CY 2018 based on our
proposal in section III.K.2.a. of this
proposed rule that MDPP services be
available on April 1, 2018. Under this
proposal, MDPP services would only be
available for 9 months of CY 2018 so no
MDPP beneficiaries would attend
ongoing maintenance sessions in CY
2018. The first ongoing maintenance
session interval performance payments
would be made in CY 2019 and would
equal $50 adjusted by the percent
change in the Consumer Price Index for
All Urban Consumers (CPI–U) (U.S. city
average) for the 12-month period ending
June 30th, 2018, as discussed in section
III.K.2.d.iii.(9) of this proposed rule.
This proposed payment amount is
somewhat higher than the potential
payment discussed in the July 15, 2016
MDPP proposed rule (81 FR 46415
through 46416) to recognize that
maintenance of the required minimum
weight loss is necessary for the reduced
incidence of type 2 diabetes and to
encourage MDPP suppliers to work to
engage beneficiaries in sustaining their
weight loss over time. The maximum
total performance payment for MDPP
ongoing maintenance sessions would be
$400, as displayed in Table 30. On a
per-session basis, this payment would
be approximately $17, which we believe
is appropriate for MDPP suppliers that
furnish ongoing maintenance sessions to
beneficiaries who maintain the required
minimum weight loss during ongoing
maintenance session interval. We note
that this per-session payment amount
would be somewhat lower than the $20
per-session payment amount included
in the core maintenance session interval
performance payment for beneficiaries
who achieve attendance and weight loss
performance goals during the 3-month
intervals in months 7 to 12 of the MDPP
core services period. Like the proposed
performance payment for core
maintenance session intervals, the
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proposed performance payment for
ongoing maintenance session intervals
values both attendance and weight loss.
However, during core maintenance
session intervals it is likely that the
required minimum weight loss would
first be achieved, and we believe that a
somewhat higher per-session payment
amount is appropriate under these
circumstances. In contrast, we believe
that a somewhat lower per-session
payment amount for ongoing
maintenance sessions during intervals
where the required minimum weight
loss is maintained, rather achieved, is
appropriate.
We considered an alternative policy
in which an MDPP supplier would
receive a payment for an ongoing
maintenance session interval so long as
the beneficiary attended at least 1
ongoing maintenance session during the
interval and maintained the required
minimum loss. In this scenario, we
considered that the MDPP supplier
would still be required to offer at least
2 additional ongoing maintenance
sessions (at least one per month) to the
beneficiary over the 3-month interval.
However, we believe that the goal of
ongoing maintenance sessions is to
promote both sustained beneficiary
engagement and weight loss and,
therefore, we believe that ongoing
maintenance session interval
performance payments should be tied to
achieving both attendance and weight
loss performance goals.
The proposed payment policy also
would align with the service limitations
for ongoing maintenance sessions at
§ 410.79(c)(1)(iii) in that beneficiaries
also would be required to attend all 3
sessions within a given ongoing
maintenance session 3-month interval to
be covered for the subsequent 3-month
interval. We note that the proposed
coverage and payment policies are
aligned for ongoing maintenance session
intervals, where attendance at 3 sessions
within an interval is required for a
performance payment as well as for
coverage of ongoing maintenance
sessions in the next interval. In contrast,
MDPP suppliers are required to offer
core maintenance sessions in both core
maintenance session intervals for all
beneficiaries, regardless of a
beneficiary’s attendance at core
maintenance sessions, although
attendance is required for a performance
payment to be made for the core
maintenance session interval.
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TABLE 30—PROPOSED PERFORMANCE PAYMENTS FOR ONGOING MAINTENANCE SESSION INTERVALS
Performance
payment per
beneficiary
(with maintenance of the
required minimum weight
loss)
Performance goal
3 sessions attended in 1 ongoing maintenance session interval ...........................................................................
Maximum total performance payment for ongoing maintenance session intervals (8 consecutive 3-month intervals over months 13–36 of the MDPP ongoing services period) ........................................................................
Performance
payment per
beneficiary
(without maintenance of the
required minimum weight
loss)
$50
$0
400
* 0–350
* = The specific payment amount depends on whether the beneficiary has coverage of 1 to 7 ongoing maintenance session intervals, as well
as whether the beneficiary meets the performance goals for the performance payment for that ongoing maintenance session interval.
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The proposed ongoing maintenance
session interval performance payments
for ongoing maintenance sessions are
included at proposed § 414.84(b)(5). We
are inviting public comments on these
proposals. We also are inviting public
comments on the alternative considered.
(6) Weight Loss Performance Payments
We are proposing that if a beneficiary
achieves the required minimum weight
loss measured at any session attended
during the core services period, an
MDPP supplier would be paid the
weight loss performance payment of
$160 displayed in Table 31. As
discussed in section III.K.2.d.iii.(2)(a) of
this proposed rule, we are proposing
that 23 percent of the maximum total
performance payment amount for the set
of MDPP services would be paid for the
achievement of weight loss, regardless
of session attendance, because weight
loss is the most important outcome for
the MDPP expanded model. The
proposed performance payment of $160
for the required minimum weight loss,
which constitutes approximately 90
percent of the maximum total weight
loss performance payment, was set to be
the large majority of the available
weight loss performance payment based
on the strong evidence for the
association of the required minimum
weight loss with a reduction in the
incidence of type 2 diabetes.
We note that this association is
evidenced by the CDC’s National DPP,
which is based on the 2002 DPP
Randomized Control Trial and followup efficacy trials.23 All of the trials
found that the greater the intensity and
duration of the diabetes prevention
program—with 1 year being the most
effective program ‘‘dose’’—the greater
the reduction in the incidence of type 2
diabetes. Specially, persons at high-risk
for type 2 diabetes who participated in
a year-long lifestyle change program,
23 Available at https://www.niddk.nih.gov/aboutniddk/research-areas/diabetes/diabetes-preventionprogram-dpp/Documents/DPP_508.pdf.
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focused on modest weight loss (5–7
percent), experienced a 58 percent
lower incidence of type 2 diabetes than
those who did not receive the lifestyle
intervention. The DPP Randomized
Control Trial, as well as the DPP model
test, involved the provision of 16
weekly core sessions and 6 monthly
core maintenance sessions (all
approximately 1 hour in length), similar
to the set of core services in the MDPP
expanded model. We recognize that not
all beneficiaries would be able to
achieve the required minimum weight
loss within the first 6 months, which is
the period when core sessions are
furnished. Therefore, we believe that
our proposed policy for payment of the
performance payment upon
achievement of the required minimum
weight loss any time during the 12
months of the MDPP core services
period would allow MDPP suppliers the
greatest flexibility to work throughout
the full MDPP core services period with
beneficiaries who face difficulty in
achieving this weight loss performance
goal.
We also are proposing that, in
addition to the weight loss performance
payment for the required minimum
weight loss, an MDPP supplier would be
paid an additional weight loss
performance payment of $25 if the
beneficiary achieves at least 9 percent
weight loss from his or her baseline
weight at any time during the MDPP
services period as displayed in Table 31.
We are proposing this additional weight
loss performance payment based on
information from stakeholders that
commercial payers paying for DPPs
frequently include an incentive
payment for 9 percent weight loss as an
incentive to try to encourage greater
and/or continued weight loss and
behavior change. We believe that
making an additional weight loss
performance payment for 9 percent
weight loss at any time during the
MDPP services period would provide an
additional incentive for MDPP suppliers
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to continue weight loss efforts with
beneficiaries, especially during the
ongoing services period, which may
extend for a period of up to 24 months.
We are proposing that MDPP
suppliers may submit claims for these
weigh loss performance payments on
the date when the beneficiary first
reaches the required minimum or 9
percent weight loss, as measured in
person during a session, respectively,
and each weight loss performance
payment would be paid to only one
supplier and only once per beneficiary.
In the unusual circumstance where the
beneficiary achieved 9 percent weight
loss as the first weight loss change
measured from baseline, the MDPP
supplier could bill and be paid both the
5 percent and 9 percent weight loss
performance payments.
TABLE 31—PROPOSED WEIGHT LOSS
PERFORMANCE PAYMENTS
Performance goal
5 percent weight loss (required minimum weight
loss) ...................................
9 percent weight loss ...........
Maximum total performance
payment for weight loss ....
Performance
payment per
beneficiary
$160
25
185
The proposed weight loss
performance payments are included at
proposed § 414.84(b)(6) and (7). We are
inviting public comments on these
proposals.
(7) Summary Table of Performance
Payments for the Set of MDPP Services
In summary, for furnishing MDPP
services during the MDPP services
period, we are proposing that MDPP
suppliers could be paid a minimum of
$25 per beneficiary (if the beneficiary
attends the first core session) and a
maximum total of $810 per beneficiary
(if the beneficiary achieves all
performance goals, maintains eligibility
for 36 months, and does not change
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MDPP suppliers). Table 32 summarizes
all of the proposed performance
payments for the set of MDPP services
that are discussed in sections
III.K.2.d.iii.(3) through (6) of this
proposed rule.
TABLE 32—PROPOSED PERFORMANCE PAYMENTS FOR THE SET OF MDPP SERVICES
Performance
payment per
beneficiary
(with the required minimum weight
loss)
Performance goal
1st core session attended .......................................................................................................................................
4 total core sessions attended ................................................................................................................................
9 total core sessions attended ................................................................................................................................
Performance
payment per
beneficiary
(without the
required minimum weight
loss)
$25
30
50
3 sessions attended in first core maintenance session interval (months 7–9 of the MDPP core services period)
3 sessions attended in second core maintenance session interval (months 10–12 of the MDPP core services
period) ..................................................................................................................................................................
5 percent weight loss achieved ...............................................................................................................................
9 percent weight loss achieved ...............................................................................................................................
3 sessions attended in ongoing maintenance session interval (eight consecutive 3-month intervals over
months 13–36 of the MDPP ongoing services period) ........................................................................................
* 60
10
* 60
160
25
10
0
0
* 50
** 0
Total performance payment .............................................................................................................................
810
125
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* The required minimum weight loss from baseline must be achieved or maintained during the core maintenance session 3-month interval or
maintained during the ongoing maintenance session 3-month interval.
** A beneficiary attends at least 1 core session during the core services period to initiate the MDPP services period; must attend at least 1 session during the final core maintenance session 3-month interval; and must achieve or maintain the required minimum weight loss at least once
during the final core maintenance session 3-month interval to have coverage of the first ongoing maintenance session interval. Then, a beneficiary must attend at least 3 sessions and maintain the required minimum weight loss at least once during an ongoing maintenance session 3month interval to have coverage of the next ongoing maintenance session interval.
(8) Considerations Related to Potential
Future Geographic Adjustment of MDPP
Payments
Although Medicare is a national
program, it frequently adjusts fee-forservice payments to hospitals,
physicians, and other providers and
suppliers according to the geographic
locations in which they furnish services.
These adjustments generally account for
differences in the relative costs of doing
business in different geographic areas
compared to the national average. For
example, section 1886(d)(3)(E) of the
Act requires that, as part of the
methodology for determining
prospective payments to hospitals, the
Secretary must adjust the standardized
amounts for area differences in hospital
wage levels by a factor (established by
the Secretary) reflecting the relative
hospital wage level in the geographic
area of the hospital compared to the
national average hospital wage level.
This adjustment factor for hospitals is
the wage index, and we currently define
hospital geographic areas (labor market
areas) based on the definitions of CoreBased Statistical Areas (CBSAs)
established by the Office of Management
and Budget. Similarly, a geographic
adjustment is also made for services
paid under the PFS, and a geographic
practice cost index (GPCI) has been
established for every Medicare PFS
payment locality, many of which are
statewide, for each of the three
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components of a service’s relative value
units (that is, the relative value units for
work, practice expense, and
malpractice).
We are proposing to make
performance-based payments to MDPP
suppliers in intervals based on
achievement of performance goals,
rather than fee-for-service payments for
individual services furnished. While we
intend for those performance payments
to make payment to MDPP suppliers for
MDPP services that involve the use of
supplier resources, we are unsure if
there is notable variation in the relative
costs of furnishing MDPP services
among geographic areas. Because the
DPP model test was carried out in only
eight States, we do not have the data to
determine whether there are geographic
differences nationwide. In addition,
because a substantial portion of the
proposed MDPP performance payments
are based on the beneficiary’s
achievement of weight loss performance
goals, we are uncertain about the
appropriateness of geographically
adjusting such performance-based
payments.
Therefore, we are not proposing
geographic adjustment of performance
payments for MDPP services. However,
we are inviting public comments on
issues related to geographic adjustment
of payment for MDPP services in the
context of the MDPP performance-based
payment methodology, including
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appropriate sources of information for
determining any geographic cost
differences. We may consider proposing
additional payment policies for the
MDPP expanded model in the future.
We request that commenters submitting
information on these issues provide
justification, including any relevant
analysis, to support any suggestions
regarding potential future geographic
adjustment of performance-based
payments for MDPP services.
(9) Updating MDPP Payment Amounts
To account for inflation, we are
proposing to update MDPP payment
amounts annually based on the CPI–U.
The CPI–U is a measure of the average
change over time in prices paid for a
market basket of consumer goods and
services, and is a measure of economywide inflation. There are no statutory
requirements for the update factor for
payments for MDPP services so there is
no requirement that a productivity
adjustment be applied to the MDPP
services update factor as there are for
certain other Medicare-covered items
and services where prices are updated
by the CPI–U, such as the Clinical
Laboratory Fee Schedule; Durable
Medical Equipment, Prosthetics/
Orthotics, and Supplies Fee Schedule;
Ambulance Fee Schedule; and
Ambulatory Surgical Center payment
system.
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We considered using other indices
such as the Medicare Economic Index
(MEI) to update the MDPP payment
amounts. The MEI measures price
changes in the inputs required to
operate a self-employed physician
practice. We do not believe that the MEI
would be appropriate to update MDPP
payment amounts because MDPP
suppliers are not similar to selfemployed physician practices. We note
that the CPI–U by definition is an
economy-wide measure of inflation and,
therefore, in the absence of an
appropriate specific index for MDPP
services, we believe the CPI–U to be the
most technically appropriate index
available to update payments for MDPP
services. We further note that the CPI–
U is used to update Medicare payments
for other Medicare-covered items and
services, such as ambulance, clinical
laboratory, and ambulatory surgical
center services.
We are proposing to update MDPP
performance payments and the bridge
payment (a proposed one-time payment
to an MDPP supplier for furnishing its
first session to an MDPP beneficiary
who has previously received MDPP
services from a different MDPP supplier
as discussed in detail in section
III.K.2.d.v. of this proposed rule) that
may be paid to MDPP suppliers in the
following manner:
• Beginning in CY 2019 and each year
forward, the performance payment and
bridge payment amounts will be
adjusted by the 12-month percent
change in the CPI–U (U.S. city average)
for the period ending June 30th of the
year preceding the update year. The
percent change update will be
calculated based on the level of
precision of the index as published by
the Bureau of Labor Statistics and
applied based on one decimal place of
precision. The annual MDPP services
payment update will be published by
CMS transmittal.
The proposed methodology to update
MDPP performance payments and the
bridge payment is included at proposed
§ 414.84(d). We are inviting public
comments on this proposal.
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(10) MDPP Supplier Billing and
Payment for MDPP Services
(a) Payment for MDPP Services on an
Assignment-Related Basis
We are proposing that performance
payments and bridge payments to MDPP
suppliers for MDPP services would be
made only on an assignment-related
basis in accordance with § 424.55. As
described in Chapter 1, Section 30.3 of
the Medicare Claims Processing
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Manual,24 CMS identifies a number of
supplier and practitioner types who
furnish services under the Medicare
program and who are required to accept
assignment for all Medicare claims for
their services. This means that they
must accept the Medicare allowed
amount as payment in full for their
services, regardless of whether the
supplier is a participating or nonparticipating provider in the Medicare
program. In these circumstances, the
beneficiary’s liability is limited to any
applicable deductible plus the 20
percent coinsurance if coinsurance
applies to the service. CMS currently
mandates assignment for claims from
multiple types of suppliers and
practitioners, including clinical
diagnostic laboratory services and
physician lab services; physician
services to individuals dually entitled to
Medicare and Medicaid; and services of
physician assistants, nurse practitioners,
clinical nurse specialists, nurse
midwives, certified registered nurse
anesthetists, clinical psychologists,
clinical social workers, registered
dietitians/nutritionists, anesthesiologist
assistants, and mass immunization
roster billers. The beneficiary (or the
person authorized to request payment
on the beneficiary’s behalf) is not
required to assign the claim to the
supplier in order for an assignment to be
effective, and when these claims are
inadvertently submitted as unassigned,
Medicare Administrative Contractors
(MACs) process them as assigned.
Consistent with our established
requirements for these other types of
suppliers, some of whom are similar to
MDPP suppliers in that they furnish a
limited breadth of Medicare-covered
services, we believe it would be
appropriate to require all MDPP
suppliers, whether they are
participating or not participating in
Medicare, to accept assignment. We also
believe that making performance
payments for MDPP services solely on
an assignment-related basis is the most
appropriate methodology, given the
performance-based MDPP payment
methodology which is based on the
achievement of weight loss and/or
attendance performance goals and not
based on the MDPP supplier resource
expended to furnish individual MDPP
services. We further note that as
finalized in the CY 2017 PFS final rule
(81 FR 80464), MDPP services are
additional preventive services under
section 1861(ddd) of the Act and,
therefore, consistent with section
24 Available at https://www.cms.gov/Regulationsand-Guidance/Guidance/Manuals/Downloads/
clm104c01.pdf.
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1833(a)(1)(W) of the Act, are not subject
to the Medicare Part B coinsurance or
deductible. Under our proposal
Medicare would pay 100 percent of the
Medicare allowed charge for MDPP
services furnished to MDPP
beneficiaries, and a beneficiary would
have no liability for covered MDPP
services. MDPP suppliers would be
required to accept the Medicare allowed
charge as payment in full and would not
be able to bill or collect from the
beneficiary any amount.
Finally, to minimize the potential
administrative burden on beneficiaries
related to payment for MDPP services
on an assignment-related basis, we are
proposing that for purposes of claims for
services submitted by an MDDP
supplier, Medicare would deem such
claims to have been assigned by the
beneficiary (or the person authorized to
request payment on the beneficiary’s
behalf) and the assignment accepted by
the MDDP supplier. This proposed
treatment of claims from MDPP
suppliers in new § 424.55(d) is
consistent with the current exception in
§ 424.55(c) regarding payment to a
supplier which specifies that when
payment under the Act can only be
made on an assignment-related basis or
when payment is for services furnished
by a participating physician or supplier,
the beneficiary (or the person
authorized to request payment on the
beneficiary’s behalf) is not required to
assign the claim to the supplier in order
for an assignment to be effective.
The proposed assignment-related
basis for performance payments and
bridge payments MDPP suppliers is
included at proposed § 414.84(b) and
(c). The proposal to not require the
beneficiary to assign the claim for MDPP
services to the MDPP supplier in order
for assignment to be effective is
included at proposed § 424.55(d). We
are inviting comments on these
proposals.
(b) Requirements for Payment of Bridge
Payments and Performance Payments
MDPP suppliers may only submit
claims for a performance payment or
bridge payment for MDPP services when
all of the proposed requirements for the
payment are met. Claims for services
that do not meet these requirements will
not be paid. In accordance with
§ 424.80, MDPP suppliers are reminded
that there are exceptions to the
prohibition of reassignment of claims by
suppliers for certain arrangements
provided the applicable requirements
are met. Of specific note, Medicare may
pay an agent who furnishes billing and
collection services to the supplier if the
conditions of § 424.80(b)(5) are met.
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Proposed requirements for
performance payments and the bridge
payment include that the MDPP services
were furnished to a beneficiary eligible
for MDPP services as specified at
§ 410.79(c) and that the MDPP supplier
complies with all applicable enrollment
and program requirements. In addition,
the MDPP services must be furnished by
an eligible coach on or after his or her
coach eligibility start date and, if
applicable, before his or her coach
eligibility end date, and the MDPP
supplier must submit the National
Provider Identifier (NPI) of the coach on
MDPP claims. We describe additional
details on how eligible coach
information would be processed in
section III.K.2.d.iii.(10)(d) of this
proposed rule. All specific additional
proposed requirements for the
performance payment or bridge
payment, as discussed in sections
III.K.2.d.iii.(3) through (6) and
III.K.2.d.v. of this proposed rule, must
also be met.
In order to submit a claim for a
performance payment under the MDPP
expanded model, the billing supplier
must have documentation in the
beneficiary’s MDPP record, as specified
in proposed § 424.205(g), that all
requirements for the payment, including
the achievement of the performance
goal(s) applicable to the performance
payment, have been met. We note that
the billing supplier’s MDPP record for
the beneficiary may include a copy of
the beneficiary’s MDPP record from a
previous MDPP supplier that has been
provided to the billing supplier at the
request of the MDPP beneficiary. For
purposes of an MDPP supplier
submitting a claim for an interval
performance payment based on
attendance at more than one session,
this copy of the MDPP record from the
previously MDPP supplier may be used
as part of the billing supplier’s
documentation demonstrating that the
attendance and weight loss, if
applicable, performance goal(s) for the
performance payment were achieved.
We note that as we finalized at
§ 424.59(b) in the CY 2017 PFS final
rule (proposed to be redesignated and
amended at § 424.205(g)), MDPP
suppliers are required to maintain and
handle any personally identifiable
information (PII) and protected health
information (PHI) in compliance with
HIPAA, other applicable state and
federal privacy laws, and CMS
standards. Therefore, MDPP suppliers
must follow these rules when providing
any copies of information from a
beneficiary’s MDPP records to another
MDPP supplier.
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We are proposing that any weight loss
measurement taken and recorded by an
MDPP supplier for the purposes of
performance payments must be taken in
person during an MDPP core session,
core maintenance session, or ongoing
maintenance session by the MDPP
supplier during the MDPP services
period. We believe that in-person
measurements are the most feasible
method for weight ascertainment at this
time for services because the beneficiary
would attend regular in-person sessions
with the MDPP supplier. Moreover, we
believe that self-reported weight loss is
not reliable for the purposes of
performance payment in the MDPP
expanded model. This proposal also
would apply to our proposed policy
regarding virtual make-up sessions,
described in detail in section
III.K.2.c.iv.(3) of this proposed rule,
meaning that weight loss could not be
measured or reported during a virtual
make-up session for the purpose of the
MDPP supplier submitting a claim for a
performance payment. We also are
proposing to require that weight loss be
measured in person at an MDPP session
to align with CDC’s DPRP standards,
which require for in-person sessions
that weight be measured in person at the
session.
In addition, we note that the
achievement or maintenance of the
required minimum weight loss that
determines the performance payment
amount for a core maintenance session
interval and the maintenance of the
required minimum weight loss that
determines whether a performance
payment for an ongoing maintenance
session interval is made must be
determined by an in-person weight
measurement at a session furnished
during the applicable interval. Thus, for
these interval performance payments,
achievement of the performance goal for
minimum weight loss does not need to
be determined based on attendance at a
session furnished by the MDPP supplier
billing for that performance payment.
However, as discussed previously, if
achievement of the performance goal for
minimum weight loss was measured at
a session furnished by a previous MDPP
supplier in the interval, the subsequent
supplier must have documentation
through a copy of the beneficiary’s
MDPP record from that previous
supplier that the weight loss
performance goal was met in the
interval to bill for the interval
performance payment. Finally, the
performance payments for the required
minimum and 9 percent weight loss
would only be billed by the MDPP
supplier furnishing the session at which
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the weight loss performance goal is met
during an in-person session.
Furthermore, we are proposing that
the beneficiary must achieve the
applicable attendance performance goal
for core session, core maintenance
session interval, or ongoing
maintenance session interval
performance payments upon attendance
at a session furnished by the MDPP
supplier billing for that specific
performance payment. An MDPP
supplier can only bill for a performance
payment on the date the beneficiary has
achieved all performance goals
associated with that performance
payment. We note that in order to bill
for an interval performance payment
that is based on attendance, the MDPP
supplier that furnished the session
where the attendance goal is met would
bill for the performance payment, even
if that supplier did not itself furnish all
sessions attended by the MDPP
beneficiary during that interval. In these
circumstances, as discussed previously,
if attendance at a session furnished by
a previous MDPP supplier occurred in
the interval, the subsequent supplier
must have documentation through a
copy of the beneficiary’s MDPP record
from that previous supplier of the
session attendance in order to bill for
the interval performance payment based
on attendance at that session. An MDPP
supplier may not bill for an interval
performance payment when the MDPP
supplier does not furnish the session
where the attendance goal is met.
For all interval performance
payments, we are proposing that the
performance payment would be based
on the date the MDPP supplier
furnished the session where the interval
attendance performance goal is met.
Thus, for those intervals where the
performance payment is based on MDPP
beneficiary session attendance that
spans two calendar years, the interval
performance payment would be the
amount applicable to the later calendar
year, reflecting the annual update from
the prior year as discussed in section
III.K.2.d.iii.(9) of this proposed rule. The
proposed conditions for payment by
CMS of performance payments and
bridge payments to MDPP suppliers are
included at proposed § 414.84(b) and
(c), as well as at the other provisions in
these sections. We are inviting public
comments on these proposals.
(c) Reporting HCPCS G-Codes on Claims
for MDPP Services
We are proposing to establish 19
unique Healthcare Common Procedure
Coding System (HCPCS) G-codes so that
MDPP suppliers may submit claims for
payment when all the requirements for
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billing the codes have been met. Our
proposal for the HCPCS G-codes is
displayed in Table 33.
We note that each MDPP supplier
would be able to bill one of the 18
payable HCPCS G-codes on the date
when all the requirements for billing the
code have been met, including the
session attendance for specific core and
ongoing maintenance session intervals
and achievement and/or maintenance of
weight loss, as applicable to the specific
HCPCS G-code. One of the proposed
HCPCS G-codes would be nonpayable
and assigned a payment amount of $0
because it would only be reported on a
claim that also includes a payable
HCPCS G-code for MDPP services as
described subsequently in this section.
HCPCS G-codes GXXX1 through
GXXX3 and GXXX8 through GXX17
may each be paid only once in a
beneficiary’s lifetime, and the Medicare
claims processing system would ensure
that no more than one of each specific
performance payment per beneficiary
reported with these HCPCS G-codes is
made. In addition, because only one
performance payment may be made for
each core maintenance session interval
per beneficiary, the claims processing
system would also ensure that no more
than one unit of HCPCS code GXXX4 or
GXXX6 and no more than one unit of
HCPCS code GXXX5 or GXXX7 was
paid in a beneficiary’s lifetime.
Due to these lifetime limitations on
payment for certain HCPCS codes for
each beneficiary, in the circumstances
where two MDPP suppliers furnished
sessions during the MDPP services
period and both MDPP suppliers met all
requirements for billing the same
HCPCS G-code, based on our
operational processes, we would pay the
first valid claim received and deny the
second claim. The first valid claim
received for a beneficiary for a given
HCPCS G-code with a lifetime limitation
would be determined through the CMS’
Common Working File (CWF), which
processes claims for all MACs.
Based on information from the CDC’s
national DPP, we expect that
circumstances where a beneficiary
changes MDPP suppliers during the
MDPP services period will be
uncommon. In addition, in view of the
typical structure of DPPs where core
sessions are offered weekly for the first
6 months of the core services period,
and then offered monthly, we believe it
would be rare for more than one MDPP
supplier to meet the requirements for
billing for the same once-per-lifetime
performance payment. However, as an
example an MDPP beneficiary could
maintain the required minimum weight
loss throughout the first core
maintenance session interval and attend
3 sessions furnished by one MDPP
supplier in the first 11⁄2 months of the
first core maintenance interval, and then
change to another supplier and attend 3
more core maintenance sessions
furnished by a subsequent MDPP
supplier before the end of that interval.
While both MDPP suppliers would meet
the requirements for billing HCPCS code
GXXX6, we would only pay the first
claim for the HCPCS G-code that was
submitted. The second claim for HCPCS
code GXXX6 received by us would be
denied. We expect that our operational
processes will result in MDPP suppliers
submitting claims for HCPCS G-codes as
soon as the sessions are furnished that
meet all of the requirements for billing
for the particular performance payment,
and that this practice will generally
result in the performance payment being
made to the MDPP supplier that
furnished the first session where the
performance goals were met.
Finally, as discussed in section
III.K.2.d.v. of this proposed rule, we are
not proposing to limit the number of
bridge payments, which would be
reported with HCPCS code GXX18, that
may be paid for an MDPP beneficiary
who changes MDPP suppliers during
the MDPP services period.
TABLE 33—PROPOSED HCPCS G-CODES FOR MDPP SERVICES
Proposed
HCPCS
G-code for
MDPP
services *
Proposed payment amount
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GXXX1 .........
GXXX2 .........
GXXX3 .........
GXXX4 .........
GXXX5 .........
GXXX6 .........
GXXX7 .........
GXXX8 .........
GXXX9 .........
GXX10 ..........
GXX11 ..........
GXX12 ..........
GXX13 ..........
GXX14 ..........
GXX15 ..........
GXX16 ..........
GXX17 ..........
GXX18 ..........
$25
30
50
10
10
60
60
160
25
50
50
50
50
50
50
50
50
25
GXX19 ..........
0
Description of MDPP service
1st core session attended.
4 total core sessions attended.
9 total core sessions attended.
3 core maintenance sessions attended in months 7–9 (weight- loss goal not achieved or maintained).
3 core maintenance sessions attended in months 10–12 (weight loss goal not achieved or maintained).
3 core maintenance sessions attended in months 7–9 and weight loss goal achieved or maintained.
3 core maintenance sessions attended in months 10–12 and weight loss goal achieved or maintained.
5 percent weight loss from baseline achieved.
9 percent weight loss from baseline achieved.
3 ongoing maintenance sessions attended in months 13–15 and weight loss goal maintained.
3 ongoing maintenance sessions attended in months 16–18 and weight loss goal maintained.
3 ongoing maintenance sessions attended in months 19–21 and weight loss goal maintained.
3 ongoing maintenance sessions attended in months 22–24 and weight loss goal maintained.
3 ongoing maintenance sessions attended in months 25–27 and weight loss goal maintained.
3 ongoing maintenance sessions attended in months 28–30 and weight loss goal maintained.
3 ongoing maintenance sessions attended in months 31–33 and weight loss goal maintained.
3 ongoing maintenance sessions attended in months 34–36 and weight loss goal maintained.
Bridge payment—first session furnished by MDPP supplier to an MDPP beneficiary who has previously received MDPP services from a different MDPP supplier.
MDPP session reported as a line-item on a claim for a payable MDPP services HCPCS G-code for a session
furnished by the billing supplier that counts toward achievement of the attendance performance goal for the
payable MDPP services HCPCS G-code.
* Illustrative HCPCS G-code numbers are placeholders to allow for comment on this proposed rule. Final HCPCS codes for MDPP services
under the MDPP expanded model will be included in the CY 2018 PFS final rule.
We also plan to issue specific billing
instructions to MDPP suppliers for those
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14 proposed HCPCS G-codes (excluding
GXXX1, GXXX8, GXXX9, GXX18, and
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GXX19) that represent an interval
performance payment where attendance
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at more than 1 session is required for
the performance payment to be made.
Suppliers would report the applicable
HCPCS G-code as a line-item on the
claim on the date the session was
furnished where the interval attendance
goal was met. On the same claim,
suppliers would also report 1 line-item
of HCPCS code GXXX19 for each other
session furnished by the supplier during
the interval that was not previously
reported on a claim but that counts
toward achievement of the attendance
performance goal for the applicable
HCPCS G-code.
For example, while beneficiary
attendance at the 2nd and 3rd of the 4
core sessions would not result in a
separate performance payment, we
would instruct MDPP suppliers that the
2nd and 3rd core sessions furnished by
the supplier submitting the claim for
HCPCS code GXXX2 (4 total core
sessions attended) be reported as 2
separate line-items of HCPCS code
GXX19 on the claim for the performance
payment for 4 core sessions attended.
The 4th core session furnished by the
billing supplier where the interval
attendance goal was met would be
represented on the claim line reporting
HCPCS code GXXX2. Each of these lineitems (one line-item of GXXX2 and 2
line-items of GXX19) would include the
date of service and the NPI of the coach
associated with that MDPP supplier
who furnished the specific session
reported as the line-item.
When billing for a HCPCS G-code that
represents a cumulative number of
MDPP sessions where some sessions
already have been reported on a
previous claim, only the sessions not
previously reported on a claim would be
reported by the MDPP supplier. For
example, HCPCS code GXXX3 (9 total
core sessions attended) would be used
to bill for 9 core sessions attended, and
the line-item of HCPCS code GXXX3
would represent the 9th core session
furnished. Separate line-items of HCPCS
code GXX19 would be reported on the
same claim only for the 5th through 8th
core sessions furnished by the MDPP
supplier. Claims for HCPCS codes
GXXX1 (1st core session attended) and
GXXX2 (4 core sessions attended)
would already have been submitted, and
those claims would have included lineitems for the 1st core session, and for
the 2nd, 3rd, and 4th core sessions.
We believe that instructing MDPP
suppliers to report a line-item for each
session on a single claim submitted for
an interval performance payment would
simplify the tracking and administrative
activities of MDPP suppliers and the
reporting of the coach NPI on claims for
MDPP services furnished to
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beneficiaries as discussed in section
III.K.2.d.iii.(10)(d) of this proposed rule.
We further believe that there should be
no significant administrative burden for
MDPP suppliers to include information
on all sessions they furnished on
interval performance payment claims
for two reasons. First, the
documentation requirements for MDPP
sessions at § 424.205(g), including the
beneficiary’s eligibility, specific session
topics attended, the NPI of the coach
who furnished the session attended, the
date and place of service of sessions
attended, and weight, would require the
MDPP supplier to document and retain
this information.
Therefore, MDPP suppliers would
have documentation of the date of each
session and the NPI of the furnishing
coach for reporting on each line-item on
the claim for the interval performance
payment. Second, MDPP suppliers
would be instructed not to submit
separate claims for each session
represented in an interval performance
payment. All sessions would be
reported on the single claim that would
be submitted for the interval
performance payment.
In the case of an MDPP supplier
submitting a claim for an interval
performance payment where the billing
supplier did not furnish all the sessions
attributable to the interval because
another supplier had furnished some of
the first sessions in the interval, the
billing supplier would report on the
claim only the sessions it furnished.
However, the supplier would need to
maintain MDPP records documenting
that all requirements, including session
attendance and achievement or
maintenance of weight loss, if
applicable, for billing the HCPCS Gcode for the interval for the beneficiary
were met. Any sessions covered by the
interval performance payment HCPCS
G-code but not furnished by the
supplier submitting the claim for that
interval would not be reported as
separate line-items on the claim.
However, the billing supplier would
need to maintain in the beneficiary’s
MDPP record a copy of his or her MDPP
record from the previous supplier in
order to consider sessions furnished by
the previous supplier in determining
that the performance goal(s) for the
interval performance payment were met.
Although the NPIs of the coaches who
furnished such sessions that would not
be reported as separate line-items would
also not be recorded on the claim, the
billing supplier would still be required
to maintain documentation in the
beneficiary’s MDPP record of the NPI of
each coach who furnished each session
through a copy of the beneficiary’s
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MDPP record about those sessions from
the previous supplier. Therefore, upon
medical review, CMS and its contractors
would be able to review and assess the
remaining coaches who furnished
sessions to Medicare beneficiaries
associated with a claim submitted for a
given interval performance payment
HCPCS G-code, but who do not have an
NPI reported on the claim. Because we
expect it to be uncommon for suppliers
not to furnish all sessions attributable to
an interval and due to the
administrative burden that could result
from a requirement that an MDPP
supplier report specific information on
sessions on a claim that the particular
supplier did not itself furnish, we
believe the program integrity risk
associated with the limitation in the
completeness of information from
administrative claims data under this
scenario is low. However, we will
monitor the completeness of reporting
line-items on claims for interval
performance payments and may
consider revising our billing
instructions in the future if we
determine that we lack information from
administrative claims on a significant
number of sessions furnished to MDPP
beneficiaries.
We are inviting public comments on
the proposal to create 19 HCPCS Gcodes for billing for the performance
payments and bridge payment and
reporting additional session line-items
on claims for MDPP services. We also
are inviting public comment on matters
related to billing instructions for MDPP
suppliers that we plan to issue so that
information on the date and furnishing
coach NPI for all sessions furnished by
the billing supplier would be submitted
on claims. However, we note that we
intend to provide additional claims
submission instructions in guidance.
(d) Reporting the Coach National
Provider Identifier (NPI) on Claims
In the CY 2017 PFS final rule, we
established the policy that coaches will
not enroll in Medicare for purposes of
furnishing MDPP services, but that they
will be required to obtain NPIs. Further
details on these policies are described in
section III.K.2.e.iii. of this proposed
rule.
According to Chapter 26, Section 10.4
of the Medicare Claims Processing
Manual,25 the NPI of the rendering
provider is to be reported as Item 24J on
the line-item for each service reported
on the CMS–1500 claim form. Our
proposal in section III.K.2.d.iii.(10)(c) of
25 Available at https://www.cms.gov/Regulationsand-Guidance/Guidance/Manuals/downloads/
clm104c26.pdf.
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this proposed rule would require that,
in the circumstances of a claim for an
interval performance payment for MDPP
services, each session furnished by the
billing supplier be reported as a separate
line-item on the claim. In addition, we
are proposing to require MDPP
suppliers to report the NPI of the coach
who furnished the session as Item 24J
on the line-item for each session
reported on claims for performance
payments for MDPP services. Under our
proposal, the coach who furnished the
session would be the rendering provider
for purposes of reporting on the CMS–
1500 claim form.
While only MDPP suppliers, not
coaches, would be subject to potential
Medicare administrative actions related
to payments the suppliers may receive,
we believe that our proposal to require
the NPI of the coach who furnished the
session to be reported as the rendering
provider for each line-item HCPCS Gcode on a claim for MDPP services
would provide us with a number of
program integrity protections, including
the ability to monitor MDPP coach
activity to identify suspected fraud or
other improper payments and to
determine the need for medical review
or investigation as appropriate. We
would only process claims for payment
of MDPP services when all of the coach
NPIs reported on the claim are
associated with eligible coaches who
have been submitted on the coach roster
in the MDPP supplier’s enrollment
application, and when all of the coaches
have successfully completed Medicare’s
screening processes. We would also
only process claims for payment of
MDPP services furnished by a coach on
or after his or her coach eligibility start
date, and, if applicable, prior to his or
her coach eligibility end date, as the
definitions of these terms are included
in proposed § 424.205(a).
Without such program integrity
protections, we would lack a sufficient
method to verify that payment is being
made for services furnished by a coach
who has met the requirements outlined
in section III.K.2.e.iii. of this proposed
rule. This verification will help protect
both Medicare beneficiaries and the
Medicare Trust Funds. Including coach
NPIs on claims may also encourage
accuracy in reporting on the
achievement of beneficiary attendance
and/or weight loss performance goals
because both CMS and MDPP suppliers
would be able to identify on the claim
in question which coaches furnished the
sessions attributable to the performance
payment. In addition, because the
accuracy of information reported on the
claim is ultimately the MDPP supplier’s
responsibility, and the MDPP supplier
attests to the accuracy of each claim
submitted, including the relevant coach
NPIs on the claim may assist the MDPP
supplier when conducting internal
monitoring of claim accuracy.
These proposed requirements for
reporting the coach NPI as the rendering
provider on session line-items included
on claims for performance payments
and bridge payments to MDPP suppliers
are included at proposed § 414.84(b)
and (c). We are inviting public
comments on these proposals.
iv. Comparison of Supplier
Requirements for Furnishing the Set of
MDPP Services and Supplier Payment
As in the DPP model test under
section 1115A(b) of the Act, MDPP
services are based on a CDC-approved
DPP curriculum and, therefore, MDPP
suppliers must offer sessions in
accordance with that curriculum. We
are proposing to apply a performancebased payment methodology to MDPP
services, which ties most payments to
outcomes—in this case, weight loss and
session attendance—to help incentivize
suppliers to be engaged in their
beneficiaries’ weight loss efforts. Given
this proposed methodology, we
recognize that there would be an
inherent amount of supplier financial
risk, and that coverage of sessions and
supplier requirements and payment
would not always align. This section
aims to clarify how we are proposing
that these elements would fit together in
the MDPP expanded model, as
displayed in Table 34.
TABLE 34—SET OF MDPP SERVICES AND PAYMENT
MDPP beneficiary eligibility for coverage
MDPP supplier must
offer
MDPP supplier payment
Core sessions (months
1 to 6 of the MDPP
services period).
An eligible beneficiary has Medicare coverage of core sessions in the first 6 months
of the MDPP core services period, regardless of attendance or weight loss.
* Note: To start the MDPP services period,
the beneficiary attends his or her first core
session, which begins the beneficiary’s
MDPP services period timeline of a maximum of 36 months.
At least 16 core sessions, furnished no
more frequently than
once per week, over
the first 6 months of
the beneficiary’s
MDPP services period.
Core maintenance sessions (months 7 to
12 of the MDPP
services period).
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MDPP services
Beneficiary has coverage of core maintenance sessions in months 7 to 12 of the
MDPP services period, regardless of attendance or weight loss.
At least 1 core maintenance session per
month in months 7
to 12 of the MDPP
services period.
• $25 performance payment for beneficiary
attendance at the first core session.
• $30 interval performance payment after the
beneficiary has attended a total of 4 core
sessions.
• $50 interval performance payment after the
beneficiary has attended a total of 9 core
sessions.
* Note: All payments for core sessions are
independent of beneficiary weight loss.
• $10 payment if a beneficiary attends 3 sessions within a 3-month core maintenance
session interval but does not achieve or
maintain the required minimum weight loss
at least once within that 3-month core
maintenance session interval; or
• $60 if a beneficiary attends 3 sessions and
achieves or maintains the required minimum weight loss at least once within that
3-month core maintenance session interval.
* Note: There are two consecutive core maintenance session intervals.
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34153
TABLE 34—SET OF MDPP SERVICES AND PAYMENT—Continued
MDPP beneficiary eligibility for coverage
MDPP supplier must
offer
MDPP supplier payment
Ongoing maintenance
sessions (months 13
to 36 of the MDPP
services period).
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MDPP services
Beneficiary has coverage of ongoing maintenance sessions in the first ongoing maintenance session interval (months 13 to 15 of
the MDPP services period) if:
• He or she attended at least 1 session
during the final core maintenance session interval (months 9 to 12 of the
MDPP services period) and had weight
measured.
• He or she achieved or maintained the
required minimum weight loss at least
once during the final core maintenance
session interval (months 10 to 12 of
the MDPP services period).
A beneficiary has coverage of a subsequent
ongoing maintenance session interval (for
up to 21 months after the end of the first
ongoing maintenance session interval), if
he or she attended at least 3 sessions and
maintained the required minimum weight
loss from baseline at least once during the
previous ongoing maintenance session interval.
At least 1 ongoing
maintenance session per month for
up to 24 months, if
the beneficiary
maintains eligibility
to have coverage of
ongoing maintenance sessions.
• $50 payment if a beneficiary attends 3 sessions and maintains the required minimum
weight loss from baseline at least once
within a 3-month ongoing maintenance
session interval.
* Note: There are up to eight consecutive ongoing maintenance session intervals.
achievement or maintenance of the
required minimum weight loss.
All of the proposed performance
payments except for the weight loss
performance payments require the
achievement of an attendance
performance goal, and if a beneficiary
does not achieve attendance
performance goals, an MDPP supplier
would not be paid a performance
payment that relies on achieving those
goals. For example, if a beneficiary does
not attend 3 sessions in the first core
maintenance session interval, a supplier
would not be paid a performance
payment for the interval that spans
months 7 to 9 of the MDPP core services
period. However, a supplier must offer
at least 1 core maintenance session per
month to the beneficiary to ensure that
the beneficiary has the opportunity to
attend. Furthermore, while the proposed
weight loss performance payments are
based solely on the achievement of the
required minimum or 9 percent weight
loss, we note that all weight loss
measurements must be obtained in
person at a session so that if a
beneficiary does not attend a session
where weight loss can be measured and
compared to baseline, the MDPP
supplier would not be paid a
performance payment that relies on
achieving a weight loss performance
goal.
time. However, we deferred specific
policies regarding attribution of
beneficiaries who change MDPP
suppliers as related to payment to future
rulemaking. We are making proposals
for payment policies when a beneficiary
changes MDPP suppliers during the
MDPP services period in this section.
At proposed § 414.84(a)(1), we are
proposing to define ‘‘bridge payment’’
as a one-time payment to an MDPP
supplier for furnishing its first MDPP
services session to an MDPP beneficiary
who has previously received one or
more MDPP services from a different
MDPP supplier. We use this definition
in the proposed MDPP payment policies
for the circumstances when a
beneficiary changes MDPP suppliers for
any reason during the MDPP services
period after the beneficiary has attended
at least the first core session.
In cases where the beneficiary
changes MDPP suppliers, there is a shift
in accountability for offering the set of
MDPP services for which the beneficiary
is eligible for coverage from one MDPP
supplier to a subsequent MDPP
supplier. Similar to our proposal for a
performance payment to an MDPP
supplier that furnishes the first core
session to an MDPP beneficiary who
initiates the MDPP services period as
discussed in section III.K.2.d.iii.(3) of
this proposed rule, we are proposing
that an MDPP supplier would be paid a
bridge payment of $25 for furnishing its
first session to an MDPP beneficiary
who has previously received MDPP
services from a different MDPP supplier,
regardless of whether the MDPP
Once an MDPP supplier enrolls in
Medicare to furnish MDPP services, it
must offer the set of MDPP services in
accordance with the MDPP supplier
standards (noted in section
III.K.2.e.iv.(4) of this proposed rule and
at § 424.205(d), including that it must
offer at least 16 core sessions, furnished
no more frequently than once per week,
over the first 6 months of the MDPP core
services period; at least 1 core
maintenance session per month over
months 7 to 12 of the MDPP core
services period; and at least 1 ongoing
maintenance session per month for up
to 24 additional months (months 13
through 36 of the MDPP services
period), if the beneficiary maintains
eligibility for coverage of ongoing
maintenance sessions. We recognize
that beneficiaries might not attend these
sessions. However, they must be made
available, in accordance with CDC’s
DPRP standards, to beneficiaries as long
as they are eligible for coverage of
MDPP sessions. We further note that the
set of MDPP services must be furnished
in compliance with all applicable
federal laws and regulations.
Although a beneficiary is not required
to use MDPP services at all, the MDPP
services period is initiated by the
beneficiary attending his or her first
core session, which begins the MDPP
services period timeline. To qualify for
coverage of ongoing maintenance
sessions, a beneficiary would also need
to attend at least 1 session during the
final core maintenance session interval
where in-person weight measurement is
performed that demonstrates the
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v. Payment Policies When a Beneficiary
Changes MDPP Suppliers
In the CY 2017 PFS final rule (81 FR
80470), we confirmed that a beneficiary
may change MDPP suppliers at any
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supplier is paid any performance
payments for that beneficiary. A
subsequent MDPP supplier would be
paid this bridge payment after
furnishing the first session to a
beneficiary and billing the appropriate
HCPCS G-code only if the supplier did
not furnish the first core session to the
MDPP beneficiary.
We believe that making a bridge
payment that is the same amount as the
proposed performance payment for the
first core session discussed in section
III.K.2.d.iii.(3) of this proposed rule is
appropriate because we expect the
MDPP supplier’s resources used to be
similar under both of these
circumstances. The subsequent supplier
would expend resources for furnishing
a first session to a beneficiary, including
collecting administrative information on
the beneficiary who is not already
known to the supplier, regardless of
whether the beneficiary goes on to
receive further MDPP sessions from that
supplier.
We are proposing that the bridge
payment would be paid to the
subsequent MDPP supplier any time a
beneficiary changes suppliers during the
MDPP services period, regardless of
when during the core services period or
ongoing services period the beneficiary
changes MDPP suppliers. The bridge
payment is not intended to be a
performance payment, which could be
paid to the subsequent MDPP supplier
in addition to the bridge payment if a
beneficiary achieves a performance goal
while receiving MDPP services from
that the subsequent supplier. Rather, the
bridge payment accounts for the
financial risk a subsequent MDPP
supplier takes on by furnishing services
to a beneficiary changing MDPP
suppliers during the MDPP services
period.
We believe that when suppliers
furnish MDPP services to MDPP
beneficiaries in these circumstances,
they generally do not have the same
opportunity for performance payments
that they would have if the beneficiary
had been receiving MDPP services from
the supplier from the beginning of the
MDPP services period because certain
performance goals, such as the required
minimum weight loss, might already
have been achieved by the beneficiary.
The proposed bridge payment policy
would play an important role in
ensuring access to MDPP services and
freedom of choice of MDPP suppliers for
those beneficiaries who either choose to
or must change suppliers during the
MDPP services period.
If we were to only make performance
payments for MDPP services as
proposed in sections III.K.2.d.iii.(3)
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through (6) of this proposed rule and
not make a bridge payment to a
subsequent supplier when an MDPP
beneficiary changes suppliers during the
MDPP services period, access problems
could result due to the number of
scenarios where subsequent MDPP
suppliers offering and furnishing MDPP
services would be paid no performance
payment for the sessions furnished. The
following examples illustrate such
scenarios.
• A beneficiary changes from MDPP
supplier A to MDPP supplier B after
attending core session 4; attends core
sessions 5 to 8 with supplier B; and then
decides not to attend any more MDPP
sessions. Supplier B does not meet the
requirements for billing for the
performance payment for the 9th core
session because only 8 core sessions
were attended, despite supplier B
offering and furnishing core sessions 5
to 8.
• A beneficiary who has not met the
required minimum weight loss
performance goal changes from MDPP
supplier A to MDPP supplier B after
completing the first 3-month core
maintenance session interval; attends 2
core maintenance sessions in months 9–
12 with supplier B; and then fails to
attend the 3rd core maintenance session
in this interval. Supplier B does not
meet the requirements for billing for the
performance payment for the second
core maintenance session interval
despite offering and furnishing core
maintenance sessions and the
beneficiary eligibility for coverage of
MDPP services then ends after month
12, the end of the core services period.
We believe that circumstances like
these examples where subsequent
MDPP suppliers would receive no
payment for sessions furnished to MDPP
beneficiaries who change suppliers
during the MDPP services period in the
absence of the bridge payment policy
could lead to those MDPP suppliers
preferentially seeking to furnish the
remaining MDPP services during the
MDPP services period to beneficiaries
who have either already achieved the
required minimum weight loss, or
whom they believe will attend sessions
and achieve weight loss, because the
required minimum weight loss is tied to
eligibility for ongoing maintenance
sessions and higher performance
payment for core maintenance session
intervals.
We note that we are proposing in
section III.K.2.e.iv.(4) of this proposed
rule that MDPP suppliers may not deny
access to MDPP services to eligible
beneficiaries based on any reason other
than the supplier’s own capacity limits
to furnish MDPP services to additional
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beneficiaries and on a discretionary
basis if a beneficiary significantly
disrupts the session for other
participants or becomes abusive.
However, MDPP suppliers could
comply with this access requirement,
while still preferentially seeking to
furnish the remaining MDPP services in
the MDPP services period to MDPP
beneficiaries they believe are most
likely to achieve the performance goals.
To ensure beneficiary freedom of choice
of MDPP supplier, including the choice
to change suppliers, we believe the
proposal to make a bridge payment
helps mitigate the likelihood of MDPP
suppliers acting on such preferences.
The subsequent supplier would be paid
a bridge payment for a beneficiary who
changes suppliers, even if the
beneficiary does not achieve
performance goals that result in a
performance payment being made to the
subsequent supplier.
We considered an alternative policy
in which the bridge payment would
only be made in circumstances where
the subsequent supplier would not be
paid a performance payment that is
based on attendance at the first session
furnished by that supplier. For example,
under this alternative if a beneficiary
attends the 1st session during the
ongoing maintenance session interval
for months 13 through 15 at one MDPP
supplier and then changes to a
subsequent MDPP supplier that
furnishes two additional ongoing
maintenance sessions within that same
interval and the beneficiary maintains
the required minimum weight loss, the
subsequent supplier would not be paid
the $25 bridge payment but would be
paid the ongoing maintenance session
interval performance payment for
months 13 through 15. The subsequent
supplier would only be paid the $25
bridge payment if the beneficiary did
not maintain the required minimum
weight loss for the performance
payment for that ongoing maintenance
session interval. We are not proposing
this alternative because we believe it is
appropriate to make a bridge payment
for the first session furnished by the
subsequent supplier that expends
resources for furnishing a session to a
beneficiary not previously known to
that supplier, unrelated to whether or
not the beneficiary achieves a
performance goal that results in a
performance payment being paid to the
subsequent supplier.
We are proposing that an MDPP
supplier can be paid either one
performance payment for furnishing the
first core session or one bridge payment
per beneficiary, but not both. We are
proposing this policy because we
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believe that the potential to be paid both
a performance payment for the first core
session and a bridge payment, or
multiple bridge payments, for the same
beneficiary, could increase the risk of
MDPP suppliers encouraging
discontinuous care patterns. Such
patterns could hinder the achievement
of the required minimum weight loss
that leads to a reduction in the
incidence of type 2 diabetes and could
lead to increased Medicare expenditures
for MDPP services. Financial incentives
resulting from the potential for multiple
bridge payments to a single supplier for
one beneficiary could lead MDPP
suppliers to encourage beneficiaries to
repeatedly change among them between
sessions during the MDPP services
period so that the suppliers may
repeatedly bill for bridge payments. We
believe that limiting the bridge payment
to one per beneficiary per supplier and
making it available for payment only if
the performance payment for the first
core session was not paid to that same
supplier helps mitigate this risk.
However, we are not proposing to limit
the number of MDPP suppliers that may
be paid a bridge payment for a
particular beneficiary because we are
not proposing to limit beneficiary
freedom of choice for MDPP suppliers.
We are proposing only to limit the
bridge payments that a particular MDPP
supplier may be paid for each MDPP
beneficiary to one.
While this proposed limit is intended
to provide some protection against
MDPP suppliers encouraging certain
care patterns for the purposes of their
financial gain alone, we understand
there may be organizations enrolled in
Medicare as the same supplier type but
under separate MDPP supplier
enrollment records that are part of a
larger franchise or umbrella
organization with shared financial
interests. There is some program
integrity risk that these organizations
could coordinate to bill multiple bridge
payments that would ultimately
increase total MDPP payments to
separately enrolled MDPP suppliers to
serve the financial interests of the
umbrella organization. This scenario
could occur if MDPP suppliers
systematically encourage beneficiaries
to change suppliers for the purpose of
being paid the bridge payment.
Although we believe that
organizations under a larger umbrella
organization may have a greater
financial incentive and opportunity to
engage in this behavior, we understand
that any two or more MDPP suppliers
could coordinate in this way,
potentially affecting large numbers of
MDPP beneficiaries. To mitigate this
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risk, we are proposing to prohibit MDPP
suppliers and other individuals or
entities performing functions or services
related to MDPP services on an MDPP
supplier’s behalf from unduly coercing
an MDPP beneficiary’s decision to
change or not to change to a different
MDPP supplier, including through the
use of pressure, intimidation, or bribery
as described further in section
III.K.2.e.iv.(4). of this proposed rule. We
will monitor MDPP supplier billing
patterns to detect how frequently bridge
payments are paid and to determine
whether patterns exists that may suggest
fraudulent activity regarding bridge
payment claim submissions across
suppliers, conducting audits, medical
reviews, and investigations as
appropriate.
In the CY 2017 PFS final rule, we
finalized at § 410.79(b) that a
beneficiary’s baseline weight refers to
the MDPP beneficiary’s body weight
recorded during that beneficiary’s first
core session. This definition applies to
determine weight loss throughout the
MDPP services period. Additionally, the
once-per-lifetime policy finalized at
§ 410.79(d)(1) applies if a beneficiary
changes MDPP suppliers, and the
services furnished by the subsequent
supplier would begin where the
beneficiary left off with the previous
supplier. We recognize these policies
may require the beneficiary to request
that a copy of his or her MDPP record
be provided by the previous supplier to
the subsequent supplier so that
subsequent supplier can determine
whether the beneficiary achieves or
maintains the required minimum weight
loss and has information about the
MDPP services already furnished. We
also finalized at § 424.59(b) (proposed to
be redesignated and amended as
§ 424.205(g)) that an MDPP supplier
shall maintain documentation that
includes services furnished and body
weight measurements. Finally, we
finalized at § 424.59(b) (proposed to be
redesignated and amended as
§ 424.205(g)) that MDPP suppliers are
required to maintain and handle any
beneficiary PII and PHI in compliance
with HIPAA, other applicable privacy
laws and CMS standards. Any sharing of
information from a beneficiary’s MDPP
record between MDPP suppliers must
follow these rules.
We are considering ways to
streamline the sharing of this
information between suppliers, such as
through the development of a model
tracker that logs the contact information
of a beneficiary’s previous supplier and/
or coach, and the beneficiary’s
attendance and weight loss.
Beneficiaries could take the tracker with
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34155
them if they change suppliers during the
MDPP services period. Such a tracker
would not supplant the previous
supplier’s beneficiary MDPP record
which the subsequent supplier would
need to have a copy of in order to
consider sessions furnished by the
previous supplier in determining
whether the subsequent supplier could
bill for a performance payment that was
based in part on those prior sessions as
discussed in section III.K.2.d.iii.(10)(b)
of this proposed rule. If the subsequent
supplier does not have the beneficiary’s
MDPP record from the previous
supplier, the subsequent supplier
cannot use information from the
sessions furnished by the previous
supplier, such as weight or session
attendance, to determine that the
performance goals for a performance
payment were met so that the
subsequent supplier can bill for the
performance payment. However, it may
help facilitate the process for
subsequent suppliers to enroll
beneficiaries partway through the MDPP
services period while the subsequent
supplier is coordinating with the
previous supplier to obtain a copy of the
beneficiary’s MDPP record from that
supplier. We are inviting public
comments on additional ways this data
sharing could be streamlined between
suppliers.
The proposed bridge payment is
included at proposed § 414.84(c). We
are inviting public comments on this
proposal and the alternative considered.
e. Supplier Enrollment and Compliance
In the CY 2017 PFS final rule, we
established MDPP supplier enrollment
eligibility and revocation policies at
§ 424.59. We propose to add subpart I,
which includes §§ 424.200, 424.205,
and 424.210. This subpart specifies the
requirements for Medicare Diabetes
Prevention Program suppliers and
beneficiary engagement incentives
under the Medicare Diabetes Prevention
Program expanded model. We propose
to redesignate all requirements under
§ 424.59 to § 424.205. These
requirements previously finalized in the
CY 2017 PFS final rule created MDPP
suppliers as a new Medicare supplier
type, and require that any organization
seeking to furnish and receive payment
for MDPP services must enroll as this
supplier type. Given that the set of
MDPP services utilizes CDC’s DPRP
curriculum, in the CY 2017 PFS final
rule we established supplier eligibility
criteria that closely match CDC’s DPRP
standards. The CY 2017 PFS final rule
provides that any organization that
meets full CDC DPRP recognition will
be eligible to enroll as an MDPP
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supplier. In this proposed rule, we are
proposing to build on these eligibility
criteria for enrollment, as well as make
some changes, as described in further
detail later in this section.
The CY 2017 PFS final rule also
established other requirements related
to MDPP suppliers. For example, we
assigned MDPP suppliers to the highrisk screening category under § 424.518.
We also established the policy that
coaches will not enroll in Medicare for
purposes of furnishing MDPP services,
but that they would be required to
obtain NPIs. We established that MDPP
suppliers must submit the active and
valid NPIs of all affiliated coaches and
provide updates of this information to
us within 30 days of a coach beginning
or ceasing to furnish MDPP services. We
provided that this roster of coach
information must include the first and
last name, social security number (SSN),
and NPI. The proposals outlined in this
section seek to build on these
requirements.
In the CY 2017 PFS final rule, we
acknowledged that many DPP
organizations have not yet achieved full
CDC DPRP recognition, and that it might
take 36 months to meet CDC’s
performance standards for full
recognition. We believe allowing only
organizations with full recognition to
enroll as an MDPP supplier would limit
the number of organizations with
demonstrated capacity to furnish MDPP
services, and therefore, constrain
beneficiary access to these services.
However, we deferred to future
rulemaking addressing the issue of
allowing certain DPP organizations with
less than full CDC recognition to enroll
in Medicare.
We are proposing an MDPP interim
preliminary recognition standard under
CMS authority (proposed at
§ 424.205(c)). We also are proposing that
organizations that meet this standard
would be eligible to enroll in Medicare
as an MDPP supplier.
i. Preliminary Recognition
The current CDC 2015 Diabetes
Prevention Recognition Program (DPRP)
Standards do not have standards for
preliminary recognition. In the CY 2017
PFS final rule, we indicated that we
would align the CDC’s DPRP and the set
of MDPP services, to the extent possible.
It will not be possible for CMS to permit
DPP organizations to enroll as MDPP
suppliers based on achievement of any
new CDC standard through this
rulemaking because any updates to the
CDC Standards are not expected to go
into effect until 2018.
However, our intent is to allow
organizations that do not yet have full
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recognition, but have demonstrated a
capacity to furnish DPP services, to
enroll in Medicare as of the effective
date of the enrollment policies proposed
in this rule. We believe this will
increase access to MDPP services. For
this reason, we are proposing, at
§ 424.205(c), to establish an MDPP
interim preliminary recognition
standard to permit DPP organizations
who meet this standard to enroll in
Medicare even if they do not have full
CDC recognition. This MDPP interim
preliminary recognition standard will be
hereafter referred to as ‘‘interim
preliminary recognition.’’ As we stated
in CY 2017 PFS final rule, our intent
with this policy is to bridge the gap
until such time as any CDC preliminary
recognition standards are established.
Once we have established the transition
process with CDC, we would expect
DPP organizations that seek to enroll
into Medicare to obtain CDC
preliminary recognition, but MDPP
suppliers who have enrolled in
Medicare with interim preliminary
recognition would maintain their
enrollment eligibility as an MDPP
supplier.
(1) MDPP Interim Preliminary
Recognition Standard
We are proposing, at
§ 424.205(c)(2)(ii), that DPP
organizations with pending CDC
recognition that meet the following
additional criteria would meet the
interim preliminary recognition
standard:
• The organization must continue to
follow the current 2015 CDC DPRP
Standards for data submission and
submit a full 12 months of performance
data to CDC on at least one completed
cohort (see Appendix D, 2015 CDC
DPRP Standards, https://www.cdc.gov/
diabetes/prevention/pdf/dprpstandards.pdf). For this purpose, a
completed cohort is a set of at least five
participants that entered into a lifestyle
change program that has a fixed first
and last session and runs for 12 months.
An organization can have multiple
cohorts running at the same time:
• The 12-month data submission to
CDC includes at least 5 participants who
attended at least 3 sessions in the first
6 months, and whose time from first
session attended to last session of the
lifestyle change program was at least 9
months; and
• Of the participants eligible for
evaluation in the first criterion, at least
60 percent attended at least 9 sessions
in months 1 through 6 and at least 60
percent attended at least 3 sessions in
months 7 through 12.
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All proposed data requirements
reflect current reporting requirements to
progress from pending recognition to
full recognition through CDC’s DPRP; no
new data collection would be required.
To implement the proposed interim
preliminary recognition standard, DPP
organizations with pending recognition
would submit data following CDC’s
typical recognition process. For the
current standards, this includes data
submission every 12 months, during the
month of the anniversary of the effective
date. The organization’s data
submission should include: (1) Data for
all sessions attended by participants
from the approval date to the day before
the first anniversary of the effective
date, (if the organization has a 2016
effective date; this should include at
least 6 months of participant data) or
data for all sessions attended by
participants from the last anniversary of
the effective date to the day before the
next anniversary of the effective date (if
an organization’s effective date is before
2016); and (2) one record for each
session attended by each participant
during the preceding year. CDC would
perform a new assessment, interim
preliminary recognition, on our behalf.
Our interim preliminary recognition
will be evaluated by CDC based on those
data submissions that use the timetables
and submission deadlines that currently
apply for CDC recognition. For interim
preliminary recognition governed under
this regulation, CDC would provide us
with its recommendation as to which
organizations have met the recognition
standards for interim preliminary
recognition, but we, using our authority,
would make the final decision. CMS
would not make any determination for
recognition status governed under
current or future CDC DPRP recognition
processes. We believe that such an
approach would minimize burden for
DPP organizations, promote consistency
in the application of the standards, and
allow for a smooth transition if and
when CDC adopts preliminary
recognition standards. We intend to
release additional guidance on the
details of this process once the CDC
2018 Standards are released.
(2) MDPP Supplier Enrollment Under
the MDPP Interim Preliminary
Recognition Standard
Our regulations at § 424.59 (proposed
to be redesignated and amended at
§ 424.205 in this proposed rule) specify
that a DPP organization with full CDC
recognition is eligible for enrollment as
an MDPP supplier if it also meets all of
the other conditions for enrollment in
§ 424.59(a) (proposed to be redesignated
and amended at § 424.205(b) in this
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proposed rule). We are proposing that
organizations that meet the MDPP
interim preliminary recognition
standard, as proposed in section
III.K.2.e.i.(1) of this proposed rule, and
meet all other enrollment conditions
would also be eligible to enroll as an
MDPP supplier.
We also are proposing that DPP
organizations would be eligible to enroll
as an MDPP supplier if they meet CDC
DPRP Standards for preliminary
recognition, once any such standards go
into effect (proposed § 424.205(c)(2)(i)).
We anticipate that CDC’s preliminary
recognition standards will be
established on or after January 1, 2018.
After the effective date of any updated
CDC standards, we are proposing that
MDPP suppliers who have enrolled in
Medicare with MDPP interim
preliminary recognition would continue
to be eligible for MDPP enrollment
(assuming they continue to meet all
other requirements for enrollment,
described in proposed § 424.205(b)).
We intend to ensure that any
transition an MDPP supplier may make
from interim preliminary recognition to
CDC preliminary recognition does not
disrupt its status as an MDPP supplier.
We will address possible transition
issues in future rulemaking or guidance,
as appropriate.
We considered an alternative to wait
until new CDC DPRP standards are
effective to allow organizations other
than those with full recognition to
enroll as MDPP suppliers. However, as
indicated in the CY 2017 PFS final rule,
based on CDC data we believe that
waiting until the new DPRP standards
are effective would limit the number of
organizations with demonstrated
capacity to furnish the set of MDPP
services from enrolling in Medicare
when enrollment starts and offering
MDPP services once they become
effective. We are inviting public
comments on this proposed MDPP
interim preliminary recognition
standard, including performance
standards, and the use of this standard
as a condition for enrollment in
Medicare, and the alternative
considered.
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ii. Enrollment and Billing Effective
Dates
(1) Date MDPP Suppliers May Begin
Enrollment
As described in section III.K.2.a. of
this proposed rule, we are proposing to
change the start date of the MDPP
expanded model to April 1, 2018. All
other policies not related to the
furnishing or billing of MDPP services
would, if finalized, be effective January
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1, 2018. Thus, although MDPP suppliers
would not be able to begin furnishing
MDPP services on January 1, 2018,
MDPP supplier enrollment would begin
on January 1, 2018, if these proposals
are finalized. In the CY 2017 PFS final
rule, we established that any
organization wishing to furnish MDPP
services must enroll as an MDPP
supplier, regardless of any existing
enrollment in Medicare. As indicated in
section J.4. of the CY 2017 PFS final
rule, we believe that including an
effective date for enrollment that
precedes the implementation date for
MDPP services is necessary to allow
organizations sufficient time to enroll as
MDPP suppliers. Thus, MDPP services
would only become available after there
is sufficient time to enroll MDPP
suppliers that will furnish those
services.
(2) Effective Date of MDPP Suppliers’
Billing Privileges
Under § 424.502, the definition of
enroll/enrollment means ‘‘the process
that Medicare uses to establish
eligibility to submit claims for
Medicare-covered items and services,
and the process that Medicare uses to
establish eligibility to order or certify
Medicare-covered items and services.’’
Thus, the purpose of enrollment is to
establish billing privileges in Medicare.
In accordance with our proposal that
MDPP services will be available
beginning on April 1, 2018, we propose
that MDPP suppliers may not have an
effective date of billing privileges that
precedes the date that MDPP services
become available (proposed at
§ 424.205(e)(2). Given that it typically
takes an enrollment application 45–60
days to process, if an MDPP supplier
submitted its application in January, the
application may be approved prior to
when MDPP services become available.
For this reason, we are specifying a
proposal that, under no circumstances
would an MDPP suppliers have an
effective date for billing privileges for
MDPP services prior to April 1, 2018.
We propose that for MDPP supplier
enrollment applications that are
submitted and subsequently approved,
the effective date for billing privileges
would be the date the application was
submitted. However for applications
submitted and subsequently approved
prior to April 1, 2018, we propose that
the effective date for billing privileges
would be April 1, 2018. This proposal
is consistent with other suppliers like
physicians, non-physician practitioner
organizations, ambulance suppliers, and
independent diagnostic testing facilities
(IDTFs). However, unlike physicians,
non-physician practitioner
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organizations, and ambulance suppliers,
MDPP suppliers would not be permitted
to retrospectively bill for services
rendered prior to their effective date for
billing privileges. Given that MDPP
suppliers do not furnish services with
immediate impacts on health like the
aforementioned Part B suppliers, we
chose to utilize the approach of IDTFs.
We have established MDPP supplier
standards as a condition of enrollment,
as described in section III.K.2.e.iv of this
proposed rule (proposed at
§ 424.205(d)), and MDPP suppliers are
required to certify in their enrollment
application that they are in compliance
and will continue to remain in
compliance with all MDPP supplier
standards. Therefore, generally, an
MDPP supplier could begin furnishing
services on the date the application was
submitted, with the goal of having their
application subsequently approved.
However, payment for those services
would depend upon whether the
enrollment application is subsequently
approved.
We propose that for any enrollment
application that is denied under
§ 424.530(a)(1) for non-compliance, but
then subsequently approved due to the
submission of a corrective action plan
(CAP), the effective date of enrollment
would be the date of the CAP
submission. This proposal is also
consistent with practices for existing
suppliers, and institutes an appropriate
safeguard for Medicare beneficiaries and
the program at-large by prohibiting
services from being furnished from
suppliers who are not compliant. We
acknowledge, however, that if a supplier
began furnishing services the date it
submitted its application, but was then
denied enrollment, it would not be paid
for any services it furnished prior to the
date it submitted the CAP, if approved.
However, as described in section
III.K.2.e.iv of this proposed rule
(proposed at § 424.205(d)), upon
submitting its enrollment application,
an MDPP supplier certifies that—to its
knowledge—it meets and agrees to
continue to meet the following MDPP
supplier standards, and all other
applicable Medicare requirements.
Thus, at the time the MDPP supplier
applicant submits its application, it
should believe that its enrollment
application will be approved. Examples
of actions the MDPP supplier could take
to improve its certainty and increase the
probability that the application will be
approved may include reviewing any
MDPP supplier supporting
documentation to fully understand
MDPP supplier enrollment requirements
and accompanying CMS guidance or
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supplier support materials, confirming
compliance with the MDPP supplier
standards in this rule (including
conducting background checks for those
who would be screened by CMS during
the enrollment process as required
under § 424.518(c) and proposed
§ 424.205(d)(3)), and conducting a
thorough review of the enrollment
application to ensure no mistakes exist
in the submitted application.
We also propose that if an MDPP
supplier adds a new administrative
location (defined and discussed further
section III.K.2.e.iii.(2) of this section of
the proposed rule) that resulted in a
new enrollment record or Provider
Transaction Access Number (PTAN), the
effective date for billing privileges
would be the date the MDPP supplier
began its MDPP operations at that
location. We believe that this proposal
is appropriate given that it follows a
similar approach for an effective date
that applies to when physician
organizations, non-physician
practitioner organizations, ambulance
suppliers, and Independent Diagnostic
Testing Facilities (IDTFs) add a new
practice location to an existing
enrollment record. Though the
definition of administrative location
differs from that of practice location, it
provides a similar function. We seek
comments on these proposals.
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iii. Enrollment Application
(1) Enrollment Application Type
Applicable to MDPP Suppliers
We are proposing to require the use of
a new, CMS-approved enrollment
application specific to MDPP suppliers.
We believe that the creation of a new
application will be more easily
navigated by and reduce the burden on
new, non-traditional suppliers because
the new enrollment application will
only solicit information relevant to the
MDPP supplier type. As this new
enrollment application is being created
specifically for the MDPP expanded
model, we have determined that this
new enrollment application is exempt
from the Paperwork Reduction Act in
accordance with section 1115A(d)(3) of
the Act. Further, this enrollment
application would be considered an
‘‘enrollment application’’ for purposes
of part 424 subpart P, and therefore, all
existing regulations and administrative
guidance that govern the CMS–855
enrollment applications would apply to
this new form, unless otherwise
specified. We also considered an
alternative option to amend the current
CMS–855B Medicare Enrollment
Application for Clinics/Group Practices
and Certain Other Suppliers (CMS–
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855B) for MDPP supplier enrollment,
but we determined that the existing
length and complexity of the CMS–855B
enrollment application and its
applicability to other non-MDPP
suppliers may add burdens or
unnecessary confusion to MDPP
suppliers given that many sections of
the current CMS–855B enrollment
application would not apply to MDPP
suppliers. In addition, we would need
to add new sections to solicit
information specific to MDPP suppliers,
which would only further increase the
length of the CMS–855B enrollment
application. We invite public comments
on this proposal.
(2) Information on MDPP Enrollment
Application
On the new MDPP enrollment
application, we intend to solicit
information specific to MDPP suppliers,
as well as information consistent with
existing reporting requirements
applicable to all suppliers who enroll
through the CMS–855B enrollment
application, while excluding all
reporting requirements that do not
apply to MDPP suppliers. As a Medicare
supplier enrolling under part 424
subpart P, MDPP suppliers are required
to provide complete and accurate
information on the MDPP enrollment
application, or be subject to enrollment
denial under § 424.530(a)(4) or
revocation under § 424.535(a)(4). This
requirement would include all
information solicited on the MDPPspecific enrollment application. The
MDPP-specific enrollment application is
under development and will be
available prior to its use, if this proposal
is finalized. While the application is
being developed, we wish to indicate
some of the information we intend to
include on the MDPP enrollment
application, as further described in this
section.
As finalized in the CY 2017 PFS final
rule, § 424.59(a)(5) requires that MDPP
suppliers submit the active and valid
NPIs of all coaches who will furnish
services on the supplier’s behalf, as well
as their first name, last name, and SSN
(in this proposed rule, § 424.59(a)(5) is
proposed to be redesignated and
amended at § 424.205(b)(4)). We are
proposing, at § 424.205(b)(4), to require
that MDPP suppliers provide this
identifying information of the coaches
directly through the enrollment
application. This information will be
used to complete background checks of
the coaches. To accompany the coach
identifying information, we propose to
require MDPP suppliers to provide an
eligibility start and end date, if
applicable, for each coach on the
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supplier’s roster. Coach eligibility start
and end dates are described at length in
section III.K.2.e.iv.(2). As described in
more detail in section III.K.2.e.iv., the
background checks would be used to
prevent MDPP suppliers from allowing
coaches to furnish MDPP services when
certain adverse histories may indicate
potential to harm Medicare beneficiaries
or undermine program integrity. We
outline further details on our proposed
enforcement of this provision in section
III.K.2.e.iv. of this proposed rule.
To enable us to conduct background
checks of coaches, we are proposing that
MDPP suppliers also submit to CMS the
date of birth of all coaches who will
furnish MDPP services (proposed
§ 424.205(b)(4)). Combined with other
identifying information, date of birth
plays a critical role in validating an
individual’s identity. By collecting date
of birth, we would be able to more
accurately screen coaches, including
accurately conducting a background
check, and distinguishing them in the
Provider Enrollment, Chain and
Ownership System (PECOS). In
addition, we want to ensure that we
have the capability to most accurately
identify individuals reported on the
form. To mitigate potential confusion or
error found when individuals have
common names, we are proposing to
collect coach’s middle initial (if
applicable) on the enrollment
application (proposed § 424.205(b)(4)).
We believe that this proposal will help
to lessen the possibility that CMS or its
contractors misattribute the background
of one individual for another.
We are proposing, at § 424.205(d)(4),
that MDPP suppliers would identify
their administrative location(s) by
reporting these location(s) on their
enrollment application. We are
proposing, at § 424.205 (a), to define
administrative location as the physical
location associated with the supplier’s
operations, from where coaches are
dispatched or based, and where MDPP
services may or may not be furnished.
We are proposing that an MDPP
supplier must have at least one such
administrative location, and report any
additional administrative locations of
the supplier, if MDPP services are either
furnished at these locations and/or if the
location reflects from where coaches are
dispatched or based. For example, if an
MDPP supplier operated 2 locations, but
only 1 of the 2 locations associated with
the entity offered MDPP, only the
location offering MDPP would be
considered an administrative location. If
coaches began offering MDPP in
community settings (described in the
subsequent paragraph and proposed to
be defined at § 424.205(a), but were
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dispatched and/or based out of the other
non-administrative location, then this
location would then be considered
under the definition of an
administrative location, and would need
to be reported on the MDPP enrollment
application within 90 days of the
change. Given that MDPP suppliers are
categorized as high risk under § 424.518,
these administrative locations may be
subject to site visits prior to approval of
an enrollment application. Collecting
information on the MDPP supplier’s
administrative location (regardless
whether they furnish services in this
location) is important because we may
utilize this information to verify that the
organization is operational per
requirements under proposed
§ 424.205(d)(4) and (6), discussed in
detail in section III.K.2.e.iii.(3) of this
proposed rule.
While we recognize that many
suppliers furnish MDPP services outside
of their administrative locations in
community settings, we are proposing to
only require enrollment of the
administrative locations. In proposed
§ 424.205(a), we define ‘‘community
setting’’ as a location where the MDPP
supplier furnishes MDPP services
outside of their administrative locations.
A community setting is a location open
to the public, not primarily associated
with the supplier. Community settings
may include, for example, church
basements or multipurpose rooms in
recreation centers. When determining
whether a location is considered an
administrative location or a community
setting, MDPP suppliers should
consider whether their organizational
entity is the primary user of that space
and whether coaches are based or
dispatched from this location. If so, the
location would be considered an
administrative location, even if this
location dually serves as a community
setting. In comparison, community
settings are locations not primarily
associated with the supplier where
many activities occur, including MDPP
services.
We seek public comments on these
proposals.
(3) Updating Information on MDPP
Enrollment Application
We are proposing, at § 424.205(d)(5),
that MDPP suppliers must update their
enrollment application within 30 days
of any changes of ownership, changes to
the coach roster, or new final adverse
action history of any individual or
entity required to report such
information on the enrollment
application. We are proposing that
MDPP suppliers report all other changes
to information required on the
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enrollment application within 90 days
of the reportable event. Timely reporting
and updating of information plays a
critical role in our ability to protect
Medicare beneficiaries and protect the
integrity of the Medicare program and
Trust Funds. We believe that these
requirements are fair and consistent
with existing reporting requirements for
other Medicare suppliers.
All suppliers are required to report
changes of ownership and new adverse
action history within 30 days. Adding
the requirement that any changes to the
coach roster be reported within 30 days
is consistent with IDTFs requirements at
§ 410.33(g)(2). Although IDTFs differ
from MDPP suppliers in many ways,
IDTFs must report a roster of
supervising physicians who serve
functions on the supplier’s behalf and
must also report changes to this roster
within 30 days. Given this similarity
with IDTFs, we modeled our approach
after this process. However, we note that
while MDPP suppliers would be
required to submit changes to the coach
roster within 30 days, we would
encourage them to submit such changes
as soon as possible, due to reasoning
explained further in section
III.K.2.e.iv.(2) of this proposed rule.
We invite public comments on these
proposals.
(4) Enrollment Application Fee
In the CY 2017 PFS final rule, we
finalized that MDPP suppliers would
enroll in Medicare. We solicited
comments on, but did not propose or
finalize, an applicable application fee
associated with the MDPP supplier’s
enrollment. In this proposed rule, we
propose to amend the definition of
‘‘institutional provider’’ as defined
under § 424.502, to include MDPP
suppliers such that, § 424.514, which
governs the application fee, would
similarly apply to MDPP suppliers.
‘‘Institutional providers’’ that are
initially enrolling in Medicare,
revalidating their enrollment, or adding
a new Medicare practice location are
required to submit a fee with their
enrollment application. We would like
to highlight that while we are proposing
to include MDPP suppliers as an
institutional provider, MDPP suppliers
utilize administrative locations, not
practice locations, and therefore the fee
would not apply when adding a new
administrative location to an existing
enrollment record. The application fee
is adjusted annually, and additional
information about how the adjustment
is calculated may be found in the
November 7, 2016 Federal Register
notice establishing the calendar year
2017 application fee (81 FR 78159). For
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34159
calendar year 2017, the application fee
is $560. Section 6401(a) of the Patient
Protection and Affordable Care Act (as
amended by section 10603 of the
Affordable Care Act, amended section
1866(j)(2)(C) of the Act to require the
Secretary to impose a fee on each
institutional provider of medical or
other items or services or supplier. This
fee would be used for program integrity
efforts including to cover the cost of
screening and to carry out the
provisions of sections 1866(j) and 1128J
of the Act. Given that section 10603 of
the Affordable Care Act excludes
individual practitioners, such as
physicians and nurse practitioners, from
paying an enrollment application fee,
we have previously determined that an
‘‘institutional provider’’ to include any
provider or supplier that submits a
paper Medicare enrollment application
using the CMS–855A, CMS–855B (not
including physician and non-physician
practitioner organizations), CMS–855S
or associated Internet-based PECOS
enrollment application.26 MDPP
suppliers are entities, and not
individual practitioners. We believe that
they would similarly qualify as a
‘‘provider of medical or other items or
services’’ used to define institutional
providers. Taken together, we believe
that the definition of institutional
provider would also apply to MDPP
suppliers. Given that the CY 2017 PFS
final rule established that MDPP
suppliers would be screened under high
categorical risk (codified at
§ 424.59(a)(3), proposed to be
redesignated as § 424.205(b)(3)(i)), the
application fee would play an important
role in executing particular aspects of
the high-risk screening. As we noted in
the CY 2017 PFS final rule, any
organization that faces financial
difficulty related to the application fee
may apply for a hardship exception. For
more information on the hardship
exemption, see https://www.cms.gov/
Outreach-and-Education/MedicareLearning-Network-MLN/MLN
MattersArticles/downloads/
MM7350.pdf. We are soliciting
comments on this proposal.
iv. MDPP Supplier Standards
We are proposing to establish
standards that MDPP suppliers must
meet and remain in compliance with to
be eligible to receive payment for an
MDPP service (proposed § 424.205(d)).
These supplier standards would build
on the conditions for enrollment
established under existing § 424.59(a)
(which in this proposed rule is
26 See CMS–6028–FC for further discussion, 76
FR 5862 and 5907 through 5908 (Feb. 2, 2011).
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proposed to be redesignated and
amended at paragraph § 424.205(b)), as
well as any existing Medicare
requirements that apply to all suppliers.
We are proposing that an MDPP
supplier wishing to participate in MDPP
must adhere to current Medicare MDPP
supplier requirements as outlined in
§ 424.59 (proposed to be redesignated as
§ 424.205), as well as all other
requirements that apply to Medicare
providers and suppliers. MDPP
suppliers may choose to utilize a third
party administrator, billing agent, or
other entity to comply with the
requirements of § 424.59 (proposed to be
redesignated as § 424.205). Regardless of
any use of such entities, any failure to
comply with the standards of
§ 424.205(d) or other relevant Medicare
requirements, may result in an
enrollment denial under § 424.530(a)(1),
revocation of the MDPP supplier for
non-compliance under § 424.535(a)(1) or
other revocation authority, as
appropriate (as proposed in
§ 424.205(g)). Consistent with existing
regulations, we are proposing that
MDPP suppliers would have appeal
rights under part 498.
We believe that the standards
outlined in this section are generally
consistent with standards established
for other Medicare suppliers while
adding safeguards to help ensure
compliance with MDPP rules and
regulations specific to this expanded
model. Because this expanded model
would pay MDPP suppliers based on a
beneficiary’s achievement of
performance goals, we believe that it is
prudent to include additional
requirements consistent with the Office
of the Inspector’s General’s compliance
guidance,27 to promote adherence to
applicable statutes, regulations, and
program requirements and help reduce
fraud, waste, and abuse. In addition to
the proposed standards, the MDPP
expanded model will be routinely
monitored for compliance with supplier
standards, consistent with section 1893
of the Act (42 U.S.C. 1395ddd).
Although we recognize that these
standards may be new for MDPP
suppliers and would, if finalized,
impose additional requirements on
these organizations that they may not
otherwise face, both individually and
collectively, these standards play an
important role in ensuring the integrity
of the Medicare program and the safety
of our beneficiaries. Therefore, given the
goals of these proposed standards to
mitigate fraud, waste, or abuse to the
Medicare program and its beneficiaries,
27 https://oig.hhs.gov/compliance/complianceguidance/.
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we believe that they are appropriate for
governing MDPP suppliers and do not
place an undue burden on suppliers. We
are inviting public comments on our
proposed approach, as well as any
unintended consequences or burdens
that we may have not considered.
(1) Medicaid Terminations
In addition to establishing standards
for MDPP suppliers with respect to their
delivery of MDPP services, we also are
proposing standards for MDPP
suppliers’ general eligibility to furnish
services to Medicare beneficiaries.
These standards would establish
program integrity safeguards that would
protect both Medicare beneficiaries and
the Medicare program. We are
proposing that MDPP suppliers must
not currently have their billing
privileges terminated for-cause from any
State Medicaid program or be excluded
from any State Medicaid program
(proposed § 424.205(d)(2)). If a
supplier’s Medicaid billing privileges
are currently terminated from or the
supplier is excluded from any State
Medicaid program, we do not believe
that supplier should be able to furnish
Medicare services. We believe that this
proposal is warranted given that a
supplier’s improper behavior in another
Federal health care program may be
duplicated in Medicare. We believe that
this proposed requirement would
mitigate the MDPP expanded model’s
susceptibility to fraud, waste, and
abuse. Consistent with all standards in
this section, any MDPP supplier who
does not meet this requirement would
be subject to a Medicare enrollment
denial or revocation. We believe that
this proposed standard would serve to
ensure continuity of safeguards across
Federal health care programs, and will
help preserve the integrity of the
Medicare program and protect
beneficiaries by prohibiting suppliers
found to be noncompliant in one
Federal health care program from
enrolling in and furnishing services in
another.
We seek comments on this proposal.
(2) Ineligible Coaches: Individuals
Prohibited From Furnishing MDPP
Services to Medicare Beneficiaries
We are proposing, at § 424.205(d)(3),
that the MDPP supplier must report
coach information on its enrollment
application and the MDPP supplier
must only permit MDPP services to be
furnished by individual coaches who
meet the eligibility criteria. We propose,
at § 424.205(e)(1) that MDPP coach
eligibility criteria require that a coach
must not:
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• Currently have his or her Medicare
billing privileges revoked and whose
reenrollment bar has not yet expired.
We believe that this proposed supplier
standard would protect beneficiaries
from receiving MDPP services from
individuals already prohibited from
furnishing other Medicare services. If an
individual is precluded from
maintaining enrollment in Medicare for
a non-MDPP service, we believe that it
is prudent that they similarly not
furnish MDPP services.
• Currently have his or her Medicaid
billing privileges terminated for-cause
or is excluded from any State Medicaid
Agency (proposed at § 424.205(e)(1)(ii)).
We believe that this proposed supplier
standard is warranted given that an
individual’s improper behavior in
another Federal health care program
may be duplicated in Medicare. We do
not believe that we should permit MDPP
suppliers to allow coaches with current
for-cause terminations or exclusions in
Medicaid to furnish MDPP services to
Medicare beneficiaries.
• Currently be excluded from any
other Federal health care program, as
defined in § 1001.2 of this chapter, in
accordance with section 1128, 1128A,
1156, 1842, 1862, 1867 or 1892 of the
Act. This includes, but is not limited to,
the Office of Inspector General (OIG)’s
List of Excluded Individuals and
Entities (LEIE). We are proposing this
supplier standard for similar reasons we
are proposing not to permit coaches
with revocations from Medicare or
current exclusions from Medicaid to
furnish MDPP services.
• Currently be debarred, suspended,
or otherwise excluded from
participating in any other Federal
procurement or non-procurement
program or activity in accordance with
the Federal Acquisition Streamlining
Act implementing regulations and the
Department of Health and Human
Services non-procurement common rule
at 45 CFR part 76. We note that this
includes individuals who have an active
status on the General Service
Administration’s System for Award
Management list. We may also utilize
the Bureau of the Fiscal Service, U.S.
Department of the Treasury’s Do Not
Pay (DNP) List as a resource for
determining which individuals fall
under this category. The Improper
Payments Elimination and Recovery
Improvement Act (IPERIA) of 2012
established the DNP to support Federal
agencies with their efforts to prevent
and detect improper payments by
aggregating various data sources for preaward, pre-payment eligibility
verification. Data sources included in
this list include Credit Alert System,
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Death Master File, LEIE, Office of
Foreign Assets Control (OFAC), System
for Award Management (SAM) Entity
Registration Records, and SAM
Exclusion Records. We believe that we
may utilize the DNP as a method of
determining whether a coach is
excluded from participating in any other
federal procurement or nonprocurement
programs. Although coaches will not
directly be receiving payment from us
for furnishing MDPP services, we do not
believe that payment should be made to
MDPP suppliers for services furnished
by individuals excluded from federal
procurement or nonprocurement
programs, particularly given that MDPP
payments rely on beneficiary’s
achievement of performance goals that
the coaches will document. Although
the MDPP supplier is ultimately
responsible for attesting to all claims
submitted for MDPP services, we do not
believe that it would be prudent to
permit MDPP suppliers to allow coaches
excluded from other federal
procurement programs to furnish MDPP
services.
• Have, in the previous 10 years, one
of the following state or federal felony
convictions:
++ Crimes against persons, such as
murder, rape, assault, and other similar
crimes for which the individual was
convicted, as defined under 42 CFR
1001.2, had a guilty plea or adjudicated
pretrial diversion.
++ Financial crimes, such as
extortion, embezzlement, income tax
evasion, insurance fraud and other
similar crimes for which the individual
was convicted, as defined under 42 CFR
1001.2, had a guilty plea or adjudicated
pretrial diversion.
++ Any felony that placed the
Medicare program or its beneficiaries at
immediate risk, such as a malpractice
suit that results in the individual being
convicted, as defined under 42 CFR
1001.2, having a guilty plea or having
adjudicated pretrial diversion of
criminal neglect or misconduct.
++ Any felonies that for which the
individual was convicted, as defined
under 42 CFR 1001.2, had a guilty plea
or adjudicated pretrial diversion that
would result in mandatory exclusion
under section 1128(a) of the Act.
We propose that CMS will screen
each individual identified on the roster
of coaches included with the supplier’s
enrollment application to verify that the
individual coach does not meet any of
these conditions and that the coach can
provide MDPP services on behalf of an
MDPP supplier (proposed at
§ 424.205(e)(2)). We are proposing these
requirements as a means to ensure the
integrity and safety of the Medicare
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program and the beneficiaries whom we
serve. We have selected these types of
felony convictions based on the risk we
believe they could pose to the Medicare
program and our beneficiaries.
Additionally, it is consistent with
existing criteria that we use to
determine felonies that are detrimental
to the best interest of the program and
its beneficiaries as described in
§ 424.535(a)(3)(ii). While we selected
these criteria to be consistent with how
we evaluate other individuals, we also
sought to create a more definite list such
that MDPP suppliers would have the
ability to conduct background checks on
coaches prior to, as well as potentially
after enrolling in Medicare, to avoid
receiving an enrollment denial or
revocation due to failure to meet this
standard. While coaches are not directly
enrolled, and therefore, not directly
receiving payment, we believe that it is
prudent to prohibit MDPP suppliers
from utilizing individuals convicted of
certain felonies to furnish services to
Medicare beneficiaries. Because coaches
will be directly interacting with
beneficiaries, recording their attendance
and weight loss, we believe that a
coach’s trustworthiness is vital.
Consequentially, we do not believe that
such coaches should have a criminal
history such as those described in
§ 424.535(a)(3)(ii).
Coaches that meet any of these criteria
would be considered ineligible to
furnish MDPP services, and therefore,
could not be on an MDPP supplier’s
roster. Coaches whose information was
submitted in an MDPP supplier’s
enrollment application, screened, and
determined as not meeting any of these
criteria would be considered eligible
coaches. Although the MDPP supplier is
the entity that is enrolled in Medicare
and submits claims, coaches furnish
MDPP services, directly interacting with
the beneficiary and documenting
attendance and weight loss. Therefore,
we believe that precluding individual
coaches who meet any of the
ineligibility criteria from directly
furnishing MDPP services to Medicare
beneficiaries would both help reduce
fraud, waste, and abuse that could occur
in the MDPP expanded model, as well
as protect beneficiaries from harm.
If after screening, CMS or its
contractors determine that a coach is
eligible to furnish MDPP services, the
coach would be assigned an eligibility
start date, similar to a supplier’s
enrollment effective date. We are
proposing to define coach eligibility
start date as follows: The start date
indicated by the MDPP supplier when
submitting an eligible coach’s
information on the MDPP enrollment
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application (proposed at 424.205(a)). On
the enrollment application, the MDPP
supplier will include a date indicating
when the coach began furnishing MDPP
services. Consistent with proposals at
§ 424.205(d)(5), the MDPP supplier must
report changes to the coach roster on its
enrollment application, including any
new coaches added, within 30 days of
such a change. Thus, the start date
associated with any new coach
information must be within 30 days of
the date the MDPP supplier actually
reports the change on its application. If
the coach has not yet begun furnishing
MDPP services, the MDPP supplier
should indicate the date the supplier is
reporting the information. Though the
date reflects either when the coach
began furnishing services or when the
coach could ultimately be determined as
eligible to begin furnishing services,
after the enrollment application was
submitted, CMS must still determine
whether the coach is eligible (proposed
at § 424.205(e)(2)). If we determine the
coach to be eligible, then his or her
eligibility start date would be the date
the MDPP supplier indicated on its
enrollment application. As described in
III.K.2.d.(10)(d), payment can be made
for services furnished by this coach on
or after his or her eligibility start date.
However, if a coach was determined
to be ineligible at the onset, the coach
would have its eligibility start and end
date on the same date, effectively never
being eligible to furnish MDPP services.
If the coach later became ineligible, he
or she would be assigned an eligibility
end date. Consistent with proposals at
414.84, payment for MDPP services is
made only if such services are furnished
by an eligible coach, on or after his or
her coach eligibility start date and, if
applicable, before his or her coach
eligibility end date, to an MDPP
beneficiary. This could pose a situation
in which an MDPP supplier could
submit an updated coach roster that
includes a new coach, and allow him or
her to begin furnishing services based
on the belief that he or she is eligible.
Should, after screening, CMS or its
contractors determine that the coach is
ineligible, the MDPP supplier could be
revoked for non-compliance. Though
the MDPP supplier would have an
opportunity to submit a corrective
action plan that removes the ineligible
coach from their enrollment application,
any claims for services furnished by the
ineligible coach would be denied, and
the MDPP supplier would not be paid
for such services. For this reason, we
encourage suppliers to report changes to
the coach roster as soon as possible. If
the MDPP supplier submits a claim that
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includes a coach NPI for a coach we
have not yet determined to be an
eligible coach for furnishing MDPP
services as of the date of service, the
claim will be rejected, and the supplier
will need to refile the claim with the
same information once CMS has made
the eligibility determination. If at that
time, CMS determined the coach to be
ineligible, the claim for the service
provided by the coach will be denied,
as described in section
III.K.2.d.iii.(10)(d).
We believe that the majority of the
coach ineligibility criteria described in
this section is crafted in such a way that
the MDPP supplier could, with
reasonable certainty, conduct an
independent background check on the
coach, to determine whether he or she
meets the ineligibility criteria. If the
MDPP supplier has any uncertainty
about whether the coach meets the
ineligibility criteria, they may wish to
preclude the coach from furnishing
services to Medicare beneficiaries until
CMS determines that the coach is
eligible. This would avoid a potential
situation of a coach furnishing services
for which the MDPP supplier could not
get paid. If the MDPP supplier believes
the coach is eligible and wishes to allow
the coach to furnish services prior CMS
determining his or her eligibility, then
the MDPP supplier would assume the
risk not receiving payment for claims for
serviced rendered by the ineligible
coach.
If a coach no longer provides MDPP
services for an MDPP supplier, the
supplier must remove that coach from
its roster and indicate the date of such
event to designate an eligibility end date
for that coach. If the MDPP supplier
voluntarily terminates its Medicare
enrollment or is revoked, CMS will
automatically reflect the date of this
action as the coach’s eligibility end date
for that MDPP supplier. We are
proposing to define coach ineligibility
end date as follows, the end date
indicated by the MDPP supplier in
submitting a change to the supplier’s
MDPP enrollment application that
removed the coach’s information, or the
date the supplier itself was revoked
from or withdrew its Medicare
enrollment as an MDPP supplier.
We are proposing that CMS or its
contractors would determine whether
coaches submitted on MDPP rosters
satisfy the previously stated criteria by
using the identifying information MDPP
suppliers submit on their enrollment
applications (including any changes that
MDPP suppliers would be required to
report). This information would be
checked against internal and publicly
available data sources. We are proposing
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that, upon identification of evidence
that a coach met any ineligibility
criteria, we may take administrative
action to deny or revoke the MDPP
supplier’s enrollment as appropriate
under §§ 424.530(a)(1) and 424.535(a)(1)
(proposed at § 424.205(g)(1)(ii)).
Consistent with existing enrollment
denial and revocation actions, we would
notify the prospective or enrolled MDPP
supplier via an enrollment denial or
revocation notification and include the
specific reason for the administrative
action. The enrollment denial or
revocation notification detailing the
findings and the reasoning for the
determination would follow
requirements under § 488.18. Consistent
with similar processes at §§ 424.530(c)
and 424.535(e), we are proposing that an
MDPP supplier could respond to the
enrollment denial or revocation by
submitting a corrective action plan
(CAP) that would include the removal of
the coach from its roster within 30 days
of receiving the enrollment denial or
revocation notification, and therefore,
come into compliance and enroll or
maintain its enrollment status. If MDPP
suppliers believe that the decision was
made in error, they could exercise
existing appeal rights under part 498.
We also are proposing that if we
determine that an MDPP supplier has
continued to allow an ineligible coach
to furnish MDPP services after having
submitted a CAP removing the coach
from its roster to enroll or maintain
enrollment in Medicare, we would
revoke the MDPP supplier without the
opportunity for additional corrective
action. This authority, outlined in
proposed § 424.205(h)(1)(v), would
allow us to revoke an MDPP supplier for
knowingly using an ‘‘ineligible coach’’
to furnish MDPP services. ‘‘Knowingly,’’
in this context, means that the supplier
received an enrollment denial or
revocation notice based on failing to
meet supplier standards at
§ 424.205(d)(3) (related to ineligible
coaches), was provided notice by CMS
or contractors working on its behalf of
this action including the reason(s) for
the administrative action, submitted a
CAP to remove the coach, but continued
to allow the coach to provide MDPP
services in violation of the CAP. We are
proposing to define an ‘‘ineligible
coach’’ in § 424.205(a) as an individual
whom CMS has screened and has
determined ineligible to furnish MDPP
services on behalf of an MDPP supplier
based on the standard specified in
§ 424.205(e), and we are proposing in
the same paragraph to define ‘‘eligible
coach’’ in § 424.205(a) as an individual
who CMS has screened and has
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determined can furnish MDPP services
on behalf of an MDPP supplier based on
the standard specified in proposed
§ 424.205(e).
While any individual may be eligible
to become a DPP coach, provided that
they meet requirements and trainings as
dictated by the CDC’s DPRP Standards,
an individual can only become an
eligible coach for purposes of furnishing
MDPP services after having their
required identifying information
submitted on an MDPP supplier’s
enrollment application, being screened
by CMS or its contractors, and as a
result, being determined to be eligible to
furnish MDPP services on behalf of an
MDPP supplier. If CMS or its
contractors deem a coach ineligible, this
would apply only to the furnishing of
MDPP services and would not preclude
the DPP organization from continuing to
allow this individual to furnish
administrative services or DPP sessions
to non-Medicare beneficiaries. However,
serving as a coach for Medicare
beneficiaries would be prohibited and
would be subject the MDPP supplier to
this revocation authority.
We are proposing this new revocation
authority due to the novel program
integrity risks that would be posed by
MDPP suppliers who knowingly
continue to permit ineligible coaches to
furnish MDPP services to Medicare
beneficiaries. We believe that this new
basis for revocation is necessary because
coaches are not enrolled in Medicare,
even though they will undergo
background checks by CMS or its
contractors and must meet specified
criteria. While we considered using
existing revocation authorities under
§ 424.535(a)(1) (related to
noncompliance), § 424.535(a)(4) (related
to false or misleading information), and
§ 424.535(a)(9) (related to failure to
report), we determined that these
authorities were too general for
purposes of specifically addressing
MDPP coaches who become ineligible to
furnish MDPP services. We are
proposing that this revocation authority
would follow similar requirements
under § 424.535(c), (g), and (h). We do
not believe that § 424.535(e) (related to
reversal of the revocation) should apply
in this case, given that the MDPP
supplier already had an opportunity to
remove the coach from their roster by
submitting a CAP, but continued to
allow the ineligible coach to furnish
MDPP services. The proposals that we
would apply from the provisions of
§ 424.535 stated in this section are as
follows:
• The revocation becomes effective 30
days after CMS or the CMS contractor
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mails notice of its determination to the
MDPP supplier;
• For the revocation authority, MDPP
suppliers are barred from participating
in the Medicare program from the date
of the revocation until the end of the reenrollment bar, which begins 30 days
after CMS or its contractor mails notice
of the revocation and lasts a minimum
of 1 year, but not greater than 3 years,
depending on the severity of the basis
for revocation; and
• A revoked MDPP supplier must,
within 60 calendar days after the
effective date of revocation, submit all
claims for items and services furnished
before the date of the revocation letter.
We believe that these proposals
would appropriately govern this
proposed new revocation authority,
given the consistency with existing
revocation authorities. Given these
consistencies, we do not believe that
this proposal places an undue burden
on MDPP suppliers, and any burden
established would be warranted given
the violation of the supplier standards
that jeopardize both the integrity of the
Medicare program and the safety of its
beneficiaries.
We are inviting public comments on
these proposals.
(3) Ensuring MDPP Suppliers Are
Legitimate, Operational Organizations
We are proposing a number of
requirements that would help ensure
that MDPP suppliers are operational,
have the resources necessary to furnish
MDPP services, and are in compliance
with MDPP supplier standards. At
§ 424.205(d)(4), we are proposing that,
regardless of whether the MDPP
supplier furnishes services solely in
community settings, it must maintain at
least one administrative location. All
administrative locations maintained by
the MDPP supplier must be on an
appropriate site available to the public
and must be reported on the CMSapproved enrollment application. We
are proposing that this administration
location may not be a private residence.
We are proposing that an appropriate
site must have signage posted on the
exterior of the building, as well as be
open for business and have employees,
staff, or volunteers present during
operational hours. For the purposes of
this requirement, such signage may
include, for example, the MDPP
supplier’s legal business name or its
‘‘doing business as’’ (DBA) name, as
well as hours of operation. This
proposal seeks to utilize measurable
objective indicators to determine that
organizations are legitimately operating
and able to furnish MDPP services to
Medicare beneficiaries. We believe that,
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regardless of whether the MDPP
supplier furnishes services at its
administrative location, establishing a
physical location is necessary for
associated requirements for furnishing
MDPP services, including recordkeeping
requirements, training facilities, and
storage for any educational materials
distributed during sessions.
We are proposing, at § 424.205(d)(6),
that a MDPP supplier must maintain a
primary business telephone number
listed under the name of the
organization in public view. Public view
could signify, for example, that the
phone number is listed on a Web site,
on flyers and materials. This proposed
policy would require that calls must not
automatically go to the answering
machine or utilize an answering service
during posted business hours. The
purpose of this proposed requirement is
to help verify that the organization is a
legitimate organization and not simply
posing as an organization and seeking to
bill Medicare fraudulently.
We are further proposing, at
§ 424.205(d)(7), that an MDPP supplier
must not knowingly sell to or allow
another individual or entity to use its
billing number, consistent with
§ 424.535(a)(7). We are including this
proposal to avoid a situation in which
another entity uses an existing MDPP
supplier’s billing number. We believe
that this proposal plays an important
role in ensuring that payments are only
being made to the intended recipient
who has met all of the supplier and
compliance standards and that we
continue to hold entities responsible for
maintaining compliance. Otherwise, we
risk making payments to suppliers
potentially engaging in fraudulent or
potentially harmful behavior.
We believe that the proposed
requirements in this section would not
pose an undue burden on MDPP
suppliers as they are minimum
requirements for any functional,
operational organization. By
establishing these requirements, we
believe that we would ensure that
MDPP suppliers that do not meet the
baseline requirements for an operational
organization would not be permitted to
furnish MDPP services to or receive
payment for such services. We are
proposing, at § 424.205(d)(15), that an
MDPP supplier must permit CMS or its
agents to conduct onsite inspections to
ascertain the supplier’s compliance with
these standards. While we believe that
any operational business that truly
furnishes MDPP services would be able
to meet these requirements, we are
inviting public comments on any
aspects of these proposed standards.
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(4) Beneficiary Access
We are proposing, at § 424.205(d)(8),
that MDPP suppliers may not deny
access to MDPP services to eligible
beneficiaries based on any reason other
than the supplier’s own self-determined
and published capacity limits to furnish
MDPP services to additional people and,
on a discretionary basis, if a beneficiary
significantly disrupts the session for
other participants or becomes abusive.
Given that we do not yet currently have
data on optimal class size for MDPP
services, we are currently allowing
MDPP suppliers to self-determine any
upper limitation on class size. Should
they establish such a limit and intent to
turn beneficiaries away once the
capacity limit is reached, the MDPP
supplier must have previously made
this limit publicly available; for
example, denoting the limit in any
brochures, Web sites, or other materials
that outline their MDPP services. We are
proposing that MDPP suppliers must
maintain a record of the number of
eligible Medicare beneficiaries turned
away for each of these reasons, as well
as the date the beneficiary was
informed. We are further proposing that
if an MDPP supplier denies a Medicare
beneficiary access citing disruptive or
abusive behavior, details of the
occurrence(s), including date(s) of the
behavior, any remediation efforts taken
by the supplier, and final action (for
example, dismissal from an MDPP
session or denial from future sessions)
must be documented in the beneficiary’s
MDPP records and adhere to
documentation requirements outlined in
§ 424.205(g). We note that one supplier’s
decision to dismiss a beneficiary for this
purpose would not limit that beneficiary
from switching to another MDPP
supplier.
We will seek to monitor compliance
with this requirement, and investigate
further if necessary, based on
beneficiary complaints, rates of access
denials citing capacity limits in
comparison to estimated capacity based
on claims submitted, as well as
monitoring claims for success rates for
achieving performance goals that are
higher than what would be expected for
a typical Medicare population.
Illustrative examples of capacity limits
could include that the MDPP supplier
has met its self-determined and
published class size maximum, or that
the supplier is providing MDPP sessions
in cohorts and does not have a new or
upcoming cohort at the time the
beneficiary is seeking MDPP services.
Furnishing MDPP services in a cohort
means that the DPP curriculum is
delivered among a single group, or
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cohort, from start to finish with sessions
furnished in a specific order, therefore,
not allowing any new individuals to
join once the cohort has begun.
Given that our proposed payment
structure for MDPP services relies on
the achievement of weight loss and
attendance goals, there may be
incentives for MDPP suppliers to seek to
serve only those beneficiaries for which
they are more likely to earn performance
payments. This, in turn, could result in
discriminatory treatment of
beneficiaries. Through this proposed
supplier standard, we would expressly
prohibit MDPP suppliers from
conditioning access to MDPP services
on the basis of a beneficiary’s weight or
health status (except as provided in our
proposed regulations). We also would
prohibit MDPP suppliers from
conditioning access to MDPP services
on the basis of a beneficiary’s
achievement of performance goals,
except where the beneficiary becomes
ineligible for additional sessions as a
result of not meeting those goals, as
proposed elsewhere in this proposed
rule. We believe that it is appropriate to
prohibit suppliers from denying access
to MDPP services except in certain
limited circumstances. If a supplier
were to deny access to a beneficiary
citing lack of capacity, but then furnish
MDPP services to a different beneficiary,
this may signal a violation of such
standards. In addition, and for the same
reasons, we are proposing to prohibit
MDPP suppliers, which includes any
coaches or entities performing functions
or furnishing services related to MDPP
services on their behalf, from unduly
coercing a beneficiary’s decision to
change or not change to a different or
specific MDPP supplier, including
through the use of pressure,
intimidation, or bribery in proposed
§ 424.205(d)(9). Information that may
result in a beneficiary changing to a
different MDPP supplier provided in
response to a beneficiary’s request for
information would not violate this
provision.
At § 424.79, the CY 2017 PFS final
rule established the set of services
included in the expanded model, but
did not stipulate that once a supplier
began furnishing such services to a
beneficiary, that it must continue to
offer them to the beneficiary as a part of
the MDPP expanded model. We are
proposing, at § 424.205(d)(10), that
MDPP suppliers must offer and provide
beneficiary access to the entire set of
MDPP services for which beneficiaries
are eligible. This includes the
requirement that suppliers offer at least
16 in-person core sessions, no more
frequently than once per week, over the
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first 6 months of the core services
period and offer at least 6 core
maintenance sessions, at least once per
month, over months 7 through 12 of the
core services period (proposed at
§ 410.79(c)(2)(i)). For beneficiaries to
whom the supplier has begun furnishing
MDPP services, and who meet the
eligibility requirements for ongoing
maintenance sessions described in
proposed § 410.79(c)(1)(ii) and (iii),
MDPP suppliers are required to offer 24
ongoing maintenance sessions,
furnished at least once per month over
the course of months 13 through 36 of
the MDPP services period, in 3-month
consecutive increments. These
requirements would also apply to any
MDPP supplier who gains a beneficiary
at some point during their receipt of
MDPP services. Should this MDPP
supplier begin furnishing services to a
beneficiary at any point during the 3year MDPP services period, it must
continue to offer the services for which
the beneficiary is eligible but has not yet
received. For example, if a beneficiary
changed suppliers after the core
sessions in month 6, the subsequent
supplier would be required to offer core
maintenance sessions for months 7
through 12, and ongoing maintenance
sessions should the beneficiary remain
eligible for these services.
We also are soliciting public
comments on a potential future policy
to require a specific class size limit for
MDPP sessions. While we acknowledge
that MDPP services may be successfully
furnished in group settings, we believe
that it is important to ensure that the
group’s size is appropriately set such
that each beneficiary gains the necessary
interaction with the coach furnishing
the session to properly learn the
curriculum. We considered different
mechanisms to ensure this program
objective, and are requesting public
comments on considerations to date.
The mechanism that currently seems
most viable would require a limitation
on the number of total attendees in a
given session taught by an individual
coach. Based on CDC’s experience with
the DPP program and review of the
literature on appropriate class sizes for
educational settings, we considered
including a class size limitation of 30
participants per coach in a given session
(including Medicare beneficiaries).
Given that limited data currently exist
on this type of requirement among DPP
sessions, we are soliciting public
comments on what an appropriate class
size limitation would be, including any
evidence to support such a proposal.
Furthermore, we are soliciting public
comments on how MDPP suppliers who
furnish sessions in no specific
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sequential order and allow drop ins
would balance the requirement of
providing beneficiary access with a
class size requirement for a given
session. For example, if a supplier offers
classes multiple times a week and gives
beneficiaries flexibility regarding when
to participate, we questioned whether a
certain class size limitation could force
a supplier to turn away a beneficiary
seeking to attend a session at a time
when attendance is high, and in so
doing potentially discourage continued
use of the set of MDPP services. In
addition, we are unsure of any
implications that would result from
establishing a class size restriction for
MDPP services while acknowledging
that MDPP beneficiaries may participate
in DPP sessions with non-Medicare
beneficiaries who may not face the same
class size limitation. Given these
considerations, we are soliciting public
comments on how we could structure
this proposal in the future that would
achieve the programmatic goals of
effectively furnishing the DPP
curriculum to Medicare beneficiaries in
a manner and setting that contributes to
positive behavioral changes and
ultimately less progression to type 2
diabetes. In providing comments on this
approach, we encourage the submission
of data and evidence to justify what
specific class size would be appropriate
for MDPP suppliers.
(5) Disclosure
We are proposing, at § 424.205(d)(11),
that MDPP suppliers must provide
information about the MDPP expanded
model to each beneficiary to whom it
furnishes MDPP services as specified by
CMS. This includes detailed
information on coverage for the set of
MDPP services, the once-per-lifetime
limit, on eligibility requirements, and
the MDPP supplier standards. We
recognize that many aspects of the
MDPP expanded model are novel for
both beneficiaries and suppliers, and we
desire that both parties are well
informed. Therefore, we believe that
requiring the supplier to fully disclose
information about the MDPP expanded
model, coverage, and the MDPP
supplier standards will help inform all
parties. We intend to provide a specific
template for the MDPP supplier to use
to disclose this information to the
beneficiaries. For this reason, we do not
believe that requiring this type of
disclosure places a significant burden
on the supplier. While we believe that
this approach will help to address the
policy goals of the MDPP expanded
model, we are inviting public comments
on this approach, particularly upon the
provision of a standard CMS disclosure
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notification as compared to CMS
providing MDPP suppliers with
information they could use to their own
disclosure notification materials. Along
these lines, we would like to highlight
that we also intent to publish
information on MDPP in the 2019
Medicare & You Handbook.
We invite public comments on these
proposals.
(6) Beneficiary Complaints
We are proposing that MDPP
suppliers must answer Medicare
beneficiaries’ questions about MDPP
services and respond to MDPP related
complaints within a reasonable
timeframe in proposed § 424.205(d)(12).
We also are proposing that MDPP
suppliers implement a complaint
resolution protocol and maintain
documentation of all beneficiary contact
regarding such complaints, including
the name and Medicare Beneficiary
Identifier of the beneficiary, a summary
of the complaint, related
correspondences, notes of actions taken,
and the names and/or NPIs of
individuals who took such action on
behalf of the MDPP supplier. We are
proposing that this information must be
kept at a supplier’s administrative
location and made available to CMS or
its contractors upon request. These
records would adhere to the same
recordkeeping requirements in
§ 424.205(g), and therefore, would need
to be maintained for 10 years. While
other records are typically required to
be held only for 7 years (per
§ 424.516(f)), given that the MDPP
expanded model includes beneficiary
engagement incentive (described further
in section III.K.2.f.v.) which typically
requires an extended documentation
requirement, we considered it important
to align all recordkeeping requirements
for the MDPP expanded model. As
noted earlier in this section, we are
proposing at § 424.205(d)(15) that an
MDPP supplier must allow CMS or its
agents to conduct recordkeeping
reviews to ascertain the supplier’s
compliance with these standards, as
well as documentation requirements as
outlined in § 424.205(g).
We believe our proposal that MDPP
suppliers must answer, respond to, and
document beneficiary complaints and
resolutions establishes a tracking
mechanism to determine whether or not
suppliers are adequately addressing
beneficiary concerns. We find this
requirement particularly important
given that complaint procedures
provide a good way to ensure best
practices by suppliers. Moreover,
DMEPOS supplier standards contain a
requirement regarding maintaining
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complaint procedures. Although we
acknowledge that this method requires
the MDPP suppliers to self-attest to
complaints, requiring such
documentation as a required Medicare
standard can help to build
accountability to following through with
complaint resolution. Additionally,
mandating that suppliers take and
maintain records of complaints may
help to address situations where
beneficiaries raise issues directly to us
after failing to receive resolution from
the supplier directly.
We believe that requiring this
documentation would provide an
additional mechanism for us to ensure
that the supplier is fully disclosing
information pertinent to the supplier
standards, specifically those regarding
beneficiary access, and other concerns.
As an additional benefit of this policy,
if a beneficiary is denied access, the
MDPP supplier would be required to
demonstrate the reasoning behind this
approach, and we could have an
opportunity to review if this reasoning
complied with the proposed standard
under § 424.205(d)(8).
This approach is consistent with
supplier standards for other Medicare
suppliers, including those for Durable
Medical Equipment Prosthetics,
Orthotics, and Supplies (DMEPOS)
suppliers. Given that CMS has imposed
similar standards regarding supplier
responsibility for addressing
beneficiaries’ complaints among other
supplier types, we do not believe that
requiring a similar such requirement
poses an undue burden on MDPP
suppliers. Rather, we believe that this
approach can facilitate beneficiary
satisfaction with the services suppliers
furnish by requiring that beneficiary
complaints are acknowledged, resolved,
and tracked appropriately. We believe
that this approach will help ensure that
the supplier is meeting beneficiaries’
needs as they relate to the MDPP
expanded model. In addition, we
believe that this will help ensure the
integrity of the MDPP expanded model.
We invite public comments on these
proposals.
(7) MDPP Expanded Model Evaluation
Compliance
In the CY 2017 PFS final rule, we
finalized a requirement for MDPP
suppliers to maintain and submit to
CMS a crosswalk file that documented
how the beneficiary identifiers
submitted to CMS for billing and the
beneficiary identifiers submitted to CDC
for session-level performance data
linked to the same beneficiary as a
documentation retention and provision
requirement (existing § 424.59(b),
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proposed to be redesignated and
amended as § 424.205(e) in this
proposed rule). CMS will use this
crosswalk for evaluation purposes so
CMS can review session level data that
MDPP suppliers provide to CDC to
supplement the claims data we receive
directly from MDPP suppliers. We
indicated that we would provide
additional information on format and
frequency of this reporting requirement
in future rulemaking or administrative
guidance as appropriate. We are
proposing the maintenance and
submission of the crosswalk as an
MDPP supplier standard and are
providing additional details regarding
the format and frequency. We are
proposing that the crosswalk file would
contain Medicare Health Insurance
Claims Numbers or Medicare
Beneficiary Identifiers and the unique
participant identifier assigned by the
organization, for the purposes of CDC
performance data reporting, for each
beneficiary receiving MDPP services
(proposed § 424.205(d)(13)).
Beneficiaries for whom at least one
Medicare claim was submitted by an
MDPP supplier would be required to be
included in the crosswalk. We are
proposing that the crosswalk be
supplied to CMS, or our contractor,
beginning 6 months after the
organization begins furnishing MDPP
services, and quarterly thereafter. The
crosswalk would be maintained in a
spreadsheet (for example, an Excel file
or a CSV file), in a form and manner as
specified by CMS. We are inviting
public comments on this approach.
Additionally, to enable evaluation of
MDPP services for a beneficiary’s entire
MDPP services period (that is, up to 3
years), we are proposing that MDPP
suppliers must submit performance data
for any beneficiaries who attend
ongoing maintenance sessions in a
manner and form as specified by CMS
(proposed § 424.205(d)(14)). This
proposal serves to ensure that MDPP
suppliers provide session-level data for
ongoing maintenance sessions that are
consistent with the data they are already
providing to CDC for the core MDPP
services period. This requirement is
necessary given that session-level
performance data plays a critical role in
the Innovation Center’s evaluation of
the entirety of the MDPP expanded
model. Without such data, the
Innovation Center would lack any
streamlined method of obtaining
session-level data for ongoing
maintenance sessions furnished to
MDPP beneficiaries. We are proposing
that this performance data must align
with the performance date elements as
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standards. We are soliciting public
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v. MDPP Supplier Revalidation
In the CY 2017 PFS final rule, we
specified that newly enrolling MDPP
suppliers as high categorical risk in
accordance with § 424.518(c), but we
did not address the risk level of MDPP
suppliers upon revalidation. Section
6401(a) of the Affordable Care Act
established that all Medicare suppliers
must revalidate their enrollments as a
program integrity measure. Upon
revalidation, suppliers are screened for
their continued enrollment in Medicare.
While MDPP suppliers enroll at the high
risk level, we are proposing, at
§ 424.205(b)(3)(ii), that MDPP suppliers
would revalidate under a moderate risk
level in accordance with § 424.518(b).
We believe that this approach is
appropriate, given that fingerprint-based
criminal history record checks through
the Federal Bureau of Investigation’s
Integrated Automated Fingerprint
Identification System requirement for
‘‘high’’ categorical risk and will have
already been completed upon initial
enrollment. In addition, we believe that
this approach is appropriate, given its
consistency with other providers and
suppliers who initially enroll under
‘‘high’’ categorical risk, but revalidate
under ‘‘moderate’’ categorical risk, such
as DMEPOS suppliers and Home Health
Agencies. We also are proposing, at
§ 424.205(b)(6), as a condition of
enrollment, that MDPP suppliers must
agree to revalidate their enrollment
every 3 years, consistent with DMEPOS
suppliers who are initially screened
under ‘‘high’’ categorical risk screening
level. While we believe that this
approach is appropriate for MDPP
suppliers, we welcome public
comments on these proposals. Interested
parties can learn more information on
revalidation available on the CMS Web
site at https://www.cms.gov/medicare/
provider-enrollment-and-certification/
medicareprovidersupenroll/
revalidations.html.
We invite comment on the proposed
risk level upon revalidation, as well as
the frequency with which MDPP
suppliers must revalidate their
enrollment.
vi. Documentation Retention and
Provisions Requirements
We are proposing that the following
requirements would apply to records
related to a MDPP supplier’s
compliance with the MDPP expanded
model (codified at § 424.59(b),
redesignated as amended at
§ 424.205(g)). We believe that these
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proposals will increase supplier
recordkeeping accuracy, and clarify
documentation retention requirements.
Specifically, we are proposing that an
MDPP supplier must:
• Provide to CMS or its contractors,
the OIG, and the Comptroller General or
their designee(s) scheduled and
unscheduled access to all books,
contracts, records, documents, and other
evidence sufficient to enable the audit,
evaluation, inspection, or investigation
of the supplier’s compliance with MDPP
requirements, including the MDPP
expanded model requirements for inkind beneficiary incentive engagements
found in § 424.210 in the event that the
MDPP supplier chooses to offer such
incentives to any MDPP beneficiary.
• Maintain all such books, contracts,
records, documents, and other evidence
for a period of 10 years from the last day
of the MDPP beneficiary’s receipt of
MDPP services furnished by the MDPP
supplier or from the date of completion
of any audit, evaluation, inspection, or
investigation, whichever is later,
unless—
++ CMS determines that there is a
special need to retain a particular record
or group of records for a longer period
and notifies the MDPP supplier at least
30 calendar days before the normal
disposition rate; or
++ There has been a dispute or
allegation of fraud or similar fault, as
defined at § 405.902, against the MDPP
supplier, in which case the records must
be maintained for an additional 6 years
from the date of any resulting final
resolution of the dispute or allegation of
fraud or similar fault.
We believe these modifications
increase the likelihood of
operationalizing MDPP program
integrity strategies that include audits,
evaluations, inspections, or
investigations, and that they provide
additional clarity on documentation
retention for ongoing program integrity.
In addition, in the CY 2017 PFS
established supplier requirements for
documentation and recordkeeping
(codified at § 424.59(b), proposed to be
redesignated and amended at
§ 424.205(g). In this proposed rule, we
are modifying these requirements to
improve clarity. We are proposing at
§ 424.205(g)(1) and (g)(2) to require that
documentation must be established
contemporaneous to the furnished
MDPP services, which we believe is
important for accuracy. We are also
proposing that for the initial core
session, these records must include the
following organizational information:
• The organizational name, CDC
DPRP organization number, and
organizational NPI;
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• Basic beneficiary information
including but not limited to beneficiary
name, HICN, and age; and
• Evidence that each such beneficiary
satisfied the eligibility requirements
under § 410.79(c) at the time of service.
For each additional session, we
propose that these records must include:
• Documentation of the type of
session, whether a core session, a core
maintenance session, an ongoing
maintenance session, an in-person
make-up session, or a virtual make-up
session.
• Identification of which CDCapproved DPRP curriculum was
associated with each session.
• The NPI of the coach who furnished
the session.
• The date and place of service of the
session.
• Each MDPP’s beneficiary’s weight
and date weight taken, in a form and
manner as specified by CMS.
We believe that this information will
play an important role in documenting
the provision of MDPP services and
fidelity to the requirements established
for the expanded model. Finally, at
§ 424.205(g)(3), we are proposing that
MDPP suppliers must maintain and
handle any beneficiary Personally
Identifiable Information (PII) and
Personal Health Information (PHI) in
compliance with HIPAA, other state and
federal privacy laws, and CMS
standards. We believe these proposals
will improve supplier recordkeeping
accuracy and lessen the possibility of
incomplete records and supplier
recordkeeping variations.
We are inviting public comments on
our proposed documentation and
maintenance of records requirements,
including whether additional or
different requirements may provide
better program integrity safeguards.
f. Beneficiary Engagement Incentives
Under the MDPP Expanded Model
We believe that the MDPP expanded
model would encourage MDPP
suppliers to furnish high quality and
engaging health behavior change
services to MDPP beneficiaries that lead
to improved beneficiary health and
reductions in Medicare spending. We
further believe that one mechanism that
may be useful to the MDPP suppliers in
achieving these goals would be allowing
MDPP suppliers to furnish certain inkind items and services to their MDPP
beneficiaries during the core services
period and ongoing services period
(described at proposed § 410.79(c)(2)).
Under such an approach, the costs of
these beneficiary engagement incentives
would be borne by the MDPP supplier.
However, we believe that certain
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conditions on these incentives are
necessary to ensure that they would be
furnished solely for the purpose of
achieving the MDPP goal of engaging
beneficiaries in making sustainable,
healthy behavior changes to reduce their
risk of type 2 diabetes.
We are proposing to establish the
rules governing the furnishing of
beneficiary engagement incentives to
MDPP beneficiaries under the MDPP
expanded model at new § 424.210. As
discussed in section III.K.2.a. of this
proposed rule, we are proposing that
MDPP services would be available
beginning on April 1, 2018. Therefore,
because there would be no MDPP
beneficiaries who could receive
beneficiary engagement incentives from
MDPP suppliers until on or after April
1, 2018, we are proposing that the
effective date of § 424.210 would be
April 1, 2018.
i. Definitions Specific to Beneficiary
Engagement Incentives
We are proposing that if an MDPP
supplier offers an in-kind beneficiary
engagement incentive, the item or
service offered as an incentive must be
furnished by an MDPP supplier to a
MDPP beneficiary during the
engagement incentive period. An
engagement incentive period would
begin when an MDPP supplier furnishes
any MDPP service to an MDPP
beneficiary. As proposed at § 424.210(a),
the term ‘‘engagement incentive period’’
means the period of time during which
an MDPP supplier may furnish in-kind
beneficiary engagement incentives to a
given MDPP beneficiary to whom the
MDPP supplier is furnishing MDPP
services. The engagement incentive
period would end upon the earliest of
the following: The beneficiary’s MDPP
services period ends (as specified in
proposed § 410.79(c)(3)) for any reason;
the MDPP supplier knows the MDPP
beneficiary will no longer be receiving
MDPP services from the MDPP supplier;
or the MDPP supplier has not had direct
contact, either in person, by telephone,
or via other telecommunications
technology, with the MDPP beneficiary
for more than 90 consecutive calendar
days during the MDPP services period.
We are proposing that items and
services may only be furnished as inkind beneficiary engagement incentives
during the engagement incentive period.
This is to ensure that the flexibilities
that MDPP suppliers would be afforded
under these proposed regulations to
furnish free items and services to
Medicare beneficiaries only apply while
the beneficiary is an MDPP beneficiary
being offered MDPP services by that
MDPP supplier. Once the MDPP
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beneficiary’s engagement incentive
period ends with an MDPP supplier, all
existing laws and regulations would
apply to the furnishing of free items and
services to a Medicare beneficiary by the
entity that is an MDPP supplier.
Limiting the furnishing of beneficiary
engagement incentives under the MDPP
expanded model to the engagement
incentive period with a particular MDPP
supplier serves as a safeguard against
the furnishing of free items and services
to Medicare beneficiaries to steer them
toward particular providers, suppliers,
or other services, rather than to engage
MDPP beneficiaries in healthy behavior
changes that reduce their incidence of
type 2 diabetes.
During the course of the MDPP
services period, an MDPP beneficiary
may begin and end multiple engagement
incentive periods, and, to the extent
feasible, the MDPP beneficiary would
not be in more than one engagement
incentive period at the same time. For
example, where, after receiving MDPP
services from MDPP supplier A, an
MDPP beneficiary notifies MDPP
supplier A that he or she has chosen to
receive MDPP services from MDPP
supplier B and subsequently receives
MDPP services from MDPP supplier B,
the first engagement incentive period
ends when MDPP supplier A is told by
the MDPP beneficiary that he or she will
no longer attend MDPP services with
MDPP supplier A. A new engagement
incentive period begins when the MDPP
beneficiary receives his or her first
MDPP service from MDPP supplier B.
Additionally, where an MDPP
beneficiary begins an engagement
incentive period with an MDPP supplier
and the engagement incentive period
has ended because the MDPP supplier
has not had direct contact, either in
person, by telephone, or via other
telecommunications technology, with
the MDPP beneficiary for 90 consecutive
days during the MDPP services period,
should that MDPP beneficiary receive
MDPP services from that MDPP supplier
on day 100, a new engagement incentive
period would begin.
These proposals for the definitions
specific to beneficiary engagement
incentives are included at proposed
§ 424.210(a). We are inviting public
comments on these proposed definitions
specific to furnishing in-kind
beneficiary engagement incentives.
ii. General Conditions for Beneficiary
Engagement Incentives
We are proposing, at § 424.210(b), that
an MDPP supplier may choose to
furnish items or services as in-kind
beneficiary engagement incentives to an
MDPP beneficiary only during the
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engagement incentive period, subject to
a number of additional conditions as
program safeguards. Under this
proposal, the in-kind items and services
furnished as beneficiary engagement
incentives under the MDPP expanded
model would not be Medicare-covered
items or services.
We are proposing that the engagement
incentive must be furnished directly by
an MDPP supplier or by an agent of the
MDPP supplier under the MDPP
supplier’s direction and control, such as
a coach, to an MDPP beneficiary. As
established in the § 410.79(b) in the CY
2017 PFS final rule, coach refers to an
individual who furnishes MDPP
services on behalf of an MDPP supplier
as an employee, contractor, or
volunteer. We considered whether this
policy on beneficiary engagement
incentives should extend to entities
other than MDPP suppliers and their
agents that may refer to or furnish
MDPP services during an engagement
incentive period.
However, given that MDPP suppliers
maintain the responsibility to ensure the
integrity of MDPP programs and would
be best positioned to comply with
beneficiary engagement incentive
documentation and technology retrieval
requirements proposed at § 424.210(e)
and (c), respectively, we believe that
they are best suited to furnished
beneficiary engagement incentives. We
are proposing that the item or service
furnished as a beneficiary engagement
incentive must be reasonably connected
to the CDC-approved curriculum taught
by an MDPP supplier to an MDPP
beneficiary during a core session, a core
maintenance session, or an ongoing
maintenance session. For example,
under this proposal, an MDPP supplier
could furnish beneficiary engagement
incentives such as gym memberships to
reduce barriers associated with
beneficiary achievement of physical
activity recommended as part of the
CDC-approved curriculum, but they
could not furnish theater tickets, which
would bear no reasonable connection to
the CDC-approved curriculum.
Similarly, MDPP suppliers may offer
incentives such as onsite child care
when the MDPP beneficiary attends
MDPP services or transportation
vouchers to the site of MDPP services
that may reduce barriers to beneficiary
attendance at MDPP services, but they
could not furnish attendance awards
such as movie tickets or retail gift cards,
which would have no reasonable
connection to the CDC-approved
curriculum. Likewise, this proposal
would allow MDPP suppliers to furnish
equipment that is reasonably necessary
for the curriculum being taught to the
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beneficiary, such as digital scales to
track and document patient weight or
pedometers to track physical activity,
but not broadly used technology that is
more valuable to the beneficiary, such
as a smartphone. If an MDPP supplier
were to furnish a smartphone at no cost
to an MDPP beneficiary, a reasonable
inference arises that the technology
would not be reasonably connected to
the curriculum being taught to the
beneficiary. Among other things, this
safeguard precludes incentives that
might serve to induce beneficiaries
inappropriately to receive other services
than MDPP services from the MDPP
supplier.
We also are proposing that the
beneficiary engagement incentive must
be a preventive care item or service, or
an item or service that advances a
clinical goal for an MDPP beneficiary as
described in section III.K.2.f.iv. of this
proposed rule by engaging him or her in
better managing his or her own health.
This ensures that a relationship between
the incentive and the goals of the MDPP
expanded model exists so that the
beneficiary engagement incentive is
necessary for testing the expanded
MDPP model. Under this proposed
condition, we note that beneficiary
engagement incentives may not be
offered to an MDPP beneficiary as a
reward for achievement of a specified
outcome, such as losing weight or
attending a certain number of sessions,
unless the beneficiary engagement
incentive meets all the proposed
conditions, including that it is
reasonably connected to the CDCapproved DPP curriculum furnished to
the MDPP beneficiary during a core
session, a core maintenance session, or
an ongoing maintenance session by the
MDPP supplier and that it is a
preventive care item or service or it
advances a clinical goal for an MDPP
beneficiary by engaging him or her in
better managing his or her own health.
Furnishing in-kind patient engagement
incentives upon achievement of an
outcome may not advance a clinical goal
for an MDPP beneficiary by engaging
him or her in better managing his or her
own health unless there are clinical
goals that the incentive itself can
continue to advance. We are further
proposing that the item or service
furnished as a beneficiary engagement
incentive must not be tied to the receipt
of items or services outside the MDPP
services, and that the item or service
must not be tied to the receipt of items
or services from a particular provider,
supplier, or coach. These provisions
provide safeguards against the
furnishing of in-kind beneficiary
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engagement incentives to steer
beneficiaries toward certain providers,
suppliers, or coaches for services
outside MDPP services.
We note that in some circumstances,
an item or service may be linked to an
MDPP supplier and be offered to the
MDPP supplier’s MDPP beneficiaries as
part of the CDC-approved curriculum
that must be furnished during the MDPP
services period, rather than being
offered to steer the MDPP beneficiary to
a particular provider, supplier, or coach.
In these situations, we believe the item
or service may be furnished as a
beneficiary engagement incentive
without violating the requirement that
the item or service not be tied to the
receipt of the items or services from a
particular provider, supplier, or coach.
For instance, where an MDPP supplier
offers a gym membership as a
beneficiary engagement incentive, we
understand that the gym membership
must be tied to a particular supplier of
services so that the beneficiary can use
the membership. However, in this case,
the gym membership would be linked to
the MDPP supplier that, in compliance
with the curriculum that must be
furnished during the MDPP services
period, is teaching MDPP beneficiaries
how to utilize a physical fitness regime
to meet the MDPP goal of reducing an
MDPP beneficiary’s risk of developing
diabetes, rather than being furnished to
steer the MDPP beneficiary to a
particular supplier. Therefore, we
believe that gym memberships may be
furnished as a beneficiary engagement
incentive without violating the
requirement that the item or service not
be tied to the receipt of items or services
from a particular provider, supplier, or
coach as long as the gym membership is
reasonably connected to the CDCapproved curriculum and not being
furnished to steer the MDPP beneficiary
to a particular supplier.
We are proposing that, in general, the
availability of the items or services
furnished as beneficiary engagement
incentives must not be advertised or
promoted as in-kind beneficiary
engagement incentives available to an
MDPP beneficiary receiving MDPP
services from the MDPP supplier.
However, an MDPP beneficiary may be
made aware of the availability of the
items or services at the time the MDPP
beneficiary could reasonably benefit
from them during the engagement
incentive period. This condition
provides a safeguard against the
advertisement of in-kind patient
engagement incentives to beneficiaries
based on their perceived ability to meet
the performance goals of attendance and
weight loss as described at proposed
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§ 414.84(a) and associated with the
MDPP performance payments proposed
at § 414.84(b). The proposed payment
structure for MDPP services largely
relies on the achievement of these
performance goals. Therefore,
advertising patient engagement
incentives to encourage participation of
MDPP-eligible beneficiaries most likely
to meet the attendance and weight loss
performance goals could produce
financial gain for MDPP suppliers that
is not related to the quality and efficacy
of the MDPP supplier’s MDPP services.
In addition, prohibiting the
advertisement or promotion of in-kind
beneficiary engagement incentives
available to an MDPP beneficiary
receiving MDPP services from the MDPP
supplier except that an MDPP
beneficiary may be made aware of the
availability of the items or services at
the time the MDPP beneficiary could
reasonably benefit from them during the
engagement incentive period provides a
safeguard against using the incentive to
steer a beneficiary toward a particular
MDPP supplier. Beneficiaries would not
be made aware of the availability of
beneficiary engagement incentives until
the MDPP beneficiary was in an
engagement incentive period, which
would begin when an MDPP supplier
furnished its first MDPP service to the
beneficiary. At that point in time, the
beneficiary would have already selected
that MDPP supplier to furnish his or her
MDPP services so the incentive could
not be used to steer the beneficiary to
that MDPP supplier. We note that we do
not intend for beneficiary engagement
incentives proposed for the MDPP
expanded model to alter an MDPP
supplier’s market share for an MDPP or
non-MDPP item or service.
Finally, we are proposing that the cost
of the items or services offered as inkind beneficiary engagement incentives
must not be shifted to another Federal
health care program, as defined at
section 1128B(f) of the Act. This
requirement affirms that the cost of any
beneficiary engagement incentive
offered by an MDPP supplier is the sole
responsibility of the MDPP supplier,
and the furnishing of a beneficiary
engagement incentive, for instance,
must not result in increased payments
to the MDPP supplier by Federal health
care programs for other items or
services.
These proposals for the general
conditions for in-kind beneficiary
engagement incentives are included at
proposed § 424.210(b). We are inviting
public comments on these proposed
general conditions for furnishing
beneficiary engagement incentives. In
addition, we are inviting public
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comments on additional or alternative
program integrity safeguards.
iii. Technology Furnished to a MDPP
Beneficiary
In some cases, items or services
involving technology may be useful as
beneficiary engagement incentives
because they can advance a clinical goal
of the MDPP expanded model by
engaging an MDPP beneficiary in
managing his or her health. However,
we believe specific enhanced safeguards
are necessary for these items and
services to prevent abuse.
First, we are proposing that items or
services involving technology furnished
by an MDPP supplier to its MDPP
beneficiary may not, in the aggregate,
exceed $1,000 in retail value for any one
MDPP beneficiary. We believe that this
proposed limit is appropriate, in
conjunction with our proposed
enhanced requirements for items of
technology with a retail value greater
than $100 as discussed subsequently in
this section. The proposed $1,000
limitation would allow sufficient MDPP
supplier flexibility to furnish items or
services involving technology as
beneficiary engagement incentives to
improve the likelihood of the
beneficiary’s achievement and
maintenance of the required minimum
weigh loss. The proposed limitation
would not allow the furnishing of items
of technology that in the aggregate
constitute an excessively high value to
the beneficiary that could increase the
risk that the items of technology would
not be in compliance with all of the
proposed requirements for beneficiary
engagement incentives.
For example, under this proposal, an
MDPP beneficiary who begins receiving
MDPP services from an MDPP supplier
and who, after receiving MDPP services
from that MDPP supplier, is furnished
items or services of technology with a
total retail value of $1,000 may not
receive additional items or services of
technology from that MDPP supplier.
Therefore, an MDPP beneficiary may
receive from a MDPP supplier a tablet
valued at $700 that is preloaded with
weight loss and fitness tracking apps
that would support the beneficiary’s
weight loss goals under the MDPP
expanded model and also receive from
the same MDPP supplier a fitness
tracking watch valued at $200 that
uploads and monitors fitness data to the
tablet, but he or she could not then
receive additional items of technology
from the MDPP supplier with an
aggregate retail value greater than $100
as this would exceed the $1,000 limit.
In addition, if the same MDPP
beneficiary chooses to receive MDPP
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services from another MDPP supplier,
the subsequent supplier is under no
obligation to determine the value of any
items or services of technology
furnished to the MDPP beneficiary by
other MDPP suppliers, and may furnish
items or services of technology to the
MDPP beneficiary so long as those items
or services furnished by the subsequent
supplier are the minimum necessary to
advance a clinical goal for the MDPP
beneficiary, are furnished during the
engagement incentive period, and do
not, in aggregate, exceed $1,000 in retail
value. We note that, while items of
technology must be furnished to the
MDPP beneficiary during an
engagement incentive period, the $1,000
limit for items of technology that may be
furnished to any one MDPP beneficiary
by any one MDPP supplier is not
otherwise affected by the engagement
incentive period. For example, if an
MDPP beneficiary begins and ends
multiple engagement incentive periods
with the same MDPP supplier as
described in section III.K.2.f.i. of this
proposed rule, the $1,000 limit for items
of technology would not ‘‘reset’’ at the
beginning of a new engagement
incentive period with that MDPP
supplier.
We are further proposing that items or
services involving technology furnished
to an MDPP beneficiary must be the
minimum necessary to advance a
clinical goal for MDPP beneficiaries as
discussed in section III.K.2.f.iv. of this
proposed rule.
We are proposing enhanced
requirements for items of technology
exceeding $100 in retail value as an
additional safeguard against misuse of
these items as beneficiary engagement
incentives. We believe it would be
inappropriate for MDPP suppliers to
furnish items of technology with a retail
value of over $100 for beneficiaries’
permanent use because the high value of
these items could unduly influence the
beneficiary to continue to receive MDPP
services from that supplier, or to receive
items or services from the supplier other
than MDPP services. Therefore, we are
proposing that items of technology with
a retail value of over $100 would remain
the property of the MDPP supplier and
be retrieved from the MDPP beneficiary
at the end of the engagement incentive
period. We do not believe that this
requirement would substantially
increase the administrative burden on
MDPP suppliers because a central
facilitator of the success of an MDPP
beneficiary in meeting MDPP
performance goals is the MDPP
supplier’s ability to maintain contact
with the MDPP beneficiary and engage
him or her in MDPP services. We note
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that items of technology with a retail
value of $100 or less could be furnished
as beneficiary engagement incentives
and would remain the property of the
beneficiary. In the case of these items of
a technology with a lower retail value,
we believe the administrative burden of
retrieving these items would outweigh
the program integrity benefits of
retrieval.
We are further proposing that the
MDPP supplier must document all
technology retrieval attempts, including
the ultimate date of retrieval. However,
because we understand that MDPP
suppliers may not always be able to
retrieve these items, such as when a
beneficiary dies or moves to another
geographic area, documented, diligent,
good faith attempts to retrieve items of
technology would be deemed to meet
the retrieval requirement.
Our proposals for enhanced
requirements for technology furnished
to MDPP beneficiaries as beneficiary
engagement incentives under the MDPP
expanded model are included at
proposed § 424.210(c). We are inviting
public comments on our proposed
requirements for beneficiary
engagement incentives that involve
technology and welcome comments on
additional or alternative program
integrity safeguards for this type of
beneficiary engagement incentive,
including whether the financial
thresholds proposed in this section are
reasonable, necessary, and appropriate.
iv. Clinical Goals of the MDPP
Expanded Model
As established at § 410.79(b) in the CY
2017 PFS final rule, MDPP services
furnished to MDPP beneficiaries must
follow a CDC-approved curriculum,
which outlines required and
recommended topics for structured
health behavior change sessions offered
as MDPP services with the goal of
preventing diabetes through long-lasting
health behavior change. MDPP suppliers
seeking recognition under the CDC’s
DPRP must furnish either the CDCpreferred curriculum, based on the
current evidence base, or may develop
their own curriculum. MDPP suppliers
who wish to develop their own
curriculum must submit it to the CDC
for approval. This requirement ensures
that all curricula furnished to MDPP
beneficiaries meet the DPRP’s
curriculum content requirements and
are based on evidence from efficacy and
effectiveness trials consistent with the
current evidence base. To be consistent
with the current evidence base, all
curricula offered by MDPP suppliers
must furnish MDPP services focused on
the overarching goal of preventing type
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2 diabetes in persons at high risk for
diabetes because they have prediabetes.
This requires MDPP suppliers to
emphasize the need to make lasting
health behavior changes, rather than
simply completing a one-time set of
MDPP services that result in the
required minimum weight loss during
the MDPP services period. MDPP
services must also emphasize long-term
improvements in nutrition and physical
activity that contribute to beneficiaries
sustaining weight loss. Therefore, we
believe that in-kind patient engagement
incentives may appropriately be
furnished to support and motivate
MDPP beneficiaries in achieving dietary
and health behavior change and to teach
MDPP beneficiaries to problem-solve
strategies to overcome challenges to
maintaining weight loss and healthy
behaviors, as well as to assist MDPP
beneficiaries in meeting the attendance
and weight loss performance goals of
the MDPP expanded model.
Therefore, we are proposing that the
following would be the clinical goals of
the MDPP expanded model, which may
be advanced through beneficiary
engagement incentives:
• Beneficiary attendance at MDPP
core sessions, core maintenance
sessions, or ongoing maintenance
sessions during the MDPP services
period.
• Beneficiary weight loss.
• Long-term dietary change for the
beneficiary.
• Beneficiary adherence to long-term
health behavior changes.
We note that under this proposal, the
MDPP supplier may not furnish
multiple free meals or meal replacement
services to an MDPP beneficiary over a
substantial portion of the engagement
incentive period because such a practice
would not advance a clinical goal for an
MDPP beneficiary by engaging him or
her in better managing his or her own
health.
When a beneficiary engagement
incentive does not qualify as a
preventive care item or service, our
proposals for the clinical goals of the
MDPP expanded model that a
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beneficiary engagement incentive must
be intended to advance are included at
proposed § 424.210(d). We are inviting
public comments on our proposed
clinical goals of the MDPP, as well as
whether the advancement of additional
or different clinical goals through
beneficiary engagement incentives may
better advance the overarching goals of
the MDPP expanded model, while
maintaining appropriate program
integrity safeguards.
v. Documentation of Beneficiary
Engagement Incentives
As a program safeguard against
misuse of beneficiary engagement
incentives under the MDPP expanded
model, we are proposing that, in
addition to the documentation
requirements for MDPP suppliers at
proposed § 424.205(g), MDPP suppliers
must maintain documentation of items
and services furnished as beneficiary
engagement incentives that individually
exceed $25 in retail value. We recognize
that an MDPP beneficiary could receive
many incentives that are each of low
dollar value but in the aggregate
constitute an excessively high value to
the beneficiary. Therefore, we believe it
is important to incorporate a
documentation threshold at a modest
level for all beneficiary incentives in
order to monitor compliance with the
proposed conditions for furnishing
these items and services. Moreover, we
believe the proposed $25 retail value
threshold strikes an appropriate balance
between beneficiary and program
protections and MDPP supplier
administrative burden.
In addition, we are proposing to
require that the documentation must be
established contemporaneously with the
furnishing of the items and services and
must include at least the date the
incentive was furnished; the identity of
the beneficiary to whom the item or
service was furnished; the agent of the
supplier who furnished the item or
service if applicable; a description of the
item or service; the retail value of the
beneficiary engagement incentive; and
documentation establishing that the
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item or service was furnished to the
MDPP beneficiary during the
engagement incentive period.
In addition to the proposed
requirements in the previous paragraph,
we are further proposing that the
documentation regarding items or
services furnished to the MDPP
beneficiary for use on an ongoing basis
during the engagement incentive period,
including items of technology exceeding
$100 in retail value, must also include
contemporaneous documentation
establishing that the MDPP beneficiary
is in the engagement incentive period
throughout the time period that the
MDPP beneficiary possesses or has
access to the item or service furnished
by the MDPP supplier. For example, if
an MDPP supplier furnishes a gym
membership to an MDPP beneficiary,
the MDPP supplier must maintain
contemporaneous documentation
establishing that the MDPP beneficiary
is in the engagement incentive period
throughout the time period that the
MDPP beneficiary has access to the gym
via the membership furnished by the
MDPP supplier.
In addition to the above requirements,
we are further proposing that the
documentation regarding items of
technology exceeding $100 in retail
value that MSPP suppliers are required
to retrieve from the MDPP beneficiary
must also include contemporaneous
documentation of any attempts to
retrieve the item of technology
furnished by the MDPP supplier from
the MDPP beneficiary as required at
proposed § 424.210(c)(3)(ii). We
reiterate that under our proposal
documented, diligent, good faith
attempts to retrieve items of technology
would be deemed to meet the retrieval
requirement.
Finally, we are proposing that the
MDPP supplier must retain and provide
access to the required documentation in
accordance with proposed § 424.205(g).
Table 35 summarizes the proposed
documentation requirements for
beneficiary engagement incentives
under the MDPP expanded model.
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TABLE 35—PROPOSED BENEFICIARY ENGAGEMENT INCENTIVE DOCUMENTATION REQUIREMENTS
Beneficiary Engagement Incentive
Documentation requirement
Item or service with retail value greater than $25 ...................................
• Contemporaneous documentation that includes at least:
D The date the incentive was furnished.
D The identity of the MDPP beneficiary to whom the item or service was
furnished.
D Documentation establishing that the item or service was furnished to
the MDPP beneficiary during the engagement incentive period.
D The agent of the supplier who furnished the item or service, if applicable.
D A description of the item or service.
D The retail value of the item or service.
• Documentation regarding items or services that are furnished to the
MDPP beneficiary for use on an ongoing basis during the engagement incentive period, including items of technology exceeding $100
in retail value, must also include contemporaneous documentation
establishing that the MDPP beneficiary is in the engagement incentive period throughout the time period that the MDPP beneficiary
possesses or has access to the item or service furnished by the
MDPP supplier.
• The documentation regarding items of technology exceeding $100 in
retail value must also include contemporaneous documentation of
any attempt to retrieve the technology.*
• The MDPP supplier must retain and provide access to the documentation.
* = Items of technology with a retail value greater than $100 remain the property of the MDPP supplier and must be retrieved from the MDPP
beneficiary at the end of the engagement incentive period.
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Our proposals for the documentation
requirements for beneficiary
engagement incentives under the MDPP
expanded model are included at
proposed § 424.210(e). We are inviting
public comments on our proposed
documentation requirements, including
whether additional or different
documentation requirements may
provide better program integrity
safeguards.
vi. Compliance With Fraud and Abuse
Laws
Certain arrangements between MDPP
suppliers and beneficiaries may
implicate the civil monetary penalty
(CMP) law (sections 1128A(a)(5), (b)(1)
and (b)(2) of the Act), or the Federal
Anti-kickback statute (section
1128B(b)(1) and (2) of the Act). In many
cases, arrangements that implicate these
laws can be structured to comply with
them by using existing safe harbors and
exceptions. Section 1115A(d)(1) of the
Act authorizes the Secretary to waive
certain specified fraud and abuse laws
as may be necessary solely for purposes
of testing of models under section
1115A(b) of the Act. A waiver is not
needed for an arrangement that does not
implicate the fraud and abuse laws or
that implicates the fraud and abuse
laws, but either fits within an existing
exception or safe harbor, as applicable,
or does not otherwise violate the law.
Accordingly, pursuant to section
1115A(d)(1) of the Act, the Secretary
will consider whether waivers of certain
fraud and abuse laws are necessary for
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the MDPP expanded model. Such
waivers, if any, would be promulgated
separately from this proposed regulation
by OIG (as to sections 1128A and 1128B
of the Act), to which the respective
authorities have been delegated.
The requirements in the final rule for
the MDPP expanded model will bear on
the need for and scope of any fraud and
abuse waivers that might be granted for
the model. Because of the close nexus
between the final regulations governing
the structure and operations of the
MDPP expanded model and the
development of any fraud and abuse
waivers necessary to carry out the
provisions of the model, CMS and OIG
may, when considering the need for or
scope of any waivers, consider
comments submitted in response to this
proposed rule and the provisions of the
final rule.
3. Virtual DPP and the MDPP Expanded
Model
The CDC’s DPRP standards allow
evidence-based DPP curricula to be
furnished through a variety of modes,
including through remote technologies.
Similar to the description noted in
section III.K.2.c.iv.3 with respect to
virtual make-up sessions, virtual DPP
refers to any modality, or method of
furnishing MDPP services, that is not in
person. This includes, but is not limited
to:
(1) Furnishing services online where
the behavior change program is
furnished 100 percent online, with
participants accessing course resources
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and lifestyle coach via a computer,
laptop, tablet, smart phone, or other
device with internet access. This
modality requires an internet
connection to participate in all aspects
of the DPP;
(2) Furnishing services online with
other means of support by a coach (for
example, telecommunications, video
conferencing). This modality requires an
internet connection for some aspects of
the DPP, but not all; and
(3) Distance learning, where a coach
is present in one location and
participants are calling, videoconferencing, or otherwise using
telecommunications technology to
access the coach from another location.
This modality does not require any
internet connection for any of the
aspects of the DPP.
These types of delivery modes are
hereafter referred to as ‘‘virtual,’’ and
DPP furnished exclusively through these
modes with no in-person delivery is
hereafter referred to as ‘‘virtual DPP.’’
We acknowledge that the public
comments in response to the MDPP
expanded model in the CY 2017 PFS
proposed rule supported the inclusion
of virtual DPP in the MDPP expanded
model. Many commenters stated that
this proposal would increase access to
MDPP services, referenced emerging
evidence that suggests virtual DPP may
be as effective as DPP furnished in a
community setting, and stated that
virtual delivery may be preferable to
some beneficiaries. In the CY 2017 PFS
final rule, we deferred policies pertinent
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to virtual DPP to future rulemaking.
While we propose to allow a limited
number of virtual make-up sessions in
the MDPP expanded model (discussed
in section III.K.2.c.iv.3), we do not
propose to include virtual DPP services
(that is, DPP furnished exclusively
through remote technologies with no inperson delivery) . We considered
including virtual DPP services in the
MDPP expanded model, however, the
DPP model test that was used to make
the statutorily required determination
for expansion did not include virtual
DPP services. Instead, we are
considering a separate model under
CMS’s Innovation Center authority to
test and evaluate virtual DPP services.
Our intention is that any separate model
test of virtual DPP services would run
in parallel with the MDPP Expanded
Model. Consistent with our regular
practice for Innovation Center models,
we would release details on the model
test for virtual DPP services separately.
We note that some DPP suppliers
currently offer DPP services through a
combination of in-person and virtual
delivery. We only propose to allow this
combination of delivery subject to the
requirements on virtual make-up
sessions discussed in section
III.K.2.c.iv.3. The combined-delivery
DPP services that are currently offered
are intended to offer a participant DPP
services through both online and inperson methods. The MDPP expanded
model, in contrast, is intended to offer
participants in-person DPP services
primarily, but allows a limited number
of virtual make-up sessions on an
individual basis. As discussed in
section III.K.2.c.iv.3., there is substantial
research on the effectiveness of DPP
furnished virtually, and emerging
evidence on DPP delivered virtually
suggests that virtual delivery can show
similarly successful participant weight
loss and health benefits to DPP
delivered in other settings, including
among Medicare-age participants.
However, since the DPP model test only
included in-person delivery, we propose
to limit the number of virtuallydelivered make-up sessions to the limits
discussed in section III.K.2.c.iv.3.
An organization may furnish separate
DPPs where some participants receive
only in-person DPP services, others
receive only virtual DPP services, and
others receive a combination program
where some sessions are offered in
person and others virtually. If an
organization that offers multiple distinct
DPPs through different delivery modes
enrolls as an MDPP supplier, we
propose that only DPP services
furnished in person will be paid in the
MDPP expanded model, with the
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exception of virtual make-up sessions as
discussed in section III.K.2.c.iv.3 of this
proposed rule.
We invite public comments on these
policies.
4. Evaluation
We intend to evaluate the MDPP
expanded model using a combination of
encounter and claims data to analyze
the long-term utilization of services by
beneficiaries who have received the
MDPP benefit. As discussed in the CY
2017 PFS final rule, we will continue to
assess whether the MDPP expanded
model is expected to improve the
quality of care without increasing
spending, reduce spending without
reducing the quality of care, or improve
the quality of care and reduce spending,
and we will terminate or modify the
MDPP expanded model if the expanded
model is not expected to meet these
criteria.
Among other possible questions we
might explore, our analysis will
specifically look at long-term utilization
and expenditures that might suggest
subsequent treatment of diabetes. We
intend to use beneficiary-level
encounter data and program data
furnished by CDC and will match these
data to Medicare claims using the
crosswalk finalized at § 424.59(b)(3) of
the CY 2017 PFS final rule (proposed to
be redesignated and amended at
§ 424.205(d)(13)). As with other
Innovation Center model evaluation
reports (which are currently published
online at https://innovation.cms.gov/
Data-and-Reports/), we
intend to publish the MDPP evaluation
annual reports publicly on a CMS Web
site. We refer readers to the supplier
requirements discussed under section
III.K.2.e.iv.(7) of this proposed rule for
the proposal regarding supplier
compliance with this requirement, as
well as specifications on the timing and
format of the crosswalk.
L. Request for Information on CMS
Flexibilities and Efficiencies
CMS is committed to transforming the
health care delivery system—and the
Medicare program—by putting an
additional focus on patient-centered
care and working with providers,
physicians, and patients to improve
outcomes. We seek to reduce burdens
for hospitals, physicians, and patients,
improve the quality of care, decrease
costs, and ensure that patients and their
providers and physicians are making the
best health care choices possible. These
are the reasons we are including this
Request for Information in this proposed
rule.
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As we work to maintain flexibility
and efficiency throughout the Medicare
program, we would like to start a
national conversation about
improvements that can be made to the
health care delivery system that reduce
unnecessary burdens for clinicians,
other providers, and patients and their
families. We aim to increase quality of
care, lower costs improve program
integrity, and make the health care
system more effective, simple and
accessible.
We would like to take this
opportunity to invite the public to
submit their ideas for regulatory,
subregulatory, policy, practice, and
procedural changes to better accomplish
these goals. Ideas could include
payment system redesign, elimination
or streamlining of reporting, monitoring
and documentation requirements,
aligning Medicare requirements and
processes with those from Medicaid and
other payers, operational flexibility,
feedback mechanisms and data sharing
that would enhance patient care,
support of the physician-patient
relationship in care delivery, and
facilitation of individual preferences.
Responses to this Request for
Information could also include
recommendations regarding when and
how CMS issues regulations and
policies and how CMS can simplify
rules and policies for beneficiaries,
clinicians, physicians, providers, and
suppliers. Where practicable, data and
specific examples would be helpful. If
the proposals involve novel legal
questions, analysis regarding CMS’
authority is welcome for CMS’
consideration. We are particularly
interested in ideas for incentivizing
organizations and the full range of
relevant professionals and
paraprofessionals to provide screening,
assessment and evidence-based
treatment for individuals with opioid
use disorder and other substance use
disorders, including reimbursement
methodologies, care coordination,
systems and services integration, use of
paraprofessionals including community
paramedics and other strategies. We are
requesting commenters to provide clear
and concise proposals that include data
and specific examples that could be
implemented within the law.
We note that this is a Request for
Information only. Respondents are
encouraged to provide complete but
concise responses. This Request for
Information is issued solely for
information and planning purposes; it
does not constitute a Request for
Proposal (RFP), applications, proposal
abstracts, or quotations. This Request for
Information does not commit the U.S.
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Government to contract for any supplies
or services or make a grant award.
Further, CMS is not seeking proposals
through this Request for Information
and will not accept unsolicited
proposals. Responders are advised that
the U.S. Government will not pay for
any information or administrative costs
incurred in response to this Request for
Information; all costs associated with
responding to this Request for
Information will be solely at the
interested party’s expense. We note that
not responding to this Request for
Information does not preclude
participation in any future procurement,
if conducted. It is the responsibility of
the potential responders to monitor this
Request for Information announcement
for additional information pertaining to
this request. In addition, we note that
CMS will not respond to questions
about the policy issues raised in this
Request for Information. CMS will not
respond to comment submissions in
response to this Request for Information
in the FY 2018 PFS final rule. Rather,
CMS will actively consider all input as
we develop future regulatory proposals
or future subregulatory policy guidance.
CMS may or may not choose to contact
individual responders. Such
communications would be for the sole
purpose of clarifying statements in the
responders’ written responses.
Contractor support personnel may be
used to review responses to this Request
for Information. Responses to this notice
are not offers and cannot be accepted by
the Government to form a binding
contract or issue a grant. Information
obtained as a result of this Request for
Information may be used by the
Government for program planning on a
nonattribution basis. Respondents
should not include any information that
might be considered proprietary or
confidential. This Request for
Information should not be construed as
a commitment or authorization to incur
cost for which reimbursement would be
required or sought. All submissions
become U.S. Government property and
will not be returned. CMS may
publically post the public comments
received, or a summary of those public
comments.
IV. Collection of Information
Requirements
Under the Paperwork Reduction Act
of 1995 (PRA) (44 U.S.C. chapter 35), 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)
34173
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): (1) The Medicare
Diabetes Prevention Program (MDPP)
Expanded Model, (2) the Physician
Quality Reporting System (PQRS), (3)
appropriate use criteria for advanced
diagnostic imaging services, and (4) the
Medicare Shared Savings Program.
A. Wage Estimates
To derive average costs, we used data
from the U.S. Bureau of Labor Statistics’
May 2016 National Occupational
Employment and Wage Estimates for all
salary estimates (https://www.bls.gov/
oes/current/oes_nat.htm). In this regard,
Table 36 presents the mean hourly
wage, the cost of fringe benefits and
overhead (calculated at 100 percent of
salary), and the adjusted hourly wage.
TABLE 36—NATIONAL OCCUPATIONAL EMPLOYMENT AND WAGE ESTIMATES
Mean hourly
wage
($/hr)
Fringe
benefits and
overhead
costs
($/hr)
Adjusted
hourly wage
($/hr)
Family and General Practitioner ......................................................................
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Occupation title
Occupation
code
29–1062
96.54
96.54
193.08
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.
B. Proposed Information Collection
Requirements (ICRs)
1. ICRs Regarding the Medicare Diabetes
Prevention Program (MDPP) Expanded
Model
In §§ 410.79, 414.84, 424.200,
424.205, 424.210, 424.502, 424.516,
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424.518 and 424.55 of this proposed
rule, we discuss our proposals to further
implement the Medicare Diabetes
Prevention Program (MDPP) Expanded
Model, which is aimed at preventing the
onset of type 2 diabetes among Medicare
beneficiaries with prediabetes. Section
1115A(d)(3) of the Act exempts
Innovation Center model tests and
expansions, which include the MDPP
expanded model, from the provisions of
the PRA. Specifically, this section
provides that the provisions of the PRA
shall not apply to the testing and
evaluation of Innovation Center models
or expansions of such models.
2. ICRs Regarding the Physician Quality
Reporting System (PQRS) (§ 414.90)
While this rule proposes to revise our
PQRS reporting criteria for the 2016
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reporting period to avoid the 2018
payment adjustment, we are not
proposing to accept any additional data
for the 2016 reporting period. In this
regard this rule does not set out any new
or revised burden or requirements that
would trigger the requirements of the
PRA.
3. ICRs Regarding Appropriate Use
Criteria for Advanced Diagnostic
Imaging Services (§ 414.94)
This rule proposes to revise
§ 414.94(i)(3) by reiterating the
availability of a significant hardship
exception for ordering professionals
who demonstrate a significant hardship
consistent with the criteria listed under
§ 495.102(d)(4)(i), (d)(4)(iii), (d)(4)(iv)(A)
or (d)(4)(iv)(B). Consistent with a final
rule that published on November 14,
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2016 (81 FR 79865 through 79866) the
hardship exception process involves the
completion of an application which
imposes no burden beyond the
provision of identifying information and
attesting to the applicable information.
In this regard, the application is not
‘‘information’’ as defined under 5 CFR
1320.3(h), and therefore, is exempt from
requirements of the PRA.
Consistent with section 1834(q)(4)(A)
of the Act (as amended by section 218(b)
of the PAMA), § 414.94(j) proposes to
require that ordering professionals
consult specified applicable AUC
through a qualified clinical decision
support mechanism (CDSM) for
applicable imaging services ordered on
or after January 1, 2019. We propose a
one-time burden associated with a
possible 6-month voluntary consulting
period beginning sometime in 2018, as
well as a mandatory annual burden
beginning January 1, 2019. Because
general practitioners are the largest
group of practitioners who order
applicable imaging services and would
be required to consult AUC under this
program we use ‘‘family and general
practitioner’’ for our estimates below.
During the 6-month voluntary
participation period, we estimate
3,410,000 responses in the form of
consultations based on market research
from current applicants for the
qualification of their CDSMs for
advanced diagnostic imaging services.
Based on feedback from CDSMs with
experience in AUC consultation as well
as standards recommended by the Office
of the National Coordinator (ONC) and
the Healthcare Information Management
Systems Society (HIMSS), we estimate it
would take 2 minutes at $193.08/hr for
a family and general practitioner to use
a qualified CDSM to consult specified
applicable AUC. Per consultation, we
estimate 2 minutes (0.033 hr) at a cost
of $6.37 (0.033 hr × $193.08/hr). In
aggregate, we estimate a one-time
burden of 112,530 hours (0.033 hr ×
3,410,000 consultations) at a cost of
$21,727,292.40 (112,530 hr × $193.08/
hr).
Annually, we estimate 37,510 hours
(112,530 hr/3 yr) at a cost of
$7,242,430.80 ($21,727,292.40/3 yr). We
are annualizing the one-time burden (by
dividing our estimates by OMB’s 3-year
approval period) since we do not
anticipate any additional burden after
the 6-month voluntary participation
period ends.
Beginning January 1, 2019, we
anticipate 43,181,818 responses in the
form of consultations based on the
aforementioned market research, as well
as Medicare claims data for advanced
diagnostic imaging services. As noted
above, we estimate it would take 2
minutes (0.033 hr) at $193.08/hr for a
family and general practitioner to use a
qualified CDSM to consult specified
applicable AUC. In this regard, we
estimate 0.033 hours per consultation at
a cost of $6.37 (0.033 hr × $193.08/hr).
In aggregate, we estimate an annual
burden of 1,425,000 hours (0.033 hr ×
43,181,818 consultations) at a cost of
$275,139,000 (1,425,000 hr × $193.08/
hr).
The consultation requirements and
burden will be submitted to OMB for
approval under control number 0938New (CMS–10654).
Consistent with section 1834(q)(4)(B)
of the Act, we are also proposing to
implement a one-time 6-month
voluntary reporting period beginning
sometime in 2018, as well as a
mandatory annual reporting
requirement beginning January 1, 2019.
Specifically, § 414.94(k) proposes to
require that furnishing professionals
report on the Medicare claims for
advanced diagnostic imaging services,
paid for under an applicable payment
system (as defined in § 414.94(b)) and
ordered on or after January 1, 2019, the
following information: (1) Identify
which qualified CDSM was consulted
by the ordering professional; (2) identify
whether the service ordered would
adhere to specified applicable AUC,
would not adhere to specified
applicable AUC, or whether specified
applicable AUC was not applicable to
the service ordered; and (3) identify the
NPI of the ordering professional (if
different from the furnishing
professional). The proposed reporting
requirement would not have any impact
on any Medicare claim forms because
the forms’ currently approved data
fields, instructions, and burden are not
expected to change. Consequently, there
is no need for review by OMB under the
authority of the PRA.
The timing and implementation of the
voluntary consultation and reporting
period is dependent on the readiness of
the Medicare claims systems to accept
and process claims including AUC
consultation information. Currently, 99
percent of all Medicare claims are
submitted electronically as a result of
The Administrative Simplification
Compliance Act amendment to section
1862(a) of the Act, which prescribes that
no payment may be made under Part B
of the Medicare Program for any
expenses incurred for items or services
for which a claim is received in a nonelectronic form. Consequently, absent
an applicable exception, paper claims
received by Medicare will not be paid.
Continued developments in the
deployment of CDSMs has produced
research 28 and best practices 29 30 31
supporting our position that any such
changes made to respondent IT systems
would be a usual and customary
business practice whose burden is
exempt from the requirements of the
PRA under 5 CFR 1320.3(b).
4. 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 37—PROPOSED ANNUAL REQUIREMENTS AND BURDEN
mstockstill on DSK30JT082PROD with PROPOSALS2
Regulation section(s)
OMB control
number
Respondents
Responses
Burden per
response
(hours)
Total annual
burden
(hours)
Labor cost of
reporting
($/hr)
Total cost
($) *
§ 414.94(j) (voluntary
consultations) ...........
0938-New
3,410,000
1,136,666.67
(3,410,000/3)
0.033
37,510
193.08
7,242,431
§ 414.94(j) (mandatory
consultations) ...........
........................
43,181,818
43,181,818
0.033
1,425,000
193.08
275,139,000
28 CDC Health Information Innovation
Consortium, May 17 2016, available at https://
www.cdc.gov/ophss/chiic/forums/2016-05-17_
index.html.
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29 ONC eCQI resource for process improvement:
bit.ly/oncecqicds.
30 CMS CDS tipsheet: bit.ly/cmscdstips.
PO 00000
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31 HIMSS CDS Guidebook Series: www.himss.org/
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34175
TABLE 37—PROPOSED ANNUAL REQUIREMENTS AND BURDEN—Continued
Regulation section(s)
OMB control
number
Respondents
Total ...............
46,591,818
Responses
Burden per
response
(hours)
44,318,485
0.033
Total annual
burden
(hours)
1,462,510
Labor cost of
reporting
($/hr)
193.08
Total cost
($) *
282,381,431
* With respect to the PRA, this rule would not impose any non-labor costs.
B. Overall Impact
D. 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.
To obtain copies of the supporting
statement and any related forms for the
proposed collections discussed above,
please visit CMS’ Web site at Web site
address at https://www.cms.gov/
Regulations-andGuidance/Legislation/
PaperworkReductionActof1995/
PRAListing.html, 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–1676–P) and
where applicable the ICR’s CFR citation,
CMS ID number, and OMB control
number.
See the DATES and ADDRESSES sections
of this proposed rule for further
information.
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
mstockstill on DSK30JT082PROD with PROPOSALS2
A. Statement of Need
This proposed rule makes payment
and policy changes under the Medicare
PFS and makes required statutory
changes under the MACRA, ABLE,
PAMA, and the Consolidated
Appropriations Act of 2016. This final
rule also makes changes to payment
policy and other related policies for
Medicare Part B, Part D, and Medicare
Advantage.
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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), the Congressional Review Act (5
U.S.C. 804(2)), and Executive Order
13771 on Reducing Regulation and
Controlling Regulatory Costs (January
30, 2017).
Executive Orders 12866 and 13563
direct agencies to assess all costs and
benefits of available regulatory
alternatives and, if regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, distributive impacts, and
equity). A regulatory impact analysis
(RIA) must be prepared for major rules
with economically significant effects
($100 million or more in any 1 year). We
estimate, as discussed in this section,
that the PFS provisions included in this
final 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-small-
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Sfmt 4702
business-size-standards (refer to the
620000 series)). Individuals and states
are not included in the definition of a
small entity.
The RFA requires that we analyze
regulatory options for small businesses
and other entities. We prepare a
regulatory flexibility analysis unless we
certify that a rule would not have a
significant economic impact on a
substantial number of small entities.
The analysis must include a justification
concerning the reason action is being
taken, the kinds and number of small
entities the rule affects, and an
explanation of any meaningful options
that achieve the objectives with less
significant adverse economic impact on
the small entities.
Approximately 95 percent of
practitioners, other providers, and
suppliers are considered to be small
entities, based upon the SBA standards.
There are over 1 million physicians,
other practitioners, and medical
suppliers that receive Medicare
payment under the PFS. Because many
of the affected entities are small entities,
the analysis and discussion provided in
this section, as well as elsewhere in this
final rule is intended to comply with the
RFA requirements regarding significant
impact on a substantial number of small
entities.
For example, the effects of changes to
payment rates for practitioners, other
providers, and suppliers are discussed
in VI.C. of this proposed rule.
Alternative options considered to the
proposed payment rates are discussed
generally in section VI.F of this
proposed rule, while specific
alternatives for individual codes are
discussed throughout this rule,
especially in section II.H.
In addition, section 1102(b) of the Act
requires us to prepare an RIA if a rule
may have a significant impact on the
operations of a substantial number of
small rural hospitals. This analysis must
conform to the provisions of section 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
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determined, and the Secretary certified,
that this final 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 2017, that
threshold is approximately $148
million. This proposed rule will 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.
Executive Order 13771, entitled
Reducing Regulation and Controlling
Regulatory Costs (82 FR 9339), was
issued on January 30, 2017. This
proposed rule is subject to the
requirements of E.O. 13771 because, if
finalized as proposed, it is expected to
result in regulatory costs.
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
implementing a variety of changes to
our regulations, payments, or payment
policies to ensure that our payment
systems reflect changes in medical
practice and the relative value of
services, and implementing 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.
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 2017 with
proposed payment rates for CY 2018
using CY 2016 Medicare utilization. The
payment impacts in this proposed rule
reflect averages by specialty based on
Medicare utilization. The payment
impact for an individual practitioner
could vary from the average and would
depend on the mix of services he or she
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 Laboratory 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 and amended section
1848(d) of the Act to specify the update
adjustment factors for calendar years
2015 and beyond. For CY 2018, the
specified update is 0.5 percent before
applying other adjustments.
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 2018 net reduction in
expenditures resulting from adjustments
to relative values of misvalued codes to
be 0.31 percent. Since this amount does
not meet 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), payments under
the fee schedule must be reduced by the
difference between the target for the
year and the estimated net reduction in
expenditures, known as the target
recapture amount. As a result, we
estimate that the CY 2018 target
recapture amount will produce a
reduction to the conversion factor of
¥0.19 percent.
To calculate the proposed conversion
factor for this year, we multiplied the
product of the current year conversion
factor and the update adjustment factor
by the target recapture amount and the
budget neutrality adjustment described
in the preceding paragraphs. We
estimate the CY 2018 PFS conversion
factor to be 35.9903, which reflects the
budget neutrality adjustment, the 0.5
percent update adjustment factor
specified under section 1848(d)(18) of
the Act, and the ¥0.31 percent target
recapture amount required under
section 1848(c)(2)(O)(iv) of the Act and
described above. We estimate the CY
2018 anesthesia conversion factor to be
22.0353, which reflects the same overall
PFS adjustments, as well as an
additional adjustment due to an update
to the malpractice risk factor for the
anesthesia specialty.
TABLE 38—CALCULATION OF THE PROPOSED CY 2018 PFS CONVERSION FACTOR
Conversion factor in effect in CY 2017
35.8887
Update Factor ...............................................................................................................
CY 2018 RVU Budget Neutrality Adjustment ..............................................................
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0.50 percent (1.0050) ...............................
¥0.03 percent (0.9997) ............................
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21JYP2
........................
........................
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TABLE 38—CALCULATION OF THE PROPOSED CY 2018 PFS CONVERSION FACTOR—Continued
Conversion factor in effect in CY 2017
35.8887
CY 2018 Target Recapture Amount ............................................................................
CY 2018 Conversion Factor .........................................................................................
¥0.19 percent (0.9981) ............................
...................................................................
........................
35.9903
TABLE 39—CALCULATION OF THE PROPOSED CY 2018 ANESTHESIA CONVERSION FACTOR
CY 2017 national average anesthesia
conversion factor
22.0454
Update Factor ...............................................................................................................
CY 2018 RVU Budget Neutrality Adjustment ..............................................................
CY 2018 Target Recapture Amount ............................................................................
CY 2018 Anesthesia Fee Schedule Practice Expense and Malpractice Adjustment
CY 2018 Conversion Factor .........................................................................................
Table 40 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 40 (CY 2018 PFS
Estimated Impact on Total Allowed
Charges by Specialty). The following is
an explanation of the information
represented in Table 40.
• Column A (Specialty): Identifies the
specialty for which data are shown.
• Column B (Allowed Charges): The
aggregate estimated PFS allowed
charges for the specialty based on CY
2016 utilization and CY 2017 rates. That
0.50 percent (1.0050) ...............................
¥0.03 percent (0.9997) ............................
¥0.19 percent (0.9981) ............................
¥0.33 percent (0.9967) ............................
...................................................................
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 2018 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 2018 impact on total
........................
........................
........................
........................
22.0353
allowed charges of the changes in the PE
RVUs.
• Column E (Impact of MP RVU
Changes): This column shows the
estimated CY 2018 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 2018
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 40—CY 2018 PFS ESTIMATED IMPACT ON TOTAL ALLOWED CHARGES BY SPECIALTY *
mstockstill on DSK30JT082PROD with PROPOSALS2
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 ........................................
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(C)
Impact of
work RVU
changes
(percent)
(B)
Allowed
charges
(mil)
(A)
Specialty
PO 00000
Frm 00229
$92,628
245
2,009
66
311
6,671
772
756
664
166
332
3,475
765
3,176
477
6,307
1,792
452
2,154
211
200
1,802
684
651
11,022
830
Fmt 4701
Sfmt 4702
(D)
Impact of
PE RVU
changes
(percent)
0
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
E:\FR\FM\21JYP2.SGM
0
¥3
0
0
0
¥1
1
2
3
0
0
0
¥6
0
0
0
0
0
0
0
0
0
¥1
0
0
0
21JYP2
(E)
Impact of
MP RVU
changes
(percent)
0
0
0
¥1
¥1
¥1
0
0
0
¥1
0
¥1
0
¥1
0
0
¥1
0
0
0
0
0
0
1
0
0
(F)
Combined
impact **
(percent)
0
¥3
0
¥1
¥2
¥2
1
2
3
¥1
0
¥1
¥6
¥1
0
0
¥1
0
¥1
1
1
0
¥2
1
0
0
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TABLE 40—CY 2018 PFS ESTIMATED IMPACT ON TOTAL ALLOWED CHARGES BY SPECIALTY *—Continued
(C)
Impact of
work RVU
changes
(percent)
(B)
Allowed
charges
(mil)
(A)
Specialty
INTERVENTIONAL RADIOLOGY .......................................
MULTISPECIALTY CLINIC/OTHER PHYS .........................
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 AND RADIATION THERAPY
CENTERS ........................................................................
RADIOLOGY ........................................................................
RHEUMATOLOGY ...............................................................
THORACIC SURGERY .......................................................
UROLOGY ...........................................................................
VASCULAR SURGERY .......................................................
(D)
Impact of
PE RVU
changes
(percent)
(E)
Impact of
MP RVU
changes
(percent)
(F)
Combined
impact **
(percent)
357
139
2,257
1,545
805
50
1,238
3,541
658
5,480
1,259
57
3,784
28
1,232
1,147
63
1,105
3,780
2,232
379
1,973
100
1,233
1,753
0
0
0
0
0
0
¥1
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
¥1
0
0
0
0
0
0
0
0
0
0
¥2
0
0
¥1
0
0
0
1
0
0
1
¥1
1
0
0
0
0
0
¥1
0
1
0
¥1
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
¥1
0
0
0
¥1
0
¥1
0
¥1
0
0
¥2
0
0
¥2
¥1
0
1
1
0
0
1
¥1
1
0
1,784
4,863
553
356
1,772
1,115
0
0
0
0
0
0
1
¥1
0
0
¥1
¥1
1
0
0
¥1
0
0
1
¥1
0
¥1
¥1
¥2
** Column F may not equal the sum of columns C, D, and E due to rounding.
2. CY 2018 PFS Impact Discussion
mstockstill on DSK30JT082PROD with PROPOSALS2
a. Changes in RVUs
The most widespread specialty
impacts of the final RVU changes are
generally related to the changes to RVUs
for specific services resulting from the
Misvalued Code Initiative, including
finalized RVUs for new and revised
codes. The estimated impacts for some
specialties, including behavioral health
specialists, physical and occupational
therapists, and radiation oncology,
reflect increases relative to other
physician specialties. These increases
can largely be attributed to proposed
increases in value for particular services
following the American Medical
Association Relative Value Update
Committee and CMS review, the
proposed change in allocation of
indirect practice expense RVUs for
office-based, face-to-face behavioral
health services, and proposed changes
based on updated professional liability
premium data.
The estimated impacts for several
specialties, including diagnostic testing
facilities, allergy/immunology,
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otolaryngology, oral/maxillofacial
surgery, and independent laboratories,
reflect decreases in payments relative to
payment to other physician specialties
as a result of proposed revaluation of
individual procedures reviewed by the
American Medical Association Relative
Value Update Committee and CMS,
proposed changes based on updated
professional liability premium data,
proposed decreases in relative payment
as a result of proposed updates to prices
for particular medical supplies, and
continued implementation of previously
finalized code-level reductions that are
being phased-in over several years. For
independent laboratories, it is important
to note that these entities receive
approximately 83 percent of their
Medicare revenues from services that
are paid under the Clinical Laboratory
Fee Schedule. As a result, the estimated
2 percent reduction for CY 2018 is only
applicable to approximately 17 percent
of the Medicare payment to these
entities.
We often receive comments regarding
the changes in RVUs displayed on the
specialty impact table, including
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comments received in response to the
proposed rates. We remind stakeholders
that although the estimated impacts are
displayed at the specialty level,
typically the changes are driven by the
valuation of a relatively small number of
new and/or potentially misvalued
codes. The percentages in the table are
based upon aggregate estimated PFS
allowed charges summed across all
services furnished by physicians,
practitioners, and suppliers within a
specialty to arrive at the total allowed
charges for the specialty, and compared
to the same summed total from the
previous calendar year. They are
therefore averages, and may not
necessarily be representative of what is
happening to the particular services
furnished by a single practitioner within
any given specialty.
b. Impact
Column F of Table 40 displays the
estimated CY 2018 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
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of the changes is available under
‘‘downloads’’ on the CY 2018 PFS
proposed rule Web site at https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/Physician
FeeSched/. 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-Feefor-Service-Payment/Physician
FeeSched/.
D. Effect of Changes in Telehealth List
As discussed in section II.D. of this
proposed rule, we are proposing to add
several new codes to the list of Medicare
telehealth services. Although we expect
these changes to have the potential to
increase access to care in rural areas,
based on recent telehealth utilization of
services already on the list, including
services similar to the proposed
additions, we estimate no significant
impact on PFS expenditures from the
proposed additions. For example, for
services already on the list, they are
furnished via telehealth, on average, less
than 0.1 percent of the time they are
reported overall.
E. Effect of Changes to Payment to
Provider-Based Departments (PBDs) of
Hospitals Paid Under the PFS
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As discussed in section II.G of this
proposed rule, for CY 2018, we are
proposing a PFS Relativity Adjuster of
25 percent, meaning that nonexcepted
items and services furnished by
nonexcepted PBDs would be paid under
the PFS at a rate that is 25 percent of
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the OPPS rate. We estimate that this
change will result in total Medicare Part
B savings of $25 million for CY 2018
relative to maintaining the CY 2017 PFS
Relativity Adjuster for CY 2018.
F. Other Provisions of the Proposed
Regulation
1. New Care Coordination Services and
Payment for RHCs and FQHCs
As discussed in section III.A of this
proposed rule, we are proposing the
establishment of two new G codes for
use by RHCs and FQHCs. The first new
G code would be a General Care
Management code for RHCs and FQHCs
with the payment amount set at the
average of the 3 national non-facility
PFS payment rates for the CCM and
general BHI codes. The second new G
code for RHCs and FQHCs would be a
Psychiatric CoCM code with the
payment amount set at the average of
the 2 national non-facility PFS payment
rates for psychiatric CoCM services. The
payment rate for each code would be
updated annually, based on the national
non-facility PFS payment rates for each
code contained in the G code.
The proposed methodology for
payment of care coordination services is
consistent with the RHC and FQHC
payment principles of not paying for
services based on time increments. It
does not create additional reporting
burden and is expected to promote
beneficiary access to comprehensive
care management services furnished by
RHCs and FQHCs.
Establishment of the RHC and FQHC
General Care Management code, which
includes all levels of CCM and general
BHI services, is projected to increase
Medicare spending by $600,000 in CY
2018 and by $7.4 million over 10 years.
This estimate is based on the proposed
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per service allowed charge increase
(from approximately $42.71 to $61.37)
applied to historical 2016 CCM and BHI
volume in RHCs and FQHCs. This
volume was adjusted with an assumed
10 percent behavioral volume increase
to reflect the increase in allowed
charges per service.
Establishment of the RHC and FQHC
Psychiatric CoCM code, which includes
all levels of psychiatric CoCM services,
is projected to increase Medicare
spending by approximately $100,000 in
CY2018 and $3.7 million over 10 years.
Because psychiatric CoCM is not
billable currently by RHCs or FQHCs
and is also new to practitioners billing
under the PFS, this estimate is based on
first quarter 2017 PFS psychiatric CoCM
claims of 0.03 percent of psychiatric
E/M visits, adjusted to an ultimate
average rate of 0.16 percent based on the
pattern of increase in CCM services in
the PFS found in the first two years of
implementation. This rate was then
applied to the number of 2016 RHC and
FQHC mental health visits to get an
estimate of CoCM volume, and then
projected forward on a per-capita basis.
PFS price updates were applied to the
initial approximate $135 psychiatric
CoCM payment amount to project future
costs.
The combined increase in Medicare
spending for both new G codes is
estimated to be approximately $600,000
in 2018, and approximately $11.1
million over 10 years. While these
services are expected to increase quality
and improve efficiency over time, the
programs are still new and the data is
not available yet to demonstrate any
cost savings. Therefore, no healthcare
cost reductions were assumed as a result
of increased care management.
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0.6
0.1
2019
may not sum to totals due to rounding.
0.8
32 Figures
Total ..........................
2018
General Care Management .............................
Psychiatric CoCM ............
CY
1.0
0.7
0.4
2020
1.1
0.7
0.4
2021
1.1
0.7
0.4
2022
1.1
0.7
0.4
2023
1.1
0.8
0.4
2024
1.2
0.8
0.4
2025
1.2
0.8
0.4
2026
1.2
0.8
0.4
2027
1.3
0.8
0.4
11.1
7.4
3.7
2018–2027
TABLE 42—CALENDAR YEARS 2018–2027 PROJECTED SPENDING IMPACT OF NEW GENERAL CARE MANAGEMENT AND PSYCHIATRIC COCM CODES FOR RHCS
AND FQHCS (MILLIONS) 32
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As discussed in section III.A. of this
proposed rule, we considered 3 other
options (for example, allowing any of
the 7 codes to be separately added to a
claim, bundling all 7 codes into one G
code, and developing 3 separate G
codes—one each for CCM, BHI, and
CoCM services). We estimate that there
would be no significant difference in the
costs among the options because all of
the options considered include the same
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services paid at the same rate and no
data is available to estimate a different
rate of billing for each code.
2. Payment for DME Infusion Drugs
As discussed in section III.B. of this
proposed rule, we proposed to conform
the regulation text at § 414.904(e)(2) to
section 5004 of the Cures Act, which
transitioned payment for DME infusion
drugs from AWP-based pricing to the
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34181
ASP-pricing methodology on January 1,
2017. Table 43 shows the effect of
changes in drug payments to DME
suppliers. We estimate adoption of the
ASP+6 pricing methodology will result
in total Medicare Part B savings ranging
over the 10-year period from $40
million in FY 2017 to $110 million in
FY 2026 with a 10-year total Medicare
Part B savings of $960 million.
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VerDate Sep<11>2014
(50)
10
2017
(40)
Benefits ...............................................
Premium Offset ...................................
FY
Total Part B .................................
(80)
(110)
30
2018
(100)
(130)
30
2019
(100)
(130)
30
2020
(100)
(130)
30
2021
(100)
(130)
30
2022
(110)
(150)
40
2023
(110)
(150)
40
2024
(110)
(150)
40
2025
(110)
(150)
40
2026
(420)
(550)
130
5-yr
impact
2017–
2021
TABLE 43—IMPACT OF CURES SECTION 5004 ON PAYMENT FOR INFUSION DRUGS FURNISHED THROUGH AN ITEM OF DMS (IN MILLIONS)
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(960)
(1,280)
320
10-yr
impact
2017–
2026
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3. Appropriate Use Criteria for
Advanced Diagnostic Imaging Services
We are proposing and requesting
public comment on the appropriate use
criteria (AUC) consulting and reporting
requirements and the effective date on
which these requirements will begin.
We are also proposing modifications to
the significant hardship exception to
better align these exceptions under the
AUC program with those under existing
quality programs. In the COI section of
this document, we have estimated the
proposed consulting requirement to
result in an annual burden of 1,425,000
hours at a cost of $275,139,000. Under
these proposals, claims for advanced
diagnostic imaging services would not
be denied in CY 2018, and thus, these
proposals would not impact CY 2018
physician payments under the PFS. The
Congressional Budget Office estimates
that section 218 of the PAMA would
save approximately 200 million dollars
over 10 years from FY 2014 through
2024, which could be the result of
identification of outlier ordering
professionals. Because we have not yet
proposed a mechanism or calculation
for outlier ordering professional
identification and prior authorization,
we are unable to quantify that impact at
this time. We will provide an impact
statement when applicable in future
rulemaking.
4. Physician Quality Reporting System
Criteria for Satisfactory Reporting for
Individual EPs
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a. Burden Estimate for PQRS Reporting
We previously discussed the burden
estimate for PQRS regarding the
program year 2016 reporting criteria,
which applies to the 2018 payment
adjustment in the CY 2016 PFS final
rule (see 80 FR 71362 through 71367).
The burden estimates for reporting that
data have not changed since these data
for program year 2016 PQRS have
already been reported; therefore, there
are no added burden estimates for the
proposed policy change in this rule in
section III.F.
b. Burden Savings Estimated Based on
PQRS Measures Reduction Proposed
Policy
Amending the policy to reduce the
amount of measures needed to
satisfactorily report to avoid the 2018
payment adjustment from 9 measures
across 3 NQS domains to 6 measures
(see section III.F. of this proposed rule)
would increase the amount of
satisfactory reporters for the 2016
reporting period, which would decrease
those subject to the 2018 payment
adjustment. Using data from the 2015
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reporting period as the basis for our
estimates, there were roughly 525,000
eligible professionals who failed the
PQRS reporting requirements for the
2015 reporting period and received a
downward payment adjustment in 2017
(see https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/PQRS/Downloads/2015_
PQRS_Experience_Report.pdf). We
estimate that, based on 2015 results,
approximately 4.5 percent of EPs that
received a downward payment
adjustment would be found successful
and therefore would avoid the payment
penalty. This equates to an estimated
23,625 EPs that would no longer be
subject to the 2018 payment adjustment
based on PQRS data for the 2015
reporting period.
Based on the estimated average
payment adjustment of $937.02 in
program year 2015, which was negative
2 percent based on 2015 PFS charges, an
estimated ($937.02 × 23,625 =
$22,137,097.50) would be the amount
EPs would receive as a result of not
being subject to the 2018 payment
adjustment due to the proposed measure
reduction policy in this rule for PQRS
program year 2016, which applies to the
2018 payment adjustment.
5. Medicare Shared Savings Program
We are proposing certain
modifications to our rules regarding
ACO assignment and financial
calculations, quality measures and
quality validation audits, TIN overlaps,
and application requirements.
Specifically we are proposing: (1)
Modifications to how services furnished
by FQHCs and RHCs are used for
purposes of beneficiary assignment to
an ACO as a result of the 21st Century
Cures Act, including reducing reporting
burden for ACOs that include FQHCs
and RHCs; (2) modifications to the
assignment methodology to include new
chronic care management and
behavioral health integration codes in
our definition of primary care services;
(3) a policy to improve the quality
validation audit process and, absent
unusual circumstances, to use the
results to proportionally modify an
ACO’s overall quality score; (4) a policy
to address substantive changes to
quality measures made under the
Quality Payment Program; (5) revisions
to our application requirements to
reduce burden for ACO applicants
seeking to participate in the Shared
Savings Program and for ACOs applying
to use the SNF 3-Day Rule Waiver; (6)
changes to our program rules to address
compliance with our ACO participant
TIN overlap policies, specifically, to
address situations in which overlapping
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ACO participant TINs begin billing for
services that are used in beneficiary
assignment during a benchmark or
performance year; and (7) a policy to
use final beneficiary identifiable nonclaims based payments in establishing
benchmarks and performing financial
reconciliation.
Each of these proposed policies is
generally expected to have a minimal
impact on affected ACOs. We do not
anticipate any overall impact for these
proposed policies because potential
individual ACO impacts are more likely
to offset one another rather than build
to a substantial total in terms of costs or
savings.
6. 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
equal the reduced payments to low
performing physicians and groups, as
well as those physicians and groups that
failed to meet the criteria to avoid the
PQRS payment adjustment as a group or
as individuals.
In the CY 2016 PFS final rule with
comment period (80 FR 71277 and
71279), we established that, beginning
with 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.
In CY 2018, 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 2016
participated in the Pioneer ACO Model,
the Comprehensive Primary Care
initiative, Next Generation ACO Model,
the Oncology Care Model, and the
Comprehensive ESRD Care Initiative in
2016 (80 FR 71286 through 71288).
In the CY 2016 PFS final rule with
comment period (80 FR 71280), we
adopted a two-category approach for the
CY 2018 VM based on participation in
the PQRS by groups and solo
practitioners. For the purposes of the CY
2018 VM, Category 1 represents those
groups and solo practitioners subject to
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the VM who met the criteria to avoid the
2018 PQRS payment adjustment (a) as a
group practice participating in the PQRS
GPRO, (b) groups that have at least 50
percent of the group’s EPs meet the
criteria to avoid the 2018 PQRS
payment adjustment for CY 2018 as
individuals, (c) solo practitioners that
meet the criteria to avoid the CY 2018
PQRS payment adjustment as
individuals, and (d) groups and solo
practitioners that participated in a
Shared Savings Program ACO, if the
ACO in which they participate
successfully reports quality data as
required by the Shared Savings
Program. Category 2 represents those
groups and solo practitioners that are
subject to the CY 2018 VM payment
adjustment and do not fall within
Category 1.
In section III.I. of this proposed rule,
we are proposing to reduce the CY 2018
VM payment adjustment amount for
groups and solo practitioners in
Category 2. We proposed to reduce the
automatic payment adjustment from
¥4.0 percent to ¥2.0 percent for
Physicians, PAs, NPs, CNSs, and CRNAs
in groups with 10 or more EPs and at
least one physician and from ¥2.0
percent to ¥1.0 percent for Physicians,
PAs, NPs, CNSs, and CRNAs in groups
of 2 or more EPs, PAs, NPs, CNSs, and
CRNAs in groups comprised solely of
non-physician EPs and physician and
non-physician solo practitioners.
Additionally, in section III.I. in this
proposed rule, we are proposing that,
under quality-tiering, which is the
methodology for evaluating performance
on quality and cost measures for the
VM, there will be no downward
adjustments for groups or solo
practitioners in Category 1 for the VM
for CY 2018. We are also proposing to
reduce the maximum upward
adjustment under the quality-tiering
methodology in CY 2018 for physicians,
PAs, NPs, CNSs, and CRNAs in groups
with 10 or more EPs and at least one
physician that are Category 1 from four
times an adjustment factor (+4.0x) to
two times an adjustment factor (+2.0x)
for those classified as high quality/low
cost and from two times an adjustment
factor (+2.0x) to one times an
adjustment factor (+1.0x) for those
classified as either average quality/low
cost or high quality/average cost. This
proposal aligns the upward adjustment
for groups of 10 or more EPs with those
previously finalized for smaller groups
and solo practitioners, as well as groups
comprised solely of non-physician EPs
and provides a smoother transition to
MIPS by bringing the incentives in line
with those in the first year of the MIPS.
Under the quality-tiering
methodology, each group and solo
practitioner’s quality and cost
composites will continue to 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 2018
payment adjustment period according to
the amounts in Table 44.
TABLE 44—PROPOSED CY 2018 VM AMOUNTS UNDER THE QUALITY-TIERING APPROACH FOR PHYSICIANS, PAS, NPS,
CNSS, AND CRNAS WHO ARE IN GROUPS OR SOLO PRACTITIONERS
Cost/Quality
Low quality
Low cost .......................................................................................................................................
Average cost ................................................................................................................................
High cost ......................................................................................................................................
+0.0%
+0.0
+0.0
Average
quality
High quality
+1.0x *
+0.0%
+0.0
+2.0x *
+1.0x *
+0.0%
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* 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.
Under the quality-tiering
methodology, for groups and solo
practitioners that participated in a
Shared Savings ACO that successfully
reports quality data for CY 2016, the
cost composite will be classified as
‘‘Average’’ and the quality of care
composite will continue to 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 2018
payment adjustment period. For groups
and solo practitioners that participate in
a Shared Savings Program ACO that did
not successfully report quality data for
CY 2016 and are Category 1 as a result
of quality data reported to the PQRS
outside of the ACO, the quality and cost
composites will continue to be
classified as ‘‘Average’’.
To ensure budget neutrality, we first
aggregate the automatic downward
payment adjustments of ¥1.0 percent or
¥2.0 percent for groups and solo
practitioners subject to the VM that fall
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within Category 2. Using the aggregate
downward payment adjustment amount,
we then calculate the upward payment
adjustment factor (x). Additionally, as
we have done when calculating the
upward payment adjustment factor for
the 2017 VM, we will also incorporate
adjustments made for estimated changes
in physician behavior (that is, 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
and announced around the start of the
payment adjustment year after the
informal review period ends.
At the time of this proposed rule, we
have not completed the analysis of the
impact of the VM in CY 2018 on
physicians and non-physicians in
groups of 2 or more EPs and physician
and non-physician solo practitioners
based on performance in 2016.
However, preliminary estimates indicate
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that the implementation of the proposed
policies discussed above, would reduce
the adjustment factor to below 10
percent. In the CY 2018 PFS final rule,
we will present the number of groups
and solo practitioners that will be
subject to the VM in CY 2018.
7. MACRA Patient Relationship
Categories and Codes
We are soliciting comments on these
HCPCS codes. Our intention is to collect
the codes beginning January 2018, and
our plan not to tie the collection of the
codes with payment until we are sure
clinicians have gained ample experience
and education in using these modifiers.
Therefore, there is no impact to CY 2018
physician payments under the PFS.
There may be a burden associated with
clinicians and their administrative staff
having to learn which codes to use and
how to submit them properly.
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8. Effects of Proposals Relating to the
Medicare Diabetes Prevention Program
Expanded Model
In section III.K of the preamble of this
proposed rule, we discuss our proposals
to further implement the MDPP
expanded model under the authority of
section 1115A of the Act, which
authorizes the Innovation Center to test
innovative payment and service
delivery models to reduce program
expenditures while preserving or
enhancing the quality of care furnished
to Medicare, Medicaid and CHIP
beneficiaries. The MDPP expanded
model was established in the November
15, 2016 MDPP final rule as an
additional preventive service with a
model effective date of January 1, 2018.
Many of the policies for the MDPP
expanded model were deferred to future
rulemaking and, therefore, are being
proposed in this rule. On March 14,
2016, the Office of the Actuary (OACT)
published a certification memorandum
setting out the conditions for expansion
of the Medicare Diabetes Prevention
Program (MDPP). Prior to its
implementation, OACT is required to
review the parameters of the MDPP
expansion and provide an updated
certification. This regulatory impact
assessment is not an updated
certification; rather, it is based on
estimates of the proposed rule.
Diabetes affects more than 25 percent
of Americans aged 65 or older and its
prevalence is projected to increase
approximately two-fold for all U.S.
adults (ages 18–79) by 2050 if current
trends continue.33 Furthermore, the risk
of progression to type 2 diabetes in an
individual with pre-diabetes is 5–10
percent per year, or 5–20 times higher
than in individuals with normal blood
glucose.34 We estimate that Medicare
spent $42 billion more in the single year
of 2016 on fee-for-service, non-dual
eligible, over age 65 beneficiaries with
diabetes and related comorbidities than
it would have spent if those
beneficiaries did not have diabetes,
including $20 billion more for Part A,
$17 billion more for Part B, and
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33 Centers
for Medicare & Medicaid Services,
‘‘Chronic Conditions Among Medicare
Beneficiaries, Chartbook: 2012 Edition,’’ Centers for
Medicare & Medicaid Services, 2012, https://
www.cms.gov/research-statistics-data-and-systems/
statistics-trends-and-reports/chronic-conditions/
downloads/2012chartbook.pdf. James Boyle, et al.,
‘‘Projection of the Year 2050 Burden of Diabetes in
the US Adult Population: Dynamic Modeling of
Incidence, Mortality, and Pre-Diabetes Prevalence,’’
Population Health Metrics 8, no. 29 (2010): 1–12.
34 X Zhang et al., ‘‘A1C Level and Future Risk of
Diabetes: A Systematic Review,’’ Diabetes Care 33,
no. 7 (2010): 1665–1673.
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$5 billion more for Part D.35 The goal of
the MDPP expanded model is to reduce
the incidence rate of type 2 diabetes
among Medicare beneficiaries with
prediabetes through a structured
behavioral change program where the
primary outcome is weight loss. Weight
loss is a key indicator of success among
persons enrolled in a Diabetes
Prevention Program due to the strong
association between weight loss and
reduction in the risk of type 2 diabetes.
In reducing the incidence rate of type 2
diabetes we expect to reduce Medicare
spending while improving quality of
care for eligible beneficiaries. In this
proposed rule, we are proposing a
value-based payment structure for the
MDPP Expanded Model. Instead of
traditional fee-for-service payment, our
proposed payment structure shifts risk
from Medicare to the rendering supplier
by making payments for MDPP services
to MDPP suppliers based on the
achievement of performance goals.
a. Anticipated Effects
(1) Effects on Beneficiaries
The MDPP expanded model is
expected to have a positive impact on
beneficiaries’ health that will generally
lead to reduced beneficiary spending on
Part A, Part B, and Part D health care
services over time due to a reduced
need for Part A, Part B, and Part D
services. As a new preventive service,
the MDPP services are available to
eligible Medicare beneficiaries without
cost-sharing. The CDC estimates that
approximately 50 percent of adults aged
65 and over living in the United States
have prediabetes 36 and that awareness
of the condition among those who have
it is relatively low—approximately 30
percent for the general population.
Therefore, we anticipate that up to 7
million Medicare beneficiaries who are
aware of their prediabetes would be
eligible for the MDPP services at the
start of the MDPP expanded model. This
estimate does not take into account any
increased beneficiary awareness of their
prediabetes due to the availability of
MDPP services. We also expect there to
be pent-up demand, with the number of
35 Erkan Erdem and Holly Korda, ‘‘Medicare FeeFor-Service Spending for Diabetes: Examining
Aging and Comorbidities,’’ Diabetes & Metabolism
5, no. 3 (2014); The Boards of Trustees: Federal
Hospital Insurance and Federal Supplementary
Medical Insurance Trust Funds, ‘‘2016 Annual
Report of the Boards of Trustees of the Federal
Hospital Insurance and Federal Supplementary
Medical Insurance Trust Funds,’’ Centers for
Medicare & Medicaid Services, 2016, https://
www.cms.gov/Research-Statistics-Data-andSystems/Statistics-Trends-and-Reports/Reports
TrustFu2016.pdf.; and CMS estimates.
36 https://www.cdc.gov/diabetes/pubs/
statsreport14national-diabetes-report-web.pdf.
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34185
beneficiaries utilizing the MDPP
services greater in the initial few years
(roughly 65,000 to 110,000 per year) but
then leveling off afterwards (to a base
demand of roughly 50,000 participants
per year).
To arrive at our participation estimate
we developed projections for pent-up
demand and ongoing demand. To
develop the projection for pent-up
demand we first analyzed data from the
CDC National Diabetes Prevention
Recognition Program (DPRP).
Specifically, we analyzed State-by-State
DPRP in-person utilization for ages 65
or older in 2015. Because the Health
Care Innovation Award (HCIA) MDPP
model test was still serving beneficiaries
during this period, and the HCIA DPP
suppliers are also part of the DPRP, we
used its enrollment data to inform what
Medicare beneficiary participation may
look like when Medicare pays for
MDPP. Given that HCIA participation
seemed to drive most of the DPRP
participation in an HCIA supplier’s
region, we determined that a welldefined HCIA region would be a
reasonable proxy for the rest of the
nation. We found the state with the
highest HCIA saturation, and calculated
the percentage of fee for service
beneficiaries that received services from
a DPRP DPP. This percentage was
applied to all fee for service
beneficiaries nationwide in order to get
a national pent-up demand estimate. We
added this pent-up demand to a stable
level of demand based on the number of
new beneficiaries utilizing the obesity
management benefit each year. Given
the limited nationwide Medicare DPP
participation data, there is a great
amount of uncertainty in these
estimates.
We believe that the eligibility criteria
for continued participation in the set of
MDPP services incentivizes
beneficiaries to lose 5-percent body
weight from baseline. Beneficiaries are
incentivized to lose weight because
continued eligibility for the services
benefit after the first 12 months is
contingent upon achieving 5-percent
weight loss and the set of MDPP
services is a once per lifetime set of
services. In addition to prevention of
type 2 diabetes, we believe participating
beneficiaries would likely receive other
possible health benefits including
prevention of obesity for those who are
overweight upon receiving MDPP
services, prevention of sleep apnoea,
and reduced risk for heart disease,
coronary artery disease and stroke.37
37 Orchard, T. J., et al. (2005). ‘‘The effect of
metformin and intensive lifestyle intervention on
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Furthermore, we believe the MDPP
expanded model could improve mental
health and wellbeing by affording
beneficiaries social interaction with
their peers during sessions and could
lead to reduced social isolation.38 The
prevention of type 2 diabetes and these
other potential health benefits of MDPP
services may result in reduced
beneficiary expenditures for health care
services over time as services will not be
needed to treat health conditions that
are avoided.
(2) Effects on the Market
Currently, more than 1,200
organizations nationally are providing
DPP services with some level of
recognition through the CDC. Service
delivery is primarily to individuals with
private or employer-sponsored
insurance, as well as some Medicare
Advantage plans. The majority of
existing DPP organizations are not
enrolled in the Medicare program. We
anticipate that the addition of MDPP
services as new preventive services in
Medicare would result in growth in the
market, including growth in the number
of individuals served per year by
existing DPP suppliers, as well as the
introduction of new suppliers into the
market. There are burdens associated
with obtaining CDC recognition and
enrolling into Medicare as an MDPP
supplier. There is also burden
associated with submitting claims to
Medicare for payment. Below we have
provided an estimate of the financial
burden to suppliers.
(3) Burden Related to Information
Collection Requirements
(a) Wage Estimates
To derive average costs for use
throughout the subsequent sections, 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). Table 45 presents the mean
hourly wage, the cost of fringe benefits
and overhead (calculated at 100 percent
of salary), and the adjusted hourly wage.
TABLE 45—NATIONAL OCCUPATIONAL EMPLOYMENT AND WAGE ESTIMATES
Occupation
code
Occupation title
Medical records and health information technician .........................................
Office and administrative support worker ........................................................
Billing and posting Clerk ..................................................................................
Mean hourly
wage
($/hr)
29–2071
43–9000
43–3011
19.93
16.31
$18.09
Fringe
benefits and
overhead
($/hr)
19.93
16.31
$18.09
Adjusted
hourly wage
($/hr)
39.84
32.62
$36.18
Our proposals under proposed
§ 424.205 would provide that an entity
is eligible to enroll in Medicare as an
MDPP supplier if it has MDPP interim
preliminary recognition, as determined
by CMS. In order to receive MDPP
interim preliminary recognition, we are
proposing that the entity must have
pending CDC recognition and must
submit a full 12 months of data on at
least one completed cohort of
participants to CDC. In order to receive
pending recognition from CDC,
organizations are required to submit an
application for recognition to CDC and
agree to CDC’s curriculum, duration and
intensity requirements. CMMI plans to
engage CDC’s services to assist CMMI in
administering its interim preliminary
recognition standard, if finalized. CMMI
would make the final determination of
which entities qualify to receive interim
preliminary recognition.
The burden associated with the
preceding requirements is the time for
MDPP staff to: submit an application for
pending recognition to CDC and then
collect and submit a full 12 months of
data (including session attendance,
body weight documentation, physical
activity minutes documentation, and
weight loss achieved) on at least one
completed cohort of participants to CDC
for the purposes of being evaluated for
interim preliminary recognition.
We estimate that it will take a medical
records and health information
technician 12 hours, at $38.88/hour to
collect and report these data for one
cohort of participants, and an office or
administrative worker 1 hour, at $31.54/
hour, to complete the CDC application
for pending recognition. The estimated
cost per supplier to achieve interim
preliminary recognition is $498.10.
the metabolic syndrome: the Diabetes Prevention
Program randomized trial.’’ Ann Intern Med 142(8):
611–619; Orchard, T. J., et al. (2013). ‘‘Long-term
effects of the Diabetes Prevention Program
interventions on cardiovascular risk factors: a report
from the DPP Outcomes Study.’’ Diabet Med 30(1):
46–55; Li, G., et al. (2014). ‘‘Cardiovascular
mortality, all-cause mortality, and diabetes
incidence after lifestyle intervention for people
with impaired glucose tolerance in the Da Qing
Diabetes Prevention Study: a 23-year follow-up
study.’’ Lancet Diabetes Endocrinol 2(6): 474–480;
Mudaliar, U., et al. (2016). ‘‘Cardiometabolic Risk
Factor Changes Observed in Diabetes Prevention
Programs in US Settings: A Systematic Review and
Meta-analysis.’’ PLoS Med 13(7): e1002095; Kuna,
S. T., et al. (2013). ‘‘Long-term effect of weight loss
on obstructive sleep apnea severity in obese
patients with type 2 diabetes.’’ Sleep 36(5): 641–
649a; Mitchell, L. J., et al. (2014). ‘‘Weight loss from
lifestyle interventions and severity of sleep apnoea:
a systematic review and meta-analysis.’’ Sleep Med
15(10): 1173–1183; Thomasouli, M. A., et al. (2013).
‘‘The impact of diet and lifestyle management
strategies for obstructive sleep apnoea in adults: a
systematic review and meta-analysis of randomised
controlled trials.’’ Sleep Breath 17(3): 925–935; U.S.
Department of Health and Human Services. 2008
Physical Activity Guidelines for Americans.
Washington (DC): U.S. Department of Health and
Human Services; 2008. ODPHP Publication No.
U0036. Available at: https://www.health.gov/
paguidelines; U.S. Department of Health and
Human Services and U.S. Department of
Agriculture. 2015—2020 Dietary Guidelines for
Americans. 8th Edition. December 2015. Available
at https://health.gov/dietaryguidelines/2015/
guidelines/.
38 Florez, H., et al. (2012). ‘‘Impact of lifestyle
intervention and metformin on health-related
quality of life: the diabetes prevention program
randomized trial.’’ J Gen Intern Med 27(12): 1594–
1601; Ackermann, R. T., et al. (2009). ‘‘Changes in
health state utilities with changes in body mass in
the Diabetes Prevention Program.’’ Obesity (Silver
Spring) 17(12): 2176–2181; Weinhold, K. R., et al.
(2015). ‘‘A Randomized Controlled Trial Translating
the Diabetes Prevention Program to a University
Worksite, Ohio, 2012–2014.’’ Preventing Chronic
Disease 12: E210.
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(b) Interim Preliminary Recognition
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(c) Supplier Standards
Our proposals under proposed revised
§ 424.59 (proposed in this rule to be
redesignated at § 424.205) would require
that an MDPP supplier must certify in
its enrollment application, which is a
new Medicare enrollment application
that we are creating specific to MDPP
suppliers, and that it meets a set of
standards. As this new enrollment
application is being created specifically
for the MDPP expanded model, we have
determined that it is exempt from the
Paperwork Reduction Act in accordance
with section 1115A(d)(3) of the Act. We
estimate that it will take an office or
administrative support worker 3 hours,
at $31.54/hour, to complete the MDPP
supplier enrollment application using
the internet-based Provider Enrollment,
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Chain and Ownership System (PECOS).
In general, provider enrollment fees for
Medicare are $560 in 2017. We also note
that CMS provides hardship exceptions
to the application fee with a written
request that describes the need for the
hardship exception. CMS determines
such exceptions on a case-by-case basis.
The estimated cost to complete the
MDPP supplier enrollment application,
without a hardship exception, is
$843.86. If a provider is granted a
hardship exception from the enrollment
fee, then the estimated cost to complete
the enrollment process is $283.86.
We also note that access to the HIPAA
Eligibility Transaction System (HETS),
which a supplier could use to check
factors of eligibility for the MDPP
services, including the beneficiary’s Part
B eligibility and whether the beneficiary
has received coverage for end-stage
renal disease (ESRD) is free to suppliers,
as long as they are active Medicare feefor-service providers or suppliers in
PECOS.
Suppliers also would be required to
maintain documentation of all
beneficiary contact regarding
complaints or questions, as specified in
proposed § 424.205(d)(11), and maintain
and submit to CMS a crosswalk file
which indicates how participant
identifications for the purposes of CDC
performance data correspond to
Medicare Beneficiary Identifiers (that is,
beneficiary health insurance claims
numbers) for each beneficiary receiving
MDPP services. We estimate that
creating and maintaining
documentation of beneficiary contact
regarding complaints or questions will
take an office or administrative support
worker 1 hour, at $31.54/hour, per
complaint or question request to create
and maintain documentation of the
request. We have no way to estimate
how many complaints or questions
MDPP suppliers will receive from
beneficiaries, and we expect that may
differ based on many factors, so have
not included an overall cost in this
burden estimate. Further, we estimate
that it will take an office and
administrative support worker
approximately 4 hours, at $31.54/hour,
to create and submit the crosswalk file
for a cohort of 100 beneficiaries
participating in the MDPP services, for
a total cost of $126.16 per cohort of 100
beneficiaries. The crosswalk is proposed
to be submitted quarterly. Therefore, for
a year of delivering the set of MDPP
services the estimated total cost to
create and submit the crosswalk file
would be $504.64 per cohort of 100
beneficiaries. We believe the
incremental costs to meet this
requirement would decrease with the
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addition of beneficiaries to a cohort,
because the work and time to establish
the file and submit it would be the same
for a cohort of 100 and a cohort of 1000.
What would be different is the
collection of the information from the
beneficiaries, and the addition of these
data points to the file. We estimate that,
for every additional 100 beneficiaries
added to the file, the office and
administrative support worker would
add 1 hour, at $31.54/hour. We estimate
the total incremental cost over 1 year for
each additional 100 beneficiaries above
the cohort of 100 beneficiaries is
$126.16.
Our proposals under proposed
§ 424.205 also would require that
suppliers meet a set of standards that
includes maintaining a physical facility
on an appropriate site and maintain a
primary business telephone that is
operating at the appropriate site.
Because we have no way to estimate
how many beneficiaries each MDPP
supplier may provide the set of MDPP
services to, and we expect this will
differ based on many factors, including
but not limited to the size of the
supplier, the number of coaches the
supplier employs, the physical space
the supplier uses to furnish MDPP
services, and the supplier’s geographic
location, we have not included an
overall cost for these requirements in
this burden estimate.
(d) Payment for MDPP Services
Our proposals under proposed
§ 414.84 specify the proposed payments
MDPP suppliers may be eligible to
receive for furnishing MDPP services
and meeting performance targets related
to beneficiary weight loss and/or
attendance. MDPP suppliers would be
paid by CMS by submitting claims for
MDPP beneficiaries using claim form
CMS–1500 (https://www.cms.gov/
Medicare/CMS-Forms/CMS-Forms/
Downloads/CMS1500.pdf), and as a
condition for payment, claims
submitted by MDPP suppliers must be
for services furnished to eligible
beneficiaries in accordance with
§ 414.84(b) and (c). Our proposal under
proposed § 424.205 would require
MDPP suppliers to include an
attestation that the MDPP beneficiary for
which it is submitting a claim has met
the performance goals laid out in
proposed § 424.205. Section 424.205
also proposes to require MDPP suppliers
to report the NPI of the coach on MDPP
claims as a program integrity safeguard.
To meet these requirements for
submitting claims, we estimate that it
would take a billing and posting clerk
10 minutes per beneficiary to fill out the
claim form and submit it to CMS at
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34187
$33.70/hour. Based on this time and
wage, we estimate the total cost per
beneficiary per claim to be $5.62. As
mentioned previously, we have no way
to estimate how many beneficiaries to
whom each MDPP supplier may furnish
MDPP services. Therefore, we have not
included an estimate of the overall cost
of submitting claims in the burden
estimate.
(4) Effects on the Medicare Program
(a) Estimated 10-Year Impact of MDPP
The set of MDPP services is an
optional set of services for beneficiaries
who meet the eligibility requirements
described elsewhere in the proposed
rule. MDPP services will be furnished
by a new provider type in Medicare.
The CDC recognizes DPPs nationwide;
these programs effectively deliver
lifestyle-changing services that reduce
the incidence of type 2 diabetes. The
number of CDC-recognized DPPs is
growing rapidly, increasing by nearly 90
percent from September 2015 to March
2017. The historical participation rate
suggests that the vast majority of these
providers are not serving a significant
volume of new participants, aside from
those served in the DPP model test.
This estimate is based on the initial
methodology used for the estimate of
the MDPP expanded model as set out in
the certification memorandum, but with
differences in several program features
including the payment parameters. It
also includes the impact of improved
longevity among those who participate
in the MDPP expanded model. This cost
of improved longevity was ignored for
certification purposes, as noted in that
memorandum.
The model is dependent on the
number of eligible participants, the
annual take-up rate, and the savings per
participant, all of which are uncertain.
The methodology determines gross
savings as the result of an assumed
reduction in the number of beneficiaries
transitioning from prediabetes to
diabetes and a marginal cost difference
between the individuals with diabetes
and those that are prediabetic. The
Office of the Actuary assumed that the
initial savings per beneficiary for
avoiding diabetes is $3,000 per year.
The progression rate from prediabetes to
diabetes absent the intervention is
expected to be roughly 5 percent per
year. Based on observed results, we
assume that the set of MDPP services
will reduce the progression rate among
those receiving the services by 50
percent in the first year and that the
reduction will be 5 percent less in each
subsequent year until leveling off at a
rate of 10 percent. The program costs in
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this estimate include payments to MDPP
suppliers in the initial year of the MDPP
services period and in the 2
maintenance years. Based on the results
of the DPP model test regarding the
number of sessions attended and the
weight loss achieved, we estimate the
average expected Medicare payment per
participant to be approximately $320 in
the first year and $75 in each of the
following 2 years. Overall, the payments
under the expanded model would occur
in the first 3 years following the
beneficiary’s first MDPP services, but
the expected reduction in medical costs
would occur over a long period
following the intervention. For the
leading cohort of 2018, we would expect
savings in excess of costs by 2019 (the
second year), with cumulative savings
by 2022 (after 4 years). Yearly net
savings reduce slightly each subsequent
year but do not result in a cost to
Medicare during the 10-year projection
window.
Table 46 shows the 10-year impact of
the MDPP expanded model, net of
payments to MDPP providers but gross
of any other model costs, based on our
expected enrollment per year. The 10year impact is a savings to Medicare of
$186 million. The estimate is expected
to cross into a cumulative savings to
Medicare in the sixth year of the MDPP
expanded model.
TABLE 46—ESTIMATED 10-YEAR IMPACT OF MDPP ON NET CLAIMS COSTS, PAYMENTS TO PROVIDERS, AND NET
SAVINGS FOR CYS 2018 THROUGH 2027
[In millions, negative values indicate savings]
Year
2018
¥$5
21
16
16
Net Claim Costs ...............................
Provider Payments ...........................
Net Savings ......................................
Cumulative Net Savings ...................
(b) Sensitivity Testing
MDPP is a new Medicare expanded
model that was tested in the DPP model
test using a small percentage of the
population. As a result, the estimated
impact from the expanded MDPP model
2019
2020
2021
2022
2023
2024
2025
2026
2027
¥$16
41
25
41
¥$29
40
11
52
¥$41
31
¥10
42
¥$52
28
¥25
17
¥$60
26
¥34
¥17
¥$66
27
¥40
¥56
¥$70
28
¥43
¥99
¥$72
28
¥44
¥143
¥$72
29
¥43
¥186
is very uncertain. In particular, it is
unknown how many beneficiaries will
be interested in participating in MDPP
and how quickly MDPP suppliers
available will be able to serve those
individuals. To understand how various
participation scenarios would affect the
Total
¥$484
298
¥186
............
financial results, we have prepared the
estimates under two other participation
scenarios. The first shows the results if
half of the beneficiaries shown in the
best estimate participate, and the second
uses twice as many beneficiaries. The
details are shown in Tables 47 and 48.
TABLE 47—SCENARIO TEST OF MDPP 10-YEAR IMPACT OF HALF THE EXPECTED PARTICIPANTS ON NET CLAIMS COSTS,
PAYMENTS TO PROVIDERS, AND NET SAVINGS FOR CYS 2018 THROUGH 2027
Year
2018
2019
¥$2
10
8
Net Claim Costs ...............................
Provider Payments ...........................
Net Savings ......................................
¥$8
20
13
2020
2021
2022
2023
2024
2025
2026
2027
¥$15
20
5
¥$21
16
¥5
¥$26
14
¥12
¥$30
13
¥17
¥$33
13
¥20
¥$35
14
¥21
¥$36
14
¥22
¥$36
14
¥22
Total
¥$242
149
¥93
TABLE 48—SCENARIO TEST OF MDPP 10-YEAR IMPACT OF DOUBLE THE EXPECTED PARTICIPANTS ON NET CLAIMS
COSTS, PAYMENTS TO PROVIDERS, AND NET SAVINGS FOR CYS 2018 THROUGH 2027
Year
2018
Net Claim Costs ...............................
Provider Payments ...........................
Net Savings ......................................
¥$9
41
32
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b. Alternatives Considered for MDPP
Section III.K. of the preamble of this
proposed rule includes a range of
proposed policies necessary to
implement the MDPP expanded model,
including benefit structure, payment,
supplier enrollment, and supplier
standards. Throughout section III.K., we
present descriptions of the relevant
statutory provisions; identify those
policies when discretion has been
exercised in our proposals, present
rationale for our proposed policies; and
discuss alternative to our proposals that
where considered.
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2019
2020
2021
¥$31
82
50
¥$58
80
22
¥$83
63
¥20
2022
2023
2024
2025
2026
2027
Total
¥$104
55
¥49
¥$121
52
¥68
¥$133
54
¥79
¥$140
55
¥85
¥$144
56
¥88
¥$145
58
¥87
¥$969
596
¥372
We considered alternatives to the
MDPP services period that would
significantly impact the potential
payment. Specifically, we considered
limiting the MDPP to a 12-month MDPP
services period without any ongoing
maintenance sessions available in
months 13 through 36. It is estimated
that the average payment to suppliers
for the maintenance years is $75 per
year per beneficiary. We also considered
limiting the ongoing maintenance
sessions to 12 months, culminating in a
total MDPP service period of up to 2
years as opposed to up to 3 years. Either
of these alternatives would reduce the
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total potential payment to MDPP
suppliers by 52 percent or 28 percent,
respectively, from a maximum of $810
for meeting all attendance and weight
loss achievement goals under our
proposals. We did not propose these
alternatives because weight loss is
difficult to achieve and can be more
difficult to sustain. Our proposal to
allow for up to 2 years of ongoing
maintenance sessions for those
beneficiaries who have achieved a
minimum 5 percent weight loss from
baseline during months 1 to 12 of the
MDPP services period will allow for
reinforcement of the lifestyle changes
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needed to maintain weight loss. Finally,
a 3-year diabetes prevention program is
supported by evidence from the NIH
DPP clinical trial.
In this proposed rule, we also
considered linking additional outcomes
beyond attendance and weight loss to
payment in the value-based payment
methodology. Specifically, we
considered linking hemoglobin A1c
level to MDPP payments. However, we
did not adopt this alternative because
the MDPP expanded model is certified
based on the DPP model test, which
demonstrated that weight loss was
associated with reductions in Medicare
expenditures. Although elevated
hemoglobin A1c levels were included as
part of the beneficiary eligibility criteria
in the DPP model test, hemoglobin A1c
levels were not evaluated postintervention in the DPP model test.
Therefore, the proposed MDPP payment
structure would incentivize MDPP
suppliers to prioritize the achievement
of beneficiary weight loss by furnishing
MDPP services, providing a balance
between value-based payments related
to weight loss and session attendance.
In conclusion, we estimate that the
10-year impact of the MDPP expanded
model, net of payments to MDPP
providers but gross of any other program
costs, based on our expected enrollment
per year would be a savings to Medicare
of $186 million. The estimate is
expected to cross into a cumulative
savings to Medicare in the sixth year of
the MDPP expanded model.
F. 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 policies 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, will result
in different proposed payment rates,
and therefore, result in different
estimates than those shown in Table 40
(CY 2018 PFS Estimated Impact on
Total Allowed Charges by Specialty).
G. 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
used to calculate payments under the
PFS, would have a positive impact and
improve the quality and value of care
provided to Medicare beneficiaries.
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 use file Impact on Payment for
Selected Procedures available on the
CMS Web site at https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/PhysicianFeeSched/, the CY
2017 national payment amount in the
nonfacility setting for CPT code 99203
(Office/outpatient visit, new) was
$109.46, which means that in CY 2017,
a beneficiary would be responsible for
20 percent of this amount, or $21.89.
Based on this proposed rule, using the
CY 2018 CF, the CY 2018 national
payment amount in the nonfacility
setting for CPT code 99203, as shown in
the Impact on Payment for Selected
Procedures table, is $109.77, which
means that, in CY 2018, the final
beneficiary coinsurance for this service
would be $21.95.
H. Estimating Regulatory
Familiarization Costs
If regulations impose administrative
costs on private entities, such as the
time needed to read and interpret this
proposed rule, we should estimate the
cost associated with regulatory review.
Due to the uncertainty involved with
34189
accurately quantifying the number of
entities that will review the rule, we
assume that the total number of unique
commenters on last year’s proposed rule
will be the number of reviewers of this
proposed rule. We acknowledge that
this assumption may understate or
overstate the costs of reviewing this
rule. It is possible that not all
commenters reviewed last year’s rule in
detail, and it is also possible that some
reviewers chose not to comment on the
proposed rule. For these reasons we
thought that the number of past
commenters would be a fair estimate of
the number of reviewers of this rule. We
welcome any comments on the
approach in estimating the number of
entities which will review this proposed
rule.
We also recognize that different types
of entities are in many cases affected by
mutually exclusive sections of this
proposed rule, and therefore for the
purposes of our estimate we assume that
each reviewer reads approximately 50
percent of the rule. We seek comments
on this assumption.
Using the wage information from the
BLS for medical and health service
managers (Code 11–9111), we estimate
that the cost of reviewing this rule is
$105.16 per hour, including overhead
and fringe benefits https://www.bls.gov/
oes/current/oes_nat.htm. Assuming an
average reading speed, we estimate that
it would take approximately 8.0 hours
for the staff to review half of this
proposed rule. For each facility that
reviews the rule, the estimated cost is
$841 (8.0 hours × $105.16). Therefore,
we estimate that the total cost of
reviewing this regulation is $4,981,243
($841 × 5,943 reviewers).
I. Accounting Statement
As required by OMB Circular A–4
(available at https://
www.whitehouse.gov/omb/circulars/
a004/a-4.pdf), in Tables 49 and 50
(Accounting Statements), we have
prepared an accounting statement. This
estimate includes growth in incurred
benefits from CY 2017 to CY 2018 based
on the FY 2018 President’s Budget
baseline.
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TABLE 49—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED EXPENDITURES
Category
Transfers
CY 2018 Annualized Monetized Transfers ..............................................
From Whom To Whom? ...........................................................................
Estimated increase in expenditures of $0.3 billion for PFS CF update.
Federal Government to physicians, other practitioners and providers
and suppliers who receive payment under Medicare.
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TABLE 50—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED COSTS, TRANSFER, AND SAVINGS
Category
Transfer
CY 2018 Annualized Monetized Transfers of beneficiary cost coinsurance.
From Whom to Whom? ............................................................................
$0.1 billion.
Federal Government to Beneficiaries.
TABLE 51—ESTIMATED COSTS AND COST SAVINGS
Category
Costs
ICR Burden ..............................................................................................
MDPP ......................................................................................................
Regulatory Familiarization .......................................................................
$282 million ...................................
........................................................
$5 million .......................................
J. Conclusion
The analysis in the previous sections,
together with the remainder of this
preamble, provided 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
Administrative practice and
procedure, Health facilities, Health
professions, Kidney diseases, Medical
devices, Medicare, Reporting and
recordkeeping requirements, Rural
areas, X-rays.
42 CFR Part 410
Health facilities, Health professions,
Kidney diseases, Laboratories,
Medicare, Reporting and recordkeeping
requirements, Rural areas, X-rays.
42 CFR Part 414
Administrative practice and
procedure, Biologics, Drugs, Health
facilities, Health professions, Kidney
diseases, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 424
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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.
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:
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$186 million.
PART 405—FEDERAL HEALTH
INSURANCE FOR THE AGED AND
DISABLED
auxiliary personnel, as defined in
§ 410.26(a)(1) of this chapter.
*
*
*
*
*
1. The authority citation for part 405
continues to read as follows:
PART 410—SUPPLEMENTARY
MEDICAL INSURANCE (SMI)
BENEFITS
■
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).
2. Section 405.2413 is amended by
revising paragraph (a)(5) to read as
follows:
■
42 CFR Part 405
Cost savings
§ 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,
General Care Management, and the
Psychiatric Collaborative Care model,
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.
*
*
*
*
*
■ 3. 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 nursemidwife, except that services and
supplies furnished incident to
Transitional Care Management, General
Care Management, and the Psychiatric
Collaborative Care model, can be
furnished under general supervision of
a nurse practitioner, physician assistant,
or certified nurse-midwife, when these
services or supplies are furnished by
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4. The authority citation for part 410
is revised to read as follows:
■
Authority: Secs. 1102, 1834, 1871, 1881,
and 1893 of the Social Security Act (42
U.S.C. 1302, 1395m, 1395hh, 1395rr, and
1395ddd).
5. Section 410.79 is amended by—
a. Revising the section heading and
paragraph (a);
■ b. Under paragraph (b):
■ i. Revising the definition of ‘‘Baseline
weight’’;
■ ii. Removing the definition ‘‘Coach’’;
■ iii. Revising the definition of ‘‘Core
maintenance session’’;
■ iv. Adding in alphabetical order a
definition for ‘‘Core maintenance
session interval;’’
■ v. Revising the definition of ‘‘Core
session’’;
■ vi. Removing the definitions of
‘‘Maintenance of weight loss’’ and
‘‘Maintenance session bundle’’;
■ vii. Adding in alphabetical order
definitions for ‘‘Make-up session’’ and
‘‘MDPP beneficiary’’;
■ viii. Removing the definitions of
‘‘MDPP core benefit’’ and ‘‘MDPP
eligible beneficiary’’;
■ ix. Revising the definition of ‘‘MDPP
services’’;
■ x. Adding in alphabetical order
definitions for ‘‘MDPP services period’’
and ‘‘MDPP session’’;
■ xi. Revising the definitions of ‘‘MDPP
supplier’’ and ‘‘Medicare Diabetes
Prevention Program (MDPP)’’;
■ xii. Adding in alphabetical order a
definition for ‘‘Ongoing maintenance
session interval’’;
■ xiii. Revising the definition of
‘‘Ongoing maintenance sessions’’; and
■ xiv. Adding in alphabetical order
definitions for ‘‘Set of MDPP services’’
and ‘‘Virtual make-up session’’; and
■
■
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c. Revising paragraphs (c) and (d).
The revisions and additions read as
follows:
■
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§ 410.79 Medicare Diabetes Prevention
Program expanded model: Conditions of
coverage.
(a) Medicare Diabetes Prevention
Program (MDPP) services will be
available beginning on April 1, 2018.
(b) * * *
Baseline weight means the MDPP
beneficiary’s body weight recorded
during that beneficiary’s first core
session.
*
*
*
*
*
Core maintenance session means an
MDPP service that—
(i) Is furnished by an MDPP supplier
to an MDPP beneficiary during a core
maintenance session interval;
(ii) Is approximately 1 hour in length;
and
(iii) Adheres to a CDC-approved DPP
curriculum for maintenance sessions.
Core maintenance session interval
means one of the two consecutive 3month time periods during months 7
through 12 of the MDPP services period,
during which an MDPP supplier offers
an MDPP beneficiary at least one core
maintenance session per month.
Core session means an MDPP service
that—
(i) Is furnished by an MDPP supplier
to an MDPP beneficiary during months
1 through 6 of the MDPP services
period;
(ii) Is approximately 1 hour in length;
and
(iii) Adheres to a CDC-approved DPP
curriculum for core sessions.
*
*
*
*
*
Make-up session means a core
session, a core maintenance session, or
an ongoing maintenance session
furnished to an MDPP beneficiary when
the MDPP beneficiary misses a regularly
scheduled core session, core
maintenance session, or ongoing
maintenance session.
MDPP beneficiary means a Medicare
beneficiary who meets the criteria
specified in paragraph (c)(1)(i) of this
section, who has initiated the MDPP
services period by attending the first
core session, and for whom the MDPP
services period has not ended as
specified in paragraph (c)(3) of this
section.
MDPP services means structured
health behavior change sessions that are
furnished under the MDPP expanded
model with the goal of preventing
diabetes among Medicare beneficiaries
with prediabetes, and that follow a CDCapproved curriculum. The sessions
provide practical training in long-term
dietary change, increased physical
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activity, and problem-solving strategies
for overcoming challenges to
maintaining weight loss and a healthy
lifestyle.
MDPP services period means the time
period, beginning on the date an MDPP
beneficiary attends his or her first core
session, over which the set of MDPP
services is furnished to the MDPP
beneficiary, to include the core services
period described in paragraph (c)(2)(i)
and, subject to paragraph (c)(3) of this
section, one or more ongoing
maintenance session intervals during
the ongoing services period described in
paragraph (c)(2)(ii) of this section.
MDPP session means a core session, a
core maintenance session, or an ongoing
maintenance session.
MDPP supplier means an entity that is
enrolled in Medicare to furnish MDPP
services as provided in § 424.205 of this
chapter.
Medicare Diabetes Prevention
Program (MDPP) refers to a model test
expanded under section 1115A(c) of the
Act that makes MDPP services available
to MDPP beneficiaries.
*
*
*
*
*
Ongoing maintenance session means
an MDPP service that—
(i) Is furnished by an MDPP supplier
to an MDPP beneficiary during an
ongoing maintenance session interval;
(ii) Is approximately 1 hour in length;
and
(iii) Adheres to a CDC-approved DPP
curriculum for maintenance sessions.
Ongoing maintenance session interval
means one of the up to eight
consecutive 3-month time periods
during the ongoing services period
described in paragraph (c)(2)(ii) of this
section, during which an MDPP
supplier offers at least one ongoing
maintenance session to an MDPP
beneficiary per month.
*
*
*
*
*
Set of MDPP services means the series
of MDPP sessions, composed of core
sessions, core maintenance sessions,
and subject to paragraph (c)(3) of this
section, ongoing maintenance sessions,
offered over the course of the MDPP
services period.
Virtual make-up session means a
make-up session that is not furnished in
person and that is furnished in a
manner consistent with the DPRP
standards for virtual sessions.
(c) Coverage for MDPP services.—
(1) Beneficiary eligibility. (i) A
Medicare beneficiary is eligible for
MDPP services offered during the core
services period described in paragraph
(c)(2)(i) of this section if the beneficiary
meets all of the following criteria:
(A) Is enrolled under Medicare Part B;
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(B) Attended the first core session
within the most recent 12-month time
period and, prior to attending this first
core session, had not previously
received the set of MDPP services in his
or her lifetime;
(C) Has, on the date of attendance at
the first core session, a body mass index
(BMI) of at least 25 if not self-identified
as Asian or a BMI of at least 23 if selfidentified as Asian;
(D) Has received, within the 12-month
time period prior to the date of
attendance at the first core session, a
hemoglobin A1c test with a value of
between 5.7 and 6.4 percent, a fasting
plasma glucose test with a value of
between 110 and 125 mg/dL, or a 2-hour
plasma glucose test (oral glucose
tolerance test) with a value of between
140 and 199 mg/dL;
(E) Has, as of the date of attendance
at the first core session, no previous
diagnosis of diabetes, other than
gestational diabetes; and
(F) Does not have end-stage renal
disease (ESRD).
(ii) An MDPP beneficiary is eligible
for the first ongoing maintenance
session interval only if the beneficiary:
(A) Attends at least one in-person core
maintenance session during the final
core maintenance session interval; and
(B) Achieves or maintains the
required minimum weight loss at a
minimum of one in-person core
maintenance session during the final
core maintenance session interval.
(iii) An MDPP beneficiary is eligible
for a subsequent ongoing maintenance
session interval only if the beneficiary:
(A) Attends at least three ongoing
maintenance sessions during the
previous ongoing maintenance session
interval, including at least one in-person
ongoing maintenance session; and
(B) Maintains the required minimum
weight loss at a minimum of one inperson ongoing maintenance session
furnished during the previous ongoing
maintenance session interval.
(iv) Weight measurements used to
determine the achievement or
maintenance of the required minimum
weight loss must be taken in person by
an MDPP supplier during an MDPP
session.
(2) MDPP services period. An MDPP
beneficiary’s MDPP services period is
composed of the following periods and
intervals:
(i) The core services period, which is
the first 12 months of the MDPP services
period, and consists of:
(A) At least 16 core sessions offered
at least one week apart during months
1 through 6 of the MDPP services
period; and
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(B) Two 3-month core maintenance
session intervals offered during months
7 through 12 of the MDPP services
period.
(ii) Subject to paragraph (c)(3) of this
section, the ongoing services period,
which consists of up to eight 3-month
ongoing maintenance session intervals
offered during months 13 through 36 of
the MDPP services period.
(3) Limitations on the MDPP services
period. (i) The MDPP services period
ends upon completion of the core
services period described in paragraph
(c)(2)(i) of this section, unless the MDPP
beneficiary qualifies for the first ongoing
maintenance session interval, in
accordance with paragraph (c)(1)(ii) of
this section.
(ii) If the MDPP beneficiary qualifies
for the first ongoing maintenance
session interval as described in
paragraph (c)(3)(i) of this section, the
MDPP services period ends upon
completion of this first ongoing
maintenance session interval or any
subsequent ongoing maintenance
session interval, unless the beneficiary
meets the eligibility requirements under
paragraph (c)(1)(iii) of this section.
(iii) Unless sooner ended in
accordance with this paragraph (c)(3),
the MDPP services period ends
automatically upon the completion of
the eighth ongoing maintenance session
interval.
(d) Make-up sessions. (1) An MDPP
supplier may offer a make-up session to
an MDPP beneficiary who missed a
regularly scheduled session. If an MDPP
supplier offers one or more make-up
sessions to an MDPP beneficiary, each
such session must be furnished in
accordance with the following
requirements:
(i) The curriculum furnished during
the make-up session must address the
same CDC-approved DPP curriculum
topic as the regularly scheduled session
that the beneficiary missed;
(ii) The MDPP supplier may furnish to
the beneficiary a maximum of one
make-up session on the same day as a
regularly scheduled session; and
(iii) The MDPP supplier may furnish
to the beneficiary a maximum of one
make-up session per week.
(2) An MDPP supplier may offer
virtual make-up sessions only if
consistent with the requirements in
paragraph (d)(1) of this section. Virtual
make-up sessions are also subject to the
following requirements:
(i) Virtual make-up sessions must be
furnished in a manner consistent with
the DPRP standards for virtual sessions;
(ii) An MDPP supplier may only offer
virtual make-up sessions based on an
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individual MDPP beneficiary’s request;
and
(iii) An MDPP supplier may offer to
an MDPP beneficiary:
(A) No more than 4 virtual make-up
sessions within the core services period
described in paragraph (c)(2)(i) of this
section, of which no more than 2 virtual
make-up sessions are core maintenance
sessions; and
(B) No more than 3 virtual make-up
sessions that are ongoing maintenance
sessions during any rolling 12-month
time period.
(3) Make-up sessions furnished in
accordance with paragraph (d)(1) of this
section that an MDPP beneficiary
attends in person are counted toward
meeting the attendance requirements
described in paragraph (c)(1) of this
section and toward achieving the
performance goals described in
§ 414.84(b) of this chapter as if the
MDPP beneficiary attended a regularly
scheduled session. Virtual make-up
sessions furnished in accordance with
paragraph (d)(2) of this section are also
counted toward such attendance
requirements and performance goals,
subject to the following limitations:
(i) The MDPP beneficiary receives no
more than 4 virtual make-up sessions
within the core services period
described in paragraph (c)(2)(i) of this
section, of which no more than 2 virtual
make-up sessions may be core
maintenance sessions; and
(ii) The MDPP beneficiary receives no
more than 3 virtual make-up sessions
that are ongoing maintenance sessions
during any rolling 12-month period.
PART 414—PAYMENT FOR PART B
MEDICAL AND OTHER HEALTH
SERVICES
6. 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)).
7. Section 414.84 is added to read as
follows:
■
§ 414.84
Payment for MDPP services.
(a) Definitions. In addition to the
definitions specified at §§ 410.79(b) and
424.205(a) of this chapter, the following
definitions apply to this section.
Bridge payment means a one-time
payment to an MDPP supplier for
furnishing its first MDDP session to an
MDPP beneficiary who has previously
received one or more MDPP services
from a different MDPP supplier.
Performance goal means an
attendance or weight-loss goal that an
MDPP beneficiary must achieve during
the MDPP services period for an MDPP
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supplier to be paid a performance
payment.
Performance payment means a
payment made to an MDPP supplier for
furnishing certain MDPP services to an
MDPP beneficiary when the MDPP
beneficiary achieves the applicable
performance goal.
(b) Performance payment. CMS makes
one or more types of performance
payments to an MDPP supplier as
specified in this paragraph. Each type of
performance payment is made only if
the beneficiary achieves the applicable
performance goal and only once per
MDPP beneficiary. A performance
payment is made only on an
assignment-related basis in accordance
with § 424.55 of this chapter, and MDPP
suppliers must accept the Medicare
allowed charge as payment in full and
may not bill or collect from the
beneficiary any amount. CMS will make
a performance payment only to an
MDPP supplier that complies with all
applicable enrollment and program
requirements and only for MDPP
services that are furnished by an eligible
coach, on or after his or her coach
eligibility start date and, if applicable,
before his or her coach eligibility end
date. As a condition of payment, the
MDPP supplier must report the NPI of
the coach who furnished each session
on the claim for the MDPP session. The
seven types of performance payments
are as follows:
(1) Performance Goal 1: Attends the
first core session that initiates the MDPP
services period. CMS makes a
performance payment to an MDPP
supplier if an MDPP beneficiary attends
the first core session, which initiates the
MDPP services period, and that first
core session was furnished by that
supplier. An MDPP supplier who has
been paid this performance payment for
an MDPP beneficiary is not eligible to be
paid a bridge payment described in
paragraph (c) of this section for that
MDPP beneficiary. The amount of this
performance payment is determined as
follows:
(i) For a first core session furnished
April 1 through December 31, 2018, the
amount of the performance payment is
$25.
(ii) For a first core session furnished
during a calendar year subsequent to CY
2018. The performance payment amount
specified in this paragraph for the prior
year, adjusted as specified in paragraph
(d) of this section.
(2) Performance Goal 2: Attends four
core sessions. CMS makes a
performance payment to an MDPP
supplier if an MDPP beneficiary
achieves attendance at the beneficiary’s
fourth core session upon attendance at
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a core session furnished by that
supplier. The amount of this
performance payment is determined as
follows:
(i) For a fourth core session furnished
April 1 through December 31, 2018, the
amount of the performance payment is
$30.
(ii) For a fourth core session furnished
during a calendar year subsequent to CY
2018, the performance payment amount
specified in this paragraph for the prior
year, adjusted as specified in paragraph
(d) of this section.
(3) Performance Goal 3: Attends nine
core sessions. CMS makes a
performance payment to an MDPP
supplier if an MDPP beneficiary
achieves attendance at the ninth core
session upon the beneficiary’s
attendance at a core session furnished
by that supplier. The amount of this
performance payment is determined as
follows:
(i) For a ninth core session furnished
April 1 through December 31, 2018, the
amount of the performance payment is
$50.
(ii) For a ninth core session furnished
during a calendar year subsequent to CY
2018, the performance payment amount
specified in this paragraph for the prior
year, adjusted as specified in paragraph
(d) of this section.
(4) Performance Goal 4: Attends three
core maintenance sessions during a core
maintenance session interval. CMS
makes a performance payment to an
MDPP supplier if an MDPP beneficiary
attends three core maintenance sessions
in a core maintenance session interval
and achieves attendance at that third
core maintenance session upon
attendance at a core maintenance
session furnished by that supplier. CMS
makes this performance payment to an
MDPP supplier only once per MDPP
beneficiary per core maintenance
session interval. The amount of this
performance payment is determined as
follows:
(i) If the beneficiary also achieves or
maintains the required minimum weight
loss as measured in-person during a
core maintenance session furnished
during the applicable core maintenance
session interval:
(A) For a third core maintenance
session furnished April 1 through
December 31, 2018, the amount of the
performance payment is $60.
(B) For a third core maintenance
session furnished during a calendar year
subsequent to CY 2018., the
performance payment amount specified
in this paragraph for the prior year,
adjusted as specified in paragraph (d) of
this section.
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(ii) If the beneficiary does not achieve
or maintain the required minimum
weight loss as measured in-person
during a core maintenance session
furnished during the applicable core
maintenance session interval:
(A) For a third core maintenance
session furnished April 1 through
December 31, 2018, the amount of the
performance payment is $10.
(B) For a third core maintenance
session furnished during a calendar year
subsequent to CY 2018, the performance
payment amount specified in this
paragraph for the prior year, adjusted as
specified in paragraph (d) of this
section.
(5) Performance Goal 5: Attends three
ongoing maintenance sessions and
maintains the required minimum weight
loss within an ongoing maintenance
session interval. CMS makes a payment
to an MDPP supplier if an MDPP
beneficiary attends three ongoing
maintenance sessions during an ongoing
maintenance session interval, achieves
attendance at that third ongoing
maintenance session upon attendance at
an ongoing maintenance session
furnished by that supplier, and achieves
or maintains the required minimum
weight loss as measured in-person
during an ongoing maintenance session
furnished during the applicable ongoing
maintenance session interval. CMS
makes this performance payment to an
MDPP supplier only once per MDPP
beneficiary per ongoing maintenance
session interval. The amount of this
performance payment is determined as
follows:
(i) For a third ongoing maintenance
session furnished April 1 through
December 31, 2018, the amount of the
performance payment is $50.
(ii) For a third ongoing maintenance
session furnished during a calendar year
subsequent to CY 2018, the performance
payment amount specified in this
paragraph for the prior year, adjusted as
specified in paragraph (d) of this
section.
(6) Performance Goal 6: Achieves the
required minimum weight loss. CMS
makes a performance payment to an
MDPP supplier for an MDPP beneficiary
who achieves the required minimum
weight loss as measured in-person
during a core session or core
maintenance session furnished by that
supplier. The amount of this
performance payment is determined as
follows:
(i) For a core session or core
maintenance session, as applicable,
furnished April 1 through December 31,
2018, the amount of the performance
payment is $160.
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(ii) For a core session or core
maintenance session, as applicable,
furnished during a calendar year
subsequent to CY 2018, the performance
payment amount specified in this
paragraph for the prior year, adjusted as
specified in paragraph (d) of this
section.
(7) Performance Goal 7: Achieves 9percent weight loss. CMS makes a
performance payment to an MDPP
supplier for an MDPP beneficiary who
achieves at least a 9-percent weight loss
as measured in-person during a core
session, core maintenance session, or
ongoing maintenance session furnished
by that supplier. The amount of this
performance payment is determined as
follows:
(i) For a core session, core
maintenance session, or ongoing
maintenance session, as applicable,
furnished April 1 through December 31,
2018, the amount of the performance
payment is $25.
(ii) For a core session, core
maintenance session, or ongoing
maintenance session, as applicable,
furnished during a calendar year
subsequent to CY 2018, the performance
payment amount specified in this
paragraph for the prior year, adjusted as
specified in paragraph (d) of this
section.
(c) Bridge payment. CMS makes a
bridge payment to an MDPP supplier
only for a core session, core
maintenance session, or ongoing
maintenance session furnished to an
MDPP beneficiary who has previously
received MDPP services from a different
MDPP supplier. An MDPP supplier who
has previously been paid either a bridge
payment or a performance payment for
an MDPP beneficiary is not eligible to be
paid a bridge payment for that
beneficiary. A bridge payment is made
only on an assignment-related basis in
accordance with § 424.55 of this
chapter, and MDPP suppliers must
accept the Medicare allowed charge as
payment in full and may not bill or
collect from the beneficiary any amount.
CMS will make a bridge payment only
to an MDPP supplier that complies with
all applicable enrollment and program
requirements, and only for MDPP
services furnished by an eligible coach,
on or after his or her coach eligibility
start date and, if applicable, before his
or her coach eligibility end date. As a
condition of payment, the MDPP
supplier must report the NPI of the
coach who furnished the session on the
claim for the MDPP session. The
amount of the bridge payment is
determined as follows:
(1) For a core session, core
maintenance session, or ongoing
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maintenance session furnished April 1
through December 31, 2018, the amount
of the bridge payment is $25.
(2) For a core session, core
maintenance session, or ongoing
maintenance session furnished during a
calendar year subsequent to CY 2018,
the bridge payment amount specified in
this paragraph for the prior year,
adjusted as specified in paragraph (d) of
this section.
(d) Updating performance payments
and the bridge payment. The
performance payments and bridge
payment will be adjusted each calendar
year by the percent change in the
Consumer Price Index for All Urban
Consumers (CPI–U) (U.S. city average)
for the 12-month period ending June
30th of the year preceding the update
year. The percent change update will be
calculated based on the level of
precision of the index as published by
the Bureau of Labor Statistics and
applied based on one decimal place of
precision. The annual MDPP services
payment update will be published by
CMS transmittal.
■ 8. Section 414.90 is amended by
revising paragraphs (j)(8)(i)(A)(1)(i),
(j)(8)(ii)(A)(1)(i), (j)(8)(ii)(A)(2), (j)(8)(iii)
and (iv), (j)(9)(ii) through (vi) and (viii),
(k)(3) introductory text subject heading,
and (k)(5)(i) and by adding (k)(5)(ii) to
read as follows:
§ 414.90 Physician Quality Reporting
System (PQRS).
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*
*
*
*
*
(j) * * *
(8) * * *
(i) * * *
(A) * * *
(1)(i) Report at least 6 measures AND
report each measure for at least 50
percent of the eligible professional’s
Medicare Part B Fee-for-Service patients
seen during the reporting period to
which the measure applies. If less than
6 measures apply to the eligible
professional, the eligible professional
must report on each measure that is
applicable, AND report each measure
for at least 50 percent of the Medicare
Part B Fee-for-Service patients seen
during the reporting period to which the
measure applies. Measures with a 0
percent performance rate will not be
counted (unless they are inverse
measures where a lower rate reflects
better performance).
*
*
*
*
*
(ii) * * *
(A) * * *
(1)(i) Report at least 6 measures AND
report each measure for at least 50
percent of the eligible professional’s
Medicare Part B Fee-for-Service patients
seen during the reporting period to
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which the measure applies. If less than
6 measures apply to the eligible
professional, the eligible professional
must report on each measure that is
applicable, AND report each measure
for at least 50 percent of the Medicare
Part B Fee-for-Service patients seen
during the reporting period to which the
measure applies.
*
*
*
*
*
(2) Measures with a 0 percent
performance rate or measures groups
containing a measure with a 0 percent
performance rate will not be counted
(unless they are inverse measures where
a lower rate reflects better performance).
*
*
*
*
*
(iii) Via EHR direct product. For the
12-month 2018 PQRS payment
adjustment reporting period, report 6
measures. If an eligible professional’s
direct EHR product or EHR data
submission vendor product does not
contain patient data for at least 6
measures, then the eligible professional
must report all of the measures for
which there is Medicare patient data.
An eligible professional must report on
at least 1 measure for which there is
Medicare patient data.
(iv) Via EHR data submission vendor.
For the 12-month 2018 PQRS payment
adjustment reporting period, report at
least 6 measures. If an eligible
professional’s direct EHR product or
EHR data submission vendor product
does not contain patient data for at least
6 measures, then the eligible
professional must report all of the
measures for which there is Medicare
patient data. An eligible professional
must report on at least 1 measure for
which there is Medicare patient data.
(9) * * *
(ii) Via qualified registry. For a group
practice of 2 or more eligible
professionals, for the 12-month 2018
PQRS payment adjustment reporting
period, report at least 6 measures AND
report each measure for at least 50
percent of the group practice’s Medicare
Part B Fee-for-Service patients seen
during the reporting period to which the
measure applies. If less than 6 measures
apply to the group practice, the group
practice must report on each measure
that is applicable, AND report each
measure for at least 50 percent of the
Medicare Part B Fee-for-Service patients
seen during the reporting period to
which the measure applies. Measures
with a 0 percent performance rate
would not be counted (unless they are
inverse measures where a lower rate
reflects better performance).
(iii) Via EHR direct product. For a
group practice of 2 or more eligible
professionals, for the 12-month 2018
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PQRS payment adjustment reporting
period, report 6 measures. If the group
practice’s direct EHR product or EHR
data submission vendor product does
not contain patient data for at least 6
measures, then the group practice must
report all of the measures for which
there is Medicare patient data. A group
practice must report on at least 1
measure for which there is Medicare
patient data.
(iv) Via EHR data submission vendor.
For a group practice of 2 or more
eligible professionals, for the 12-month
2018 PQRS payment adjustment
reporting period, report 6 measures. If
the group practice’s direct EHR product
or EHR data submission vendor product
does not contain patient data for at least
6 measures, then the group practice
must report all of the measures for
which there is Medicare patient data. A
group practice must report on at least 1
measure for which there is Medicare
patient data.
(v) Via a certified survey vendor in
addition to a qualified registry. For a
group practice of 2 or more eligible
professionals that elects to report via a
certified survey vendor in addition to a
qualified registry for the 12-month 2018
PQRS payment adjustment reporting
period, the group practice must have all
CAHPS for PQRS survey measures
reported on its behalf via a CMScertified survey vendor. In addition, the
group practice must report at least 3
additional measures using the qualified
registry AND report each measure for at
least 50 percent of the group practice’s
Medicare Part B Fee-for-Service patients
seen during the reporting period to
which the measure applies. If less than
3 measures apply to the group practice,
the group practice must report on each
measure that is applicable, AND report
each measure for at least 50 percent of
the Medicare Part B Fee-for-Service
patients seen during the reporting
period to which the measure applies.
Measures with a 0 percent performance
rate would not be counted (unless they
are inverse measures where a lower rate
reflects better performance).
(vi) Via a certified survey vendor in
addition to a direct EHR product or EHR
data submission vendor. For a group
practice of 2 or more eligible
professionals that elects to report via a
certified survey vendor in addition to a
direct EHR product or EHR data
submission vendor for the 12-month
2018 PQRS payment adjustment
reporting period, the group practice
must have all CAHPS for PQRS survey
measures reported on its behalf via a
CMS-certified survey vendor. In
addition, the group practice must report
at least 3 additional measures using the
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direct EHR product or EHR data
submission vendor product. If less than
3 measures apply to the group practice,
the group practice must report all of the
measures for which there is patient data.
Of the additional 3 measures that must
be reported in conjunction with
reporting the CAHPS for PQRS survey
measures, a group practice must report
on at least 1 measure for which there is
Medicare patient data.
*
*
*
*
*
(viii) If the CAHPS for PQRS survey
is applicable to the practice, group
practices comprised of 100 or more
eligible professionals that register to
participate in the GPRO may administer
the CAHPS for PQRS survey, regardless
of the GPRO reporting mechanism
selected.
(k) * * *
(3) Satisfactory participation criteria
for individual eligible professionals for
the 2016 PQRS payment adjustment.
* * *
*
*
*
*
*
(5) * * *
(i) Individual eligible professional. For
the applicable 12-month reporting
period, report at least 6 measures
available for reporting under a QCDR
AND report each measure for at least 50
percent of the eligible professional’s
patients seen during the reporting
period to which the measure applies. If
less than 6 measures apply to the
eligible professional, the eligible
professional must report on each
measure that is applicable, AND report
each measure for at least 50 percent of
the eligible professional’s patients.
(ii) Group practices. For the
applicable 12-month reporting period,
report at least 6 measures available for
reporting under a QCDR AND report
each measure for at least 50 percent of
the group practice’s patients seen during
the reporting period to which the
measure applies. If less than 6 measures
apply to the group practice, the group
practice must report on each measure
that is applicable, AND report each
measure for at least 50 percent of the
group practice’s patients. If a group
practice reports the CAHPS for PQRS
survey measures, apply reduced criteria
as follows: 3 measures, as applicable.
*
*
*
*
*
■ 9. Section 414.94 is amended by
revising paragraph (i)(3) and adding
paragraphs (j) and (k) to read as follows:
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§ 414.94 Appropriate use criteria for
advanced diagnostic imaging services.
*
*
*
*
*
(i) * * *
(3) The significant hardship exception
applies to ordering professionals who:
(i) Are granted re-weighting of the
advancing care information performance
category to zero percent of the final
score for the year under MIPS pursuant
to § 414.1380(c)(2) due to circumstances
that include the criteria listed in
§ 495.102(d)(4)(i) and (iii) and
(d)(4)(iv)(A) and (B) of this chapter. The
AUC significant hardship exception is
available for the same period the reweight is applied for purposes of the
MIPS payment adjustments, or
(ii) Demonstrate a significant hardship
consistent with the criteria listed in
§ 495.102(d)(4)(i) and (iii) and
(d)(4)(iv)(A) or (B) of this chapter. The
AUC significant hardship exception
may be available for a period no longer
than 12 months.
(j) Consulting. Ordering Professionals
must consult specified applicable AUC
through qualified CDSMs for applicable
imaging services furnished in an
applicable setting, paid for under an
applicable payment system and ordered
on or after January 1, 2019.
(k) Reporting. Furnishing
Professionals must report the following
information on Medicare claims for
advanced diagnostic imaging services
furnished in an applicable setting, paid
for under an applicable payment system
defined in § 414.94(b), and ordered on
or after January 1, 2019:
(1) The qualified CDSM consulted by
the ordering professional.
(2) Information indicating:
(i) Whether the service ordered would
adhere to specified applicable AUC;
(ii) Whether the service ordered
would not adhere to specified
applicable AUC, or
(iii) Whether the specified applicable
AUC consulted was not applicable to
the service ordered.
(3) The NPI of the ordering
professional who consulted specified
applicable AUC as required in
paragraph (j) of this section, if different
from the furnishing professional.
■ 10. Section 414.904 is amended by
revising paragraph (e)(2) to read as
follows:
§ 414.904 Average sales price as the basis
for payment.
*
*
*
*
*
(e) * * *
(2) Infusion drugs furnished through a
covered item of durable medical
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34195
equipment. The payment limit for an
infusion drug furnished before January
1, 2017, through a covered item of
durable medical equipment is
calculated using 95 percent of the
average wholesale price in effect on
October 1, 2003.
*
*
*
*
*
■ 11. Section 414.1270 is amended by
revising paragraph (d)(1) to read as
follows:
§ 414.1270 Determination and calculation
of the Value-Based Payment Modifier
adjustments.
*
*
*
*
*
(d) * * *
(1) A downward payment adjustment
of ¥1.0 percent will be applied to a solo
practitioner, a group with two to nine
eligible professionals, and a group
consisting only of nonphysician eligible
professionals subject to the value-based
payment modifier and no physicians;
and a downward payment adjustment of
¥2.0 percent will be applied to a group
with 10 or more eligible professionals
and at least one physician if, during the
applicable performance period as
defined in § 414.1215, the following
apply:
(i) For groups:
(A) Such group does not meet the
criteria as a group to avoid the PQRS
payment adjustment for CY 2018 as
specified by CMS; and
(B) Fifty percent of the eligible
professionals in such group do not meet
the criteria as individuals to avoid the
PQRS payment adjustment for CY 2018
as specified by CMS.
(ii) For solo practitioners, such solo
practitioner does not meet the criteria as
an individual to avoid the PQRS
payment adjustment for CY 2018 as
specified by CMS.
*
*
*
*
*
■ 12. Section 414.1275 is amended by
revising paragraphs (c)(4) and (d)(3)(i)
and (ii) to read as follows:
§ 414.1275 Value-based payment modifier
quality-tiering scoring methodology.
*
*
*
*
*
(c) * * *
(4) The following value-based
payment modifier percentages apply to
the CY 2018 payment adjustment
period, for physicians, physician
assistants, nurse practitioners, clinical
nurse specialists, and certified
registered nurse anesthetists who are
solo practitioners or who are in groups
of any size:
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CY 2018—VALUE-BASED PAYMENT MODIFIER AMOUNTS FOR THE QUALITY-TIERING APPROACH FOR PHYSICIANS, PHYSICIAN ASSISTANTS, NURSE PRACTITIONERS, CLINICAL NURSE SPECIALISTS, AND CERTIFIED REGISTERED NURSE ANESTHETISTS
Cost/quality
Low quality
Low Cost ......................................................................................................................................
Average Cost ...............................................................................................................................
High Cost .....................................................................................................................................
+0.0%
+0.0%
+0.0%
Average
quality
+*1.0x
+0.0%
+0.0%
High quality
+*2.0x
+*1.0x
+0.0%
* Eligible for an additional +1.0x if reporting Physician Quality Reporting System quality measures and average beneficiary risk score is in the
top 25 percent of all beneficiary risk scores, where ‘x’ represents the upward payment adjustment factor.
(d) * * *
(3) * * *
(i) Classified as high quality/low cost
receive an upward adjustment of +3x
(rather than +2x); and
(ii) Classified as either high quality/
average cost or average quality/low cost
receive an upward adjustment of +2x
(rather than +1x).
PART 424—CONDITIONS FOR
MEDICARE PAYMENT
13. 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).
14. Section 424.55 is amended by
adding paragraph (d) to read as follows:
■
§ 424.55
Payment to the supplier.
*
*
*
*
*
(d) For purposes of claims for services
submitted by an MDDP supplier (as
defined at § 410.79(b)), Medicare deems
such claims to have been assigned by
the beneficiary (or the person
authorized to request payment on the
beneficiary’s behalf) and the assignment
accepted by the MDDP supplier.
§ 424,59
[Removed]
15. Remove § 424.59.
16. Subpart I, consisting of §§ 424.200
through 424.210, is added to read as
follows:
■
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■
Subpart I—Requirements for Medicare
Diabetes Prevention Program
Suppliers and Beneficiary Engagement
Incentives Under the Medicare
Diabetes Prevention Program
Expanded Model
Sec.
424.200 Scope.
424.205 Requirements for Medicare
Diabetes Prevention Program suppliers.
424.210 Beneficiary engagement incentives
under the Medicare Diabetes Prevention
Program expanded model.
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Subpart I—Requirements for Medicare
Diabetes Prevention Program
Suppliers and Beneficiary Engagement
Incentives Under the Medicare
Diabetes Prevention Program
Expanded Model
§ 424.200
Scope.
This subpart specifies the
requirements for Medicare Diabetes
Prevention Program suppliers and
beneficiary engagement incentives
under the Medicare Diabetes Prevention
Program expanded model.
§ 424.205 Requirements for Medicare
Diabetes Prevention Program suppliers.
(a) Definitions. In addition to the
definitions specified at §§ 410.79(b) and
414.84(a) of this subchapter, the
following definitions apply to this
section:
Administrative location means a
physical location associated with the
MDPP supplier’s operations, from where
coaches are dispatched or based, and
where MDPP services may or may not
be furnished.
Coach means an individual who
furnishes MDPP services on behalf of an
MDPP supplier as an employee,
contractor, or volunteer.
Coach eligibility end date means the
end date indicated by the MDPP
supplier in submitting a change to the
supplier’s MDPP enrollment application
in accordance with paragraph (d)(5) of
this section that removed the coach’s
information, or the date the supplier
itself was revoked from or withdrew its
Medicare enrollment as an MDPP
supplier.
Coach eligibility start date, means the
start date indicated by the MDPP
supplier when submitting an eligible the
coach’s information on the MDPP
enrollment application.
Community setting means a location
where the MDPP supplier furnishes
MDPP services outside of their
administrative locations. A community
setting is a location open to the public
not primarily associated with the
supplier. Community settings may
include, for example, church basements
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or multipurpose rooms in recreation
centers.
Eligible coach means an individual
who CMS has screened and has
determined can provide MDPP services
on behalf of an MDPP supplier in
accordance with paragraph (e) of this
section.
Ineligible coach means an individual
whom CMS has screened and has
determined cannot provide MDPP
services on behalf of an MDPP supplier
in accordance with paragraph (e) of this
section.
MDPP interim preliminary recognition
means a status that CMS has granted to
an entity in accordance with paragraph
(c) of this section.
(b) Conditions for MDPP supplier
enrollment. An entity may enroll as an
MDPP supplier only if it satisfies the
following requirements and all other
applicable Medicare enrollment
requirements:
(1) Has either an MDPP preliminary
recognition, as defined in paragraph
(c)(1) of this section or a full CDC DPRP
recognition.
(2) Maintains an active and valid TIN
and NPI at the organizational level.
(3) Has passed screening requirements
as follows:
(i) Upon initial enrollment, at a
‘‘high’’ categorical risk in accordance
with § 424.518(c)(2); and
(ii) Upon revalidation, at a
‘‘moderate’’ categorical risk in
accordance with § 424.518(b)(2).
(4) Maintains, and submits to CMS
through the CMS-approved enrollment
application, a roster of all coaches who
will be furnishing MDPP services on the
entity’s behalf that includes each
coach’s first and last names, middle
initial (if applicable), date of birth,
Social Security Number (SSN), active
and valid NPI, coach eligibility start
date, and coach eligibility end date (if
applicable). This roster must be updated
in accordance with paragraph (d)(5) of
this section.
(5) Meets and certifies in its CMSapproved enrollment application that it
meets and will continue to meet the
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supplier enrollment standards described
in paragraph (d) of this section.
(6) Revalidates its Medicare
enrollment every 3 years after the
effective date of enrollment.
(c) MDPP preliminary recognition. (1)
For the purposes of this section, an
MDPP preliminary recognition may
include either:
(i) Any preliminary recognition
established by CDC for the purposes of
the DPRP; or
(ii) An MDPP interim preliminary
recognition.
(A) MDPP interim preliminary
recognition application period. Entities
may apply to CDC for CMS’ MDPP
interim preliminary by submitting
information at the time and in the form
and manner specified by CMS.
(B) MDPP Interim preliminary
recognition requirements. An entity may
qualify for MDPP interim preliminary
recognition if—
(1) The entity has pending CDC
recognition.
(2) The entity submits a full 12
months of performance data to CDC on
at least one completed cohort. The 12
month data submission includes at least
5 participants who attended at least 3
sessions in the first 6 months and whose
time from first session attended to last
session of the lifestyle change program
was at least 9 months, at least 60
percent of whom attended at least 9
sessions in months 1 through 6, and at
least 60 percent of whom attended at
least 3 sessions in months 7 through 12.
(2) [Reserved]
(d) Medicare Diabetes Prevention
Program supplier standards. An MDPP
supplier must meet and must certify in
its CMS-approved enrollment
application that it meets and will
continue to meet the following
standards.
(1) The MDPP supplier must have and
maintain MDPP preliminary
recognition, as defined under paragraph
(c)(1) of this section, or a full CDC DPRP
recognition.
(2) The MDPP supplier must not
currently have its billing privileges
terminated for-cause or be excluded by
a State Medicaid agency.
(3) The MDPP supplier must not
include on the roster of coaches,
described in paragraph (b)(4) of this
section and updated in accordance with
paragraph (d)(5) of this section, nor
permit MDPP services to be furnished
by any individual coach who meets any
of ineligibility criteria outlined in
paragraph (e)(1) of this section.
(4) The MDPP supplier must maintain
at least one administrative location. All
administrative locations maintained by
the MDPP supplier must be located at
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an appropriate site and be reported on
the CMS-approved enrollment
application. An appropriate site for such
an administrative location would
include all of the following
characteristics:
(i) Signage posted on the exterior of
the building. Such signage may include,
for example, the MDPP supplier’s legal
business name or DBA, as well as hours
of operation.
(ii) Open for business during stated
operational hours.
(iii) Employees, staff, or volunteers
present during operational hours; and
(iv) Not a private residence.
(5) The MDPP supplier must update
its enrollment application within 30
days of any changes of ownership,
changes to the coach roster (including
due to coach ineligibility or because the
coach is no longer an employee,
contractor, or volunteer of the MDPP
supplier), and final adverse action
history, and report all other changes,
including but not limited to changes in
the MDPP supplier’s administrative
location(s), to CMS within 90 days of
the reportable event.
(6) The MDPP supplier must maintain
a primary business telephone that
operates either at administrative
locations described in paragraph (d)(4)
of this section or directly where services
are furnished, if services are furnished
in community settings. The associated
telephone number must be listed with
the either the legal or doing business as
name of the supplier in public view,
including on Web sites, flyers, and
materials.
(7) The MDPP supplier must not
knowingly sell to or allow another
individual or entity to use its supplier
billing number.
(8) Subject to paragraph (d)(8)(i) of
this section, the MDPP supplier must
not deny an MDPP beneficiary access to
MDPP services during the MDPP
services period described in
§ 410.79(c)(2) of this chapter, including
on the basis of the beneficiary’s weight,
health status, or achievement of
performance goals.
(i) Suppliers may deny an MDPP
beneficiary access to MDPP services
during the MDPP services period only
under one of the following conditions:
(A) The MDPP beneficiary no longer
meets the eligibility criteria for MDPP
services under § 410.79(c)(1) of this
chapter.
(B) The MDPP supplier lacks the selfdetermined capacity to furnish MDPP
services to additional MDPP
beneficiaries.
(C) The MDPP supplier determines
that the MDPP beneficiary significantly
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34197
disrupts the session for other MDPP
beneficiaries or becomes abusive.
(ii) MDPP suppliers must maintain a
record of the number of MDPP
beneficiaries turned away for the
reasons outlined in paragraphs
(d)(8)(i)(B) and (C) of this section, to
include the date each such beneficiary
was turned away. For beneficiaries
turned away for reasons described in
paragraph (d)(8)(i)(C) of this section, the
MDPP supplier must document details
of the occurrence(s), including date(s) of
the behavior, any remediation efforts
taken by the MDPP supplier, and final
action (for example, dismissal from an
MDPP session or denial from future
sessions) in the beneficiary’s MDPP
records.
(9) The MDPP supplier and other
individuals or entities performing
functions or services related to MDPP
services on the MDPP supplier’s behalf
must not unduly coerce an MDPP
beneficiary’s decision to change or not
to change to a different MDPP supplier,
including through the use of pressure,
intimidation, or bribery.
(10) Except as allowed under
paragraph (d)(8) of this section, the
MDPP supplier must offer an MDPP
beneficiary no fewer than all of the
following:
(i) Sixteen in-person core sessions no
more frequently than weekly for the first
6 months of the MDPP services period,
which begins on the date of attendance
at the first such core session.
(ii) One in-person core maintenance
session each month during months 7
through 12 (6 months total) of the MDPP
services period.
(iii) One in-person ongoing
maintenance session each month for
months 13 through 36 of the MDPP
services period, as long as the
beneficiary maintains eligibility to
receive such services in accordance
with § 410.79(c)(1)(ii) and (iii) of this
chapter.
(11) Before the initial core session is
furnished, the MDPP supplier must
disclose detailed information about the
set of MDPP services to each MDPP
beneficiary to whom it wishes to begin
furnishing MDPP services. Such
information must include all of the
following:
(i) Eligibility requirements under
§ 410.79(c)(1) of this chapter, including
the once-per-lifetime nature of MDPP
services.
(ii) The MDPP supplier standards as
outlined in this section.
(12) The MDPP supplier must answer
MDPP beneficiaries’ questions about
MDPP services and respond to MDPPrelated complaints within a reasonable
timeframe. An MDPP supplier must
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implement a complaint resolution
protocol and maintain documentation of
all beneficiary contact regarding such
complaints, including the name and
Medicare Beneficiary Identifier of the
beneficiary, a summary of the
complaint, related correspondences,
notes of actions taken, and the names
and/or NPIs of individuals who took
such actions on behalf of the MDPP
supplier. Failure to maintain a
complaint resolution protocol or to
retain information regarding MDPP
related complaints in accordance with
paragraph (g) of this section may be
considered evidence that the MPPP
supplier standards have not been met.
This information must be kept at each
administrative location and made
available to CMS or its contractors upon
request.
(13) The MDPP supplier must
maintain a crosswalk file which
indicates how beneficiary
identifications for the purposes of CDC
performance data requirements
correspond to corresponding beneficiary
health insurance claims numbers or
Medicare Beneficiary Identifiers for
each MDPP beneficiary receiving MDPP
services from the MDPP supplier. The
MDPP supplier must submit the
crosswalk file to CMS or its contractor.
(14) The MDPP supplier must submit
performance data for MDPP
beneficiaries who attend ongoing
maintenance sessions with data
elements consistent with the CDC’s
DPRP standards for data elements
required for the core services period.
(15) The MDPP supplier must allow
CMS or its agents to conduct onsite
inspections or recordkeeping reviews in
order to ascertain the MDPP supplier’s
compliance with these standards, and
must adhere to the documentation
requirements as outlined in paragraph
(g) of this section.
(e) Coach eligibility—(1) Criteria. To
furnish MDPP services to a beneficiary,
an MDPP coach must not:
(i) Currently have Medicare billing
privileges revoked and be currently
subject to the reenrollment bar.
(ii) Currently have its Medicaid
billing privileges terminated for-cause
or be excluded by a State Medicaid
agency.
(iii) Currently be excluded from any
other Federal health care program, as
defined in 42 CFR 1001.2, in accordance
with section 1128, 1128A, 1156, 1842,
1862, 1867 or 1892 of the Act.
(iv) Currently be debarred, suspended,
or otherwise excluded from
participating in any other Federal
procurement or nonprocurement
program or activity in accordance with
the Federal Acquisition Streamlining
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Act implementing regulations and the
Department of Health and Human
Services nonprocurement common rule
at 45 CFR part 76.
(v) Have, in the previous 10 years, one
of the following State or Federal felony
convictions:
(A) Crimes against persons, such as
murder, rape, assault, and other similar
crimes for which the individual was
convicted, as defined under 42 CFR
1001.2, had a guilty plea or adjudicated
pretrial diversion.
(B) Financial crimes, such as
extortion, embezzlement, income tax
evasion, insurance fraud and other
similar crimes for which the individual
was convicted, as defined under 42 CFR
1001.2, had a guilty plea or adjudicated
pretrial diversion.
(C) Any felony that placed the
Medicare or its beneficiaries at
immediate risk, such as a malpractice
suit that results in the individual being
convicted, as defined under 42 CFR
1001.2, had a guilty plea or adjudicated
pretrial diversion of criminal neglect or
misconduct.
(D) Any felonies for which the
individual was convicted, as defined
under 42 CFR 1001.2, had a guilty plea
or adjudicated pretrial diversion that
would result in mandatory exclusion
under section 1128(a) of the Act.
(2) CMS determination of coach
eligibility. CMS will screen each
individual identified on the roster of
coaches included with the supplier’s
enrollment application described in
paragraph (b)(4) of this section and
updated in accordance with paragraph
(d)(5) of this section to verify that the
individual coach does not meet any of
the conditions specified in paragraph
(e)(1) of this section and that the coach
can provide MDPP services on behalf of
an MDPP supplier. For each individual
coach successfully screened by CMS,
his or her eligibility start date becomes
effective and remains effective until an
MDPP supplier or CMS takes action that
results in an eligibility end date.
(f) Effective date for billing privileges.
(1) For MDPP suppliers initially
enrolling and for newly established
administrative locations that result in a
new enrollment record or Provider
Transaction Access Number, the
effective date for Medicare billing
privileges for MDPP suppliers is—
(i) The later of—
(A) The date of filing of a Medicare
enrollment application that was
subsequently approved by a Medicare
contractor;
(B) The date of filing of a corrective
action plan that was subsequently
approved by a Medicare contractor; or
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(C) The date that the supplier first
began furnishing services at a new
administrative location that resulted in
a new enrollment record or Provider
Transaction Access Number
(ii) Under no circumstances should
the effective date of billing privileges for
any MDPP supplier be prior to April 1,
2018
(2) For any newly established
administrative locations that do not
result in a new enrollment record or
Provider Transaction Access Number,
the existing billing privilege effective
date for their Provider Transaction
Access Number will apply, but not
earlier than April 1, 2018.
(g) Documentation retention and
provision requirements. An MDPP
supplier must maintain all
documentation related to participation
in the MDPP in accordance with all
applicable Federal and State laws. The
MDPP supplier must provide to CMS, a
contractor acting on CMS’ behalf, the
Office of the Inspector General, and the
Comptroller General or their designee(s)
scheduled and unscheduled access to
the MDPP supplier’s records, including,
but not limited to, all books, contracts,
records, documents, and other evidence
sufficient to enable the audit,
evaluation, inspection, or investigation
of the MDPP supplier’s compliance with
the MDPP expanded model’s
requirements, including the MDPP
expanded model requirements for inkind beneficiary incentive engagements
in § 424.210 of this chapter in the event
that the MDPP supplier chooses to offer
such incentives to any MDPP
beneficiary.
(1) The documentation for the first
core session must be established
contemporaneous with the furnishing of
MDPP services and must include at least
all of the following:
(i) Organizational information,
including MDPP supplier name, CDC
DPRP number, and NPI.
(ii) Basic beneficiary information for
each MDPP beneficiary in attendance,
including but not limited to beneficiary
name, HICN, age.
(iii) Evidence that each such
beneficiary satisfied the eligibility
requirements under § 410.79(c) at the
time of service.
(2) The documentation for each MDPP
session attended must be established
contemporaneous with the furnishing of
MDPP services and must include at least
all of the following:
(i) Documentation of the type of
session, whether a core session, a core
maintenance session, an ongoing
maintenance session, an in-person
make-up session, or a virtual make-up
session.
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(ii) Identification of which CDCapproved DPRP curriculum was
associated with the session.
(iii) The NPI of the coach who
furnished the session.
(iv) The date and place of service of
the session.
(v) Each MDPP’s beneficiary’s weight
and date weight taken, in a form and
manner as specified by CMS.
(3) If an MDPP supplier chooses to
offer in-kind beneficiary engagement
incentives to MDPP beneficiaries as
permitted under § 424.210, the records
maintained by the MDPP supplier in
accordance with this section must also
include the information required by
§ 424.210(e).
(4) An MDPP supplier is required to
maintain and handle any beneficiary
Personally Identifiable Information (PII)
and Protected Health Information (PHI)
in compliance with HIPAA, other
applicable state and federal privacy
laws, and CMS standards.
(5) The MDPP supplier’s records must
include an attestation from the MDPP
supplier that, as applicable, the MDPP
beneficiary for which it is submitting a
claim—
(i) Has attended their first, fourth or
ninth core session, as applicable, if the
claim submitted is for a performance
payment under § 414.84(b)(1), (2), or (3)
of this chapter.
(ii) Has attended at least three core
maintenance sessions, achieved
required minimum weight loss, or both,
as applicable, if the claim submitted is
for a performance payment under
§ 414.84(b)(4) of this chapter.
(iii) Has achieved the required
minimum weight loss and attended at
least three ongoing maintenance
sessions within an ongoing maintenance
session interval, if the claim submitted
is for a performance payment under
§ 414.84(b)(5) of this chapter, if the
claim submitted is for a performance
payment under § 414.84(b)(6) of this
chapter.
(iv) Has achieved required minimum
weight loss as measured in-person
during a core session or core
maintenance session furnished by that
supplier, if the claim submitted is for a
performance payment under
§ 414.84(b)(6) of this chapter.
(v) Has achieved at least a 9-percent
weight loss percentage as measured inperson during a core session, core
maintenance session, or ongoing
maintenance session furnished by that
supplier, if the claim submitted is for a
performance payment under
§ 414.84(b)(7) of this chapter.
(6) The MDPP supplier must maintain
all records required under this section
for a period of 10 years from the last day
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of the MDPP beneficiary’s receipt of
MDPP services provided by the MDPP
supplier or from the date of completion
of any audit, evaluation, inspection, or
investigation, whichever is later, unless
either of the following apply:
(i) CMS determines that there is a
special need to retain a particular record
or group of records for a longer period
and notifies the MDPP supplier at least
30 calendar days before the normal
disposition rate; or
(ii) There has been a dispute or
allegation of fraud or similar fault
against the MDPP supplier, in which
case the records must be maintained for
an additional 6 years from the date of
any resulting final resolution of the
dispute or allegation of fraud or similar
fault, as defined at § 405.902 of this
chapter.
(h) Denial or revocation of MDPP
supplier enrollment. (1) An MDPP
supplier is subject to enrollment denial
or revocation of its MDPP supplier
enrollment for one or more of the
following reasons:
(i) Failure to meet enrollment
requirements. The MDPP supplier does
not satisfy the conditions specified in
paragraph (b) of this section.
(A) An enrollment denial under this
paragraph (h)(1)(i) is considered an
enrollment denial under § 424.530(a)(1)
of this chapter.
(B) A revocation under this paragraph
(h)(1)(i) is considered a revocation
under § 424.535(a)(1) of this chapter.
(C) An MDPP supplier that does not
satisfy the requirements in paragraph
(b)(1) of this section may become
eligible to bill for MDPP services again
if it successfully achieves MDPP
preliminary recognition or full CDC
DPRP recognition, and successfully
enrolls again in Medicare as an MDPP
supplier after any applicable
reenrollment bar has expired.
(ii) Failure to meet MDPP supplier
standards. The MDPP supplier fails to
meet the standards specified in
paragraph (d) of this section.
(A) An enrollment denial under this
paragraph (h)(1)(ii) is considered an
enrollment denial under § 424.530(a)(1)
of this part.
(B) A revocation under this paragraph
(h)(1)(ii) is considered a revocation
under § 424.535(a)(1) of this part.
(iii) Application of existing
enrollment denial reasons. One of the
enrollment denial reasons specified in
§ 424.530(a) of this part applies.
(iv) Application of existing revocation
reasons. One of the revocation reasons
specified in § 424.535(a) of this chapter
applies.
(v) Use of an ineligible coach. (A) The
MDPP supplier knowingly allows an
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34199
ineligible coach to furnish MDPP
services to Medicare beneficiaries.
Knowingly means that the MDPP
supplier received an enrollment denial
or revocation notice based on failing to
meet the standard specified in
§ 424.205(d)(3), was provided notice by
CMS or contractors working on its
behalf of this coach’s ineligibility
including the reason(s) for ineligibility,
submitted a corrective action plan (CAP)
to remove the coach and become
compliant therefore maintaining its
enrollment, but continued to allow the
coach to provide MDPP services in
violation of the CAP.
(B) Revocation under this paragraph
(h)(1)(v) is subject to the following
requirements:
(1) The revocation becomes effective
30 days after CMS or the CMS
contractor mails notice of its
determination to the MDPP supplier.
(2) For the revocation authority under
this paragraph, MDPP suppliers are
barred from participating in the
Medicare program from the date of the
revocation, which begins 30 days after
CMS or its contractor mails notice of the
revocation, until the end of the
reenrollment bar, which lasts a
minimum of 1 year, but not greater than
3 years, depending on the severity of the
basis for revocation.
(3) A revoked MDPP supplier must,
within 60 calendar days after the
effective date of revocation, submit all
claims for items and services furnished
before the date of the revocation letter.
(2) An MDPP supplier may appeal an
enrollment denial or revocation
decision in accordance with the
procedures specified in part 498 of this
chapter. References to suppliers in that
section apply to MDPP suppliers.
§ 424.210 Beneficiary engagement
incentives under the Medicare Diabetes
Prevention Program expanded model.
(a) Definitions. In addition to the
definitions specified at § 410.79(b) and
§ 424.205(a) of this chapter, the
following definition applies to this
section:
Engagement incentive period means
the period of time during which an
MDPP supplier may furnish in-kind
beneficiary engagement incentives to a
given MDPP beneficiary to whom the
MDPP supplier is furnishing MDPP
services. This period begins when an
MDPP supplier furnishes any MDPP
service to an MDPP eligible beneficiary
and ends when one of the following
occurs, whichever occurs first:
(i) The MDPP beneficiary’s MDPP
services period ends as described in
§ 410.79(c)(3) of this chapter.
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(ii) The MDPP supplier knows the
MDPP beneficiary will no longer be
receiving MDPP services from the MDPP
supplier.
(iii) The MDPP supplier has not had
direct contact, either in-person, by
telephone, or via other
telecommunications technology, with
the MDPP beneficiary for more than 90
consecutive calendar days during the
MDPP services period.
(b) General. An MDPP supplier may
choose to furnish an item or service as
an in-kind beneficiary engagement
incentive to an MDPP beneficiary only
during the engagement incentive period,
subject to the following conditions:
(1) The item or service must be
furnished directly to an MDPP
beneficiary by an MDPP supplier or by
an agent of the MDPP supplier, such as
a coach, under the MDPP supplier’s
direction and control.
(2) The item or service must be
reasonably connected to the CDCapproved DPP curriculum furnished to
the MDPP beneficiary during a core
session, a core maintenance session, or
ongoing maintenance session furnished
by the MDPP supplier.
(3) The item or service must be a
preventive care item or service or an
item or service that advances a clinical
goal, as specified in paragraph (d) of this
section, for an MDPP beneficiary by
engaging him or her in better managing
his or her own health.
(4) The item or service must not be
tied to the receipt of services outside of
the MDPP services
(5) The item or service must not be
tied to the receipt of services from a
particular provider, supplier, or coach.
(6) The availability of the item or
service must not be advertised or
promoted as an in-kind beneficiary
engagement incentive available to an
MDPP beneficiary receiving MDPP
services from the MDPP supplier except
that an MDPP beneficiary may be made
aware of the availability of the item or
service at the time the MDPP beneficiary
could reasonably benefit from it during
the engagement incentive period.
(7) The cost of the item or service
must not be shifted to another Federal
health care program, as defined at
section 1128B(f) of the Act.
(c) Technology furnished to an MDPP
beneficiary. In-kind beneficiary
engagement incentives involving
technology furnished by an MDPP
supplier to an MDPP beneficiary are
subject to the following conditions:
(1) Items or services involving
technology may not, in the aggregate,
exceed $1,000 in retail value for any one
MDPP beneficiary.
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(2) Items or services involving
technology must be the minimum
necessary to advance a clinical goal, as
listed in paragraph (d) of this section,
for an MDPP beneficiary.
(3) Items involving technology
exceeding $100 in retail value must—
(i) Remain the property of the MDPP
supplier; and
(ii) Be retrieved from the MDPP
beneficiary at the end of the engagement
incentive period. The MDPP supplier
must document all retrieval attempts,
including the ultimate date of retrieval
in accordance with paragraph (e)(3) of
this section. Documented diligent, good
faith attempts to retrieve items of
technology will be deemed to meet the
retrieval requirement.
(d) Clinical goals of the MDPP
expanded model. The following are the
clinical goals for MDPP beneficiaries,
that may be advanced through in-kind
beneficiary engagement incentives:
(1) Attendance at core sessions, core
maintenance sessions, or ongoing
maintenance sessions.
(2) Weight loss.
(3) Long-term dietary change.
(4) Adherence to long-term health
behavior changes.
(e) Documentation of beneficiary
engagement incentives. In addition to
the documentation requirements at
§ 424.205(g), an MDPP supplier must
maintain documentation of items and
services furnished as in-kind beneficiary
engagement incentives that exceed $25
in retail value.
(1) The documentation must be
established contemporaneous with the
furnishing of the in-kind items and
services and must include at least the
following:
(i) The date the item or service is
furnished.
(ii) The identity of the MDPP
beneficiary to whom the item or service
is furnished.
(iii) The agent of the MDPP supplier
who furnished the item or service, if
applicable.
(iv) A description of the item or
service.
(v) The retail value of the item or
service.
(vi) Documentation establishing that
the item or service was furnished to the
MDPP beneficiary during the
engagement incentive period.
(2) Documentation regarding items or
services that are furnished to the MDPP
beneficiary for use on an ongoing basis
during the engagement incentive period,
including items of technology exceeding
$100 in retail value, must also include
contemporaneous documentation
establishing that the MDPP beneficiary
is in the engagement incentive period
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throughout the time period that the
MDPP beneficiary possesses or has
access to the item or service furnished
by the MDPP supplier.
(3) The documentation regarding
items of technology exceeding $100 in
retail value must also include
contemporaneous documentation of any
attempt to retrieve technology as
required by paragraph (c)(3)(ii) of this
section.
(4) The MDPP supplier must retain
and provide access to the
documentation required in this section
in accordance with § 424.205(g).
■ 17. Section 424.502 is amended by
revising the definition for ‘‘Institutional
provider’’ to read as follows.
§ 424.502
Definitions.
*
*
*
*
*
Institutional provider means any
provider or supplier that submits a
paper Medicare enrollment application
using the CMS–855A, CMS–855B (not
including physician and nonphysician
practitioner organizations), CMS–855S,
any enrollment application designated
for MDPP suppliers, or an associated
Internet-based PECOS enrollment
application.
*
*
*
*
*
■ 18. Section 424.516 is amended by
revising paragraph (e) introductory text
to read as follows.
§ 424.516 Additional provider and supplier
requirements for enrolling and maintaining
active enrollment status in the Medicare
program.
*
*
*
*
*
(e) Reporting requirements for all
other providers and suppliers. Reporting
requirements for all other providers and
suppliers not identified in paragraphs
(a) through (d) of this section, with the
exception of MDPP suppliers whose
reporting requirements are established
in § 424.205(d), must report to CMS the
following information within the
specified timeframes:
*
*
*
*
*
PART 425—MEDICARE SHARED
SAVINGS PROGRAM
19. The authority citation for part 425
continues to read as follows:
■
Authority: Secs. 1102, 1106, 1871, and
1899 of the Social Security Act (42 U.S.C.
1302, 1306 1395hh, and 1395jjjj).
20. Section 425.20 is amended by
revising the definitions of ‘‘Primary care
physician’’ and ‘‘Primary care services’’
to read as follows:
■
§ 425.20
*
Definitions.
*
*
*
*
Primary care physician means:
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(1) For performance years 2012
through 2015, a physician included in
an attestation by the ACO as provided
under § 425.404 for services furnished
in an FQHC or RHC, or a physician who
has a primary care specialty designation
of internal medicine, general practice,
family practice, or geriatric medicine;
(2) For performance years 2016
through 2018, a physician included in
an attestation by the ACO as provided
under § 425.404 for services furnished
in an FQHC or RHC, or a physician who
has a primary care specialty designation
of internal medicine, general practice,
family practice, geriatric medicine, or
pediatric medicine; and
(3) For performance year 2019 and
subsequent years, a physician who has
a primary care specialty designation of
internal medicine, general practice,
family practice, geriatric medicine, or
pediatric medicine.
Primary care services means the set of
services identified by the HCPCS and
revenue center codes designated under
§ 425.400(c).
*
*
*
*
*
■ 22. Section 425.112 is amended—
■ a. In paragraph (a)(3)(i) by removing
the phrase ‘‘Explain how it will require
ACO participants’’ and adding in its
place the phrase ‘‘Require ACO
participants’’;
■ b. In paragraph (a)(3)(ii) by removing
the phrase ‘‘Explain how it will employ
its internal assessments’’ and adding in
its place the phrase ‘‘Employ its internal
assessments’’; and
■ c. By revising paragraph (b)(4)(ii).
The revision reads as follows:
§ 425.112 Required processes and patientcenteredness criteria.
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*
*
*
*
*
(b) * * *
(4) * * *
(ii) Have a written plan to:
(A) Implement an individualized care
program that promotes improved
outcomes for, at a minimum, the ACO’s
high-risk and multiple chronic
condition patients.
(B) Identify additional target
populations that would benefit from
individualized care plans.
Individualized care plans must take into
account the community resources
available to the individual.
(C) Encourage and promote use of
enabling technologies for improving
care coordination for beneficiaries.
Enabling technologies may include one
or more of the following:
(1) Electronic health records and other
health IT tools.
(2) Telehealth services, including
remote patient monitoring.
(3) Electronic exchange of health
information.
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(4) Other electronic tools to engage
beneficiaries in their care.
(D) Partner with long-term and postacute care providers, both inside and
outside the ACO, to improve care
coordination for its assigned
beneficiaries.
■ 23. Section 425.204 is amended by—
■ a. Revising paragraph (c)(1)
introductory text;
■ b. Removing paragraph (c)(5)(iii);
■ c. Redesignating paragraph (c)(5)(iv)
as paragraph (c)(5)(iii); and
■ d. Revising paragraph (d).
The revisions read as follows:
§ 425.204
Content of the application.
*
*
*
*
*
(c) * * *
(1) As part of its application, an ACO
must certify that the ACO satisfies the
requirements set forth in this part. Upon
request, the ACO must submit the
following supporting materials to
demonstrate that it satisfies the
requirements set forth in this part:
*
*
*
*
*
(d) Distribution of savings. As part of
its application to participate in the
Shared Savings Program, an ACO must
certify it has a mechanism and plan to
receive and use payments for shared
savings, including criteria for
distributing shared savings among its
ACO participants and ACO providers/
suppliers.
*
*
*
*
*
■ 24. Section 425.306 is amended by
revising paragraph (b)(2) to read as
follows:
§ 425.306 Participant agreement and
exclusivity of ACO participants.
*
*
*
*
*
(b) * * *
(2) Each ACO participant that submits
claims for services used to determine
the ACO’s assigned population under
subpart E of this part must be exclusive
to one Shared Savings Program ACO. If,
during a benchmark or performance
year (including the 3-month claims
runout for such benchmark or
performance year), an ACO participant
that participates in more than one ACO
submits claims for services used in
assignment under subpart E of this part,
then:
(i) CMS will not consider any services
billed through the TIN of the ACO
participant when performing
assignment under subpart E of this part
for the benchmark or performance year.
(ii) The ACO may be subject to the
pre-termination actions set forth in
§ 425.216, termination under § 425.218,
or both.
■ 25. Section 425.400 is amended by
adding paragraph (a)(1)(iii) and revising
paragraph (c) to read as follows:
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General.
(a) * * *
(1) * * *
(iii) In determining final assignment
for a benchmark or performance year,
CMS will exclude any services
furnished during the benchmark or
performance year that are billed through
the TIN of an ACO participant that is an
ACO participant in more than one ACO.
*
*
*
*
*
(c) Primary care services for purposes
of assigning beneficiaries are identified
by selected HCPCS/CPT codes, or
revenue center codes.
(1) Primary care service codes are as
follows:
(i) For performance years 2012
through 2015:
(A) CPT codes:
(1) 99201 through 99215.
(2) 99304 through 99340.
(3) 99341 through 99350.
(B) HCPCS codes G0402 (the code for
the Welcome to Medicare visit) and
G0438 and G0439 (codes for the annual
wellness visits).
(C) Revenue center codes 0521, 0522,
0524, and 0525 submitted by FQHCs
(for services furnished prior to January
1, 2011), or by RHCs.
(ii) For performance year 2016 as
follows:
(A) CPT codes:
(1) 99201 through 99215.
(2) 99304 through 99340.
(3) 99341 through 99350.
(4) 99495, 99496, and 99490.
(B) HCPCS codes:
(1) G0402 (the code for the Welcome
to Medicare visit) and
(2) G0438 and G0439 (codes for the
annual wellness visits).
(3) G0463 for services furnished in
ETA hospitals.
(C) Revenue center codes 0521, 0522,
0524, and 0525 submitted by FQHCs
(for services furnished prior to January
1, 2011), or by RHCs.
(iii) For performance year 2017 and
2018 as follows:
(A) CPT codes:
(1) 99201 through 99215.
(2) 99304 through 99318 (excluding
claims including the POS 31 modifier).
(3) 99319 through 99340.
(4) 99341 through 99350.
(5) 99495, 99496, and 99490.
(B) HCPCS Codes:
(1) G0402 (the code for the Welcome
to Medicare visit) and
(2) G0438 and G0439 (codes for the
annual wellness visits).
(3) G0463 for services furnished in
ETA hospitals.
(C) Revenue center codes 0521, 0522,
0524, and 0525 submitted by FQHCs
(for services furnished prior to January
1, 2011), or by RHCs.
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(iv) For performance year 2019 as
follows:
(A) CPT codes:
(1) 99201 through 99215.
(2) 99304 through 99318 (excluding
claims including the POS 31 modifier).
(3) 99319 through 99340.
(4) 99341 through 99350.
(5) 99487 and 99489.
(6) 99495, 99496, and 99490.
(B) HCPCS Codes:
(1) G0402 (the code for the Welcome
to Medicare visit) and
(2) G0438 and G0439 (codes for the
annual wellness visits).
(3) G0463 for services furnished in
ETA hospitals.
(4) G0506 (code for chronic care
management).
(5) G0502, G0503, G0504 and G0507
(codes for behavioral health integration).
■ 26. Section 425.404 is amended—
■ a. In the introductory text by
removing the phrase ‘‘with two special
conditions:’’ and adding in its place the
phrase ‘‘with special conditions:’’; and
■ b. By revising paragraphs (a) and (b).
The revisions read as follows:
§ 425.404 Special assignment conditions
for ACOs including FQHCs and RHCs.
mstockstill on DSK30JT082PROD with PROPOSALS2
*
*
*
*
*
(a) For performance years 2012
through 2018—
(1) Such ACOs are required to
identify, through an attestation,
physicians who directly provide
primary care services in each FQHC or
RHC that is an ACO participant and/or
ACO provider/supplier in the ACO.
(2) Under the assignment
methodology in § 425.402, CMS treats a
service reported on an FQHC/RHC claim
as a primary care service—
(i) If the claim includes a HCPCS or
revenue center code that meets the
definition of primary care services
under § 425.20;
(ii) Performed by a primary care
physician if the NPI of a physician
identified in the attestation provided
under paragraph (a)(1) of this section is
reported on the claim for a primary care
service (as described in paragraph
(a)(2)(i) of this section) as the attending
provider; and
(iii) Performed by a non-physician
ACO professional if the NPI reported on
the claim for a primary care service (as
described in paragraph (a)(2)(i) of this
section) as the attending provider is an
ACO professional but is not identified
in the attestation provided under
paragraph (a)(1) of this section.
(b) For performance year 2019 and
subsequent performance years, under
the assignment methodology in
§ 425.402, CMS treats a service reported
on an FQHC/RHC claim as a primary
VerDate Sep<11>2014
00:24 Jul 21, 2017
Jkt 241001
care service performed by a primary
care physician.
§ 425.500
[Amended]
27. Section 425.500 is amended—
a. In paragraph (e)(2) by removing the
phrase ‘‘of this section is less than 90
percent, absent unusual circumstances,’’
and adding in its place the phrase ‘‘of
this section is less than 80 percent,
absent unusual circumstances,’’; and
■ b. In paragraph (e)(3) by removing the
phrase ‘‘determines there is a match rate
of less than 90 percent, the ACO’’ and
adding in its place the phrase
‘‘determines there is a match rate of less
than 80 percent, the ACO’’.
■
■
§ 425.502
[Amended]
28. Section 425.502 is amended in
paragraph (a)(5) by removing the phrase
‘‘or causes patient harm.’’ and adding in
its place the phrase ‘‘or causes patient
harm, or when there is a determination
under the Quality Payment Program that
the measure has undergone a
substantive change.’’
■ 29. Section § 425.602 is amended by
adding paragraphs (a)(1)(ii)(A) through
(C) to read as follows:
■
§ 425.602 Establishing, adjusting, and
updating the benchmark for an ACO’s first
agreement period.
(a) * * *
(1) * * *
(ii) * * *
(A) For agreement periods beginning
before 2018, this calculation considers
all individually beneficiary identifiable
payments, including interim payments,
made under a demonstration, pilot or
time limited program.
(B) For agreement periods beginning
in 2018 and subsequent years, this
calculation considers individually
beneficiary identifiable final payments
made under a demonstration, pilot or
time limited program.
(C) For the 2018 performance year and
subsequent performance years in
agreement periods beginning in 2015,
2016 and 2017, the benchmark is
adjusted to reflect only individually
beneficiary identifiable final payments
made under a demonstration, pilot or
time limited program.
*
*
*
*
*
■ 30. Section § 425.603 is amended by
adding paragraphs (c)(1)(ii)(A) through
(C) and (e)(2)(ii)(A) through (C) to read
as follows:
§ 425.603 Resetting, adjusting, and
updating the benchmark for a subsequent
agreement period.
*
PO 00000
*
*
(c) * * *
(1) * * *
(ii) * * *
Frm 00254
*
Fmt 4701
*
Sfmt 4702
(A) For agreement periods beginning
before 2018, considers all individually
beneficiary identifiable payments,
including interim payments, made
under a demonstration, pilot or time
limited program.
(B) For agreement periods beginning
in 2018 and subsequent years, considers
individually beneficiary identifiable
final payments made under a
demonstration, pilot or time limited
program.
(C) For the 2018 and 2019
performance years in agreement periods
beginning in 2017, the benchmark is
adjusted to reflect only individually
beneficiary identifiable final payments
made under a demonstration, pilot or
time limited program.
*
*
*
*
*
(e) * * *
(2) * * *
(ii) * * *
(A) For agreement periods beginning
before 2018, considers all individually
beneficiary identifiable payments,
including interim payments, made
under a demonstration, pilot or time
limited program.
(B) For agreement periods beginning
in 2018 and subsequent years, considers
individually beneficiary identifiable
final payments made under a
demonstration, pilot or time limited
program.
(C) For the 2018 and 2019
performance years in agreement periods
beginning in 2017, risk adjusted county
fee-for-service expenditures are adjusted
to reflect only individually beneficiary
identifiable final payments made under
a demonstration, pilot or time limited
program.
*
*
*
*
*
■ 31. Section § 425.604 is amended by
adding paragraphs (a)(6)(ii)(A) and (B)
to read as follows:
§ 425.604 Calculation of savings under the
one-sided model.
(a) * * *
(6) * * *
(ii) * * *
(A) For performance years beginning
before 2018, these calculations will take
into consideration all individually
beneficiary identifiable payments,
including interim payments, made
under a demonstration, pilot or time
limited program.
(B) For performance year 2018 and
subsequent performance years, these
calculations will take into consideration
individually beneficiary identifiable
final payments made under a
demonstration, pilot or time limited
program.
*
*
*
*
*
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32. Section § 425.606 is amended by
adding paragraphs (a)(6)(ii)(A) and (B)
to read as follows:
■
§ 425.606 Calculation of shared savings
and losses under Track 2.
mstockstill on DSK30JT082PROD with PROPOSALS2
(a) * * *
(6) * * *
(ii) * * *
(A) For performance years beginning
before 2018, these calculations will take
into consideration all individually
beneficiary identifiable payments,
including interim payments, made
under a demonstration, pilot or time
limited program.
(B) For performance year 2018 and
subsequent performance years, these
calculations will take into consideration
individually beneficiary identifiable
final payments made under a
VerDate Sep<11>2014
00:24 Jul 21, 2017
Jkt 241001
demonstration, pilot or time limited
program.
*
*
*
*
*
■ 33. Section § 425.610 is amended by
adding paragraphs (a)(6)(ii)(A) and (B)
to read as follows:
34203
individually beneficiary identifiable
final payments made under a
demonstration, pilot or time limited
program.
*
*
*
*
*
§ 425.612
[Amended]
§ 425.610 Calculation of shared savings
and losses under Track 3.
■
(a) * * *
(6) * * *
(ii) * * *
(A) For performance years beginning
before 2018, these calculations will take
into consideration all individually
beneficiary identifiable payments,
including interim payments, made
under a demonstration, pilot or time
limited program.
(B) For performance year 2018 and
subsequent performance years, these
calculations will take into consideration
Dated: June 28, 2017.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
Dated: June 28, 2017.
Thomas E. Price,
Secretary, Department of Health and Human
Services.
PO 00000
Frm 00255
Fmt 4701
Sfmt 9990
34. Section 425.612 is amended by
removing paragraphs (a)(1)(i)(A)(4) and
(a)(1)(i)(C).
[FR Doc. 2017–14639 Filed 7–13–17; 4:15 pm]
BILLING CODE 4120–01–P
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Agencies
[Federal Register Volume 82, Number 139 (Friday, July 21, 2017)]
[Proposed Rules]
[Pages 33950-34203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14639]
[[Page 33949]]
Vol. 82
Friday,
No. 139
July 21, 2017
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, 414, et al.
Medicare Program; Revisions to Payment Policies Under the Physician
Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared
Savings Program Requirements; and Medicare Diabetes Prevention Program;
Proposed Rule
Federal Register / Vol. 82 , No. 139 / Friday, July 21, 2017 /
Proposed Rules
[[Page 33950]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 410, 414, 424, and 425
[CMS-1676-P]
RIN 0938-AT02
Medicare Program; Revisions to Payment Policies Under the
Physician Fee Schedule and Other Revisions to Part B for CY 2018;
Medicare Shared Savings Program Requirements; and Medicare Diabetes
Prevention Program
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: This major proposed rule addresses changes to the Medicare
physician fee schedule (PFS) and other Medicare Part B payment
policies.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on September 11,
2017. (See the SUPPLEMENTARY INFORMATION section of this final rule
with comment period for a list of provisions open for comment.)
ADDRESSES: In commenting, please refer to file code CMS-1676-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-1676-P, P.O. Box 8016,
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-1676-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:
Jamie Hermansen, (410) 786-2064, for issues related to the
valuation of anesthesia services and any physician payment issues not
identified below.
Lindsey Baldwin, (410) 786-1694, and Emily Yoder, (410) 786-1804,
for issues related to telehealth services and primary care.
Roberta Epps, (410) 786-4503, for issues related to PAMA section
218(a) policy and transition from traditional X-ray imaging to digital
radiography.
Isadora Gil, (410) 786-4532, for issues related to the valuation of
cardiovascular services, bone marrow services, surgical respiratory
services, dermatological procedures, and payment rates for nonexcepted
items and services furnished by nonexcepted off-campus provider-based
departments of a hospital.
Donta Henson, (410) 786-1947, for issues related to ophthalmology
services.
Tourette Jackson, (410) 786-4735, for issues related to the
valuation of musculoskeletal services, allergy and clinical immunology
services, endocrinology services, genital surgical services, nervous
system services, INR monitoring services, injections and infusions, and
chemotherapy services.
Ann Marshall, (410) 786-3059, for issues related to primary care,
chronic care management (CCM), and evaluation and management (E/M)
services.
Geri Mondowney, (410) 786-4584, for issues related to malpractice
RVUs.
Patrick Sartini, (410) 786-9252, for issues related to the
valuation of imaging services and malpractice RVUs.
Michael Soracoe, (410) 786-6312, for issues related to the practice
expense methodology, impacts, conversion factor, and valuation of
pathology and surgical procedures.
Pamela West, (410) 786-2302, for issues related to therapy
services.
Corinne Axelrod, (410) 786-5620, for issues related to rural health
clinics or federally qualified health centers.
Felicia Eggleston, (410) 786-9287, for issues related to DME
infusion drugs.
Rasheeda Johnson, (410) 786-3434, for issues related to initial
data collection and reporting periods for the clinical laboratory fee
schedule.
Edmund Kasaitis, (410) 786-0477, for issues related to biosimilars.
JoAnna Baldwin, (410) 786-7205, or Sarah Fulton, (410) 786-2749,
for issues related to appropriate use criteria for advanced diagnostic
imaging services.
Alesia Hovatter, (410) 786-6861, for issues related to PQRS.
Alexandra Mugge, (410) 786-4457, or Elizabeth Holland, (410) 786-
1309, for issues related to the EHR incentive program.
Rabia Khan or Terri Postma, (410) 786-8084 or ACO@cms.hhs.gov, for
issues related to the Medicare Shared Savings Program.
Kimberly Spalding Bush, (410) 786-3232, or Fiona Larbi, (410) 786-
7224, for issues related to Value-based Payment Modifier and Physician
Feedback Program.
Wilbert Agbenyikey, (410) 786-4399, for issues related to MACRA
patient relationship categories and codes.
Carlye Burd, (410) 786-1972, or Albert Wesley, (410) 786-4204, for
issues related to diabetes prevention program.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
II. Provisions of the Proposed Rule for PFS
A. Background
B. Determination of Practice Expense Relative Value Units (PE
RVUs)
C. Determination of Malpractice Relative Value Units (MRVUs)
D. Medicare Telehealth Services
E. Potentially Misvalued Services Under the PFS
F. Implementation of Reduced Payment for Film-Based Imaging
Services
G. Proposed Payment Rates Under the Medicare PFS for Nonexcepted
Items and Services Furnished by Nonexcepted Off-Campus Provider-
Based Departments of a Hospital
[[Page 33951]]
H. Proposed Valuation of Specific Codes
I. Evaluation & Management (E/M) Guidelines and Care Management
Services
III. Other Provisions of the Proposed Rule
A. New Care Coordination Services and Payment for Rural Health
Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)
B. Payment for DME Infusion Drugs
C. Solicitation of Public Comments on Initial Data Collection
and Reporting Periods for Clinical Laboratory Fee Schedule
D. Solicitation of Public Comments on Biosimilars
E. Appropriate Use Criteria for Advanced Diagnostic Imaging
Services
F. Physician Quality Reporting System Criteria for Satisfactory
Reporting for Individual EPs and Group Practices for the 2018 PQRS
Payment Adjustment
G. Medicare EHR Incentive Program
H. Medicare Shared Savings Program
I. Value-Based Payment Modifier and Physician Feedback Program
J. MACRA Patient Relationship Categories and Codes
K. Medicare Diabetes Prevention Program
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 final 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)
BLS Bureau of Labor Statistics
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
FSHCAA Federally Supported Health Centers Assistance Act
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
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)
PAMPA Patient Access and Medicare Protection Act (Pub. L. 114-115)
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
PPS Prospective Payment System
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
Scale 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
TCM Transitional Care Management
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
[[Page 33952]]
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 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 2018 PFS Proposed Rule, refer to item
CMS-1676-P. Readers with questions related to accessing any of the
Addenda or other supporting documents referenced in this proposed rule
and posted on the CMS Web site identified above should contact Jamie
Hermansen at (410) 786-2064.
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 2016 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
A. Purpose
This major proposed rule proposes to revise payment polices under
the Medicare PFS and make other policy changes related to Medicare Part
B payment, applicable to services furnished in CY 2018. In addition,
this proposed rule includes proposals related to payment policy changes
that are addressed in section III. of this proposed rule.
1. 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 2018 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 Codes.
Telehealth Services.
Establishing Values for New, Revised, and Misvalued Codes.
Establishing Payment Rates under the PFS for Nonexcepted
Items and Services Furnished by Nonexcepted Off-Campus Provider-Based
Departments of a Hospital.
Evaluation & Management (E/M) Guidelines and Care
Management Services.
Care Coordination Services and Payment for Rural Health
Clinics (RHCs) and Federally Qualified Health Centers (FQHCs).
Payment for DME Infusion Drugs.
Solicitation of Public Comments on Initial Data Collection
and Reporting Periods for Clinical Laboratory Fee Schedule.
Solicitation of Public Comments on Payment for Biosimilar
Biological Products under Section 1847A of the Act.
Appropriate Use Criteria for Advanced Diagnostic Imaging
Services.
PQRS Criteria for Satisfactory Reporting for Individual
EPs and Group Practices for the 2018 PQRS Payment Adjustment.
Medicare EHR Incentive Program.
Medicare Shared Savings Program.
Value-Based Payment Modifier and the Physician Feedback
Program.
MACRA Patient Relationship Categories and Codes.
Medicare Diabetes Prevention Program.
2. Summary of Costs and Benefits
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.
II. Provisions of the Proposed Rule for PFS
A. Background
Since January 1, 1992, Medicare has paid for physicians' services
under section 1848 of the Act, ``Payment for Physicians' Services.''
The PFS 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 Scale
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
[[Page 33953]]
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 hospital outpatient department
(HOPD)) would reflect costs typically incurred by the facility. Thus,
payment associated with those facility resources is not made under the
PFS.
Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L.
106-113, enacted on November 29, 1999) (BBRA) directed the Secretary of
Health and Human Services (the Secretary) to establish a process under
which we accept and use, to the maximum extent practicable and
consistent with sound data practices, data collected or developed by
entities and organizations to supplement the data we normally collect
in determining the PE component. On May 3, 2000, we published the
interim final rule (65 FR 25664) that set forth the criteria for the
submission of these supplemental PE survey data. The criteria were
modified in response to comments received, and published in the Federal
Register (65 FR 65376) as part of a November 1, 2000 final rule. The
PFS final rules published in 2001 and 2003, respectively, (66 FR 55246
and 68 FR 63196) extended the period during which we would accept these
supplemental data through March 1, 2005.
In the CY 2007 PFS final rule with comment period (71 FR 69624), we
revised the methodology for calculating direct PE RVUs from the top-
down to the bottom-up methodology beginning in CY 2007. We adopted a 4-
year transition to the new PE RVUs. This transition was completed for
CY 2010. In the CY 2010 PFS final rule with comment period, we updated
the practice expense per hour (PE/HR) data that are used in the
calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010,
we began a 4-year transition to the new PE RVUs using the updated PE/HR
data, which was completed for CY 2013.
c. Malpractice RVUs
Section 4505(f) of the BBA amended section 1848(c) of the Act to
require that we implement resource-based MP RVUs for services furnished
on or after CY 2000. The resource-based MP RVUs were implemented in the
PFS final rule with comment period published November 2, 1999 (64 FR
59380). The MP RVUs are based on commercial and physician-owned
insurers' malpractice insurance premium data from all the states, the
District of Columbia, and Puerto Rico. For more information on MP RVUs,
see section II.C. of this 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 5-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, that require 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 do 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.
[[Page 33954]]
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
conversion factor (CF), which is calculated based on a statutory
formula by CMS's Office of the Actuary (OACT). The formula for
calculating the Medicare PFS 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.
B. Determination of Proposed 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 5 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 use crosswalks for specialties
that did not participate in the PPIS. These crosswalks have been
generally established through notice and
[[Page 33955]]
comment rulemaking and are available in the file called ``CY 2018 PFS
Proposed Rule PE/HR'' on the CMS Web site under downloads for the CY
2018 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
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
We allocate 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 incorporate
the survey data described earlier in the PE/HR discussion (see section
II.B.2.b of this proposed rule). The general approach to developing the
indirect portion of the PE RVUs is as follows:
For a given service, we use the direct portion of the PE
RVUs calculated as previously described and the average percentage that
direct costs represent of total costs (based on survey data) across the
specialties that furnish the service to determine an initial indirect
allocator. 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, represent 25 percent of total costs for the specialties that
furnish 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 RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75
percent of 8.00).
Next, we add the greater of the work RVUs or clinical
labor portion of the direct portion of the PE RVUs to this initial
indirect allocator. In our example, if this service had a work RVU of
4.00 and the clinical labor portion of the direct PE RVU 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 facility setting, where Medicare makes a separate payment
to the facility for its costs in furnishing a service, 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.
(4) Services With Technical Components and Professional Components
Diagnostic services are generally comprised of two components: A
professional component (PC) and a technical component (TC). The PC and
TC may be furnished independently or by different providers, or they
may be furnished together as a global service. When services have
separately billable PC and TC components, the payment for the global
service equals the sum of the payment for the TC and PC. To achieve
this, we use a weighted average of the ratio of indirect to direct
costs across all the specialties that furnish the global service, TCs,
and PCs; that is, we apply the same weighted average indirect
percentage factor to allocate indirect expenses to the global service,
PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum
to the global.)
(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 2018 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 in this proposed rule for individual 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, use the conversion
factor to calculate a direct PE scaling adjustment to ensure that the
aggregate pool of direct PE costs calculated in Step 3 does not vary
from the aggregate pool of direct PE costs for the current year. Apply
the scaling adjustment to the direct costs for each service (as
calculated in Step 1).
[[Page 33956]]
Step 5: Convert the results of Step 4 to a RVU scale for each
service. To do this, divide the results of Step 4 by the conversion
factor (CF). Note that the actual value of the CF used in this
calculation does not influence the final direct cost PE RVUs as long as
the same CF is used in Step 4 and Step 5. Different CFs would result in
different direct PE scaling adjustments, but this has no effect on the
final direct cost PE RVUs since changes in the CFs and changes in the
associated direct scaling adjustments 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 generally use an average of the 3 most recent years of available
Medicare claims data to determine the specialty mix assigned to each
code. Prior to implementing that policy, we used the most recent year
of available claims data to determine the specialty mix assigned to
each code.
Under either of these approaches, codes with low Medicare service
volume require special attention since billing or enrollment
irregularities for a given year can result in significant changes in
specialty mix assignment. Prior to adopting the 3-year average of data,
for low-volume services (fewer than 100 Medicare allowed services), we
assigned the values associated with the specialty that most frequently
reported the service in the most recent claims data (dominant
specialty). For some time, stakeholders, including the RUC, have
requested that we use a recommended ``expected'' specialty for all low
volume services instead of the information contained in the claims
data. Currently, in the development of PE RVUs we use ``expected
specialty'' overrides for only several dozen services based on several
code-specific policies we established in prior rulemaking. As we stated
in the CY 2016 final rule with comment period (80 FR 70894), we hoped
that the 3-year average would mitigate the need to use dominant or
expected specialty instead of the specialty identified using claims
data. Because we incorporated CY 2015 claims data for use in the CY
2017 proposed rates, we believe that the finalized PE RVUs associated
with the CY 2017 PFS final rule provided a first opportunity to
determine whether service-level overrides of claims data are necessary.
Although we believe that the use of the 3-year average of claims
data to determine specialty mix has led to an improvement in the
stability of PE and MP RVUs from year to year, after reviewing the RVUs
for low volume services, we continue to see possible distortions and
wide variability from year to year in PE and MP RVUs for low volume
services. Several stakeholders have suggested that CMS implement
service-level overrides based on the expected specialty in order to
determine the specialty mix for these low volume procedures. The RUC
previously supplied us with a list of nearly 2,000 lower volume codes
and their suggested specialty overrides. After reviewing the finalized
PE RVUs for the CY 2017 PFS final rule, we agree that the use of
service-level overrides for low volume services would help mitigate
annual fluctuations and provide greater stability in the valuation of
these services. While the use of the 3-year average of claims data to
determine specialty mix has helped to mitigate some of the year-to-year
variability for low volume services, it has not fully mitigated what
appear to be anomalies for many of these lower volume codes.
We are, therefore, proposing to use the most recent year of claims
data to determine which codes are low volume for the coming year (those
that have fewer than 100 allowed services in the Medicare claims data).
For codes that fall into this category, instead of assigning specialty
mix based on the specialties of the practitioners reporting the
services in the claims data, we are proposing to instead use the
expected specialty that we identify on a list. For CY 2018, we are
proposing to use a list that was developed based on our medical review
of the list most recently recommended by the RUC, in addition to our
own proposed expected specialty for certain other low-volume codes for
which we have historically used expected specialty assignments. We
would display this list as part of the annual set of data files we make
available as part of notice and comment rulemaking. We propose to
consider recommendations from the RUC and other stakeholders on changes
to this list on an annual basis.
We are also proposing to apply these service-level overrides for
both PE and MP, rather than one or the other category. We believe that
this would simplify the implementation of service-level overrides for
PE and MP, and would also address stakeholder concerns about the year-
to-year variability for low volume services. We are soliciting public
comment on the proposal to use service-level overrides to determine the
specialty mix for low volume procedures, as well as on the proposed
list of expected specialty overrides itself, which is largely based on
the recommendations submitted by the RUC last year. The proposed list
of expected specialty assignments for individual low volume services is
available on our Web site under downloads for the CY 2018 PFS proposed
rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. Services for
which the specialty is automatically assigned based on previously
finalized policies under our established methodology (for example,
``always therapy'' services) would be unaffected by this proposal.
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 would be allocated
using the work RVUs, and for the TC service, indirect PEs would 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.
[[Page 33957]]
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 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 proposed rule.)
Step 19: Apply the phase-in of significant RVU reductions and its
associated adjustment. 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 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. To comply
with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure
that the total RVUs for all services that are not new or revised codes
decrease by no more than 19 percent, and then apply a relativity
adjustment to ensure that the total pool of aggregate PE RVUs remains
relative to the pool of work and MP RVUs. For a more detailed
description of the methodology for the phase-in of significant RVU
changes, we refer readers to the CY 2016 PFS final rule with comment
period (80 FR 70927 through 70931).
(e) Setup File Information
Specialties excluded from ratesetting calculation: For the
purposes of calculating the PE RVUs, we exclude certain specialties,
such as certain NPPs paid at a percentage of the PFS and low-volume
specialties, from the calculation. These specialties are included for
the purposes of calculating the BN adjustment. They are displayed in
Table 1.
TABLE 1--Specialties Excluded From Ratesetting Calculation
------------------------------------------------------------------------
Specialty code Specialty description
------------------------------------------------------------------------
49....................... Ambulatory surgical center.
50....................... Nurse practitioner.
51....................... Medical supply company with certified
orthotist.
52....................... Medical supply company with certified
prosthetist.
53....................... Medical supply company with certified
prosthetist[dash]orthotist.
54....................... Medical supply company not included in 51,
52, or 53.
55....................... Individual certified orthotist.
56....................... Individual certified prosthetist.
57....................... Individual certified
prosthetist[dash]orthotist.
58....................... Medical supply company with registered
pharmacist.
59....................... Ambulance service supplier, e.g., private
ambulance companies, funeral homes, etc.
60....................... Public health or welfare agencies.
61....................... Voluntary health or charitable agencies.
73....................... Mass immunization roster biller.
74....................... Radiation therapy centers.
87....................... All other suppliers (e.g., drug and
department stores).
88....................... Unknown supplier/provider specialty.
89....................... Certified clinical nurse specialist.
96....................... Optician.
[[Page 33958]]
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
Physician Assistant. portion.
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 Percentages Intraoperative
on the payment files used portion.
by Medicare contractors to
process Medicare claims.
55................................ Postoperative Care only Postoperative Percentage on Postoperative portion.
the payment files used by
Medicare contractors to
process Medicare claims.
62................................ Co-surgeons............ 62.5%...................... 50%.
66................................ Team Surgeons.......... 33%........................ 33%.
----------------------------------------------------------------------------------------------------------------
We also make adjustments to volume and time that correspond to
other payment rules, including special multiple procedure endoscopy
rules and multiple procedure payment reductions (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:
[[Page 33959]]
minutes per year = maximum minutes per year if usage were continuous
(that is, usage=1); generally 150,000 minutes.
usage = variable, see discussion in this proposed rule.
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 in this proposed rule.
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 finalized in the CY
1998 PFS final rule with comment period (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 (see 77 FR 68902 for a thorough
discussion of this issue). 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). We
are not proposing any changes to these interest rates for CY 2018. The
interest rates are listed in Table 3.
Table 3--SBA Maximum Interest Rates
------------------------------------------------------------------------
Interest rate
Price Useful life (%)
------------------------------------------------------------------------
<$25K............................. <7 Years............ 7.50
$25K to $50K...................... <7 Years............ 6.50
>$50K............................. <7 Years............ 5.50
<$25K............................. 7+ Years............ 8.00
$25K to $50K...................... 7+ Years............ 7.00
>$50K............................. 7+ Years............ 6.00
------------------------------------------------------------------------
3. Changes to Direct PE Inputs for Specific Services
This section focuses on specific PE inputs. The direct PE inputs
are included in the CY 2018 direct PE input database, which is
available on the CMS Web site under downloads for the CY 2018 PFS
proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
(a) PE Inputs for Digital Imaging Services
In the CY 2017 PFS final rule (81 FR 80179 through 80184), we
finalized our proposal to add a professional PACS workstation (ED053)
used for interpretation of digital images to a series of CPT codes and
to address costs related to the use of film that had previously been
incorporated as direct PE inputs for these services. We finalized the
following criteria for the inclusion of a professional PACS
workstation:
We did not add the professional PACS workstation to any
code that currently lacks a technical PACS workstation (ED050) or lacks
a work RVU. We continue to believe that procedures that do not include
a technical workstation, or do not have physician work, would not
require a professional workstation.
We did not add the professional PACS workstation to add-on
codes. Because the base codes include equipment minutes for the
professional PACS workstation, we continue to believe it would be
duplicative to add additional equipment time for the professional PACS
workstation in the add-on code.
We also did not add the professional PACS workstation to
image guidance codes where the dominant provider is not a radiologist
according to the most recent year of claims data, because we believe a
single technical PACS workstation would be more typical in those cases.
We agreed with commenters that because the clinical
utility of the PACS workstation is not necessarily limited to
diagnostic services, there may be therapeutic codes where it would be
reasonable to assume its use to be typical. Based on information
provided by commenters and our own medical review, we stated that we
believe that the use of the professional PACS workstation is typical
for many of the specific codes that were identified. We added the
workstation to many of the therapeutic codes requested by commenters,
specifically CPT codes listed outside the 70000 series, where we agreed
that use of the professional PACS workstation was typical.
For CPT codes in the 80000 and 90000 series, we expressed
our concerns about whether it is appropriate to include the technical
PACS workstation in many of these services. PACS workstations were
created for imaging purposes, but many of these services that include a
technical PACS workstation do not appear to make use of imaging.
Although we did not remove the technical PACS workstation from these
codes at that time, we did not believe that a professional PACS
workstation should be added to these procedures.
Prior to the publication of this CY 2018 PFS proposed rule, a
stakeholder expressed concern about our decision not to include the
professional PACS workstation in a series of vascular ultrasound codes
that use technical PACS workstations. The stakeholder indicated that
the vascular ultrasound codes in question do make use of a professional
PACS workstation, and that the dominant specialty provider requirement
(that is, that the code's dominant specialty provider being diagnostic
radiology) would exclude codes for which the professional PACS
workstation is typical based on a mistaken assumption. The stakeholder
stated that to furnish vascular ultrasound services following the
transition from film to digital imaging, both a technical and a
professional PACS workstation are required, regardless of whether the
practitioner furnishing the service is a radiologist, cardiologist,
neurologist, or vascular surgeon.
We appreciate the submission of this additional information
regarding the use of the professional PACS workstation in vascular
ultrasound codes. Therefore, we seek comments regarding whether or not
the use of the professional PACS workstation would be typical in the
following list of CPT and HCPCS codes. The codes brought to our
attention by the stakeholder are CPT codes 93880, 93882, 93886, 93888,
93890, 93892, 93893, 93922, 93923, 93924, 93925, 93926, 93930, 93931,
93965, 93970, 93971, 93975, 93976, 93978, 93979, 93980, 93981, 93990,
and 76706, and HCPCS code G0365. We will consider information submitted
in comments to determine whether the professional
[[Page 33960]]
PACS workstation should be included as a direct PE input for these
codes.
(2) Standardization of Clinical Labor Tasks
As we noted in the CY 2015 PFS final rule with comment period (79
FR 67640-67641), we continue to make improvements 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 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 simultaneously 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. Preservice Clinical Labor for 0-Day and 10-Day Global Services
Several years ago, the RUC's PE Subcommittee reviewed the
preservice clinical labor times for CPT codes with 0-day and 10-day
global periods. The RUC concluded that these codes are assumed to have
no preservice clinical staff time (standard time of 0 minutes) unless
the specialty can provide evidence that the preservice time is
appropriate. In other words, for minor procedures, it is assumed that
there is no clinical staff time typically spent preparing for the
specific procedure prior to the patient's arrival. However, we note
that for CY 2018, 41 of the 53 reviewed codes with 0-day or 10-day
global periods include preservice clinical labor of some kind,
suggesting that it is typical for clinical staff to prepare for the
procedure prior to the patient's arrival. As we review misvalued codes,
we believe that the general adherence to values that we have
established as standards supports relativity within the PFS. Because 77
percent of the reviewed codes for the current calendar year deviate
from the ``standard,'' we are seeking comment on the value and
appropriate application of the standard in our review of RUC
recommendations in future rulemaking. In reviewing the inputs included
in the direct PE inputs database, we found that for the 1,142 total 0-
day global codes, 741 of them had preservice clinical labor of some
kind (65 percent). We also noticed a general correlation between
preservice clinical labor time and the recent review. We are seeking
comment specifically on whether the standard preservice clinical labor
time of 0 minutes should be consistently applied for 0-day and 10-day
global codes in future rulemaking.
b. Obtain Vital Signs Clinical Labor
The direct PE inputs for each CPT code paid under the PFS include
minutes assigned to a series of standard clinical labor tasks assumed
to be typical for the service in question. The minutes assigned to each
of these tasks for each CPT code have been developed over several
decades, and what was previously considered to be a standard value in
the review of the codes has changed over time. Because each year we
perform a detailed review of all of the inputs for only several hundred
of the over 7,000 CPT codes paid under the PFS, valuation for
individual services can be influenced by shifts in review standards
over time rather than purely based on changes in practice.
For example, we traditionally assigned a clinical labor time of 3
minutes for the ``Obtain vital signs'' clinical labor activity, based
on the amount of time typically required to check a patient's vitals.
Over time, that number of minutes has increased as codes are reviewed.
For example, many of the reviewed codes for the current CY 2018
rulemaking cycle have a recommended clinical labor time of 5 minutes
for ``Obtain vital signs,'' based on the understanding that these
services are measuring two additional vital signs: The patient's height
and weight. We do not have any reason to believe that measuring a
patient's height and weight is only typical for services described by
recently reviewed codes. Instead, we believe that the review standards
have changed, perhaps in conjunction with changes in medical practice,
and that the change in the minutes assigned for the ``Obtain vital
signs'' task for newer-reviewed services is detrimental to relativity
among PFS services.
Therefore, to preserve relativity among the PFS codes, we are
proposing to assign 5 minutes of clinical labor time for all codes that
include the ``Obtain vital signs'' task, regardless of the date of last
review. We are proposing to assign this 5 minutes of clinical labor
time for all codes that include at least 1 minute previously assigned
to this task. We are also proposing to update the equipment times of
the codes with this clinical labor task accordingly to match the
changes in clinical labor time. For codes that were not recently
reviewed and for which we lacked a breakdown of how the equipment time
was derived from the clinical labor tasks, we could not determine if
the equipment time included time assigned for the ``Obtain vital
signs'' task. In these cases, we are proposing to adjust the equipment
time of any equipment item that matched the clinical labor time of the
full service period to match the change in the ``Obtain vital signs''
clinical labor time. The proposed list of all codes affected by these
proposed vital signs changes to direct PE inputs is available on the
CMS Web site under downloads for the CY 2018 PFS proposed rule at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
c. Establishment of Clinical Labor Activity Codes
Historically, the RUC has submitted a ``PE worksheet'' that details
the recommended direct PE inputs for our use in developing PE RVUs. The
format of the PE worksheet has varied over time and among the medical
specialties developing the recommendations. These variations have made
it difficult for both the RUC's development and our review of code
values for individual codes. Beginning for the CY 2019 PFS rulemaking
cycle, we understand that the RUC intends to mandate the use of a new
PE worksheet for purposes of their recommendation development process
that standardizes the clinical labor tasks and assigns them a clinical
labor activity code. We believe the RUC's use of the new PE worksheet
in developing and submitting recommendations to us would, in turn, help
us to simplify and standardize the hundreds of different clinical labor
tasks
[[Page 33961]]
currently listed in our direct PE database.
To help facilitate this transition to the new clinical labor
activity codes, we have developed a crosswalk to link the old clinical
labor tasks to the new clinical labor activity codes. Our crosswalk is
for informational purposes only, and would not change either the direct
PE input values or the PE RVUs for codes. Instead, we hope that the
crosswalk would help us to translate the sprawling, existing data set
into a condensed version that would significantly improve the
standardization of clinical labor recommendations and improve the
ability of commenters to identify concerns with our proposed valuation.
For CY 2018 rulemaking, we are displaying two versions of the Labor
Task Detail public use file: One version with the old listing of
clinical labor tasks, and one with the same tasks as described by the
new listing of clinical labor activity codes. These lists are available
on the CMS Web site under downloads for the CY 2018 PFS proposed rule
at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
(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 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
proposed standalone prices for each scope, and separate prices for the
video systems that are used with scopes. We proposed to 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 was the ``video system, endoscopy
(processor, digital capture, monitor, printer, cart)'' equipment item
(ES031), which we proposed 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 proposed to use for this re-pricing. We understand that there
may be other accessories associated with the use of scopes; we proposed
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 also proposed 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 scope video
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 proposed 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 proposed 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 planned to propose input prices for
these equipment items through future rulemaking.
We proposed these changes only for the reviewed codes for CY 2017
that made use of scopes, along with updated prices for the equipment
items related to scopes utilized by these services. But, we did not
propose to apply these policies to codes with inputs reviewed prior to
CY 2017. We also solicited comment on this separate pricing structure
for scopes, scope video systems, and scope accessories, which we could
consider proposing to apply to other codes in future rulemaking. In
response to comments, we finalized the addition of a digital capture
device to the endoscopy video system (ES031) in the CY 2017 PFS final
rule. We finalized our proposal to price the system at $33,391, based
on component prices of $9,000 for the processor, $18,346 for the
digital capture device, $2,000 for the monitor, $2,295 for the printer,
and $1,750 for the cart. We also finalized a price of $16,843.87 for
the stroboscopy system scope accessory (ES065). We did not finalize
price increases for a series of other scopes and scope accessories, as
the invoices submitted for these components indicated that they are
different forms of equipment with different product IDs and different
prices. We did not receive any data to indicate that the equipment on
the newly submitted invoices was more typical in its use than the
equipment that we were currently using for pricing.
We did not make further changes to existing scope equipment in CY
2017 in order to allow the RUC's PE Subcommittee the opportunity to
provide feedback. However, we believe there was some miscommunication
on this point, as the RUC's PE Subcommittee workgroup that was created
to address scope systems stated that no further action was required
following the finalization of our proposal. We are making further
proposals to continue clarifying scope equipment inputs, and seek
comments regarding the new set of scope proposals. We welcome feedback
from all stakeholders, including practitioners with direct experience
in the use of scope equipment.
We are seeking comment on several potential categories of scope
system PE inputs. We are considering creating a single scope equipment
code for each of the five categories detailed in this proposed rule:
(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. Under the current classification system, there
are many different scopes in each category depending on the medical
specialty furnishing the service and the part of the body affected. We
believe that the variation between these scopes is not significant
enough to warrant maintaining these distinctions, and we believe that
creating and pricing a single scope equipment code for each category
would help provide additional clarity. We are seeking public comment on
the merits of this potential scope organization, as well as any pricing
information regarding these five new scope categories.
[[Page 33962]]
For CY 2018, we are proposing two minor changes to PE inputs
related to scopes. We are proposing to add an LED light source into the
cost of the scope video system (ES031), which would remove the need for
a separate light source in these procedures. If this proposal were to
be finalized, we would remove the equipment time for the separate light
source from CPT codes that include the scope video system. We are also
proposing an increase to the price of the scope video system of
$1,000.00 to cover the expense of miscellaneous small equipment
associated with the system that falls below the threshold of individual
equipment pricing as scope accessories (such as cables, microphones,
foot pedals, etc.) We seek comments on the inclusion of the LED light
in the scope video system, and the appropriate pricing of the system
with the inclusion of these additional equipment items.
We anticipate adopting detailed changes to scope systems at the
code level through rulemaking for CY 2019, because we believe that
additional feedback from expert stakeholders will improve the details
of the proposed changes. We are not proposing any additional pricing
changes to scope equipment for CY 2018 due to the proposed
reorganization into a single type of scope equipment for each of the
five scope categories. However, we would consider updating prices for
these equipment items through the public request process for price
updates, or based on information submitted as part of RUC
recommendations.
(4) Clarivein Kit for Mechanochemical Vein Ablation
In the CY 2017 PFS final rule, we finalized work RVUs and direct PE
inputs for two new codes related to mechanochemical vein ablation, CPT
codes 36473 and 36474. Following the publication of the final rule,
stakeholders contacted CMS and requested that a Clarivein kit supply
item (SA122) be added to the direct PE inputs for CPT code 36474, the
add-on code for ablation of subsequent veins. They stated that the
Clarivein kit was accidentally omitted from the RUC recommendations,
and that an additional kit is necessary to perform the service
described by the add-on procedure. We are soliciting comment regarding
the use of multiple kits during procedures described by the base and
add-on codes to determine whether or not this supply should be included
as a direct PE input for CPT code 36474 for CY 2018.
(5) Removal of Oxygen From Non-Moderate Sedation Post-Procedure
Monitoring
After finalizing the creation of separately billable codes for
moderate sedation during the CY 2017 PFS final rule, we received
additional recommendations to remove the oxygen gas supply item (SD084)
from a series of CPT codes that were previously valued with moderate
sedation as an inherent part of the procedure. Because oxygen gas is
included in the moderate sedation pack contained within the separately
billed moderate sedation codes, we believe that the continued inclusion
of the oxygen gas in these codes is a duplicative supply. We are
therefore proposing to remove the oxygen gas from the following codes
(see Table 4):
Table 4--CY 2018 Proposed Removal of Oxygen (SD084) From Non-Moderate Sedation Post-Procedure Monitoring
----------------------------------------------------------------------------------------------------------------
Current
HCPCS NF/F (liters) Cost
----------------------------------------------------------------------------------------------------------------
31622......................................... NF.............................. 90 -0.27
31625......................................... NF.............................. 105 -0.32
31626......................................... NF.............................. 135 -0.41
31627......................................... NF.............................. 150 -0.45
31628......................................... NF.............................. 120 -0.36
31629......................................... NF.............................. 105 -0.32
31632......................................... NF.............................. 54 -0.16
31633......................................... NF.............................. 60 -0.18
31645......................................... NF.............................. 175 -0.53
31652......................................... NF.............................. 180 -0.54
31653......................................... NF.............................. 225 -0.68
31654......................................... NF.............................. 90 -0.27
52647......................................... NF.............................. 10 -0.03
52648......................................... NF.............................. 10 -0.03
90870......................................... NF.............................. 198 -0.59
----------------------------------------------------------------------------------------------------------------
(6) Technical Corrections to Direct PE Input Database and Supporting
Files
Subsequent to the publication of the CY 2017 PFS final rule,
stakeholders alerted us to several clerical inconsistencies in the
direct PE database. We are proposing to correct these inconsistencies
as described in this proposed rule and reflected in the CY 2018
proposed direct PE input database displayed on the CMS Web site under
downloads for the CY 2018 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
For CY 2018, we are proposing to address the following
inconsistencies:
For CY 2018, we are proposing to make direct PE changes
for CPT code 96416 (Chemotherapy administration, intravenous infusion
technique; initiation of prolonged chemotherapy infusion (more than 8
hours), requiring use of a portable or implantable pump) to improve
payment accuracy, in response to a stakeholder inquiry regarding the
use of the ambulatory IV pump equipment for this service. We are
proposing to add 6 additional minutes of RN/OCN clinical labor (L056A),
4 minutes for the ``Review charts by chemo nurse regarding course of
treatment & obtain chemotherapy-related medical hx'' task, and 2
minutes for the ``Greet patient and provide gowning'' task. We are
proposing to add 1 quantity of the IV infusion set supply (SC018) and
proposing to lower the quantity from 2 to 1 of the 20 ml syringe supply
(SC053). We are proposing to add 1800 minutes for the new ambulatory IV
pump equipment, and we are proposing to increase the equipment time of
the medical recliner chair (EF009) from 83 minutes to 89 minutes to
match the increase in RN/OCN clinical labor. For CY 2018, these
[[Page 33963]]
proposed direct PE changes would be used to calculate the PE RVU for
CPT code 96416. We seek comments on these proposed direct PE
refinements.
We propose to correct an anomaly in the postservice work
time for CPT code 91200 (Liver elastography, mechanically induced shear
wave (e.g., vibration), without imaging, with interpretation and
report) by changing it from 5 minutes to 3 minutes, which also results
in a refinement in the total work time for the code from 18 minutes to
16 minutes.
In the process of making updates to our direct PE
database, we discovered a series of discrepancies between the finalized
direct PE inputs and the values entered into the database from previous
calendar years. To reconcile these discrepancies, we are proposing the
following direct PE refinements:
Table 5--Direct PE Database Data Discrepancies and Proposed Changes
--------------------------------------------------------------------------------------------------------------------------------------------------------
HCPCS Input code Input code description NF/F Old New Cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
11307............................ SF033.............. scalpel with blade, NF 1 2 0.69
surgical (#10-20).
11311............................ SG056.............. gauze, sterile 4in x 4in NF 1 2 0.80
(10 pack uou).
11311............................ SH046.............. lidocaine 1% w-epi inj NF 10 4 -0.38
(Xylocaine w-epi).
11719............................ L037D.............. Greet patient, provide NF 1 3 0.74
gowning, ensure
appropriate medical
records are available.
11719............................ L037D.............. Provide pre-service NF 1 2 0.37
education/obtain
consent.
11719............................ L037D.............. Prepare room, equipment, NF 1 2 0.37
supplies.
11719............................ L037D.............. Clean room/equipment by NF 1 3 0.74
physician staff.
17312............................ SL097.............. OCT Tissue-Tek.......... NF 8 6 -0.12
17313............................ SF004.............. blade, microtome........ NF 1 0 -1.72
17313............................ SF044.............. blade, surgical, super- NF 0 1 4.17
sharp.
17313............................ SG056.............. gauze, sterile 4in x 4in NF 3 0 -2.39
(10 pack uou).
17313............................ SG088.............. tape, foam, elastic, 2in NF 10 8 -0.01
(Microfoam).
17314............................ SG056.............. gauze, sterile 4in x 4in NF 2 0 -1.60
(10 pack uou).
17314............................ SL097.............. OCT Tissue-Tek.......... NF 8 6 -0.12
17315............................ SL078.............. histology freezing spray NF 0 0.2 0.29
(Freeze-It).
19283............................ L043A.............. Service total costs..... NF 55 54 -0.43
19286............................ L051B.............. Service total costs..... NF 30 31 0.51
19286............................ EL015.............. room, ultrasound, NF 19 20 1.40
general.
19286............................ EQ168.............. light, exam............. NF 19 20 0.00
23333............................ L037D.............. Post service total costs F 63 90 9.99
28045............................ SC029.............. needle, 18-27g.......... NF 2 1 -0.09
32405............................ L041B.............. Service total costs..... NF 52 57 2.05
37765............................ L037D.............. Service total costs..... NF 91 94 1.11
37766............................ L037D.............. Service total costs..... NF 121 124 1.11
45171............................ SJ052.............. swab, procto 16in....... F 2 3 0.12
45172............................ L037D.............. Service total costs..... F 6 12 2.22
45172............................ SJ052.............. swab, procto 16in....... F 2 3 0.12
52214............................ SH047.............. lidocaine 1%-2% inj NF 1 50 1.72
(Xylocaine).
72120............................ EL012.............. room, basic radiology... NF 16 17 0.48
72148............................ L047A.............. Service total costs..... NF 47 49 0.84
74230............................ L041B.............. Technologist QC's images NF 0 2 0.82
in PACS, checking for
all images, reformats,
and dose page.
91013............................ EF023.............. table, exam............. NF 0 9 0.03
91013............................ EF015.............. mayo stand.............. NF 0 9 0.01
91013............................ EQ235.............. suction machine (Gomco). NF 0 9 0.02
91013............................ EQ181.............. manometry system NF 0 9 1.15
(computer, transducers,
catheter).
91013............................ EQ339.............. manometry accessory NF 0 9 0.05
cable.
91013............................ ED050.............. PACS Workstation Proxy.. NF 0 9 0.20
91132............................ EQ019.............. EGG monitoring system... NF 22 30 0.83
92227............................ EL006.............. lane, screening (oph)... NF 12 0 -1.07
92227............................ EL005.............. lane, exam (oph)........ NF 0 12 1.15
93017............................ L051A.............. Preservice total costs.. NF 15 5 -5.10
95819............................ SG079.............. tape, surgical paper 1in NF 6 42 0.07
(Micropore).
--------------------------------------------------------------------------------------------------------------------------------------------------------
The proposed PE RVUs displayed in Addendum B on our Web site were
calculated with the inputs displayed in the CY 2018 proposed direct PE
input database.
(7) 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 2018,
we are proposing the following price updates for existing direct PE
inputs.
We are proposing to update the price of thirteen supplies and one
equipment item in response to the public submission of invoices. For
the details of these proposed price updates, please refer to section
II.H, of this proposed rule, Table 14: Invoices Received for Existing
Direct PE Inputs.
We are not proposing to update the price of the blood warmer
(EQ072), the cell separator system (EQ084), or the photopheresor system
(EQ206) equipment items. The only pricing information that we received
for these three equipment items was an invoice that included a hand-
written price over redacted information. We were unable to verify the
accuracy of this invoice. We are also not proposing to update the price
of the DNA image analyzer (ACIS) (EP001) equipment item, due to the
[[Page 33964]]
inclusion of many components on the submitted invoice that are not part
of the price of the DNA image analyzer. We were unable to determine
which of these components were included in the cost of the DNA image
analyzer, and which of these components were unrelated types of
equipment. To price these equipment items accurately, we believe that
we need additional information. We continue to use the current price
for these equipment items pending the submission of additional pricing
information. We welcome the submission of updated pricing information
regarding these equipment items through valid invoices from commenters
and other stakeholders.
We are also proposing to change the name of the ED050 equipment
from the ``PACS Workstation Proxy'' to the ``Technologist PACS
workstation.'' In the CY 2017 final rule (81 FR 80180-80182), we
finalized a policy to add a professional PACS workstation (ED053) to
the list of approved equipment items, and we believe that renaming
ED050 to the technologist PACS workstation would help to alleviate
potential confusion between the two PACS workstations.
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 2018, we note that
some stakeholders have submitted invoices for new, revised, or
potentially misvalued codes after the February 10th deadline
established for code valuation recommendations. To be included in a
given year's proposed rule, we generally need to receive invoices by
the same February 10th deadline. However, we would consider invoices
submitted as public comments during the comment period following the
publication of the proposed rule, and would consider any invoices
received after February or outside of the public comment process as
part of our established annual process for requests to update supply
and equipment prices.
4. Adjustment to Allocation of Indirect PE for Some Office-Based
Services
As we explain in section II.B.2.c.(2) of this proposed rule, we
allocate indirect costs for each code 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. Indirect expenses include
administrative labor, office expense, and all other expenses. For PFS
services priced in both the facility and non-facility settings, the
difference in indirect PE RVUs between the settings is driven by
differences in direct PE inputs for those settings since the other
allocator of indirect PE, the work RVU, does not differ between
settings. For most services, the direct PE input costs are higher in
the nonfacility setting than in the facility setting. As a result,
indirect PE RVUs allocated to these services are higher in the
nonfacility setting than in the facility setting. When direct PE inputs
for a service are very low, however, the allocation of indirect PE RVUs
is almost exclusively based on work RVUs, which results in a very small
(or no) site of service differential between the total PE RVUs in the
facility and nonfacility setting.
Some stakeholders have suggested that for codes in which direct PE
inputs for a service are very low, this allocation methodology does not
allow for a site of service differential that accurately reflects the
relative indirect costs involved in furnishing services in nonfacility
settings. Among the services most affected by this anomaly are the
primary therapy and counseling services available to Medicare
beneficiaries for treatment of behavioral health conditions, including
substance use disorders. For example, for the most commonly reported
psychotherapy service (CPT code 90834), the difference between the
nonfacility and facility PE RVUs is only 0.02 RVUs, which seems
unlikely to represent the difference in relative resource costs in
terms of administrative labor, office expense, and all other expenses
incurred by the billing practitioner for 45 minutes of psychotherapy
services when furnished in the office setting versus the facility
setting.
We agree with these stakeholders that the site of service
differential for these services that is produced by our PE methodology
seems unlikely to reflect the relative resource costs for the
practitioners furnishing these services in nonfacility settings. For
example, we believe the 0.02 RVUs, which translates to approximately
$0.72, would be unlikely to reflect the relative administrative labor,
office rent, and other overhead involved in furnishing the 45 minute
psychotherapy service in a nonfacility setting. Consequently, we
believe it would be appropriate to modify the existing methodology for
allocating indirect PE RVUs in order to better reflect the relative
indirect PE resources involved in furnishing these kinds of services in
the nonfacility setting.
In examining the range of services furnished in the nonfacility
setting that are most affected by this circumstance, we identified
HCPCS codes that describe face-to-face services, have work RVUs greater
than zero, and are priced in both the facility and nonfacility setting.
From among these codes, we further selected those with the lowest ratio
between nonfacility PE RVUs and work RVUs. We selected 0.4 as an
appropriate threshold based on several factors, including the range of
nonfacility PE RVU to work RVU ratios among the codes identified. Based
on these criteria, there were fewer than 50 codes that we identified
with a ratio of less than 0.4 nonfacility PE RVUs for each work RVU,
most of which are primarily furnished by behavioral health
professionals, for a potential modification to our indirect PE
allocation methodology.
In considering how to address the anomaly and ensure that an
appropriate number of indirect PE RVUs are allocated to these services
in the nonfacility setting, we looked at the indirect, nonfacility PE
RVU for the most commonly billed physician office visit, CPT code
99213, which is billed by a wide range of physicians and non-physician
practitioners under the PFS. We believe that the indirect PE costs
allocated to services reported with CPT code 99213, including
administrative labor and office rent, would be common for a broad range
of physicians and non-physician practitioners across the PFS. We
recognize that the services we seek to address are primarily furnished
by behavioral health professionals who may be unlikely to incur some of
the costs incurred by other practitioners furnishing a broader range of
medical services. For instance, a practitioner furnishing a broader
range of primary care services likely requires separate office and
examination room space, and storage for disposable medical supplies and
equipment. Some costs, however, such as those for office staff and
records maintenance, would be analogous.
We looked at the relationship between indirect PE and work RVUs for
CPT code 99213 as a marker because that is the most commonly and
broadly reported PFS code that describes face-to-face office-based
services. We compared the relationship between indirect PE and work
RVUs for the set of HCPCS codes that we identified using the criteria
discussed above and found that for the significant majority of codes,
that ratio was at least 0.4 nonfacility PE RVUs for each work RVU. We
believe the 0.4 nonfacility PE RVUs can serve as an appropriate marker
that appropriately reflects the relative resources involved in
furnishing these services.
[[Page 33965]]
For the fewer than 50 outlier codes identified using the criteria
above, we believe it would be appropriate to establish a minimum
nonfacility indirect PE RVU that would be a better reflection the
resources involved in furnishing these services. We propose to set the
nonfacility indirect PE RVUs for these codes using the indirect PE RVU
to work RVU ratio for the most commonly furnished office-based, face-
to-face service (CPT 99213) as a marker. Specifically, for each of
these outlier codes, we propose to compare the ratio between indirect
PE RVUs and work RVUs that result from the preliminary application of
the standard methodology to the ratio for the marker code, CPT code
99213. Our proposed change in the methodology would then increase the
allocation of indirect PE RVUs to the outlier codes to at least one
quarter of the difference between the two ratios. We believe this
approach reflects a reasonable minimum allocation of indirect PE RVUs,
but we do not currently have empirical data that would be useful in
establishing a more precise number.
In developing the proposed PE RVUs for CY 2018, we propose to
implement only one quarter of this proposed minimum value for
nonfacility indirect PE for the outlier codes. We recognize that this
change in the PE methodology could have a significant impact on the
allocation of indirect PE RVUs across all PFS services. In making
significant changes to the PE methodology in previous years, we have
implemented such changes using 4 year transitions, based largely on
concerns that some specialties experience significant payment
reductions with changes in PE relativity, and a transition period
allows for a more gradual adjustment for affected practitioners. Under
the approach we are proposing, we estimate that approximately $40
million, or approximately 0.04 percent of total PFS allowed charges,
would shift within the PE methodology for each year of the proposed 4-
year transition, including for CY 2018. We also note that we are
proposing to exclude the codes directly subject to this proposed change
from the misvalued code target calculation because the proposed change
is a methodological change to address an anomaly produced by our
indirect PE allocation process as opposed to a change to address
misvalued codes. The PE RVUs displayed in Addendum B on our Web site
were calculated with the one quarter of the indirect PE adjustment
factor implemented.
C. 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 (MP)
expense. As required by section 1848(c)(2)(C)(iii) of the Act,
beginning in CY 2000, MP RVUs are resource based. 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 is composed of three factors: (1) Specialty-level risk
factors derived from data on specialty-specific MP premiums incurred by
practitioners, (2) service level risk factors derived from Medicare
claims data of the weighted average risk factors of the specialties
that furnish each service, and (3) an intensity/complexity of service
adjustment to the service level risk factor based on either the higher
of the work RVU or clinical labor RVU. 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 adjusted (or scaled) 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
was applied for the new/revised code and source code, but the work RVU
for the new/revised code was 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,
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. Under
this approach, for new and revised codes, we generally assign a
specialty risk factor to individual codes based on the same utilization
assumptions we make regarding specialty mix we use for calculating PE
RVUs and for PFS budget neutrality. We continue to use the work RVU or
clinical labor RVU to adjust the MP RVU for each code for intensity and
complexity. In finalizing this policy, we stated 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.
In CY 2017, we finalized the eighth GPCI update, which reflected
updated MP premium data. We did not propose to use the updated MP
premium data to propose updates for CY 2017 to the specialty risk
factors used in the calculation of MP RVUs because it was inconsistent
with the policy we previously finalized in the CY 2016 PFS final rule
with comment period, whereby 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. However, we solicited comment on
whether we should consider doing so, perhaps as early as for CY 2018,
prior to the fourth review and update of MP RVUs that must occur no
later than CY 2020. After consideration of the comments received, we
stated that we would consider the possibility of using the updated MP
data to update the specialty risk factors used in the calculation of
the MP RVUs prior to the next 5-year update in future rulemaking (81 FR
80191 through 80192). Since MP premium data are used to update both the
MP GPCIs and the MP RVUs, going forward we believe it would be logical
to align the update of MP premium data used to determine the MP RVUs
with the update of the MP GPCI. Section 1848(e)(1)(C) of the Act
requires us to review and, if necessary, adjust the
[[Page 33966]]
GPCIs at least every 3 years. The next review of the GPCIs must occur
by CY 2020.
We propose to use the most recent data for the proposed MP RVUs for
CY 2018 and to align the update of MP premium data and MP GPCIs to once
every 3 years. We are seeking comment on these proposals, and we are
also seeking comment on methodologies and sources that we might use to
improve the next update of MP premium data.
2. Methodology for the Proposed Revision of Resource Based Malpractice
RVUs
a. General Discussion
The proposed MP RVUs were calculated based on updated malpractice
premium data obtained from state insurance rate filings by a CMS
contractor. The methodology used in calculating the proposed CY 2018
review and update of resource based MP RVUs largely parallels the
process used in the CY 2015 update. The calculation requires using
information on specialty-specific malpractice premiums linked to
specific services based upon the relative risk factors of the various
specialties that furnish a particular service. Because malpractice
premiums vary by state and specialty, the malpractice premium
information must be weighted geographically and by specialty.
Accordingly, the proposed MP RVUs are based upon four data sources: CY
2014 and CY 2015 malpractice premium data; CY 2016 and 2017 Medicare
payment and utilization data; CY 2017 geographic practice cost indices
(GPCIs), and CY 2018 proposed work and clinical labor RVUs.
Similar to the previous update, we calculated the proposed MP RVUs
using specialty-specific malpractice premium data because they
represent the actual expense incurred by practitioners to obtain
malpractice insurance. We obtained malpractice premium data exclusively
from the most recently available data published in the 2014 and 2015
Market Share Reports accessed from the National Association of
Insurance Commissioners (NAIC) Web site. We used information obtained
from malpractice insurance rate filings with effective dates in 2014
and 2015. These were the most current data available during our data
collection process. We collected malpractice insurance premium data
from all 50 States, and the District of Columbia, and Puerto Rico. Rate
filings were not available in American Samoa, Guam or the Virgin
Islands. Premiums were for $1 million/$3 million, mature, claims-made
policies (policies covering claims made, rather than those covering
services furnished, during the policy term). A $1 million/$3 million
liability limit policy means that the most that would be paid on any
claim is $1 million and the most that the policy would pay for claims
over the timeframe of the policy is $3 million. We made adjustments to
the premium data to reflect mandatory surcharges for patient
compensation funds (funds to pay for any claim beyond the statutory
amount, thereby limiting an individual physician's liability in cases
of a large suit) in states where participation in such funds is
mandatory.
We included premium information for all physician and NPP
specialties, and all risk classifications available in the collected
rate filings. Although we collected premium data from all states, the
District of Columbia, and Puerto Rico, not all specialties had distinct
premium data in the rate filings from all states. Additionally, for
some specialties, MP premiums were not available from the rate filings
in any state. Therefore, for specialties for which there were not
premium data for at least 35 states, and specialties for which there
were not distinct premium data in the rate filings, we crosswalked the
specialty to a similar specialty, either conceptually or by available
premium data, for which we did have sufficient and reliable data. These
specialties and the specialty data that we propose to use are shown in
Table 6.
For example, for radiation oncology, data were only available from
23 states, and therefore this specialty does not meet our 35-state
threshold, which determines whether or not a specialty is deemed to
have premium data sufficient to construct a unique risk factor.
However, based on the 23 states' worth of rate filings for radiation
oncology, the resource costs for the premiums suggests a similar,
though slightly lesser average than that of the premiums for diagnostic
radiology. We developed the proposed MP RVUs for radiation oncology by
crosswalking the risk factor for diagnostic radiology as a similar
specialty with similar premium data. We are seeking comment as to the
appropriateness of this and the other crosswalks used in developing MP
RVUs.
For the proposed CY 2018 MP RVU update, sufficient and reliable
premium data were available for 43 specialty types, representing over
76 percent of allowed Medicare PFS services, which we used to develop
specialty specific malpractice risk factors. (See Table 8 for a list of
these specialties.)
Table 6--Proposed Crosswalk of Specialties to Similar Specialties
----------------------------------------------------------------------------------------------------------------
Crosswalk
Specialty code Medicare specialty name specialty code Crosswalk specialty
----------------------------------------------------------------------------------------------------------------
12............................ Osteopathic Manipulative 03 Allergy/Immunology.
Medicine.
15............................ Speech Language Pathology...... 03 Allergy/Immunology.
17............................ Hospice and Palliative Care.... 03 Allergy/Immunology.
19............................ Oral Surgery (Dentist only).... 24 Plastic and Reconstructive
Surgery.
23............................ Sports Medicine................ 01 General Practice.
27............................ Geriatric Psychiatry........... 26 Psychiatry.
32............................ Anesthesiology Assistant....... 05 Anesthesiology.
35............................ Chiropractic................... 03 Allergy/Immunology.
36............................ Nuclear Medicine............... 30 Diagnostic Radiology.
40............................ Hand Surgery................... 20 Orthopedic Surgery.
41............................ Optometry...................... 03 Allergy/Immunology.
42............................ Certified Nurse Midwife........ 16 Obstetrics & Gynecology.
43............................ Certified Registered Nurse 05 Anesthesiology.
Anesthetist (CRNA).
48............................ Podiatry....................... 07 Dermatology.
62............................ Psychologist................... 03 Allergy/Immunology.
64............................ Audiologist.................... 03 Allergy/Immunology.
65............................ Physical Therapist in Private 03 Allergy/Immunology.
Practice.
67............................ Occupational Therapist in 03 Allergy/Immunology.
Private Practice.
68............................ Psychologist, Clinical......... 03 Allergy/Immunology.
[[Page 33967]]
76............................ Peripheral Vascular Disease.... 77 Vascular Surgery.
79............................ Addiction Medicine............. 03 Allergy/Immunology.
80............................ Licensed Clinical Social Worker 03 Allergy/Immunology.
81............................ Critical Care (Intensivists)... 29 Pulmonary Disease.
85............................ Maxillofacial Surgery.......... 24 Plastic and Reconstructive
Surgery.
86............................ Neuropsychiatry................ 26 Psychiatry.
89............................ Certified Clinical Nurse 01 General Practice.
Specialist.
92............................ Radiation Oncology............. 30 Diagnostic Radiology.
94............................ Interventional Radiology....... 30 Diagnostic Radiology.
97............................ Physician Assistant............ 03 Allergy/Immunology.
98............................ Gynecological Oncology......... 02 General Surgery.
C0............................ Sleep Medicine................. 01 General Practice.
----------------------------------------------------------------------------------------------------------------
b. Steps for Calculating Malpractice RVUs
Calculation of the proposed MP RVUs conceptually follows the
specialty-weighted approach used in the CY 2015 final rule with comment
period (79 FR 67591). The specialty-weighted approach bases the MP RVUs
for a given service upon a weighted average of the risk factors of all
specialties furnishing the service. This approach ensures that all
specialties furnishing a given service are accounted for in the
calculation of the MP RVUs. The steps for calculating the proposed MP
RVUs are described below.
Step (1): Compute a preliminary national average premium for each
specialty.
Insurance rating area malpractice premiums for each specialty are
mapped to the county level. The specialty premium for each county is
then multiplied by its share of the total U.S. population (from the
U.S. Census Bureau's 2014 American Community (ACS) estimates). This is
in contrast to the method used for creating national average premiums
for each specialty in the 2015 update; in that update, specialty
premiums were weighted by the total RVU per county, rather than by the
county share of the total U.S. population. We refer readers to the PFS
2016 Final Rule with comment period (80 FR 70909) for a discussion of
why we have adopted a weighting method based on share of total U.S.
population. This calculation is then divided by the average MP GPCI
across all counties for each specialty to yield a normalized national
average premium for each specialty. The specialty premiums are
normalized for geographic variation so that the locality cost
differences (as reflected by the GPCIs) would not be counted twice.
Without the geographic variation adjustment, the cost differences among
fee schedule areas would be reflected once under the methodology used
to calculate the MP RVUs and again when computing the service specific
payment amount for a given fee schedule area.
Step (2): Determine which premium class(es) to use within each
specialty.
Some specialties had premium rates that differed for surgery,
surgery with obstetrics, and non-surgery. These premium classes are
designed to reflect differences in risk of professional liability and
the cost of malpractice claims if they occur. To account for the
presence of different classes in the malpractice premium data and the
task of mapping these premiums to procedures, we calculated distinct
risk factors for surgical, surgical with obstetrics, and nonsurgical
procedures. However, the availability of data by surgery and non-
surgery varied across specialties. Consistent with the CY 2015 MP RVU
update, because no single approach accurately addressed the variability
in premium class among specialties, we employed several methods for
calculating average premiums by specialty. These methods are discussed
below.
(a) Substantial Data for Each Class: For 10 out of 86 specialties,
we determined that there were sufficient data for surgery and non-
surgery premiums, as well as sufficient differences in rates between
classes. These specialties are listed in Table 7. Therefore, we
calculated a national average surgical premium and non-surgical
premium. We note that, unlike in the CY 2015 MP RVU update, for CY
2018, there were no specialties that fell under the ``unspecified
dominates'' specialty/surgery class scenario, therefore we have omitted
that surgical class category.
(b) Major Surgery Dominates: For 9 surgical specialties, rate
filings that included non-surgical premiums were relatively rare. For
most of these surgical specialties, the rate filings did not include an
``unspecified'' premium. When it did, the unspecified premium was lower
than the major surgery rate. For these surgical specialties, we
calculated only a surgical premium and used the premium for major
surgery for all procedures furnished by this specialty.
(c) Blend All Available: For the remaining specialties, there was
wide variation across the rate filings in terms of whether or not
premium classes were reported and which categories were reported.
Because there was no clear strategy for these remaining specialties, we
blended the available rate information into one general premium rate.
For these specialties, we developed a weighted average ``blended''
premium at the national level, according to the percentage of work RVUs
correlated with the premium classes within each specialty. For example,
the surgical premiums for a given specialty were weighted by that
specialty's work RVUs for surgical services; the nonsurgical premiums
were weighted by the work RVUs for non-surgical services and the
unspecified premiums were weighted by all work RVUs for the specialty
type.
The three methods for calculating premiums by specialty type are
summarized in Table 7. (See Table 8: ``Proposed Risk Factors by
Specialty Type'' for the specialty names associated with the specialty
codes listed in Table 7.)
Table 7--Proposed Premium Calculation Approach by Specialty Type
------------------------------------------------------------------------
Method Medicare specialty codes
------------------------------------------------------------------------
(a) Substantial Data for Each Class (10).. 01, 04, 08, 09, 13, 16, 18,
34, 72, 93.
(b) Major Surgery Dominates (9)........... 02, 14, 20, 24, 28, 33, 77,
78, 91.
[[Page 33968]]
(c) Blend all Available (24).............. 03, 05, 06, 07, 10, 11, 22,
25, 26, 29, 30, 37, 38, 39,
44, 46, 50, 66, 71, 82, 83,
84, 90, 99.
------------------------------------------------------------------------
Step (3): Calculate a risk factor for each specialty.
The relative differences in national average premiums between
specialties are expressed in our methodology as a specialty risk
factor. These risk factors are an index calculated by dividing the
national average premium for each specialty by the national average
premium for the specialty with the lowest premiums for which we had
sufficient and reliable data, allergy and immunology. For specialties
with sufficient surgical and non-surgical premium data, we calculated
both a surgical and non-surgical risk factor. For specialties with rate
filings that distinguished surgical premiums with obstetrics, we
calculated a separate surgical with obstetrics risk factor. For all
other specialties we calculated a single risk factor and applied the
specialty risk factor to both surgery and non-surgery services.
We note that for determining the risk factor for suppliers of TC-
only services in the CY 2015 update, we updated the premium data for
independent diagnostic testing facilities (IDTFs) that we used in the
CY 2010 update. These data were obtained from a survey conducted by the
Radiology Business Management Association (RBMA) in 2009; we ultimately
used these data to calculate an updated TC specialty risk factor. We
applied the updated TC specialty risk factor to suppliers of TC-only
services. In the CY 2015 final rule with comment period (79 FR 67595),
RBMA voluntarily submitted updated MP premium information collected
from independent diagnostic testing facilities (IDTFs) in 2014, and
requested that we use the data for calculating the CY 2015 MP RVUs for
TC services. We declined to utilize the data and stated that we believe
further study is necessary and we would consider this matter and
propose any changes through future rulemaking. We believe that data for
a broader set of technical component services are needed, and seek
comment on appropriate, comparable data sources for such information.
We also seek comment on whether the data for IDTFs are comparable and
appropriate as a proxy for the broader set of TC services. We endeavor
to, in the next update of specialty risk factors, collect more data
across a broader set of the technical component services, not just for
radiology (as is currently reflected in the RBMA data), but data for
services performed by other non-physician practitioners including
cytotechnologists, and cardiovascular technologists. In the interim,
for CY 2018, we propose to assign a TC risk factor of 1.0, which
corresponds to the lowest physician specialty risk factor.
We assigned the risk factor of 1.0 to the TC services because we do
not have comparable professional liability premium data for the full
range of clinicians that furnish these services. In lieu of
comprehensive, comparable data, we used 1.0 as the default minimum risk
factor, though we seek information on the best available data sources
for use in the next update, as well as empirical information that would
support assignment of an alternative risk factor for these services.
Table 8 shows the proposed risk factors by specialty type.
Table 8--Proposed Risk Factors by Specialty Type
----------------------------------------------------------------------------------------------------------------
Non-surgical Surgical risk
Specialty code Medicare specialty name risk factor factor
----------------------------------------------------------------------------------------------------------------
01......................................... General Practice................... 1.80 3.72
01......................................... General Practice w/OB.............. .............. 4.30
02......................................... General Surgery.................... .............. 6.75
03......................................... Allergy/Immunology................. 1.00 1.00
04......................................... Otolaryngology..................... 1.53 4.08
05......................................... Anesthesiology..................... 2.58 2.58
06......................................... Cardiovascular Disease (Cardiology) 1.90 1.90
07......................................... Dermatology........................ 2.77 2.77
08......................................... Family Practice.................... 1.67 3.74
08......................................... Family Practice w/OB............... .............. 4.31
09......................................... Interventional Pain Management..... 2.08 2.97
10......................................... Gastroenterology................... 2.40 2.40
11......................................... Internal Medicine.................. 2.70 2.70
12......................................... Osteopathic Manipulative Medicine.. 1.00 1.00
13......................................... Neurology.......................... 2.46 13.02
14......................................... Neurosurgery....................... .............. 10.66
15......................................... Speech Language Pathology.......... 1.00 1.00
16......................................... Obstetrics & Gynecology............ 1.59 4.52
16......................................... Obstetrics & Gynecology w/OB....... .............. 8.67
17......................................... Hospice and Palliative Care........ 1.00 1.00
18......................................... Ophthalmology...................... 1.03 2.16
19......................................... Oral Surgery (Dentist only)........ .............. 4.93
20......................................... Orthopedic Surgery................. .............. 6.22
22......................................... Pathology.......................... 1.60 1.60
23......................................... Sports Medicine.................... 1.80 3.72
24......................................... Plastic and Reconstructive Surgery. .............. 4.93
25......................................... Physical Medicine and 1.49 1.49
Rehabilitation.
26......................................... Psychiatry......................... 1.27 1.27
27......................................... Geriatric Psychiatry............... 1.27 1.27
28......................................... Colorectal Surgery (Proctology).... .............. 4.19
29......................................... Pulmonary Disease.................. 1.82 1.82
30......................................... Diagnostic Radiology............... 2.82 2.82
32......................................... Anesthesiology Assistant........... 2.58 2.58
33......................................... Thoracic Surgery................... .............. 6.06
34......................................... Urology............................ 1.66 2.97
[[Page 33969]]
35......................................... Chiropractic....................... 1.00 1.00
36......................................... Nuclear Medicine................... 2.82 2.82
37......................................... Pediatric Medicine................. 1.82 1.82
38......................................... Geriatric Medicine................. 1.52 1.52
39......................................... Nephrology......................... 1.56 1.56
40......................................... Hand Surgery....................... .............. 6.22
41......................................... Optometry.......................... 1.00 1.00
42......................................... Certified Nurse Midwife............ 1.59 4.52
42......................................... Certified Nurse Midwife w/OB....... .............. 8.67
43......................................... Certified Registered Nurse 2.58 2.58
Anesthetist (CRNA).
44......................................... Infectious Disease................. 2.03 2.03
46......................................... Endocrinology...................... 1.75 1.75
48......................................... Podiatry........................... 2.77 2.77
50......................................... Nurse Practitioner................. 1.95 1.95
62......................................... Psychologist....................... 1.00 1.00
64......................................... Audiologist........................ 1.00 1.00
65......................................... Physical Therapist in Private 1.00 1.00
Practice.
66......................................... Rheumatology....................... 1.58 1.58
67......................................... Occupational Therapist in Private 1.00 1.00
Practice.
68......................................... Psychologist, Clinical............. 1.00 1.00
71......................................... Registered Dietitian or Nutrition 1.37 1.37
Professional.
72......................................... Pain Management.................... 2.65 3.65
76......................................... Peripheral Vascular Disease........ .............. 6.67
77......................................... Vascular Surgery................... .............. 6.67
78......................................... Cardiac Surgery.................... .............. 6.87
79......................................... Addiction Medicine................. 1.00 1.00
80......................................... Licensed Clinical Social Worker.... 1.00 1.00
81......................................... Critical Care (Intensivists)....... 1.82 1.82
82......................................... Hematology......................... 1.77 1.77
83......................................... Hematology-Oncology................ 1.85 1.85
84......................................... Preventive Medicine................ 1.15 1.15
85......................................... Maxillofacial Surgery.............. .............. 4.93
86......................................... Neuropsychiatry.................... 1.27 1.27
89......................................... Certified Clinical Nurse Specialist 1.80 3.72
90......................................... Medical Oncology................... 1.82 1.82
91......................................... Surgical Oncology.................. .............. 4.32
92......................................... Radiation Oncology................. 2.82 2.82
93......................................... Emergency Medicine................. 2.29 5.03
94......................................... Interventional Radiology........... 2.82 2.82
97......................................... Physician Assistant................ 1.95 1.95
98......................................... Gynecological Oncology............. .............. 6.75
99......................................... Undefined Physician type........... 1.95 1.95
C0......................................... Sleep Medicine..................... 1.80 3.72
----------------------------------------------------------------------------------------------------------------
Step (4): Calculate malpractice RVUs for each HCPCS code.
Resource-based MP RVUs were calculated for each HCPCS code that has
work or PE RVUs. The first step was to identify the percentage of
services furnished by each specialty for each respective HCPCS code.
This percentage was then multiplied by each respective specialty's risk
factor as calculated in Step 3. The products for all specialties for
the HCPCS code were then added together, yielding a specialty-weighted
service specific risk factor reflecting the weighted malpractice costs
across all specialties furnishing that procedure. The service specific
risk factor was multiplied by the greater of the work RVU or PE
clinical labor index for that service to reflect differences in the
complexity and risk-of-service between services.
Low volume service codes: As we discussed in section II.B. of this
proposed rule, we are proposing to use a list of expected specialties
instead of the claims-based specialty mix for low volume services in
order to address stakeholder concerns about the year to year
variability in PE and MP RVUs for low volume services. We are
soliciting comments on the proposal to use these service-level
overrides to determine the specialty for low volume procedures, as well
as on the list of overrides itself. The proposed list of codes and
expected specialties is available on our Web site under downloads for
the CY 2018 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. In previous MP RVU updates, as discussed in the CY 2015
final rule with comment period (79 FR 40354), we assigned specialty for
low volume services based on dominant specialty. As discussed in the CY
2012 final rule with comment period (76 FR 73187 through 73189), we
applied an additional list of service-level overrides for purposes of
calculating MP RVUs for a number of cardiothoracic surgery codes.
Therefore, we note that there are certain codes for which we have
previously applied expected specialty overrides for purposes of
calculating MP RVUs based on assumptions regarding low Medicare volume.
Because we are consolidating policies for low volume service expected
specialty overrides into a single list for PE and MP, and because we do
not believe that there is a reason to assume different specialties for
purposes of calculating PE RVUs than for MP RVUs for any particular
code, we
[[Page 33970]]
are also proposing to assign the specialty mix solely based on the
claims data for any code that does not meet the low volume threshold of
99 allowed services or fewer in the previous year, for the purposes of
calculating MP RVUs.
Given that we now annually recalibrate MP RVUs based on claims
data, and in light of our proposed introduction of the service-level
specialty override for low volume services, we believe that there would
no longer be a need to apply service-level MP crosswalks in order to
assign a specialty-mix risk factor. Contingent on finalizing this
proposal, we are also proposing to eliminate general use of an MP-
specific specialty-mix crosswalk for new and revised codes. However, we
would continue to consider, in conjunction with annual recommendations,
specific recommendations from the public and the RUC regarding
specialty mix assignments for new and revised codes, particularly in
cases where coding changes are expected to result in differential
reporting of services by specialty, or where the new or revised code is
expected to be low-volume. Absent such information, we would derive the
specialty mix assumption for the first year for a new or revised code
from the specialty mix used for purposes of ratesetting. In subsequent
years when claims data are available, we would assign the specialty
based on claims data unless the service does not exceed the low volume
threshold (99 or fewer allowed services). If the service is low volume,
we would assign the expected specialty, establishing a new expected
specialty through rulemaking as needed, which is consistent with our
approach for developing PE RVUs.
Step (5): Rescale for budget neutrality.
The statute requires that changes to fee schedule RVUs must be
budget neutral. Thus, the last step is to adjust for relativity by
rescaling the proposed MP RVUs so that the total proposed resource
based MP RVUs are equal to the total current resource based MP RVUs
scaled by the ratio of current aggregate MP and work RVUs. This scaling
is necessary in order to maintain the work RVUs for individual services
from year to year while also maintaining the overall relationship among
work, PE, and MP RVUs.
The proposed resource based MP RVUs are shown in Addendum B, which
is available on the CMS Web site under the downloads section of the CY
2018 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
Because a different share of the resources involved in furnishing
PFS services is reflected in each of the three fee schedule components,
implementation of the resource based MP RVU update will have much
smaller payment effects than implementing updates of resource based
work RVUs and resource based PE RVUs. On average, work represents about
50.9 percent of payment for a service under the fee schedule, PE about
44.8 percent, and MP about 4.3 percent. Therefore, a 25 percent change
in PE RVUs or work RVUs for a service would result in a change in
payment of about 11 to 13 percent. In contrast, a corresponding 25
percent change in MP values for a service would yield a change in
payment of only about one percent. Estimates of the effects on payment
by specialty type can be found in section VI. of this proposed rule.
Additional information on our proposed methodology for updating the
MP RVUs may be found in our contractor's report, ``Interim Report on
Malpractice RVUs for the CY 2018 PFS Proposed Rule,'' which is
available on the CMS Web site under the downloads section of the CY
2018 PFS proposed rule located at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
We are seeking comments on these proposals for calculating the MP
RVUs for CY 2018.
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 professional 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
[[Page 33971]]
telehealth services to the Medicare Administrative Contractors (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. For geographic qualifications,
our regulation at 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 Federal Office of Rural Health
Policy 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 our Web site at https://www.cms.gov/MedicareMedicare-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 CY 2003 PFS final rule with comment
period (67 FR 79988), we established a process for adding services to
or deleting services from the list of Medicare telehealth services.
This process provides the public with an ongoing opportunity to submit
requests for adding services. Under this process, we assign any
qualifying request to make additions to the list of telehealth services
to one of two categories. Revisions to criteria that we use to review
requests in the second category were finalized in the CY 2012 PFS final
rule with comment period (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
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 furnish 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.
The list of telehealth services, including the proposed additions
described below, is included in the Downloads section to this proposed
rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
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 2017 will
be considered for the CY 2019 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 our
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 2018
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
[[Page 33972]]
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 2016 to add various services as
Medicare telehealth services effective for CY 2018. The following
presents a discussion of these requests, and our proposals for
additions to the CY 2018 telehealth list. Of the requests received, we
found that three services were sufficiently similar to services
currently on the telehealth list to qualify on a category 1 basis.
Therefore, we are proposing to add the following services to the
telehealth list on a category 1 basis for CY 2018:
HCPCS code G0296 (Counseling visit to discuss need for
lung cancer screening using low dose ct scan (ldct) (service is for
eligibility determination and shared decision making))
We found that the service described by HCPCS code G0296 is
sufficiently similar to office visits currently on the telehealth list.
We believe that all the components of this service, which include
assessment of the patient's risk for lung cancer, shared decision
making, and counseling on the risks and benefits of LDCT, can be
furnished via interactive telecommunications technology.
CPT codes 90839 and 90840 (Psychotherapy for crisis; first
60 minutes) and (Psychotherapy for crisis; each additional 30 minutes
(List separately in addition to code for primary service))
We are proposing to add CPT codes 90839 and 90840 on a Category 1
basis. We found that these services are sufficiently similar to the
psychotherapy services currently on the telehealth list, even though
these codes describe patients requiring more urgent care and
psychotherapeutic interventions to minimize the potential for
psychological trauma. However, we did identify one specific element of
the services as described in the CPT prefatory language that we
concluded may or may not be able to be furnished via telehealth,
depending on the circumstances of the particular service. The CPT
prefatory language specifies that the treatment described by these
codes requires, ``mobilization of resources to defuse the crisis and
restore safety.'' In many cases, we believe that a distant site
practitioner would have access (via telecommunication technology,
presumably) to the resources at the originating site that would allow
for the kind of mobilization required to restore safety. However, we
also believe that it would be possible that a distant site practitioner
would not have access to such resources. Therefore we are proposing to
add the codes to the telehealth list with the explicit condition of
payment that the distant site practitioner be able to mobilize
resources at the originating site to defuse the crisis and restore
safety, when applicable, when the codes are furnished via telehealth.
``Mobilization of resources'' is a description used in the CPT
prefatory language. We believe the critical element of ``mobilizing
resources'' is the ability to communicate with and inform staff at the
originating site to the extent necessary to restore safety. We solicit
comment on whether our assumption that the remote practitioner is able
to mobilize resources at the originating site to defuse the crisis and
restore safety is valid.
Although we did not receive specific requests, we are also
proposing to add four additional services to the telehealth list based
on our review of services. All four of these codes are add-on codes
that describe additional elements of services currently on the
telehealth list and would only be considered telehealth services when
billed as an add-on to codes already on the telehealth list. The four
codes are:
CPT code 90785 (Interactive complexity (List separately in
addition to the code for primary procedure))
CPT codes 96160 and 96161 (Administration of patient-
focused health risk assessment instrument (e.g., health hazard
appraisal) with scoring and documentation, per standardized instrument)
and (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))
HCPCS code G0506 (Comprehensive assessment of and care
planning for patients requiring chronic care management services (list
separately in addition to primary monthly care management service))
In the case of CPT codes 96160 and 96161, and HCPCS code G0506, we
recognize that these services may not necessarily be ordinarily
furnished in-person with a physician or billing practitioner.
Ordinarily, services that are typically not considered to be face-to-
face services do not need to be on the list of Medicare telehealth
services; however, these services would only be considered Medicare
telehealth services when billed with a base code that is also on the
telehealth list and would not be considered Medicare telehealth
services when billed with codes not on the Medicare telehealth list. We
believe that by adding these services to the telehealth list it will be
administratively easier for practitioners who report these services in
association with a visit code that is furnished via telehealth as both
the base code and the add-on code would be reported with the telehealth
place of service.
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 physical,
occupational, and speech therapy, initial hospital care, and online E/M
by physician/qualified healthcare professional to the telehealth list,
or changing the requirements for ESRD procedure codes furnished via
telehealth, for the reasons noted in the paragraphs that follow.
a. Physical and Occupational Therapy and Speech-Language Pathology
Services: CPT Codes--
CPT code 97001: Now deleted and reported as CPT code 97161
(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.)
CPT code 97002: Now deleted and reported as CPT code 97162
(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)
CPT code 97003: Now deleted and reported as CPT code 97165
(Occupational therapy evaluation, low
[[Page 33973]]
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)
CPT code 97004: Now deleted and reported as CPT code 97166
(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))
CPT code 97110 (Therapeutic procedure, 1 or more areas,
each 15 minutes; therapeutic exercises to develop strength and
endurance, range of motion and flexibility)
CPT code 97112 (Therapeutic procedure, 1 or more areas,
each 15 minutes; neuromuscular reeducation of movement, balance,
coordination, kinesthetic sense, posture, and/or proprioception for
sitting and/or standing activities)
CPT code 97116 (Therapeutic procedure, 1 or more areas,
each 15 minutes; gait training (includes stair climbing))
CPT code 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)
CPT code 97750 (Physical performance test or measurement
(e.g., musculoskeletal, functional capacity), with written report, each
15 minutes)
CPT code 97755 (Assistive technology assessment (e.g., to
restore, augment or compensate for existing function, optimize
functional tasks and/or maximize environmental accessibility), direct
one-on-one contact, with written report, each 15 minutes).
CPT 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).
CPT code 97761 (Prosthetic training, upper and/or lower
extremity(s), each 15 minutes).
CPT code 97762 (Checkout for orthotic/prosthetic use,
established patient, each 15 minutes).
In section 1834(m)(4)(E) of the Act, the statute specifies the
types of practitioners who may furnish and bill for Medicare telehealth
services as those practioners under section 1842(b)(18)(C) of the Act.
Physical therapists, occupational therapists and speech-language
pathologists are not among the practitioners identified in section
1842(b)(18)(C) of the Act. We stated in the CY 2017 PFS final rule (81
FR 80198) that because these services are predominantly furnished by
physical therapists, occupational therapists and speech-language
pathologists, we did not believe it would be appropriate to add them to
the list of telehealth services at this time. In an ensuing submission
for 2018, the original requester suggested that we might propose these
services to be added to the list so that they can be furnished via
telehealth when furnished by eligible distant site practitioners. We
considered that possibility; however, since the majority of the codes
are furnished by therapy professionals over 90 percent of the time, we
believe that adding therapy services to the telehealth list that
explicitly describe the services of the kinds of professionals not
included on the statutory list of distant site practitioners could
result in confusion about who is authorized to furnish and bill for
these services when furnished via telehealth. We also note that several
of these services, such as CPT code 97761, require directly physically
manipulating the beneficiary, which is not possible to do through
telecommunications technology. Therefore, we are not proposing to add
these codes to the list of Medicare telehealth services.
b. Initial Hospital Care Services: CPT Codes--
CPT code 99221 (Initial hospital care, per day, for the
evaluation and management of a patient, which requires these 3 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/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 problem(s)
requiring admission are of low severity.)
CPT code 99222 (Initial hospital care, per day, for the
evaluation and management of a patient, which requires these 3 key
components: A comprehensive history; A comprehensive examination; and
Medical decision making of moderate 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
problem(s) requiring admission are of moderate severity.)
CPT code 99223 (Initial hospital care, per day, for the
evaluation and management of a patient, which requires these 3 key
components: A comprehensive history; A comprehensive examination; and
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
problem(s) requiring admission are of high severity.)
We previously considered a request to add these codes to the
telehealth list. As we stated in the CY 2011 PFS final rule with
comment period (75 FR 73315), while initial inpatient consultation
services are currently on the list of approved telehealth services,
there are no services on the current list of telehealth services that
resemble initial hospital care for an acutely ill patient by the
admitting practitioner who has ongoing responsibility for the patient's
[[Page 33974]]
treatment during the hospital course. Therefore, consistent with prior
rulemaking, we are not proposing initial hospital care services be
added to the Medicare telehealth services list on a category 1 basis.
The initial hospital care codes describe the first visit of the
hospitalized patient by the admitting practitioner who may or may not
have seen the patient in the decision-making phase regarding
hospitalization. Based on the description of the services for these
codes, we believe it is critical that the initial hospital visit by the
admitting practitioner be conducted in person to ensure that the
practitioner with ongoing treatment responsibility comprehensively
assesses the patient's condition upon admission to the hospital through
a thorough in-person examination. Additionally, the requester submitted
no additional research or evidence that the use of a telecommunications
system to furnish the service produces demonstrated clinical benefit to
the patient; therefore, we also are not proposing to add initial
hospital care services to the Medicare telehealth services list on a
category 2 basis.
We note that Medicare beneficiaries who are being treated in the
hospital setting can receive reasonable and necessary E/M services
using other HCPCS codes that are currently on the Medicare telehealth
list including those for subsequent hospital care, initial and followup
telehealth inpatient and emergency department consultations, as well as
initial and followup critical care telehealth consultations.
Therefore, we do not propose to add the initial hospital care
services to the list of Medicare telehealth services for CY 2018.
c. Online E/M by physician/QHP: CPT Code--
CPT code 99444 (Online evaluation and management service
provided by a physician or other qualified health care professional who
may report evaluation and management services provided to an
established patient or guardian, not originating from a related E/M
service provided within the previous 7 days, using the Internet or
similar electronic communications network)
As we indicated in the CY 2016 final rule with comment period (80
FR 71061), CPT code 99444 is assigned a status indicator of ``N'' (Non-
covered service). Under section 1834(m)(2)(A) of the Act, Medicare pays
the physician or practitioner furnishing a telehealth service an amount
equal to the amount that would have been paid if the service was
furnished without the use of a telecommunications system. Because CPT
code 99444 is currently non-covered, there would be no Medicare payment
if this service were furnished without the use of a telecommunications
system. Because this code is a non-covered service for which no
Medicare payment may be made under the PFS, we do not propose to add
online E/M services to the list of Medicare telehealth services for CY
2018.
d. Monthly Capitation Payment (MCP) for ESRD-Related Services for Home
Dialysis, by Age: CPT Codes--
CPT codes 90963 (End-stage renal disease (ESRD) related
services for home dialysis per full month, for patients younger than 2
years of age to include monitoring for the adequacy of nutrition,
assessment of growth and development, and counseling of parents); 90964
(End-stage renal disease (ESRD) related services for home dialysis per
full month, for patients 2- 11 years of age to include monitoring for
the adequacy of nutrition, assessment of growth and development, and
counseling of parents); 90965 (End-stage renal disease (ESRD) related
services for home dialysis per full month, for patients 12-19 years of
age to include monitoring for the adequacy of nutrition, assessment of
growth and development, and counseling of parents); and 90966 (End-
stage renal disease (ESRD) related services for home dialysis per full
month, for patients 20 years of age and older)
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); and 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).
In the CY 2004 PFS final rule (68 FR 63216), we established G-codes
for ESRD monthly capitation payments (MCPs), which were replaced by CPT
codes in CY 2009 (73 FR 69898). The services described by CPT codes
90963 through 90966 were added to the Medicare telehealth list in CY
2005 (69 FR 66276) and CPT codes 90967 through 90970 were added to the
Medicare telehealth list in the CY 2017 PFS final rule (81 FR 80194);
however, we specified that the required clinical examination of the
vascular access site must be furnished face-to-face ``hands on''
(without the use of an interactive telecommunications system) by a
physician, clinical nurse specialist (CNS), nurse practitioner (NP), or
physician assistant (PA). The American Telemedicine Association (ATA)
submitted a new request for CY 2018 requesting that we allow telehealth
coverage of ESRD procedure codes without in-person exam of the catheter
access site monthly. Our current policy reflects our understanding that
evaluation of the integrity and functionality of the access site is a
critical element of the services described by the codes and that this
element cannot be performed via telecommunications technology. The
requester did not submit evidence to support the assertation that
effective examination of the access site can be executed via
telecommunications technology. Therefore, for CY 2018, we are not
proposing any changes to the policy requiring that the MCP practitioner
must furnish at least one face-to-face encounter with the home dialysis
patient per month for clinical examination of the catheter access site.
However, we are interested in more information about current clinically
accepted care practices and to what extent telecommunications
technology can be used to examine the access site. We are also
interested in information about the clinical standards of care
regarding the frequency of the evaluation of the access site.
In summary, we are proposing to add the following codes to the list
of Medicare telehealth services beginning in CY 2018 on a category 1
basis:
HCPCS code G0296 (Counseling visit to discuss need for
lung cancer screening using low dose CT scan (ldct) (service is for
eligibility determination and shared decision making)).
HCPCS code G0506 (Comprehensive assessment of and care
planning for patients requiring chronic care management services (list
separately in addition to primary monthly care management service)).
CPT code 90785 (Interactive complexity (List separately in
addision to the code for primary procedure)).
CPT codes 90839 and 90840 (Psychotherapy for crisis; first
60 minutes) and (Psychotherapy for crisis; each additional 30 minutes
(List separately in addition to code for primary procedure)).
CPT codes 96160 and 96161 (Administration of patient-
focused health risk assessment instrument (e.g., health hazard
appraisal) with scoring and documentation, per standardized
[[Page 33975]]
instrument) and (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).
4. Elimination of the Required Use of the GT Modifier on Professional
Claims
Medicare has required distant site practitioners to report one of
two longstanding HCPCS modifiers when reporting telehealth services.
Current guidance instructs practitioners to submit claims for
telehealth services using the appropriate CPT or HCPCS code for the
professional service along with the telehealth modifier GT (via
interactive audio and video telecommunications systems). For federal
telemedicine demonstration programs in Alaska or Hawaii, practitioners
are instructed to submit claims using the appropriate CPT or HCPCS code
for the professional service along with the telehealth modifier GQ if
telehealth services are performed ``via an asynchronous
telecommunications system.'' By coding and billing these modifiers with
a service code, practitioners are certifying that both the broad and
code-specific telehealth requirements have been met.
In the CY 2017 PFS final rule (81 FR 80201), we finalized payment
policies regarding Medicare's use of a new Place of Service (POS) Code
describing services furnished via telehealth. The new POS code became
effective January 1, 2017, and we believe its use is redundant with the
requirements to apply the GT modifier for telehealth services. We did
not propose to implement a change to the modifier requirements during
CY 2017 rulemaking because at the time of the CY 2017 PFS proposed
rule, we did not know whether the telehealth POS code would be made
effective for January 1, 2017. However, we noted in the CY 2017 PFS
final rule that, like the modifiers, use of the telehealth POS code
certifies that the service meets the telehealth requirements.
Because a valid POS code is required on professional claims for all
services, and the appropriate reporting of the telehealth POS code
serves to indicate both the provision of the service via telehealth and
certification that the requirements have been met, we believe that it
is unnecessary to also require the distant site practitioner report the
GT modifier on the claim. Therefore, we are proposing to eliminate the
required use of the GT modifier on professional claims. Because
institutional claims do not use a POS code, we propose for distant site
practitioners billing under CAH Method II to continue to use the GT
modifier on institutional claims. For purposes of the federal
telemedicine demonstration programs in Alaska or Hawaii, we propose to
retain the GQ modifier to maintain the distinction between synchronous
and asynchronous telehealth services, as reflected in statute.
5. Comment Solicitation on Medicare Telehealth Services
We have received numerous requests from stakeholders to expand
access to telehealth services. As noted above, Medicare payment for
telehealth services is restricted by statute, which establishes the
services initially eligible for Medicare telehealth and limits the use
of telehealth by defining both eligible originating sites (the location
of the beneficiary) and the distant site practitioners who may furnish
and bill for telehealth services. Originating sites are limited both by
geography and provider setting. We have the authority to add to the
list of eligible services based on our annual process, but cannot
change the limitations relating to geography, patient setting, or type
of furnishing practitioner because these requirements are specified in
statute. For CY 2018, we are seeking information regarding ways that we
might further expand access to telehealth services within the current
statutory authority and pay appropriately for services that take full
advantage of communication technologies.
6. Comment Solicitation on Remote Patient Monitoring
In addition to the broad comment solicitation regarding Medicare
telehealth services, we are also specifically seeking comment on
whether to make separate payment for CPT codes that describe remote
patient monitoring. We note that remote patient monitoring services
would generally not be considered Medicare telehealth services as
defined under section 1834(m) of the Act. Rather, like the
interpretation by a physician of an actual electrocardiogram or
electroencephalogram tracing that has been transmitted electronically,
these services involve the interpretation of medical information
without a direct interaction between the practitioner and beneficiary.
As such, they are paid under the same conditions as in-person
physicians' services with no additional requirements regarding
permissible originating sites or use of the telehealth place of service
code.
We are particularly interested in comments regarding CPT code 99091
(Collection and interpretation of physiologic data (e.g., ECG, blood
pressure, glucose monitoring) digitally stored and/or transmitted by
the patient and/or caregiver to the physician or other qualified health
care professional, qualified by education, training, licensure/
regulation (when applicable) requiring a minimum of 30 minutes of
time). This code is currently assigned a procedure status of B
(bundled). As with many other bundled codes, we currently assign RVUs
for this code based on existing RUC recommendations, even though we
have considered the services described by the code to be bundled with
other services. In addition to comments on the payment status and
valuation for this code (the RUC-recommended value, specifically) we
are seeking information about the circumstances under which this code
might be reported for separate payment, including how to differentiate
the time related to these services from other services, including care
management services. For example, PFS payment for analysis of patient-
generated health data is considered included in chronic care management
(CCM) services (CPT codes 99487, 99489, and 99490) to the extent that
this activity is medically necessary and performed as part of CCM (see
the CY 2015 PFS final rule (79 FR 67727), CY 2016 PFS final rule (81 FR
80244), and the CMS FAQ available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/Payment_for_CCM_Services_FAQ.pdf.). We also seek comment from
beneficiaries and beneficiary advocacy organizations on the value of
such services and what protections might be necessary to assure that
beneficiaries are properly informed that they are receiving a remote
monitoring service, since beneficiaries would be required to pay
standard cost sharing for such services. Finally, regarding CPT code
99091, we are seeking available information regarding potential
utilization assumptions we might make for the service for purposes of
PFS ratesetting, were we to make it payable for CY 2018 or in the
future; since making such asumptions would be necessary to implement
separate payment. We note that since the PFS is a budget neutral
system, any increase in payment made for particular services would
result in decreases in payment for other services, and the degree of
that decrease would depend, in large part, on the utilization
assumptions.
We are also seeking comment on other existing codes that describe
extensive use of communications technology for
[[Page 33976]]
consideration for future rulemaking, including CPT code 99090 (Analysis
of clinical data stored in computers (e.g., ECGs, blood pressures,
hematologic data)). CPT code 99090 is also assigned a procedure status
of B (bundled). However, we do not have RUC recommended values for this
service, and therefore, currently do not assign RVUs.
E. Proposed 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.H. 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
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 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'
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 0l 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
[[Page 33977]]
(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 approximately
1,700 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 (76
FR 73055 through 73958), we finalized our policy to consolidate the
review of physician work and PE at the same time, 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 (73 FR 38589), 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. 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 our screen of high expenditure services across specialties.
In the CY 2017 PFS final rule, we finalized for review a list of
potentially misvalued services, which included eight codes in the end-
stage renal disease home dialysis family (CPT codes 90963-90970). We
also finalized as potentially misvalued 19 codes identified through our
screen for 0-day global services that are typically billed with an
evaluation and management (E/M) service with modifier 25.
3. CY 2018 Identification and Review of Potentially Misvalued Services
In the CY 2012 PFS final rule with comment period (76 FR 73058), we
finalized a process for the public to nominate potentially misvalued
codes. The public and stakeholders may nominate potentially misvalued
codes for review by submitting the code with supporting documentation
by February 10 of each year. Supporting documentation for codes
nominated for the annual review of potentially misvalued codes may
include the following:
Documentation in peer reviewed medical literature or other
reliable data that there have been changes in physician work due to one
or more of the following: technique, knowledge and technology, patient
population, site-of-service, length of hospital stay, and work time.
An anomalous relationship between the code being proposed
for review and other codes.
Evidence that technology has changed physician work.
Analysis of other data on time and effort measures, such
as operating room logs or national and other representative databases.
Evidence that incorrect assumptions were made in the
previous valuation of the service, such as a misleading vignette,
survey, or flawed crosswalk assumptions in a previous evaluation.
Prices for certain high cost supplies or other direct PE
inputs that are used to determine PE RVUs are inaccurate and do not
reflect current information.
Analyses of work time, work RVU, or direct PE inputs using
other data sources (for example: Department of Veteran Affairs (VA)
National Surgical Quality Improvement Program (NSQIP), the Society for
Thoracic Surgeons (STS) National Database, and the Physician Quality
Reporting System (PQRS) databases).
National surveys of work time and intensity from
professional and management societies and organizations, such as
hospital associations.
We evaluate the supporting documentation submitted with the
nominated codes and assess whether the nominated codes appear to be
potentially misvalued codes appropriate for review under the annual
process. In the following year's PFS proposed rule, we publish the list
of nominated codes and indicate whether we are proposing each nominated
code as a potentially misvalued code. The public has the opportunity to
comment on these and all other proposed potentially misvalued codes. In
that year's final rule, we finalize our list of potentially misvalued
codes.
After we issued the CY 2017 PFS final rule, we received a
nomination and supporting documentation for one code to be considered
as potentially misvalued. We evaluated the supporting documentation for
this nominated code to ascertain whether the submitted information
demonstrated that the code should be proposed as potentially misvalued.
CPT code 27279 (Arthrodesis, sacroiliac joint, percutaneous or
minimally invasive (indirect visualization), with image guidance,
includes obtaining bone graft when performed, and placement of
transfixing device) was nominated for review as a potentially misvalued
code because the current work RVU is potentially undervalued and
stakeholders recommend that it should be increased to 14.23. We are
proposing this code as a potentially misvalued code. In the CY 2017 PFS
final rule, we noted that some assertions regarding appropriate values
for the dialysis vascular access codes newly created in CY 2017 (CPT
codes 36901 through 36909) did not include data that would warrant
increases to the work RVUs. However, we urged interested stakeholders
to consider
[[Page 33978]]
submitting robust data regarding costs for these and other services (81
FR 80294). We have continued to receive feedback from stakeholders
regarding the work valuation of these codes. Stakeholders have
expressed concerns regarding the typical patient for these procedures
as reflected in the information included in the RUC recommendations for
CY 2017 and the importance of appropriate payment for ensuring access
to care for Medicare beneficiaries. Therefore, we are seeking
additional comment and continuing to request robust data regarding the
potentially misvalued work RVUs for CPT codes 36901 through 36909 and
considering alternate work valuations for CY 2018, such as the RUC-
recommended work RVUs from CY 2017, or other potential values based on
submission of data through the public comment process. We note that the
RUC recommended work RVUs for these services are displayed in the CY
2017 PFS final rule (81 FR 80290 through 80296). We have received
conflicting information about the direct PE inputs for CPT codes 88184
(Flow cytometry, cell surface, cytoplasmic, or nuclear marker,
technical component only; first marker) and 88185 (Flow cytometry, cell
surface, cytoplasmic, or nuclear marker, technical component only; each
additional marker (List separately in addition to code for first
marker)), and we are proposing these codes as potentially misvalued so
that they can be reviewed again because some stakeholders have
suggested the clinical labor and supplies that were previously
finalized are no longer accurate.
We have received information suggesting that the work RVUs for
emergency department visits may not appropriately reflect the full
resources involved in furnishing these services. Specifically,
stakeholders have expressed concerns that the work RVUs for these
services have been undervalued given the increased acuity of the
patient population and the heterogeneity of the sites, such as
freestanding and off-campus emergency departments, where emergency
department visits are furnished. We are, therefore, seeking comment on
whether CPT codes 99281-99385 (Emergency department visits for the
evaluation and management of a patient) should be reviewed under the
misvalued code initiative.
For over a decade, CMS has collaborated with the RUC to regularly
prioritize codes for review by using the categories specified in the
statute or as determined appropriate. We generally have referred to
these categories as ``misvalued code screens.'' To supplement ongoing
RUC identification of potentially misvalued codes through established
screens, CMS regularly uses PFS rulemaking to identify other screens
for use in identifying potentially misvalued codes. For example, in
recent years, CMS has prioritized the following screens:
Codes with low work RVUs commonly billed in multiple units
per single encounter.
Codes with high volume and low work RVUs.
Codes with site-of-service-anomalies.
E/M codes.
PFS high expenditure services.
Services with standalone PE procedure time.
Services with anomalous time.
Contractor Medical Director identified potentially
misvalued codes.
Codes with higher total Medicare payments in office than
in hospital or ASC.
Publicly nominated potentially misvalued codes.
0-day global services that are typically billed with an
evaluation and management (E/M) service with modifier 25.
Although we are not proposing a new screen for CY 2018, we continue
to believe that it is important to prioritize codes for review under
the misvalued code initiative. As a result, we are seeking public
comment on the best approach for developing screens, as well as what
particular new screens we might consider. We will consider these
comments for future rulemaking.
F. Payment Incentive for the Transition From Traditional X-Ray Imaging
to Digital Radiography and Other Imaging Services
Section 502(a)(1) of Division O, Title V of the Consolidated
Appropriations Act of 2016 (Pub. L. 114-113) amended section 1848(b) of
the Act by establishing a new paragraph (9) of subsection (b). Section
1848(b)(9)(B) of the Act provides for a 7 percent reduction in payments
for the technical component (TC) for imaging services made under the
PFS that are X-rays (including the technical component portion of a
global service) taken using computed radiography technology furnished
during CYs 2018, 2019, 2020, 2021, or 2022, and for a 10 percent
reduction for the technical component of such imaging services
furnished during CY 2023 or a subsequent year. Computed radiography
technology is defined for purposes of this paragraph as cassette-based
imaging that utilizes an imaging plate to create the image involved.
Section 1848(b)(9) of the Act also requires implementation of the
reduction in payments through appropriate mechanisms, which can include
the use of modifiers. In accordance with section 1848(c)(2)(B)(v)(X) of
the Act, the adjustments under section 1848(b)(9)(A) of the Act are
exempt from the budget neutrality requirement.
We stated in the CY 2017 PFS proposed rule that because the
required reductions in PFS payment for the TC of imaging services
(including the TC portion of a global service) that are X-rays taken
using computed radiography technology did not apply for CY 2017, we
would address implementation of section 1848(b)(9)(B) of the Act in
future rulemaking. Therefore, to implement the provisions of section
1848(b)(9)(B) of the Act relating to the payment reduction for the TC
(including the TC portion of a global service) of X-rays taken using
computed radiography technology during CY 2018 or subsequent years, we
are proposing to establish a new modifier to be used on claims for
these services.
We are proposing that beginning January 1, 2018, this modifier
would be required to be used when reporting imaging services for which
payment is made under the PFS that are X-rays (including the X-ray
component of a packaged service) taken using computed radiography
technology. The modifier would be required on claims for the technical
component of the X-ray service, including when the service is billed
globally because the PFS payment adjustment is made to the technical
component regardless of whether it is billed globally, or billed
separately using the TC modifier. The modifier must be used to report
the specific services that are subject to the payment reduction and
accurate use is subject to audit. The use of this proposed modifier to
indicate an X-ray taken using computed radiography would result in a 7
percent reduction for CYs 2018 through 2022 and a 10 percent reduction
for CY 2023 or a subsequent calendar year to the payments for the TC
for such imaging services furnished as specified under section
1848(b)(9)(B) of the Act.
G. Proposed Payment Rates Under the Medicare Physician Fee Schedule for
Nonexcepted Items and Services Furnished by Nonexcepted Off-Campus
Provider-Based Departments of a Hospital
1. Background
Sections 1833(t)(1)(B)(v) and (t)(21) of the Act require that
certain items and services furnished by certain off-campus
[[Page 33979]]
provider-based departments (PBDs) (collectively referenced here as
nonexcepted items and services furnished by nonexcepted off-campus
PBDs) shall not be considered covered OPD services for purposes of
payment under the OPPS, and payment for those nonexcepted items and
services furnished on or after January 1, 2017 shall be made under the
applicable payment system. In the CY 2017 OPPS/ASC final rule with
comment period (81 FR 79713), we finalized the PFS as the ``applicable
payment system'' for most nonexcepted items and services furnished by
off-campus PBDs.
As part of that discussion, we indicated that, in response to
public comments received on the proposed payment policies for
nonexcepted items and services, we would issue an interim final rule
with comment period (the CY 2017 interim final rule, 81 FR 79720
through 79729) to establish payment policies under the PFS for
nonexcepted items and services furnished on or after January 1, 2017.
In the following paragraphs, we propose the payment policies under the
PFS for nonexcepted items and services furnished during CY 2018. The CY
2017 interim final rule can be found on the Internet at https://www.gpo.gov/fdsys/pkg/FR-2016-11-14/pdf/2016-26515.pdf. We anticipate
responding to public comments and finalizing the CY 2017 interim final
rule in future PFS rulemaking.
2. Payment Mechanism
Coding and payment policies under the PFS have long recognized the
differences between the portions of services for which direct costs
generally are incurred by practitioners and the portions of services
for which direct costs generally are incurred by facilities. At
present, the coding and RVUs established for particular groups of
services under the PFS generally reflect such direct cost differences.
As described in section II.B of this proposed rule, we establish
separate nonfacility and facility RVUs for many HCPCS codes describing
particular services paid under the PFS. For many other services, we
establish separate RVUs for the professional component and the
technical component of the service described by the same HCPCS code.
For other services, we establish RVUs for the different HCPCS codes
that segregate and describe the discrete professional and technical
aspects of particular services.
Because hospitals with nonexcepted off-campus PBDs that furnish
nonexcepted items and services are likely to furnish a broader range of
services than other provider or supplier types for which there is a
separately valued technical component under the PFS, for CY 2017, we
established a new set of payment rates under the PFS that reflected the
relative resource costs of furnishing the technical component of a
broad range of services to be paid under the PFS specific to the off-
campus PBD of a hospital with packaging (bundling) rules that are
unique to the hospital outpatient setting under the OPPS.
In principle, the coding and billing mechanisms required to make
appropriate payment to hospitals for nonexcepted items and services
furnished by nonexcepted off-campus PBDs are parallel to those used to
make payment for the technical component services for a range of
supplier types paid under the PFS. That is, payments to hospitals are
made for the technical aspect of services, while physicians and other
practitioners report the professional aspect of these same services. In
some cases, the entities reporting the technical aspect of services use
the same coding that is used by the individuals reporting the
professional services. In other cases, different coding applies. We are
proposing to maintain this mechanism for CY 2018.
3. Establishment of Payment Rates
Using the relativity among OPPS payments to establish rates for the
nonexcepted items and services furnished by nonexcepted off-campus PBDs
and billed by hospitals under the PFS was only one aspect of
establishing the necessary relativity of these services under the PFS
more broadly. It was necessary to estimate the relativity of these
services compared to PFS services furnished in other settings. For CY
2017, we used our best estimate of the more general relativity between
the technical component of PFS services furnished in nonexcepted off-
campus PBDs and all other PFS services furnished in other settings
using the limited information available to us at that time. As
described in the CY 2017 interim final rule (81 FR 79722 through
79726), we estimated that for CY 2017, scaling the OPPS payment rates
by 50 percent would strike an appropriate balance that avoided
potentially underestimating the relative resources involved in
furnishing services in nonexcepted off-campus PBDs as compared to the
services furnished in other settings for which payment was made under
the PFS. Specifically, we established site-specific rates under the PFS
for the technical component of the broad range of nonexcepted items and
services furnished by nonexcepted off-campus PBDs to be paid under the
PFS that was based on the OPPS payment amount for the same items and
services, scaled downward by 50 percent. We called this adjustment the
``PFS Relativity Adjuster.'' The PFS Relativity Adjuster refers to the
percentage of the OPPS payment amount paid under the PFS for a
nonexcepted item or service to the non-excepted off-campus PBD under
this policy.
a. Methodology for Establishing CY 2017 PFS Relativity Adjuster
In developing the CY 2017 interim final rule, we began by analyzing
hospital outpatient claims data from January 1 through August 26, 2016,
that contained the ``PO'' modifier signifying that they were billed by
an off-campus department of a hospital paid under the OPPS other than a
remote location, a satellite facility, or a dedicated emergency
department (ED). We noted that the use of the ``PO'' modifier was a new
mandatory reporting requirement for CY 2016. We limited our analysis to
those claims billed on the 13X Type of Bill because those claims were
used for Medicare Part B billing under the OPPS. We then identified the
top (most frequently billed) 25 major codes that were billed by claim
line; that is, items and services that were separately payable or
conditionally packaged. Specifically, we restricted our analysis to
codes with OPPS status indicators ``J1'', ``J2'', ``Q1'', ``Q2'',
``Q3'', ``S'', ``T'', or ``V''. We did not include separately payable
drugs or biologicals in this analysis because those drugs or
biologicals were not paid under the PFS under the CY 2017 interim final
rule. As such, under the CY 2017 interim final rule, the PFS Relativity
Adjuster did not apply to separately payable drugs and biologicals
furnished by a nonexcepted PBD. Similarly, we excluded codes assigned
an OPPS status indicator ``A'' because the services described by those
codes were already paid at a rate under a fee schedule other than the
OPPS and payment for those nonexcepted items and services was not
changed by the rates established under the CY 2017 interim final rule.
Next, for the same major codes (or analogous codes in the rare instance
that different coding applies under the OPPS than the PFS), we compared
the CY 2016 payment rate under the OPPS to a CY 2016 payment rate under
the PFS attributable to the nonprofessional relative resource costs
involved in furnishing the services.
The most frequently billed service with the ``PO'' modifier was
described by HCPCS code G0463 (Hospital outpatient clinic visit for
assessment and management of a patient), which is paid under APC 5012;
the total number
[[Page 33980]]
of CY 2016 claim lines for that service was approximately 6.7 million
as of August 2016. In CY 2016, the OPPS payment rate for APC 5012 was
$102.12. Because there were multiple CPT codes (CPT codes 99201 through
99215) used under the PFS for billing that service, an exact comparison
between the $102.12 OPPS payment rate for APC 5012 and the payment rate
for a single CPT code billed under the PFS was not possible. However,
for purposes of the analysis, we examined the difference between the
nonfacility payment rates and the facility payment rates under the PFS
for CPT codes 99213 and 99214, which were the billing codes for a Level
III and a Level IV office visit. While we did not have data to
precisely determine the equivalent set of PFS visit codes to use for
the comparison, we believed that, based on the distribution of services
billed for the visit codes under the PFS and the distribution of the
visit codes under the OPPS from the last time period the CPT codes were
used under the OPPS in CY 2014, those two codes provided reliable
points of comparison. For CPT code 99213, the difference between the
nonfacility payment rate and the facility payment rate under the PFS in
CY 2016 was $21.86, which was 21 percent of the OPPS payment rate for
APC 5012 of $102.12. For CPT code 99214, the difference between the
nonfacility payment rate and the facility payment rate under the PFS in
CY 2016 was $29.02, which was 28 percent of the OPPS payment rate for
APC 5012. However, we recognized that, due to the more extensive
packaging that occurred under the OPPS for services provided along with
clinic visits relative to the more limited packaging that occurred
under the PFS for office visits, those payment rates were not entirely
comparable.
We then assessed the next 24 major codes most frequently billed on
the 13X claim form by hospitals. We removed HCPCS code 36591
(Collection of blood specimen from a completely implantable venous
access device) because, under current PFS policies, the code is used
only to pay separately under the PFS when no other service was on the
claim. We also removed HCPCS code G0009 (Administration of Pneumococcal
Vaccine) because there was no payment for the code under the PFS. For
the remaining 22 major codes most frequently billed, we estimated the
amount that would have been paid to the physician in the office setting
under the PFS for practice expenses not associated with the
professional component of the service. As indicated in Table 9, this
amount reflected (1) the difference between the PFS nonfacility payment
rate and the PFS facility rate, (2) the technical component, or (3) in
instances where payment would have been made only to the facility or
only to the physician, the full nonfacility rate. This estimate ranged
from zero percent to 137.8 percent of the OPPS payment rate for a code.
Overall, the average (weighted by claim line volume times rate) of the
nonfacility payment rate estimate for the PFS compared to the estimate
for the OPPS for the 22 remaining major codes was 45 percent.
Table 9--Comparison of CY 2016 OPPS Payment Rate to CY 2016 PFS Payment Rate for Top Hospital Codes Billed Using
the ``PO'' Modifier
----------------------------------------------------------------------------------------------------------------
CY 2016
applicable PFS Col (5) as a
HCPCS code Code description Total claim CY 2016 OPPS technical percent of PFS estimate
lines payment rate payment amount OPPS
estimate
(1) (2)............. (3) (4) (5) (6)
----------------------------------------------------------------------------------------------------------------
96372....... Injection 338,444 $42.31 $25.42 60.1 Single rate paid
beneath the exclusively to
skin or into either
muscle for practitioner or
therapy, facility: Full
diagnosis, or nonfacility
prevention. rate.
71020....... X-ray of chest, 333,203 60.80 16.83 27.7 Technical
2 views, front component: Full
and side. nonfacility
rate.
93005....... Routine 318,099 55.94 8.59 15.4 Technical
electrocardiogr component: Full
am (EKG) with nonfacility
tracing using rate.
at least 12
leads.
96413....... Infusion of 254,704 280.27 136.41 48.7 Single rate paid
chemotherapy exclusively to
into a vein up either
to 1 hour. practitioner or
facility: Full
nonfacility
rate.
93798....... Physician 203,926 103.92 11.10 10.7 Nonfacility
services for rate--Facility
outpatient rate.
heart
rehabilitation
with continuous
EKG monitoring
per session.
96375....... Injection of 189,140 42.31 22.56 53.3 Single rate paid
different drug exclusively to
or substance either
into a vein for practitioner or
therapy, facility: Full
diagnosis, or nonfacility
prevention. rate.
93306....... Ultrasound 179,840 416.80 165.77 39.8 Technical
examination of component: Full
heart including nonfacility
color-depicted rate.
blood flow
rate,
direction, and
valve function.
77080....... Bone density 155,513 100.69 31.15 30.9 Technical
measurement component: Full
using dedicated nonfacility
X-ray machine. rate.
77412....... Radiation 137,241 194.35 267.86 137.8 Technical
treatment component (Full
delivery. nonfacility
rate) based on
weighted
averages for
the following
PFS codes:
G6011; G6012;
G6013; and
G6014.
[[Page 33981]]
90853....... Group 123,282 69.65 0.36 0.5 Nonfacility
psychotherapy. rate--Facility
rate.
96365....... Infusion into a 122,641 173.18 69.82 40.3 Nonfacility
vein for rate--Facility
therapy, rate.
prevention, or
diagnosis up to
1 hour.
20610....... Aspiration and/ 106,769 223.76 13.96 6.2 Nonfacility
or injection of rate--Facility
large joint or rate.
joint capsule.
11042....... Removal of skin 99,134 225.55 54.78 24.3 Nonfacility
and tissue rate--Facility
first 20 sq cm rate.
or less.
96367....... Infusion into a 98,930 42.31 30.79 72.8 Single rate paid
vein for exclusively to
therapy either
prevention or practitioner or
diagnosis facility: Full
additional nonfacility
sequential rate.
infusion up to
1 hour.
93017....... Exercise or drug- 96,312 220.35 39.74 18.0 Technical
induced heart component: Full
and blood nonfacility
vessel stress rate.
test with EKG
tracing and
monitoring.
77386....... Radiation 81,925 505.51 347.30 68.7 Technical
therapy component:
delivery. Nonfacility
rate for CPT
code G6015
(analogous code
used under the
PFS).
78452....... Nuclear medicine 79,242 1,108.46 412.82 37.2 Technical
study of component: Full
vessels of nonfacility
heart using rate.
drugs or
exercise
multiple
studies.
74177....... CT scan of 76,393 347.72 220.20 63.3 Technical
abdomen and component: Full
pelvis with nonfacility
contrast. rate.
71260....... CT scan chest 75,052 236.86 167.21 70.6 Technical
with contrast. component: Full
nonfacility
rate.
71250....... CT scan chest... 74,570 112.49 129.61 115.2 Technical
component: Full
nonfacility
rate.
73030....... X-ray of 71,330 60.80 19.33 31.8 Technical
shoulder, component: Full
minimum of 2 nonfacility
views. rate.
90834....... Psychotherapy, 70,524 125.04 0.36 0.3 Nonfacility
45 minutes with rate--Facility
patient and/or rate.
family member.
----------------------------------------------------------------------------------------------------------------
Weighted Average (claim line volume*rate) of the PFS payment compared to OPPS payment for the 45%
22 major codes:
----------------------------------------------------------------------------------------------------------------
As noted with the clinic visits, we recognized that there were
limitations to our data analysis, including that OPPS payment rates
include the costs of packaged items or services billed with the
separately payable code, and therefore the comparison to rates under
the PFS was not a one-to-one comparison. Also, we included only a
limited number of services, and noted that additional services may have
different patterns than the services described. After considering the
payment differentials for major codes billed by off-campus departments
of hospitals with the ``PO'' modifier and based on the data limitations
of our analysis, we adopted, with some exceptions noted below, a set of
PFS payment rates that were based on a 50-percent PFS Relativity
Adjuster to the OPPS payment rates (inclusive of packaging) for
nonexcepted items and services furnished by nonexcepted off-campus PBDs
in the CY 2017 interim final rule. Generally speaking, we arrived at
the 50 percent PFS Relativity Adjuster by examining the 45-percent
comparison noted above, the ASC payment rate--which was roughly 55
percent of the OPPS payment rate on average--and the payment rate
differential for the large number of OPPS and PFS evaluation and
management services, as described above. We recognized that the
equivalent PFS nonfacility rates may be higher or lower on a code-
specific basis than the rates that result from applying the overall PFS
Relativity Adjuster to the OPPS payment rates on a code specific basis.
However, we believed that, on the whole, the percentage reduction did
not underestimate the overall relativity between the OPPS and the PFS
based on the limited data that was available. We were concerned,
however, that the 50 percent PFS Relativity Adjuster might overestimate
PFS nonfacility payments relative to OPPS payments. For example, if we
were able at the time to sufficiently estimate the effect of the
packaging differences between the OPPS and PFS, we suspected that the
equivalent portion of PFS payments for evaluation and management codes,
and for PFS services on average, would likely have been less than 50
percent for the same services. We considered the 50 percent PFS
Relativity Adjuster for CY 2017 to be a transitional policy until such
time that we had more precise data to better
[[Page 33982]]
identify and value nonexcepted items and services furnished by
nonexcepted off-campus PBDs and billed by hospitals.
We established several significant exceptions to the application of
the 50 percent PFS Relativity Adjuster. For example, we did not apply
the 50 percent PFS Relativity Adjuster to services that are currently
paid under the OPPS based on payment rates from other Medicare fee
schedules (including the PFS) on an institutional claim. The items and
services that are assigned status indicator ``A'' in Addendum B to the
CY 2017 OPPS/ASC final rule with comment period (available on the CMS
Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices-Items/CMS-1656-FC.html) continue to be reported on an
institutional claim and paid under the PFS, the CLFS, or the Ambulance
Fee Schedule (ASC) without a payment reduction. Similarly, drugs and
biologicals that are separately payable under the OPPS (identified by
status indicator ``G'' or ``K'' in Addendum B to the CY 2017 OPPS/ASC
final rule with comment period) are paid in accordance with section
1847A of the Act (that is, typically ASP + 6 percent), consistent with
payment rules in the physician office setting. Drugs and biologicals
that are unconditionally packaged under the OPPS and are not separately
payable (that is, those drugs and biologicals assigned status indicator
of ``N'' in Addendum B to the CY 2017 OPPS/ASC final rule with comment
period) are bundled into the PFS payment and are not separately paid to
hospitals billing for nonexcepted items and services furnished by
nonexcepted off-campus PBDs. The full range of exceptions and
adjustments to the otherwise applicable OPPS payment rate that were
adopted in the new PFS site-of-service payment rates in the CY 2017
interim final rule can be found on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/CMS-1656-FC-2017-OPPS-Status-Indicator.zip.
All nonexcepted items and services furnished by nonexcepted off-
campus PBDs and billed by a hospital on an institutional claim with
modifier ``PN'' (Nonexcepted service provided at an off-campus,
outpatient, provider-based department of a hospital) are currently paid
under the PFS at the rate established in the CY 2017 interim final
rule. Specifically, nonexcepted off campus PBDs must report modifier
``PN'' on each UB-04 claim line to indicate a nonexcepted item or
service, and otherwise continue to bill as they currently do. Further
billing instructions on the PN modifier can be found in the January
2017 OPPS Quarterly Update (transmittal 3685, Change Request 9930)
released December 22, 2016, available on the CMS Web site at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3685CP.pdf.
b. PFS Relativity Adjuster
As noted in the CY 2017 interim final rule, we considered the CY
2017 50 percent PFS Relativity Adjuster to be a transitional policy
until such time that we had more precise data to better identify and
value nonexcepted items and services furnished by nonexcepted off-
campus PBDs and billed by hospitals. At present, we do not have more
precise data than were available when we established the PFS Relativity
Adjuster in the CY 2017 interim final rule, and we do not anticipate
having such data until after the end of CY 2017, at the earliest.
However, in developing a proposed policy for CY 2018, we have continued
to explore options for modifying the calculation of the CY 2018 PFS
Relativity Adjuster.
There is no consensus among stakeholders regarding the appropriate
PFS Relativity Adjuster. Many stakeholders have suggested that making
separate facility fee payments to hospitals under the PFS for all
services that are separately paid under the OPPS itself undermines
site-neutral payment because practitioners are only paid a single
combined fee for many services when furnished in an office setting,
while there are two separate fees (professional and facility) paid when
the service is furnished in the hospital setting. We acknowledge that
there are many cases where single fees are paid to practitioners for
services furnished in an office setting while fees for comparable
services when furnished in the hospital setting are paid to both the
professional and facility entities. However, we do not agree that this
necessarily means that overall payment cannot be site neutral. We point
out that the sum of the professional and the facility portions of
payment for a service furnished in a nonexcepted off-campus PBD or in a
different institutional setting could be equivalent to a single fee
paid to the professional in the office setting. In the case of some
services, in fact, the single payment made under the PFS at the
nonfacility rate exceeds the sum of the separate payments Medicare
makes to the professional at the facility rate under the PFS and to the
facility under the OPPS. We also note that there are many separately
reportable services under the PFS (for example, the vast majority of
services described by add-on codes) for which separate payment is made
to physician offices but no separate payment is made under either the
OPPS or under the site-specific PFS payments made to hospitals billing
for nonexcepted items and services furnished by nonexcepted off-campus
PBDs. For these reasons, we believe that the overall total payment made
for services is more relevant to the goal of site neutrality than the
quantity of individual payments made. Nonetheless, we continue to
recognize and share stakeholders' concerns regarding the importance of
equivalent overall payment for services, regardless of setting.
In considering the appropriate PFS Relativity Adjuster for CY 2018,
we continue to believe that claims data from CY 2017, which are not yet
available, are needed to guide potential changes to our general
approach. In the absence of such data, however, we have continued to
consider the appropriate PFS Relativity Adjuster based on the
information that is available. In the analysis we used to establish the
PFS Relativity Adjuster for CY 2017, we attempted to identify the
appropriate value by comparing OPPS and PFS payment rates for services
frequently reported in PBDs and described by the same codes under the
two payment systems. As we acknowledged in the CY 2017 interim final
rule, that data analysis did not include the most frequently billed
service furnished in nonexcepted off-campus hospital PBDs, outpatient
visits. Outpatient visits are reported using a single code under the
OPPS and by one of ten different codes under the PFS.
Consistent with our previously stated concern that the PFS
Relativity Adjuster for CY 2017 might be too small, generally resulting
in greater overall payments to hospitals for services furnished by
nonexcepted off-campus PBDs than would otherwise be paid under the PFS
in the non-facility setting, we believe it is appropriate to propose
changing the PFS Relativity Adjuster in order to ensure that payment
made to these nonexcepted PBDs better aligns with these services that
are the most frequently furnished in this setting.
For CY 2018, we propose to revise the PFS Relativity Adjuster for
nonexcepted items and services furnished by nonexcepted off-campus PBDs
to be 25 percent of the OPPS payment rate. We arrived at this proposed
PFS Relativity Adjuster by making a code-level comparison for the
service most
[[Page 33983]]
commonly billed in the off-campus PBD setting under the OPPS: A clinic
visit reported using HCPCS code G0463. In order to determine the
analogous payment for the technical aspects of this service under the
PFS in nonfacility settings, we compared the CY 2017 OPPS national
payment rate for HCPCS code G0463 ($102.12) to the difference between
the nonfacility and facility PFS payment amounts under the PFS using CY
2017 rates for the weighted average of outpatient visits (CPT codes
99201-99205 and CPT codes 99211-99215) billed by physicians and other
professionals in an outpatient hospital place of service.
This proposed 25 percent PFS Relativity Adjuster is based solely on
the comparison for the visit services that reflect greater than 50
percent of services billed in off-campus PBDs. We continue to recognize
that the comparison between the OPPS and PFS rates for other services
varies greatly, and that there are other factors, including the
specific mix of services furnished by non-excepted PBDs, policies
related to packaging of codes under OPPS, and payment adjustments like
MPPRs and bundling under the PFS that rely on empirical information
about whether or not codes are billed on the same day, that contribute
to the differences in aggregate payment amounts for a broader range of
services. However, for CY 2018, as for CY 2017, we must set the PFS
Relativity Adjuster prior to studying the CY 2017 claims data that
might allow us to consider and incorporate many more factors, including
the ones stated above. When we established the 50 percent PFS
Relativity Adjuster for CY 2017, we stated that we did so with the goal
of ensuring adequate payment but remained concerned that the resulting
reduction was too small. For CY 2018, we are focused on ensuring that
we do not overestimate the appropriate overall payments for these
services. Until we are able to study claims data, we believe that the
comparison between PFS and OPPS payment for the most common services
furnished in off-campus PBDs, outpatient visits, is a better proxy than
our previous approach.
We welcome stakeholder input with regard to this analysis and the
resulting rate. We also request comment on whether we should adopt a
different PFS Relativity Adjuster, such as 40 percent, that represents
a relative middle ground between the CY 2017 PFS Relativity Adjuster,
selected to ensure adequate payment to hospitals and our proposed CY
2018 PFS Relativity Adjuster, selected to ensure that hospitals are not
paid more than others would be paid through the PFS nonfacility rate.
We intend to continue to study this issue and welcome comments
regarding potential future refinements to payment rates for non-
excepted items and services furnished by non-excepted off-campus PBDs
as we gain more experience with these new site-of-service PFS rates.
Finally, we note that for CY 2018, as in recent years, the proposed
annual update to OPPS payments exceeds the proposed annual update to
PFS payments. Because we are proposing to make a single, across-the-
board and, by necessity, imprecise adjustment to OPPS payment rates to
establish PFS payment rates for nonexcepted items and services
furnished by nonexcepted off-campus PBDs, we expect that the actual
difference between OPPS and PFS payment rates for nonexcepted items and
services furnished by nonexcepted off-campus PBDs falls in a range
which includes our proposed PFS Relativity Adjuster (that is, the
actual differential may differ from our proposed PFS Relativity
Adjuster). As such, taking into account the differential between the
OPPS and PFS annual updates by making an adjustment to the PFS
Relativity Adjuster our proposal for CY 2018 would presume a level of
precision in our estimates that is simply not present in our analysis.
Therefore, we will not adjust our proposal to reflect the relative
updates to PFS and OPPS between CY 2017 and CY 2018, and instead note
that the differential between the OPPS and PFS payment update for CY
2018 is a factor that suggests that the proposed PFS Relativity
Adjuster may overestimate PFS nonfacility payment relative to OPPS
payments; in future years, we intend to more precisely account for any
differential between these two update factors.
c. Geographic Adjustments
For CY 2017, we established class-specific geographic practice cost
indices (GPCIs) under the PFS exclusively used to adjust these site-
specific, technical component rates for nonexcepted items and services
furnished in nonexcepted off-campus PBDs. These class-specific GPCIs
are parallel to the geographic adjustments made under the OPPS based on
the hospital wage index. We believed it was appropriate to adopt the
hospital wage index areas for purposes of geographic adjustment because
non-excepted off-campus PBDs are still considered to be part of a
hospital, and the PFS payments to these entities will be limited to the
subset of PFS services furnished by hospitals. We also believed it was
appropriate, as an initial matter for CY 2017, to adopt the actual wage
index values for these hospitals in addition to the wage index areas.
The PFS GPCIs that would otherwise currently apply are not based on the
hospital wage index areas. For CY 2018, we are proposing to continue
using the authority under section 1848(e)(1)(B) of the Act to maintain
a class-specific set of GPCIs for these site-specific technical
component rates that are based both on the hospital wage index areas
and the hospital wage index value themselves. For purposes of payment
to hospitals, this means that the geographic adjustments used under the
OPPS continue to apply.
d. Coding Consistency
For most services, the same HCPCS codes are used to describe
services paid under both the PFS and the OPPS. There are two notable
exceptions that describe high-volume services. The first is the set of
codes that describe evaluation and management (E/M) services which are
reported under the PFS using the 5 levels of CPT codes describing new
or established patient visits (for a total of 10 codes). However, since
CY 2014, these visits have been reported under the OPPS using the
single HCPCS code G0463 (Hospital Outpatient Clinic Visit) (see 78 FR
75042). We are proposing to maintain the current PFS payment rate for
HCPCS code G0463 based on the OPPS payment rate modified by the PFS
Relativity Adjuster.
The second is a set of radiation treatment delivery and imaging
guidance services that are reported using different codes under the PFS
and the OPPS. CMS established HCPCS Level II G codes to describe
radiation treatment delivery services when furnished in the physician
office setting (see 79 FR 67666 through 67667). However, these HCPCS G
codes are not recognized under the OPPS; rather, CPT codes are used to
describe these services when furnished in the HOPD. Both sets of codes
were implemented for CY 2015 and were maintained for CY 2016. Under the
PFS, there is a particular statutory provision under section
1848(c)(2)(K) of the Act that required maintenance of the CY 2016
coding and payment inputs for these services for CY 2017 and also for
CY 2018. Accordingly, the proposed CY 2018 PFS rates for these services
are calculated based on the maintenance of the CY 2016 coding and
payment inputs. Because non-excepted items and services furnished by a
nonexcepted off-campus PBD are paid under the PFS, and we are required
to maintain the CY 2016 coding and payment inputs for these services
under
[[Page 33984]]
the CY 2018 PFS, we are proposing to maintain payment amounts for
nonexcepted items and services furnished by a nonexcepted off-campus
PBD consistent with the payments that would be made to other facilities
under the PFS. That is, nonexcepted off-campus PBDs submitting claims
for these nonexcepted items and services will continue to bill the
HCPCS G codes established under the PFS to describe radiation treatment
delivery services. Under this proposal, the nonexcepted off-campus PBD
must append modifier PN to each applicable claim line for these
nonexcepted items and services, even though the PFS Relativity Adjuster
will not apply. The payment amount for these services would be set to
reflect the technical component rate for the code under the PFS.
4. OPPS Payment Adjustments
In the CY 2017 interim final rule, we adopted the packaging payment
rates and multiple procedure payment reduction (MPPR) percentage that
applied under the OPPS to establish the PFS payment rates for
nonexcepted items and services furnished by nonexcepted off-campus PBDs
and billed by hospitals. That is, the claims processing logic that was
used for payments under the OPPS for comprehensive APCs (C-APCs),
conditionally and unconditionally packaged items and services, and
major procedures, was incorporated into the newly established PFS
rates. We continue to believe it is necessary to incorporate the OPPS
payment policies for C-APCs, packaged items and services, and the MPPR
in order to maintain the integrity of the PFS Relativity Adjuster
because the adjuster is intended in part to account for the
methodological differences between the OPPS and the PFS rates that
would otherwise apply. We also direct interested stakeholders to
related proposed policies under the OPPS, since prospective changes in
the applicable adjustments and policies would generally apply to non-
excepted items and services furnished by nonexcepted off-campus PBDs
for CY 2018. We are interested in comments regarding the applicability
of particular prospective OPPS adjustments to non-excepted items and
services.
In order to apply these OPPS payment policies and adjustments to
non-excepted items and services, we propose that hospitals continue to
bill on an institutional claim form that will pass through the
Outpatient Code Editor and into the OPPS PRICER for calculation of
payment. This approach will yield data based on claims for non-excepted
items and services furnished by nonexcepted off-campus PBDs, which can
be used to refine PFS payment rates for these services in future years.
There were several OPPS payment adjustments that we did not adopt
in the CY 2017 interim final rule, including, but not limited to,
outlier payments, the rural sole community hospital (SCH) adjustment,
the cancer hospital adjustments, transitional outpatient payments, the
hospital outpatient quality reporting payment adjustment, and the
inpatient hospital deductible cap to the cost-sharing liability for a
single hospital outpatient service. We believed these payment
adjustments were expressly authorized for, and should be limited to,
hospitals that are paid under the OPPS for covered OPD services in
accordance with section 1833(t) of the Act. We continue to believe that
these policies should not apply to non-excepted items and services
furnished by nonexcepted off-campus PBDs, and are not proposing that
they apply for CY 2018.
5. Partial Hospitalization Services
With respect to partial hospitalization programs (PHP) (intensive
outpatient psychiatric day treatment programs furnished to patients as
an alternative to inpatient psychiatric hospitalization or as a
stepdown to shorten an inpatient stay and transition a patient to a
less intensive level of care), section 1861(ff)(3)(A) of the Act
specifies that a PHP is a program furnished by a hospital, to its
outpatients, or by a CMHC. In the CY 2017 OPPS/ASC proposed rule (81 FR
45690), in the discussion of the proposed implementation of section 603
of Public Law 114-74, we noted that because CMHCs also furnish PHP
services and are ineligible to be provider-based to a hospital, a
nonexcepted off-campus PBD would be eligible for PHP payment if the
entity enrolls and bills as a CMHC for payment under the OPPS. We
further noted that a hospital may choose to enroll a nonexcepted off-
campus PBD as a CMHC, provided it meets all Medicare requirements and
conditions of participation.
Commenters expressed concern that without a clear payment mechanism
for PHP services furnished by nonexcepted off-campus PBDs, access to
partial hospitalization services would be limited, and pointed out the
critical role PHPs play in the continuum of mental health care. Many
commenters believed that Congress did not intend for partial
hospitalization services to no longer be paid for by Medicare when such
services are furnished by nonexcepted off-campus PBDs. Several
commenters disagreed with the notion of enrolling as a CMHC in order to
receive payment for PHP services. These commenters stated that
hospital-based PHPs and CMHCs are inherently different in structure,
operation, and payment, and noted that the conditions of participation
for hospital departments and CMHCs are different. Several commenters
requested that CMS find a mechanism to pay hospital-based PHPs in
nonexcepted off-campus PBDs.
Because we shared the commenters' concerns, in the CY 2017 OPPS/ASC
final rule with comment period and the CY 2017 interim final rule (81
FR 79727), we adopted payment for partial hospitalization items and
services furnished by nonexcepted off-campus hospital-based PBDs under
the PFS. When billed in accordance with the CY 2017 interim final rule,
these partial hospitalization services are paid at the CMHC per diem
rate for APC 5853, for providing three or more partial hospitalization
services per day (81 FR 79727).
In the CY 2017 OPPS/ASC proposed rule (81 FR 45681), the CY 2017
OPPS/ASC final rule with comment period, and the CY 2017 interim final
rule (81 FR 79727), we noted that when a beneficiary receives
outpatient services in an off-campus department of a hospital, the
total Medicare payment for those services is generally higher than when
those same services are provided in a physician's office. Similarly,
when partial hospitalization services are provided in a hospital-based
PHP, Medicare pays more than when those same services are provided by a
CMHC. Our rationale for adopting the CMHC per diem rate for APC 5853 as
the PFS payment amount for nonexcepted off-campus PBDs providing PHP
services is because CMHCs are freestanding entities that are not part
of a hospital, but they provide the same PHP services as hospital-based
PHPs (81 FR 79727). This is similar to the differences between
freestanding entities paid under the PFS that furnish other services
also provided by hospital-based entities. Similar to other entities
currently paid for their technical component services under the PFS, we
believe CMHCs would typically have lower cost structures than hospital-
based PHPs, largely due to lower overhead costs and other indirect
costs such as administration, personnel, and security. We believe that
paying for nonexcepted hospital-based partial hospitalization services
at the lower CMHC per diem rate aligns with section 603 of Pubic Law
114-74, while also preserving access to PHP services. In addition,
nonexcepted off-campus PBDs will not be required to enroll as CMHCs
[[Page 33985]]
in order to bill and be paid for providing partial hospitalization
services. However, a nonexcepted off-campus PBD that wishes to provide
PHP services may still enroll as a CMHC if it chooses to do so and
meets the relevant requirements. Finally, we recognize that because
hospital-based PHPs are providing partial hospitalization services in
the hospital outpatient setting, they can offer benefits that CMHCs do
not have, such as an easier patient transition to and from inpatient
care, and easier sharing of health information between the PHP and the
inpatient staff. We are not proposing to require these PHPs to enroll
as CMHCs but instead we are proposing to continue to pay non-excepted
off-campus PBDs providing PHP items and services under the PFS.
Further, we are proposing to continue to adopt the CMHC per diem rate
for APC 5853 as the PFS payment amount for nonexcepted off-campus PBDs
providing three or more PHP services per day in CY 2018.
6. Supervision Rules
The supervision rules that apply for hospitals continue to apply
for nonexcepted off-campus PBDs that furnish nonexcepted items and
services. The amendments made by section 603 of the Bipartisan Budget
Act of 2015 (Pub. L. 114-74, enacted November 2, 2015) did not change
the status of these PBDs, only the status of, and payment mechanism
for, the services they furnish. These supervision requirements are
specified in Sec. 410.27.
7. Beneficiary Cost-Sharing
Under the PFS, the beneficiary copayment is generally 20 percent of
the fee schedule amount, unless there is an applicable exception in
accordance with the statute. All cost-sharing rules that apply under
the PFS in accordance with section 1848(g) of the Act and section
1866(a)(2)(A) of the Act continue to apply for all nonexcepted items
and services furnished by nonexcepted off-campus PBDs, regardless of
the cost-sharing obligation under the OPPS.
8. CY 2019 and Future Years
We continue to believe the amendments made to the statute by
section 603 of the Bipartisan Budget Act of 2015 intended to eliminate
the Medicare payment incentive for hospitals to purchase physician
offices, convert them to off-campus PBDs, and bill under the OPPS for
items and services they furnish there. Therefore, we continue to
believe the payment policy under this provision should ultimately
equalize payment rates between nonexcepted off-campus PBDs and
physician offices to the greatest extent possible, while allowing
nonexcepted off-campus PBDs to bill in a straight-forward way for
services they furnish.
We note that a full year of claims data regarding the mix of
services reported using the ``PN'' modifier (from CY 2017) will first
be available for use in PFS ratesetting for CY 2019. Under the current
methodology, we would expect to use that data in order to ensure that
Medicare payment to hospitals billing for non-excepted items and
services furnished by nonexcepted off-campus PBDs under the PFS would
reflect the relative resources involved in furnishing the items and
services relative to other PFS services. We recognize that under our
current approach, the payment rates would not be equal on a procedure-
by-procedure basis, application of the PFS Relativity Adjuster would
move toward equalizing payment rates in the aggregate between physician
offices and nonexcepted off-campus PBDs to the extent appropriate.
Therefore, for certain specialties, service lines, and nonexcepted off-
campus PBD types, total Medicare payments for the same services might
be either higher or lower when furnished by a nonexcepted off-campus
PBD rather than in a physician office.
Depending on the mix of services for particular off-campus PBDs, we
remain concerned that such specialty-specific patterns in payment
differentials could result in continued incentives for hospitals to buy
certain types of physician offices and convert them to nonexcepted off-
campus PBDs; these are the incentives we believe Congress intended to
avoid. However, continuing a policy similar to the one we are proposing
in this proposed rule would allow hospitals to continue billing through
a facility claim form and would allow for continuation of the packaging
rules and cost report-based relative payment rate determinations under
OPPS, which we believe are preferable to using the current valuation
methodologies under the PFS that are not well-suited for nonexcepted
items and services furnished by nonexcepted off-campus PBDs. Therefore,
for CY 2019 and for future years, we intend to examine the claims data
in order to determine not only the appropriate PFS Relativity
Adjuster(s), but also to determine whether additional adjustments to
the methodology are appropriate--especially with the goal of attaining
site neutral payments to promote a level playing field under Medicare
between physician office settings and nonexcepted off-campus PBD
settings, without regard to the kinds of services furnished by
particular off-campus PBDs. We solicit comments on potential changes to
our methodology that would better account for these specialty-specific
patterns.
H. Proposed 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.E.4 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 for a year. Then, during the 60-day period
following the publication of the final rule, 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. 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 the
CY 2017 PFS proposed rule, the new process was applicable to all codes,
except for new codes that describe truly new services.
[[Page 33986]]
For CY 2017, we proposed new values in the CY 2017 PFS 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 re-proposed values for those codes in the CY
2017 PFS proposed rule.
We considered public comments received during the 60-day public
comment period for the proposed rule before establishing final values
in the CY 2017 PFS final rule. As part of our established process we
will 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. For CY 2017, we
were not aware of any new codes that described such wholly new
services. Therefore, we did not establish any code values on an interim
final basis.
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 reviews of recommended work RVUs and time
inputs have generally included, but have not been limited to, a review
of information provided by the RUC, the Health Care Professionals
Advisory Committee (HCPAC), and other public commenters, medical
literature, and comparative databases, as well as a comparison with
other codes within the PFS, consultation with other physicians and
health care professionals within CMS and the federal government, as
well as Medicare claims data. We have also assessed the methodology and
data used to develop the recommendations submitted to us by the RUC and
other public commenters and the rationale for the recommendations. In
the CY 2011 PFS final rule with comment period (75 FR 73328 through
73329), we discussed a variety of methodologies and approaches used to
develop work RVUs, including survey data, building blocks, crosswalks
to key reference or similar codes, and magnitude estimation (see the CY
2011 PFS final rule with comment period (75 FR 73328 through 73329) 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. We have used the building block methodology to
construct, or deconstruct, the work RVU for a CPT code based on
component pieces of the code.
Components that we have used in the building block approach may
have included 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 and 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 have refined 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 preservice time packages for
services typically furnished in the facility setting (for example:
Preservice time packages reflecting the different combinations of
straightforward or difficult procedure, and straightforward or
difficult patient). Currently, there are three preservice time packages
for services typically furnished in the nonfacility setting.
We 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
have believed that the RUC has not adequately accounted for the
overlapping activities in the recommended work RVU and/or times, we
have adjusted 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 have removed 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 have also
removed a work RVU of 0.09 (4 minutes x 0.0224 IWPUT) if we have not
believed the overlap in time had 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 had regarding the time resources involved
in furnishing individual services. We have been 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. We are
statutorily obligated to consider both time and intensity in
establishing work RVUs for PFS services. As explained in the CY 2016
PFS final rule with comment period (80 FR 70933), we recognize that
adjusting work RVUs for changes in time is not always a straightforward
process, so we have applied various methodologies to identify several
potential work values for individual codes.
[[Page 33987]]
We have observed that for many codes reviewed by the RUC,
recommended work RVUs have appeared to be incongruous with recommended
assumptions regarding the resource costs in time. This has been 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 have begun by looking at the change in
the time in the context of the RUC-recommended work RVU. When the
recommended work RVUs have not appeared to account for significant
changes in time, we have employed 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 block, 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 have sometimes used 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
have used the recommended values as a starting reference and then
applied one of these several methodologies to account for the
reductions in time that we believe had not otherwise been reflected in
the RUC-recommended value. When we have believed that such changes in
time have already been accounted for in the RUC recommendation, then we
have not made such adjustments. Likewise, we have not arbitrarily
applied time ratios to current work RVUs to calculate proposed work
RVUs. We have used the ratios to identify potential work RVUs and
considered these work RVUs as potential options relative to the values
developed through other options.
We do not imply 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 have believed that, since the two components of
work are time and intensity, absent an obvious or explicitly stated
rationale for why the relative intensity of a given procedure has
increased, significant decreases in time should be reflected in
decreases to work RVUs. If the RUC recommendation had 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 have generally used 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 stakeholders, 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; other stakeholders have
also expressed concerns with CMS refinements to RUC recommended values
in general. In the CY 2017 PFS final rule (81 FR 80272 through 80277)
we responded in detail to several comments that we received regarding
this issue. In the CY 2017 PFS proposed rule, we requested comments
regarding potential alternatives to making adjustments that would
recognize overall estimates of work in the context of changes in the
resource of time for particular services; however, we did not receive
any specific potential alternatives as requested.
In developing proposed values for new, revised, and potentially
misvalued codes for CY 2018, we considered the lack of alternative
approaches to making the adjustments, especially since many
stakeholders have routinely urged us to propose and finalize the RUC
recommended values. We also considered the RUC's consistent reassurance
that these kinds of concerns (regarding changes in time, for example)
had already been considered, and either incorporated or dismissed, as
part of the development of their recommended values. These have led us
to shift our approach to reviewing RUC recommendations, especially as
we believe that the majority of practitioners paid under the PFS,
though not necessarily those in any particular specialty, would prefer
CMS rely more heavily on RUC recommended values in establishing payment
rates under the PFS.
For CY 2018, we have generally proposed RUC-recommended work RVUs
for new, revised, and potentially misvalued codes. We are proposing
these values based on our understanding that the RUC generally
considers the kinds of concerns we have historically raised regarding
appropriate valuation of work RVUs. During our review of these
recommended values, however, we identified some concerns similar to
those we have recognized in prior years. Given the relative nature of
the PFS and our obligation to ensure that the RVUs reflect relative
resource use, we have included descriptions of potential approaches we
might have taken in developing work RVUs that differ from the RUC
recommended values. We are seeking comment on both the RUC-recommended
values as well as the alternatives considered.
Table 10 contains a list of codes for which we proposed work RVUs;
this includes all codes for which we received RUC recommendations by
February 10, 2017. The proposed work RVUs, work time and other payment
information for all proposed CY 2018 payable codes are available on the
CMS Web site under downloads for the CY 2018 PFS proposed rule at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. Table 10 also
contains the CPT code descriptors for all proposed, new, revised, and
potentially misvalued codes discussed in this section.
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, and 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's recommendations appropriately estimate the
direct PE inputs (clinical labor, disposable supplies, and medical
equipment) required for the typical service, are 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
[[Page 33988]]
across codes, as well as refinements that are specific to particular
services. Table 11 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 $0.30 or less, the
refinement has no impact on the proposed PE RVUs. This calculation
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
11 result in changes under the $0.30 threshold and are unlikely to
result in a change to the proposed RVUs.
We also note that the proposed direct PE inputs for CY 2018 are
displayed in the CY 2018 direct PE input database, available on the CMS
Web site under the downloads for the CY 2018 PFS proposed rule at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The inputs
displayed there have also been used in developing the proposed CY 2018
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.
We refer readers to section II.B. of this proposed rule for more
information regarding the collaborative work of CMS and the RUC in
improvements in standardizing 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 2018, we received invoices for several new supply and
equipment items. Tables 13 and 14 detail the invoices received for new
and existing items in the direct PE database. As discussed in section
II.B. of this proposed rule, we encourage stakeholders to review the
prices associated with these new and existing
[[Page 33989]]
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 13 and 14 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 did not include clinical
labor minutes assigned to the service period 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 2018 are
available on the CMS Web site under downloads for the CY 2018 PFS
proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html For more
information regarding the history of the MPPR policy, we refer readers
to the CY 2014 PFS final rule (78 FR 74261-74263). For more information
regarding the history of the OPPS cap, we refer readers to the CY 2007
PFS final rule (71 FR 69659-69662).
4. Proposed Valuation of Specific Codes for CY 2018
(1) Anesthesia Services for Gastrointestinal (GI) Procedures (CPT codes
007X1, 007X2, 008X1, 008X2, and 008X3)
In the CY 2016 PFS proposed rule (80 FR 41686), we discussed that
in reviewing Medicare claims data, a separate anesthesia service is
typically reported more than 50 percent of the time that various
colonoscopy procedures are reported. We discussed that given the
significant change in relative frequency with which anesthesia codes
are reported with colonoscopy services, we believed the relative values
of the anesthesia services should be reexamined and proposed to
identify CPT codes 00740 (Anesth upper gi visualize) and 00810 (Anesth
low intestine scope) as potentially misvalued. For CY 2018, the CPT
Editorial Panel is deleting CPT codes 00740 and 00810 and creating new
codes for anesthesia services furnished in conjunction with and in
support of gastrointestinal endoscopic procedures: Two codes for upper
GI procedures (007X1 and 007X2), two codes for lower GI procedures
(008X1 and 008X2), and one code for upper and lower GI procedures
(008X3).
For CY 2018, we are proposing the RUC-recommended base units
without refinement for CPT codes 007X1 (5.00 base units), 007X2 (6.00
base units), 008X1 (4.00 base units), 008X2 (4.00 base units) and 008X3
(5.00 base units). We considered 3.00 base units (the 25th percentile
survey result) for CPT code 008X2 (Anesthesia for lower intestinal
endoscopic procedures, endoscope introduced distal to duodenum;
screening colonoscopy), based on our comparison of the surveyed post-
induction anesthesia-intensity allocation for CPT code 008X2 to codes
with similar allocations (CPT code 01382 (Anesth dx knee arthroscopy)).
We found that CPT code 01382, which was also valued with 3.00 base
units, had similar allocations compared to the survey results for CPT
code 008X2. We are seeking comment on our proposed and alternative
value for CPT code 008X2.
(2) Acne Surgery (CPT code 10040)
CPT code 10040 was identified as potentially misvalued on a screen
of Harvard-valued codes with utilization over 30,000 in CY 2014. We are
proposing the RUC-recommended work RVU of 0.91 for CPT code 10040 and
the RUC-recommended work time values. We considered using the current
number of 0.5 post-procedure office visits of CPT code 99212 (Office/
outpatient visit est) rather than the RUC-recommended number of 1.0
post-procedure office visits. For CPT code 10040, the RUC states that
it is a low intensity service that can be performed by a nurse under a
physician's supervision, and that the average number of office visits
in the follow-up period of acne surgery is 0.4. We are seeking public
comments regarding the typical number of postoperative visits for this
code, considering there have been no changes made to the code
descriptor and we have not found evidence of changes to the typical
patient population.
We are proposing the RUC-recommended direct PE inputs for CPT code
10040 without refinement. We considered refinements to the clinical
[[Page 33990]]
labor for ``Assist physician in performing procedure'' from 10 minutes
to 3 minutes. CPT code 10040 previously used about one third of the
intraservice work time for this clinical labor activity (5 minutes out
of 14 minutes), and the RUC-recommended value of 10 minutes would have
increased this to 100 percent of the intraservice work time without
rationale for the change. We considered 3 minutes for this clinical
labor activity, which is about one third of the intraservice work time
(3 minutes out of 10 minutes) and would have maintained the current
ratio between clinical labor time and work time.
For CY 2018, we are proposing the RUC-recommended work RVUs and
direct PE inputs for CPT code 10040 and are seeking comment on our
proposed and alternative values.
(3) Muscle Flaps (CPT codes 15734, 15736, 15738, 157X1, and 157X2)
CPT codes 15732 and 15736 were identified via a screen of high
level E/M visits included in their global periods. This screen
identified that a CPT code 99214 office visit was included for CPT
codes 15732 and 15736 but not included in the other codes in this
family. During the review process for this family of codes, CPT code
15732 was deleted and replaced with two new codes, CPT codes 157X1 and
157X2, to better differentiate and describe the work of large muscle
flaps performed on patients with head and neck cancer depending on the
site where the service was performed.
For CY 2018, we are proposing the RUC-recommended work RVUs for CPT
codes 15734 (a work RVU of 23.00), 15736 (a work RVU of 17.04), 15738
(a work RVU of 19.04), 157X1 (a work RVU of 13.50), and 157X2 (a work
RVU of 15.68). For CPT code 157X1, we considered a work RVU of 12.03,
crosswalking to CPT code 36830 (Creation of arteriovenous fistula by
other than direct arteriovenous anastomosis (separate procedure);
nonautogenous graft (eg, biological collagen, thermoplastic graft)). We
have concerns because the RUC-recommended work RVU of 13.50 would
represent nearly double the intensity of CPT codes 15734 through 15738,
as well as nearly double the intensity of deleted CPT code 15732. The
RUC-recommended work RVU for CPT code 157X1 is also based on a direct
crosswalk to CPT code 36832 (Revision, open, arteriovenous fistula;
without thrombectomy, autogenous or nonautogenous dialysis graft
(separate procedure)), which has the same intraservice time, but with
20 additional minutes of total time. We considered a potential
crosswalk to another code in the same family, CPT code 36830, which
also shares the same intraservice time with CPT code 157X1 but differs
by only 8 minutes of total time. However, we seek comment on whether
the RUC recommendation is appropriate given the significant variation
in intensity among these services.
We considered a work RVU of 14.63 for CPT code 157X2 (survey 25th
percentile), crosswalking to CPT code 36833 (Revision, open,
arteriovenous fistula; with thrombectomy, autogenous or nonautogenous
dialysis graft (separate procedure)), which has the same intraservice
time, 1 minute of additional total time, and a work RVU of 14.50. We
are seeking comment on the effect that an alternative work RVU of 14.50
would have on relativity among the codes in this family.
We considered refining the clinical labor time for ``Check
dressings & wound/home care instructions'' for CPT code 157X1 from 10
minutes to 5 minutes. We are seeking comment on the typical time input
for checking dressings, and whether removing and replacing dressings,
would typically take place during the intraservice or postservice
period.
We are also seeking comments regarding the use of the new ``plate,
surgical, mini-compression, 4 hole'' (SD189) supply included in CPT
code 157X1, including whether use of this supply would be typical, and
if so, whether it should be included in the work description. We note
that SD189 is mentioned in the direct PE recommendations, but the
supply does not appear in the work description. In the work
description, the fixation screws are applied to the orbital rim and
lateral nasal wall, not the surgical plate.
(4) Application of Rigid Leg Cast (CPT code 29445)
CPT code 29445 appeared on a high growth screen of all services
with total Medicare utilization of 10,000 or more that increased by at
least 100 percent from 2008 through 2013. This screen also indicated
that the code was last surveyed more than 10 years previously, and that
the dominant specialty had changed during that time.
For CY 2018, we are proposing the RUC-recommended work RVU of 1.78
for CPT code 29445. For the direct PE inputs, we are proposing to
refine the clinical labor time for ``Check dressings & wound/home care
instructions'' from 5 minutes to 3 minutes. We believe that the
additional 2 minutes of clinical labor time that we are proposing to
remove would take place during the monitoring time following the
procedure and be accounted for in that clinical labor time.
We also considered refining the clinical labor time for ``Remove
cast'' from 22 minutes to 11 minutes: 1 minute for room prep, 10
minutes for assisting the physician, and 0 minutes for the additional
activities described in the RUC recommendations, which would have only
taken place during the initial casting. We have concerns that the RUC-
recommended clinical labor regarding the ``remove cast'' task is based
only on an initial visit where a new cast would be applied and 22
minutes may be an appropriate length of time. However, the RUC
recommendations suggest that four to twelve cast changes are common for
patients, and we are seeking comment on whether the initial application
of a new cast would be typical for CPT code 29445. We reviewed the
Medicare claims data for CPT code 29445 and found that three or more
castings took place for 52 percent of beneficiaries, which suggests
that three or more castings may be the typical case. A single casting
only took place for 30 percent of services reported with CPT code
29445.
(5) Strapping Multi-Layer Compression (CPT codes 29580 and 29581)
The RUC reviewed CPT code 29580 since it appeared on the screen for
high expenditure services and reviewed CPT code 29581 as part of this
family of codes. For CY 2018, the CPT Editorial Panel is deleting two
additional codes in the family: CPT codes 29582 (Application of multi-
layer compression system; thigh and leg, including ankle and foot, when
performed) and 29583 (Application of multi-layer compression system;
upper arm and forearm).
For CY 2018, we are proposing the RUC-recommended work RVUs for CPT
code 29580 (a work RVU of 0.55) and CPT code 29581 (a work RVU of
0.60).
However, we are concerned about the changes in preservice time
reflected in the specialty surveys compared to the RUC-recommended work
RVUs. For instance, for CPT code 29580, we considered a work RVU of
0.46, crosswalking to CPT code 98925 (Osteopathic manipulative
treatment (OMT); 1-2 body regions involved)), which has a work RVU of
0.46 and shares a similar intraservice time. Compared to the specialty
survey times, the RUC recommended a slight decrease (9 minutes) in
preservice time for CPT code 29580, with the intraservice and immediate
postservice times remaining unchanged.
[[Page 33991]]
For CPT code 29581, we considered a work RVU of 0.5 by using the
RUC-recommended work RVU increment between CPT codes 29580 and 29581
(+0.05), added to the work RVU we considered for CPT code 29580 (0.46),
and crosswalking to CPT code 97597 (Debridement (eg, high pressure
waterjet with/without suction, sharp selective debridement with
scissors, scalpel and forceps), open wound, (eg, fibrin, devitalized
epidermis and/or dermis, exudate, debris, biofilm), including topical
application(s), wound assessment, use of a whirlpool, when performed
and instruction(s) for ongoing care, per session, total wound(s)
surface area; first 20 sq cm or less)), which has similar intraservice
and total times to the RUC-recommended services times for CPT code
29581. We are seeking comment on whether a work RVU of 0.51 would
improve relativity among the codes in this family.
For CY 2018, we are proposing the RUC-recommended work RVUs for CPT
codes 29580 and 29581 and are seeking comment on whether the
alternative values we considered would be more appropriate.
(6) Resection Inferior Turbinate (CPT Code 30140)
CPT code 30140 was identified as potentially misvalued on a screen
of Harvard-valued codes with utilization over 30,000 in CY 2014. During
the review process, the RUC re-surveyed the code as a 0-day global
period, based on the presence of a negative intensity value in the
initial survey and highly variable postoperative office visits.
For CY 2018, we are proposing the RUC-recommended work RVU of 3.00
for CPT code 30140 as a 0-day global code. We also considered a work
RVU of 2.68 for CPT code 30140 and are seeking comment on changes in
practice patterns since the code was previously reviewed, service times
of comparable services, and whether a work RVU of 2.68 would better
maintain relativity among similar codes. We note that the RUC-
recommended work RVU of 3.0 nearly doubles the derived intensity of the
code as currently valued. We note that the RUC recommendations
referenced services that had similar service times to CPT code 30140
(CPT code 31240 (Nasal/sinus endoscopy, surgical; with concha bullosa
resection), with a work RVU of 2.61; and CPT code 31295 (Nasal/sinus
endoscopy, surgical; with dilation of maxillary sinus ostium (eg,
balloon dilation), transnasal or via canine fossa), with a work RVU of
2.70).
We note that the initial survey for CPT code 30140 as a 90-day
global resulted in a RUC-recommended work RVU of 3.57, while the second
survey for the code as a 0-day global resulted in a RUC-recommended
work RVU of 3.00, despite the removal of two postoperative office
visits of CPT code 99212 and a half discharge visit of CPT code 99238.
These removed postoperative visits have a total work RVU of 2.58, which
is notably higher than the difference in the RUC-recommended work RVU
between the two surveys.
We are also proposing to create equipment codes for three new
equipment items based on invoices submitted with the RUC
recommendations for CPT code 30140. We are proposing to create three
new equipment codes based on the invoices submitted for this code
family: the 2mm reusable shaver blade (EQ383) at a price of $790, the
microdebrider handpiece (EQ384) at a price of $4,760, and the
microdebrider console (EQ385) at a price of $9,034.
(7) Control Nasal Hemorrhage (CPT Codes 30901, 30903, 30905, and 30906)
For CY 2018, we are proposing the RUC-recommended work RVUs for CPT
codes 30901 (a work RVU of 1.10), 30903 (a work RVU of 1.54), 30905 (a
work RVU of 1.97), and 30906 (a work RVU of 2.45). We are also
proposing to use the RUC-recommended direct PE inputs for CPT codes
30901, 30903, 30905, and 30906, with standard refinements to the
equipment times to account for patient monitoring times. We noted that
as part of its recommendation, the RUC informed us that the specialty
societies presented evidence stating that the 1995 valuations for these
services factored in excessive times, specifically to account for
infection control procedures that were necessary at that time due to
the prevalence of HIV/AIDS. The specialty societies also noted that
increased availability and use of blood thinner medications compared to
those available in 1995, has increased the difficulty and intensity of
these procedures. We are seeking additional information regarding the
presumption that the relative resource intensity of these services,
specifically, would be affected by the commercial availability of
additional blood thinner medications. We believe that blood thinner
medications were widely available before 1995 when these codes were
last valued. Additionally, we seek comments on the prevalence of HIV/
AIDS and whether the work related to infection control procedures would
be relative across many PFS services or specifically related to nasal
hemorrhage control procedures.
For CPT code 30901 (Control nasal hemorrhage, anterior, simple
(limited cautery and/or packing) any method), we considered a work RVU
of 1.00 (the 25th percentile survey result), crosswalking to CPT code
20606 (Drain/inj joint/bursa w/us), which has similar service times.
The median survey total time (24 minutes) dropped by 2 minutes (from
preservice time), to 24 minutes compared to the existing total time.
The difference in total time reflected a small decrease in preservice
time, with no change in intraservice time (10 minutes). Among codes
with similar service times, we found only three codes that had a higher
work RVU than the RUC-recommended value.
For CPT code 30903 (Control nasal hemorrhage, anterior, complex
(extensive cautery and/or packing) any method), we considered a work
RVU of 1.30 (the 25th percentile survey result), which would have been
further supported by CPT codes 36584 and 51710 which have similar
service times to the median survey results. The RUC recommended a
decreased total time of 39 minutes compared to the existing total time
(70 minutes), with intraservice time dropping from 30 to 15 minutes.
For CPT code 30905 (Control nasal hemorrhage, posterior, with
posterior nasal packs and/or cautery, any method; initial), we
considered a work RVU of 1.73, using the RUC-recommended work RVU
increment between CPT code 30903 and CPT code 30905 (0.43), added to
the work RVU we considered for CPT code 30903 (1.30), and crosswalking
to CPT code 45321 (Proctosigmoidoscopy volvul), which has similar
service times. The surveyed intraservice time dropped from 48 minutes
to 20 minutes. The RUC recommendations indicated that surveyed service
times for CPT code 30905 are longer than for CPT code 30903 since the
service is performed to control an arterial posterior bleed. According
to the specialty society, arterial posterior bleeds are more difficult
to treat and require a more extensive procedure in comparison to
services reported with CPT code 30903. We considered using the RUC-
recommended work RVU increment between CPT code 30903 and CPT code
30905 (0.43), added to the work RVU we considered for CPT code 30903
(1.30), resulting in a work RVU of 1.73. We are seeking comment on
whether a work RVU of 1.73 would potentially affect relativity among
the codes in this family.
[[Page 33992]]
For CPT code 30906 (Control nasal hemorrhage, posterior, with
posterior nasal packs and/or cautery, any method; subsequent), we
considered a work RVU of 2.21, using the RUC-recommended work RVU
increment between CPT codes 30905 and 30906 (0.48), added to the work
RVU we considered for CPT code 30905 (1.73), and crosswalking to
services with similar service times (CPT codes 19281 (Perq device
breast 1st imag), 51727 (Cystometrogram w/up), 49185 (Sclerotx fluid
collection), and 62305 (Myelography lumbar injection)). The surveyed
median intraservice time dropped from 60 minutes to 30 minutes. We are
seeking comment on whether a work RVU of 2.21 would potentially improve
relativity among the codes in this family.
Given the RUC's consensus for CY 2018, we are proposing the RUC-
recommended work RVUs for each code in this family and seeking comment
on whether our alternative values would be more appropriate.
(8) Nasal Sinus Endoscopy (CPT Codes 31254, 31255, 31256, 31267, 31276,
31287, 31288, 31295, 31296, 31297, 31XX1, 31XX2, 31XX3, 31XX4, and
31XX5)
In October 2016, the CPT Editorial Panel created five new codes
(CPT codes 31XX1, 31XX2, 31XX3, 31XX4 and 31XX5) and revised CPT codes
31238, 31254, 31255, 31276, 31287, 31288, 31296, and 31297. CPT codes
31XX2--31XX5 are newly bundled services representing services that are
frequently reported together. CPT code 31XX1 represents a new service.
The RUC reviewed this family of codes at their January 2017 meeting.
For CY 2018, we are proposing the RUC-recommended work RVUs for all 15
CPT codes in this family as follows: 4.27 for CPT code 31254, 5.75 for
CPT code 31255, 3.11 for CPT code 31256, 4.68 for CPT code 31267, 6.75
for CPT code 31276, 3.50 for CPT code 31287, 4.10 for CPT code 31288,
2.70 for CPT code 31295, 3.10 for CPT code 31296, 2.44 for CPT code
31297, 8.00 for CPT code 31XX1, 9.00 for CPT code 31XX2, 8.00 for CPT
code 31XX3, 8.48 for CPT code 31XX4, and 4.50 for CPT code 31XX5.
For CPT code 31296, we considered a work RVU of 2.82, supported by
a crosswalk to CPT code 36901 (Intro cath dialysis circuit) with an
intraservice time of 25 minutes and total time of 66 minutes, similar
to the service times for CPT code 31296. We are concerned about the
decrease in service time compared to the work RVU and we seek comment
on whether or not a work RVU of 2.82 might improve relativity with
other PFS services.
For CPT code 31256, we considered a work RVU of 2.80, supported by
a crosswalk to CPT code 43231 (Esophagoscopy, flexible, transoral; with
endoscopic ultrasound examination), which has 30 minutes of
intraservice time and 81 minutes of total time, similar to the RUC-
recommended service times. We are concerned about the difference in
total time between CPT code 31256 and the RUC-recommended crosswalk to
CPT code 43247. CPT code 43247 has 30 minutes intraservice time and 58
minutes total time), and CPT code 31256 (30 minutes intraservice time
and 83 minutes total time).
For CPT code 31254, we note the RUC's explanation that this service
is more intense than the functional endoscopic sinus surgery on the
maxillary or sphenoid sinuses due to the risk of major complications
such as injury to the eye muscles, bleeding into the eye or brain fluid
leak and, consequently, that the RUC concluded that it should be valued
higher than either CPT code 31256 or CPT code 31287. Since CPT code
31256 has the same total time (30 minutes) and intraservice time (30
minutes) as CPT code 31254, we considered whether the incremental
difference recommended by the RUC between these two codes (work RVU of
1.16) would reflect the intensity of the service. We considered a work
RVU of 2.80 for CPT code 31256, and also considered an alternative work
RVU of 3.97 for CPT code 31254.
For CPT code 31287, we considered a work RVU of 3.19 based on the
difference between the RUC-recommended work RVU for the maxillary sinus
surgery (CPT code 31256) and the sphenoid sinus surgery (CPT code
31287) (difference = 0.28) added to the work RVU that we considered for
the base code (CPT code 31256, a work RVU of 2.80). We note that the
magnitude of decreases in service times are greater than those for the
work RVU, which potentially could affect relativity among PFS services.
For CPT code 31255, we considered a work RVU of 5.30, based on a
crosswalk to CPT codes 36475 (Endovenous rf 1st vein) and 36478
(Endovenous laser 1st vein) since both of these services have the same
intraservice times, total times, and work RVUs). We note that there are
several CPT codes with similar total and intraservice times that have
lower work RVUs than the crosswalk to CPT code 36246 (Ins cath abd/l-
ext art 2nd) noted by the RUC, which has 45 minutes intraservice and 96
minutes total time, has work RVU of 5.02; CPT code 36475 (Endovenous rf
1st vein) has 94 minutes intraservice and 94 minutes total time and has
work RVU of 5.30).
For CPT code 31276 (Nasal/sinus endoscopy, surgical; with frontal
sinus exploration, including removal of tissue from frontal sinus, when
performed), we considered a work RVU of 6.30, which is similar to other
functional endoscopic surgeries. We note that the services reported
with CPT code 31276 are the most intense and complex of the functional
endoscopic surgeries due to the risks of working in the narrow confines
in the frontal recess. However, we have concerns that a crosswalk to
CPT code 52352 (Cystourethroscopy, with ureteroscopy and/or pyeloscopy;
with removal or manipulation of calculus (ureteral catheterization is
included)), and we seek comment on whether the RUC-recommended decrease
in service times is appropriate since CPT code 52352 has 20 minutes
more total time than CPT code 31276.
For CPT 31XX1 (nasal/sinus endoscopy, surgical; with ligation of
Sphenopalatine artery), we have concerns and seek comment regarding the
accuracy and applicability of the surveys as the RUC indicated that the
specialty society did not use the survey instrument that contains
questions about the number and types of visits and that this service
requires a half day discharge day management as the patients typically
stay overnight to be monitored for further bleeding. We seek comment on
whether inclusion of a half day discharge day visit is typical for this
service since services assigned 0-day global periods do not typically
include discharge visits. We considered reducing the total time from
142 minutes to 123 minutes by removing the half day discharge. Using
the alternative total time of 123 minutes, we found services with
similar total and intraservice time (60 minutes) and total time (123
minutes).
We considered a work RVU of 7.30 for CPT code 31XX1, supported by a
direct crosswalk to CPT code 36253 (Superselective catheter placement
(one or more second order or higher renal artery branches) renal artery
and any accessory renal artery(s) for renal angiography, including
arterial puncture, catheterization, fluoroscopy, contrast injection(s),
image postprocessing, permanent recording of images, and radiological
supervision and interpretation, including pressure gradient
measurements when performed, and flush aortogram when performed;
unilateral), since CPT code 36253 has a similar total time compared to
our alternative total time.
For CPT code 31XX3, we considered a work RVU of 7.30, based on a
crosswalk to CPT code 36253 (Superselective catheter placement (one
[[Page 33993]]
or more second order or higher renal artery branches) renal artery and
any accessory renal artery(s) for renal angiography, including arterial
puncture, catheterization, fluoroscopy, contrast injection(s), image
postprocessing, permanent recording of images, and radiological
supervision and interpretation, including pressure gradient
measurements when performed, and flush aortogram when performed;
unilateral). We have similar concerns regarding the service times for
this service, including the cited reference codes, compared to the
recommended work RVU. We are seeking comment on whether a work RVU of
7.30 for CPT code 31XX3 would improve consistency among the combined
CPT codes in this family.
CPT code 31XX4 is a new code representing a combination of the
services previously described by CPT codes 31255 and 31288. We note the
changes in overall service times compared to other codes in this family
and other PFS services. We considered a work RVU of 7.85 for CPT code
31XX4, crosswalking to CPT code 93461 (R&l hrt art/ventricle angio),
which has identical intraservice times. We are seeking comment on the
effect that this alternative work RVU might have on consistency and
rank order compared to the other bundled codes in this family.
CPT code 31XX5 represents a combination of CPT codes 31296 and
31297. We have concerns about the use of CPT codes 47532 and 58558,
which were used by the RUC as comparison codes, due to differences in
both intraservice and total time compared to the service times for CPT
code 31XX5. We considered a work RVU of 4.10 for CPT code 31XX5,
crosswalking to CPT code 44406 (Colonoscopy w/ultrasound), which has
similar service times.
For CY 2018, we are proposing the RUC-recommended work RVUs for
each code in this family and are seeking comment on our alternative
values.
Regarding the recommended direct PE inputs, we are concerned about
one of the supply items used in furnishing services for several CPT
codes in this family:, ``sinus surgery balloon (maxillary, frontal, or
sphenoid) kit'' (SA106). In the current recommendations, half of one
kit (each kit has sufficient supply for two sinuses) is included in the
practice expense inputs for CPT codes 31295, 31296, and 31297. The new
CPT code 31XX5 has one full kit, reflecting a service consisting of two
sinuses, according to the RUC's explanation. The price of the full kit
(two sinuses) of this disposable supply is $2599.06. Our analysis of
2016 Medicare claims data indicates that 48 percent of the time one of
the three CPT codes (31295, 31296, and 31297) is billed, it is reported
on a claim with either one or both of the other codes. Ten percent of
the time one of the three CPT codes is billed, it is reported on a
claim with both of the other two codes. Effectively, 10 percent of
claims reporting these CPT codes are being paid for three sinuses.
We are seeking comments on the number of units of this supply item
that are used for each service. We welcome suggestions about improved
methodologies for identifying the quantity of this disposable supply
used during these procedures and will continue to monitor utilization
and reporting of these services.
In reviewing the RUC recommendations for this family of CPT codes,
we note that CPT codes in this family are subject to the standard
payment adjustment for multiple surgeries. In our analysis of the
claims data, we noted that the average number of HCPCS codes in this
family reported together on a claim line is approximately 2.89. In
addition, about 15 percent of claims have two of the newly bundled CPT
codes reported together on a claim line. We are concerned about the
frequency with which the nasal sinus endoscopy CPT codes in this family
are billed together. We are seeking comments on whether we should
consider the endobase code adjustments as a better approach to
adjusting payment for these services instead of the current multiple
procedure reduction. For additional information about the payment
adjustment under the special rule for multiple endoscopic services, we
refer readers to the Medicare Claims Processing Manual, Chapter 23
(available on the CMS Web site at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c23.pdf.).
We note that in developing the utilization crosswalk we use for
purposes of PFS ratesetting, for this complex set of newly bundled
codes, we adopted ratios that differ significantly from the ratios
accompanying the RUC recommendations to better account for the
reductions in overall reporting frequency. We direct readers to the
file called ``CY 2017 Analytic Crosswalk to CY 2018'' on the CMS Web
site under downloads for the CY 2018 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
(9) Tracheostomy (CPT Codes 31600, 31601, 31603, 31605, and 31610)
CPT code 31600 was identified as part of a screen of high
expenditure services with Medicare allowed charges of $10 million or
more that had not been recently reviewed. CPT codes 31601, 31603,
31605, and 31610 were added and reviewed as part of the code family.
We are proposing the RUC-recommended work RVUs for all five codes
in this family. We are proposing a work RVU of 5.56 for CPT code 31600,
a work RVU of 8.00 for CPT code 31601, a work RVU of 6.00 for CPT code
31603, a work RVU of 6.45 for CPT code 31605, and a work RVU of 12.00
for CPT code 31610.
We considered a work RVU of 6.50 for CPT code 31601. We seek
comment on the effect that this alternative value would have on
relativity compared to other PFS services, especially since the survey
data does not suggest an increase in the time required to perform the
procedure.
We considered a work RVU of 4.77 for CPT code 31605, based on the
survey 25th percentile from the combined survey total. We also
considered an intraservice work time of 15 minutes, based on the median
intraservice work time from the combined survey total for CPT code
31605. We are seeking comments on the methodology used to determine the
RUC-recommended work RVU and intraservice work time. We are concerned
that the number of respondents (20) is below the threshold typically
required for submission of a survey, and the effect of using survey
results only from physicians who had personal experience performing the
procedure (20 respondents). CPT code 31605 has a lower intraservice and
total time, but a higher work RVU than comparable codes under the PFS.
We note that the next highest 0-day global code with 20 minutes of
intraservice time is CPT code 16035 (Escharotomy; initial incision) at
a work RVU of 3.74. All other 0-day global codes with a work RVU of
6.45 or greater have at least 40 minutes of intraservice time. We are
seeking comment on the effect that an alternative work RVU of 4.77
would have on the relativity of this service compared to other services
in this family of codes and compared to other PFS services, taking into
account that CPT code 31605 describes a difficult and dangerous life-
threatening emergency procedure.
We considered a work RVU of 6.50 for CPT code 31610 based on a
direct crosswalk to CPT code 31601 (Incision of windpipe). We
understand that the RUC considered the possibility of
[[Page 33994]]
recommending this code be assigned a 0-day global period based on
concerns about negative derived intensity. We share the RUC's concerns
with the current construction of CPT code 31610, particularly with the
242 minutes of work time included in the postoperative visits, which is
an unusually large amount for a procedure with only 45 minutes of
intraservice time. We did not identify any other comparable codes under
the PFS with 45 minutes of intraservice time and more than 300 minutes
of total time. We seek comment on whether the unusual volume of
physician work time included in the postoperative visits for CPT code
31610 contributed to the negative derived intensity reported by the
survey data. Considering that the other codes in this family have 0-day
global periods, we considered and are seeking comment on whether a 0-
day global period should be assigned to CPT code 31610. Removal of the
postoperative E/M visits from CPT code 31610 would result in an
intraservice time of 45 minutes and a total time of 125 minutes,
similar to CPT code 31601 with 45 minutes of intraservice time and 135
minutes of total time.
We are proposing the RUC-recommended direct PE inputs for all five
CPT codes in this family without refinements. As discussed earlier, we
considered a 0-day global period for CPT code 31610, which would also
have resulted in removal of the clinical labor associated with the
postoperative E/M visits, along with the supplies and equipment
utilized during those visits.
While we remain concerned about the global period assigned to CPT
code 31610 and the changes in service times reflected in the specialty
surveys compared to the RUC-recommended work RVUs, for CY 2018, we are
proposing the RUC-recommended work RVUs and direct PE inputs for each
code in this family and are seeking comment on our proposed and
alternative values.
(10) Bronchial Aspiration of Tracheobronchial Tree (CPT Codes 31645 and
31646)
CPT code 31645 was identified as potentially misvalued on a screen
of Harvard-valued codes with utilization over 30,000 in CY 2014. CPT
code 31646 was added for review as part of the family of codes, and
both were revised to reflect recent changes in how the services are
typically performed. For CY 2018, we are proposing the RUC-recommended
work RVU of 2.88 for CPT code 31645 and the RUC-recommended work RVU of
2.78 for CPT code 31646.
We considered a work RVU of 2.72 for CPT code 31645, crosswalking
to CPT code 45347 (Sigmoidoscopy, flexible; with placement of
endoscopic stent). We have concerns regarding the decrease in
intraservice and total time compared to the current values (we also
believe that it is important to note how these related codes have been
affected by the creation of separately billable codes for moderate
sedation (see CY 2017 PFS final rule (81 FR 80339)). The RUC-
recommended values CPT code 31645 higher than CPT code 31622
(Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when
performed; diagnostic, with cell washing, when performed), which is the
base procedure for this wider group of codes. We agree that CPT code
31645 should be valued at a higher work RVU than CPT code 31622,
however, we are seeking comment on whether the work of moderate
sedation was inadvertently included in the development of the
recommended work RVU. We note that as part of the CY 2017 PFS final
rule (81 FR 80339), we finalized separate payment for moderate
sedation.
Following the creation of separately billable codes for moderate
sedation, CPT code 31622 is currently valued at a work RVU of 2.53, not
2.78 as it was previously valued, and we do not believe it would be
appropriate to continue to value CPT code 31645 as though moderate
sedation was still an inherent part of the work of this service. As a
result, we considered a direct crosswalk to CPT code 45347, which has
the same intraservice time and 8 additional minutes of total time, at a
work RVU of 2.72.
We considered a work RVU of 2.53 for CPT code 31646, crosswalking
to CPT code 31622 (Dx bronchoscope/wash). The RUC recommendation for
CPT code 31646 indicated that the code was comparable to CPT code
31622, since they share the same intraservice time and similar total
time, and that the recommended work RVU of 2.78 for CPT code 31646 was
equal to the work RVU of CPT code 31622 before the CY 2017 changes to
reporting of moderate sedation. We agree with the survey participants
that these two codes are comparable to one another, but have concerns
about valuation of CPT code 31646 using a cross reference to a code
that included moderate sedation. We considered crosswalking CPT code
31646 (Bronchoscopy reclear airway) using the current CY 2017 valuation
for CPT code 31622 (a work RVU of 2.53).
For the direct PE inputs, we are proposing to remove the oxygen gas
(SD084) from CPT code 31645. This supply is included in the separately
billable moderate sedation codes, and we are proposing to remove the
oxygen gas as recommended by the RUC's PE Subcommittee as part of the
removal of oxygen from non-moderate sedation post-procedure monitoring
codes. We are proposing to remove the equipment time for the IV
infusion pump (EQ032) from CPT code 31645. We do not agree that there
would typically be a need for a separate infusion pump in CPT code
31645, as the infusion pump is contained in the separately reportable
moderate sedation codes. We are also proposing to remove the equipment
time for the CO2 respiratory profile monitor (EQ004) and the
mobile instrument table (EF027) from CPT code 31645. These equipment
items are not contained in the current composition of the code, and
there was no rationale provided in the RUC recommendations for their
inclusion. As a result, we do not believe that their use would be
typical for CPT code 31645.
We are proposing to increase the equipment time for the flexible
bronchoscopy fiberscope (ES017) for CPT code 31645 consistent with
standard equipment times for scopes. We are also proposing to increase
the equipment time for the Gomco suction machine (EQ235) and the power
table (EF031) consistent with standard equipment times for non-highly
technical equipment.
For CY 2018, we are proposing the RUC-recommended work RVUs for
both codes in this family and are seeking comment on whether we should
finalize refined values consistent with the implementation of
separately billable codes for moderate sedation.
(11) Cryoablation of Pulmonary Tumor (CPT Codes 32998 and 32X99)
For CY 2018, the CPT Editorial Panel modified the descriptor for
CPT code 32998 (Ablation therapy for reduction or eradication of 1 or
more pulmonary tumor(s) including pleura or chest wall when involved by
tumor extension, percutaneous, including imaging guidance when
performed, unilateral; radiofrequency) to include imaging guidance. In
addition, the panel deleted Category III CPT Code 0304T and replaced it
with a new CPT code 32X99, to describe ablation therapy for reduction
of pulmonary tumor using cryoablation with imaging guidance. For CY
2018, we are proposing the RUC-recommended work RVUs for CPT codes
32998 (a work RVU of 9.03) and 32X99 (a work RVU of 9.03).
However, we have concerns about the descriptions of the codes and
the recommended valuations assuming that imaging guidance is inherent
to the
[[Page 33995]]
procedure. Based on our analysis of claims data from 2014, existing CPT
code 32998 is currently reported with one of the three imaging guidance
codes (CPT codes 76940, 77013, or 77022) less than 50 percent of the
time. We seek comment on whether there is additional information that
would help explain why the codes are being bundled despite what is
reflected in the Medicare claims data. We considered a work RVU of 7.69
for CPT code 32998, that included approximately one half the value of
the imaging guidance in the new codes that describe the work of both
the procedure and the image guidance (that is, the sum of the current
work RVU for CPT code 32998 and one-half of the work RVU for CPT code
77013 (the imaging guidance code most frequently billed with CPT code
32998 according to 2014 claims data)). We applied the same general
rationale regarding the use of imaging guidance for new CPT code 32X99.
Since the RUC recommended identical work RVUs for these codes, we also
considered a work RVU of 7.69 for CPT 32X99.
For CPT codes 32998 and 32X99, we are proposing to use the RUC-
recommended direct PE inputs with standard refinements.
For CY 2018, we are proposing the RUC-recommended work RVUs and
direct PE inputs for both codes and are seeking comment on our proposed
and alternative values.
(12) Artificial Heart System Procedures (CPT Codes 339X1, 339X2, and
339X3)
For CY 2018, the CPT Editorial Panel deleted Category III CPT Codes
0051T through 0053T and created CPT codes 339X1, 339X2, and 339X3 to
report artificial heart system procedures. We are proposing the RUC-
recommended work RVU of 49.00 for CPT code 339X1, and proposing to
assign contractor-priced status to CPT codes 339X2 and 339X3 as
recommended by the RUC.
We considered assigning contractor-priced status for CPT code
339X1. We have concerns regarding the accuracy of the RUC-recommended
work valuation for CPT code 339X1, due to its low utilization and the
resulting difficulties in finding enough practitioners with direct
experience of the procedure for the specialty societies to survey. We
seek comment on the sufficiency of the survey data, especially since
new technologies and those with lower utilization are typically
contractor-priced. For CY 2018, we are proposing the RUC-recommended
work RVUs for CPT code 339X1. We are seeking comment on alternative
pricing for this CPT code 339X1.
We are not proposing any direct PE inputs, as we did not receive
RUC-recommended PE information for CPT codes 339X1, 339X2, and 339X3.
These three codes will be placed on the RUC's new technology list and
will be re-reviewed by the RUC in 3 years.
(13) Endovascular Repair Procedures (CPT Codes 34X01, 34X02, 34X03,
34X04, 34X05, 34X06, 34X07, 34X08, 34X09, 34X10, 34X11, 34X12, 34X13,
34812, 34X15, 34820, 34833, 34834, 34X19, and 34X20)
The CPT/RUC joint workgroup on codes recommended in October 2015 to
bundle endovascular abdominal aortic aneurysm repair (EVAR) codes
together with radiologic supervision and interpretation codes, since
these codes were typically reported together at least 50 percent of the
time. The CPT Editorial Panel bundled these services together in
September 2016, creating 16 new codes, revising four existing codes,
and deleting 14 other codes related to endovascular repair procedures.
We are proposing the RUC-recommended work RVUs for all 20 codes in
this family. We are proposing a work RVU of 23.71 for CPT code 34X01, a
work RVU of 36.00 for CPT code 34X02, a work RVU of 26.52 for CPT code
34X03, a work RVU of 45.00 for CPT code 34X04, a work RVU of 29.58 for
CPT code 34X05, a work RVU of 45.00 for CPT code 34X06, a work RVU of
22.28 for CPT code 34X07, a work RVU of 36.50 for CPT code 34X08, a
work RVU of 6.50 for CPT code 34X09, a work RVU of 15.00 for CPT code
34X10, a work RVU of 6.00 for CPT code 34X11, a work RVU of 12.00 for
CPT code 34X12, a work RVU of 2.50 for CPT code 34X13, a work RVU of
4.13 for CPT code 34812, a work RVU of 5.25 for CPT code 34X15, a work
RVU of 7.00 for CPT code 34820, a work RVU of 8.16 for CPT code 34833,
a work RVU of 2.65 for CPT code 34834, a work RVU of 6.00 for CPT code
34X19, and a work RVU of 7.19 for CPT code 34X20.
We are also proposing the RUC-recommended direct PE inputs without
refinement for all 20 codes in the family.
We considered a work RVU of 32.00 for CPT code 34X02 based on the
survey 25th percentile, and further supported with a crosswalk to CPT
code 48000 (Placement of drains, peripancreatic, for acute
pancreatitis), which has the same intraservice time of 120 minutes and
a work RVU of 31.95. When we compared the RUC-recommended work RVU to
similar codes valued under the PFS, we were unable to find any 90-day
global services with 120 minutes of intraservice time and approximately
677 minutes of total time that had a work RVU greater than 36.00.
We considered a work RVU of 40.00 for CPT code 34X04 based on the
survey 25th percentile, crosswalking to CPT code 33534 (Coronary artery
bypass, using arterial graft(s); 2 coronary arterial grafts) which has
a work RVU of 39.88. CPT code 33534 has 193 minutes of intraservice
time, but a lower total time of 717 minutes. When we compared the RUC-
recommended work RVU for CPT code 34X04 to similar codes paid under the
PFS, we were unable to find any 90-day global services with 180 minutes
of intraservice time and approximately 737 minutes of total time that
had a work RVU greater than 45.00.
We considered a work RVU of 40.00 for CPT code 34X06 based on the
survey 25th percentile. CPT code 34X06 has nearly identical time values
to CPT code 34X04, with 2 fewer minutes of intraservice time and total
time, and the RUC-recommended work RVU was the same for both of these
codes. The survey respondents also believe that these two codes had a
comparable amount of work, as the survey 25th percentile work RVU is
40.00 for both codes.
We considered a work RVU of 30.00 for CPT code 34X08 based on the
survey 25th percentile and seek comment on whether a work RVU of 30.00
would improve relativity among the codes in this family. CPT code 34X08
has identical intraservice and total times as CPT code 34X02. However,
we note that the RUC-recommended work RVU of 36.50 for CPT code 34X08
is higher than the RUC-recommended work RVU of 36.00 for CPT code
34X02. This is the inverse of the relationship between CPT codes 34X07
and 34X01, which describe the same procedures in a non-emergent state
when a rupture does not take place. CPT code 34X07 has a RUC-
recommended work RVU of 22.28 while CPT code 34X01 has a RUC-
recommended work RVU of 23.71. We seek comment on whether the RUC-
recommended work RVUs would create a rank order anomaly within the
family by reversing the relationship between these paired codes when
performed in an emergent state. We note that if CPT codes 34X08 and
34X02 were valued at the survey 25th percentile, this potential rank
order anomaly disappears; in this scenario, we considered valuing CPT
code 34X08 at a work RVU of 30.00 and CPT code 34X02 at a work RVU of
32.00. We seek comment on whether these alternative work values would
improve relativity with the RUC-recommended work RVUs for CPT code
34X07 (22.28) and CPT code 34X01 (23.71), with an increment of
[[Page 33996]]
approximately 1.50 to 2.00 RVUs between the two code pairs.
For the eight remaining codes that describe endovascular access
procedures, we considered assignment of a 0-day global period, instead
of the RUC-recommended add-on (ZZZ) global period and subsequently
adding back the preservice and immediate postservice work time, and
increasing the work RVU of each code accordingly using a building block
methodology. We note that as add-on procedures, these eight codes would
not be subject to the multiple procedure payment discount. We are
concerned that the total payment for these services will be increasing
in the aggregate based on changes in coding that alter MPPR
adjustments, despite the information in the surveys that reflects a
decrease in the intraservice time required to perform the procedures,
and a decrease in their overall intensity as compared to the current
values.
We considered a work RVU of 3.95 for CPT code 34X13, based on the
RUC-recommended work RVU of 2.50 plus an additional 1.45 work RVUs.
This additional work results from the addition of 38 total minutes of
preservice work time and 30 minutes of postservice work time based on a
crosswalk to CPT code 37224 (Revascularization, endovascular, open or
percutaneous, femoral, popliteal artery(s), unilateral; with
transluminal angioplasty) as valued by using the building block
methodology. Using the same method, we considered a work RVU of:
6.48 for CPT code 34812 based on maintaining the current
75 minutes of preservice work time and the current 30 minutes of
postservice work time, with a total work RVU of 2.35, added to the RUC-
recommended work RVU of 4.13;
7.53 for CPT code 34X15 with the addition of 75 minutes of
preservice work time and 27 minutes of postservice work time to match
CPT code 34833;
9.46 for CPT code 34820 based on maintaining the current
80 minutes of preservice work time and the current 30 minutes of
postservice work time;
10.44 for CPT code 34833 based on maintaining the current
75 minutes of preservice work time and the current 27 minutes of
postservice work time;
5.00 for CPT code 34834 based on maintaining the current
70 minutes of preservice work time and the current 35 minutes of
postservice work time;
8.35 for CPT code 34X19 with the addition of 70 minutes of
preservice work time and 35 minutes of postservice work time to match
CPT code 34834; and
9.47 for CPT code 34X20 with the addition of 75 minutes of
preservice work time and 27 minutes of postservice work time to match
CPT code 34833.
(14) Selective Catheter Placement (CPT Codes 36215, 36216, 36217, and
36218)
CPT code 36215 was identified as potentially misvalued on a screen
of Harvard-valued codes with utilization over 30,000 in CY 2014, as
well as on a screen of high expenditure services across specialties
with Medicare allowed charges of over $10 million. CPT codes 36216,
36217, and 36218 were added to the family to be reviewed together with
CPT code 36215.
We are proposing the RUC-recommended work RVUs for each code in
this family as follows: A work RVU of 4.17 for CPT code 36215, a work
RVU of 5.27 for CPT code 36216, a work RVU of 6.29 for CPT code 36217,
and a work RVU of 1.01 for CPT code 36218.
We also considered refinements to the intraservice work time for
CPT code 36217 from 60 minutes to 50 minutes, consistent with the RUC's
usual use of the survey median intraservice work time. We have concerns
that the use of the recommended survey 75th percentile intraservice
work time will not be clinically appropriate for this code, as the 75th
percentile time was identical for both CPT code 36216 and 36217, and
therefore, the use of this value would not preserve the incremental,
linear consistency between the work RVU and the intraservice time
within the family.
For the direct PE inputs, we are proposing to refine the clinical
labor time for the ``Post-procedure doppler evaluation (extremity)''
activity from 3 minutes to 1 minute for CPT codes 36215, 36216, and
36217. We believe that 1 minute would be more typical for this task, as
the practitioner would be able to quickly evaluate if there was an
issue with the extremity because there would be visual signs of
arterial insufficiency resulting from the procedure.
We are proposing to remove the equipment time for the mobile
instrument table (EF027) from CPT codes 36215, 36216, and 36217. We
believe that the mobile instrument table would be used for moderate
sedation, which was removed from these procedures in CY 2017 (see CY
2017 PFS final rule (81 FR 80339)). While we recognize that 180 minutes
of post-procedure monitoring time remains in these codes during which
the stretcher (EF018), IV infusion pump (EQ032), and 3-channel ECG
(EQ011) would remain in use, we do not agree that the mobile instrument
table would typically be in use during this period of monitoring. As a
result, we are proposing to remove this equipment time from these three
codes.
While we remain concerned about the use of the survey 75th
percentile intraservice work time for CPT code 36217, for CY 2018, we
are proposing the RUC-recommended work RVUs for each code in this
family and seek comment on whether our alternative values would be more
appropriate.
(15) Treatment of Incompetent Veins (CPT Codes 36470, 36471, 364X3,
364X4, 364X5, and 364X6)
In September 2016, the CPT Editorial Panel created four new codes
to describe the treatment of incompetent veins, and revised existing
CPT codes 36470 and 36471. These six codes were reviewed together as
part of the same family of procedures. For CY 2018, we are proposing
the RUC-recommended work RVU for all six codes as follows: A work RVU
of 0.75 for CPT code 36470, a work RVU of 1.50 for CPT code 36471, a
work RVU of 3.50 for CPT code 364X3, and a work RVU of 1.75 for CPT
code 364X4, a work RVU of 2.35 for CPT code 364X5, and a work RVU of
3.00 for CPT code 364X6.
We considered a work RVU of 4.38 for CPT code 364X3, which would
have been based on the RUC-recommended work RVU of 3.50 plus half of
the RUC-recommended work RVU of CPT code 364X4. We also considered
assigning CPT code 364X4 a status indicator of ``bundled.'' The
services that would be reported using CPT codes 364X3 and 364X4 in CY
2018, are currently reported with unlisted CPT code 37799 (Unlisted
procedure, vascular surgery). We have concerns about the frequency that
the current services include treatment of an initial vein (CPT code
364X3) as compared to the treatment of initial and subsequent veins
(CPT codes 364X3 and 364X4 together). It may be more accurate to
describe these services through the use of a single code, as in the
rest of this code family, instead of a base code and add-on code pair.
Under this potential scenario, we looked at the RUC-recommended
crosswalk and noted that the add-on CPT code 364X4 was estimated to be
billed 50 percent of the time together with CPT code 364X3. We
therefore considered adding half of the RUC-recommended work RVU of CPT
code 364X4 (0.88) to the RUC-recommended work RVU of CPT code 364X3
(3.50), resulting in a work RVU of 4.38.
We are proposing to remove the 2 minutes of clinical labor for the
``Setup scope'' (CA015) activity and add the same 2 minutes of clinical
labor for the ``Prepare room, equipment and
[[Page 33997]]
supplies'' (CA013) activity for CPT codes 364X3, 364X5, and 364X6. The
RUC-recommended materials stated that these 2 minutes were a proxy for
setting up the ultrasound machine, and we believe that this 2 minutes
is more accurately described by the ``Prepare room, equipment and
supplies'' (CA013) activity code, since there is no scope equipment
utilized in these procedures. We are proposing to maintain the Vascular
Tech (L054A) clinical labor type for these 2 minutes. We are also
proposing to refine the clinical labor for the ``Check dressings,
catheters, wounds'' (CA029) activity for CPT codes 36470, 36471, 364X3,
364X5, and 364X6, consistent with the standard times for this clinical
labor activity.
We are proposing to remove the six individual 4x4 sterile gauze
(SG055) supplies and replace them with a 4x4 sterile gauze pack of 10
(SG056) for CPT codes 36470, 36471, 364X3, 364X5, and 364X6. The pack
of 10 sterile gauze is cheaper than six individual pieces of sterile
gauze, and we do not agree that it would be typical to pay a higher
cost for fewer supplies. We are also proposing to create three new
supply codes in response to the invoices submitted for this family of
codes. We are proposing to establish a price of $1495 for the Venaseal
glue (SD323) supply, a price of $3195 for the Varithena foam (SD324)
supply, and a price of $40 for the Varithena admin pack (SA125) supply.
We are proposing to adjust the equipment times for the surgical
light (EF014), the power table (EF031), and the portable ultrasound
unit (EQ250) for CPT codes 364X3, 364X5, and 364X6 consistent with the
standards for non-highly technical equipment and to reflect the changes
in the clinical labor described in this section of the proposed rule.
While we remain concerned about the creation of a base code and
add-on code pairing (CPT codes 364X3 and 364X4) out of services that
are currently reported using an unlisted code, for CY 2018, we are
proposing the RUC-recommended work RVUs for each code in this family
and are seeking comment on whether our alternative values would be more
appropriate.
(16) Therapeutic Apheresis (CPT Codes 36511, 36512, 36513, 36514,
36516, and 36522)
CPT code 36516 was nominated as potentially misvalued in the CY
2016 PFS proposed rule. The CPT Editorial Panel deleted CPT code 36515
and made revisions to CPT code 36516 to include immunoabsorption. CPT
codes 36511, 36512, 36513, 36514, and 36522 were added to CPT code
36516 to be reviewed together as part of the therapeutic apheresis
family.
For CY 2018, we are proposing the RUC-recommended work RVU for all
six codes in the family as follows: A work RVU of 2.00 for CPT code
36511, a work RVU of 2.00 for CPT 36512, a work RVU of 2.00 for CPT
code 36513, a work RVU of 1.81 for CPT code 36514, a work RVU of 1.56
for CPT code 36516, and a work RVU of 1.75 for CPT code 36522.
We are proposing to use the RUC-recommended direct PE inputs for
these codes without refinement. We considered refining the clinical
labor time for the ``Prepare room, equipment, supplies'' activity from
20 minutes to 10 minutes for CPT codes 36514 and 36522, and from 30
minutes to 10 minutes for CPT code 36516. We also considered refining
the clinical labor for the ``Prepare and position patient/monitor
patient/set up IV'' activity from 15 minutes to 10 minutes for these
same three codes. In both cases, we considered maintaining the current
clinical labor time for CPT codes 36514 and 36516, and adjusting the
clinical labor time for CPT code 36522 to match the other two codes in
the family. We have concerns about the lack of a rationale provided for
these changes in clinical labor time, and whether these clinical labor
tasks would typically require this additional time.
We are proposing the RUC-recommended work RVUs and to use the RUC-
recommended direct PE inputs for each code in this family and seeking
comment on whether our alternative values would be more appropriate. We
are also seeking comment on whether these procedures are creating a new
point of venous access or utilizing a previously placed access.
(17) Insertion of Catheter (CPT Codes 36555, 36556, 36620, and 93503)
CPT code 36556 was identified as part of a screen of high
expenditure services with Medicare allowed charges of $10 million or
more that had not been recently reviewed. CPT codes 36555, 36620, and
93503 were added for review as part of the code family. We are
proposing the RUC-recommended work RVUs for each code in this family as
follows: A work RVU of 1.93 for CPT code 36555, a work RVU of 1.75 for
CPT code 36556, a work RVU of 1.00 for CPT code 36620, and a work RVU
of 2.00 for CPT code 93503.
We are proposing to remove the clinical labor time for the
``Monitor pt. following procedure'' activity and the equipment time for
the 3-channel ECG (EQ011) for CPT code 36555. CPT code 36555 no longer
includes moderate sedation as part of the procedure (see CY 2017 PFS
final rule (81 FR 80339). We are proposing to remove the direct PE
inputs related to moderate sedation from CPT code 36555 as they would
now be included in the separately reported moderate sedation services.
We are also proposing to refine the equipment times for the exam table
(EF023) and the exam light (EQ168) to reflect changes in the clinical
labor time.
(18) Insertion of PICC Catheter (CPT Code 36569)
CPT code 36569 was identified as part of a screen of high
expenditure services with Medicare allowed charges of $10 million or
more that had not been recently reviewed. For CY 2018, we are proposing
the RUC-recommended work RVU of 1.70 for CPT code 36569.
We are proposing to remove the equipment time for the exam table
(EF023), as this equipment item is a component part of the
radiographic-fluoroscopic room (EL014) included in CPT code 77001
(Fluoroscopic guidance for central venous access device placement,
replacement (catheter only or complete), or removal). Because CPT code
36569 is typically billed together with CPT code 77001, we believe that
the additional equipment time for the exam table would be duplicative.
(19) Bone Marrow Aspiration (CPT Codes 38220, 38221, 382X3, and 2093X)
CPT code 38221 was identified as part of a screen of high
expenditure services with Medicare allowed charges of $10 million or
more that had not been recently reviewed. The descriptors for CPT codes
38220 and 38221 were revised to reflect changes in practice patterns,
and two new CPT codes (382X3 and 2093X) were created to more accurately
describe new services that are now available. For CY 2018, we are
proposing the RUC-recommended work RVUs for each code in this family as
follows: A work RVU of 1.20 for CPT code 38220, a work RVU of 1.28 for
CPT code 38221, a work RVU of 1.44 for CPT code 382X3, and a work RVU
of 1.16 for CPT code 2093X.
We also received a recommendation from the RUC to change the global
period for CPT codes 38220, 38221, and 382X3 from XXX global periods to
0-day global periods, even though these codes were surveyed under the
XXX global period. We agree with the recommendation that for these
three particular codes, their services are more accurately described
when assigned 0-day global periods as opposed to the XXX global status.
Therefore, we propose to assign a 0-day global period
[[Page 33998]]
to all three codes in this family. We note, however, that we believe
that global period changes must be addressed on an individual basis,
especially when the routine survey methodologies rely on assumptions
regarding global periods for particular codes. Subsequently, we are
proposing to refine the preservice work time from 15 minutes of
evaluation time to 9 minutes of evaluation time, 1 minute of
positioning time, and 5 minutes of scrub, dress, and wait time. We are
proposing these refinements to the work times for these three codes to
more closely align with the preservice times of other recently reviewed
0-day global procedures, such as CPT code 30903 (Control nasal
hemorrhage, anterior, complex (extensive cautery and/or packing) any
method). We also note that given our proposal to value CPT code 382X3,
we are proposing to eliminate payment using HCPCS code G0364 for CY
2018 since the changes to the set of CPT codes will now accurately
describe the services currently reported by G0364. For CPT code 2093X,
we considered a work RVU of 1.00 based on a direct crosswalk to CPT
codes 64494 (Injection(s), diagnostic or therapeutic agent,
paravertebral facet (zygapophyseal) joint (or nerves innervating that
joint) with image guidance (fluoroscopy or CT), lumbar or sacral;
second level) and 64495 (Injection(s), diagnostic or therapeutic agent,
paravertebral facet (zygapophyseal) joint (or nerves innervating that
joint) with image guidance (fluoroscopy or CT), lumbar or sacral; third
and any additional level(s)). CPT code 2093X is a global ZZZ add-on
code for CPT code 38220, and we are concerned with maintaining
relativity among PFS services, considering that an add-on code
typically has significantly less intraservice time and total time
compared to the base code. We considered an alternative crosswalk to
CPT codes 64494 and 64495, which share the same intraservice and total
time with CPT code 2093X and have a work RVU of 1.00.
We are also proposing to refine the clinical labor for ``Lab Tech
activities'' from 12 minutes to 9 minutes for CPT code 38220, from 7.5
minutes to 7 minutes for CPT code 38221, and from 12.5 minutes to 10
minutes for CPT code 382X3. We are maintaining the current time value
for the two existing codes, as we have no reason to believe that the
typical duration has increased for these lab activities. We are
assigning 10 minutes for CPT code 382X3 based on the statement in the
RUC-recommended materials for the direct PE inputs that this activity
takes 0.5 minutes longer than it does in the current version of CPT
code 38220. We are also proposing to remove the breakout lines for the
lab activities. We believe that the breakout of activities into
numerous subactivities generally tends to inflate the total time
assigned to clinical labor activities and results in values that are
not consistent with the analogous times for other PFS services.
We considered refining the clinical labor for ``Provide preservice
education/obtain consent'' for CPT codes 38220, 38221, and 382X3 from
12 minutes to 6 minutes. We have concerns regarding whether 12 minutes
would be typical for education and consent prior to these procedures,
as much of the patient education takes place following the procedure,
in the clinical labor activity described under the ``Check dressings &
wound/home care instructions'' heading.
We are proposing the RUC-recommended work RVUs for each code in
this family and are seeking comment on whether our alternative values
would be more appropriate.
(20) Esophagectomy (CPT Codes 43107, 43112, 43117, 432X5, 432X6, and
432X7)
CPT codes 432X5, 432X6, and 432X7 were created by the CPT Editorial
Panel to report esophagectomy via laparoscopic and thoracoscopic
approaches. CPT codes 43107, 43112, and 43117 were also reviewed as
part of the family with the three new codes. CPT code 43112 was revised
to clarify the nature of the service being performed. We are proposing
the RUC-recommended work RVUs and work times for all six codes in the
family as follows: A work RVU of 52.05 for CPT code 43107, a work RVU
of 62.00 for CPT code 43112, a work RVU of 57.50 for CPT code 43117, a
work RVU of 55.00 for CPT code 432X5, a work RVU of 63.00 for CPT code
432X6, and a work RVU of 66.42 for CPT code 432X7.
We are also proposing the RUC-recommended work times for all six
codes in this family. We considered removing 20 minutes from the
preservice evaluation work time from all six of the codes in this
family. We have concerns as to whether this additional evaluation time
should be included for surgical procedures, due to the lack of evidence
indicating that it takes longer to review outside imaging and lab
reports for surgical services than for non-surgical services. We also
considered refining the preservice positioning work time and the
immediate postservice work time for all six of the codes in this family
consistent with standard preservice and postservice work times
allocated to other PFS services.
We have concerns about the presence of two separate surveys
conducted for the three new codes. We note that CPT codes 432X5, 432X6,
and 432X7 were surveyed initially in January 2016, and then were
surveyed again in October 2016 together with CPT codes 43107, 43112,
and 43117 due to concerns about the description of the typical patient
in the original vignette and a change in the codes on the reference
service list (RSL). We note that CPT codes 432X5 and 432X6 had the same
median intraservice time on both surveys, while CPT code 432X7 had a
median intraservice time that was an hour longer on its second survey
(420 minutes) as compared to its first survey (360 minutes). We also
note that the total survey time for CPT code 432X5 decreased from 1058
minutes in the first survey to 972 minutes in the second survey, while
the median work RVU increased from 50.00 to 65.00. We do not understand
how the survey median intraservice time could increase so significantly
from the first survey to the second survey for CPT code 432X7, or how
the surveyed times for CPT code 432X5 could be decreasing while the
work RVU was simultaneously increasing by 15.00 work RVUs.
Based on our analysis, it appears that the accompanying RSL is the
main difference between the two surveys; the codes on the initial RSL
had a median work RVU of 44.18, while the codes on the second RSL had a
median work RVU of 59.64. This increase of 15.00 work RVUs between the
two RSLs that accompanied the surveys appears to account for the
increase in the work RVUs for the three new codes. We are concerned
that the second survey may have overestimated the work required to
perform these procedures, as the 25th percentile work RVU of the second
survey is higher than the median work RVU of the initial survey for all
three codes, despite no change in the median intraservice work time for
CPT codes 432X5 and 432X6.
Given these concerns, we considered a work RVU of 50.00 for CPT
code 432X5, a work RVU of 60.00 for CPT code 432X6, and a work RVU of
61.00 for CPT code 432X7, by using the survey median work RVU from the
first survey for the three new codes. For CPT codes 43107 and 43117, we
considered employing the intraservice time ratio between the
laparoscopic version of the procedure represented by the new code and
the open version of the same procedure represented by the existing
code.
[[Page 33999]]
We considered a work RVU of 45.00 for CPT code 43107 based on the
intraservice time ratio with CPT code 432X5 and a work RVU of 55.00 for
CPT code 43117 based on the intraservice time ratio with CPT code
432X6. CPT code 43107 has 270 minutes of intraservice time as compared
with 300 minutes of intraservice time for CPT code 432X5, which
produces a ratio of 0.9, and when multiplied by a work RVU of 50.00
(CPT code 432X5), results in the proposed work RVU of 45.00. We
considered using the same methodology for CPT codes 43117 and 432X6.
Finally, we considered a work RVU of 58.94 for CPT code 43112 based
on a direct crosswalk to CPT code 46744 (Repair of cloacal anomaly by
anorectovaginoplasty and urethroplasty, sacroperineal approach). We
note that the intraservice time ratio when applied to CPT codes 43112
and 432X7, the paired McKeown esophagectomy procedures, would have
produced a potential work RVU of 52.29, creating a rank order anomaly
within the family by establishing a higher work RVU for CPT code 43117
than CPT code 43112, and are concerned with whether this is an
appropriate valuation for the code. We are seeking comment on whether
the alternative work RVUs that we considered may reflect the relative
difference in work more accurately between the six codes in the family.
We note, for example, that these valuations correct the rank order
anomaly between CPT codes 43112 and 43121 as noted in the RUC
recommendations.
We are proposing the RUC-recommended direct PE inputs for all six
codes in the family without refinement. We considered changing the
preservice clinical labor type for all six codes from an RN (L051) to
an RN/LPN/MTA blend (L037D). We have concerns about whether the use of
RN clinical labor would be typical for filling out referral forms or
for scheduling space and equipment in the facility. We also considered
removing the additional clinical labor time for the ``Additional
coordination between multiple specialties for complex procedures (eg,
tests, meds, scheduling)'' activity, consistent with preservice
standards for codes with 90-day global periods. We are concerned that
this time would not typically be included in non-surgical procedures
performed by other specialties even when additional coordination is
required.
We are seeking comment regarding the changes in the valuation
between the two surveys, the preservice and immediate postservice work
times, and the RN staffing type employed for routine preservice
clinical labor.
(21) Transurethral Electrosurgical Resection of Prostate (CPT Code
52601)
CPT code 52601 appeared on a screen of potentially misvalued codes
which indicated that it was performed less than 50 percent of the time
in the inpatient setting, yet included inpatient hospital E/M services
within the global period. For CY 2018, we are proposing the RUC-
recommended work RVU of 13.16 for CPT code 52601 and proposing to use
the RUC-recommended direct PE inputs without refinements.
We considered a work RVU of 12.29 for CPT code 52601 based on a
direct crosswalk to CPT code 58541 (Laparoscopy, surgical,
supracervical hysterectomy, for uterus 250 g or less), which is one of
the reference codes. CPT code 58541 may potentially be a more accurate
crosswalk for CPT code 52601 than the RUC-recommended direct crosswalk
to CPT code 29828 (Arthroscopy, shoulder, surgical; biceps tenodesis).
Although all three of these codes share the same intraservice time of
75 minutes, CPT code 58541 is a closer match in terms of the total time
at only 10 minutes difference. CPT code 58541 also shares the same
postoperative office visits as CPT code 52601, a pair of CPT code 99213
office visits, while CPT code 29828 also contains two CPT code 99212
office visits that are not present in the reviewed code.
We note that if we were to use a reverse building block methodology
for CPT code 52601 and subtract out the value of the E/M visits being
removed, the proposed work RVU would be 11.21. We are not proposing
this work RVU, however, because as we noted in the CY 2017 PFS final
rule (81 FR 80274), 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 and building block
methodologies 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.
For CPT code 52601, we are concerned as to how the RUC-recommended
derived intensity of the procedure could be increasing by 30 percent
over the current derived intensity, while at the same time the typical
site of service is changing from inpatient to outpatient status. In
other words, if it is now typical for CPT code 52601 to be performed on
an outpatient basis, then we would generally expect the intensity of
the procedure to be decreasing, not increasing. We considered a work
RVU of 12.29 for CPT code 52601 based on a direct crosswalk to CPT code
58541 (Lsh uterus 250 g or less), and seek comment on whether this
alternative value might better reflect relativity.
(22) Peri-Prostatic Implantation of Biodegradable Material (CPT Code
55X87)
In October 2016, the CPT Editorial Panel deleted CPT Category III
code 0438T and created a new CPT code 55X87 (Transperineal placement of
biodegradable material, peri-prostatic, single or multiple
injection(s), including image guidance, when performed). For CY 2018,
we are proposing the RUC-recommended work RVU of 3.03 for CPT code
55X87.
In reviewing the RUC recommendations, we noted a decrease in
preservice time (30 minutes) compared to the current value. In order to
account for this change in time, we considered calculating the
intraservice time ratio between the key reference code (CPT code
49411), which has an intraservice time of 40 minutes, and the RUC-
recommended intraservice time (30 minutes) and multiplying that against
the work RVU for CPT code 49411 (3.57), which would have resulted in a
work RVU of 2.68. A work RVU of 2.68 would have been further supported
by a bracket of two crosswalk codes, CPT code 65779 (Placement of
amniotic membrane on the ocular surface; single layer, sutured) which
has a work RVU of 2.50 and CPT code 43252 (Esophagogastroduodenoscopy,
flexible, transoral; with optical endomicroscopy), which has a work RVU
of 2.96. Compared with CPT code 55X87, these codes have identical
intraservice and similar total times. We are seeking comment on whether
these alternative values should be considered, especially given the
changes in time reflected in the survey data.
We received invoices with pricing information regarding two new
supply items: ``endocavity balloon'' and ``biodegradeable material
kit--periprostatic''. The invoice for endocavity balloon was $399.00
and the input price on the PE spreadsheet for this supply item was
noted as such. We believe the input price noted on the PE spreadsheet
was an error, given that the invoice noted that the price of $399.00
was for a box of ten and the specialty society requested a single unit
of this supply item. Therefore, we are proposing to use this
information to propose for supply item ``endocavity balloon'' a price
of $39.90. The invoice
[[Page 34000]]
for the ``biodegradeable material kit--periprostatic'' totaled
$2850.00. We are proposing to use this information to propose for the
supply item ``biodegradeable material kit--periprostatic'' a price of
$2850.00. We also received an invoice with pricing information
regarding the new equipment item ``endocavitary US probe'' which
totaled $16,146.00. We are proposing to use this information to propose
for equipment item ``endocavitary US probe'', a per-minute price of
$0.0639. We question, given an invoice price of $29,999.00 for this
existing equipment item EQ250 (portable ultrasound unit), whether this
equipment item includes probes. We are seeking public comments related
to whether equipment item EQ250 (portable ultrasound) includes probes.
(23) Colporrhaphy With Cystourethroscopy (CPT Codes 57240, 57250, 57260
and 57265)
In October 2015, CPT code 57240 was identified by analysis of the
Medicare data from 2011-2013 that indicated that services reported with
CPT code 57240 were performed less than 50 percent of the time in the
inpatient setting, yet include inpatient hospital E/M services within
the global period. The RUC recommended that CPT codes 57240 (Anterior
colporrhaphy, repair of cystocele with or without repair of
urethrocele), 57250 (Posterior colporrhaphy, repair of rectocele with
or without perineorrhaphy), 57260 (Combined anteroposterior
colporrhaphy), and 57265 (Combined anteroposterior colporrhaphy; with
enterocele repair) be referred to the CPT Editorial Panel. In September
2016, the CPT Editorial Panel revised 57240, 57260 and 57265 to
preclude separate reporting of follow up cystourethroscopy after
colporrhaphy (CPT code 52000).
For CY 2018, we are proposing the RUC-recommended work RVUs for CPT
code 57240 (a work RVU of 10.08), CPT code 57250 (a work RVU of 10.08),
CPT code 57260 (a work RVU of 13.25), and CPT code 57265 (a work RVU of
15.00).
We note that there were changes in service times reflected in the
specialty surveys compared to the RUC-recommended work RVUs for CPT
code 57240. Specifically, we note that the RUC recommended a 48 minute
decrease in total time, compared to the specialty survey total time of
259 minutes. The difference in total time reflected a decrease in
preservice time (29 minutes) and inpatient visits (0.5 visits = 19
minutes). We considered a work RVU of 9.77 for CPT code 57240,
crosswalking to CPT code 50590 (Lithotripsy, extracorporeal shock
wave), which has similar service times. We are seeking comment on
whether CPT code 57250 would be a relevant comparator for CPT code
57240, based on the described elements of each service and existing or
surveyed service times, compared to CPT code 57240.
We considered a work RVU of 11.47 for CPT code 57265, crosswalking
to CPT code 47563 (Laparoscopy, surgical; cholecystectomy with
cholangiography) with similar service times. We seek comment on how an
alternative work RVU of 11.47 for CPT code 57265 would affect
relativity among PFS services, and on whether CPT code 57260 is a
relevant comparator for CPT code 57265, considering differences in the
described procedures and service times.
We are proposing the RUC-recommended direct PE inputs for CPT codes
57240, 57250, 57260 and 57265 without refinements.
(24) Nerve Repair With Nerve Allograft (CPT Codes 64910, 64911, 64X91
and 64X92)
The CPT Editorial Panel created two new CPT Category I codes (64X91
and 64X92) to report the repair of a nerve using a nerve allograft. CPT
codes 64910 and 64911 were also reviewed as part of this code family.
CPT codes 64X91 and 64X92 will be placed on the new technology list to
be re-reviewed by the RUC in 3 years to ensure correct valuation and
utilization assumptions.
For CY 2018, we are proposing the RUC-recommended work RVUs for the
following codes: A work RVU of 10.52 for CPT code 64910, a work RVU of
14.00 for CPT code 64911, a work RVU of 12.00 for CPT code 64X91, and a
work RVU of 3.00 for CPT code 64X92.
We noted a decrease in preservice time (7 minutes) for CPT code
64910 and considered an alternate work RVU of 10.15, crosswalking to
CPT code 15120 (Split-thickness autograft, face, scalp, eyelids, mouth,
neck, ears, orbits, genitalia, hands, feet, and/or multiple digits;
first 100 sq cm or less, or 1 percent of body area of infants and
children (except 15050)), which has similar service times. We seek
comments on whether an alternative work RVU of 10.15 for CPT code 64910
would better reflect relativity among PFS services with similar service
times.
For CPT code 64911 (Nerve repair; with autogenous vein graft
(includes harvest of vein graft), each nerve)), we considered a work
RVU of 13.50, crosswalking to CPT code 31591 (Laryngoplasty,
medicalization, unilateral), which has similar service times. We seek
comments on whether a work RVU of 13.50 for CPT code 64911 would better
reflect relativity among other PFS services with similar service times.
The new coding structure for these services increases granularity
by including add-on codes that describe each strand of nerve repair.
While we recognize that additional granularity may be important and
useful for purposes of data collection, the advantages to Medicare for
such granularity for purposes of payment are unclear, especially since
we are unaware of a payment-related reason for such coding complexity.
We considered proposing a bundled status to the new add-on codes and
incorporating the relative resources in furnishing the add-on code (CPT
code 64X92) into the base code (CPT code 64X91) based on the
utilization assumptions that accompanied the RUC recommendations. The
RUC estimated that CPT code 64X91 would have 750 Medicare allowed
services in CY 2018, and that the corresponding add-on CPT code 64X92
would have 150 Medicare allowed services in CY 2018. Therefore, the RUC
estimates that CPT code 64X91 will be billed without add-on CPT code
64X92 for 80 percent (750/900) of the Medicare allowed services, and
that CPT code 64X91 will be billed with add-on CPT code time 64X92 for
20 percent (150/900) of the Medicare allowed services in CY 2018. To
account for the additional work involved in 20 percent of the allowed
services, we added a work RVU of 0.60 (20 percent of a work RVU of 3.00
for CPT code 64X92) to the work RVU of 12.00 for CPT code 64X91, to get
to an alternate work RVU of 12.60 for CPT code 64X91 and increased the
intraservice time by 6 minutes to account for the bundling of services
from CPT code 64X92. The alternative work RVU of 12.60 would have been
further supported by a crosswalk to CPT code 14301 (Adjacent tissue
transfer or rearrangement, any area; defect 30.1 sq cm to 60.0 sq cm),
which has similar intraservice and total times.
We are proposing the RUC-recommended direct PE inputs for CPT codes
64910, 64911, 64X91 and 64X92 without refinements.
(25) CT Soft Tissue Neck (CPT Codes 70490, 70491, and 70492)
CPT codes 70490 and 70492 were identified through the high
expenditure services across specialties with Medicare allowed charges
of $10 million or more screen. CPT code 70491 was also included for
review as part of this code family. For CY 2018, we are proposing the
RUC-recommended work RVUs of 1.28 for CPT code 70490, 1.38
[[Page 34001]]
for CPT code 70491, and 1.62 for CPT code 70492.
For CPT code 70490, we considered a work RVU of 1.07 based on a
crosswalk to CPT code 72125 (Computed tomography, cervical spine;
without contrast material). CPT code 72125 is a non-contrast CT service
on a similar anatomical area and has identical intraservice and total
times to those recommended by the RUC for CPT code 70490. We also
considered work RVUs of 1.17 for CPT code 70491 and 1.41 for CPT code
70492. We are seeking comment on how relativity among other CT services
paid under the PFS would be affected by applying the alternative work
RVUs described above for CPT codes in this family.
(26) Magnetic Resonance Angiography (MRA) Head (CPT Codes 70544, 70545,
and 70546)
CPT code 70544 was identified by a screen of services across
specialties with Medicare allowed charges of $10 million or more.
Subsequently, CPT codes 70545 and 70546 were also reviewed as part of
this code family. We are proposing the RUC-recommended work RVUs of
1.20 for CPT code 70544, 1.20 for CPT code 70545, and 1.48 for CPT code
70546.
We are also proposing the following refinements to the RUC-
recommended direct PE inputs. For the service period clinical labor
activity ``Provide preservice education/obtain consent,'' we are
proposing 5 minutes for CPT code 70544, 7 minutes for CPT code 70545,
and 7 minutes for CPT code 70546 so that the times for this activity
are consistent with other magnetic resonance (MR) services performed
without-contrast materials, with-contrast materials, and without-and-
with contrast materials, respectively. For the clinical labor task
``Acquire images,'' we are proposing to use the RUC-recommended
clinical time of 26 minutes for CPT code 70544. We considered proposing
20 minutes of clinical time to maintain the relativity among the three
codes in this family and for consistency with other MRA and magnetic
resonance imaging (MRI) codes, which do not typically assign more
clinical labor time to this task for services without contrast material
than for services with contrast material. We seek comments as to the
appropriate time value for this clinical labor task.
(27) Magnetic Resonance Angiography (MRA) Neck (CPT Codes 70547, 70548,
and 70549)
CPT code 70549 was identified through a high expenditure screen.
CPT codes 70547 and 70748 were also reviewed as part of this family of
codes. We are proposing the RUC-recommended work RVUs of 1.20 for CPT
code 70547, 1.50 for CPT code 70548, and 1.80 for CPT code 70549.
We are also proposing several refinements to the RUC-recommended
direct PE inputs for these services. For the service period clinical
labor activity ``Provide preservice education/obtain consent'', we are
proposing 5 minutes for CPT code 70547, 7 minutes for CPT code 70548,
and 7 minutes for CPT code 70549 so that the times for this activity
are consistent with other MR services performed without contrast
material, with contrast material, and without-and-with contrast
material, respectively.
For the intraservice clinical labor task acquire images, for CPT
code 70547, we are proposing to use the RUC-recommended 26 minutes. We
considered applying 20 minutes to this clinical labor task, which would
have maintained consistency with the 20 minutes recommended by the RUC
for CPT code 70548 (the service that includes with-contrast material).
We are concerned about the lack of evidence that a non-contrast MRA
would require more clinical labor time than the with-contrast MRA
service. We are seeking comment as to the appropriate time value for
this clinical labor task.
(28) CT Chest (CPT Codes 71250, 71260, and 71270)
CMS identified this code family through the high expenditures
screen. We are proposing the RUC-recommended work RVUs of 1.16 for CPT
code 71250, 1.24 for CPT code 71260, and 1.38 for CPT code 71270.
For CPT code 71250, we considered maintaining the CY 2017 work RVU
of 1.02. We are concerned with the lack of evidence that the physician
time or intensity of furnishing this service has changed since it was
last valued. In addition, a comparison to other CT codes indicates that
the RUC-recommended work values could be overvalued relative to other
CT services and compared to similar, non-contrast CT studies such as
CPT codes 72131 (Computed tomography, lumbar spine; without contrast
material) and 73700 (Computed tomography, lower extremity; without
contrast material), both of which have work RVUs of 1.00.
For CPT code 71260, we considered proposing a work RVU of 1.10 by
applying the RUC-recommended increment between CPT code 71250 and 71260
(0.08) to CPT code 71260. For CPT code 71270, we considered a work RVU
of 1.24 by applying the RUC-recommended increment between CPT codes
71260 and 71270 (0.22) to CPT code 71270. In addition to maintaining
relatively among the codes in this family, we considered further
supporting these alternative values based on a comparison to other CT
studies, such as with-contrast material CT studies, and without-and-
with contrast CT studies.
While we have concerns about the RUC-recommended work RVUs for
these codes, for CY 2018, we are proposing the RUC recommended work
RVUs for CPT code 71250, 71260, and 71270 and are seeking comment on
whether our alternative values would improve relativity.
(29) MRI of Abdomen and Pelvis (CPT Codes 72195, 72196, 72197, 74181,
74182, and 74183)
CPT codes 74182 and 72196 were identified as part of the screen of
high expenditure services across specialties with Medicare allowed
charges of $10 million or more. CPT codes 74181, 74183, 72195, and
72197 were also reviewed as part of this code family. We are proposing
the RUC-recommended work RVUs of 1.46 for CPT code 72195, 1.73 for CPT
code 72196, 2.20 for CPT code 72197, 1.46 for CPT code 74181, 1.73 for
CPT code 74182, and 2.20 for CPT code 74183.
While we are proposing the RUC-recommended direct PE inputs, we
considered 30 minutes for clinical labor task ``Acquire images'' for
CPT codes 74181 and 74182, which appears to be more consistent with the
codes in this family and more consistent with other MR codes. We also
note that for CPT codes 74181 and 74182, the clinical labor time for
acquired images appears to have been developed through a consensus
panel from the specialty society over 15 years ago. Given that these
times are estimates based on expert panel consensus rather than survey
data, we seek comments on whether using a structure that matches other
MR code families would be more appropriate to value these clinical
labor times.
(30) MRI Lower Extremity (CPT Codes 73718, 73719, and 73720)
CPT codes 73718 and 73720 were identified as part of the screen of
high expenditure services, and CPT code 73719 was included for review
as part of the code family. We are proposing the RUC-recommended work
RVUs of 1.35 for CPT code 73718, 1.62 for CPT code 73719, and 2.15 for
CPT code 73720.
We are also proposing the following refinements to the RUC-
recommended direct PE inputs. For the service period clinical labor
activity ``Provide preservice education/obtain consent,''
[[Page 34002]]
we are proposing 5 minutes for CPT code 73718, 7 minutes for CPT code
73719, and 7 minutes for CPT code 73720. Likewise, for the service
period task ``Prepare room, equipment, supplies,'' we are proposing 3
minutes for CPT code 73718, 5 minutes for CPT code 73719, and 5 minutes
for CPT code 73720. We are proposing these changes to maintain
consistency with other MR services without contrast materials, with
contrast materials, and without-and-with contrast materials,
respectively.
(31) Abdominal X-ray (CPT Codes 74022, 740X1, 740X2, and 740X3)
CPT codes 74000 (Radiologic examination, abdomen; single
anteroposterior view) and 74022 (Radiologic examination, abdomen;
complete acute abdomen series, including supine, erect, and/or
decubitus views, single view chest) were identified via a high
expenditure screen. The CPT Editorial Panel created CPT codes 740X1,
740X2, and 740X3 to replace CPT codes 74000, 74010, and 74020. For CY
2018, we are proposing the RUC-recommended work values for these codes.
As part of their recommendations, the RUC's utilization crosswalk
suggests that 25 percent of services currently reported with CPT code
74010 will be reported with CPT code 740X2 and 75 percent will be
reported with CPT code 740X3; and 75 percent of services currently
reported with CPT code 74020 will be reported with CPT code 740X2 and
25 percent will be reported with CPT code 740X3. However, we did not
identify evidence or a rationale for these assumptions. For purposes of
calculating the proposed RVUs, we used an even distribution of services
previously reported as CPT codes 74010 and 74020 to CPT codes 740X2 and
740X3 instead of the RUC-recommended distribution because we think that
the services previously reported with codes 74010 and 74020 will be
reported in equal volume between the code representing two views and
the code representing three views. We seek comment on information that
would help us improve on this distribution for purposes of developing
final RVUs, including rationale for the distribution reflected in the
RUC's utilization crosswalk.
(32) Angiography of Extremities (CPT Codes 75710 and 75716)
This code family was identified through the $10 million or more
screen of high expenditure services. We are proposing the RUC-
recommended work RVUs of 1.75 for CPT code 75710 and 1.97 for CPT code
75716. We are also proposing to use the RUC-recommended direct PE
inputs for both CPT codes 75710 and 75716, with the following
refinements. For the clinical labor task ``Technologist QC's images in
PACS, checking for all images, reformats, and dose page,'' we are
proposing refinements consistent with the standard clinical labor times
for tasks associated with the PACS Workstation.
We are also proposing to refine the clinical labor by removing the
2 minutes associated with the task ``prepare room, equipment, and
supplies.'' CPT codes 75710 and 75716, which represent radiological
supervision and interpretation, are billed with codes that include
activities such as needle placement and imaging, and the ``prepare
room, equipment, supplies,'' activity will be accounted for with the
codes that are billed with these interpretation codes.
(33) Ophthalmic Biometry (CPT Codes 76516, 76519, and 92136)
In the CY 2016 PFS final rule with comment period, CMS identified
CPT codes 76519 and 92136 as potentially misvalued on the high
expenditure screen. For CY 2018, we are proposing the RUC-recommended
work RVUs for each code in this family as follows: A work RVU of 0.40
for CPT code 76516, a work RVU of 0.54 for CPT code 76519, and a work
RVU of 0.54 for CPT code 92136.
For both CPT codes 76519 and 92136, the RUC recommended adding an
additional 8 minutes of immediate postservice time for dictating the
report of the procedure for the medical record, review and sign report,
communicate results to the patient, discussing lens implant options for
desired post-operative refractive result, and entering an order for the
intraocular lens implant. We considered time and work values that would
not include the additional 8 minutes of immediate postservice time in
either of these codes, due to the concern that the additional time may
not reflect the typical case. Were we to not include those 8 minutes,
each of these procedures would have a total time of 14 minutes. We
considered applying the total time ratio (decrease from 17 minutes to
14 minutes; ratio of 0.824) to the RUC-recommended work RVU of 0.54,
which would have resulted in a work RVU of 0.44 for both CPT codes
76519 and 92136. We are seeking comment on whether these alternative
values would improve relativity.
(34) Ultrasound of Extremity (CPT Codes 76881 and 76882)
The RUC identified CPT codes 76881 and 76882 for review of PE
inputs. For CPT code 76881, we are proposing the recommended inputs
with refinements. We are proposing to remove 1 minute from the clinical
labor task ``Exam documents scanned into PACS. Exam completed in RIS
system to generate billing process and to populate images into
Radiologist work queue,'' because this code does not include any
equipment time for the PACS workstation proxy or professional PACS
workstation. We note that the RUC-recommended inputs shift the general
ultrasound room from the PE inputs for CPT code 76881 to the PE inputs
for CPT code 76882. We are proposing to make this change, consistent
with the RUC recommendations. We are also seeking comment on whether a
portable ultrasound unit would be a more accurate PE input for both
codes, given that the dominant specialty for both of these services is
podiatry based on available 2016 Medicare claims data. However, we are
proposing that these codes would not be subject to the phase-in of
significant RVU reductions given the significance of this shift of
resource costs between codes in the same family. In the CY 2016 PFS
final rule (80 FR 70927 through 70931), we finalized a policy to
identify services that are not subject to the phase-in because they are
new or revised codes. We excluded as new and revised codes those codes
that describe a different set of services in the update year when
compared to the current year by virtue of changes in other related
codes or codes that are part of a family with significant coding
revisions. Significant coding revisions within a family of codes can
change the relationships among codes to the extent that it changes the
way that all services in the group are reported, even if some
individual codes retain the same number or, in some cases, the same
descriptor. Moving the general ultrasound room input from CPT code
76881 to CPT code 76882 as recommended by the RUC would represent a
significant shift in direct PE due to the high cost nature of this
equipment item. As a result, these codes describe different services in
the update year than in the current year, producing a substantial
revision in the valuation of the coding. We are seeking comment on this
proposed application of the phase-in policy.
(35) Radiation Therapy Planning (CPT Codes 77261, 77262, and 77263)
CPT code 77263 was identified through a screen of high expenditure
services across specialties. CPT codes 77261 and 77262 were included
for review. For CY 2018, we are proposing the RUC-recommended work RVUs
of
[[Page 34003]]
1.30 for CPT code 77261, 2.00 for CPT code 77262, and 3.14 for CPT code
77263.
However, we have concerns regarding the RUC-recommended work RVUs
given the decreases in service times as recommended by the RUC and
reflected in the survey data compared to the current values. For CPT
code 77263, we considered a work RVU of 2.60 based on a crosswalk to
CPT code 96111 (Developmental testing, (includes assessment of motor,
language, social, adaptive, and/or cognitive functioning by
standardized developmental instruments) with interpretation and
report), which has an identical intraservice time, and similar total
time to the RUC-recommended time values for CPT code 77263. We are
concerned that despite a 15 minute decrease in intraservice time, the
RUC did not recommend a work RVU decrease.
We note that the majority of the utilization among the codes in
this family would be reported with CPT code 77263. Therefore, we
considered using a work RVU of 2.60 for CPT code 77263 as a base for
alternative valuations for CPT codes 77261 and 77262 by applying the
ratio of the crosswalk work RVU of CPT code 96111 (Developmental test
extend) to the RUC-recommended work RVU of CPT code 77263 (that is,
2.60/3.14 = 0.83) to the RUC-recommended work RVU for CPT code 77261
(that is, 0.83 x 1.30 = 1.08) and CPT code 77262 (that is, 0.83 x 2.0 =
1.66), which would have resulted in work RVUs of 1.08 for CPT code
77261 and 1.66 for CPT code 77262. We seek comments on whether the
alternative valuation would be more appropriate for these codes.
(36) Pathology Consultation during Surgery (CPT Codes 88333 and 88334)
CPT codes 88333 and 88334 were surveyed for both work and PE for
the CY 2018 rule cycle. We are proposing the RUC-recommended work RVU
of 1.20 for CPT code 88333 and the RUC-recommended work RVU of 0.73 for
CPT code 88334. For the direct PE inputs, we are proposing to remove
the clinical labor for the ``Prepare room. Filter and replenish stains
and supplies (including setting up grossing station with colored
stains)'' activity from CPT code 88333. This clinical labor is not
currently included in the direct PE inputs for CPT code 88333, and we
continue to believe that this is a form of indirect PE that is not
individually allocable to a particular patient for a particular
service. While we agree that replenishing stains and supplies is a
necessary task, under the established methodology, it is more
appropriately classified as indirect PE.
We are proposing to refine the clinical labor time for ``Clean
room/equipment following procedure'' activity for CPT code 88333,
consistent with the standard clinical labor time assigned for room
cleaning when used by laboratory services. We seek comments related to
the equipment time assigned to the ``grossing station w-heavy duty
disposal'' (EP015) for both CPT codes 88333 and 88334. Although the
recommended equipment time of 10 minutes maintains the current
equipment time assigned to the grossing station, and we have no reason
to believe that this time is incorrect, it is unclear to us how this
equipment time is derived.
(37) Tumor Immunohistochemistry (CPT Codes 88360 and 88361)
CPT codes 88360 and 88361 appeared on a high expenditure services
screen across specialties with Medicare allowed charges of over $10
million. We are proposing the RUC-recommended work RVU of 0.85 for CPT
code 88360 and the RUC-recommended work RVU of 0.95 for CPT code 88361.
We are proposing to refine the clinical labor time for the ``Enter
patient data, computational prep for antibody testing, generate and
apply bar codes to slides, and enter data for automated slide stainer''
activity for both codes, consistent with the standard time for this
clinical labor activity across different pathology services. For CPT
code 88361, we are also proposing to remove the 1 minute of clinical
labor time from the ``Performing instrument calibration, instrument qc
and start up and shutdown'' and the ``Gate areas to be counted by the
machine'' activities. These clinical labor activities do not appear in
other recently reviewed computer-assisted pathology codes. We believe
that these clinical labor activities would not be typical for CPT code
88361 and are already included in the allocation of indirect PE
consistent with our established methodology.
We are proposing to remove the clinical labor time for ``Clean
room/equipment following procedure'' for CPT codes 88360 and 88361, as
we believe that this clinical labor is duplicative of the 4 minutes of
clinical labor assigned to ``Clean equipment and work station in
histology lab''. We are also proposing to remove the clinical labor
time for the ``Verify results and complete work load recording logs''
and the ``Recycle xylene from tissue processor and stainer'' activities
for CPT codes 88360 and 88361. As we have stated in previous rules,
such as in the CY 2017 PFS final rule (81 FR 80319), we believe these
clinical labor activities to be already included in the allocation of
indirect PE consistent with our established methodology.
We are proposing to refine the equipment time for the ``Benchmark
ULTRA auto slide prep & E-Bar Label system'' (EP112) from 18 minutes to
16 minutes for both codes. The RUC-recommended equipment time of 18
minutes was an increase of 3 minutes from the current EP112 equipment
time to incorporate the equipment time of the ``E-Bar II Barcode Slide
Label System'' (EP113), which the recommended materials have clarified
is part of the EP112 equipment item. We are proposing to add 1 minute
over the current value of 15 minutes to the EP112 equipment time to
reach the aforementioned 16 minutes, as we believe that this would be
more typical for the slide labeling taking place.
For CPT code 88361, we are proposing to maintain the current price
of $195,000.00 for the DNA image analyzer (EP001) equipment, as the
submitted invoice contains a series of unrelated items that have been
crossed out, making it difficult to determine the cost of the
equipment. We considered refining the equipment time for the DNA image
analyzer from 30 minutes to 5 minutes. The equipment literature for the
DNA image analyzer states that the machine can run 50 slides per hour,
and CPT code 88361 only requires 3 slides per procedure. This works out
to 3.6 minutes of equipment usage (3 slides divided by 50 slides per
hour multiplied by 60 minutes in an hour), to which we considered
adding 1 minute for preparing the slides. The resulting figure of 4.6
minutes would then round up to 5 minutes, which we considered as the
potential equipment time for EP001 assigned to CPT code 88361. We seek
comments on additional pricing information for the EP001 DNA image
analyzer equipment, specifically invoices solely for this equipment
containing a rationale for each component part, as well as the
appropriate equipment time typically required for use in CPT code
88361.
(38) Cardiac Electrophysiology Device Monitoring Services (CPT Codes
93279, 93281, 93282, 93283, 93284, 93285, 93286, 93287, 93288, 93289,
93290, 93291, 93292, 93293, 93294, 93295, 93296, 93297, 93298, and
93299)
As part of the CY 2016 PFS final rule (80 FR 70914), several
services in this family (reported with CPT codes 93288, 93293, 93294,
93295, and 93296) were identified as potentially misvalued through the
high expenditure by
[[Page 34004]]
specialty screen. Seven of the 21 services in this family involve
remote monitoring of cardiovascular devices, and two of these services
(reported with CPT codes 93296 and 93299) are valued for practice
expense only. For CY 2018, we are proposing the RUC-recommended work
RVUs for the 19 CPT codes in this family that are valued with physician
work as follows: 0.65 for CPT code 93279, 0.77 for CPT code 93280, 0.85
for CPT code 93281, 0.85 for CPT code 93282, 1.15 for CPT code 93283,
1.25 for CPT code 93284, 0.52 for CPT code 93285, 0.30 for CPT code
93286, 0.45 for CPT code 93287, 0.43 for CPT code 93288, 0.75 for CPT
code 93289, 0.43 for CPT code 93290, 0.37 for CPT code 93291, 0.43 for
CPT code 93292, 0.31 for CPT code 93293, 0.60 for CPT code 93294, 0.74
for CPT code 93295, 0.52 for CPT code 93297, and 0.52 for CPT code
93298.
For CPT code 93293, we considered a work RVU of 0.91 (25th
percentile survey result) and seek comment on whether this alternative
work RVU for this service would better maintain relativity between
single and dual lead pacemaker systems and cardioverter defibrillator
services. We considered reducing the work RVU for CPT code 93282 by
0.11 work RVUs and seek comments on whether this alternative value
would better reflect relativity between the single and dual lead
systems that exist within pacemaker services and within cardioverter
defibrillator services. We also noted that there is a difference of
0.10 work RVUs between the RUC-recommended values for CPT codes 93289
and 93282. Therefore, we considered a proportionate reduction for CPT
code 93289 to a work RVU of 0.69. For CPT code 93283, we considered a
work RVU of 0.91, consistent with the 25th percentile from the survey
results, and seek comment on whether this value would improve
relativity.
As noted in this section of the proposed rule, several of the CPT
codes (99392, 99294, 99295, 99297, and 99298) reviewed by the RUC in
January 2017 involve remote monitoring services for cardiac devices. We
agree with the RUC that these services are difficult to value
considering that the monitoring duration (number of days between 30 and
90) and the average number of transmissions vary. We also note that
these codes were surveyed twice, and in both cases the intraservice and
total times were considered by the specialty societies to be
inconsistent with existing times. The RUC explained that they
extrapolated total and intraservice time data for these codes and
warned against making comparisons. Without additional information about
the methods and sources used for extrapolation, however, we have no
basis for assuming the imputed values are of higher quality and/or
accuracy than those from the survey. We do not agree, therefore, that
survey results should not be used as a point of comparison in the
context of other factors, particularly when they are used to support
other considerations.
Although we are proposing the RUC-recommended work RVUs for each of
these CPT codes, we considered alternative values. The RUC recommended
a work RVU of 0.31 for CPT code 93293, which is 0.01 work RVUs lower
than the existing work RVU for this code. We have concerns that the
amount of the reduction in the work RVU recommended by the RUC may not
be consistent with the decrease in total time of 7 minutes. We
considered an alternative crosswalk for CPT code 93293 (Pm phone r-
strip device eval) (5 minutes intraservice time and 13 minutes total
time) to CPT code 94726 (Pulm funct tst plethysmograp), which has 5
minutes intraservice time and 15 minutes total time and a work RVU of
0.26. We seek comments our proposed and alternative valuations for this
code.
For CPT code 93294, we considered a work RVU of 0.55, crosswalking
from CPT code 76706 (Us abdl aorta screen aaa), and we seek comments on
whether it would better align with the RUC-recommended service times.
We are concerned that a work RVU of 0.60 may not account for the
difference between existing service times and the RUC-recommended
service times. Similarly, the RUC recommended a work RVU for CPT code
93294 of 0.60, which is 0.05 work RVUs less than the existing work RVU.
The total time for furnishing services reported with CPT code 93294
decreased by 10 minutes, however, and we believe this reduction in time
may not be appropriately reflected by a decrease of 0.05 work RVUs.
Compared to services with similar total and intraservice times, we
identified CPT code 76706 (Us abdl aorta screen aaa) as potentially a
more appropriate crosswalk. CPT code 76706 has identical intraservice
and total service times as CPT code 93294, with a work RVU of 0.55. We
seek comments on whether our alternative value would better reflect the
time and intensity involved in furnishing this service.
For CPT code 93295, we considered a work RVU of 0.69, crosswalking
to CPT code 76586, which has identical intraservice and total times
compared to CPT code 93295. We considered using a work RVU of 0.69 to
maintain the differential between CPT code 93295 and the work RVU we
considered for the previous code in this family (a work RVU of 0.11 for
CPT code 93295). We are concerned about the decrease in service time
compared to the work RVU. We note that the existing intraservice time
is 22.5 minutes, compared to the RUC-recommended intraservice time of
10 minutes. We seek comments on whether our alternative value would
better reflect the time and intensity involved in furnishing this
service.
For CPT code 93298, the RUC recommended a work RVU of 0.52, which
is unchanged from the current work RVU for this code. We are concerned
about that recommendation given the reduction in both intraservice and
total time for this service. The intraservice time decreased from 24 to
7 minutes, while total time decreased from 44 to 17 minutes. We
acknowledge that the current times for this CPT code and others in this
family are extrapolations. However, without additional information
about the extrapolation of data from survey results, we question
whether the survey results should be excluded from consideration
altogether. We considered a work RVU of 0.37 for CPT code 93297,
crosswalking to CPT code 96446 (Chemotx admn prtl cavity). We also
considered a work RVU of 0.37 for CPT code 93298 based on a crosswalk
to CPT code 96446, since the RUC indicated that the work RVUs for CPT
codes 93297 and 93298 should be the same. We are seeking comment on our
proposed valuation and whether our alternative valuation would be more
appropriate for this code.
We propose the RUC-recommended direct PE inputs with the following
refinements. We propose to remove 2 minutes for ``review charts'' from
CPT codes 93279, 93281, 93282, 93283, 93284, 93285, 93286, 93287,
93288, 93289, 93290, 93291, and 93292 to maintain relativity since it
is not typically incorporated for similar PFS codes. We also propose
removing 2 minutes for ``complete diagnostic forms, lab & X-ray
requisitions'' for the labor category ``med tech/asst'' (L026A) for
these services because we believe the same activity is being performed
by labor category RN/LPN/MTA (L037D). We seek comments regarding
whether this row was included in error. Also for the same group of CPT
codes, we also propose standard refinements for the time for equipment
items EF023 and EQ198.
We propose to use the RUC-recommended direct practice expense
inputs and times for all other CPT codes in this family (CPT codes
93293, 93294,
[[Page 34005]]
93295, 93296, 93297, 93298, and 93299) without refinement.
(39) Transthoracic Echocardiography (TTE) (CPT Codes 93306, 93307, and
93308)
In the CY 2016 PFS final rule with comment period (80 FR 70914),
CMS identified CPT code 93306 through the high expenditures screen.
Subsequently, the RUC reviewed CPT codes 93307 and 93308, in addition
to CPT code 93306 as part of this family of codes that describe
transthoracic echocardiograms. For CY 2018, we are proposing the RUC-
recommended work RVUs for CPT codes 99306 (a work RVU of 1.50), 99307
(a work RVU of 0.92), and 99308 (a work RVU of 0.53), and proposing the
RUC-recommended direct PE inputs for CPT codes 93306, 93307, and 93308
without refinement.
For CPT code 93306 (Echocardiography, transthoracic, real-time with
image documentation (2D), includes M-mode recording, when performed,
complete, with spectral Doppler echocardiography, and with color flow
Doppler echocardiography), we considered maintaining the CY 2017 work
RVU of 1.30. The surveyed total time for this code dropped slightly due
to changes in the immediate postservice time. The median preservice and
intraservice time remained unchanged.
For CPT code 93307 (Echocardiography, transthoracic, real-time with
image documentation (2D), includes M-mode recording, when performed,
complete, without spectral or color Doppler echocardiography), we
considered a work RVU of 0.80, crosswalking to services with similar
service times (CPT codes 93880 (Extracranial bilat study), 93925 (Lower
extremity study), 93939, 93976 (Vascular study), and 93978 (Vascular
study)). The surveyed total time dropped 3 minutes (from the
intraservice time) compared to the existing service times for this
code.
For CPT code 93308 (Echocardiography, transthoracic, real-time with
image documentation (2D), includes M-mode recording, when performed,
follow-up or limited study), we considered a work RVU of 0.43,
crosswalking to CPT code 93292 (Wcd device interrogate) based on
similar service times. The surveyed total time dropped by 5 minutes
(from the intraservice time) compared to the existing service times for
this code.
For CY 2018, we are proposing the RUC-recommended work RVUs for CPT
codes 93306, 93307, and 93308 and seek comments on whether our
alternative values would better reflect the time and intensity of these
services.
(40) Stress Transthoracic Echocardiography (TTE) Complete (CPT Codes
93350 and 93351)
CPT code 93351 was identified as potentially misvalued and the RUC
reviewed CPT code 93350 as part of the same code family. For CY 2018,
we are proposing the RUC-recommended work RVUs for CPT codes 93350 (a
work RVU of 1.46) and 93351 (a work RVU of 1.75).
We are proposing the following refinements to the RUC-recommended
direct PE inputs for CPT codes 93350 and 93351. For both codes, we
applied the standard formula in developing the minutes for equipment
item ED053 (professional PACS workstation), which results in 18 minutes
for CPT code 93350 and 25 minutes for CPT code 93351. We are also
proposing standard clinical labor times for providing preservice
education/obtaining consent. We are not proposing to include clinical
labor time for the task setup scope since there is no scope used in the
procedure and we do not agree with the RUC's statement that this
replicates 5 minutes in CPT code 93015 when the RN prepares patients
for 10-lead ECG. We have found that there is no corresponding time of 5
minutes for setup scope in the PE inputs for CPT code 93015. We are
proposing refinements to the equipment time for ED050 (PACS workstation
proxy) for CPT code 93351, consistent with our standard equipment times
for PACS Workstation Proxy.
(41) Peripheral Artery Disease (PAD) Rehabilitation (CPT Code 93668)
We have issued a national coverage determination (NCD) for Medicare
coverage of supervised exercise therapy (SET) for the treatment of
peripheral artery disease (PAD). Information regarding the NCD can be
found on the CMS Web site at https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=287. For the remainder of
CY 2017, we anticipate that CPT code 93668, currently assigned PROCSTAT
N (noncovered service by Medicare), will be payable before the end of
CY 2017, retroactive to the effective date of the NCD to implement
payment under the NCD.
For CY 2018, we are proposing to make payment for Medicare-covered
SET for the treatment of PAD, consistent with the NCD, reported with
CPT code 93668. For CPT code 93668, we are proposing to use the most
recent RUC-recommended work and direct PE inputs. We are also seeking
comment on the coding structure and valuation assumptions. Since the
RUC has not reviewed CPT code 93668 since 2001, we seek comments on the
direct PE inputs assigned to the code, which appear in the direct PE
input database. We also note that CPT code 93668 is a PE only code and
does not include physician work.
CPT prefatory language states that CPT code 93668 may be separately
reported with appropriate E/M services, including office and/or
outpatient services (CPT codes 99201 through 99215), initial hospital
care (CPT codes 99221 through 99223), subsequent hospital care (CPT
codes 99231 through 99233), and critical care services (CPT codes 99291
through 99292). Our understanding of CPT's prefatory language is that
these E/M codes may only be billed when review or exam of the patient
is medically indicated and must conform to all existing E/M
documentation requirements. E/M visit codes should not be billed to
account for supervision of SET for the treatment of PAD by a physician
or other qualified healthcare practitioner. We seek comments on whether
to develop professional coding to reflect the supervision of clinical
staff, and on the potential overlap with CPT code 99211 (Office or
other outpatient visit for the evaluation and management of an
established patient, that may not require the presence of a physician
or other qualified health care professional. Usually, the presenting
problem(s) are minimal. Typically, 5 minutes are spent performing or
supervising these services.) and any distinctions between time spent by
clinical staff for CPT code 99211 and time spent by clinical staff for
CPT code 93668.
(42) Pulmonary Diagnostic Tests (CPT Codes 94621, 946X2, and 946X3)
CPT code 94620 was identified as part of a screen of high
expenditure services with Medicare allowed charges of $10 million or
more that had not been recently reviewed. CPT code 94621 was added to
the family for review. The CPT Editorial Panel deleted CPT code 94620
and split it into two new codes, CPT codes 946X2 and 946X3, to describe
two different tests commonly performed for evaluation of dyspnea. We
are proposing the RUC-recommended work RVUs of 1.42 for CPT code 94621,
0.70 for CPT code 946X2, and 0.48 for CPT code 946X3.
We are proposing to refine the clinical labor time for the
``Provide preservice education/obtain consent'' activity from 10
minutes to 5 minutes for CPT code 94621, which is the current time
assigned for this task. While we agree that CPT code 94621 requires
additional time above the standard for this clinical
[[Page 34006]]
labor activity, we do not believe that double the current time would be
typical for this procedure. We are also proposing to refine the
clinical labor time for the ``Prepare and position patient/monitor
patient/set up IV'' activity from 5 minutes to 3 minutes for the same
code. The standard time for this activity is 2 minutes, and we are
proposing a value of 3 minutes to reflect 1 minute of additional
preparation time above the standard. We believe that additional
clinical labor time used for preparation would be included under the 10
minutes assigned to the ``Prepare room, equipment, supplies'' activity
for this code.
We are proposing to refine the clinical labor time for the
``Complete diagnostic forms, lab & X-ray requisitions'' activity,
consistent with the standard clinical labor time for this activity. We
also propose to refine the equipment times for CPT codes 94621 and
946X2 to account for 1:4 patient monitoring time, and to refine the
equipment times for CPT code 946X3 consistent with standards for non-
highly technical equipment.
We considered refining the clinical labor time for the ``pre
exercise ECG, VC, Min Vent. Calculation'' activity from 27 minutes to
15 minutes for CPT code 94621. We considered proposing this value of 15
minutes based on assigning 5 minutes apiece for the ECG, the MVV, and
the spirometry. We believe that each of these three components of this
clinical labor activity would typically take no longer than 5 minutes
based on a comparison to the use of these tasks in other CPT codes. We
also considered refining the clinical labor time for the ``Clinical
staff performs procedure'' activity from 55 minutes to 35 minutes for
CPT code 946X2 and from 14 minutes to 12 minutes for CPT code 94621.
The RUC-recommended materials for the PE inputs state that this
clinical labor task consists of performing 5 spirometries at 9 minutes
each plus 10 minutes of exercise time for CPT code 946X2; we believe
that the spirometries typically take 5 minutes each, which would reduce
this activity from 55 minutes to 35 minutes. For CPT code 94621, we
considered maintaining the current value of 12 minutes due to a lack of
justification for increasing the time to 14 minutes.
While we remain concerned about the intraservice period clinical
labor times, for CY 2018, we are proposing the RUC-recommended work
RVUs for each code in this family and seek comment on whether our
alternative clinical labor times would better reflect the work and
times for these services.
(43) Percutaneous Allergy Skin Tests (CPT Code 95004)
In the CY 2016 PFS proposed rule (80 FR 41706), CPT code 95004 was
identified through the high expenditures screen as potentially
misvalued. The RUC suggested in its comments on the CY 2016 PFS
proposed rule (80 FR 41706), that CPT code 95004 should be removed from
the list of potentially misvalued codes because it has a work RVU of
0.01 and that it would serve little purpose to survey physician work
for this code. The RUC and CMS previously determined that there is
physician work involved in providing this service since the physician
must interpret the test and prepare a report. In the CY 2016 PFS final
rule with comment period (80 FR 70913), CMS reiterated an interest in
the review of work and PE for this service. We note that our interest
in stakeholder review of a particular code should not be considered a
directive for survey under the RUC process. We intend to more clearly
state our interests in the future, so that under similar circumstances,
such effort need not be undertaken based on a mistaken impression. To
reiterate, we believe that whether or not a code should be surveyed in
response to our interest in receiving recommendations regarding the
work RVUs should be at the RUC and the specialties' discretion. In many
cases, we have used recommendations developed through means other than
surveys in developing RVUs. For example, for many PFS services, the
direct PE inputs are the primary drivers of overall RVUs and Medicare
payment. In most of these cases, the recommended inputs are not derived
from survey data. In some cases, especially for resource-intensive and
highly technical services, we have expressed some concern about the
lack of survey or other broad-based data that we have relied on in
developing rates across the PFS for many years.
For CY 2018, we are proposing the RUC-recommended work RVU of 0.01
for CPT code 95004.
Regarding direct PE inputs, we are proposing to refine the
equipment times for exam table (EF023) and mayo stand (EF015) to 79
minutes each to account for clinical 1:4 patient monitoring time. We
received invoices with new pricing information for two supplies: SH101
``negative control, allergy test'' ($5.17) and SH102 ``positive
control, allergy test'' ($26.12). Using this information, we are
proposing a price of $0.03 per test for supply item SH101 and a price
of $0.13 per test for supply item SH102.
(44) Continuous Glucose Monitoring (CPT Codes 95250 and 95251)
CPT codes 95250 (Ambulatory continuous glucose monitoring of
interstitial tissue fluid via a subcutaneous sensor for a minimum of 72
hours; sensor placement, hook-up, calibration of monitor, patient
training, removal of sensor, and printout of recording) and 95251
(Ambulatory continuous glucose monitoring of interstitial tissue fluid
via a subcutaneous sensor for a minimum of 72 hours; interpretation and
report) are used to report the technical and professional component for
continuous glucose monitoring. In April 2013, CPT code 95251 was
identified through the high volume growth services screen and
subsequently this code family was reviewed at the RUC's October 2016
meeting.
For CY 2018, we are proposing the RUC-recommended work RVU of 0.70
for CPT code 95251. However, we are concerned and seek comments on
whether the 2 minutes of physician preservice time is necessary. Since
CPT code 95251 is typically billed with an E/M service on the same day,
we believe the 2 minutes of preservice time may be duplicative.
Furthermore, we seek comment on whether it would be typical for the
physician to spend 2 minutes to obtain the CGM reports for review since
we believe the report would typically be obtained by clinical staff on
behalf of the physician.
For the direct PE inputs, the RUC submitted 19 invoices to update
the price of the medical supply item ``glucose monitoring
(interstitial) sensor'' (SD114) for CPT code 95250. We are proposing to
use these invoice prices for the glucose monitoring (interstitial)
sensor (SD114), with an average cost of $53.08. Therefore, we are
proposing to use the average price of $53.08 for this supply item.
As part of our review of this service, we obtained publicly
available pricing information for the CGM system (EQ125). We reviewed
the information provided in a study titled, ``The cost-effectiveness of
continuous glucose monitoring in type 1 diabetes,'' (Huang, SE.,
O'Grady, M., Basu, A. et al., Diabetes Care. June 2010), which
indicated the price of CGM technology (without sensors) from 3
different vendors, reflective of full retail prices with no insurer
discounts, to be $600.00, $1119.00, and $1250.00, which equated to an
average cost of $1016.00 for the CGM system. In addition, we obtained
publicly available pricing information for two vendors. This
information indicated the price of a
[[Page 34007]]
CGM system to be $1061.90 and $1279.17, which equated to an average
cost of $1170.54. For CY 2018, we are proposing to price supply items
SD114 at $53.08 and EQ125 at $1170.54. We seek comments on current
pricing for equipment item ``continuous glucose monitoring system''
(EQ125).
(45) Parent, Caregiver-Focused Health Risk Assessment (CPT Codes 96160
and 96161)
In the CY 2017 PFS final rule (81 FR 80330), we discussed that in
October 2015, the CPT Editorial Panel created two new PE-only codes,
CPT code 96160 (Administration of patient focused health risk
assessment instrument (e.g., health hazard appraisal) with scoring and
documentation, per standardized instrument) and CPT code 96161
(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). We assigned an
active payment status to both codes for CY 2017 and finalized use of
the RUC-recommended values for these codes. We also assigned an add-on
code status to both of these services. As add-on codes, CPT codes 96160
and 96161 describe additional resource components of a broader service
furnished to the patient that are not accounted for in the valuation of
the base code.
The RUC submitted updated recommendations for the direct PE inputs
for CPT codes 96160 and 96161 after reviewing new specialty society
surveys. The RUC recommended 7 total minutes of clinical staff time,
and we are proposing to adopt this number of minutes in valuing the
services. The PE worksheet included several distinct tasks with minutes
for each; however, in keeping with the standardization of clinical
labor tasks, we are proposing to designate all 7 minutes under
``administration, scoring, and documenting results of completed
standardized instrument'' rather than dividing the minutes into the
four categories as shown in the RUC recommendations.
(46) Chemotherapy Administration (CPT codes 96401, 96402, 96409, and
96411)
In the CY 2016 PFS proposed rule, CPT codes 96401 (Chemotherapy
administration, subcutaneous or intramuscular; non-hormonal anti-
neoplastic), 96402 (Chemotherapy administration, subcutaneous or
intramuscular; hormonal anti-neoplastic), 96409 (Chemotherapy
administration; intravenous, push technique, single or initial
substance/drug), and 96411 (Chemotherapy administration; intravenous,
push technique, each additional substance/drug (List separately in
addition to code for primary procedure)) were identified through the
high expenditure services screen across specialties with Medicare
allowed charges of over $10 million.
For CY 2018, we are proposing the RUC-recommended work RVUs for CPT
code 96401 (a work RVU of 0.21), CPT code 96402 (a work RVU of 0.19),
CPT code 96409 (a work RVU of 0.24) and CPT code 96411 (a work RVU of
0.20).
For CPT code 96402, we are proposing the RUC-recommended equipment
times with refinements for the biohazard hood (EP016) and exam table
(EF023) from 31 minutes to 34 minutes to reflect the service period
time associated with this code. We are proposing the RUC-recommended
direct PE inputs for CPT codes 96401, 96409, and 96411 without
refinements.
(47) Photochemotherapy (CPT Code 96910)
CPT code 96910 appeared on a high expenditure services screen
across specialties with Medicare allowed charges of over $10 million,
which is a PE-only code that does not have work RVUs.We are proposing
to refine the clinical labor time for the ``Provide preservice
education/obtain consent'' from 3 minutes to 1 minute for CPT code
96910. We believe that 1 minute would be typical for patient education,
as CPT code 96910 is a repeat procedure where there would not be a need
to obtain consent again. We are also proposing to remove the 2 minutes
of clinical labor for the ``Complete diagnostic forms, lab & X-ray
requisitions'' activity, as this item is considered indirect PE
consistent with our established methodology. We are also proposing to
create a new supply code (SB054) for the sauna suit, and proposing to
price at $9.99 based on the submitted invoice. Finally, we are also
proposing to adjust the equipment times to reflect changes in the
clinical labor for CPT code 96910.
We are proposing the RUC-recommended clinical labor time of 15
minutes for the ``Prepare and position patient/monitor patient/set up
IV'' activity, the RUC-recommended clinical labor time of 16 minutes
for the ``Monitor patient during procedure'' activity, and the RUC-
recommended clinical labor time of 15 minutes for the ``Clean room/
equipment by physician staff'' activity, but seeking additional
information regarding the rationale for these values. Given the lack of
explanation, we considered using the current clinical labor time of 7
minutes for the ``Prepare and position patient/monitor patient/set up
IV'' activity, the current clinical labor time of 4 minutes for the
``Monitor patient during procedure'' activity, and the current clinical
labor time of 10 minutes for the ``Clean room/equipment by physician
staff'' activity. We seek comment on whether maintaining the current
values would improve relativity.
We considered removing the ``Single Patient Discard Bag, 400 ml''
(SD236) supply and replacing it with the ``biohazard specimen transport
bag'' (SM008). We are concerned about whether the single patient
discard bag is the appropriate size for storing the sauna suit used in
this procedure, and whether use of a biohazard specimen transport bag
would be typical. We seek comments on our proposed and alternative
values for these direct PE inputs.
(48) Photodynamic Therapy (CPT Codes 96567, 96X73, and 96X74)
CPT code 96567 was identified as potentially misvalued through a
CMS screen for codes with high expenditures. This code describes a
service furnished by clinical staff and does not include physician
work. For CY 2018, the CPT Editorial Panel created two new codes, CPT
codes 96X73 and 96X74, to describe photodynamic therapy by external
application of light to destroy premalignant skin lesions, including
the physician work involved in furnishing the service. CPT codes 96567,
96X73, and 96X74 were reviewed during the RUC's January 2017 meeting.
For CY 2018, we are proposing the RUC-recommended work RVUs for CPT
code 96X73 (a work RVU of 0.48) and CPT code 96X74 (a work RVU of
1.01).
We are proposing the RUC-recommended PE inputs with refinements due
to inconsistencies between the stated description of clinical
activities and the submitted spreadsheets. First, we propose to add
assist physician clinical staff time to CPT codes 96X73 (10 minutes)
and 96X74 (16 minutes), which is equivalent to the physician
intraservice times for these services. For both CPT codes 96X73 and
96X74, we propose a reduction from 35 minutes to 17 minutes for
clinical activity in the postservice time, consistent with the
description of clinical work in the summary of recommendations, which
states that the patient receives activation of the affected area with
the BLU-U Photodynamic Therapy Illuminator for approximately 17
minutes. For CPT codes 96X73 and 96X74, we are
[[Page 34008]]
proposing to refine equipment formulas for two items: Power table
(EF031) and LumaCare external light with probe set (EQ169), consistent
with standards for nonhighly technical equipment. An explanation of the
standards and formulas for equipment related to direct PE inputs is in
the CY 2014 PFS final rule with comment period (79 FR 67557).
We identified several vendors with publically available prices
available for supply item LMX 4 percent cream (SH092) for significantly
less than the existing $1.60 per gram. Based on our research of
vendors, we are proposing to set the price of supply item SH092 to
$0.78 per gram. Other CPT codes affected by the proposed change in the
price of supply item LMX 4 percent cream (SH092) are: CPT code 46607
(Anoscopy; with high-resolution magnification (HRA) (eg, colposcope,
operating microscope) and chemical agent enhancement, with biopsy,
single or multiple), CPT code 17000 (Destruction (eg, laser surgery,
electrosurgery, cryosurgery, chemosurgery, surgical curettement),
premalignant lesions (eg, actinic keratoses); first lesion), CPT code
17003 (Destruction (eg, laser surgery, electrosurgery, cryosurgery,
chemosurgery, surgical curettement), premalignant lesions (eg, actinic
keratoses); second through 14 lesions, each (List separately in
addition to code for first lesion)), and CPT code 17004 (Destruction
(eg, laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical
curettement), premalignant lesions (eg, actinic keratoses), 15 or more
lesions)).
In addition, the RUC forwarded an invoice for a new supply item,
safety goggles, at $6.00 and requested three goggles each for CPT codes
96X73 and 96X74. Because we do not have a basis for distinguishing the
requested new goggles from the existing UV-blocking goggles, we
consider this invoice to be an additional price point for SJ027 rather
than an entirely new item. We propose a price of $4.10 for supply item
SJ027 (the average of the two prices for this supply item ($2.30 +
$6.00)/2=$4.10)). Other CPT codes affected by the proposed change in
the price of supply item UV-blocking goggles (SJ027) are: CPT code
36522 (Photopheresis, extracorporeal), CPT code 96910
(Photochemotherapy; tar and ultraviolet B (Goeckerman treatment) or
petrolatum and ultraviolet B), CPT code 96912 (Photochemotherapy;
psoralens and ultraviolet A (PUVA)), and CPT code 96913
(Photochemotherapy (Goeckerman and/or PUVA) for severe photoresponsive
dermatoses requiring at least 4-8 hours of care under direct
supervision of the physician (includes application of medication and
dressings)), CPT code 96920 (Laser treatment for inflammatory skin
disease (psoriasis); total area less than 250 sq cm), CPT code 96921
(Laser treatment for inflammatory skin disease (psoriasis); 250 sq cm
to 500 sq cm), and CPT code 96922 (Laser treatment for inflammatory
skin disease (psoriasis); over 500 sq cm). We seek comments on our
proposed PE refinements, including our proposed supply item prices.
(49) Physical Medicine and Rehabilitation (PM&R) (CPT Codes 97012,
97016, 97018, 97022, 97032, 97033, 97034, 97035, 97110, 97112, 97113,
97116, 97140, 97530, 97533, 97535, 97537, 97542, and HCPCS code G0283)
In our CY 2015 PFS final rule (79 FR 67576) and CY 2016 PFS final
rule (80 FR 70917), we identified a total of ten codes through the high
expenditure by specialty screen for services primarily furnished by
physical and occupational therapists: CPT codes 97032, 97035, 97110,
97112, 97113, 97116, 97140, 97530, 97535, and HCPCS code G0283. An
additional nine codes in this PM&R family were identified for review by
the physical therapy (PT) and occupational therapy (OT) specialty
societies: CPT codes 97012, 97016, 97018, 97022, 97033, 97034, 97533,
97537, and 97542. Many of these code values had not been reviewed since
they were established in 1994, 1995 or 1998.
After review during its January 2017 meeting, the HCPAC submitted
recommendations for all 19 codes. While the HCPAC included
recommendations for CPT code 97014, we note that this is a code we have
not recognized for PFS payment since 2002 when we implemented our wound
care electrical stimulation policies. For payment under the PFS,
instead of CPT code 97014, we recognize HCPCS code G0281 for wound care
electrical stimulation and HCPCS code G0283 for all other electrical
stimulation scenarios, when covered. For CY 2018, we are proposing the
HCPAC recommendations for CPT code 97014, HCPCS code G0283, and HCPCS
code G0281.
CMS considers all 19 codes as ``always therapy'' which means they
are always considered to be furnished under a physical therapy (PT),
occupational therapy (OT), or speech-language pathology (SLP) plan of
care regardless of who furnishes them and the payment amounts are
counted towards the appropriate statutory therapy cap--either the
therapy cap for PT and SLP services combined, or the single therapy cap
for OT services. These always therapy codes are also subject to the
therapy MPPR.
For CY 2018, we are proposing the HCPAC's recommended work RVUs for
CPT codes 97012, 97016, 97018, 97022, 97032, 97033, 97533, 97034,
97035, 97110, 97112, 97113, 97116, 97140, 97530, 97533, 97535, 97537,
97542, and G0283 (97014).
For supervised modality services reported with CPT codes 97012,
97016, 97018, and 97022, and HCPCS code G0283 (97014), we considered
maintaining the current values for these codes rather than the HCPAC
recommendations. We note that the work times recommended by the HCPAC
reflect use of the survey data even though the HCPAC explained in its
recommendations that the survey results were not deemed credible
because of a lack of evidence to support higher work RVUs of each
survey's 25th percentile or median values. We note total time decreases
among these codes ranging from 1 to 8 minutes.
While we are proposing the HCPAC-recommended work RVUs and work
times for each code in this family, we seek comments on whether
maintaining the current times, given the HCPAC's lack of confidence in
the survey data, would better reflect the work times for these
services.
We are proposing to maintain the existing CY 2017 PE inputs for all
19 codes. We note that section 1848(b)(7) of the Act requires a 50
percent therapy MPPR instead of the 25 percent therapy MPPR established
during CY 201l PFS rulemaking. One of the primary rationales for the
MPPR policy developed through the rulemaking process was that the
direct PE inputs for these services did not fully recognize the
redundant inputs when these services were furnished together, or in
multiple units. After reviewing the recommended direct PE inputs, it is
evident that they were developed based on an acknowledgement of the
efficiencies of services typically furnished together as well as codes
billed in multiple units. Given this assessment, we believe that were
we to use the recommended inputs to develop the PE RVUs, the 50 percent
MPPR on the PE for these services, as required by current law, would
functionally duplicate the payment adjustments to account for
efficiencies that had already been addressed through code-level
valuation. Therefore, for CY 2018, we are proposing to retain the
existing CY 2017 PE inputs for these services and seek comments on
whether there is an
[[Page 34009]]
alternative approach that would avoid duplicative downward payment
adjustments while still allowing for the direct PE inputs to be updated
to better reflect current practice.
We note that we believe that the always therapy codes subject to
the therapy MPPR on PE are unique from other therapeutic and diagnostic
procedure codes paid under the PFS and subject to MPPRs. For example,
unlike most surgical services, these ``always therapy'' codes are
typically billed either with other therapy codes or in multiple units,
or both. Generally, MPPRs are used when codes are often, but not
typically, furnished with other particular codes. When full sets of
related codes are almost all typically billed with other codes, or
billed in multiple units, coding and valuation have changed to reflect
these practices. For example, new codes have been introduced to
describe combined services or some related services are described by
add-on codes. In other cases, the MPPR is considered in the valuation
for individual services.
(50) Management and/or Training: Orthotics and Prosthetics (CPT Codes
97760, 97761, and 977X1)
For CY 2018, the CPT Editorial Panel revised the set of codes that
comprise the CPT manual's PM&R subsection for orthotic management and
prosthetic management at its September 2016 meeting. According to the
CPT Editorial Panel, these revisions were made at the request of the
specialty societies representing physical and occupational therapists
to differentiate between the initial and subsequent encounters and to
describe the ongoing management and/or training that is involved in
subsequent encounters. These changes include:
Revising the code descriptors by adding the term ``initial
encounter'' to CPT code 97760 (Orthotic(s) management and training
(including assessment and fitting when not otherwise reported), upper
extremity(ies), lower extremity(ies) and/or trunk, initial orthotic(s)
encounter, each 15 minutes), and CPT code 97761 (Prosthetic(s)
training, upper and/or lower extremity(ies), initial prosthetic(s)
encounter, each 15 minutes);
Creating a new CPT code 977X1 (Orthotic(s)/prosthetic(s)
management and/or training, upper extremity(ies), lower extremity(ies),
and/or trunk, subsequent orthotic(s)/prosthetic(s) encounter, each 15
minutes); and
Deleting CPT code 97762 (checkout for orthotic/prosthetic
use, established patient, each 15 minutes).
Intended for the management and/or training of patients with
orthotics and/or prosthetics, CPT codes 97760 and 97761 were previously
used to report both the initial and subsequent encounters, that, when
furnished under the Medicare outpatient therapy services benefit,
included services occurring during the same PT or OT episode of care.
CPT code 97762 was used to separately report the assessment and fitting
(including any adjustments) of an orthotic or prosthetic for an
established patient when these services were not bundled into another
code or service. For CY 2018, CPT codes 97760 and 97761 are intended to
be reported only for the initial encounter, and CPT code 977X1 is
intended to be reported for all other orthotic and/or prosthetic
services for an established patient that occur on a ``subsequent
encounter'' or a different date of service from that of the initial
encounter service.
The HCPAC submitted work and PE recommendations for CPT codes
97760, 97761, and 977X1 from their January 2017 meeting. For CY 2018,
we propose the HCPAC recommended work RVU of 0.5 for CPT code 97760, a
work RVU of 0.5 for CPT code 97761, and a work RVU of 0.48 for CPT code
977X1. We note that for budget neutrality purposes, the HCPAC
recommendations also included utilization crosswalks for each of the
three codes that were each assigned a one-to-one crosswalk to the
utilization of the prior codes: All the prior services of CPT codes
97760 and 97761 were each crosswalked to the same newly revised codes;
and, all the utilization from CPT code 97762 was crosswalked to the new
CPT code 977X1.
For CPT code 977X1, we considered a work RVU of 0.33, crosswalking
to CPT code 92508 (Speech/hearing therapy), which has a similar total
therapist time (22 minutes). We are concerned and seek comments on the
HCPAC one-to-one utilization crosswalk recommendations for all three
codes in this family since the utilization assumptions are potentially
flawed when viewed in the context of the new CPT code descriptors. For
instance, for CPT code 977X1, the new descriptor indicates that the
services inherent to CPT code 97762 (over 14,000 in 2015), as well as
the new services for subsequent encounters previously reported via CPT
codes 97760 and 97761 will also be encompassed, although it is
difficult to estimate the number of additional services the latter
represents. We are concerned that the HCPAC's valuation is inconsistent
with the submitted information regarding how services will be reported
under the new coding. We seek comments on our proposed and alternative
values for CPT code 977X1. We are also interested in receiving comments
from stakeholders and clinicians with expertise in furnishing these
orthotic management and/or prosthetics training services about the
utilization and types of services that would be furnished under the new
CPT coding structure, particularly those of the newly created CPT code
977X1 and how these services differ from the services reported with the
predecessor CPT code 97762.
We propose to maintain the current PE inputs for CPT codes 97760,
97761, and 977X1, as we discussed in our proposals for the PM&R codes
discussed above; the same therapy MPPR applies. We are proposing the
current direct PE inputs for CPT code 97762 and for new CPT code 977X1,
though we are seeking comment as to whether or not a different
crosswalk or other adjustment would be appropriate given the change in
code descriptor.
We also note that these codes are designated as always therapy,
meaning that they always represent therapy services regardless of who
furnishes them; and that a GO or GP therapy modifier is always required
to indicate that the services are furnished under an OT or PT plan of
care, respectively. As always therapy, these codes are subject to the
therapy MPPR and the statutory therapy caps.
(51) Cognitive Function Intervention (CPT Code 97X11)
We received HCPAC recommendations for new CPT code 97X11 that
describes services currently reported under CPT code 97532 (Development
of cognitive skills to improve attention, memory, problem solving
(includes compensatory training), direct (one-on-one) patient contact,
each 15 minutes). CPT code 97532 is scheduled to be deleted for CY 2018
and replaced by CPT code 97X11.
The existing code is reported per 15 minutes and the new code is
reported once. Under current coding, Medicare utilization for these
services is heterogeneous and indicates that practitioners of different
disciplines incur significantly different resource costs (especially in
time) when furnishing these services to Medicare beneficiaries. As
described by both the existing and new code, the service might be
appropriately furnished both by therapists under the outpatient therapy
(OPT) services benefit (includes physical therapy (PT), occupational
therapy (OT) or speech-language pathology (SLP)); and outside the
therapy benefit by physicians, certain
[[Page 34010]]
NPPs, and psychologists. As an OPT service, it can (1) be billed by
physicians, certain NPPs, or private practice therapists including
physical therapists (PT-PPs), occupational therapists (OT-PPs) and
speech-language pathologists (SLP-PPs) in private practice, or (2) be
billed by institutional providers (for example, skilled nursing
facilities, rehabilitation agencies, outpatient hospitals, etc.) when
furnished by therapists working for the institutional providers.
According to the HCPAC, professional claims data indicate that CPT
code 97532 was most often billed in 4 units. The HCPAC recommended a
work RVU of 1.50 for CPT code 97X11, which is only 3.4 times greater
than the work RVU for the predecessor code (0.44). Assuming
professional billing patterns remain the same, the recommended coding
and valuation could result in a significant reduction in overall
Medicare payment under the PFS.
However, our analysis of the claims data indicates that the number
of units typically reported for the current code suggests a significant
difference in the amount of time spent with the patient, depending on
which discipline (and implicitly under which benefit) bills Medicare
for services described by this single code.
Based on our review of claims data by specialty, SLP-PPs, OT-PPs
and PT-PPs furnishing the same services under the OPT benefit would
receive overall payment increases due simply to the change in coding
because they typically bill for fewer than 4 units, while overall
payment for clinical psychologists furnishing therapeutic interventions
for cognitive function would decrease because they typically bill in
units of four or more.
We are seeking additional information regarding the potential
impact of this coding and payment change prior to proposing its use
under the PFS. For CY 2018, we are proposing to maintain the current
coding and valuation for these cognitive function services. If the CPT
Editorial Panel deletes the existing CPT code for CY 2018, we would
effectuate this proposal through use of a new a G-code, GXXX1, which
would maintain the descriptor and values from existing CPT code 97532.
Under this proposal, new CPT code 97X11 would be given a procedure
status of ``I'' (Invalid for Medicare).
We also note that this change in coding and payment could have
significant impact for payment to Medicare institutions for OPT
services. Under section 1834(k) of the Act, when reported by Medicare
institutional providers, OPT services are paid at PFS non-facility
payment rates. Institutional claims data for CPT code 97532 when
furnished by the three therapist disciplines show a much higher
utilization overall than that for professional claims but significantly
fewer 15 minute units reported. This suggests that professionals
generally spend significantly less time with patients in the
institutional setting. Use of the new CPT code could therefore result
in significant additional expenditure to the Medicare program, as well
as other payers, including Medicaid programs, based on the change in
coding alone.
(52) INR Monitoring (CPT Codes 993X1 and 993X2)
In October 2015, AMA staff assembled a list of all services with
total Medicare utilization of 10,000 or more that have increased by at
least 100 percent from 2008 through 2013 and these services were
identified on that list. The RUC recommended that HCPCS codes G0248,
G0249 and G0250, which describe related INR monitoring services, be
referred to the CPT Editorial Panel to create Category I codes to
describe these services. For CY 2018, the CPT Editorial Panel is
deleting CPT codes 99363 and 99364 and creating new CPT codes 993X1
(Patient/caregiver training for initiation of home INR monitoring under
the direction of a physician or other qualified health care
professional, including face-to-face, use and care of the INR monitor,
obtaining blood sample, instructions for reporting home INR test
results, and documentation of patient's/caregiver's ability to perform
testing and report results) and 993X2 (Anticoagulant management for a
patient taking warfarin, must include review and interpretation of a
new home, office, or lab International Normalized Ratio (INR) test
result, patient instructions, dosage adjustment (as needed), and
scheduling of additional test(s) when performed). CPT code 993X1 is a
technical component-only code. With the creation CPT codes 993X1 and
993X2, the RUC recommended that CMS delete HCPCS codes G0248, G0249 and
G0250.
For CPT code 993X2, we are proposing the RUC-recommended work RVU
of 0.18. Because HCPCS codes G0248, G0249 and G0250 are used to report
related services under a national coverage determination, we do not
intend to delete the G-codes.
In reviewing the recommended PE inputs for these services, we
obtained updated invoices for prices for particular items. We are
proposing to use the invoices to update the price of the supply ``INR
test strip'' (SJ055). We obtained publically available pricing
information from two vendors. The pricing from one vendor indicated the
price for a box of 24 of supply item SJ055 item (INR test strip) to be
$150.00, which equated to a unit price of $6.25. Pricing from a second
vendor indicated the price of a box of 48 of the supply item SJ055 to
be $233.00, which equated to a unit price of $5.06. The average price
of these two unit prices is $5.66.
Therefore, we are proposing to re-price SJ055 from $21.86 to $5.66
for CPT code 993X1. We are seeking public comments on current pricing
for the INR test strip supply.
(53) Psychiatric Collaborative Care Management Services (CPT Codes
994X1, 994X2, 994X3, and HCPCS Code G0507)
In the CY 2017 PFS final rule (81 FR 80230), we established
separate payment for three services (HCPCS codes G0502, G0503, and
G0504) under the psychiatric collaborative care model that paralleled
CPT codes that were being created to report these services as well as a
G-code for general behavioral health integration (BHI) services (HCPCS
code G0507).
For CY 2018, the CPT Editorial Panel is creating CPT codes 994X1,
994X2, 994X3, and 99XX5 to describe these services. We are proposing
the RUC-recommended work RVUs for each of these services, which are
identical to the current values for HCPCS codes G0502, G0503, G0504,
and G0507.
We are proposing the RUC-recommended PE inputs, with one
refinement. The RUC-recommended values included clinical labor inputs
in the facility setting, but we are not proposing to include these
minutes in developing the facility PE RVUs.
Were we to develop facility PE RVUs for these services that
included clinical staff time, when a practitioner working in a
provider-based department of a hospital was furnishing these services,
both the professional and the hospital would be paid for the same
clinical labor costs. We presume that this aspect of the RUC's
recommendation reflects the circumstance where the patient receiving
the services spends a significant period of time in a facility setting,
but the billing practitioner is nonetheless incurring the cost
associated with the non-face-to-face clinical staff time over the
course of a month. We recognize that the binary site of service
differential may not recognize the different models of this kind of
care and may not be appropriate in some cases. We seek comments on how
to best address this valuation issue for these and other monthly care
[[Page 34011]]
management services. We could consider a range of options for future
rulemaking, including allowing separate billing for the professional,
technical, and global components of these services to allow
practitioners to bill the component of the service they furnish.
We stated in the CY 2017 PFS final rule (81 FR 80236) that the
general BHI code (CPT code 99XX5) may be used to report a range of
models of BHI services and that we expected this code to be refined
over time as we receive more information about other BHI models in use.
We remain interested in how this code is being used and look forward to
hearing from stakeholders regarding its use in reporting different
models of BHI services. Additionally, we have received inquiries from
stakeholders about whether or not professionals who cannot report E/M
services to Medicare might nonetheless serve as a primary hub for BHI
services. For example, stakeholders have suggested that a clinical
psychologist might serve as the primary practitioner that integrates
medical care and psychiatric expertise. For purposes of future
rulemaking, we are seeking comment on the circumstances under which
this model of care is happening and whether additional coding would be
needed to accurately describe and value other models of care.
(54) Hyperbaric Oxygen Therapy (HCPCS Code G0277)
In the CY 2016 PFS final rule (80 FR 71005), we discussed the CY
2015 valuation of hyperbaric oxygen therapy services (79 FR 67677).
Prior to CY 2015, CPT code 99183 was used to report both the
professional attendance and supervision, and the costs associated with
treatment delivery were included in the nonfacility direct PE inputs
for the code. We created HCPCS code G0277 to be used to report the
treatment delivery separately, consistent with the OPPS coding
mechanism, to allow the use of the same coding structure across
settings. In establishing interim final direct PE inputs for HCPCS code
G0277, we used the RUC-recommended direct PE inputs for CPT code 99183,
which assumed a 120-minute treatment interval and adjusted them to
align with the 30-minute treatment interval of HCPCS code G0277. We
observed that the quantity of oxygen increased significantly relative
to the previous inputs for CPT code 99183.
To better understand why the oxygen supply increased, we reviewed
the instruction manual for the Sechrist Model 3600E Hyperbaric Chamber,
which was the model noted on the invoice that was included with the RUC
recommendations for use in pricing the capital equipment. The
instruction manual for the Sechrist 3600E model provided guidance
regarding the quantity of oxygen to be used in furnishing the service
described by HCPCS code G0277. Based on our review at that time, we
determined that 12,000 liters, rather than 47,000 liters, was the
typical number of units for the oxygen gas. Therefore, in aligning the
direct PE inputs as described in this section of the proposed rule, we
first adjusted the units of oxygen to 12,000 liters for the recommended
120 minute time, and subsequently adjusted it to align with the 30-
minute G-code by dividing by 4. We stated that we agreed that an
initial high purge flow rate is needed to reach maximum pressure/
O2; however, we still had not seen data that demonstrated
the need to continue the high purge flow rate throughout the entire
session. According to the manufacturer's instruction manual for this
model, ``once the nitrogen has been purged from the chamber and the
internal oxygen concentration has exceeded 95 percent, high flows are
no longer needed to maintain the patient's saturation level.'' The
manual also stated that ``the plateau purge flow can be set to 80
liters per minute (lpm).'' We calculated that 13 minutes at 400 lpm
plus 120 minutes at 80 lpm equals 14,800 liters of oxygen. We stated
that based on information in the manufacturer's manual that was
publicly available at the time, we believed that this represented the
typical usage for a 120-minute treatment. That amount represented an
increase from the interim final amount of 12,000 liters. We aligned
this total oxygen requirement to the 30-minute G-code by dividing
14,800 liters of oxygen by 4 and stated we were updating the direct PE
inputs to 3,700 liters of oxygen for HCPCS code G0277.
For CY 2018, we received requests from stakeholders to update the
direct PE inputs for HCPCS code G0277. In the CY 2016 PFS final rule
(80 FR 71005), we explained that we had previously established values
for this service based on information suggesting that the Sechrist
Model 3600E Hyperbaric Chamber was typically used in furnishing the
service in the non-facility setting. As we noted in that rule, we
established the amount of oxygen used in furnishing the service based
on use of the equipment item described as part of the RUC
recommendation, instead of the RUC-recommended amount of oxygen, which
appeared to be based on use of a different equipment product, the
Sechrist Model 3200. Based on information received from stakeholders,
we are proposing to update both the equipment item and the amount of
oxygen so that the amount of oxygen conforms to the RUC-recommended
value of 47,600 liters of oxygen, which we divided by 4 to conform to
the 30-minute service period for HCPCS code G0277, and that the
equipment item is consistent with that recommendation. The proposed
direct PE inputs for HCPCS code G0277 are displayed in the proposed CY
2018 direct PE input database, available on the CMS Web site under the
downloads for the CY 2018 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
We are also proposing to exclude this change in direct PE inputs
from calculation of the misvalued code target since we view this
proposed change as a refinement of a single recommendation over several
years. Since the initial recommendation (79 FR 67677) was undertaken in
a year without the misvalued code target, we believe it would be
consistent with our previously established policy (80 FR 70923) to
exclude this change from the calculation. We note that this change
would represent an increase from the current PE RVUs for this service.
(55) Physician Coding for Insertion and Removal of Subdermal Drug
Implants for the Treatment of Opioid Addiction (HCPCS Codes GDDD1,
GDDD2, and GDDD3)
We met with representatives from the American Society of Addiction
Medicine (ASAM) in April 2016 to discuss the possibility of making
separate payment for insertion and removal of buprenorphine
hydrochloride, formulated as a 4-rod, 80 mg, long-acting subdermal drug
implant for the treatment of opioid addiction. There are existing CPT
codes that broadly describe the insertion and removal of non-
biodegradable drug delivery implants (CPT codes 11981 through 11983).
However, ASAM contended that the resources associated with the
administration of this particular drug are greater than that of other
drug delivery implants, stating that the physician must insert four
rods using a newly designed applicator and obturator and use a
specially designed clamp to remove the four rods, which in some cases
requires careful shaving of tissue that has attached to the rods during
the 6-month period that the rods have been inserted. They noted that
these procedures can have unique
[[Page 34012]]
challenges associated with treating patients with opioid addiction, who
often have complications and/or co-morbidities. They also noted that
the FDA has recognized the complexity of the technology and patient
needs by establishing regulatory standards to adhere to the protocol
and imposing special training requirements on physicians. ASAM
indicated that they would pursue an application to the CPT Editorial
Panel for new CPT codes.
ASAM informed CMS that the CPT Editorial Panel did not approve
their application; therefore, they repeated their request that CMS
establish separate payment for the insertion, removal, and removal with
reinsertion of the buprenorphine subdermal implants.
To improve payment accuracy, for CY 2018, we are proposing to make
separate payment for the insertion, removal, and removal with
reinsertion of Buprenorphine subdermal implants using HCPCS G codes:
HCPCS code GDDD1: Insertion, non-biodegradable drug
delivery implants, 4 or more.
HCPCS code GDDD2: Removal, non-biodegradable drug delivery
implants, 4 or more.
HCPCS code GDDD3: Removal with reinsertion, non-
biodegradable drug delivery implants, 4 or more.
For HCPCS code GDDD1, ASAM states that performing the procedure
according to the FDA-required Risk Evaluation and Mitigation Strategies
(REMS) program takes approximately 23-25 minutes for the a physician
who is not a trainer/proctor for this procedure. They state that in
developing crosswalk recommendations for physician work values, they
used a total time of 35-40 minutes, which is based on a preservice time
of 10 minutes, an intraservice time of 20-25 minutes, and a postservice
time of 5 minutes. Based on ASAM's recommendations, we are proposing a
work RVU of 1.82 for HCPCS code GDDD1, which is supported by a direct
crosswalk to CPT code 64644 (Chemodenervation of one extremity; 5 or
more muscles).
For HCPCS code GDDD2, ASAM states that data from physicians who
perform this procedure indicated that it takes approximately 15-20
additional minutes compared to the insertion procedure (HCPCS code
GDDD1) based on the FDA-required REMS program for removal of the
implant. They note that this procedure is of a higher intensity
compared to CPT code 11982 as this service requires identification and
removal of multiple subdermal implants. They state that in developing
crosswalk recommendations for physician work values, they used a total
time of 45-60 minutes, which is based on a preservice time of 10
minutes, an intraservice time of 30-45 minutes, and a postservice time
of 5 minutes. Based on ASAM's recommendations, we are proposing a work
RVU of 2.10 for HCPCS code GDDD2, which is supported by a direct
crosswalk to CPT code 96922 (Laser treatment for inflammatory skin
disease (psoriasis); over 500 sq cm).
For HCPCS code GDDD3, ASAM indicated that there is minimal
consolidation of effort since the removal of the implants from one arm
is followed by insertion of a new set of implants in the contralateral
arm. Physician data from those who have performed this procedure
indicated that it takes approximately 70 minutes of total intra-service
time. They state that in developing crosswalk recommendations for
physician work values, they assumed a preservice evaluation time of 10
minutes (7 minutes for removal and 3 minutes for insertion),
positioning of 4 minutes (2 minutes for each arm), and wait time of 2
minutes (1 minute for each arm). They state that using the multiple
surgical procedure rule, they calculated an intraservice time of 40-58
minutes based on 100 percent of the intraservice time for HCPCS code
GDDD2 (30-45 minutes) and 50 percent of the intraservice time for HCPCS
code GDDD1 (0.5 x (20 - 25) = 10 - 13). They used a postservice time of
8 minutes based on 100 percent of the postservice time for the removal
arm and 50 percent of the postservice time for the insertion arm,
equaling a total time of 58-76 minutes. Based on ASAM's
recommendations, we are proposing a work RVU of 3.55 for HCPCS code
GDDD3, which is supported by a direct crosswalk to CPT code 31628
(Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when
performed; with transbronchial lung biopsy(s), single lobe).
We are proposing to use the direct PE inputs requested by ASAM for
HCPCS codes GDDD1, GDDD2, and GDDD3, which are reflected in the Direct
PE Inputs public use files for clinical labor, supplies, and equipment,
available on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
In addition to seeking comment on the proposal to make separate
payment for these services using HCPCS G codes, we are also seeking
comment on the appropriateness and accuracy of our proposed work RVUs
and direct PE inputs.
(56) Superficial Radiation Treatment Planning and Management (HCPCS
Code GRRR1)
In the CY 2015 PFS final rule with comment period (79 FR 67666
through 67667), we noted that changes to the CPT prefatory language
limited the codes that could be reported when describing services
associated with superficial radiation treatment (SRT) delivery,
described by CPT code 77401 (radiation treatment delivery, superficial
and/or ortho voltage, per day). The changes effectively meant that many
other related services were bundled with CPT code 77401, instead of
being separately reported. For example, CPT guidance clarified that
certain codes used to describe clinical treatment planning, treatment
devices, isodose planning, physics consultation, and radiation
treatment management cannot be reported when furnished in association
with superficial radiation treatment. Stakeholders stated that these
changes to the CPT prefatory language prohibited them from billing
Medicare for codes that were previously frequently billed in addition
to CPT code 77401. We solicited comments as to whether the coding for
SRT allowed for accurate reporting of the associated services.
In the CY 2016 PFS final rule with comment period (80 FR 70955), we
noted that the RUC did not review the inputs for superficial radiation
therapy procedures, and therefore, did not assess whether changes in
its valuation were appropriate in light of the bundling of associated
services. In addition, we solicited recommendations from stakeholders
regarding whether or not it would be appropriate to add physician work
for this service, even though physician work is not included in other
radiation treatment services. As commenters were not in agreement as to
whether the service should be valued with physician work, we introduced
the possibility of creating a HCPCS G code to describe total work
associated with the course of treatment for these services.
The 2016 National Correct Coding Initiative (NCCI) Policy Manual
for Medicare Services states that radiation oncology services may not
be separately reported with E/M codes. While this edit is no longer
active, stakeholders have stated that MACs have denied claims for E/M
services associated with SRT based on the NCCI policy manual language.
According to stakeholders, the bundling of services associated with
SRT, as well as the confusion regarding the appropriate use of E/M
coding to report associated physician work, means
[[Page 34013]]
that practitioners are not being accurately paid for planning and
treatment management associated with furnishing SRT.
In recognition of these concerns, we are proposing to make separate
payment for the professional planning and management associated with
SRT using HCPCS code GRRR1 (Superficial radiation treatment planning
and management related services, including but not limited to, when
performed, clinical treatment planning (for example, 77261, 77262,
77263), therapeutic radiology simulation-aided field setting (for
example, 77280, 77285, 77290, 77293), basic radiation dosimetry
calculation (for example, 77300), treatment devices (for example,
77332, 77333, 77334), isodose planning (for example, 77306, 77307,
77316, 77317, 77318), radiation treatment management (for example,
77427, 77431, 77432, 77435, 77469, 77470, 77499), and associated
evaluation and management per course of treatment). We intend for this
code to describe the range of professional services associated with a
course of SRT, including services similar to those not otherwise
separately reportable under CPT guidance and the NCCI manual.
To value this code, we are including the physician work and work
time associated with radiation management-related services that we
think would be typical for a course of SRT treatment. These services
include: CPT code 77261 (Therapeutic radiology treatment planning;
simple), CPT code 77280 (Therapeutic radiology simulation-aided field
setting; simple), CPT code 77300 (Basic radiation dosimetry
calculation, central axis depth dose calculation, TDF, NSD, gap
calculation, off axis factor, tissue inhomogeneity factors, calculation
of non-ionizing radiation surface and depth dose, as required during
course of treatment, only when prescribed by the treating physician),
CPT code 77306 (Teletherapy isodose plan; simple (1 or 2 unmodified
ports directed to a single area of interest), includes basic dosimetry
calculation(s)), CPT code 77332 (Treatment devices, design and
construction; simple (simple block, simple bolus)), and CPT code 77427
(Radiation treatment management, 5 treatments). Therefore, for CY 2018,
we are proposing a work RVU of 7.93 for HCPCS code GRRR1.
To develop the proposed direct PE inputs for this code, we are
proposing to use the RUC-recommended direct PE inputs from the
aforementioned codes with several adjustments. We are proposing to
apply the staff type ``RN/LPN/MTA'' for all of the clinical labor
inputs for this code because we believe that the typical office
performing SRT will be staffed with this labor type, rather than with
another clinical labor type such as radiation therapists, and we seek
comments as to the appropriateness of the staff type ``RN/LPN/MTA'' for
this SRT-related service. Some stakeholders have suggested that many
services related to SRT are personally performed by the billing
practitioner rather than by clinical staff.
We are proposing to remove the supply items ``gown, patient'' and
``pillow case'' that are associated with CPT code 77280, as these items
are included in the minimum multi-specialty visit pack that is
associated with CPT code 77427. We are not proposing to include the
equipment items ``radiation virtual simulation system,'' ``room, CT''
and ``PACS Workstation Proxy'' that are associated with CPT code 77280,
as we do not believe that a typical office furnishing SRT uses this
kind of equipment. Instead, we are including additional time for the
capital equipment used in delivering SRT in the proposed direct PE
inputs. For ``radiation dose therapy plan,'' we are proposing to apply
the clinical labor time that is associated with CPT code 77300 to HCPCS
code GRRR1 for purposes of developing a proposed value, but we seek
comments as to whether the clinical staff would typically perform the
radiation dose therapy planning for this service, or if the physician
would perform this and/or other tasks, and, in the case of the latter,
what the appropriate physician time would be. Likewise, we are
soliciting comment as to whether the clinical labor associated with the
teletherapy isodose plan would be performed by the physician. We are
proposing to assign 14 minutes each to the equipment items ``radiation
therapy dosimetry software (Argus QC)'', ``computer workstation'', and
``3D teletherapy treatment planning'' as these are the times assigned
to these equipment items for CPT code 77300.
We are not proposing to include inputs related to radiation physics
consultation, described by CPT code 77336, as we think that a typical
course of SRT would not require this service, and the typical
practitioner providing SRT would not be performing physics
consultation, and we are seeking comment as to whether inputs
associated with this code or other inputs used in furnishing analogous
services should be included. We are not proposing to include the post-
operative office visits included in the valuation of CPT code 77427, as
we do not believe that a typical course of SRT will require post-
operative visits; however, we are seeking comment regarding the amount
of face-to-face time typically spent by the practitioner with the
patient for radiation treatment management associated with SRT.
As discussed in the CY 2016 PFS final rule (80 FR 70924 through
70927), in the case of new codes that describe services that were
previously included in the payment for other codes, we finalized the
policy that these new codes are excluded from the misvalued code target
when they were previously bundled into a set of broadly reported E/M
codes and services that include E/M visits. We noted that we did not
believe that the change to separate payment for these kinds of services
should be counted as increases that are included in calculating ``net
reductions'' in expenditure attributable to adjustments for misvalued
codes. Therefore, we are proposing to exclude HCPCS code GRRR1 from the
misvalued code target.
(57) Payment Accuracy for Prolonged Preventive Services (HCPCS Codes
GYYY1 and GYYY2)
Most services paid under the PFS are coded to reflect differential
resource costs associated with different levels of care. However, this
level of granularity is not applied evenly across the PFS. For example,
there are far fewer Evaluation and Management (E/M) visit codes than
there are codes that describe procedures. While not a comprehensive
solution to address the differential resource costs of certain E/M
visits, prolonged services codes can be used to report medically
necessary E/M visits that require additional amounts of time. Like E/M
visit codes, many of the Medicare-covered preventive services codes
describe a service that has an atypically broad range of potential
resource costs, including differential amounts of time required to
furnish services. However, unlike for most E/M visit codes, there are
not prolonged services codes that apply to Medicare-covered preventive
services.
Some stakeholders have expressed concerns to CMS that there is no
coding mechanism for practitioners to report the additional time
sometimes required to appropriately furnish care to a patient receiving
a Medicare-covered preventive service. We note that Medicare covers a
broad range of preventive services, such as a ``Welcome to Medicare
Preventive Visit'', yearly wellness visits, cancer screenings, and many
types of counseling. Medicare beneficiary coinsurance and deductible
payments are not applicable for certain Medicare-covered preventive
services. Additional information about preventive services
[[Page 34014]]
covered under Medicare, including whether beneficiary coinsurance or
deductible apply, is available on the CMS Web site at https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/Downloads/MPS-QuickReferenceChart-1TextOnly.pdf. To more accurately reflect the
differential resource costs when additional time is required to furnish
a Medicare-covered preventive service, we are proposing to make payment
for prolonged preventive services using two new HCPCS G codes that
could be billed along with the Medicare-covered preventive service
codes, when a clinician provides a prolonged Medicare-covered
preventive service.
GYYY1: Prolonged preventive 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 30 minutes (List separately in addition to code for
preventive service)), and
GYYY2: Prolonged preventive 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; each additional 30 minutes (List separately in addition to
code for preventive service)). These proposed services (HCPCS codes
GYYY1 and GYYY2) are only permitted to be billed with Medicare-covered
preventive services. Beneficiary coinsurance and deductible would not
be applicable for HCPCS codes GYYY1 and GYYY2 because the codes can
only be reported to describe prolonged portions of services where
beneficiary coinsurance and deductible are not applicable.
We are proposing to use prolonged services codes in 30-minute
increments instead of the 60-minute increments that apply for the
parallel office/outpatient prolonged services codes, since some
Medicare-covered preventive services have a shorter duration than E/M
visits. For purposes of valuation for both initial and additional 30
minute codes, we are proposing to use one half of the current work RVUs
and direct PE inputs for CPT code 99354 (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
(List separately in addition to code for office or other outpatient
Evaluation and Management or psychotherapy service)). CPT code 99354
has a total time of 60 minutes and a work RVU of 2.33. Therefore, we
are proposing a work RVU of 1.17 and 30 minutes of total work time for
HCPCS codes GYYY1 and GYYY2. We are proposing to use one half of the
direct PE inputs for CPT code 99354, which results in a proposal of 7
minutes of clinical labor type L037D (RN/LPN/MTA) and 15 minutes for
equipment type EF031 (table, power) for HCPCS code GYYY1 and HCPCS code
GYYY2 as the best reflection of typical direct PE costs. We understand
that these specific clinical labor and equipment types may be
functioning as proxy inputs for some Medicare-covered preventive
services.
As described in this section of the rule, we propose that HCPCS
codes GYYY1 and GYYY2 be billed for prolonged preventive services
beyond the typical service time of the primary procedure. For
preventive services with both physician work and practice expense, we
are considering the typical service time of the primary procedure to be
the intraservice work time used for the purposes of ratesetting. For
Medicare-covered preventive services with no face-to-face physician
work, the typical time is the service period clinical staff time that
best represents the face-to-face time with the patient. The counted
time requirements (derived from the typical times assumed for
ratesetting) for all eligible companion Medicare-covered preventive
services are available in the file called ``CY 2018 Preventive Services
Billed with Prolonged Preventives Code'' on the CMS Web site under
downloads for the CY 2018 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Table 10--Proposed CY 2018 Work RVUs for New, Revised and Potentially Misvalued Codes
----------------------------------------------------------------------------------------------------------------
Current RUC work CMS work
HCPCS Descriptor work RVU RVU RVU CMS time refinement
----------------------------------------------------------------------------------------------------------------
007X1.................... Anesthesia for upper NEW 0.00 0.00 No.
gastrointestinal
endoscopic procedures,
endoscope introduced
proximal to duodenum; not
otherwise specified.
007X2.................... Anesthesia for upper NEW 0.00 0.00 No.
gastrointestinal
endoscopic procedures,
endoscope introduced
proximal to duodenum;
endoscopic retrograde
cholangiopancreatography
(ERCP).
008X1.................... Anesthesia for lower NEW 0.00 0.00 No.
intestinal endoscopic
procedures, endoscope
introduced distal to
duodenum; not otherwise
specified.
008X2.................... Anesthesia for lower NEW 0.00 0.00 No.
intestinal endoscopic
procedures, endoscope
introduced distal to
duodenum; screening
colonoscopy.
008X3.................... Anesthesia for combined NEW 0.00 0.00 No.
upper and lower
gastrointestinal
endoscopic procedures,
endoscope introduced both
proximal to and distal to
the duodenum.
10040.................... Acne surgery (e.g., 1.21 0.91 0.91 No.
marsupialization, opening
or removal of multiple
milia, comedones, cysts,
pustules).
15734.................... Muscle, myocutaneous, or 19.86 23.00 23.00 No.
fasciocutaneous flap;
trunk.
15736.................... Muscle, myocutaneous, or 17.04 17.04 17.04 No.
fasciocutaneous flap;
upper extremity.
15738.................... Muscle, myocutaneous, or 19.04 19.04 19.04 No.
fasciocutaneous flap;
lower extremity.
157X1.................... Midface flap (i.e., NEW 13.50 13.50 No.
zygomaticofacial flap)
with preservation of
vascular pedicle(s).
157X2.................... Muscle, myocutaneous, or NEW 15.68 15.68 No.
fasciocutaneous flap;
head and neck with named
vascular pedicle (i.e.,
buccinators,
genioglossus, temporalis,
masseter,
sternocleidomastoid,
levator scapulae).
192X1.................... Preparation of tumor NEW 3.00 3.00 No.
cavity with placement of
a radiation therapy
applicator for
intraoperative radiation
therapy (IORT) concurrent
with partial mastectomy.
19303.................... Mastectomy, simple, 15.85 15.00 15.00 No.
complete.
2093X.................... Bone marrow aspiration for NEW 1.16 1.16 No.
bone grafting, spine
surgery only, through
separate skin or fascial
incision.
29445.................... Application of rigid total 1.78 1.78 1.78 No.
contact leg cast.
29580.................... Strapping; Unna boot...... 0.55 0.55 0.55 No.
29581.................... Application of multi-layer 0.25 0.60 0.60 No.
compression system; leg
(below knee), including
ankle and foot.
30140.................... Submucous resection 3.57 3.00 3.00 No.
inferior turbinate,
partial or complete, any
method.
30901.................... Control nasal hemorrhage, 1.10 1.10 1.10 No.
anterior, simple (limited
cautery and/or packing)
any method.
30903.................... Control nasal hemorrhage, 1.54 1.54 1.54 No.
anterior, complex
(extensive cautery and/or
packing) any method.
30905.................... Control nasal hemorrhage, 1.97 1.97 1.97 No.
posterior, with posterior
nasal packs and/or
cautery, any method;
initial.
[[Page 34015]]
30906.................... Control nasal hemorrhage, 2.45 2.45 2.45 No.
posterior, with posterior
nasal packs and/or
cautery, any method;
subsequent.
31XX1.................... Nasal/sinus endoscopy, NEW 8.00 8.00 No.
surgical; with ligation
of sphenopalatine artery.
31XX2.................... Nasal/sinus endoscopy, NEW 9.00 9.00 No.
surgical with
ethmoidectomy; total
(anterior and posterior),
including frontal sinus
exploration, with removal
of tissue from frontal
sinus, when performed.
31XX3.................... Nasal/sinus endoscopy, NEW 8.00 8.00 No.
surgical with
ethmoidectomy; total
(anterior and posterior),
including sphenoidotomy.
31XX4.................... Nasal/sinus endoscopy, NEW 8.48 8.48 No.
surgical with
ethmoidectomy; total
(anterior and posterior),
including sphenoidotomy,
with removal of tissue
from the sphenoid sinus.
31XX5.................... Nasal/sinus endoscopy, NEW 4.50 4.50 No.
surgical; with dilation
of frontal and sphenoid
sinus ostia (e.g.,
balloon dilation).
31254.................... Nasal/sinus endoscopy, 4.64 4.27 4.27 No.
surgical with
ethmoidectomy; partial
(anterior).
31255.................... Nasal/sinus endoscopy, 6.95 5.75 5.75 No.
surgical with
ethmoidectomy; total
(anterior and posterior).
31256.................... Nasal/sinus endoscopy, 3.29 3.11 3.11 No.
surgical, with maxillary
antrostomy.
31267.................... Nasal/sinus endoscopy, 5.45 4.68 4.68 No.
surgical, with maxillary
antrostomy; with removal
of tissue from maxillary
sinus.
31276.................... Nasal/sinus endoscopy, 8.84 6.75 6.75 No.
surgical, with frontal
sinus exploration,
including removal of
tissue from frontal
sinus, when performed.
31287.................... Nasal/sinus endoscopy, 3.91 3.50 3.50 No.
surgical, with
sphenoidotomy.
31288.................... Nasal/sinus endoscopy, 4.57 4.10 4.10 No.
surgical, with
sphenoidotomy; with
removal of tissue from
the sphenoid sinus.
31295.................... Nasal/sinus endoscopy, 2.70 2.70 2.70 No.
surgical; with dilation
of maxillary sinus ostium
(e.g., balloon dilation),
transnasal or canine
fossa.
31296.................... Nasal/sinus endoscopy, 3.29 3.10 3.10 No.
surgical; with dilation
of frontal sinus ostium
(e.g., balloon dilation).
31297.................... Nasal/sinus endoscopy, 2.64 2.44 2.44 No.
surgical; with dilation
of sphenoid sinus ostium
(e.g., balloon dilation).
31600.................... Tracheostomy, planned 7.17 5.56 5.56 No.
(separate procedure).
31601.................... Tracheostomy, planned 4.44 8.00 8.00 No.
(separate procedure);
younger than 2 years.
31603.................... Tracheostomy, emergency 4.14 6.00 6.00 No.
procedure; transtracheal.
31605.................... Tracheostomy, emergency 3.57 6.45 6.45 No.
procedure; cricothyroid
membrane.
31610.................... Tracheostomy, fenestration 9.38 12.00 12.00 No.
procedure with skin flaps.
31645.................... Bronchoscopy, rigid or 2.91 2.88 2.88 No.
flexible, including
fluoroscopic guidance,
when performed with
therapeutic aspiration of
tracheobronchial tree,
initial.
31646.................... Bronchoscopy, rigid or 2.47 2.78 2.78 No.
flexible, including
fluoroscopic guidance,
when performed with
therapeutic aspiration of
tracheobronchial tree,
subsequent, same hospital
stay.
32998.................... Ablation therapy for 5.68 9.03 9.03 No.
reduction or eradication
of 1 or more pulmonary
tumor(s) including pleura
or chest wall when
involved by tumor
extension, percutaneous,
including imaging
guidance when performed,
unilateral;
radiofrequency.
32X99.................... Ablation therapy for NEW 9.03 9.03 No.
reduction or eradication
of 1 or more pulmonary
tumor(s) including pleura
or chest wall when
involved by tumor
extension, percutaneous,
including imaging
guidance when performed,
unilateral; cryoablation.
339X1.................... Implantation of a total NEW 49.00 49.00 No.
replacement heart system
(artificial heart) with
recipient cardiectomy.
339X2.................... Removal and replacement of NEW C C No.
total replacement heart
system (artificial heart).
339X3.................... Removal of a total NEW C C No.
replacement heart system
(artificial heart) for
heart transplantation.
34812.................... Open femoral artery 6.74 4.13 4.13 No.
exposure for delivery of
endovascular prosthesis
by groin incision,
unilateral.
34820.................... Open iliac artery exposure 9.74 7.00 7.00 No.
for delivery of
endovascular prosthesis
or iliac occlusion by
abdominal or
retroperitoneal incision,
unilateral.
34833.................... Open iliac artery exposure 11.98 8.16 8.16 No.
with creation of conduit
for delivery of
endovascular prosthesis
or for establishment of
cardiopulmonary bypass,
by abdominal or
retroperitoneal incision,
unilateral.
34834.................... Open brachial artery 5.34 2.65 2.65 No.
exposure for delivery of
endovascular prosthesis
unilateral.
34X01.................... Endovascular repair of NEW 23.71 23.71 No.
infrarenal aorta by
deployment of an aorto-
aortic tube endograft
including pre-procedure
sizing and device
selection, all
nonselective
catheterization(s), all
associated radiological
supervision and
interpretation, all
endograft extension(s)
placed in the aorta from
the level of the renal
arteries to the aortic
bifurcation, and all
angioplasty/stenting
performed from the level
of the renal arteries to
the aortic bifurcation;
for other than rupture
(e.g., for aneurysm,
pseudoaneurysm,
dissection, penetrating
ulcer).
34X02.................... Endovascular repair of NEW 36.00 36.00 No.
infrarenal aorta by
deployment of an aorto-
aortic tube endograft
including pre-procedure
sizing and device
selection, all
nonselective
catheterization(s), all
associated radiological
supervision and
interpretation, all
endograft extension(s)
placed in the aorta from
the level of the renal
arteries to the aortic
bifurcation, and all
angioplasty/stenting
performed from the level
of the renal arteries to
the aortic bifurcation;
for rupture including
temporary aortic and/or
iliac balloon occlusion
when performed (e.g., for
aneurysm, pseudoaneurysm,
dissection, penetrating
ulcer, traumatic
disruption).
34X03.................... Endovascular repair of NEW 26.52 26.52 No.
infrarenal aorta and/or
iliac artery(ies) by
deployment of an aorto-
uniiliac endograft
including pre-procedure
sizing and device
selection, all
nonselective
catheterization(s), all
associated radiological
supervision and
interpretation, all
endograft extension(s)
placed in the aorta from
the level of the renal
arteries to the iliac
bifurcation, and all
angioplasty/stenting
performed from the level
of the renal arteries to
the iliac bifurcation;
for other than rupture
(e.g., for aneurysm,
pseudoaneurysm,
dissection, penetrating
ulcer).
34X04.................... Endovascular repair of NEW 45.00 45.00 No.
infrarenal aorta and/or
iliac artery(ies) by
deployment of an aorto-
uniiliac endograft
including pre-procedure
sizing and device
selection, all
nonselective
catheterization(s), all
associated radiological
supervision and
interpretation, all
endograft extension(s)
placed in the aorta from
the level of the renal
arteries to the iliac
bifurcation, and all
angioplasty/stenting
performed from the level
of the renal arteries to
the iliac bifurcation;
for rupture including
temporary aortic and/or
iliac balloon occlusion
when performed (e.g., for
aneurysm, pseudoaneurysm,
dissection, penetrating
ulcer, traumatic
disruption).
[[Page 34016]]
34X05.................... Endovascular repair of NEW 29.58 29.58 No.
infrarenal aorta and/or
iliac artery(ies) by
deployment of an aorto-
biiliac endograft
including pre-procedure
sizing and device
selection, all
nonselective
catheterization(s), all
associated radiological
supervision and
interpretation, all
endograft extension(s)
placed in the aorta from
the level of the renal
arteries to the iliac
bifurcation, and all
angioplasty/stenting
performed from the level
of the renal arteries to
the iliac bifurcation;
for other than rupture
(e.g., for aneurysm,
pseudoaneurysm,
dissection, penetrating
ulcer).
34X06.................... Endovascular repair of NEW 45.00 45.00 No.
infrarenal aorta and/or
iliac artery(ies) by
deployment of an aorto-
biiliac endograft
including pre-procedure
sizing and device
selection, all
nonselective
catheterization(s), all
associated radiological
supervision and
interpretation, all
endograft extension(s)
placed in the aorta from
the level of the renal
arteries to the iliac
bifurcation, and all
angioplasty/stenting
performed from the level
of the renal arteries to
the iliac bifurcation;
for rupture including
temporary aortic and/or
iliac balloon occlusion
when performed (e.g., for
aneurysm, pseudoaneurysm,
dissection, penetrating
ulcer, traumatic
disruption).
34X07.................... Endovascular repair of NEW 22.28 22.28 No.
iliac artery by
deployment of an ilio-
iliac tube endograft
including pre-procedure
sizing and device
selection, all
nonselective
catheterization(s), all
associated radiological
supervision and
interpretation, and all
endograft extension(s)
proximally to the aortic
bifurcation and distally
to the iliac bifurcation,
and treatment zone
angioplasty/stenting when
performed, unilateral;
for other than rupture
(e.g., for aneurysm,
pseudoaneurysm,
dissection, arteriovenous
malformation).
34X08.................... Endovascular repair of NEW 36.50 36.50 No.
iliac artery by
deployment of an ilio-
iliac tube endograft
including pre-procedure
sizing and device
selection, all
nonselective
catheterization(s), all
associated radiological
supervision and
interpretation, and all
endograft extension(s)
proximally to the aortic
bifurcation and distally
to the iliac bifurcation,
and treatment zone
angioplasty/stenting when
performed, unilateral;
for rupture including
temporary aortic and/or
iliac balloon occlusion
when performed (e.g., for
aneurysm, pseudoaneurysm,
dissection, arteriovenous
malformation, traumatic
disruption).
34X09.................... Placement of extension NEW 6.50 6.50 No.
prosthesis(es) distal to
the common iliac
artery(ies) or proximal
to the renal artery(ies)
for endovascular repair
of infrarenal abdominal
aortic or iliac aneurysm,
false aneurysm,
dissection, penetrating
ulcer, including pre-
procedure sizing and
device selection, all
nonselective
catheterization(s), all
associated radiological
supervision and
interpretation, and
treatment zone
angioplasty/stenting when
performed, per vessel
treated.
34X10.................... Delayed placement of NEW 15.00 15.00 No.
distal or proximal
extension prosthesis for
endovascular repair of
infrarenal abdominal
aortic or iliac aneurysm,
false aneurysm,
dissection, endoleak, or
endograft migration,
including pre-procedure
sizing and device
selection, all
nonselective
catheterization(s), all
associated radiological
supervision and
interpretation, and
treatment zone
angioplasty/stenting when
performed; initial vessel
treated.
34X11.................... Delayed placement of NEW 6.00 6.00 No.
distal or proximal
extension prosthesis for
endovascular repair of
infrarenal abdominal
aortic or iliac aneurysm,
false aneurysm,
dissection, endoleak, or
endograft migration,
including pre-procedure
sizing and device
selection, all
nonselective
catheterization(s), all
associated radiological
supervision and
interpretation, and
treatment zone
angioplasty/stenting when
performed; each
additional vessel treated.
34X12.................... Transcatheter delivery of NEW 12.00 12.00 No.
enhanced fixation
device(s) to the
endograft (e.g., anchor,
screw, tack) and all
associated radiological
supervision and
interpretation.
34X13.................... Percutaneous access and NEW 2.50 2.50 No.
closure of femoral artery
for delivery of endograft
through a large sheath
(12 French or larger),
including ultrasound
guidance, when performed,
unilateral.
34X15.................... Open femoral artery NEW 5.25 5.25 No.
exposure with creation of
conduit for delivery of
endovascular prosthesis
or for establishment of
cardiopulmonary bypass,
by groin incision,
unilateral.
34X19.................... Open axillary/subclavian NEW 6.00 6.00 No.
artery exposure for
delivery of endovascular
prosthesis by
infraclavicular or
supraclavicular incision,
unilateral.
34X20.................... Open axillary/subclavian NEW 7.19 7.19 No.
artery exposure with
creation of conduit for
delivery of endovascular
prosthesis or for
establishment of
cardiopulmonary bypass,
by infraclavicular or
supraclavicular incision,
unilateral.
36215.................... Selective catheter 4.67 4.17 4.17 No.
placement, arterial
system; each first order
thoracic or
brachiocephalic branch,
within a vascular family.
36216.................... Selective catheter 5.27 5.27 5.27 No.
placement, arterial
system; initial second
order thoracic or
brachiocephalic branch,
within a vascular family.
36217.................... Selective catheter 6.29 6.29 6.29 No.
placement, arterial
system; initial third
order or more selective
thoracic or
brachiocephalic branch,
within a vascular family.
36218.................... Selective catheter 1.01 1.01 1.01 No.
placement, arterial
system; additional second
order, third order, and
beyond, thoracic or
brachiocephalic branch,
within a vascular family.
36470.................... Injection of sclerosant; 1.10 0.75 0.75 No.
single incompetent vein
(other than
telangiectasia).
36471.................... Injection of sclerosant; 1.65 1.50 1.50 No.
multiple incompetent
veins (other than
telangiectasia), same leg.
364X3.................... Endovenous ablation NEW 3.50 3.50 No.
therapy of incompetent
vein, extremity, by
transcatheter delivery of
a chemical adhesive
(e.g., cyanoacrylate)
remote from the access
site, inclusive of all
imaging guidance and
monitoring, percutaneous;
first vein treated.
364X4.................... Endovenous ablation NEW 1.75 1.75 No.
therapy of incompetent
vein, extremity, by
transcatheter delivery of
a chemical adhesive
(e.g., cyanoacrylate)
remote from the access
site, inclusive of all
imaging guidance and
monitoring, percutaneous;
subsequent vein(s)
treated in a single
extremity, each through
separate access sites.
364X5.................... Injection of non- NEW 2.35 2.35 No.
compounded foam
sclerosant with
ultrasound compression
maneuvers to guide
dispersion of the
injectate, inclusive of
all imaging guidance and
monitoring; single
incompetent extremity
truncal vein (e.g., great
saphenous vein, accessory
saphenous vein).
364X6.................... Injection of non- NEW 3.00 3.00 No.
compounded foam
sclerosant with
ultrasound compression
maneuvers to guide
dispersion of the
injectate, inclusive of
all imaging guidance and
monitoring; multiple
incompetent truncal veins
(e.g., great saphenous
vein, accessory saphenous
vein), same leg.
36511.................... Therapeutic apheresis; for 1.74 2.00 2.00 No.
white blood cells.
36512.................... Therapeutic apheresis; for 1.74 2.00 2.00 No.
red blood cells.
36513.................... Therapeutic apheresis; for 1.74 2.00 2.00 No.
platelets.
36514.................... Therapeutic apheresis; for 1.74 1.81 1.81 No.
plasma pheresis.
[[Page 34017]]
36516.................... Therapeutic apheresis; 1.22 1.56 1.56 No.
with extracorporeal
selective adsorption or
selective filtration and
plasma reinfusion.
36522.................... Photopheresis, 1.67 1.75 1.75 No.
extracorporeal.
36555.................... Insertion of non-tunneled 2.43 1.93 1.93 No.
centrally inserted
central venous catheter;
younger than 5 years of
age.
36556.................... Insertion of non-tunneled 2.50 1.75 1.75 No.
centrally inserted
central venous catheter;
age 5 years or older.
36569.................... Insertion of peripherally 1.82 1.70 1.70 No.
inserted central venous
catheter (PICC), without
subcutaneous port or
pump; age 5 years or
older.
36620.................... Arterial catheterization 1.15 1.00 1.00 No.
or cannulation for
sampling, monitoring or
transfusion (separate
procedure); percutaneous.
38220.................... Diagnostic bone marrow; 1.08 1.20 1.20 Yes.
aspiration(s).
38221.................... Diagnostic bone marrow; 1.37 1.28 1.28 Yes.
biopsy(ies).
382X3.................... Diagnostic bone marrow; NEW 1.44 1.44 Yes.
biopsy(ies) and
aspiration(s).
3857X.................... Laparoscopy, surgical; NEW 20.00 20.00 No.
with bilateral total
pelvic lymphadenectomy
and peri-aortic lymph
node sampling peritoneal
washings, peritoneal
biopsy(s), omentectomy,
and diaphragmatic
washings, including
biopsy(s) when performed.
43107.................... Total or near total 44.18 52.05 52.05 No.
esophagectomy, without
thoracotomy; with
pharyngogastrostomy or
cervical
esophagogastrostomy, with
or without pyloroplasty
(transhiatal).
43112.................... Total or near total 47.48 62.00 62.00 No.
esophagectomy, with
thoracotomy; with
pharyngogastrostomy or
cervical
esophagogastrostomy, with
or without pyloroplasty
(i.e., McKeown
esophagectomy, or tri-
incisional esophagectomy).
43117.................... Partial esophagectomy, 43.65 57.50 57.50 No.
distal two-thirds, with
thoracotomy and separate
abdominal incision, with
or without proximal
gastrectomy; with
thoracic
esophagogastrostomy, with
or without pyloroplasty
(Ivor Lewis).
432X5.................... Esophagectomy, total or NEW 55.00 55.00 No
near total, with
laparoscopic mobilization
of the abdominal and
mediastinal esophagus and
proximal gastrectomy,
with laparoscopic pyloric
drainage procedure if
performed, with open
cervical
pharyngogastrostomy or
esophagogastrostomy
(i.e., laparoscopic
transhiatal
esophagectomy).
432X6.................... Esophagectomy, distal two- NEW 63.00 63.00 No.
thirds, with laparoscopic
mobilization of the
abdominal and lower
mediastinal esophagus and
proximal gastrectomy,
with laparoscopic pyloric
drainage procedure if
performed, with separate
thoracoscopic
mobilization of the
middle and upper
mediastinal esophagus and
thoracic
esophagogastrostomy
(i.e., laparoscopic
thoracoscopic
esophagectomy, Ivor Lewis
esophagectomy).
432X7.................... Esophagectomy, total or NEW 66.42 66.42 No.
near total, with
thoracoscopic
mobilization of the
upper, middle, and lower
mediastinal esophagus,
with separate
laparoscopic proximal
gastrectomy, with
laparoscopic pyloric
drainage procedure if
performed, with open
cervical
pharyngogastrostomy or
esophagogastrostomy
(i.e., thoracoscopic,
laparoscopic and cervical
incision esophagectomy,
McKeown esophagectomy,
tri-incisional
esophagectomy).
51798.................... Measurement of post- 0.00 0.00 0.00 No.
voiding residual urine
and/or bladder capacity
by ultrasound, non-
imaging.
52601.................... Transurethral 15.26 13.16 13.16 No.
electrosurgical resection
of prostate, including
control of postoperative
bleeding, complete
(vasectomy, meatotomy,
cystourethroscopy,
urethral calibration and/
or dilation, and internal
urethrotomy are included).
55X87.................... Transperineal placement of NEW 3.03 3.03 No.
biodegradable material,
peri-prostatic, single or
multiple injection(s),
including image guidance,
when performed.
57240.................... Anterior colporrhaphy, 11.50 10.08 10.08 No.
repair of cystocele with
or without repair of
urethrocele, including
cystourethroscopy, when
performed.
57250.................... Posterior colporrhaphy, 11.50 10.08 10.08 No.
repair of rectocele with
or without perineorrhaphy.
57260.................... Combined anteroposterior 14.44 13.25 13.25 No.
colporrhaphy, including
cystourethroscopy, when
performed.
57265.................... Combined anteroposterior 15.94 15.00 15.00 No.
colporrhaphy, including
cystourethroscopy, when
performed; with
enterocele repair.
5857X.................... Laparoscopy, surgical, NEW 32.60 32.60 No.
total hysterectomy; with
or without salpingo-
oophorectomy, unilateral
or bilateral, with
resection of malignancy
(tumor debulking), with
omentectomy.
64418.................... Injection, anesthetic 1.32 1.10 1.10 No.
agent; suprascapular
nerve.
64553.................... Percutaneous implantation 2.36 6.13 6.13 No
of neurostimulator
electrode array; cranial
nerve.
64555.................... Percutaneous implantation 2.32 5.76 5.76 No.
of neurostimulator
electrode array;
peripheral nerve
(excludes sacral nerve).
64910.................... Nerve repair; with 11.39 10.52 10.52 No.
synthetic conduit or vein
allograft (e.g., nerve
tube), each nerve.
64911.................... Nerve repair; with 14.39 14.00 14.00 No
autogenous vein graft
(includes harvest of vein
graft), each nerve.
64X91.................... Nerve repair; with nerve NEW 12.00 12.00 No.
allograft, each nerve,
first strand (cable).
64X92.................... Nerve repair; with nerve NEW 3.00 3.00 No.
allograft, each
additional strand.
67820.................... Correction of trichiasis; 0.71 0.32 0.32 No.
epilation, by forceps
only.
70490.................... Computed tomography, soft 1.28 1.28 1.28 No.
tissue neck; without
contrast material.
70491.................... Computed tomography, soft 1.38 1.38 1.38 No.
tissue neck; with
contrast material(s).
70492.................... Computed tomography, soft 1.45 1.62 1.62 No.
tissue neck; without
contrast material
followed by contrast
material(s) and further
sections.
70544.................... Magnetic resonance 1.20 1.20 1.20 No.
angiography, head;
without contrast
material(s).
70545.................... Magnetic resonance 1.20 1.20 1.20 No.
angiography, head; with
contrast material(s).
70546.................... Magnetic resonance 1.80 1.48 1.48 No.
angiography, head;
without contrast
material(s), followed by
contrast material(s) and
further sequences.
70547.................... Magnetic resonance 1.20 1.20 1.20 No.
angiography, neck;
without contrast
material(s).
70548.................... Magnetic resonance 1.20 1.50 1.50 No.
angiography, neck; with
contrast material(s).
70549.................... Magnetic resonance 1.80 1.80 1.80 No.
angiography, neck;
without contrast
material(s), followed by
contrast material(s) and
further sequences.
710X1.................... Radiologic examination, NEW 0.18 0.18 No.
chest; single view.
710X2.................... Radiologic examination, NEW 0.22 0.22 No.
chest; 2 views.
710X3.................... Radiologic examination, NEW 0.27 0.27 No.
chest; 3 views.
710X4.................... Radiologic examination, NEW 0.31 0.31 No.
chest; 4 or more views.
71100.................... Radiologic examination, 0.22 0.22 0.22 No.
ribs, unilateral; 2 views.
71101.................... Radiologic examination, 0.27 0.27 0.27 No.
ribs, unilateral;
including posteroanterior
chest, minimum of 3 views.
71110.................... Radiologic examination, 0.27 0.29 0.29 No.
ribs, bilateral; 3 views.
71111.................... Radiologic examination, 0.32 0.32 0.32 No.
ribs, bilateral;
including posteroanterior
chest, minimum of 4 views.
[[Page 34018]]
71250.................... Computed tomography, 1.02 1.16 1.16 No.
thorax; without contrast
material.
71260.................... Computed tomography, 1.24 1.24 1.24 No.
thorax; with contrast
material(s).
71270.................... Computed tomography, 1.38 1.38 1.38 No.
thorax; without contrast
material, followed by
contrast material(s) and
further sections.
72195.................... Magnetic resonance (e.g., 1.46 1.46 1.46 No.
proton) imaging, pelvis;
without contrast
material(s).
72196.................... Magnetic resonance (e.g., 1.73 1.73 1.73 No.
proton) imaging, pelvis;
with contrast material(s).
72197.................... Magnetic resonance (e.g., 2.26 2.20 2.20 No.
proton) imaging, pelvis;
without contrast
material(s), followed by
contrast material(s) and
further sequences.
73100.................... Radiologic examination, 0.16 0.16 0.16 No.
wrist; 2 views.
73110.................... Radiologic examination, 0.17 0.17 0.17 No.
wrist; complete, minimum
of 3 views.
73120.................... Radiologic examination, 0.16 0.16 0.16 No.
hand; 2 views.
73130.................... Radiologic examination, 0.17 0.17 0.17 No.
hand; minimum of 3 views.
73140.................... Radiologic examination, 0.13 0.13 0.13 No.
finger(s), minimum of 2
views.
73718.................... Magnetic resonance (e.g., 1.35 1.35 1.35 No.
proton) imaging, lower
extremity other than
joint; without contrast
material(s).
73719.................... Magnetic resonance (e.g., 1.62 1.62 1.62 No.
proton) imaging, lower
extremity other than
joint; with contrast
material(s).
73720.................... Magnetic resonance (e.g., 2.15 2.15 2.15 No.
proton) imaging, lower
extremity other than
joint; without contrast
material(s), followed by
contrast material(s) and
further sequences.
74022.................... Radiologic examination, 0.32 0.32 0.32 No.
abdomen; complete acute
abdomen series, including
supine, erect, and/or
decubitus views, single
view chest.
740X1.................... Radiologic examination, NEW 0.18 0.18 No.
abdomen; 1 view.
740X2.................... Radiologic examination, NEW 0.23 0.23 No.
abdomen; 2 views.
740X3.................... Radiologic examination, NEW 0.27 0.27 No.
abdomen; 3 or more views.
74181.................... Magnetic resonance (e.g., 1.46 1.46 1.46 No.
proton) imaging, abdomen;
without contrast
material(s).
74182.................... Magnetic resonance (e.g., 1.73 1.73 1.73 No.
proton) imaging, abdomen;
with contrast material(s).
74183.................... Magnetic resonance (e.g., 2.26 2.20 2.20 No.
proton) imaging, abdomen;
without contrast
material(s), followed by
with contrast material(s)
and further sequences.
75635.................... Computed tomographic 2.40 2.40 2.40 No.
angiography, abdominal
aorta and bilateral
iliofemoral lower
extremity runoff, with
contrast material(s),
including noncontrast
images, if performed, and
image postprocessing.
75710.................... Angiography, extremity, 1.14 1.75 1.75 No.
unilateral, radiological
supervision and
interpretation.
75716.................... Angiography, extremity, 1.31 1.97 1.97 No.
bilateral, radiological
supervision and
interpretation.
76510.................... Ophthalmic ultrasound, 1.55 0.70 0.70 No.
diagnostic; B-scan and
quantitative A-scan
performed during the same
patient encounter.
76511.................... Ophthalmic ultrasound, 0.94 0.64 0.64 No.
diagnostic; quantitative
A-scan only.
76512.................... Ophthalmic ultrasound, 0.94 0.56 0.56 No.
diagnostic; B-scan (with
or without superimposed
non-quantitative A-scan).
76516.................... Ophthalmic biometry by 0.54 0.40 0.40 No.
ultrasound echography, A-
scan.
76519.................... Ophthalmic biometry by 0.54 0.54 0.54 No.
ultrasound echography, A-
scan; with intraocular
lens power calculation.
76881.................... Ultrasound, extremity, 0.63 0.63 0.63 No.
nonvascular, real-time
with image documentation;
complete.
76882.................... Ultrasound, extremity, 0.49 0.49 0.49 No.
nonvascular, real-time
with image documentation;
limited, anatomic
specific.
77261.................... Therapeutic radiology 1.39 1.30 1.30 No.
treatment planning;
simple.
77262.................... Therapeutic radiology 2.11 2.00 2.00 No.
treatment planning;
intermediate.
77263.................... Therapeutic radiology 3.14 3.14 3.14 No.
treatment planning;
complex.
78300.................... Bone and/or joint imaging; 0.62 0.62 0.62 No.
limited area.
78305.................... Bone and/or joint imaging; 0.83 0.83 0.83 No.
multiple areas.
78306.................... Bone and/or joint imaging; 0.86 0.86 0.86 No.
whole body.
88333.................... Pathology consultation 1.20 1.20 1.20 No.
during surgery; cytologic
examination (e.g., touch
prep, squash prep),
initial site.
88334.................... Pathology consultation 0.73 0.73 0.73 No.
during surgery; cytologic
examination (e.g., touch
prep, squash prep), each
additional site.
88360.................... Morphometric analysis, 1.10 0.85 0.85 No.
tumor
immunohistochemistry
(e.g., Her-2/neu,
estrogen receptor/
progesterone receptor),
quantitative or
semiquantitative, per
specimen, each single
antibody stain procedure;
manual.
88361.................... Morphometric analysis, 1.18 0.95 0.95 No.
tumor
immunohistochemistry
(e.g., Her-2/neu,
estrogen receptor/
progesterone receptor),
quantitative or
semiquantitative, per
specimen, each single
antibody stain procedure;
using computer-assisted
technology.
92136.................... Ophthalmic biometry by 0.54 0.54 0.54 No.
partial coherence
interferometry with
intraocular lens power
calculation.
93279.................... Programming device 0.65 0.65 0.65 No.
evaluation (in person)
with iterative adjustment
of the implantable device
to test the function of
the device and select
optimal permanent
programmed values with
analysis, review and
report by a physician or
other qualified health
care professional; single
lead pacemaker system.
93280.................... Programming device 0.77 0.77 0.77 No.
evaluation (in person)
with iterative adjustment
of the implantable device
to test the function of
the device and select
optimal permanent
programmed values with
analysis, review and
report by a physician or
other qualified health
care professional; dual
lead pacemaker system.
93281.................... Programming device 0.90 0.85 0.85 No.
evaluation (in person)
with iterative adjustment
of the implantable device
to test the function of
the device and select
optimal permanent
programmed values with
analysis, review and
report by a physician or
other qualified health
care professional;
multiple lead pacemaker
system.
93282.................... Programming device 0.85 0.85 0.85 No.
evaluation (in person)
with iterative adjustment
of the implantable device
to test the function of
the device and select
optimal permanent
programmed values with
analysis, review and
report by a physician or
other qualified health
care professional; single
lead transvenous
implantable defibrillator
system.
93283.................... Programming device 1.15 1.15 1.15 No.
evaluation (in person)
with iterative adjustment
of the implantable device
to test the function of
the device and select
optimal permanent
programmed values with
analysis, review and
report by a physician or
other qualified health
care professional; dual
lead transvenous
implantable defibrillator
system.
[[Page 34019]]
93284.................... Programming device 1.25 1.25 1.25 No.
evaluation (in person)
with iterative adjustment
of the implantable device
to test the function of
the device and select
optimal permanent
programmed values with
analysis, review and
report by a physician or
other qualified health
care professional;
multiple lead transvenous
implantable defibrillator
system.
93285.................... Programming device 0.52 0.52 0.52 No.
evaluation (in person)
with iterative adjustment
of the implantable device
to test the function of
the device and select
optimal permanent
programmed values with
analysis, review and
report by a physician or
other qualified health
care professional;
implantable loop recorder
system.
93286.................... Peri-procedural device 0.30 0.30 0.30 No.
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 pacemaker system.
93287.................... Peri-procedural device 0.45 0.45 0.45 No.
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.
93288.................... Interrogation device 0.43 0.43 0.43 No.
evaluation (in person)
with analysis, review and
report by a physician or
other qualified health
care professional,
includes connection,
recording and
disconnection per patient
encounter; single, dual,
or multiple lead
pacemaker system.
93289.................... Interrogation device 0.92 0.75 0.75 No.
evaluation (in person)
with analysis, review and
report by a physician or
other qualified health
care professional,
includes connection,
recording and
disconnection per patient
encounter; single, dual,
or multiple lead
transvenous implantable
defibrillator system,
including analysis of
heart rhythm derived data
elements.
93290.................... Interrogation device 0.43 0.43 0.43 No.
evaluation (in person)
with analysis, review and
report by a physician or
other qualified health
care professional,
includes connection,
recording and
disconnection per patient
encounter; implantable
cardiovascular monitor
system, including
analysis of 1 or more
recorded physiologic
cardiovascular data
elements from all
internal and external
sensors.
93291.................... Interrogation device 0.43 0.37 0.37 No.
evaluation (in person)
with analysis, review and
report by a physician or
other qualified health
care professional,
includes connection,
recording and
disconnection per patient
encounter; implantable
loop recorder system,
including heart rhythm
derived data analysis.
93292.................... Interrogation device 0.43 0.43 0.43 No.
evaluation (in person)
with analysis, review and
report by a physician or
other qualified health
care professional,
includes connection,
recording and
disconnection per patient
encounter; wearable
defibrillator system.
93293.................... Transtelephonic rhythm 0.32 0.31 0.31 No.
strip pacemaker
evaluation(s) single,
dual, or multiple lead
pacemaker system,
includes recording with
and without magnet
application with
analysis, review and
report(s) by a physician
or other qualified health
care professional, up to
90 days.
93294.................... Interrogation device 0.65 0.60 0.60 No.
evaluation(s) (remote),
up to 90 days; single,
dual, or multiple lead
pacemaker system with
interim analysis,
review(s) and report(s)
by a physician or other
qualified health care
professional.
93295.................... Interrogation device 1.29 0.74 0.74 No.
evaluation(s) (remote),
up to 90 days; single,
dual, or multiple lead
implantable defibrillator
system with interim
analysis, review(s) and
report(s) by a physician
or other qualified health
care professional.
93296.................... Interrogation device 0.00 0.00 0.00 No.
evaluation(s) (remote),
up to 90 days; single,
dual, or multiple lead
pacemaker system or
implantable defibrillator
system, remote data
acquisition(s), receipt
of transmissions and
technician review,
technical support and
distribution of results.
93297.................... Interrogation device 0.52 0.52 0.52 No.
evaluation(s), (remote)
up to 30 days;
implantable
cardiovascular monitor
system, including
analysis of 1 or more
recorded physiologic
cardiovascular data
elements from all
internal and external
sensors, analysis,
review(s) and report(s)
by a physician or other
qualified health care
professional.
93298.................... Interrogation device 0.52 0.52 0.52 No.
evaluation(s), (remote)
up to 30 days;
implantable loop recorder
system, including
analysis of recorded
heart rhythm data,
analysis, review(s) and
report(s) by a physician
or other qualified health
care professional.
93299.................... Interrogation device 0.00 0.00 0.00 No.
evaluation(s), (remote)
up to 30 days;
implantable
cardiovascular monitor
system or implantable
loop recorder system,
remote data
acquisition(s), receipt
of transmissions and
technician review,
technical support and
distribution of results.
93306.................... Echocardiography, 1.30 1.50 1.50 No.
transthoracic, real-time
with image documentation
(2D), includes M-mode
recording, when
performed, complete, with
spectral Doppler
echocardiography, and
with color flow Doppler
echocardiography.
93307.................... Echocardiography, 0.92 0.92 0.92 No.
transthoracic, real-time
with image documentation
(2D), includes M-mode
recording, when
performed, complete,
without spectral or color
Doppler echocardiography.
93308.................... Echocardiography, 0.53 0.53 0.53 No.
transthoracic, real-time
with image documentation
(2D), includes M-mode
recording, when
performed, follow-up or
limited study.
93350.................... Echocardiography, 1.46 1.46 1.46 No.
transthoracic, real-time
with image documentation
(2D), includes M-mode
recording, when
performed, during rest
and cardiovascular stress
test using treadmill,
bicycle exercise and/or
pharmacologically induced
stress, with
interpretation and report.
93351.................... Echocardiography, 1.75 1.75 1.75 No.
transthoracic, real-time
with image documentation
(2D), includes M-mode
recording, when
performed, during rest
and cardiovascular stress
test using treadmill,
bicycle exercise and/or
pharmacologically induced
stress, with
interpretation and
report; including
performance of continuous
electrocardiographic
monitoring, with
supervision by a
physician or other
qualified health care
professional.
93503.................... Insertion and placement of 2.91 2.00 2.00 No.
flow directed catheter
(e.g., Swan-Ganz) for
monitoring purposes.
93613.................... Intracardiac 6.99 5.23 5.23 No.
electrophysiologic 3-
dimensional mapping.
93668.................... Peripheral arterial N 0.00 0.00 No.
disease (PAD)
rehabilitation, per
session.
94621.................... Cardiopulmonary exercise 1.42 1.42 1.42 No.
testing, including
measurements of minute
ventilation, CO2
production, O2 uptake,
and electrocardiographic
recordings.
946X2.................... Exercise test for NEW 0.70 0.70 No.
bronchospasm, including
pre- and post-spirometry
and pulse oximetry.
946X3.................... Pulmonary stress testing NEW 0.48 0.48 No.
(e.g., 6-minute walk
test), including
measurement of heart
rate, oximetry, and
oxygen titration, when
performed.
95004.................... Percutaneous tests 0.01 0.01 0.01 No.
(scratch, puncture,
prick) with allergenic
extracts, immediate type
reaction, including test
interpretation and
report, specify number of
tests.
[[Page 34020]]
95250.................... Ambulatory continuous 0.00 0.00 0.00 No.
glucose monitoring of
interstitial tissue fluid
via a subcutaneous sensor
for a minimum of 72
hours; sensor placement,
hook-up, calibration of
monitor, patient
training, removal of
sensor, and printout of
recording.
95251.................... Ambulatory continuous 0.85 0.70 0.70 No.
glucose monitoring of
interstitial tissue fluid
via a subcutaneous sensor
for a minimum of 72
hours; interpretation and
report.
95930.................... Visual evoked potential 0.35 0.35 0.35 No.
(VEP) testing central
nervous system except
glaucoma, checkerboard or
flash, with
interpretation and report.
96160.................... Administration of patient- 0.00 0.00 0.00 No.
focused health risk
assessment instrument
(e.g., health hazard
appraisal) with scoring
and documentation, per
standardized instrument.
96161.................... Administration of 0.00 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.
96360.................... Intravenous infusion, 0.17 0.17 0.17 No.
hydration; initial, 31
minutes to 1 hour.
96361.................... Intravenous infusion, 0.09 0.09 0.09 No.
hydration; each
additional hour.
96372.................... Therapeutic, prophylactic, 0.17 0.17 0.17 No.
or diagnostic injection
(specify substance or
drug); subcutaneous or
intramuscular.
96374.................... Therapeutic, prophylactic, 0.18 0.18 0.18 No.
or diagnostic injection
(specify substance or
drug); intravenous push,
single or initial
substance/drug.
96375.................... Therapeutic, prophylactic, 0.10 0.10 0.10 No.
or diagnostic injection
(specify substance or
drug); each additional
sequential intravenous
push of a new substance/
drug.
96377.................... Application of on-body 0.00 0.17 0.17 No.
injector (includes
cannula insertion) for
timed subcutaneous
injection.
96401.................... Chemotherapy 0.21 0.21 0.21 No.
administration,
subcutaneous or
intramuscular; non-
hormonal anti-neoplastic.
96402.................... Chemotherapy 0.19 0.19 0.19 No.
administration,
subcutaneous or
intramuscular; hormonal
anti-neoplastic.
96409.................... Chemotherapy 0.24 0.24 0.24 No.
administration;
intravenous, push
technique, single or
initial substance/drug.
96411.................... Chemotherapy 0.20 0.20 0.20 No.
administration;
intravenous, push
technique, each
additional substance/drug.
96910.................... Photochemotherapy; tar and 0.00 0.00 0.00 No.
ultraviolet B (Goeckerman
treatment) or petrolatum
and ultraviolet B.
96X73.................... Photodynamic therapy by NEW 0.48 0.48 No.
external application of
light to destroy
premalignant lesions of
the skin and adjacent
mucosa with application
and illumination/
activation of
photosensitizing drug(s),
per day.
96X74.................... Debridement of NEW 1.01 1.01 No.
premalignant
hyperkeratotic lesion(s)
(i.e., targeted
curettage, abrasion)
followed with
photodynamic therapy by
external application of
light to destroy
premalignant lesions of
the skin and adjacent
mucosa with application
and illumination/
activation of
photosensitizing drug(s),
per day.
97012.................... Application of a modality 0.25 0.25 0.25 No.
to 1 or more areas;
traction, mechanical.
97014.................... Application of a modality 0.18 0.18 0.18 No.
to 1 or more areas;
electrical stimulation
(unattended).
97016.................... Application of a modality 0.18 0.18 0.18 No.
to 1 or more areas;
vasopneumatic devices.
97018.................... Application of a modality 0.06 0.06 0.06 No.
to 1 or more areas;
paraffin bath.
97022.................... Application of a modality 0.17 0.17 0.17 No.
to 1 or more areas;
whirlpool.
97032.................... Application of a modality 0.25 0.25 0.25 No.
to 1 or more areas;
electrical stimulation
(manual), each 15 minutes.
97033.................... Application of a modality 0.26 0.26 0.26 No.
to 1 or more areas;
iontophoresis, each 15
minutes.
97034.................... Application of a modality 0.21 0.21 0.21 No.
to 1 or more areas;
contrast baths, each 15
minutes.
97035.................... Application of a modality 0.21 0.21 0.21 No.
to 1 or more areas;
ultrasound, each 15
minutes.
97110.................... Therapeutic procedure, 1 0.45 0.45 0.45 No.
or more areas, each 15
minutes; therapeutic
exercises to develop
strength and endurance,
range of motion and
flexibility.
97112.................... Therapeutic procedure, 1 0.45 0.50 0.50 No.
or more areas, each 15
minutes; neuromuscular
reeducation of movement,
balance, coordination,
kinesthetic sense,
posture, and/or
proprioception for
sitting and/or standing
activities.
97113.................... Therapeutic procedure, 1 0.44 0.48 0.48 No.
or more areas, each 15
minutes; aquatic therapy
with therapeutic
exercises.
97116.................... Therapeutic procedure, 1 0.40 0.45 0.45 No.
or more areas, each 15
minutes; gait training
(includes stair climbing).
97140.................... Manual therapy techniques 0.43 0.43 0.43 No.
(e.g., mobilization/
manipulation, manual
lymphatic drainage,
manual traction), 1 or
more regions, each 15
minutes.
97530.................... Therapeutic activities, 0.44 0.44 0.44 No.
direct (one-on-one)
patient contact (use of
dynamic activities to
improve functional
performance), each 15
minutes.
97533.................... Sensory integrative 0.44 0.48 0.48 No.
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 0.45 0.45 0.45 No.
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 0.45 0.48 0.48 No.
reintegration training
(e.g., shopping,
transportation, money
management, avocational
activities and/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 0.45 0.48 0.48 No.
(e.g., assessment,
fitting, training), each
15 minutes.
97760.................... Orthotic(s) management and 0.45 0.50 0.50 No.
training (including
assessment and fitting
when not otherwise
reported), upper
extremity(ies), lower
extremity(ies) and/or
trunk, initial
orthotic(s) encounter,
each 15 minutes.
97761.................... Prosthetic(s) training, 0.45 0.50 0.50 No.
upper and/or lower
extremity(ies), initial
prosthetic(s) encounter,
each 15 minutes.
977X1.................... Orthotic(s)/prosthetic(s) NEW 0.48 0.48 No.
management and/or
training, upper
extremity(ies), lower
extremity(ies), and/or
trunk, subsequent
orthotic(s)/prosthetic(s)
encounter, each 15
minutes.
97X11.................... Therapeutic interventions NEW 1.50 I Yes.
that focus on cognitive
function (e.g.,
attention, memory,
reasoning, executive
function, problem
solving, and/or pragmatic
functioning) and
compensatory strategies
to manage the performance
of an activity (e.g.,
managing time or
schedules, initiating,
organizing and sequencing
tasks, direct (one-on-
one) patient contact (do
not report 97X11 in
conjunction with 0364T,
0365T, 0368T, 0369T)
(report 97X11 only once
per day).
993X1.................... Patient/caregiver training NEW 0.00 0.00 No.
for initiation of home
INR monitoring under the
direction of a physician
or other qualified health
care professional,
including face-to-face,
use and care of the INR
monitor, obtaining blood
sample, instructions for
reporting home INR test
results, and
documentation of
patient's/caregiver's
ability to perform
testing and report
results.
[[Page 34021]]
993X2.................... Anticoagulant management NEW 0.18 0.18 No.
for a patient taking
warfarin, must include
review and interpretation
of a new home, office, or
lab International
No.rmalized Ratio (INR)
test result, patient
instructions, dosage
adjustment (as needed),
and scheduling of
additional test(s) when
performed.
994X1.................... Initial psychiatric NEW 1.70 1.70 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, 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.
994X2.................... Subsequent psychiatric NEW 1.53 1.53 No.
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.
994X3.................... Initial or subsequent NEW 0.82 0.82 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.
99XX3.................... Assessment of and care NEW 3.44 3.44 No.
planning for a patient
with cognitive
impairment, requiring an
independent historian, in
the office or other
outpatient, home or
domiciliary or rest home,
with all of the following
required elements:
Cognition-focused
evaluation including a
pertinent history and
examination; Medical
decision making of
moderate or high
complexity; Functional
assessment (e.g., Basic
and Instrumental
Activities of Daily
Living), including
decision-making capacity;
Use of standardized
instruments for staging
of dementia (e.g.,
Functional Assessment
Staging Test [FAST],
Clinical Dementia Rating
[CDR]); Medication
reconciliation and review
for high-risk
medications; Evaluation
for neuropsychiatric and
behavioral symptoms,
including depression,
including use of
standardized screening
instrument(s); Evaluation
of safety (e.g., home),
including motor vehicle
operation; Identification
of caregiver(s),
caregiver knowledge,
caregiver needs, social
supports, and the
willingness of caregiver
to take on caregiving
tasks; Development,
updating or revision, or
review of an Advance Care
Plan; Creation of a
written care plan,
including initial plans
to address any
neuropsychiatric
symptoms, neuro-cognitive
symptoms, functional
limitations, and referral
to community resources as
needed (e.g.,
rehabilitation services,
adult day programs,
support groups) shared
with the patient and/or
caregiver with initial
education and support.
Typically, 50 minutes are
spent face-to-face with
the patient and/or family
or caregiver.
99XX5.................... Care management services NEW 0.61 0.61 No.
for behavioral health
conditions, at least 20
minutes of clinical staff
time, directed by a
physician or other
qualified health care
professional, per
calendar month, with the
following required
elements: Initial
assessment or follow-up
monitoring, including the
use of applicable
validated rating scales;
Behavioral health care
planning in relation to
behavioral/psychiatric
health problems,
including revision for
patients who are not
progressing or whose
status changes;
Facilitating and
coordinating treatment
such as psychotherapy,
pharmacotherapy,
counseling and/or
psychiatric consultation;
and Continuity of care
with a designated member
of the care team.
G0283.................... Electrical stimulation 0.18 0.18 0.18 No.
(unattended), to one or
more areas for
indication(s) other than
wound care, as part of a
therapy plan of care.
GDDD1.................... Insertion, non- NEW ......... 1.82 No.
biodegradable drug
delivery implants, 4 or
more.
GDDD2.................... Removal, non-biodegradable NEW ......... 2.10 No.
drug deliver implants, 4
or more.
GDDD3.................... Removal with reinsertion, NEW ......... 3.55 No.
non-biodegradable drug
delivery implants, 4 or
more.
GRRR1.................... Superficial radiation NEW ......... 7.93 No.
treatment planning and
management related
services, including but
not limited to, when
performed, clinical
treatment planning (e.g.,
77261, 77262, 77263),
therapeutic radiology
simulation-aided field
setting (e.g., 77280,
77285, 77290, 77293),
basic radiation dosimetry
calculation (e.g.,
77300), treatment devices
(e.g., 77332, 77333,
77334), isodose planning
(e.g., 77306, 77307,
77316, 77317, 77318),
radiation treatment
management (e.g., 77427,
77431, 77432, 77435,
77469, 77470, 77499), and
associated evaluation and
management per course of
treatment.
GXXX1.................... Therapeutic interventions NEW ......... 0.44 No.
that focus on cognitive
function (e.g.,
attention, memory,
reasoning, executive
function, problem
solving, and/or pragmatic
functioning) and
compensatory strategies
to manage the performance
of an activity (e.g.,
managing time or
schedules, initiating,
organizing and sequencing
tasks, direct (one-on-
one) patient contact.
GYYY1.................... Prolonged preventive NEW ......... 1.17 No.
service(s), initial 30
minutes.
GYYY2.................... Prolonged preventive NEW ......... 1.17 No.
service(s), first 30
minutes.
----------------------------------------------------------------------------------------------------------------
[[Page 34022]]
Table 11--CY 2018 Proposed Codes With Direct PE Input Recommendations With Refinements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
RUC CMS Direct
HCPCS code Input code Nonfacility (NF)/ Labor activity recommendation or refinement costs
HCPCS code description Input code description Facility (F) (where applicable) current value (min or Comment change (in
(min or qty) qty) dollars)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
157X1............. Mdfc flap w/prsrv ED050 Technologist PACS NF .................... 115 117 E15: Refined $0.04
vasc pedcl. workstation. equipment time to
conform to changes
in clinical labor
time.
157X1............. Mdfc flap w/prsrv EF014 light, surgical...... NF .................... 115 117 E15: Refined 0.02
vasc pedcl. equipment time to
conform to changes
in clinical labor
time.
157X1............. Mdfc flap w/prsrv EF031 table, power......... NF .................... 115 117 E15: Refined 0.03
vasc pedcl. equipment time to
conform to changes
in clinical labor
time.
157X1............. Mdfc flap w/prsrv EQ011 ECG, 3-channel (with NF .................... 115 117 E15: Refined 0.03
vasc pedcl. SpO2, NIBP, temp, equipment time to
resp). conform to changes
in clinical labor
time.
157X1............. Mdfc flap w/prsrv EQ110 electrocautery- NF .................... 115 117 E15: Refined 0.01
vasc pedcl. hyfrecator, up to 45 equipment time to
watts. conform to changes
in clinical labor
time.
157X1............. Mdfc flap w/prsrv EQ138 instrument pack, NF .................... 127 129 E15: Refined 0.01
vasc pedcl. medium ($1500 and equipment time to
up). conform to changes
in clinical labor
time.
157X1............. Mdfc flap w/prsrv L038A COMT/COT/RN/CST...... NF Obtain vital signs.. 3 5 L1: Refined time to 0.76
vasc pedcl. standard for this
clinical labor task.
29445............. Apply rigid leg cast. EF031 table, power......... NF .................... 69 67 E15: Refined -0.03
equipment time to
conform to changes
in clinical labor
time.
29445............. Apply rigid leg cast. EQ080 cast cart............ NF .................... 69 67 E15: Refined -0.02
equipment time to
conform to changes
in clinical labor
time.
29445............. Apply rigid leg cast. EQ168 light, exam.......... NF .................... 69 67 E15: Refined -0.01
equipment time to
conform to changes
in clinical labor
time.
29445............. Apply rigid leg cast. L037D RN/LPN/MTA........... NF Check dressings & 5 3 L1: Refined time to -0.74
wound/home care standard for this
instructions/ clinical labor task.
coordinate office
visits/
prescriptions.
[[Page 34023]]
29580............. Application of paste EF023 table, exam.......... NF .................... 35 34 E15: Refined 0.00
boot. equipment time to
conform to changes
in clinical labor
time.
29580............. Application of paste EQ168 light, exam.......... NF .................... 35 34 E15: Refined 0.00
boot. equipment time to
conform to changes
in clinical labor
time.
29580............. Application of paste L037D RN/LPN/MTA........... NF Provide pre-service 3 2 L1: Refined time to -0.37
boot. education/obtain standard for this
consent. clinical labor task.
29581............. Apply multlay comprs EF023 table, exam.......... NF .................... 37 36 E15: Refined 0.00
lwr leg. equipment time to
conform to changes
in clinical labor
time.
29581............. Apply multlay comprs EQ168 light, exam.......... NF .................... 37 36 E15: Refined 0.00
lwr leg. equipment time to
conform to changes
in clinical labor
time.
29581............. Apply multlay comprs L037D RN/LPN/MTA........... NF Provide pre-service 3 2 L1: Refined time to -0.37
lwr leg. education/obtain standard for this
consent. clinical labor task.
30140............. Resect inferior EF008 chair with headrest, NF .................... 98 100 E15: Refined 0.02
turbinate. exam, reclining. equipment time to
conform to changes
in clinical labor
time.
30140............. Resect inferior EQ137 instrument pack, NF .................... 102 104 E15: Refined 0.00
turbinate. basic ($500-$1499). equipment time to
conform to changes
in clinical labor
time.
30140............. Resect inferior EQ170 light, fiberoptic NF .................... 98 100 E15: Refined 0.02
turbinate. headlight w-source. equipment time to
conform to changes
in clinical labor
time.
30140............. Resect inferior EQ234 suction and pressure NF .................... 98 100 E15: Refined 0.02
turbinate. cabinet, ENT (SMR). equipment time to
conform to changes
in clinical labor
time.
30140............. Resect inferior EQ383 reusable shaver NF .................... 102 104 E15: Refined 0.01
turbinate. blade, 2mm. equipment time to
conform to changes
in clinical labor
time.
[[Page 34024]]
30140............. Resect inferior EQ384 Microdebrider NF .................... 98 100 E15: Refined 0.03
turbinate. handpiece. equipment time to
conform to changes
in clinical labor
time.
30140............. Resect inferior EQ385 Microdebrider console NF .................... 98 100 E15: Refined 0.06
turbinate. equipment time to
conform to changes
in clinical labor
time.
30140............. Resect inferior L037D RN/LPN/MTA........... NF Obtain vital signs.. 3 5 L1: Refined time to 0.74
turbinate. standard for this
clinical labor task.
30901............. Control of nosebleed. EF008 chair with headrest, NF .................... 22 26 E1: Refined 0.04
exam, reclining. equipment time to
conform to
established
policies for non-
highly technical
equipment.
30901............. Control of nosebleed. EQ137 instrument pack, NF .................... 29 33 E5: Refined 0.01
basic ($500-$1499). equipment time to
conform to
established
policies for
surgical instrument
packs.
30901............. Control of nosebleed. EQ170 light, fiberoptic NF .................... 22 26 E1: Refined 0.03
headlight w-source. equipment time to
conform to
established
policies for non-
highly technical
equipment.
30901............. Control of nosebleed. EQ234 suction and pressure NF .................... 22 26 E1: Refined 0.04
cabinet, ENT (SMR). equipment time to
conform to
established
policies for non-
highly technical
equipment.
30903............. Control of nosebleed. EF008 chair with headrest, NF .................... 27 31 E1: Refined 0.04
exam, reclining. equipment time to
conform to
established
policies for non-
highly technical
equipment.
30903............. Control of nosebleed. EQ110 electrocautery- NF .................... 27 31 E1: Refined 0.01
hyfrecator, up to 45 equipment time to
watts. conform to
established
policies for non-
highly technical
equipment.
30903............. Control of nosebleed. EQ137 instrument pack, NF .................... 34 38 E5: Refined 0.01
basic ($500-$1499). equipment time to
conform to
established
policies for
surgical instrument
packs.
[[Page 34025]]
30903............. Control of nosebleed. EQ170 light, fiberoptic NF .................... 27 31 E1: Refined 0.03
headlight w-source. equipment time to
conform to
established
policies for non-
highly technical
equipment.
30903............. Control of nosebleed. EQ234 suction and pressure NF .................... 27 31 E1: Refined 0.04
cabinet, ENT (SMR). equipment time to
conform to
established
policies for non-
highly technical
equipment.
30905............. Control of nosebleed. EF008 chair with headrest, NF .................... 32 62 E1: Refined 0.32
exam, reclining. equipment time to
conform to
established
policies for non-
highly technical
equipment.
30905............. Control of nosebleed. EQ110 electrocautery- NF .................... 32 62 E1: Refined 0.08
hyfrecator, up to 45 equipment time to
watts. conform to
established
policies for non-
highly technical
equipment.
30905............. Control of nosebleed. EQ137 instrument pack, NF .................... 39 69 E5: Refined 0.07
basic ($500-1499). equipment time to
conform to
established
policies for
surgical instrument
packs.
30905............. Control of nosebleed. EQ170 light, fiberoptic NF .................... 32 62 E1: Refined 0.24
headlight w-source. equipment time to
conform to
established
policies for non-
highly technical
equipment.
30905............. Control of nosebleed. EQ234 suction and pressure NF .................... 32 62 E1: Refined 0.28
cabinet, ENT (SMR). equipment time to
conform to
established
policies for non-
highly technical
equipment.
30906............. Repeat control of EF008 chair with headrest, NF .................... 42 72 E1: Refined 0.32
nosebleed. exam, reclining. equipment time to
conform to
established
policies for non-
highly technical
equipment.
30906............. Repeat control of EQ110 electrocautery- NF .................... 42 72 E1: Refined 0.08
nosebleed. hyfrecator, up to 45 equipment time to
watts. conform to
established
policies for non-
highly technical
equipment.
[[Page 34026]]
30906............. Repeat control of EQ137 instrument pack, NF .................... 49 79 E5: Refined 0.07
nosebleed. basic ($500-$1499). equipment time to
conform to
established
policies for
surgical instrument
packs.
30906............. Repeat control of EQ170 light, fiberoptic NF .................... 42 72 E1: Refined 0.24
nosebleed. headlight w-source. equipment time to
conform to
established
policies for non-
highly technical
equipment.
30906............. Repeat control of EQ234 suction and pressure NF .................... 42 72 E1: Refined 0.28
nosebleed. cabinet, ENT (SMR). equipment time to
conform to
established
policies for non-
highly technical
equipment.
31254............. Nsl/sins ndsc w/prtl EF008 chair with headrest, NF .................... 47 52 E1: Refined 0.05
ethmdct. exam, reclining. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31254............. Nsl/sins ndsc w/prtl EF015 mayo stand........... NF .................... 47 52 E1: Refined 0.01
ethmdct. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31254............. Nsl/sins ndsc w/prtl EQ138 instrument pack, NF .................... 59 64 E5: Refined 0.03
ethmdct. medium ($1500 and equipment time to
up). conform to
established
policies for
surgical instrument
packs.
31254............. Nsl/sins ndsc w/prtl EQ167 light source, xenon.. NF .................... 47 52 E1: Refined 0.14
ethmdct. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31254............. Nsl/sins ndsc w/prtl EQ170 light, fiberoptic NF .................... 47 52 E1: Refined 0.04
ethmdct. headlight w-source. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31254............. Nsl/sins ndsc w/prtl EQ234 suction and pressure NF .................... 47 52 E1: Refined 0.05
ethmdct. cabinet, ENT (SMR). equipment time to
conform to
established
policies for non-
highly technical
equipment.
[[Page 34027]]
31254............. Nsl/sins ndsc w/prtl EQ383 reusable shaver NF .................... 47 52 E1: Refined 0.02
ethmdct. blade, 2mm. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31254............. Nsl/sins ndsc w/prtl EQ384 Microdebrider NF .................... 47 52 E1: Refined 0.06
ethmdct. handpiece. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31254............. Nsl/sins ndsc w/prtl EQ385 Microdebrider console NF .................... 47 52 E1: Refined 0.15
ethmdct. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31254............. Nsl/sins ndsc w/prtl ES005 endoscope NF .................... 37 51 E4: Refined 0.85
ethmdct. disinfector, rigid equipment time to
or fiberoptic, w- conform to
cart. established
policies for scopes.
31254............. Nsl/sins ndsc w/prtl ES031 video system, NF .................... 47 44 E19: Refined -0.39
ethmdct. endoscopy equipment time to
(processor, digital conform to
capture, monitor, established
printer, cart). policies for scope
accessories.
31254............. Nsl/sins ndsc w/prtl ES040 PROXY endoscope, NF .................... 37 51 E4: Refined 0.11
ethmdct. rigid, sinoscopy (0 equipment time to
degrees). conform to
established
policies for scopes.
31254............. Nsl/sins ndsc w/prtl L037D RN/LPN/MTA........... NF Complete pre-service 3 0 L1: Refined time to -1.11
ethmdct. diagnostic and standard for this
referral forms. clinical labor task.
31254............. Nsl/sins ndsc w/prtl L037D RN/LPN/MTA........... NF Obtain vital signs.. 3 5 L1: Refined time to 0.74
ethmdct. standard for this
clinical labor task.
31254............. Nsl/sins ndsc w/prtl L037D RN/LPN/MTA........... NF Provide pre-service 3 0 L1: Refined time to -1.11
ethmdct. education/obtain standard for this
consent. clinical labor task.
31254............. Nsl/sins ndsc w/prtl L037D RN/LPN/MTA........... NF Complete pre- 3 0 L1: Refined time to -1.11
ethmdct. procedure phone standard for this
calls and clinical labor task.
prescription.
31295............. Sinus endo w/balloon EF008 chair with headrest, NF .................... 37 42 E1: Refined 0.05
dil. exam, reclining. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31295............. Sinus endo w/balloon EF015 mayo stand........... NF .................... 37 42 E1: Refined 0.01
dil. equipment time to
conform to
established
policies for non-
highly technical
equipment.
[[Page 34028]]
31295............. Sinus endo w/balloon EQ138 instrument pack, NF .................... 49 54 E5: Refined 0.03
dil. medium ($1500 and equipment time to
up). conform to
established
policies for
surgical instrument
packs.
31295............. Sinus endo w/balloon EQ167 light source, xenon.. NF .................... 37 42 E1: Refined 0.14
dil. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31295............. Sinus endo w/balloon EQ170 light, fiberoptic NF .................... 37 42 E1: Refined 0.04
dil. headlight w-source. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31295............. Sinus endo w/balloon EQ234 suction and pressure NF .................... 37 42 E1: Refined 0.05
dil. cabinet, ENT (SMR). equipment time to
conform to
established
policies for non-
highly technical
equipment.
31295............. Sinus endo w/balloon EQ383 reusable shaver NF .................... 37 42 E1: Refined 0.02
dil. blade, 2mm. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31295............. Sinus endo w/balloon EQ384 Microdebrider NF .................... 37 42 E1: Refined 0.06
dil. handpiece. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31295............. Sinus endo w/balloon EQ385 Microdebrider console NF .................... 37 42 E1: Refined 0.15
dil. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31295............. Sinus endo w/balloon ES005 endoscope NF .................... 27 41 E4: Refined 0.85
dil. disinfector, rigid equipment time to
or fiberoptic, w- conform to
cart. established
policies for scopes.
31295............. Sinus endo w/balloon ES031 video system, NF .................... 37 34 E19: Refined -0.39
dil. endoscopy equipment time to
(processor, digital conform to
capture, monitor, established
printer, cart). policies for scope
accessories.
31295............. Sinus endo w/balloon ES040 PROXY endoscope, NF .................... 27 41 E4: Refined 0.11
dil. rigid, sinoscopy (0 equipment time to
degrees). conform to
established
policies for scopes.
[[Page 34029]]
31295............. Sinus endo w/balloon L037D RN/LPN/MTA........... NF Provide pre-service 3 0 L1: Refined time to -1.11
dil. education/obtain standard for this
consent. clinical labor task.
31295............. Sinus endo w/balloon L037D RN/LPN/MTA........... NF Complete pre- 3 0 L1: Refined time to -1.11
dil. procedure phone standard for this
calls and clinical labor task.
prescription.
31295............. Sinus endo w/balloon L037D RN/LPN/MTA........... NF Obtain vital signs.. 3 5 L1: Refined time to 0.74
dil. standard for this
clinical labor task.
31295............. Sinus endo w/balloon L037D RN/LPN/MTA........... NF Complete pre-service 3 0 L1: Refined time to -1.11
dil. diagnostic and standard for this
referral forms. clinical labor task.
31296............. Sinus endo w/balloon EF008 chair with headrest, NF .................... 40 45 E1: Refined 0.05
dil. exam, reclining. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31296............. Sinus endo w/balloon EF015 mayo stand........... NF .................... 40 45 E1: Refined 0.01
dil. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31296............. Sinus endo w/balloon EQ138 instrument pack, NF .................... 52 57 E5: Refined 0.03
dil. medium ($1500 and equipment time to
up). conform to
established
policies for
surgical instrument
packs.
31296............. Sinus endo w/balloon EQ167 light source, xenon.. NF .................... 40 45 E1: Refined 0.14
dil. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31296............. Sinus endo w/balloon EQ170 light, fiberoptic NF .................... 40 45 E1: Refined 0.04
dil. headlight w-source. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31296............. Sinus endo w/balloon EQ234 suction and pressure NF .................... 40 45 E1: Refined 0.05
dil. cabinet, ENT (SMR). equipment time to
conform to
established
policies for non-
highly technical
equipment.
31296............. Sinus endo w/balloon EQ383 reusable shaver NF .................... 40 45 E1: Refined 0.02
dil. blade, 2mm. equipment time to
conform to
established
policies for non-
highly technical
equipment.
[[Page 34030]]
31296............. Sinus endo w/balloon EQ384 Microdebrider NF .................... 40 45 E1: Refined 0.06
dil. handpiece. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31296............. Sinus endo w/balloon EQ385 Microdebrider console NF .................... 40 45 E1: Refined 0.15
dil. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31296............. Sinus endo w/balloon ES005 endoscope NF .................... 32 44 E4: Refined 0.73
dil. disinfector, rigid equipment time to
or fiberoptic, w- conform to
cart. established
policies for scopes.
31296............. Sinus endo w/balloon ES031 video system, NF .................... 40 37 E19: Refined -0.39
dil. endoscopy equipment time to
(processor, digital conform to
capture, monitor, established
printer, cart). policies for scope
accessories.
31296............. Sinus endo w/balloon ES040 PROXY endoscope, NF .................... 32 44 E4: Refined 0.09
dil. rigid, sinoscopy (0 equipment time to
degrees). conform to
established
policies for scopes.
31296............. Sinus endo w/balloon L037D RN/LPN/MTA........... NF Complete pre-service 3 0 L1: Refined time to -1.11
dil. diagnostic and standard for this
referral forms. clinical labor task.
31296............. Sinus endo w/balloon L037D RN/LPN/MTA........... NF Provide pre-service 3 0 L1: Refined time to -1.11
dil. education/obtain standard for this
consent. clinical labor task.
31296............. Sinus endo w/balloon L037D RN/LPN/MTA........... NF Obtain vital signs.. 3 5 L1: Refined time to 0.74
dil. standard for this
clinical labor task.
31296............. Sinus endo w/balloon L037D RN/LPN/MTA........... NF Complete pre- 3 0 L1: Refined time to -1.11
dil. procedure phone standard for this
calls and clinical labor task.
prescription.
31297............. Sinus endo w/balloon EF008 chair with headrest, NF .................... 37 42 E1: Refined 0.05
dil. exam, reclining. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31297............. Sinus endo w/balloon EF015 mayo stand........... NF .................... 37 42 E1: Refined 0.01
dil. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31297............. Sinus endo w/balloon EQ138 instrument pack, NF .................... 49 54 E5: Refined 0.03
dil. medium ($1500 and equipment time to
up). conform to
established
policies for
surgical instrument
packs.
[[Page 34031]]
31297............. Sinus endo w/balloon EQ167 light source, xenon.. NF .................... 37 42 E1: Refined 0.14
dil. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31297............. Sinus endo w/balloon EQ170 light, fiberoptic NF .................... 37 42 E1: Refined 0.04
dil. headlight w-source. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31297............. Sinus endo w/balloon EQ234 suction and pressure NF .................... 37 42 E1: Refined 0.05
dil. cabinet, ENT (SMR). equipment time to
conform to
established
policies for non-
highly technical
equipment.
31297............. Sinus endo w/balloon EQ383 reusable shaver NF .................... 37 42 E1: Refined 0.02
dil. blade, 2mm. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31297............. Sinus endo w/balloon EQ384 Microdebrider NF .................... 37 42 E1: Refined 0.06
dil. handpiece. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31297............. Sinus endo w/balloon EQ385 Microdebrider console NF .................... 37 42 E1: Refined 0.15
dil. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31297............. Sinus endo w/balloon ES005 endoscope NF .................... 27 41 E4: Refined 0.85
dil. disinfector, rigid equipment time to
or fiberoptic, w- conform to
cart. established
policies for scopes.
31297............. Sinus endo w/balloon ES031 video system, NF .................... 37 34 E19: Refined -0.39
dil. endoscopy equipment time to
(processor, digital conform to
capture, monitor, established
printer, cart). policies for scope
accessories.
31297............. Sinus endo w/balloon ES040 PROXY endoscope, NF .................... 27 41 E4: Refined 0.11
dil. rigid, sinoscopy (0 equipment time to
degrees). conform to
established
policies for scopes.
31297............. Sinus endo w/balloon L037D RN/LPN/MTA........... NF Obtain vital signs.. 3 5 L1: Refined time to 0.74
dil. standard for this
clinical labor task.
31297............. Sinus endo w/balloon L037D RN/LPN/MTA........... NF Complete pre- 3 0 L1: Refined time to -1.11
dil. procedure phone standard for this
calls and clinical labor task.
prescription.
[[Page 34032]]
31297............. Sinus endo w/balloon L037D RN/LPN/MTA........... NF Complete pre-service 3 0 L1: Refined time to -1.11
dil. diagnostic and standard for this
referral forms. clinical labor task.
31297............. Sinus endo w/balloon L037D RN/LPN/MTA........... NF Provide pre-service 3 0 L1: Refined time to -1.11
dil. education/obtain standard for this
consent. clinical labor task.
31645............. Brnchsc w/ther aspir EF027 table, instrument, NF .................... 57 0 G1: See preamble -0.08
1st. mobile. text.
31645............. Brnchsc w/ther aspir EF031 table, power......... NF .................... 57 58 E1: Refined 0.02
1st. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31645............. Brnchsc w/ther aspir EQ004 CO2 respiratory NF .................... 57 0 G1: See preamble -1.47
1st. profile monitor. text.
31645............. Brnchsc w/ther aspir EQ032 IV infusion pump..... NF .................... 57 0 G1: See preamble -0.36
1st. text.
31645............. Brnchsc w/ther aspir EQ235 suction machine NF .................... 57 58 E1: Refined 0.00
1st. (Gomco). equipment time to
conform to
established
policies for non-
highly technical
equipment.
31645............. Brnchsc w/ther aspir ES017 fiberscope, flexible, NF .................... 72 82 E4: Refined 0.82
1st. bronchoscopy. equipment time to
conform to
established
policies for scopes.
31645............. Brnchsc w/ther aspir ES031 video system, NF .................... 42 55 E19: Refined 1.68
1st. endoscopy equipment time to
(processor, digital conform to
capture, monitor, established
printer, cart). policies for scope
accessories.
31645............. Brnchsc w/ther aspir SD084 gas, oxygen.......... NF .................... 175 0 G1: See preamble -0.53
1st. text.
31XX5............. Nsl/sins ndsc w/sins EF008 chair with headrest, NF .................... 59 64 E1: Refined 0.05
dilat. exam, reclining. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31XX5............. Nsl/sins ndsc w/sins EF015 mayo stand........... NF .................... 59 64 E1: Refined 0.01
dilat. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31XX5............. Nsl/sins ndsc w/sins EQ138 instrument pack, NF .................... 71 76 E5: Refined 0.03
dilat. medium ($1500 and equipment time to
up). conform to
established
policies for
surgical instrument
packs.
31XX5............. Nsl/sins ndsc w/sins EQ167 light source, xenon.. NF .................... 59 64 E1: Refined 0.14
dilat. equipment time to
conform to
established
policies for non-
highly technical
equipment.
[[Page 34033]]
31XX5............. Nsl/sins ndsc w/sins EQ170 light, fiberoptic NF .................... 59 64 E1: Refined 0.04
dilat. headlight w-source. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31XX5............. Nsl/sins ndsc w/sins EQ234 suction and pressure NF .................... 59 64 E1: Refined 0.05
dilat. cabinet, ENT (SMR). equipment time to
conform to
established
policies for non-
highly technical
equipment.
31XX5............. Nsl/sins ndsc w/sins EQ383 reusable shaver NF .................... 59 64 E1: Refined 0.02
dilat. blade, 2mm. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31XX5............. Nsl/sins ndsc w/sins EQ384 Microdebrider NF .................... 59 64 E1: Refined 0.06
dilat. handpiece. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31XX5............. Nsl/sins ndsc w/sins EQ385 Microdebrider console NF .................... 59 64 E1: Refined 0.15
dilat. equipment time to
conform to
established
policies for non-
highly technical
equipment.
31XX5............. Nsl/sins ndsc w/sins ES005 endoscope NF .................... 57 73 E4: Refined 0.97
dilat. disinfector, rigid equipment time to
or fiberoptic, w- conform to
cart. established
policies for scopes.
31XX5............. Nsl/sins ndsc w/sins ES031 video system, NF .................... 59 56 E19: Refined -0.39
dilat. endoscopy equipment time to
(processor, digital conform to
capture, monitor, established
printer, cart). policies for scope
accessories.
31XX5............. Nsl/sins ndsc w/sins ES040 PROXY endoscope, NF .................... 57 73 E4: Refined 0.12
dilat. rigid, sinoscopy (0 equipment time to
degrees). conform to
established
policies for scopes.
31XX5............. Nsl/sins ndsc w/sins L037D RN/LPN/MTA........... NF Complete pre-service 3 0 L1: Refined time to -1.11
dilat. diagnostic and standard for this
referral forms. clinical labor task.
31XX5............. Nsl/sins ndsc w/sins L037D RN/LPN/MTA........... NF Provide pre-service 3 0 L1: Refined time to -1.11
dilat. education/obtain standard for this
consent. clinical labor task.
31XX5............. Nsl/sins ndsc w/sins L037D RN/LPN/MTA........... NF Complete pre- 3 0 L1: Refined time to -1.11
dilat. procedure phone standard for this
calls and clinical labor task.
prescription.
31XX5............. Nsl/sins ndsc w/sins L037D RN/LPN/MTA........... NF Obtain vital signs.. 3 5 L1: Refined time to 0.74
dilat. standard for this
clinical labor task.
[[Page 34034]]
32998............. Ablate pulm tumor ED050 Technologist PACS NF .................... 133 112 E18: Refined -0.46
perq rf. workstation. equipment time to
conform to
established
policies for PACS
Workstations.
32998............. Ablate pulm tumor EL007 room, CT............. NF .................... 98 96 E2: Refined -9.73
perq rf. equipment time to
conform to
established
policies for highly
technical equipment.
32998............. Ablate pulm tumor EQ168 light, exam.......... NF .................... 98 107 E1: Refined 0.04
perq rf. equipment time to
conform to
established
policies for non-
highly technical
equipment.
32998............. Ablate pulm tumor EQ214 radiofrequency NF .................... 98 96 E2: Refined -0.25
perq rf. generator (NEURO). equipment time to
conform to
established
policies for highly
technical equipment.
32X99............. Ablate pulm tumor ED050 Technologist PACS NF .................... 138 117 E18: Refined -0.46
perq crybl. workstation. equipment time to
conform to
established
policies for PACS
Workstations.
32X99............. Ablate pulm tumor EL007 room, CT............. NF .................... 103 101 E2: Refined -9.73
perq crybl. equipment time to
conform to
established
policies for highly
technical equipment.
32X99............. Ablate pulm tumor EQ168 light, exam.......... NF .................... 103 112 E1: Refined 0.04
perq crybl. equipment time to
conform to
established
policies for non-
highly technical
equipment.
32X99............. Ablate pulm tumor EQ302 cryosurgery system NF .................... 103 101 E2: Refined -0.19
perq crybl. (for tumor ablation). equipment time to
conform to
established
policies for highly
technical equipment.
36215............. Place catheter in ED050 Technologist PACS NF .................... 61 59 E15: Refined -0.04
artery. workstation. equipment time to
conform to changes
in clinical labor
time.
36215............. Place catheter in EF027 table, instrument, NF .................... 180 0 G1: See preamble -0.25
artery. mobile. text.
[[Page 34035]]
36215............. Place catheter in L037D RN/LPN/MTA........... NF Other Clinical 3 1 G1: See preamble -0.74
artery. Activity--specify: text.
Post-procedure
doppler evaluation
(extremity).
36216............. Place catheter in ED050 Technologist PACS NF .................... 76 74 E15: Refined -0.04
artery. workstation. equipment time to
conform to changes
in clinical labor
time.
36216............. Place catheter in EF027 table, instrument, NF .................... 180 0 G1: See preamble -0.25
artery. mobile. text.
36216............. Place catheter in L037D RN/LPN/MTA........... NF Other Clinical 3 1 G1: See preamble -0.74
artery. Activity--specify: text.
Post-procedure
doppler evaluation
(extremity).
36217............. Place catheter in ED050 Technologist PACS NF .................... 91 89 E15: Refined -0.04
artery. workstation. equipment time to
conform to changes
in clinical labor
time.
36217............. Place catheter in EF027 table, instrument, NF .................... 180 0 G1: See preamble -0.25
artery. mobile. text.
36217............. Place catheter in L037D RN/LPN/MTA........... NF Other Clinical 3 1 G1: See preamble -0.74
artery. Activity--specify: text.
Post-procedure
doppler evaluation
(extremity).
36217............. Place catheter in L037D RN/LPN/MTA........... NF Circulator (25%).... 12 15 G1: See preamble 1.11
artery. text.
36470............. Njx sclrsnt 1 L037D RN/LPN/MTA........... NF Obtain vital signs.. 3 5 L1: Refined time to 0.74
incmptnt vein. standard for this
clinical labor task.
36470............. Njx sclrsnt 1 L037D RN/LPN/MTA........... NF Check dressings, 5 3 L1: Refined time to -0.74
incmptnt vein. catheters, wounds. standard for this
clinical labor task.
36470............. Njx sclrsnt 1 SG055 gauze, sterile 4in x NF .................... 6 0 S7: Supply item -0.95
incmptnt vein. 4in. replaced by another
item; see preamble
SG056.
36470............. Njx sclrsnt 1 SG056 gauze, sterile 4in x NF .................... 0 1 S8: Supply item 0.80
incmptnt vein. 4in (10 pack uou). replaces another
item; see preamble
SG055.
36471............. Njx sclrsnt mlt L037D RN/LPN/MTA........... NF Obtain vital signs.. 3 5 L1: Refined time to 0.74
incmptnt vn. standard for this
clinical labor task.
36471............. Njx sclrsnt mlt L037D RN/LPN/MTA........... NF Check dressings, 5 3 L1: Refined time to -0.74
incmptnt vn. catheters, wounds. standard for this
clinical labor task.
36471............. Njx sclrsnt mlt SG055 gauze, sterile 4in x NF .................... 6 0 S7: Supply item -0.95
incmptnt vn. 4in. replaced by another
item; see preamble
SG056.
36471............. Njx sclrsnt mlt SG056 gauze, sterile 4in x NF .................... 0 1 S8: Supply item 0.80
incmptnt vn. 4in (10 pack uou). replaces another
item; see preamble
SG055.
[[Page 34036]]
364X3............. Endoven ther chem EF014 light, surgical...... NF .................... 58 53 E1: Refined -0.05
adhes 1st. equipment time to
conform to
established
policies for non-
highly technical
equipment.
364X3............. Endoven ther chem EF031 table, power......... NF .................... 58 53 E1: Refined -0.08
adhes 1st. equipment time to
conform to
established
policies for non-
highly technical
equipment.
364X3............. Endoven ther chem EQ250 ultrasound unit, NF .................... 58 53 E1: Refined -0.58
adhes 1st. portable. equipment time to
conform to
established
policies for non-
highly technical
equipment.
364X3............. Endoven ther chem L037D RN/LPN/MTA........... NF Check dressings, 5 3 L1: Refined time to -0.74
adhes 1st. catheters, wounds. standard for this
clinical labor task.
364X3............. Endoven ther chem L037D RN/LPN/MTA........... NF Obtain vital signs.. 3 5 L1: Refined time to 0.74
adhes 1st. standard for this
clinical labor task.
364X3............. Endoven ther chem L054A Vascular Technologist NF Prepare room, 0 2 G1: See preamble 1.08
adhes 1st. equipment and text.
supplies.
364X3............. Endoven ther chem L054A Vascular Technologist NF Setup scope 2 0 G1: See preamble -1.08
adhes 1st. (nonfacility text.
setting only).
364X3............. Endoven ther chem SG055 gauze, sterile 4in x NF .................... 6 0 S7: Supply item -0.95
adhes 1st. 4in. replaced by another
item; see preamble
SG056.
364X3............. Endoven ther chem SG056 gauze, sterile 4in x NF .................... 0 1 S8: Supply item 0.80
adhes 1st. 4in (10 pack uou). replaces another
item; see preamble
SG055.
364X5............. Njx noncmpnd sclrsnt EF014 light, surgical...... NF .................... 48 43 E1: Refined -0.05
1 vein. equipment time to
conform to
established
policies for non-
highly technical
equipment.
364X5............. Njx noncmpnd sclrsnt EF031 table, power......... NF .................... 48 43 E1: Refined -0.08
1 vein. equipment time to
conform to
established
policies for non-
highly technical
equipment.
364X5............. Njx noncmpnd sclrsnt EQ250 ultrasound unit, NF .................... 48 43 E1: Refined -0.58
1 vein. portable. equipment time to
conform to
established
policies for non-
highly technical
equipment.
364X5............. Njx noncmpnd sclrsnt L037D RN/LPN/MTA........... NF Check dressings, 5 3 L1: Refined time to -0.74
1 vein. catheters, wounds. standard for this
clinical labor task.
[[Page 34037]]
364X5............. Njx noncmpnd sclrsnt L037D RN/LPN/MTA........... NF Obtain vital signs.. 3 5 L1: Refined time to 0.74
1 vein. standard for this
clinical labor task.
364X5............. Njx noncmpnd sclrsnt L054A Vascular Technologist NF Setup scope 2 0 G1: See preamble -1.08
1 vein. (nonfacility text.
setting only).
364X5............. Njx noncmpnd sclrsnt L054A Vascular Technologist NF Prepare room, 0 2 G1: See preamble 1.08
1 vein. equipment and text.
supplies.
364X5............. Njx noncmpnd sclrsnt SG055 gauze, sterile 4in x NF .................... 6 0 S7: Supply item -0.95
1 vein. 4in. replaced by another
item; see preamble
SG056.
364X5............. Njx noncmpnd sclrsnt SG056 gauze, sterile 4in x NF .................... 0 1 S8: Supply item 0.80
1 vein. 4in (10 pack uou). replaces another
item; see preamble
SG055.
364X6............. Njx noncmpnd sclrsnt EF014 light, surgical...... NF .................... 58 53 E1: Refined -0.05
mlt vn. equipment time to
conform to
established
policies for non-
highly technical
equipment.
364X6............. Njx noncmpnd sclrsnt EF031 table, power......... NF .................... 58 53 E1: Refined -0.08
mlt vn. equipment time to
conform to
established
policies for non-
highly technical
equipment.
364X6............. Njx noncmpnd sclrsnt EQ250 ultrasound unit, NF .................... 58 53 E1: Refined -0.58
mlt vn. portable. equipment time to
conform to
established
policies for non-
highly technical
equipment.
364X6............. Njx noncmpnd sclrsnt L037D RN/LPN/MTA........... NF Obtain vital signs.. 3 5 L1: Refined time to 0.74
mlt vn. standard for this
clinical labor task.
364X6............. Njx noncmpnd sclrsnt L037D RN/LPN/MTA........... NF Check dressings, 5 3 L1: Refined time to -0.74
mlt vn. catheters, wounds. standard for this
clinical labor task.
364X6............. Njx noncmpnd sclrsnt L054A Vascular Technologist NF Setup scope 2 0 G1: See preamble -1.08
mlt vn. (nonfacility text.
setting only).
364X6............. Njx noncmpnd sclrsnt L054A Vascular Technologist NF Prepare room, 0 2 G1: See preamble 1.08
mlt vn. equipment and text.
supplies.
364X6............. Njx noncmpnd sclrsnt SG055 gauze, sterile 4in x NF .................... 6 0 S7: Supply item -0.95
mlt vn. 4in. replaced by another
item; see preamble
SG056.
364X6............. Njx noncmpnd sclrsnt SG056 gauze, sterile 4in x NF .................... 0 1 S8: Supply item 0.80
mlt vn. 4in (10 pack uou). replaces another
item; see preamble
SG055.
36555............. Insert non-tunnel cv EF023 table, exam.......... NF .................... 68 38 E1: Refined -0.09
cath. equipment time to
conform to
established
policies for non-
highly technical
equipment.
[[Page 34038]]
36555............. Insert non-tunnel cv EQ011 ECG, 3-channel (with NF .................... 68 0 G1: See preamble -0.95
cath. SpO2, NIBP, temp, text.
resp).
36555............. Insert non-tunnel cv EQ168 light, exam.......... NF .................... 68 38 E1: Refined -0.13
cath. equipment time to
conform to
established
policies for non-
highly technical
equipment.
36555............. Insert non-tunnel cv L037D RN/LPN/MTA........... NF Monitor pt. 7.5 0 L11: Removed -2.78
cath. following procedure/ clinical labor
check tubes, associated with
monitors, drains, moderate sedation;
multitasking 1:4. moderate sedation
not typical for
this procedure.
36569............. Insert picc cath..... EF023 table, exam.......... NF .................... 30 0 G1: See preamble -0.09
text.
36569............. Insert picc cath..... EQ168 light, exam.......... NF .................... 30 32 E15: Refined 0.01
equipment time to
conform to changes
in clinical labor
time.
36569............. Insert picc cath..... L037D RN/LPN/MTA........... NF Obtain vital signs.. 3 5 L1: Refined time to 0.74
standard for this
clinical labor task.
38220............. Dx bone marrow EF023 table, exam.......... NF .................... 84 82 E1: Refined -0.01
aspirations. equipment time to
conform to
established
policies for non-
highly technical
equipment.
38220............. Dx bone marrow L033A Lab Technician....... NF Other Clinical 12 9 G1: See preamble -0.99
aspirations. Activity--specify:L text.
ab Tech activities.
38221............. Dx bone marrow EF023 table, exam.......... NF .................... 83 82 E1: Refined 0.00
biopsies. equipment time to
conform to
established
policies for non-
highly technical
equipment.
38221............. Dx bone marrow L033A Lab Technician....... NF Other Clinical 7.5 7 G1: See preamble -0.17
biopsies. Activity--specify:L text.
ab Tech activities.
382X3............. Dx bone marrow bx & EF023 table, exam.......... NF .................... 95 92 E1: Refined -0.01
aspir. equipment time to
conform to
established
policies for non-
highly technical
equipment.
382X3............. Dx bone marrow bx & L033A Lab Technician....... NF Other Clinical 12.5 10 G1: See preamble -0.83
aspir. Activity--specify:L text.
ab Tech activities.
55X87............. Tprnl plmt EF031 table, power......... NF .................... 63 65 E15: Refined 0.03
biodegrdabl matrl. equipment time to
conform to changes
in clinical labor
time.
[[Page 34039]]
55X87............. Tprnl plmt EQ250 ultrasound unit, NF .................... 48 50 E15: Refined 0.23
biodegrdabl matrl. portable. equipment time to
conform to changes
in clinical labor
time.
55X87............. Tprnl plmt EQ386 Endocavitary US probe NF .................... 48 50 E15: Refined 0.13
biodegrdabl matrl. equipment time to
conform to changes
in clinical labor
time.
55X87............. Tprnl plmt ER061 stepper, stabilizer, NF .................... 48 50 E15: Refined 0.12
biodegrdabl matrl. template (for equipment time to
brachytherapy conform to changes
treatment). in clinical labor
time.
55X87............. Tprnl plmt ER062 stirrups (for NF .................... 48 50 E15: Refined 0.02
biodegrdabl matrl. brachytherapy table). equipment time to
conform to changes
in clinical labor
time.
55X87............. Tprnl plmt L037D RN/LPN/MTA........... NF Obtain vital signs.. 3 5 L1: Refined time to 0.74
biodegrdabl matrl. standard for this
clinical labor task.
5857X............. Laps tot hyst resj EQ168 light, exam.......... F .................... 142 125 E7: Refined -0.07
mal. equipment time to
conform to office
visit duration.
5857X............. Laps tot hyst resj SA051 pack, pelvic exam.... F .................... 4 3 G1: See preamble -1.17
mal. text.
67820............. Revise eyelashes..... EL006 lane, screening (oph) NF .................... 11 5 G1: See preamble -0.54
text.
67820............. Revise eyelashes..... L038A COMT/COT/RN/CST...... F Coordinate pre- 3 0 L1: Refined time to -1.14
surgery services. standard for this
clinical labor task.
67820............. Revise eyelashes..... L038A COMT/COT/RN/CST...... F Provide pre-service 3 0 L1: Refined time to -1.14
education/obtain standard for this
consent. clinical labor task.
67820............. Revise eyelashes..... L038A COMT/COT/RN/CST...... F Schedule space and 3 0 L1: Refined time to -1.14
equipment in standard for this
facility. clinical labor task.
67820............. Revise eyelashes..... L038A COMT/COT/RN/CST...... F Complete pre-service 3 0 L1: Refined time to -1.14
diagnostic and standard for this
referral forms. clinical labor task.
67820............. Revise eyelashes..... L038A COMT/COT/RN/CST...... F Follow-up phone 3 0 L1: Refined time to -1.14
calls and standard for this
prescriptions. clinical labor task.
70544............. Mr angiography head w/ ED050 Technologist PACS NF .................... 72 69 E15: Refined -0.07
o dye. workstation. equipment time to
conform to changes
in clinical labor
time.
70544............. Mr angiography head w/ ED053 Professional PACS NF .................... 17 15 E18: Refined -0.12
o dye. Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
[[Page 34040]]
70544............. Mr angiography head w/ EL008 room, MR............. NF .................... 39 38 E15: Refined -3.38
o dye. equipment time to
conform to changes
in clinical labor
time.
70544............. Mr angiography head w/ L047A MRI Technologist..... NF Technologist QCs 4 3 L1: Refined time to -0.47
o dye. images in PACS, standard for this
checking all clinical labor task.
images, reformats,
and dose page.
70544............. Mr angiography head w/ L047A MRI Technologist..... NF Provide pre-service 7 5 G1: See preamble -0.94
o dye. education/obtain text.
consent.
70545............. Mr angiography head w/ ED050 Technologist PACS NF .................... 75 74 E15: Refined -0.02
dye. workstation. equipment time to
conform to changes
in clinical labor
time.
70545............. Mr angiography head w/ ED053 Professional PACS NF .................... 17 15 E18: Refined -0.12
dye. Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
70545............. Mr angiography head w/ EL008 room, MR............. NF .................... 37 36 E15: Refined -3.38
dye. equipment time to
conform to changes
in clinical labor
time.
70545............. Mr angiography head w/ L047A MRI Technologist..... NF Technologist QCs 4 3 L1: Refined time to -0.47
dye. images in PACS, standard for this
checking all clinical labor task.
images, reformats,
and dose page.
70545............. Mr angiography head w/ L047A MRI Technologist..... NF Obtain vital signs.. 3 5 L1: Refined time to 0.94
dye. standard for this
clinical labor task.
70545............. Mr angiography head w/ L047A MRI Technologist..... NF Provide pre-service 9 7 G1: See preamble -0.94
dye. education/obtain text.
consent.
70546............. Mr angiograph head w/ ED050 Technologist PACS NF .................... 116 115 E15: Refined -0.02
o&w/dye. workstation. equipment time to
conform to changes
in clinical labor
time.
70546............. Mr angiograph head w/ ED053 Professional PACS NF .................... 20 18 E18: Refined -0.12
o&w/dye. Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
70546............. Mr angiograph head w/ EL008 room, MR............. NF .................... 58 57 E15: Refined -3.38
o&w/dye. equipment time to
conform to changes
in clinical labor
time.
[[Page 34041]]
70546............. Mr angiograph head w/ L047A MRI Technologist..... NF Obtain vital signs.. 3 5 L1: Refined time to 0.94
o&w/dye. standard for this
clinical labor task.
70546............. Mr angiograph head w/ L047A MRI Technologist..... NF Technologist QCs 4 3 L1: Refined time to -0.47
o&w/dye. images in PACS, standard for this
checking all clinical labor task.
images, reformats,
and dose page.
70546............. Mr angiograph head w/ L047A MRI Technologist..... NF Provide pre-service 9 7 G1: See preamble -0.94
o&w/dye. education/obtain text.
consent.
70547............. Mr angiography neck w/ ED050 Technologist PACS NF .................... 72 69 E15: Refined -0.07
o dye. workstation. equipment time to
conform to changes
in clinical labor
time.
70547............. Mr angiography neck w/ ED053 Professional PACS NF .................... 17 15 E18: Refined -0.12
o dye. Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
70547............. Mr angiography neck w/ EL008 room, MR............. NF .................... 39 38 E15: Refined -3.38
o dye. equipment time to
conform to changes
in clinical labor
time.
70547............. Mr angiography neck w/ L047A MRI Technologist..... NF Technologist QCs 4 3 L1: Refined time to -0.47
o dye. images in PACS, standard for this
checking all clinical labor task.
images, reformats,
and dose page.
70547............. Mr angiography neck w/ L047A MRI Technologist..... NF Provide pre-service 7 5 G1: See preamble -0.94
o dye. education/obtain text.
consent.
70548............. Mr angiography neck w/ ED050 Technologist PACS NF .................... 75 74 E15: Refined -0.02
dye. workstation. equipment time to
conform to changes
in clinical labor
time.
70548............. Mr angiography neck w/ ED053 Professional PACS NF .................... 20 18 E18: Refined -0.12
dye. Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
70548............. Mr angiography neck w/ EL008 room, MR............. NF .................... 37 36 E15: Refined -3.38
dye. equipment time to
conform to changes
in clinical labor
time.
70548............. Mr angiography neck w/ L047A MRI Technologist..... NF Technologist QCs 4 3 L1: Refined time to -0.47
dye. images in PACS, standard for this
checking all clinical labor task.
images, reformats,
and dose page.
[[Page 34042]]
70548............. Mr angiography neck w/ L047A MRI Technologist..... NF Provide pre-service 9 7 G1: See preamble -0.94
dye. education/obtain text.
consent.
70548............. Mr angiography neck w/ L047A MRI Technologist..... NF Obtain vital signs.. 3 5 L1: Refined time to 0.94
dye. standard for this
clinical labor task.
70549............. Mr angiograph neck w/ ED050 Technologist PACS NF .................... 116 115 E15: Refined -0.02
o&w/dye. workstation. equipment time to
conform to changes
in clinical labor
time.
70549............. Mr angiograph neck w/ ED053 Professional PACS NF .................... 25 23 E18: Refined -0.12
o&w/dye. Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
70549............. Mr angiograph neck w/ EL008 room, MR............. NF .................... 58 57 E15: Refined -3.38
o&w/dye. equipment time to
conform to changes
in clinical labor
time.
70549............. Mr angiograph neck w/ L047A MRI Technologist..... NF Obtain vital signs.. 3 5 L1: Refined time to 0.94
o&w/dye. standard for this
clinical labor task.
70549............. Mr angiograph neck w/ L047A MRI Technologist..... NF Provide pre-service 9 7 G1: See preamble -0.94
o&w/dye. education/obtain text.
consent.
70549............. Mr angiograph neck w/ L047A MRI Technologist..... NF Technologist QCs 4 3 L1: Refined time to -0.47
o&w/dye. images in PACS, standard for this
checking all clinical labor task.
images, reformats,
and dose page.
71250............. Ct thorax w/o dye.... ED053 Professional PACS NF .................... 20 18 E18: Refined -0.12
Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
71260............. Ct thorax w/dye...... ED053 Professional PACS NF .................... 21 19 E18: Refined -0.12
Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
71270............. Ct thorax w/o & w/dye ED053 Professional PACS NF .................... 25 23 E18: Refined -0.12
Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
72195............. Mri pelvis w/o dye... ED053 Professional PACS NF .................... 25 23 E18: Refined -0.12
Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
[[Page 34043]]
72196............. Mri pelvis w/dye..... ED050 Technologist PACS NF .................... 64 66 E15: Refined 0.04
workstation. equipment time to
conform to changes
in clinical labor
time.
72196............. Mri pelvis w/dye..... ED053 Professional PACS NF .................... 30 28 E18: Refined -0.12
Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
72196............. Mri pelvis w/dye..... L047A MRI Technologist..... NF Obtain vital signs.. 3 5 L1: Refined time to 0.94
standard for this
clinical labor task.
72197............. Mri pelvis w/o & w/ ED050 Technologist PACS NF .................... 79 81 E15: Refined 0.04
dye. workstation. equipment time to
conform to changes
in clinical labor
time.
72197............. Mri pelvis w/o & w/ ED053 Professional PACS NF .................... 32 30 E18: Refined -0.12
dye. Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
72197............. Mri pelvis w/o & w/ L047A MRI Technologist..... NF Obtain vital signs.. 3 5 L1: Refined time to 0.94
dye. standard for this
clinical labor task.
73718............. Mri lower extremity w/ ED050 Technologist PACS NF .................... 55 53 E15: Refined -0.04
o dye. workstation. equipment time to
conform to changes
in clinical labor
time.
73718............. Mri lower extremity w/ ED053 Professional PACS NF .................... 20 18 E18: Refined -0.12
o dye. Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
73718............. Mri lower extremity w/ EL008 room, MR............. NF .................... 44 42 E15: Refined -6.76
o dye. equipment time to
conform to changes
in clinical labor
time.
73718............. Mri lower extremity w/ L047A MRI Technologist..... NF Prepare room, 5 3 G1: See preamble -0.94
o dye. equipment, supplies. text.
73719............. Mri lower extremity w/ ED050 Technologist PACS NF .................... 62 64 E15: Refined 0.04
dye. workstation. equipment time to
conform to changes
in clinical labor
time.
73719............. Mri lower extremity w/ ED053 Professional PACS NF .................... 25 23 E18: Refined -0.12
dye. Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
[[Page 34044]]
73719............. Mri lower extremity w/ EL008 room, MR............. NF .................... 48 46 E15: Refined -6.76
dye. equipment time to
conform to changes
in clinical labor
time.
73719............. Mri lower extremity w/ L047A MRI Technologist..... NF Provide pre-service 5 7 G1: See preamble 0.94
dye. education/obtain text.
consent.
73719............. Mri lower extremity w/ L047A MRI Technologist..... NF Prepare room, 7 5 G1: See preamble -0.94
dye. equipment, supplies. text.
73719............. Mri lower extremity w/ L047A MRI Technologist..... NF Obtain vital signs.. 3 5 L1: Refined time to 0.94
dye. standard for this
clinical labor task.
73720............. Mri lwr extremity w/ ED050 Technologist PACS NF .................... 77 79 E15: Refined 0.04
o&w/dye. workstation. equipment time to
conform to changes
in clinical labor
time.
73720............. Mri lwr extremity w/ ED053 Professional PACS NF .................... 29 27 E18: Refined -0.12
o&w/dye. Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
73720............. Mri lwr extremity w/ EL008 room, MR............. NF .................... 63 61 E15: Refined -6.76
o&w/dye. equipment time to
conform to changes
in clinical labor
time.
73720............. Mri lwr extremity w/ L047A MRI Technologist..... NF Prepare room, 7 5 G1: See preamble -0.94
o&w/dye. equipment, supplies. text.
73720............. Mri lwr extremity w/ L047A MRI Technologist..... NF Provide pre-service 5 7 G1: See preamble 0.94
o&w/dye. education/obtain text.
consent.
73720............. Mri lwr extremity w/ L047A MRI Technologist..... NF Obtain vital signs.. 3 5 L1: Refined time to 0.94
o&w/dye. standard for this
clinical labor task.
74181............. Mri abdomen w/o dye.. ED053 Professional PACS NF .................... 25 23 E18: Refined -0.12
Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
74182............. Mri abdomen w/dye.... ED050 Technologist PACS NF .................... 74 76 E15: Refined 0.04
workstation. equipment time to
conform to changes
in clinical labor
time.
74182............. Mri abdomen w/dye.... ED053 Professional PACS NF .................... 30 28 E18: Refined -0.12
Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
74182............. Mri abdomen w/dye.... L047A MRI Technologist..... NF Obtain vital signs.. 3 5 L1: Refined time to 0.94
standard for this
clinical labor task.
[[Page 34045]]
74183............. Mri abdomen w/o & w/ ED050 Technologist PACS NF .................... 79 81 E15: Refined 0.04
dye. workstation. equipment time to
conform to changes
in clinical labor
time.
74183............. Mri abdomen w/o & w/ ED053 Professional PACS NF .................... 35 33 E18: Refined -0.12
dye. Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
74183............. Mri abdomen w/o & w/ L047A MRI Technologist..... NF Obtain vital signs.. 3 5 L1: Refined time to 0.94
dye. standard for this
clinical labor task.
75635............. Ct angio abdominal ED050 Technologist PACS NF .................... 119 124 E18: Refined 0.11
arteries. workstation. equipment time to
conform to
established
policies for PACS
Workstations.
75635............. Ct angio abdominal ED053 Professional PACS NF .................... 49 44 E18: Refined -0.29
arteries. Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
75635............. Ct angio abdominal EL007 room, CT............. NF .................... 71 70 E15: Refined -2.70
arteries. equipment time to
conform to changes
in clinical labor
time.
75635............. Ct angio abdominal L046A CT Technologist...... NF Technologist QCs 4 3 L1: Refined time to -0.46
arteries. images in PACS, standard for this
checking all clinical labor task.
images, reformats,
and dose page.
75710............. Artery x-rays arm/leg ED050 Technologist PACS NF .................... 52 49 E15: Refined -0.07
workstation. equipment time to
conform to changes
in clinical labor
time.
75710............. Artery x-rays arm/leg ED053 Professional PACS NF .................... 55 48 E18: Refined -0.41
Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
75710............. Artery x-rays arm/leg L041B Radiologic NF Technologist QCs 4 3 L1: Refined time to -0.41
Technologist. images in PACS, standard for this
checking all clinical labor task.
images, reformats,
and dose page.
75710............. Artery x-rays arm/leg L041B Radiologic NF Prepare room, 2 0 G1: See preamble -0.82
Technologist. equipment, supplies. text.
75716............. Artery x-rays arms/ ED050 Technologist PACS NF .................... 62 59 E15: Refined -0.07
legs. workstation. equipment time to
conform to changes
in clinical labor
time.
[[Page 34046]]
75716............. Artery x-rays arms/ ED053 Professional PACS NF .................... 65 58 E18: Refined -0.41
legs. Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
75716............. Artery x-rays arms/ L041B Radiologic NF Prepare room, 2 0 G1: See preamble -0.82
legs. Technologist. equipment, supplies. text.
75716............. Artery x-rays arms/ L041B Radiologic NF Technologist QCs 4 3 L1: Refined time to -0.41
legs. Technologist. images in PACS, standard for this
checking all clinical labor task.
images, reformats,
and dose page.
76881............. Us xtr non-vasc EF031 table, power......... NF .................... 8 7 E1: Refined -0.02
complete. equipment time to
conform to
established
policies for non-
highly technical
equipment.
76881............. Us xtr non-vasc EQ250 ultrasound unit, NF .................... 8 7 E1: Refined -0.12
complete. portable. equipment time to
conform to
established
policies for non-
highly technical
equipment.
76881............. Us xtr non-vasc L026A Medical/Technical NF Exam document 1 0 G1: See preamble -0.26
complete. Assistant. scanned into PACS. text.
Exam completed in
RIS system to
generate billing
process and to
populate images
into Radiologist
work queue.
78300............. Bone imaging limited ED053 Professional PACS NF .................... 15 13 E18: Refined -0.12
area. Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
78305............. Bone imaging multiple ED053 Professional PACS NF .................... 15 13 E18: Refined -0.12
areas. Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
78306............. Bone imaging whole ED053 Professional PACS NF .................... 78 13 E18: Refined -3.76
body. Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
88333............. Intraop cyto path L033A Lab Technician....... NF Prepare room. Filter 10 0 G6: Indirect -3.30
consult 1. and replenish Practice Expense
stains and input and/or not
supplies. individually
(including OCT allocable to a
blocks, set up particular patient
grossing station for a particular
with colored service.
stains).
[[Page 34047]]
88333............. Intraop cyto path L037B Histotechnologist.... NF Clean room/equipment 5 1 L1: Refined time to -1.48
consult 1. following procedure standard for this
(including any clinical labor task.
equipment
maintenance that
must be done after
the procedure).
88360............. Tumor immunohistochem/ EP112 Benchmark ULTRA NF .................... 18 16 G1: See preamble -1.14
manual. automated slide text.
preparation system.
88360............. Tumor immunohistochem/ L033A Lab Technician....... NF Recycle xylene from 1 0 G6: Indirect -0.33
manual. tissue processor Practice Expense
and stainer. input and/or not
individually
allocable to a
particular patient
for a particular
service.
88360............. Tumor immunohistochem/ L037B Histotechnologist.... NF Clean room/equipment 1 0 L2: Clinical labor -0.37
manual. following procedure task redundant with
(including any clinical labor task
equipment Clean equipment and
maintenance that work station in
must be done after histology lab.
the procedure).
88360............. Tumor immunohistochem/ L037B Histotechnologist.... NF Verify results and 1 0 G6: Indirect -0.37
manual. complete work load Practice Expense
recording logs. input and/or not
individually
allocable to a
particular patient
for a particular
service.
88360............. Tumor immunohistochem/ L037B Histotechnologist.... NF Enter patient data, 5 1 L1: Refined time to -1.48
manual. computational prep standard for this
for antibody clinical labor task.
testing, generate
and apply bar codes
to slides, and
enter data for
automated slide
stainer.
88361............. Tumor immunohistochem/ EP112 Benchmark ULTRA NF .................... 18 16 G1: See preamble -1.14
comput. automated slide text.
preparation system.
88361............. Tumor immunohistochem/ L033A Lab Technician....... NF Recycle xylene from 1 0 G6: Indirect -0.33
comput. tissue processor Practice Expense
and stainer. input and/or not
individually
allocable to a
particular patient
for a particular
service.
[[Page 34048]]
88361............. Tumor immunohistochem/ L037B Histotechnologist.... NF Verify results and 1 0 G6: Indirect -0.37
comput. complete work load Practice Expense
recording logs. input and/or not
individually
allocable to a
particular patient
for a particular
service.
88361............. Tumor immunohistochem/ L037B Histotechnologist.... NF Performing 1 0 G1: See preamble -0.37
comput. instrument text.
calibration,
instrument qc and
start up and
shutdown..
88361............. Tumor immunohistochem/ L037B Histotechnologist.... NF Gate areas to be 1 0 G1: See preamble -0.37
comput. counted by the text.
machine.
88361............. Tumor immunohistochem/ L037B Histotechnologist.... NF Enter patient data, 5 1 L1: Refined time to -1.48
comput. computational prep standard for this
for antibody clinical labor task.
testing, generate
and apply bar codes
to slides, and
enter data for
automated slide
stainer.
88361............. Tumor immunohistochem/ L037B Histotechnologist.... NF Clean room/equipment 1 0 L2: Clinical labor -0.37
comput. following procedure task redundant with
(including any clinical labor task
equipment Clean equipment and
maintenance that work station in
must be done after histology lab.
the procedure).
93279............. Pm device progr eval EF023 table, exam.......... NF .................... 33 26 E1: Refined -0.02
sngl. equipment time to
conform to
established
policies for non-
highly technical
equipment.
93279............. Pm device progr eval EQ198 pacemaker follow-up NF .................... 33 26 E1: Refined -0.53
sngl. system (incl equipment time to
software and conform to
hardware) (Paceart). established
policies for non-
highly technical
equipment.
93279............. Pm device progr eval L026A Medical/Technical NF Complete diagnostic 2 0 L2: Clinical labor -0.52
sngl. Assistant. forms, lab, X-ray task redundant with
requisitions. clinical labor task
L037D.
93279............. Pm device progr eval L037D RN/LPN/MTA........... NF Other Clinical 2 0 L1: Refined time to -0.74
sngl. Activity--specify: standard for this
Review charts. clinical labor task.
93280............. Pm device progr eval EF023 table, exam.......... NF .................... 38 31 E1: Refined -0.02
dual. equipment time to
conform to
established
policies for non-
highly technical
equipment.
[[Page 34049]]
93280............. Pm device progr eval EQ198 pacemaker follow-up NF .................... 38 31 E1: Refined -0.53
dual. system (incl equipment time to
software and conform to
hardware) (Paceart). established
policies for non-
highly technical
equipment.
93280............. Pm device progr eval L026A Medical/Technical NF Complete diagnostic 2 0 L2: Clinical labor -0.52
dual. Assistant. forms, lab, X-ray task redundant with
requisitions. clinical labor task
L037D.
93280............. Pm device progr eval L037D RN/LPN/MTA........... NF Other Clinical 2 0 L1: Refined time to -0.74
dual. Activity--specify: standard for this
Review charts. clinical labor task.
93281............. Pm device progr eval EF023 table, exam.......... NF .................... 39 31 E1: Refined -0.02
multi. equipment time to
conform to
established
policies for non-
highly technical
equipment.
93281............. Pm device progr eval EQ198 pacemaker follow-up NF .................... 39 31 E1: Refined -0.61
multi. system (incl equipment time to
software and conform to
hardware) (Paceart). established
policies for non-
highly technical
equipment.
93281............. Pm device progr eval L026A Medical/Technical NF Complete diagnostic 2 0 L2: Clinical labor -0.52
multi. Assistant. forms, lab, X-ray task redundant with
requisitions. clinical labor task
L037D.
93281............. Pm device progr eval L037D RN/LPN/MTA........... NF Other Clinical 2 0 L1: Refined time to -0.74
multi. Activity--specify: standard for this
Review charts. clinical labor task.
93281............. Pm device progr eval L037D RN/LPN/MTA........... NF Assist physician in 16 15 L15: Refined -0.37
multi. performing clinical labor time
procedure. to match
intraservice work
time.
93282............. Prgrmg eval EF023 table, exam.......... NF .................... 35 28 E1: Refined -0.02
implantable dfb. equipment time to
conform to
established
policies for non-
highly technical
equipment.
93282............. Prgrmg eval EQ198 pacemaker follow-up NF .................... 35 28 E1: Refined -0.53
implantable dfb. system (incl equipment time to
software and conform to
hardware) (Paceart). established
policies for non-
highly technical
equipment.
93282............. Prgrmg eval L026A Medical/Technical NF Complete diagnostic 2 0 L2: Clinical labor -0.52
implantable dfb. Assistant. forms, lab, X-ray task redundant with
requisitions. clinical labor task
L037D.
93282............. Prgrmg eval L037D RN/LPN/MTA........... NF Other Clinical 2 0 L1: Refined time to -0.74
implantable dfb. Activity--specify: standard for this
Review charts. clinical labor task.
[[Page 34050]]
93283............. Prgrmg eval EF023 table, exam.......... NF .................... 38 31 E1: Refined -0.02
implantable dfb. equipment time to
conform to
established
policies for non-
highly technical
equipment.
93283............. Prgrmg eval EQ198 pacemaker follow-up NF .................... 38 31 E1: Refined -0.53
implantable dfb. system (incl equipment time to
software and conform to
hardware) (Paceart). established
policies for non-
highly technical
equipment.
93283............. Prgrmg eval L026A Medical/Technical NF Complete diagnostic 2 0 L2: Clinical labor -0.52
implantable dfb. Assistant. forms, lab, X-ray task redundant with
requisitions. clinical labor task
L037D.
93283............. Prgrmg eval L037D RN/LPN/MTA........... NF Other Clinical 2 0 L1: Refined time to -0.74
implantable dfb. Activity--specify: standard for this
Review charts. clinical labor task.
93284............. Prgrmg eval EF023 table, exam.......... NF .................... 40.5 33.5 E1: Refined -0.02
implantable dfb. equipment time to
conform to
established
policies for non-
highly technical
equipment.
93284............. Prgrmg eval EQ198 pacemaker follow-up NF .................... 40.5 33.5 E1: Refined -0.53
implantable dfb. system (incl equipment time to
software and conform to
hardware) (Paceart). established
policies for non-
highly technical
equipment.
93284............. Prgrmg eval L026A Medical/Technical NF Complete diagnostic 2 0 L2: Clinical labor -0.52
implantable dfb. Assistant. forms, lab, X-ray task redundant with
requisitions. clinical labor task
L037D.
93284............. Prgrmg eval L037D RN/LPN/MTA........... NF Other Clinical 2 0 L1: Refined time to -0.74
implantable dfb. Activity--specify: standard for this
Review charts. clinical labor task.
93285............. Ilr device eval progr EF023 table, exam.......... NF .................... 30 25 E1: Refined -0.01
equipment time to
conform to
established
policies for non-
highly technical
equipment.
93285............. Ilr device eval progr EQ198 pacemaker follow-up NF .................... 30 25 E1: Refined -0.38
system (incl equipment time to
software and conform to
hardware) (Paceart). established
policies for non-
highly technical
equipment.
93285............. Ilr device eval progr L026A Medical/Technical NF Complete diagnostic 1 0 L2: Clinical labor -0.26
Assistant. forms, lab, X-ray task redundant with
requisitions. clinical labor task
L037D.
93285............. Ilr device eval progr L037D RN/LPN/MTA........... NF Other Clinical 2 0 L1: Refined time to -0.74
Activity--specify: standard for this
Review charts. clinical labor task.
[[Page 34051]]
93286............. Peri-px pacemaker EF023 table, exam.......... NF .................... 27 20 E1: Refined -0.02
device evl. equipment time to
conform to
established
policies for non-
highly technical
equipment.
93286............. Peri-px pacemaker EQ198 pacemaker follow-up NF .................... 27 20 E1: Refined -0.53
device evl. system (incl equipment time to
software and conform to
hardware) (Paceart). established
policies for non-
highly technical
equipment.
93286............. Peri-px pacemaker L026A Medical/Technical NF Complete diagnostic 2 0 L2: Clinical labor -0.52
device evl. Assistant. forms, lab, X-ray task redundant with
requisitions. clinical labor task
L037D.
93286............. Peri-px pacemaker L037D RN/LPN/MTA........... NF Other Clinical 2 0 L1: Refined time to -0.74
device evl. Activity--specify: standard for this
Review charts. clinical labor task.
93287............. Peri-px device eval & EF023 table, exam.......... NF .................... 27 20 E1: Refined -0.02
prgr. equipment time to
conform to
established
policies for non-
highly technical
equipment.
93287............. Peri-px device eval & EQ198 pacemaker follow-up NF .................... 27 20 E1: Refined -0.53
prgr. system (incl equipment time to
software and conform to
hardware) (Paceart). established
policies for non-
highly technical
equipment.
93287............. Peri-px device eval & L026A Medical/Technical NF Complete diagnostic 2 0 L2: Clinical labor -0.52
prgr. Assistant. forms, lab, X-ray task redundant with
requisitions. clinical labor task
L037D.
93287............. Peri-px device eval & L037D RN/LPN/MTA........... NF Other Clinical 2 0 L1: Refined time to -0.74
prgr. Activity--specify: standard for this
Review charts. clinical labor task.
93288............. Pm device eval in EF023 table, exam.......... NF .................... 33 26 E1: Refined -0.02
person. equipment time to
conform to
established
policies for non-
highly technical
equipment.
93288............. Pm device eval in EQ198 pacemaker follow-up NF .................... 33 26 E1: Refined -0.53
person. system (incl equipment time to
software and conform to
hardware) (Paceart). established
policies for non-
highly technical
equipment.
93288............. Pm device eval in L026A Medical/Technical NF Complete diagnostic 2 0 L2: Clinical labor -0.52
person. Assistant. forms, lab, X-ray task redundant with
requisitions. clinical labor task
L037D.
93288............. Pm device eval in L037D RN/LPN/MTA........... NF Other Clinical 2 0 L1: Refined time to -0.74
person. Activity--specify: standard for this
Review charts. clinical labor task.
[[Page 34052]]
93289............. Interrog device eval EF023 table, exam.......... NF .................... 33 26 E1: Refined -0.02
heart. equipment time to
conform to
established
policies for non-
highly technical
equipment.
93289............. Interrog device eval EQ198 pacemaker follow-up NF .................... 33 26 E1: Refined -0.53
heart. system (incl equipment time to
software and conform to
hardware) (Paceart). established
policies for non-
highly technical
equipment.
93289............. Interrog device eval L026A Medical/Technical NF Complete diagnostic 2 0 L2: Clinical labor -0.52
heart. Assistant. forms, lab, X-ray task redundant with
requisitions. clinical labor task
L037D.
93289............. Interrog device eval L037D RN/LPN/MTA........... NF Other Clinical 2 0 L1: Refined time to -0.74
heart. Activity--specify: standard for this
Review charts. clinical labor task.
93290............. Icm device eval...... EF023 table, exam.......... NF .................... 28 24 E1: Refined -0.01
equipment time to
conform to
established
policies for non-
highly technical
equipment.
93290............. Icm device eval...... EQ198 pacemaker follow-up NF .................... 28 24 E1: Refined -0.30
system (incl equipment time to
software and conform to
hardware) (Paceart). established
policies for non-
highly technical
equipment.
93290............. Icm device eval...... L026A Medical/Technical NF Complete diagnostic 1 0 L2: Clinical labor -0.26
Assistant. forms, lab, X-ray task redundant with
requisitions. clinical labor task
L037D.
93290............. Icm device eval...... L037D RN/LPN/MTA........... NF Other Clinical 2 0 L1: Refined time to -0.74
Activity--specify: standard for this
Review charts. clinical labor task.
93291............. Ilr device EF023 table, exam.......... NF .................... 27 22 E1: Refined -0.01
interrogate. equipment time to
conform to
established
policies for non-
highly technical
equipment.
93291............. Ilr device EQ198 pacemaker follow-up NF .................... 27 22 E1: Refined -0.38
interrogate. system (incl equipment time to
software and conform to
hardware) (Paceart). established
policies for non-
highly technical
equipment.
93291............. Ilr device L026A Medical/Technical NF Complete diagnostic 1 0 L2: Clinical labor -0.26
interrogate. Assistant. forms, lab, X-ray task redundant with
requisitions. clinical labor task
L037D.
93291............. Ilr device L037D RN/LPN/MTA........... NF Other Clinical 2 0 L1: Refined time to -0.74
interrogate. Activity--specify: standard for this
Review charts. clinical labor task.
[[Page 34053]]
93292............. Wcd device EF023 table, exam.......... NF .................... 30 25 E1: Refined -0.01
interrogate. equipment time to
conform to
established
policies for non-
highly technical
equipment.
93292............. Wcd device EQ198 pacemaker follow-up NF .................... 30 25 E1: Refined -0.38
interrogate. system (incl equipment time to
software and conform to
hardware) (Paceart). established
policies for non-
highly technical
equipment.
93292............. Wcd device L026A Medical/Technical NF Complete diagnostic 1 0 L2: Clinical labor -0.26
interrogate. Assistant. forms, lab, X-ray task redundant with
requisitions. clinical labor task
L037D.
93292............. Wcd device L037D RN/LPN/MTA........... NF Other Clinical 2 0 L1: Refined time to -0.74
interrogate. Activity--specify: standard for this
Review charts. clinical labor task.
93350............. Stress tte only...... ED053 Professional PACS NF .................... 20 18 E18: Refined -0.12
Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
93351............. Stress tte complete.. ED050 Technologist PACS NF .................... 104 114 E18: Refined 0.22
workstation. equipment time to
conform to
established
policies for PACS
Workstations.
93351............. Stress tte complete.. ED053 Professional PACS NF .................... 30 25 E18: Refined -0.29
Workstation. equipment time to
conform to
established
policies for PACS
Workstations.
93351............. Stress tte complete.. EQ078 cardiac monitor w- NF .................... 104 91 E1: Refined -0.49
treadmill (12-lead equipment time to
PC-based ECG). conform to
established
policies for non-
highly technical
equipment.
93351............. Stress tte complete.. L037D RN/LPN/MTA........... NF Obtain vital signs.. 3 5 L1: Refined time to 0.74
standard for this
clinical labor task.
93351............. Stress tte complete.. L037D RN/LPN/MTA........... NF Provide pre-service 3 2 L1: Refined time to -0.37
education/obtain standard for this
consent. clinical labor task.
93351............. Stress tte complete.. L051A RN................... NF Setup scope (non 5 0 G1: See preamble -2.55
facility setting text.
only).
94621............. Cardiopulm exercise EQ042 Vmax 29c (cardio-pulm NF .................... 127 115 E6: Refined -1.98
testing. stress test equip, equipment time to
treadmill, computer conform to
system). established
policies for
equipment with 4x
monitoring time.
[[Page 34054]]
94621............. Cardiopulm exercise EQ211 pulse oximeter w- NF .................... 127 115 E6: Refined -0.05
testing. printer. equipment time to
conform to
established
policies for
equipment with 4x
monitoring time.
94621............. Cardiopulm exercise L047C RN/Respiratory NF Prepare and position 5 3 G1: See preamble -0.94
testing. Therapist. pt/monitor pt/set text.
up IV.
94621............. Cardiopulm exercise L047C RN/Respiratory NF Provide pre-service 10 5 G1: See preamble -2.35
testing. Therapist. education/obtain text.
consent.
94621............. Cardiopulm exercise L047C RN/Respiratory NF Complete diagnostic 5 3 L1: Refined time to -0.94
testing. Therapist. forms, lab, X-ray standard for this
requisitions. clinical labor task.
946X2............. Exercise tst brncspsm EQ043 Vmax 29s (spirometry NF .................... 87 83 E6: Refined -0.31
testing equip, equipment time to
computer system). conform to
established
policies for
equipment with 4x
monitoring time.
946X2............. Exercise tst brncspsm EQ078 cardiac monitor w- NF .................... 87 83 E6: Refined -0.15
treadmill (12-lead equipment time to
PC-based ECG). conform to
established
policies for
equipment with 4x
monitoring time.
946X2............. Exercise tst brncspsm EQ211 pulse oximeter w- NF .................... 87 83 E6: Refined -0.02
printer. equipment time to
conform to
established
policies for
equipment with 4x
monitoring time.
946X2............. Exercise tst brncspsm L047C RN/Respiratory NF Complete diagnostic 4 3 L1: Refined time to -0.47
Therapist. forms, lab, X-ray standard for this
requisitions. clinical labor task.
946X3............. Pulmonary stress EQ211 pulse oximeter w- NF .................... 17 15 E1: Refined -0.01
testing. printer. equipment time to
conform to
established
policies for non-
highly technical
equipment.
946X3............. Pulmonary stress L047C RN/Respiratory NF Complete diagnostic 2 3 L1: Refined time to 0.47
testing. Therapist. forms, lab, X-ray standard for this
requisitions. clinical labor task.
95004............. Percut allergy skin EF015 mayo stand........... NF .................... 1.28 1.58 E6: Refined 0.00
tests. equipment time to
conform to
established
policies for
equipment with 4x
monitoring time.
95004............. Percut allergy skin EF023 table, exam.......... NF .................... 1.28 1.58 E6: Refined 0.00
tests. equipment time to
conform to
established
policies for
equipment with 4x
monitoring time.
[[Page 34055]]
96160............. Pt-focused hlth risk L026A Medical/Technical NF Explain purpose of 2 0 G1: See preamble -0.52
assmt. Assistant. assessment to text.
patient/caregiver
and answer
questions.
96160............. Pt-focused hlth risk L026A Medical/Technical NF Remain in exam room 2 0 G1: See preamble -0.52
assmt. Assistant. with patient/ text.
caregiver exclusive
to completion of
assessment.
96160............. Pt-focused hlth risk L026A Medical/Technical NF Collate and score 1 0 G1: See preamble -0.26
assmt. Assistant. data elements on text.
assessment in
advance of
physician exam.
96160............. Pt-focused hlth risk L026A Medical/Technical NF Scan assessment or 2 0 G1: See preamble -0.52
assmt. Assistant. enter data elements text.
and total score
into electronic
health record.
96160............. Pt-focused hlth risk L026A Medical/Technical NF Administration, 0 7 G1: See preamble 1.82
assmt. Assistant. scoring, and text.
documenting results
of completed
standardized
instrument.
96161............. Caregiver health risk L026A Medical/Technical NF Explain purpose of 2 0 G1: See preamble -0.52
assmt. Assistant. assessment to text.
patient/caregiver
and answer
questions.
96161............. Caregiver health risk L026A Medical/Technical NF Remain in exam room 2 0 G1: See preamble -0.52
assmt. Assistant. with patient/ text.
caregiver exclusive
to completion of
assessment.
96161............. Caregiver health risk L026A Medical/Technical NF Collate and score 1 0 G1: See preamble -0.26
assmt. Assistant. data elements on text.
assessment in
advance of
physician exam.
96161............. Caregiver health risk L026A Medical/Technical NF Scan assessment or 2 0 G1: See preamble -0.52
assmt. Assistant. enter data elements text.
and total score
into electronic
health record.
96161............. Caregiver health risk L026A Medical/Technical NF Administration, 0 7 G1: See preamble 1.82
assmt. Assistant. scoring, and text.
documenting results
of completed
standardized
instrument.
96360............. Hydration iv infusion EF023 table, exam.......... NF .................... 16 24 E6: Refined 0.02
init. equipment time to
conform to
established
policies for
equipment with 4x
monitoring time.
[[Page 34056]]
96360............. Hydration iv infusion EQ032 IV infusion pump..... NF .................... 16 24 E6: Refined 0.05
init. equipment time to
conform to
established
policies for
equipment with 4x
monitoring time.
96360............. Hydration iv infusion L056A RN/OCN............... NF Obtain vital signs.. 3 5 L1: Refined time to 1.58
init. standard for this
clinical labor task.
96361............. Hydrate iv infusion EF023 table, exam.......... NF .................... 7 9 E15: Refined 0.01
add-on. equipment time to
conform to changes
in clinical labor
time.
96361............. Hydrate iv infusion EQ032 IV infusion pump..... NF .................... 7 9 E15: Refined 0.01
add-on. equipment time to
conform to changes
in clinical labor
time.
96361............. Hydrate iv infusion L056A RN/OCN............... NF Obtain vital signs.. 3 5 L1: Refined time to 1.58
add-on. standard for this
clinical labor task.
96372............. Ther/proph/diag inj EF023 table, exam.......... NF .................... 12 9 E15: Refined -0.01
sc/im. equipment time to
conform to changes
in clinical labor
time.
96372............. Ther/proph/diag inj EQ189 otoscope- NF .................... 12 9 E15: Refined -0.01
sc/im. ophthalmoscope (wall equipment time to
unit). conform to changes
in clinical labor
time.
96372............. Ther/proph/diag inj L037D RN/LPN/MTA........... NF Complete medical 1 0 G6: Indirect -0.37
sc/im. record Practice Expense
documentation. input and/or not
individually
allocable to a
particular patient
for a particular
service.
96372............. Ther/proph/diag inj L037D RN/LPN/MTA........... NF Document lot number 1 0 L3: Refined clinical -0.37
sc/im. and expiration date. labor time to
conform with
identical labor
activity in other
codes in the family.
96372............. Ther/proph/diag inj L037D RN/LPN/MTA........... NF Clean room/equipment 1 0 G8: Input removed; -0.37
sc/im. by physician staff. code is typically
billed with an E/M
or other evaluation
service.
96374............. Ther/proph/diag inj EF023 table, exam.......... NF .................... 23 31 E6: Refined 0.02
iv push. equipment time to
conform to
established
policies for
equipment with 4x
monitoring time.
[[Page 34057]]
96374............. Ther/proph/diag inj EQ189 otoscope- NF .................... 23 31 E6: Refined 0.01
iv push. ophthalmoscope (wall equipment time to
unit). conform to
established
policies for
equipment with 4x
monitoring time.
96374............. Ther/proph/diag inj L056A RN/OCN............... NF Complete medical 1 0 G6: Indirect -0.79
iv push. record Practice Expense
documentation. input and/or not
individually
allocable to a
particular patient
for a particular
service.
96375............. Tx/pro/dx inj new EF023 table, exam.......... NF .................... 12 17 E6: Refined 0.01
drug addon. equipment time to
conform to
established
policies for
equipment with 4x
monitoring time.
96375............. Tx/pro/dx inj new EQ189 otoscope- NF .................... 12 17 E6: Refined 0.01
drug addon. ophthalmoscope (wall equipment time to
unit). conform to
established
policies for
equipment with 4x
monitoring time.
96375............. Tx/pro/dx inj new L056A RN/OCN............... NF Complete medical 1 0 G6: Indirect -0.79
drug addon. record Practice Expense
documentation. input and/or not
individually
allocable to a
particular patient
for a particular
service.
96377............. Applicaton on-body EF023 table, exam.......... NF .................... 12 11 E15: Refined 0.00
injector. equipment time to
conform to changes
in clinical labor
time.
96377............. Applicaton on-body EQ189 otoscope- NF .................... 12 11 E15: Refined 0.00
injector. ophthalmoscope (wall equipment time to
unit). conform to changes
in clinical labor
time.
96377............. Applicaton on-body L056A RN/OCN............... NF Complete medical 1 0 G6: Indirect -0.79
injector. record Practice Expense
documentation. input and/or not
individually
allocable to a
particular patient
for a particular
service.
96910............. Photochemotherapy EF023 table, exam.......... NF .................... 67 65 E15: Refined -0.01
with uv-b. equipment time to
conform to changes
in clinical labor
time.
[[Page 34058]]
96910............. Photochemotherapy EQ168 light, exam.......... NF .................... 67 65 E15: Refined -0.01
with uv-b. equipment time to
conform to changes
in clinical labor
time.
96910............. Photochemotherapy EQ204 phototherapy unit, NF .................... 67 65 E15: Refined -0.01
with uv-b. hand-foot, UVA-UVB. equipment time to
conform to changes
in clinical labor
time.
96910............. Photochemotherapy EQ205 phototherapy unit, NF .................... 67 65 E15: Refined -0.07
with uv-b. whole body, UVA-UVB. equipment time to
conform to changes
in clinical labor
time.
96910............. Photochemotherapy L037D RN/LPN/MTA........... NF Complete diagnostic 2 0 G6: Indirect -0.74
with uv-b. forms, lab & X-ray Practice Expense
requisitions, and input and/or not
documentation. individually
allocable to a
particular patient
for a particular
service.
96910............. Photochemotherapy L037D RN/LPN/MTA........... NF Provide pre-service 3 1 G1: See preamble -0.74
with uv-b. education/obtain text.
consent.
96910............. Photochemotherapy L037D RN/LPN/MTA........... NF Obtain vital signs.. 3 5 L1: Refined time to 0.74
with uv-b. standard for this
clinical labor task.
96X73............. Pdt dstr prmlg les EF031 table, power......... NF .................... 230 52 E1: Refined -2.91
phys/qhp. equipment time to
conform to
established
policies for non-
highly technical
equipment.
96X73............. Pdt dstr prmlg les EQ169 light, external PDT, NF .................... 20 52 E1: Refined 1.12
phys/qhp. w-probe set equipment time to
(LumaCare). conform to
established
policies for non-
highly technical
equipment.
96X73............. Pdt dstr prmlg les L037D RN/LPN/MTA........... NF Obtain vital signs.. 3 5 L1: Refined time to 0.74
phys/qhp. standard for this
clinical labor task.
96X73............. Pdt dstr prmlg les SJ027 goggles, uv-blocking. NF .................... 0 3 S8: Supply item 12.30
phys/qhp. replaces another
item; see preamble.
96X74............. Dbrdmt prmlg les w/ EF031 table, power......... NF .................... 232 54 E1: Refined -2.91
pdt. equipment time to
conform to
established
policies for non-
highly technical
equipment.
[[Page 34059]]
96X74............. Dbrdmt prmlg les w/ EQ168 light, exam.......... NF .................... 52 54 E1: Refined 0.01
pdt. equipment time to
conform to
established
policies for non-
highly technical
equipment.
96X74............. Dbrdmt prmlg les w/ EQ169 light, external PDT, NF .................... 20 54 E1: Refined 1.19
pdt. w-probe set equipment time to
(LumaCare). conform to
established
policies for non-
highly technical
equipment.
96X74............. Dbrdmt prmlg les w/ L037D RN/LPN/MTA........... NF Obtain vital signs.. 3 5 L1: Refined time to 0.74
pdt. standard for this
clinical labor task.
96X74............. Dbrdmt prmlg les w/ SJ027 goggles, uv-blocking. NF .................... 0 3 S8: Supply item 12.30
pdt. replaces another
item; see preamble.
97012............. Mechanical traction EQ241 traction system (hi- NF .................... 13 15 G1: See preamble 0.03
therapy. low table, digital text.
unit, accessories).
97012............. Mechanical traction L023A Physical Therapy Aide NF Clean room/equipment 1 2 G1: See preamble 0.23
therapy. by physician staff. text.
97012............. Mechanical traction L023A Physical Therapy Aide NF Assist therapist.... 2 0 G1: See preamble -0.46
therapy. text.
97012............. Mechanical traction L023A Physical Therapy Aide NF Other clinical 0 1 G1: See preamble 0.23
therapy. Activity--specify: text.
post-treatment
assistance.
97012............. Mechanical traction L023A Physical Therapy Aide NF Prepare room, 1 0 G1: See preamble -0.23
therapy. equipment, supplies. text.
97012............. Mechanical traction L023A Physical Therapy Aide NF Prepare and position 1 0 G1: See preamble -0.23
therapy. patient. text.
97012............. Mechanical traction L039B Physical Therapy NF Check dressings & 0 1 G1: See preamble 0.39
therapy. Assistant. wound/home care text.
instructions/
coordinate office
visits/
prescriptions.
97012............. Mechanical traction L039B Physical Therapy NF Assist therapist.... 0 5 G1: See preamble 1.95
therapy. Assistant. text.
97012............. Mechanical traction SB022 gloves, non-sterile.. NF .................... 1 0 G1: See preamble -0.08
therapy. text.
97012............. Mechanical traction SB026 gown, patient........ NF .................... 1 0 G1: See preamble -0.53
therapy. text.
97012............. Mechanical traction SG039 dressing, 5in x 9in NF .................... 0 1 G1: See preamble 0.27
therapy. (ABD-Combine). text.
97012............. Mechanical traction SK082 towel, paper (Bounty) NF .................... 2 0 G1: See preamble -0.01
therapy. (per sheet). text.
97012............. Mechanical traction SM012 disinfectant spray NF .................... 2 0 G1: See preamble -0.06
therapy. (Transeptic). text.
97014............. Electric stimulation EF028 table, mat, hi-lo, 6 NF .................... 10 15 G1: See preamble 0.05
therapy. x 8 platform. text.
97014............. Electric stimulation EQ116 electrotherapy NF .................... 10 15 G1: See preamble 0.03
therapy. stimulator, high text.
volt, 2 channel.
97014............. Electric stimulation L023A Physical Therapy Aide NF Prepare room, 1 0 G1: See preamble -0.23
therapy. equipment, supplies. text.
97014............. Electric stimulation L023A Physical Therapy Aide NF Assist therapist.... 2 0 G1: See preamble -0.46
therapy. text.
[[Page 34060]]
97014............. Electric stimulation L023A Physical Therapy Aide NF Clean room/equipment 1 2 G1: See preamble 0.23
therapy. by physician staff. text.
97014............. Electric stimulation L023A Physical Therapy Aide NF Other clinical 0 1 G1: See preamble 0.23
therapy. Activity--specify: text.
post-treatment
assistance.
97014............. Electric stimulation L023A Physical Therapy Aide NF Prepare and position 1 0 G1: See preamble -0.23
therapy. patient. text.
97014............. Electric stimulation L039B Physical Therapy NF Assist therapist.... 0 3 G1: See preamble 1.17
therapy. Assistant. text.
97014............. Electric stimulation L039B Physical Therapy NF Check dressings & 0 1 G1: See preamble 0.39
therapy. Assistant. wound/home care text.
instructions/
coordinate office
visits/
prescriptions.
97014............. Electric stimulation SB026 gown, patient........ NF .................... 1 0 G1: See preamble -0.53
therapy. text.
97014............. Electric stimulation SJ024 electrolyte coupling NF .................... 0 1 G1: See preamble 0.02
therapy. gel. text.
97014............. Electric stimulation SK068 razor................ NF .................... 0 1 G1: See preamble 0.39
therapy. text.
97014............. Electric stimulation SK082 towel, paper (Bounty) NF .................... 1 0 G1: See preamble -0.01
therapy. (per sheet). text.
97014............. Electric stimulation SM012 disinfectant spray NF .................... 1 0 G1: See preamble -0.03
therapy. (Transeptic). text.
97016............. Vasopneumatic device EF028 table, mat, hi-lo, 6 NF .................... 11 20 G1: See preamble 0.09
therapy. x 8 platform. text.
97016............. Vasopneumatic device EQ263 vasopneumatic NF .................... 11 20 G1: See preamble 0.02
therapy. compression system. text.
97016............. Vasopneumatic device L023A Physical Therapy Aide NF Other clinical 0 2 G1: See preamble 0.46
therapy. Activity--specify: text.
post-treatment
assistance.
97016............. Vasopneumatic device L023A Physical Therapy Aide NF Prepare room, 1 0 G1: See preamble -0.23
therapy. equipment, supplies. text.
97016............. Vasopneumatic device L023A Physical Therapy Aide NF Clean room/equipment 1 2 G1: See preamble 0.23
therapy. by physician staff. text.
97016............. Vasopneumatic device L023A Physical Therapy Aide NF Prepare and position 1 0 G1: See preamble -0.23
therapy. patient. text.
97016............. Vasopneumatic device L023A Physical Therapy Aide NF Assist therapist.... 2 0 G1: See preamble -0.46
therapy. text.
97016............. Vasopneumatic device L039B Physical Therapy NF Assist therapist.... 0 10 G1: See preamble 3.90
therapy. Assistant. text.
97016............. Vasopneumatic device L039B Physical Therapy NF Check dressings & 0 5 G1: See preamble 1.95
therapy. Assistant. wound/home care text.
instructions/
coordinate office
visits/
prescriptions.
97016............. Vasopneumatic device L039B Physical Therapy NF Obtain vital signs.. 0 2 G1: See preamble 0.78
therapy. Assistant. text.
97016............. Vasopneumatic device SB026 gown, patient........ NF .................... 1 0 G1: See preamble -0.53
therapy. text.
97018............. Paraffin bath therapy EQ200 paraffin bath, hand- NF .................... 11 15 G1: See preamble 0.03
foot (institutional). text.
[[Page 34061]]
97018............. Paraffin bath therapy L023A Physical Therapy Aide NF Prepare room, 1 3 G1: See preamble 0.46
equipment, supplies. text.
97018............. Paraffin bath therapy L023A Physical Therapy Aide NF Other clinical 0 1 G1: See preamble 0.23
Activity--specify: text.
post-treatment
assistance.
97018............. Paraffin bath therapy L023A Physical Therapy Aide NF Clean room/equipment 1 2 G1: See preamble 0.23
by physician staff. text.
97018............. Paraffin bath therapy L023A Physical Therapy Aide NF Assist therapist.... 2 0 G1: See preamble -0.46
text.
97018............. Paraffin bath therapy L023A Physical Therapy Aide NF Prepare and position 1 3 G1: See preamble 0.46
patient. text.
97018............. Paraffin bath therapy L039B Physical Therapy NF Check dressings & 0 1 G1: See preamble 0.39
Assistant. wound/home care text.
instructions/
coordinate office
visits/
prescriptions.
97018............. Paraffin bath therapy L039B Physical Therapy NF Assist therapist.... 0 5 G1: See preamble 1.95
Assistant. text.
97018............. Paraffin bath therapy SA048 pack, minimum multi- NF .................... 0 0.5 G1: See preamble 0.57
specialty visit. text.
97022............. Whirlpool therapy.... EF012 lift, hydraulic, NF .................... 26 4 G1: See preamble -0.28
chair. text.
97022............. Whirlpool therapy.... EF036 whirlpool, lo-boy NF .................... 26 24 G1: See preamble -0.02
tank (whole body). text.
97022............. Whirlpool therapy.... L023A Physical Therapy Aide NF Prepare and position 2 3 G1: See preamble 0.23
patient. text.
97022............. Whirlpool therapy.... L023A Physical Therapy Aide NF Assist therapist.... 2 0 G1: See preamble -0.46
text.
97022............. Whirlpool therapy.... L023A Physical Therapy Aide NF Other clinical 0 3 G1: See preamble 0.69
Activity--specify: text.
post-treatment
assistance.
97022............. Whirlpool therapy.... L039B Physical Therapy NF Assist therapist.... 0 5 G1: See preamble 1.95
Assistant. text.
97022............. Whirlpool therapy.... L039B Physical Therapy NF Check dressings & 0 1 G1: See preamble 0.39
Assistant. wound/home care text.
instructions/
coordinate office
visits/
prescriptions.
97022............. Whirlpool therapy.... SB022 gloves, non-sterile.. NF .................... 1 0 G1: See preamble -0.08
text.
97022............. Whirlpool therapy.... SB024 gloves, sterile...... NF .................... 0 1 G1: See preamble 0.84
text.
97022............. Whirlpool therapy.... SB033 mask, surgical....... NF .................... 0 1 G1: See preamble 0.20
text.
97022............. Whirlpool therapy.... SG017 bandage, Kling, non- NF .................... 0 1 G1: See preamble 0.36
sterile 2in. text.
97022............. Whirlpool therapy.... SG027 cast, stockinette 4in NF .................... 0 1 G1: See preamble 0.46
text.
97022............. Whirlpool therapy.... SG055 gauze, sterile 4in x NF .................... 0 5 G1: See preamble 0.80
4in. text.
97022............. Whirlpool therapy.... SG079 tape, surgical paper NF .................... 0 12 G1: See preamble 0.02
1in (Micropore). text.
97022............. Whirlpool therapy.... SJ046 silver nitrate NF .................... 0 1 G1: See preamble 0.07
applicator. text.
97032............. Electrical EF028 table, mat, hi-lo, 6 NF .................... 18 15 G1: See preamble -0.03
stimulation. x 8 platform. text.
97032............. Electrical EQ116 electrotherapy NF .................... 18 15 G1: See preamble -0.02
stimulation. stimulator, high text.
volt, 2 channel.
[[Page 34062]]
97032............. Electrical L023A Physical Therapy Aide NF Prepare room, 1 0 G1: See preamble -0.23
stimulation. equipment, supplies. text.
97032............. Electrical L023A Physical Therapy Aide NF Prepare and position 1 0 G1: See preamble -0.23
stimulation. patient. text.
97032............. Electrical L023A Physical Therapy Aide NF Other clinical 0 1 G1: See preamble 0.23
stimulation. Activity--specify: text.
post-treatment
assistance.
97032............. Electrical L023A Physical Therapy Aide NF Clean room/equipment 1 2 G1: See preamble 0.23
stimulation. by physician staff. text.
97032............. Electrical L039B Physical Therapy NF Assist therapist.... 0 3 G1: See preamble 1.17
stimulation. Assistant. text.
97032............. Electrical L039B Physical Therapy NF Check dressings & 0 1 G1: See preamble 0.39
stimulation. Assistant. wound/home care text.
instructions/
coordinate office
visits/
prescriptions.
97032............. Electrical SB022 gloves, non-sterile.. NF .................... 1 0 G1: See preamble -0.08
stimulation. text.
97032............. Electrical SB026 gown, patient........ NF .................... 1 0 G1: See preamble -0.53
stimulation. text.
97032............. Electrical SD055 electrode, electrical NF .................... 0 2 G1: See preamble 2.62
stimulation. stimulation. text.
97032............. Electrical SG079 tape, surgical paper NF .................... 0 6 G1: See preamble 0.01
stimulation. 1in (Micropore). text.
97032............. Electrical SJ020 electrode conductive NF .................... 0 5 G1: See preamble 0.08
stimulation. gel. text.
97032............. Electrical SJ053 swab-pad, alcohol.... NF .................... 1 2 G1: See preamble 0.01
stimulation. text.
97032............. Electrical SK068 razor................ NF .................... 0 1 G1: See preamble 0.39
stimulation. text.
97032............. Electrical SK082 towel, paper (Bounty) NF .................... 1 0 G1: See preamble -0.01
stimulation. (per sheet). text.
97032............. Electrical SM012 disinfectant spray NF .................... 1 0 G1: See preamble -0.03
stimulation. (Transeptic). text.
97033............. Electric current EF028 table, mat, hi-lo, 6 NF .................... 20 15 G1: See preamble -0.05
therapy. x 8 platform. text.
97033............. Electric current EQ141 iontophoresis machine NF .................... 20 15 G1: See preamble -0.01
therapy. text.
97033............. Electric current L023A Physical Therapy Aide NF Other clinical 0 1 G1: See preamble 0.23
therapy. Activity--specify: text.
post-treatment
assistance.
97033............. Electric current L023A Physical Therapy Aide NF Prepare room, 2 3 G1: See preamble 0.23
therapy. equipment, supplies. text.
97033............. Electric current L023A Physical Therapy Aide NF Clean room/equipment 1 3 G1: See preamble 0.46
therapy. by physician staff. text.
97033............. Electric current L039B Physical Therapy NF Other Clinical 0 1 G1: See preamble 0.39
therapy. Assistant. Activity--specify: text.
Obtain measurements.
97033............. Electric current SG055 gauze, sterile 4in x NF .................... 0 1 G1: See preamble 0.16
therapy. 4in. text.
97033............. Electric current SK068 razor................ NF .................... 0 1 G1: See preamble 0.39
therapy. text.
97034............. Contrast bath therapy L023A Physical Therapy Aide NF Clean room/equipment 2 5 G1: See preamble 0.69
by physician staff. text.
97034............. Contrast bath therapy L023A Physical Therapy Aide NF Prepare room, 2 3 G1: See preamble 0.23
equipment, supplies. text.
97034............. Contrast bath therapy L023A Physical Therapy Aide NF Prepare and position 1 2 G1: See preamble 0.23
patient. text.
[[Page 34063]]
97034............. Contrast bath therapy L039B Physical Therapy NF Assist therapist.... 0 3 G1: See preamble 1.17
Assistant. text.
97034............. Contrast bath therapy L039B Physical Therapy NF Check dressings & 0 3 G1: See preamble 1.17
Assistant. wound/home care text.
instructions/
coordinate office
visits/
prescriptions.
97034............. Contrast bath therapy SB022 gloves, non-sterile.. NF .................... 1 0 G1: See preamble -0.08
text.
97034............. Contrast bath therapy SB026 gown, patient........ NF .................... 1 0 G1: See preamble -0.53
text.
97035............. Ultrasound therapy... EF028 table, mat, hi-lo, 6 NF .................... 16 15 G1: See preamble -0.01
x 8 platform. text.
97035............. Ultrasound therapy... EQ251 ultrasound unit, NF .................... 16 8 G1: See preamble -0.03
therapeutic. text.
97035............. Ultrasound therapy... L023A Physical Therapy Aide NF Prepare and position 1 0 G1: See preamble -0.23
patient. text.
97035............. Ultrasound therapy... L023A Physical Therapy Aide NF Prepare room, 1 0 G1: See preamble -0.23
equipment, supplies. text.
97035............. Ultrasound therapy... L023A Physical Therapy Aide NF Other clinical 0 1 G1: See preamble 0.23
Activity--specify: text.
post-treatment
assistance.
97035............. Ultrasound therapy... L039B Physical Therapy NF Assist therapist.... 0 3 G1: See preamble 1.17
Assistant. text.
97035............. Ultrasound therapy... SB022 gloves, non-sterile.. NF .................... 1 0 G1: See preamble -0.08
text.
97035............. Ultrasound therapy... SB026 gown, patient........ NF .................... 1 0 G1: See preamble -0.53
text.
97035............. Ultrasound therapy... SJ024 electrolyte coupling NF .................... 0 1 G1: See preamble 0.02
gel. text.
97035............. Ultrasound therapy... SJ062 ultrasound NF .................... 30 0 G1: See preamble -0.39
transmission gel. text.
97035............. Ultrasound therapy... SK082 towel, paper (Bounty) NF .................... 1 0 G1: See preamble -0.01
(per sheet). text.
97035............. Ultrasound therapy... SM012 disinfectant spray NF .................... 1 0 G1: See preamble -0.03
(Transeptic). text.
97110............. Therapeutic exercises EF028 table, mat, hi-lo, 6 NF .................... 22 10 G1: See preamble -0.12
x 8 platform. text.
97110............. Therapeutic exercises EQ118 exercise equipment NF .................... 22 8 G1: See preamble -0.40
(treadmill, bike, text.
stepper, UBE,
pulleys, balance
board).
97110............. Therapeutic exercises EQ129 hydrocollator, cold.. NF .................... 0 4 G1: See preamble 0.02
text.
97110............. Therapeutic exercises EQ130 hydrocollator, hot... NF .................... 0 4 G1: See preamble 0.01
text.
97110............. Therapeutic exercises L023A Physical Therapy Aide NF Other clinical 0 1 G1: See preamble 0.23
Activity--specify: text.
post-treatment
assistance.
97110............. Therapeutic exercises L023A Physical Therapy Aide NF Prepare room, 1 0 G1: See preamble -0.23
equipment, supplies. text.
97110............. Therapeutic exercises L023A Physical Therapy Aide NF Prepare and position 1 0 G1: See preamble -0.23
patient. text.
97110............. Therapeutic exercises L023A Physical Therapy Aide NF Assist therapist.... 5 0 G1: See preamble -1.15
text.
97110............. Therapeutic exercises L023A Physical Therapy Aide NF Other Clinical 0 1.5 G1: See preamble 0.35
Activity--specify: text.
Verify/Coordinate
availability of
resources/equipment.
[[Page 34064]]
97110............. Therapeutic exercises L039B Physical Therapy NF Check dressings & 1.5 2.5 G1: See preamble 0.39
Assistant. wound/home care text.
instructions/
coordinate office
visits/
prescriptions.
97110............. Therapeutic exercises L039B Physical Therapy NF Other Clinical 0 1.5 G1: See preamble 0.59
Assistant. Activity--specify: text.
Obtain measurements.
97110............. Therapeutic exercises L039B Physical Therapy NF Assist therapist.... 2.5 7.5 G1: See preamble 1.95
Assistant. text.
97110............. Therapeutic exercises L039B Physical Therapy NF Other Clinical 0 1 G1: See preamble 0.39
Assistant. Activity--specify: text.
Conduct phone calls/
call in
prescriptions.
97110............. Therapeutic exercises L039B Physical Therapy NF Other Clinical 0 1.5 G1: See preamble 0.59
Assistant. Activity--specify: text.
Review/read
documentation, plan
of care, treatment
goals.
97110............. Therapeutic exercises SA048 pack, minimum multi- NF .................... 0 0.5 G1: See preamble 0.57
specialty visit. text.
97110............. Therapeutic exercises SB022 gloves, non-sterile.. NF .................... 1 0 G1: See preamble -0.08
text.
97110............. Therapeutic exercises SK082 towel, paper (Bounty) NF .................... 4 0 G1: See preamble -0.03
(per sheet). text.
97110............. Therapeutic exercises SM012 disinfectant spray NF .................... 5 0 G1: See preamble -0.14
(Transeptic). text.
97112............. Neuromuscular EF028 table, mat, hi-lo, 6 NF .................... 22 10 G1: See preamble -0.12
reeducation. x 8 platform. text.
97112............. Neuromuscular EQ068 balance assessment- NF .................... 22 15 G1: See preamble -0.37
reeducation. retraining system text.
(Balance Master).
97112............. Neuromuscular EQ118 exercise equipment NF .................... 22 15 G1: See preamble -0.20
reeducation. (treadmill, bike, text.
stepper, UBE,
pulleys, balance
board).
97112............. Neuromuscular EQ201 parallel bars, NF .................... 22 5 G1: See preamble -0.06
reeducation. platform mounted. text.
97112............. Neuromuscular L023A Physical Therapy Aide NF Prepare room, 1 0 G1: See preamble -0.23
reeducation. equipment, supplies. text.
97112............. Neuromuscular L023A Physical Therapy Aide NF Prepare and position 1 0 G1: See preamble -0.23
reeducation. patient. text.
97112............. Neuromuscular L023A Physical Therapy Aide NF Assist therapist.... 5 0 G1: See preamble -1.15
reeducation. text.
97112............. Neuromuscular L023A Physical Therapy Aide NF Other clinical 0 1 G1: See preamble 0.23
reeducation. Activity--specify: text.
post-treatment
assistance.
97112............. Neuromuscular L023A Physical Therapy Aide NF Other Clinical 0 1.5 G1: See preamble 0.35
reeducation. Activity--specify: text.
Verify/Coordinate
availability of
resources/equipment.
[[Page 34065]]
97112............. Neuromuscular L039B Physical Therapy NF Check dressings & 1.5 2.5 G1: See preamble 0.39
reeducation. Assistant. wound/home care text.
instructions/
coordinate office
visits/
prescriptions.
97112............. Neuromuscular L039B Physical Therapy NF Other Clinical 0 1.5 G1: See preamble 0.59
reeducation. Assistant. Activity--specify: text.
Review/read
documentation, plan
of care, treatment
goals.
97112............. Neuromuscular L039B Physical Therapy NF Assist therapist.... 2.5 7.5 G1: See preamble 1.95
reeducation. Assistant. text.
97112............. Neuromuscular L039B Physical Therapy NF Other Clinical 0 1 G1: See preamble 0.39
reeducation. Assistant. Activity--specify: text.
Conduct phone calls/
call in
prescriptions.
97112............. Neuromuscular L039B Physical Therapy NF Other Clinical 0 1.5 G1: See preamble 0.59
reeducation. Assistant. Activity--specify: text.
Obtain measurements.
97112............. Neuromuscular SA048 pack, minimum multi- NF .................... 0 0.5 G1: See preamble 0.57
reeducation. specialty visit. text.
97112............. Neuromuscular SB022 gloves, non-sterile.. NF .................... 1 0 G1: See preamble -0.08
reeducation. text.
97112............. Neuromuscular SK082 towel, paper (Bounty) NF .................... 4 0 G1: See preamble -0.03
reeducation. (per sheet). text.
97112............. Neuromuscular SM012 disinfectant spray NF .................... 5 0 G1: See preamble -0.14
reeducation. (Transeptic). text.
97113............. Aquatic therapy/ EF012 lift, hydraulic, NF .................... 0 4 G1: See preamble 0.05
exercises. chair. text.
97113............. Aquatic therapy/ EQ050 aquatic therapy pool. NF .................... 30 15 G1: See preamble -1.15
exercises. text.
97113............. Aquatic therapy/ EQ145 kit, aquatic exercise NF .................... 30 10 G1: See preamble -0.03
exercises. text.
97113............. Aquatic therapy/ EQ207 pool cleaner......... NF .................... 0 15 G1: See preamble 0.05
exercises. text.
97113............. Aquatic therapy/ L023A Physical Therapy Aide NF Prepare room, 2 0 G1: See preamble -0.46
exercises. equipment, supplies. text.
97113............. Aquatic therapy/ L023A Physical Therapy Aide NF Other Clinical 0 1.5 G1: See preamble 0.35
exercises. Activity--specify: text.
Verify/Coordinate
availability of
resources/equipment.
97113............. Aquatic therapy/ L023A Physical Therapy Aide NF Other clinical 2 3 G1: See preamble 0.23
exercises. Activity--specify: text.
post-treatment
assistance.
97113............. Aquatic therapy/ L023A Physical Therapy Aide NF Greet patient, 2 1.5 G1: See preamble -0.12
exercises. provide gowning, text.
ensure appropriate
medical records are
available.
97113............. Aquatic therapy/ L023A Physical Therapy Aide NF Prepare and position 3 1.5 G1: See preamble -0.35
exercises. patient. text.
97113............. Aquatic therapy/ L023A Physical Therapy Aide NF Clean room/equipment 2 1 G1: See preamble -0.23
exercises. by physician staff. text.
[[Page 34066]]
97113............. Aquatic therapy/ L023A Physical Therapy Aide NF Assist therapist.... 15 0 G1: See preamble -3.45
exercises. text.
97113............. Aquatic therapy/ L039B Physical Therapy NF Check dressings & 2 2.5 G1: See preamble 0.20
exercises. Assistant. wound/home care text.
instructions/
coordinate office
visits/
prescriptions.
97113............. Aquatic therapy/ L039B Physical Therapy NF Obtain vital signs.. 2 1 G1: See preamble -0.39
exercises. Assistant. text.
97113............. Aquatic therapy/ L039B Physical Therapy NF Other Clinical 0 1.5 G1: See preamble 0.59
exercises. Assistant. Activity--specify: text.
Review/read
documentation, plan
of care, treatment
goals.
97113............. Aquatic therapy/ L039B Physical Therapy NF Other Clinical 0 1.5 G1: See preamble 0.59
exercises. Assistant. Activity--specify: text.
Obtain measurements.
97113............. Aquatic therapy/ L039B Physical Therapy NF Other Clinical 0 1 G1: See preamble 0.39
exercises. Assistant. Activity--specify: text.
Conduct phone calls/
call in
prescriptions.
97113............. Aquatic therapy/ L039B Physical Therapy NF Assist therapist.... 2 7.5 G1: See preamble 2.15
exercises. Assistant. text.
97113............. Aquatic therapy/ SA048 pack, minimum multi- NF .................... 0 0.5 G1: See preamble 0.57
exercises. specialty visit. text.
97113............. Aquatic therapy/ SB022 gloves, non-sterile.. NF .................... 1 0 G1: See preamble -0.08
exercises. text.
97113............. Aquatic therapy/ SB041 swimsuit, female for NF .................... 0 1 G1: See preamble 6.87
exercises. hydrotherapy. text.
97113............. Aquatic therapy/ SK082 towel, paper (Bounty) NF .................... 4 0 G1: See preamble -0.03
exercises. (per sheet). text.
97113............. Aquatic therapy/ SL032 culture media........ NF .................... 0 10 G1: See preamble 0.13
exercises. text.
97113............. Aquatic therapy/ SL033 culture swab system NF .................... 0 1 G1: See preamble 0.87
exercises. (Culturette). text.
97113............. Aquatic therapy/ SM012 disinfectant spray NF .................... 5 0 G1: See preamble -0.14
exercises. (Transeptic). text.
97116............. Gait training therapy EF028 table, mat, hi-lo, 6 NF .................... 22 0 G1: See preamble -0.22
x 8 platform. text.
97116............. Gait training therapy EQ144 kit, ambulation...... NF .................... 0 15 G1: See preamble 0.03
text.
97116............. Gait training therapy EQ201 parallel bars, NF .................... 22 10 G1: See preamble -0.04
platform mounted. text.
97116............. Gait training therapy EQ231 stairs, ambulation NF .................... 22 5 G1: See preamble -0.03
training. text.
97116............. Gait training therapy EQ243 treadmill............ NF .................... 22 0 G1: See preamble -0.29
text.
97116............. Gait training therapy L023A Physical Therapy Aide NF Other clinical 0 1 G1: See preamble 0.23
Activity--specify: text.
post-treatment
assistance.
97116............. Gait training therapy L023A Physical Therapy Aide NF Prepare room, 1 0 G1: See preamble -0.23
equipment, supplies. text.
97116............. Gait training therapy L023A Physical Therapy Aide NF Prepare and position 1 0 G1: See preamble -0.23
patient. text.
97116............. Gait training therapy L023A Physical Therapy Aide NF Assist therapist.... 5 0 G1: See preamble -1.15
text.
[[Page 34067]]
97116............. Gait training therapy L023A Physical Therapy Aide NF Other Clinical 0 1.5 G1: See preamble 0.35
Activity--specify: text.
Verify/Coordinate
availability of
resources/equipment.
97116............. Gait training therapy L039B Physical Therapy NF Assist therapist.... 2.5 7.5 G1: See preamble 1.95
Assistant. text.
97116............. Gait training therapy L039B Physical Therapy NF Check dressings & 1.5 2.5 G1: See preamble 0.39
Assistant. wound/home care text.
instructions/
coordinate office
visits/
prescriptions.
97116............. Gait training therapy L039B Physical Therapy NF Other Clinical 0 1.5 G1: See preamble 0.59
Assistant. Activity--specify: text.
Review/read
documentation, plan
of care, treatment
goals.
97116............. Gait training therapy L039B Physical Therapy NF Other Clinical 0 1 G1: See preamble 0.39
Assistant. Activity--specify: text.
Conduct phone calls/
call in
prescriptions.
97116............. Gait training therapy L039B Physical Therapy NF Other Clinical 0 1.5 G1: See preamble 0.59
Assistant. Activity--specify: text.
Obtain measurements.
97116............. Gait training therapy SA048 pack, minimum multi- NF .................... 0 0.5 G1: See preamble 0.57
specialty visit. text.
97116............. Gait training therapy SB022 gloves, non-sterile.. NF .................... 1 0 G1: See preamble -0.08
text.
97116............. Gait training therapy SJ056 Thera-bands (6in NF .................... 1.5 0 G1: See preamble -0.90
width). text.
97116............. Gait training therapy SK082 towel, paper (Bounty) NF .................... 4 0 G1: See preamble -0.03
(per sheet). text.
97116............. Gait training therapy SM012 disinfectant spray NF .................... 5 0 G1: See preamble -0.14
(Transeptic). text.
97116............. Gait training therapy SM021 sanitizing cloth-wipe NF .................... 0 1 G1: See preamble 0.04
(patient). text.
97140............. Manual therapy 1/> EF029 table, mobolization- NF .................... 22 15 G1: See preamble -0.13
regions. manipulation text.
(Lloyd's).
97140............. Manual therapy 1/> L023A Physical Therapy Aide NF Prepare room, 1 0 G1: See preamble -0.23
regions. equipment, supplies. text.
97140............. Manual therapy 1/> L023A Physical Therapy Aide NF Other Clinical 0 1.5 G1: See preamble 0.35
regions. Activity--specify: text.
Verify/Coordinate
availability of
resources/equipment.
97140............. Manual therapy 1/> L023A Physical Therapy Aide NF Prepare and position 1 0 G1: See preamble -0.23
regions. patient. text.
97140............. Manual therapy 1/> L023A Physical Therapy Aide NF Other clinical 0 1 G1: See preamble 0.23
regions. Activity--specify: text.
post-treatment
assistance.
97140............. Manual therapy 1/> L023A Physical Therapy Aide NF Assist therapist.... 5 0 G1: See preamble -1.15
regions. text.
[[Page 34068]]
97140............. Manual therapy 1/> L039B Physical Therapy NF Other Clinical 0 1 G1: See preamble 0.39
regions. Assistant. Activity--specify: text.
Conduct phone calls/
call in
prescriptions.
97140............. Manual therapy 1/> L039B Physical Therapy NF Other Clinical 0 1.5 G1: See preamble 0.59
regions. Assistant. Activity--specify: text.
Obtain measurements.
97140............. Manual therapy 1/> L039B Physical Therapy NF Other Clinical 0 1.5 G1: See preamble 0.59
regions. Assistant. Activity--specify: text.
Review/read
documentation, plan
of care, treatment
goals.
97140............. Manual therapy 1/> L039B Physical Therapy NF Check dressings & 1.5 2.5 G1: See preamble 0.39
regions. Assistant. wound/home care text.
instructions/
coordinate office
visits/
prescriptions.
97140............. Manual therapy 1/> L039B Physical Therapy NF Assist therapist.... 2.5 7.5 G1: See preamble 1.95
regions. Assistant. text.
97140............. Manual therapy 1/> SA048 pack, minimum multi- NF .................... 0 0.5 G1: See preamble 0.57
regions. specialty visit. text.
97140............. Manual therapy 1/> SB022 gloves, non-sterile.. NF .................... 1 0 G1: See preamble -0.08
regions. text.
97140............. Manual therapy 1/> SK046 lotion, massage, NF .................... 2 0.5 G1: See preamble -0.24
regions. unscented. text.
97140............. Manual therapy 1/> SK082 towel, paper (Bounty) NF .................... 4 0 G1: See preamble -0.03
regions. (per sheet). text.
97140............. Manual therapy 1/> SM012 disinfectant spray NF .................... 5 0 G1: See preamble -0.14
regions. (Transeptic). text.
97530............. Therapeutic EL003 environmental module-- NF .................... 22 12 G1: See preamble -0.50
activities. the workshop. text.
97530............. Therapeutic EQ219 rehab and testing NF .................... 22 4 G1: See preamble -3.20
activities. system (BTE primus). text.
97530............. Therapeutic EQ267 work samples, small NF .................... 22 12 G1: See preamble -0.06
activities. tools (Valpar 1). text.
97530............. Therapeutic L023A Physical Therapy Aide NF Prepare and position 1 0 G1: See preamble -0.23
activities. patient. text.
97530............. Therapeutic L023A Physical Therapy Aide NF Assist therapist.... 3.75 0 G1: See preamble -0.86
activities. text.
97530............. Therapeutic L023A Physical Therapy Aide NF Other Clinical 0 1.5 G1: See preamble 0.35
activities. Activity--specify: text.
Verify/Coordinate
availability of
resources/equipment.
97530............. Therapeutic L023A Physical Therapy Aide NF Other clinical 0 1 G1: See preamble 0.23
activities. Activity--specify: text.
post-treatment
assistance.
97530............. Therapeutic L023A Physical Therapy Aide NF Prepare room, 1 1.5 G1: See preamble 0.12
activities. equipment, supplies. text.
97530............. Therapeutic L039B Physical Therapy NF Assist therapist.... 3.75 7.5 G1: See preamble 1.46
activities. Assistant. text.
[[Page 34069]]
97530............. Therapeutic L039B Physical Therapy NF Other Clinical 0 1.5 G1: See preamble 0.59
activities. Assistant. Activity--specify: text.
Review/read
documentation, plan
of care, treatment
goals.
97530............. Therapeutic L039B Physical Therapy NF Check dressings & 1.5 2.5 G1: See preamble 0.39
activities. Assistant. wound/home care text.
instructions/
coordinate office
visits/
prescriptions.
97530............. Therapeutic SB022 gloves, non-sterile.. NF .................... 1 0 G1: See preamble -0.08
activities. text.
97530............. Therapeutic SK082 towel, paper (Bounty) NF .................... 4 0 G1: See preamble -0.03
activities. (per sheet). text.
97530............. Therapeutic SM012 disinfectant spray NF .................... 5 0 G1: See preamble -0.14
activities. (Transeptic). text.
97533............. Sensory integration.. EQ224 sensory integration NF .................... 22 15 G1: See preamble -0.06
equip (eg, ball pit, text.
glider, trampoline,
ramp).
97533............. Sensory integration.. EQ225 sensory integration NF .................... 22 15 G1: See preamble -0.05
equipment, text.
suspension system.
97533............. Sensory integration.. L023A Physical Therapy Aide NF Obtain vital signs.. 0 1 G1: See preamble 0.23
text.
97533............. Sensory integration.. L023A Physical Therapy Aide NF Other Clinical 0 1.5 G1: See preamble 0.35
Activity--specify: text.
Verify/Coordinate
availability of
resources/equipment.
97533............. Sensory integration.. L023A Physical Therapy Aide NF Assist therapist.... 0 7.5 G1: See preamble 1.73
text.
97533............. Sensory integration.. L023A Physical Therapy Aide NF Prepare room, 1 1.5 G1: See preamble 0.12
equipment, supplies. text.
97533............. Sensory integration.. L023A Physical Therapy Aide NF Prepare and position 1 0 G1: See preamble -0.23
patient. text.
97533............. Sensory integration.. L023A Physical Therapy Aide NF Other clinical 0 1 G1: See preamble 0.23
Activity--specify: text.
post-treatment
assistance.
97533............. Sensory integration.. L023A Physical Therapy Aide NF Check dressings & 0 2.5 G1: See preamble 0.58
wound/home care text.
instructions/
coordinate office
visits/
prescriptions.
97533............. Sensory integration.. L039B Physical Therapy NF Obtain vital signs.. 1 0 G1: See preamble -0.39
Assistant. text.
97533............. Sensory integration.. L039B Physical Therapy NF Assist therapist.... 7.5 0 G1: See preamble -2.93
Assistant. text.
97533............. Sensory integration.. L039B Physical Therapy NF Check dressings & 1.5 0 G1: See preamble -0.59
Assistant. wound/home care text.
instructions/
coordinate office
visits/
prescriptions.
[[Page 34070]]
97533............. Sensory integration.. L039B Physical Therapy NF Other Clinical 0 1.5 G1: See preamble 0.59
Assistant. Activity--specify: text.
Review/read
documentation, plan
of care, treatment
goals.
97533............. Sensory integration.. SJ053 swab-pad, alcohol.... NF .................... 0 3 G1: See preamble 0.04
text.
97533............. Sensory integration.. SK082 towel, paper (Bounty) NF .................... 4 0 G1: See preamble -0.03
(per sheet). text.
97533............. Sensory integration.. SM012 disinfectant spray NF .................... 5 0 G1: See preamble -0.14
(Transeptic). text.
97535............. Self care mngment EL002 environmental module-- NF .................... 22 12 G1: See preamble -1.15
training. kitchen. text.
97535............. Self care mngment EQ143 kit, ADL............. NF .................... 22 16 G1: See preamble -0.01
training. text.
97535............. Self care mngment L023A Physical Therapy Aide NF Other Clinical 0 1.5 G1: See preamble 0.35
training. Activity--specify: text.
Verify/Coordinate
availability of
resources/equipment.
97535............. Self care mngment L023A Physical Therapy Aide NF Prepare room, 1 1.5 G1: See preamble 0.12
training. equipment, supplies. text.
97535............. Self care mngment L023A Physical Therapy Aide NF Prepare and position 1 0 G1: See preamble -0.23
training. patient. text.
97535............. Self care mngment L023A Physical Therapy Aide NF Other clinical 0 1 G1: See preamble 0.23
training. Activity--specify: text.
post-treatment
assistance.
97535............. Self care mngment L039B Physical Therapy NF Check dressings & 1.5 2.5 G1: See preamble 0.39
training. Assistant. wound/home care text.
instructions/
coordinate office
visits/
prescriptions.
97535............. Self care mngment L039B Physical Therapy NF Other Clinical 0 1.5 G1: See preamble 0.59
training. Assistant. Activity--specify: text.
Review/read
documentation, plan
of care, treatment
goals.
97535............. Self care mngment SB022 gloves, non-sterile.. NF .................... 1 0 G1: See preamble -0.08
training. text.
97535............. Self care mngment SK009 bath soap (one bar NF .................... 0 0.5 G1: See preamble 0.34
training. uou). text.
97535............. Self care mngment SK080 toothbrush........... NF .................... 0 1 G1: See preamble 0.81
training. text.
97535............. Self care mngment SK081 toothpaste........... NF .................... 0 0.25 G1: See preamble 0.12
training. text.
97535............. Self care mngment SK082 towel, paper (Bounty) NF .................... 4 0 G1: See preamble -0.03
training. (per sheet). text.
97535............. Self care mngment SM012 disinfectant spray NF .................... 5 0 G1: See preamble -0.14
training. (Transeptic). text.
[[Page 34071]]
97535............. Self care mngment SM013 disinfectant, surface NF .................... 0 2 G1: See preamble 0.33
training. (Envirocide, text.
Sanizide).
97537............. Community/work EL001 environmental module-- NF .................... 22 8 G1: See preamble -1.01
reintegration. car. text.
97537............. Community/work EQ147 kit, ergonomic NF .................... 22 8 G1: See preamble -0.08
reintegration. (office). text.
97537............. Community/work L023A Physical Therapy Aide NF Prepare room, 1 1.5 G1: See preamble 0.12
reintegration. equipment, supplies. text.
97537............. Community/work L023A Physical Therapy Aide NF Other clinical 0 1 G1: See preamble 0.23
reintegration. Activity--specify: text.
post-treatment
assistance.
97537............. Community/work L023A Physical Therapy Aide NF Prepare and position 1 0 G1: See preamble -0.23
reintegration. patient. text.
97537............. Community/work L023A Physical Therapy Aide NF Other Clinical 0 1.5 G1: See preamble 0.35
reintegration. Activity--specify: text.
Verify/Coordinate
availability of
resources/equipment.
97537............. Community/work L039B Physical Therapy NF Check dressings & 1.5 2.5 G1: See preamble 0.39
reintegration. Assistant. wound/home care text.
instructions/
coordinate office
visits/
prescriptions.
97537............. Community/work L039B Physical Therapy NF Other Clinical 0 1.5 G1: See preamble 0.59
reintegration. Assistant. Activity--specify: text.
Review/read
documentation, plan
of care, treatment
goals.
97537............. Community/work SB022 gloves, non-sterile.. NF .................... 1 0 G1: See preamble -0.08
reintegration. text.
97537............. Community/work SK082 towel, paper (Bounty) NF .................... 4 0 G1: See preamble -0.03
reintegration. (per sheet). text.
97537............. Community/work SM012 disinfectant spray NF .................... 5 0 G1: See preamble -0.14
reintegration. (Transeptic). text.
97542............. Wheelchair mngment EL002 environmental module-- NF .................... 22 8 G1: See preamble -1.61
training. kitchen. text.
97542............. Wheelchair mngment L023A Physical Therapy Aide NF Prepare room, 1 1.5 G1: See preamble 0.12
training. equipment, supplies. text.
97542............. Wheelchair mngment L023A Physical Therapy Aide NF Other clinical 0 1 G1: See preamble 0.23
training. Activity--specify: text.
post-treatment
assistance.
97542............. Wheelchair mngment L023A Physical Therapy Aide NF Prepare and position 1 0 G1: See preamble -0.23
training. patient. text.
97542............. Wheelchair mngment L023A Physical Therapy Aide NF Assist therapist.... 3.75 0 G1: See preamble -0.86
training. text.
[[Page 34072]]
97542............. Wheelchair mngment L023A Physical Therapy Aide NF Other Clinical 0 1.5 G1: See preamble 0.35
training. Activity--specify: text.
Verify/Coordinate
availability of
resources/equipment.
97542............. Wheelchair mngment L039B Physical Therapy NF Check dressings & 1.5 2.5 G1: See preamble 0.39
training. Assistant. wound/home care text.
instructions/
coordinate office
visits/
prescriptions.
97542............. Wheelchair mngment L039B Physical Therapy NF Other Clinical 0 1.5 G1: See preamble 0.59
training. Assistant. Activity--specify: text.
Review/read
documentation, plan
of care, treatment
goals.
97542............. Wheelchair mngment L039B Physical Therapy NF Assist therapist.... 3.75 7.5 G1: See preamble 1.46
training. Assistant. text.
97542............. Wheelchair mngment SB022 gloves, non-sterile.. NF .................... 1 0 G1: See preamble -0.08
training. text.
97542............. Wheelchair mngment SK082 towel, paper (Bounty) NF .................... 4 0 G1: See preamble -0.03
training. (per sheet). text.
97542............. Wheelchair mngment SM012 disinfectant spray NF .................... 5 0 G1: See preamble -0.14
training. (Transeptic). text.
97760............. Orthotic mgmt&trainj EF005 cart-workbench, NF .................... 27 10 G1: See preamble -0.03
1st enc. orthotic, mobile. text.
97760............. Orthotic mgmt&trainj EF033 table, treatment, hi- NF .................... 27 10 G1: See preamble -0.09
1st enc. lo. text.
97760............. Orthotic mgmt&trainj EQ219 rehab and testing NF .................... 27 5 G1: See preamble -3.91
1st enc. system (BTE primus). text.
97760............. Orthotic mgmt&trainj ER064 water bath, NF .................... 27 10 G1: See preamble -0.04
1st enc. thermoplastic text.
softener (20in x
12in).
97760............. Orthotic mgmt&trainj L023A Physical Therapy Aide NF Assist therapist.... 5 0 G1: See preamble -1.15
1st enc. text.
97760............. Orthotic mgmt&trainj L023A Physical Therapy Aide NF Other Clinical 0 1.5 G1: See preamble 0.35
1st enc. Activity--specify: text.
Verify/Coordinate
availability of
resources/equipment.
97760............. Orthotic mgmt&trainj L023A Physical Therapy Aide NF Other clinical 0 1 G1: See preamble 0.23
1st enc. Activity--specify: text.
post-treatment
assistance.
97760............. Orthotic mgmt&trainj L023A Physical Therapy Aide NF Greet patient, 2 1.5 G1: See preamble -0.12
1st enc. provide gowning, text.
ensure appropriate
medical records are
available.
97760............. Orthotic mgmt&trainj L023A Physical Therapy Aide NF Clean room/equipment 2 1 G1: See preamble -0.23
1st enc. by physician staff. text.
[[Page 34073]]
97760............. Orthotic mgmt&trainj L023A Physical Therapy Aide NF Prepare room, 2 1.5 G1: See preamble -0.12
1st enc. equipment, supplies. text.
97760............. Orthotic mgmt&trainj L023A Physical Therapy Aide NF Prepare and position 2 0 G1: See preamble -0.46
1st enc. patient. text.
97760............. Orthotic mgmt&trainj L039B Physical Therapy NF Assist therapist.... 2.5 7.5 G1: See preamble 1.95
1st enc. Assistant. text.
97760............. Orthotic mgmt&trainj L039B Physical Therapy NF Obtain vital signs.. 2 1 G1: See preamble -0.39
1st enc. Assistant. text.
97760............. Orthotic mgmt&trainj L039B Physical Therapy NF Other Clinical 0 1.5 G1: See preamble 0.59
1st enc. Assistant. Activity--specify: text.
Review/read
documentation, plan
of care, treatment
goals.
97760............. Orthotic mgmt&trainj L039B Physical Therapy NF Check dressings & 2 2.5 G1: See preamble 0.20
1st enc. Assistant. wound/home care text.
instructions/
coordinate office
visits/
prescriptions.
97760............. Orthotic mgmt&trainj L039B Physical Therapy NF Conduct phone calls/ 2 0 G1: See preamble -0.78
1st enc. Assistant. call in text.
prescriptions.
97760............. Orthotic mgmt&trainj SH035 fluori-methane (cold NF .................... 5 7.5 G1: See preamble 1.06
1st enc. spray). text.
97760............. Orthotic mgmt&trainj SK082 towel, paper (Bounty) NF .................... 4 0 G1: See preamble -0.03
1st enc. (per sheet). text.
97760............. Orthotic mgmt&trainj SK087 water, distilled..... NF .................... 85 128 G1: See preamble 0.56
1st enc. text.
97760............. Orthotic mgmt&trainj SM012 disinfectant spray NF .................... 5 0 G1: See preamble -0.14
1st enc. (Transeptic). text.
97761............. Prosthetic trainj 1st EF028 table, mat, hi-lo, 6 NF .................... 27 5 G1: See preamble -0.22
enc. x 8 platform. text.
97761............. Prosthetic trainj 1st EQ069 balance board........ NF .................... 27 4 G1: See preamble -0.03
enc. text.
97761............. Prosthetic trainj 1st EQ201 parallel bars, NF .................... 27 4 G1: See preamble -0.09
enc. platform mounted. text.
97761............. Prosthetic trainj 1st EQ231 stairs, ambulation NF .................... 27 3 G1: See preamble -0.04
enc. training. text.
97761............. Prosthetic trainj 1st EQ243 treadmill............ NF .................... 27 3 G1: See preamble -0.32
enc. text.
97761............. Prosthetic trainj 1st L023A Physical Therapy Aide NF Greet patient, 2 1.5 G1: See preamble -0.12
enc. provide gowning, text.
ensure appropriate
medical records are
available.
97761............. Prosthetic trainj 1st L023A Physical Therapy Aide NF Prepare room, 2 0 G1: See preamble -0.46
enc. equipment, supplies. text.
97761............. Prosthetic trainj 1st L023A Physical Therapy Aide NF Prepare and position 2 0 G1: See preamble -0.46
enc. patient. text.
97761............. Prosthetic trainj 1st L023A Physical Therapy Aide NF Other Clinical 0 1.5 G1: See preamble 0.35
enc. Activity--specify: text.
Verify/Coordinate
availability of
resources/equipment.
[[Page 34074]]
97761............. Prosthetic trainj 1st L023A Physical Therapy Aide NF Other clinical 0 1 G1: See preamble 0.23
enc. Activity--specify: text.
post-treatment
assistance.
97761............. Prosthetic trainj 1st L023A Physical Therapy Aide NF Assist therapist.... 10 0 G1: See preamble -2.30
enc. text.
97761............. Prosthetic trainj 1st L023A Physical Therapy Aide NF Clean room/equipment 2 1 G1: See preamble -0.23
enc. by physician staff. text.
97761............. Prosthetic trainj 1st L039B Physical Therapy NF Other Clinical 0 1.5 G1: See preamble 0.59
enc. Assistant. Activity--specify: text.
Obtain measurements.
97761............. Prosthetic trainj 1st L039B Physical Therapy NF Obtain vital signs.. 2 1 G1: See preamble -0.39
enc. Assistant. text.
97761............. Prosthetic trainj 1st L039B Physical Therapy NF Assist therapist.... 5 7.5 G1: See preamble 0.98
enc. Assistant. text.
97761............. Prosthetic trainj 1st L039B Physical Therapy NF Other Clinical 0 1.5 G1: See preamble 0.59
enc. Assistant. Activity--specify: text.
Review/read
documentation, plan
of care, treatment
goals.
97761............. Prosthetic trainj 1st L039B Physical Therapy NF Other Clinical 0 1 G1: See preamble 0.39
enc. Assistant. Activity--specify: text.
Conduct phone calls/
call in
prescriptions.
97761............. Prosthetic trainj 1st L039B Physical Therapy NF Conduct phone calls/ 2 0 G1: See preamble -0.78
enc. Assistant. call in text.
prescriptions.
97761............. Prosthetic trainj 1st L039B Physical Therapy NF Check dressings & 2 2.5 G1: See preamble 0.20
enc. Assistant. wound/home care text.
instructions/
coordinate office
visits/
prescriptions.
97761............. Prosthetic trainj 1st SB026 gown, patient........ NF .................... 0.75 0 G1: See preamble -0.40
enc. text.
97761............. Prosthetic trainj 1st SG027 cast, stockinette 4in NF .................... 0.3 1 G1: See preamble 0.32
enc. text.
97761............. Prosthetic trainj 1st SG058 moleskin 9in width... NF .................... 0.2 0.33 G1: See preamble 0.45
enc. text.
97761............. Prosthetic trainj 1st SK082 towel, paper (Bounty) NF .................... 4 0 G1: See preamble -0.03
enc. (per sheet). text.
97761............. Prosthetic trainj 1st SM012 disinfectant spray NF .................... 5 0 G1: See preamble -0.14
enc. (Transeptic). text.
977X1............. Orthc/prostc mgmt EF005 cart-workbench, NF .................... 27 10 G1: See preamble -0.03
sbsq enc. orthotic, mobile. text.
977X1............. Orthc/prostc mgmt EF033 table, treatment, hi- NF .................... 27 16 G1: See preamble -0.06
sbsq enc. lo. text.
977X1............. Orthc/prostc mgmt ER064 water bath, NF .................... 27 10 G1: See preamble -0.04
sbsq enc. thermoplastic text.
softener (20in x
12in).
977X1............. Orthc/prostc mgmt L023A Physical Therapy Aide NF Other clinical 0 1 G1: See preamble 0.23
sbsq enc. Activity--specify: text.
post-treatment
assistance.
[[Page 34075]]
977X1............. Orthc/prostc mgmt L023A Physical Therapy Aide NF Greet patient, 2 1.5 G1: See preamble -0.12
sbsq enc. provide gowning, text.
ensure appropriate
medical records are
available.
977X1............. Orthc/prostc mgmt L023A Physical Therapy Aide NF Clean room/equipment 2 1 G1: See preamble -0.23
sbsq enc. by physician staff. text.
977X1............. Orthc/prostc mgmt L023A Physical Therapy Aide NF Other Clinical 0 1.5 G1: See preamble 0.35
sbsq enc. Activity--specify: text.
Verify/Coordinate
availability of
resources/equipment.
977X1............. Orthc/prostc mgmt L023A Physical Therapy Aide NF Assist therapist.... 5 0 G1: See preamble -1.15
sbsq enc. text.
977X1............. Orthc/prostc mgmt L023A Physical Therapy Aide NF Prepare room, 2 1.5 G1: See preamble -0.12
sbsq enc. equipment, supplies. text.
977X1............. Orthc/prostc mgmt L023A Physical Therapy Aide NF Prepare and position 2 0 G1: See preamble -0.46
sbsq enc. patient. text.
977X1............. Orthc/prostc mgmt L039B Physical Therapy NF Other Clinical 0 1.5 G1: See preamble 0.59
sbsq enc. Assistant. Activity--specify: text.
Review/read
documentation, plan
of care, treatment
goals.
977X1............. Orthc/prostc mgmt L039B Physical Therapy NF Obtain vital signs.. 2 1 G1: See preamble -0.39
sbsq enc. Assistant. text.
977X1............. Orthc/prostc mgmt L039B Physical Therapy NF Check dressings & 2 2.5 G1: See preamble 0.20
sbsq enc. Assistant. wound/home care text.
instructions/
coordinate office
visits/
prescriptions.
977X1............. Orthc/prostc mgmt L039B Physical Therapy NF Assist therapist.... 2.5 7.5 G1: See preamble 1.95
sbsq enc. Assistant. text.
977X1............. Orthc/prostc mgmt SA048 pack, minimum multi- NF .................... 0.5 1 G1: See preamble 0.57
sbsq enc. specialty visit. text.
977X1............. Orthc/prostc mgmt SG027 cast, stockinette 4in NF .................... 0.4 0.5 G1: See preamble 0.05
sbsq enc. text.
977X1............. Orthc/prostc mgmt SG058 moleskin 9in width... NF .................... 0.7 1 G1: See preamble 1.04
sbsq enc. text.
977X1............. Orthc/prostc mgmt SG060 outrigger line....... NF .................... 7 50 G1: See preamble 3.91
sbsq enc. text.
977X1............. Orthc/prostc mgmt SG061 outrigger post....... NF .................... 3 4 G1: See preamble 0.40
sbsq enc. text.
977X1............. Orthc/prostc mgmt SH035 fluori-methane (cold NF .................... 5 7.5 G1: See preamble 1.06
sbsq enc. spray). text.
977X1............. Orthc/prostc mgmt SJ047 splint straps 1in.... NF .................... 0.7 1 G1: See preamble 0.39
sbsq enc. text.
977X1............. Orthc/prostc mgmt SJ048 splint straps 2in.... NF .................... 1.3 2 G1: See preamble 1.07
sbsq enc. text.
977X1............. Orthc/prostc mgmt SK071 rubber bands, non- NF .................... 4 6 G1: See preamble 0.04
sbsq enc. sterile. text.
[[Page 34076]]
977X1............. Orthc/prostc mgmt SK082 towel, paper (Bounty) NF .................... 4 0 G1: See preamble -0.03
sbsq enc. (per sheet). text.
977X1............. Orthc/prostc mgmt SK087 water, distilled..... NF .................... 85 128 G1: See preamble 0.56
sbsq enc. text.
977X1............. Orthc/prostc mgmt SM012 disinfectant spray NF .................... 5 0 G1: See preamble -0.14
sbsq enc. (Transeptic). text.
97X11............. Ther ivntj w/focus ED038 notebook (Dell NF .................... 60 0 G1: See preamble -0.52
cog funcj. Latitute D600). text.
97X11............. Ther ivntj w/focus EF027 table, instrument, NF .................... 60 5 G1: See preamble -0.08
cog funcj. mobile. text.
97X11............. Ther ivntj w/focus L023A Physical Therapy Aide NF Assist physician in 0 12 G1: See preamble 2.76
cog funcj. performing text.
procedure.
97X11............. Ther ivntj w/focus SK057 paper, laser printing NF .................... 10 0 G1: See preamble -0.05
cog funcj. (each sheet). text.
994X1............. 1st psyc collab care EF042 One Couch and Two F .................... 38 0 G1: See preamble -0.15
mgmt. Chairs. text.
994X1............. 1st psyc collab care L057B Behavioral Health F Other clinical 85 0 G1: See preamble -48.45
mgmt. Care Manager. Activity--specify: text.
994X1 and 994X3.
994X2............. Sbsq psyc collab care EF042 One Couch and Two F .................... 27 0 G1: See preamble -0.11
mgmt. Chairs. text.
994X2............. Sbsq psyc collab care L057B Behavioral Health F Other clinical 60 0 G1: See preamble -34.20
mgmt. Care Manager. Activity--specify: text.
994X2.
994X3............. 1st/sbsq psyc collab EF042 One Couch and Two F .................... 13.5 0 G1: See preamble -0.05
care. Chairs. text.
994X3............. 1st/sbsq psyc collab L057B Behavioral Health F Other clinical 30 0 G1: See preamble -17.10
care. Care Manager. Activity--specify: text.
994X1 and 994X3.
99XX5............. Care mgmt svc bhvl L057B Behavioral Health F Other clinical 20 0 G1: See preamble -11.40
hlth cond. Care Manager. Activity--specify: text.
G0507.
G0507............. Care manage serv L057B Behavioral Health F Other clinical 20 0 G1: See preamble -11.40
minimum 20. Care Manager. Activity--specify: text.
G0507.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Table 12--CY 2018 Proposed Codes With Direct PE Input Recommendations
Without Refinement
------------------------------------------------------------------------
HCPCS code Description
------------------------------------------------------------------------
007X1............................. Anes upr gi ndsc px nos.
007X2............................. Anes upr gi ndsc px ercp.
008X1............................. Anes lwr intst ndsc nos.
008X2............................. Anes lwr intst scr colsc.
008X3............................. Anes upr lwr gi hdsc px.
10040............................. Acne surgery.
15734............................. Muscle-skin graft trunk.
15736............................. Muscle-skin graft arm.
15738............................. Muscle-skin graft leg.
157X2............................. Musc myoq/fscq flp h&n pedcl.
19303............................. Mast simple complete.
31255............................. Nsl/sins ndsc w/tot ethmdct.
31256............................. Exploration maxillary sinus.
31267............................. Endoscopy maxillary sinus.
31276............................. Nsl/sins ndsc frnt tiss rmvl.
31287............................. Nasal/sinus endoscopy surg.
31288............................. Nasal/sinus endoscopy surg.
31600............................. Incision of windpipe.
31601............................. Incision of windpipe.
31603............................. Incision of windpipe.
31610............................. Incision of windpipe.
31646............................. Brnchsc w/ther aspir sbsq.
31XX1............................. Nsl/sins ndsc w/artery lig.
31XX2............................. Nsl/sins ndsc total.
31XX3............................. Nsl/sins ndsc tot w/sphendt.
31XX4............................. Nsl/sins ndsc sphn tiss rmvl.
34812............................. Opn fem art expos.
34820............................. Opn ilac art expos.
34833............................. Opn ilac art expos cndt crtj.
34834............................. Opn brach art expos.
34X01............................. Evasc rpr a-ao ndgft.
34X02............................. Evasc rpr a-ao ndgft rpt.
34X03............................. Evasc rpr a-unilac ndgft.
34X04............................. Evasc rpr a-unilac ndgft rpt.
34X05............................. Evac rpr a-biiliac ndgft.
34X06............................. Evasc rpr a-biiliac rpt.
34X07............................. Evasc rpr ilio-iliac ndgft.
34X08............................. Evasc rpr ilio-iliac rpt.
34X09............................. Plmt xtn prosth evasc rpr.
34X10............................. Dlyd plmt xtn prosth 1st vsl.
34X11............................. Dlyd plmt xtn prosth ea addl.
34X12............................. Tcat dlvr enhncd fixj dev.
[[Page 34077]]
34X13............................. Perq access & clsr fem art.
34X15............................. Opn fem art expos cndt crtj.
34X19............................. Opn ax/subcla art expos.
34X20............................. Opn ax/subcla art expos cndt.
36218............................. Place catheter in artery.
364X4............................. Endoven ther chem adhes sbsq.
36514............................. Apheresis plasma.
36516............................. Apheresis immunoads slctv.
36522............................. Photopheresis.
36556............................. Insert non-tunnel cv cath.
3857X............................. Laps pelvic lymphadec.
43107............................. Removal of esophagus.
43112............................. Esphg tot w/thrcm.
43117............................. Partial removal of esophagus.
432X5............................. Esphg tot w/laps moblj.
432X6............................. Esphg dstl \2/3\ w/laps moblj.
432X7............................. Esphg tot thrsc moblj.
51798............................. Us urine capacity measure.
52601............................. Prostatectomy (turp).
57240............................. Anterior colporrhaphy.
57250............................. Repair rectum & vagina.
57260............................. Cmbn ant pst colprhy.
57265............................. Cmbn ap colprhy w/ntrcl rpr.
64418............................. N block inj suprascapular.
64553............................. Implant neuroelectrodes.
64555............................. Implant neuroelectrodes.
64910............................. Nerve repair w/allograft.
64911............................. Neurorraphy w/vein autograft.
64X91............................. Nrv rpr w/nrv algrft 1st.
70490............................. Ct soft tissue neck w/o dye.
70491............................. Ct soft tissue neck w/dye.
70492............................. Ct sft tsue nck w/o & w/dye.
710X1............................. X-ray exam chest 1 view.
710X2............................. X-ray exam chest 2 views.
710X3............................. X-ray exam chest 3 views.
710X4............................. X-ray exam chest 4+ views.
71100............................. X-ray exam ribs uni 2 views.
71101............................. X-ray exam unilat ribs/chest.
71110............................. X-ray exam ribs bil 3 views.
71111............................. X-ray exam ribs/chest4/> vws.
73100............................. X-ray exam of wrist.
73110............................. X-ray exam of wrist.
73120............................. X-ray exam of hand.
73130............................. X-ray exam of hand.
73140............................. X-ray exam of finger(s).
74022............................. X-ray exam series abdomen.
740X1............................. X-ray exam abdomen 1 view.
740X2............................. X-ray exam abdomen 2 views.
740X3............................. X-ray exam abdomen 3+ views.
76510............................. Ophth us b & quant a.
76511............................. Ophth us quant a only.
76512............................. Ophth us b w/non-quant a.
76516............................. Echo exam of eye.
76519............................. Echo exam of eye.
76882............................. Us xtr non-vasc lmtd.
88334............................. Intraop cyto path consult 2.
92136............................. Ophthalmic biometry.
93293............................. Pm phone r-strip device eval.
93296............................. Pm/icd remote tech serv.
93299............................. Icm/ilr remote tech serv.
93306............................. Tte w/doppler complete.
93307............................. Tte w/o doppler complete.
93308............................. Tte f-up or lmtd.
95250............................. Glucose monitoring cont.
95930............................. Visual ep test cns w/i&r.
96401............................. Chemo anti-neopl sq/im.
96402............................. Chemo hormon antineopl sq/im.
96409............................. Chemo iv push sngl drug.
96411............................. Chemo iv push addl drug.
96567............................. Pdt dstr prmlg les skn.
993X1............................. Pt/caregiver trainj home inr.
993X2............................. Anticoag mgmt pt warfarin.
99XX3............................. Assmt & care pln pt cog imp.
GXXX1............................. Cognitive skills development.
------------------------------------------------------------------------
Table 13--CY 2018 Proposed Rule--Invoices Received for New Direct PE Inputs
----------------------------------------------------------------------------------------------------------------
Estimated non-
facility
allowed
CMS code Average price Number of services for
invoices HCPCS codes
using this
item
----------------------------------------------------------------------------------------------------------------
EQ383........................................................... 790.00 1 39,006
SD322........................................................... 25.00 1 3,435
EQ384........................................................... 4,760.00 1 39,006
EQ385........................................................... 9,034.00 1 39,006
SD323........................................................... 1,495.00 1 387
SD324........................................................... 3,195.00 2 1550
SA125........................................................... 40.00 2 1550
SD328........................................................... 353.64 1 41
SD325........................................................... 39.90 1 4
SA126........................................................... 2,850.00 3 4
EQ386........................................................... 16,146.00 1 4
SA124........................................................... 2.35 2 421,539
SJ092........................................................... 8.44 209 9,931,981
SJ093........................................................... 0.19 5 9,931,981
SB054........................................................... 9.99 1 387,359
----------------------------------------------------------------------------------------------------------------
Table 14--CY 2018 Proposed Rule--Invoices Received for Existing Direct PE Inputs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated non-
facility
allowed
CPT/HCPCS codes Item name CMS code Current price Updated price Percent change Number of services for
invoices HCPCS codes
using this
item
--------------------------------------------------------------------------------------------------------------------------------------------------------
17000, 17003, 17004, 46607, LMX 4% anesthetic SH092 1.60 0.78 -51 1 23,584,412
96567, 96X73, 96X74. cream.
20982, 32998, 50592.............. probe, SD109 353.64 2233.00 531 1 2,972
radiofrequency, 3
array
(StarBurstSDE).
[[Page 34078]]
30140, 30901, 30903, 30905, Atomizer tips SL464 0.00 2.66 .............. 1 625,876
30906, 31231, 31237, 31238, (disposable).
43197, 43198.
36514............................ tubing set, plasma SC085 173.33 273.66 58 1 1,237
exchange.
36514, 36516..................... ACD-A anticoagulant SJ071 6.58 7.10 8 1 2,517
none (formerly in deleted code kit, apheresis SA072 140.00 243.33 74 1 22
36515). treatment.
36522............................ kit, photopheresis SA024 858.00 1598.00 86 1 25
procedure.
36522, 96567, 96910, 96912, goggles, uv- SJ027 2.30 4.1 78 1 697,047
96913, 96920, 96921, 96922, blocking.
96X73, 96X74.
88360, 88361..................... Antibody Estrogen SL493 14.00 14.47 3 3 209,384
Receptor
monoclonal.
95004, 95017, 95018.............. negative control, SH101 5.08 5.17 2 2 10,036,050
allergy test.
95004, 95017, 95018.............. positive control, SH102 17.28 26.12 51 6 10,036,050
allergy test.
95250............................ sensor, glucose SD114 29.50 53.08 80 19 26,205
monitoring
(interstitial).
95250............................ glucose continuous EQ125 2465.00 1170.54 -53 5 26,205
monitoring system.
993X1, G0249..................... test strip, INR.... SJ055 21.88 5.66 -74 2 1,265,540
--------------------------------------------------------------------------------------------------------------------------------------------------------
I. Evaluation & Management (E/M) Guidelines and Care Management
Services
In recent years, we have sought to recognize significant changes in
health care practice, especially innovations in the active management
and ongoing care of chronically ill patients. We have been engaged in
an ongoing incremental effort to identify gaps in appropriate coding
and payment for care management/coordination, cognitive services and
primary care within the PFS. This has included working with the CPT
Editorial Panel (CPT) to develop and value (or revalue) the following
service codes:
Transitional care management (TCM) services (2013).
Chronic care management services (CCM) (2015, 2017).
Behavioral health integration (BHI) services (2017).
Assessment/care planning services for cognitive impairment
(2017).
Prolonged E/M services without direct patient contact
(2017).
In response to public feedback regarding the initial implementation
of TCM and CCM, in the CY 2017 PFS final rule (81 FR 80225 through
80256), we finalized significant administrative burden reduction for
CCM and focused on limiting as much as possible the ways in which
Medicare's rules differed from the CPT guidance that generally applies
for all payers. We also worked with the CPT Editorial Panel and other
stakeholders to develop coding and improve payment accuracy for BHI,
cognitive impairment assessment/management, and prolonged services. In
the CY 2017 PFS final rule (81 FR 80255), we also reiterated our
commitment to addressing disparities for individuals with disabilities
and advancing health equity, and noted that we will continue to explore
improvements in payment accuracy for services furnished to individuals
with disabilities. We look forward to continued work with stakeholders
to ensure that the coding and valuation of these services accurately
reflects the resource costs involved in furnishing these services. We
are soliciting public comments on ways we might further reduce
administrative burden for these and similar services under the PFS.
1. E/M Guidelines
a. Background
Most physicians and other billing practitioners bill patient visits
to the PFS under a relatively generic set of codes that distinguish
level of complexity, site of care, and in some cases between new or
established patients. These codes are called Evaluation and Management
(E/M) visit codes. For example, there are generally three levels of
hospital and nursing facility inpatient E/M visit codes, and five
levels of office or hospital outpatient E/M visit codes, that vary
based on complexity. The latter also distinguish whether or not the
patient is new to the billing practitioner.
Billing practitioners must maintain information in the medical
record to document that they have reported the appropriate level of E/M
visit code. CMS maintains guidelines that specify the kind of
information that is required to support Medicare payment for each
level. According to these documentation guidelines, there are three key
components to selecting the appropriate level:
History of Present Illness (HPI or History);
Physical Examination (Exam); and
Medical Decision Making (MDM).
There are two versions of the documentation guidelines, commonly
referenced based on the year of their
[[Page 34079]]
release (the ``1995'' and ``1997'' guidelines), available under
downloads on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/. The most
substantial differences between the two sets of guidelines pertain to
requirements for the physical exam. The two versions have a slight
difference in requirements for documenting the history, and no
difference in requirements for MDM. In documenting a given E/M service,
practitioners must use one version of the guidelines or the other, with
one exception related to extended histories (see the Evaluation and
Management Services guide available on the CMS Web site at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/eval-mgmt-serv-guide-ICN006764.pdf). These
guidelines are very similar to guidelines within the CPT codebook for
E/M visits. We provide an example of how the guidelines distinguish
between level 2 and level 3 visits in Table 15.
Stakeholders have long maintained that both the 1995 and 1997
guidelines are administratively burdensome and outdated with respect to
the practice of medicine, stating that they are too complex, ambiguous,
and that they fail to distinguish meaningful differences among code
levels. In general, we agree that there may be unnecessary burden with
these guidelines and that they are potentially outdated, and believe
this is especially true for the requirements for the history and the
physical exam. The guidelines have not been updated to account for
significant changes in technology, especially electronic health record
(EHR) use, which presents challenges for data and program integrity and
potential upcoding given the frequently automated selection of code
level.
While CMS conducts few audits on E/M visits relative to the volume
of PFS services they comprise, we have repeatedly heard from
practitioners that compliance with the guidelines is a source of
significant audit vulnerability and administrative burden. Our prior
attempts to revise the guidelines met with a lack of stakeholder
consensus and support, which contributed to the current policy that
allows practitioners to use either the 1995 guidelines or 1997
guidelines, resulting in further complexity in determining or selecting
the applicable requirements.
b. E/M Guidelines Public Comment Solicitation
We continue to agree with stakeholders that the E/M documentation
guidelines should be substantially revised. We believe that a
comprehensive reform of E/M documentation guidelines would require a
multi-year, collaborative effort among stakeholders. We believe that
revised guidelines could both reduce clinical burden and improve
documentation in a way that would be more effective in clinical
workflows and care coordination. We also think updated E/M guidelines
coupled with technological advancements in voice recognition, natural
language processing and user-centered design of EHRs could improve
documentation for patient care while also meeting requirements for
billing and population health management. We recognize that achieving
the goal of reduced clinician burden and improved, meaningful
documentation for patient care will require both updated E/M
guidelines, as well as changes in technology, clinician documentation
practices and workflow. We are seeking input from a broad array of
stakeholders, including patient advocates, on the specific changes we
should undertake to reform the guidelines, reduce the associated
burden, and better align E/M coding and documentation with the current
practice of medicine. We are specifically seeking comment on how we
might focus on initial changes to the guidelines for the history and
physical exam because we believe documentation for these elements may
be more significantly outdated, and that differences in MDM are likely
the most important factors in distinctions between visits of different
levels. We are also specifically seeking comment on whether it would be
appropriate to remove our documentation requirements for the history
and physical exam for all E/M visits at all levels. We believe medical
decision-making and time are the more significant factors in
distinguishing visit levels, and that the need for extended histories
and exams is being replaced by population-based screening and
intervention, at least for some specialties. In addition, an increase
in the utilization of EHRs, and to some extent, shared health
information via EHRs, may have changed the character of extended
patient histories since the guidelines were established. As long as a
history and physical exam are documented and generally consistent with
complexity of MDM, there may no longer be a need for us to maintain
such detailed specifications for what must be performed and documented
for the history and physical exam (for example, which and how many body
systems are involved). We are seeking comment on whether clinicians and
other stakeholders believe removing the documentation requirements for
the history and physical exam would be a good approach.
While we believe MDM guidelines may also need to be updated, we
believe in the nearer term it may be possible to eliminate the current
focus on details of history and physical exam, and allow MDM and/or
time to serve as the key determinant of E/M visit level. We are seeking
public comment on this approach. We are also seeking comment on how
such reforms may differentially affect physicians and practitioners of
different specialties, including primary care clinicians, and how we
could or should account for such effects as we examine this issue. We
note, however, that there may still be clinical or legal reasons for
individual practitioners to document an extended history or physical
exam (for example, where there are negative findings for certain body
systems in support of differential diagnosis). We are additionally
seeking comment on whether CMS should leave it largely to the
discretion of individual practitioners to what degree they should
perform and document the history and physical exam. We also welcome
comments on specific ideas that stakeholders may have on how to update
MDM guidelines to foster appropriate documentation for patient care
commensurate with the level of patient complexity, while avoiding
burdensome documentation requirements and/or inappropriate upcoding.
We note that through letters, meetings, public comment letters in
past rulemaking cycles, and other avenues, we have heard from many
stakeholders that the E/M code set itself is outdated and needs to be
revised. For example, some stakeholders recommend an extensive research
effort to revise and revalue E/M services, especially physician work
inputs (see 81 FR 46200). In prior rulemaking cycles, we acknowledged
the limitations of the current E/M code set and agree that the
structure of the underlying code set and its valuation relative to
other PFS services are also important issues that we expect to continue
to explore, though we are immediately focused on revision of the
current E/M guidelines in order to reduce unnecessary administrative
burden.
2. Care Management Public Comment Solicitation
We continue to be interested in the ongoing work of the medical
community and other stakeholders to refine the set of codes used to
describe care
[[Page 34080]]
management services. In section II.H., we are proposing to adopt CPT
codes for CY 2018 to replace the G-codes we established for several of
the care management services finalized last year. We are committed to
continued work with stakeholders on necessary refinements to the code
set, especially describing the professional work involved in caring for
complex patients in other clinical contexts. We are seeking comment on
ways we might further reduce burden on reporting practitioners for care
management services, including through stronger alignment between CMS
requirements and CPT guidance for existing and potential new codes.
Table 15--Key Component Documentation Requirements for Level 2 vs 3 Evaluation & Management (E/M) Visit
----------------------------------------------------------------------------------------------------------------
Key component [dagger] Level 2 (1995) Level 3 (1995) Level 2 (1997) Level 3 (1997)
----------------------------------------------------------------------------------------------------------------
History (History of Present Review of Systems Problem Pertinent No change from No change from
Illness or HPI). (ROS) n/a. ROS: inquires 1995. 1995.
about the system
directly related
to the problem(s)
identified in the
HPI.
Physical Examination (Exam)..... A limited A limited General multi- General multi-
examination of examination of system exam: system exam:
the affected body the affected body Performance and Performance and
area or organ area or organ documentation of documentation of
system. system and other one to five at least six
symptomatic or elements in one elements in one
related organ or more organ or more organ
system(s). system(s) or body system(s) or body
area(s). area(s).
Single organ Single organ
system exam: system exam:
Performance and Performance and
documentation of documentation of
one to five at least six
elements. elements.
---------------------------------------
Medical Decision Making (MDM) Straightforward: Low complexity: No change from 1995.
1. Minimal........ 1. Limited........
2. Minimal or no 2. Limited data
data review. review.
3. Minimal risk... 3. Low risk.......
---------------------------------------
Measured by: *
1. Problem--Number of diagnoses/
treatment options
2. Data--Amount and/or
complexity of data to be
reviewed
3. Risk--Risk of complications
and/or morbidity or mortality
----------------------------------------------------------------------------------------------------------------
* Two of three met or exceeded.
[dagger] For certain settings and patient types, each of these three key components must be met or exceeded (for
example, new patients; initial hospital visits). For others, only two of the three key components must be met
or exceeded (for example, established patients, subsequent hospital or other visits).
III. Other Provisions of the Proposed Rule
A. New Care Coordination Services and Payment for Rural Health Clinics
(RHCs) and Federally-Qualified Health Centers (FQHCs)
1. Overview
We have been engaged in a multi-year examination of coordinated and
collaborative care services in professional settings, and as a result
established codes and separate payment in the Physician Fee Schedule
(PFS) to separately recognize and pay for these important services. As
part of this initiative, the CY 2016 PFS proposed rule (80 FR 41708)
solicited public comments on (1) improving payment for the professional
work of care management services; (2) establishing separate payment for
collaborative care, particularly inter-professional consultation
between primary care physicians, psychiatrists, and other
practitioners; and (3) assessing whether current PFS payment for
Chronic Care Management (CCM) services is adequate and whether the
administrative burden associated with furnishing and billing these
services should be reduced.
As a result of the comments we received in response to our request,
we established in the PFS separate payment for complex CCM services,
and temporary codes to make separate payment for general behavioral
health integration (BHI) services and a psychiatric collaborative care
model (CoCM). We established four G codes to describe BHI and
psychiatric CoCM services and stated that we would consider whether to
adopt and establish values for any associated new CPT codes being
developed under our standard process once those codes are active. The
separate payment for complex CCM services, general BHI, and psychiatric
CoCM services were finalized in the CY 2017 PFS final rule (81 FR
80225) beginning January 1, 2017, for practitioners billing under the
PFS. Based on these payments and codes, we are proposing revisions to
the CCM payment for RHCs and FQHCs, and proposing requirements and
payment for general BHI and psychiatric CoCM services furnished in RHCs
and FQHCs, beginning on January 1, 2018.
[[Page 34081]]
2. Background
a. RHC and FQHC Payment Methodologies
RHC and FQHC visits are face-to-face encounters between a patient
and one or more RHC or FQHC practitioners during which time one or more
RHC or FQHC qualifying services are furnished. RHC and FQHC
practitioners are physicians, nurse practitioners (NPs), physician
assistants (PA), certified nurse midwives (CNMs), clinical
psychologists, and clinical social workers, and under certain
conditions, a registered nurse or licensed practical nurse furnishing
care to a homebound RHC or FQHC patient. A Transitional Care Management
(TCM) service can also be an RHC or FQHC visit, and a Diabetes Self-
Management Training (DSMT) service or a Medical Nutrition Therapy (MNT)
service furnished by a certified DSMT or MNT provider may also be an
FQHC visit. Only medically-necessary medical, mental health, or
qualified preventive health services that require the skill level of an
RHC or FQHC practitioner are RHC or FQHC billable visits. Services
furnished by auxiliary personnel (for example, nurses, medical
assistants, or other clinical personnel acting under the supervision of
the RHC or FQHC practitioner) are considered incident to the visit and
are included in the per-visit payment.
RHCs are paid an all-inclusive rate (AIR) for medically necessary
medical and mental health services and qualified preventive health
services furnished on the same day (with some exceptions). In general,
the A/B Medicare Administrative Contractor (MAC) calculates the AIR for
each RHC by dividing total allowable costs by the total number of
visits for all patients. Productivity, payment limits, and other
factors are also considered in the calculation. Allowable costs must be
reasonable and necessary and may include practitioner compensation,
overhead, equipment, space, supplies, personnel, and other costs
incident to the delivery of RHC services. The AIR is subject to a
payment limit, except for certain provider-based RHCs that have an
exception to the payment limit.
FQHCs were paid under the same AIR methodology until October 1,
2014, when, in accordance with section 1834(o) of the Act (as added by
section 10501(i)(3) of the Affordable Care Act), they began to
transition to an FQHC PPS system in which they are paid based on the
lesser of the FQHC PPS rate or their actual charges. The FQHC PPS rate
is adjusted for geographic differences in the cost of services by the
FQHC PPS geographic adjustment factor (GAF). The rate is increased by
34 percent when an FQHC furnishes care to a patient that is new to the
FQHC, or to a beneficiary receiving an Initial Preventive Physical
Examination (IPPE) or has an Annual Wellness Visit (AWV).
Both the RHC AIR and FQHC PPS payment rates were designed to
reflect the cost of all services and supplies that an RHC or FQHC
furnishes to a patient in a single day. The rates are not adjusted for
the complexity of the patient health care needs, the length of the
visit, or the number or type of practitioners involved in the patient's
care.
b. Current CCM Requirements and Payment for RHCs and FQHCs
In the CY 2016 PFS final rule with comment period (80 FR 71080), 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. The requirement
that RHC or FQHC services be furnished face-to-face was waived for CCM
services.
In the CY 2017 PFS final rule (81 FR 80256), we finalized revisions
to the CCM requirements for RHCs and FQHCs. Specifically, we revised
Sec. 405.2413(a)(5) and Sec. 405.2415(a)(5) to state that services
and supplies furnished incident to CCM and TCM services can be
furnished under general supervision of an RHC or FQHC practitioner,
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. We also revised requirements
pertaining to the provision of CCM services, consistent with the same
revisions for practitioners billing under the PFS to reduce the burden
of furnishing these services and promote beneficiary access to these
services. These revisions were effective beginning on January 1, 2017,
and included:
Revising the requirement that CCM be initiated during a
comprehensive evaluation and management (E/M), AWV, or IPPE visit, to
require a separately billable initiating visit only for new patients or
patients that have not had an E/M, AWV, or IPPE visit within the
previous year;
Revising the requirement that CCM services be available
24/7 with an RHC or FQHC practitioner who has access to the patient's
electronic care plan, to allow 24/7 access to auxiliary personnel with
a means to make contact with an RHC or FQHC practitioner;
Removing the restriction on faxing information, and no
longer requiring that care plan information be available on a 24/7
basis;
Removing the requirement that clinical summaries must be
formatted according to certified EHR technology, and instead requiring
that the RHC or FQHC create, exchange, and transmit continuity of care
document(s) in a timely manner with other practitioners and providers;
Removing the description of the format of the care plan
that is given to the patient or caregiver; and
Revising the requirement that RHCs and FQHCs obtain a
written agreement that the elements of CCM were discussed, to allowing
this information to be documented in the medical record.
In the CY 2017 PFS final rule, we stated that although CCM is
typically associated with primary care conditions, patient eligibility
is determined by the RHC or FQHC practitioner, and mental health
conditions are not excluded. We invited comments on whether an
additional code specifically for mental health conditions is necessary
for RHCs and FQHCs that want to include beneficiaries with mental
health conditions in their CCM services. We received a few comments
regarding mental health services in RHCs and FQHCs and appreciate the
information that was provided.
The CCM payment rate for RHCs and FQHCs is set annually based on
the PFS national non-facility payment rate, and is paid when CPT code
99490 is billed alone or with other payable services on an RHC or FQHC
claim. The 2017 rate for RHCs and FQHCs is $42.71 for 20 minutes or
more of CCM services. This is the only RHC and FQHC service that is
paid in this manner, and RHCs and FQHCs are not currently authorized to
be paid for any other CCM or other care management codes. Also, RHCs
and FQHCs cannot bill for CCM services for a beneficiary during the
same service period as billing for TCM or any other program that
provides additional payment for care management services (outside of
the RHC AIR or FQHC PPS payment) for the same beneficiary.
Additional information on CCM requirements is available on the CMS
Care Management Web page at https://www.cms.gov/Medicare/Medicare-Fee-
[[Page 34082]]
for-Service-Payment/PhysicianFeeSched/Care-Management.html and on the
CMS RHC and FQHC Web pages at https://www.cms.gov/Center/Provider-Type/Rural-Health-Clinics-Center.html and https://www.cms.gov/Center/Provider-Type/Federally-Qualified-Health-Centers-FQHC-Center.html.
c. Payment for Care Management Codes under the PFS
CCM Services (CPT Code 99487 and CPT Code 99489)
As we stated in the CY 2017 PFS final rule (81 FR 80244), the
initial claims data for CCM services billed under the PFS showed that
although utilization was increasing steadily, use of CPT code 99490 was
still relatively low, and interviews with practitioners indicated that
many believed that they were exceeding the 20-minute time threshold for
billing this code. To pay as accurately as possible and to encourage
access to CCM services, the CY 2017 PFS final rule established separate
payment for two additional CCM codes, CPT code 99487 and CPT code
99489, effective beginning on January 1, 2017, for practitioners
billing under the PFS. These codes are for complex CCM services that
reflect additional clinical staff time, more extensive care planning,
and higher complexity of the patient.
CPT code 99487 is for complex CCM services. It requires multiple
(two or more) chronic conditions expected to last at least 12 months,
or until the death of the patient; chronic conditions that 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; and 60 minutes of clinical staff time directed
by a physician or other qualified health care professional, per
calendar month.
CPT code 99489 is for each additional 30 minutes of clinical staff
time directed by a physician or other qualified health care
professional, per calendar month.
Practitioners paid under the PFS can bill either complex (CPT code
99487 and CPT code 99489) or non-complex (CPT code 99490) CCM services
during a given service period, and can submit only one professional
claim for CCM services for that service period.
General BHI Services (HCPCS Code G0507)
The types of chronic conditions that are eligible for CCM services
are not specified and could include chronic mental health or behavioral
health conditions or chronic cognitive disorders as long as the CCM
requirements are met. However, because not all behavioral health issues
fit into the CCM model, and Medicare beneficiaries with behavioral
health conditions often require extensive care management discussions,
information-sharing, and planning between a primary care practitioner
and a behavioral health specialist, the CY 2017 PFS final rule
established HCPCS code G0507 for 20 minutes or more of general BHI
services. Payment for this code was effective beginning on January 1,
2017, for practitioners billing under the PFS.
BHI is a team-based, collaborative approach to care that focuses on
integrative treatment of patients with primary care and mental or
behavioral health conditions. As finalized in the CY 2017 PFS final
rule, requirements for this code include an initial assessment or
follow-up monitoring (including the use of applicable validated rating
scales); behavioral health care planning in relation to behavioral/
psychiatric health problems (including revision for patients who are
not progressing or whose status changes); facilitating and coordinating
treatment such as psychotherapy, pharmacotherapy, counseling and/or
psychiatric consultation; and continuity of care with a designated
member of the care team.
Psychiatric CoCM Services (HCPCS codes G0502, G0503, and G0504)
Psychiatric CoCM is a specific model of care provided by a primary
care team consisting of a primary care provider and a health care
manager who works in collaboration with a psychiatric consultant. As
finalized in the CY 2017 PFS final rule, we provide Medicare payment
for psychiatric CoCM services to practitioners billing under the PFS
when these services are directed by a treating physician or other
qualified health care professional. We also finalized that the treating
physician or other qualified health care professional directs the
behavioral health care manager, who must be an individual with formal
education or specialized training in behavioral health, including
social work, nursing, or psychology, working under the oversight and
direction of the physician or qualified health care professional. We
finalized that a psychiatric consultant must be a medical professional
trained in psychiatry and qualified to prescribe the full range of
medications. Finally, psychiatric CoCM services may be furnished to
beneficiaries with any psychiatric or behavioral health condition(s)
and may include substance use disorders. The three psychiatric CoCM
codes established in the CY 2017 PFS final rule were G0502, G0503, and
G0504.
HCPCS code G0502 is for 70 minutes or more of initial psychiatric
CoCM services 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. Required elements include: outreach to and treatment of a
patient as 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 of the patient
into a registry and tracking patient follow-up and progress using the
registry (with appropriate documentation), 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.
HCPCS code G0503 is for 60 minutes of subsequent psychiatric CoCM
services in a subsequent month and includes: 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.
HCPCS code G0504 is for each additional 30 minutes of initial or
subsequent psychiatric CoCM services in a calendar month.
[[Page 34083]]
3. Proposed Care Management Requirements and Payment for RHCs and FQHCs
To ensure that RHC and FQHC patients have access to new care
management services in a manner consistent with the RHC and FQHC per
diem payment methodologies, we are proposing the establishment of two
new G codes for use by RHCs and FQHCs. The first new G code, GCCC1,
would be a General Care Management code for RHCs and FQHCs, with the
payment amount set at the average of the national non-facility PFS
payment rates for CCM codes 99490 and 99487 and general BHI code G0507.
The second new G code for RHCs and FQHCs, GCCC2, would be a Psychiatric
CoCM code,with the payment amount set at the average of the national
non-facility PFS payment rates for psychiatric CoCM codes G0502 and
G0503. The following is a detailed discussion of our proposal, as well
as alternatives that we considered.
a. Proposed Establishment of a General Care Management Code for RHCs
and FQHCs
The RHC AIR and the FQHC PPS rate, which include all costs
associated with an RHC or FQHC visit, are based on the RHC's and FQHC's
costs. Although many RHCs and FQHCs have always provided some
coordination of care within and outside their facilities, the type of
structured care management services that are now billable under the PFS
are generally not included in the RHC AIR or the FQHC PPS rate. Because
CCM services are not required to be face-to-face encounters, and do not
require the skill level of an RHC or FQHC practitioner, they do not
meet the requirements for an RHC or FQHC billable visit. In addition,
RHC and FQHC services cannot be separately billed to the PFS.
Therefore, in the CY 2016 PFS final rule with comment period, we
established payment for CCM services at the PFS national non-facility
rate when CPT code 99490 is billed alone or with other payable services
on an RHC or FQHC claim to pay for the costs of CCM services that are
not already captured in the RHC AIR or the FQHC PPS payment.
When CCM services were first established for RHCs and FQHCs, CPT
code 99490 was the only CCM code that was billable under the PFS. Now
that there are additional codes for more complex CCM services and for
general BHI and psychiatric CoCM services, we believe it is necessary
to revise our payment approach for payment of care management services.
RHCs and FQHCs are paid per-visit rates that are not adjusted based
on the complexity of a service or the time spent furnishing services,
and the payment rate is not designed to be equal to the payment under
the PFS for a specific service. We sought to develop a methodology for
payment of care management services that is consistent with the RHC and
FQHC payment principles of bundling services and not paying for
services based on time increments. We also sought to develop a
methodology that would support the provision of care management
services without creating additional reporting burdens, while promoting
beneficiary access to comprehensive CCM and BHI services furnished by
RHCs and FQHCs.
Therefore, effective for services furnished on or after January 1,
2018, we are proposing to create General Care Management code GCCC1 for
RHCs and FQHCs, with the payment amount set at the average of the 3
national non-facility PFS payment rates for the CCM and general BHI
codes and updated annually based on the PFS amounts. The 3 codes are:
CPT 99490--20 minutes or more of CCM services
CPT 99487--at least 60 minutes of complex CCM services
HCPCS G0507--20 minutes or more of BHI services
RHCs and FQHCs could bill the new General Care Management code when
the requirements for any of these 3 codes (CPT codes 99490, 99487, or
HCPCS code G0507) are met. The General Care Management code would be
billed alone or in addition to other services furnished during the RHC
or FQHC visit. This code could only be billed once per month per
beneficiary, and could not be billed if other care management services
(such as TCM or home health care supervision) are billed for the same
time period. We note that CPT 99489 is an add-on code when CPT 99487 is
furnished, and is therefore not included as RHCs and FQHCs are not paid
for additional time once the minimum requirements have been met.
As previously noted, the program requirements for RHCs and FQHCs
furnishing CCM services were established in the CY 2016 PFS final rule
with comment period (80 FR 71080) and revised in the CY 2017 PFS final
rule (81 FR 80256). We are not proposing any changes to these
requirements at this time.
BHI refers to care management services that integrate behavioral
health services with primary care and other clinical services. To bill
for this service using the proposed General Care Management Code for
RHCs and FQHCs, 20 minutes or more of clinical staff time, directed by
an RHC or FQHC practitioner, must be furnished per calendar month. We
are proposing the following requirements for RHCs and FQHCs furnishing
BHI services:
Initiating Visit: An E/M, AWV, or IPPE visit with an RHC
or FQHC primary care practitioner (physician, NP, PA, or CNM) occurring
no more than one-year prior to commencing BHI services. This could be
the same initiating visit that is used for initiating CCM services, and
would be billed separately as an RHC or FQHC visit (if the RHC or FQHC
has not already billed for this visit).
Beneficiary Consent: Documentation in the medical record
that the beneficiary has consented to receive BHI services, given
permission to consult with relevant specialists as needed, and been
informed that there may be beneficiary cost-sharing, including
deductible and coinsurance amounts as applicable, for both in-person
and non-face-to-face services that are provided. The beneficiary
consent process would also include informing the patient that only one
practitioner/facility can furnish and be paid for these services during
a calendar month, and that the patient can stop care coordination
services at any time (effective at the end of the calendar month). This
could be obtained at the same time that beneficiary consent is obtained
for CCM services.
Billing Requirements: At least 20 minutes of care
management services per calendar month, furnished under the direction
of the RHC or FQHC primary care physician, NP, PA, or CNM, and
furnished by an RHC or FQHC practitioner, or by clinical personnel
under general supervision. These are the same billing requirements as
for CCM services. If both CCM and BHI services are furnished in the
same month, the time would be combined and billed as one under the new
care coordination code.
Patient Eligibility: One or more new or pre-existing
behavioral health or psychiatric conditions being treated by the RHC or
FQHC primary care practitioner, including substance use disorders,
that, in the clinical judgment of the RHC or FQHC primary care
practitioner, warrants BHI services.
Required Service Elements: An initial assessment or
follow-up monitoring, including the use of applicable validated rating
scales; behavioral health care planning in relation to behavioral/
psychiatric health problems, including revision for patients who are
not progressing or whose status changes; facilitating and
[[Page 34084]]
coordinating treatment such as psychotherapy, pharmacotherapy,
counseling and/or psychiatric consultation; and continuity of care with
a designated member of the care team.
Both CCM and general BHI services are intended to provide a
structured and coordinated approach to care management that is not
typically included in the RHC's AIR or the FQHC PPS payment
methodology. Care management services are directed by the RHC or FQHC
primary care practitioner, who remains involved through ongoing
oversight, management, collaboration and reassessment, while care
management services are typically furnished in a non-face-to-face
setting primarily by a non-RHC or FQHC practitioner working under
general supervision requirements. Time spent by administrative or
clerical staff cannot be counted towards the time required to bill
these services.
Table 16 compares the requirements for CCM and general BHI
services. We believe that even though there are some differences in the
requirements of CCM and general BHI, bundling them together will help
to promote integrated care management services for Medicare
beneficiaries who have either or both primary care and behavioral
health needs. It will also result in the least amount of reporting
burden for RHCs and FQHCs because once the 20-minute threshold is met
for either CCM or general BHI, reporting and tracking of additional
time increments is not required.
If this policy had been adopted for CY 2017, the payment amount for
General Care Management for RHCs and FQHCs would have been
approximately $61 (CPT 99490 at $42.71, + CPT 99487 at $93.67, + G0507
at $47.73 = $184.11/3 = $61.37). This is more than is the CY 2017 PFS
national non-facility rates for CPT code 99490 and HCPCS code G0507,
and less than the PFS national non-facility rate for CPT code 99487. We
believe that this bundling methodology is consistent with the RHC and
FQHC payment methodology of averaging costs to determine a payment rate
rather than paying for each individual service.
Table 16--Comparison of Proposed CCM and General BHI Requirements For
RHCs and FQHCs
------------------------------------------------------------------------
General BHI
Requirements CCM (CPT codes 99490 (proposed) (HCPCS
and 99487) code G0507)
------------------------------------------------------------------------
Initiating Visit............ An E/M, AWV, or IPPE Same.
visit occurring no
more than one-year
prior to commencing
care coordination
services.
Furnished by a Same.
primary care
physician, NP, PA,
or CNM.
Billed as an RHC/ Same.
FQHC visit.
Beneficiary Consent......... Obtained during or Same.
after initiating
visit and before
provision of care
coordination
services by RHC or
FQHC practitioner
or clinical staff.
Written or verbal, Same.
documented in the
medical record.
Includes Same.
information:.
On the
availability of
care coordination
services and
applicable cost-
sharing;.
That only
one practitioner
can furnish and be
paid for care
coordination
services during a
calendar month;.
That the
patient has right
to stop care
coordination
services at any
time (effective at
the end of the
calendar month);
and.
That the
patient has given
permission to
consult with
relevant
specialists..
Billing Requirements........ At least 20 minutes Same.
of care
coordination
services per
calendar month that
is:
Furnished
under the direction
of the RHC or FQHC
primary care
physician, NP, PA,
or CNM; and.
Furnished
by an RHC or FQHC
practitioner, or by
clinical personnel
under general
supervision.
Patient Eligibility......... Multiple (two or Any behavioral
more) chronic health or
conditions expected psychiatric
to last at least 12 condition being
months, or until treated by the RHC
the death of the or FQHC primary
patient, and place care practitioner,
the patient at including substance
significant risk of use disorders,
death, acute that, in the
exacerbation/ clinical judgment
decompensation, or of the RHC or FQHC
functional decline. practitioner,
warrants BHI
services.
[[Page 34085]]
Requirement Service Elements Includes: Includes:
Structured Initial
recording of assessment or
patient health follow-up
information using monitoring,
Certified EHR including the use
Technology and of applicable
includes validated rating
demographics, scales;
problems, Behavioral
medications, and health care
medication planning in
allergies that relation to
inform the care behavioral/
plan, care psychiatric health
coordination, and problems, including
ongoing clinical revision for
care;. patients who are
24/7 access not progressing or
to physicians or whose status
other qualified changes;
health care
professionals or Facilitating and
clinical staff coordinating
including providing treatment (such as
patients/caregivers psychotherapy,
with a means to pharmacotherapy,
make contact with counseling and/or
health care psychiatric
professionals in consultation); and
the practice to Continuity
address urgent of care with a
needs regardless of designated member
the time of day or of the care team.
day of week, and
continuity of care
with a designated
member of the care
team with whom the
patient is able to
schedule successive
routine
appointments;.
Comprehensive care
management
including
systematic
assessment of the
patient's medical,
functional, and
psychosocial needs;
system-based
approaches to
ensure timely
receipt of all
recommended
preventive care
services;
medication
reconciliation with
review of adherence
and potential
interactions; and
oversight of
patient self-
management of
medications;.
Comprehensive care
plan including the
creation, revision,
and/or monitoring
of an electronic
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 with
particular focus on
the chronic
conditions being
managed;.
Care plan
information made
available
electronically
(including fax) in
a timely manner
within and outside
the RHC or FQHC as
appropriate and a
copy of the plan of
care given to the
patient and/or
caregiver;.
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;
timely creation and
exchange/transmit
continuity of care
document(s) with
other practitioners
and providers;.
Coordination with
home- and community-
based clinical
service providers,
and documentation
of communication to
and from home- and
community-based
providers regarding
the patient's
psychosocial needs
and functional
deficits in the
patient's medical
record; and.
Enhanced
opportunities for
the patient and any
caregiver to
communicate with
the practitioner
regarding the
patient'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..
CY 2017 PFS Non-Facility CPT 99490--$42.71... G0507--$47.73.
Payment. CPT 99487--$93.67...
RHC/FQHC Payment for new Current: $42.71..... Current: N/A
General Care Management G Proposed: Average of Proposed: Average of
code. CPT codes 99490, CPT codes 99490,
99487 and G0507 (If 99487 and G0507 (If
using the 2017 using the 2017
payment amounts, payment amounts,
this would be this would be
$61.37). $61.37).
------------------------------------------------------------------------
We expect that utilization of care coordination services will
continue to increase as more health care practices, including RHCs and
FQHCs, implement these services. Because the separate payments for the
complex CCM codes have only been implemented this year for
practitioners billing under the PFS, we do not have adequate data to
determine the frequency of billing for CCM codes CPT codes 99487 by
practitioners billing under the PFS compared with CPT code 99490.
Although billing practices may vary between physician offices and RHCs
and FQHCs (and within and between RHCs and FQHCs), we believe that
utilization patterns under the PFS can provide a reasonable proxy for
utilization practices in RHCs and FQHCs of care coordination
utilization. If the PFS data starts to show definitive trends in
billing certain CCM and BHI codes, or if data becomes available that
provides information on the extent of these services in RHCs and FQHCs,
we may consider using a weighted average
[[Page 34086]]
in determining the payment rate in the future. Similarly, if the
proposal to create a new care management code for RHCs and FQHCs is
finalized, and any additional care management codes become available on
the PFS, we would review the new codes to determine if they should also
be factored into the RHC and FQHC General Care Management Code. Any
changes would be undertaken through future rulemaking.
b. Proposed Establishment of a Psychiatric CoCM Code for RHCs and FQHCs
Psychiatric CoCM is a defined model of care that integrates primary
health care services with care management support for patients
receiving behavioral health treatment, and includes regular psychiatric
inter-specialty consultation with the primary care team, particularly
regarding patients whose conditions are not improving. We recognize
that the requirements of this model may be challenging for some RHCs
and FQHCs, especially those who have difficulty maintaining adequate
primary care and mental health staffing in rural and or underserved
areas. For those RHCs and FQHCs that choose to offer these services, we
believe this model may be particularly helpful, especially for patients
with primary care and mental health conditions who have not benefited
from standard treatment.
Effective for services furnished on or after January 1, 2018, we
are proposing to create a psychiatric CoCM code for RHCs and FQHCs,
GCCC2, with the payment amount set at the average of the 2 national
non-facility PFS payment rates for CoCM codes, to be updated annually
based on the PFS amounts. The 2 codes are:
G0502--70 minutes or more of initial psychiatric CoCM
services
G0503--60 minutes or more of subsequent psychiatric CoCM
services
RHCs and FQHCs could bill the new psychiatric CoCM code when the
requirements for any of these 2 codes (G0502 or G0503) are met. The
psychiatric CoCM code would be billed alone or in addition to other
services furnished during the RHC or FQHC visit. To prevent duplication
of payment, this code could only be billed once per month per
beneficiary, and could not be billed if other care management services,
including the proposed General Care Management code, are billed for the
same time period. We note that G0504 is an add-on code when G0503 is
furnished and is therefore not included as RHCs and FQHCs are not paid
for additional time once the minimum requirements have been met.
If this policy had been adopted for CY 2017, the payment amount for
psychiatric CoCM for RHCs and FQHCs would have been approximately
$134.58 (G0502 at $142.84 + G0503 at $126.33 = $269.17/2 = $134.58).
All care management services, including psychiatric CoCM, require a
separately billable initiating visit (E/M, AWV, or IPPE) for new
patients or beneficiaries not seen within 1 year prior to commencement
of care management services. Prior to commencement of psychiatric CoCM
services, the beneficiary must provide consent for this service,
including permission to consult with a psychiatric consultant and
relevant specialists. Advance consent must also include information on
cost sharing for both face-to-face and non-face-to-face services, and
acceptance of these requirements must be documented in the medical
record.
Patients with mental health, behavioral health, or psychiatric
conditions, including substance use disorders, who are being treated by
an RHC or FQHC practitioner, may be eligible for psychiatric CoCM
services, as determined by the RHC or FQHC practitioner. Psychiatric
CoCM services, like CCM and general BHI services, are intended to
provide a structured and coordinated approach to care management that
is not typically included in the RHC's AIR or the FQHC PPS payment
methodology.
The psychiatric CoCM team must include the RHC or FQHC
practitioner, a behavioral health manager, and a psychiatric
consultant. Proposed specific requirements of the psychiatric CoCM team
are as follows:
Psychiatric CoCM Team--RHC or FQHC Practitioner
For psychiatric CoCM, the RHC or FQHC practitioner may be a primary
care physician, NP, PA, or CNM. The psychiatric CoCM requirements of
the RHC or FQHC practitioner are to:
Direct the behavioral health care manager and any other
clinical staff;
Oversee the beneficiary's care, including prescribing
medications, providing treatments for medical conditions, and making
referrals to specialty care when needed; and
Remain involved through ongoing oversight, management,
collaboration and reassessment.
Psychiatric CoCM Team--Behavioral Health Care Manager
For psychiatric CoCM, the behavioral health care manager is a
designated individual with formal education or specialized training in
behavioral health such as social work, nursing, or psychology. A
behavioral health care manager in an RHC or FQHC would be expected to
have a minimum of a bachelor's degree in a behavioral health field
(such as in clinical social work or psychology), or be a clinician with
behavioral health training, including RNs and LPNs. The behavioral
health care manager furnishes both face-to-face and non-face-to-face
services under the general supervision of the RHC or FQHC practitioner
and may be employed by or working under contract to the RHC or FQHC.
The psychiatric CoCM requirements of the behavioral health care manager
are:
Providing assessment and care management services,
including the administration of validated rating scales; behavioral
health care planning in relation to behavioral/psychiatric health
problems, including revision for patients who are not progressing or
whose status changes; provision of brief psychosocial interventions;
ongoing collaboration with the RHC or FQHC practitioner; maintenance of
the registry; acting in consultation with the psychiatric consultant;
Being available to provide services face-to-face with the
beneficiary; having a continuous relationship with the patient and a
collaborative, integrated relationship with the rest of the care team;
and
Being available to contact the patient outside of regular
RHC or FQHC hours as necessary to conduct the behavioral health care
manager's duties.
Psychiatric CoCM Team--Psychiatric Consultant
For CoCM, a psychiatric consultant is a medical professional
trained in psychiatry and qualified to prescribe the full range of
medications. The psychiatric consultant is not required to be on site
or to have direct contact with the patient and does not prescribe
medications or furnish treatment to the beneficiary directly. The CoCM
requirements of the psychiatric consultant are:
Participating in regular reviews of the clinical status of
patients receiving psychiatric CoCM services;
Advising the RHC or FQHC practitioner regarding diagnosis
and options for resolving issues with beneficiary adherence and
tolerance of behavioral health treatment; making adjustments to
behavioral health treatment for beneficiaries who are not progressing;
managing any negative interactions between beneficiaries'
[[Page 34087]]
behavioral health and medical treatments; and
Facilitating referral for direct provision of psychiatric
care when clinically indicated.
RHCs and FQHCs could bill the new psychiatric CoCM code, GCCC2,
when the requirements for HCPCS code G0502 or G0503 are met. This code
could only be billed once per month per beneficiary, and could not be
billed if other care management services, including the General Care
Management code GCCC1, are billed for the same time period.
As with the proposed General Care Management code GCCC1, we would
monitor PFS data to determine if a weighted average would be more
appropriate in determining the psychiatric CoCM payment rate for RHCs
and FQHCs, and whether any additional codes that may be added to the
PFS in the future should also be factored into the RHC and FQHC
psychiatric CoCM code. Any changes would be done through future
rulemaking.
Table 17 compares the requirements for general BHI, which would be
billed using the proposed General Care Management code GCCC1, and
psychiatric CoCM services, which would be billed using the proposed
psychiatric CoCM code, GCCC2.
Table 17--Comparison of Proposed General BHI and Psychiatric CoCM
Requirements for RHCs and FQHCs
------------------------------------------------------------------------
Psychiatric CoCM
General BHI (proposed) (HCPCS
Requirements (proposed) (HCPCS code G0502 and
code G0507) G0503)
------------------------------------------------------------------------
Initiating Visit............ An E/M, AWV, or IPPE Same.
visit occurring no
more than one-year
prior to commencing
care coordination
services.
Furnished by a Same.
primary care
physician, NP, PA,
or CNM.
Billed as an RHC or Same.
FQHC visit.
Beneficiary Consent......... Obtained during or Same.
after initiating
visit and before
provision of care
coordination
services by RHC or
FQHC practitioner
or clinical staff.
Written or verbal, Same.
documented in the
medical record.
Includes Same.
information:
On the
availability of
care coordination
services and
applicable cost-
sharing;
That only
one entity can
furnish and be paid
for care
coordination
services during a
calendar month;
That the
patient has the
right to stop care
coordination
services at any
time (effective at
the end of the
calendar month);
and
That the
patient has given
permission to
consult with
relevant
specialists.
Billing Requirements........ At least 20 minutes At least 70 minutes
of care management in the first
services per calendar month, and
calendar month that at least 60 minutes
is: in subsequent
Furnished calendar months of
under the direction psychiatric CoCM
of the RHC or FQHC services that is:
primary care Furnished
physician, NP, PA, under the direction
or CNM; and. of the RHC or FQHC
Furnished primary care
by an RHC or FQHC practitioner; and
practitioner, or by Furnished
clinical personnel by an RHC or FQHC
under general practitioner or
supervision.. behavioral health
care manager under
general
supervision.
Patient Eligibility......... Any mental, Same.
behavioral health,
or psychiatric
condition being
treated by the RHC
or FQHC primary
care practitioner,
including substance
use disorders,
that, in the
clinical judgment
of the RHC or FQHC
practitioner,
warrants BHI
services.
Requirement Elements........ Includes: Includes:
Initial RHC or FQHC primary
assessment or care practitioner:
follow-up Direct the
monitoring, behavioral health
including the use care manager or
of applicable clinical staff;
validated rating Oversee the
scales. beneficiary's care,
Behavioral including
health care prescribing
planning in medications,
relation to providing
behavioral/ treatments for
psychiatric health medical conditions,
problems, including and making
revision for referrals to
patients who are specialty care when
not progressing or needed; and
whose status Remain
changes. involved through
ongoing oversight,
Facilitating and management,
coordinating collaboration and
treatment (such as reassessment
psychotherapy, Behavioral Health
pharmacotherapy, Care Manager:
counseling and/or
psychiatric
consultation)
Continuity of care
with a designated
member of the care
team.
Provide
assessment and care
management
services, including
the administration
of validated rating
scales; behavioral
health care
planning in
relation to
behavioral/
psychiatric health
problems, including
revision for
patients who are
not progressing or
whose status
changes; provision
of brief
psychosocial
interventions;
ongoing
collaboration with
the RHC or FQHC
practitioner;
maintenance of the
registry; acting in
consultation with
the psychiatric
consultant;
[[Page 34088]]
Be
available to
provide services
face-to-face with
the beneficiary;
having a continuous
relationship with
the patient and a
collaborative,
integrated
relationship with
the rest of the
care team; and
Be
available to
contact the patient
outside of regular
RHC or FQHC hours
as necessary to
conduct the
behavioral health
care manager's
duties.
Psychiatric
Consultant:
Participate
in regular reviews
of the clinical
status of patients
receiving CoCM
services;
Advise the
RHC or FQHC
practitioner
regarding
diagnosis, options
for resolving
issues with
beneficiary
adherence and
tolerance of
behavioral health
treatment; making
adjustments to
behavioral health
treatment for
beneficiaries who
are not
progressing;
managing any
negative
interactions
between
beneficiaries'
behavioral health
and medical
treatments; and
Facilitate
referral for direct
provision of
psychiatric care
when clinically
indicated.
Cy 2017 PFS Non-Facility G0507--$47.73....... G0502--$142.84.
Payment. G0503--$126.33.
RHC/FQHC Payment for New Current: N/A........ Current: N/A
Psychiatric CoCM G Code. Proposed: Average of Proposed: Average of
CPT codes 99490, HCPCS codes G0502
99487, and G0507. and G0503. (If
(If using the 2017 using the 2017
payment amounts, payment amounts,
this would be this would be
$61.37). $134.58).
------------------------------------------------------------------------
c. Other Options Considered
We considered allowing RHCs and FQHCs to bill for the complex CCM
codes, the BHI code, and the psychiatric CoCM codes by allowing the
individual CPT or HCPCS codes to be added to an RHC or FQHC claim, in
the same manner as we currently allow CPT code 99490 to be added to a
claim. We do not believe this approach is in the best interest of RHCs
and FQHCs. There are now 5 separate care management codes that are
applicable to RHCs and FQHCs, and more codes could be added in the
future as we learn more about the benefits of non-face-to-face care
management services. Each of these codes has specific time increments
that must be tracked and reported for payment under the PFS. We believe
that bundling the CCM and BHI codes and the psychiatric CoCM codes into
2 G codes is more consistent with the RHC and FQHC payment methodology
of averaging actual costs to determine a payment rate and not paying
for services based on time increments. It also requires less record
keeping, monitoring, and coding expertise, while maintaining the same
quality of care standards.
We also considered bundling all 5 codes together into one G code,
or developing 3 G codes--one for the CCM codes, one for the BHI code,
and one for the psychiatric CoCM codes. We did not choose either of
these approaches because CCM and BHI are similar services that
complement each other, and bundling them together is consistent with an
integrated approach to care with reduced reporting requirements. We
also believe that psychiatric CoCM is different enough from both CCM
and BHI in its requirements, particularly in staffing and required
services, that it warrants a separate G code. We believe that our
proposal of creating 2 new G codes to encompass the 5 care management
codes is the best option for RHCs and FQHCs now and in the future if
new care management codes are developed. We welcome comments on the
proposal.
4. Implementation
RHCs and FQHCs are familiar with billing G codes. If this proposal
is finalized as proposed, RHCs and FQHCs would continue to receive
payment for CCM when CPT code 99490 is billed alone or with other
payable services on an RHC or FQHC claim until December 31, 2017.
Beginning on January 1, 2018, we propose that RHCs and FQHCs would use
the new General Care Management G code GCCC1 when billing for CCM or
general BHI services, and the new psychiatric CoCM G code GCCC2 when
billing for psychiatric CoCM services, either alone or with other
payable services on an RHC or FQHC claim. Claims submitted using CPT
99490 on January 1, 2018, or after, will not be paid.
Both the current RHC and FQHC payment rate for CCM, and the
proposed RHC and FQHC payment rates for General Care Management and
Psychiatric CoCM codes, are based on the PFS national non-facility
rates. The PFS rates are updated annually, and the new G codes for RHCs
and FQHCs would be updated accordingly and finalized when the PFS rates
are finalized for the year. No geographic adjustment would be applied
to the General Care Management or Psychiatric CoCM G codes. RHCs and
FQHCs are required to submit claims for RHC and FQHC services on an
institutional claim (electronically per the HIPAA compliant ANSI X12
837I or the Form CMS 1450, also known as the UB-04,) and are not
authorized to bill RHC or FQHC services separately to the PFS. Specific
information on billing and claims processing for the new G codes will
be provided when the policy is finalized.
We note that in section X of this proposed rule, G0502, G0503, and
G0507 are proposed to be replaced by new CPT codes. Corresponding
changes would be made for RHCs and FQHCs when the new CPT codes become
available.
5. Regulatory Changes
As previously noted, Sec. 405.2413(a)(5) and Sec. 405.2415(a)(5)
was revised
[[Page 34089]]
effective January 1, 2017, to state that services and supplies
furnished incident to CCM and TCM services can be furnished under
general supervision of an RHC or FQHC practitioner, 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. We propose to further revise Sec. 405.2413(a)(5) and
Sec. 405.2415(a)(5) to state that services and supplies incident to
the services of a physician, NP, PA, or CNM are furnished under the
direct supervision of a physician, NP, PA, or CNM, except for TCM,
General Care Management, and Psychiatric CoCM services, which can be
furnished under general supervision of a physician, NP, PA, or CNM when
these services or supplies are furnished by auxiliary personnel, as
defined in Sec. 410.26(a)(1).
B. Part B Drug Payment: Infusion Drugs Furnished Through an Item of
Durable Medical Equipment (DME)
Section 303(c) of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (Pub. L. 108-173, enacted on December
8, 2003) revised the payment methodology for most Medicare-covered Part
B drugs and biologicals by adding section 1847A to the Act, which
established a new average sales price (ASP) drug payment methodology
beginning January 1, 2005. However, section 303(b) of the MMA specified
payments for certain drugs using methodologies other than the ASP
pricing methodology. Specifically, section 303(b) of the MMA added
section 1842(o)(1)(D)(i) of the Act that required that an infusion drug
furnished through an item of DME covered under section 1861(n) of the
Act be paid 95 percent of the average wholesale price (AWP) for that
drug in effect on October 1, 2003.
Section 5004(a) of the 21st Century Cures Act (Cures Act) (Pub. L.
114-255, enacted on December 13, 2016) revised sections 1842(o)(1)(C)
and (D) of the Act, changing the payment methodology for DME infusion
drugs from being based on AWP to the methodologies in sections 1847,
1847A, 1847B, or 1881(b)(13) of the Act, as the case may be for the
drug or biological. To implement the pricing changes required by
section 5004(a) of Cures Act, which modifies the payment for DME
infusion drugs to the amount under section 1847A of the Act (ASP
payment methodology), by the statutorily mandated effective date of
January 1, 2017, we incorporated the ASP-based infusion drug payment
amounts into the January 2017 quarterly ASP drug pricing files and
instructed claims processing contractors to use the updated payment
limits for DME infusion drugs.
To conform regulations with the new payment requirements in section
5004(a) of the Cures Act as they pertain to section 1847A of the Act,
we propose revising Sec. 414.904(e)(2). Currently, this describes an
exception to ASP-based payments and requires pricing DME infusion drugs
at 95 percent of the 2003 AWP. Consistent with section 5004(a) of the
Cures Act, the proposed revision limits the exception to infusion drugs
furnished before January 1, 2017. In addition, we propose at Sec.
414.904(e)(2) to delete the phrase ``and is not updated in 2006.'' We
believe this language is not relevant since there was no update for
pricing DME infusion drugs in 2006, and the proposed revision will
serve to simplify the language. Effective January 1, 2017, payment
limits for these drugs are determined under section 1847A of the Act.
C. Solicitation of Public Comments on Initial Data Collection and
Reporting Periods for Clinical Laboratory Fee Schedule
1. Background on Medicare Clinical Diagnostic Laboratory Tests Payment
System Final Rule
In the final rule published in the June 23, 2016 Federal Register
(81 FR 41036) entitled, ``Medicare Program; Medicare Clinical
Diagnostic Laboratory Tests Payment System,'' we implemented the
requirements of section 1834A of the Act, which requires extensive
revisions to the Medicare payment, coding, and coverage for clinical
diagnostic laboratory tests (CDLTs) paid under the Clinical Laboratory
Fee Schedule (CLFS).
Under the CLFS final rule, reporting entities are required to
report to CMS certain applicable information for their component
applicable laboratories. The applicable information includes, for each
CDLT furnished during a data collection period, the specific HCPCS code
associated with the test, each private payor rate for which final
payment has been made, and the associated volume of tests performed
corresponding to each private payor rate. In general, the payment
amount for a test on the CLFS furnished on or after January 1, 2018,
will be equal to the weighted median of private payor rates determined
for the test, based on the applicable information that is collected
during a data collection period and reported to us during a data
reporting period.
In the CLFS final rule, we established a data collection period
that is the 6 months from January 1 through June 30 during which
applicable information is collected and that precedes the data
collection period. We established a data reporting period that is the
3-month period, January 1 through March 31, during which a reporting
entity reports applicable information to CMS and that follows the
preceding data collection period. The first data collection period was
January 1, 2016 through June 30, 2016. The first data reporting period
was January 1, 2017 through March 31, 2017. This 6-month data
collection period and 3-month data reporting period schedule will be
repeated every 3 years for CDLTs that are not advanced diagnostic
laboratory tests (ADLTs), and every year for ADLTS that are not new
ADLTs.
For the first data reporting period, industry feedback suggested
that many reporting entities would not be able to submit a complete set
of applicable information to us by the March 31, 2017 deadline, and
that entities required additional time to review collected data,
address any issues identified during such review, and compile the data
into our required reporting format. As a result, on March 30, 2017, we
announced that we would exercise enforcement discretion until May 30,
2017, with respect to the data reporting period for reporting
applicable information under the Medicare CLFS and the application of
the Secretary's potential assessment of civil monetary penalties for
failure to report applicable information.\1\ The enforcement discretion
applied to entities that were subject to the data reporting
requirements adopted in the CLFS final rule (81 FR 41036). We noted in
the announcement that the 60-day enforcement discretion period was the
maximum amount of time we could permit to still have sufficient time to
calculate the CLFS payment rates scheduled to go into effect on January
1, 2018.
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\1\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/2017-March-Announcement.pdf.
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The announcement stated that the enforcement discretion period
would not prevent reporting entities prepared to report applicable
information from doing so before May 30, 2017. We explained in the
announcement that we were committed to the successful implementation of
the new private payor rate-based CLFS and looked forward to working
with the laboratory industry to ensure accurate payment rates. Over the
coming months, we will be analyzing the applicable information we
received, holding our Annual
[[Page 34090]]
Laboratory Public Meeting, meeting with the Advisory Panel for Clinical
Diagnostic Laboratory tests, and posting preliminary payment rates.
2. Solicitation of Public Comments on Medicare Clinical Diagnostic
Laboratory Tests Payment System Initial Data Collection and Reporting
Periods
To better understand the applicable laboratories' experiences with
the data reporting, data collection, and other compliance requirements
for the first data collection and reporting periods, we are interested
in public comments from applicable laboratories and reporting entities
on the following questions:
Was the CMS data reporting system easy to use? Please
describe your overall experience with navigating the CMS data reporting
system. For example, describe the aspects of the CMS data reporting
system that worked well for your reporting entity and/or any problems
the reporting entity experienced with submitting applicable information
to us.
Did the applicable laboratory (or its reporting entity)
request and receive assistance from our Help Desk regarding the CMS
data reporting system? Please describe your experience with receiving
assistance.
Did the applicable laboratory (or its reporting entity)
request and receive assistance from the CMS CLFS Inquiries Mailbox
regarding policy questions? Please describe your experience with
receiving assistance.
Did the applicable laboratory (or its reporting entity)
use the subregulatory guidance on data reporting provided on the CMS
CLFS Web site? \2\ If so, was the information presented useful?
---------------------------------------------------------------------------
\2\ https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/PAMA-Regulations.html.
---------------------------------------------------------------------------
Was the information that the applicable laboratory was
required to report readily available in the applicable laboratory's
record systems?
Did the reporting entity have a manual, automated, or
semi-automated remittance process for data reporting?
If the reporting entity used a manual or semi-automated
remittance process for data reporting, what percentage of the process
was manual?
How much time (hours) was required to assemble and report
applicable information to CMS?
Is there any other information that will inform us
regarding the reporting, recordkeeping, and other compliance
requirements from the first data collection and reporting periods?
We believe that industry feedback on these issues will help inform
us regarding potential refinements to the private payor rate-based CLFS
for future data collection and reporting periods. We welcome comments
on these questions from the public.
D. Payment for Biosimilar Biological Products Under Section 1847A of
the Act
In the CY 2016 Physician Fee Schedule (PFS) final rule with comment
period, we finalized a proposal to amend the regulation text at Sec.
414.904(j) to make clear that the payment amount for a biosimilar
biological product is based on the ASP of all NDCs assigned to the
biosimilar biological products included within the same billing and
payment code (80 FR 71096 through 71101, November 16, 2015 Federal
Register). In general, this means that products that rely on a common
reference product's biologics license application are grouped into the
same payment calculation for determining a single ASP payment limit and
that a single HCPCS code is used for such biosimilar products. The
regulation went into effect on January 1, 2016.
The comments received on the rule revealed that stakeholders had
varying opinions about payment for biosimilar biological products under
Part B. The commenters included individuals, pharmaceutical
manufacturers, patient advocate groups, providers, insurers, and
members of Congress. A number of commenters opposed a single payment
amount for all biosimilars that rely on a common reference product.
Most of these commenters believed that the proposed regulation would
decrease incentives for biosimilar development and that grouping
payment for biosimilar biological products is inconsistent with the
statute. Some commenters also expressed concerns that prescribers'
choices will be limited, that tracking or pharmacovigilance activities
will be impaired, and that innovation and product development will be
harmed, leading to market consolidation and increased costs for
biosimilar biological products. Many commenters who opposed our
proposal suggested that we determine a payment amount for each
biosimilar biological product. These stakeholders have expressed
concerns that the finalized policy restricts and threatens the
viability of their business models and expressed support for a market-
based solution. Some of these stakeholders believe that determining a
payment for each biosimilar product by using individual HCPCS codes,
would drive and reward innovators producing potential cost savings, of
at least 10-15 percent compared to the reference biologic ASP,
necessary for biosimilar products to compete with the reference
biological.
However, some commenters supported our proposed regulation, stating
that the potential marketplace for biosimilar biological products is
large and it is less risky than the marketplace for reference
biologicals. Commenters also expressed concern that separate payment
for each biosimilar biological product would result in less competition
among manufacturers, which in turn could lead to higher payment amounts
for Medicare and beneficiaries. Some commenters stated that separate
billing codes could be perceived as a type of price protection and
could artificially increase prices for biosimilars. Commenters who
supported the proposed regulation suggested that we remain mindful of
our policy as the biosimilar biological product marketplace evolves.
Several commenters requested that policy decisions be delayed while
issues such as naming conventions and interchangeability standards are
finalized by the FDA.
As CMS expected, since the regulation was finalized, the biosimilar
product marketplace has continued to grow, and several biosimilar
biological products that are paid under Part B have been licensed,
including one product that we expect will share a HCPCS code with
another biosimilar biological product. Over the next year or so, we
anticipate that several more biosimilar biological products will be
licensed for use in the United States and that during the following
years, the marketplace will continue to grow steadily. We also
anticipate that biological products will continue to be heavily
utilized in Part B. At the same time, we are aware of concerns that
current policy may discourage development of new biosimilars and other
innovation in this area potentially resulting in higher costs over time
due to a lack of competition in the market place.
In the 2016 PFS final rule, we stated that it is desirable to have
fair reimbursement in a healthy marketplace that encourages product
development (80 FR 71101). CMS seeks to promote innovation, to provide
more options to patients and physicians, and competition to drive
prices down, recognizing that even though these two goals may be
difficult to achieve concurrently, to delink them would be
counterproductive.
Although we believe that the United States biosimilar biological
product marketplace is still in an early phase (because only a few
products are on the market), we are interested in assessing
[[Page 34091]]
the effects of Medicare payment policy on this important portion of the
Part B drug marketplace at this time, particularly for fostering a
robust, and competitive marketplace and encouraging the innovation that
is necessary to bring these products to the marketplace. It is
essential to take a measured approach that considers all options given
the significant federal spending by Medicare on Part B drugs, the
effect of payment policies on program sustainability for taxpayers,
health care affordability and access for beneficiaries, and the
considerable investment the biosimilar industry is making in the
nascent market. Failure to do so could potentially restrict innovation
in the marketplace, increase costs to the American taxpayer, and limit
treatment options. With that in mind, it is CMS's goal to further
investigate a solution that allows market forces to provide a robust
and comprehensive selection of choices for patients at a fair price.
Additionally, we are interested in better understanding if and how the
innate differences in biological products and their current regulatory
environment should be reflected in Medicare payment policy for
biosimilars, particularly as it relates to biosimilars that are
licensed for fewer than all indications for which the reference product
is licensed or situations where different biosimilars may be licensed
for different subsets of indications for which the reference product is
licensed.
Thus, we are requesting comments regarding our Medicare Part B
biosimilar biological product payment policy. This comment solicitation
is seeking new or updated information on the effects of the current
biosimilar payment policy that is based on experience with the United
States marketplace. We are particularly interested in obtaining
material, such as market analyses or research articles that provide
data and insight into the current economics of the biosimilar market
place. This includes patient, plan, and manufacturer data both domestic
and, where applicable, from European markets that may be more
established than, and provide insight for, the current United States'
market.
We also seek data to demonstrate how individual HCPCS codes could
impact the biosimilar market, including innovation, the number of
biosimilar products introduced to the market, patient access, and drug
spending. Finally, we also seek comment regarding other novel payment
policies that would foster competition, increase access, and drive cost
savings in the biological product marketplace. These solutions may
include legislation, demonstrations, and administrative options. Please
note that this is a solicitation for comments on this issue for future
consideration. We are not making a proposal to change the existing
payment policy in this proposed rule.
E. Appropriate Use Criteria for Advanced Diagnostic Imaging Services
Section 218(b) of the Protecting Access to Medicare Act (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 (80 FR 70886), we established an 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 was posted on the CMS Web site at the end of June 2016
at which time their AUC libraries became specified applicable AUC for
purposes of section 1834(q)(2)(A) of the Act. The CY 2017 PFS final
rule addressed the second component of this program, specification of
qualified clinical decision support mechanisms (CDSMs). In that rule
(81 FR 80170), we defined CDSM, identified the requirements CDSMs must
meet for qualification including an opportunity for preliminary
qualification for mechanisms still working toward full adherence, and
established a process by which CDSMs may become qualified. We also
defined applicable payment systems under this program, specified the
first list of priority clinical areas and identified exceptions to the
requirements that ordering professionals consult specified applicable
AUC when ordering applicable imaging services. The first list of
qualified CDSMs will be posted on the CMS Web site in conjunction with
this proposed rule.
This rule proposes the start date of the Medicare AUC program for
advanced diagnostic imaging services. It is on and after this date that
ordering professionals must consult specified applicable AUC using a
qualified CDSM when ordering applicable imaging services and furnishing
professionals must report consultation information on the Medicare
claim. This rule also proposes to modify the policy related to
significant hardship exceptions and requests public feedback on details
regarding how AUC consultation information must be included on the
Medicare claim. To further this iterative process of implementation, we
also discuss briefly the potential for alignment with other Medicare
quality programs.
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
is 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 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 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 descriptions of clinical decision support 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. 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
[[Page 34092]]
directs the Secretary to establish a new program to promote the use of
AUC. Section 1834(q)(4) of the Act requires ordering professionals to
consult with a qualified CDSM for applicable imaging services 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.
3. Discussion of Statutory Requirements
There are four major components of the AUC program under section
1834(q) of the Act, and each component has its own implementation date:
(1) Establishment of AUC by November 15, 2015 (section 1834(q)(2) of
the Act); (2) identification of mechanisms for consultation with AUC by
April 1, 2016 (section 1834(q)(3) of the Act); (3) AUC consultation by
ordering professionals, and reporting on AUC consultation by furnishing
professionals by January 1, 2017 (section 1834(q)(4) of the Act); and
(4) annual identification of outlier ordering professionals for
services furnished after January 1, 2017 (section 1834(q)(5) of the
Act). As we will discuss later in this preamble and in prior PFS rules,
we did not identify mechanisms for consultation by April 1, 2016.
Therefore, we did not require ordering professionals to consult CDSMs
or furnishing professionals to report information on the consultation
by the January 1, 2017 date.
a. Establishment of AUC
In the CY 2016 PFS final rule with comment period, we addressed the
first component of the Medicare AUC program 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.
In the same rule we established a timeline and process under Sec.
414.94(c)(2) for PLEs to apply to become qualified. Consistent with
this timeline the first list of qualified PLEs was published at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/PLE.html (OMB Control
Number 0938-1288).
b. Mechanism for AUC Consultation
In the CY 2017 PFS final rule, we addressed the second major
component of the Medicare AUC program--the specification of qualified
CDSMs for use by ordering professionals for consultation with specified
applicable AUC under section 1834(q)(3) of the Act, along with relevant
aspects of the definitions under section 1834(q)(1) of the Act. This
included defining the term CDSM and finalizing functionality
requirements of mechanisms, upon which qualification is based, as
provided in section 1834(q)(3)(B) of the Act and in the CY 2017 PFS
final rule. We included an opportunity for mechanisms still working
toward full adherence to these requirements to receive preliminary
qualification during the preliminary qualification period that begins
June 30, 2017, and ends when the AUC consulting and reporting
requirements become effective. The preliminarily qualified CDSMs must
meet all requirements by that time. We defined CDSM 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. 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.
In the CY 2017 PFS final rule we established a timeline and process
in Sec. 414.94(g)(2) for CDSM developers to apply to have their CDSMs
qualified. Consistent with this timeline, the first list of qualified
CDSMs will be posted on the CMS Web site https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/CDSM.html in conjunction with this proposed rule (OMB
Control Number 0938-1315).
c. AUC Consultation and Reporting
The third major component of the Medicare 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. Since a list of qualified CDSMs was not available by January
1, 2017, we did not require ordering professionals to meet the
consultation requirement by that date.
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. In the CY 2017 PFS final rule, we identified the
circumstances specific to ordering professionals under which consulting
and reporting requirements are not required. These include orders for
applicable imaging services: (1) For 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; and (3) by ordering professionals who are
granted a significant hardship exception to the Medicare EHR Incentive
Program payment adjustment for that year under 42 CFR 495.102(d)(4),
except for those granted such an exception under Sec.
495.102(d)(4)(iv)(C). We propose changes to the significant hardship
exception later in this preamble.
Section 1834(q)(4)(D) of the Act specifies that the applicable
payment systems for the AUC consultation and reporting requirements,
and, in the CY 2017 PFS final rule we defined them as:
[[Page 34093]]
(1) The physician fee schedule established under section 1848(b) of the
Act; (2) the prospective payment system for hospital outpatient
department services under section 1833(t) of the Act; and (3) the
ambulatory surgical center payment system under section 1833(i) of the
Act.
d. Identification of Outliers
The fourth component of the Medicare 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. Given that we are proposing a program
start date of January 1, 2019, we anticipate that implementation of the
prior authorization component would be delayed. We expect to discuss
details around outlier calculations and prior authorization in the CY
2019 PFS proposed rule. However, we did finalize in the CY 2017 PFS
final rule the first list of priority clinical areas to guide
identification of outlier ordering professionals as follows:
Coronary artery disease (suspected or diagnosed).
Suspected pulmonary embolism.
Headache (traumatic and non-traumatic).
Hip pain.
Low back pain.
Shoulder pain (to include suspected rotator cuff injury).
Cancer of the lung (primary or metastatic, suspected or
diagnosed).
Cervical or neck pain.
As established in Sec. 414.94(e)(4) of our regulations, priority
clinical areas may be used in the identification of outlier ordering
professionals. By starting to identify these areas now, we believe
ordering professionals will have the opportunity to become familiar
with AUC within identified priority clinical areas prior to Medicare
claims for those services being part of the input for calculating
outlier ordering professionals.
We are not including proposals to expand or modify the list of
priority clinical areas in this rule.
4. Proposals for Continuing Implementation
We propose to amend Sec. 414.94 of our regulations, ``Appropriate
Use Criteria for Certain Imaging Services,'' to reflect the following
proposals.
a. Consultation by Ordering Professional and Reporting by Furnishing
Professional
We are proposing that ordering professionals must consult specified
applicable AUC through qualified CDSMs for applicable imaging services
furnished in an applicable setting, paid for under an applicable
payment system and ordered on or after January 1, 2019. This proposed
effective date for the consulting and reporting requirements 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. Although there will be
another rulemaking cycle next year before the consulting and reporting
requirement is effective as proposed on January 1, 2019, we are
establishing this date through rulemaking this year because the agency
expects practitioners and other stakeholders to begin preparing
themselves to report on that date and, in response to public comment
and stakeholder feedback, we want to ensure all impacted parties have
sufficient time to prepare to meet the requirements of this program.
After proposing the timeline and process for qualification of CDSMs
in the CY 2017 PFS proposed rule (81 FR 46392), we anticipated that
furnishing professionals may begin reporting as early as January 1,
2018. However, we received comments that these timelines did not allow
enough time to address the needs of different stakeholder groups. Some
commenters requested that CMS delay the timeline and process to give
practitioners sufficient time to obtain a qualified CDSM. Other
commenters cited insufficient time for CDSMs to incorporate
requirements between the release of the final CDSM requirements and
January 1, 2018, and requested that CMS fully implement the program at
a later date. Additionally, in the CY 2017 PFS final rule (81 FR 80411)
we discussed commenters' recommendations that CMS develop and launch an
educational campaign, including a Town Hall meeting. Some commenters
requesting additional time suggested that, for purposes of both CDSM
vendor readiness and practitioner readiness, consulting and reporting
requirements should not go into effect for an additional 12-18 months
after the initial list of CMS qualified CDSMs is posted.
By proposing the consulting and reporting requirements begin on
January 1, 2019 we believe that we are allowing needed time for
education and outreach efforts, time for practitioners and stakeholders
to prepare, and time for CDSMs to continue current strides in being
more user-friendly and less burdensome. We note that the statute
required publication of qualified CDSMs by April 1, 2016, and required
AUC consultation and reporting by January 1, 2017; therefore, our
proposal substantially lags the statutory requirements. As noted above
and in previous rulemaking, a delay in the statutory timeline is
necessary to maximize the opportunity for public comment and
stakeholder engagement, also a statutory requirement, and allows for
adequate advance notice to practitioners, beneficiaries, AUC
developers, and CDSM developers.
Consistent with section 1834(q)(4)(B) of the Act, we are also
proposing that furnishing professionals report the following
information on Medicare claims for applicable imaging services,
furnished in an applicable setting, paid for under an applicable
payment system as defined in Sec. 414.94(b), and ordered on or after
January 1, 2019: (1) Which qualified CDSM was consulted by the ordering
professional; (2) whether the service ordered would adhere to specified
applicable AUC, would not adhere to specified applicable AUC, or
whether specified applicable AUC were not applicable to the service
ordered; and (3) the NPI of the ordering professional (if different
from the furnishing 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 remind readers as required under Sec.
414.94(g)(1)(iii) that qualified CDSMs must make available, at a
minimum, AUC that reasonably address common and important clinical
scenarios within all priority clinical areas. As discussed in the CY
2017 PFS final rule (81 FR 80170), the current list of priority
clinical areas represents about 40 percent of advanced diagnostic
imaging services paid for by Medicare in 2014. We also remind readers
that consistent with section 1834(q)(4)(A) of the Act, ordering
professionals must consult AUC for every advanced diagnostic
[[Page 34094]]
imaging service ordered. While section 218(b) of the PAMA allows
qualified CDSMs to return a response of ``not applicable'' if a
qualified CDSM does not contain specified applicable AUC for the
service ordered, we expect these situations to be limited in scope and
number, and to decrease over time. The ``not applicable'' responses
should decrease as qualified PLEs continue to build out their AUC
libraries and qualified CDSMs update their content and potentially
collaborate with more qualified PLEs so as to make available highly
comprehensive tools.
Section 1834(q)(4)(B) requires that payment may only be made if the
claim for the service includes the specific information discussed in
this proposed rule. This information, to the extent feasible, is
required across claim types (including both the furnishing professional
and facility claims) and across all three applicable payment systems
(PFS, hospital outpatient prospective payment system and ambulatory
surgical center payment system). In other words, we would expect this
information to be included on the practitioner claim that includes the
professional component of the imaging service and on the hospital
outpatient claim for the technical component of the imaging service.
Claims for services for which payment is not made under the three
identified payment systems would not be required to include
consultation related information.
To implement this requirement we propose to establish a series of
HCPCS level 3 codes. These G-codes would describe the specific CDSM
that was used by the ordering professional. Ultimately there would be
one G-code for every qualified CDSM with the code description including
the name of the CDSM. However, because the claims processing system can
only recognize new codes quarterly, we may not be able to update the G-
code descriptors simultaneously with the announcement of any new
qualified CDSMs which is expected to occur in June of each year. To
ensure that there is a code available to immediately describe newly
qualified CDSMs, we propose to establish a generic G-code that would be
used to report that a qualified CDSM was consulted, but would not
identify a specific qualified CDSM; clinicians would only be permitted
to use this code if a more specific named code did not yet exist for
that clinician's CDSM. Furnishing professionals would report this code
temporarily until a specific G-code describing the newly qualified CDSM
by name becomes available. We also propose to establish a G-code to
identify circumstances where there was no AUC consultation through a
qualified CDSM. The description of this code would indicate that a
qualified CDSM was not consulted by the ordering professional.
G-codes would be a line-item on both practitioner claims and
facility claims. We would expect that one AUC consulatation G-code
would be reported for every advanced diagnostic imaging service on the
claim. If there are two codes billed for advanced imaging services on
the claim then we would expect two G-codes. Each G-code would be
expected, on the same claim line, to contain at least one new HCPCS
modifier. We propose to develop a series of modifiers to provide
necessary information as to whether, when a CDSM is used to consult
AUC: (1) The imaging service would adhere to the applicable appropriate
use criteria; (2) the imaging service would not adhere to such
criteria; or (3) such criteria were not applicable to the imaging
service ordered. We propose to create additional modifiers to describe
situations where an exception applies and a qualified CDSM was not used
to consult AUC: (1) The imaging service was ordered for a patient with
an emergency medical condition or (2) the ordering professional has a
significant hardship exception. Based on this proposal we specifically
seek comments on any additional HCPCS modifiers that might be needed to
separately identify allowable scenarios for which a qualified CDSM was
not consulted by the ordering professional.
The proposed AUC consultation and reporting start date of January
1, 2019 is expected to allow adequate time for us to operationalize the
claims-based procedures and systems changes needed to accomplish the
processing of Medicare claims with AUC consultation information.
There are aspects of the AUC program that are novel and complex for
the CMS claims processing system and for ordering and furnishing
professionals. An AUC consultation by an ordering professional has
never before been required by fee-for-service Medicare with such a
broad application (all professionals ordering advanced diagnostic
tests). Additional considerations for the complex communication of AUC
consultation information from the ordering professional to the
furnishing professional and facility that must include that information
when billing for the service are warranted. Their billing systems will
need to translate the AUC consultation information onto Medicare claims
in the form of G-codes and HCPCS modifiers. These processes are new for
many professionals, and there are many areas for potential error. For
these reasons an educational and operations testing period is needed.
During this period, ordering professionals would consult AUC and
furnishing professionals would report AUC consultation information on
the claim, but we would continue to pay claims whether or not they
correctly include such information. This educational period allows
professionals to actively participate in the program while avoiding
claims denials during the learning curve. It also gives us an
opportunity to make any needed claims processing adjustments before
payments are impacted.
We believe it is preferable to begin implementation using a single
year educational and operations testing period, rather than possibly
further delaying the start-date of the program. We do not expect to
continue this educational and operations testing period beyond the
first year of the AUC program.
We look forward to receiving public comments on all aspects of our
proposal, and specifically, comments related to whether the program
should be delayed beyond the proposed start date of January 1, 2019.
Although our proposal is based in part on comments received in prior
rulemaking cycles, it is important to receive comments that help us
understand the current readiness of stakeholders. In addition, we have
proposed that the program begin with an educational and operations
testing period and are interested in comments regarding how long, if
longer than one year, such a period should be available.
We expect a voluntary reporting period to be available ahead of
January 1, 2019 and anticipate such a period will begin July 2018. The
timing for this opportunity for voluntary reporting is dependent on the
readiness of the Medicare claims system to accept and process claims
that include AUC consultation information. When the voluntary period
becomes available we will make announcements through our educational
channels such as the CMS Web site and listservs. It is important to
note that the proposed educational and operations testing period
beginning January 1, 2019, is separate from the anticipated voluntary
reporting period that we expect to allow before January 1, 2019. During
the voluntary reporting period, AUC consultation and reporting are not
required. However, for applicable imaging services ordered on and after
January 1, 2019, consulting specified applicable AUC and reporting
consultation information on the
[[Page 34095]]
Medicare claim would be required for all ordering and furnishing
professionals, respectively.
b. Alignment With Other Medicare Quality Programs
The CY 2017 Merit-based Incentive Payment System and Alternative
Payment Model final rule with comment period (Quality Payment Program
final rule) (81 FR 77008) finalized policies to improve physician and
other clinician payments by changing the way Medicare incorporates
quality measurement into payments and developing new policies to
address and incentivize participation in Advanced Alternative Payment
Models (APMs). We expect the Quality Payment Program to evolve over
multiple years and to continue iterating on these policies. To this
end, the AUC program has the potential to provide new opportunities to
improve care delivery by supporting and rewarding clinicians as they
find new ways to engage patients, families and caregivers as well as
improving care coordination and patient health management.
Therefore, we have proposed in the CY 2018 Quality Payment Program
proposed rule to develop a direct tie between MIPS and the AUC program
(See CY 2018 Quality Payment Program Proposed Rule (82 FR 30010)
published in the June 30, 2017 Federal Register). In that rule, we
proposed to give MIPS credit to ordering professionals for consulting
AUC using a qualified CDSM as a high-weight improvement activity for
the performance period beginning January 1, 2018 (82 FR 30484). We
believe this will incentivize early use of qualified CDSMs to consult
AUC by motivated eligible clinicians looking to improve patient care
and to better prepare themselves for the AUC program. Although the AUC
program would not officially begin until January 1, 2019, we are able
to support this proposed improvement activity because the first
qualified CDSMs will be announced in conjunction with this proposed
rule; therefore, ordering professionals will be able to begin
consulting AUC using those tools.
We are also considering how the AUC program could serve to support
a quality measure under the MIPS quality performance category and seek
feedback from the public regarding feasibility and value of pursuing
this idea further.
c. Significant Hardship Exceptions to Consulting and Reporting
Requirements
We are proposing to modify Sec. 414.94(i)(3) of our regulations to
reflect the sunsetting of the payment adjustments under the Medicare
EHR Incentive Program and to substitute an alignment with the advancing
care information performance category of MIPS. The categories that we
included in the CY 2017 PFS final rule for purposes of the AUC program
significant hardship exceptions were the following from Sec.
495.102(d)(4):
Insufficient Internet Connectivity (as specified in Sec.
495.102(d)(4)(i)).
Practicing for less than 2 years (as specified in Sec.
495.102(d)(4)(ii)).
Extreme and Uncontrollable Circumstances (as specified in
Sec. 495.102(d)(4)(iii)).
Lack of Control over the Availability of CEHRT (as
specified in Sec. 495.102(d)(4)(iv)(A)).
Lack of Face-to-Face Patient Interaction (as specified in
Sec. 495.102(d)(4)(iv)(B)).
In addition, in the CY 2017 Quality Payment Program final rule, we
finalized a policy (81 FR 77240-77243) to reweight the advancing care
information performance category to zero in the MIPS final score for
the year for MIPS eligible clinicians who meet the criteria in one of
the above listed categories of Sec. 495.102(d)(4), with the exception
of the category for clinicians practicing for less than 2 years. Under
section 1848(q)(1)(C)(v) of the Act, eligible clinicians who first
enroll in Medicare during the performance period for a year and have
not previously submitted claims under Medicare are not considered MIPS
eligible clinicians, and thus are excluded from MIPS. We believe it is
likely that many clinicians who have been practicing for less than 2
years would be excluded from MIPS on the basis that they are new
Medicare-enrolled MIPS eligible clinicians as defined in Sec.
414.1305. Because these clinicians are not MIPS eligible clinicians,
they would never meet the criteria for re-weighting of their MIPS
advancing care information performance category for the year.
Therefore, to implement a hardship exception for purposes of the AUC
program that is both operationally consistent and administratively
efficient, we propose to remove as a criterion for a significant
hardship exception for the AUC program the criterion specified in Sec.
495.102(d)(4)(ii) of our regulations for those practicing for less than
2 years. We propose to keep the remaining listed categories including
insufficient internet connectivity, extreme and uncontrollable
circumstances, lack of control over availability of CEHRT and lack of
face-to-face patient interaction. We note that section
1843(q)(4)(C)(iii) of the Act only allows the ordering professional to
seek a significant hardship exception, not the furnishing professional.
As such, we propose to amend the AUC significant hardship exception
regulation to specify that ordering professionals who are granted re-
weighting of the advancing care information performance category to
zero percent of the final score for the year under MIPS per Sec.
414.1380(c)(2) due to circumstances that include the criteria listed in
Sec. 495.102(d)(4)(i), (iii), (iv)(A) and (iv)(B) would be excepted
from the AUC consultation requirement during the same year that the re-
weighting applies for purposes of the MIPS payment adjustment.
There will be scenarios when a clinician's experience of a
significant hardship or extraordinary circumstance does not align with
the prospective identification of these ordering professionals with
reference to MIPS criteria and processes. However, we believe the
prospective identification process allows us to apply exceptions in
real-time for claims submitted for advanced imaging services. There are
timing differences between the MIPS and the AUC program (the MIPS
payment adjustment year is based on performance in a prior year while
the Medicare AUC program requires real-time AUC consultation and
claims-based reporting). In addition to the timing, there will be
instances when a clinician who is not a MIPS eligible clinician will
need to seek a significant hardship exception to the Medicare AUC
program. To accommodate these two separate scenarios, we propose to
establish a process to identify ordering professionals in need of a
significant hardship exception to the Medicare AUC program requirements
that is outside the MIPS re-weighting process. For purposes of these
scenarios, we propose to use the criteria for clinicians seeking an AUC
significant hardship exception described under Sec. 495.102(d)(4) to
include (i), (iii), (iv)(A) and (iv)(B) of our regulations. We propose
these criteria to align with the criteria used under MIPS for re-
weighting under the advancing care information performance category,
and to provide predictability and consistency to the determination of
significant hardship. We further propose that a significant hardship
exception from the Medicare AUC program requirements would be granted
for no longer than 12 months, and that we could establish an exception
for a shorter period where warranted by the circumstances.
Therefore we propose that ordering professionals who have not
received a re-weighting to zero for the MIPS
[[Page 34096]]
advancing care information performance category for the year, but
experience one of the circumstances described in Sec. 495.102(d)(4) to
include (i), (iii), (iv)(A) and (iv)(B), may be granted an AUC
significant hardship exception for no longer than one year. We expect
to provide further information on this execption process in future
rulemaking.
In addition to the proposals above, we invite the public to comment
on additional circumstances for which it may be appropriate for an
ordering professional to be granted a significant hardship exception
under the AUC program.
5. Summary
Section 1834(q) of the Act includes rapid timelines for
establishing a Medicare AUC program for advanced diagnostic imaging
services. The impact of this program is extensive as it will apply to
every physician or other practitioner who orders or furnishes advanced
diagnostic imaging services (for example, magnetic resonance imaging
(MRI), computer tomography (CT) or positron emission tomography (PET)).
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. Stakeholders have expressed concern that program
requirements may inadvertently encourage physicians to order imaging
services that they do not believe are right for their patients. The
goal of evidence-based AUC is to assist clinicians in ordering the most
appropriate imaging service for their patients' specific clinical
scenarios. However, to ensure we are implementing the program
effectively, we are asking for public comment on such potential
unintended consequences. Additionally, as we continue to develop the
AUC program, we continue to engage a variety of stakeholders interested
in participating in the development of AUC. We seek comment about how
we can continue to engage interested participants, consistent with
statutory requirements at section 1834(q) of the Act, in developing AUC
in a transparent and scientifically robust manner. We are particularly
interested in how qualified PLEs develop or modify AUC in collaboration
with non-PLE entities and what additional challenges such entities
might face.
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 propose to continue a stepwise
approach, adopted through notice and comment rulemaking. We propose
policies to implement the third component of the AUC program--the
consulting and reporting requirements and the effective date on which
these requirements would begin. Under this proposal, ordering
professionals must begin consulting specified applicable AUC through
qualified CDSMs for applicable imaging services ordered on and after
January 1, 2019, and furnishing professionals must begin reporting AUC
consultation information on Medicare claims for advanced diagnostic
imaging services for which payment is made under an applicable payment
system as defined in Sec. 414.94(b) and ordered on or after January 1,
2019.
We also propose modifications to the significant hardship exception
to better align these exceptions under the AUC program with those under
existing quality programs.
In summary, we are proposing requirements necessary to implement
the third component of the AUC program. We invite the public to submit
comments on these proposals.
F. Physician Quality Reporting System (PQRS) Criteria for Satisfactory
Reporting for Individual EPs and Group Practices for the 2018 PQRS
Payment Adjustment
1. Background
Section 1848(a)(8) of the Act provides that for covered
professional services furnished by an EP during each of 2015 through
2018, if the EP does not satisfactorily report data on quality measures
for covered professional services for the reporting period for the
year, the PFS amount for services furnished by such professional during
the year (including the PFS amount for purposes of determining a
payment based on such amount) shall be equal to the applicable percent
of the PFS amount that would otherwise apply to such services. For 2016
through 2018, the applicable percent is 98.0 percent. Thus, individual
EPs and group practices who did not satisfactorily report data on
quality measures for the CY 2016 reporting period are subject to a
downward payment adjustment of 2.0 percent to the PFS payment amount
for covered professional services they furnish in 2018.
2. Previously Finalized Satisfactory Reporting Criteria for Individual
EPs and Group Practices for the 2018 PQRS Payment Adjustment
We previously finalized the satisfactory reporting criteria for
individual EPs and group practices for the CY 2016 reporting period to
avoid the 2018 PQRS payment adjustment in the CY 2016 PFS final rule
(80 FR 71140 through 71250) at Sec. 414.90(j)(8) and (9) and Sec.
414.90(k)(5).
Table 18 summarizes the previously finalized satisfactory reporting
criteria for individual EPs at Sec. 414.90(j)(8) and Sec.
414.90(k)(5).
[[Page 34097]]
Table 18--Summary of Requirements for the 2018 PQRS Payment Adjustment: Individual Reporting Criteria for the
Satisfactory Reporting of Quality Measures Data via Claims, Qualified Registry, and Electronic Health Records
(EHRs) and Satisfactory Participation Criteria in Qualified Clinical Data Registries (QCDRs)
----------------------------------------------------------------------------------------------------------------
Satisfactory reporting/
Reporting period Measure type Reporting mechanism satisfactory participation
criteria
----------------------------------------------------------------------------------------------------------------
12-month (Jan 1-Dec 31, 2016)...... Individual Measures... Claims................ Report at least 9 measures,
covering at least 3 of the
National Quality Strategy
(NQS) domains AND report
each measure for at least
50 percent of the EP's
Medicare Part B Fee-for-
Service (FFS) patients
seen during the reporting
period to which the
measure applies. Of the
measures reported, if the
EP sees at least 1
Medicare patient in a face-
to-face encounter, the EP
will report on at least 1
measure contained in the
PQRS cross-cutting measure
set. If less than 9
measures apply to the EP,
the EP would report on
each measure that is
applicable), AND report
each measure for at least
50 percent of the Medicare
Part B FFS patients seen
during the reporting
period to which the
measure applies. Measures
with a 0 percent
performance rate would not
be counted.
12-month (Jan 1-Dec 31, 2016)...... Individual Measures... Qualified Registry.... Report at least 9 measures,
covering at least 3 of the
NQS domains AND report
each measure for at least
50 percent of the EP's
Medicare Part B FFS
patients seen during the
reporting period to which
the measure applies. Of
the measures reported, if
the EP sees at least 1
Medicare patient in a face-
to-face encounter, the EP
will report on at least 1
measure contained in the
PQRS cross-cutting measure
set. If less than 9
measures apply to the EP,
the EP would report on
each measure that is
applicable, AND report
each measure for at least
50 percent of the Medicare
Part B FFS patients seen
during the reporting
period to which the
measure applies. Measures
with a 0 percent
performance rate would not
be counted.
12-month (Jan 1-Dec 31, 2016)...... Individual Measures... Direct EHR Product or Report 9 measures covering
EHR Data Submission at least 3 of the NQS
Vendor Product. domains. If an EP's direct
EHR product or EHR data
submission vendor product
does not contain patient
data for at least 9
measures covering at least
3 domains, then the EP
would be required to
report all of the measures
for which there is
Medicare patient data. An
EP would be required to
report on at least 1
measure for which there is
Medicare patient data.
12-month (Jan 1-Dec 31, 2016)...... Measures Groups....... Qualified Registry.... Report at least 1 measures
group AND report each
measures group for at
least 20 patients, the
majority (11 patients) of
which are required to be
Medicare Part B FFS
patients. Measures groups
containing a measure with
a 0 percent performance
rate will not be counted.
12-month (Jan 1-Dec 31, 2016)...... Individual PQRS QCDR.................. Report at least 9 measures
measures and/or non- available for reporting
PQRS measures under a QCDR covering at
reportable via a QCDR. least 3 of the NQS
domains, AND report each
measure for at least 50
percent of the EP's
patients. Of these
measures, the EP would
report on at least 2
outcome measures, OR, if 2
outcomes measures are not
available, report on at
least 1 outcome measures
and at least 1 of the
following types of
measures--resource use,
patient experience of
care, efficiency/
appropriate use, or
patient safety.
----------------------------------------------------------------------------------------------------------------
Table 19 summarizes the previously finalized satisfactory reporting
criteria for group practices via the group practice reporting option
(GPRO) at Sec. 414.90(j)(9) and Sec. 414.90(k)(5).
[[Page 34098]]
Table 19--Summary of Requirements for the 2018 PQRS Payment Adjustment: Group Practice Reporting Criteria for
Satisfactory Reporting of Quality Measures Data via the GPRO
----------------------------------------------------------------------------------------------------------------
Group practice Reporting Satisfactory reporting
Reporting period size Measure type mechanism criteria
----------------------------------------------------------------------------------------------------------------
12-month (Jan 1-Dec 1, 2016)... 25-99 EPs; 100+ Individual GPRO Web Interface.... Report on all measures
EPs (if Consumer Measures in the included in the web
Assessment of Web Interface. interface; AND
Healthcare populate data fields
Providers and for the first 248
Systems (CAHPS) consecutively ranked
for PQRS does and assigned
not apply). beneficiaries in the
order in which they
appear in the group's
sample for each
module or preventive
care measure. If the
pool of eligible
assigned
beneficiaries is less
than 248, then the
group practice must
report on 100 percent
of assigned
beneficiaries. In
other words, we
understand that, in
some instances, the
sampling methodology
we provide will not
be able to assign at
least 248 patients on
which a group
practice may report,
particularly those
group practices on
the smaller end of
the range of 25-99
EPs. If the group
practice is assigned
less than 248
Medicare
beneficiaries, then
the group practice
must report on 100
percent of its
assigned
beneficiaries. A
group practice must
report on at least 1
measure for which
there is Medicare
patient data.
12-month (Jan 1-Dec 31, 2016).. 25-99 EPs that Individual GPRO Web Interface + The group practice
elect CAHPS for Measures in the CMS-Certified must have all CAHPS
PQRS; 100+ EPs Web Interface + Survey Vendor. for PQRS survey
(if CAHPS for CAHPS for PQRS. measures reported on
PQRS applies). its behalf via a CMS-
certified survey
vendor. In addition,
the group practice
must report on all
measures included in
the Web Interface;
AND populate data
fields for the first
248 consecutively
ranked and assigned
beneficiaries in the
order in which they
appear in the group's
sample for each
module or preventive
care measure. If the
pool of eligible
assigned
beneficiaries is less
than 248, then the
group practice must
report on 100 percent
of assigned
beneficiaries. A
group practice will
be required to report
on at least 1 measure
for which there is
Medicare patient
data.
Please note that, if
the CAHPS for PQRS
survey is applicable
to a group practice
who reports quality
measures via the Web
Interface, the group
practice must
administer the CAHPS
for PQRS survey in
addition to reporting
the Web Interface
measures.
12-month (Jan 1-Dec 31, 2016).. 2-99 EPs; 100+ Individual Qualified Report at least 9
EPs (if CAHPS Measures. Registry. measures, covering at
for PQRS does least 3 of the NQS
not apply). domains. Of these
measures, if a group
practice sees at
least 1 Medicare
patient in a face-to-
face encounter, the
group practice would
report on at least 1
measure in the PQRS
cross-cutting measure
set. If less than 9
measures covering at
least 3 NQS domains
apply to the group
practice, the group
practice would report
on each measure that
is applicable to the
group practice, AND
report each measure
for at least 50
percent of the
group's Medicare Part
B FFS patients seen
during the reporting
period to which the
measure applies.
Measures with a 0
percent performance
rate would not be
counted.
12-month (Jan 1-Dec 31, 2016).. 2-99 EPs that Individual Qualified The group practice
elect CAHPS for Measures + CAHPS Registry + CMS- must have all CAHPS
PQRS; 100+ EPs for PQRS. Certified Survey for PQRS survey
(if CAHPS for Vendor. measures reported on
PQRS applies). its behalf via a CMS-
certified survey
vendor, and report at
least 6 additional
measures, outside of
the CAHPS for PQRS
survey, covering at
least 2 of the NQS
domains using the
qualified registry.
If less than 6
measures apply to the
group practice, the
group practice must
report on each
measure that is
applicable to the
group practice. Of
the additional
measures that must be
reported in
conjunction with
reporting the CAHPS
for PQRS survey
measures, if any EP
in the group practice
sees at least 1
Medicare patient in a
face-to-face
encounter, the group
practice must report
on at least 1 measure
in the PQRS cross-
cutting measure set.
12-month (Jan 1-Dec 31, 2016).. 2-99 EPs; 100+ Individual Direct EHR Report 9 measures
EPs (if CAHPS Measures. Product or EHR covering at least 3
for PQRS does Data Submission domains. If the group
not apply). Vendor Product. practice's direct EHR
product or EHR data
submission vendor
product does not
contain patient data
for at least 9
measures covering at
least 3 domains, then
the group practice
must report all of
the measures for
which there is
Medicare patient
data. A group
practice must report
on at least 1 measure
for which there is
Medicare patient
data.
[[Page 34099]]
12-month (Jan 1-Dec 31, 2016).. 2-99 EPs that Individual Direct EHR The group practice
elect CAHPS for Measures + CAHPS Product or EHR must have all CAHPS
PQRS; 100+ EPs for PQRS. Data Submission for PQRS survey
(if CAHPS for Vendor Product + measures reported on
PQRS applies). CMS-Certified its behalf via a CMS-
Survey Vendor. certified survey
vendor, and report at
least 6 additional
measures, outside of
CAHPS for PQRS,
covering at least 2
of the NQS domains
using the direct EHR
product or EHR data
submission vendor
product. If less than
6 measures apply to
the group practice,
the group practice
must report all of
the measures for
which there is
Medicare patient
data. Of the
additional 6 measures
that must be reported
in conjunction with
reporting the CAHPS
for PQRS survey
measures, a group
practice would be
required to report on
at least 1 measure
for which there is
Medicare patient
data.
12-month (Jan 1-Dec 31, 2016).. 2+ EPs........... Individual PQRS QCDR............. Report at least 9
measures and/or measures available
non-PQRS for reporting under a
measures QCDR covering at
reportable via a least 3 of the NQS
QCDR. domains, AND report
each measure for at
least 50 percent of
the group practice's
patients. Of these
measures, the group
practice would report
on at least 2 outcome
measures, OR, if 2
outcomes measures are
not available, report
on at least 1 outcome
measures and at least
1 of the following
types of measures--
resource use, patient
experience of care,
efficiency/
appropriate use, or
patient safety.
----------------------------------------------------------------------------------------------------------------
3. Proposed Modifications to the Satisfactory Reporting Criteria for
Individual EPs and Group Practices for the 2018 PQRS Payment Adjustment
Since we finalized these requirements, we have heard from
stakeholders that EPs have had difficulty with the previously finalized
satisfactory reporting criteria for the CY 2016 reporting period, which
is the final reporting period for the PQRS. Specifically, we have heard
from stakeholders through written communications to CMS that EPs have
found the requirements complex, and had difficulty in understanding the
requirements to be a satisfactory reporter for PQRS. Stakeholders have
also requested that the requirements for the CY 2016 reporting period
be aligned with those of the Quality Payment Program, specifically the
Merit-based Incentive Payment System (MIPS). In particular, we have
heard requests to lower the previously finalized requirement from 9
measures across 3 NQS domains, where applicable, to only 6 measures
with no domain requirement associated with these measures. While the
PQRS and the MIPS are separate programs, we understand that
stakeholders would like to see greater continuity between the final
year of the PQRS and the beginning of the MIPS.
The final reporting period for the PQRS was CY 2016. The Quality
Payment Program, authorized by the Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA), consolidates and replaces three
existing programs (the Medicare EHR Incentive Program for EPs, the
PQRS, and the Value-Based Payment Modifier (VM)). There are two ways
eligible clinicians can participate in this program: (1) Through the
MIPS; and (2) through Advanced Alternative Payment Models (APMs). The
initial performance period for the MIPS began on January 1, 2017. Under
MIPS, there are four connected pillars that affect how MIPS eligible
clinicians will be paid by Medicare: Quality; Improvement Activities;
Advancing Care Information; and Cost. For more information on the
Quality Payment Program, see https://qpp.cms.gov/.
While we understand that the data submission period for the CY 2016
reporting period has already ended and that all data that has been
submitted to CMS is based on the previously finalized satisfactory
reporting criteria for the CY 2016 reporting period, we are revisiting
our previously finalized policy because we want individual EPs and
groups to be assessed for purposes of the 2018 PQRS payment adjustment
based on satisfactory reporting criteria that are simpler, more
understandable, and more consistent with the beginning of MIPS. We
believe that such criteria will help clinicians more accurately gauge
their readiness for the beginning of MIPS and transition into the
Quality Payment Program successfully. Additionally, we want to be
responsive to the concerns of the clinician community. Therefore, while
we are not proposing to collect any additional data for the CY 2016
reporting period, we are proposing to modify the criteria we would
apply to the data already submitted for the CY 2016 reporting period to
determine whether an individual EP or group practice has satisfactorily
reported for purposes of avoiding the 2018 PQRS payment adjustment.
Specifically, we are proposing to revise the previously finalized
satisfactory reporting criteria for the CY 2016 reporting period to
lower the requirement from 9 measures across 3 NQS domains, where
applicable, to only 6 measures with no domain or cross-cutting measure
requirement. For individual EPs, this would apply to the following
reporting mechanisms: claims, qualified registry (except for measures
groups), QCDR, direct EHR product and EHR data submissions vendor
product. This proposal would not affect the criteria used to determine
whether an individual EP or group practice has satisfactorily reported
for purposes of avoiding the 2017 PQRS payment adjustment, with the
exception of the criteria applicable to individual EPs and group
practices reporting using the secondary reporting period established
under Sec. 414.90(j)(1)(ii) for the 2017 PQRS payment adjustment
(hereinafter referred to as the ``ACO Secondary Reporting Period''), as
discussed in section III.F.4. of this proposed rule.
Table 20 summarizes our proposed modifications to the previously
finalized satisfactory reporting criteria for individual EPs to avoid
the 2018
[[Page 34100]]
PQRS payment adjustment, based on data previously submitted for the CY
2016 reporting period. We are not proposing to collect any additional
data for the CY 2016 reporting period, as the data submission period
for the CY 2016 reporting period has already ended. As summarized in
Table 20, the NQS domain requirement would no longer apply. No changes
are being proposed for the measures groups criteria.
Additionally, we are also proposing that individual EPs and group
practices reporting via claims or qualified registry, as applicable,
would no longer be required to report a cross-cutting measure and that
individual EPs and group practices reporting via QCDR would no longer
be required to report an outcome or ``high priority'' measure (that is,
for purposes of PQRS, a resource use, patient experience of care,
efficiency/appropriate use, or patient safety measure). We note that
what is considered to be a ``high-priority'' measure in PQRS is
different from what is considered a ``high-priority'' measure in MIPS,
and we are not proposing to align this requirement with MIPS for the
last year of PQRS as this could cause confusion. While certain MIPS
eligible clinicians are required to report at least one outcome or
other high-priority measure (see Sec. 414.1335(a)(1)(i)), we are also
not aligning with that requirement because, while we agree that outcome
and high-priority measures are valuable for reporting, we want to
revise the satisfactory reporting criteria for the last year of PQRS to
be less complex for individual EPs and groups to understand.
Lastly, where we are proposing to lower the requirement to only 6
measures, if less than 6 measures apply to the individual EP or group
practice, each measure that is applicable would need to have been
reported. We define ``applicable'' to mean measures relevant to a
particular individual EP's or group practice's services or care
rendered. As previously finalized, individual EPs and group practices
would continue to be subject to the measure application validity (MAV)
process (80 FR 71140 through 71145). The MAV process seeks to identify
clinically similar measures and creates clusters of measures that can
be reported if one of the measures in the cluster is reported. We would
maintain the requirement that each required measure be reported for at
least 50 percent of the individual EP's or group practice's patients to
which the measure applies.
Table 20--Summary of Proposed Modifications to the Requirements for the 2018 PQRS Payment Adjustment: Individual
Reporting Criteria for the Satisfactory Reporting of Quality Measures Data via Claims, Qualified Registry, and
EHRs and Satisfactory Participation Criterion in QCDRs
----------------------------------------------------------------------------------------------------------------
Proposed satisfactory
Reporting period Measure type Reporting mechanism reporting criteria
----------------------------------------------------------------------------------------------------------------
12-month (Jan 1-................... Individual Measures... Claims................ Report at least 6 measures,
Dec 31, 2016)...................... AND report each measure
for at least 50 percent of
the EP's Medicare Part B
FFS patients seen during
the reporting period to
which the measure applies.
If less than 6 measures
apply to the EP, the EP
must report on each
measure that is
applicable, AND report
each measure for at least
50 percent of the Medicare
Part B FFS patients seen
during the reporting
period to which the
measure applies. Measures
with a 0 percent
performance rate will not
be counted (unless they
are inverse measures where
a lower rate reflects
better performance).
12-month (Jan 1-................... Individual Measures... Qualified Registry.... Report at least 6 measures,
Dec 31, 2016)...................... AND report each measure
for at least 50 percent of
the EP's Medicare Part B
FFS patients seen during
the reporting period to
which the measure applies.
If less than 6 measures
apply to the EP, the EP
must report on each
measure that is
applicable, AND report
each measure for at least
50 percent of the Medicare
Part B FFS patients seen
during the reporting
period to which the
measure applies. Measures
with a 0 percent
performance rate will not
be counted (unless they
are inverse measures where
a lower rate reflects
better performance).
12-month (Jan 1-................... Individual Measures... Direct EHR Product or Report at least 6 measures.
Dec 31, 2016)...................... EHR Data Submission If an EP's direct EHR
Vendor Product. product or EHR data
submission vendor product
does not contain patient
data for at least 6
measures, then the EP must
report all of the measures
for which there is
Medicare patient data. An
EP must report on at least
1 measure for which there
is Medicare patient data.
12-month (Jan 1-................... Measures Groups....... Qualified Registry.... No proposed changes.
Dec 31, 2016)......................
12-month (Jan 1-................... Individual............ QCDR.................. Report at least 6 measures
Dec 31, 2016)...................... PQRS measures and/or available for reporting
non-PQRS measures under a QCDR AND report
reportable via a QCDR. each measure for at least
50 percent of the EP's
patients seen during the
reporting period to which
the measure applies. If
less than 6 measures apply
to the EP, the EP must
report on each measure
that is applicable, AND
report each measure for at
least 50 percent of the
EP's patients.
----------------------------------------------------------------------------------------------------------------
[[Page 34101]]
Accordingly, we are proposing to revise Sec. 414.90(j)(8) and
(k)(5) consistent with our proposals above. We believe these proposals
will result in fewer individual EPs being subject to the 2018 PQRS
payment adjustment, and will impose no additional burden on individual
EPs because this data has already been submitted to CMS. We request
comment on these proposals.
As discussed above, while we are not proposing to collect any
additional data for the CY 2016 reporting period, we are proposing to
modify the satisfactory reporting criteria for the CY 2016 reporting
period for purposes of the 2018 PQRS payment adjustment. Specifically,
we are proposing to lower the requirement from 9 measures across 3 NQS
domains, where applicable, to only 6 measures with no domain or cross-
cutting measure requirement. For group practices, this would apply to
the following reporting mechanisms: Qualified registry; QCDR; direct
EHR product; and EHR data submissions vendor product. This proposal
would not affect the criteria used to determine whether an individual
EP or group practice has satisfactorily reported for purposes of
avoiding the 2017 PQRS payment adjustment, with the exception of the
criteria applicable to individual EPs and group practices reporting
using the ACO Secondary Reporting Period, as discussed in section
III.F.4. of this proposed rule.
Table 21 summarizes our proposed modifications to the previously
finalized satisfactory reporting criteria for group practices to avoid
the 2018 PQRS payment adjustment, based on data previously submitted
for the CY 2016 reporting period. We are not proposing to collect any
additional data for the CY 2016 reporting period, as the data
submission period for the CY 2016 reporting period has already ended.
As summarized in Table 21, the NQS domain requirement would no longer
apply. No changes are being proposed for the Web Interface criteria.
Additionally, as discussed above, we are proposing that individual
EPs and group practices reporting via claims and qualified registry, as
applicable, would no longer be required to report a cross-cutting
measure and that individual EPs and group practices reporting via QCDR
would no longer be required to report an outcome or high priority
measure. We note that what is considered to be a ``high-priority''
measure in PQRS is different from what is considered a ``high-
priority'' measure in MIPS, and are not proposing to align this
requirement with MIPS for the last year of PQRS as this could cause
confusion. While certain MIPS eligible clinicians are required to
report at least one outcome or other high-priority measure (see Sec.
414.1335(a)(1)(i)), we are also not aligning with that requirement
because, while we agree that outcome and high-priority measures are
valuable for reporting, we want to revise the satisfactory reporting
criteria for the last year of PQRS to be less complex for individual
EPs and groups.
Where we are proposing to lower the requirement to only 6 measures,
if less than 6 measures apply to the individual EP or group practice,
each measure that is applicable would need to have been reported. We
define ``applicable'' to mean measures relevant to a particular
individual EP's or group practice's services or care rendered. As
previously finalized, individual EPs and group practices would continue
to be subject to the MAV process (80 FR 71140 through 71145). The MAV
process seeks to identify clinically similar measures and creates
clusters of measures that can be reported if one of the measures in the
cluster is reported. We would maintain the requirement that each
required measure be reported for at least 50 percent of the individual
EP's or group practice's patients to which the measure applies.
Lastly, for purposes of the 2018 PQRS payment adjustment, Sec.
414.90(j)(9)(viii) currently provides that if the CAHPS for PQRS survey
is applicable to the practice, group practices comprised of 100 or more
eligible professionals that register to participate in the GPRO must
administer the CAHPS for PQRS survey, regardless of the GPRO reporting
mechanism selected. For the reasons discussed above, we are proposing
to revise Sec. 414.90(j)(9)(viii) to provide that such group practices
may administer the CAHPS for PQRS survey, regardless of the GPRO
reporting mechanism selected, but are not required to do so. This
change would be consistent with the data submission criteria for the
MIPS quality performance category, under which groups may voluntarily
elect to participate in the CAHPS for MIPS survey (see Sec.
414.1335(a)(3)(i)). As summarized in Table 21, the previously finalized
satisfactory reporting criteria for group practices administering the
CAHPS for PQRS survey would continue to apply to group practices that
elected to administer the survey.
Table 21--Summary of Proposed Modifications to the Requirements for the 2018 PQRS Payment Adjustment: Group
Practice Reporting Criteria for Satisfactory Reporting of Quality Measures Data via the GPRO
----------------------------------------------------------------------------------------------------------------
Group practice Reporting Proposed satisfactory
Reporting period size \3\ Measure type mechanism reporting criteria
----------------------------------------------------------------------------------------------------------------
12-month (Jan 1-Dec 31,2016)... 25+ EPs.......... Individual GPRO Web Interface.... No proposed changes.
Measures in the
Web Interface.
12-month (Jan 1-Dec 31,2016)... 25+ EPs that Individual GPRO Web Interface + No proposed changes.
elect CAHPS for Measures in the CMS-Certified
PQRS. Web Interface+ Survey Vendor..
CAHPS for PQRS.
12-month (Jan 1-Dec 31,2016)... 2+ EPs........... Individual Qualified Report at least 6
Measures. Registry. measures AND report
each measure for at
least 50 percent of
the group's Medicare
Part B FFS patients
seen during the
reporting period to
which the measure
applies. If less than
6 measures apply to
the group, the group
practice must report
on each measure that
is applicable, AND
report each measure
for at least 50
percent of the
Medicare Part B FFS
patients seen during
the reporting period
to which the measure
applies. Measures
with a 0 percent
performance rate will
not be counted
(unless they are
inverse measures
where a lower rate
reflects better
performance).
[[Page 34102]]
12-month (Jan 1-Dec 31,2016)... 2+ EPs that elect Individual Qualified The group practice
CAHPS for PQRS. Measures+CAHPS Registry+CMS- must have all CAHPS
for PQRS. Certified Survey for PQRS survey
Vendor. measures reported on
its behalf via a CMS-
certified survey
vendor. In addition,
the group practice
must report at least
3 additional measures
using the qualified
registry AND report
each measure for at
least 50 percent of
the group's Medicare
Part B FFS patients
seen during the
reporting period to
which the measure
applies. If less than
3 measures apply to
the group practice,
the group practice
must report on each
measure that is
applicable, AND
report each measure
for at least 50
percent of the
Medicare Part B FFS
patients seen during
the reporting period
to which the measure
applies. Measures
with a 0 percent
performance rate will
not be counted
(unless they are
inverse measures
where a lower rate
reflects better
performance).
12-month (Jan 1-Dec 31,2016)... 2+ EPs........... Individual Direct EHR Report 6 measures. If
Measures. Product or EHR the group practice's
Data Submission direct EHR product or
Vendor Product. EHR data submission
vendor product does
not contain patient
data for at least 6
measures, then the
group practice must
report all of the
measures for which
there is Medicare
patient data. A group
practice must report
on at least 1 measure
for which there is
Medicare patient
data.
12-month (Jan 1-Dec 31,2016)... 2+ EPs that elect Individual Direct EHR The group practice
CAHPS for PQRS. Measures+CAHPS Productor EHR must have all CAHPS
for PQRS. Data Submission for PQRS survey
Vendor measures reported on
Product+CMS- its behalf via a CMS-
Certified Survey certified survey
Vendor. vendor. In addition,
the group practice
must report at least
3 additional measures
using the direct EHR
product or EHR data
submission vendor
product. If less than
3 measures apply to
the group practice,
the group practice
must report all of
the measures for
which there is
patient data. Of the
additional 3 measures
that must be reported
in conjunction with
reporting the CAHPS
for PQRS survey
measures, a group
practice must report
on at least 1 measure
for which there is
Medicare patient
data.
12-month (Jan 1-Dec 31,2016)... 2+ EPs........... Individual PQRS QCDR............. Report at least 6
measures and/or measures available
non-PQRS for reporting under a
measures QCDR AND report each
reportable via a measure for at least
QCDR. 50 percent of the
group practice's
patients seen during
the reporting period
to which the measure
applies. If less than
6 measures apply to
the group practice,
the group practice
must report on each
measure that is
applicable, AND
report each measure
for at least 50
percent of the group
practice's patients.
----------------------------------------------------------------------------------------------------------------
\3\ Please note that the group practice size descriptions have been revised for greater consistency with our
proposal to make the CAHPS for PQRS survey voluntary.
Accordingly, we are proposing to revise Sec. 414.90(j)(9) and
(k)(5) consistent with our proposals above. We believe these proposals
will result in fewer group practices being subject to the 2018 PQRS
payment adjustment, and will impose no additional burden on group
practices because this data has already been submitted to CMS. We
request comment on these proposals.
4. Accountable Care Organization (ACO) Participants Who Report PQRS
Quality Measures Separately During the Secondary Reporting Period
As discussed in the CY 2017 PFS final rule (81 FR 80441 through
80445), individual EPs and group practices who bill under the TIN of an
ACO participant may report separately from the ACO, if the ACO failed
to report on behalf of such individual EPs or group practices for the
applicable reporting period, during the CY 2016 reporting period for
purposes of the 2017 and 2018 PQRS payment adjustments, as applicable.
Please note that, in accordance with our previously established
policies for the ACO Secondary Reporting Period, our proposed
modifications to the satisfactory reporting criteria for individual EPs
and group practices for the CY 2016 reporting period would apply to
such individual EPs and group practices for purposes of the 2017 PQRS
payment adjustment. This proposal would not affect the 2017 PQRS
payment adjustment for any other individual EP or group practice.
[[Page 34103]]
5. Physician Compare Downloadable Database--Addition of Value Modifier
(VM) Data
We previously finalized in the CY 2016 PFS final rule (80 FR 71129
through 71130) a decision to publicly report three data points for the
2018 VM based on 2016 data in the Physician Compare downloadable file
in late 2017:
2018 VM quality tiers for cost and quality, based on the
2016 data, noting if the EP or group is high, low, or average on cost
and quality per the VM.
A notation of the payment adjustment received based on the
cost and quality tiers--upward, downward, or neutral--for each EP or
group.
An indication if the EP or group was eligible to but did
not report quality measures to CMS for CY 2016 under PQRS.
In light of the proposals to change the 2016 reporting criteria to
avoid the 2018 payment adjustment for PQRS (see section III.F. of this
proposed rule) and subsequent VM proposed policies to hold all
physician groups and solo practitioners who met minimum quality
reporting requirements harmless from downward payment adjustments for
performance under quality-tiering for the last year of the program (see
section III.I. of this proposed rule), and because the proposed
policies for PQRS and VM in this rule would change the nature of how
the PQRS data will be used under the VM, we are now proposing not to
report this data specific to the VM. Given the fact that VM data would
be available for posting in the Physician Compare downloadable database
for only one year and the VM data may not reflect an EP or group's
actual performance or payment adjustment given they could have chosen
to report fewer measures, we believe that proceeding with the posting
of this data could be confusing for the public.
Additionally, we have created other VM data files intended to
promote transparency. For each VM performance year, we will publish a
Public Use File (PUF) that contains VM performance results of de-
identified practices. Supporting documentation for each PUF that
contains the field name, length, type, label, description, and notes
for each variable included in the PUF. The Value Modifier program years
2015 and 2016 (performance year 2013 and 2014) are currently available
at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/VMPUF/Value-Modifier-PUF.html. In addition, three
Research Identifiable Files (RIFs) for Value Modifier program years
2015 and 2016 (performance year 2013 and 2014) are available through
the Research Data Assistance Center (ResDAC) and will be made available
for each program year. These files include a practice-level, an NPI-
practice level, and a beneficiary-level file, as described at: https://www.resdac.org/news/cms-creates-set-rif-data-files-support-value-based-payment-modifier-program/2017/06.
All other previously finalized policies related to 2016 PQRS data
available for public reporting on Physician Compare in late 2017 remain
unchanged (80 FR 71116 through 71132). Appreciating this, we believe
the best course of action is to not move forward with publicly
reporting this VM data for 2016. All data required to be reported by
law will remain available for public reporting as previously finalized
(80 FR 71116 through 71132). For more information on the public
reporting policies previously finalized and proposed for MIPS, we refer
readers to the 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 77390 through 77399) and Medicare Program; CY 2018
Updates to the Quality Payment Program (82 FR 30163 through 30170),
respectively. We request comment on this proposal and specifically, if
we were to release this data, how it could be used by the public.
G. Clinical Quality Measurement for Eligible Professionals
Participating in the Electronic Health Record (EHR) Incentive Program
for 2016
1. Background
Sections 1848(o), 1853(l) and (m), 1886(n), and 1814(l) of the Act
provide the statutory basis for the Medicare incentive payments made to
eligible professionals (EPs), Medicare Advantage (MA) organizations
(for certain qualifying EPs and hospitals), subsection (d) hospitals,
and critical access hospitals (CAHs) that demonstrate meaningful use of
certified electronic health record (EHR) technology (CEHRT). Sections
1848(a)(7), 1853(l) and (m), 1886(b)(3)(B), and 1814(l) of the Act also
establish downward adjustments to Medicare payments, beginning with
calendar or fiscal year (FY) 2015, for EPs, MA organizations,
subsection (d) hospitals, and CAHs that are not meaningful users of
CEHRT for certain associated reporting periods. Sections 1903(a)(3)(F)
and 1903(t) of the Act provide the statutory basis for the Medicaid
incentive payments made to EPs and eligible hospitals for the adoption,
implementation, upgrade, and meaningful use of CEHRT. We have
implemented these statutory provisions in prior rulemakings to
establish the Medicare and Medicaid EHR Incentive Programs.
Under these statutory provisions and the regulations at 42 CFR
495.4, one of the requirements of being a meaningful EHR user is
successfully reporting the clinical quality measures selected by CMS to
CMS or the states, as applicable, in the form and manner specified by
CMS or the states, as applicable. Section 1848(o)(2)(B)(iii) of the Act
requires that in selecting clinical quality measures (CQMs) for EPs to
report under the EHR Incentive Program, and in establishing the form
and manner of reporting, the Secretary shall seek to avoid redundant or
duplicative reporting otherwise required, including reporting under
section 1848(k)(2)(C) of the Act (the Physician Quality Reporting
System). As such, we have taken steps to establish alignments among
various quality reporting and payment programs that include the
submission of CQMs.
2. Clinical Quality Measure (CQM) Requirements for Meaningful Use in
2016
Under sections 1848(o)(2)(A)(iii) and 1903(t)(6)(C)(i)(II) of the
Act and the definition of ``meaningful EHR user'' at Sec. 495.4, EPs
must report on CQMs selected by CMS using CEHRT, as part of being a
meaningful EHR user under the Medicare and Medicaid EHR Incentive
Programs. In the final rule titled ``Medicare and Medicaid Programs;
Electronic Health Record Incentive Program--Stage 3 and Modifications
to Meaningful Use in 2015 Through 2017,'' we finalized the options for
CQM submission for EPs in the Medicare EHR Incentive Program in 2016 as
follows (80 FR 62888 through 62889):
EP Options for Medicare EHR Incentive Program
Participation (single program Participation--EHR Incentive Program
only):
++ Option 1: Attest to CQMs through the EHR Registration &
Attestation System.
++ Option 2: Electronically report CQMs through Physician Quality
Reporting System (PQRS) Portal.
EP Options for Electronic Reporting for Multiple Programs
(for example: EHR Incentive Program plus PQRS participation):
++ Option 1: Report individual EP's CQMs through PQRS Portal.
++ Option 2: Report group's CQMs through PQRS Portal.
(NOTE: Under option 2, this may include an EP reporting using the
group
[[Page 34104]]
reporting option, either electronically using QRDA, or via the GPRO Web
Interface.)
For the Medicaid EHR Incentive Program, we specified (80 FR 62888)
that states would continue to be responsible for determining whether
and how electronic reporting of CQMs would occur, or if they wish to
allow reporting through attestation. Any changes that states make to
their CQM reporting methods must be submitted through the state
Medicaid Health IT Plan (SMHP) process for our review and approval
prior to being implemented.
We maintained a requirement that EPs report 9 CQMs covering at
least 3 NQS domains (80 FR 62888 through 62889). This requirement was
established in the final rule titled ``Medicare and Medicaid Programs;
Electronic Health Record Incentive Program--Stage 2'' (77 FR 54058).
We also continued (80 FR 62888 through 62889) our existing policy
that under Medicare, healthcare providers in any year of participation
for the EHR Incentive Program for 2015 through 2017 may electronically
report CQM data using the options previously outlined for electronic
reporting either for single program participation in the Medicare EHR
Incentive Program, or for participation in multiple programs if the
requirements of the aligned quality program are also met.
We noted that an EHR certified for CQMs under the 2014 Edition
certification criteria does not need to be recertified each time it is
updated to a more recent version of the eCQMs (80 FR 62889).
3. CQM Requirements for EPs and Groups Under the Medicare EHR Incentive
Program in 2016
As we discussed in section III.F. in this proposed rule, since we
finalized these requirements, we have heard from stakeholders through
written communications that EPs and groups have found the previously
finalized reporting criteria for the CY 2016 reporting period to be
complex and had difficulty in understanding the requirements to be a
satisfactory reporter, and these same EPs and groups subsequently
requested that the CQM reporting requirements for EPs and groups
participating in the Medicare EHR Incentive Program in 2016 who chose
to report CQMs electronically through the Physician Quality Reporting
System (PQRS) Portal be aligned with those of the Quality Payment
Program, specifically the Merit-based Incentive Payment System (MIPS).
Therefore, while we are not proposing to collect any additional
data for 2016, we are proposing to change the reporting criteria for
EPs and groups who chose to electronically report CQMs through the PQRS
Portal for purposes of the Medicare EHR Incentive Program.
Specifically, we are proposing to change the reporting criteria from 9
CQMs covering at least 3 NQS domains to 6 CQMs with no domain
requirement. We are proposing this change so that the reporting
criteria for the Medicare EHR Incentive Program would be in alignment
with the modified requirement that we are proposing for the final PQRS
reporting period (2016) in section III.F. of this proposed rule, as
well as the transition year of the Quality Payment Program. We are
proposing that an EP or group who satisfies the proposed reporting
criteria may qualify for the 2016 incentive payment under section
1848(o) of the Act and may avoid the downward payment adjustment in
2017 and/or 2018 under section 1848(a)(7)(A) of the Act, depending on
the EP or group's applicable EHR reporting period for the payment
adjustment year. This proposed change would help maintain alignment
with PQRS per the requirement under section 1848(o)(2)(B)(iii) of the
Act for the Secretary to seek to avoid redundant or duplicative
reporting otherwise required, including reporting under section
1848(k)(2)(C) of the Act (the PQRS). We are not proposing to change the
previously finalized requirements for CQM reporting in 2016 for
eligible hospitals and CAHs; or the previously finalized requirements
for EPs who chose to report CQMs through attestation in 2016 for the
Medicare EHR Incentive Program (80 FR 62888). Our reasoning for not
proposing to change the eligible hospital or CAH requirements for CQM
reporting is because the changes proposed for PQRS in section III.F. of
this proposed rule and the policies established for the transition year
of the Quality Payment Program would only affect clinicians and groups,
and therefore, there is no reason to propose changes to the established
policy for eligible hospitals or CAHs. We are not proposing to change
the requirements for EPs who reported CQMs through attestation because
those who attested were successful, therefore we believe there is no
need to change the requirement. Additionally, the Registration and
Attestation portal is scheduled to sunset as of October 1, 2017 before
this final rule is published.
Lastly, we are also not proposing to change the previously
finalized requirements for 2016 for EPs participating in the Medicaid
EHR Incentive Program. We have already proposed in ``Medicare Program;
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals
and the Long-Term Care Hospital Prospective Payment System and Proposed
Policy Changes and Fiscal Year 2018 Rates; Quality Reporting
Requirements for Specific Providers; Medicare and Medicaid Electronic
Health Record (EHR) Incentive Program Requirements for Eligible
Hospitals, Critical Access Hospitals, and Eligible Professionals;
Provider-Based Status of Indian Health Service and Tribal Facilities
and Organizations; Costs Reporting and Provider Requirements; Agreement
Termination Notices'' that, for 2017, Medicaid EPs would be required to
report on any six CQMs that are relevant to the EP's scope of practice
(82 FR 20135). In proposing that change, we indicated that it is our
intention to align CQM requirements for Medicaid EPs with requirements
under the Medicare quality improvement programs, to the extent
practicable. However, we believe that due to the timing of when any
changes we might propose for 2016 through this rulemaking would take
effect (if finalized), the benefits of proposing to extend the policy
proposed for Medicare EPs for 2016 to Medicaid EPs for 2016 would not
be realized, and the burden on states to implement such a policy would
be significant. There is no negative payment adjustment for not
participating in the Medicaid EHR Incentive Program, so it is likely
that applying the proposed policy for Medicare EPs to Medicaid EPs for
2016 would benefit Medicaid EPs only if they are able to submit new
data to states for a Medicaid EHR incentive payment for 2016. Because
we anticipate that most states will have completed processing and
paying 2016 Medicaid EHR incentive payments by the time such a proposal
(if finalized) would take effect, we believe that applying this change
to the Medicaid EHR Incentive Program for 2016 would significantly
burden states. We seek comment on our assessment of the difficulty
states might face implementing this policy for 2016 for Medicaid EPs,
and on the number of Medicaid EPs who might benefit if we instead
decided to apply this policy in the Medicaid EHR Incentive Program for
2016, to the extent that doing so would be legally permissible.
H. Medicare Shared Savings Program
Under section 1899 of the Act, we established the Medicare Shared
Savings Program (Shared Savings Program) to facilitate coordination and
[[Page 34105]]
cooperation among health care providers to improve the quality of care
for Medicare Fee-For-Service (FFS) beneficiaries and reduce the rate of
growth in expenditures under Medicare Parts A and B. 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 Program; Medicare Shared
Savings Program: Accountable Care Organizations; Final Rule (76 FR
67802) (hereinafter referred to as the ``November 2011 final rule'')).
A subsequent major update to the program rules appeared in the June 9,
2015 Federal Register (Medicare Program; Medicare Shared Savings
Program: Accountable Care Organizations; Final Rule (80 FR 32692)
(hereinafter referred to as the ``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) (hereinafter referred to as the
``June 2016 final rule'')). We have also made use of the annual
calendar year (CY) Physician Fee Schedule (PFS) rules to address
quality reporting and certain other issues. In addition, in the CY 2017
Quality Payment Program final rule (81 FR 77255 through 77256), we
finalized policies related to quality performance category scoring for
Merit-Based Incentive Payment System (MIPS) eligible clinicians that
participate in the Shared Savings Program. In that final rule, we
adopted an APM scoring standard that reduces burden for eligible
clinicians that participate in Shared Savings Program ACOs by using the
same quality data reported by the ACO using the the CMS web interface
for purposes of the Shared Savings Program to score the MIPS quality
performance category for these eligible clinicians.
In this CY 2018 PFS proposed rule, we propose further refinements
to the Shared Savings Program rules. This rule includes two proposed
modifications to the Shared Savings Program beneficiary assignment
methodology: (1) Revisions to the assignment methodology under 42 CFR
part 425, subpart E to reflect the requirement under section 17007 of
the 21st Century Cures Act (Pub. L. 114-255, December 13, 2016), that
for performance years beginning on or after January 1, 2019, the
Secretary determine an appropriate method to assign Medicare FFS
beneficiaries to an ACO based on their utilization of services
furnished by rural health clinics (RHCs) or federally qualified health
centers (FQHCs), and (2) addition of new chronic care management and
BHI service codes to our definition of primary care services. In
addition, we propose to revise the methodology used in our quality
validation audits and the manner in which the results of these audits
may be used to adjust an ACO's sharing rate. We also propose to reserve
the discretion to redesignate a measure reported through the CMS web
interface as pay-for-reporting when substantive changes are made to the
measure under the Quality Payment Program.
We also address proposals intended to reduce application burden for
stakeholders by reducing certain documentation submission requirements
included in the initial Shared Savings Program application and the
application for use of the skilled nursing facility (SNF) 3-Day Rule
Waiver. We also propose to establish specific procedures to address
situations where a Taxpayer Identification Number (TIN) that is an ACO
participant in more than one ACO begins to submit claims for services
used in the beneficiary assignment process and becomes out of
compliance with the ``exclusivity'' requirement in Sec. 425.306(b)(2).
Finally, we propose that, for performance year 2018 and subsequent
years, we would only include individually beneficiary identifiable
payments made under a demonstration, pilot or time limited program that
are final and not subject to further reconciliation in financial
calculations related to establishing and updating benchmarks and
determining performance year expenditures under the Shared Savings
Program.
1. Modifications to the Shared Savings Program Beneficiary Assignment
Methodology
a. Assignment of Beneficiaries to ACOs That Include RHCs and/or FQHCs
(1) Background
(a) General Shared Savings Program Assignment Methodology
As originally enacted in the Affordable Care Act, section 1899(c)
of the Act requires us to assign FFS beneficiaries 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 or with a particular ACO, and they retain
the right to seek Medicare-covered services from any Medicare-enrolled
provider or supplier of their choosing. Furthermore, 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 during a prior 12 month period
(the ``assignment window'') furnished by physicians and certain
nonphysician practitioners that are ACO professionals in the ACO
determines the beneficiary's assignment to an ACO under the Shared
Savings Program.
The regulations governing the assignment methodology under the
Shared Savings Program are in part 425, subpart E. Consistent with the
statutory requirement to base assignment on the utilization of primary
care services furnished by physicians who are ACO professionals, a
beneficiary is eligible for assignment to an ACO under Sec. 425.402 if
the beneficiary had at least one primary care service during the
applicable assignment window furnished by a physician who is an ACO
professional in the ACO and who is a primary care physician as defined
under Sec. 425.20 or has one of the primary specialty designations
specified in Sec. 425.402(c). This initial process for determining
whether a beneficiary is eligible for assignment is referred to as the
assignment ``pre-step''. Under the first step of the assignment
process, a beneficiary who is eligible for assignment to the ACO will
be assigned to the ACO if the allowed charges for primary care services
furnished to the beneficiary during the assignment window 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 during the assignment window 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
billing TIN. The second step of the assignment process considers the
remainder of beneficiaries who have received at least one primary care
service during the assignment window from an ACO physician who is a
primary care physician as defined under Sec. 425.20 or who has one of
the primary specialty designations specified in Sec. 425.402(c),
[[Page 34106]]
but have received no primary care services during the assignment window
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 during the assignment window by
physicians who are ACO professionals in the ACO with one of the
specialty designations specified in Sec. 425.402(c) are greater than
the allowed charges for primary care services furnished during the
assignment window by physicians with such specialty designations who
are ACO professionals in another ACO or who are not affiliated with any
ACO and are identified by a Medicare-enrolled billing TIN. Thus, the
assignment methodology simultaneously maintains the statutory
requirement to focus on physician 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.
(b) Retrospective vs Prospective Assignment
As discussed in detail in the November 2011 final rule we finalized
a claims-based hybrid approach (called preliminary prospective
assignment with retrospective reconciliation) for assigning
beneficiaries to an ACO (76 FR 67851 through 67870), which is currently
applicable to ACOs participating under Track 1 or Track 2 of the Shared
Savings Program. Under this approach, beneficiaries are preliminarily
assigned to an ACO at the beginning of a performance year and quarterly
thereafter during the performance year, but the final beneficiary
assignment is determined after 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 during the performance year
with the ACO's desire to know in advance about beneficiaries who have
chosen to receive such services from practitioners participating in the
ACO in the past and who are likely to continue to choose to receive
such services during the performance year. Knowing in advance which
beneficiaries are likely to receive a plurality of their primary care
from ACO practitioners during the performance year gives ACOs greater
opportunities to proactively impact the quality and cost of care for
beneficiaries who may be assigned to the ACO at the end of the
performance year.
In the June 2015 final rule, and in response to stakeholders'
suggestions, we implemented an option for ACOs to participate in a new
two-sided performance-based risk track, Track 3 (80 FR 32771 through
32781). Under Track 3, beneficiaries are prospectively assigned to the
ACO at the beginning of the performance year using the same two-step
methodology described previously, based on where the beneficiaries have
chosen to receive a plurality of their primary care services during a
12-month assignment window offset from the calendar year that reflects
the most recent 12 months for which data are available prior to the
start of the performance year. The ACO is held accountable for
beneficiaries who are prospectively assigned to it for the performance
year. Under limited circumstances, a beneficiary may be excluded from
the prospective assignment list during or after the performance year.
For example, a beneficiary will be excluded from the prospective
assignment list if the beneficiary enrolls in Medicare Advantage during
the performance year or no longer lives in the United States or U.S.
territories and possessions, based on the most recent available data
regarding the beneficiary's residence at the end of the performance
year. A beneficiary is not excluded from the ACO's prospective
assignment list during the performance year or at the time of
reconciliation for most other reasons, such as if 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 during the performance year or at the time of
reconciliation even if they chose to receive a plurality of their
primary care during the performance year from ACO professionals
participating in the ACO and were not previously identified on the
prospective assignment list. 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 assigned
beneficiaries who meet the exclusion criteria specified in Sec.
425.401(b) during the performance year will not be assigned to the ACO
at the end of the year; further, as noted, beneficiaries remain free
under FFS Medicare to choose the healthcare providers from whom they
receive services.
Finally, in the CY 2017 Physician Fee Schedule final rule (81 FR
80501 through 80510), we further enhanced the claims-based beneficiary
assignment methodology by finalizing a policy to incorporate data
gathered directly from beneficiaries who designate a ``main doctor''
they believe is responsible for coordinating their overall care.
Beginning in performance year 2017, beneficiaries may designate a
provider or supplier as responsible for coordinating their overall care
using MyMedicare.gov, a secure, online, patient portal. Notwithstanding
the assignment methodology in Sec. 425.402(b), beneficiaries who
designate an ACO professional whose services are used in assignment as
responsible for their overall care will be prospectively assigned to
the ACO in which that ACO professional participates, provided the
beneficiary meets the eligibility criteria established at Sec.
425.401(a) and has had at least one primary care service during the
assignment window with an ACO professional in the ACO who is a primary
care physician or a physician with one of the primary specialty
designations included in Sec. 425.402(c). Such beneficiaries will be
added prospectively to the ACO's list of assigned beneficiaries for the
subsequent performance year.
(c) Special Assignment Conditions for RHCs and FQHCs
RHCs and FQHCs are facilities that furnish services that are
typically furnished in an outpatient clinic setting. Prior to October
1, 2014, FQHCs were paid an all-inclusive rate (AIR) per visit for
qualified primary and preventive health services furnished to Medicare
beneficiaries. On October 1, 2014, FQHCs began to transition to a new
FQHC prospective payment system (PPS). FQHCs were required to use HCPCS
coding on all their claims starting on January 1, 2011, to inform the
development of the PPS and for limited other purposes, and are now
required to use HCPCS coding for payment purposes under the FQHC PPS.
[[Page 34107]]
RHCs are paid an AIR per visit for qualified primary and preventive
health services furnished to Medicare beneficiaries. Prior to April 1,
2016, RHCs were required to report HCPCS codes for a few services, such
as certain preventive services eligible for a waiver of the deductible
and/or coinsurance, services subject to frequency limits, and services
eligible for payments in addition to the AIR. Effective April 1, 2016,
all RHCs are required to report the appropriate HCPCS code for each
service furnished during the visit, along with the appropriate revenue
code (For additional background, please see the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/FQHCPPS/Downloads/RHC-Reporting-FAQs.pdf).
As we noted in the November 2011 final rule, RHC and FQHC claims
contain very limited information concerning the individual
practitioner, or even the type of health professional (for example,
physician, PA, or NP) who provided the service because this information
is not necessary to determine payment rates for services in RHCs and
FQHCs s (76 FR 67858 through 67861). Therefore, unlike physician fee
schedule claims, there is no direct way for us to determine if a claim
was for a service furnished by a physician at the RHC or FQHC.
In spite of the difference in claims billing, based on detailed
comments from some RHC and FQHC representatives, in the November 2011
final rule, we established a process that allows primary care services
furnished in RHCs and FQHCs to be considered in the assignment process
for any ACO that includes an RHC or FQHC as an ACO participant. This
process is set forth in Sec. 425.404. We assign beneficiaries to ACOs
that include RHCs or FQHCs as ACO participants in a manner generally
consistent with how we assign beneficiaries to other ACOs based on
primary care services performed by certain physicians and non-physician
practitioners who are ACO professionals in the ACO, as described
previously. However, to address the requirement under section 1899(c)
of the Act that beneficiaries be assigned to an ACO based on their use
of primary care services furnished by physicians, we require ACOs that
include RHCs or FQHCs to identify, through an attestation, the
physicians that directly provide patient primary care services in their
ACO participant RHCs or FQHCs (see Sec. Sec. 425.204(c)(5)(iii) and
425.404(a)). We use the combination of the RHC or FQHC ACO participant
TIN (and another unique identifier, such as a CCN, where appropriate)
and the NPIs of the RHC or FQHC physicians provided to us through the
attestation process to identify those beneficiaries who received a
primary care service from a physician in the RHC or FQHC and who are
therefore eligible to be assigned to the ACO as provided under Sec.
425.402(b)(1), which we refer to as the assignment ``pre-step''. Then,
we assign those beneficiaries to the ACO, using the step-wise
assignment methodology under Sec. 425.402(b), if they received the
plurality of their primary care services, as determined based on
allowed charges for the HCPCS codes and revenue center codes included
in the definition of primary care services at Sec. 425.20, from ACO
professionals in the ACO.
The special procedures that we have established for using RHC and
FQHC services in the assignment methodology are discussed in detail in
the June 2015 final rule (80 FR 32755 through 32756). RHC and FQHC
services are billed on an institutional claim form and require special
handling to incorporate them into the beneficiary assignment process.
For RHCs and FQHCs that are ACO participants, we treat an RHC or FQHC
service reported on an institutional claim as a primary care service
performed by a primary care physician if the claim includes a HCPCS or
revenue center code that is included in the definition of a primary
care service at Sec. 425.20 and the service was furnished by a
physician who was identified as directly providing primary care
services on the attestation provided under Sec. 425.404(a). All such
physicians are considered primary care physicians for purposes of the
assignment methodology and no specialty code is required for these
claims. If the claim is for a primary care service furnished by someone
other than a physician listed on the attestation, we treat the service
as a primary care service furnished by a non-physician ACO
professional. As a result, all primary care services furnished by an
ACO professional in an RHC or FQHC to a beneficiary eligible for
assignment to the ACO are considered in step 1 of the assignment
methodology. Finally, for RHCs and FQHCs that are not ACO participants,
we assume a primary care physician performed all primary care services
so that all primary care services furnished by non-ACO RHCs/FQHCs are
considered in step 1 of the assignment methodology. We believe this
approach helps to ensure that we do not disrupt established
relationships between beneficiaries and their caregivers in non-ACO
participant RHCs and FQHCs by inappropriately assigning beneficiaries
to ACOs that are not primarily responsible for coordinating their
overall care.
We developed and implemented these regulatory and operational
policies to facilitate full participation of rural providers, including
RHCs and FQHCs, in the Shared Savings Program, within the statutory
requirements for the program. In general, stakeholders have been
appreciative of our policies to include rural providers and suppliers
in the Shared Savings Program. However, some stakeholders have
expressed concerns that the special conditions required for us to
consider RHC and FQHC institutional claims in beneficiary assignment
are burdensome and discourage ACOs from including RHCs and FQHCs as ACO
participants in the Shared Savings Program. Stakeholders have commented
that the requirement for ACOs that include an RHC or FQHC as an ACO
participant to provide an attestation identifying ACO professionals who
are physicians who directly furnish primary care services at the RHC or
FQHC is particularly burdensome. In addition, due to the operational
complexities of collecting identifying information about ACO
participants, screening them for program integrity and other potential
issues, and incorporating claims data for approved ACO participants
into beneficiary assignment and financial calculations, we have
implemented a policy that limits the addition of entities to the ACO
participant list, absent unusual circumstances, to an annual basis. The
limitation also applies to changes to the attestation to identify
additional physicians who directly furnish primary care services at an
ACO participant RHC or FQHC. In contrast, when a new ACO professional
begins billing for primary care services under the TIN of an ACO
participant that is not an RHC or FQHC, those services will be
considered for purposes of assignment in the current performance year.
As a result, there are a number of unique burdens and anomalies in the
way in which RHC and FQHC institutional claims are used for purposes of
assignment under the Shared Savings Program. First, as noted by
stakeholders, the required attestation process for submitting physician
identifiers requires more effort to ensure the accuracy of the ACO
participant list (including the attestation that includes the physician
identifiers) than the level of effort required for ACOs that do not
include RHCs and FQHCs. Second, we have recognized that the required
attestation process for submitting physician identifiers is also prone
to error because some RHCs and FQHCs
[[Page 34108]]
(particularly rural FQHCs) have multiple locations with potentially
hundreds of NPIs to report which, in turn, increases the likelihood
that ACOs that include RHCs or FQHCs as ACO participants will make
inadvertent clerical errors, such as transposing digits, in submitting
the required information. Errors that are not identified and corrected
by the specified deadline for additions to the ACO participant list may
result in fewer claims being considered for purposes of assignment
under the Shared Savings Program than would otherwise occur.
(2) Proposals
Section 17007 of the 21st Century Cures Act, amended section
1899(c) of the Act (42 U.S.C. 1395jjj(c)) to require the Secretary to
assign beneficiaries to ACOs participating in the Shared Savings
Program based not only on their utilization of primary care services
furnished by physicians but also on their utilization of services
furnished by RHCs and FQHCs, effective for performance years beginning
on or after January 1, 2019. The statute provides the Secretary with
broad discretion to determine how to incorporate services provided by
RHCs and FQHCs into the Shared Savings Program beneficiary assignment
methodology.
We believe that the 21st Century Cures Act provides the Secretary
with broad discretion to revise the assignment methodology to address
the concerns expressed by certain stakeholders regarding the burdens
placed on ACOs that include RHCs and FQHCs as ACO participants, as
described above. Section 17007 of the 21st Century Cures Act provides
that for performance years beginning on or after January 1, 2019,
Medicare services furnished in an FQHC or RHC should be considered in
beneficiary assignment for the Shared Savings Program, as may be
determined by the Secretary. Accordingly, in implementing section 17007
of the 21st Century Cures Act, we believe it would be appropriate to
reduce operational burdens for ACOs that include RHCs or FQHCs as ACO
participants and bring greater consistency to the operational method of
using claims to assign beneficiaries to ACOs. In order to promote
participation of RHCs and FQHCs under the Shared Savings Program, we
propose to remove the burdensome attestation requirement and instead
treat a service reported on an RHC or FQHC institutional claim as a
primary care service furnished by a primary care physician. Consistent
with the 21st Century Cures Act, under this proposal: (1) The
requirement for an attestation identifying physicians who directly
provide primary care services in each RHC or FQHC that is an ACO
participant and/or ACO provider/supplier in the ACO would be removed;
(2) all RHC and FQHC claims would be used to establish beneficiary
eligibility to be assigned to the ACO (pre-step); and (3) all RHC and
FQHC claims would be included in step 1. We would note that in
considering all services billed under the TIN of the ACO participant
RHC or FQHC, we would include services that do not meet the definition
of primary care services, and such services would not be limited to
those provided by a primary care physician, as defined under program
rules. This means that under the proposal, a beneficiary could be
furnished services in an RHC and FQHC only by a nurse practitioner,
physician assistant, clinical nurse specialist, or any other
practitioner in an RHC and FQHC and still be eligible for assignment to
the ACO.
More specifically, we are proposing the following changes to our
regulations: (1) Remove Sec. 425.204(c)(5)(iii) in its entirety; (2)
revise Sec. 425.404; and (3) make conforming changes to the definition
of primary care physician found at Sec. 425.20. Under our proposal,
for performance year 2019 and subsequent performance years, ACOs with
ACO participants that are RHCs and FQHCs would no longer be required to
submit NPIs or other identifying information for physicians who
directly provide primary care services in the ACO participant RHCs and
FQHCs as indicated in Sec. 425.204(c)(5)(iii)(A) and Sec. 425.404(a).
Therefore we propose to remove Sec. 425.204(c)(5)(iii) in its
entirety. Additionally, we propose revisions to Sec. 425.402 and Sec.
425.404 to reflect that for performance year 2019 and subsequent
performance years, we would assign beneficiaries to ACOs based on
services furnished in RHCs or FQHCs consistent with the general
assignment methodology in Sec. 425.402, by treating a service reported
on an RHC or FQHC institutional claim in the same way as a primary care
service performed by a primary care physician. We also propose to
remove revenue center codes from the definition of primary care
services (Sec. 425.20) for performance year 2019 and subsequent
performance years because all RHC and FQHC services will be used for
purposes of assignment for benchmark and performance years; therefore,
we believe it is appropriate to modify our definition of primary care
services for performance year 2019 and subsequent years to no longer
include revenue center codes. Additionally, we note that the
requirement for an attestation under Sec. 425.404 is also referenced
in the definition of primary care physician at Sec. 425.20;
accordingly, we propose to make a conforming revision to that
definition to remove the reference to the attestation requirement for
performance year 2019 and subsequent years.
Consistent with how we have implemented other changes to the
assignment methodology (see, for example, 80 FR 32757 through 32758),
we propose to adjust all ACO benchmarks at the start of the first
performance year in which the new assignment rules are applied so that
the ACO benchmarks reflect the use of the same assignment rules as will
apply in the performance year. Also consistent with how we have
implemented previous changes to the Shared Savings Program assignment
methodology, we would use the new methodology each time assignment is
determined for purposes of performance year 2019, including using the
new methodology in late CY 2018 to determine the eligibility of ACOs
wishing to enter into or renew a participation agreement beginning
January 1, 2019. Under the Shared Savings Program, ACOs must have and
maintain at least 5,000 assigned beneficiaries.
We believe this proposal would reduce administrative burden for
ACOs that include RHCs or FQHCs as ACO participants and support our
policy goal of assigning beneficiaries to the entity that is primarily
responsible for the beneficiary's overall care. That is, including all
services furnished by RHCs or FQHCs to establish beneficiary
eligibility to be assigned to an ACO (pre-step) and in the stepwise
assignment methodology should help to ensure that a beneficiary is
assigned to an ACO when the ACO participants in that ACO are providing
the plurality of care for that beneficiary and thus the ACO should be
accountable for the patient's overall care.
We welcome comments on our proposal to: (1) Remove Sec.
425.204(c)(5)(iii) and modify Sec. 425.402 and Sec. 425.404, for
performance year 2019 and subsequent performance years, to eliminate
the requirement for ACOs that include an RHC or FQHC as an ACO
participant to provide an attestation identifying physicians who
directly provide primary care services in each RHC or FQHC that is an
ACO participant and/or ACO provider/supplier in the ACO, and make
conforming changes to the definition of primary care physician at Sec.
425.20; and (2) for performance year 2019 and subsequent performance
years, to: (a)
[[Page 34109]]
Use all claims submitted by RHCs and FQHCs in the ``pre-step'' of the
assignment methodology under Sec. 425.402 to determine whether a
beneficiary is eligible for assignment to an ACO participating in the
Shared Savings Program, (b) treat a service reported on an RHC or FQHC
claim as if it were a primary care service performed by a primary care
physician, and (c) remove revenue center codes from the definition of
primary care services.
We recognize the unique needs and challenges of rural and
underserved communities and the important role played by providers and
suppliers serving these communities in assuring access to primary
health care. RHCs, FQHCs, and other providers furnishing care in rural
and underserved communities play an important role in the nation's
health care delivery system by serving as safety net providers of
primary care and other health care services, and we believe these
proposed changes will enhance their ability to participate in the
Shared Savings Program.
We also invite suggestions on how we might further support
participation of RHCs and FQHCs in the Shared Savings Program.
b. Revisions to the Definition of Primary Care Services
(1) Background
Section 1899(c) of the Act requires the Secretary to assign
beneficiaries to an ACO ``based on their utilization of primary care
services'' provided by a physician. However, the statute does not
specify which kinds of services may be considered primary care services
for this purpose, nor the amount of those services that would be an
appropriate basis for making assignments. In this section of this
proposed rule, we summarize how we currently identify the appropriate
primary care services on which we base assignment. In addition, we
propose a revision to our current policies for defining primary care
services for purposes of beneficiary assignment, consistent with our
statement in the November 2011 final rule (76 FR 67853), that we
intended to monitor this issue and would consider making changes to the
definition of primary care services to add or delete HCPCS codes used
to identify primary care services, if there were sufficient evidence
that revisions were warranted.
We currently define primary care services for purposes of the
Shared Savings Program in Sec. 425.20 as the set of services
identified by the following HCPCS/CPT codes: 99201 through 99215, 99304
through 99318 (excluding claims including the POS 31 modifier), 99319
through 99340, 99341 through 99350, 99495, 99496, 99490, the Welcome to
Medicare visit (G0402), and the annual wellness visits (G0438 and
G0439). In addition, we have established a cross-walk for these codes
to certain revenue center codes used by FQHCs (for services furnished
prior to January 1, 2011) and RHCs so that their services can be
included in the beneficiary assignment process. Lastly, we include
G0463 for services furnished in electing teaching amendment (ETA)
hospitals.
In the November 2011 final rule (76 FR 67853), we established the
initial list of codes that we considered to constitute primary care
services for several reasons. First, we believed the listed codes
represented a reasonable approximation of the kinds of services that
are described by the statutory language which refers to assignment of
``Medicare fee-for-service beneficiaries to an ACO based on their
utilization of primary care services'' furnished by physicians. In
addition, we selected this list to be largely consistent with the
definition of primary care services in section 5501 of the Affordable
Care Act. That section establishes the Primary Care Incentive Payment
Program to expand access to primary care services, and thus its
definition of primary care services provides a compelling precedent for
adopting a similar list of codes for purposes of the beneficiary
assignment process under the Shared Savings Program. We slightly
expanded the list of codes found in section 5501 of the Affordable Care
Act to include the Welcome to Medicare visit (HCPCS code G0402) and the
annual wellness visits (HCPCS codes G0438 and G0439) as primary care
services for purposes of the Shared Savings Program. These codes
clearly represent primary care services frequently received by Medicare
beneficiaries, and in the absence of the special G codes the services
provided during these visits would be described by one or more of the
regular office visit codes that are included in the list under Section
5501 of the Affordable Care Act.
In the June 2015 final rule (80 FR 32746 through 32748), we
expanded the definition of primary care services to include two
transitional care management (TCM) codes (CPT codes 99495 and 99496),
and one chronic care management (CCM) code, (CPT 99490). As discussed
in the final rule, the TCM codes were established to pay a patient's
physician or practitioner to coordinate the patient's care in the 30
days following a hospital or skilled nursing facility (SNF) stay.
Including these codes in the definition of primary care services
reflects our belief that the work of community physicians and
practitioners in managing a patient's care following discharge from a
hospital or nursing facility to ensure better continuity of care for
these patients and help reduce avoidable readmissions is a key aspect
of primary care.
In the CY 2017 PFS Final Rule, we finalized a separate payment for
three additional CCM service codes, CPT codes 99487 and 99489 (see 81
FR 80251), and an additional add-on code G0506 (see 81 FR 80245), to
support care management for the most complex and time-consuming cases
of beneficiaries with multiple chronic conditions. These codes are used
to report complex CCM services furnished to patients with multiple (two
or more) chronic conditions. CCM services generally include regular
development and revision of a plan of care, communication with other
treating health professionals, and medication management. We explained
in the CY 2017 PFS final rule that we believe the addition of the
complex CCM codes will retain elements of the CCM service that are
characteristic of the changes in medical practice toward advanced
primary care, while eliminating redundancy, simplifying provision of
the services, and improving access to the services. Additional
explanation of required elements for billing CCM services can be found
in the CY 2017 PFS Final Rule (81 FR 80243 through 80251).
Finally, in the 2017 PFS final rule (81 FR 80230 through 80243), we
finalized a policy to make separate payments to physicians and non-
physician practitioners for behavioral health integration (BHI)
services they furnish to beneficiaries over a calendar month service
period using four new Medicare Part B billing codes. Three of these BHI
codes (G0502, G0503, G0504) are used to bill for monthly services
furnished using the Psychiatric Collaborative Care Model (CoCM), an
approach to BHI shown to improve outcomes in multiple studies. CoCM is
a model of BHI that enhances ``usual'' primary care by adding two key
services: Care management support for patients receiving behavioral
health treatment; and regular psychiatric inter-specialty consultation
to the primary care team, particularly regarding patients whose
conditions are not improving. The fourth BHI service code (G0507) is
used to bill monthly services furnished using BHI models of care other
than CoCM that similarly include ``core'' service elements such as
systematic assessment and monitoring, care plan revision for
[[Page 34110]]
patients whose condition is not improving adequately, and a continuous
relationship with a designated care team member. The BHI service codes
may be billed by the treating practitioner. Physicians billing for
these services would typically be primary care physicians, but may be
of another specialty such as cardiology or oncology. Non-physician
practitioners (PAs, NPs, CNSs, or CNMs), may also bill for these
services.
(2) Proposals
As discussed above, we previously finalized the inclusion of CCM
code 99490 in the definition of primary care services for the Shared
Savings Program. For the same reason that we included CCM code 99490,
we believe that it would be also be appropriate to include the complex
CCM service codes 99487, 99489, and G0506 in the definition of primary
care services and to utilize these codes in the beneficiary assignment
methodology under the Shared Savings Program beginning in 2018 for
performance year 2019 and subsequent years. These three additional CCM
codes reflect the changes in medical practice toward advanced primary
care and differ from each other only in the amount of clinical staff
service time provided; the complexity of medical decision-making as
defined in the Evaluation and Management 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).
In addition, we believe that it would be also be appropriate to
include the four BHI codes G0502, G0503, G0504 and G0507 in the
definition of primary care services and to utilize these codes in the
beneficiary assignment methodology under the Shared Savings Program
beginning in 2018 for performance year 2019 and subsequent years. These
BHI codes reflect important enhancements in primary care to support
improvement and integration of care provided for patients receiving
behavioral health treatment. As discussed above, the BHI service codes
may be billed by the treating practitioner (a physician and/or non-
physician practitioner (PA, NP, CNS, CNM)). Physicians billing for
these services would typically be primary care physicians, but may be
of another specialty such as cardiology or oncology. (See fact sheet
available on our Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/Behavioral-Health-Integration-Fact-Sheet.pdf.)
Therefore, we propose to revise the definition of primary care
services currently located in Sec. 425.20 to include three additional
CCM service codes 99487, 99489, and G0506, and four BHI service codes
G0502, G0503, G0504 and G0507, beginning in 2018 for performance year
2019 and subsequent performance years and to include these codes when
performing beneficiary assignment under Sec. 425.402. In addition, we
propose to move the list of service codes currently listed in the
definition in Sec. 425.20 to Sec. 425.400(c). We believe Sec.
425.400, which specifies general requirements related to the assignment
methodology and currently contains a cross-reference at Sec.
425.400(c) to the definition of primary care services under Sec.
425.20, is the more appropriate place to specify the particular primary
care codes that will be considered in the assignment methodology. We
also propose to reorganize the list of service codes, grouping HCPCS
codes, G codes, and revenue center codes together, respectively, by
relevant performance year(s). We seek comments on this proposal. In
addition, we seek comments as to whether there are any additional
existing HCPCS/CPT codes, that we should consider adding to the
definition of primary care services in future rulemaking for purposes
of assignment of beneficiaries to ACOs under the Shared Savings
Program.
We also propose to remove paragraph (3) from the definition of
primary care services. Paragraph (3) indicates that we will include
additional codes designated by us as primary care services, including
new HCPCS/CPT and revenue center codes and any subsequently modified or
replacement codes for the HCPCS/CPT and revenue center codes identified
in the definition. We finalized this policy in the June 2015 final rule
(80 FR 32746), explaining that it was intended to promote flexibility
for the Shared Savings Program and allow us to respond more quickly to
HCPCS/CPT coding changes made in the annual PFS rulemaking process. We
now believe this paragraph which directs CMS to respond to HCPCS/CPT
coding changes though rulemaking is unnecessary because we always have
the flexibility to propose, through the annual PFS rulemaking (or other
rulemaking for the Shared Savings Program), to make changes to the
definition of primary care services to reflect HCPCS/CPT coding changes
made elsewhere in the same PFS rulemaking or in a previous PFS final
rule. We therefore believe it would be reasonable to remove this
paragraph rather than move it to subpart E under part 425 along with
the other paragraphs making up the definition of primary care services.
2. ACO Quality Reporting
a. Changes to the Quality Measure Set Used in Establishing the Quality
Performance Standard
(1) Background
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
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. We designate the quality performance
standard that will apply for each performance year. The quality
performance standard is the overall standard the ACO must meet in order
to be eligible for shared savings.
In the November 2011 final rule (76 FR 67973), we initially
established a quality performance standard consisting of 33 measures
across 4 domains (see Sec. 425.502(d)), including patient experience
of care, care coordination/patient safety, preventive health, and at-
risk population and a methodology for scoring the measures submitted by
ACOs (see Sec. 425.502(e)). Quality measures are submitted by the ACO
through the CMS web interface, calculated by us 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. To qualify for shared savings
(see Sec. Sec. 425.604(c), 425.606(c), and 425.610(c)), an ACO must
meet or exceed its minimum savings rate, meet the minimum quality
performance standards established under Sec. 425.502, and otherwise
maintain its eligibility to participate in the Shared Savings Program.
For example, under the
[[Page 34111]]
regulation at Sec. 425.604(d), an ACO participating in the Shared
Savings Program under Track 1 that meets all the requirements for
receiving shared savings payments will receive a shared savings payment
of 50 percent of all savings under the updated benchmark (up to the
performance payment limit).
Since the November 2011 Shared Savings Program final rule, we have
continued to review the quality measures used for the Shared Savings
Program to ensure that they are up to date with current clinical
practice and are aligned with the CMS web interface reporting for PQRS,
and most recently, with reporting requirements under the Quality
Payment Program. Through the annual rulemaking for the PFS we have
reviewed and updated the quality measures reported by ACOs through the
CMS web interface, including adding new measures and retiring measures
that were redundant or no longer met the goals for group reporting, and
ensuring that the ACO CMS web interface reported measures align with
the measures reported through the CMS web interface by group practices
in other CMS initiatives such as PQRS and the Quality Payment Program.
The quality measure set currently includes 31 quality measures (see
Tables 42 and 43 at 81 FR 80488 and 80489). To avoid confusion and
duplication of rulemaking, and reduce provider burden, we also
finalized a policy in the 2017 PFS final rule that future changes to
the CMS web interface measure will be made through rulemaking for the
Quality Payment Program and will be applicable to ACO quality reporting
under the Shared Savings Program (81 FR 80499 and 80500). Under the APM
scoring standard finalized in the CY 2017 Quality Payment Program final
rule (81 FR 77255 through 77256), measures reported by Shared Savings
Program ACOs through the CMS web interface will also be used to
determine the Merit-Based Incentive Payment System (MIPS) quality
performance category score for eligible clinicians participating in a
Shared Savings Program ACO in 2017.
When scoring ACO quality performance in the Shared Savings Program,
we designate a performance benchmark and minimum attainment level for
each measure. 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 the measure will
receive points on a sliding scale based on the level of performance. We
update the quality performance benchmarks every 2 years. For the first
performance year of an ACO's first agreement period, we define the
quality performance standard at the level of complete and accurate
reporting for all quality measures. During subsequent performance years
of the ACO's first agreement period, the quality performance standard
is phased in such that the ACO must continue to report all measures but
the ACO will be assessed on performance based on the quality
performance benchmark and minimum attainment level for certain measures
that are designated a pay for performance. The quality performance
standard that applies to an ACO's final year in its first agreement
period also applies for each performance year of an ACO's subsequent
agreement period. A newly introduced measure is set at the level of
complete and accurate reporting for the first 2 reporting periods the
measure is required. For subsequent reporting periods, the quality
performance standard for the measure will be assessed according to the
phase-in schedule for the measure. Pay for reporting measures are worth
2 points each for complete and accurate reporting, whereas pay for
performance measures are worth 0-2 points based on ACO performance
compared to the established benchmark. The EHR measure (ACO-11),
however, is double-weighted and ACOs can earn up to 4 points based on
their performance on this measure.
Additionally, as discussed in the CY 2016 PFS final rule with
comment period (see 80 FR 71269), occasionally issues arise with
measures that cause us to reevaluate whether it is appropriate to hold
an ACO accountable for performance on a measure. For instance, in the
CY 2015 PFS final rule with comment period we retired measures that
were no longer consistent with updated clinical guidelines for
cholesterol targets, but we were unable to finalize retirement of the
measures for the 2014 reporting year due to the timing of the guideline
updates and rulemaking cycle. Because these measures did not align with
updated clinicial guidance, in February 2015, we issued an update to
the guidance document on the Medicare Shared Savings Program Quality
Measure Benchmarks for the 2014 Reporting Year that maintained these
measures, including the Diabetes Composite measure, as pay for
reporting for the 2014 reporting year. In order to address such issues
in the future, we finalized a policy in the CY 2016 PFS final rule with
comment period (80 FR 71269) under which we reserve the right to
maintain a measure as pay for reporting or revert a pay for performance
measure to pay for reporting when the measure owner determines the
measure no longer aligns with clinical practice or continued
application of the measure may result in patient harm (see Sec.
425.502(a)(5)).
(2) Proposals
As previously noted in the background section, we finalized a
policy that future changes to the CMS web interface measures will be
adopted through rulemaking for the Quality Payment Program and will be
applicable to ACO quality reporting under the Shared Savings Program
(81 FR 80501). We also note that, as discussed in the CY 2017 Quality
Payment Program final rule with comment period (81 FR 77136), section
1848(q)(2)(D)(i)(II) of the Act requires the Secretary to update the
final list of quality measures from the previous year (and publish an
updated list in the Federal Register) annually. Updates may include the
removal of quality measures the addition of new quality measures, and
the exclusion of existing quality measures that the Secretary
determines have gone through substantive changes. In the CY 2017
Quality Payment Program final rule with comment period, we indicated
that in the future we would use rulemaking for the MIPS program to
address substantive changes to measures (81 FR 77143). On June 20,
2017, HHS issued a proposed rule that includes a number of proposals to
revise certain policies under the Quality Payment Program for CY 2018,
including a proposal to make substantive changes to several measures
reported through the CMS web interface. For example, substantive
changes are proposed for the way ACO-17 Tobacco Use: Screening and
Cessation Intervention measure rate is calculated via the CMS web
interface (see Table E, 82 FR 30469). This measure was originally
developed as a two-part measure: The first part of the measure assessed
whether a patient had been screened for tobacco use within the past 24
months; the second part of the measure assessed whether those who had
been screened and identified as tobacco users in the first part of the
measure also received tobacco cessation intervention (either counseling
and/or pharmacotherapy). To date, the two parts of the measure have
been combined into a single performance rate. We have identified two
notable limitations with this approach, including (1) the performance
rate does not show the difference in performance with respect to how
well clinicians adhere to performing tobacco use screenings and how
well clinicians follow the guidelines to provide tobacco
[[Page 34112]]
cessation interventions, and (2) the measure is topped out, meaning it
continuously shows a high performance rate. The changes to the measure
proposed in the CY 2018 Quality Payment Program proposed rule would not
modify the sampling methodology or the data reported into the CMS web
interface. The proposed changes would simply revise the measure
specifications to measure the percent of tobacco users that received
cessation counseling; instead of measuring a combined performance rate
for beneficiaries that were screened for tobacco use and for the subset
of beneficiaries that are tobacco users that received tobacco cessation
counseling.
Substantive changes to other CMS web interface measures are also
proposed. A substantive change is proposed to the Influenza
Immunization measure (ACO-14), however, the changes apply only to the
Registry and EHR data submission methods and not the CMS web interface
reporting method (82 FR 30472). Finally, a substantive change is
proposed for the Body Mass Index Screening and Follow-Up Plan (ACO-16);
specifically, the frequency of documenting BMI will change from 6 to 12
months (82 FR 30471).
Consistent with how we have addressed previous changes to measures,
we reviewed the proposed substantive changes to the CMS web interface
measures proposed in the CY 2018 Quality Payment Program proposed rule
to assess whether the changes, if finalized, would warrant a change in
how the measures are used to assess ACO performance under the Shared
Savings Program. As part of this review, we considered whether the
proposed substantive changes might raise sampling issues or require
that we recalculate the measure benchmarks for purposes of the Shared
Savings Program. Based on our preliminary review of the Quality Payment
Program proposals, we believe the proposed ``substantive'' changes to
the CMS web interface measures would not require that we revert these
measures to pay for reporting for the 2018 performance year. The
Quality Payment Program proposals do not appear to modify the current
structure and reporting of the measures for which substantive changes
are proposed; rather, in the case of the Tobacco Use: Screening and
Cessation Intervention measure, the proposed change would only modify
the way the data are manipulated and calculated after the data are
submitted. Similarly, we do not believe that the proposed substantive
change to the BMI measure to change the frequency of reporting would
impact an ACO's ability to perform well compared to the established
benchmark for this measure. Finally, the substantive change to the
Influenza Immunization measure does not apply to the CMS web interface
reporting method. Therefore, we believe that we will have the data
necessary from past submission periods to calculate appropriate
benchmarks that could be used to assess ACO performance for the CMS web
interface measures under consideration for performance year 2018 and
subsequent years. Additionally, the recalculation of the benchmark
coincides with the biannual timing of the benchmark updates. Therefore,
if the proposed changes to the measures are finalized under the Quality
Payment Program, we do not believe it would be necessary or
appropriate, to revert the measures to pay for reporting under the
Shared Savings Program. Instead, we believe it would be appropriate
under the Shared Savings Program to: (1) Update the measure
specifications through subregulatory guidance in order to continue to
align the measures with the measure specifications used under the
Quality Payment Program and Million Hearts initiative, and (2) retain
the current phase-in schedule for the measures rather than
redesignating any of the measures as pay for reporting.
Because the particular substantive changes that are proposed in the
CY 2018 Quality Payment Program proposed rule do not appear to change
the information that must be collected for these measures (which makes
it possible for us to use data submitted previously to determine prior
performance under the new measure rate, and therefore calculate an
appropriate prospective quality benchmark), we do not believe any
changes to the measures' phase-in schedules are necessary. However, the
statutory directive under the Quality Payment Program to address
substantive changes to measures in rulemaking and the proposals in the
CY 2018 Quality Payment Program proposed rule to address substantive
changes to certain web interface measures have caused us to evaluate
what recourse we might have in the future under the Shared Savings
Program rules to modify a measure's phase-in in instances where a
substantive change to the measure makes it inappropriate to hold ACOs
accountable for performance on a measure that has been substantively
modified. We anticipate that there could be future substantive changes
to the CMS web interface measures made under the Quality Payment
Program that would give us reason to redesignate a measure as pay-for-
reporting under the Shared Savings Program. Currently, although the
Shared Savings Program rules afford flexibility to redesignate a
measure as pay for reporting whem the measure owner determines the
measure no longer aligns with clinical practice or causes patient harm,
there is no discretion to modify how we assess CMS web interface
measures in the event substantive changes are made to those measures
under the Quality Payment Program that make it inappropriate to hold
ACOs accountable for performance on the measure. Given the timing of
the Quality Payment Program proposals in relationship to the timing for
when the quality performance benchmarks must be established under the
Shared Savings Program, it may in some cases be necessary to have
flexibility to designate a pay for performance measure as pay for
reporting just before or following the start of a performance year
outside of the formal rulemaking process, consistent with the way in
which we have redesignated measures in the past when measure owners
have made changes after the start of a performance year. Accordingly,
we believe it would be appropriate to modify the Shared Savings Program
regulations to provide additional flexibility to address substantive
changes to CMS web interface measures that are made under the Quality
Payment Program and to continue to facilitate alignment of measures
with the Quality Payment Program and other CMS initiatives.
We are therefore proposing to modify Sec. 425.502(a)(5) to include
the right for CMS to redesignate a measure as pay-for-reporting when a
substantive change to a CMS web interface measure is made under the
Quality Payment Program. This proposed revision would supplement CMS's
existing discretion to redesignate a measure as pay-for-reporting when
the measure owner determines the measure no longer aligns with clinical
practice or causes patient harm. Specifically, we are proposing to
revise the regulation at Sec. 425.502(a)(5) to reserve CMS's right to
redesignate CMS web interface measures that have undergone a
substantive change as determined under the Quality Payment Program to
pay-for-reporting status. Such measures would not necessarily be
automatically redesignated as pay for reporting when a substantive
change occurs (for example, as indicated previously, we do not believe
the currently proposed substantive changes present an impediment to
holding ACOs accountable for performance on these measures in
performance year 2018 and
[[Page 34113]]
subsequent years); however, in the future, substantive changes made to
CMS web interface measures under the Quality Payment Program (such as
when the substantive change to a measure results in an issue with
sampling, calculating performance, or the calculating the quality
benchmark) may make it inappropriate to hold an ACO accountable for
performance on the measure for the time needed for CMS to obtain the
information necessary to calculate a quality benchmark for the
substantively changed measure in advance of a performance year and/or
until ACOs gain experience reporting the measure, as substantively
changed. Although we expect to conduct at least a preliminary
assessment of any substantive changes to the CMS web interface measures
as part of the annual PFS rulemaking in order to determine whether any
change to the phase in schedule for a measure is warranted, because we
cannot always anticipate the types of substantive changes that may be
finalized under the Quality Payment Program or the effect of those
changes on our ability to calculate performance on the measure, this
proposal would provide us with additional flexibility to redesignate
existing measures undergoing a substantive change as pay-for-reporting
on a measure by measure basis. We believe this additional flexibility
would enable us to more appropriately assess ACO quality performance,
by ensuring that ACOs are not held accountable for performance on a
measure when substantive changes to that measure affect our ability to
assess performance on that measure appropriately. Otherwise, ACOs could
be inappropriately held accountable for performance on such measures
until such time as we could undertake rulemaking to modify the phase-in
schedule for the measure. As with redesignations that occur when the
measure owner determines the measure no longer aligns with clinical
practice or causes patient harm, redesignations that occur due to
substantive changes to a measure would be communicated to ACOs as soon
as possible through operational documents and other typical methods we
use to communicate with ACOs. We invite comments on this proposal.
b. Further Refining 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 quality measure data ACOs enter into the web
interface (76 FR 67893 through 67894). We believe that the data
validation process implicitly incentivizes ACOs to keep organized and
up-to-date medical records and is necessary to protect against gaming.
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 Sec.
425.500(e) and involved a process under which we selected a subset of
web interface measures and a random sample of 30 confirmed and
completely reported beneficiaries for each measure in the subset. The
ACO was required to provide medical records to support the data
reported in the web interface for those beneficiaries. A measure-
specific audit performance rate was then calculated using a multi-
phased audit process. If at the conclusion of the third phase there was
a discrepancy greater than 10 percent between the quality data reported
and the medical records provided during the audit, the ACO was not
given credit for meeting the quality target for any measure(s) for
which the mismatch rate existed.
In the CY 2017 PFS final rule (81 FR 80489 through 80492), we
revisited the quality validation audit process and finalized several
significant changes as a result of our experience in conducting audits
and in an effort to increase the statistical rigor of the audit
methodology while streamlining audit operations. We expressed our
intent to align the quality measures validation audit used in the
Shared Savings Program more closely with other CMS quality program
audits, including those performed in the Physician Quality Reporting
Program and the Hospital Inpatient and Outpatient Quality Reporting
programs. We therefore finalized four improvements to our audit process
that addressed 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.
Specifically, we finalized a policy under which we will audit enough
medical records to achieve a 90 percent confidence interval; conduct
the audit in a single phase; and calculate an overall audit performance
rate. If at the conclusion of the audit process the overall match rate
between the quality data reported and the medical records provided by
the ACO is less than 90 percent, absent unusual circumstances, we will
adjust the ACO's overall quality score proportional to the ACO's audit
performance. The audit-adjusted quality score is calculated by
multiplying the ACO's overall quality score by the ACO's overall audit
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 would be 60 percent. The audit-adjusted quality score is
the quality score that will be 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. We note that under the revised audit
methodology, our intent was to continue to audit a subset of ACOs,
which we would identify by looking for data anomalies such as high skip
rates, although we have flexibility to randomly select ACOs or specific
measures for audit as we have done in the past.
We also finalized a new requirement at Sec. 425.500(e)(3) that an
ACO that has an audit match rate of less than 90 percent may be
required to submit a corrective action plan (CAP) under Sec. 425.216
for our approval. In the CAP, the ACO would be required to explain the
reasons for the low audit match rate and how it plans to improve the
accuracy of its quality reporting in the future. In addition, we noted
that we maintain the right, as described in Sec. 425.500(f), to
terminate or impose other sanctions on any ACO that does not report
quality data accurately, completely, or timely. We indicated that we
would begin applying these policies to the quality validation audits
beginning in 2017 with the quality validation audits of quality
reporting for the 2016 performance year.
(2) Proposals
Since publication of the CY 2017 PFS final rule, we have gained
additional experience with the quality validation audits, and have
performed additional analyses related to these audits. Our analysis of
the 2016 quality measure validation audit results for Shared Savings
Program ACOs indicates that the average match rate of ACOs audited in
calendar year 2016 was 72 percent and the median performance was 80
percent. Typically, during the audit, we review medical record
documentation and work with ACOs to better understand the mismatch
between what was reported and what was documented and have determined
through our analyses that ACOs continue to experience challenges in
understanding certain aspects of the measure specifications,
coordinating collection of information across many different providers
and practices, and satisfying the requirements for supporting
documentation. Many of these errors are not indicative of poor quality
of care but rather reflect minor errors in process or
[[Page 34114]]
in understanding measure requirements. For instance, we have identified
errors by individuals abstracting data from the medical record. In one
case, a medical record abstractor incorrectly misinterpreted the less
than symbol (<) in the quality measure specifications for the ACO-31
Heart Failure: Beta Blocker Therapy for Left Ventricular Systolic
Dysfunction and ACO-33 Angiotensin-Converting Enzyme (ACE) Inhibitor or
Angiotensin Receptor Blocker (ARB) Therapy, and therefore, abstracted
the data incorrectly for reporting.
Under our newly finalized single-phase approach to quality
validation audits, minor errors are more likely to affect the final
audit results and impact the calculation of shared savings or shared
losses when the overall match rate is below 90 percent. Additionally,
we note that the match rate threshold under the Hospital Inpatient
Quality Reporting (HIQR) Program is 75 percent. The HIQR validates data
submitted by hospitals, which are entities that generally have more
experience with quality reporting, greater health record accessibility
and integration, and a longer history of validation of quality data
submitted to CMS.
In light of our analyses of the 2016 quality measure validation
audit results, we believe it is appropriate to consider making
additional modifications to our quality validation audit process.
First, we are concerned that the 90 percent match rate adopted in CY
2017 PFS final rule may be too high and could inappropriately penalize
ACOs that make quality data reporting errors that are unrelated to care
quality. In the early years of phasing in this new audit methodology,
we believe that the match rate should instead be based on actual ACO
experience in order to focus on holding ACOs accountable for clinically
related mismatches in reporting quality measures as they continue to
gain experience with how to measure, report and improve quality under
the program. We believe that basing the audit match rate threshold on
actual validation audit results would strike an appropriate balance
between ensuring the accuracy of ACO quality reporting while not unduly
penalizing ACOs for minor quality reporting errors that are not
necessarily indicative of poor quality care. Accordingly, we believe it
would be appropriate to set the audit match rate threshold based on the
median match rate (80 percent) for ACOs audited in calendar year 2016
rather than an alternative approach such as the mean match rate because
the median match rate would be less affected by data outliers.
Therefore, we are proposing to revise Sec. 425.500(e)(2) to indicate
that if an ACO has a match rate below 80 percent, absent unusual
circumstances, we would adjust the ACO's overall quality score
proportional to the ACO's audit performance.
Second, we propose to amend the method by which we adjust an ACO's
overall quality score to reflect the ACO's audit performance.
Specifically, we propose to revise the methodology described in the
2017 PFS final rule (81 FR 80490) under which the audit-adjusted
quality score is calculated by multiplying the ACO's overall quality
score by the ACO's audit match rate. Instead, we propose that for each
percentage point difference between the ACO's match rate and the match
rate considered passing the audit, the ACO's overall quality score
would be adjusted downward by 1 percent. That is, if we finalize the
proposal to establish an 80 percent match rate as the threshold for
passing the quality validation audit, and the ACO's match rate is 75
percent, then under this proposal we would adjust the ACO's overall
quality score downward by 5 percent. To illustrate, assuming a match
rate threshold of 80 percent, an ACO with an overall quality score of
90 percent would have an audit-adjusted quality score of 85.50 percent,
that is, (90-[.05x90]) = 85.50.
Finally, we propose a conforming change to Sec. 425.500(e)(3) to
reflect the 80 percent threshold such that if at the conclusion of the
audit process CMS determines there is an audit match rate of less than
80 percent, the ACO may be required to submit a CAP.
We believe that over time, as ACOs become more experienced with
quality reporting requirements, improve their quality reporting
processes and become better clinically integrated, quality validation
audit results that show a significant mismatch between the information
reported and the underlying medical records will more consistently
reflect meaningful, clinically related quality reporting errors for
which ACOs should be held accountable. In addition, because the audit
process involves the exchange of information regarding medical record
review and communication between ACOs and us, the audit process,
itself, provides additional education on the quality measures and
quality reporting. Accordingly, we will periodically review the audit
match threshold and seek to increase the match rate over time. We may
also consider requiring a higher match rate for ACOs that have been in
the program longer. Therefore, we anticipate that we will continue to
closely monitor quality validation audit results and the reasons for
mismatches and, over time, seek to increase the audit match rate
threshold.
Although at this time we are proposing the change the audit match
rate threshold to 80 percent, we also seek comment on an alternative
approach we considered to address the quality validation audit match
rate and the resulting impact on an ACO's overall quality score.
Consistent with the approach used under the HIQR program, we
considered revising Sec. 425.500(e)(2) to provide that we would adjust
the ACO's overall quality score if an ACO has a match rate below 75
percent. We did not propose this approach because the results of the
Quality Measures Validation Audits conducted on Shared Savings Program
ACOs in calendar year 2016 yielded a median match rate of 80 percent,
suggesting that a match rate of 75 percent would be too low.
We invite comment on the proposed refinements to the process used
to validate ACO quality data reporting and to adjust an ACO's overall
quality score to reflect the ACO's audit performance, and on the
alternative that was considered, but not proposed.
3. Reducing Shared Savings Program Application Burden
a. SNF 3-Day Rule Waiver Application Requirement That ACOs Report Their
Financial Relationships
(1) 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 3 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, 32808), we provided ACOs participating in Track 3 with
additional flexibility to attempt to increase quality and decrease
costs by allowing these ACOs to apply for a waiver of the SNF 3-day
rule to permit their prospectively assigned beneficiaries to receive
coverage for inpatient SNF care without a prior 3-day inpatient
hospital stay when they are admitted to a ``SNF affiliate,'' that is, a
SNF with which the ACO has executed a SNF affiliate agreement, and
certain additional eligibility criteria are met (see Sec.
425.612(a)(1)). Waivers are effective upon our notification to the ACO
of approval for the waiver or the start date of the ACO's participation
agreement, whichever is later (see Sec. 425.612(c)). We stated in the
June 2015 final rule that the SNF 3-day rule waiver
[[Page 34115]]
would be effective for services furnished on or after January 1, 2017.
Program requirements for this waiver are codified at Sec. 425.612.
These requirements are primarily based on criteria previously developed
under the Pioneer ACO Model. Specifically, under Sec. 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 (and as provided in Sec.
425.612(a)(1)(iv) for certain other beneficiaries), who receive
otherwise covered post-hospital 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 SNF services furnished to
a particular beneficiary are eligible for payment under the SNF 3-day
rule waiver 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 Sec. 425.401(b)), so it will be clearer to a Track 3
ACO and its SNF affiliates 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 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 Sec.
425.612 that ACOs, ACO providers/suppliers, SNF affiliates, and
beneficiaries must meet for SNF services to be covered under the SNF 3-
day rule waiver under the Shared Savings Program. All ACOs electing to
participate in Track 3 are 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. The program rules for a waiver of the SNF 3-day rule are
under Sec. 425.612 and are discussed in detail in the 2015 final rule
(80 FR 32804 through 32806).
To qualify to use the SNF 3-day rule waiver, ACOs must submit a SNF
3-Day Rule Waiver application that includes supplemental information
sufficient to demonstrate that the ACO has 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. Required application materials include but are not limited to the
following:
Narratives describing how the ACO plans to implement the
waiver. Narratives must include a 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 health care
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.
A list of SNFs with which the ACO will partner along with
executed written SNF affiliate agreements between the ACO and each
listed SNF. The agreements must include elements determined by CMS
including but not limited to the following:
++ Agreement to comply with the requirements and conditions of the
Shared Savings Program.
++ The effective dates of the SNF affiliate agreement.
++ Agreement to implement and comply with the ACO's beneficiary
evaluation and admission plan and care management plan.
++ Agreement to validate the eligibility of a beneficiary to
receive covered SNF services in accordance with the waiver prior to
admission.
++ Remedial processes and penalties that will apply for non-
compliance.
Documentation demonstrating that each SNF included on the
submitted list of SNF affiliates has an overall rating of 3 or higher
under the CMS 5-star Quality Rating System as reported on CMS's Nursing
Home Compare Web site.
In addition, Sec. 425.612(b)(3) provides that we will evaluate the
information submitted with the ACO's application for the SNF 3-day rule
waiver and any supplemental information submitted in response to a CMS
request for information to determine whether the ACO's waiver request
satisfies the requirements of Sec. 425.612(a)(1). The effective date
and termination date of the waiver are determined in accordance with
Sec. 425.612(c). Section 425.612(d) provides for monitoring of the use
of the waiver and termination of the waiver, and includes a requirement
that ACOs that have been approved for the SNF 3-day rule waiver post
their approval to use the waiver as part of public reporting under
Sec. 425.308. If our monitoring of an ACO's use of the waiver reveals
misuse of the waiver, we may revoke the ACO's approval to use the
waiver. Additionally, we may revoke an ACO's approval to use a waiver
if the ACO does not successfully meet the quality performance standard
or we identify another program integrity issue affecting the ACO's use
of the waiver.
To be eligible to receive covered services under the SNF 3-day rule
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 in Sec. 425.612(a)(1)(ii).
We noted in the 2015 final rule 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 (80 FR 32806). We indicated that in the event we
determined that changes were necessary, we would propose these changes
through future rulemaking. Subsequently, based on initial experiences
with the SNF 3-day rule waiver under the Pioneer ACO Model and Next
Generation ACO Model, we proposed and finalized additional SNF 3-day
rule waiver beneficiary protections under Sec. 425.612(a)(1)(iv) and
(v). (See the CY 2017 PFS final rule (81 FR 80510 through 80515)).
We began accepting SNF 3-Day Rule Waiver applications in the summer
of 2016 and approved 26 Track 3 ACOs to begin using the SNF 3-day rule
waiver under the Shared Savings Program effective January 1, 2017.
(2) Proposal
As discussed in this proposed rule, the SNF 3-day rule waiver
requirements are primarily based on criteria previously developed under
the Pioneer
[[Page 34116]]
ACO Model. As a result of our recent experience implementing the waiver
in the Next Generation ACO Model and the Shared Savings Program, we
believe that the rules governing use of the SNF 3-day rule waiver are
generally reasonable. However, based on our initial experiences in
reviewing SNF 3-Day Rule Waiver applications, we believe there are two
requirements, in particular, that impose an unnecessary burden on
applicants, without a sufficient benefit to the administration of the
Shared Savings Program to justify the burden.
First, the requirement under Sec. 425.612(a)(1)(i)(A)(4) that ACOs
submit, as part of their application for the SNF 3-day rule waiver, a
narrative describing any financial relationships that exist between the
ACO, SNF affiliates, and acute care hospitals is burdensome for ACOs
and CMS. As explained in the 2015 final rule (81 FR 32806), the SNF 3-
day rule waiver only provides for coverage of SNF services that meet
all applicable requirements except the requirement for a prior 3-day
inpatient stay. The waiver does not protect financial or other
arrangements between or among ACOs, ACO participants, ACOs providers/
suppliers, or other individuals or entities providing services to
Medicare beneficiaries from liability under the fraud and abuse laws or
any other applicable laws (Sec. 425.612(e)(1)). The Shared Savings
Program regulations do not prohibit ACOs or SNFs from having financial
arrangements with acute care hospitals, nor do they require such
arrangements. Therefore, we have found that the narratives are not
useful to us for purposes of determining whether to approve a waiver
request. Based on our experience with the implementation of SNF 3-day
rule waivers, we are proposing to remove the requirement at Sec.
425.612(a)(1)(i)(A)(4) under which ACOs applying for the SNF 3-day rule
waiver must submit a narrative describing any financial relationships
between the ACO, SNF affiliate, and acute care hospitals. Removing this
requirement would not only reduce burden for ACOs applying for the
waiver but would also enable us to devote our application review
resources to a rigorous review of other, more relevant application
elements. Focusing our resources on the review of the information that
is most directly relevant to determining an ACO's capacity to manage
beneficiaries who are admitted to a SNF without a prior 3-day inpatient
hospital stay, along with ongoing oversight and program compliance
monitoring of the use of the waiver by approved ACOs (as described in
section III.G.3.a.(1) of this proposed rule), would also allow us to
more efficiently use our resources to ensure that the SNF 3-day rule
waiver is being used appropriately and to address any potential
concerns about use of the waiver. Although we do not believe it is
necessary for ACOs to submit separate narratives describing their
financial relationships for purposes of the SNF 3-day rule waiver, we
note that under the Shared Savings Program rules, ACOs, ACO
participants, ACO providers/suppliers, and other individuals or
entities performing functions or services related to ACO activities,
including SNF affiliates, must maintain and give us access to certain
documents and information related to items including financial
arrangements related to ACO activities (Sec. 425.314(b)(1)). We
continue to retain broad discretion under Sec. 425.316 to audit ACOs,
ACO participants, and ACO providers/suppliers for compliance with
program rules, and the program rules also make it clear that waivers
under Sec. 425.612 do not protect financial or other arrangements
between or among ACOs, ACO participants, ACO providers/suppliers, or
other individuals or entities providing services to Medicare
beneficiaries from liability under the fraud and abuse laws or any
other applicable laws (Sec. 425.612(e)).
Second, we believe that the requirement under Sec.
425.612(a)(1)(i)(C) that ACOs submit documentation demonstrating that
each SNF included on their list of SNF affiliates has an overall rating
of 3 or higher under the CMS 5-star Quality Rating System is
unnecessarily burdensome. In order to meet this requirement, ACOs
typically submit a screen shot from the CMS Nursing Home Compare Web
site or other Nursing Home Compare information that reflects the star
rating for each listed SNF. The submission of this documentation by the
ACO does not add value to our review and approval of SNFs included on
the ACO's SNF affiliate list. Instead, we obtain the information
directly from our Web site during the application review process. In
this way, we insure that the most current information is used during
the application review process. We also periodically monitor this
information after an ACO has been approved to use the waiver because
SNF affiliates are required to maintain an overall rating of 3 stars or
higher, under Sec. 425.612(a)(1)(iii)(A). Because we are able to
obtain the required information directly from the CMS Nursing Home
Compare Web site, the additional documentation submitted by the ACO as
part of its application does not add value to our ability to review and
approve SNF affiliates. Accordingly, we are proposing to eliminate this
documentation submission requirement by removing Sec.
425.612(a)(1)(i)(C). We note that we are not proposing to remove or
modify the requirement in Sec. 425.612(a)(1)(iii)(A) that SNF
affiliates must have and maintain an overall rating of 3 or higher
under the CMS 5-star Quality Rating System in order to remain eligible
to partner with the ACO for purposes of the SNF 3-day rule waiver. The
requirement for SNF affiliates to have and maintain a 3-star or higher
rating is retained. Furthermore, as part of the application process, we
intend to continue to verify that the ACO has met all requirements
related to the SNF 3-day rule waiver, but we believe that the
burdensome and duplicative submission of CMS 5-star Quality Rating
System documentation is not necessary to ensure compliance with the
requirement that the ACO's SNF affiliates have a star rating of 3 or
more.
We welcome comments on our proposal to remove Sec.
425.612(a)(1)(i)(A)(4) which requires SNF 3-Day Rule Waiver applicants
to submit a narrative describing any financial relationships that exist
between the ACO, SNF affiliate, and acute care hospitals. We further
welcome comments on our proposal to remove Sec. 425.612(a)(1)(i)(C)
which requires waiver applicants to submit documentation demonstrating
that each SNF affiliate on their SNF affiliate list has an overall
rating of 3 or higher under the CMS 5-star Quality Rating System. We
also welcome other suggestions on how we might further decrease the
burden for ACOs requesting approval to use the SNF 3-day rule waiver,
without compromising our ability to ensure that ACOs and their SNF
affiliates have the capacity to identify and manage beneficiaries
receiving covered SNF services pursuant to the waiver. We may consider
any such suggestions in future rulemaking.
b. Modifications to the Shared Savings Program Initial Application
(1) Background
In order to participate in the Shared Savings Program,
organizations must meet certain eligibility requirements, including the
statutory requirement to define processes to promote evidence-based
medicine and patient engagement, report on quality and cost measures,
and coordinate care. Additionally, the ACO
[[Page 34117]]
must demonstrate it meets patient-centeredness criteria specified by
the Secretary, such as the use of patient and caregiver assessments or
the use of individualized care plans. We discussed and finalized
details for ACO eligibility criteria, including the four required
processes and patient-centeredness criteria, in the November 2011 final
rule (76 FR 67826 and 67827) and made updates to them in the June 2015
final rule (80 FR 32722 through 32725).
Section 425.204(c)(1) articulates the supporting documents and
materials an ACO must submit to demonstrate that the ACO satisfies the
eligibility requirements to participate in the Shared Savings Program.
To obtain a determination regarding whether an ACO meets the
requirements to participate in the Shared Savings Program, a
prospective ACO must submit a complete application in the form and
manner required by us by the deadline established by us (Sec.
425.202(a)(1)). The content of the application is outlined at Sec.
425.204. Section 425.204(c) states that as part of the application, and
upon request thereafter, an ACO must submit to us certain supporting
documentation to demonstrate that the ACO satisfies the requirements of
the Shared Savings Program. Supporting documentation in this section
includes:
Documents (for example, ACO participant agreements,
agreements with ACO providers/suppliers, employment contracts, and
operating policies) sufficient to describe the ACO participants' and
ACO providers'/suppliers' rights and obligations in and representation
by the ACO, and how the opportunity to receive shared savings or other
financial arrangements will encourage ACO participants and ACO
providers/suppliers to adhere to the quality assurance and improvement
program and evidence-based clinical guidelines.
A description, or documents sufficient to describe, how
the ACO will implement the required processes and patient-centeredness
criteria under Sec. 425.112, including descriptions of the remedial
processes and penalties (including the potential for expulsion) that
will apply if an ACO participant or an ACO provider/supplier fails to
comply with and implement these processes.
Materials documenting the ACO's organization and
management structure, including an organizational chart, a list of
committees (including names of committee members) and their structures,
and job descriptions for senior administrative and clinical leaders.
Evidence that the ACO's governing body is an identifiable
body, represents a mechanism for shared governance for ACO
participants, is composed of representatives of its ACO participants;
and is at least 75 percent controlled by its ACO participants.
Evidence that the governing body includes a Medicare
beneficiary representative(s) served by the ACO who does not have a
conflict of interest with the ACO, and who has no immediate family
member with a conflict of interest with the ACO.
A copy of the ACO's compliance plan or documentation
describing the plan that will be put in place at the time the
participation agreement with CMS becomes effective. Additionally, Sec.
425.204(d) states that as part of the application to participate in the
Shared Savings Program, an ACO must describe the following:
++ How it plans to use shared savings payments, including the
criteria it plans to employ for distributing shared savings among its
ACO participants and ACO providers/suppliers.
++ How the proposed plan will achieve the specific goals of the
Shared Savings Program.
++ How the proposed plan will achieve the general aims of better
care for individuals, better health for populations, and lower growth
in expenditures.
Section 425.204(c)(1)(ii) includes a reference to the required
processes and patient centeredness criteria under Sec. 425.112. Of
note, Sec. 425.112(b)(4)(ii) requires that, as part of its
application, an ACO must submit a description of its individualized
care program, along with a sample individual care plan, that explains
how the ACO's program is used to promote improved outcomes for, at a
minimum, its high risk and multiple chronic condition patients (Sec.
425.112(b)(4)(ii)(A)). The ACO must also, as part of its application,
describe additional target populations that would benefit from
individualized care plans (Sec. 425.112(b)(4)(ii)(B)) and describe how
it will encourage and promote the use of enabling technologies for
improving care coordination for beneficiaries (Sec.
425.112(b)(4)(ii)(C)). Finally, as part of its application, the ACO
must describe how it intends to partner with long-term and post-acute
care providers, both inside and outside the ACO, to improve care
coordination for its assigned beneficiaries (Sec.
425.112(b)(4)(ii)(D)).
Once an applicant has submitted the information required under
Sec. 425.204, we evaluate it to determine whether the applicant
satisfies the Shared Savings Program requirements. We notify ACO
applicants during the application review process when information is
missing or when supplemental documentation or other information is
necessary to make a determination on the ACO's application and provide
opportunities for the ACO to submit the requested additional
information for review. At the end of the application review process,
we approve or deny the application and notify the ACO of our
determination.
(2) Proposals
In conducting Shared Savings Program application reviews, we have
found that many of the document submission requirements in Sec.
425.204(c)(1) substantially increase application and review burden
without lending significant value to our review of an organization's
application to confirm that the ACO meets the eligibility requirements
for participation in the Shared Savings Program. We believe it would
meet program needs and reduce applicant burden if we were to revise
Sec. 425.204(c)(1) to remove the requirement to submit supporting
documents or narratives and instead provide that we may request these
materials if additional information is needed in order to fully assess
the ACO's application before making a decision to approve or deny the
application.
To illustrate, as discussed in this proposed rule, we require under
Sec. 425.204(c)(1)(ii), as part of the application process, that the
ACO submit documentation addressing the required processes and patient
centeredness criteria under Sec. 425.112. This requirement is
addressed in the Medicare Shared Savings Program Initial Application
(see application on the CMS Web site at https://www.cms.gov/medicare/medicare-fee-for-service-payment/sharedsavingsprogram/application.html)
through the requirement that an applicant ACO submit narratives
describing how it will define, establish, implement, evaluate, and
periodically update each process. In these narratives, the ACO must
also describe certain additional details regarding the required
processes:
Process to promote evidence-based medicine. The ACO must
describe how it will:
++ Encourage the use of protocols grounded in evidence-based
medicine in the case of diagnoses with significant potential for the
ACO to achieve quality improvements, while taking into account the
circumstances of individual beneficiaries; and
[[Page 34118]]
++ Use the internal assessments of this process to continuously
improve the ACO's care practices.
Process to promote beneficiary engagement. The ACO must
describe how it will:
++ Evaluate the health needs of its assigned beneficiary population
(including consideration of diversity in its patient population) and
develop a plan to address the needs of its population;
++ Communicate clinical knowledge/evidence-based medicine to
beneficiaries in a way they can understand;
++ Engage beneficiaries in shared decision-making in ways that
consider beneficiaries' unique needs, preferences, values and
priorities;
++ Establish written standards for beneficiary access and
communication as well as a process for beneficiaries to access their
medical records; and
++ Use the internal assessments of this process to continuously
improve the ACO's care practices.
Process to internally report quality and cost metrics. The
ACO must describe how:
++ The ACO will use these results to improve care and service over
time; and
++ The ACO will use the internal assessments of this process to
continuously improve the ACO's care practices.
Process to promote coordination of care. The ACO must
describe:
++ The ACO's methods and processes to coordinate care throughout an
episode of care and during care transitions, such as discharge from a
hospital or transfer of care from a primary care physician to a
specialist (both inside and outside the ACO).
++ The ACO's individualized care program, along with a sample
individual care plan, and explain how the ACO uses this program to
promote improved outcomes for, at a minimum, high-risk and multiple
chronic-condition patients.
++ How individual care plans take into account the community
resources available to beneficiaries.
++ Additional target populations that would benefit from
individualized care plans.
++ How the ACO will use the internal assessments of this process to
continuously improve the ACO's care practices.
++ How the ACO will encourage and promote use of enabling
technologies for improving care coordination for beneficiaries.
++ How the ACO intends to partner with long-term and post-acute
care providers, both inside and outside of the ACO, to improve care
coordination for their assigned beneficiaries.
As a result of our experience in reviewing these narratives, we
have determined that while they can be helpful to verify that the ACO
has established the required processes and defined patient-centeredness
criteria prior to its entry into the Shared Savings Program, the
specific details of the processes the ACO has established are not
particularly important or relevant for purposes of assessing whether
the ACO is eligible to participate in the program. In fact, ACOs have
indicated that their initial plans for the processes required under
Sec. 425.112 as articulated in their program application often change
as a result of obtaining additional information about their ACO
participants' and ACO providers/suppliers' processes and gaining
additional experience during implementation of the processes. We
believe such improvements to ACO processes based on program experience
are reasonable to expect and should be encouraged. First, under Sec.
425.112(b), ACOs are required to evaluate and periodically update each
process and as they do so, initially implemented processes will
necessarily change to accommodate lessons learned. Moreover, once the
ACO begins to request claims information and other CMS data and to
incorporate this information into its operations, the ACO may discover
that certain assumptions it made at the time of application should be
adjusted to maximally improve the quality of care or cost efficiencies
for the ACO's assigned population. In rare instances, particularly in
the early days of the program before stakeholders fully understood the
implications of program participation, we found review of such
narratives useful to understand the level of an ACO's readiness for
participation in the Shared Savings Program. However, such narratives
have not been particularly useful in determining if the ACO meets the
requirements for participation in the Shared Savings Program. In a vast
majority of cases, we now believe it is sufficient that the ACO certify
at the time of application that it has defined the required processes
and patient centeredness criteria consistent with the requirements
specified in section Sec. 425.112. Therefore, we believe it would
reduce burden for ACOs, without compromising our ability to determine
whether an ACO meets the criteria for participation in the Shared
Savings Program, to require that the ACO certify that it meets the
requirements in Sec. 425.112, and only submit a narrative or other
documentation describing how the ACO will implement the required
processes and patient-centeredness criteria upon our request. Further,
we do not anticipate that this change would have a significant effect
on beneficiaries receiving services from ACO providers/suppliers
because as noted earlier, we anticipate that ACOs would update each
process as they gain experience and, as they do so, initially
implemented processes that might have been reflected in the narrative
or other supporting documentation submitted with their application
would necessarily change to accommodate lessons learned.
Similarly, as part of the application process, the Shared Savings
Program regulations require the ACO to submit materials documenting the
ACO's organization and management structure, including an
organizational chart, a list of committees (including names of
committee members) and their structures, and job descriptions for
senior administrative and clinical leaders (Sec. 425.204(c)(1)(iii)).
While we have found the organizational chart useful for purposes of our
review and approval of an ACO's application, and we anticipate
continuing to request this chart from many applicants, we have found
that further detail including lists of committees and job descriptions
for senior administrative and clinical leaders have not added
particular value to our review and approval of applications. Moreover,
the receipt of such materials as part of the ACO's application has not
significantly impacted our ability to determine whether the ACO meets
the requirements regarding leadership and management in Sec. 425.108.
We believe, on balance, that our need for such detailed information
from all applicants is outweighed by our desire to reduce application
burden. In particular circumstances where additional information would
aid our review, we believe our need for such detailed information can
be reasonably met by requiring applicants to submit such materials upon
our request. As a result, we believe it would be less burdensome for us
to require ACO applicants to certify that, for example, they meet the
leadership and management requirements found at Sec. 425.108 rather
than requiring all ACO applicants to submit detailed materials (such as
job descriptions) or narratives about the ACO's committees and
leadership.
While we do not anticipate having to routinely request such
materials to supplement our review and approval of ACO applications to
participate in the Shared Savings Program, we believe it is important
to retain the discretion to do
[[Page 34119]]
so in limited cases where such detail could be useful. Therefore, we
propose to make revisions to our application requirements as discussed
in this section. We would note that in cases where an ACO is requested
to submit additional material for review in conjunction with its
application, and we find that the material is inconsistent with program
requirements, then we may deny the ACO's application. Similarly, if we
discover the inconsistency after the ACO has already been approved to
participate in the program, the ACO may be subject to the pre-
termination actions set forth in Sec. 425.216, termination under Sec.
425.218, or both.
Additionally, we do not believe it is necessary for ACO applicants
to submit narratives describing how they would distribute shared
savings payments or how the proposed plan would achieve the specific
goals of the Shared Savings Program and the general aims of better care
for individuals, better health for populations, and lower growth in
expenditures, as required by Sec. 425.204(d). Based on our experience,
such narratives have not been useful in determining if the ACO meets
requirements for participation in the program or whether an ACO's
application should be approved. We believe it would be more useful to
us and less burdensome for ACOs if we were instead to require that, an
ACO, as part of its application to participate in the Shared Savings
Program, certify that it has a method and plan to receive shared
savings payments and to distribute those payments to its ACO
participants and ACO providers/suppliers, as required by the statute.
We note, however, that we continue to believe it is useful to
stakeholders to know how various ACOs have chosen to use or distribute
the shared savings they earn. Therefore, in the interest of
transparency, we will continue to require ACOs to publicly report
information on their dedicated Web pages about their shared savings and
shared losses, including information about the total proportion of
shared savings invested in infrastructure, redesigned care processes,
and other resources to support the three-part aim goals of better
health for populations, better care for individuals, and lower growth
in expenditures, including the proportion distributed among ACO
participants, as required under Sec. 425.308(b)(4).
In light of our experience with the review of the documentation
submitted as part of the ACO's initial application, we are proposing
several modifications to our requirements for document submission.
Under this proposal, we would retain all requirements related to ACO
eligibility criteria and public reporting, as currently specified under
the Shared Savings Program regulations. However, in order to reduce
application burden without compromising our ability to evaluate
applications effectively for compliance with Shared Savings Program
requirements, we propose to modify certain sections of our regulations
that require ACOs to submit supporting materials and documentation at
the time of application. Instead of requiring submission of certain
materials, narratives, or supporting documentation, as discussed in
this section, we propose to require ACOs to certify that they meet the
applicable eligibility and documentation requirements as specified
under our program rules. At the same time, while we are interested in
reducing burden, we recognize that there have been instances when the
review of supporting documentation and/or narratives has been helpful
in making a determination about an ACO's eligibility for participation
in the program. Therefore, although we are proposing to eliminate the
general requirement that ACOs submit certain documentation as part of
their initial application to participate in the Shared Savings Program,
we propose to retain the right to request the submission of supporting
materials and documentation in cases when such additional information
would be useful in making a determination regarding the ACO's
application. We believe that this proposed modification to the
regulations governing ACO applications would introduce additional
flexibility that would reduce the level of burden inherent in the
Shared Savings Program application process while also ensuring we are
still able to appropriately evaluate an ACO's eligibility for program
participation.
Accordingly, in order to reduce application burden while retaining
flexibility to obtain additional documentation when necessary to
determine ACO eligibility and compliance with program rules, we propose
to remove the requirements in Sec. Sec. 425.204(c)(1) and (d),
425.112(a)(3)(i) and (ii), and 425.112(b)(4)(ii) for the submission of
certain specified documents and narratives as part of an ACO's
application to participate in the Shared Savings Program. Specifically,
we propose to revise paragraph Sec. 425.204(c)(1) to require an ACO,
as part of its application, to certify that it satisfies the Shared
Savings Program requirements and to submit, upon CMS request,
supporting materials (including narratives) and documentation
demonstrating that the ACO satisfies program requirements indicated in
proposed revised Sec. 425.204(c). Additionally, we propose to revise
Sec. 425.204(d) to indicate that the ACO must certify, as part of its
application to participate in the Shared Savings Program, that it has a
mechanism and plan to receive and use payments for shared savings,
including criteria for distributing shared savings among its ACO
participants and ACO providers/suppliers. We also propose to make a
conforming change to remove paragraphs (d)(1) through (3) of Sec.
425.204, which relate to the submission of narratives related to the
ACO's use of shared savings payments. This proposal does not include a
requirement that the ACO submit information regarding its mechanism and
plan for receiving and using shared savings upon request. We do not
intend to request this information as part of the application process
because in our experience, how an ACO intends to use or distribute
shared savings has not been a relevant consideration during any
application cycle to determine whether the ACO has met the eligibility
requirements to participate in the Shared Savings Program. However, we
note that we continue to believe that information on how an ACO uses
and distributes its shared savings is useful for the public, and
therefore ACOs will continue to be required to publicly report this
information under Sec. 425.308(b)(4)(ii).
We also propose similar changes to the requirements in Sec.
425.112(a)(3)(i), (a)(3)(ii), and (b)(4)(ii) to remove reference to the
submission of narratives to explain or describe how the ACO will
implement the required elements of the ACO's care processes and
patient-centeredness criteria. ACOs must still implement these care
processes and adopt a focus on patient-centeredness, however, they will
no longer need to submit descriptions of how they will satisfy these
requirements as part of their initial application. We note, however,
that ACOs may still be required to submit upon request a description or
documentation sufficient to describe how the ACO will implement the
required processes and patient-centeredness criteria found at Sec.
425.112 because under the proposed revisions to Sec.
425.204(c)(1)(ii), CMS would retain the discretion to request such
documentation from the ACO at any time.
In summary, we believe these modifications to the application
requirements will significantly reduce
[[Page 34120]]
the burden of applying to participate in the Shared Savings Program
without reducing our ability to ensure that applicants meet the
established eligibility requirements. Rather than requiring every
applicant to submit detailed supporting documents or narratives for all
of these requirements, we would instead request supporting documents or
narratives only if additional information is needed in order to fully
assess an ACO's application before making a decision to approve or deny
the application. Further, we do not anticipate that the proposed
modifications to our application requirements would have any effect on
beneficiaries receiving care from providers and suppliers participating
in the Shared Saving Program, nor do we believe that the proposed
changes would affect our program integrity efforts, because we would
retain discretion to request such information (and more targeted and
appropriate information) as needed. We seek comment on these proposals
and on additional ways to reduce burden in the application process.
4. Addressing Compliance With ACO Participant TIN Exclusivity
Requirement
a. Background
Under the Shared Savings Program, ACO participant TINs are not
required to be exclusive to one Shared Savings Program ACO unless the
TIN submits claims for primary care services used to determine the
ACO's assigned population (Sec. 425.306(b)). The purpose behind this
requirement is to ensure that we are able to assign a unique set of
beneficiaries to each ACO participating in the Shared Savings Program.
Therefore, as part of the Shared Savings Program application process
and upon an ACO's request to add an ACO participant TIN, we check the
TIN against all other Shared Savings Program ACO participant lists. If
the TIN appears on the ACO participant list one or more other ACOs, the
TIN is considered to be ``overlapping.'' We then determine whether the
overlap is permissible under our program rules. If the overlap is not
permissible (because the TIN has a history of billing for primary care
services used in our assignment methodology) then we require the ACO
that is seeking to add the TIN to its ACO participant list to rectify
the overlap by the deadline we have established for making changes to
the next performance year's ACO participant list. If the overlap is
permissible (because the TIN does not have a history of billing for
primary care services used in our assignment methodology) then the ACO
participant TIN can be approved to be an ACO participant in more than
one ACO for the performance year. Each time we run the assignment
algorithm during the course of the performance year, we monitor
overlaps to ensure that the overlaps continue to be in compliance with
Sec. 425.306(b).
In a few instances, as a result of our monitoring, we have
discovered that ACO participant TINs that had been approved to
participate in multiple ACOs subsequently began billing for primary
care services used in assignment during a benchmark or performance
year. For example, for performance year 2016, we identified four TINs
that were initially permitted to overlap and participate in more than
one ACO because they had not previously billed Medicare for primary
care services used in our assignment methodology. At some point during
the performance year, however, the TINs began billing Medicare for
primary care services that are used to assign beneficiaries to the ACO
(including claims for services furnished during the performance year,
but submitted during the three-month claims runout for the performance
year). This can occur, for example, if a single specialty practice made
up of physician specialty types not used in assignment (for example, a
practice of ophthalmologists) hires a nurse practitioner who then
begins billing Medicare under the billing TIN of the ACO participant
for primary care services as defined under the Shared Savings Program
rules. Thus, the ACO participant TIN would be used to bill Medicare for
primary care services furnished by a practitioner used in our
assignment methodology (the nurse practitioner) and would therefore
trigger our requirement under Sec. 425.306(b)(2) that the ACO
participant TIN be exclusive to a single Shared Savings Program ACO.
Although our program rules permit us to take compliance action against
ACOs for violations of Shared Savings Program requirements, they do not
specifically address what compliance actions we would impose on ACOs in
instances where an ACO participant falls out of compliance with Sec.
425.306(b)(2) during a benchmark or performance year or when non-
compliance with Sec. 425.306(b)(2) is discovered during the 3-month
claims runout for a benchmark or performance year. Moreover, the
program rules do not address what modifications to our assignment
methodology could be made to account for this overlap. In the case of
the four overlapping TINs discovered during the 2016 performance year,
we notified the respective ACOs of the overlap and the ACO participant
TINs were required to terminate their participation in the ACO of their
choice. As a result, each ACO from which the TINs terminated was
required to recertify its ACO participant list for the 2016 performance
year. Depending on the timing of recertification, such changes to an
ACO participant list may also require us to recalculate performance
year beneficiary assignment and financial benchmarks. For example, if a
TIN, that was previously allowed to appear on more than one ACO
participant list, hires a nurse practitioner who begins billing primary
care claims in the month of December for the ACO's third benchmark
year, we would discover the now impermissible overlap when we begin
creating the historical benchmark reports after the 3-month claims
runout. We would contact the ACOs involved, each ACO would contact the
TIN and ask the TIN to select the ACO it wishes to remain aligned with.
The ACO not selected would be asked to remove the TIN from its ACO
Participant List and recertify the list. As a result of the
recertification of the list, the ACO's assigned population would need
to be redetermined and calculation of its benchmark would be delayed.
We are therefore concerned about the uncertainty the current process
(which includes recertification of ACO participant lists, recalculation
of assignment, and resulting delay of calculations for the benchmark or
performance year) could introduce for ACOs that may have little
influence over or knowledge of ACO participant TIN billing practices.
We believe it is important for ACOs, ACO participants, and ACO
providers/suppliers to have updated and accurate information regarding
their participation status in the Shared Savings Program. For example,
participation in a Shared Savings Program ACO has implications for ACO
providers/suppliers under the new Quality Payment Program (see 81 FR
80496 through 80501). The Quality Payment Program replaces a patchwork
system of Medicare programs with a flexible system that allows eligible
clinicians to choose from two paths that link payments to quality: The
Merit-Based Incentive Payment System (MIPS) and participation in
Advanced Alternative Payment Models (APMs). The Quality Payment
Program, through MIPS and the APM incentive, will impact eligible
clinicians' payments
[[Page 34121]]
beginning in payment year 2019 based on 2017 reporting.
Under the CY 2017 Quality Payment Program final rule with comment
period, eligible clinicians participating in Advanced APMs (including
Tracks 2 and 3 under the Shared Savings Program) may become Qualifying
APM Participants and receive a 5 percent APM Incentive Payment if they
have a sufficient percentage of payments for Part B covered
professional services, or a sufficient percentage of Medicare patients
that are attributable to services furnished through an Advanced APM for
a year. In addition to earning a 5 percent APM Incentive Payment,
Qualifying APM Participants are not subject to the MIPS reporting
requirements and payment adjustment for the year. As a result,
revisions to ACO participant lists that occur mid-year or following the
end of a benchmark or performance year could have widespread
implications not only for the ACO but also for its ACO providers/
suppliers under the Quality Payment Program.
b. Proposals
As participation in the Shared Savings Program grows and more ACOs
and ACO participants join the program, we believe the overlap situation
described previously is likely to become more common. We also believe
that changes to our program rules regarding the claims that will be
considered in assigning FFS beneficiaries to an ACO (specifically, the
policy finalized in the June 2015 final rule to exclude services
furnished by several physician specialty types from the assignment
methodology) may result in a greater number of permissible ACO
participant TIN overlaps (see 80 FR 32753 and 32754). As a result, we
anticipate there could also be an increased number of cases where ACO
participant TINs with initially permissible overlaps could become out
of compliance with the requirement at Sec. 425.306(b)(2) that an ACO
participant TIN be exclusive to a single Shared Savings Program ACO if
the TIN bills for primary care services that are used to assign
beneficiaries to the ACO. This could occur, for example, if a group
practice that initially includes only physician specialty types whose
services are excluded from the assignment methodology were to
subsequently employ a non-physician practitioner who bills for primary
care services. We believe these types of practice arrangements are
becoming increasingly common.
We therefore believe it is necessary to streamline our approach to
handling such situations in order to reduce the burden and uncertainty
for ACOs when changes in ACO participant billing practices result in an
ACO participant falling out of compliance with the exclusivity
requirement at Sec. 425.306(b)(2). Rather than the current policy
under which an ACO may be required to remove an overlapping ACO
participant and recertify its ACO participant list for the performance
year (thus necessitating redetermination of beneficiary assignment and
delays in or revisions to benchmark or performance year calculations),
we believe it would be less disruptive for ACOs if we were to permit
overlapping TINs that begin billing for services used in assignment
during a benchmark or performance year (including claims for services
furnished during the benchmark of performance year, but submitted
during the 3-month claims runout) to remain on the ACO participant
lists for all affected ACOs for the remainder of the performance year
in which we determine that an overlap exists. For example, assume that,
based on an analysis of claims for services furnished in performance
year 2018, we were to identify an impermissibly overlapping TIN in
January 2019 after the ACO participant lists for performance year 2019
had already been certified. Under this proposal, the TIN would be able
to remain on the ACO participant lists of all affected ACOs for the
2018 performance year as well as the remainder of performance year
2019. In order to ensure that the TIN overlap does not inadvertently
result in assignment of the same beneficiaries to multiple ACOs, we
would simply exclude any claims for services furnished by the
overlapping TIN from the assignment methodology when conducting final
beneficiary assignment for any benchmark or performance year in which
the TIN bills Medicare for services used in our assignment methodology.
The affected ACOs would be required to resolve the overlap prior to
recertification of their ACO participant lists for the subsequent
performance year. If the overlap remains unresolved when the ACOs
certify their ACO participant lists for the next performance year, we
would remove the TIN from the ACO participant lists of all ACOs seeking
to include the TIN, in accordance with our current policy for resolving
overlaps. For example, in the hypothetical case above, if the overlap
were to remain unresolved when the ACOs certify their ACO participant
lists for performance year 2020, we would remove the TIN from the ACO
participant lists for all ACOs seeking to include the TIN as an ACO
participant for performance year 2020.
We therefore propose to modify our program rules in Sec. 425.306
and subpart E of part 425 to address this issue. We propose to modify
Sec. 425.306(b) to indicate that if, during a benchmark or performance
year (including the 3-month claims run out period for such benchmark or
performance year), an ACO participant that participates in more than
one ACO begins billing for services that would be used in assignment,
we would not consider any services billed through that TIN during the
relevant performance year when performing beneficiary assignment for
the applicable benchmark or performance year. As part of this proposed
modification, we would also eliminate the references to ``primary
care'' when describing the services used to determine the ACO's
assigned beneficiary population in order to conform with our proposal
to implement section 17007 of the 21st Century Cures Act under which we
would consider all services furnished in FQHCs and RHCs in the
assignment methodology as primary care services starting in the 2019
performance year. In addition, the ACOs in which the overlapping TIN is
an ACO participant may be subject to compliance action (as provided
under Sec. 425.216) or termination under Sec. 425.218. Compliance
actions may include requiring each ACO that includes the TIN as an ACO
participant to submit a corrective action plan explaining how the ACO
plans to work with the overlapping ACO participant to resolve the
overlap for the next performance year. If the overlap remains
unresolved by the date specified by us in our request for a corrective
action plan, we would remove the overlapping ACO participant TIN from
the ACO participant list of each ACO for the subsequent performance
year.
We also propose to revise our general assignment methodology at
Sec. 425.400(a)(1) to add new paragraph (a)(1)(iii) to indicate that
when we determine final assignment after the end of each benchmark or
performance year, we will exclude claims for services furnished during
the benchmark or performance year by an ACO participant that
participates in more than one ACO. We believe that this policy will
ensure a uniquely assigned beneficiary population for each ACO and
prevent the same beneficiaries from being included in determining
benchmark or performance year expenditures for more than one ACO.
We believe that implementing this proposed process would improve
ACO
[[Page 34122]]
and ACO participant understanding of our policies and requirements
regarding ACO participant overlaps while also reducing burden for ACOs
that currently must recertify ACO participant lists and may be subject
to retrospective modifications or delays in assignment and other
dependent benchmark or performance year calculations. We also note that
this policy allows us to preserve the flexibility that is currently
extended to ACO participants that do not bill for services used in
assignment, while recognizing the possibility for mid-year changes in
care and billing practices by these ACO participants. Additionally, ACO
participant TINs and the eligible clinicians that bill through those
TINs would be provided greater certainty regarding whether they qualify
as participating in an APM or Advanced APM for a performance year.
Under this proposed policy, an ACO participant would know for the
entire performance year with certainty that it is participating in a
particular APM entity.
5. Treatment of Individually Beneficiary Identifiable Payments Made
Under a Demonstration, Pilot, or Time Limited Program
a. Background
Under section 1899(d) of Act, ACOs participating in the Shared
Savings Program are accountable for the total Parts A and B costs for
the Medicare fee-for-service beneficiaries assigned to the ACO.
Therefore, we include all payments made from the Medicare Trust Fund
for Parts A and B services furnished to assigned Medicare FFS
beneficiaries, including individually beneficiary identifiable non-
claims based payments made under a demonstration, pilot or time limited
program, when computing average per capita Medicare expenditures for an
ACO during both the benchmark period and performance years. We believe
it is appropriate to take into account non-claims based payments from a
demonstration, pilot, or time limited program in Medicare Shared
Savings Program financial calculations to ensure that the final shared
savings payments that are made to ACOs are accurate and reflect all
Parts A and B expenditures for the ACO's assigned beneficiaries. We
also review individually beneficiary identifiable payments made under a
demonstration, pilot, or time-limited program as part of our efforts to
ensure there is no duplication of payments for beneficiaries that may
be assigned to both the Shared Savings Program and other Innovation
Center models. This general policy of considering individually
beneficiary identifiable non-claims based payments made under a
demonstration, pilot or time limited program was initially established
in the 2011 final rule implementing the Shared Savings Program (76 FR
67915) for:
Establishing, adjusting, and updating the benchmark for an
ACO's first agreement period under Sec. 425.602(a)(1)(ii),
Calculation of savings under the one-sided model (Track 1)
at Sec. 425.604(a)(6)(ii), and
Calculation of shared savings and losses under Track 2 at
Sec. 425.606(a)(6)(ii).
This policy has also been included in subsequent program
modifications to the program for:
Resetting, adjusting, and updating the benchmark for a
subsequent agreement period under Sec. Sec. 425.603(c)(1)(ii) and
425.603(e)(2)(ii), and
Calculation of shared savings and losses under Track 3 at
Sec. 425.610(a)(6)(ii).
More specifically, in addition to Medicare Parts A and B claims, we
include non-claims based individually beneficiary identifiable payments
when performing financial calculations for the Shared Savings Program,
including setting the preliminary and final benchmarks, updating the
financial benchmark at the time of reconciliation and calculating
performance year expenditures. We internally track non-claims based
beneficiary identifiable payments (that is, payments made outside the
Medicare fee-for-service claims system) through a separate CMS system
that receives and stores these non-claims based payments made from the
Medicare Trust Funds under a demonstration, pilot or time limited
program. The non-claims based payments are loaded into the separate
system at various points in time, depending on the terms of payment
under each specific demonstration, pilot or time limited program. The
amounts that are reflected in this separate system include interim
payment amounts that are subject to final reconciliation and may not
reflect the actual final payments to the provider or site. For example,
the Bundled Payments for Care Improvement (BPCI) initiative is
comprised of four broadly defined models of care, which link payments
for the multiple services beneficiaries receive during an episode of
care. (See the CMS Web site at https://innovation.cms.gov/initiatives/bundled-payments/). Under the retrospective BPCI payment models,
Medicare continues to make fee-for-service (FFS) payments for the Part
A and Part B services furnished to a beneficiary during an episode;
but, the total Part A and Part B expenditures for the episode are later
reconciled against a bundled payment amount (the target price)
determined by CMS. A payment or recoupment amount is determined by
comparing the aggregate expenditures to the target price. Interim
payment and recoupment amounts are calculated quarterly but it is only
after the BPCI claims run out period that the final reconciliation can
be performed and the final expenditure amount is known. In contrast,
under certain other demonstrations, pilots, or time limited programs
only final non-claims based payment data are loaded into the system.
For example, under the Community-based Care Transitions Program (CCTP),
the participating community-based organizations were paid an all-
inclusive rate per eligible discharge. This final non-claims based
payment was then loaded into the system and was not subject to
subsequent reconciliations.
To date, when we perform ACO benchmarking and financial
calculations under the Shared Savings Program, we have included (in
addition to all Medicare Parts A and B claims) all non-claims based
beneficiary identifiable payments for the applicable benchmark or
performance year that are included in the separate CMS system,
including any payments made during the benchmark or performance year's
3-months claims run-out period. This means that to date we have
included some interim payments made under a demonstration, pilot or
time limited program that will undergo subsequent reconciliation to
determine the final payment amount in the calculation of historical
benchmarks and performance year expenditures. However, because the
various demonstrations, pilots or time limited programs may have
different operational schedules to the Shared Savings Program, it is
not possible for us to include all interim and final beneficiary
identifiable payments made under these initiatives in benchmarking and
financial reconciliation calculations for the Shared Savings Program;
and, as a result, these calculations have excluded some interim and
final non-claims based beneficiary identifiable payments made under
certain demonstrations, pilots or time limited programs. For example,
because of the timing and availability of BPCI non-claims based payment
amounts, to date we have included only up to two quarters of interim
payment data for BPCI in ACO benchmarking and financial reconciliation
calculations for the
[[Page 34123]]
Shared Savings Program and no final payment amounts.
To date, non-claims based individually beneficiary identifiable
payments represent a relatively minor proportion of an ACO's total Part
A and B beneficiary expenditure amounts as determined under the Shared
Savings Program (mean of 0.09 percent overall impact of ACO non-claims
based payments on total per capita expenditures and a mean of 137
person-years in an ACO's assigned beneficiary population with a non-
claims based payment during the year; minimum -0.72 percent, 0 person-
years; maximum 1.24 percent, 1,865 person-years). For the
demonstrations, pilots or time limited programs that include interim
and final reconciliations, the impact of including the non-claims based
payments could be positive or negative for an ACO for a given
performance year. Additionally, a preliminary analysis suggests that
interim payments made under select demonstrations, pilots or time-
limited program fluctuate on a quarterly basis. An examination of
trends in total per capita non-claims based payments in 2016 quarterly
program reports across 416 Track 1 and 2 ACOs found a mean decline of
14 percent from Quarter 1 to Quarter 2, followed by a mean increase of
144 percent from Quarter 2 to Quarter 3, and a mean increase of 742
percent from Quarter 3 to Quarter 4. Quarterly trends for individual
ACOs also tended to fluctuate. Per capita amounts in this analysis were
based on those ACOs with at least one non-claims based payment in each
quarterly report period. Almost half of the ACOs in the analysis (201
out of 416) had at least one quarter in 2016 with a net negative per
capita payment across all beneficiaries with at least one non-claims
based payment and at least one quarter with a net positive per capita
payment. A review of non-claims based payments incorporated in PY 2017
preliminary historical benchmarks also found similar swings between
negative and positive amounts, with roughly one third of ACOs receiving
a benchmark (156 of 480) having at least one benchmark year with a net
negative per capita payment across all beneficiaries with at least one
non-claims based payment and at least one benchmark year with a net
positive per capita payment.
These fluctuations in the non-claims based payments for certain
initiatives like BPCI have generated stakeholder concern. Further,
stakeholders note that the impact of including interim payments in
financial calculations may become greater in the future, given the
increasingly widespread interest in participation in alternative
payment models and the growing number of such models being tested
through the CMS Innovation Center. Stakeholders have therefore
suggested that we should revise our policies to clarify that only final
non-claims based payments made within the 3 months claims run out
period under a demonstration, pilot or time limited program will be
included in the calculation of an ACO's benchmark and performance year
expenditures.
b. Proposals
Our preliminary analysis, as discussed in the background section,
suggests that interim non-claims based payments (that is, payments that
are subject to reconciliation at a later date) made under a
demonstration, pilot, or time limited program can fluctuate
significantly from quarter to quarter and may not reflect the actual
final reconciled payment amount. Thus, we agree with the stakeholders
who have suggested that only final non-claims based payments made under
a demonstration, pilot or time limited program should be included in
financial calculations related to benchmarks and performance year
expenditures under the Shared Savings Program. We believe this would be
a reasonable approach to determining Parts A and B expenditures for
assigned beneficiaries for both benchmark and performance years given
the uncertain impact on ACOs' financial calculations of including
interim payments that will be subsequently revised to reflect the final
reconciled payment amounts. We also agree that use of interim payments
made under a demonstration, pilot or time limited program could have an
increasingly large effect on ACO benchmarks and performance year
expenditure calculations in the future given widespread stakeholder
interest in participating in alternative payment models and CMS
interest in testing and expanding additional payment models that may
lead to higher quality and more coordinated care at a lower cost to
Medicare.
Therefore, we are proposing to revise the applicable regulations to
make clear that we would include only final individually beneficiary
identifiable payments made under a demonstration, pilot or time limited
program in financial calculations related to establishing and updating
benchmarks and determining performance year expenditures under the
Shared Savings Program. We propose that this policy would be applied to
calculations that are necessary to determine ACO performance for the
2018 performance year and subsequent performance years. For ACOs that
are in the middle of an agreement period when this revised policy takes
effect, we would adjust the benchmarks for these ACOs at the start of
the 2018 performance year and each subsequent performance year so that
the benchmark for the ACO reflects the use of the same payment
information that would apply in expenditure calculations for the
performance year. More specifically, we propose to modify our
regulations at Sec. Sec. 425.602(a)(1)(ii), 425.603(c)(1)(ii), and
425.603(e)(2)(ii) to add new provisions to indicate that, (1) when
establishing benchmarks for agreement periods before 2018, we will
include all individually beneficiary identifiable payments, including
interim payments, made under a demonstration, pilot, or time limited
program, (2) for agreement periods beginning in 2018 and subsequent
years, we would only include individually beneficiary identifiable
payments made under a demonstration, pilot or time limited program that
are final and not subject to further reconciliation, and (3) For the
2018 performance year and subsequent performance years in agreement
periods beginning in 2015, 2016 and 2017, the benchmark would be
adjusted to reflect only individually beneficiary identifiable final
payments made under a demonstration, pilot or time limited program.
Additionally, we propose to add new Sec. Sec. 425.604(a)(6)(ii)(A),
425.606(a)(6)(ii)(A) and 425.610(a)(6)(ii)(A) indicating that when
calculating expenditures for performance years before 2018, we will
include all individually beneficiary identifiable payments, including
interim payments, made under a demonstration, pilot, or time limited
program. We also propose to add new Sec. Sec. 425.604(a)(6)(ii)(B),
425.606(a)(6)(ii)(B) and 425.610(a)(6)(ii)(B) indicating that when
calculating expenditures for performance year 2018 and subsequent
performance years, we would only include individually beneficiary
identifiable payments made under a demonstration, pilot or time limited
program that are final and not subject to further reconciliation. To be
consistent with our treatment of claims-based payments, such final
payments would have to be available in the separate CMS system by the
end of the 3-month claims run out period.
We invite comments on this proposal.
[[Page 34124]]
I. Value-Based Payment Modifier and Physician Feedback Program
1. Overview
Section 1848(p) of the Act requires the establishment of a value-
based payment modifier (VM) that applies 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 programs continue our 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
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L.
114-10) 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 phase-in 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
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 non-physician 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.
In the CY 2016 PFS final rule with comment period (80 FR 71288 to
71291), we finalized that we would apply the following adjustments to
payments, for items and services furnished under the Medicare PFS in CY
2018, to physicians, PAs, NPs, CNSs, and CRNAs in groups with 10 or
more EPs and at least one physician:
Negative 4 percent (-4.0 percent) for those that fall into
Category 2, meaning that they did not meet the criteria to avoid the
2018 PQRS payment adjustment.
Negative 4 percent (-4.0 percent) under the quality-
tiering methodology for those classified as low quality/high cost and
negative 2 percent (-2.0 percent) for those classified as either low
quality/average cost or average quality/high cost.
An upward adjustment of four times an adjustment factor
(+4.0x) under the quality-tiering methodology for those classified as
high quality/low cost and two times an adjustment factor (+2.0x) for
those classified as either average quality/low cost or high quality/
average cost.
We finalized that we would apply the following adjustments to
payments, for items and services furnished under the Medicare PFS in CY
2018, to physician solo practitioners and physicians, PAs, NPs, CNSs,
and CRNAs in groups with 2 to 9 EPs and at least one physician:
Negative 2 percent (-2.0 percent) to those that fall into
Category 2, meaning that they did not meet the criteria to avoid the
2018 PQRS payment adjustment.