81 FR 80170 - Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss Ratio Data Release; Medicare Advantage Provider Network Requirements; Expansion of Medicare Diabetes Prevention Program Model; Medicare Shared Savings Program Requirements
DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services
Federal Register Volume 81, Issue 220 (November 15, 2016)
Page Range
80170-80562
FR Document
2016-26668
This major final rule addresses changes to the physician fee schedule and other Medicare Part B payment policies, such as changes to the Value Modifier, to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This final rule also includes changes related to the Medicare Shared Savings Program, requirements for Medicare Advantage Provider Networks, and provides for the release of certain pricing data from Medicare Advantage bids and of data from medical loss ratio reports submitted by Medicare health and drug plans. In addition, this final rule expands the Medicare Diabetes Prevention Program model.
Federal Register, Volume 81 Issue 220 (Tuesday, November 15, 2016)
[Federal Register Volume 81, Number 220 (Tuesday, November 15, 2016)]
[Rules and Regulations]
[Pages 80170-80562]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2016-26668]
[[Page 80169]]
Vol. 81
Tuesday,
No. 220
November 15, 2016
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 405, 410, 411, et al.
Medicare Program; Revisions to Payment Policies Under the Physician Fee
Schedule and Other Revisions to Part B for CY 2017; Medicare Advantage
Bid Pricing Data Release; Medicare Advantage and Part D Medical Loss
Ratio Data Release; Medicare Advantage Provider Network Requirements;
Expansion of Medicare Diabetes Prevention Program Model; Medicare
Shared Savings Program Requirements; Final Rule
Federal Register / Vol. 81 , No. 220 / Tuesday, November 15, 2016 /
Rules and Regulations
[[Page 80170]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 410, 411, 414, 417, 422, 423, 424, 425, and 460
[CMS-1654-F]
RIN 0938-AS81
Medicare Program; Revisions to Payment Policies Under the
Physician Fee Schedule and Other Revisions to Part B for CY 2017;
Medicare Advantage Bid Pricing Data Release; Medicare Advantage and
Part D Medical Loss Ratio Data Release; Medicare Advantage Provider
Network Requirements; Expansion of Medicare Diabetes Prevention Program
Model; Medicare Shared Savings Program Requirements
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule.
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SUMMARY: This major final rule addresses changes to the physician fee
schedule and other Medicare Part B payment policies, such as changes to
the Value Modifier, to ensure that our payment systems are updated to
reflect changes in medical practice and the relative value of services,
as well as changes in the statute. This final rule also includes
changes related to the Medicare Shared Savings Program, requirements
for Medicare Advantage Provider Networks, and provides for the release
of certain pricing data from Medicare Advantage bids and of data from
medical loss ratio reports submitted by Medicare health and drug plans.
In addition, this final rule expands the Medicare Diabetes Prevention
Program model.
DATES: These regulations are effective on January 1, 2017.
FOR FURTHER INFORMATION CONTACT:
Jessica Bruton, (410) 786-5991, for issues related to
identification of potentially misvalued services and any physician
payment issues not identified below.
Gail Addis, (410) 786-4522, for issues related to diabetes self-
management training.
Jaime Hermansen, (410) 786-2064, for issues related to moderate
sedation coding and anesthesia services.
Roberta Epps, (410) 786-4503, for issues related to PAMA section
218(a) policy and the transition from traditional x-ray imaging to
digital radiography.
Ann Marshall, (410) 786-3059, for primary care issues related to
chronic care management (CCM), burden reduction, telehealth services
and evaluation and management services.
Emily Yoder, (410) 786-1804, for issues related to resource
intensive services, telehealth services and other primary care issues.
Lindsey Baldwin, (410) 786-1694, for primary care issues related to
behavioral health integration services.
Geri Mondowney, (410) 786-4584, and Donta Henson, (410) 786-1947,
for issues related to geographic practice cost indices.
Michael Soracoe, (410) 786-6312, for issues related to the target
and phase-in provisions, the practice expense methodology, impacts,
conversion factor, and the valuation of pathology and surgical
procedures.
Pamela West, (410) 786-2302, for issues related to therapy.
Patrick Sartini, (410) 786-9252, for issues related to malpractice
RVUs, radiation treatment, mammography and other imaging services.
Kathy Bryant, (410) 786-3448, for issues related to collecting data
on resources used in furnishing global services.
Donta Henson, (410) 786-1947, for issues related to ophthalmology
services.
Corinne Axelrod, (410) 786-5620, for issues related to rural health
clinics or federally qualified health centers.
Simone Dennis, (410) 786-8409, for issues related to FQHC-specific
market basket.
JoAnna Baldwin, (410) 786-7205, or Sarah Fulton, (410) 786-2749,
for issues related to appropriate use criteria for advanced diagnostic
imaging services.
Robin Usi, (410) 786-0364, for issues related to open payments.
Sean O'Grady, (410) 786-2259, or Julie Uebersax, (410) 786-9284,
for issues related to release of pricing data from Medicare Advantage
bids and release of medical loss ratio data submitted by Medicare
Advantage organizations and Part D sponsors.
Sara Vitolo, (410) 786-5714, for issues related to prohibition on
billing qualified Medicare beneficiary individuals for Medicare cost-
sharing.
Michelle Peterman, (410) 786-2591, for issues related to
Accountable Care Organization (ACO) participants who report PQRS
quality measures separately.
Katie Mucklow, (410) 786-0537 or John Spiegel, (410) 786-1909, for
issues related to Provider Enrollment Medicare Advantage Program.
Jen Zhu, (410) 786-3725, Carlye Burd, (410) 786-1972, or Nina
Brown, (410) 786-6103, for issues related to Medicare Diabetes
Prevention Program model expansion.
Rabia Khan or Terri Postma, (410) 786-8084 or [email protected], 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.
Lisa Ohrin Wilson, (410) 786-8852, or Gabriel Scott, (410) 786-
3928, for issues related to physician self-referral updates.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary and Background
A. Executive Summary
B. Background
II. Provisions of the Final Rule for PFS
A. Determination of Practice Expense Relative Value Units (PE
RVUs)
B. Determination of Malpractice Relative Value Units (MRVUs)
C. Medicare Telehealth Services
D. Potentially Misvalued Services Under the Physician Fee
Schedule
1. Background
2. Progress in Identifying and Reviewing Potentially Misvalued
Codes
3. Validating RVUs of Potentially Misvalued Codes
4. CY 2017 Identification and Review of Potentially Misvalued
Services
5. Valuing Services That Include Moderate Sedation as an
Inherent Part of Furnishing the Procedure
6. Collecting Data on Resources Used in Furnishing Global
Services
E. Improving Payment Accuracy for Primary Care, Care Management
Services, and Patient-Centered Services
F. Improving Payment Accuracy for Services: Diabetes Self-
Management Training (DSMT)
G. Target for Relative Value Adjustments for Misvalued Services
H. Phase-In of Significant RVU Reductions
I. Geographic Practice Cost Indices (GPCIs)
J. Payment Incentive for the Transition From Traditional X-Ray
Imaging to Digital Radiography and Other Imaging Services
K. Procedures Subject to the Multiple Procedure Payment
Reduction (MPPR) and the OPPS Cap
L. Valuation of Specific Codes
M. Therapy Caps
III. Other Provisions of the Final Rule for PFS
A. Chronic Care Management (CCM) and Transitional Care
Management (TCM) Supervision Requirements in Rural Health Clinics
(RHCs) and Federally Qualified Health Centers (FQHCs)
B. FQHC-Specific Market Basket
C. Appropriate Use Criteria for Advanced Diagnostic Imaging
Services
D. Reports of Payments or Other Transfers of Value to Covered
Recipients: Summary of Public Comments
E. Release of Part C Medicare Advantage Bid Pricing Data and
Part C and Part D Medical Loss Ratio (MLR) Data
[[Page 80171]]
F. Prohibition on Billing Qualified Medicare Beneficiary
Individuals for Medicare Cost-Sharing
G. Recoupment or Offset of Payments to Providers Sharing the
Same Taxpayer Identification Number
H. Accountable Care Organization (ACO) Participants Who Report
Physician Quality Reporting System (PQRS) Quality Measures
Separately
I. Medicare Advantage Provider Enrollment
J. Expansion of the Diabetes Prevention Program (DPP) Model
K. Medicare Shared Savings Program
L. Value-Based Payment Modifier and Physician Feedback Program
M. Physician Self-Referral Updates
N. Designated Health Services
IV. Collection of Information Requirements
V. 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)
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
Addenda Available Only Through the Internet on the CMS Web Site
The PFS Addenda along with other supporting documents and tables
referenced in this final rule are available through the Internet on the
CMS Web site at http://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,
[[Page 80172]]
``PFS Federal Regulations Notices'' for a chronological list of PFS
Federal Register and other related documents. For the CY 2017 PFS Final
Rule, refer to item CMS-1654-F. Readers who experience any problems
accessing any of the Addenda or other documents referenced in this rule
and posted on the CMS Web site identified above should contact Jessica
Bruton at (410) 786-5991.
CPT (Current Procedural Terminology) Copyright Notice
Throughout this final rule, we use CPT codes and descriptions to
refer to a variety of services. We note that CPT codes and descriptions
are copyright 2015 American Medical Association. All Rights Reserved.
CPT is a registered trademark of the American Medical Association
(AMA). Applicable Federal Acquisition Regulations (FAR) and Defense
Federal Acquisition Regulations (DFAR) apply.
I. Executive Summary and Background
A. Executive Summary
1. Purpose
This major final rule revises payment polices under the Medicare
Physician Fee Schedule (PFS) and makes other policy changes related to
Medicare Part B payment. These changes will be applicable to services
furnished in CY 2017. In addition, this final rule includes the
following provisions: Payment policy changes for Rural Health Clinics
(RHCs) and Federally Qualified Health Centers (FQHCs); expansion of the
Medicare Diabetes Prevention Program model; policy changes related to
the Medicare Shared Savings Program; and release of pricing data
submitted to CMS by Medicare Advantage (MA) organizations; and medical
loss ratio reports submitted by MA plans and Part D plans. These
additional policies are addressed in section III. of this final rule.
2. Summary of the Major Provisions
The statute requires us to establish payments under the PFS based
on national uniform relative value units (RVUs) that account for the
relative resources used in furnishing a service. The statute requires
that RVUs be established for three categories of resources: Work,
practice expense (PE); and malpractice (MP) expense; and, that we
establish by regulation each year's payment amounts for all physicians'
services paid under the PFS, incorporating geographic adjustments to
reflect the variations in the costs of furnishing services in different
geographic areas. In this major final rule, we establish RVUs for CY
2017 for the PFS, and other Medicare Part B payment policies, to ensure
that our payment systems are updated to reflect changes in medical
practice and the relative value of services, as well as changes in the
statute. In addition, this final rule includes summaries of public
comments and final policies regarding:
Potentially Misvalued Codes.
Telehealth Services.
Establishing Values for New, Revised, and Misvalued Codes.
Target for Relative Value Adjustments for Misvalued
Services.
Phase-in of Significant RVU Reductions.
Chronic Care Management (CCM) and Transitional Care
Management (TCM) Supervision Requirements in Rural Health Clinics
(RHCs) and Federally Qualified Health Centers (FQHCs).
FQHC-Specific Market Basket.
Appropriate Use Criteria for Advanced Diagnostic Imaging
Services.
Reports of Payments or Other Transfers of Value to Covered
Recipients: Solicitation of Public Comments.
Release of Part C Medicare Advantage Bid Pricing Data and
Part C and Part D Medical Loss Ratio (MLR) Data.
Prohibition on Billing Qualified Medicare Beneficiary
Individuals for Medicare Cost-Sharing.
Recoupment or Offset of Payments to Providers Sharing the
Same Taxpayer Identification Number.
Accountable Care Organization (ACO) Participants Who
Report Physician Quality Reporting System (PQRS) Quality Measures
Separately.
Medicare Advantage Provider Enrollment.
Expansion of the Diabetes Prevention Program (DPP) Model.
Medicare Shared Savings Program.
Value-Based Payment Modifier and the Physician Feedback
Program.
Physician Self-referral Updates.
Designated Health Services.
3. Summary of Costs and Benefits
The statute requires that annual adjustments to PFS RVUs may not
cause annual estimated expenditures to differ by more than $20 million
from what they would have been had the adjustments not been made. If
adjustments to RVUs would cause expenditures to change by more than $20
million, we must make adjustments to preserve budget neutrality. These
adjustments can affect the distribution of Medicare expenditures across
specialties. In addition, several changes in this final rule will
affect the specialty distribution of Medicare expenditures. When
considering the combined impact of work, PE, and MP RVU changes, the
projected payment impacts would be small for most specialties; however,
the impact would be larger for a few specialties.
We have determined that this major final rule is economically
significant. For a detailed discussion of the economic impacts, see
section VI. of this final rule.
B. Background
Since January 1, 1992, Medicare has paid for physicians' services
under section 1848 of the Social Security Act (the Act), ``Payment for
Physicians' Services.'' The 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 final 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
[[Page 80173]]
of the resources used in furnishing the service that reflects physician
time and intensity. We establish work RVUs for new, revised and
potentially misvalued codes based on our review of information that
generally includes, but is not limited to, recommendations received
from the American Medical Association/Specialty Society Relative Value
Update Committee (RUC), the Health Care Professionals Advisory
Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC),
and other public commenters; medical literature and comparative
databases; as well as a comparison of the work for other codes within
the Medicare PFS, and consultation with other physicians and health
care professionals within CMS and the federal government. We also
assess the methodology and data used to develop the recommendations
submitted to us by the RUC and other public commenters, and the
rationale for their recommendations. In the CY 2011 PFS final rule with
comment period (75 FR 73328 through 73329), we discussed a variety of
methodologies and approaches used to develop work RVUs, including
survey data, building blocks, crosswalk to key reference or similar
codes, and magnitude estimation. More information on these issues is
available in that rule.
b. Practice Expense RVUs
Initially, only the work RVUs were resource-based, and the PE and
MP RVUs were based on average allowable charges. Section 121 of the
Social Security Act Amendments of 1994 (Pub. L. 103-432, enacted on
October 31, 1994), amended section 1848(c)(2)(C)(ii) of the Act and
required us to develop resource-based PE RVUs for each physicians'
service beginning in 1998. We were required to consider general
categories of expenses (such as office rent and wages of personnel, but
excluding malpractice expenses) comprising PEs. The PE RVUs continue to
represent the portion of these resources involved in furnishing PFS
services.
Originally, the resource-based method was to be used beginning in
1998, but section 4505(a) of the Balanced Budget Act of 1997 (Pub. L.
105-33, enacted on August 5, 1997) (BBA) delayed implementation of the
resource-based PE RVU system until January 1, 1999. In addition,
section 4505(b) of the BBA provided for a 4-year transition period from
the charge-based PE RVUs to the resource-based PE RVUs.
We established the resource-based PE RVUs for each physicians'
service in a final rule, published on November 2, 1998 (63 FR 58814),
effective for services furnished in CY 1999. Based on the requirement
to transition to a resource-based system for PE over a 4-year period,
payment rates were not fully based upon resource-based PE RVUs until CY
2002. This resource-based system was based on two significant sources
of actual PE data: The Clinical Practice Expert Panel (CPEP) data; and
the AMA's Socioeconomic Monitoring System (SMS) data. (These data
sources are described in greater detail in the CY 2012 final rule with
comment period (76 FR 73033).
Separate PE RVUs are established for services furnished in facility
settings, such as a hospital outpatient department (HOPD) or an
ambulatory surgical center (ASC), and in nonfacility settings, such as
a physician's office. The nonfacility RVUs reflect all of the direct
and indirect PEs involved in furnishing a service described by a
particular HCPCS code. The difference, if any, in these PE RVUs
generally results in a higher payment in the nonfacility setting
because in the facility settings some costs are borne by the facility.
Medicare's payment to the facility (such as the outpatient prospective
payment system (OPPS) payment to the HOPD) would reflect costs
typically incurred by the facility. Thus, payment associated with those
facility resources is not made under the PFS.
Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L.
106-113, enacted on November 29, 1999) (BBRA) directed the Secretary of
Health and Human Services (the Secretary) to establish a process under
which we accept and use, to the maximum extent practicable and
consistent with sound data practices, data collected or developed by
entities and organizations to supplement the data we normally collect
in determining the PE component. On May 3, 2000, we published the
interim final rule (65 FR 25664) that set forth the criteria for the
submission of these supplemental PE survey data. The criteria were
modified in response to comments received, and published in the Federal
Register (65 FR 65376) as part of a November 1, 2000 final rule. The
PFS final rules published in 2001 and 2003, respectively, (66 FR 55246
and 68 FR 63196) extended the period during which we would accept these
supplemental data through March 1, 2005.
In the CY 2007 PFS final rule with comment period (71 FR 69624), we
revised the methodology for calculating direct PE RVUs from the top-
down to the bottom-up methodology beginning in CY 2007. We adopted a 4-
year transition to the new PE RVUs. This transition was completed for
CY 2010. In the CY 2010 PFS final rule with comment period, we updated
the practice expense per hour (PE/HR) data that are used in the
calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010,
we began a 4-year transition to the new PE RVUs using the updated PE/HR
data, which was completed for CY 2013.
c. Malpractice RVUs
Section 4505(f) of the BBA amended section 1848(c) of the Act to
require that we implement resource-based MP RVUs for services furnished
on or after CY 2000. The resource-based MP RVUs were implemented in the
PFS final rule with comment period published November 2, 1999 (64 FR
59380). The MP RVUs are based on commercial and physician-owned
insurers' malpractice insurance premium data from all the states, the
District of Columbia, and Puerto Rico. For more information on MP RVUs,
see section II.B.2. of this final rule.
d. Refinements to the RVUs
Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no
less often than every 5 years. Prior to CY 2013, we conducted periodic
reviews of work RVUs and PE RVUs independently. We completed five-year
reviews of work RVUs that were effective for calendar years 1997, 2002,
2007, and 2012.
Although refinements to the direct PE inputs initially relied
heavily on input from the RUC Practice Expense Advisory Committee
(PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to
the use of the updated PE/HR data in CY 2010 have resulted in
significant refinements to the PE RVUs in recent years.
In the CY 2012 PFS final rule with comment period (76 FR 73057), we
finalized a proposal to consolidate reviews of work and PE RVUs under
section 1848(c)(2)(B) of the Act and reviews of potentially misvalued
codes under section 1848(c)(2)(K) of the Act into one annual process.
In addition to the five-year reviews, beginning for CY 2009, CMS
and the RUC have identified and reviewed a number of potentially
misvalued codes on an annual basis based on various identification
screens. This annual review of work and PE RVUs for potentially
misvalued codes was supplemented by the amendments to section 1848 of
the Act, as enacted by section 3134 of the Affordable Care Act, that
require the agency to periodically
[[Page 80174]]
identify, review and adjust values for potentially misvalued codes.
e. Application of Budget Neutrality to Adjustments of RVUs
As described in section VI.C. of this final rule, in accordance
with section 1848(c)(2)(B)(ii)(II) of the Act, if revisions to the RVUs
cause expenditures for the year to change by more than $20 million, we
make adjustments to ensure that expenditures did not increase or
decrease by more than $20 million.
2. Calculation of Payments Based on RVUs
To calculate the payment for each service, the components of the
fee schedule (work, PE, and MP RVUs) are adjusted by geographic
practice cost indices (GPCIs) to reflect the variations in the costs of
furnishing the services. The GPCIs reflect the relative costs of work,
PE, and MP in an area compared to the national average costs for each
component.
RVUs are converted to dollar amounts through the application of a
CF, which is calculated based on a statutory formula by CMS's Office of
the Actuary (OACT). The formula for calculating the Medicare fee
schedule payment amount for a given service and fee schedule area can
be expressed as:
Payment = [(RVU work x GPCI work) + (RVU PE x GPCI PE) + (RVU MP x GPCI
MP)] x CF.
3. Separate Fee Schedule Methodology for Anesthesia Services
Section 1848(b)(2)(B) of the Act specifies that the fee schedule
amounts for anesthesia services are to be based on a uniform relative
value guide, with appropriate adjustment of an anesthesia conversion
factor, in a manner to ensure that fee schedule amounts for anesthesia
services are consistent with those for other services of comparable
value. Therefore, there is a separate fee schedule methodology for
anesthesia services. Specifically, we establish a separate conversion
factor for anesthesia services and we utilize the uniform relative
value guide, or base units, as well as time units, to calculate the fee
schedule amounts for anesthesia services. Since anesthesia services are
not valued using RVUs, a separate methodology for locality adjustments
is also necessary. This involves an adjustment to the national
anesthesia CF for each payment locality.
4. Most Recent Changes to the Fee Schedule
Section 220(d) of the Protecting Access to Medicare Act of 2014
(Pub. L. 113-93, enacted on April 1, 2014) (PAMA) added a new
subparagraph (O) to section 1848(c)(2) of the Act to establish an
annual target for reductions in PFS expenditures resulting from
adjustments to relative values of misvalued codes. If the estimated net
reduction in expenditures for a year is equal to or greater than the
target for that year, the provision specifies that reduced expenditures
attributable to such adjustments shall be redistributed in a budget-
neutral manner within the PFS. The provision specifies that the amount
by which such reduced expenditures exceed the target for a given year
shall be treated as a reduction in expenditures for the subsequent year
for purposes of determining whether the target for the subsequent year
has been met. The provision also specifies that an amount equal to the
difference between the target and the estimated net reduction in
expenditures, called the target recapture amount, shall not be taken
into account when applying the budget neutrality requirements specified
in section 1848(c)(2)(B)(ii)(II) of the Act. The PAMA amendments
originally made the target provisions applicable for CYs 2017 through
2020 and set the target for reduced expenditures at 0.5 percent of
estimated expenditures under the PFS for each of those 4 years.
Subsequently, section 202 of the Achieving a Better Life Experience
Act of 2014 (Division B of Pub. L. 113-295, enacted December 19, 2014)
(ABLE) accelerated the application of the target, amending section
1848(c)(2)(O) of the Act to specify that target provisions apply for
CYs 2016, 2017, and 2018; and setting a 1 percent target for reduced
expenditures for CY 2016 and a 0.5 percent target for CYs 2017 and
2018. The implementation of the target legislation was finalized in the
CY 2016 PFS final rule with comment period, and revisions are discussed
in section II.G. of this final rule.
Section 1848(c)(7) of the Act, as added by section 220(e) of the
PAMA, specified that for services that are not new or revised codes, if
the total RVUs for a service for a year would otherwise be decreased by
an estimated 20 percent or more as compared to the total RVUs for the
previous year, the applicable adjustments in work, PE, and MP RVUs
shall be phased in over a 2-year period. Section 220(e) of the PAMA
required the phase-in of RVU reductions of 20 percent or more to begin
for 2017. Section 1848(c)(7) of the Act was later amended by section
202 of the ABLE Act to require instead that the phase-in must begin in
CY 2016. The implementation of the phase-in legislation was finalized
in the CY 2016 PFS final rule with comment period and revisions in this
year's rulemaking are discussed in section II.H. of this final rule.
II. Provisions of the Final Rule for PFS
A. Determination of Practice Expense (PE) Relative Value Units (RVUs)
1. Overview
Practice expense (PE) is the portion of the resources used in
furnishing a service that reflects the general categories of physician
and practitioner expenses, such as office rent and personnel wages, but
excluding malpractice expenses, as specified in section 1848(c)(1)(B)
of the Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use
a resource-based system for determining PE RVUs for each physicians'
service. We develop PE RVUs by considering the direct and indirect
practice resources involved in furnishing each service. Direct expense
categories include clinical labor, medical supplies, and medical
equipment. Indirect expenses include administrative labor, office
expense, and all other expenses. The sections that follow provide more
detailed information about the methodology for translating the
resources involved in furnishing each service into service-specific PE
RVUs. We refer readers to the CY 2010 PFS final rule with comment
period (74 FR 61743 through 61748) for a more detailed explanation of
the PE methodology.
2. Practice Expense Methodology
a. Direct Practice Expense
We determine the direct PE for a specific service by adding the
costs of the direct resources (that is, the clinical staff, medical
supplies, and medical equipment) typically involved with furnishing
that service. The costs of the resources are calculated using the
refined direct PE inputs assigned to each CPT code in our PE database,
which are generally based on our review of recommendations received
from the RUC and those provided in response to public comment periods.
For a detailed explanation of the direct PE methodology, including
examples, we refer readers to the Five-Year Review of Work Relative
Value Units under the PFS and Proposed Changes to the Practice Expense
Methodology proposed notice (71 FR 37242) and the CY 2007 PFS final
rule with comment period (71 FR 69629).
[[Page 80175]]
b. Indirect Practice Expense per Hour Data
We use survey data on indirect PEs incurred per hour worked in
developing the indirect portion of the PE RVUs. Prior to CY 2010, we
primarily used the practice expense per hour (PE/HR) by specialty that
was obtained from the AMA's Socioeconomic Monitoring Surveys (SMS). The
AMA administered a new survey in CY 2007 and CY 2008, the Physician
Practice Expense Information Survey (PPIS). The PPIS is a
multispecialty, nationally representative, PE survey of both physicians
and nonphysician practitioners (NPPs) paid under the PFS using a survey
instrument and methods highly consistent with those used for the SMS
and the supplemental surveys. The PPIS gathered information from 3,656
respondents across 51 physician specialty and health care professional
groups. We believe the PPIS is the most comprehensive source of PE
survey information available. We used the PPIS data to update the PE/HR
data for the CY 2010 PFS for almost all of the Medicare-recognized
specialties that participated in the survey.
When we began using the PPIS data in CY 2010, we did not change the
PE RVU methodology itself or the manner in which the PE/HR data are
used in that methodology. We only updated the PE/HR data based on the
new survey. Furthermore, as we explained in the CY 2010 PFS final rule
with comment period (74 FR 61751), because of the magnitude of payment
reductions for some specialties resulting from the use of the PPIS
data, we transitioned its use over a 4-year period from the previous PE
RVUs to the PE RVUs developed using the new PPIS data. As provided in
the CY 2010 PFS final rule with comment period (74 FR 61751), the
transition to the PPIS data was complete for CY 2013. Therefore, PE
RVUs from CY 2013 forward are developed based entirely on the PPIS
data, except as noted in this section.
Section 1848(c)(2)(H)(i) of the Act requires us to use the medical
oncology supplemental survey data submitted in 2003 for oncology drug
administration services. Therefore, the PE/HR for medical oncology,
hematology, and hematology/oncology reflects the continued use of these
supplemental survey data.
Supplemental survey data on independent labs from the College of
American Pathologists were implemented for payments beginning in CY
2005. Supplemental survey data from the National Coalition of Quality
Diagnostic Imaging Services (NCQDIS), representing independent
diagnostic testing facilities (IDTFs), were blended with supplementary
survey data from the American College of Radiology (ACR) and
implemented for payments beginning in CY 2007. Neither IDTFs, nor
independent labs, participated in the PPIS. Therefore, we continue to
use the PE/HR that was developed from their supplemental survey data.
Consistent with our past practice, the previous indirect PE/HR
values from the supplemental surveys for these specialties were updated
to CY 2006 using the Medicare Economic Index (MEI) to put them on a
comparable basis with the PPIS data.
We also do not use the PPIS data for reproductive endocrinology and
spine surgery since these specialties currently are not separately
recognized by Medicare, nor do we have a method to blend the PPIS data
with Medicare-recognized specialty data.
Previously, we established PE/HR values for various specialties
without SMS or supplemental survey data by crosswalking them to other
similar specialties to estimate a proxy PE/HR. For specialties that
were part of the PPIS for which we previously used a crosswalked PE/HR,
we instead used the PPIS-based PE/HR. We continue previous crosswalks
for specialties that did not participate in the PPIS. However,
beginning in CY 2010, we changed the PE/HR crosswalk for portable X-ray
suppliers from radiology to IDTF, a more appropriate crosswalk because
these specialties are more similar to each other for work time.
For registered dietician services, the resource-based PE RVUs have
been calculated in accordance with the final policy that crosswalks the
specialty to the ``All Physicians'' PE/HR data, as adopted in the CY
2010 PFS final rule with comment period (74 FR 61752) and discussed in
more detail in the CY 2011 PFS final rule with comment period (75 FR
73183). We have incorporated the available utilization data for
interventional cardiology, which became a recognized Medicare specialty
during 2014. We finalized the use of a proxy PE/HR value for
interventional cardiology in the CY 2016 final rule with comment period
(80 FR 70892), as there are no PPIS data for this specialty, by
crosswalking the PE/HR from Cardiology, since the specialties furnish
similar services in the Medicare claims data.
Comment: A commenter questioned the validity of the PPIS survey
data since it is nearly 10 years old. Several other commenters stated
that CMS' estimated per-minute labor cost inputs are lower than actual
labor costs.
Response: We have previously identified several concerns regarding
the underlying data used in determining PE RVUs in the CY 2014 PFS
final rule (78 FR 74246-74247). Even when we first incorporated the
survey data into the PE methodology, many in the community expressed
serious concerns over the accuracy of this or other PE surveys as a way
of gathering data on PE inputs from the diversity of providers paid
under the PFS. However, we currently lack another source of
comprehensive data regarding PE costs, and as a result, we continue to
believe that the PPIS survey data is the best data currently available.
We continue to seek the best broad-based, auditable, routinely-updated
source of information regarding PE costs.
c. Allocation of PE to Services
To establish PE RVUs for specific services, it is necessary to
establish the direct and indirect PE associated with each service.
(1) Direct Costs
The relative relationship between the direct cost portions of the
PE RVUs for any two services is determined by the relative relationship
between the sum of the direct cost resources (that is, the clinical
staff, medical supplies, and medical equipment) typically involved with
furnishing each of the services. The costs of these resources are
calculated from the refined direct PE inputs in our PE database. For
example, if one service has a direct cost sum of $400 from our PE
database and another service has a direct cost sum of $200, the direct
portion of the PE RVUs of the first service would be twice as much as
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
Section II.A.2.b. of this final rule describes the current data
sources for specialty-specific indirect costs used in our PE
calculations. We allocated the indirect costs to the code level on the
basis of the direct costs specifically associated with a code and the
greater of either the clinical labor costs or the work RVUs. We also
incorporated the survey data described earlier in the PE/HR discussion.
The general approach to developing the indirect portion of the PE RVUs
is as follows:
For a given service, we used the direct portion of the PE
RVUs calculated as previously described and the average percentage that
direct costs represent of total costs (based on survey data) across the
specialties that furnish the service to determine an initial indirect
allocator. That is, the initial indirect allocator is
[[Page 80176]]
calculated so that the direct costs equal the average percentage of
direct costs of those specialties furnishing the service. For example,
if the direct portion of the PE RVUs for a given service is 2.00 and
direct costs, on average, represented 25 percent of total costs for the
specialties that furnished the service, the initial indirect allocator
would be calculated so that it equals 75 percent of the total PE RVUs.
Thus, in this example, the initial indirect allocator would equal 6.00,
resulting in a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and
6.00 is 75 percent of 8.00).
Next, we added the greater of the work RVUs or clinical
labor portion of the direct portion of the PE RVUs to this initial
indirect allocator. In our example, if this service had 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 (TCs) and Professional
Components (PCs)
Diagnostic services are generally comprised of two components: A
professional component (PC) and a technical component (TC). The PC and
TC may be furnished independently or by different providers, or they
may be furnished together as a ``global'' service. When services have
separately billable PC and TC components, the payment for the global
service equals the sum of the payment for the TC and PC. To achieve
this, we use a weighted average of the ratio of indirect to direct
costs across all the specialties that furnish the global service, TCs,
and PCs; that is, we apply the same weighted average indirect
percentage factor to allocate indirect expenses to the global service,
PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum
to the global.)
(5) PE RVU Methodology
For a more detailed description of the PE RVU methodology, we refer
readers to the CY 2010 PFS final rule with comment period (74 FR 61745
through 61746). We also direct interested readers to the file called
``Calculation of PE RVUs under Methodology for Selected Codes'' which
is available on our Web site under downloads for the CY 2017 PFS final
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. This file
contains a table that illustrates the calculation of PE RVUs as
described below for individual 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 factor to ensure that the
aggregate pool of direct PE costs calculated in Step 3 does not vary
from the aggregate pool of direct PE costs for the current year. Apply
the scaling factor to the direct costs for each service (as calculated
in Step 1).
Step 5: Convert the results of Step 4 to an RVU scale for each
service. To do this, divide the results of Step 4 by the CF. Note that
the actual value of the CF used in this calculation does not influence
the final direct cost PE RVUs, as long as the same CF is used in Step 4
and Step 5. Different CFs will result in different direct PE scaling
factors, but this has no effect on the final direct cost PE RVUs since
changes in the CFs and changes in the associated direct scaling factors
offset one another.
(c) Create the Indirect Cost PE RVUs
Create indirect allocators.
Step 6: Based on the survey data, calculate direct and indirect PE
percentages for each physician specialty.
Step 7: Calculate direct and indirect PE percentages at the service
level by taking a weighted average of the results of Step 6 for the
specialties that furnish the service. Note that for services with TCs
and PCs, the direct and indirect percentages for a given service do not
vary by the PC, TC, and global service.
We use an average of the 3 most recent years of available Medicare
claims data to determine the specialty mix assigned to each code. As we
stated in the CY 2016 final rule with comment period (80 FR 70894), we
believe that the 3-year average will mitigate the need to use dominant
or expected specialty instead of the claims data. Because we
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 provide a first opportunity to determine whether service-
level overrides of claims data are necessary. Currently, in the
development of PE RVUs we apply only the overrides that also apply to
the MP RVU calculation. Since the proposed PE RVUs include a new year
of claims into the 3-year average for the first time, we solicited
comment on the proposed CY 2017 PFS rates and whether or not the
incorporation of a new year of utilization data into a 3-year average
mitigates the need for alternative service-level overrides such as a
claims-based approach (dominant specialty) or stakeholder-recommended
approach
[[Page 80177]]
(expected specialty) in the development of PE (and MP) RVUs for low-
volume codes. Prior year RVUs are available at several locations on the
PFS Web site located at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
Comment: Several commenters contended that even a multi-year
average of claims data to determine the mix of specialties that furnish
the services creates distortions and wide variability for low volume
services, particularly those services with fewer than 100 annual
Medicare claims. Commenters stated that low volume codes that use a
specialty override appear to have stable PE and MP RVUs, while other
low volume codes without overrides continue to shift from year to year.
Given these fluctuations, commenters suggested that CMS implement
service-level overrides to determine the specialty mix for these low
volume procedures. These commenters provided a list of nearly 2000
codes and suggested specialty overrides.
Response: We appreciate commenters' interest in relatively stable
PE and MP RVUs and for continuing to highlight the challenges faced
when determining the specialty allocation for low volume services.
Since we did not make a proposal regarding specialty overrides for low
volume services, we do not believe that it would be appropriate to
establish overrides for several thousand codes at this time. However,
given the continued concerns, we will consider the issue, including
these specific recommendations, for future rulemaking.
Step 8: Calculate the service level allocators for the indirect PEs
based on the percentages calculated in Step 7. The indirect PEs are
allocated based on the three components: The direct PE RVUs; the
clinical labor PE RVUs; and the work RVUs.
For most services the indirect allocator is: Indirect PE percentage
* (direct PE RVUs/direct percentage) + work RVUs.
There are two situations where this formula is modified:
If the service is a global service (that is, a service
with global, professional, and technical components), then the indirect
PE allocator is: Indirect percentage (direct PE RVUs/direct percentage)
+ clinical labor PE RVUs + work RVUs.
If the clinical labor PE RVUs exceed the work RVUs (and
the service is not a global service), then the indirect allocator is:
Indirect PE percentage (direct PE RVUs/direct percentage) + clinical
labor PE RVUs.
(Note: For global services, the indirect PE allocator is based on
both the work RVUs and the clinical labor PE RVUs. We do this to
recognize that, for the PC service, indirect PEs will be allocated
using the work RVUs, and for the TC service, indirect PEs will be
allocated using the direct PE RVUs and the clinical labor PE RVUs. This
also allows the global component RVUs to equal the sum of the PC and TC
RVUs.)
For presentation purposes, in the examples in the download file
called ``Calculation of PE RVUs under Methodology for Selected Codes'',
the formulas were divided into two parts for each service.
The first part does not vary by service and is the
indirect percentage (direct PE RVUs/direct percentage).
The second part is either the work RVU, clinical labor PE
RVU, or both depending on whether the service is a global service and
whether the clinical PE RVUs exceed the work RVUs (as described earlier
in this step).
Apply a scaling adjustment to the indirect allocators.
Step 9: Calculate the current aggregate pool of indirect PE RVUs by
multiplying the result of step 8 by the average indirect PE percentage
from the survey data.
Step 10: Calculate an aggregate pool of indirect PE RVUs for all
PFS services by adding the product of the indirect PE allocators for a
service from Step 8 and the utilization data for that service.
Step 11: Using the results of Step 9 and Step 10, calculate an
indirect PE adjustment so that the aggregate indirect allocation does
not exceed the available aggregate indirect PE RVUs and apply it to
indirect allocators calculated in Step 8.
Calculate the indirect practice cost index.
Step 12: Using the results of Step 11, calculate aggregate pools of
specialty-specific adjusted indirect PE allocators for all PFS services
for a specialty by adding the product of the adjusted indirect PE
allocator for each service and the utilization data for that service.
Step 13: Using the specialty-specific indirect PE/HR data,
calculate specialty-specific aggregate pools of indirect PE for all PFS
services for that specialty by adding the product of the indirect PE/HR
for the specialty, the work time for the service, and the specialty's
utilization for the service across all services furnished by the
specialty.
Step 14: Using the results of Step 12 and Step 13, calculate the
specialty-specific indirect PE scaling factors.
Step 15: Using the results of Step 14, calculate an indirect
practice cost index at the specialty level by dividing each specialty-
specific indirect scaling factor by the average indirect scaling factor
for the entire PFS.
Step 16: Calculate the indirect practice cost index at the service
level to ensure the capture of all indirect costs. Calculate a weighted
average of the practice cost index values for the specialties that
furnish the service. (Note: For services with TCs and PCs, we calculate
the indirect practice cost index across the global service, PCs, and
TCs. Under this method, the indirect practice cost index for a given
service (for example, echocardiogram) does not vary by the PC, TC, and
global service.)
Step 17: Apply the service level indirect practice cost index
calculated in Step 16 to the service level adjusted indirect allocators
calculated in Step 11 to get the indirect PE RVUs.
(d) Calculate the Final PE RVUs
Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs
from Step 17 and apply the final PE budget neutrality (BN) adjustment.
The final PE BN adjustment is calculated by comparing the sum of steps
5 and 17 of to the proposed aggregate work RVUs scaled by the ratio of
current aggregate PE and work RVUs. This adjustment ensures that all PE
RVUs in the PFS account for the fact that certain specialties are
excluded from the calculation of PE RVUs but included in maintaining
overall PFS budget neutrality. (See ``Specialties excluded from
ratesetting calculation'' later in this section.)
(e) Setup File Information
Specialties excluded from ratesetting calculation: For the
purposes of calculating the PE RVUs, we exclude certain specialties,
such as certain 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-orthotist.
54............................. Medical supply company not included in
51, 52, or 53.
55............................. Individual certified orthotist.
[[Page 80178]]
56............................. Individual certified prosthetist.
57............................. Individual certified prosthetist-
orthotist.
58............................. Medical supply company with registered
pharmacist.
59............................. Ambulance service supplier, e.g.,
private ambulance companies, funeral
homes, etc.
60............................. Public health or welfare agencies.
61............................. Voluntary health or charitable
agencies.
73............................. Mass immunization roster biller.
74............................. Radiation therapy centers.
87............................. All other suppliers (e.g., drug and
department stores).
88............................. Unknown supplier/provider specialty.
89............................. Certified clinical nurse specialist.
96............................. Optician.
97............................. Physician assistant.
A0............................. Hospital.
A1............................. SNF.
A2............................. Intermediate care nursing facility.
A3............................. Nursing facility, other.
A4............................. HHA.
A5............................. Pharmacy.
A6............................. Medical supply company with respiratory
therapist.
A7............................. Department store.
B2............................. Pedorthic personnel.
B3............................. Medical supply company with pedorthic
personnel.
------------------------------------------------------------------------
Crosswalk certain low volume physician specialties:
Crosswalk the utilization of certain specialties with relatively low
PFS utilization to the associated specialties.
Physical therapy utilization: Crosswalk the utilization
associated with all physical therapy services to the specialty of
physical therapy.
Identify professional and technical services not
identified under the usual TC and 26 modifiers: Flag the services that
are PC and TC services but do not use TC and 26 modifiers (for example,
electrocardiograms). This flag associates the PC and TC with the
associated global code for use in creating the indirect PE RVUs. For
example, the professional service, CPT code 93010 (Electrocardiogram,
routine ECG with at least 12 leads; interpretation and report only), is
associated with the global service, CPT code 93000 (Electrocardiogram,
routine ECG with at least 12 leads; with interpretation and report).
Payment modifiers: Payment modifiers are accounted for in
the creation of the file consistent with current payment policy as
implemented in claims processing. For example, services billed with the
assistant at surgery modifier are paid 16 percent of the PFS amount for
that service; therefore, the utilization file is modified to only
account for 16 percent of any service that contains the assistant at
surgery modifier. Similarly, for those services to which volume
adjustments are made to account for the payment modifiers, time
adjustments are applied as well. For time adjustments to surgical
services, the intraoperative portion in the work time file is used;
where it is not present, the intraoperative percentage from the payment
files used by contractors to process Medicare claims is used instead.
Where neither is available, we use the payment adjustment ratio to
adjust the time accordingly. Table 2 details the manner in which the
modifiers are applied.
Table 2--Application of Payment Modifiers to Utilization Files
--------------------------------------------------------------------------------------------------------------------------------------------------------
Modifier Description Volume adjustment Time adjustment
--------------------------------------------------------------------------------------------------------------------------------------------------------
80, 81, 82......................... Assistant at Surgery...... 16%....................... Intraoperative portion.
AS................................. Assistant at Surgery-- 14% (85% * 16%)........... Intraoperative portion.
Physician Assistant.
50 or LT and RT.................... Bilateral Surgery......... 150%...................... 150% of work time.
51................................. Multiple Procedure........ 50%....................... Intraoperative portion.
52................................. Reduced Services.......... 50%....................... 50%.
53................................. Discontinued Procedure.... 50%....................... 50%.
54................................. Intraoperative Care only.. Preoperative + Preoperative + Intraoperative portion.
Intraoperative
Percentages on the
payment files used by
Medicare contractors to
process Medicare claims.
55................................. Postoperative Care only... Postoperative Percentage Postoperative portion.
on 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
final rule.
(6) Equipment Cost Per Minute
The equipment cost per minute is calculated as:
[[Page 80179]]
(1/(minutes per year * usage)) * price * ((interest rate/(1-(1/((1 +
interest rate)[supcaret] life of equipment)))) + maintenance)
Where:
minutes per year = maximum minutes per year if usage were continuous
(that is, usage = 1); generally 150,000 minutes.
usage = variable, see discussion below.
price = price of the particular piece of equipment.
life of equipment = useful life of the particular piece of
equipment.
maintenance = factor for maintenance; 0.05.
interest rate = variable, see discussion below.
Usage: We currently use an equipment utilization rate assumption of
50 percent for most equipment, with the exception of expensive
diagnostic imaging equipment, for which we use a 90 percent assumption
as required by section 1848(b)(4)(C) of the Act.
Stakeholders have often suggested that particular equipment items
are used less frequently than 50 percent of the time in the typical
setting and that CMS should reduce the equipment utilization rate based
on these recommendations. We appreciate and share stakeholders'
interest in using the most accurate assumption regarding the equipment
utilization rate for particular equipment items. However, we believe
that absent robust, objective, auditable data regarding the use of
particular items, the 50 percent assumption is the most appropriate
within the relative value system. We welcome the submission of data
that illustrates an alternative rate.
Maintenance: This factor for maintenance was finalized in the CY
1998 PFS final rule (62 FR 33164).
We continue to investigate potential avenues for determining
equipment maintenance costs across a broad range of equipment items.
Comment: One commenter stated that the cost of maintaining imaging
equipment exceeds the cost of general medical equipment, and that for
imaging modalities the median maintenance cost is approximately 10
percent of the equipment purchase price. The commenter stated that the
current 5 percent equipment maintenance rate continues to be an
inadequate and outdated reflection of actual maintenance costs. The
commenter also stated that information on maintenance costs is readily
available to CMS through both public and private sources. The commenter
did not identify these sources.
Response: As we previously stated in the CY 2016 final rule with
comment period (80 FR 70897), we agree with the commenter that we do
not believe the annual maintenance factor for all equipment is exactly
5 percent, and we concur that the current rate likely understates the
true cost of maintaining some equipment. We also believe it likely
overstates the maintenance costs for other equipment. When we solicited
comments regarding sources of data containing equipment maintenance
rates, commenters were unable to identify an auditable, robust data
source that could be used by CMS on a wide scale. As a result, in the
absence of publicly available datasets regarding equipment maintenance
costs or another systematic data collection methodology for determining
maintenance factor, we do not believe that we have sufficient
information at present to adopt a variable maintenance factor for
equipment cost per minute pricing. We continue to investigate potential
avenues for determining equipment maintenance costs across a broad
range of equipment items.
Interest Rate: In the CY 2013 PFS final rule with comment period
(77 FR 68902), we updated the interest rates used in developing an
equipment cost per minute calculation. The interest rate was based on
the Small Business Administration (SBA) maximum interest rates for
different categories of loan size (equipment cost) and maturity (useful
life). The interest rates are listed in Table 3. (See 77 FR 68902 for a
thorough discussion of this issue.) We did not propose any changes to
these interest rates for CY 2017.
Table 3--SBA Maximum Interest Rates
------------------------------------------------------------------------
Interest
Price Useful life rate (%)
------------------------------------------------------------------------
<$25K.............................. <7 Years.............. 7.50
$25K to $50K....................... <7 Years.............. 6.50
>$50K.............................. <7 Years.............. 5.50
<$25K.............................. 7+ Years.............. 8.00
$25K to $50K....................... 7+ Years.............. 7.00
>$50K.............................. 7+ Years.............. 6.00
------------------------------------------------------------------------
d. Changes to Direct PE Inputs for Specific Services
This section focuses on specific PE inputs. The direct PE inputs
are included in the CY 2017 direct PE input database, which is
available on our Web site under downloads for the CY 2017 PFS final
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
(1) PE Inputs for Digital Imaging Services
Prior to the CY 2015 PFS rulemaking cycle, the RUC provided a
recommendation regarding the PE inputs for digital imaging services.
Specifically, the RUC recommended that we remove supply and equipment
items associated with film technology from a previously specified list
of codes since these items were no longer typical resource inputs. The
RUC also recommended that the Picture Archiving and Communication
System (PACS) equipment be included for these imaging services since
these items are typically used in furnishing imaging services. However,
since we did not receive any invoices for the PACS system prior to that
year's proposed rule, we were unable to determine the appropriate
pricing to use for the inputs. For CY 2015, we finalized our proposal
to remove the film supply and equipment items, and to create a new
equipment item as a proxy for the PACS workstation as a direct expense
(79 FR 67561-67563). We used the price associated with ED021 (computer,
desktop, w-monitor) to price the new item, ED050 (PACS Workstation
Proxy), pending receipt of invoices to facilitate pricing specific to
the PACS workstation. Subsequent to establishing payment rates for CY
2015, we received information from several stakeholders regarding
pricing for items related to the digital acquisition and storage of
images. We received invoices from one stakeholder that facilitated a
proposed price update for the PACS workstation in the CY 2016 PFS
proposed rule, and we updated the price for the PACS workstation to
$5,557 in the CY 2016 PFS final rule with comment period (80 FR 70899).
In addition to the workstation used by the clinical staff for
acquiring the images and furnishing the technical component (TC) of the
services, a stakeholder also submitted more detailed information
regarding a workstation used by the practitioner interpreting the image
in furnishing the professional component (PC) of many of these
services.
As we stated in the CY 2015 PFS final rule with comment period (79
FR 67563), we generally believe that workstations used by these
practitioners are more accurately considered indirect costs associated
with the PC of the service. However, we understand that the
professional workstations for interpretation of digital images are
similar in principle to some of the previous film inputs incorporated
into the global and technical components of the codes, such as the view
box equipment. Given that the majority of these services are reported
globally in the nonfacility setting, we believe it is appropriate to
include these costs as direct inputs for the associated HCPCS codes.
Based on our established
[[Page 80180]]
methodology in which single codes with professional and technical
components are constructed by assigning work RVUs exclusively to the
professional component and direct PE inputs exclusively to the
technical components, these costs would be incorporated into the PE
RVUs of the global and technical component of the HCPCS code.
We stated in the CY 2016 PFS final rule with comment period that
the costs of the professional workstation may be analogous to costs
related to the use of film previously incorporated as direct PE inputs
for these services. We also solicited comments on whether including the
professional workstation as a direct PE input for these codes would be
appropriate, given that the resulting PE RVUs would be assigned to the
global and technical components of the codes. Commenters responded by
indicating their approval of the concept of a professional PACS
workstation used for interpretation of digital images. We received
invoices for the pricing of a professional PACS workstation, as well as
additional invoices for the pricing of a mammography-specific version
of the professional PACS workstation. The RUC also included these new
equipment items in its recommendations for the CY 2017 PFS rulemaking
cycle.
Based on our analysis of submitted invoices, we proposed to price
the professional PACS workstation (ED053) at $14,616.93. We did not
propose a change in price for the current technical PACS workstation
(ED050), which will remain at a price of $5,557.00.
The price of the professional PACS workstation is based upon
individual invoices submitted for the cost of a PC Tower ($1531.52), a
pair of 3 MP monitors ($10,500.00 in total), a keyboard and mouse
($84.95), a UPS power backup devices for TNP ($1098.00), and a switch
for PACS monitors/workstations ($1402.46).
We proposed to add the professional PACS workstation to many CPT
codes in the 70000 series that use the current technical PACS
workstation (ED050) and include professional work for which such a
workstation would be used. We did not propose to add the equipment item
to add-on codes since the base codes would include minutes for the
item. We also did not propose to add the item to codes that are
therapeutic in nature, as the professional PACS workstation is intended
for use in diagnostic services. We therefore did not propose to add the
item to codes in the Radiation Therapy section (77261 through 77799) or
the Nuclear Medicine Cardiology section (78414-78499). We also did not
propose to add the item to image guidance codes where the dominant
provider is not a radiologist (77002, 77011, 77071, 77077, and 77081)
according to the most recent year of claims data, since we believe a
single workstation would be more typical in those cases. We identified
approximately 426 codes to which we proposed to add a professional PACS
workstation. Please see Table 4 for the full list of affected codes.
For the professional PACS workstation, we proposed to assign
equipment time equal to the intraservice work time plus half of the
preservice work time associated with the codes, since the work time
generally reflects the time associated with the professional
interpretation. We proposed half of the preservice work time for the
professional PACS workstation because we do not believe that the
practitioner would typically spend all of the preservice work period
using the equipment. For older codes that do not have a breakdown of
physician work time by service period, and only have an overall
physician work time, we proposed to use half the total work time as an
approximation of the intraservice work time plus one half of the
preservice work time. In our review of services that contained an
existing PACS workstation and had a breakdown of physician work time,
we found that half of the total time was a reasonable approximation for
the value of intraservice work time plus one half of preservice work
time where no such breakdown existed. We also considered using an
equipment time formula of the physician intraservice time plus 1 minute
(as a stand-in for the physician preservice work time). We solicited
public comment on the most accurate equipment time formula for the
professional PACS workstation.
We solicited public comment on the proposed list of codes that
would incorporate the professional PACS workstation. We were interested
in public comment on the codes for which a professional PACS
workstation should be included, and whether one of these professional
workstations should be included for codes outside the 70000 series. In
cases within the 70000 series where radiologists are not the typical
specialty reporting the code, such as CPT codes 77002 and 77011, we
asked whether it would be appropriate to add one of the professional
PACS workstations to these services.
The following is a summary of the comments we received on the
proposed addition of the professional PACS workstation, the pricing of
the workstation, the list of codes that would incorporate the
professional PACS workstation, and the equipment minutes to assign to
the workstation.
Comment: Commenters supported the general concept of the
professional PACS workstation and its addition to the proposed list of
codes. Commenters stated that the professional PACS workstation is an
essential component of diagnostic imaging procedures due to the switch
from film to digital technology, and the professional workstation would
be an appropriate inclusion as a direct PE input for these services.
Response: We appreciate the support from the commenters for the
addition of the professional PACS workstation.
Comment: Many commenters addressed the subject of the proper
pricing of the professional PACS workstation. Several commenters
requested that CMS increase the price of the workstation to include a
third and fourth monitor (for speech recognition) priced at $1,715.98,
an Admin Monitor (the extra working monitor) priced at $279.27, and a
Powerscribe Microphone priced at $424.00. Commenters stated that speech
recognition equipment is typical for a professional PACS workstation,
and that physicians typically employed a monitor with greater
resolution than what would be typically used for other purposes (such
as for electronic health records). Related comments contended that the
proposed pricing of the workstation remained significantly less than
what the average imaging facility spends on PACS technology. Other
commenters disagreed with these sentiments and supported the pricing of
the professional PACS workstation at the proposed rate of $14,616.93.
Response: We appreciate the feedback from the commenters regarding
the proper pricing of the professional PACS workstation. When proposing
a price for the professional PACS workstation, we did not include the
cost of the additional monitors and the Powerscribe microphone because
these items represent indirect costs under the established PE
methodology and the functionality would unlikely have been included in
the previously existing film inputs the professional PACS workstation
is replacing. Generally, we believe that monitors used to access
electronic health records and microphones used for dictation are often
used by practitioners who furnish a range a PFS services, are not
allocable to particular services or patients, and therefore, are
included in the administrative cost category of practice expense, and
therefore, are allocated to
[[Page 80181]]
individual codes through indirect PE RVUs.
Comment: Many commenters stated that CMS should expand the list of
codes with a professional PACS workstation. Commenters generally
focused on three of the criteria proposed by CMS: The exclusion of the
workstation from add-on services, the exclusion of therapeutic (as
opposed to diagnostic) services, and the exclusion of codes outside the
70000 series. Commenters stated that add-on codes should be
incorporated into the professional PACS workstation list, as they
require additional time to perform, and therefore, more time with the
technical PACS workstation for the technician, as well as additional
time for the review and interpretation performed by the physician using
the professional PACS workstation. Commenters also indicated that many
therapeutic services would also require a professional PACS
workstation, and disagreed with limiting the workstation to diagnostic
services only. Finally, commenters supplied extensive lists of
additional codes, both inside and outside of the 70000 series, where
they stated that the inclusion of a professional PACS workstation was
warranted.
Response: We appreciate the feedback from the commenters in helping
to define the criteria for inclusion of the professional PACS
workstation, along with more specific recommendations about which codes
should include the workstation. After considering these comments, we
will be adding the professional PACS workstation to additional
suggested codes. We took the following into account in making these
additions:
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 which 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
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 agree 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. We believe that in these specific
cases, the use of the professional PACS workstation has been
established to be typical for the code in question by the specialties
furnishing the service, as a result of the evidence provided in the
comments submitted in response to our proposal. We have added the
workstation to many of the therapeutic codes requested by commenters,
specifically codes listed outside the 70000 series, where use of the
professional PACS station is typical.
Within the 70000 series, we reviewed each of the codes
submitted by commenters. Most of these codes did not fall within one of
the categories where we proposed to add the professional PACS
workstation in the proposed rule: They lacked a technical PACS
workstation, they were add-on codes, or they were diagnostic procedures
for which radiology is not the dominant specialty providing the
service. We continue to believe that the professional PACS workstation
should not be added to codes that do not fall into these categories,
since we believe that the image must be captured in order to for it to
be interpreted, that the use of the PACS workstation in the base code
reported with add-on codes would accurately capture the associated
resources used, and that the PACS professional workstation is only
typically used by radiologists. Based on comments, we are adding the
professional workstation to only one code in the 70000 series, CPT code
73562, as it includes a technical PACS workstation, is not an add-on
code, and is typically furnished by radiologists.
For codes in the 80000 and 90000 series, we are concerned
about whether it is appropriate to include the technical PACS
workstation into 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 are not removing the technical PACS workstation from these
codes at this time, we do not believe that a professional PACS
workstation should be added to these procedures. We will consider the
inclusion of both PACS workstations for future rulemaking.
Comment: Several commenters addressed the topic of equipment time
for the professional PACS workstation. Commenters requested that CMS
allocate the entire preservice physician work time associated with the
codes, as opposed to the proposed half of the preservice physician work
time. Commenters stated that although certain physician work activities
in the preservice period may not directly involve the professional
workstation, even when the physician is engaged in these parallel work
activities, the professional workstation is ``open'' to the patient at
hand and cannot be used for other patients. Commenters also disagreed
with the proposal to use half the total time for older codes in which
there is no separation of preservice and intraservice period times.
Commenters stated that using the entire physician work time would be
the best option since there is no accurate way to estimate the service
period times, and that it would avoid potential confusion in equipment
formulas in the future.
Response: We continue to believe that the professional PACS
workstation is more accurately assigned equipment time by using half of
the preservice physician work time rather than the full preservice
physician work time. As we stated in the proposed rule, we do not
believe that the practitioner would typically spend all of the
preservice work period using the equipment. Commenters agreed that the
physician may not need the professional workstation for the full
preservice period, but contended that the equipment would be ``open''
and unavailable for use by other physicians or for other patients. We
disagree with this argument on clinical practice and methodological
grounds. We do not agree that the professional PACS workstation would
necessarily be unavailable for use by other physicians when the
physician in question is not using the machine, Additionally, we note
that the number of minutes assigned to the predecessor film inputs did
not generally include the full number of pre-service minutes. Finally,
our PE methodology is based on the resources typically used to furnish
the procedure, and we typically assign time for equipment items based
on when it cannot be used by another practitioner or for another
patient due to its use in the given procedure. We continue to believe
that half of the preservice physician work time (along with the full
physician intraservice work time) is a good approximation of the time
in the preservice period that the professional PACS workstation will
typically be in use. As we stated in the proposed rule, we do not
believe that the practitioner would typically spend all of the
preservice time using the equipment, and would also spend preservice
time on other activities, such as scrubbing and dressing, for example.
For older codes where there is no breakdown of work time values by
service period, we do not agree with commenters that the professional
PACS workstation should use the total work time. The comments do not
provide a
[[Page 80182]]
persuasive rationale for using the total work time instead of our
proposed alternative, developed for consistency with codes for which we
do have work time breakdowns by service period. Therefore, in the
absence of service period work time detail, we continue to believe that
half of the total work time is a reasonable proxy for the small number
of old codes affected by this issue. We are not concerned about the
potential for confusion in the future with differing equipment time
formulas, as the addition of the professional PACS workstation to these
codes is a one-time inclusion that will not affect the future review of
this equipment.
Finally, we believe that there is a difference in the pattern of
equipment usage for the professional PACS workstation between
diagnostic and therapeutic codes. Generally, the intraservice work for
diagnostic imaging codes describes the review of images, while the
intraservice work for therapeutic services describes a broader range of
activities. Therefore, although we used an equipment formula of half
the preservice physician work time and the full intraservice physician
work time for the diagnostic procedures, we do not believe that this
same time formula would be appropriate for therapeutic procedures since
the professional PACS workstation would not be in use during the
intraservice portion of these services. Therefore, we will use an
equipment time formula of half the preservice physician work time and
half the postservice physician work time for the therapeutic codes to
which we are adding a professional PACS workstation, which we believe
is more consistent with the descriptions of work for the codes in
question. Consistent with our ongoing efforts to improve payment
accuracy for these costs, we seek recommendations from the RUC and
other stakeholders on a more precise allocation methodology for
equipment minutes for these procedures.
After consideration of comments received, we are finalizing our
proposal to add a professional PACS workstation (ED053) to the
equipment database and price it at the proposed rate of $14,616.93. We
are dividing the codes that will contain a professional PACS
workstation into diagnostic and therapeutic categories. For diagnostic
codes, we are assigning equipment minutes equal to half the preservice
physician work time and the full intraservice physician work time. For
the relatively smaller group of diagnostic codes with no service period
time breakdown, we are assigning equipment time equal to half of the
total physician work time. For therapeutic codes, we are assigning
equipment minutes equal to half the preservice physician work time and
half the postservice physician work time for the second group. There
are no therapeutic codes on our current list which lack a service
period time breakdown. The following table lists all of the codes that
include a professional PACS workstation for CY 2017, along with the
equipment minutes for the workstation.
Table 4--Codes With Professional PACS Workstation in the Direct PE Input
Database
------------------------------------------------------------------------
ED053
HCPCS Procedure type Minutes
------------------------------------------------------------------------
10030........................ Therapeutic................. 23
10035........................ Therapeutic................. 15
19081........................ Therapeutic................. 19
19083........................ Therapeutic................. 17
19085........................ Therapeutic................. 19
19281........................ Therapeutic................. 18
19283........................ Therapeutic................. 19
19285........................ Therapeutic................. 18
19287........................ Therapeutic................. 19
22510........................ Therapeutic................. 32
22511........................ Therapeutic................. 32
22513........................ Therapeutic................. 32
22514........................ Therapeutic................. 32
32555........................ Therapeutic................. 19
32557........................ Therapeutic................. 19
36221........................ Therapeutic................. 34
36222........................ Therapeutic................. 34
36223........................ Therapeutic................. 34
36224........................ Therapeutic................. 34
36225........................ Therapeutic................. 34
36226........................ Therapeutic................. 34
36251........................ Therapeutic................. 31
36252........................ Therapeutic................. 31
36253........................ Therapeutic................. 31
36254........................ Therapeutic................. 31
36598........................ Therapeutic................. 13
37184........................ Therapeutic................. 30
37187........................ Therapeutic................. 25
37188........................ Therapeutic................. 23
37191........................ Therapeutic................. 22
37192........................ Therapeutic................. 23
37193........................ Therapeutic................. 23
37197........................ Therapeutic................. 26
37220........................ Therapeutic................. 34
37221........................ Therapeutic................. 34
37224........................ Therapeutic................. 34
37225........................ Therapeutic................. 34
37226........................ Therapeutic................. 34
37227........................ Therapeutic................. 34
37228........................ Therapeutic................. 34
37229........................ Therapeutic................. 34
37230........................ Therapeutic................. 34
37231........................ Therapeutic................. 34
37236........................ Therapeutic................. 31
37238........................ Therapeutic................. 31
37241........................ Therapeutic................. 26
37242........................ Therapeutic................. 31
37243........................ Therapeutic................. 38
37244........................ Therapeutic................. 38
47531........................ Therapeutic................. 20
47532........................ Therapeutic................. 22
47533........................ Therapeutic................. 26
47534........................ Therapeutic................. 26
47535........................ Therapeutic................. 19
47536........................ Therapeutic................. 16
47537........................ Therapeutic................. 19
47538........................ Therapeutic................. 22
47539........................ Therapeutic................. 26
47540........................ Therapeutic................. 26
47541........................ Therapeutic................. 26
49083........................ Therapeutic................. 18
49405........................ Therapeutic................. 28
49406........................ Therapeutic................. 28
49407........................ Therapeutic................. 28
49418........................ Therapeutic................. 27
49440........................ Therapeutic................. 29
49441........................ Therapeutic................. 29
49442........................ Therapeutic................. 29
49446........................ Therapeutic................. 22
49450........................ Therapeutic................. 20
49451........................ Therapeutic................. 20
49452........................ Therapeutic................. 20
49460........................ Therapeutic................. 20
49465........................ Therapeutic................. 13
50382........................ Therapeutic................. 28
50384........................ Therapeutic................. 24
50385........................ Therapeutic................. 27
50386........................ Therapeutic................. 25
50387........................ Therapeutic................. 22
50389........................ Therapeutic................. 15
50430........................ Therapeutic................. 23
50431........................ Therapeutic................. 20
50432........................ Therapeutic................. 25
50433........................ Therapeutic................. 25
50434........................ Therapeutic................. 23
50435........................ Therapeutic................. 18
50693........................ Therapeutic................. 25
50694........................ Therapeutic................. 25
50695........................ Therapeutic................. 25
58340........................ Therapeutic................. 7
62302........................ Therapeutic................. 17
62303........................ Therapeutic................. 17
62304........................ Therapeutic................. 17
62305........................ Therapeutic................. 18
70015........................ Diagnostic.................. 12
70030........................ Diagnostic.................. 3
70100........................ Diagnostic.................. 3
70110........................ Diagnostic.................. 4
70120........................ Diagnostic.................. 3
70130........................ Diagnostic.................. 4
70134........................ Diagnostic.................. 4
70140........................ Diagnostic.................. 3
70150........................ Diagnostic.................. 4
70160........................ Diagnostic.................. 3
70190........................ Diagnostic.................. 3
70200........................ Diagnostic.................. 4
70210........................ Diagnostic.................. 3
70220........................ Diagnostic.................. 4
70240........................ Diagnostic.................. 3
70250........................ Diagnostic.................. 4
70260........................ Diagnostic.................. 7
70300........................ Diagnostic.................. 2
70310........................ Diagnostic.................. 3
70320........................ Diagnostic.................. 3
70328........................ Diagnostic.................. 3
70330........................ Diagnostic.................. 22
70332........................ Diagnostic.................. 6
70336........................ Diagnostic.................. 20
70350........................ Diagnostic.................. 3
70355........................ Diagnostic.................. 5
70360........................ Diagnostic.................. 3
70370........................ Diagnostic.................. 4
70371........................ Diagnostic.................. 9
[[Page 80183]]
70380........................ Diagnostic.................. 3
70390........................ Diagnostic.................. 5
70450........................ Diagnostic.................. 12
70460........................ Diagnostic.................. 15
70470........................ Diagnostic.................. 18
70480........................ Diagnostic.................. 13
70481........................ Diagnostic.................. 13
70482........................ Diagnostic.................. 14
70490........................ Diagnostic.................. 13
70491........................ Diagnostic.................. 13
70492........................ Diagnostic.................. 14
70540........................ Diagnostic.................. 14
70542........................ Diagnostic.................. 19
70543........................ Diagnostic.................. 19
70544........................ Diagnostic.................. 13
70545........................ Diagnostic.................. 18
70546........................ Diagnostic.................. 18
70547........................ Diagnostic.................. 13
70548........................ Diagnostic.................. 20
70549........................ Diagnostic.................. 25
70551........................ Diagnostic.................. 21
70552........................ Diagnostic.................. 23
70553........................ Diagnostic.................. 28
70554........................ Diagnostic.................. 43
71010........................ Diagnostic.................. 4
71015........................ Diagnostic.................. 3
71020........................ Diagnostic.................. 4
71021........................ Diagnostic.................. 4
71022........................ Diagnostic.................. 4
71023........................ Diagnostic.................. 5
71030........................ Diagnostic.................. 4
71034........................ Diagnostic.................. 5
71035........................ Diagnostic.................. 3
71100........................ Diagnostic.................. 5
71101........................ Diagnostic.................. 4
71110........................ Diagnostic.................. 4
71111........................ Diagnostic.................. 5
71120........................ Diagnostic.................. 3
71130........................ Diagnostic.................. 3
71250........................ Diagnostic.................. 18
71260........................ Diagnostic.................. 17
71270........................ Diagnostic.................. 13
71275........................ Diagnostic.................. 28
71550........................ Diagnostic.................. 15
71551........................ Diagnostic.................. 30
71552........................ Diagnostic.................. 28
71555........................ Diagnostic.................. 33
72020........................ Diagnostic.................. 3
72040........................ Diagnostic.................. 4
72050........................ Diagnostic.................. 6
72052........................ Diagnostic.................. 6
72070........................ Diagnostic.................. 4
72072........................ Diagnostic.................. 3
72074........................ Diagnostic.................. 3
72080........................ Diagnostic.................. 3
72081........................ Diagnostic.................. 6
72082........................ Diagnostic.................. 7
72083........................ Diagnostic.................. 8
72084........................ Diagnostic.................. 9
72100........................ Diagnostic.................. 4
72110........................ Diagnostic.................. 6
72114........................ Diagnostic.................. 6
72120........................ Diagnostic.................. 4
72125........................ Diagnostic.................. 18
72126........................ Diagnostic.................. 12
72127........................ Diagnostic.................. 12
72128........................ Diagnostic.................. 18
72129........................ Diagnostic.................. 12
72130........................ Diagnostic.................. 12
72131........................ Diagnostic.................. 18
72132........................ Diagnostic.................. 12
72133........................ Diagnostic.................. 12
72141........................ Diagnostic.................. 23
72142........................ Diagnostic.................. 26
72146........................ Diagnostic.................. 23
72147........................ Diagnostic.................. 26
72148........................ Diagnostic.................. 23
72149........................ Diagnostic.................. 26
72156........................ Diagnostic.................. 28
72157........................ Diagnostic.................. 28
72158........................ Diagnostic.................. 28
72159........................ Diagnostic.................. 31
72170........................ Diagnostic.................. 5
72190........................ Diagnostic.................. 3
72191........................ Diagnostic.................. 28
72192........................ Diagnostic.................. 12
72193........................ Diagnostic.................. 12
72194........................ Diagnostic.................. 12
72195........................ Diagnostic.................. 30
72196........................ Diagnostic.................. 26
72197........................ Diagnostic.................. 30
72198........................ Diagnostic.................. 28
72200........................ Diagnostic.................. 3
72202........................ Diagnostic.................. 3
72220........................ Diagnostic.................. 3
72240........................ Diagnostic.................. 19
72255........................ Diagnostic.................. 18
72265........................ Diagnostic.................. 18
72270........................ Diagnostic.................. 23
72275........................ Diagnostic.................. 36
72285........................ Diagnostic.................. 9
72295........................ Diagnostic.................. 9
73000........................ Diagnostic.................. 3
73010........................ Diagnostic.................. 3
73020........................ Diagnostic.................. 3
73030........................ Diagnostic.................. 5
73040........................ Diagnostic.................. 6
73050........................ Diagnostic.................. 3
73060........................ Diagnostic.................. 4
73070........................ Diagnostic.................. 3
73080........................ Diagnostic.................. 4
73085........................ Diagnostic.................. 6
73090........................ Diagnostic.................. 3
73092........................ Diagnostic.................. 3
73100........................ Diagnostic.................. 4
73110........................ Diagnostic.................. 4
73115........................ Diagnostic.................. 6
73120........................ Diagnostic.................. 4
73130........................ Diagnostic.................. 4
73140........................ Diagnostic.................. 3
73200........................ Diagnostic.................. 18
73201........................ Diagnostic.................. 11
73202........................ Diagnostic.................. 12
73206........................ Diagnostic.................. 35
73218........................ Diagnostic.................. 25
73219........................ Diagnostic.................. 25
73220........................ Diagnostic.................. 30
73221........................ Diagnostic.................. 23
73222........................ Diagnostic.................. 23
73223........................ Diagnostic.................. 35
73225........................ Diagnostic.................. 31
73501........................ Diagnostic.................. 4
73502........................ Diagnostic.................. 5
73503........................ Diagnostic.................. 6
73521........................ Diagnostic.................. 5
73522........................ Diagnostic.................. 6
73523........................ Diagnostic.................. 7
73525........................ Diagnostic.................. 6
73551........................ Diagnostic.................. 4
73552........................ Diagnostic.................. 5
73560........................ Diagnostic.................. 4
73562........................ Diagnostic.................. 5
73564........................ Diagnostic.................. 6
73565........................ Diagnostic.................. 4
73580........................ Diagnostic.................. 6
73590........................ Diagnostic.................. 4
73592........................ Diagnostic.................. 3
73600........................ Diagnostic.................. 4
73610........................ Diagnostic.................. 4
73615........................ Diagnostic.................. 6
73620........................ Diagnostic.................. 4
73630........................ Diagnostic.................. 4
73650........................ Diagnostic.................. 3
73660........................ Diagnostic.................. 3
73700........................ Diagnostic.................. 18
73701........................ Diagnostic.................. 11
73702........................ Diagnostic.................. 12
73706........................ Diagnostic.................. 35
73718........................ Diagnostic.................. 20
73719........................ Diagnostic.................. 25
73720........................ Diagnostic.................. 30
73721........................ Diagnostic.................. 23
73722........................ Diagnostic.................. 24
73723........................ Diagnostic.................. 32
73725........................ Diagnostic.................. 33
74000........................ Diagnostic.................. 4
74010........................ Diagnostic.................. 3
74020........................ Diagnostic.................. 4
74022........................ Diagnostic.................. 4
74150........................ Diagnostic.................. 14
74160........................ Diagnostic.................. 17
74170........................ Diagnostic.................. 21
74174........................ Diagnostic.................. 33
74175........................ Diagnostic.................. 28
74176........................ Diagnostic.................. 25
74177........................ Diagnostic.................. 28
74178........................ Diagnostic.................. 33
74181........................ Diagnostic.................. 15
74182........................ Diagnostic.................. 28
74183........................ Diagnostic.................. 35
74185........................ Diagnostic.................. 33
74210........................ Diagnostic.................. 5
74220........................ Diagnostic.................. 5
74230........................ Diagnostic.................. 12
74240........................ Diagnostic.................. 7
74241........................ Diagnostic.................. 7
74245........................ Diagnostic.................. 9
74246........................ Diagnostic.................. 7
74247........................ Diagnostic.................. 18
74249........................ Diagnostic.................. 9
74250........................ Diagnostic.................. 5
74251........................ Diagnostic.................. 33
74260........................ Diagnostic.................. 6
74261........................ Diagnostic.................. 43
74262........................ Diagnostic.................. 48
74263........................ Diagnostic.................. 42
74270........................ Diagnostic.................. 7
74280........................ Diagnostic.................. 23
74283........................ Diagnostic.................. 19
74290........................ Diagnostic.................. 4
74400........................ Diagnostic.................. 18
74410........................ Diagnostic.................. 6
74415........................ Diagnostic.................. 6
74430........................ Diagnostic.................. 4
74440........................ Diagnostic.................. 5
74455........................ Diagnostic.................. 4
74485........................ Diagnostic.................. 6
[[Page 80184]]
74710........................ Diagnostic.................. 4
74712........................ Diagnostic.................. 68
74740........................ Diagnostic.................. 5
75557........................ Diagnostic.................. 45
75559........................ Diagnostic.................. 58
75561........................ Diagnostic.................. 50
75563........................ Diagnostic.................. 66
75571........................ Diagnostic.................. 13
75572........................ Diagnostic.................. 25
75573........................ Diagnostic.................. 38
75574........................ Diagnostic.................. 35
75600........................ Diagnostic.................. 6
75605........................ Diagnostic.................. 11
75625........................ Diagnostic.................. 11
75630........................ Diagnostic.................. 13
75635........................ Diagnostic.................. 50
75658........................ Diagnostic.................. 13
75705........................ Diagnostic.................. 20
75710........................ Diagnostic.................. 11
75716........................ Diagnostic.................. 13
75726........................ Diagnostic.................. 11
75731........................ Diagnostic.................. 11
75733........................ Diagnostic.................. 13
75736........................ Diagnostic.................. 11
75741........................ Diagnostic.................. 13
75743........................ Diagnostic.................. 16
75746........................ Diagnostic.................. 11
75756........................ Diagnostic.................. 11
75791........................ Diagnostic.................. 33
75809........................ Diagnostic.................. 5
75820........................ Diagnostic.................. 7
75822........................ Diagnostic.................. 11
75825........................ Diagnostic.................. 11
75827........................ Diagnostic.................. 11
75831........................ Diagnostic.................. 11
75833........................ Diagnostic.................. 14
75840........................ Diagnostic.................. 11
75842........................ Diagnostic.................. 14
75860........................ Diagnostic.................. 11
75870........................ Diagnostic.................. 11
75872........................ Diagnostic.................. 11
75880........................ Diagnostic.................. 7
75885........................ Diagnostic.................. 14
75887........................ Diagnostic.................. 14
75889........................ Diagnostic.................. 11
75891........................ Diagnostic.................. 11
75893........................ Diagnostic.................. 6
75901........................ Diagnostic.................. 11
75902........................ Diagnostic.................. 13
75962........................ Diagnostic.................. 6
75966........................ Diagnostic.................. 13
75978........................ Diagnostic.................. 6
75984........................ Diagnostic.................. 8
75989........................ Diagnostic.................. 12
76000........................ Diagnostic.................. 3
76010........................ Diagnostic.................. 3
76080........................ Diagnostic.................. 6
76098........................ Diagnostic.................. 3
76100........................ Diagnostic.................. 6
76101........................ Diagnostic.................. 6
76102........................ Diagnostic.................. 6
76120........................ Diagnostic.................. 5
76376........................ Diagnostic.................. 8
76380........................ Diagnostic.................. 10
76390........................ Diagnostic.................. 28
76506........................ Diagnostic.................. 10
76536........................ Diagnostic.................. 12
76604........................ Diagnostic.................. 9
76700........................ Diagnostic.................. 14
76705........................ Diagnostic.................. 11
76706........................ Diagnostic.................. 13
76770........................ Diagnostic.................. 13
76775........................ Diagnostic.................. 11
76776........................ Diagnostic.................. 13
76800........................ Diagnostic.................. 14
76801........................ Diagnostic.................. 18
76805........................ Diagnostic.................. 18
76811........................ Diagnostic.................. 35
76813........................ Diagnostic.................. 23
76815........................ Diagnostic.................. 8
76816........................ Diagnostic.................. 18
76817........................ Diagnostic.................. 13
76818........................ Diagnostic.................. 35
76819........................ Diagnostic.................. 28
76820........................ Diagnostic.................. 13
76821........................ Diagnostic.................. 13
76825........................ Diagnostic.................. 45
76826........................ Diagnostic.................. 11
76830........................ Diagnostic.................. 13
76831........................ Diagnostic.................. 30
76856........................ Diagnostic.................. 13
76857........................ Diagnostic.................. 10
76870........................ Diagnostic.................. 10
76872........................ Diagnostic.................. 20
76873........................ Diagnostic.................. 40
76881........................ Diagnostic.................. 18
76885........................ Diagnostic.................. 20
76886........................ Diagnostic.................. 15
76936........................ Diagnostic.................. 71
76942........................ Diagnostic.................. 19
76970........................ Diagnostic.................. 8
77012........................ Diagnostic.................. 11
77014........................ Diagnostic.................. 9
77021........................ Diagnostic.................. 53
77053........................ Diagnostic.................. 5
77054........................ Diagnostic.................. 5
77058........................ Diagnostic.................. 50
77059........................ Diagnostic.................. 55
77072........................ Diagnostic.................. 3
77074........................ Diagnostic.................. 5
77075........................ Diagnostic.................. 6
77076........................ Diagnostic.................. 12
77084........................ Diagnostic.................. 15
78012........................ Diagnostic.................. 8
78013........................ Diagnostic.................. 13
78014........................ Diagnostic.................. 13
78015........................ Diagnostic.................. 31
78016........................ Diagnostic.................. 49
78018........................ Diagnostic.................. 29
78070........................ Diagnostic.................. 13
78071........................ Diagnostic.................. 18
78072........................ Diagnostic.................. 23
78075........................ Diagnostic.................. 38
78102........................ Diagnostic.................. 18
78103........................ Diagnostic.................. 22
78104........................ Diagnostic.................. 20
78135........................ Diagnostic.................. 48
78140........................ Diagnostic.................. 40
78185........................ Diagnostic.................. 16
78190........................ Diagnostic.................. 40
78195........................ Diagnostic.................. 30
78201........................ Diagnostic.................. 16
78202........................ Diagnostic.................. 20
78205........................ Diagnostic.................. 20
78206........................ Diagnostic.................. 25
78215........................ Diagnostic.................. 13
78216........................ Diagnostic.................. 22
78226........................ Diagnostic.................. 13
78227........................ Diagnostic.................. 18
78230........................ Diagnostic.................. 19
78231........................ Diagnostic.................. 23
78232........................ Diagnostic.................. 28
78258........................ Diagnostic.................. 27
78261........................ Diagnostic.................. 21
78262........................ Diagnostic.................. 25
78264........................ Diagnostic.................. 13
78265........................ Diagnostic.................. 18
78266........................ Diagnostic.................. 23
78278........................ Diagnostic.................. 18
78290........................ Diagnostic.................. 18
78291........................ Diagnostic.................. 31
78300........................ Diagnostic.................. 15
78305........................ Diagnostic.................. 22
78306........................ Diagnostic.................. 11
78315........................ Diagnostic.................. 11
78320........................ Diagnostic.................. 24
78579........................ Diagnostic.................. 8
78580........................ Diagnostic.................. 13
78582........................ Diagnostic.................. 15
78597........................ Diagnostic.................. 13
78598........................ Diagnostic.................. 13
78600........................ Diagnostic.................. 16
78601........................ Diagnostic.................. 18
78605........................ Diagnostic.................. 21
78606........................ Diagnostic.................. 22
78607........................ Diagnostic.................. 29
78610........................ Diagnostic.................. 10
78630........................ Diagnostic.................. 24
78635........................ Diagnostic.................. 36
78645........................ Diagnostic.................. 32
78647........................ Diagnostic.................. 15
78650........................ Diagnostic.................. 40
78660........................ Diagnostic.................. 16
78700........................ Diagnostic.................. 17
78701........................ Diagnostic.................. 18
78707........................ Diagnostic.................. 22
78708........................ Diagnostic.................. 32
78709........................ Diagnostic.................. 40
78710........................ Diagnostic.................. 21
78740........................ Diagnostic.................. 30
78761........................ Diagnostic.................. 20
78800........................ Diagnostic.................. 28
78801........................ Diagnostic.................. 32
78802........................ Diagnostic.................. 24
78803........................ Diagnostic.................. 43
78804........................ Diagnostic.................. 35
78805........................ Diagnostic.................. 25
78806........................ Diagnostic.................. 23
78807........................ Diagnostic.................. 37
79440........................ Diagnostic.................. 24
G0106........................ Diagnostic.................. 24
G0120........................ Diagnostic.................. 24
G0297........................ Diagnostic.................. 18
G0365........................ Diagnostic.................. 20
G0389........................ Diagnostic.................. 9
------------------------------------------------------------------------
(2) Standardization of Clinical Labor Tasks
As we noted in the CY 2015 PFS final rule (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
[[Page 80185]]
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) Clinical Labor Tasks Associated With Digital Imaging
In CY 2015 PFS rulemaking, we noted that the RUC recommendation
regarding inputs for digital imaging services indicated that, as each
code is reviewed under the misvalued code initiative, the clinical
labor tasks associated with digital technology (instead of film) would
need to be addressed. When we reviewed that recommendation, we did not
have the capability of assigning standard clinical labor times for the
hundreds of individual codes since the direct PE input database did not
previously allow for comprehensive adjustments for clinical labor times
based on particular clinical labor tasks. Therefore, consistent with
the recommendation, we proposed to remove film-based supply and
equipment items but maintain clinical labor minutes that were assigned
based on film technology.
As noted in the paragraphs above, we continue to improve the direct
PE input database by specifying for each code the minutes associated
with each clinical labor task. Once completed, this work would allow
adjustments to be made to minutes assigned to particular clinical labor
tasks related to digital technology that occur in multiple codes,
consistent with the changes that were made to individual supply and
equipment items. In the meantime, we believe it would be appropriate to
establish standard times for clinical labor tasks associated with all
digital imaging services for purposes of reviewing individual services
at present, and for possible broad-based standardization once the
changes to the direct PE input database facilitate our ability to
adjust time across services. During the CY 2016 PFS rulemaking cycle,
we proposed appropriate standard minutes for five different clinical
labor tasks associated with services that use digital imaging
technology. In the CY 2016 PFS final rule with comment period (80 FR
70901), we finalized appropriate standard minutes for four of those
five activities, which are listed in Table 5.
Table 5--Clinical Labor Tasks Associated With Digital Imaging Technology
------------------------------------------------------------------------
Typical
Clinical labor task minutes
------------------------------------------------------------------------
Availability of prior images confirmed.................. 2
Patient clinical information and questionnaire reviewed 2
by technologist, order from physician confirmed and
exam protocoled by radiologist.........................
Review examination with interpreting MD................. 2
Exam documents scanned into PACS. Exam completed in RIS 1
system to generate billing process and to populate
images into Radiologist work queue.....................
------------------------------------------------------------------------
We did not finalize standard minutes for the activity
``Technologist QC's images in PACS, checking for all images, reformats,
and dose page.'' We agreed with commenters that this task may require a
variable length of time depending on the number of images to be
reviewed. We stated that it may be appropriate to establish several
different standard times for this clinical labor task for a low/medium/
high quantity of images to be reviewed, in the same fashion that the
clinical labor assigned to clean a surgical instrument package has two
different standard times depending on the use of a basic pack (10
minutes) or a medium pack (30 minutes). We solicited public comment and
feedback on this subject, with the anticipation of including a proposal
in the CY 2017 proposed rule.
We received many comments suggesting that this clinical labor
activity should not have a standard time value. Commenters stated that
the number of minutes varies significantly for different imaging
modalities; and the time is not simply based on the quantity of images
to be reviewed, but also the complexity of the images. The commenters
recommended that time for this clinical labor activity should be
assigned on a code by code basis. We agree with the commenters that the
amount of clinical labor needed to check images in a PACS workstation
may vary depending on the service. However, we do not believe that this
precludes the possibility of establishing standards for clinical labor
tasks as we have done in the past by creating multiple standard times,
for example, those assigned to cleaning different kinds of scopes. We
continue to believe that the use of clinical labor standards provides
greater consistency among codes that share the same clinical labor
tasks and can improve relativity of values among codes. We proposed to
establish a range of appropriate standard minutes for the clinical
labor activity, ``Technologist QCs images in PACS, checking for all
images, reformats, and dose page.'' These standard minutes will be
applied to new and revised codes that make use of this clinical labor
activity when they are reviewed by us for valuation. We proposed 2
minutes as the standard for the simple case, 3 minutes as the standard
for the intermediate case, and 4 minutes as the standard for the
complex case. We proposed the simple case of 2 minutes as the standard
for the typical procedure code involving routine use of imaging. These
values are based upon a review of the existing minutes assigned for
this clinical labor activity; we have determined that 2 minutes is the
[[Page 80186]]
duration for most services and a small number of codes with more
complex forms of digital imaging have higher values. We proposed to use
2 minutes for services involving routine X-rays (simple), 3 minutes for
services involving CTs and MRIs (intermediate), and 4 minutes for the
most highly complex services, which would exceed these more typical
cases. We solicited comments regarding the most accurate category--
simple, intermediate, or complex for existing codes, and in particular
what criteria might be used to identify complex cases systematically.
The following is summary of the comments we received regarding the
ongoing standardization of clinical labor tasks, and our specific
proposal regarding the clinical labor task, ``Technologist QCs images
in PACS, checking for all images, reformats, and dose page.''
Comment: Many commenters restated their opposition to the principle
of establishing standard values for clinical labor tasks. Commenters
contended that clinical labor tasks were highly variable across
different specialties, that the standardization process would disrupt
the relativity of direct PE inputs across the PFS, and that the
proposed standard times were too low and underestimated the staffing
time needed to carry out the tasks in question. Commenters stressed
that each code should be evaluated on an individual basis. One
commenter expressed support for the overall concept regarding efforts
to streamline the time for clinical labor activities.
Response: We note the objections raised by the commenters to the
process of standardizing time values for clinical labor tasks. However,
as we have stated previously, we believe the establishment of standards
can provide greater consistency among codes that share the same
clinical labor tasks, as well as improve relativity of values among
codes. We also note that we do evaluate each code on an individual
basis for direct PE inputs, and establishing clinical labor standards
assists in that process of individual review. We continue to allow
clinical labor times above the standard values for individual services,
provided that there is a compelling rationale to explain why that
particular service requires additional clinical labor time above and
beyond the standard. We believe that establishing a range of standard
minutes for this particular digital imaging clinical labor task will
provide clarity and help maintain relativity across a wide range of
imaging services.
Comment: One commenter requested a broad study of the actual
clinical labor times associated with digital imaging.
Response: We appreciate the importance of incorporating robust,
auditable, and routinely updated data sources for use in the
determination of RVUs. We welcome stakeholder information on the
availability of such data, while we continue to consider the best means
of acquiring such data.
Comment: Several commenters addressed our specific proposal for the
clinical labor task, ``Technologist QCs images in PACS, checking for
all images, reformats, and dose page.'' Commenters requested that,
short of no standard times at all, the establishment of categories for
this clinical labor task should be as follows: Simple (2 min);
intermediate (3 min), complex (4 min) and highly complex (5 min).
Response: We appreciate the suggestion from the commenters to adopt
a categorization system very similar to our proposal, with the addition
of an extra category for highly complex services valued at 5 minutes.
We agree with this addition to our proposal, as it will allow for
additional specificity in classifying different types of imaging
services, including those that are unusually complex. However, we note
that we proposed to define the simple case of 2 minutes as the standard
for the typical procedure code involving routine use of imaging, and we
believe only a small number of codes with more complex forms of digital
imaging would typically involve more time for the task. We proposed to
use 2 minutes for services involving routine X-rays (the simple case),
and 3 minutes for services involving CTs and MRIs (the intermediate
case). We seek recommendations from the RUC and other stakeholders and
we intend to request feedback from commenters through future rulemaking
to assist in identifying what we believe would be the small number of
services that fall into the complex (4 min) and highly complex (5 min)
categories, and the specific basis used to set the two categories apart
from one another. In the meantime, we will consider individual codes on
a case by case basis for this clinical labor task.
After considering the comments received, we are finalizing a range
of appropriate standard minutes for the clinical labor activity,
``Technologist QCs images in PACS, checking for all images, reformats,
and dose page'' as follows: Simple (2 min); intermediate (3 min),
complex (4 min) and highly complex (5 min). We are also finalizing our
criteria for determining the simple and intermediate categories as
proposed.
(b) Pathology Clinical Labor Tasks
As with the clinical labor tasks associated with digital imaging,
many of the currently assigned times for the specialized clinical labor
tasks associated with pathology services are not consistent across
codes. In reviewing past RUC recommendations for pathology services, we
have not identified information that supports the judgment that the
same tasks take significantly more or less time depending on the
individual service for which they are performed, especially given the
high degree of specificity with which the tasks are described. We
continue to believe that, in general, a clinical labor task will tend
to take the same amount of time to perform for one individual service
as the same clinical labor task when it is performed in a clinically
similar service.
Therefore, we developed standard times for clinical labor tasks
that we have used in finalizing direct PE inputs in recent years,
starting in the CY 2012 PFS final rule with comment period (76 FR
73213). These times were based on our review and assessment of the
current times included for these clinical labor tasks in the direct PE
input database. We proposed in the CY 2016 PFS proposed rule to
establish standard times for a list of 17 clinical labor tasks related
to pathology services, and solicited public feedback regarding our
proposed standards. Many commenters stated in response to our proposal
that they did not support the standardization of clinical labor
activities across pathology services. Commenters stated that
establishing a single standard time for each clinical labor task was
infeasible due to the differences in batch size or number of blocks
across different pathology procedures. Several commenters indicated
that it might be possible to standardize across codes with the same
batch sizes, and urged us to consider pathology-specific details, such
as batch size and block number, in the creation of any future standard
times for clinical labor tasks related to pathology services.
As we stated in the CY 2016 PFS proposed rule, we developed the
proposed standard times based on our review and assessment of the
current times included for these clinical labor tasks in the direct PE
input database. We believe that, generally speaking, clinical labor
tasks with the same description are comparable across different
pathology procedures. We believe this to be true based on the
comparability of clinical labor tasks in
[[Page 80187]]
non-pathology services, as well as the high degree of specificity with
which most clinical labor tasks for pathology services are described
relative to clinical labor tasks associated with other PFS services. We
concurred with commenters that accurate clinical labor times for
pathology codes may be dependent on the number of blocks or batch size
typically used for each individual service. However, we also believe
that it is appropriate and feasible to establish ``per block''
standards or standards varied by batch size assumptions for many
clinical labor activities that would be comparable across a wide range
of individual services. We have received detailed information regarding
batch size and number of blocks during review of individual pathology
services on an intermittent basis in the past. We requested regular
submission of these details on the PE worksheets supplied by the RUC as
part of the review process for pathology services, as a means to assist
in the determination of the most accurate direct PE inputs.
We also stated our belief that many of the clinical labor
activities for which we proposed to establish standard times were tasks
that do not depend on number of blocks or batch size. Clinical labor
activities such as ``Clean room/equipment following procedure'' and
``Dispose of remaining specimens'' would typically remain standard
across different services without varying by block number or batch
size, with the understanding that additional time may be required above
the standard value for a clinical labor task that is part of an
unusually complex or difficult service. As a result, we ultimately
finalized standard times for 6 of the 17 proposed clinical labor
activities in the CY 2016 final rule with comment period (80 FR 70902).
We have listed the finalized standard times in Table 6. We are taking
no further action on the remaining 11 clinical labor activities in this
final rule, pending further action by the RUC (see below).
Table 6--Standard Times for Clinical Labor Tasks Associated With
Pathology Services
------------------------------------------------------------------------
Standard
Clinical labor task clinical labor
time (minutes)
------------------------------------------------------------------------
Accession specimen/prepare for examination............ 4
Assemble and deliver slides with paperwork to 0.5
pathologists.........................................
Assemble other light microscopy slides, open nerve 0.5
biopsy slides, and clinical history, and present to
pathologist to prepare clinical pathologic
interpretation.......................................
Clean room/equipment following procedure (including 1
any equipment maintenance that must be done after the
procedure)...........................................
Dispose of remaining specimens, spent chemicals/other 1
consumables, and hazardous waste.....................
Prepare, pack and transport specimens and records for 1
in-house storage and external storage (where
applicable)..........................................
------------------------------------------------------------------------
We remain committed to the process of establishing standard
clinical labor times for tasks associated with pathology services. This
may include establishing standards on a per-block or per-batch basis,
as we indicated during the previous rulemaking cycle. However, we are
aware that the PE Subcommittee of the RUC is currently working to
standardize the pathology clinical labor activities they use in making
their recommendations. We believe the RUC's efforts to narrow the
current list of several hundred pathology clinical labor tasks to a
more manageable number through the consolidation of duplicative or
highly similar activities into a single description may serve PFS
relativity and facilitate greater transparency in PFS ratesetting. We
also believe that the RUC's standardization of pathology clinical labor
tasks would facilitate our capacity to establish standard times for
pathology clinical labor tasks in future rulemaking. Therefore, we did
not propose any additional changes to clinical labor tasks associated
with pathology services.
(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 would define the scope
video system as including: (1) A monitor; (2) a processor; (3) a form
of digital capture; (4) a cart; and (5) a printer. We believe that
these equipment components represent the typical case for a scope video
system. Our model for this system is the ``video system, endoscopy
(processor, digital capture, monitor, printer, cart)'' equipment item
(ES031), which we 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 video scope
systems, while the non-video scopes would not. The
[[Page 80188]]
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 plan to propose input prices for these equipment items through
future rulemaking.
We proposed these changes only for the reviewed codes that make use
of scopes; this applies to the codes in the Flexible Laryngoscope
family (CPT codes 31572, 31573, 31574, 31575, 31576, 31577, 31578,
31579) (see section II.L) and the Laryngoplasty family (CPT codes
31551, 31552, 31553, 31554, 31580, 31584, 31587, 31591, 31592) (see
section II.L) along with updated prices for the equipment items related
to scopes utilized by these services. 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.
The following is a summary of the comments we received on this
separate pricing structure for scopes, scope video systems, and scope
accessories.
Comment: Many commenters addressed our general proposal to
reclassify scopes and their related equipment items. Commenters
expressed their support for the decision to remove the scopes from the
proposed scope packages, and the proposed definition of the scope video
system based on the current endoscopy video system equipment item
(ES031). There were no comments opposing the general principle behind
reclassifying scopes and scope equipment.
Response: We appreciate the support from the commenters for the
broad project to clarify these issues related to scopes.
Comment: Many commenters also requested that CMS delay implementing
the scope proposal until additional time could be devoted to the
subject. Several commenters asked CMS to wait to make any changes until
the RUC could form a PE Subcommittee to address this issue. For codes
with proposed CY 2017 values, commenters urged CMS to adopt the RUC-
recommended direct PE inputs instead of the proposed direct PE inputs,
pending anticipated RUC recommendations on the subject. Another
commenter requested that CMS make no change for CY 2017 for any
endoscopy procedures until proper identification of the capital and
disposable cost inputs could be confirmed.
Response: We appreciate commenters' interests in making certain
that there is appropriate opportunity for stakeholders to provide
feedback and recommendations on the reclassification of scopes and
related scope equipment. This was our primary rationale for limiting
proposed changes regarding these kinds of inputs to codes reviewed for
the current CY 2017 rule cycle, that is, the Flexible Laryngoscope and
Laryngoplasty families of codes. Because these codes are under current
review; however, we believe that they should be valued according to a
scheme that accurately describes the scope equipment typically used in
the services. As a result, we continue to believe that our proposed
classification system for scopes is the more sound methodology to use
for valuation of these two families of codes for CY 2017. However, we
note that we would expect to include examination of these codes as part
of any broader proposal we would make regarding scope equipment items,
in response to new recommendations on the subject.
We look forward to receiving recommendations from the upcoming RUC
PE Subcommittee regarding scopes and related scope equipment items. We
note that in order for these recommendations to be considered for CY
2018 rulemaking, we would need to receive these recommendations by the
same February deadline for the submission of recommendations on code
valuations.
Comment: Many commenters disagreed with the CMS proposal to price
the endoscopy video system (ES031) at a price of $15,045.00. Some
commenters stated that CMS should use the submitted invoices for the
pricing of this equipment, which recommended a price of $49,400.00. One
commenter stated that the proposed amount did not accurately reflect
the current price of GI endoscopy video systems. Another commenter
stated that CMS had defined the endoscopy video system as containing
five items: (1) A monitor; (2) a processor; (3) a form of digital
capture; (4) a cart; and (5) a printer. However, the commenter pointed
out that CMS had not included a price for the digital capture device,
which the commenter stressed was a significant part of the overall cost
and needed to be included in the equipment's pricing. The commenter
submitted a series of new invoices for endoscopy video system and
requested that CMS incorporate them into the pricing of the equipment.
Response: We appreciate the feedback from the commenters about
pricing, especially the submission of new data in the form of
additional invoices. We agree that the cost of a digital capture device
should be included in the cost of the endoscopy video system; it was
our belief that the digital capture device was included in the cost of
the processor. We appreciate the clarification from the commenters
indicating that this is not the case, and that the digital capture
device is a separately priced component of the video system. As a
result, we are averaging the price of the digital capture device on the
two submitted invoices and pricing it at $18,346.00. We will add this
into the overall cost of the endoscopy video system.
For the other four components of the video system, we are
finalizing the prices as proposed. The invoices submitted for these
components indicate that they are different forms of equipment with
different product IDs and different prices. For example, our price for
the processor comes from a ``Video Processor with keyboard & video
cable'' (CV-180) as opposed to the newly submitted invoice for a
``Viscera Elite Video System'' (OTV-S190). These are two distinct
equipment items, and we do not have any data to indicate that the
equipment on the newly submitted invoices is more typical in its use
than the equipment that we are currently using to price the endoscopy
video system.
Therefore, we are finalizing the price of the endoscopy video
system at $33,391.00, based on component prices of $9,000.00 for the
processor, $18,346.00 for the digital capture device, $2,000.00 for the
monitor, $2,295.00 for the printer, and $1,750.00 for the cart.
Comment: A few commenters also addressed the pricing of related
scope accessories. They stated that the proposed price for the
fiberscope, flexible, rhinolaryngoscopy (ES020) was decreased by 33
percent based on one unrepresentative invoice and that this price
undervalued the actual cost. Similarly, commenters stated that the
proposed price for the stroboscopy system (ES065) at $19,100 was much
lower than the manufacturer average invoice pricing. The proposed
prices for the channeled and non-channeled flexible video
rhinolaryngoscopes (ES064 and ES063 respectively) were also both two to
three times lower than the manufacturer's average invoice price. One
commenter submitted additional invoices for pricing these scopes and
scope accessories.
[[Page 80189]]
Response: We appreciate the submission of this additional pricing
data for review. Although many commenters stated that the price of the
stroboscopy system was too low, only one commenter supplied additional
invoices for the same equipment item that we defined in the proposed
rule, the StrobeLED system, and these invoices reflected lower prices
than the one we had proposed. These invoices reflected prices of
$16,431.00 and $15,000.00. We are averaging these together with our
previously submitted price of $19,100.00 for the stroboscopy system,
which results in a new price of $16,843.87.
When we reviewed the invoices for the channeled and non-channeled
flexible video rhinolaryngoscopes (ES064 and ES063 respectively), we
found that the product numbers indicated that these were different
equipment items than the scopes that we priced in the proposed rule. As
we mentioned for the pricing of the endoscopy video system, we have no
data to indicate that use of these particular rhinolaryngoscopes would
be typical, as opposed to the rhinolaryngoscopes that we proposed to
use to establish prices in the proposed rule. As a result, we are
maintaining our current prices for these scopes pending the submission
of additional information.
We similarly found that the invoices with recommended price
increases for the endoscope, rigid, sinoscopy (ES013) from the current
price of $2,414.17 to $4,024.00 and for the videoscope, colonoscopy
(ES033) from $23,650.00 to $37,273.00 related to different equipment
items that we do not believe are a better reflection of the typical
case than the item we currently use. We did not propose to make price
changes for these scopes, and we have not incorporated these equipment
items into the new scope classification system. As we stated
previously, we are currently limiting the scope changes to the CPT
codes under review for CY 2017 and their associated equipment items. We
will consider pricing changes for the rest of the scopes and associated
scope equipment as part of the broader scope reclassification and
pricing effort in future rulemaking.
We received invoices for a series of equipment items listed as
``other capital inputs not included in CMS estimate'' as part of this
collection of invoices. Since these equipment items were not included
in the original recommendations or our proposed valuations for the
Flexible Laryngoscope and Laryngoplasty families of codes, we are not
adding them to our equipment database at this time. We will consider
the addition of these equipment items as part of the broader
recommendations from the RUC PE Subcommittee on the scope
classification project.
We did not receive an invoice or other data to support a change in
the pricing of the fiberscope, flexible, rhinolaryngoscopy (ES020).
Comment: Many commenters objected to the use of a vendor quote for
pricing of the scope equipment. Commenters requested that specialty
societies should also be allowed to submit quotes for pricing as they
are easier to obtain than paid invoices. Commenters also stated that
the use of vendor prices created transparency issues and asked CMS to
explain why they are appropriate to use rather than invoices supplied
by specialties. One commenter stated that a single invoice was not an
adequate sample to use as a pricing input for many types of endoscopic
equipment.
Response: We are always interested in investigating multiple data
sources for use in pricing supplies and equipment, provided that the
information can be verified as accurate. We agree with the commenter
that a single voluntarily submitted invoice may not be an adequate
source for making wide ranging pricing decisions. We prefer to have
pricing information from multiple data sources whenever possible, which
may include information obtained from vendors of medical supplies and
equipment. We continue to believe that there are risks of bias in
submission of price quotes used for purposes of ratesetting. However,
given the way we use these prices in the current ratesetting
methodologies, we believe the risk of bias is located in submission of
overstated, not understated prices. Therefore, we believe it is
reasonable to assume that practitioners would generally be able acquire
particular items at the prices vendors submit to CMS.
After consideration of comments received, we are finalizing our
proposals as detailed in the proposed rule, with the updated prices for
the endoscopy video system and the stroboscopy system.
(4) Technical Corrections to Direct PE Input Database and Supporting
Files
Subsequent to the publication of the CY 2016 PFS final rule with
comment period, stakeholders alerted us to several clerical
inconsistencies in the direct PE database. We proposed to correct these
inconsistencies as described below and reflected in the CY 2017 direct
PE input database displayed on our Web site under downloads for the CY
2017 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
For CY 2017, we proposed the following technical corrections:
For CPT codes 72081-72084, a stakeholder informed us that
the equipment time for the PACS workstation (ED050) should be equal to
the clinical labor during the service period; the equipment time
formula we used for these codes for CY 2016 erroneously included 4
minutes of preservice clinical labor. We agree with the stakeholder
that the PACS workstation should use the standard equipment time
formula for a PACS workstation for these codes. As a result, we
proposed to refine the ED050 equipment time to 21 minutes for CPT code
72081, 36 minutes for CPT code 72082, 44 minutes for CPT code 72083,
and 53 minutes for CPT code 72084 to reflect the clinical labor time
associated with these codes. This same commenter also indicated that a
number of clinical labor activities had been entered in the database in
the incorrect service period for CPT codes 37215, 50432, 50694, and
72081. These clinical labor activities were incorrectly listed in the
``postservice'' period instead of the ``service post'' period. We
proposed to make these technical corrections as well so that the
minutes are assigned to the appropriate service period within the
direct PE input database.
Another stakeholder alerted us that ileoscopy CPT codes
44380, 44381 and 44382 did not include the direct PE input equipment
item called the Gomco suction machine (EQ235) and indicated that this
omission appeared to be inadvertent. We agreed that it was. We have
included the item EQ235 in the final direct PE input database for CPT
code 44380 at a time of 29 minutes, for CPT code 44381 at a time of 39
minutes, and CPT code 44382 at a time of 34 minutes.
The PE RVUs displayed in Addendum B on our Web site were calculated
with the inputs displayed in the CY 2017 direct PE input database.
Comment: One commenter expressed support for the proposed technical
corrections to these services.
Response: We appreciate the support from the commenter. After
consideration of comments received, we are finalizing these technical
corrections.
Comment: Several commenters contacted CMS during the comment period
after noticing that six services where CMS proposed to accept the
refinement panel work RVU did not contain the updated work RVU in the
[[Page 80190]]
Addendum B file for the proposed rule. These commenters requested that
CMS address these discrepancies.
Response: We appreciate the assistance from the commenters in
recognizing these discrepancies. We have corrected them and assigned
the refinement panel work RVUs to the six services in question.
Comment: One commenter stated that there were potential technical
errors in the clinical labor inputs for CPT codes 88329, 88331, 88360,
and 88361.
Response: We have reviewed these codes and they do not contain
technical errors. The clinical labor inputs were adjusted in the CY
2016 rule cycle as a result of CMS refinement (80 FR 70981-70983).
(5) Restoration of Inputs
Several of the PE worksheets included in the RUC recommendations
for CY 2016 contained time for the equipment item ``xenon light
source'' (EQ167). Because there appeared to be two special light
sources already present (the fiberoptic headlight and the endoscope
itself) in the services for which this equipment item was recommended
by the RUC, we believed that the use of only one of these light sources
would be typical and proposed to remove the xenon light equipment time.
In the CY 2016 PFS final rule with comment period, we restored the
xenon light (EQ167) and removed the fiberoptic headlight (EQ170) with
the same number of equipment minutes for CPT codes 30300, 31295, 31296,
31297, and 92511.
We received comments expressing approval for the restoration of the
xenon light. However, the commenters also stated that the two light
sources were not duplicative, but rather, both a headlight and a xenon
light source are required concurrently for otolaryngology procedures
when scopes are utilized. The commenters requested that the fiberoptic
headlight be restored to these codes.
We agreed with the commenters that the use of both light sources
would be typical for these procedures. Therefore, we proposed in the CY
2017 proposed rule to add the fiberoptic headlight (EQ170) to CPT codes
30300, 31295, 31296, 31297, and 92511 at the same number of equipment
minutes as the xenon light (EQ167).
Comment: One commenter expressed appreciation for the CMS proposal
to restore the fiberoptic headlight to the codes in question. The
commenter also stated that it had supplied invoices for LED lights,
which are significantly less expensive than the xenon light source, as
it was this commenter's understanding that xenon lights are no longer
the typical light source for these procedures and they are no longer
widely available for purchase from vendors. The commenter expressed
support for retaining the xenon light as the standard light source line
item for all endoscopy codes if that remained CMS' preference.
Response: We appreciate the support for our proposal from the
commenter, as well as the submission of additional information
regarding the typical light source for these procedures. We will add
the LED light source to our equipment database at the submitted invoice
price of $1,915.00. However, we will not replace the xenon light with
the LED light at this time, as we believe the subject deserves further
consideration. We will consider proposing this change in future
rulemaking.
Comment: We received new invoices for the xenon light equipment
from a different commenter which averaged out to a price of $12,298.00.
Response: We are finalizing our proposed price of $7,000.00 for the
xenon light source. Since we received a comment stating that xenon
lights are no longer a typical light source for procedure use, and that
they have been supplanted by the use of LED lights, we are viewing the
current input as a proxy item, and therefore, do not believe that it
would be appropriate to increase the cost of the xenon light source at
this time. We will consider making a proposal to address this subject
in future rulemaking.
After consideration of comments received, we are finalizing our
proposal to add the fiberoptic headlight (EQ170) to CPT codes 30300,
31295, 31296, 31297, and 92511 at the same number of equipment minutes
as the xenon light (EQ167).
(6) Updates to Prices for Existing Direct PE Inputs
In the CY 2011 PFS final rule with comment period (75 FR 73205), we
finalized a process to act on public requests to update equipment and
supply price and equipment useful life inputs through annual
rulemaking, beginning with the CY 2012 PFS proposed rule. For CY 2017,
we proposed the following price updates for existing direct PE inputs:
Several commenters wrote to discuss the price of the Antibody
Estrogen Receptor monoclonal (SL493). We received information including
three invoices with new pricing information regarding the SL493 supply.
We proposed to use this information to propose for the supply item
SL493 a price of $14.00 per test, which is the average price based on
the invoices that we received in total for the item.
Comment: Several commenters supported the proposed price increase
and urged CMS to finalize the proposal.
Response: We appreciate the support from the commenters. After
consideration of comments received, we are finalizing the price of the
Antibody Estrogen Receptor monoclonal (SL493) supply at $14.00 as
proposed.
We also proposed to update the price for two supplies in response
to the submission of new invoices. The proposed price for ``antigen,
venom'' supply (SH009) reflects an increase from $16.67 to $20.14 per
milliliter, and the proposed price for ``antigen, venom, tri-vespid''
supply (SH010) reflects an increase from $30.22 to $44.05 per
milliliter.
Comment: Several commenters stated that they strongly supported the
proposed price updates for antigen supplies and urged CMS to finalize
the proposal.
Response: We appreciate the support from the commenters. After
consideration of comments received, we are finalizing the price of the
``antigen, venom'' (SH009) and ``antigen, venom, tri-vespid'' (SH010)
supplies as proposed.
We proposed to remove the laser tip, diffuser fiber supply (SF030)
and replace it with the laser tip, bare (single use) supply (SF029) for
CPT code 31572 (formerly placeholder code 317X1). We did not propose a
price change for the SF030 supply.
Comment: In reference to CPT code 52648, a commenter stated that
the price for the laser tip, diffuser fiber supply (SF030) was
decreasing from $850 to $197.50. The commenter stated that the
methodology for this adjustment was opaque, unanticipated, and not
proposed for comment in the proposed rule. The commenter stated that
the $850 supply cost would be more appropriate for the laser tip,
diffuser fiber supply.
Response: We stated in the CY 2017 proposed rule (81 FR 46247) that
we did not believe that the submitted invoice for the laser tip,
diffuser supply at $197.50 was current enough to establish a new price
for the supply. As a result, we proposed to remove the laser tip,
diffuser fiber supply (SF030) and replaced it with the laser tip, bare
(single use) supply (SF029) for CPT code 31572 (Laryngoscopy, flexible;
with ablation or destruction of lesion(s) with laser, unilateral), as
we did not believe that it was appropriate to use a supply with an
outdated invoice. However, we inadvertently set the price of the laser
tip, diffuser fiber supply to
[[Page 80191]]
$197.50 in the proposed direct PE input database in contradiction of
our written proposal. We apologize for the confusion caused by this
error. In the final direct PE input database, we are restoring the
price of the laser tip, diffuser fiber supply to $850.00, since we did
not intend to propose a change the price of this supply. We are also
requesting the submission of additional current pricing information for
the laser tip, diffuser fiber supply, given the significant difference
between the $197.50 and $850.00 prices.
Comment: A commenter submitted two invoices containing pricing data
for a Cook Biopsy device.
Response: While we appreciate the submission of this pricing
information from the commenter, we are unable to determine which supply
or equipment item these invoices were in reference to. The invoices
were not mentioned in the text of the commenter's letter. We request
that invoices submitted for pricing updates should contain clear
documentation regarding the item in question: its name, the CMS supply/
equipment code that it references (if any), the unit quantity if the
item is shipped in boxes or batches, and any other information relevant
for pricing.
We routinely accept public submission of invoices as part of our
process for developing payment rates for new, revised, and potentially
misvalued codes. Often these invoices are submitted in conjunction with
the RUC-recommended values for the codes. For CY 2017, we note that
some stakeholders have submitted invoices for new, revised, or
potentially misvalued codes after the February deadline established for
code valuation recommendations. To be considered for a given year's
proposed rule, we generally need to receive invoices by the same
February deadline. In similar fashion, we generally need to receive
invoices by the end of the comment period for the proposed rule in
order to consider them for supply and equipment pricing in the final
rule for that calendar year. Of course, we consider invoices submitted
as public comments during the comment period following the publication
of the proposed rule when relevant for services with values open for
comment, and will consider any other invoices received after February
and/or outside of the public comment process as part of our established
annual process for requests to update supply and equipment prices as
finalized in the CY 2011 final rule with comment period (75 FR 73205).
(7) Radiation Treatment Delivery Practice Expense RVUs
Comment: Several commenters noticed that there was a 10 percent
decrease in the proposed Non Facility PE RVUs for HCPCS code G6011
despite proposed changes in direct PE inputs. Commenters requested an
explanation for why this decrease was taking place, and referenced
section 3 of the Patient Access and Medicare Protection Act (PAMPA)
(Pub. L. 114-115, enacted December 18, 2015), which requires CMS to
maintain the associated ``definitions, units, and inputs'' for certain
radiation treatment and related services for CY 2017 and CY 2018.
Several commenters stated that they believed that this decrease in the
PE RVU was in violation of section 1848(c)(2)(C)(i-ii) of the Act
(added by section 3 of the PAMPA), which requires inputs for these
services to remain unchanged for CY 2017 and 2018.
Response: We agree with the commenters that we did not propose to
change any of the direct PE inputs for HCPCS code G6011, and we
understand the proposed change in the nonfacility PE RVUs would
generally not be expected absent a corresponding change in direct PE
inputs. However, the change in the PE RVU for HCPCS code G6011 is
caused by a significant shift in the specialties furnishing the service
in the Medicare claims data. In the claims data we used to establish
the PE RVUs for CY 2016, dermatology furnished 51 percent of the
services, while radiation oncology furnished 43 percent. The most
recent claims data reflects a major shift, with radiation oncology now
furnishing about 85 percent of the services and dermatology only about
6 percent. The decrease in the PE RVU between CY 2016 and CY 2017
resulted from this shift in specialty mix, as the specialties actually
furnishing the service, reflected in the claims data, have a higher
percentage of direct PE relative to indirect PE, and therefore, a lower
percentage of indirect PE, than the specialties that were previously
furnishing the service in the claims data. In other words, consistent
with the established methodology for allocating indirect PE to
services, a specialty mix with a lower percentage of indirect PE
results in fewer indirect PE RVUs being allocated and a lower overall
PE RVU for the code even though the direct PE inputs have remained the
same. This kind of shift is relatively unusual outside of low-volume
codes, but it is consistent with our established methodology for
allocating indirect PE to services. We believe that in many cases, the
change in specialty utilization for a particular service would warrant
a re-examination of the direct PE inputs for the service under the
misvalued code initiative. Given the statutory provision that prohibits
us from changing the direct PE inputs prior to CY 2019 or considering
these services as potentially misvalued, we will consider this issue
further for future rulemaking.
We recognize that this change would be unanticipated, but we do not
believe there is a straightforward, transparent way to offset the
change since the statutory provision requires that we maintain the
direct inputs for the PE RVUs. We note that this change is unique among
the radiation therapy and related imaging codes where the maintenance
of inputs has generally resulted in payment rate stability for these
services.
B. Determination of Malpractice Relative Value Units (RVUs)
1. Overview
Section 1848(c) of the Act requires that each service paid under
the PFS be composed of three components: Work, PE, and malpractice (MP)
expense. As required by section 1848(c)(2)(C)(iii) of the Act,
beginning in CY 2000, MP RVUs are resource based. Malpractice RVUs for
new codes after 1991 were extrapolated from similar existing codes or
as a percentage of the corresponding work RVU. Section 1848(c)(2)(B)(i)
of the Act also requires that we review, and if necessary adjust, RVUs
no less often than every 5 years. In the CY 2015 PFS final rule with
comment period, we implemented the third review and update of MP RVUs.
For a comprehensive discussion of the third review and update of MP
RVUs see the CY 2015 proposed rule (79 FR 40349 through 40355) and
final rule with comment period (79 FR 67591 through 67596).
To determine MP RVUs for individual PFS services, our MP
methodology is comprised 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
[[Page 80192]]
73208), MP RVUs for new and revised codes effective before the next 5-
year review of MP RVUs were determined either by a direct crosswalk
from a similar source code or by a modified crosswalk to account for
differences in work RVUs between the new/revised code and the source
code. For the modified crosswalk approach, we adjust (or scale) the MP
RVU for the new/revised code to reflect the difference in work RVU
between the source code and the new/revised work RVU (or, if greater,
the difference in the clinical labor portion of the fully implemented
PE RVU) for the new code. For example, if the proposed work RVU for a
revised code were 10 percent higher than the work RVU for its source
code, the MP RVU for the revised code would be increased by 10 percent
over the source code MP RVU. Under this approach, the same risk factor
is applied for the new/revised code and source code, but the work RVU
for the new/revised code is used to adjust the MP RVUs for risk.
In the CY 2016 PFS final rule with comment period (80 FR 70906
through 70910), we finalized a policy to begin conducting annual MP RVU
updates to reflect changes in the mix of practitioners providing
services (using Medicare claims data), and to adjust MP RVUs for risk
for intensity and complexity (using the work RVU or clinical labor
RVU). We also finalized a policy to modify the specialty mix assignment
methodology (for both MP and PE RVU calculations) to use an average of
the 3 most recent years of data instead of a single year of data. We
stated that under this approach, the specialty-specific risk factors
would continue to be updated through notice and comment rulemaking
every 5 years using updated premium data, but would remain unchanged
between the 5-year reviews.
For CY 2016, we did not propose to discontinue our current approach
for determining MP RVUs for new/revised codes. For the new and revised
codes for which we proposed work RVUs and PE inputs, we also published
the proposed MP crosswalks used to determine their MP RVUs. We address
comments regarding valuation of new and revised codes in section II.L
of this final rule, which makes clear the codes with interim final
values for CY 2016 had newly proposed values for CY 2017, all of which
were again open for comment. The MP crosswalks for new and revised
codes with interim final values were established in the CY 2016 PFS
final rule with comment period; we proposed these same crosswalks in
the CY 2017 PFS proposed rule.
2. Updating Specialty Specific Risk Factors
The proposed CY 2017 GPCI update (eighth update), discussed in
section II.E of this final rule, reflects updated MP premium data,
collected for the purpose of proposing updates to the MP GPCIs.
Although we could have used the updated MP premium data obtained for
the purposes of the proposed eighth GPCI update to propose updates to
the specialty risk factors used in the calculation of MP RVUs, this
would not be consistent with the policy we previously finalized in the
CY 2016 PFS final rule with comment period. In that rule, we indicated
that the specialty-specific risk factors would continue to be updated
through notice and comment rulemaking every 5 years using updated
premium data, but would remain unchanged between the 5-year reviews.
Additionally, consistent with the statutory requirement at section
1848(e)(1)(C) of the Act, only one half of the adjustment to MP GPCIs
would be applied for CY 2017 based on the new MP premium data. As such,
we did not think it would be appropriate to propose to update the
specialty risk factors for CY 2017 based on the updated MP premium data
that is reflected in the proposed CY 2017 GPCI update. Therefore, we
did not propose to update the specialty-risk factors based on the new
premium data collected for the purposes of the 3-year GPCI update for
CY 2017 at this time. However, we solicited comment on whether we
should consider doing so, perhaps as early as for 2018, prior to the
fourth review and update of MP RVUs that must occur no later than CY
2020.
The following is summary of the comments we received on whether we
should consider updating the specialty-risk factors based on the new
premium data collected for the purposes of the 3-year GPCI update,
perhaps as early as for 2018, prior to the fourth review and update of
MP RVUs that must occur no later than CY 2020.
Comment: We received few comments regarding this issue. Some
commenters, including the RUC, recommended that CMS use the updated MP
premium data collected as part of the CY 2017 GPCI update in the
creation of the MP RVUs for CY 2017. One commenter stated that CMS
should follow its normal process to update MP RVUs for CY 2020. Another
commenter supported the technical and policy changes that CMS made
related to the MP RVUs for the CY 2016 PFS, and appreciated CMS'
reluctance to change direction a year later and use the updated
malpractice premium data gathered for the purpose of the GPCI update,
in advance of the next 5-year review of the MP RVUs, to propose updates
to the specialty risk factors used in the calculation of MP RVUs. The
commenter suggested that CMS consider using the updated data to update
the specialty-risk factors in the MP RVU methodology as early as CY
2018, noting that by CY 2018, the adjustment of the malpractice GPCIs
would be complete, so the potential disconnect in the use of the
updated premium data would no longer be an issue.
Response: We appreciate the commenters' feedback. In response to
the commenters who recommended that CMS use the updated MP premium data
collected as part of the CY 2017 GPCI update in the creation of the MP
RVUs for CY 2017, we reiterate that we did not propose to update the
specialty-risk factors based on the new premium data collected for the
purposes of the 3-year GPCI update for the CY 2017 MP RVUs. Instead, we
solicited comment on whether we should consider doing so prior to the
next 5-year interval, perhaps as early as for CY 2018. We will 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.
Comment: One commenter stated that CPT code 93355 should be added
to the MP RVUs Invasive Cardiology Outside of Surgical Range list so
that the surgical risk factor is applied when calculating the MP RVU.
Response: We did not previously propose to include this code on the
list of Invasive Cardiology Outside of Surgical Range when we updated
MP risk factors for CY 2015 and we did not propose the change in the CY
2017 PFS proposed rule. We will consider that request for future
rulemaking in conjunction with the next update of MP risk factors.
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.
[[Page 80193]]
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 http://www.hhs.gov/ocr/civilrights/resources/specialtopics/hospitalcommunication.
Practitioners furnishing Medicare telehealth services submit claims
for telehealth services to the MACs that process claims for the service
area where their distant site is located. Section 1834(m)(2)(A) of the
Act requires that a practitioner who furnishes a telehealth service to
an eligible telehealth individual be paid an amount equal to the amount
that the practitioner would have been paid if the service had been
furnished without the use of a telecommunications system.
Originating sites, which can be one of several types of sites
specified in the statute where an eligible telehealth individual is
located at the time the service is being furnished via a
telecommunications system, are paid a facility fee under the PFS for
each Medicare telehealth service. The statute specifies both the types
of entities that can serve as originating sites and the geographic
qualifications for originating sites. With regard to geographic
qualifications, Sec. 410.78(b)(4) limits originating sites to those
located in rural health professional shortage areas (HPSAs) or in a
county that is not included in a metropolitan statistical area (MSA).
Historically, we have defined rural HPSAs to be those located
outside of MSAs. Effective January 1, 2014, we modified the regulations
regarding originating sites to define rural HPSAs as those located in
rural census tracts as determined by the 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 the CMS Web site at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
An entity participating in a federal telemedicine demonstration
project that has been approved by, or received funding from, the
Secretary as of December 31, 2000 is eligible to be an originating site
regardless of its geographic location.
Effective January 1, 2014, we also changed our policy so that
geographic status for an originating site would be established and
maintained on an annual basis, consistent with other telehealth payment
policies (78 FR 74400). Geographic status for Medicare telehealth
originating sites for each calendar year is now based upon the status
of the area as of December 31 of the prior calendar year.
For a detailed history of telehealth payment policy, see 78 FR
74399.
2. Adding Services to the List of Medicare Telehealth Services
As noted previously, in the CY 2003 PFS final rule (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 (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
[[Page 80194]]
improves the diagnosis or treatment of an illness or injury or improves
the functioning of a malformed body part, including dates and findings,
and a list and copies of published peer reviewed articles relevant to
the service when furnished via telehealth. Our evidentiary standard of
clinical benefit does not include minor or incidental benefits.
Some examples of clinical benefit include the following:
Ability to diagnose a medical condition in a patient
population without access to clinically appropriate in-person
diagnostic services.
Treatment option for a patient population without access
to clinically appropriate in-person treatment options.
Reduced rate of complications.
Decreased rate of subsequent diagnostic or therapeutic
interventions (for example, due to reduced rate of recurrence of the
disease process).
Decreased number of future hospitalizations or physician
visits.
More rapid beneficial resolution of the disease process
treatment.
Decreased pain, bleeding, or other quantifiable symptom.
Reduced recovery time.
For the list of telehealth services, see the CMS Web site at
https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.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 2016 will
be considered for the CY 2018 proposed rule. Each request to add a
service to the list of Medicare telehealth services must include any
supporting documentation the requester wishes us to consider as we
review the request. Because we use the annual PFS rulemaking process as
a vehicle for making changes to the list of Medicare telehealth
services, requesters should be advised that any information submitted
is subject to public disclosure for this purpose. For more information
on submitting a request for an addition to the list of Medicare
telehealth services, including where to mail these requests, see the
CMS Web site at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
3. Submitted Requests To Add Services to the List of Telehealth
Services for CY 2017
Under our existing policy, we add services to the telehealth list
on a category 1 basis when we determine that they are similar to
services on the existing telehealth list for the roles of, and
interactions among, the beneficiary, physician (or other practitioner)
at the distant site and, if necessary, the telepresenter. As we stated
in the CY 2012 final rule with comment period (76 FR 73098), we believe
that the category 1 criteria not only streamline our review process for
publicly requested services that fall into this category, but also
expedite our ability to identify codes for the telehealth list that
resemble those services already on this list.
We received several requests in CY 2015 to add various services as
Medicare telehealth services effective for CY 2017. The following
presents a discussion of these requests, and our decisions regarding
additions to the CY 2017 telehealth list. Of the requests received, we
found that four services were sufficiently similar to ESRD-related
services currently on the telehealth list to qualify on a category 1
basis. Therefore, we proposed to add the following services to the
telehealth list on a category 1 basis for CY 2017:
CPT codes 90967 (End-stage renal disease (ESRD) related
services for dialysis less than a full month of service, per day; for
patients younger than 2 years of age; 90968 (End-stage renal disease
(ESRD) related services for dialysis less than a full month of service,
per day; for patients 2-11 years of age; 90969 (End-stage renal disease
(ESRD) related services for dialysis less than a full month of service,
per day; for patients 12-19 years of age); and 90970 (End-stage renal
disease (ESRD) related services for dialysis less than a full month of
service, per day; for patients 20 years of age and older).
As we indicated in the CY 2015 final rule with comment period (80
FR 41783), for the ESRD-related services (CPT codes 90963-90966) added
to the telehealth list for CY 2016, the required clinical examination
of the catheter access site must be furnished face-to-face ``hands on''
(without the use of an interactive telecommunications system) by a
physician, CNS, NP, or PA. This requirement also applies to CPT codes
90967-90970.
While we did not receive a specific request, we also proposed to
add two advance care planning services to the telehealth list. We have
determined that these services are similar to the annual wellness
visits (HCPCS codes G0438 & G0439) currently on the telehealth list:
CPT codes 99497 (advance care planning including the
explanation and discussion of advance directives such as standard forms
(with completion of such forms, when performed), by the physician or
other qualified health care professional; first 30 minutes, face-to-
face with the patient, family member(s), or surrogate); and 99498
(advance care planning including the explanation and discussion of
advance directives such as standard forms (with completion of such
forms, when performed), by the physician or other qualified health care
professional; each additional 30 minutes (list separately in addition
to code for primary procedure)).
We also received requests to add services to the telehealth list that
do not meet our criteria for Medicare telehealth services. We did not
propose to add the following procedures for observation care, emergency
department visits, critical care E/M, psychological testing, and
physical, occupational and speech therapy, for the reasons noted:
a. Observation Care: CPT Codes--
99217 (observation care discharge day management (this
code is to be utilized to report all services provided to a patient on
discharge from ``observation status'' if the discharge is on other than
the initial date of ``observation status.'' To report services to a
patient designated as ``observation status'' or ``inpatient status''
and discharged on the same date, use the codes for observation or
inpatient care services [including admission and discharge services,
99234-99236 as appropriate.]));
99218 (initial observation care, per day, for the
evaluation and management of a patient which requires these three key
components: A detailed or comprehensive history; a detailed or
comprehensive examination; and medical decision making that is
straightforward or of low complexity. Counseling and coordination of
care with other physicians, other qualified health care professionals,
or agencies are provided consistent with the nature of the problem(s)
and the patient's and family's needs. Usually, the problem(s) requiring
admission to ``observation status'' are of low severity. Typically, 30
minutes are spent at the bedside and on the patient's hospital floor or
unit);
99219 (initial observation care, per day, for the
evaluation and management of a patient, which requires these three key
components: A comprehensive history; a comprehensive examination; and
medical decision making of moderate complexity. Counseling and
coordination of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and family's needs. Usually, the
problem(s) requiring admission to ``observation status'' are of
moderate severity.
[[Page 80195]]
Typically, 50 minutes are spent at the bedside and on the patient's
hospital floor or unit);
99220 (initial observation care, per day, for the
evaluation and management of a patient, which requires these three key
components: A comprehensive history; a comprehensive examination; and
medical decision making of high complexity. Counseling and coordination
of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and family's needs. Usually, the
problem(s) requiring admission to ``observation status'' are of high
severity. Typically, 70 minutes are spent at the bedside and on the
patient's hospital floor or unit);
99224 (subsequent observation care, per day, for the
evaluation and management of a patient, which requires at least two of
these three key components: Problem focused interval history; problem
focused examination; medical decision making that is straightforward or
of low complexity. Counseling and coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and family's needs. Usually, the patient is stable, recovering, or
improving. Typically, 15 minutes are spent at the bedside and on the
patient's hospital floor or unit);
99225 (subsequent observation care, per day, for the
evaluation and management of a patient, which requires at least two of
these three key components: An expanded problem focused interval
history; an expanded problem focused examination; medical decision
making of moderate complexity. Counseling and coordination of care with
other physicians, other qualified health care professionals, or
agencies are provided consistent with the nature of the problem(s) and
the patient's and family's needs. Usually, the patient is responding
inadequately to therapy or has developed a minor complication.
Typically, 25 minutes are spent at the bedside and on the patient's
hospital floor or unit);
99226 (subsequent observation care, per day, for the
evaluation and management of a patient, which requires at least two of
these three key components: A detailed interval history; a detailed
examination; medical decision making of high complexity. Counseling and
coordination of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and family's needs. Usually, the
patient is unstable or has developed a significant complication or a
significant new problem. Typically, 35 minutes are spent at the bedside
and on the patient's hospital floor or unit);
99234 (observation or inpatient hospital care, for the
evaluation and management of a patient including admission and
discharge on the same date, which requires these three key components:
A detailed or comprehensive history; a detailed or comprehensive
examination; and medical decision making that is straightforward or of
low complexity. Counseling and coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and family's needs. Usually the presenting problem(s) requiring
admission are of low severity. Typically, 40 minutes are spent at the
bedside and on the patient's hospital floor or unit);
99235 (observation or inpatient hospital care, for the
evaluation and management of a patient including admission and
discharge on the same date, which requires these three key components:
A comprehensive history; a comprehensive examination; and medical
decision making of moderate complexity. Counseling and coordination of
care with other physicians, other qualified health care professionals,
or agencies are provided consistent with the nature of the problem(s)
and the patient's and family's needs. Usually the presenting problem(s)
requiring admission are of moderate severity. Typically, 50 minutes are
spent at the bedside and on the patient's hospital floor or unit);
99236 (observation or inpatient hospital care, for the
evaluation and management of a patient including admission and
discharge on the same date, which requires these three key components:
A comprehensive history; a comprehensive examination; and medical
decision making of high complexity. Counseling and coordination of care
with other physicians, other qualified health care professionals, or
agencies are provided consistent with the nature of the problem(s) and
the patient's and family's needs. Usually the presenting problem(s)
requiring admission are of high severity. Typically, 55 minutes are
spent at the bedside and on the patient's hospital floor or unit);
The request to add these observation services referenced various
studies supporting the use of observation units. The studies indicated
that observation units provide safe, cost effective care to patients
that need ongoing evaluation and treatment beyond the emergency
department visit by having reduced hospital admissions, shorter lengths
of stay, increased safety and reduced cost. Additional studies cited
indicated that observation units reduce the work load on emergency
department physicians, and reduce emergency department overcrowding.
In the CY 2005 PFS proposed rule (69 FR 47510), we considered a
request but did not propose to add the observation CPT codes 99217-
99220 to the list of Medicare telehealth services on a category two
basis for the reasons described in that rule. The most recent request
did not include any information that would cause us to question the
previous evaluation under the category one criterion, which has not
changed, regarding the significant differences in patient acuity
between these services and services on the telehealth list. While the
request included evidence of the general benefits of observation units,
it did not include specific information demonstrating that the services
described by these codes provided clinical benefit when furnished via
telehealth, which is necessary for us to consider these codes on a
category two basis. Therefore, we did not propose to add these services
to the list of approved telehealth services.
b. Emergency Department Visits: CPT Codes--
99281 (emergency department visit for the evaluation and
management of a patient, which requires these three key components: A
problem focused history; a problem focused examination; and
straightforward medical decision making. Counseling and coordination of
care with other physicians, other qualified health care professionals,
or agencies are provided consistent with the nature of the problem(s)
and the patient's and family's needs. Usually, the presenting
problem(s) are self-limited or minor);
99282 (emergency department visit for the evaluation and
management of a patient, which requires these three key components: An
expanded problem focused history; an expanded problem focused
examination; and medical decision making of low complexity. Counseling
and coordination of care with other physicians, other qualified health
care professionals, or agencies are provided consistent with the nature
of the problem(s) and the patient's and family's needs. Usually, the
presenting problem(s) are of low to moderate severity);
[[Page 80196]]
99283 (emergency department visit for the evaluation and
management of a patient, which requires these three key components: An
expanded problem focused history; an expanded problem focused
examination; and medical decision making of moderate complexity.
Counseling and coordination of care with other physicians, other
qualified health care professionals, or agencies are provided
consistent with the nature of the problem(s) and the patient's and
family's needs. Usually, the presenting problem(s) are of moderate
severity);
99284 (emergency department visit for the evaluation and
management of a patient, which requires these three key components: A
detailed history; a detailed examination; and medical decision making
of moderate complexity. Counseling and coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and family's needs. Usually, the presenting problem(s) are of high
severity, and require urgent evaluation by the physician, or other
qualified health care professionals but do not pose an immediate
significant threat to life or physiologic function); and
99285 (emergency department visit for the evaluation and
management of a patient, which requires these three key components
within the constraints imposed by the urgency of the patient's clinical
condition and mental status: A comprehensive history; a comprehensive
examination; and medical decision making of high complexity. Counseling
and coordination of care with other physicians, other qualified health
care professionals, or agencies are provided consistent with the nature
of the problem(s) and the patient's and family's needs. Usually, the
presenting problem(s) are of high severity and pose an immediate
significant threat to life or physiologic function).
In the CY 2005 PFS proposed rule (69 FR 47510), we considered a
request but did not propose to add the emergency department visit CPT
codes 99281-99285 to the list of Medicare telehealth services for the
reasons described in that rule.
The current request to add the emergency department E/M services
stated that the codes are similar to outpatient visit codes (CPT codes
99201-99215) that have been on the telehealth list since CY 2002. As we
noted in the CY 2005 PFS final rule, while the acuity of some patients
in the emergency department might be the same as in a physician's
office; we believe that, in general, more acutely ill patients are more
likely to be seen in the emergency department, and that difference is
part of the reason there are separate codes describing evaluation and
management visits in the Emergency Department setting. The practice of
emergency medicine often requires frequent and fast-paced patient
reassessments, rapid physician interventions, and sometimes the
continuous physician interaction with ancillary staff and consultants.
This work is distinctly different from the pace, intensity, and acuity
associated with visits that occur in the office or outpatient setting.
Therefore, we did not propose to add these services to the list of
approved telehealth services on a category one basis.
The requester did not provide any studies supporting the clinical
benefit of managing emergency department patients with telehealth which
is necessary for us to consider these codes on a category two basis.
Therefore, we did not propose to add these services to the list of
approved telehealth services on a category two basis.
Many requesters of additions to the telehealth list urged us to
consider the potential value of telehealth for providing beneficiaries
access to needed expertise. We note that if clinical guidance or advice
is needed in the emergency department setting, a consultation may be
requested from an appropriate source, including consultations that are
currently included on the list of telehealth services.
c. Critical Care Evaluation and Management: CPT Codes--
99291 (critical care, evaluation and management of the
critically ill or critically injured patient; first 30-74 minutes); and
99292 (critical care, evaluation and management of the critically ill
or critically injured patient; each additional 30 minutes (list
separately in addition to code for primary service).
We previously considered and rejected adding these codes to the
list of Medicare telehealth services in the CY 2009 PFS final rule (74
FR 69744) on a category 1 basis because, due to the acuity of
critically ill patients, we did not believe critical care services are
similar to any services on the current list of Medicare telehealth
services. In that rule, we said that critical care services must be
evaluated as category 2 services. Because we considered critical care
services under category 2, we needed to evaluate whether these are
services for which telehealth can be an adequate substitute for a face-
to-face encounter, based on the category 2 criteria at the time of that
request. We had no evidence suggesting that the use of telehealth could
be a reasonable surrogate for the face-to-face delivery of this type of
care.
The American Telemedicine Association (ATA) submitted a new request
for CY 2016 that cited several studies to support adding these services
on a category 2 basis. To qualify under category 2, we would need
evidence that the service furnished via telehealth is still described
accurately by the requested code and produces a clinical benefit for
the patient via telehealth. However, in reviewing the information
provided by the ATA and a study titled, ``Impact of an Intensive Care
Unit Telemedicine Program on Patient Outcomes in an Integrated Health
Care System,'' published July 2014 in JAMA Internal Medicine, which
found no evidence that the implementation of ICU telemedicine
significantly reduced mortality rates or hospital length of stay, which
could be indicators of clinical benefit. Therefore, we stated that we
do not believe that the submitted evidence demonstrates a clinical
benefit to patients. Therefore, we did not propose to add these
services on a category 2 basis to the list of Medicare telehealth
services for CY 2016 (80 FR 71061).
This year, requesters cited additional studies to support adding
critical care services to the Medicare telehealth list on a category 2
basis. Eight of the studies dealt with telestroke and one with
teleneurology. Telestroke is an approach that allows a neurologist to
provide remote treatment to vascular stroke victims. Teleneurology
offers consultations for neurological problems from a remote location.
It may be initiated by a physician or a patient, for conditions such as
headaches, dementia, strokes, multiple sclerosis and epilepsy.
However, according to the literature, the management of stroke via
telehealth requires more than a single practitioner and is distinct
from the work described by the above E/M codes, 99291 and 99292. One
additional study cited involved pediatric patients, while another noted
that the Department of Defense has used telehealth to provide critical
care services to hospitals in Guam for many years. Another reference
study indicated that consulting intensivists thought that telemedicine
consultations were superior to telephone consultations. In all of these
cases, we believe the evidence demonstrates that interaction between
these patients and distant site practitioners can have clinical
benefit.
[[Page 80197]]
However, we do not agree that the kinds of services described in the
studies are those that are included in the above critical care E/M
codes 99291 and 99292. We note that CPT guidance makes clear that a
variety of other services are bundled into the payment rates for
critical care, including gastric intubations and vascular access
procedures among others We do not believe these kinds of services are
furnished via telehealth. Public comments, included cited studies, can
be viewed at https://www.regulations.gov/#!documentDetail;D=CMS-2015-
0081-0002. Therefore, we did not propose to add CPT codes 99291 or
99292 to the list of Medicare telehealth services for CY 2017.
However, we are persuaded by the requests that we recognize the
potential benefit of critical care consultation services that are
furnished remotely. We note that there are currently codes on the
telehealth list that could be reported when consultation services are
furnished to critically ill patients. In consideration of these public
requests, we recognize that there may be greater resource costs
involved in furnishing these services relative to the existing
telehealth consultation codes. We also agree with the requesters that
there may be potential benefits of remote care by specialists for these
patients. For these reasons, we think it would be advisable to create a
coding distinction between telehealth consultations for critically ill
patients, for example stroke patients, relative to telehealth
consultations for other hospital patients. Such a coding distinction
would allow us to recognize the additional resource costs in terms of
time and intensity involved in furnishing such services, under the
conditions where remote, intensive consultation is required to provide
access to appropriate care for the critically ill patient. We recognize
that the current set of E/M codes, including current CPT codes 99291
and 99292, may not adequately describe such services because current E/
M coding presumes that the services are occurring in-person, in which
case the expert care would be furnished in a manner described by the
current codes for critical care.
Therefore, we proposed to make payment through new HCPCS codes
G0508 and G0509, initial and subsequent, used to describe critical care
consultations furnished via telehealth. This new coding would provide a
mechanism to report an intensive telehealth consultation service,
initial or subsequent, for the critically ill patient, such as a stroke
patient, under the circumstance when a qualified health care
professional has in-person responsibility for the patient but the
patient benefits from additional services from a distant-site
consultant specially trained in providing critical care services. We
proposed limiting these services to once per day per patient. Like the
other telehealth consultations, these services would be valued relative
to existing E/M services.
More details on the new coding (G0508 and G0509) and valuation for
these services are discussed in section II.L. of this final rule and
the final RVUs for this service are included in Addendum B of this
final rule, including a summary of the public comments we received and
our responses to the comments. Like the other telehealth consultation
codes, we proposed that these services would be added to the telehealth
list and would be subject to the geographic and other statutory
restrictions that apply to telehealth services.
d. Psychological Testing: CPT Codes--
96101 (psychological testing (includes psychodiagnostic
assessment of emotionality, intellectual abilities, personality and
psychopathology, e.g., MMPI, Rorschach, WAIS), per hour of the
psychologist's or physician's time, both face-to-face time
administering tests to the patient and time interpreting these test
results and preparing the report);
96102 psychological testing (includes psychodiagnostic
assessment of emotionality, intellectual abilities, personality and
psychopathology, e.g., MMPI and WAIS), with qualified health care
professional interpretation and report, administered by technician, per
hour of technician time, face-to-face);
96118 Neuropsychological testing (e.g., Halstead-Reitan
neuropsychological battery, Wechsler memory scales and Wisconsin card
sorting test), per hour of the psychologist's or physician's time, both
face-to-face time administering tests to the patient and time
interpreting these test results and preparing the report); and,
96119 Neuropsychological testing (e.g., Halstead-Reitan
neuropsychological battery, Wechsler memory scales and Wisconsin card
sorting test), with qualified health care professional interpretation
and report, administered by technician, per hour of technician time,
face-to-face).
Requesters indicated that there is nothing in the Minnesota
Multiphasic Personality Inventory (MMPI), the Rorschach inkblot test,
the Wechsler Adult Intelligence Scale (WAIS), the Halstead-Reitan
Neuropsychological Battery and Allied Procedures, or the Wisconsin Card
Sorting Test (WCST), that cannot be done via telehealth nor is
different than neurological tests done for Parkinson's disease, seizure
medication side effects, gait assessment, nor any of the many
neurological examinations done via telehealth with the approved
outpatient office visit and inpatient visit CPT codes currently on the
telehealth list. As an example, requesters indicated that the MPPI is
administered by a computer, which generates a report that is
interpreted by the clinical psychologist, and that the test requires no
interaction between the clinician and the patient.
We previously considered the request to add these codes to the
Medicare telehealth list in the CY 2015 final rule with comment period
(79 FR 67600). We decided not to add these codes, indicating that these
services are not similar to other services on the telehealth list
because they require close observation of how a patient responds. We
noted that the requesters did not submit evidence supporting the
clinical benefit of furnishing these services via telehealth so that we
could evaluate them on a category 2 basis. While we acknowledge that
requesters believe that some of these tests require minimal, if any,
interaction between the clinician and patient, we disagree. We continue
to believe that successful completion of the tests listed as examples
in these codes require the clinical psychologist to closely observe the
patient's response, which cannot be performed via telehealth. Some
patient responses, for example, sweating and fine tremors, may be
missed when the patient and examiner are not in the same room.
Therefore, we did not propose to add these services to the list of
Medicare telehealth services for CY 2017.
e. Physical and Occupational Therapy and Speech-Language Pathology
Services: CPT Codes--
92507 (treatment of speech, language, voice,
communication, and auditory processing disorder; individual); and,
92508 (treatment of speech, language, voice, communication, and
auditory processing disorder; group, 2 or more individuals); 92521
(evaluation of speech fluency (e.g., stuttering, cluttering)); 92522
(evaluation of speech sound production (e.g., articulation,
phonological process, apraxia, dysarthria)); 92523 (evaluation of
speech sound production (e.g., articulation, phonological process,
apraxia, dysarthria); with evaluation of language comprehension and
expression
[[Page 80198]]
(e.g., receptive and expressive language)); 92524 (behavioral and
qualitative analysis of voice and resonance); (evaluation of oral and
pharyngeal swallowing function); 92526 (treatment of swallowing
dysfunction or oral function for feeding); 92610 (evaluation of oral
and pharyngeal swallowing function); CPT codes 97001 (physical therapy
evaluation); 97002 (physical therapy re-evaluation); 97003
(occupational therapy evaluation); 97004 (occupational therapy re-
evaluation); 97110 (therapeutic procedure, 1 or more areas, each 15
minutes; therapeutic exercises to develop strength and endurance, range
of motion and flexibility); 97112 (therapeutic procedure, 1 or more
areas, each 15 minutes; neuromuscular reeducation of movement, balance,
coordination, kinesthetic sense, posture, or proprioception for sitting
or standing activities); 97116 (therapeutic procedure, 1 or more areas,
each 15 minutes; gait training (includes stair climbing)); 97532
(development of cognitive skills to improve attention, memory, problem
solving (includes compensatory training), direct (one-on-one) patient
contact, each 15 minutes); 97533 (sensory integrative techniques to
enhance sensory processing and promote adaptive responses to
environmental demands, direct (one-on-one) patient contact, each 15
minutes); 97535 (self-care/home management training (e.g., activities
of daily living (adl) and compensatory training, meal preparation,
safety procedures, and instructions in use of assistive technology
devices/adaptive equipment) direct one-on-one contact, each 15
minutes); 97537 (community/work reintegration training (e.g., shopping,
transportation, money management, avocational activities or work
environment/modification analysis, work task analysis, use of assistive
technology device/adaptive equipment), direct one-on-one contact, each
15 minutes); 97542 (wheelchair management (e.g., assessment, fitting,
training), each 15 minutes); 97750 (physical performance test or
measurement (e.g., musculoskeletal, functional capacity), with written
report, each 15 minutes); 97755 (assistive technology assessment (e.g.,
to restore, augment or compensate for existing function, optimize
functional tasks and maximize environmental accessibility), direct one-
on-one contact, with written report, each 15 minutes); 97760
Orthotic(s) management and training (including assessment and fitting
when not otherwise reported), upper extremity(s), lower extremity(s)
and/or trunk, each 15 minutes); 97761 (prosthetic training, upper and
lower extremity(s), each 15 minutes); and 97762 (checkout for orthotic/
prosthetic use, established patient, each 15 minutes).
The statute defines who is an authorized practitioner of telehealth
services. Physical therapists, occupational therapists and speech-
language pathologists are not authorized practitioners of telehealth
under section 1834(m)(4)(E) of the Act, as defined in section
1842(b)(18)(C) of the Act. Because the above services are predominantly
furnished by physical therapists, occupational therapists and speech-
language pathologists, we do not believe it would be appropriate to add
them to the list of telehealth services at this time. One requester
suggested that we can add telehealth practitioners without legislation,
as evidenced by the addition of nutritional professionals. However, we
do not believe we have such authority and note that nutritional
professionals are included as practitioners in the definition at
section 1834(b)(18)(C)(vi) of the Act, and thus, are within the
statutory definition of telehealth practitioners. Therefore, we did not
propose to add these services to the list of Medicare telehealth
services for CY 2017.
In summary, we proposed to add the following codes to the list of
Medicare telehealth services beginning in CY 2017 on a category 1
basis:
ESRD-related services 90967 through 90970. The required
clinical examination of the catheter access site must be furnished
face-to-face ``hands on'' (without the use of an interactive
telecommunications system) by a physician, CNS, NP, or PA.
Advance care planning (CPT codes 99497 and 99498).
Telehealth Consultations for a Patient Requiring Critical
Care Services (G0508 and G0509).
The following is summary of the comments we received regarding the
proposed addition of services to the list of Medicare telehealth
services:
Comment: Many commenters supported one or more of our proposals to
add ESRD-related services (CPT codes 90967, 90968, 90969 and 90970) and
advance care planning services (CPT codes 99497 and 99498) to the list
of Medicare telehealth services for CY 2017.
Response: We appreciate the commenters' support for the proposed
additions to the list of Medicare telehealth services. After
consideration of the public comments received, we are finalizing our
proposal to add these services to the list of Medicare telehealth
services for CY 2017 on a category 1 basis.
Comment: Many commenters also supported the proposal to make
payment through new codes, initial and subsequent, used to describe
critical care consultations furnished via telehealth. Commenters
indicated that the codes will improve patient outcomes and quality of
care.
Response: We thank the commenters for their support. We believe the
new coding G0508 and G0509 would provide a mechanism to report an
intensive telehealth consultation service, initial or subsequent, for
the critically ill patient, for example a stroke patient, under the
circumstance when a qualified health care professional has in-person
responsibility for the patient but the patient benefits from additional
services from a distant-site consultant specially trained in furnishing
critical care services. After consideration of the public comments
received, we are finalizing our proposal to add these critical care
consultation services to the list of Medicare telehealth services for
CY 2017 on a category 1 basis. We are finalizing these services as
limited to once per day per patient.
We are also finalizing our proposal to make payment for these
critical care consultation services through new codes G0508 and G0509,
initial and subsequent, used to describe critical care consultations
furnished via telehealth. More details on the new coding and valuation
for these services are discussed in section II.L. of this final rule
and the final RVUs for this service are included in Addendum B of this
final rule. Like the other telehealth consultation codes, we proposed
and are finalizing that these services would be added to the telehealth
list and would be subject to the geographic and other statutory
restrictions that apply to telehealth services.
Comment: Several commenters agreed with our decision not to add
psychological and neuropsychological testing services to the telehealth
list, noting that the face-to-face contact between the psychologist or
technician and the beneficiary is critical for detecting behaviors
related to test taking, such as movements or other nonverbal signals
that could be missed by using current telehealth media.
A few commenters disagreed with our decision not to add
psychological and neuropsychological testing services. Commenters cited
general benefits, such as increased access to care, improved health
outcomes, and as a remedy to address provider shortages. One commenter
maintained that the requested codes are similar to many
[[Page 80199]]
neurological examinations done via telehealth with the approved
outpatient office visit and inpatient visit CPT codes currently on the
telehealth list.
Response: As noted above, we previously considered the request to
add these codes to the telehealth list, on a category 1 basis, in the
CY 2015 final rule with comment period (79 FR 67600). We decided not to
add these codes, indicating that these services are not similar to
other services on the telehealth list because they require close
observation of how a patient responds. Commenters provided no evidence
of clinical benefit, which is necessary to support adding these
services on a category 2 basis. Therefore, we are not adding these
services to the list of Medicare list telehealth services for CY 2017.
Comment: A few commenters disagreed with our decision not to add
observation care and emergency department visits. Commenters cited
general benefits, such as improved quality of care, reduced physician
workload, reduced emergency department overcrowding, and reduced
shortage of available specialty services. Concerning CPT codes 99281-
99283, one commenter indicated that none of these codes include what is
categorized as a ``detailed'' or ``comprehensive'' history or exam;
none of these codes include complexity in medical decision making that
is categorized as ``high;'' and none of these codes include presenting
problems of ``high'' or ``high severity/immediate significant threat to
life or physiological function.''
Response: As noted above, we previously considered and rejected
adding these codes to the list of Medicare telehealth services in the
CY 2005 PFS final rule (69 FR 66276) on a category 1 basis because of
the difference in typical patient acuity relative to any services on
the current list of Medicare telehealth services. While CPT codes
99281-99283 may not include a detailed or comprehensive history or exam
or a high level of medical decision making, we do not agree that these
codes are similar to outpatient visit codes (CPT codes 99201-99215)
currently on the list of Medicare telehealth services. As previously
stated, more acutely ill patients are more likely to be seen in the
emergency department, and that difference is part of the reason there
are separate codes describing evaluation and management visits in the
Emergency Department setting. The work in an Emergency Department
setting is distinctly different from the pace, intensity, and acuity
associated with visits that occur in the office or outpatient setting.
Commenters provided no evidence of clinical benefit for these services
when furnished via telehealth specifically, which is necessary to
support adding these services on a category 2 basis. Therefore, we are
not adding these services to the list of Medicare telehealth services
for CY 2017.
We remind stakeholders that if consultative telehealth services are
required for patients where emergency department or observation care
services would ordinarily be reported, multiple codes describing
consultative services are currently on the telehealth list and can be
used to bill for such telehealth services.
Comment: Concerning various services primarily furnished by
physical therapists, occupational therapists, and speech-language
pathologists, commenters recognized that a statutory change is required
to allow such services to be added to the list of Medicare telehealth
services.
Response: We appreciate commenters recognizing the statutory
limitation on adding these services. Therefore, we are not adding these
services to the list of Medicare telehealth services for CY 2017.
4. Place of Service (POS) Code for Telehealth Services
We have received multiple requests from various stakeholders to
establish a POS code to identify services furnished via telehealth.
These requests have come from other payers, but may also be related to
confusion concerning whether to use the POS where the distant site
physician is located or the POS where the patient is located. The
process for establishing POS codes is managed by the POS Workgroup
within CMS, is available for use by all payers, and is not contingent
upon Medicare PFS rulemaking. We noted in the CY 2017 proposed rule (81
FR 46184) that, if such a POS code were created, in order to make it
valid for use in Medicare, we would have to determine the appropriate
payment rules associated with the code. Therefore, we proposed how a
POS code for telehealth would be used under the PFS with the
expectation that, if such a code is available, it would be used as
early as January 1, 2017. We proposed that the physicians or
practitioners furnishing telehealth services would be required to
report the telehealth POS code to indicate that the billed service is
furnished as a telehealth service from a distant site. As noted below,
since the publication of the CY 2017 proposed rule, the telehealth POS
code has been created.
Our requirement for physicians and practitioners to use the
telehealth POS code to report that telehealth services were furnished
from a distant site would improve payment accuracy and consistency in
telehealth claims submission. Currently, for services furnished via
telehealth, we have instructed practitioners to report the POS code
that would have been reported had the service been furnished in person.
However, some practitioners use the POS where they are located when the
service is furnished, while others use the POS corresponding to the
patient's location.
Under the PFS, the POS code determines whether a service is paid
using the facility or non-facility practice expense relative value
units (PE RVUs). The facility rate is paid when a service is furnished
in a location where Medicare is making a separate facility payment to
an entity other than the physician or practitioner that is intended to
reflect the facility costs associated with the service (clinical staff,
supplies and equipment). We note that in accordance with section
1834(m)(2)(B) of the Act, the payment amount for the telehealth
facility fee paid to the originating site is a national fee, paid
without geographic or site of service adjustments that generally are
made for payments to different kinds of Medicare providers and
suppliers. In the case of telehealth services, we believe that facility
costs (clinical staff, supplies, and equipment) associated with
furnishing the service would generally be incurred by the originating
site, where the patient is located, and not by the practitioner at the
distant site. The statute requires Medicare to pay a fee to the site
that hosts the patient. This is analogous to the circumstances under
which the facility PE RVUs are used to pay for services under the PFS.
Therefore, we proposed to use the facility PE RVUs to pay for
telehealth services reported by physicians or practitioners with the
telehealth POS code. We note that there are only three codes on the
telehealth list with a difference greater than 1.0 PE RVUs between the
facility PE RVUs and the non-facility PE RVUs. We did not anticipate
that this proposal would result in a significant change in the total
payment for the majority of services on the telehealth list. Moreover,
many practitioners already use a facility POS when billing for
telehealth services (those that report the POS of the originating site
where the beneficiary is located). The policy to use the telehealth POS
code for telehealth services would not affect payment for
[[Page 80200]]
telehealth services for these practitioners.
The POS code for telehealth would not apply to originating sites
billing the facility fee. Originating sites are not furnishing a
service via telehealth since the patient is physically present in the
facility. Accordingly, the originating site would continue to use the
POS code that applies to the type of facility where the patient is
located.
We also proposed a change to Sec. 414.22(b)(5)(i)(A) that
addresses the PE RVUs used in different settings. These revisions would
improve clarity regarding our current policies. Specifically, we
proposed to amend this section to specify that the facility PE RVUs are
paid for practitioner services furnished via telehealth under Sec.
410.78. In addition, we proposed a change to resolve any potential
ambiguity and clarify that payment under the PFS is made at the
facility rate (facility PE RVUs) when services are furnished in a
facility setting paid by Medicare, including in off-campus provider
based departments. As proposed, the regulation reflected the policy
being proposed, for CY 2017 only, to pay the physician the nonfacility
rate for services furnished in an off-campus provider based department
that was not excepted under section 603 of the Bipartisan Budget Act of
2015. Finally, to streamline the existing regulation, we also proposed
to delete Sec. 414.32 of our regulation that refers to the calculation
of payments for certain services prior to 2002.
The following is summary of the comments we received regarding the
proposal to use a POS code for services furnished via telehealth:
Comment: Many commenters supported the proposal to use the POS code
for telehealth, indicating that it would clarify and simplify billing
requirements, improve payment accuracy and consistency in telehealth
claims submissions, and provide more reliable data regarding telehealth
services.
Response: We appreciate the support for this proposal.
Comment: One commenter asked us to reconsider the proposal, noting
that the AMA's CPT Editorial Panel has adopted a telehealth modifier
for those medical services that are currently covered telehealth
services by Medicare or other payers, which obviates the need for the
POS code.
Response: The POS code was requested by other payers, and we
continue to believe that adopting it for use in the Medicare program
would provide consistency in reporting and identifying services
furnished via telehealth. We have had longstanding HCPCS modifiers for
telehealth. While these modifiers were not adopted by CPT, they have
been available for use by other payers. Despite the availability of
these HCPCS modifiers noting telehealth services, payers have requested
creation of the new POS code. Therefore, we do not understand why
introduction of a new CPT modifier as opposed to a HCPCS modifier would
obviate the need for a POS code. Instead, we agree with other payers
that the POS code would provide consistency in reporting and
identifying services furnished via telehealth, since it eliminates the
need for service-specific rules regarding appropriate POS reporting for
telehealth services.
Comment: Another commenter stated that use of the POS code, or
originating site restrictions, would place additional administrative
barriers for telepsychiatric access.
Response: We note that the POS is a required field on the
professional claim, regardless of whether the service is furnished via
telehealth. Since a selection needs to be made, we believe that
requiring the selection of a specific code is no more burdensome than
requiring the claim to specify the POS appropriate to either the
setting of the telehealth patient or the setting of the distant site
practitioner. The POS code does not entail any new originating site
restrictions.
Comment: Various commenters asked for clarification of the
following:
Whether the POS code would replace the GT modifier.
Whether the description of telehealth as a service
furnished via an interactive audio and video telecommunications system
applies to the POS code as it does to the GT modifier.
How to ensure proper payment when the distant site
practitioner is at a facility, but the patient is not.
Response: Under current policy, use of the GT and GQ modifiers
certifies that the service meets the telehealth requirements, and would
continue to be required. The POS code would be used in addition to the
GT and GQ modifiers. We did not propose to implement a change in the
requirement to use either the GT and GQ modifier because at the time of
the proposed rule, we did not know whether the telehealth POS code
would be made effective for January 1, 2017. However, because under our
proposal the POS code would serve to identify telehealth services
furnished under section 1834(m) of the Act via an interactive audio and
video telecommunications system, we believe that we should consider
eliminating the required use of the GT and GQ telehealth modifiers, and
we may revisit this question through future rulemaking. Like the
modifiers, use of the POS code certifies that the service meets the
telehealth requirements. Distant site providers will be paid using the
facility PE RVUs, regardless of their location. The setting of the
patient does not affect the payment to the distant site provider.
Comment: Commenters also asked for clarification that the proposal
to adopt the telehealth POS relates solely to payment, and not to
licensure requirements. The commenter noted that practitioners who
furnish telehealth services must adhere to the standard of care and
licensure rules, regulations and laws of the state where the patient is
located, just as the practitioner would in a traditional face-to-face
encounter.
Response: The commenters are correct that the purpose of our POS
proposal is to assist in determining proper payment. It will also help
us to accurately track telehealth utilization and spending. The
proposal to adopt the telehealth POS code has no bearing on state
licensure requirements or other state regulations. We appreciate the
commenters' request for clarification.
Comment: Several commenters supported the proposal to use the
facility PE RVUs for telehealth services. One commenter said paying
some telehealth services at non-facility rates creates undesirable
financial incentives to prefer telehealth services over services that
are furnished in person at the originating site.
Response: We appreciate the support for the proposal and agree with
the commenter's articulation regarding the importance of developing
payment rates that reflect the relative resource costs of furnishing
the services and that do not create unintended financial incentives.
Comment: Many other commenters opposed the proposal. Commenters
stated that it would result in lower fees for telehealth services
furnished by psychologists. Commenters also stated that PE costs
increase for services furnished via telehealth due to the costs of
HIPAA-compliant telecommunication equipment.
One commenter remarked that use of a POS code should not be the
basis for reducing payments and that many codes would experience a
significant payment change. The commenter noted that a 1.0 RVU
reduction would result in a $36 payment reduction for the service. One
commenter stated CMS should propose budget neutral PE and originating
site fees, based on data, for CY 2018. One commenter noted that there
are no facility PE RVUs for several codes.
[[Page 80201]]
Response: We do not believe that use of the telehealth POS code
produces a significant payment change in the vast majority of
circumstances. For distant site practitioners who are already paid
using the facility PE RVUs and for services where there is no payment
difference between the facility and non-facility PE RVUs, there will be
no change in payment as a result of the telehealth POS code.
There is utilization data for 56 of the 81 codes on the telehealth
list. For these codes, 20 are not paid differently based on site of
service, and 27 codes are paid differently by fewer than 0.5 RVUs.
There are only three codes on the telehealth list with a difference
greater than 1.0 PE RVUs between the facility PE RVUs and the non-
facility PE RVUs.
Concerning psychotherapy and psychological testing services, we
note that for the vast majority of psychiatric services the difference
between the two rates is very small. For example, the difference
between the facility and non-facility national rates for 45 minutes of
psychotherapy is 0.02 RVUs per service: Less than $1.00. The
differences between the facility PE RVUs and non-facility PE RVUS
ranges from 0.01-0.03 RVUs for nine of the psychological testing codes
on the Medicare telehealth list, and 0.12 RVUs lower for two other
codes. We do not consider these reductions significant, nor do we have
any evidence that practice expense costs are greater for furnishing
such services via telehealth than for furnishing a face-to-face
service. Commenters provided no evidence that practice expense costs
for services furnished via telehealth are greater, due to the
requirement for HIPAA-compliant equipment, than for furnishing in-
person services, even in the facility setting.
There are a few HCPCS codes on the telehealth list that do not have
a calculated facility PE RVU. For these services, the non-facility PE
RVUs would serve as a proxy, and therefore, there would be no payment
change for these codes.
Finally, we note that the originating site facility fee is
established by statute (section 1834(m)(2)(B) of the Act) and is not
affected by this proposal.
We note that we believe that payment using the facility PE RVUs for
telehealth services is consistent our belief that the direct practice
expense costs are generally incurred at the location of the beneficiary
and not by the distant site practitioner. After reviewing the current
list of telehealth services in the context of the comments, we continue
to believe this is accurate.
After consideration of the public comments received, we are
finalizing our proposal to use the POS code for telehealth and to use
the facility PE RVUs to pay for telehealth service reported by
physicians or practitioners with the telehealth POS code for CY 2017.
However, we understand commenters' concerns and will consider the
concerns regarding use of the facility payment rate as we monitor
utilization of telehealth services. We will welcome information from
stakeholders regarding any potential unintended consequences of the
payment policy. We will also consider the applicability of the facility
rate to any codes newly added to the list of telehealth services.
We have updated the POS code list on our Web site at https://www.cms.gov/Medicare/Coding/place-of-service-codes/Place_of_Service_Code_Set.html to include POS 02: Telehealth
(Descriptor: The location where health services and health related
services are provided or received, through telecommunication
technology). The new code will be used for services furnished on or
after January 1, 2017.
We are finalizing proposed revisions to our regulation at Sec.
414.22(b)(5)(i)(A) that addresses the PE RVUs used in different
settings as described above, except that we are not finalizing the
proposed change that would have resulted in the payment of the
nonfacility rate for services furnished in off-campus provider based
departments that are not excepted under Section 603 of the Bipartisan
Budget Act of 2015 since we are finalizing that payments to such non-
excepted PBDs will be made under the PFS. In a separate interim final
rule with comment period issued in conjunction with the CY 2017 OPPS/
ASC final rule with comment period (see Medicare Program: Hospital
Outpatient Prospective Payment and Ambulatory Surgical Center Payment
Systems and Quality Reporting Programs; Organ Procurement Organization
Reporting and Communication; Transplant Outcome Measures and
Documentation Requirements; Electronic Health Record (EHR) Incentive
Programs; Payment to Certain Off-Campus Outpatient Departments of a
Provider; Hospital Value-Based Purchasing (VBP) Program; Establishment
of Physician Fee Schedule Payment Rates for Nonexcepted Items and
Services Billed by Applicable Departments of a Hospital), we are
finalizing other payment policies for nonexcepted items and services
furnished by such non-excepted off-campus provider based departments.
Accordingly, physicians furnishing services in such provider-based
departments will continue to be paid the facility rate. We are also
finalizing the proposal to delete Sec. 414.32 of our regulation that
refers to the calculation of payments for certain services prior to
2002.
We remind the public that we are currently soliciting requests to
add services to the list of Medicare telehealth services. To be
considered during PFS rulemaking for CY 2018, these requests must be
submitted and received by December 31, 2016. Each request to add a
service to the list of Medicare telehealth services must include any
supporting documentation the requester wishes us to consider as we
review the request. For more information on submitting a request for an
addition to the list of Medicare telehealth services, including where
to mail these requests, we refer readers to the CMS Web site at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
5. Telehealth Originating Site Facility Fee Payment Amount Update
Section 1834(m)(2)(B) of the Act establishes the Medicare
telehealth originating site facility fee for telehealth services
furnished from October 1, 2001 through December 31, 2002, at $20.00.
For telehealth services furnished on or after January 1 of each
subsequent calendar year, the telehealth originating site facility fee
is increased by the percentage increase in the MEI as defined in
section 1842(i)(3) of the Act. The originating site facility fee for
telehealth services furnished in CY 2016 is $25.10. The MEI increase
for 2017 is 1.2 percent and is based on the most recent historical
update through 2016Q2 (1.6 percent), and the most recent historical MFP
through calendar year 2015 (0.4 percent). Therefore, for CY 2017, the
payment amount for HCPCS code Q3014 (Telehealth originating site
facility fee) is 80 percent of the lesser of the actual charge or
$25.40. The Medicare telehealth originating site facility fee and the
MEI increase by the applicable time period is shown in Table 6.
Table 6--The Medicare Telehealth Originating Site Facility Fee and MEI
[Increase by the applicable time period]
------------------------------------------------------------------------
MEI Facility
Time period increase fee
------------------------------------------------------------------------
10/01/2001-12/31/2002............................. N/A $20.00
01/01/2003-12/31/2003............................. 3.0 20.60
01/01/2004-12/31/2004............................. 2.9 21.20
01/01/2005-12/31/2005............................. 3.1 21.86
01/01/2006-12/31/2006............................. 2.8 22.47
01/01/2007-12/31/2007............................. 2.1 22.94
01/01/2008-12/31/2008............................. 1.8 23.35
01/01/2009-12/31/2009............................. 1.6 23.72
[[Page 80202]]
01/01/2010-12/31/2010............................. 1.2 24.00
01/01/2011-12/31/2011............................. 0.4 24.10
01/01/2012-12/31/2012............................. 0.6 24.24
01/01/2013-12/31/2013............................. 0.8 24.43
01/01/2014-12/31/2014............................. 0.8 24.63
01/01/2015-12/31/2015............................. 0.8 24.83
01/01/2016-12/31/2016............................. 1.1 25.10
01/01/2017-12/31/2017............................. 1.2 25.40
------------------------------------------------------------------------
D. Potentially Misvalued Services Under the Physician Fee Schedule
1. Background
Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a
periodic review, not less often than every 5 years, of the RVUs
established under the PFS. Section 1848(c)(2)(K) of the Act requires
the Secretary to periodically identify potentially misvalued services
using certain criteria and to review and make appropriate adjustments
to the relative values for those services. Section 1848(c)(2)(L) to the
Act also requires the Secretary to develop a process to validate the
RVUs of certain potentially misvalued codes under the PFS, using the
same criteria used to identify potentially misvalued codes, and to make
appropriate adjustments.
As discussed in section II.B. of this final rule, each year we
develop appropriate adjustments to the RVUs taking into account
recommendations provided by the American Medical Association/Specialty
Society Relative Value Scale Update Committee (RUC), the Medicare
Payment Advisory Commission (MedPAC), and others. For many years, the
RUC has provided us with recommendations on the appropriate relative
values for new, revised, and potentially misvalued PFS services. We
review these recommendations on a code-by-code basis and consider these
recommendations in conjunction with analyses of other data, such as
claims data, to inform the decision-making process as authorized by the
law. We may also consider analyses of work time, work RVUs, or direct
PE inputs using other data sources, such as Department of Veteran
Affairs (VA), National Surgical Quality Improvement Program (NSQIP),
the Society for Thoracic Surgeons (STS), and the Physician Quality
Reporting System (PQRS) databases. In addition to considering the most
recently available data, we also assess the results of physician
surveys and specialty recommendations submitted to us by the RUC for
our review. We also consider information provided by other
stakeholders. We conduct a review to assess the appropriate RVUs in the
context of contemporary medical practice. We note that section
1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and
other techniques to determine the RVUs for physicians' services for
which specific data are not available and requires us to take into
account the results of consultations with organizations representing
physicians who provide the services. In accordance with section 1848(c)
of the Act, we determine and make appropriate adjustments to the RVUs.
In its March 2006 Report to the Congress (http://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 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 (http://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
[[Page 80203]]
any RVU with the periodic review described in section 1848(c)(2)(B) of
the Act. Section 1848(c)(2)(K)(iii)(V) of the Act specifies that the
Secretary may make appropriate coding revisions (including using
existing processes for consideration of coding changes) that may
include consolidation of individual services into bundled codes for
payment under the physician fee schedule.
2. Progress in Identifying and Reviewing Potentially Misvalued Codes
To fulfill our statutory mandate, we have identified and reviewed
numerous potentially misvalued codes as specified in section
1848(c)(2)(K)(ii) of the Act, and we plan to continue our work
examining potentially misvalued codes in these areas over the upcoming
years. As part of our current process, we identify potentially
misvalued codes for review, and request recommendations from the RUC
and other public commenters on revised work RVUs and direct PE inputs
for those codes. The RUC, through its own processes, also identifies
potentially misvalued codes for review. Through our public nomination
process for potentially misvalued codes established in the CY 2012 PFS
final rule with comment period, other individuals and stakeholder
groups submit nominations for review of potentially misvalued codes as
well.
Since CY 2009, as a part of the annual potentially misvalued code
review and Five-Year Review process, we have reviewed over 1,671
potentially misvalued codes to refine work RVUs and direct PE inputs.
We have assigned appropriate work RVUs and direct PE inputs for these
services as a result of these reviews. A more detailed discussion of
the extensive prior reviews of potentially misvalued codes is included
in the CY 2012 PFS final rule with comment period (76 FR 73052 through
73055). In the CY 2012 PFS final rule with comment period, we finalized
our policy to consolidate the review of physician work and PE at the
same time (76 FR 73055 through 73958), and established a process for
the annual public nomination of potentially misvalued services.
In the CY 2013 PFS final rule with comment period, we built upon
the work we began in CY 2009 to review potentially misvalued codes that
have not been reviewed since the implementation of the PFS (so-called
``Harvard-valued codes''). In CY 2009, we requested recommendations
from the RUC to aid in our review of Harvard-valued codes that had not
yet been reviewed, focusing first on high-volume, low intensity codes
(73 FR 38589). In the fourth Five-Year Review (76 FR 32410), we
requested recommendations from the RUC to aid in our review of Harvard-
valued codes with annual utilization of greater than 30,000. In the CY
2013 PFS final rule with comment period, we identified specific
Harvard-valued services with annual allowed charges that total at least
$10,000,000 as potentially misvalued. In addition to the Harvard-valued
codes, in the CY 2013 PFS final rule with comment period we finalized
for review a list of potentially misvalued codes that have stand-alone
PE (codes with physician work and no listed work time and codes with no
physician work that have listed work time).
In the CY 2016 PFS final rule with comment period, we finalized for
review a list of potentially misvalued services, which included eight
codes in the neurostimulators analysis-programming family (CPT 95970-
95982). We also finalized as potentially misvalued 103 codes identified
through our screen of high expenditure services across specialties.
3. Validating RVUs of Potentially Misvalued Codes
Section 1848(c)(2)(L) of the Act requires the Secretary to
establish a formal process to validate RVUs under the PFS. The Act
specifies that the validation process may include validation of work
elements (such as time, mental effort and professional judgment,
technical skill and physical effort, and stress due to risk) involved
with furnishing a service and may include validation of the pre-, post-
, and intra-service components of work. The Secretary is directed, as
part of the validation, to validate a sampling of the work RVUs of
codes identified through any of the 16 categories of potentially
misvalued codes specified in section 1848(c)(2)(K)(ii) of the Act.
Furthermore, the Secretary may conduct the validation using methods
similar to those used to review potentially misvalued codes, including
conducting surveys, other data collection activities, studies, or other
analyses as the Secretary determines to be appropriate to facilitate
the validation of RVUs of services.
In the CY 2011 PFS proposed rule (75 FR 40068) and CY 2012 PFS
proposed rule (76 FR 42790), we solicited public comments on possible
approaches, methodologies, and data sources that we should consider for
a validation process. A summary of the comments along with our
responses are included in the CY 2011 PFS final rule with comment
period (75 FR 73217) and the CY 2012 PFS final rule with comment period
(73054 through 73055).
We contracted with two outside entities to develop validation
models for RVUs.
Given the central role of time in establishing work RVUs and the
concerns that have been raised about the current time values used in
rate setting, we contracted with the Urban Institute to develop
empirical time estimates based on data collected from several health
systems with multispecialty group practices. The Urban Institute
collected data by directly observing the delivery of services and
through the use of electronic health records for services selected by
the contractor in consultation with CMS and is using this data to
produce objective time estimates. We expect the final Urban Institute
report will be made available on the CMS Web site later this year.
The second contract is with the RAND Corporation, which used
available data to build a validation model to predict work RVUs and the
individual components of work RVUs, time and intensity. The model
design was informed by the statistical methodologies and approach used
to develop the initial work RVUs and to identify potentially misvalued
procedures under current CMS and RUC processes. RAND consulted with a
technical expert panel on model design issues and the test results. The
RAND report is available under downloads on the Web site for the CY
2015 PFS final rule with comment period at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices-Items/CMS-1612-FC.html.
After posting RAND's report on the models and results on our Web
site, we received comments indicating that the models did not
adequately address global surgery services due to the lack of available
data on included visits. Therefore, we modified the RAND contract to
include the development of G-codes that could be used to collect data
about post-surgical follow-up visits on Medicare claims to meet the
requirements in section 1848(c)(8)(B) of the Act regarding collection
of data on global services. Our discussion related to this data
collection requirement is in section II.D.6. Also, the data from this
project would provide information that would allow the time for these
services to be included in the model for validating RVUs.
[[Page 80204]]
4. CY 2017 Identification and Review of Potentially Misvalued Services
a. 0-Day Global Services That Are Typically Billed With an Evaluation
and Management (E/M) Service With Modifier 25
Because routine E/M is included in the valuation of codes with 0-,
10-, and 90-day global periods, Medicare only makes separate payment
for E/M services that are provided in excess of those considered
included in the global procedure. In such cases, the physician would
report the additional E/M service with Modifier 25, which is defined as
a significant, separately identifiable E/M service performed by the
same physician on the day of a procedure above and beyond other
services provided or beyond the usual preservice and postservice care
associated with the procedure that was performed. Modifier 25 allows
physicians to be paid for E/M services that would otherwise be denied
as bundled.
In reviewing misvalued codes, both CMS and the RUC have often
considered how frequently particular codes are reported with E/M codes
to account for potential overlap in resources. Some stakeholders have
expressed concern with this policy especially with regard to the
valuation of 0-day global services that are typically billed with a
separate E/M service with the use of Modifier 25. For example, when we
established our valuation of the osteopathic manipulative treatment
(OMT) services, described by CPT codes 98925-98929, we did so with the
understanding that these codes are usually reported with E/M codes.
For our CY 2017 proposal (81 FR 46187), we investigated Medicare
claims data for CY 2015 and found that 19 percent of the codes that
described 0-day global services were billed over 50 percent of the time
with an E/M with Modifier 25. Since routine E/M is included in the
valuation of 0-day global services, we believed that the routine
billing of separate E/M services may have indicated a possible problem
with the valuation of the bundle, which is intended to include all the
routine care associated with the service.
In the proposed rule (81 FR 46187), we stated that reviewing the
procedure codes typically billed with an E/M with Modifier 25 may be
one avenue to appropriate valuation for these services. Therefore, we
developed and proposed a screen for potentially misvalued codes that
identified 0-day global codes billed with an E/M 50 percent of the time
or more, on the same day of service, with the same physician and same
beneficiary. We included a list of codes with total allowed services
greater than 20,000. There are 83 codes that met the proposed criteria
for the screen and were proposed as potentially misvalued. We also
sought comment regarding additional ways to address appropriate
valuations for all services that are typically billed with an E/M with
Modifier 25.
The following is the summary of the comments we received.
Comment: Several commenters disagreed with CMS' assertion that
there is a possible valuation problem with the bundle when an E/M with
Modifier 25 is typically reported on the same day of service as a 0-day
global procedure. Commenters stated that billing an E/M with Modifier
25 pays physicians for the justifiable and appropriate services they
render to patients; allowing for a patient-centered approach to care.
Some commenters considered the possibility that there could be
fraudulent billing practices when reporting an E/M with Modifier 25 and
a few offered various solutions for rectifying the problem from a
program integrity perspective. For example, one commenter suggested
that further education on the appropriate use of Modifier 25 or penalty
for misuse would be effective alternatives to combat inappropriate
billing while another commenter suggested investigating the diagnosis
coding for services.
Commenters overwhelmingly opposed any change to billing policies or
standard valuation for 0-day services that are billed with an E/M with
Modifier 25.
Response: We appreciate commenters' perspective on this issue.
While we understand the commenters' views, since routine E/M is
included in the valuation of 0-day global services we continue to
believe that the routine billing of separate E/M services may still
indicate a possible problem with the valuation of the global period or
the assignment of the global period for particular codes, given that
the period is intended to include all the routine care associated with
the service. As discussed below, we are finalizing some of the 0-day
global services as potentially misvalued. We will also continue to
consider this issue for future rulemaking.
Comment: Several commenters expressed appreciation for the
identification of an objective screen and reasonable query. While some
commenters were accepting of the screen as proposed, others stated
their preference for the screen to be withdrawn entirely or limited in
scope, with some commenters suggesting the screen be limited to the
codes that met the criteria and for which the overlap had not already
been considered by the RUC in developing recommended values. Several
thousand commenters suggested withdrawing or limiting the scope of this
screen, particularly as it pertains to the OMT codes.
Response: Section 1848(c)(2)(K) of the Act requires the Secretary
to periodically identify potentially misvalued services and to review
and make appropriate adjustments to the relative values for those
services. Section 1848(c)(2)(K) of the Act identifies several
categories of services as potentially misvalued, including codes for
services where there may be efficiencies when a service is furnished at
the same time as other services, along with codes as determined
appropriate by the Secretary. Based on the comments received, we
understand that stakeholders would have us identify as potentially
misvalued only those individual codes with obvious overlapping resource
costs when typically reported with an E/M, rather than consider the
issue of misvaluation of the global period more broadly. In response to
these comments, we are finalizing the use of our screen for 0-day
global services that are typically billed with an E/M with Modifier 25
as a mechanism for identifying services that are potentially misvalued.
Because we recognize that the primary purpose in displaying lists
of misvalued codes in rulemaking has been to seek recommendations
regarding appropriate valuation from stakeholders, including the RUC,
for 2017 we are only identifying the services for which we believe
there might be the kind of misvaluation the RUC and the medical
specialty societies recognize. Based on the comments from these
organizations, we believe that for codes reviewed in the past 5 years,
the RUC has already addressed that kind of misvaluation. In other
words, commenters have made clear that external review of these
services is likely to be limited to clear overlap in resource costs,
but will not address the broader concerns we have about developing
rates for services that include routine E/M when evaluation and
management is also routinely separately reported. As a result, we will
continue to consider that issue for future rulemaking. We note that we
are required under statute to improve the valuation of the 10- and 90-
day global periods, and therefore, we will consider this issue in that
context, as well.
Comment: While some commenters supported our review of the 83 codes
that were proposed as potentially
[[Page 80205]]
misvalued through the screen, the majority of commenters, including the
RUC, stated that the codes detailed in Table 7 did not meet the
criteria for the screen because they were either reviewed in the last 5
years and/or are not typically reported with an E/M, and therefore,
should be removed. While commenters largely disagreed on the list of
proposed codes, most agreed that the services they believed met the
screen criteria should be reviewed.
Table 7--Codes Requested To Be Removed From the List of Potentially
Misvalued Services
------------------------------------------------------------------------
HCPCS Long descriptor
------------------------------------------------------------------------
11000............................. Removal of inflamed or infected
skin, up to 10% of body surface.
11100............................. Biopsy of single growth of skin and/
or tissue.
11300............................. Shaving of 0.5 centimeters or less
skin growth of the trunk, arms, or
legs.
11301............................. Shaving of 0.6 centimeters to 1.0
centimeters skin growth of the
trunk, arms, or legs.
11302............................. Shaving of 1.1 to 2.0 centimeters
skin growth of the trunk, arms, or
legs.
11305............................. Shaving of 0.5 centimeters or less
skin growth of scalp, neck, hands,
feet, or genitals.
11306............................. Shaving of 0.6 centimeters to 1.0
centimeters skin growth of scalp,
neck, hands, feet, or genitals.
11307............................. Shaving of 1.1 to 2.0 centimeters
skin growth of scalp, neck, hands,
feet, or genitals.
11310............................. Shaving of 0.5 centimeters or less
skin growth of face, ears, eyelids,
nose, lips, or mouth.
11311............................. Shaving of 0.6 centimeters to 1.0
centimeters skin growth of face,
ears, eyelids, nose, lips, or
mouth.
11312............................. Shaving of 1.1 to 2.0 centimeters
skin growth of face, ears, eyelids,
nose, lips, or mouth.
11740............................. Removal of blood accumulation
between nail and nail bed.
11900............................. Injection of up to 7 skin growths.
11901............................. Injection of more than 7 skin
growths.
12001............................. Repair of wound (2.5 centimeters or
less) of the scalp, neck,
underarms, trunk, arms and/or legs.
12002............................. Repair of wound (2.6 to 7.5
centimeters) of the scalp, neck,
underarms, genitals, trunk, arms
and/or legs.
12004............................. Repair of wound (7.6 to 12.5
centimeters) of the scalp, neck,
underarms, genitals, trunk, arms
and/or legs.
12011............................. Repair of wound (2.5 centimeters or
less) of the face, ears, eyelids,
nose, lips, and/or mucous
membranes.
12013............................. Repair of wound (2.6 to 5.0
centimeters) of the face, ears,
eyelids, nose, lips, and/or mucous
membranes.
17250............................. Application of chemical agent to
excessive wound tissue.
20550............................. Injections of tendon sheath,
ligament, or muscle membrane.
20552............................. Injections of trigger points in 1 or
2 muscles.
20553............................. Injections of trigger points in 3 or
more muscles.
20600............................. Aspiration and/or injection of small
joint or joint capsule.
20604............................. Arthrocentesis, aspiration and/or
injection, small joint or bursa
(eg, fingers, toes); with
ultrasound guidance, with permanent
recording and reporting.
20605............................. Aspiration and/or injection of
medium joint or joint capsule.
20606............................. Arthrocentesis, aspiration and/or
injection, intermediate joint or
bursa (eg, temporomandibular,
acromioclavicular, wrist, elbow or
ankle, olecranon bursa); with
ultrasound guidance, with permanent
recording and reporting.
20610............................. Aspiration and/or injection of large
joint or joint capsule.
20611............................. Arthrocentesis, aspiration and/or
injection, major joint or bursa
(eg, shoulder, hip, knee,
subacromial bursa); with ultrasound
guidance, with permanent recording
and reporting.
20612............................. Aspiration and/or injection of
cysts.
29125............................. Application of non-moveable, short
arm splint (forearm to hand).
29515............................. Application of short leg splint
(calf to foot).
30901............................. Simple control of nose bleed.
30903............................. Complex control of nose bleed.
31231............................. Diagnostic examination of nasal
passages using an endoscope.
31238............................. Control of nasal bleeding using an
endoscope.
31500............................. Emergent insertion of breathing tube
into windpipe cartilage using an
endoscope.
31575............................. Diagnostic examination of voice box
using flexible endoscope.
31579............................. Examination to assess movement of
vocal cord flaps using an
endoscope.
31645............................. Aspiration of lung secretions from
lung airways using an endoscope.
32551............................. Removal of fluid from between lung
and chest cavity, open procedure.
32554............................. Removal of fluid from chest cavity.
40490............................. Biopsy of lip.
46600............................. Diagnostic examination of the anus
using an endoscope.
51701............................. Insertion of temporary bladder
catheter.
51702............................. Insertion of indwelling bladder
catheter.
51703............................. Insertion of indwelling bladder
catheter.
56605............................. Biopsy of external female genitals.
57150............................. Irrigation of vagina and/or
application of drug to treat
infection.
57160............................. Fitting and insertion of vaginal
support device.
58100............................. Biopsy of uterine lining.
64418............................. Injection of anesthetic agent,
collar bone nerve.
65222............................. Removal of foreign body, external
eye, cornea with slit lamp
examination.
67810............................. Biopsy of eyelid.
67820............................. Removal of eyelashes by forceps.
68200............................. Injection into conjunctiva.
69100............................. Biopsy of ear.
69200............................. Removal of foreign body from ear
canal.
69210............................. Removal of impact ear wax, one ear.
69220............................. Removal of skin debris and drainage
of mastoid cavity.
92511............................. Examination of the nose and throat
using an endoscope.
92941............................. Insertion of stent, removal of
plaque and/or balloon dilation of
coronary vessel during heart
attack, accessed through the skin.
92950............................. Attempt to restart heart and lungs.
[[Page 80206]]
98925............................. Osteopathic manipulative treatment
to 1-2 body regions.
98926............................. Osteopathic manipulative treatment
to 3-4 body regions.
98927............................. Osteopathic manipulative treatment
to 5-6 body regions.
98928............................. Osteopathic manipulative treatment
to 7-8 body regions.
98929............................. Osteopathic manipulative treatment
to 9-10 body regions.
------------------------------------------------------------------------
Response: After considering the comments received, we are
significantly reducing the number of codes identified as potentially
misvalued. We agree with commenters that the majority of the codes that
we are not finalizing have been recently reviewed. Due to a drafting
error in the proposed rule, we stated that we had exempted codes that
had been reviewed in the past 5 years. While that exclusion has been
standard for many other misvalued code screens, we did not intend to
apply it in this case, given our concerns with the valuation of the
global period when E/M visits are routinely reported at the same time.
As displayed in the proposed rule, the list of codes reflected our
intention to include codes that have been recently reviewed.
Regardless, we understand based on comments that any review by
stakeholders for recently reviewed codes would be likely to result in
similar valuation. Therefore, we do not believe that we should include
codes reviewed in the past 5 years on this list of misvalued codes,
given the limited nature of the likely review. Regarding the accuracy
of which of the codes are typically reported with E/M codes, we note
that our review included analysis was based on more recent, full claims
data than had yet been made public. In the interest of transparency, we
are finalizing the list of services based on the publically available
data.
Table 8--List of Potentially Misvalued Services Identified Through the
Screen for 0-Day Global Services That Are Typically Billed With an
Evaluation and Management (E/M) Service With Modifier 25
------------------------------------------------------------------------
HCPCS Long descriptor
------------------------------------------------------------------------
11755............................. Biopsy of finger or toe nail.
20526............................. Injection of carpal tunnel.
20551............................. Injections of tendon attachment to
bone.
20612............................. Aspiration and/or injection of
cysts.
29105............................. Application of long arm splint
(shoulder to hand).
29540............................. Strapping of ankle and/or foot.
29550............................. Strapping of toes.
43760............................. Change of stomach feeding, accessed
through the skin.
45300............................. Diagnostic examination of rectum and
large bowel using an endoscope.
57150............................. Irrigation of vagina and/or
application of drug to treat
infection.
57160............................. Fitting and insertion of vaginal
support device.
58100............................. Biopsy of uterine lining.
64405............................. Injection of anesthetic agent,
greater occipital nerve.
64455............................. Injections of anesthetic and/or
steroid drug into nerve of foot.
65205............................. Removal of foreign body in external
eye, conjunctiva.
65210............................. Removal of foreign body in external
eye, conjunctiva or sclera.
67515............................. Injection of medication or substance
into membrane covering eyeball.
G0168............................. Wound closure utilizing tissue
adhesive(s) only.
G0268............................. Removal of impacted cerumen (one or
both ears) by physician on same
date of service as audiologic
function testing.
------------------------------------------------------------------------
b. End-Stage Renal Disease Home Dialysis Services (CPT Codes 90963
Through 90970)
In the CY 2004 PFS final rule with comment period (68 FR 63216), we
established new Level II HCPCS G-codes for end-stage renal disease
(ESRD) services and established payment for those codes through monthly
capitation payment (MCP) rates. For ESRD center-based patients, payment
for the G-codes varied based on the age of the beneficiary and the
number of face-to-face visits furnished each month (for example, 1
visit, 2-3 visits and 4 or more visits). We believed that many
physicians would provide 4 or more visits to center-based ESRD patients
and a small proportion will provide 2-3 visits or only one visit per
month. Under the MCP methodology, to receive the highest payment, a
physician would have to provide at least four ESRD-related visits per
month. However, payment for home dialysis MCP services only varied by
the age of beneficiary. Although we did not initially specify a
frequency of required visits for home dialysis MCP services, we stated
that we expect physicians to provide clinically appropriate care to
manage the home dialysis patient.
The CPT Editorial Panel created new CPT codes to replace the G-
codes for monthly ESRD-related services, and we accepted the new codes
for use under the PFS in CY 2009. The CPT codes created were 90963-
90966 for monthly ESRD-related services for home dialysis patient and
CPT codes 90967-90970 for dialysis with less than a full month of
services.
In a GAO report titled ``END-STAGE RENAL DISEASE Medicare Payment
Refinements Could Promote Increased Use of Home Dialysis'' dated
October 2015, http://www.gao.gov/products/GAO-16-125, the GAO stated
that experts and stakeholders they interviewed indicated that home
dialysis could be clinically appropriate for at least half of patients.
Also, at a meeting in 2013, the chief medical officers of 14 dialysis
facility chains jointly estimated that a realistic target for home
dialysis would be 25 percent of dialysis patients. The GAO noted that
CMS data showed that about 10 percent of adult Medicare dialysis
patients use home dialysis as of March 2015.
[[Page 80207]]
In the report, the GAO noted that CMS intended for the existing
payment structure to create an incentive for physicians to prescribe
home dialysis, because the monthly payment rate for managing the
dialysis care of home patients, which requires a single in-person
visit, was approximately equal to the rate for managing and providing
two to three visits to ESRD center-based patients. However, GAO found
that, in 2013, the rate of $237 for managing home patients was lower
than the average payment of $266 and maximum payment of $282 for
managing ESRD center-based patients. The GAO stated that this
difference in payment rates may discourage physicians from prescribing
home dialysis.
Physician associations and other physicians GAO interviewed stated
that the visits with home patients are often longer and more
comprehensive than in-center visits; this is in part because physicians
may conduct visits with individual home patients in a private setting,
but they may be able to more easily visit multiple in-center patients
on a single day as they receive dialysis. The physician associations
GAO interviewed also said that they may spend a similar amount of time
outside of visits to manage the care of home patients and that they are
required to provide at least one visit per month to perform a complete
assessment of the patient.
It is important to note that, as stated in the CY 2011 PFS final
rule with comment period (75 FR 73296), we believe that furnishing
monthly face-to-face visits is an important component of high quality
medical care for ESRD patients being dialyzed at home and generally
would be consistent with the current standards of medical practice.
However, we also acknowledged that extenuating circumstances may arise
that make it difficult for the MCP physician (or NPP) to furnish a
visit to a home dialysis patient every month. Therefore, we allow
Medicare contractors the discretion to waive the requirement for a
monthly face-to-face visit for the home dialysis MCP service on a case-
by-case basis, for example, when the MCP physician's (or NPP's) notes
indicate that the MCP physician (or NPP) actively and adequately
managed the care of the home dialysis patient throughout the month.
The GAO recommended, and we agreed, that CMS examine Medicare
policies for monthly payments to physicians to manage the care of
dialysis patients and revise them if necessary to ensure that these
policies are consistent with our goal of encouraging the use of home
dialysis among patients for whom it is appropriate. Therefore, we
proposed to identify CPT codes 90963 through 90970 as potentially
misvalued codes based on the volume of claims submitted for these
services relative to those submitted for facility ESRD services.
The following is summary of the comments we received.
Comment: Commenters supported the proposal to identify these codes
as potentially misvalued and supported CMS' goal of encouraging the use
of home dialysis among patients for whom it is appropriate. Some
commenters suggested we establish parity between payment for four ESRD-
related visits per month for in-center dialysis patients and payment
for the care of home dialysis patients for an entire month. One
commenter cautioned that CMS should also consider factors other than
payment that play a critical role in whether a patient decides to use a
home dialysis modality as outlined in a recent GAO report and requested
that CMS work closely with nephrologists on this issue. One commenter
encouraged CMS to focus on incentives for the adult population
separately from pediatrics as they see no benefit from reanalysis of
the pediatric home and daily dialysis CPT codes 90963-90965 and 90967-
90969.
Response: We appreciate all of the comments and agree that CPT
codes 90963 through 90970 should be identified as potentially
misvalued. After considering the comments, we are finalizing the
addition of CPT codes 90963 through 90970 to the list of potentially
misvalued codes. We will also continue to consider these issues for
future rulemaking.
c. Direct PE Input Discrepancies
i. Appropriate Direct PE Inputs Involved in Procedures Involving
Endoscopes
In the proposed rule (81 FR 46190), we stated that stakeholders had
raised concerns about potential inconsistencies with the inputs and the
prices related to endoscopic procedures in the direct PE database. Upon
review, we noted that there are 45 different pieces of endoscope
related-equipment and 25 different pieces of endoscope related-supplies
that are currently associated with these services. Relative to other
kinds of equipment items in the direct PE input, these items are much
more varied and used for many fewer services. Given the frequency with
which individual codes can be reviewed and the importance of
standardizing inputs for purposes of maintaining relativity across PFS
services, we believed that this unusual degree of variation was likely
to result in code misvaluation. To facilitate efficient review of this
particular kind of misvaluation, and because we believed that
stakeholders would prefer the opportunity to contribute to such
standardization, we requested that stakeholders like the AMA RUC review
and make recommendations on the appropriate endoscopic equipment and
supplies typically provided in all endoscopic procedures for each
anatomical body region, along with their appropriate prices.
The following is summary of the comments we received.
Comment: Many commenters stated that the RUC is the appropriate
resource for the review of appropriate direct PE inputs involved in
procedures involving endoscopes and urged CMS to work with the RUC to
address this issue. Additionally, the RUC stated that due to the
complexity of this issue and the need to incorporate input from various
specialty societies that the RUC planned to form a workgroup of the PE
subcommittee to review the issue.
Response: We appreciate the comments and will review any
recommendation provided to us by the RUC for use in future rulemaking,
consistent with our normal review processes.
ii. Appropriate Direct PE Inputs in the Facility Post-Service Period
When Post-Operative Visits Are Excluded
In the proposed rule (81 FR 46190), we identified a potential
inconsistency in instances where there are direct PE inputs included in
the facility postservice period even though post-operative visit is not
included in a service. We identified 13 codes affected by this issue
and stated that we were unclear if the discrepancy was caused by
inaccurate direct PE inputs or inaccurate post-operative data in the
work time file. We requested that stakeholders including the AMA RUC
review these discrepancies and provide their recommendations on the
appropriate direct PE inputs for the codes.
The following is summary of the comments we received.
Comment: The RUC stated that for CPT codes 21077 (Impression and
preparation of eye socket prosthesis), 21079 (Impression and custom
preparation of temporary oral prosthesis), 21080 (Impression and custom
preparation of permanent oral prosthesis), 21081 (Impression and custom
preparation of lower jaw bone prosthesis), 21082 (Impression and custom
preparation of prosthesis for
[[Page 80208]]
roof of mouth enlargement), 21083 (Impression and custom preparation of
roof of mouth prosthesis), and 21084 (Impression and custom preparation
of speech aid prosthesis) the practice expense time in the postservice
period in the facility setting is completely distinct from the
physician post-operative visit and that time must be accounted for the
manufacture and fitting of the prosthetics. The RUC stated that the
following codes all had inaccurate post-operative data in the work time
file and provided recommendations on appropriate post-operative visits:
CPT codes 28636 (Insertion of hardware to foot bone dislocation with
manipulation, accessed through the skin), 28666 (Insertion of hardware
to toe joint dislocation with manipulation, accessed through the skin),
43652 (Incision of vagus nerves of stomach using an endoscope), 47570
(Connection of gall bladder to bowel using an endoscope), and 66986
(Exchange of lens prosthesis). Additionally, another commenter stated
that CPT code 46900 (Chemical destruction of anal growths) also had
inaccurate post-operative data in the work time file and provided a
recommendation on the appropriate post-operative visit.
Response: We thank stakeholders for their comments. We will review
the recommendations provided to us by the AMA RUC and other commenters
and will consider for future rulemaking, consistent with our normal
review processes.
d. Insertion and Removal of Drug Delivery Implants--CPT Codes 11981 and
11983
In the proposed rule (81 FR 46190), we stated that stakeholders had
urged CMS to create new coding describing the insertion and removal of
drug delivery implants for buprenorphine hydrochloride, formulated as a
4 rod, 80 mg, long acting subdermal drug implant for the treatment of
opioid addiction. The stakeholders suggested that current coding
describing insertion and removal of drug delivery implants was too
broad and that new coding was needed to account for specific additional
resource costs associated with particular treatment. We identified
existing CPT codes 11981 (Insertion, non-biodegradable drug delivery
implant), 11982 (Removal, non-biodegradable drug delivery implant), and
11983 (Removal with reinsertion, non-biodegradable drug delivery
implant) as potentially misvalued codes and sought comment and
information regarding whether the current resource inputs in work and
practice expense for the codes appropriately accounted for variations
in the service relative to which devices and related drugs are inserted
and removed.
The following is summary of the comments we received.
Comment: One commenter stated that CMS should create distinct codes
and payment levels for a four-rod implant as opposed to the one-rod
implant detailed in CPT codes 11981-11983. In contrast, another
commenter stated that the identified codes adequately describe the work
and practice expense for drug implant delivery and removal services.
Additionally, another commenter stated the codes should be removed from
the potentially misvalued list. The RUC stated that a coding change
proposal had been submitted for the services under the CPT process and
that the RUC anticipated providing relevant recommendations for CY
2018.
Response: We thank stakeholders for their comments. We will review
new coding and recommended valuations for future rulemaking, consistent
with our normal review processes.
5. Valuing Services That Include Moderate Sedation as an Inherent Part
of Furnishing the Procedure
The CPT manual identifies more than 400 diagnostic and therapeutic
procedures (listed in Appendix G) for which the CPT Editorial Panel has
determined that moderate sedation is an inherent part of furnishing the
procedure. In developing RVUs for these services, we include the
relative resources associated with moderate sedation in the valuation
since the CPT codes include moderate sedation as an inherent part of
the procedure. Therefore, practitioners only report the procedure code
when furnishing the service. Endoscopic procedures constitute a
significant portion of the services identified in Appendix G. In the CY
2015 PFS proposed rule (79 FR 40349), we noted that it appeared that
practice patterns for endoscopic procedures were changing, with
anesthesia increasingly being separately reported for these procedures,
meaning that the relative resources associated with sedation were no
longer incurred by the practitioner reporting the Appendix G procedure.
We indicated that, in order to reflect apparent changes in medical
practice, we were considering establishing a uniform approach to the
appropriate valuation of all Appendix G services for which moderate
sedation is no longer inherent, rather than addressing the issue at the
procedure level as individual codes are revalued. We solicited public
comment on approaches to the appropriate valuation of these services.
In the CY 2016 PFS proposed rule (80 FR 41707), we again solicited
public comment and recommendations on approaches to address the
appropriate valuation of moderate sedation related to Appendix G
services. Following our comment solicitation, the CPT Editorial Panel
created CPT codes for separately reporting moderate sedation services
in association with the elimination of Appendix G from the CPT manual
for CY 2017. This coding change would provide for payment for moderate
sedation services only in cases where they are furnished. In addition
to providing recommended values for the new codes used to separately
report moderate sedation, the RUC provided a methodology for revaluing
all services previously identified in Appendix G, without moderate
sedation, in order to make appropriate corresponding adjustments for
the procedural services. The RUC recommended this methodology to
address moderate sedation valuation generally instead of recommending
that it be addressed as individual codes are reviewed. The RUC's
recommended methodology would remove work RVUs for moderate sedation
from Appendix G codes based on a code-level assessment of whether the
procedures are typically furnished to straightforward patients or more
difficult patients. Based on its recommended methodology, the RUC
recommended removal of fewer RVUs from each of the procedural services
than it recommended for valuing the moderate sedation services. If we
were to use the RUC-recommended values for both the moderate sedation
codes and the Appendix G procedural codes without refinement, overall
payments for these procedures, when moderate sedation is furnished,
would increase relative to the current payment.
We direct readers to section II.L. of this final rule, which
includes more detail regarding our valuation of the new moderate
sedation codes, our methodology for revaluation of the procedural codes
previously identified in Appendix G, and discussion and responses to
the public comments we received regarding our proposal. We believe that
the RVUs assigned under the PFS should reflect the overall relative
resources of PFS services, regardless of how many codes are used to
report the services. Therefore, our methodology for valuation of
Appendix G procedural services maintains current resource assumptions
for the procedures when furnished with moderate sedation and
redistributes the RVUs associated with moderate sedation (previously
[[Page 80209]]
included in the Appendix G procedural codes) to other PFS services. We
believe that this methodology for revaluation of Appendix G services
without moderate sedation is consistent with our general principle that
the overall relative resources for the procedures do not change based
solely on changes in coding.
We also noted in the CY 2017 PFS proposed rule that stakeholders
presented information to CMS regarding specialty group survey data for
physician work. The stakeholders shared survey results for physician
work involved in furnishing moderate sedation that demonstrated a
significant bimodal distribution between procedural services furnished
by gastroenterologists (GI) and procedural services furnished by other
specialties. Since we believe that gastroenterologists furnish the
highest volume of services previously identified in Appendix G, and
services primarily furnished by gastroenterologists prompted the
concerns that led to our identification of changes in medical practice
and potentially duplicative payment for these codes, we have addressed
the variations between GI and other specialties in our review of the
new moderate sedation CPT codes and their recommended values. We again
direct readers to section II.L. of this final rule where we discuss our
establishment of an endoscopy-specific moderate sedation G-code that
augments the new CPT codes for moderate sedation, the public comments
we received, and our finalized valuations reflecting the differences in
the physician survey data between GI and other specialties.
6. Collecting Data on Resources Used in Furnishing Global Services
a. Background
(1) Current Payment Policy for Global Packages
Under the PFS, certain services, such as surgery, are valued and
paid for as part of global packages that include the procedure and the
services typically furnished in the periods immediately before and
after the procedure. For each of these global packages, we establish a
single PFS payment that includes payment for particular services that
we assume to be typically furnished during the established global
period. There are three primary categories of global packages that are
labeled based on the number of post-operative days included in the
global period: 0-day; 10-day; and 90-day. The 0-day global packages
include the surgical procedure and the pre-operative and post-operative
services furnished by the physician on the day of the service. The 10-
day global packages include these services and, in addition, visits
related to the procedure during the 10 days following the day of the
procedure. The 90-day global packages include the same services as the
0-day global codes plus the pre-operative services furnished one day
prior to the procedure and post-operative services during the 90 days
immediately following the day of the procedure. Section 40.1 of Chapter
12 of the Claims Processing Manual (Pub. 100-04) defines the global
surgical package to include the following services related to the
surgery when furnished during the global period by the same physician
or another practitioner in the same group practice:
Pre-operative Visits: Pre-operative visits after the
decision is made to operate beginning with the day before the day of
surgery for major procedures and the day of surgery for minor
procedures;
Intra-operative Services: Intra-operative services that
are normally a usual and necessary part of a surgical procedure;
Complications Following Surgery: All additional medical or
surgical services required of the surgeon during the post-operative
period of the surgery because of complications that do not require
additional trips to the operating room;
Post-operative Visits: Follow-up visits during the post-
operative period of the surgery that are related to recovery from the
surgery;
Post-surgical Pain Management: By the surgeon; and
Miscellaneous Services: Items such as dressing changes;
local incisional care; removal of operative pack; removal of cutaneous
sutures and staples, lines, wires, tubes, drains, casts, and splints;
insertion, irrigation and removal of urinary catheters, routine
peripheral intravenous lines, nasogastric and rectal tubes; and changes
and removal of tracheostomy tubes.
In the CY 2015 PFS proposed and final rules we extensively
discussed the problems with accurate valuation of 10- and 90-day global
packages. Our concerns included the fact that we do not use actual data
on services furnished to update the rates, questions regarding the
accuracy of our current assumptions about typical services, whether we
will be able to adjust values on a regular basis to reflect changes in
the practice of medicine and health care delivery, and how our global
payment policies affect what services are actually furnished (79 FR
67582 through 67585). In finalizing a policy to transform all 10- and
90-day global codes to 0-day global codes in CY 2017 and CY 2018,
respectively, to improve the accuracy of valuation and payment for the
various components of global packages, including pre- and post-
operative visits and the procedure itself, we stated that we were
adopting this policy because it is critical that PFS payment rates be
based upon RVUs that reflect the relative resources involved in
furnishing the services. We also stated our belief that transforming
all 10- and 90-day global codes to 0-day global packages would:
Increase the accuracy of PFS payment by setting payment
rates for individual services that more closely reflect the typical
resources used in furnishing the procedures;
Avoid potentially duplicative or unwarranted payments when
a beneficiary receives post-operative care from a different
practitioner during the global period;
Eliminate disparities between the payment for E/M services
in global periods and those furnished individually;
Maintain the same-day packaging of pre- and post-operative
physicians' services in the 0-day global packages; and
Facilitate the availability of more accurate data for new
payment models and quality research.
(2) Data Collection & Revaluation of Global Packages Required by MACRA
Section 523(a) of the Medicare Access and CHIP Reauthorization Act
of 2015 (MACRA) (Pub. L. 114-10, enacted April 16, 2015) added section
1848(c)(8)(A) of the Act, which prohibits the Secretary from
implementing the policy, described above, that would have transformed
all 10-day and 90-day global surgery packages to 0-day global packages.
Section 1848(c)(8)(B) of the Act, which was also added by section
523(a) of the MACRA, requires us to collect data to value surgical
services. Section 1848(c)(8)(B)(i) of the Act requires us to develop,
through rulemaking, a process to gather information needed to value
surgical services from a representative sample of physicians, and
requires that the data collection begin no later than January 1, 2017.
The collected information must include the number and level of medical
visits furnished during the global period and other items and services
related to the surgery and furnished during the global period, as
appropriate. This information must be reported on claims at the end of
the global period or in another manner specified by the Secretary.
Section 1848(c)(8)(B)(ii) of the Act requires that,
[[Page 80210]]
every 4 years, we reassess the value of this collected information; and
allows us to discontinue the collection of this information if the
Secretary determines that we have adequate information from other
sources to accurately value global surgical services. Section
1848(c)(8)(B)(iii) of the Act specifies that the Inspector General
shall audit a sample of the collected information to verify its
accuracy. Section 1848(c)(9) of the Act (added by section 523(b) of the
MACRA) authorizes the Secretary, through rulemaking, to delay up to 5
percent of the PFS payment for services for which a physician is
required to report information under section 1848(c)(8)(B)(i) of the
Act until the required information is reported.
Section 1848(c)(8)(C) of the Act, which was also added by section
523(a) of the MACRA, requires that, beginning in CY 2019, we must use
the information collected as appropriate, along with other available
data, to improve the accuracy of valuation of surgical services under
the PFS.
(3) Public Input
As noted above, section 1848(c)(8)(C) of the Act mandates that we
use the collected data to improve the accuracy of valuation of surgery
services beginning in 2019. We described in the CY 2015 PFS final rule
(79 FR 67582 through 67591) the limitations and difficulties involved
in the appropriate valuation of the global packages, especially when
the resources and the related values assigned to the component services
are not defined. To gain input from stakeholders on implementation of
this data collection, we sought comment on various aspects of this task
in the CY 2016 proposed rule (80 FR 41707 through 41708). We solicited
comments from the public regarding the kinds of auditable, objective
data (including the number and type of visits and other services
furnished during the post-operative period by the practitioner
furnishing the procedure) needed to increase the accuracy of the
valuation and payment for 10- and 90-day global packages. We also
solicited comment on the most efficient means of acquiring these data
as accurately and efficiently as possible. For example, we sought
information on the extent to which individual practitioners or
practices may currently maintain their own data on services furnished
during the post-operative period, and how we might collect and
objectively analyze those data and use the results for increasing the
accuracy of the values beginning in CY 2019.
We received many comments in response to the comment solicitation
in the CY 2016 proposed rule regarding potential methods of valuing the
individual components of the global surgical package. A large number of
comments expressed strong support for our proposal to hold an open door
forum or town hall meetings with the public. In response, we held a
national listening session on January 20, 2016. Prior to the listening
session, the topics for which guidance was being sought were sent
electronically to those who registered for the session and made
available on our Web site. The topics were:
Capturing the types of services typically furnished during
the global period.
Determining the representative sample for the claims-based
data collection.
Determining whether we should collect data on all surgical
services or, if not, which services should be sampled.
Potential for designing data collection elements to
interface with existing infrastructure used to track follow-up visits
within the global period.
Consideration of using the 5 percent withhold until
required information is furnished to encourage reporting.
The 658 participants in the national listening session provided
valuable information on this task. A written transcript and an audio
recording of this session are available at https://www.cms.gov/Outreach-and-Education/Outreach/NPC/National-Provider-Calls-and-Events-Items/2016-01-20-MACRA.html.
b. Data Collection Required To Accurately Value Global Packages
Resource-based valuation of individual physicians' services is a
critical foundation for Medicare payment to physicians. It is essential
that the RVUs under the PFS be based as closely and accurately as
possible on the actual resources used in furnishing specific services
to make appropriate payment and preserve relativity among services. For
global surgical packages, this requires using objective data on all of
the resources used to furnish the services that are included in the
package. Not having such data for some components may significantly
skew relativity and create unwarranted payment disparities within the
PFS.
The current valuations for many services valued as global packages
are based upon the total package as a unit rather than by determining
the resources used in furnishing the procedure and each additional
service/visit and summing the results. As a result, we do not have the
same level of information about the components of global packages as we
do for other services. To value global packages accurately and relative
to other procedures, we need accurate information about the resources--
work, PEs and malpractice--used in furnishing the procedure, similar to
what is used to determine RVUs for all services. In addition we need
the same information on the post-operative services furnished in the
global period (and pre-operative services the day before for 90-day
global packages). Public comments about our CY 2015 proposal to value
all global services as 0-day global services and pay separately for
additional post-operative services when furnished indicated that there
were no reliable data available on the value of the underlying
procedure that did not also incorporate the value of the post-operative
services, reinforcing our view that more data are needed across the
board.
While we believe that most of the services furnished in the global
period are visits for follow-up care, we do not have accurate
information on the number and level of visits typically furnished
because those billing for global services are not required to submit
claims for post-operative visits. A May 2012 Office of Inspector
General (OIG) report, titled Cardiovascular Global Surgery Fees Often
Did Not Reflect the Number of Evaluation and Management Services
Provided (http://oig.hhs.gov/oas/reports/region5/50900054.pdf) found
that for 202 of the 300 sampled cardiovascular global surgeries, the
Medicare payment rates were based on a number of visits that did not
reflect the actual number of services provided. Specifically,
physicians provided fewer services than the visits included in the
payment calculation for 132 global surgery services and provided more
services than were included in the payment calculations for 70
services. Similar results were found in OIG reports titled
``Musculoskeletal Global Surgery Fees Often Did Not Reflect The Number
Of Evaluation And Management Services Provided'' (http://oig.hhs.gov/oas/reports/region5/50900053.asp) and ``Review of Cataract Global
Surgeries and Related Evaluation and Management Services, Wisconsin
Physicians Service Insurance Corporation Calendar Year 2003, March
2007.'' (http://oig.hhs.gov/oas/reports/region5/50600040.pdf).
Claims data plays a major role in PFS ratesetting. Specifically,
Medicare claims data are a primary driver in the allocation of indirect
PE RVUs and MP RVUs across the codes used by
[[Page 80211]]
particular specialties, and in making overall budget neutrality and
relativity adjustments. In most cases, a claim must be filed for all
visits. Such claims provide information such as the place of service,
the type and, if relevant, the level of the service, the date of the
service, and the specialty of the practitioner furnishing the services.
Because we have not required claims reporting of visits included in
global surgical packages, we do not have any of this information for
the services bundled in the package.
In addition to the lack of information about the number and level
of visits actually furnished, the current global valuations rely on
crosswalks to E/M visits, based upon the assumption that the resources,
including work, used in furnishing pre- and post-operative visits are
similar to those used in furnishing E/M visits. We are unaware of any
studies or surveys that verify this assertion. Although we generally
value the visits included in global packages using the same direct PE
inputs as are used for E/M visits, for services for which the RUC
recommendations include specific PE inputs in addition to those
typically included for E/M visits, we generally use the additional
inputs in the global package valuation. In contrast, when a visit
included in a global package would use fewer resources than a
comparable E/M service, the RUC generally does not include
recommendations to decrease the PE inputs of the visit included in the
global package, and we have not generally made comparable reductions.
Another inconsistency with our current global package valuation
approach is that even though we effectively assume that the E/M codes
are appropriate for valuing pre- and post-operative services, the
indirect PE inputs used for calculating payments for global services
are based upon the specialty mix furnishing the global service, not the
specialty mix of the physicians furnishing the E/M services, resulting
in a different valuation for the E/M services contained in global
packages than for separately billable E/M services. There is a critical
need to obtain complete information if we are to value global packages
accurately and in a way that preserves relativity across the fee
schedule.
In response to the requirement of section 1848(c)(8)(B)(i) of the
Act that we develop, through rulemaking, a process to gather
information needed to value surgical services, we proposed a rigorous
data collection effort to provide us the data needed to accurately
value the 4,200 codes with a 10- or 90-day global period. Using our
authority under sections 1848(c)(2)(M) and (c)(8)(B)(i) of the Act, we
proposed to gather the data needed to determine how to best structure
global packages with post-operative care that is typically delivered
days, weeks or months after the procedure and whether there are some
procedures for which accurate valuation for packaged post-operative
care is not possible. Finally, we indicated that these data would
provide useful information to assess the resources used in furnishing
pre- and post-operative care in global periods. To accurately do so, we
need to know the volume and costs of the resources typically used.
We proposed a three-pronged approach to collect timely and accurate
data on the frequency of and the level of pre- and post-operative
visits and the resources involved in furnishing the pre-operative
visits, post-operative visits, and other services for which payment is
included in the global surgical payment. By analyzing these data, we
would not only have the most comprehensive information available on the
resources used in furnishing these services, but also would be able to
determine the appropriate packages for such services. Specifically, the
proposal included:
A requirement for claims-based reporting about the number
and level of pre- and post-operative visits furnished for 10- and 90-
day global services.
A survey of a representative sample of practitioners about
the activities involved in and the resources used in providing a number
of pre- and post-operative visits during a specified, recent period of
time, such as two weeks.
A more in-depth study, including direct observation of the
pre- and post-operative care delivered in a small number of sites, and
a separate survey module for practitioners practicing in ACOs.
The information collected and analyzed through the activities would
be the first comprehensive look at the volume and level of services in
a global period, and the activities and inputs involved in furnishing
global services. The data from these activities would ultimately inform
our revaluation of global surgical packages as required by statute.
To expand awareness of the proposal for data collection, we held a
national listening session in which CMS reviewed the proposal for
participants. Subsequent to this national listening session, we held a
town hall meeting at the CMS headquarters in which participants, in
person and virtual, shared their views on the proposal with CMS. The
transcript from these town halls is available on the CMS Web site with
the CY 2017 final rule downloads.
(1) Statutory Authority for Data Collection
As described in this section of the final rule, section
1848(c)(8)(B)(i) of the Act requires us to develop, through rulemaking,
a process to gather information needed to value surgical services from
a representative sample of physicians. The statute requires that the
collected information include the number and level of medical visits
furnished during the global period and other items and services related
to the surgery and furnished during the global period, as appropriate.
In addition, section 1848(c)(2)(M) of the Act, which was added to
the Act by section 220 of the PAMA, authorizes the Secretary to collect
or obtain information on resources directly or indirectly related to
furnishing services for which payment is made under the PFS. Such
information may be collected or obtained from any eligible professional
or any other source. Information may be collected or obtained from
surveys of physicians, other suppliers, providers of services,
manufacturers, and vendors. That section also authorizes the Secretary
to collect information through any other mechanism determined
appropriate. When using information gathered under this authority, the
statute requires the Secretary to disclose the information source and
discuss the use of such information in the determination of relative
values through notice and comment rulemaking.
As described in this section of the final rule, to gain information
to assist CMS in determining the appropriate packages for global
services and to revalue those services, CMS needs more information on
the resources used in furnishing such services. Through the claims-
based data collection and the study we are finalizing in this final
rule, we would have better information about the actual number of
services furnished to Medicare beneficiaries to use in valuation for
these codes than has been typically available, such as from RUC surveys
that reflect practitioner's estimates of the number of services
typically furnished. We anticipate that such efforts would inform how
to more regularly collect data on the resources used in furnishing
physicians' services. To the extent that such mechanisms prove
valuable, they may be used to collect data for valuing other services.
To achieve this significant data collection, we proposed to collect
data under the authority of both section 1848(c)(8)(B) and (c)(2)(M) of
the Act.
[[Page 80212]]
(2) Claims-Based Data Collection
We proposed a claims-based data collection that would have required
all those providing 10- or 90-day global services to report on services
furnished during the global period using a series of G-codes specially
created for this purpose, beginning January 1, 2017.
In response to the comments submitted on the proposal, we are
finalizing a claims-based data collection that differs from this
proposal in the following significant ways:
CPT code 99024 will be used for reporting post-operative
services rather than the proposed set of G-codes. Reporting will not be
required for pre-operative visits included in the global package or for
services not related to patient visit.
Reporting will be required only for services related to
codes reported annually by more than 100 practitioners and that are
reported more than 10,000 times or have allowed charges in excess of
$10 million annually.
Practitioners are encouraged to begin reporting post-
operative visits for procedures furnished on or after January 1, 2017,
but the mandatory requirement to report will be effective for services
related to global procedures furnished on or after July 1, 2017.
Only practitioners who practice in groups with 10 or more
practitioners in Florida, Kentucky, Louisiana, Nevada, New Jersey,
North Dakota, Ohio, Oregon, and Rhode Island will be required to
report. Practitioners who only practice in smaller practices or in
other geographic areas are encouraged to report data, if feasible.
Given that the data collection will be limited to only some states,
a subset of global services, and only to those who practice in larger
practices the information collected through claims for global packages
services will not parallel the claims data that are available in
pricing other PFS services. However, we believe that the information
collected through this data collection will be a significant
improvement over the information currently available to value these
services and will be supplemented with information obtained through
other mechanisms.
In the following sections, we discuss the comments on each element
of our data collection proposal, our responses and our final decision.
(a) Information To Be Reported
A key element of claims-based reporting is using codes that
appropriately reflect the services furnished. In response to the
comment solicitation in the CY 2016 PFS proposed rule and the input
received via the January 2016 listening session, we received numerous
recommendations for the information to be reported on claims. The most
frequently recommended approach was for practitioners to report the
existing CPT code for follow-up visits included in the surgical package
(CPT 99024--Postoperative follow-up visit, normally included in the
surgical package, to indicate that an E/M service was performed during
a postoperative period for a reason(s) related to the original
procedure). Others suggested using this code for outpatient visits and
using length of stay data to estimate the number of inpatient visits
during the global period. In response to our concerns that CPT code
99024 would provide only the number of visits and not the level of
visits as required by the statute, one commenter suggested using
modifiers in conjunction with CPT code 99024 to indicate the level of
the visit furnished. Others recommended using existing CPT codes for E/
M visits to report post-operative care. One commenter suggested that
CMS analyze data from a sample of large systems and practices that are
using electronic health records that require entry of some CPT code for
every visit to capture the number of post-operative visits. After
noting that the documentation requirements and PEs required for post-
operative visits differ from those of E/M visits outside the global
period, one commenter encouraged us to develop a separate series of
codes to capture the work of the post-operative services and to
measure, not just estimate, the number and complexity of visits during
the global period.
Other commenters opposed the use of a new set of codes or the use
of modifiers to report post-operative visits. Commenters also noted
several issues for us to consider in developing data collection
mechanisms, including that many post-operative services do not have CPT
codes to bill separately, that surgeons perform a wide range of
collaborative care services, and that patient factors, including
disease severity and comorbidities, influence what post-operative care
is furnished.
To assist us in determining appropriate coding for claims-based
reporting, we added a task to the RAND validation contract for
developing a model to validate the RVUs in the PFS, which was awarded
in response to a requirement in the Affordable Care Act. Comments that
we received on the validation report suggested the models did not
adequately address global surgery services due to the lack of available
data on visits included in the global package. Therefore, we modified
the validation contract to include the development of G-codes that
could be used to collect data about post-surgical follow-up visits on
Medicare claims for valuing global services under MACRA so that this
time could be included in the model for validating RVUs.
To inform its work on developing coding for claims-based reporting,
the contractor conducted interviews with surgeons and other physicians/
non-physician practitioners (NPP) who provide post-operative care. A
technical expert panel (TEP), convened by the contractor, reviewed the
findings of the interviews and provided input on how to best capture
care provided in the post-operative period on claims.
In summarizing the input from the interviews and the TEP, the
contractor indicated that several considerations were important in
developing a claims-based method for capturing post-operative services.
First, a simple system to facilitate reporting was needed. Since it was
reported that a majority of post-operative visits are straightforward,
the contractor found that a key for any proposed system is identifying
the smaller number of complex post-operative visits. Another
consideration was not using the existing CPT E/M structure to capture
postoperative care because of concerns that E/M codes are inadequately
designed to capture the full scope of post-operative care and that
using such codes might create confusion. Another consideration was that
the TEP was most enthusiastic about a set of codes that used site of
care, time, and complexity to report visits. The contractor also
believed it was important to distinguish--particularly in the inpatient
setting--between circumstances where a surgeon is providing primary
versus secondary management of a patient. Finally, a mechanism for
reporting the postoperative care occurs outside of in-person visits and
by clinical staff was needed. The report noted that in the inpatient
setting in particular, surgeons spend considerable time reviewing test
results and coordinating care with other practitioners.
After reviewing various approaches, a set of time-based, post-
operative visit codes that could be used for reporting care provided
during the post-operative period was recommended.
The recommended codes distinguish services by the setting of care
and whether they are furnished by a physician/NPP or by clinical staff.
All codes are intended to be reported in 10-minute increments. A copy
of the report
[[Page 80213]]
is available on the CMS Web site under downloads for the CY 2017 PFS
proposed rule with comment period at http://www.cms.gov/physicianfeesched/downloads/.
We proposed the following no-pay codes be used for reporting on
claims the services actually furnished but not paid separately because
they are part of global packages.
Table 9--Proposed Global Service Codes
------------------------------------------------------------------------
------------------------------------------------------------------------
Inpatient...................... GXXX1 Inpatient visit,
typical, per 10
minutes, included in
surgical package.
GXXX2 Inpatient visit,
complex, per 10
minutes, included in
surgical package.
GXXX3 Inpatient visit,
critical illness, per
10 minutes, included in
surgical package.
Office or Other Outpatient..... GXXX4 Office or other
outpatient visit,
clinical staff, per 10
minutes, included in
surgical package.
GXXX5 Office or other
outpatient visit,
typical, per 10
minutes, included in
surgical package.
GXXX6 Office or other
outpatient visit,
complex, per 10
minutes, included in
surgical package.
Via Phone or Internet.......... GXXX7 Patient interactions via
electronic means by
physician/NPP, per 10
minutes, included in
surgical package.
GXXX8 Patient interactions via
electronic means by
clinical staff, per 10
minutes, included in
surgical package.
------------------------------------------------------------------------
(i) Coding for Inpatient Global Service Visits
Our proposal included three codes for reporting inpatient pre- and
post-operative visits that distinguish the intensity involved in
furnishing the services. Under this proposal, visits that involve any
combination or number of the services listed in Table 10, which were
recommended by the contractor as those in a typical visit, would be
reported using GXXX1. Based on the findings from the interviews and the
TEP, the report indicated that the vast majority of inpatient post-
operative visits would be expected to be reported using GXXX1.
Table 10--Activities Included in Typical Visit (GXXX1 & GXXX5)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Review vitals, laboratory or pathology results, imaging, progress notes.
Take interim patient history and evaluate post-operative progress.
Assess bowel function.
Conduct patient examination with a specific focus on incisions and
wounds, post-surgical pain, complications, fluid and diet intake.
Manage medications (for example, wean pain medications).
Remove stitches, sutures, and staples.
Change dressings.
Counsel patient and family in person or via phone.
Write progress notes, post-operative orders, prescriptions, and
discharge summary.
Contact/coordinate care with referring physician or other clinical
staff.
Complete forms or other paperwork.
------------------------------------------------------------------------
Under our proposal, inpatient pre- and post-operative visits that
are more complex than typical visits but do not qualify as critical
illness visits would be coded using GXXX2 (Inpatient visit, complex,
per 10 minutes, included in surgical package). To report this code, the
practitioner would be required to furnish services beyond those
included in a typical visit and have documentation that indicates what
services were provided that exceeded those included in a typical visit.
In the proposed rule, we noted some circumstances that might merit the
use of the complex visit code are secondary management of a critically
ill patient where another provider such as an intensivist is providing
the primary management, primary management of a particularly complex
patient such as a patient with numerous comorbidities or high
likelihood of significant decline or death, management of a significant
complication, or complex procedures outside of the operating room (For
example, significant debridement at the bedside).
The highest level of inpatient pre- and post-operative visits,
critical illness visits (GXXX3--Inpatient visit, critical illness, per
10 minutes, included in surgical package) would be reported when the
physician is providing primary management of the patient at a level of
care that would be reported using critical care codes if it occurred
outside of the global period. This involves acute impairment of one or
more vital organ systems such that there is a high probability of
imminent or life threatening deterioration in the patient's condition.
Similar to how time is now counted for the existing CPT critical
care codes, we proposed that all time spent engaged in work directly
related to the individual patient's care would count toward the time
reported with the inpatient visit codes; this includes time spent at
the immediate bedside or elsewhere on the floor or unit, such as time
spent with the patient and family members, reviewing test results or
imaging studies, discussing care with other staff, and documenting
care.
(ii) Coding for Office and Other Outpatient Global Services Visits
For the three codes in our proposal that would be used for
reporting post-operative visits in the office or other outpatient
settings, codes, time would be defined as the face-to-face time with
patient, which reflects the current rules for time-based outpatient
codes.
Like GXXX1, GXXX5 (Office or other outpatient visit, typical, per
10 minutes, included in surgical package) would be used for reporting
any combination of activities in Table 10 under our proposal.
We proposed only face-to-face time spent by the practitioner with
the patient and their family members would count toward the time
reported with the office visit codes.
(iii) Coding for Services Furnished via Electronic Means
Services that are furnished via phone, the internet, or other
electronic means outside the context of a face-to-face visit would be
reported using GXXX7 when furnished by a practitioner and GXXX8 when
provided by clinical staff under our proposal. We proposed that
practitioners would not report these services if they are furnished the
day before, the day of, or the day after a visit as we believe these
would be included in the pre- and post-service activities in the
typical visit. However, we proposed that these codes be used to report
non-face-to-face services provided by clinical staff prior to the
primary procedure since global surgery codes are typically valued with
assumptions regarding pre-service clinical labor time. Given that some
practitioners have indicated that services they furnish commonly
include activities outside the face-to-face service, we believed it was
important to capture information about those activities in both the
pre- and post-service periods. We also believed these requirements to
report on clinical
[[Page 80214]]
labor time are consistent with and no more burdensome than those used
to report clinical labor time associated with chronic care management
services, which similarly describe care that takes place over more than
one patient encounter.
In addition, we proposed for services furnished via interactive
telecommunications that meet the requirements of a Medicare telehealth
service visit, the appropriate global service G-code for the services
would be reported with the GT modifier to indicate that the service was
furnished ``via interactive audio and video telecommunications
systems.''
(iv) Rationale for Use of G-Codes
After considering the contractor report, the comments in response
to the comment solicitation in the CY 2016 proposed rule and other
stakeholder input that we have received, and our needs for data to
fulfill our statutory mandate and to value surgical services
appropriately, we proposed this new set of codes because we believe it
provides us the most robust data upon which to determine the most
appropriate way and amounts to pay for PFS surgical services. We noted
that these proposed codes would provide data of the kind that can
reasonably collected through claims data and that reflect what we
believe are key issues in the valuation of post-operative care--where
the service is provided, who furnishes the service, its relative
complexity, and the time involved in the service.
We solicited public comments about all aspects of these codes,
including the nature of the services described, the time increment, and
any other areas of interest to stakeholders. We noted particular
interest in any pre- or post-operative services furnished that could
not be appropriately captured by these codes. We solicited comments on
whether the proposed codes were appropriate for collecting data on pre-
operative services. We also sought comment on any activities that
should be added to the list of activities in Table 10 to reflect
typical pre-operative visit activities.
(v) Alternative Approach to Coding
In making the proposal for G-codes, we noted that many stakeholders
had expressed strong support for the use of CPT code 99024
(Postoperative follow-up visit, normally included in the surgical
package, to indicate that an evaluation and management service was
performed during a post-operative period for a reason(s) related to the
original procedure) to collect data on post-operative care. In response
to stakeholders noting that practitioners are familiar with this
existing CPT code and the burden on practitioners would be minimized by
only having to report that a visit occurred, not the level of the
visit, we noted that we did not believe that this code alone would
provide the information that we need for valuing surgical services nor
do we believe it alone can meet the statutory requirement that we
collect data on the number and level of visits. Given the strong
support for the use of CPT code 99024, we solicited comments
specifically on how we could use this code to capture the statutorily
required data on the number and level of visits and the data that we
would need to value global services in the future.
We also discussed in the proposed rule our concern that using CPT
code 99024 with modifiers to indicate to which of the existing levels
of E/M codes the visit corresponds may not accurately capture what
drives greater complexity in post-operative visits. We noted that as
outlined in the contractor's report, E/M billing requirements are built
upon complexity in elements such as medical history, review of systems,
family history, social history, and how many organ systems are
examined. In the context of a post-operative visit, many of these
elements may be irrelevant. The contractor's report also notes that
there was significant concern from interviewees and the expert panel
about documentation that is required for reporting E/M codes.
Specifically, they stated that documentation requirements for surgeons
to support the relevant E/M visit code would place undue administrative
burden on surgeons given that many surgeons currently use minimal
documentation when they provide a postoperative visit. We also noted
that to value surgical packages accurately we need to understand the
activities involved in furnishing post-operative care and as discussed
above, we lack information that would demonstrate that activities
involved in post-operative care are similar to those in E/M services.
In addition, the use of modifiers to report levels of services is more
difficult to operationalize than using unique HCPCS codes. However, we
sought comments on whether, and if so, why, practitioners would find it
easier to report CPT code 99024 with modifiers corresponding to the
proposed G-code levels rather than the new G-codes, as proposed. We
also sought comment on whether practitioners would find it difficult to
use this for pre-operative visits since the CPT code descriptor
specifically defines it as a ``post-operative follow-up'' service.
We also sought comment on whether time of visits could alone be a
proxy for the level of visit. If pre- and post-operative care varies
only by the time the practitioner spends on care so that time could be
a proxy for complexity of the service, then we could use the reporting
of CPT code 99024 in 10-minute increments to meet the statutory
requirement of collecting claims-based data on the number and level of
visits. In addition to comments on whether time is an accurate proxy
for level of visit, we solicited comment on the feasibility and
desirability of reporting CPT code 99024 in 10-minute increments.
The following is a summary of the comments that we received on our
proposal to use G-codes for reporting the services furnished during the
pre- and post-operative periods of 10- and 90-day global services.
Comment: Many commenters offered critiques of the G-codes. Most
objected to reporting using the proposed G-codes. Some commenters
raised concerns with the code definitions. These included: Lack of
alignment with clinical workflow, failure to adequately account for
variation in complexity and medical decision-making, and use of the
term ``typical'' to define visits in a different way than the term is
generally used in PFS valuations. One commenter suggested that CMS
should require care plans for outpatient visits in the post-operative
period. It was also suggested that the complex visit code could be
improved by using a term other than ``complex'' in the definition. A
commenter questioned whether that vast majority of cases would be
complex instead of ``typical,'' since the definition of ``complex''
included management of a patient with multiple comorbidities and most
Medicare beneficiaries have multiple comorbidities. A commenter also
suggested that CMS refine the G-codes to distinguish physician visits
from NPP visits. In addition, several commenters objected to the
proposed G-codes for on-line and telephone services because they
believed it would be nearly impossible to track these data and
extremely burdensome to do so. Commenters indicated that the G-codes
were not well-defined overall and should not be used without testing to
determine their validity.
Response: We appreciate the detailed comments on the design of the
G-codes and the concerns regarding their limitations in appropriately
reflecting the services furnished in 10- and 90-day global periods.
These comments provide information for how the G-codes could
[[Page 80215]]
be modified to better reflect services furnished in global periods,
however, as is discussed at the outset of this section, we are not
using the proposed G-codes for this data collection effort.
Comment: Most commenters objected to using codes based on time
increments and the proposed 10-minute increments, specifically. Some
stated that reporting of services by time did not reflect the way
surgeons practiced and would divert practitioners from patient care.
One commenter stated that it was not feasible for practitioners to
collect time data for every task that they or their clinical staff
performed. Another stated that requesting physicians and/or their staff
to use a stop-watch to, in effect, conduct time and motion studies for
all their non-operating room patient care activities is an incredible
burden. Another stated that reporting time in 10-minute increments ``is
untenable,'' noting that, except for a few specialties, physicians do
not think of providing care in terms of timed increments. The commenter
added that surgeons, in particular, are not accustomed to reporting
time for all pre- and post-operative visits and to do so would be a
huge disruption to workflow. In addition to objections about the burden
of reporting time data, some commenters objected to the use of time
data as a factor in valuations.
Three organizations commented that it was appropriate to collect
time data, but recommended that we do so based upon 15-minute
increments as these were more familiar to physicians than the proposed
10-minue increments. In addition, some other groups, including MedPAC,
agreed that data on time was needed for valuations.
Response: Time is a key factor in valuing physician services under
the physician fee schedule. Section 1848(c)(1) of the Act defines the
work component as the portion of the resources used in furnishing the
service that reflects physician time and intensity in furnishing the
service. We also note that time-based codes are used by practitioners
for a range of services in the PFS including psychotherapy,
anesthesiology and critical care services. Critical care services are
notable because these services are likely to be furnished
intermittently as many commenters suggested is typical for post-
operative follow-up services. Since issues have not been raised about
the difficulty of using the current critical care codes, it is unclear
why reporting of time would be burdensome and disruptive of care in
this area. We have no reason to believe the documentation of time is
more difficult or burdensome for those furnishing 10- and 90-day global
services than for other practitioners. However, based on the comments,
it is clear that many practitioners would perceive reporting of time
involved in furnishing these services to be a significant increase in
burden relative to existing practice. Before implementing a change
considered by so many to be so burdensome, we are exploring other ways
of obtaining information that can be used to improve the accuracy of
valuing these services. Accordingly, we are not finalizing, at this
time, the requirement to use time-based codes.
Comment: Many commenters stated that the use of these codes would
be costly, requiring extensive education of practitioners and staff and
necessitating updates to EHR systems and billing software. Some also
noted the cost of processing additional claims. Many commenters noted
that this would be particularly difficult as this additional
administrative burden would come at the same time practitioners are
adjusting the Merit-based Incentive Payment System (MIPS). One
commenter provided the results of a survey of surgical practitioners in
20 specialties in which 30 percent of respondents stated that the cost
of integrating the new G-codes into their practice would cost more than
$100,000 and only about 10 percent stated that it would cost less than
$25,000.
Some commenters expressed specific concern about the documentation
burden that would come from using these codes. On the other hand, other
commenters suggested that providers of visits during the global
surgical services should be held to the same documentation standards as
providers of E/M services. One stated that the ``administrative burden
on surgeons should be no different and certainly no less than that on
non-surgeons when it comes to documenting a visit with a patient. If
many surgeons currently use minimal documentation when they provide a
post-operative visit that is no excuse for expecting the same
inadequate level of documentation going forward. To require anything
less than the same level of documentation for all clinicians providing
E/M services would be irresponsible and unfair and would defeat the
very purpose of documenting the actual types and extent of these
services in the post-operative period.''
Response: The need for accurate, complete and useful data must be
balanced with administrative burden and cost. We articulated that using
a select number of G-codes based on time would impose a burden on
providers, but that burden is necessary for us to comply with the
statutory requirement to gather the data necessary to value global
procedures. We note that CPT routinely incorporates more than 100 new
codes in annual updates, and for this reason we did not anticipate that
the inclusion of eight new G-codes was likely to present significant
challenges to EHR systems or other infrastructure. Based on the
comments we received, however, it is clear that the majority of
stakeholders believe the burden is much greater than we had assumed. In
general, we agree with commenters that comparable documentation is
appropriate for all physicians furnishing and being paid by Medicare
for similar services.
Comment: Several commenters noted that the difficulties of using
these codes would affect the accuracy of the data reported. One
commenter stated that the G-code proposal would be impossible to
implement and ``at the very least'' would yield incomplete and
unreliable results.
Response: We agree with commenters that implementation burden is an
important consideration in determining how practitioners should report
on care provided in the post-operative period and that if practitioners
find the reporting requirements to be excessive and require great
expenditures to incorporate into their practice, the accuracy of the
data could be undermined. We considered this in determining the final
policy described below.
Comment: Some commenters criticized the proposed G-codes because
they were not directly linked to E/M codes or comparable to existing E/
M codes. On the other hand, some commenters preferred the codes
describing such visits not be linked or comparable to E/M codes to
avoid confusion or unintentional, inappropriate payments. One commenter
stated that the follow-up work performed within the global periods and
the continuity work performed by cognitive physicians should not be
represented by the same codes. Another commenter stated that the care
required by a patient recovering from a procedure is fundamentally
different from the typical follow-up of an established outpatient or
inpatient, especially when there are multiple simultaneous interacting
conditions, a single metastable chronic illness, or one or more acute
exacerbated chronic illnesses that requires inpatient care and
expertise.
Response: Commenters' belief that the work in follow-up visits
included in the global package is not necessarily well described by the
work of current E/M
[[Page 80216]]
codes is worth exploring. Current data does not allow us to determine
the validity of these commenters' assertion but given its importance,
we believe it is critical to gather data on whether follow-up visits
provided in the post-operative period are different than other E/M
services. To the extent the services in the post-operative period are
different from other E/M services, it would not make sense to use E/M
codes in valuing global services as is ostensibly the case under the
current process the RUC uses in developing recommended values for PFS
services.
Comment: Most commenters supported using CPT codes, rather than the
proposed G-codes. A few pointed to the existing E/M codes, but most
recommended that any claims-based reporting use CPT code 99024, an
existing CPT code that describes post-operative services in a global
period. Commenters noted that since this is a current CPT code the
administrative burden would be much less than that associated with
using the proposed new G-codes. These commenters suggest that
practitioners are likely already familiar with the code, some already
use it to track services within their practice, and some others already
report it to other payers. Also, they suggest that because EHR and
billing systems already include CPT code 99024, it will be less costly
to implement than the proposal. Some also preferred using CPT code
99024 because unlike the proposed G-codes it does not require the
reporting of time units.
Most commenters disagreed that time could be a proxy for the
complexity of the visit and objected to reporting time for the same
reasons discussed above. These commenters did not agree that CPT code
99024 could be reported in time units as a proxy for collecting the
required information about the level of visits.
Three organizations disagreed, however, stating that time is a
sufficient proxy for work relativity in post-operative visits and that
the number units of CPT code 99024 could reflect the complexity
involved. These commenters recommended reporting data in 15-minute
intervals, rather than the proposed 10-minute increments, stating that
physicians are familiar with 15-minute increments and thus the use of
15-minute increments would greatly reduce the administrative burden.
They recommended that CMS clearly define how time is to be reported and
suggested that the 8-minute rule is already a familiar concept that
could be used.
Many commenters suggested that other approaches, such as a survey,
clinical registries, or on-line portals be used to collect data on
level of visits.
Several commenters stated that CMS should not collect data on the
level of visits based on these commenters' perspective that there is no
problem with the level of visits currently used in the valuation of
global packages. One commenter pointed out that only 1 percent of all
established patient office visits used in valuing 10-day and 90-day
global surgery packages have a visit level above a CPT code 99213.
Another commenter suggested that the survey be used to collect data on
the level of visits. Others suggested that RUC surveys be used to
measure level of visits.
Response: We understand that stakeholders believe that using CPT
code 99024 rather than the proposed G-codes will significantly lower
administrative burden and lower costs related to the collection of this
data. We do not have data showing that the level of visits used in
valuation of global packages are correct or incorrect; to the best of
our knowledge, this has never been assessed outside of the RUC process.
While the current valuations for global packages rely primarily on CPT
codes 99212 and 99213 for the visit component, we do not agree that
this means that the levels are accurate. Further, as some commenters
have made clear, there is not consensus among stakeholders that the
post-operative visits are equivalent to other E/M visits. Additionally,
the relationship between the number and level of visits assumed to be
in the global period and the overall work RVUs for the global codes is
often unclear. For all of these reasons, we disagree with commenters
that we do not need to collect data on the level of services.
In addition to the statutory reference to collecting data on the
level of visits, we believe that code valuations can be more accurate
with more complete information. While we continue to believe that data
only on the number of visits furnished would not provide data on both
the number and level of visits needed for valuation of services, data
on the number of visits alone is an important input in valuing global
packages and having accurate data on the number of visits could be a
useful first step in analyzing the global packages.
After considering the comments, we are finalizing a requirement to
report post-operative visits furnished during 10- and 90-day global
periods. However, rather than using the proposed set of G-codes for
this reporting, we are requiring that CPT code 99024 be used to report
such visits. We will not, at this time, require time units or modifiers
to distinguish levels of visits to be reported. Since this code is
specifically limited to post-operative care, we are only requiring
reporting of post-operative visits. We expect that the reporting of
this information through Medicare claims will provide us with
information about the actual number of visits furnished during the
post-operative periods for many services reported using global codes.
Because the number of visits is a major factor in valuation of global
services, we believe that examination of such information, when
available, can improve the accuracy of the global codes. The use of a
simple code that practitioners are familiar with should facilitate the
submission of accurate information. We expect practitioners to note the
visit in the medical chart documenting the post-operative visit.
Since CPT code 99024 will only provide data on the number of visits
and no data on the level or resources used in furnishing the visit, we
believe this is only the first step in gathering the data required by
Section 1848(c)(8). The proposed G-codes could have provided
information to better understand the resources used in furnishing
services during global periods and in valuation of such services
assuming that they could be accurately reported. However, widespread
concerns from groups representing the practitioners that would be
reporting these services, including concerns about the burdens
regarding and the inability of physicians to track time and the need to
learn a new 8-code coding system, persuade us that we should pursue
less burdensome ways of obtaining information. We will assess whether
these methods will lead to the collection of necessary data, including
data on time and intensity, of these services.
As suggested by commenters, we will explore whether the data
collected from the survey that we are conducting, which is discussed
later in this preamble, can provide information on the level of visits
and other resources needed to value surgical services accurately.
Stakeholders should be aware that since this a new approach for
collecting data, and one that has not been used previously, we are
concerned that additional or different reporting will be necessary to
collect data on the number and level of visits and other information
needed to value surgical services as required by Section 1848(c)(8).
[[Page 80217]]
b. Reporting of Claims
We proposed that the G-codes detailed above would be reported for
services related to and within 10- and 90-day global periods for
procedures furnished on or after January 1, 2017. Services related to
the procedure furnished following recovery and otherwise within the
relevant global period would be required to be reported. These codes
would be included on claims filed through the usual process. Through
this mechanism, we would collect all of the information reported on a
claim for services, including information about the practitioner,
service furnished, date of service, and the units of service. By not
imposing special reporting requirements on these codes, we proposed to
allow practitioners the flexibility to report the services on a rolling
basis as they are furnished or to report all of the services on one
claim once all have been furnished, as long as the filed claims meet
the requirements for filing claims.
We did not propose any special requirements for inclusion of
additional data on claims that could be used for linking the post-
operative care furnished to a particular service. To use the data
reported on post-operative visits for analysis and valuation, we
proposed to link the data reported on post-operative care to the
related procedure using date of service, practitioner, beneficiary, and
diagnosis. While we believed this approach to matching would allow us
to accurately link the preponderance of G-codes to the related
procedure, we sought comment on the extent to which post-operative care
may not be appropriately linked to related procedures whether we should
consider using additional variables to link these aspects of the care,
and whether additional data should be required to be reported to enable
a higher percentage of matching.
The following is summary of the comments we received on our
proposal to require reporting on pre- and post-operative care
associated with all procedures with 10- and 90-day global periods.
Comment: Many commenters objected to the proposal to require
reporting on post-operative services for all 10- or 90-day global
services. Some suggested that many of the global services are low
volume and have little impact on Medicare spending. It was also noted
that it would be difficult to obtain a meaningful sample of low-volume
services. Others discussed the burden of reporting on all services. The
RUC recommended that CMS only require reporting on services that are
furnished by more than 100 providers and that either are furnished more
than 10,000 times or have allowed charges of more than $10 million
annually to obtain meaningful data for valuation. The RUC noted that
many procedures were infrequently furnished and thus useful data would
not be obtained. This position was supported by a significant number of
commenters. In response to the stated concern about having complete
data when more than one surgical service is furnished during the global
period, a commenter pointed out that a review of the 2014 Medicare 5
percent sample file shows that, two surgical global codes are performed
on the same date of service, by the same physician, only 18 percent of
the time.
Response: The commenters are correct that the vast majority of 10-
and 90-day procedures are furnished infrequently and thus have little
effect on Medicare expenditures or direct impact on the valuations of
other services under the PFS. We proposed to collect data on all
procedures since we believed the data we collected would be more
accurate if physicians reported on all services as it would be routine
and would not have required physicians to determine at each pre- and
post-operative visit whether or not reporting the service was required.
Moreover, as pointed out by commenters, we believe that reporting on
all applicable services would have provided more complete data when
multiple surgeries occurred during the global period.
Having specific data on all procedures would provide specific
information for each service that Medicare pays for using a global
period. In assessing the likely benefit of the additional data as
compared to the burden of reporting based on the comments we received,
we agree with commenters that collecting the data from high volume/high
cost procedures could provide adequate information to improve the
accuracy of valuation of global packages overall. Even if all
practitioners reported data on all procedures, it is likely that we
would not receive enough data on low-volume services for the data to be
reliable for use in valuations. There are more than 1,500 services that
are furnished less than 100 times per year. Because of this, data that
we could collect on these services would be extremely limited. We also
find that data on services with low volumes are not reliable due to
variability from year to year. Since we often value related services by
extrapolating data on one service to other services in the family, with
adjustments as necessary to reflect variations in the procedure, the
data gathered on high-volume services could similarly be used to value
low-volume services in the same family. As a result we, believe that
the data on high-volume services can improve the accuracy of values for
all 10- and 90-day services.
After consideration of the comments, we are implementing a
requirement for reporting on services that are furnished by more than
100 practitioners and are either furnished more than 10,000 times or
have allowed charges of more than $10 million annually as recommended
by the RUC and many other commenters. Under this policy, we estimate
that we would collect data on about 260 codes that describe
approximately 87 percent of all furnished 10- and 90-day global
services and about 77 percent of all Medicare expenditures for 10- and
90-day global services under the PFS. Given that this data would
provide information on the codes describing the vast majority of 10-
and 90-day global services and expenditures, it will provide
significant data for valuation. For 2017, we will use the CY 2014
claims data to determine the codes for which reporting is required and
display the list on the CMS Web site. In subsequent years, we will
update the list to reflect more recent claims data and publish a list
of codes prior to the beginning of the reporting year. The services for
which reporting is required will include successor codes to those
deleted or modified since CY 2014 for which reporting would have been
required if the code had not been deleted or modified.
The following is summary of the comments we received on our
proposal to require claims-based reporting for services related to
procedures furnished on or after January 1, 2017.
Comments: Many commenters expressed concerns regarding the
difficulty of making the changes required to implement this new
reporting by January 1, 2017. Some commenters noted that this change
was coming at the same time as the new MIPS program. Some commenters
stated that the statute required a process to be in place by January 1,
2017, but that CMS has flexibility regarding when to begin the required
reporting. Some commenters suggested that CMS consider conducting the
proposed survey before implementing any claims-based reporting.
Response: We proposed to begin required reporting on January 1,
2017, based upon the statutory language regarding both the collection
and use of the data for revaluation of services. We understand that
some practices will need to make modifications to their EHR and billing
systems to report this data to
[[Page 80218]]
us. We also acknowledge that an opportunity for testing the systems and
training will enhance the quality of data that we receive.
After consideration of comments, we are encouraging practitioners
to begin reporting data on post-operative services for procedures
furnished on or after January 1, 2017. However, the requirement to
report will become mandatory for post-operative services related to
procedures furnished on or after July 1, 2017 rather than as of January
1, 2017, as proposed. This delay will not negatively impact the use
value of the collected data since we expect that data received early in
the year might be less complete than data submitted once practitioners
adjusted to the requirements. Also, by allowing time for practitioners
to adjust EHR and billing software, to test such systems and to train
staff, we think the quality of the data will be enhanced by providing
flexibility with regard to the effective date of the requirement.
Finally, because we are limiting required reporting to high-volume
codes, meaningful data for CY 2017 should be available from 6 months of
reporting. Our systems can now accept the post-operative visit data so
practitioners can begin submitting such claims at any time.
c. Special Provisions for Teaching Physicians
We sought comment on whether special provisions are needed to
capture the pre- and post-operative services provided by residents in
teaching settings. If the surgeon is present for the key portion of the
visit, should the surgeon report the joint time spent by the resident
and surgeon with the patient? If the surgeon is not present for the key
portion of the visit, should the resident report the service? If we
value services without accounting for services provided by residents
that would otherwise be furnished by the surgeon in non-teaching
settings, subsequent valuations based upon the data we collect may
underestimate the resources used, particularly for the types of
surgeries typically furnished in teaching facilities. However, there is
also a risk of overvaluing services if the reporting includes services
that are provided by residents when those services would otherwise be
furnished by a physician other than the surgeon, such as a hospitalist
or intensivist, and as such, should not be valued in the global
package.
Comment: We received only a few comments on this issue. Some
commenters suggested using the CMS policies that apply to other
services that teaching surgeons report to CMS for the reporting of CPT
code 99024. More specifically, when the appropriate conditions are met
they would use the GC or GE modifier to identify those services in
which surgical residents are involved. One of these suggested that once
we have the data we discuss with stakeholders how to use the data
involving residents in future valuations. Others suggested that we
capture data on resident's time as it could be important for valuation,
especially for the more complex cases in a teaching facility setting.
Some urged that we provide clear guidance on when the resident's time
could be reported. One commenter stated that teaching physicians should
be exempt from reporting requirements.
Response: These comments reinforce the importance of collecting
data from teaching physicians and to do so using the existing Medicare
rules that teaching physicians use in reporting services in which
residents are involved in furnishing. Because we are finalizing data
collection using CPT code 99024, the issues regarding the reporting of
time data are no longer relevant.
After consideration of the comments, we are finalizing a
requirement that teaching physicians will be subject to the reporting
requirements in the same way that other physicians are. Such physicians
should report CPT code 99024 only when the services furnished would
meet the general requirements for reporting services and should use the
GC or GE modifier as appropriate.
e. Who Reports
In both the comments on the CY 2016 proposed rule and in input from
the January 2016 national listening session, there was a great deal of
discussion regarding the challenges that we are likely to encounter in
obtaining adequate data to support appropriate valuation. Some
indicated that a broad sample and significant cooperation from
physicians would be necessary to understand what is happening as part
of the global surgical package. One commenter suggested that
determining a representative sample would be difficult and, due to the
variability related to the patient characteristics, it would be easier
to have all practitioners report. Many suggested that we conduct an
extensive analysis across surgical specialties with a sample that is
representative of the entire physician community and covers the broad
spectrum of the various types of physician practice to avoid problems
that biased or inadequate data collection would cause. Suggestions of
factors to account for in selecting a sample include specialty,
practice size (including solo practices), practice setting, volume of
claims, urban, rural, type of surgery, and type of health care delivery
systems. Another commenter pointed out that small sample sizes may lead
to unreliable data. Some commenters stated that requiring all
practitioners to report this information is unreasonable and would be
an insurmountable burden. A participant acknowledged that it would be
difficult for practitioners to report on only certain procedures, while
another stated that this would not be an administrative burden.
After considering the input of stakeholders on the CY 2016 proposed
rule and at the January 2016 national listening session discussed
above, we proposed that any practitioner who furnishes a procedure that
is a 10- or 90-day global service report the pre- and post-operative
services furnished on a claim using the proposed G-codes. We agreed
with stakeholders that it would be necessary to obtain data from a
broad, representative sample. However, as we struggled to develop a
nationally representative sampling approach that would result in
statistically reliable and valid data, it became apparent that we do
not have adequate information about how post-operative care is
delivered, how it varies and, more specifically, what drives variation
in post-operative care to develop a sampling frame. In its work to
develop the coding used for its study, the contractor found a range of
opinions on what drives variation in post-operative care. (The report
is available on the CMS Web site under downloads for the CY 2017 PFS
proposed rule with comment period at http://www.cms.gov/physicianfeesched/downloads/.) Without information on what drives
variation in pre- and post-operative care, we would have to speculate
about the factors upon which to base a sample or assume that the
variation in such care results from the same variables as are
frequently identified for explaining variation in health care and
clinical practice. In addition, we expressed concern about whether a
sample could provide sufficient volume to value accurately the global
package, except in the case of a few high-volume procedures.
In addition to concerns about achieving a statistically
representative sample of all practitioners nationally, we noted in the
proposed rule significant operational concerns with limiting data
collection to a subset of practitioners or a subset of services. These
include how to gain sufficient information on practitioners to stratify
the sample, how to identify the
[[Page 80219]]
practitioners who must report, and for those who practice in multiple
settings or with multiple groups in which settings the practitioner
would report. We concluded that establishing the rules to govern which
post-operative care should be reported based on our proposed G-codes
would be challenging for us to develop and difficult for physicians to
apply in the limited time between the issuance of the CY 2017 PFS final
rule with comment period and the beginning of reporting on January 1,
2017. We do not believe that the same problems apply to the same extent
to our final policy to use a single code that already exists to report
services described only by codes reported in high volumes. For example,
implementation of new sets of codes associated with annual PFS updates
are often supported by informational and educational efforts undertaken
by national organizations, like the national medical specialty
societies. Given that many practitioners are already familiar with CPT
code 99024 (as noted by many commenters), the need for such efforts is
significantly mitigated.
We also noted in the proposed rule that the more robust the
reported data, the more accurate our ultimate valuations can be. We
stated that given the importance of data on visits in accurate
valuations for global packages, collecting data on all pre- and post-
operative visits in the global period is the best way to accurately
value surgical procedures with global packages.
We recognized that reporting would require submission of additional
claims by those practitioners furnishing global services, but indicated
that we believed the benefits of accurate data for valuation of
services merited the imposition of this requirement. By using the
claims system to report the data, we believed the additional burden
would be minimized and referred to stakeholder reports that many
practitioners are already required by their practice or health care
system to report a code for each visit for internal control purposes
and some of these systems already submit claims for these services,
which are denied. We noted that requiring only some physicians to
report this information, or requiring reporting for only some codes,
could actually be more burdensome to physicians than requiring this
information from all physicians on all services because of the
additional steps necessary to determine whether a report is required
for a particular service and adopting a mechanism to assure that data
is collected and reported when required. Moreover, we stated that the
challenges with implementing a limited approach at the practice level
as compared to a requirement for all global services would result in
less reliable data being reported.
We noted that as we analyzed the data collected and made decisions
about valuations, we would reassess the data needed and what should be
required from whom. Through the data collected under our proposal, we
indicated that we would have the information to assess whether the
post-operative care furnished varies by factors such as specialty,
geography, practice setting, and practice size, and thus, the
information needed for a sample selection to be representative.
While section 1848(c)(8)(B) of the Act requires us to collect data
from a representative sample of physicians on the number and level of
visits provided during the global period, we stated that it does not
prohibit us from collecting data from a broad set of practitioners. In
addition, section 1848(c)(2)(M) of the Act authorizes the collection of
data from a wide range of physicians. Given the benefits of more robust
data, including avoiding sample bias, obtaining more accurate data, and
facilitating operational simplicity, we noted that we believed
collecting data on all post-operative care initially is the best way to
undertake an accurate valuation of surgical services in the future.
The following is a summary of the comments that we received on our
proposal to require all practitioners furnishing 10- or 90-day global
services to submit claims for the pre- and post-operative services
furnished.
Comment: Commenters overwhelmingly opposed requiring all
practitioners to submit claims for postoperative services. Several
reasons were cited for the opposition. The most significant reason was
the administrative burden and costs to physicians. Many commenters also
stated that requiring all practitioners who furnish 10- or 90-day
global services to report data is counter to the statute because the
statute refers to collection of data from a representative sample of
physicians.
One commenter stated that requiring every practitioner to report
these codes will be in many ways less representative than a targeted
sample, explaining that given the limited time for education, only
large, technologically rich practices will have the ability to properly
report these services. The commenter noted that this will leave many,
smaller or rural practices without the proper education and robust
billing systems in place to adequately, if at all, report these G-
codes. The commenter also noted that smaller, rural practices have
smaller patient populations, which can often be older and sicker than
the typical patient seen in a large practice and by creating a complex
system that favors one type of practice, the collected data is more
likely to be biased rather than representative. Another commenter
suggested that a small number of representative practices could provide
us with the same level of accuracy as collected data from all
physicians.
Response: In response to commenters' opposition to our proposal to
require all providers of covered services to report data, we
acknowledge that the stakeholders describe a much larger burden from
using the G-codes than we anticipated. On the other hand, we also
believe that our final policy will result in a much lower burden than
the proposed policy would have. As noted above, we are not finalizing
the proposed requirements to use the G-codes or the proposed
requirement to report on all 10- and 90-day global procedures and thus,
we believe that the overall administrative burden is significantly
reduced.
We do not agree with commenters that state that we do not have the
statutory authority to require reporting by all practitioners
furnishing certain services. We point commenters to section
1848(c)(2)(M) of the Act, which authorizes the collection of data to
use in valuing PFS services. We continue to believe that section
1848(c)(8) of the Act requires us to collect data that is
representative. We also continue to believe that requiring all
practitioners to report is more likely to be representative than a
sample given our lack of information about what drives variation in
post-operative care. However, after considering the information
presented by commenters regarding the difficulties that would be placed
on many physicians by the proposal, we believe that requiring reporting
by all practitioners for CY 2017 may present unforeseen, alternative
impediments to the sample being nationally representative of all
practitioners, such as practitioners being unable to report data
accurately due to constraints of time, finances or technical ability.
Comment: We did not receive any comments on the appropriate sample
size. Nor did we receive data on variations in the delivery of post-
operative care in response to our concern that we lacked data on how
post-operative care was delivered to select a representative sample.
Many commenters stated that it was possible to select a representative
sample, but none provided details on how to do so.
[[Page 80220]]
Several commenters suggested broadly sampling using the
characteristics that are frequently used for health care sampling
generally, such as geographic areas, urban and rural, practice types,
practice sizes, specialties and academic and non-academic. One
commenter recommended that we select a sample using geographical data
to identify a sample including practices of all sizes. The commenter
suggested, for example, that large hospital-based practices often have
practice patterns that are different from the majority of the
practicing physicians in suburban and rural areas. Another commenter
stated that we should not only collect data from MSAs but also from
rural and less urban areas.
One commenter suggested that we consider phasing in the
requirement, perhaps starting with larger groups. The commenter stated
that through one of these approaches we could avoid ``burdening
providers with unfunded work that has not yet been tested.''
One commenter suggested that we use a geographic sampling approach
similar to that one used for Comprehensive Care for Joint Replacement
(CJR) model or the episode payment models proposed for cardiac and
surgical hip/femur fraction and modify it to choose a geographic
sampling unit of MSAs and non-MSAs.
Response: We agree with commenters that we could select a sample
using an approach typically used in health care surveys or in Medicare
models and other programs. To the extent that the delivery of post-
operative care varies only based upon the criteria we selected, a
sample based on being representative for that criteria would be likely
to produce valid data.
However, instead of sampling by practice or practitioner or type of
service, a geographic approach to sampling (for example, sampling all
practitioners in a selected state) could help to alleviate the need to
stratify the sample on a long list of criteria. By using broad
geographical areas from varied areas of the country, we believe our
sample will capture data from practitioners who practice in a variety
of settings, single and multispecialty practices, urban and rural, a
variety of medical specialties, and practitioners operating in both
academic and non-academic institutions. Surgeons interviewed for the G-
code development suggested that post-operative care might vary across
these dimensions. A geographic approach could also mitigate some of the
practical operational barriers. For example, we believe that by having
all practitioners in the practice participate in reporting, we avoid
concerns about incomplete data when a required reporter furnishes a
procedure and another practitioner in the practice furnishes the post-
operative visits. A geographic approach also makes it easier to educate
practitioners on data collection requirements.
Comment: In response to operational difficulties with a
representative sample, such as how to make sure participants were aware
of the requirement to report and how to do so, one commenter stated
that notifying a small targeted sample is a much smaller task than
notifying the entire population of participating Medicare
practitioners. They also stated that a targeted approach will encourage
open dialogue between the participating practices and CMS, ensuring the
data collected are reliable. Others suggested providing compensation
for a sample of physicians to submit detailed data, would lead to
capturing accurate data because they would more likely to understand
and prioritize reporting because of their participation in this type of
study.
Response: We disagree that it is operationally easier to notify a
small segment of broadly diverse practitioners than the entire
population of practitioners unless that small segment has a degree of
cohesiveness, such as being in the same geographic area or specialty.
We have long appreciated the stakeholder community's collaboration in
broad communication efforts. In general, we have found that when
something affects a small number of providers it does not receive the
same response from entities that are critical for widespread adoption
such as associations, who are key purveyors of information, and those
developing software systems. We appreciate the suggestion that
interaction among those that need to report will facilitate compliance
and the quality of the data. With regard to compensation, we note that
the statute provided for a 5 percent withhold to encourage compliance
and we chose not to propose to implement this provision.
After consideration of the comments, we are finalizing a
requirement for reporting that only applies to practitioners in
selected states. In addition, those practicing only in small practices
are excluded from required reporting. Those not required to report can
do so voluntarily and we encourage them to do so.
Geographic Sample
As we noted in the proposed rule, we do not have adequate data on
what drives variations in the delivery of pre- and post-operative care
to design a sampling methodology that is certain to be representative.
We also believe that submission by all practitioners would be
consistent with our extensive use of claims data for other PFS
services. Additionally, we understand the statute directs us to gather
data from more than a select group of practitioners based on any
particular attributes, such as gathering data only from ``efficient''
practices, consistent with longstanding recommendations from MedPAC
regarding limiting data collection. We also believed that there were
significant operational impairments to data reporting by a limited
sample of physicians. In consideration of these factors, we proposed to
require reporting by all physicians to make sure that the data we
obtained reflected all services furnished. In light of the comments
regarding the burden that would be created by requiring reporting by
all physicians and the data that was actually needed for valuation, we
think that reporting by a subset of practitioners could provide us
valuable information on the number of visits typically furnished in
global periods. This data could enhance the information we currently
use to establish values for these services. While we acknowledge that
we believe the data under this less burdensome approach will provide
less information than necessary for optimal valuation for these
services, we believe that the information on the number of actual
visits from a subset of practitioners is preferable to the information
on which we currently rely, which is the results of survey data
reflecting respondents' assessment of the number of visits considered
to be typical.
One commenter suggested that we could develop a geographic sample
using a similar approach used by the Center for Medicare and Medicaid
Innovation for the Comprehensive Care for Joint Replacement (CJR) or
other proposed episode payment models, with an adjustment that would
make certain we received data from rural, as well as urban areas. We
reviewed these approaches and concluded that such an approach for
sample selection could maximize the variability of the sample, mitigate
some of our concerns, and provide a robust set of data for
consideration.
Commenters suggested a sample should include geographic diversity.
Studies show that health care delivery patterns often vary between
geographic areas and while we have no specific information that the
number of post-operative visits varies by geographic areas, it seems
prudent to gather data from a variety of geographic areas to determine
if there is such variation and
[[Page 80221]]
to account for it in our data collection if it exists. In order to
maximize the variability of our limited sample, we are using a
methodology that requires reporting from practices in 9 states of
various sizes and from various geographic areas of the country. We are
using whole states for the geographic areas rather than MSAs as are
used for the CJR and proposed for other models for several reasons.
First, MSAs are not used for geographic adjustments under the PFS.
Indeed, practitioners in most states receive state-wide geographic
adjustments under the PFS. Additionally, an MSA-based approach would,
by definition, not include large rural areas, something mentioned by
many commenters as an important factor in variation in medical
practice, and therefore, a critical criterion for sampling. Also, due
to a variety of governmental and institutional requirements, the
practice of medicine is primarily a state-based activity and thus the
use of states will reduce the number of practitioners for whom we have
only partial data based on geographic location. In contrast, we believe
that practitioners often practice across county lines or in more than
one MSA. We also believe that the state-wide approach will be helpful
for compliance and education because there are state medical
associations in every state and specialty associations in many.
To make sure that we had states of a variety of sizes, we ranked
states according to the number of Medicare beneficiaries in each state.
We chose the number of Medicare beneficiaries to reflect the general
need for Medicare services. We divided states into four groups: The top
5 states in terms of the number of Medicare beneficiaries (group 1);
6th through 15th largest states in terms Medicare beneficiaries (group
2); the 16th through 25th largest states in terms of Medicare
beneficiaries (group 3); and all remaining states (26 including the
District of Columbia, group 4). The states in each group are:
Group 1--California, Florida, New York, Pennsylvania &
Texas.
Group 2--Georgia, Illinois, Massachusetts, Michigan, New
Jersey, North Carolina, Ohio, Tennessee, Virginia, and Washington.
Group 3--Alabama, Arizona, Indiana, Kentucky, Louisiana,
Maryland, Minnesota, Missouri, Wisconsin, and South Carolina.
Group 4--Alaska, Arkansas, Colorado, Connecticut, District
of Columbia, Delaware, Hawaii, Idaho, Iowa, Kansas, Maine, Mississippi,
Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Dakota,
Oklahoma, Oregon, Rhode Island, South Dakota, Utah, Vermont, West
Virginia and Wyoming.
We also recorded the Census region for each state using the Census
Bureau's nine regions (New England, Middle Atlantic, South Atlantic,
East South Central, West South Central, East North Central, West North
Central, Mountain, and Pacific). Puerto Rico and other territories were
excluded.
To ensure a mix of states in terms of size (measured by number of
Medicare beneficiaries), we selected 1 state at random from group 1,
followed by 2 states each at random from groups 2 and 3, and lastly 4
states from group four. After each random selection, we eliminated the
remaining states in the same Census region from the remaining groups
for which selection was pending to maximize geographic variation in the
selection of states. In the event that this process resulted in fewer
than 9 selected states (for example if none of the three Middle
Atlantic states--all in Group 1 and 2--were selected in the first three
picks), the last selection(s) were made randomly from states in the
remaining Census region from which selections previously had not been
made.
Practitioners located in the following states who meet the criteria
for required reporting will be required to report the data discussed in
this section of the final rule:
Florida.
Kentucky.
Louisiana.
Nevada.
New Jersey.
North Dakota.
Ohio.
Oregon.
Rhode Island.
Exclusion for Practitioners in Small Practices
In response to comment about the burden of our proposed requirement
and the concern that the burden would result in the submission of data
of poor quality, we are exempting practitioners who only practice in
practices with fewer than 10 practitioners from the reporting. Based
upon the comments, we believe larger practices are more likely to
currently require practitioners to track all visits and often use CPT
code 99024 to do so. Moreover, larger practices are more likely to have
coding and billing staff that can more easily adapt to this claims-
based requirement. The combination of experience with reporting CPT
code 99024 and the staff and resource base to devote to developing the
infrastructure for such reporting will result in greater accuracy from
such practitioners. By excluding practitioners who only practice in
practices with fewer than 10 practitioners, we estimate that about 45
percent of practitioners will not be required to report. In defining
small practices, we reviewed other programs. We chose 10 practitioners
as the threshold for reporting as practices of this size are large
enough to support coding and billing staff, which will make this
reporting less burdensome. Also, this is the same threshold used by the
value-based modifier program for its phase-in of a new requirement
because of concerns about the burden of small practices.
For this purpose, we define practices as a group of practitioners
whose business or financial operations, clinical facilities, records,
or personnel are shared by two or more practitioners. For the purposes
of this reporting requirement, such practices do not necessarily need
to share the same physical address; for example, if practitioners
practice in separate locations but are part of the same delivery system
that shares business or financial operations, clinical facilities,
records, or personnel, all practitioners in the delivery system would
be included when determining if the practice includes at least 10
practitioners. Because qualified non-physician practitioners may also
furnish procedures with global periods, the exception for reporting
post-operative visits applies only to practices with fewer than ten
physicians and qualified non-physician practitioners regardless of
specialty. We are including all practitioners and specialties in the
count because the exception policy uses practice size as a proxy for
the likely ability of the practice to meet the reporting requirements
without undue administrative burden. We recognize that physicians and
qualified non-physician practitioners furnish services under a variety
of practice arrangements. In determining whether a practitioner
qualifies for the exception based on size of the practice, all
physicians and qualified non-physician practitioners that furnish
services as part of the practice should be included. This would include
all practitioners, regardless of whether they are furnishing services
under an employment model, a partnership model, or an independent
contractor model under which they practice as a group and share
facility and other resources but continue to bill Medicare
independently instead of reassigning benefits. We also recognize that
practice size can fluctuate over the year and anticipate that practices
will determine their eligibility for the exception based
[[Page 80222]]
on their expected staffing. Generally, practitioners in short-term
locum tenens arrangements would not be included in the count of
practitioners. When practitioners are also providing services in
multiple settings, the count may be adjusted to reflect the estimated
proportion of time spent in the group practice and other settings.
Although this policy excludes a significant number of
practitioners, a majority of the global procedures furnished will be
included in the reporting requirements and thus we will have data on a
majority of services.
Several commenters also expressed concern that data from small
practices be included to have complete information. If those practicing
in small practices are motivated to report and either have the
infrastructure to do so in place or the resources to develop such
infrastructure, then, taken together, these attributes would minimize
concerns with accuracy of data from small practices. Accordingly, we
are encouraging, but not requiring, small practices to report the
visits. As we collect data, we will explore mechanisms to appropriately
use the voluntarily submitted claims data. Analysis of this and other
data we are able to procure will allow us to assess whether the number
of post-operative visits varies based upon the size of practice. To the
extent that it does and that we do not have adequate data on the
practice patterns in small practices from voluntarily submitted data
and other sources, we will reconsider for future notice and comment
rulemaking the exemption of practitioners in small practices from the
reporting requirements.
The claims data received from practitioners in these states will
provide more information about the number of visits typically provided
in post-operative periods than is available from any other source.
Through analysis of this data, we hope to learn more about what drives
variations in the delivery of post-operative care. Many of the
characteristics that were suggested by commenters, such as size of
practice, type of practice, geographic, urban/rural, academic, hospital
based, specialty, etc., will be able to be evaluated using the claims
data. Moreover, we hope to be able to stratify the data received based
upon comparisons to the national characteristics so that the submitted
claims data can contribute to improved valuation of PFS services.
In summary, our claims-based data collection policy requires that,
for procedures furnished on or after July 1, 2017, practitioners who
practice in practices that includes of 10 or more practitioners in
Florida, Kentucky, Louisiana, Nevada, New Jersey, North Dakota, Ohio,
Oregon, and Rhode Island will be required to report on claims data on
post-operative visits furnished during the global period of a specified
procedure using CPT code 99024. The specified procedures are those that
are furnished by more than 100 practitioners and either are nationally
furnished more than 10,000 times annually or have more than $10 million
in annual allowed charges. The final list of codes subject to required
reporting will be available on the CMS Web site. Although required
reporting begins for global procedures furnished on or after July 1,
2017, we encourage all practitioners to begin reporting for procedures
furnished on or after January 1, 2017, if feasible. Similarly, we
encourage those practicing in practices with fewer than 10
practitioners to report data if they can do so.
(1) Survey of Practitioners
We agreed with commenters on the CY 2016 proposed rule and at the
listening session that we need more information than is currently
provided on claims and that we should utilize a number of different
data sources and collection approaches to collect the data needed to
assess and revalue global surgery services. In addition to the claims-
based reporting, we proposed to survey a large, national sample of
practitioners and their clinical staff in which respondents would
report information about approximately 20 discrete pre-operative and
post-operative visits and other global services like care coordination
and patient training. This sample would be stratified based upon
specialty and geography, as well as by physician volume (procedures
billed) and practice setting. The proposed survey would produce data on
a large sample of pre-operative and post-operative visits and is being
designed so that we could analyze the data collected in conjunction
with the claims-based data that we would be collecting. We expect to
obtain data from approximately 5,000 practitioners.
We noted that, if our proposal was finalized, RAND would develop
and conduct this survey. RAND would also assist us in collecting and
analyzing data for this survey and the claims-based data. While the
primary data collection would be via a survey instrument, semi-
structured interviews would be conducted and direct observations of
post-operative visits would occur in a small number of pilot sites to
inform survey design, validate survey results, and collect information
that is not conducive to survey-based reporting.
Our proposed sampling approach would sample practitioners rather
than specific procedures or visits to streamline survey data collection
and minimize respondent burden. Specifically, we will use a random
sample from a frame of practitioners who billed Medicare for more than
a minimum threshold of surgical procedures with a 10- or 90-day global
period (for example, 200 procedures) in the most recent available prior
year of claims data. The sampling frame would provide responses from
approximately 5,000 practitioners, stratified by specialty, geography,
and practice type. Based upon preliminary analysis, we believe this
number of participants will allow us to collect information on post-
operative care following the full range of CPT level-2 surgical
procedure code groups. For many common types of post-operative visits,
we anticipate a standard deviation of the time distribution at around 9
minutes. To achieve a 95 percent confidence intervals with a width of 2
minutes, we would need 311 reported post-operative visits per
procedure/procedure group. The most comprehensive approach would be to
sample sufficient practitioners to observe 311 post-operative visits
for each HCPCS procedure, but this approach would be cost- and time-
prohibitive. Since post-operative care following similar procedures may
involve similar activities and times even if there are differences in
the number of visits, we proposed to sample differentially by specialty
to maximize our ability to estimate attributes of post-operative care
for the largest range of procedures.
Sample sizes for each specialty will be determined on the basis of
number of procedures billed by the specialty and number of
practitioners billing, assuming a uniform distribution of procedures
across the year, an average of 2 post-operative visits by each patient
and an equal distribution of procedures across practitioners within a
specialty. If the procedure represented only 5 percent of total billed
procedures for the specialty, we could expect only one of 20 visits
sampled and reported by each practitioner would be for the particular
procedure, and thus we would need to sample 311 practitioners within
the specialty to achieve the target precision level on estimated post-
operative visit time.
We propose targeting 311 reporting practitioners from each
specialty which is the only specialty contributing at least 5 percent
of billings for any one
[[Page 80223]]
procedure group code, defined as procedures sharing a CPT level 2
heading. For other specialties, the target will be defined by the
maximum value of 311 divided by the number of specialties contributing
at least 5 percent for any procedure group code for which that
specialty contributes. The target sample size for a specialty will be
capped at 25 percent of the eligible practitioners within the
specialty. For example, if a specialty contributed to two procedure
group codes, one of which had four contributing specialties and the
other had three contributing specialties, the specialty of interest
would have a target of 104 reporting practitioners (which is driven by
the procedure group code that is tied to three specialties). These
guidelines will target at least 311 reporting practitioners for each
procedure group code, and result in a total target sample size of 4,872
providers. A smaller sample size would reduce the precision of
estimates from the survey and more importantly risk missing important
differences in post-operative care for specific specialties or
following different types of surgical procedures. We expect a response
rate in excess of 50 percent. Given this response rate (and some
uncertainty in this response rate estimate), we will need to approach
at least 9,722 practitioners for our target of 4,872 practitioners.
Should the response rate be lower than expected, we will continue to
sample in waves until we reach the target of approximately 4,872
practitioners. Non-response bias will be assessed by comparing
available characteristics of non-respondents (for example, practice
type, geography, procedure volume etc.) to those of respondents.
We did not propose that respondents report on the entire period of
post-operative care for individual patients, as a 90-day follow-up
window (for surgeries currently with a 90-day global period) is too
long to implement practically in this study setting and would be more
burdensome to practitioners. Instead, we proposed to collect
information on a range of different post-operative services resulting
from surgeries furnished by the in-sample practitioner prior to or
during a fixed reporting period.
Practitioners will be asked to describe 20 post-operative visits
furnished to Medicare beneficiaries or other patients during the
reporting period. The information collected through the survey
instrument, which will be developed based upon direct observation and
discussions in a small number of pilot sites, will include contextual
information to describe the background for the post-operative care,
including, for example:
Procedure codes(s) and date of service for procedure upon
which the global period is based.
Procedure place of service.
Whether or not there were complications during or after
the procedure.
The number in sequence of the follow-up visit (for
example, the first visit after the procedure).
The survey instrument will also collect information on the visit in
question including, for example:
Which level of visit using existing billing codes.
Specific face-to-face and non-face-to-face activities
furnished on the day of the visit.
The total time spent on face-to-face and non-face-to-face
activities on the day of the visit.
Direct practice expense items used during the visit, for
example supplies like surgical dressings and clinical staff time.
Finally, the instrument will ask respondents to report other prior
or anticipated care furnished to the patient by the practice outside of
the context of a post-operative visit, for example non-face-to-face
services.
The survey approach will complement the claims data collection by
collecting detailed information on the activities, time, intensity, and
resources involved in delivering global services. The resulting visit-
level survey data would allow us to explore in detail the variation in
activities, time, intensity, and resources associated with global
services within and between physicians and procedures, and would help
to validate the information gathered through claims. A summary of the
work that RAND would be doing is available on the CMS Web site under
downloads for the CY 2017 PFS proposed rule with comment period at
http://www.cms.gov/physicianfeesched/downloads/.
The following is a summary of the comments that we received on our
proposal to conduct a survey of practitioners furnishing 10- and 90-day
global services to obtain information about the face-to-face activities
and other activities included in post-operative care.
Comment: Most commenters were generally supportive of the survey
effort and noted that the provider survey will collect useful
information on the level of visits, as well as important contextual
detail that will not be available from the claims-based reporting. One
commenter stated that a limited approach through surveys of physicians
and practices looking at a targeted selection of services, and using
CPT code 99024 for the claims based component would yield meaningful
and actionable data for the agency and stakeholders.
Response: We agree that the survey portion of the data collection
approach will provide useful information on level and context. The
survey will complement claims-based reporting and will provide us with
important information on non-face-to-face activities and other
activities that are not reported with CPT code 99024.
Comment: One commenter pointed out challenges in survey response
and in estimating time for visits by aggregating practitioner time
estimates for specific activities.
Response: While we have not finalized the design of the survey
instrument, we are aware of challenges in collecting detailed time
estimates for specific activities. We do not intend to sum estimated
times for specific activities to arrive at a total duration for the
visit. We also recognize the challenges related to survey response
rates and are working with our contractor accordingly.
Comment: Several commenters suggested that the survey effort should
not target all 4,200 procedure codes.
Response: The survey component of the data collection effort is not
designed to collect information on visits following all global
procedure codes. Rather, we expect the sample to be stratified by
specialty and to result in a sufficient qualitative data to address key
procedures in each specialty furnishing procedures with global periods.
Comment: Some commenters believed that the purpose of the direct
observation component of the data collection effort was unclear.
Response: The direct observation component will consist of external
observers capturing the activities conducted in a sample of post-
operative visits at a small number of practices. It is designed to
provide additional context to inform future data collection efforts and
to gauge where the practitioner survey does or does not capture the
full range of activities. It is not a data collection activity per se.
After consideration of the comments, we are finalizing our proposal
to conduct a survey of practitioners to gain information on post-
operative activities to supplement our claims-based data collection as
proposed. We expect that the survey will be in the field mid-2017.
(2) Required Participation in Data Collection
Using the authority we are provided under sections 1848(c)(8) and
[[Page 80224]]
1848(c)(2)(M) of the Act, we proposed to require all practitioners who
furnish a 10- or 90-day global service to submit a claim(s) providing
information on all services furnished within the relevant global
service period in the form and manner described in this section of the
final rule, beginning with surgical or procedural services furnished on
or after January 1, 2017. We also proposed to require participation by
practitioners selected for the broad-based survey through which we
proposed to gather additional data needed to value surgical services,
such as the clinical labor and equipment involved that cannot be
efficiently collected on claim (see below).
Given the importance of the proposed survey effort, making sure
that we get valid data is critical. By eliminating the bias that would
be associated with using only data reported voluntarily, we stated that
we expected to get more accurate and representative data. In addition
to the potential bias inherent in voluntary surveys, we expressed
concern that relying on voluntary data reporting would limit the
adequacy of the volume of data we obtain, would require more effort to
recruit participants, and may make it impossible to obtain data for
valuation for CY 2019 as required by the statute.
Based on our previous experience with requesting voluntary
cooperation in data collection activity, voluntary participation poses
a significant challenge in collection and use of data. Specifically,
the Urban Institute's work (under contract with us) to validate work
RVUs by conducting direct observation of the time it took to furnish
certain elements of services paid under the physician fee schedule
provides evidence of this challenge. (See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/RVUs-Validation-Urban-Interim-Report.pdf for an interim report that
describes challenges in securing participation in voluntary data
collection.) Similarly, we routinely request invoices on equipment and
supplies that are used in furnishing PFS services and often receive no
more than one invoice. These experiences support the idea that
mandatory participation in data collection activities is essential if
we are to collect valid and unbiased data.
Section 1848(a)(9) of the Act authorizes us, through rulemaking, to
withhold payment of up to 5 percent of the payment for services on
which the practitioner is required to report under section
1848(c)(8)(B)(i) of the Act until the practitioner has completed the
required reporting. Some commenters opposed the imposition of this
payment consequence for failure to report, and others stated that it
was too large a penalty. While withholding a portion of payment would
encourage practitioners to report the required information, we did not
propose to implement this option for CY 2017. We stated that requiring
physicians to report the information on claims, combined with the
incentive to report complete information so that revaluations of
payment rates for global services are based on accurate data, would
result in compliance with the reporting requirements. However, we noted
that if we find that compliance with required claims-based reporting is
not acceptable, we would consider in future rulemaking imposing up to a
5 percent payment withhold as authorized by the statute.
Consistent with the requirements of section 1848(c)(2)(M) of the
Act, should the data collected under this requirement be used to
determine RVUs, we will disclose the information source and discuss the
use of such information in such determination of relative values
through future notice and comment rulemaking.
The following is a summary of the comments we received on our
proposal to require reporting in the claims-based survey and
participation in the survey.
Comment: Many commenters objected overall to the administrative
burden of our proposal and questioned the need for some of the data we
were proposing to collect, primarily through the claims-based
reporting, and made many recommendations for less burdensome data
collection to achieve our goals. Some objected to any claims-based
reporting at this time. A few recommended a different approach that
involved collecting information from a small number of practices that
agree to participate and that we pay such practices for participation.
However, none recommended that we go forward with data collection on a
totally voluntary basis. Some indicated concern that practitioners
would not provide required information.
Response: We appreciate the many ideas for how to improve our data
collection effort, particularly those that provided information on how
to collect the information that we need while imposing a lower
administrative burden on practitioners.
Comment: A few commenters supported our not proposing to implement
the 5 percent withhold until claims on the post-operative care were
submitted.
Response: We appreciate the support of commenters.
After considering the comments, we are finalizing our proposal to
require participation in the claims-based reporting. It should be
noted, however, due to our modifying the requirement to apply only to
those identified as part of the geographic sample, on selected
procedures, using one code, and exempting those practicing in groups
with fewer than 10 practitioners, as discussed above, the impact of the
requirement is significantly reduced overall, including for the subset
of practitioners who will have to report under the finalized
requirements.
We are not implementing the statutory provision that authorizes a 5
percent withhold of payment for the global services until claims are
filed for the post-operative care, if required. We reiterate that
should we find that compliance with required claims-based reporting
limits confidence in the use of the information for improving the
accuracy of payments for the global codes, we would consider in future
rulemaking imposing up to a 5 percent payment withhold as authorized by
the statute.
(3) Data Collection From Accountable Care Organizations (ACOs)
We are particularly interested in knowing whether physicians and
practices affiliated with ACOs expend greater time and effort in
providing post-operative global services in keeping with their goal of
improving care coordination for their assigned beneficiaries. ACOs are
organizations in which practitioners and hospitals voluntarily come
together to provide high-quality and coordinated care for their
patients. Because such organizations share in the savings realized by
Medicare, their incentive is to minimize post-operative visits while
maintaining high quality post-operative care for patients. In addition,
we believe that such organizations offer us the opportunity to gain
more in-depth information about delivery of surgical services.
We proposed to collect data on the activities and resources
involved in delivering services in and around surgical events in the
ACO context by surveying a small number of ACOs (Pioneer and Next
Generation ACOs). Similar to the approach of the more general
practitioner survey, this effort would begin with an initial phase of
primary data collection using a range of methodologies in a small
number of ACOs; development, piloting, and validation of an additional
survey module specific to ACOs. A survey of practitioners participating
in approximately 4 to 6 ACOs using the
[[Page 80225]]
survey instrument along with the additional ACO-specific module will be
used to collect data from on pre- and post-operative visits.
The following is summary of the comments we received about our
proposal for data ACO data collection.
Comment: Several commenters supported a separate survey of
practitioners participating in ACOs. One commenter agreed with CMS that
this data collection effort may provide a unique and useful perspective
on the matter at hand. Several commenters indicated that there are
likely differences in pre- and post-operative care between
practitioners who do participate in ACOs and those that do not. One
commenter cautioned against extrapolating information gathered from
ACOs to value global surgery services that are provided outside of the
ACO setting because ACOs are structured differently than other practice
settings and data from ACOs may, therefore, be skewed [and] that ACO
participants typically are larger practices and thus would
underrepresent smaller or solo practitioners.
Response: We agree that ACOs may be structured differently than
other practice settings and that these differences may contribute to
variations in the provision of outpatient care. By separately surveying
ACOs we will be able to investigate whether there are differences in
pre- and post-operative care in ACO settings compared to non-ACO
settings.
After consideration of the comments received, we are finalizing our
proposal for data collection in ACOs. We recognize and will continue to
consider the concerns raised by commenters as we implement this
project.
(6) Re-Valuation Based Upon Collected Data
We recognize that the some of the data collection activities being
undertaken vary from how information is currently gathered to support
PFS valuations for global surgery services. However, we believe the
proposed claims-based data collection is generally consistent with how
claims data is reported for other kinds of services paid under the PFS.
We believe that the authority and requirements included in the statute
through the MACRA and PAMA were intended to expand and enhance data
that might be available to enhance the accuracy of PFS payments. In the
proposed rule, we indicated that because these are new approaches to
collecting data and in an area--global surgery--where very little data
has previously been collected, we cannot describe exactly how this
information would be used in valuing services. What is clear is that
the claims-based data would provide information parallel to the kinds
of claims-data used in developing RVUs for other PFS services and that
by collecting these data, we would know far more than we do now about
how post-operative care is delivered and gain insight to support
appropriate packaging and valuation. We would include any revaluation
proposals based on these data in subsequent notice and comment
rulemaking.
Even though we did not make a proposal regarding how future re-
valuations would use the data collected under these proposals, we
received several comments on such revaluations. The following is
summary of the comments we received regarding use of the data we obtain
through this three-pronged data collection activity in future re-
valuations.
Comment: Some commenters stated that the RUC process worked well to
value services and should continue to be used to value these and other
services. Some of these objected to any claims-based data collection
for a variety of reasons including that it was unlikely to provide
valid and reliable data, that the RUC process worked well and should
continue to be used, and the that since other codes would not be valued
on the basis of similar data use of this data would harm the fee
schedule's relativity. Some suggested that we use the data obtained
here to identify misvalued codes and refer them to the RUC for further
evaluation under the usual process. Some commenters suggested that we
not collect any data until we could describe how it would be used.
Response: We believe that the Congress enacted the two data
collection provisions included in the Act to further the accuracy of
PFS rates by having additional data available to the RUC as it makes
recommendations to us and to us to inform our evaluation of those
recommendations. We do not believe this data collection was intended to
replace the RUC or the processes that have been established over the
last two decades for valuing physician services. We agree with
commenters that one way the data might be used is to identify
potentially misvalued codes for the RUC to evaluate. However, we also
stress that we do not agree that the use of claims data to value
services within global surgery packages would be inconsistent with the
valuation of other PFS services. On the contrary, very few other PFS
services include estimated work RVUs based on face-to-face patient
encounters over multiple days or months. Outside of these services,
work RVUs are estimated per patient encounter (or in other cases over
longer periods of time for non-face-to-face work). Therefore, the outer
limit of any misvaluation between the estimated typical and the actual
is the overall value for a single face-to-face service. Under the
global packages, potential misvaluations can range from the difference
between the estimated typical services for a full global period and the
actual services furnished for a full global period for a given patient.
We are not finalizing any provisions regarding valuation of global
surgical services. Instead, such issues will be addressed in future
rulemaking after we collect data and analyze data.
E. Improving Payment Accuracy for Primary Care, Care Management and
Patient-Centered Services
1. Overview
In recent years, we have undertaken ongoing efforts to support
primary care and patient-centered care management within the PFS as
part of HHS' broader efforts to achieve better care, smarter spending
and healthier people through delivery system reform. We have recognized
the need to improve payment accuracy for these services over several
years, especially beginning in the CY 2012 PFS proposed rule (76 FR
42793) and continuing in each subsequent year of rulemaking. In the CY
2012 proposed rule, we acknowledged the limitations of the current code
set that describes evaluation and management (E/M) services within the
PFS. For example, E/M services represent a high proportion of PFS
expenditures, but have not been recently revalued to account for
significant changes in the disease burden of the Medicare patient
population and changes in health care practice that are underway to
meet the current population's health care needs. These trends in the
Medicare population and health care practice have been widely
recognized in the provider community and by health services researchers
and policymakers alike.\1\ We believe the focus of the
[[Page 80226]]
health care system has shifted to delivery system reforms, such as
patient-centered medical homes, clinical practice improvement, and
increased investment in primary and comprehensive care management/
coordination services for chronic and other conditions. This shift
requires more centralized management of patient needs and extensive
care coordination among practitioners and providers, often on a non-
face-to-face basis across an extended period of time. In contrast, the
current CPT code set is designed with an overall orientation to pay for
discrete services and procedural care as opposed to ongoing primary
care, care management and coordination, and cognitive services. It
includes thousands of separately paid, individual codes, most of which
describe highly specialized procedures and diagnostic tests, while
there are relatively few codes that describe care management and
cognitive services. The term ``cognitive services'' refers to the type
of work that is usually classified and described under the current code
set for E/M services, such as the critical thinking involved in data
gathering and analysis, planning, management, decision-making, and
exercising judgment in ambiguous or uncertain situations.\2\ It is
often used to describe PFS services that are not procedural or strictly
diagnostic in nature. Further, in the past, we have not recognized as
separately payable many existing CPT codes that describe care
management and cognitive services, viewing them as bundled and paid as
part of other services including the broadly drawn E/M codes that
describe face-to-face visits billed by physicians and practitioners in
all specialties.
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\1\ See, for example, http://content.healthaffairs.org/content/25/5/w378.full; http://www.commonwealthfund.org/publications/issue-
briefs/2008/feb/how-disease-burden-influences-medication-patterns-
for-medicare-beneficiaries--implications-for-polic; http://www.hhs.gov/ash/about-ash/multiple-chronic-conditions/index.html;
http://www.nejm.org/doi/full/10.1056/NEJMp1600999#t=article; https://www.pcpcc.org/about; https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html.
\2\ http://www.nejm.org/doi/full/10.1056/NEJMp1600999#t=article.
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This has resulted in minimal service variation for ongoing primary
care, care management and coordination, and cognitive services relative
to other PFS services, and in potential misvaluation of E/M services
under the PFS (76 FR 42793). Some stakeholders believe that there is
substantial misvaluation of physician work within the PFS, and that the
current service codes fail to capture the range and intensity of
nonprocedural physician activities (E/M services) and the ``cognitive''
work of certain specialties (http://www.nejm.org/doi/full/10.1056/NEJMp1600999#t=article).
Recognizing the inverse for specialties that furnish other kinds of
services, MedPAC has noted that the PFS allows some specialties to more
easily increase the volume of services they provide, and therefore,
their revenue from Medicare relative to other specialties, particularly
those that spend most of their time providing E/M services. (MedPAC
March 2015 Report to the Congress, available at http://www.medpac.gov/-documents-/reports). We agree with this analysis, and we recognize that
the current set of E/M codes limits Medicare's ability under the PFS to
appropriately recognize the relative resource costs of primary care,
care management/coordination and cognitive services relative to
specialized procedures and diagnostic tests.
In recent years, we have been engaged in an ongoing incremental
effort to update and improve the relative value of primary care, care
management/coordination, and cognitive services within the PFS by
identifying gaps in appropriate payment and coding. These efforts
include changes in payment and coding for a broad range of PFS
services. This effort is particularly vital in the context of the
forthcoming transition to the Quality Payment Program that includes the
Merit-Based Incentive Payment System (MIPS) and Alternative Payment
Models (APMs) incentives under the Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted April 16,
2015), since MIPS and many APMs will adopt and build on PFS coding,
RVUs and PFS payment as their foundation.
In CY 2013, we began by focusing on post-discharge care management
and transition of beneficiaries back into the community, establishing
new codes to pay separately for transitional care management (TCM)
services. Next we finalized new coding and separate payment beginning
in CY 2015 for chronic care management (CCM) services provided by
clinical staff. In the CY 2016 PFS proposed rule (80 FR 41708 through
41711), we solicited public comments on three additional policy areas
of consideration: (1) Improving payment for the professional work of
care management services through coding that would more accurately
describe and value the work of primary care and other cognitive
specialties for complex patients (for example, monthly timed services
including care coordination, patient/caregiver education, medication
management, assessment and integration of data, care planning); (2)
establishing separate payment for collaborative care, particularly, how
we might better value and pay for robust inter-professional
consultation between primary care physicians and psychiatrists
(developing codes to describe and provide payment for the evidence-
based psychiatric collaborative care model (CoCM)), and between primary
care physicians and other (non-mental health) specialists; and (3)
assessing whether current PFS payment for CCM services is adequate and
whether we should reduce the administrative burden associated with
furnishing and billing these services.
We received substantial feedback on this comment solicitation,
which we summarized in the CY 2017 PFS proposed rule and used to
develop the following coding and payment proposals for CY 2017 (81 FR
46200 through 46215, and 46263 through 46265):
Separate payment for existing codes describing prolonged
E/M services without direct patient contact by the physician (or other
billing practitioner), and increased payment for prolonged E/M services
with direct patient contact by the physician (or other billing
practitioner) adopting the RUC-recommended values.\3\
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\3\ ``Without direct patient contact'' and ``with direct patient
contact'' in this sentence are the terms used in the CPT code
descriptor or prefatory language for these prolonged E/M services.
---------------------------------------------------------------------------
New coding and payment mechanisms for behavioral health
integration (BHI) services including substance use disorder treatment,
specifically three codes to describe services furnished as part of the
psychiatric CoCM and one code to address other BHI care models.
Separate payment for complex CCM services, reduced
administrative burden for CCM, and an add-on code to the visit during
which CCM is initiated (the CCM initiating visit) to reflect the work
of the billing practitioner in assessing the beneficiary and
establishing the CCM care plan.
A new code for cognition and functional assessment and
care planning, for treatment of cognitive impairment.
An adjustment to payment for routine visits furnished to
beneficiaries for whom the use of specialized mobility-assistive
technology (such as adjustable height chairs or tables, patient lifts,
and adjustable padded leg supports) is medically necessary.
We noted that the development of coding for these and other kinds
of services across the PFS is typically an iterative process that
responds to changes in medical practice and may be best refined over
several years, with PFS rulemaking and the development of CPT codes as
important parts of that process. We noted with interest that the CPT
Editorial Panel and AMA/RUC restructured the former Chronic Care
Coordination Workgroup to establish a
[[Page 80227]]
new Emerging CPT and RUC Issues Workgroup that we hope will continue to
consider the issues raised in this section of our CY 2017 proposed
rule. At the time of publication of the proposed rule, we were aware
that CPT had approved a code to describe assessment and care planning
for treatment of cognitive impairment; however, it would not be ready
in time for valuation in CY 2017. Therefore, we proposed to make
payment using a G-code (G0505 \4\) for this service in CY 2017. We were
also aware that CPT had approved three codes that describe services
furnished consistent with the psychiatric CoCM, but that they would
also not be ready in time for valuation in CY 2017. We discuss these
services in more detail in the next section of this final rule.
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\4\ We note that we used placeholder codes (GPPP1, GPPP2, GPPP3,
GPPPX, GPPP6, GPPP7, and GDDD1) in the proposed rule. In order to
avoid confusion, we have replaced those codes with those that have
been finalized as part of the 2017 HCPCS set, even when describing
the language in the proposed rule.
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To facilitate separate payment for these services furnished to
Medicare beneficiaries during CY 2017, we proposed to make payment
through the use of three G-codes (G0502, G0503, and G0504--see below)
that parallel the new CPT codes, as well as a fourth G-code (G0507--see
below) to describe services furnished using other models of BHI in the
primary care setting. We intended for these to be temporary codes and
would consider whether to adopt and establish values for the new CPT
codes under our standard process, potentially for CY 2018. We
anticipated continuing the multi-year process of implementing
initiatives designed to improve payment for, and recognize long-term
investment in, primary care, care management and cognitive services,
and patient-centered services. While we recognized that there may be
some overlap in the patient populations for the proposed new codes, we
noted that time spent by a practitioner or clinical staff could not be
counted more than once for any code (or assigned to more than one
patient), consistent with PFS coding conventions. We expressed
continued consideration of additional codes for CCM services that would
describe the time of the physician or other billing practitioner. We
also expressed interest in whether there should be changes under the
PFS to reflect additional models of inter-professional collaboration
for health conditions, in addition to those we proposed for BHI.
We proposed to pay under the PFS for services described by new
coding as follows (please note that the descriptions included for
G0502, G0503, and G0504 are from Current Procedural Terminology
(CPT[supreg]) Copyright 2016 American Medical Association (and we
understand from CPT that they will be effective as part of CPT codes
January 1, 2018). All rights reserved):
G0502: 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.
G0503: 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.
G0504: Initial or subsequent psychiatric collaborative
care management, each additional 30 minutes in a calendar month of
behavioral health care manager activities, in consultation with a
psychiatric consultant, and directed by the treating physician or other
qualified health care professional (List separately in addition to code
for primary procedure) (Use G0504 in conjunction with G0502, G0503).
G0507: Care management services for behavioral health
conditions, at least 20 minutes of clinical staff time, directed by a
physician or other qualified health care professional time, per
calendar month.
G0505: Cognition and functional assessment using
standardized instruments with development of recorded care plan for the
patient with cognitive impairment, history obtained from patient and/or
caregiver, by the physician or other qualified health care professional
in office or other outpatient setting or home or domiciliary or rest
home.
G0506: Comprehensive assessment of and care planning by
the physician or other qualified health care professional for patients
requiring chronic care management services, including assessment during
the provision of a face-to-face service (billed separately from monthly
care management services) (Add-on code, list separately in addition to
primary service).
G0501: Resource-intensive services for patients for whom
the use of specialized mobility-assistive technology (such as
adjustable height chairs or tables, patient lifts, and adjustable
padded leg supports) is medically necessary and used during the
provision of an office/outpatient evaluation and management visit (Add-
on code, list separately in addition to primary procedure).
Regarding the majority of these proposals, the public comments were
broadly supportive, some viewing our proposals as a temporary solution
to an underlying need to revalue E/M services, especially outpatient E/
M. Several commenters recommended that CMS utilize the global surgery
data collection effort or another major research initiative to
distinguish and revalue different kinds of E/M work.
[[Page 80228]]
The commenters made recommendations about the scope and definition of
the proposed services, what types of individuals should be able to
provide them, and potential alignment and overlap. The commenters
agreed with the need to increase the relative value of primary care,
care management and other cognitive care under the PFS and minimize
administrative burden for such services, while ensuring value to the
program and beneficiaries. The public comments raise or inform a number
of issues around how to define and pay for care that is collaborative,
integrative or continuous, and we discuss the comments in greater
detail below.
2. Non-Face-to-Face Prolonged Evaluation & Management (E/M) Services
In public comments on the CY 2016 PFS proposed rule, many
commenters recommended that CMS should establish separate payment for
non-face-to-face prolonged E/M service codes that we currently consider
to be ``bundled'' under the PFS (CPT codes 99358, 99359). The CPT
descriptors are:
CPT code 99358 (Prolonged evaluation and management
service before and/or after direct patient care, first hour); and
CPT code 99359 (Prolonged evaluation and management
service before and/or after direct patient care, each additional 30
minutes (List separately in addition to code for prolonged service).
Commenters believed that separate payment for these existing CPT
codes would provide a means for physicians and other billing
practitioners to receive payment that more appropriately accounts for
time that they spend providing non-face-to-face care. We agreed that
these codes would provide a means to recognize the additional resource
costs of physicians and other billing practitioners, when they spend an
extraordinary amount of time outside of an E/M visit performing work
that is related to that visit and does not involve direct patient
contact (such as extensive medical record review, review of diagnostic
test results or other ongoing care management work). We also believed
that doing so in the context of the ongoing changes in health care
practice to meet the current population's health care needs would be
beneficial for Medicare beneficiaries and consistent with our
overarching goals related to patient-centered care.
These non-face-to-face prolonged service codes are broadly
described (although they include only time spent personally by the
physician or other billing practitioner) and have a relatively high
time threshold (the time counted must be an hour or more beyond the
usual service time for the primary or ``companion'' E/M code that is
also billed). They are not reported for time spent in care plan
oversight services or other non-face-to-face services that have more
specific codes and no upper time limit in the CPT code set. We believed
this made these codes sufficiently distinct from the other codes we
proposed for CY 2017 as part of our primary care/cognitive care/care
management initiative described in this section of our final rule.
Accordingly, we proposed to recognize CPT codes 99358 and 99359 for
separate payment under the PFS beginning in CY 2017. We noted that time
could not be counted more than once towards the provision of CPT codes
99358 or 99359 and any other PFS service. We addressed their valuation
in the valuation section of the CY 2017 proposed rule.
Through a drafting error, we stated in the proposed rule that we
would require these services to be furnished on the same day by the
same physician or other billing practitioner as the companion E/M code.
We intended to propose conformity with CPT guidance that requires that
time counted towards the codes describe services furnished during a
single day directly related to a discrete face-to-face service that may
be provided on a different day, provided that the services are directly
related to those furnished in a face-to-face visit.
We also solicited public comment on our interpretation of existing
CPT guidance governing concurrent billing or overlap of CPT codes 99358
and 99359 with complex CCM services (CPT codes 99487 and 99489) and TCM
services (CPT codes 99495 and 99496). Specifically CPT provides, ``Do
not report 99358, 99359 during the same month with 99487-99489. Do not
report 99358, 99359 when performed during the service time of codes
99495 or 99496.'' Complex CCM services and TCM services are similar to
the non-face-to-face prolonged services in that they include
substantial non-face-to-face work by the billing physician or other
practitioner. The TCM and CCM codes similarly focus on a broader
episode of patient care that extends beyond a single day, although they
have a monthly service period and the prolonged service codes do not.
We sought public input on the intersection of the non-face-to-face
prolonged service codes with CCM and TCM services, and with the
proposed add-on code to the CCM initiating visit G0506 (Comprehensive
assessment of and care planning for patients requiring CCM services).
We also solicited comment regarding how distinctions could be made
between time associated with prolonged services and the time bundled
into other E/M services, particularly pre- and post-service times,
which would continue to be bundled with the other E/M service codes.
For all of these services, we expressed concern that there would
potentially be program integrity risks as the same or similar non-face-
to-face activities could be undertaken to meet the billing requirements
for a number of codes. We solicited public comment to help us identify
the full extent of program integrity considerations, as well as options
for mitigating program integrity risks.
Comment: Many commenters recommended that we adopt the CPT coding
provision for CPT codes 99358 and 99359 that allows the prolonged
services to be provided on a different day than the companion E/M code.
At the same time, several commenters indicated that they request
changes to the codes through the established processes of the CPT
Editorial Panel. For example, some commenters suggested that CPT codes
99358 and 99359 should be revised so that they have a limited (calendar
month) service period or measure shorter time increments (15 minutes).
Some commenters recommended that a given physician should not be
allowed to report CPT codes 99358 and 99359 for the same beneficiary
during the same time he or she reported CCM, TCM, or G0506. These
commenters stated that CCM, TCM, and proposed G0506 encompass non-face-
to-face care provided to the beneficiary during a given period of time
that would be duplicated if the physician is also allowed to report CPT
codes 99358 and 99359 during the same time period. Other commenters
stated that it would be unusual for G0506 and non-face-to-face
prolonged services (CPT codes 99358 and 99359) to be reported for
services on the same day, but that both should be allowed if time
thresholds are met. To facilitate determination of whether time
thresholds are met for various potential code combinations, some
commenters recommended that CMS establish a time for G0506 and publish
typical times for the companion codes to the prolonged service codes.
This would enable practitioners to determine when they have exceeded
``usual'' or average times for E/M services and may bill prolonged
services. Some commenters recommended that CMS provide tables
[[Page 80229]]
showing times for E/M visits, CCM, G0506 and prolonged services with
specific clinical examples for concurrent billing.
Some commenters believed there might be some overlap between the
proposed non-face-to-face prolonged service codes and the post-service
work of G0505 (Cognition and functional assessment by the physician or
other qualified health care professional in office or other
outpatient). Some commenters believed there is a discrepancy between
our proposal to allow G0505 to be a companion code to prolonged
services, and CPT's intent that G0505 should only be billed on the same
day as another E/M visit if they are unrelated.
MedPAC commented that the companion E/M codes should be revalued
instead of providing separate payment for prolonged services associated
with the companion codes. However, if we finalize as proposed, MedPAC
recommended that we clarify what situations the prolonged codes are
appropriate for, beyond average times. Another commenter recommended an
alternative policy instead of the non-face-to-face prolonged service
codes, namely several modifiers and add-on codes to E/M services,
associated with increased work RVUs. A typical time for the primary
service would not need to be established. This coding schema would
focus on visits actively treating patients with four or more chronic
conditions; patients with three or more chronic problems introducing an
acute problem during their visit; unexpected abnormal studies; and
electronic communication after visits with the patient, lab, and other
clinicians. One commenter drew a distinction between prolonged service
work and care management services, where care management does not
include extensive review of medical records, review of diagnostic tests
and further discussion with a caregiver.
Response: We appreciate the comments. First, we had intended to
propose to adopt the CPT coding provision for CPT codes 99358 and 99359
that allows the prolonged time to be provided on a different day than
the companion E/M code, along with the rest of the CPT prefatory
language for these codes. Our final policy will adopt the CPT guidance
that allows the prolonged time to be reported for time on a different
day than the companion E/M code, along with the rest of the CPT
prefatory language for CPT codes 99358 and 99359.
Second, the public comments elucidate that it is difficult to
assess potential overlap between prolonged services and many other
codes because the included services, service periods and timeframes are
not aligned. For example, most services paid under the PFS are valued
based on assumptions regarding the typical pre-service, intra-service
and post-service time, but do not have required thresholds for time
spent. It is difficult to distinguish the times associated with these
services from the times for codes that include time requirements in
their descriptor. It is also difficult to distinguish the time and
other work included in codes that generally describe services furnished
during one day (prolonged services and E/M visits) with codes that
describe time and work over substantially different service periods
(such as the calendar month services like CCM or BHI services) or add-
on codes with no pre or post-service time (such as G0506). In addition,
because portions of many services are likely describing work that is
furnished ``incident to'' a physician's or practitioner's services, the
time and effort of the billing practitioner may not be the only
relevant time and effort to consider. Moreover, the comments reflect a
desire and intent on the part of stakeholders to alter the prolonged
service codes in the near future, which would, in turn, alter their
intersection with the codes proposed in this section of our 2017 rule
and many other codes. The public comments also reflect a lack of
consensus regarding appropriate medical practice and reporting patterns
for prolonged services in relation to the services described by the
CCM, TCM, proposed G0505 and proposed G0506 codes.
Having considered this feedback, we have decided to finalize our
proposal for separate payment of the non-face-to-face prolonged service
codes (CPT 99358, 99359) and adopt the CPT code descriptors and
prefatory language for reporting these services. We stress that we
intend these codes to be used to report extended non-face-to-face time
that is spent by the billing physician or other practitioner (not
clinical staff) that is not within the scope of practice of clinical
staff, and that is not adequately identified or valued under existing
codes or the 2017 finalized new codes. We appreciate the commenters'
suggestion to display the typical times associated with relevant
services. We have posted a file that notes the times assumed to be
typical for purposes of PFS rate-setting. That file is available on our
Web site under downloads for the CY 2017 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. We note that
while these typical times are not required to bill the displayed codes,
we would expect that only time spent in excess of these times would be
reported under a non-face-to-face prolonged service code.
Based on our analysis of comments, we do not believe there is
significant overlap between CPT codes 99358 and 99359 and the CCM codes
(CPT 99487, 99489, 99490) or our finalized BHI service codes (G0502,
G0503, G0504, G0507 discussed below). The work of the billing
practitioner in the provision of non-complex CCM and the BHI services
is related to the direction of ongoing care management and coordination
activities of other individuals, compared to the work of 99358 and
99359 which is described as personally performed and directly related
to a face-to-face service. On that basis, we do not believe that there
is significant overlap in the description of services or the valuation.
The potential intersection of CPT codes 99358 and 99359 with the
complex CCM codes is harder to assess because complex CCM explicitly
includes medical decision-making of moderate to high complexity by the
billing practitioner, which is not performed by clinical staff. The
complex CCM codes, however, only measure or count the time of clinical
staff. Similarly, TCM includes moderate to high complexity medical
decision-making during the service period as well as a level 4 or 5
face-to-face visit, even though clinical staff may perform a number of
other aspects of the service. For CY 2017, for administrative
simplicity, we are adopting the CPT provision (and finalizing as
proposed) that complex CCM cannot be reported during the same month as
non-face-to-face prolonged services, CPT codes 99358 and 99359 (by a
single practitioner). Similarly, we are adopting the CPT provision that
non-face-to-face prolonged services, CPT codes 99358 and 99359 may not
be reported when performed during the service time of TCM (CPT codes
99495 and 99496) (by a single practitioner). We interpret the CPT
provision to mean that CPT codes 99358 and 99359 cannot be reported
during the TCM 30-day service period, by the same practitioner who is
reporting the TCM.
Regarding potential intersection of CPT codes 99358 and 99359 with
proposed G0505 (Cognition and functional assessment by the physician or
other qualified health care professional in office or other
outpatient), we are finalizing our proposal that G0505 be designated as
a
[[Page 80230]]
companion or ``base'' E/M code to non-face-to-face prolonged services
(CPT codes 99358 and 99359) (see section II.E.5 for a detailed
discussion of G0505). That is, for CY 2017 CPT codes 99358 and 99359
may be reported with G0505 as the associated companion code, whether
furnished on the same day or a different day. We believe CPT intended
the code on which G0505 is modeled to function like a specific E/M
service, and that while the specificity of the service explicitly
includes care planning unique to the needs of patients with particular
conditions, there may well be circumstances where the pre- or post-time
for a particular beneficiary may be prolonged. In their current form,
the non-face-to-face prolonged service codes exist for the purpose of
providing additional payment to account for the biller's additional
time related to E/M visits. Therefore, we believe the non-face-to-face
prolonged service codes should be reportable when related to E/M
services, including those such as G0505 that describe more specific E/M
work. We look forward to continued feedback on this issue, including
through potential revisions to CPT guidance.
Regarding intersection of CPT codes 99358 and 99359 with G0506, we
note that G0506 is already an add-on code to another E/M service (the
CCM initiating visit, which can be the AWV/IPPE or a qualifying face-
to-face E/M visit). We are providing in section II.E.4.a that at this
time (beginning in CY 2017), G0506 will be a code that is only billable
one time, at the outset of CCM services. We agree with commenters that
it would be unusual for physicians to spend enough time with a given
beneficiary on a given day to warrant reporting all three codes (the
initiating visit code, G0506, and a prolonged service code). We also
believe that a simpler approach is preferable at this time (two related
codes for CCM initiation, instead of possibly three). Therefore our
final policy for CY 2017 is that prolonged services (whether face-to-
face or non-face-to-face) cannot be reported in addition to G0506 in
association with a companion E/M code that also qualifies as the CCM
initiating visit. In association with the CCM initiating visit, a
billing practitioner may choose to report either prolonged services or
G0506 (if requirements to bill both prolonged services and G0506 are
met), but cannot report both a prolonged service code and G0506.
3. Establishing Separate Payment for Behavioral Health Integration
(BHI)
In the CY 2016 PFS final rule with comment period (80 FR 70920), we
stated that we believe the care and management for Medicare
beneficiaries with behavioral health conditions often requires
extensive discussion, information-sharing and planning between a
primary care physician and a specialist. In CY 2016 rulemaking, we
described that in recent years, many randomized controlled trials have
established an evidence base for an approach to caring for patients
with behavioral health conditions called the psychiatric Collaborative
Care Model (CoCM). We sought information to assist us in considering
refinements to coding and payment to address this model in particular.
The psychiatric CoCM is one of many models for behavioral health
integration or BHI, a term that refers broadly to collaborative care
that integrates behavioral health services principally with primary
care, but that may also integrate behavioral health care with inpatient
and other clinical care. BHI is a team-based approach to care that
focuses on integrative treatment of patients with medical and mental or
behavioral health conditions. In the CY 2017 proposed rule (81 FR 46203
through 46205), we proposed four new G-codes for BHI services: Three
describing the psychiatric CoCM specifically, and one generally
describing related models of care.
a. Psychiatric Collaborative Care Model (CoCM)
A specific model for BHI, psychiatric CoCM typically is provided by
a primary care team consisting of a primary care provider and a care
manager who works in collaboration with a psychiatric consultant, such
as a psychiatrist. Care is directed by the primary care team and
includes structured care management with regular assessments of
clinical status using validated tools and modification of treatment as
appropriate. The psychiatric consultant provides regular consultations
to the primary care team to review the clinical status and care of
patients and to make recommendations. As we previously noted, several
resources have been published that describe the psychiatric CoCM in
greater detail and assess the impact of the model, including pieces
from the University of Washington (http://aims.uw.edu/), the Institute
for Clinical and Economic Review (http://icer-review.org/announcements/icer-report-presents-evidence-based-guidance-to-support-integration-of-behavioral-health-into-primary-care/), and the Cochrane Collaboration
(http://www.cochrane.org/CD006525/DEPRESSN_collaborative-care-forpeople-with-depression-and-anxiety). Because this particular kind of
collaborative care model has been tested and documented in medical
literature, in the CY 2016 proposed rule we expressed particular
interest in how coding used to describe PFS services might facilitate
appropriate valuation of the services furnished under this model. We
solicited public comments to assist us in considering refinements to
coding and payment to address this model in particular relative to
current coding and payment policies, as well as information related to
various requirements and aspects of these services.
After consideration of the comments, we proposed in the CY 2017 PFS
proposed rule to begin making separate payment for services furnished
using the psychiatric CoCM, beginning January 1, 2017. We were aware
that the CPT Editorial Panel, recognizing the need for new coding for
services under this model of care, had approved three codes to describe
the psychiatric collaborative care that is consistent with this model,
but the codes would not be ready in time for valuation in CY 2017.
Current CPT coding does not accurately describe or facilitate
appropriate payment for the treatment of Medicare beneficiaries under
this model of care. For example, under current Medicare payment policy,
there is no payment made specifically for regular monitoring of
patients using validated clinical rating scales or for regular
psychiatric caseload review and consultation that does not involve
face-to-face contact with the patient. We believed that these resources
are directly involved in furnishing ongoing care management services to
specific patients with specific needs, but they are not appropriately
recognized under current coding and payment mechanisms. Because PFS
valuation is based on the relative resource costs of the PFS services
furnished to Medicare beneficiaries, we believed that appropriate
coding for these services for CY 2017 will facilitate accurate payment
for these and other PFS services. Therefore, we proposed separate
payment for services under the psychiatric CoCM using three new G-
codes, as detailed below: G0502, G0503, and G0504, which would parallel
the CPT codes that are being created to report these services.
The proposed code descriptors were as follows (from Current
Procedural Terminology (CPT[supreg]) Copyright 2016 American Medical
Association (and we understand from CPT that they will be effective as
part of CPT codes January 1, 2018). All rights reserved):
G0502: Initial psychiatric collaborative care management,
first 70 minutes in the first calendar month of
[[Page 80231]]
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.
G0503: 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.
G0504: Initial or subsequent psychiatric collaborative
care management, each additional 30 minutes in a calendar month of
behavioral health care manager activities, in consultation with a
psychiatric consultant, and directed by the treating physician or other
qualified health care professional (List separately in addition to code
for primary procedure) (Use G0504 in conjunction with G0502, G0503).
We stated that we intend these to be temporary codes and would
consider whether to adopt and establish values for the associated new
CPT codes under our standard process once those codes are active.
We proposed that these services would be furnished under the
direction of a treating physician or other qualified health care
professional during a calendar month. These services would be furnished
when a patient has a diagnosed psychiatric disorder that requires a
behavioral health care assessment; establishing, implementing,
revising, or monitoring a care plan; and provision of brief
interventions. The diagnosis could be either pre-existing or made by
the billing practitioner. These services would be reported by the
treating physician or other qualified health care professional and
include the services of the treating physician or other qualified
health care professional, the behavioral health care manager (see
description below) who would furnish services incident to services of
the treating physician or other qualified health care professional, and
the psychiatric consultant (see description below) whose consultative
services would be furnished incident to services of the treating
physician or other qualified health care professional. We proposed that
beneficiaries who are appropriate candidates for care reported using
the psychiatric CoCM codes could have newly diagnosed conditions, need
help in engaging in treatment, have not responded to standard care
delivered in a non-psychiatric setting, or require further assessment
and engagement prior to consideration of referral to a psychiatric care
setting. Beneficiaries would be treated for an episode of care, defined
as beginning when the behavioral health care manager engages in care of
the beneficiary under the appropriate supervision of the billing
practitioner and ending with:
The attainment of targeted treatment goals, which
typically results in the discontinuation of care management services
and continuation of usual follow-up with the treating physician or
other qualified healthcare professional; or
Failure to attain targeted treatment goals culminating in
referral to a psychiatric care provider for ongoing treatment; or
Lack of continued engagement with no psychiatric
collaborative care management services provided over a consecutive 6-
month calendar period (break in episode).
A new episode of care would start after a break in episode of 6
calendar months or more.
The treating physician or other qualified health care professional
would direct the behavioral health care manager and continue to oversee
the beneficiary's care, including prescribing medications, providing
treatments for medical conditions, and making referrals to specialty
care when needed. Medically necessary E/M and other services could be
reported separately by the treating physician or other qualified health
care professional, or other physicians or practitioners, during the
same calendar month. Time spent by the treating physician or other
qualified health care professional on activities for services reported
separately could not be included in the services reported using G0502,
G0503, and G0504. We proposed that the behavioral health care manager
would be a member of the treating physician or other qualified health
care professional's clinical staff with formal education or specialized
training in behavioral health (which could include a range of
disciplines, for example, social work, nursing, and psychology) who
provides care management services, as well as an assessment of needs,
including the administration of validated rating scales,\5\ the
development of a care plan, provision of brief interventions, ongoing
collaboration with the treating physician or other qualified health
care professional, maintenance of a registry,\6\ all in consultation
with a psychiatric consultant. The behavioral health care manager would
furnish these services both face-to-face and non-face-to-face, and
consult with the psychiatric consultant minimally on a weekly basis. We
proposed that the behavioral health care manager would be on-site at
the location where the treating physician or other qualified health
care professional furnishes services to the beneficiary.
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\5\ For example, see https://aims.uw.edu/resource-library/measurement-based-treatment-target.
\6\ For example, see https://aims.uw.edu/collaborative-care/implementation-guide/plan-clinical-practice-change/identify-population-based.
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We proposed that the behavioral health care manager may or may not
be a professional who meets all the requirements to independently
furnish and report services to Medicare. If otherwise eligible, then
that individual
[[Page 80232]]
could report separate services furnished to a beneficiary receiving the
services described by G0502, G0503, G0504, and G0507 in the same
calendar month. These could include: Psychiatric evaluation (90791,
90792), psychotherapy (90832, 90833, 90834, 90836, 90837, 90838),
psychotherapy for crisis (90839, 90840), family psychotherapy (90846,
90847), multiple family group psychotherapy (90849), group
psychotherapy (90853), smoking and tobacco use cessation counseling
(99406, 90407), and alcohol or substance abuse intervention services
(G0396, G0397). Time spent by the behavioral health care manager on
activities for services reported separately could not be included in
the services reported using time applied to G0502, G0503, and G0504.
The psychiatric consultant involved in the ``incident to'' care
furnished under this model would be a medical professional trained in
psychiatry and qualified to prescribe the full range of medications.
The psychiatric consultant would advise and make recommendations, as
needed, for psychiatric and other medical care, including psychiatric
and other medical diagnoses, treatment strategies including appropriate
therapies, medication management, medical management of complications
associated with treatment of psychiatric disorders, and referral for
specialty services, that are communicated to the treating physician or
other qualified health care professional, typically through the
behavioral health care manager. The psychiatric consultant would not
typically see the patient or prescribe medications, except in rare
circumstances, but could and should facilitate a referral to a
psychiatric care provider when clinically indicated.
In the event that the psychiatric consultant furnished services to
the beneficiary directly in the calendar month described by other
codes, such as E/M services or psychiatric evaluation (CPT codes 90791
and 90792), those services could be reported separately by the
psychiatric consultant. Time spent by the psychiatric consultant on
activities for services reported separately could not be included in
the services reported using G0502, G0503, and G0504.
We also noted that, although the psychiatric CoCM has been studied
extensively in the setting of specific behavioral health conditions
(for example, depression), we received persuasive comments in response
to the CY 2016 proposed rule recommending that we not specify
particular diagnoses required for use of the codes for several reasons,
including that: There may be overlap in behavioral health conditions;
there are concerns that there could be modification of diagnoses to fit
within payment rules which could skew the accuracy of submitted
diagnosis code data; and for many patients for whom specialty care is
not available, or who choose for other reasons to remain in primary
care, primary care treatment will be more effective if it is provided
within a model of integrated care that includes care management and
psychiatric consultation.
Comment: The public comments were very supportive of our creation
of the three G-codes for CY 2017 to pay for services furnished using
the psychiatric CoCM. The commenters offered a number of
recommendations regarding valuation of the codes. Some commenters
requested additional codes, sought clarification, or presented
statements in favor of including the services of practitioners other
than psychiatrists, especially psychologists and social workers, within
the proposed codes.
Response: We thank the commenters for their support of coding and
valuation for services furnished using the psychiatric CoCM, and for
their recommendations regarding appropriate valuation. We address the
comments on valuation in section II.L of this final rule. We address
the comments regarding payment for services of psychologists and social
workers below.
Comment: Several commenters expressed concern that making separate
payment for psychiatric CoCM for the treatment of mood disorders might
result in neglecting treatment for other mental health conditions.
Other commenters expressed support for not designating a limited set of
eligible behavioral health diagnoses. One commenter stated that
requiring a diagnosed behavioral health condition might mean that
subclinical issues or undiagnosed behavioral health conditions would be
neglected.
Response: We continue to believe that we should not limit billing
and payment for the psychiatric CoCM codes to a limited set of
behavioral health conditions. As we understand it, the psychiatric CoCM
model of care may be used to treat patients with any behavioral health
condition that is being treated by the billing practitioner, including
substance use disorders. In the Collaborative Care literature reviewed
by the Cochrane Collaboration and others, there is stronger evidence of
effectiveness and cost-effectiveness for certain behavioral disorders,
particularly mood and anxiety disorders, than for others. However, we
continue to receive persuasive comments indicating that the psychiatric
CoCM is recommended for broader incorporation into clinical practice,
and recommending that we not specify the use of the psychiatric CoCM
codes for only particular behavioral health diagnoses. Therefore we are
not limiting billing and payment for the psychiatric CoCM codes to a
specified set of behavioral health conditions.
In response to the public comment regarding whether we should
require a diagnosed psychiatric disorder (as opposed to a subclinical
or undiagnosed condition), we are clarifying that as described, the
services require that there must be a presenting psychiatric or
behavioral health condition(s) that, in the clinical judgment of the
treating physician or other qualified health professional, warrants
``referral'' to the behavioral health care manager for further
assessment and treatment through provision of psychiatric CoCM
services. ``Referral'' is placed in quotes because the behavioral
health care manager may be located in the same practice as the treating
physician or other qualified health professional, who in any event
provides ongoing oversight and continues to treat the beneficiary.
However, the referring diagnosis (or diagnoses) may be either pre-
existing or made by the treating physician or other qualified health
professional, and we are not establishing any specific list of eligible
or included diagnoses or conditions. The treating physician or other
qualified health professional may not be qualified or able to fully
diagnose all relevant psychiatric or behavioral health condition(s)
prior to referring the beneficiary for psychiatric CoCM services. If in
the course of providing psychiatric CoCM services, it becomes clear
that the referring condition(s) or other diagnoses cannot be addressed
by psychiatric CoCM services, then we understand that the beneficiary
should be referred for other psychiatric treatment or should continue
usual follow-up care with the treating practitioner, because the
episode of psychiatric CoCM services ends if there is failure to attain
targeted treatment goals after or despite changes in treatment, as
indicated. Beneficiaries receiving care reported using the psychiatric
CoCM codes may, but are not required to have comorbid chronic or other
medical condition(s) that are being managed by the treating
practitioner.
Comment: Several commenters who supported payment for the proposed
codes for psychiatric CoCM services in primary care settings, raised
questions about whether these codes could be
[[Page 80233]]
used to bill for services furnished in other settings that are not
traditional primary care settings, such as inpatient or long-term care,
oncology practices, or emergency departments. Some of these commenters
recommended additional new codes to pay for services furnished in these
other settings.
Response: The psychiatric CoCM trials and real world implementation
have mainly included primary care practice that broadly includes
pediatrics, obstetrics/gynecology, and geriatrics as well as family
practice and general internal medicine. The psychiatric CoCM has also
been used in cardiology and oncology practice, and we believe it could
be used in various medical specialty settings, as long as the
specialist physician or practitioner is managing the beneficiary's
behavioral health condition(s) as well as other medical conditions (for
example, cancer, status-post acute myocardial infarction and other
conditions where co-morbid depression is common). Accordingly, we are
not limiting the code to reporting by only ``traditional'' primary care
specialties. We believe primary care practitioners will most frequently
perform the services described by the new psychiatric CoCM codes, but
if other specialist practitioners perform these services and meet all
of the requirements to bill the code(s), then they may report the
psychiatric CoCM codes. We are interested in receiving additional, more
specific information from stakeholders regarding which specialties
furnish psychiatric CoCM services. We note that we would generally not
expect psychiatrists to bill the psychiatric CoCM codes, because
psychiatric work is defined as a sub-component of the psychiatric CoCM
codes.
Regarding psychiatric CoCM services furnished to inpatients or
beneficiaries in long-term care settings such as nursing or custodial
care facilities, we note that the forthcoming CPT codes are not limited
to office or other outpatient or domiciliary services. Moreover, our
goal is to separately identify and pay for psychiatric CoCM services
furnished to beneficiaries in any appropriate setting of care, whether
inpatient or outpatient, in recognition of the associated time and
service complexity. Care of beneficiaries who are admitted to a
facility, are in long-term care, or are transitioning among settings
during the month may be more complex than the care of other types of
patients. While there is some overlap between psychiatric CoCM and CCM
services, they are distinct services with differing patient
populations, as discussed elsewhere in this section of our final rule.
Therefore, we have valued the psychiatric CoCM services in both
facility and non-facility settings (see section II.L on valuation). We
are not limiting the time that can be counted towards the monthly time
requirement to bill the psychiatric CoCM code(s) to time that is spent
in the care of an outpatient or a beneficiary residing in the
community. However, we also stress that G0502, G0503 and G0504 can only
be reported by a treating physician or other qualified health care
professional when he or she has directed the psychiatric CoCM service
for the duration of time that he or she is reporting it, and has a
qualifying relationship with individuals providing the service under
his or her direction and control. Also, time and effort that is spent
managing care transitions for CCM or TCM patients and that is counted
towards reporting TCM or CCM services, cannot also be counted towards
reporting any transitional care management activities reported under a
BHI service code(s), either the psychiatric CoCM codes or the code
describing other BHI services. We welcome additional input from
stakeholders regarding appropriate (or inappropriate) sites of service
for G0502, G0503 and G0504.
We note that for CY 2017, the facility PE RVU for psychiatric CoCM
services will include the indirect PE allocated based on the work RVUs,
but no direct PE (which is explicitly comprised of other labor,
equipment and supplies). This is because historically, the PFS facility
rate for a given professional service assumes that the billing
practitioner is not bearing a significant resource cost in labor by
other individuals, equipment or supplies. We generally assume that
those costs are instead borne by the facility, and are adequately
accounted for in a separate payment made to the facility to account for
these costs and other costs incurred by the facility for the
beneficiary's facility stay. For BHI services and similar care
management services such as CCM, we have been considering whether this
approach to PFS valuation is optimal because the PFS service, in
significant part, may be provided by the behavioral health care
manager, clinical staff, or even other physicians under the employment
of the billing practitioner or under contract to the billing
practitioner. These individuals may provide much of the PFS service
remotely, and are not necessarily employees or staff of the facility.
Indeed, the BHI services are defined in terms of activities performed
by individual(s) other than the billing practitioner and who may not be
affiliated with or located within the facility, even though as we
discuss below the billing practitioner must also perform certain work.
For this type of PFS service, there may be more direct practice expense
borne by the billing practitioner even though the beneficiary is
located, for part or all of the month, in a facility receiving
institutional payment. We plan to consider these issues further in the
future.
Comment: One specialty association supported the proposed
psychiatric CoCM codes, noting that although few of their members would
use these codes, they set an important precedent to recognize
interdisciplinary care that requires significant non-face-to-face work.
This commenter anticipated that similar code series may be developed in
the future to describe complex management in other specialties
including neurology, and supported the adoption of language approved at
CPT that carefully defined the roles of multiple professionals. Other
commenters similarly expressed support for separate payment for
additional collaborative care services, including inter-professional
consultation in the treatment of other illnesses such as cancer or
multiple sclerosis.
Response: We continue to be interested in new coding that describes
integrative, collaborative or consultative care among specialties other
than primary care and behavioral health/psychiatry. We are especially
interested in new coding that describes such care in sufficient detail
that distinguishes it from existing service codes, and that would
further the appropriate valuation of cognitive services. We will
continue to follow any new coding proposals at CPT relevant for the
Medicare population. We note that we have followed CPT's lead in
finalizing proposed code G0505 for cognitive impairment assessment and
care planning (see section II.E.5) as well as for psychiatric CoCM
services. BHI is a unique type of service that we believe until now has
not been well identified nor appropriately valued under existing codes.
BHI is not comprised of mere consultation among professionals and has a
unique evidence base, in addition to being recently addressed by
forthcoming CPT coding. In addition, given the shortage of available
psychiatric and other mental health professionals in many parts of the
country, we believe it is important to identify and make accurate
payment for models of care that facilitate access to psychiatric and
other behavioral health specialty care through innovations in medical
practice, like the ones described by these codes.
[[Page 80234]]
Comment: One commenter asked CMS to clarify inclusion of nurse
practitioners who are primary care practitioners and, in the specialty
of psychiatry, psychiatric nurse practitioners who can perform
psychiatric evaluations and treat psychiatric problems.
Response: Nurse practitioners are authorized to independently bill
Medicare for their services, and can also bill Medicare for services
furnished incident to their services. Therefore, nurse practitioners
who furnish the psychiatric CoCM services as described may bill for the
psychiatric CoCM codes. Nurse practitioners who meet our final
qualifications to serve as the behavioral health care manager may
provide the behavioral health care manager services incident to the
services of another (billing) practitioner. Nurse practitioners who
meet all of our final requirements to serve as the psychiatric
consultant may provide the psychiatric consultant services incident to
the services of the billing practitioner.
Comment: Regarding the care planning requirements for psychiatric
CoCM services, some commenters noted that there is not necessarily
value in accumulating or enumerating a number of different types of
care plans addressing different aspects of the beneficiary's problems,
such as a behavioral or psychiatric care plan, a CCM care plan, and a
cognitive impairment care plan (see G0505 in section II.E.5).
Response: While the proposed descriptors for the psychiatric CoCM
services referred to an ``individualized treatment plan,'' not a ``care
plan,'' we proposed in addition that the behavioral health care manager
would ``develop a care plan.'' While any care planning should take into
account the whole patient, our intent is that the care planning
included in the CCM coding (and G0506, the CCM initiating visit add-on
code) will be the most comprehensive in nature, addressing all health
issues with particular focus on the multiple chronic conditions being
managed by the billing practitioner. In that sense, the CCM care plan
is an integrative care plan incorporating more comprehensive health
information on all of the beneficiary's health issues, or reconciling
care plans of other practitioners. In contrast, the BHI care planning
will focus on behavioral health or psychiatric issues, in particular,
just as cognitive impairment care planning will focus on cognitive
impairment issues, in particular (see section II.E.5). We are not
requiring the psychiatric CoCM treating practitioner or behavioral
health consultant to perform care planning that incorporates
comprehensive health information on all of the beneficiary's health
issues or reconciles the care plans of other practitioners, as would be
expected for CCM care planning.
We understand that adoption of EHRs may be lower among behavioral
health practitioners \7\ and note that resources are available to help
inform how care plans can support team-based care and BHI.\8\ Our
understanding from the public comments last year and subsequent
discussions with experts on the psychiatric CoCM model of care, is that
no specific electronic technology or format is necessary or
indispensable to carry out the psychiatric CoCM model of care, or
perform the services included in the codes we are creating to describe
the services furnished using that model. We believe the format of the
behavioral health care plan (or any care plan) is less important than
having a process whereby feedback and expertise from all relevant
practitioners and providers, whether internal or external to the
billing practice, are integrated into the beneficiary's treatment plan
and goals; that this plan be regularly assessed and revisited by the
practitioner who is assuming an overall care management role for the
beneficiary in a given month; that the patient is engaged in the care
planning process; and that the care planning be documented in the
medical record (as with any required element of any PFS service). We
are revising the requirement for care planning by the behavioral health
care manager accordingly, that he or she will perform ``behavioral
health care planning in relation to behavioral/psychiatric health
problems, including revision for patients who are not progressing or
whose status changes.''
---------------------------------------------------------------------------
\7\ See for instance http://dashboard.healthit.gov/quickstats/pages/physician-ehr-adoption-trends.php and https://www.thenationalcouncil.org/wp-content/uploads/2012/10/HIT-Survey-Full-Report.pdf.
\8\ For instance, AHRQ has a variety of resources on how shared
care plans can support team-based care and behavioral health
integration at https://integrationacademy.ahrq.gov/playbook/develop-shared-care-plan.
---------------------------------------------------------------------------
Comment: A number of commenters recommended that we should not
require the behavioral health care manager for the psychiatric CoCM
services to be located on site within the primary care practice. The
commenters noted that in some settings, particularly rural areas or
smaller practices, this may be especially important. Some commenters
assumed that there is also a behavioral health care manager for G0507
(discussed below). These commenters compared BHI services (the
psychiatric CoCM services and G0507) to CCM and recommended that CMS
adopt the same requirements for all the BHI codes as for CCM, regarding
supervision, location of a behavioral health care manager, and third
party outsourcing.
Response: For the psychiatric CoCM services, we proposed that the
behavioral health care manager would be a member of the treating
physician or other qualified health care professional's clinical staff,
and would be required to be located on site but able to work under
general supervision. In addition, we proposed that the behavioral
health care manager provides his or her services both face-to-face and
non-face-to-face. We believed that services provided using the
psychiatric CoCM model of care commonly involve face-to-face
interaction between the behavioral health care manager and the
beneficiary on appropriate occasions, such as the outset of services (a
``warm hand-off'' from the treating physician or other qualified health
care professional). In addition, whether face-to-face or non-face-to-
face, many of the included behavioral health care manager duties could
be performed while the treating practitioner is not in the office and
could be performed after hours. We note that the behavioral health care
manager duties are listed in full above, and include care management
services, as well as an assessment of needs, including the
administration of validated rating scales, behavioral health care
planning, provision of brief interventions, ongoing collaboration with
the treating physician or other qualified health care professional, and
maintenance of a registry, all in consultation with a psychiatric
consultant.
The delivery of the psychiatric CoCM depends, in part, on
continuity of care between a given patient and the assigned behavioral
health care manager. Also it requires collaboration, integration and
ongoing data flow between the behavioral health care manager and the
treating practitioner the behavioral health care manager is supporting,
as well as with the psychiatric consultant who is usually remotely
located under the psychiatric CoCM model of care. As previously
discussed, the psychiatric CoCM is an integrative model of care, and in
considering our proposal we were concerned that allowing the behavioral
health care manager to be located remotely would compromise their
ability to collaborate, communicate, and timely treat and share
information with the beneficiary and the rest of the care team. We are
aware of many care
[[Page 80235]]
management companies and health information technology companies that
may seek to provide remote care management and related services under
all of the new BHI codes, as they have for CCM and similar services
recently adopted under the PFS. We received public comments from
several such stakeholders that indicated an interest in the provision
of BHI services and related health information technology. We
understand that there have been successful implementations (positive
randomized controlled trials) of the psychiatric CoCM using remote call
centers; however, in these implementations, call center staff were not
randomly rotated among patients and there was ongoing data flow and
connectivity between the behavioral health care manager and the other
members of the care team, as well as the patient. Moreover, the
behavioral health care manager would presumably have to be on site at
least some of the time (even if under general supervision), in order to
provide some of their services in-person with the beneficiary.
The fact that we proposed and are finalizing general supervision
for the psychiatric CoCM codes as we did for CCM services (see section
II.E.3.b) does not mean that general supervision alone suffices to meet
the requirements of the psychiatric CoCM for continuity, collaboration
and integration among the care team members, including the beneficiary.
General supervision means that the service is furnished under the
overall direction and control of the practitioner billing the service,
but without the presence of the practitioner being required during the
performance of the service. This definition does not directly govern
where individual(s) providing the service on an incident to basis are
located, whether on site or remote. Rather, it governs the location and
informs the involvement of the billing practitioner.
For payment purposes, we are assigning general supervision to the
psychiatric CoCM codes because we do not believe it is clinically
necessary that the professionals on the team who provide services other
than the treating practitioner (namely, the behavioral health care
manager and the psychiatric consultant) must have the billing
practitioner immediately available to them at all times, as would be
required under a higher level of supervision. However, general
supervision sets the minimum standard for supervision and does not, by
itself, meet the requirements we are setting for billing new codes
G0502, G0503 and G0504. While certain aspects of psychiatric CoCM
services might be furnished under general supervision, we do not
believe the general supervision requirement adequately describes the
nature of the relationship and interactions of the respective team
members for services furnished using the psychiatric CoCM or the codes
we are creating to describe those services. Moreover it only directly
addresses the physical location of the billing practitioner, not the
behavioral health care manager, necessarily.
After considering the public comments, we are not finalizing our
proposal that the behavioral health care manager must be a member of
the treating physician or other qualified health care professional's
clinical staff. As some of the psychiatric CoCM services can be
contracted out to a third party (subject to rules discussed below), the
contracted individuals are not necessarily employees of the treating
practitioner.
Regarding the face-to-face provision of services by the behavioral
health care manager, we are requiring that the behavioral health care
manager must be available to provide services on a face-to-face basis,
but not that face-to-face services must be provided. We are not
finalizing the proposed requirement that the behavioral health care
manager must be located on site, in order to allow for after-hours or
appropriate remote provision of services. However, to ensure clinical
integration with the treating practitioner and familiarity and
continuity with the beneficiary, which are characteristic of services
furnished under the psychiatric CoCM model of care, we are requiring
that the behavioral health care manager must have a collaborative,
integrated relationship with the rest of the care team members, and be
able to perform all of the required elements of the psychiatric CoCM
services delineated for the behavioral health care manager. The
behavioral health care manager must have the ability to engage the
beneficiary outside of regular clinic hours as necessary to perform
their duties under the CoCM model, and have a continuous relationship
with the beneficiary. This does not mean the behavioral health care
manager is necessarily an employee of or always physically located
within the practice, nor does it require provision of behavioral health
care manager services to the beneficiary on site. The behavioral health
care manager may provide his or her services from a remote location
that is remote from the billing practitioner or remote from the
beneficiary, subject to incident to rules and regulations in 42 CFR
410.26, if he or she has a qualifying relationship with the rest of the
care team including the beneficiary, and is available to provide
services face-to-face.
We will monitor this issue going forward, not just for the
psychiatric CoCM but also for the general BHI service code (G0507) we
are finalizing, as well as for TCM and CCM services. As we discuss in
the final rule section on CCM below, we are continuing to consider
whether outsourcing certain aspects of these services to a third party
fragments care, leads to insufficient involvement and oversight of the
billing practitioner or results in services that do not actually
represent or facilitate continuous, seamless transitional care and
other required aspects of these services. We will continue to consider
how to best define the continuity of care that is required for services
furnished and billed under all of these codes, and whether arrangements
for remote provision of services whether by a case management company
or another entity increases rather than reduces service fragmentation.
Advances in health information technology provide opportunities for
remote connectivity and interoperability that may assist and be useful,
if not necessary, for reducing care fragmentation. However, remote
provision of services by entities having only a loose association with
the treating practitioner can detract from continuous, patient-centered
care, whether or not those entities employ certified or other
electronic technology.
We note that while time spent by the treating practitioner is not
explicitly counted for in codes G0502, G0503 and G0504, these codes are
valued to include work performed directly by the treating practitioner.
The treating practitioner directs the behavioral health care manager
and continues to oversee the patient's care, including prescribing
medications, providing treatments for medical conditions, and making
referrals to specialty care when needed. We are finalizing as proposed
that some of these services may be separately billable. However, we
wish to emphasize that the treating practitioner must remain involved
in ongoing oversight, management, collaboration and reassessment as
appropriate to bill the psychiatric CoCM codes.
Comment: We received a number of comments requesting that we allow
or recognize pharmacists, especially neurologic or psychiatric
pharmacists, or doctoral-level clinical psychologists to serve as the
psychiatric consultant. Some commenters were concerned that CMS is
advocating pharmacotherapy over psychotherapy by requiring a
psychiatric consultant who can prescribe medication.
[[Page 80236]]
Response: We agree with the commenters that there are multiple
types of indicated treatment for behavioral health conditions,
including psychotherapy and other psychosocial interventions as well as
pharmacotherapy that are available and should be offered to
beneficiaries receiving psychiatric CoCM services. Our intent is not to
inappropriately steer beneficiaries into medication-based treatment,
but rather that the psychiatric consultant be able to present and
recommend the full range of treatment options including but not limited
to medications, and to advise regarding any medications the beneficiary
chooses to take. Under the psychiatric CoCM, the psychiatric consultant
must be able to prescribe medication. As we discuss in section II.L on
valuation of G0502, G0503 and G0504, we agree with the commenters who
stated that the role of the psychiatric consultant under these codes is
primarily evaluation and management, which is not within the scope of
pharmacists or clinical psychologists under Medicare rules. Therefore,
we are finalizing the role and qualifications of the psychiatric
consultant as proposed. The general BHI code (G0507), which we are
finalizing, was intended and may be used to report other models of
care, where the beneficiary may not receive E/M services from the
consultant and the consultant may only be authorized to provide
psychotherapy or consultation regarding medications (see section
II.E.3.b).
Comment: We received a number of comments recommending various
types of professionals as qualified to serve as the behavioral health
care manager, such as licensed clinical social workers (LCSWs) and
psychologists.
Response: Unlike CCM and the general BHI service (code G0507), the
psychiatric CoCM codes are used to report time that is spent in
specified activities performed by a behavioral health care manager
having formal education or specialized training in those activities,
whether or not the behavioral health care manager is eligible to
directly bill Medicare for other services. The behavioral health care
manager may or may not be a professional who meets all the requirements
to independently furnish and report services to Medicare. The
behavioral health care manager must also meet any applicable licensure
and state law requirements, which is required under 42 CFR 410.26 for
all services provided under the PFS. LCSWs would meet these
requirements, as would qualified registered nurses, clinical
psychologists and other qualified clinical staff. Time spent by
administrative or clerical staff cannot be counted towards the time
required to bill G0502, G0503 or G0504.
Evaluation and management services (such as face-to-face E/M
visits) may be separately billed during the service period or on the
same day as the psychiatric CoCM services, provided time is not counted
twice towards the same code.
b. General Behavioral Health Integration (BHI)
We recognize that the psychiatric CoCM is prescriptive and that
much of its demonstrated success may be attributable to adherence to a
set of elements and guidelines of care. We are finalizing the code set
discussed above to pay accurately for care furnished using this
specific model of care, given its widespread adoption and recognized
effectiveness. However, we note that PFS coding, in general, does not
dictate how physicians practice medicine and believe that it should,
instead, reflect the practice of medicine. We also recognize that there
are primary care practices that are incurring, or may incur, resource
costs inherent to treatment of patients with similar conditions based
on BHI models of care other than the psychiatric CoCM that may benefit
beneficiaries with behavioral health conditions (see, for example, the
approaches described at http://www.integration.samhsa.gov/integrated-care-models). There are a variety of care models ranging from
behavioral health professionals embedded within a primary care office
for same-day treatment, to remote consultation, to assessment-and-
referral (see, for example, http://www.commonwealthfund.org/publications/newsletters/quality-matters/2014/august-september/profiles; and http://www.integration.samhsa.gov/integrated-care-models). These models of care have tended to arise from clinical
practice as opposed to the research environment (http://psychnews.psychiatryonline.org/doi/full/10.1176/appi.pn.2014.10b25),
and include resource costs that differ in various respects from those
associated with the psychiatric CoCM.
To recognize the resource costs associated with furnishing such BHI
services to Medicare beneficiaries, we also proposed to make payment
using a new G-code that describes care management for beneficiaries
with behavioral health conditions under other models of care. We
believe that the resources associated with such care are not currently
adequately recognized under the PFS. The proposed code was G0507 (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). We noted that
we would expect this code to be refined over time as we receive more
information about other BHI models being used and how they are
implemented.
We sought stakeholder input on whether we should consider different
increments of time for this code, such as a base code plus an add-on
code comprised of additional 20 minute increments. We recognized that
BHI services furnished under the proposed code may range in resource
costs. We believed that appropriate payment for these services would
further the refinement and implementation of BHI models of care, and
that having utilization data would inform future refinement of the
proposed code's valuation.
Comment: The commenters were supportive of new coding to support
payment for other BHI models of care. They believed G0507 could be used
by some smaller or medium sized practices who could not conform to the
strict parameters of the psychiatric CoCM but provide very similar
services. They also stated that G0507 would be appropriate to report
services furnished under other BHI models of care that may not require
psychiatric services. We received a few comments describing particular
models of care in great detail; a few commenters referenced the
Veterans' Administration BHI care models, the Primary Care Behavioral
Health/Behavioral Health Consultation (PCBH/BHC) Model, or general
models in place within other health care systems. However, there was
consensus among the commenters that another code(s) in addition to the
psychiatric CoCM codes would be useful to collect information on how
other behavioral health care models are being used and implemented.
Many commenters recommended that CMS provide more of a framework or
description of included services and provider types without being
unduly burdensome. Some commenters recommended service elements similar
to the CCM service elements (continuity of care with a designated
member of the care team; a written care plan; a comprehensive
assessment of behavioral health or psychiatric and other medical
conditions as well as any functional and psychosocial needs, updated as
necessary; routine evaluation of patient progress using a tracking
system; services should be documented in the medical record and
available to other treating professionals). These
[[Page 80237]]
commenters recommended that eligible patients should have a diagnosed
psychiatric or substance use disorder that requires care management
services. Several commenters recommended that BHI payments be tied to
the use of behavioral health assessment tools for screening and
collection of treatment outcomes throughout the sessions of care in
primary care. These commenters believed this would better position
behavioral health to benefit from the movement toward value-based
payment in the future. Some commenters assumed there is a designated
behavioral health care manager for the service described by G0507, and
recommended that we adopt similar rules for this care manager as apply
for clinical staff providing CCM services.
Response: We continue to believe that another code, or set of BHI
codes, in addition to the psychiatric CoCM code set would be useful to
pay appropriately for BHI services furnished to Medicare beneficiaries.
We also believe that such payment could facilitate our ability to
identify and collect data regarding similar or related BHI service
models. We agree with the commenters that we should provide more
specificity around the services eligible for reporting under this other
code(s). One way to do this would be to create codes with tiered times.
Some commenters supported such an approach, while others believed it
would be premature. At this time, we are not creating multiple levels
of codes distinguishing levels of general BHI services using time or
any other metric, but we may reconsider this in the future (also see
section II.L on G0507 valuation).
Regarding included elements of the general BHI service (G0507), we
agree with the commenters that we should be more specific in our
definition of this service. We wish to provide greater specificity
without being overly prescriptive, since a range of activities may be
included in BHI models of care other than the psychiatric CoCM. We
believe we should include a core set of service elements that are
similar to core elements of the psychiatric CoCM, especially a
systematic process for initial assessment and routine follow up
evaluation, revising the treatment approach or methods for patients who
are not progressing or whose status changes; facilitating and
coordinating behavioral health expertise and treatment; and designating
a member of the care team with whom the beneficiary has a continuous
relationship. We may revisit the included services in future years, but
for CY 2017 the required service elements for the general BHI service
(G0507) will be:
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.
Accordingly, the final code descriptor will be, G0507: 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.
We are aware of a number of validated rating scales that are
available for use for a number of conditions addressed by BHI models of
care, such as those described by the Kennedy Forum (see http://thekennedyforum-dot-org.s3.amazonaws.com/documents/MBC_supplement.pdf).
We are requiring the use of such scales when applicable to the
condition(s) that are being treated. Medication Assisted Treatment
(MAT) may be a treatment that is facilitated under the facilitating
treatment service element.
Regarding diagnosis, we believe we should specify similar
diagnostic criteria for G0507 and the psychiatric CoCM services (G0502,
G0503 and G0504). Accordingly we are providing that beneficiaries who
are appropriate candidates for services billed under G0507 will have an
identified psychiatric or behavioral health condition(s) that requires
a behavioral health care assessment, behavioral health care planning,
and provision of interventions. Eligible beneficiaries must present
with a condition(s) that in the treating practitioner's clinical
judgment, warrants the services included in G0507. The presenting
condition(s) may be pre-existing or newly diagnosed by the treating
practitioner, and may be refined as treatment progresses. Beneficiaries
receiving services reported under G0507 may, but are not required to
have comorbid chronic or other medical condition(s) that are being
managed by the treating practitioner. We are not limiting billing and
payment for G0507 to a specified set of behavioral health conditions,
because there may be overlap in behavioral health conditions; if we
specified only certain diagnoses, practitioners might modify diagnoses
to fit within payment rules; and for many beneficiaries for whom
specialty care is not available, or who choose for other reasons to
remain within primary care, their behavioral health condition(s) can be
addressed using a model of integrated care.
Regarding rules for clinical staff, we are clarifying that services
included in the code G0507 may be provided directly by the treating
practitioner or provided by other qualifying individuals (whom we term
``clinical staff'') under his or her direction, during the calendar
month service period. Unlike the psychiatric CoCM codes, for G0507
there is not necessarily a specific individual designated as a
``behavioral health care manager'' with formal or specialized education
in providing the services (although there could be). Similarly, there
is not necessarily a psychiatric or other behavioral health specialist
consultant (although there could be), and we note that G0507 is not
valued to explicitly account for such a consultant. We will apply the
same definition of the term ``clinical staff'' that we have applied for
CCM to G0507, namely, the CPT definition of this term, subject to the
incident to rules and regulations and applicable state law, licensure
and scope of practice at 42 CFR 410.26. For G0507, then, we note that
the term ``clinical staff'' will encompass or include a psychiatric or
other behavioral health specialist consultant, if the treating
practitioner obtains consultative expertise. Clinical staff that
provide included services do not have to be employed by the treating
practitioner or located on site, necessarily, and may or may not be a
professional who is permitted to independently furnish and report
services to Medicare. Time spent by administrative or clerical staff
cannot be counted towards the time required to bill G0507.
G0507 is valued to include minimal work by the treating
practitioner; the bulk of the valuation is based on clinical staff time
(see section II.L on valuation). However, we want to emphasize that the
[[Page 80238]]
treating practitioner must direct the service, continue to oversee the
beneficiary's care, and perform ongoing management, collaboration and
reassessment. If the service (or part thereof) is provided incident to
the treating practitioner's services, whether on site or remotely, the
clinical staff providing services must have a collaborative, integrated
relationship with the treating practitioner. They must also have a
continuous relationship with the beneficiary.
Evaluation and management services, such as face-to-face E/M
visits, may be separately billed during the service period or on the
same day as G0507, provided time is not counted twice towards the same
code.
For payment purposes, we are categorizing this service as a
designated care management service assigned general supervision for
purposes of ``incident to'' billing, because we do not believe it is
clinically necessary for the individuals on the team who provide
services other than the treating practitioner (namely, clinical staff)
to have the treating practitioner immediately available to them at all
times, as would be required under a higher level of supervision.
However, general supervision sets the minimum standard for supervision
and does not, by itself, meet the requirements we are setting for
billing new code G0507. While certain aspects of G0507 might be
furnished under general supervision, we do not believe the general
supervision requirement adequately describes the nature of the
relationship and interactions of the respective team members for
services furnished using BHI models of care or the codes we are
creating to describe those services. Moreover the general supervision
requirement only directly addresses the physical location of the
treating practitioner, not the location of clinical staff, necessarily.
Comment: Regarding behavioral health care planning, some commenters
noted that there is not necessarily value in accumulating or
enumerating a number of different types of care plans addressing
different aspects of the beneficiary's problems, such as a behavioral
or psychiatric care plan, a CCM care plan, and a cognitive impairment
care plan (see G0505 in section II.E.5).
Response: While any care planning should take into account the
whole patient, our intent is that the care planning included in the CCM
coding (and G0506, the CCM initiating visit add-on code) will be the
most comprehensive in nature, addressing all health issues with
particular focus on the multiple chronic conditions being managed by
the treating practitioner. In contrast, the BHI care planning will
focus on behavioral health or psychiatric issues, in particular, just
as the cognitive impairment care planning will focus on cognitive
impairment issues, in particular (see section II.E.5. of this final
rule).
However, we understand that adoption of EHRs may be lower among
behavioral health practitioners \9\ and note that resources are
available to help inform how care plans can support team-based care and
BHI.\10\ While we understand that practitioners, in general, are
exploring a wide variety of innovative approaches and tools that
facilitate care plan integration across clinical disciplines, at this
time, there may not be sufficient adoption of interoperable health IT
interoperability among all practitioners and providers treating a given
beneficiary to necessarily have a single, master care plan that
adequately addresses the progress of the beneficiary in relation to all
of these issues. In general, practitioners are encouraged to pursue
approaches that integrate health information from multiple sources into
a single care plan, but we understand that practitioners may need to
create separate documents or the relevant care planning may be
documented in another format within the medical record.
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\9\ See for instance http://dashboard.healthit.gov/quickstats/pages/physician-ehr-adoption-trends.php and https://www.thenationalcouncil.org/wp-content/uploads/2012/10/HIT-Survey-Full-Report.pdf.
\10\ For instance, AHRQ has a variety of resources on how shared
care plans can support team-based care and behavioral health
integration at https://integrationacademy.ahrq.gov/playbook/develop-shared-care-plan.
---------------------------------------------------------------------------
We believe the format of the care plan(s) is less important than
having a process whereby feedback and expertise from all relevant
practitioners and providers, whether internal or external to the
billing practice, are integrated into the beneficiary's treatment plan
and goals; that this plan be regularly assessed and revisited by the
practitioner who is assuming an overall care management role for the
beneficiary in a given month; that the patient is engaged in the care
planning process; and that the care planning be documented in the
medical record (as with any required element of any PFS service). We
have framed the care planning service element for G0507 accordingly,
``Behavioral health care planning in relation to behavioral/psychiatric
health problems, including revision for patients who are not
progressing or whose status changes.''
Comment: We received a few comments recommending codes in addition
to the psychiatric CoCM codes that would pay for similar services to
inpatients, or for behavioral health services by psychologists to
psychologically and medically complex patients in skilled nursing
facilities (SNF) and nursing homes. Some of these commenters stated
that in SNF and long-term care settings, psychologists work closely
with primary care physicians, psychiatrists, nurses, and other
consultants to improve outcomes by reducing inappropriate use or dosing
of psychotropic medications, improving activities of daily living, and
preventing avoidable admissions/falls. These commenters stated that
many health systems employ psychologists as BHI team leaders or
coordinators, and sought clarification on how psychologist-led teams
would operationalize the new BHI codes. These commenters believe that
psychology training provides unique skills in facilitating
interdisciplinary teams. While they acknowledged that psychologists are
not qualified to perform the full range of BHI services and
interventions, they believed psychologists should be able to separately
report and bill for care coordination and BHI initiation activities.
We received similar comments supporting the addition of psychiatric
collaborative care services to the PFS, and other evidence-based models
in a variety of primary care-based treatment settings. However, these
commenters supported the inclusion of social workers at all levels of
licensures as reimbursable providers of these services.
Response: We appreciate the commenters' descriptions of some
particular working models of care, and we welcome additional
information in this regard. We continue to believe it would be
appropriate to have new coding for a range of BHI care models
applicable to inpatient as well as outpatient and facility settings.
Our goal in separately identifying and paying for BHI services is to
prioritize accurate payment for these services, in recognition of the
associated time and complexity of the services. We agree that
beneficiaries who are admitted to a facility, are in long-term care, or
are transitioning among settings during the month are likely to be more
complex than other types of patients, and to warrant more- not less-
BHI services. Therefore, we have valued G0507 in both facility and non-
facility settings (see section II.L on valuation). We are not limiting
the time that can be counted towards the monthly time
[[Page 80239]]
requirement to bill G0507 to time that is spent in the care of an
outpatient or a beneficiary residing in the community. As we provide
for the psychiatric CoCM services, G0507 may be reported by specialties
that are not ``traditional'' primary care specialties, if such
specialists furnish the included services. However, we stress that
G0507 can only be reported by a treating physician or other qualified
health care professional when he or she has directed the BHI service
for the duration of time that he or she is reporting it, and has a
qualifying relationship with individuals providing the service under
his or her direction and control. Also, time and effort that is spent
managing care transitions for CCM or TCM patients and that is counted
towards reporting TCM or CCM services, cannot also be counted towards
reporting any transitional care management activities reported under a
BHI service code(s). We welcome additional input from stakeholders
regarding appropriate (or inappropriate) settings of service for G0507.
Since the BHI initiating visit that is required to bill G0507 is
not within the scope of practice of a psychologist or social worker
(see below), psychologists and social workers will not be able to
report G0507 directly (although a psychiatrist may be able to do so).
Psychologists and social workers may provide care management services
included in G0507 incident to the services of another (billing)
practitioner. They may also provide services that are separately
billable during the service period. We appreciate the commenters'
support for team-based care, and we recognize the substantial role of
various types of mental health professionals within a primary care
team. We are interested in receiving additional input from stakeholders
as to whether and why behavioral health care management services by a
social worker, psychologist or similarly qualified professional should
be reportable in its own right, rather than incident to the services of
a practitioner authorized to bill Medicare for a BHI initiating visit.
Consistent with our recent approaches to making proposals under PFS
notice and comment rulemaking, we could consider adopting new coding
under a different construct that was not defined as BHI, if
stakeholders provided sufficient input on how to design, define and
value the services. We would also consider such changes if adopted by
the CPT Editorial Panel, per our usual process. BHI integrates
behavioral health expertise into evaluation and management care.
Therefore G0507 is designed to include services that require the
oversight and involvement of a practitioner who can perform evaluation
and management services, including facilitation of any needed
pharmacotherapy, referral for specialty care, and overall management of
the beneficiary's treatment in relation to primary care treatment. We
note that G0507 would not be independently billed by psychologists or
social workers, though from our understanding of various models of BHI,
these professionals seem likely to be participants in team-based care
for beneficiaries receiving these services.
c. BHI Initiating Visit
Similar to CCM services (see section II.E.4), we proposed to
require an initiating visit for all of the BHI codes (G0502, G0503,
G0504 and G0507) that would be billable separate from the BHI services
themselves. We proposed that the same services that can serve as the
initiating visit for CCM services (see section II.E.4.a. of this final
rule) could serve as the initiating visit for the proposed BHI codes.
The initiating visit would establish the beneficiary's relationship
with the billing practitioner (most aspects of the BHI services would
be furnished incident to the billing practitioner's professional
services), ensure the billing practitioner assesses the beneficiary
prior to initiating care management processes, and provide an
opportunity to obtain beneficiary consent (discussed below). We
solicited public comment on the types of services that are appropriate
for an initiating visit for the BHI codes, and within what timeframe
the initiating visit should be conducted prior to furnishing BHI
services.
Comment: The commenters were largely supportive of our proposal to
allow the same services to qualify for the initiating visit to CCM as
for the initiating visit to BHI services. We received a few comments
stating that in addition to the qualifying E/M services (or an AWV or
IPPE), initiating services should include in-depth psychological
evaluations delivered by a psychologist including CPT codes 90791,
96116 or 96118 which, in turn, include care plan development. These
commenters agreed that psychologists cannot personally furnish all BHI
services (for example, medication reconciliation), but believe
psychologists effectively coordinate care and perform other aspects of
BHI services as part of a team under current practice models. They
believe this approach would be particularly effective for reducing
inappropriate use or dosing of psychotropic medications in elderly and
complex patients, improving activities of daily living, and preventing
avoidable admissions and falls.
Response: We appreciate the commenters' feedback. We agree that
psychologists would be qualified to perform care coordination that is
included in the psychiatric CoCM codes (G0502, G0503 and G0504) and the
general BHI code (G0507) under the direction of a physician or other
qualified health care professional. In addition, beneficiaries
receiving BHI services under any of those codes may be referred to
psychologists for psychotherapy or other services that are separately
billable and within the scope of practice of psychologists, as
discussed elsewhere in this section of our final rule. However many
commenters acknowledged, and we agree, that a BHI initiating visit is
necessary. The initiating visit is not, in its entirety, within the
scope of psychologist practice. Therefore, we are finalizing our
proposal that the same services that qualify as the initiating visit
for CCM will also qualify as initiating services for BHI, and they do
not include in-depth psychological evaluation by a psychologist. Also,
we will require an initiating visit for BHI only for new patients or
beneficiaries not seen within a year of commencement of BHI services
(the same requirement we are finalizing for CCM, see section II.E.4.a).
As more experience is gained with the psychiatric CoCM services and
other models of BHI care, we may reassess these provisions.
As discussed above, we are interested in receiving input from
stakeholders regarding circumstances other than BHI in which behavioral
health care management services by a psychologist, social worker or
similarly qualified professional should be reportable in its own right,
rather than incident to the services of a practitioner authorized to
bill Medicare for a BHI initiating visit.
Comment: Some commenters recommended that CMS establish an add-on
code to the initiating visit for BHI services, parallel to G0506 (the
proposed add-on code for the CCM initiating visit).
Response: We do not believe we have enough information about
practice patterns at this time to create an add-on code to the BHI
initiating visit, and we did not propose such a code. We may re-examine
this issue in the future.
d. Beneficiary Consent for BHI Services
Commenters to the CY 2016 PFS proposed rule indicated that they did
not believe a specific patient consent for BHI services is necessary
and indicated that requiring special informed consent
[[Page 80240]]
for these services may reduce access due to stigma associated with
behavioral health conditions. Instead, the commenters recommended
requiring a more general consent prior to initiating these services
whereby the beneficiary gives the initiating physician or practitioner
permission to consult with relevant specialists, which would include
conferring with a psychiatric consultant. Accordingly, we proposed to
require a general beneficiary consent to consult with relevant
specialists prior to initiating these services, recognizing that
applicable rules continue to apply regarding privacy. The proposed
general consent would encompass conferring with a psychiatric
consultant when furnishing the psychiatric CoCM codes (G0502, G0503,
and G0504) or the proposed broader BHI code (G0507). Similar to the
proposed beneficiary consent process for CCM services, we proposed that
the billing practitioner must document in the beneficiary's medical
record that the beneficiary's consent was obtained to consult with
relevant specialists including a psychiatric consultant, and that, as
part of the consent, the beneficiary is informed that there is
beneficiary cost-sharing, including potential deductible and
coinsurance amounts, for both in-person and non-face-to-face services
that are provided. We solicited stakeholder comments on this proposal.
We recognized that special informed consent could also be helpful
in cases when a particular service is limited to being billed by a
single practitioner for a particular beneficiary. We did not believe
that there are circumstances where it would reasonable for multiple
practitioners to be reporting these codes during the same month.
However, we did not propose a formal limit at this time. We solicited
comment on whether such a limitation would be beneficial or whether
there are circumstances under which a beneficiary might reasonably
receive BHI services from more than one practitioner during a given
month.
Comment: The commenters were largely supportive of our proposal
regarding BHI consent, some noting that physician-to-physician
communication as well as communication within treatment teams happens
routinely, without an extra layer of formal written consent, for other
medical conditions. A few commenters intimated that CMS might pursue a
single broad consent that could be used across care management
services; for example, applying for both CCM and BHI. We did not
receive any public comments delineating the circumstances under which
it would be appropriate to bill for services furnished using more than
one BHI service model per month, or appropriate for more than one
practitioner (whether in the same practice or different practices) to
bill for services furnished in a BHI care model per month.
Response: We agree with the commenters that physician-to-physician
communication as well as communication within treatment teams happens
routinely, without an extra layer of formal written consent, for other
medical conditions. However there are particular privacy concerns
addressed by other rules and regulations for some behavioral health or
substance use care. Also we are concerned that beneficiaries should not
incur unexpected expenses for care that is largely, or in significant
part, non-face-to-face in nature. Finally, there are issues to
consider, that we considered for CCM, regarding prevention of
duplicative practitioner billing, and whether BHI services can actually
be furnished under the direction and control of any given practitioner
if for a given service period, more than one practitioner is furnishing
BHI services and billing them.
The public comments were supportive of our proposal for a broad
consent that could be verbally obtained but must be documented in the
medical record, and we are finalizing as proposed. At this time, we do
not believe a single consent process for both BHI and CCM is advisable.
It is not clear how frequently BHI and CCM would or should be furnished
concurrently. BHI and CCM are distinct, separate services, having
significant differences in time thresholds, the nature of the services,
types of individuals providing the services, and payment and cost
sharing amounts. Therefore, at this time, we are maintaining separate
consent processes for CCM and BHI, as provided in the respective
sections of this final rule. Also, as discussed in section II.E.4 on
CCM, CCM and BHI may be billed during the same service period.
It remains unclear whether it would be reasonable and necessary for
more than one practitioner (whether in the same practice or different
practices) to bill BHI services for a given beneficiary for a given
service period, given the lack of public response and input on this
issue. It may depend on the conditions(s) being treated and whether
specialty care, other than psychiatric or behavioral health specialty
care, and primary care are both involved. We are not proposing a formal
limit at this time, but we stress that BHI services can only be
reported by a treating physician or other qualified health care
professional when he or she has obtained the required beneficiary
consent, directed the BHI services he or she reports for the duration
of time reported, and has a qualifying relationship with individuals
providing the reported services under his or her direction and control.
We would not expect a single practitioner to furnish care to a given
beneficiary under more than one BHI model of care during a given month.
Therefore a single practitioner must choose whether to report
psychiatric CoCM code(s) (G0502, G0503, and G0504 as applicable) or the
general BHI code (G0507) for a given month for a given beneficiary. We
remind stakeholders that time cannot be counted more than once towards
any code(s), all services must be medically reasonable and necessary,
and that beneficiary cost sharing and advance consent apply. We will be
monitoring the claims data and studying the utilization patterns. We
will continue to assess appropriate reporting patterns, and we expect
that potential coding changes by the CPT Editorial Panel may inform
this issue.
Comment: We received a number of comments recommending that cost
sharing be removed for all care management services, whether through
legislative change, demonstration, waiver safe harbor, or designation
as preventive services.
Response: We appreciate commenters' concerns and recognize many of
the challenges associated with patient cost-sharing for these kinds of
services. At this time, we do not have authority to waive cost sharing
for the BHI or other care management services. We appreciate the
commenters' acknowledgement of our current limitations and we will
continue to consider this issue.
e. Summary of Final BHI Policies
Beginning in CY 2017, we are providing separate payment for a range
of BHI services. Specifically, we are providing payment for psychiatric
CoCM services under the following codes:
G0502: 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;
[[Page 80241]]
++ 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.
G0503: 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.
G0504: Initial or subsequent psychiatric collaborative
care management, each additional 30 minutes in a calendar month of
behavioral health care manager activities, in consultation with a
psychiatric consultant, and directed by the treating physician or other
qualified health care professional (List separately in addition to code
for primary procedure) (Use G0504 in conjunction with G0502, G0503).
These psychiatric CoCM services are reported by the treating
physician or other qualified health care professional for services
furnished during a calendar month service period. These services may be
furnished when a beneficiary has a psychiatric or behavioral health
condition(s) that in the treating physician or other qualified health
care professional's clinical judgment, requires a behavioral health
care assessment; establishing, implementing, revising, or monitoring a
care plan; and provision of brief interventions. The diagnosis or
diagnoses may be pre-existing or made by the treating physician or
other qualified health care professional, and may be refined over time.
The psychiatric CoCM services may be furnished to beneficiaries with
any psychiatric or behavioral health condition(s) that is being treated
by the physician or other qualified health care professional, including
substance use disorders. Beneficiaries receiving psychiatric CoCM
services may, but are not required to have comorbid chronic or other
medical condition(s) that are being managed by the treating
practitioner.
Psychiatric CoCM services include the services of the treating
physician or other qualified health care professional, the behavioral
health care manager (see description below) who provides services
incident to services of the treating physician or other qualified
health care professional, and the psychiatric consultant (see
description below) whose consultative services are furnished incident
to services of the treating physician or other qualified health care
professional. Time spent by administrative or clerical staff cannot be
counted towards the time required to bill the psychiatric CoCM service
codes.
Beneficiaries receiving psychiatric CoCM services may have newly
diagnosed conditions, need help in engaging in treatment, have not
responded to standard care delivered in a non-psychiatric setting, or
require further assessment and engagement prior to consideration of
referral to a psychiatric care setting. Beneficiaries are treated for
an episode of care, defined as beginning when the behavioral health
care manager engages in care of the beneficiary under the appropriate
supervision of the billing practitioner and ending with:
The attainment of targeted treatment goals, which
typically results in the discontinuation of care management services
and continuation of usual follow-up with the treating physician or
other qualified healthcare professional; or
Failure to attain targeted treatment goals culminating in
referral to a psychiatric care provider for ongoing treatment; or
Lack of continued engagement with no psychiatric
collaborative care management services provided over a consecutive 6-
month calendar period (break in episode).
A new episode of care will start after a break in episode of 6 calendar
months or more.
The treating physician or other qualified health care professional
directs the behavioral health care manager and continues to oversee the
beneficiary's care, including prescribing medications, providing
treatments for medical conditions, and making referrals to specialty
care when needed. The treating physician or other qualified health care
professional must remain involved in ongoing oversight, management,
collaboration and reassessment as appropriate to bill the psychiatric
CoCM codes.
The behavioral health care manager has formal education or
specialized training in behavioral health (which could include a range
of disciplines, for example, social work, nursing, and psychology). The
behavioral health care manager provides care management services, as
well as an assessment of needs, including the administration of
validated rating scales; \11\ 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 interventions; ongoing collaboration with the treating
physician or other qualified health care professional; maintenance of a
registry; \12\ all in consultation with the psychiatric consultant. The
behavioral health care manager is available to provide these services
face-to-face and non-face-to-face, and consults with the psychiatric
consultant minimally on a weekly basis.
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\11\ For example, see https://aims.uw.edu/resource-library/measurement-based-treatment-target.
\12\ For example, see https://aims.uw.edu/collaborative-care/implementation-guide/plan-clinical-practice-change/identify-population-based.
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The behavioral health care manager must have a collaborative,
integrated relationship with the rest of the care team members, and be
able to perform all of the required elements of the service delineated
for the behavioral health care manager. The behavioral health care
manager must have the ability to engage the beneficiary outside of
regular clinic hours as necessary to perform the behavioral health care
manager's duties under the psychiatric CoCM model, and must have a
continuous relationship with the beneficiary. The behavioral health
care manager may or may not be a
[[Page 80242]]
professional who meets all the requirements to independently furnish
and report services to Medicare. The behavioral health care manager is
subject to the incident to rules and regulations and applicable state
law, licensure and scope of practice (see 42 CFR 410.26).
The psychiatric consultant is a medical professional trained in
psychiatry and qualified to prescribe the full range of medications.
The psychiatric consultant advises and makes recommendations, as
needed, for psychiatric and other medical care, including psychiatric
and other medical diagnoses, treatment strategies including appropriate
therapies, medication management, medical management of complications
associated with treatment of psychiatric disorders, and referral for
specialty services, that are communicated to the treating physician or
other qualified health care professional, typically through the
behavioral health care manager. The psychiatric consultant does not
typically see the beneficiary or prescribe medications, except in rare
circumstances, but can and should facilitate referral for direct
provision of psychiatric care when clinically indicated. The
psychiatric consultant is subject to the incident to rules and
regulations and applicable state law, licensure and scope of practice
(see 42 CFR 410.26).
Beginning in CY 2017, we are providing separate payment for BHI
services furnished under models of care other than the psychiatric CoCM
model, under HCPCS code G0507: 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.
G0507 is reported by the treating physician or other qualified
health care professional for services furnished during a calendar month
service period. This service may be furnished when the beneficiary has
a psychiatric or behavioral health condition(s) that in the treating
physician or other qualified health care professional's clinical
judgment, requires a behavioral health care assessment, behavioral
health care planning, and provision of interventions. The presenting
condition(s) may be pre-existing or newly diagnosed by the treating
physician or other qualified health care professional, and may be
refined over time. Beneficiaries receiving services reported under
G0507 may have any psychiatric or behavioral health condition(s) that
is being treated by the physician or other qualified health care
professional, including substance use disorders. Beneficiaries
receiving services reported under G0507 may, but are not required to
have comorbid chronic or other medical condition(s) that are being
managed by the treating practitioner.
Services reported under G0507 may be provided directly by the
treating physician or other qualified health care professional, or
provided by clinical staff under his or her direction, during a
calendar month service period. For G0507, there is not necessarily a
specific individual designated as a ``behavioral health care manager''
with formal or specialized education in providing the services
(although there could be). Similarly, there is not necessarily a
psychiatric or other behavioral health specialist consultant (although
there could be) and we note that G0507 is not valued to explicitly
account for expert consultation. For G0507, the term ``clinical staff''
means the CPT definition of this term, subject to the incident to rules
and regulations and applicable state law, licensure and scope of
practice at 42 CFR 410.26. For G0507, then, we note that the term
``clinical staff'' will encompass or include any psychiatric or other
behavioral health specialist consultant that may provide consultative
services. Clinical staff providing services are not required to be
employed by the treating practitioner or located on site, and these
individuals may or may not be a professional permitted to independently
furnish and report services to Medicare. Time spent by administrative
or clerical staff cannot be counted towards the time required to report
G0507. We emphasize that the physician or other qualified health care
professional must direct the service, continue to oversee the
beneficiary's care, and perform ongoing management, collaboration and
reassessment. If the service (or part thereof) is provided incident to
services of the treating practitioner, whether on site or remotely, the
clinical staff providing services must have a collaborative, integrated
relationship with the treating practitioner. They must also have a
continuous relationship with the beneficiary.
For all of the BHI service codes (G0502, G0503, G0504 and G0507),
we are requiring an initiating visit that is billable separate from the
BHI services themselves. The same services that qualify as initiating
visits for CCM services can serve as the initiating visit for BHI
services (certain face-to-face E/M services including the face-to-face
visit required for TCM services, and the AWV or IPPE). The BHI
initiating visit establishes the beneficiary's relationship with the
treating practitioner (BHI services may be furnished incident to the
treating practitioner's professional services); ensures that the
treating practitioner assesses the beneficiary prior to initiating care
management processes; and provides an opportunity to obtain beneficiary
consent (consent may also be obtained outside of the BHI initiating
visit, as long as it is obtained prior to commencement of BHI
services).
For all of the BHI service codes, we are also requiring prior
beneficiary consent, recognizing that applicable rules continue to
apply regarding privacy. The consent will include permission to consult
with relevant specialists including a psychiatric consultant, and
inform the beneficiary that cost sharing will apply to in-person and
non-face-to-face services provided. Consent may be verbal (written
consent is not required) but must be documented in the medical record.
For payment purposes, we are assigning general supervision to all
of the BHI service codes (G0502, G0503, G0504 and G0507). However we
note that general supervision does not, by itself, comprise a
qualifying relationship between the treating practitioner and other
individuals providing BHI services under the incident to relationship.
Also we note that we valued BHI services in both facility and non-
facility settings. BHI services may be furnished to beneficiaries in
any setting of care. Time that is spent furnishing BHI services to a
beneficiary who is an inpatient or in any other facility setting during
service provision or for any part of the service period may be counted
towards reporting a BHI code(s). We refer the reader to our discussion
above on this matter, as well as reporting by specialty, intersection
with other services, and potential reporting by more than one
practitioner for a given beneficiary within a service period. A single
practitioner must choose whether to report psychiatric CoCM code(s)
(G0502, G0503, and
[[Page 80243]]
G0504 as applicable) or the general BHI code (G0507) for a given month
(service period) for a given beneficiary.
4. Reducing Administrative Burden and Improving Payment Accuracy for
Chronic Care Management (CCM) Services
Beginning in CY 2015, we implemented separate payment for CCM
services under CPT code 99490 (Chronic care management services, at
least 20 minutes of clinical staff time directed by a physician or
other qualified health professional, per calendar month, with the
following required elements:
Multiple (two or more) chronic conditions expected to last
at least 12 months, or until the death of the patient;
Chronic conditions place the patient at significant risk
of death, acute exacerbation/decompensation, or functional decline;
Comprehensive care plan established, implemented, revised,
or monitored).
In the CY 2015 final rule with comment period, we finalized a
proposal to make separate payment for CCM services as one initiative in
a series of initiatives designed to improve payment for, and encourage
long-term investment in, care management services (79 FR 67715). In
particular, we sought to address an issue raised to us by the physician
community, which stated that the care management included in many of
the existing E/M services, such as office visits, does not adequately
describe the typical non-face-to-face care management work required by
certain categories of beneficiaries (78 FR 43337). We began to re-
examine how Medicare should pay under the PFS for non-face-to-face care
management services that were bundled into the PFS payment for face-to-
face E/M visits, being included in the pre- and post-encounter work (78
FR 43337). In proposing separate payment for CCM, we acknowledged that,
even though we had previously considered non-face-to-face care
management services as bundled into the payment for face-to-face E/M
visits, the E/M office/outpatient visit CPT codes may not reflect all
the services and resources required to furnish comprehensive,
coordinated care management for certain categories of beneficiaries. We
stated that we believed that the resources required to furnish complex
chronic care management services to beneficiaries with multiple (that
is, two or more) chronic conditions were not adequately reflected in
the existing E/M codes. Medical practice and patient complexity
required physicians, other practitioners and their clinical staff to
spend increasing amounts of time and effort managing the care of
comorbid beneficiaries outside of face-to-face E/M visits, for example,
complex and multidisciplinary care modalities that involve regular
physician development and/or revision of care plans; subsequent report
of patient status; review of laboratory and other studies;
communication with other health care professionals not employed in the
same practice who are involved in the patient's care; integration of
new information into the care plan; and/or adjustments of medical
therapy.
Therefore, in the CY 2014 PFS final rule with comment period, we
established a separate payment under the PFS for CPT code 99490 (78 FR
43341 through 43342). We sought to include a relatively broad eligible
patient population within the code descriptor, established a moderate
payment amount, and established bundled payment for concurrently new
CPT codes that were reserved for beneficiaries requiring ``complex''
CCM services (base CPT code 99487 and its add-on code 99489) (79 FR
67716 through 67719). We stated that we would evaluate the services
reported under CPT code 99490 to assess whether the service is targeted
to the right population and whether the payment amount is appropriate
(79 FR 67719). We remind stakeholders that CMS did not limit the
eligible population to any particular list of chronic conditions other
than the language in the CPT code descriptor. Accordingly, one or more
of the chronic conditions being managed through CCM services could be
chronic mental health or behavioral health conditions or chronic
cognitive disorders, as long as the chronic conditions meet the
eligibility language in the CPT code descriptor for CCM services and
the billing practitioner meets all of Medicare's requirements to bill
the code including comprehensive, patient-centered care planning for
all health conditions.
In finalizing separate payment for CPT code 99490, we considered
whether we should develop standards to ensure that physicians and other
practitioners billing the service would have the capability to fully
furnish the service (79 FR 67721). We sought to make certain that the
newly payable PFS code(s) would provide beneficiary access to
appropriate care management services that are characteristic of
advanced primary care, such as continuity of care; patient support for
chronic diseases to achieve health goals; 24/7 patient access to care
and health information; receipt of preventive care; patient, family and
caregiver engagement; and timely coordination of care through
electronic health information exchange. Accordingly, we established a
set of scope of service elements and payment rules in addition to or in
lieu of those established in CPT guidance (in the CPT code descriptor
and CPT prefatory language), that the physician or nonphysician
practitioner must satisfy to fully furnish CCM services and report CPT
code 99490 (78 FR 74414 through 74427, 79 FR 67715 through 67730, and
80 FR 14854). We established requirements to furnish a preceding
qualifying visit, obtain advance written beneficiary consent, use
certified electronic health record (EHR) technology to furnish certain
elements of the service, share the care plan and clinical summaries
electronically, document specified activities, and other items
summarized in Table 11 of our CY 2017 proposed rule. For the CCM
service elements for which we required use of a certified EHR, the
billing practitioner must use, at a minimum, technology meeting the
edition(s) of certification criteria that is acceptable for purposes of
the EHR Incentive Programs as of December 31st of the calendar year
preceding each PFS payment year. (For the CY 2017 PFS payment year,
this would mean technology meeting the 2014 edition of certification
criteria).
These elements and requirements for separately payable CCM services
are extensive and generally exceed those required for payment of codes
describing procedures, diagnostic tests, or other E/M services under
the PFS. In addition, both CPT guidance and Medicare rules specify that
only a single practitioner who assumes the care management role for a
given beneficiary can bill CPT code 99490 per service period (calendar
month). Because the new CCM service closely overlapped with several
Medicare demonstration models of advanced primary care (the Multi-Payer
Advanced Primary Care Practice (MAPCP) demonstration and the
Comprehensive Primary Care Initiative (CPCI)), we provided that
practitioners participating in one of these two initiatives could not
be paid for CCM services furnished to a beneficiary attributed by the
initiative to their practice (79 FR 67729).
Given the non-face-to-face nature of CCM services, we also sought
to ensure that beneficiaries would receive advance notice that Part B
cost sharing applies since we currently have no legislative authority
to ``waive'' cost sharing for this service. Also since only one
practitioner can bill for CCM each service period, we believed the
[[Page 80244]]
beneficiary notice requirement would help prevent duplicate payment to
multiple practitioners.
Since the establishment of CPT code 99490 for separate payment of
CCM services, in a number of forums and in public comments to the CY
2016 PFS final rule (80 FR 70921), many practitioners have stated that
the service elements and billing requirements are burdensome, redundant
and prevent them from being able to provide the services to
beneficiaries who could benefit from them. Stakeholders have stated
that CPT code 99490 is underutilized because it is underpaid relative
to the resources involved in furnishing the services, especially given
the extensive Medicare rules for payment, and they have suggested a
number of potential changes to our current payment rules. Stakeholders
continue to believe that many of the CCM payment rules are duplicative,
and to recommend that we reduce the rules and expand CCM coding and
payment to distinguish among different levels of patient complexity. We
also note that section 103 of the MACRA requires CMS to assess and
report to Congress (no later than December 31, 2017) on access to CCM
services by underserved rural and racial and ethnic minority
populations and to conduct an outreach/education campaign that is
underway.
The professional claims data for CPT code 99490 show that
utilization is steadily increasing but may remain low considering the
number of eligible Medicare beneficiaries. To date, approximately
513,000 unique Medicare beneficiaries received the service an average
of four times each, totaling $93 million in total payments. Since CPT
code 99490 describes a minimum of 20 minutes of clinical staff time
spent furnishing CCM services during a month and does not have an upper
time limit, and since we currently do not separately pay the other
codes in the CCM family of CPT codes (which would provide us with
utilization data on the number of patients requiring longer service
times during a billing period), we do not know how often beneficiaries
required more than 20 minutes of CCM services per month. We also do not
know their complexity relative to one another, other than meeting the
acuity criteria in the CPT code descriptor. Initial information from
practitioner interviews conducted as part of our CCM evaluation efforts
indicates that practitioners overwhelmingly meet and exceed the 20-
minute threshold time for billing CCM. Typically, these practitioners
reported spending between 45 minutes and an hour per month on CCM
services for each patient, with times ranging between 20 minutes and
several hours per month. CCM beneficiaries tend to exhibit a higher
disease burden, are more likely to be dually eligible for Medicare and
Medicaid, and are older than the general Medicare fee-for-service
population.\13\ However, absent multiple levels of CCM coding, we do
not have comprehensive data on the relative complexity of the CCM
services furnished to beneficiaries.
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\13\ Schurrer, John, and Rena Rudavsky. ``Evaluation of the
Diffusion and Impact of the Chronic Care Management (CCM) Fees:
Third Quarterly Report.'' Report submitted to the Center for
Medicare and Medicaid Innovation. Washington, DC: Mathematica Policy
Research, May 6, 2016.
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In light of this stakeholder feedback and our mandate under MACRA
section 103 to encourage and report on access to CCM services, we
proposed several changes in the payment rules for CCM services. Our
primary goal, and our statutory mandate, is to pay as accurately as
possible for services furnished to Medicare beneficiaries based on the
relative resources required to furnish PFS services, including CCM
services. In so doing, we also expect to facilitate beneficiaries'
access to reasonable and necessary CCM services that improve health
outcomes. First, for CY 2017 we proposed to more appropriately
recognize and pay for the other codes in the CPT family of CCM services
(CPT codes 99487 and 99489 describing complex CCM), consistent with our
general practice to price services according to their relative ranking
within a given family of services. We direct the reader to section II.L
of this final rule for a discussion of valuation for base CPT code
99487 and its add-on CPT code 99489. The CPT code descriptors are:
CPT code 99487--Complex chronic care management services,
with the following required elements:
++ Multiple (two or more) chronic conditions expected to last at
least 12 months, or until the death of the patient;
++ Chronic conditions place the patient at significant risk of
death, acute exacerbation/decompensation, or functional decline;
++ Establishment or substantial revision of a comprehensive care
plan;
++ Moderate or high complexity medical decision making;
++ 60 minutes of clinical staff time directed by a physician or
other qualified health care professional, per calendar month.
CPT code 99489--Each additional 30 minutes of clinical
staff time directed by a physician or other qualified health care
professional, per calendar month (List separately in addition to code
for primary procedure).
As CPT provides, less than 60 minutes of clinical staff time in the
service period could not be reported separately, and similarly, less
than 30 minutes in addition to the first 60 minutes of complex CCM in a
service period could not be reported. We would require 60 minutes of
services for reporting CPT code 99487 and 30 additional minutes for
each unit of CPT code 99489.
We proposed to adopt the CPT provision that CPT codes 99487, 99489
and 99490 may only be reported once per service period (calendar month)
and only by the single practitioner who assumes the care management
role with a particular beneficiary for the service period. That is, a
given beneficiary would be classified as eligible to receive either
complex or non-complex CCM during a given service period, not both, and
only one professional claim could be submitted to the PFS for CCM for
that service period by one practitioner.
Comment: Several commenters were supportive of separate payment for
complex CCM services.
Response: We thank the commenters for their support and are
finalizing separate payment for CPT codes 99487 and 99489 as proposed.
As finalized, these separate payments for complex CCM services will
support care management for the most complex and time-consuming cases
of beneficiaries with multiple chronic conditions.
Except for differences in the CPT code descriptors, we proposed to
require the same CCM service elements for CPT codes 99487, 99489 and
99490. In other words, all the requirements in Table 11 of our proposed
rule would apply, whether the code being billed for the service period
is CPT code 99487 (plus CPT code 99489, if applicable) or CPT code
99490. These three codes would differ in the amount of clinical staff
service time provided; the complexity of medical decision-making as
defined in the E/M guidelines (determined by the problems addressed by
the reporting practitioner during the month); and the nature of care
planning that was performed (establishment or substantial revision of
the care plan for complex CCM versus establishment, implementation,
revision or monitoring of the care plan for non-complex CCM). Billing
practitioners could consider identifying beneficiaries who require
complex CCM services using criteria suggested in CPT guidance (such as
number of illnesses, number of medications or repeat admissions or
emergency department visits) or the profile of typical patients in the
CPT
[[Page 80245]]
prefatory language, but these would not comprise Medicare conditions of
eligibility for complex CCM.
We proposed several changes to our current scope of service
elements for CCM, and proposed that the same scope of service elements,
as amended, would apply to all codes used to report CCM services
beginning in 2017 (i.e., CPT codes 99487, 99489 and 99490). In
particular, we proposed changes in the requirements for the initiating
visit, 24/7 access to care and continuity of care, format and sharing
of the care plan and clinical summaries, beneficiary receipt of the
care plan, beneficiary consent and documentation.
Comment: Commenters were broadly supportive of these proposals. We
received several comments recommending changes to the scope of service
for non-complex CCM that might improve the distinction between non-
complex and complex CCM and inform which ``level'' of service a given
beneficiary is eligible for. For example, these commenters suggested
changes to the time included in the code descriptor to reflect two or
more time increments for CPT code 99490 using add-on codes, or
retaining the current low time threshold while allowing practitioners
to choose among certain service elements. Some commenters do not
believe CPT code 99490 is intended for beneficiaries who require all
the current service elements in a given month, and that only a more
limited set of elements is medically necessary for the non-complex
population.
Response: We appreciate the commenters' recommendations about how
we might better distinguish complex CCM services from non-complex CCM
services. The CPT Editorial Panel currently maintains the coding for
CCM services. Further changes in codes and/or descriptors may be
appropriately addressed by CPT and in subsequent PFS rulemaking.
a. CCM Initiating Visit & Add-On Code (G0506)
As provided in the CY 2014 PFS final rule with comment period (78
FR 74425) and subregulatory guidance (available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/Payment_for_CCM_Services_FAQ.pdf), CCM must be initiated by the billing
practitioner during a ``comprehensive'' E/M visit, AWV or IPPE. This
face-to-face, initiating visit is not part of the CCM service and can
be separately billed to the PFS, but is required before CCM services
can be provided directly or under other arrangements. The billing
practitioner must discuss CCM with the patient at this visit. While
informed patient consent does not have to be obtained during this
visit, the visit is an opportunity to obtain the required consent. The
face-to-face visit included in transitional care management (TCM)
services (CPT codes 99495 and 99496) qualifies as a ``comprehensive''
visit for CCM initiation. Levels 2 through 5 E/M visits (CPT codes
99212 through 99215) also qualify; CMS does not require the practice to
initiate CCM during a level 4 or 5 E/M visit. However, CPT codes that
do not involve a face-to-face visit by the billing practitioner or are
not separately payable by Medicare (such as CPT code 99211,
anticoagulant management, online services, telephone and other E/M
services) do not qualify as initiating visits. If the practitioner
furnishes a ``comprehensive'' E/M, AWV, or IPPE and does not discuss
CCM with the patient at that visit, that visit cannot count as the
initiating visit for CCM.
We continued to believe that we should require an initiating visit
in advance of furnishing CCM services, separate from the services
themselves, because a face-to-face visit establishes the beneficiary's
relationship with the billing practitioner and most aspects of the CCM
services are furnished incident to the billing practitioner's
professional services. The initiating visit also ensures collection of
comprehensive health information to inform the care plan. We continued
to believe that the types of face-to-face services that qualify as an
initiating visit for CCM are appropriate. We did not propose to change
the kinds of visits that can qualify as initiating CCM visits. However,
we proposed to require the initiating visit only for new patients or
patients not seen within one year instead of for all beneficiaries
receiving CCM services. We believed this would allow practitioners with
existing relationships with patients who have been seen relatively
recently to initiate CCM services without furnishing a potentially
unnecessary E/M visit. We solicited public comment on whether a period
of time shorter than one year would be more appropriate.
Comment: The commenters were generally supportive of requiring the
CCM initiating visit only for beneficiaries who are new patients or
have not been seen in a year. A few commenters suggested a 6-month
timeframe, or adopting one year and reconsidering as we gain more
experience with CCM. Some commenters misinterpreted our proposal as
requiring face-to-face visits every year to periodically reassess the
beneficiary or the appropriateness of CCM services. Some recommended a
similar coding structure for specialists managing a single condition,
in place of prolonged services, or for BHI services.
Response: Our intent was to revise the timeframe for the single CCM
initiating visit that is required at the outset of services. We did not
propose subsequent ``re-initiation'' of CCM services or face-to-face
reassessment within a given timeframe. We discuss further below that we
have some concerns about how to ensure that the billing practitioner
remains involved in the beneficiary's care and continually reassesses
the beneficiary's care, but at this time we do not believe we should
require subsequent face-to-face visits within certain timeframes to
address those concerns.
We believe that the proposed one-year timeframe for the single, CCM
initiating visit is appropriate for CY 2017, so we are finalizing as
proposed. We will require the CCM initiating visit only for new
patients or patients not seen within the year prior to commencement of
CCM (instead of for all beneficiaries receiving CCM services). We will
continue to consider in future years whether a different timeframe is
warranted. The goal of our final policy is to allow practitioners with
existing relationships with beneficiaries who have been seen relatively
recently to initiate CCM services (for the first time) without
furnishing a potentially unnecessary E/M visit. Regarding subsequent
visits (after CCM services begin), practitioners are already permitted
to furnish and separately bill subsequent E/M visits (or AWVs) for
beneficiaries receiving CCM services. If a face-to-face reassessment is
reasonable and necessary and furnished by the billing practitioner,
then he or she may bill an appropriate code describing the face-to-face
assessment of a beneficiary to whom they have previously furnished CCM
services.
We also proposed for CY 2017 to create a new add-on G-code that
would improve payment for services that qualify as initiating visits
for CCM services. The code would be billable for beneficiaries who
require extensive face-to-face assessment and care planning by the
billing practitioner (as opposed to clinical staff), through an add-on
code to the initiating visit, G0506 (Comprehensive assessment of and
care planning by the physician or other qualified health care
professional for patients requiring chronic care management services
(billed separately from monthly care management services) (Add-on code,
list separately in addition to primary service)).
We proposed that when the billing practitioner initiating CCM
personally
[[Page 80246]]
performs extensive assessment and care planning outside of the usual
effort described by the billed E/M code (or AWV or IPPE code), the
practitioner could bill G0506 in addition to the E/M code for the
initiating visit (or in addition to the AWV or IPPE), and in addition
to the CCM CPT code 99490 (or proposed 99487 and 99489) if all
requirements to bill for CCM services are also met. We proposed
valuation for G0506 in a separate section of our proposed rule.
The code G0506 would account specifically for additional work of
the billing practitioner in personally performing a face-to-face
assessment of a beneficiary requiring CCM services, and personally
performing CCM care planning (the care planning could be face-to-face
and/or non-face-to-face) that is not already reflected in the
initiating visit itself (nor in the monthly CCM service code). We
believed G0506 might be particularly appropriate to bill when the
initiating visit is a less complex visit (such as a level 2 or 3 E/M
visit), although G0506 could be billed along with higher level visits
if the billing practitioner's effort and time exceeded the usual effort
described by the initiating visit code. It could also be appropriate to
bill G0506 when the initiating visit addresses problems unrelated to
CCM, and the billing practitioner does not consider the CCM-related
work he or she performs in determining what level of initiating visit
to bill. We believed that this proposal would more appropriately
recognize the relative resource costs for the work of the billing
practitioner in initiating CCM services, specifically for extensive
work assessing the beneficiary and establishing the CCM care plan that
is reasonable and necessary, and that is not accounted for in the
billed initiating visit or in the unit of the CCM service itself that
is billed for a given service period. In addition, we believed this
proposal would help ensure that the billing practitioner personally
performs and meaningfully contributes to the establishment of the CCM
care plan when the patient's complexity warrants it.
Comment: Several commenters were supportive of the add-on code
(G0506) to the CCM initiating visit to describe physician assessment
and care planning for patients requiring CCM services. Some commenters
raised questions about whether G0506 should be a one-time service or
could also be billed as an add-on code to subsequent reassessments by
the billing practitioner (whether E/M visits or subsequent AWVs).
Response: At this time, we do not believe we should permit billing
of G0506 more than once by the billing practitioner for a given
beneficiary. G0506 was proposed as an add-on code to the single
initiating visit, to help ensure the billing practitioner's assessment
and involvement at the outset of CCM services. At this time there are
no requirements for the billing practitioner to ``re-initiate'' CCM
services; therefore we do not believe we should create an add-on code
for a CCM ``re-initiation'' service. We would have to define ``re-
initiation'' and develop rules regarding when subsequent E/M visits or
AWVs are related to the performance of CCM. We do not believe
beneficiaries would understand why they are incurring additional cost
sharing for an add-on code to a ``re-initiation'' visit that has not
been required or defined by CMS.
As we stated in the CY 2017 proposed rule, we were very interested
in coding that was presented to the CPT Editorial Panel, but not
adopted, to create code(s) that would separately identify and account
for monthly CCM work by the billing practitioner. Such coding may be a
better means of separately identifying and valuing the subsequent work
of the billing practitioner after CCM is initiated. We want to
establish policies that help ensure that the billing practitioner is
not merely handing the beneficiary off to a remote care manager under
general supervision while no longer remaining involved in their care.
We believe that the practitioner billing CCM services should be
actively re-assessing the beneficiary's chronic conditions, reviewing
whether treatment goals are being met, updating the care plan,
performing any medical decision-making that is not within the scope of
practice of clinical staff, performing any necessary face-to-face care,
and performing other related work. However, it would be more
straightforward to separately identify this CCM-related work under
code(s) that in their own right describe it, instead of add-on codes to
very broadly drawn E/M codes where it becomes difficult to assess the
relationship between the two services. Also for beneficiaries receiving
complex CCM, some of this work is explicitly included in the complex
CCM service codes (i.e., medical decision-making of moderate to high
complexity). Therefore, at this time, G0506 will only serve as an add-
on code to describe work performed by the billing practitioner once, in
conjunction with the start or initiation of CCM services.
We note that despite the role of the billing practitioner in the
initiation and provision of CCM services provided by clinical staff,
non-complex CCM (CPT code 99490) is described based on the time spent
by clinical staff. Complex CCM (CPT codes 99487 and 99489) similarly
counts only clinical staff time, although it also includes complex
medical decision-making by the billing practitioner. This raises issues
regarding appropriate valuation in the facility setting that we will
continue to consider in future rulemaking. The facility PE RVU for CCM
includes indirect PE (which is an allocation based on physician work),
but no direct PE (which would be comprised of other labor, supplies and
equipment). This is because historically, the PFS facility rate assumes
that the billing practitioner is not bearing a significant resource
cost in labor by other individuals, equipment or supplies. Medicare
assumes that those costs are instead borne by the facility and
adequately accounted for in a separate payment made to the facility.
The PFS non-facility rate generally does include such costs, assuming
that the billing practitioner bears the resource costs in clinical and
other staff labor, supplies and equipment.
For CCM, we have been considering whether this approach to
valuation remains appropriate, because the service, in whole or in
significant part, is provided by clinical staff under the direction of
the billing practitioner. These individuals may provide the service or
part thereof remotely, and are not necessarily employees or staff of
the facility. Under this construct, there may be more direct practice
expense borne by the billing practitioner that should be separately
identified and valued over and above any institutional payment to the
facility for its staff and infrastructure. We plan to explore these
issues in future rulemaking and consider other approaches to valuation
that would recognize the accurate relative resource costs to the
billing practitioner for CCM and similar services furnished to
beneficiaries who remain or reside in a facility setting during some or
all of the service period.
Consistent with general coding guidance, we proposed that the work
that is reported under G0506 (including time) could not also be
reported under or counted towards the reporting of any other billed
code, including any of the monthly CCM services codes. The care plan
that the practitioner must create to bill G0506 would be subject to the
same requirements as the care plan included in the monthly CCM
services, namely, it must be an electronic patient-centered care plan
based on a physical, mental, cognitive, psychosocial, functional and
environmental (re)assessment and an
[[Page 80247]]
inventory of resources and supports; a comprehensive care plan for all
health issues. This would distinguish it from the more limited care
planning included in the BHI codes G0502, G0503, G0504 or G0507 which
focus on behavioral health issues, or the care planning included in
G0505 which focuses on cognitive status. We sought public input on
potential overlap among these codes and further clinical input as to
how the assessments and care planning that is included in them would
differ.
We received a number of comments regarding the relationship between
proposed G0506, G0505 (Cognition and functional assessment by the
physician or other qualified health care professional in office or
other outpatient), prolonged non-face-to-face services, and BHI. We
address these comments in the sections of this final rule regarding
G0505, prolonged non-face-to-face services and BHI services (sections
II.E.5, II.E.2 and II.E.3). In brief, we are not allowing G0506 and
G0505 to be billed the same day (by a single practitioner). G0506 will
not be an add-on code for the BHI initiating visit or BHI services.
G0506 will be a one-time service code for CCM initiation, and the
billing practitioner must choose whether to report either G0506 or
prolonged services in association with CCM initiation (if requirements
to bill both are met).
The CCM and BHI service codes differ substantially in potential
diagnosis and comorbidity, the expected duration of the condition(s)
being treated, the kind of care planning performed (comprehensive care
planning versus care planning focused on behavioral/mental health
issues), service elements and who performs them, and the interventions
the beneficiary needs and receives apart from the CCM and BHI services
themselves. The BHI codes include a more focused process than CCM for
the clinical integration of primary care and behavioral health/
psychiatric care, and for continual reassessment and treatment
progression to a target or goal outcome that is specific to mental and
behavioral health or substance abuse issues. However there is no
explicit BHI service element for managing care transitions or
systematic assessment of receipt of preventive services; there is no
requirement to perform comprehensive care planning for all health
issues (not just behavioral health issues); and there are different
emphases on medication management or medication reconciliation, if
applicable. In deciding which code(s) to report for services furnished
to a beneficiary who is eligible for both CCM and BHI services,
practitioners should consider which service elements were furnished
during the service period, who provided them, how much time was spent,
and should select the code(s) that most accurately and specifically
identifies the services furnished without duplicative time counting.
Practitioners should generally select the more specific code(s) when an
alternative code(s) potentially includes the services provided. We are
not precluding use of the CCM codes to report, or count, behavioral
health care management if it is provided as part of a broader CCM
service by a practitioner who is comprehensively overseeing all of the
beneficiary's health issues, even if there are no imminent non-
behavioral health needs. However, such behavioral care management
activities could not also be counted towards reporting a BHI code(s).
If a BHI service code more specifically describes the service furnished
(service time and other relevant aspects of the service being equal),
or if there is no focus on the health of the beneficiary outside of a
narrower set of behavioral health issues, then it is more appropriate
to report the BHI code(s) than the CCM code(s). Similarly, it may be
more appropriate for certain specialists to bill BHI services than CCM
services, since specialists are more likely to be managing the
beneficiary's behavioral health needs in relation to a narrow subset of
medical condition(s). CCM and BHI services can only be billed the same
month for the same beneficiary if all the requirements to bill each
service are separately met. We will monitor the claims data, and we
welcome further stakeholder input to inform appropriate reporting
rules.
b. 24/7 Access to Care, Continuity of Care, Care Plan and Managing
Transitions
We proposed several revisions to the scope of service elements of
24/7 Access to Care, Continuity of Care, Care Plan and Managing
Transitions. We continued to believe these elements are important
aspects of CCM services, but that we should reduce the requirements for
the use of specified electronic health information technology (IT) in
their provision. In sum, we proposed to retain a core requirement to
use a certified electronic health record (EHR), but allow fax to count
for electronic transmission of clinical summaries and the care plan; no
longer require access to the electronic care plan outside of normal
business hours to those providing CCM services; and remove standards
for clinical summaries in managing care transitions.
We sought to improve alignment with CPT provisions by removing the
requirement for the care plan to be available remotely to individuals
providing CCM services after hours. Studies have shown that after-hours
care is best implemented as part of a larger practice approach to
access and continuity (see for example, the peer-review article
available at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3475839/).
There is substantial local variation in how 24/7 access and continuity
of care are achieved, depending on the contractual relationships among
practitioners and providers in a particular geographic area and other
factors. Care models include various contractual relationships between
physician practices and after-hours clinics, urgent care centers and
emergency departments; extended primary care office hours; physician
call-sharing; telephone triage systems; and health information
technology such as shared EHRs and systematic notification procedures
(http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3475839/). Some or all of
these may be used to provide access to urgent care on a 24/7 basis
while maintaining information continuity between providers.
We recognized that some models of care require more significant
investment in practice infrastructure than others, for example
resources in staffing or health information technology. In addition, we
believed there is room to reduce the administrative complexity of our
current payment rules for CCM services to accommodate a range of
potential care models. In re-examining what should be included in the
CCM scope of service elements for 24/7 Access to Care and Continuity of
Care, we believed the CPT language adequately and more appropriately
describes the services that should, at a minimum, be included in these
service elements. Therefore, we proposed to adopt the CPT language for
these two elements. For 24/7 Access to Care, the scope of service
element would be to provide 24/7 access to physicians or other
qualified health care professionals or clinical staff including
providing patients/caregivers with a means to make contact with health
care professionals in the practice to address urgent needs regardless
of the time of day or day of week. We believed the CPT language more
accurately reflects the potential role of clinical staff or call-
sharing services in addressing after-hours care needs than our current
language does. In addition, the 24/7 access would be for ``urgent''
needs
[[Page 80248]]
rather than ``urgent chronic care needs,'' because we believed after-
hours services typically would and should address any urgent needs and
not only those explicitly related to the beneficiary's chronic
conditions.
We recognized that health information systems that include remote
access to the care plan or the full EHR after hours, or a feedback loop
that communicates back to the primary care physician and others
involved in the beneficiary's care regarding after-hours care or advice
provided, are extremely helpful (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3475839/#CR25). They help ensure that the beneficiary
receives necessary follow up, particularly if he or she is referred to
the emergency department, and follow up after an emergency department
visit is required under the CCM element of Management of Care
Transitions. Accordingly, we continued to support and encourage the use
of interoperable EHRs or remote access to the care plan in providing
the CCM service elements of 24/7 Access to Care, Continuity of Care,
and Management of Care Transitions. However, adoption of such
technology would be optimal not only for CCM services, but also for a
number of other PFS services and procedures (including various other
care management services), and we have not required adoption of any
certified or non-certified health information technology as a condition
of payment for any other PFS service. We noted that there are
incentives under other Medicare programs to adopt such information
technology, and were concerned that imposing too many EHR-related
requirements at the service level as a condition of PFS payment could
create disparities between these services and others under the fee
schedule. Lastly, we recognized that not all after-hours care warrants
follow-up or a feedback loop with the practitioner managing the
beneficiary's care overall, and that under particular circumstances
feedback loops can be achieved through oral, telephone or other less
sophisticated communication methods. Therefore, we proposed to remove
the requirement that the individuals providing CCM after hours must
have access to the electronic care plan.
This proposal reflected our understanding that flexibility in how
practices can provide the requisite 24/7 access to care, as well as
continuity of care and management of care transitions, for their CCM
patients could facilitate appropriate access to these services for
Medicare beneficiaries. This proposal was not intended to undermine the
significance of standardized communication methods as part of effective
care. Instead, we recognized that other CMS initiatives (such as MIPS
and APMs under the Quality Payment Program) may be better mechanisms to
incentivize increased interoperability of health information systems
than conditions of payment assigned to particular services under the
PFS. We also anticipated that improved accuracy of payment for care
management services and reduced administrative burden associated with
billing for them would contribute to practitioners' capacity to invest
in the best tools for managing the care of Medicare beneficiaries.
For Continuity of Care, we currently require the ability to obtain
successive routine appointments ``with the practitioner or a designated
member of the care team,'' while CPT only references successive routine
appointments ``with a designated member of the care team.'' We do not
believe there is any practical difference between these two phrases and
therefore proposed to omit the words ``practitioner or'' from our
requirement. The billing practitioner is a member of the CCM care team,
so the CPT language already allows for successive routine appointments
either with the billing practitioner or another appropriate member of
the CCM care team.
Based on review of extensive public comment and stakeholder
feedback, we had also come to believe that we should not require
individuals providing the beneficiary with the required 24/7 access to
care for urgent needs to have access to the care plan as a condition of
CCM payment. As discussed above, we believed that in general, provision
of effective after-hours care of the beneficiary would require access
to the care plan, if not the full EHR. However, we have heard from
rural and other practices that remote access to the care plan is not
always necessary or possible because urgent care needs after-hours are
often referred to a practitioner or care team member who established
the care plan or is familiar with the beneficiary. In some instances,
the care plan does not need to be available to address urgent patient
needs after business hours. In addition, we have not required the use
of any certified or non-certified health information technology in the
provision of any other PFS services (including various other care
management services). We were concerned that imposing EHR-related
requirements at the service level as a condition of PFS payment could
distort the relative valuation of services priced under the fee
schedule. Therefore, we proposed to change the CCM service element to
require timely electronic sharing of care plan information within and
outside the billing practice, but not necessarily on a 24/7 basis, and
to allow transmission of the care plan by fax.
We acknowledged that it is best for practitioners and providers to
have access to care plan information any time they are providing
services to beneficiaries who require CCM services. This proposal was
not intended to undermine the significance of electronic communication
methods other than fax transmission in providing effective, continuous
care. On the contrary, we believed that fax transmission, while
commonly used, is much less efficient and secure than other methods of
communicating patient health information, and we encouraged
practitioners to adopt and use electronic technologies other than fax
for transmission and exchange of the CCM care plan. We continued to
believe the best means of exchange of all relevant patient health
information is through standardized electronic means. However, we
recognized that other CMS initiatives (such as MIPS and APMs under the
Quality Payment Program) may be better mechanisms to incentivize
increased interoperability of health information systems than
conditions of payment assigned to particular services under the PFS. We
believed our proposal would still allow timely availability of health
information within and outside the practice for purposes of providing
CCM, and would simplify the rules governing provision of the service
and improve access to the service. The proposed revisions would better
align the service with appropriate CPT prefatory language, which may
reduce unnecessary administrative complexity for practitioners in
navigating the differences between CPT guidance and Medicare rules.
The CCM scope of service element Management of Care Transitions
includes a requirement for the creation and electronic transmission and
exchange of continuity of care documents referred to as ``clinical
summaries'' (see Table 11 of the CY 2017 PFS proposed rule). We
patterned our requirements regarding clinical summaries after the EHR
Incentive Program requirement that an eligible professional who
transitions their patient to another setting of care or provider of
care, or refers their patient to another provider of care, should
provide a summary care record for each transition of care or referral.
This clinical summary includes demographics, the medication list,
medication allergy list, problem list, and a number of other data
elements if the
[[Page 80249]]
practitioner knows them. As a condition of CCM payment, we required
standardized content for clinical summaries (that they must be created/
formatted according to certified EHR technology). For the exchange/
transport function, we did not require the use of a specific tool or
service to exchange/transmit clinical summaries, as long as they are
transmitted electronically (this can include fax only when the
receiving practitioner or provider can only receive by fax).
Based on review of extensive public comment and stakeholder
feedback, we had come to believe that we should not require the use of
any specific electronic technology in managing a beneficiary's care
transitions as a condition of payment for CCM services. Instead, we
proposed more simply to require the billing practitioner to create and
exchange/transmit continuity of care document(s) timely with other
practitioners and providers. To avoid confusion with the requirements
of the EHR Incentive Programs, and since we would no longer require
standardized content for the CCM continuity of care document(s), we
would refer to them as continuity of care documents instead of clinical
summaries. We would no longer specify how the billing practitioner must
transport or exchange these document(s), as long as it is done timely
and consistent with the Care Transitions Management scope of service
element. We welcomed public input on how we should refer to these
document(s), noting that CPT does not provide model language specific
to CCM services. The proposed term ``continuity of care document(s)''
draws on CPT prefatory language for TCM services, which CPT provides
may include ``obtaining and reviewing the discharge information (for
example, discharge summary, as available, or continuity of care
document).''
Again, this proposal was not intended to undermine the significance
of a standardized, electronic format and means of exchange (other than
fax) of all relevant patient health information, for achieving timely,
seamless care across settings especially after discharge from a
facility. On the contrary, we believed that fax transmission, while
commonly used, is much less efficient and secure than other methods of
communicating patient health information, and we encourage
practitioners to adopt and use electronic technologies other than fax
for transmission and exchange of continuity of care documents in
providing CCM services. We continued to believe the best means of
exchange of all relevant patient health information is through
standardized electronic means. However, as we discussed above regarding
the CCM care plan, we have not applied similar requirements to other
PFS services specifically (including various other care management
services) and had concerns about how doing so may create disparities
between these services and others under the PFS. We also recognized
that other CMS initiatives (such as MIPS and APMs under the Quality
Payment Program) may be better mechanisms to incentivize increased
interoperability of health information systems than conditions of
payment assigned to particular services under the PFS.
Comment: Most of the commenters supported our proposed revisions to
the health IT use requirements for billing the CCM code. They shared
CMS' goal of interoperability but believed the changes were necessary
to improve CCM uptake. Some commenters favored hardship exceptions or
rural or small practice exceptions instead of changes to the current
requirements that would apply to all practitioners alike. Some
commenters expressed particular concern about relaxing the current
rules in instances where CCM outsourcing reduces clinical integration.
These commenters noted that CCM is commonly outsourced to third party
companies that provide remote care management services (including after
hours) via telephone and online contact only, using staff who have no
established relationship with the beneficiary or other members of the
care team and have no interaction with the office staff and physicians
other than electronic communication. These commenters were concerned
that our proposed changes to the health IT requirements for CCM payment
would result in little to no oversight or guidance of the third party,
and recommended that CMS make the proposed changes cautiously. One of
these commenters recommended in addition that CMS should seek to
increase access to CCM services and reduce administrative burden by
pursuing alignment between the provision of CCM and other programs and
incentives, such as the Quality Payment Program. Other commenters
recommended further reduction in payment rules, such as removing all
requirements to use a certified EHR, or movement away from timed codes
that require documentation in short time increments and disrupt
workflow.
Response: We continue to believe that other Medicare initiatives
and programs (such as MIPS and APMs under the Quality Payment Program)
are better suited to advance use of interoperable health IT systems
than establishing code-level conditions of payment, unique to CCM or
other primary care or cognitive services. We also believe that a
hardship, rural or small practice exception would greatly increase
rather than decrease administrative complexity for practitioners and
CMS, and CCM uptake has been relatively high among solo practices. We
believe that reducing code-level conditions of payment is necessary to
improve beneficiary access to appropriate CCM services. Therefore, we
are finalizing revisions to the CCM scope of service elements as
proposed.
However, we appreciate the commenters' feedback that relaxing the
health IT use requirements may be of particular concern in situations
where CCM is outsourced to a third party, reducing clinical
integration. As we discuss in the section of this final rule on BHI
services (section II.E.3.b), health IT holds significant promise for
remote connectivity and interoperability that may assist and be useful
(if not necessary) for reducing care fragmentation. However, we agree
that remote provision of services by entities having only a loose
association with the treating practitioner can detract from continuous,
patient-centered care, whether or not those entities employ certified
or other electronic technology. We will continue to consider the
potential impacts of remote provision of CCM and similar types of
services by third parties. We wish to emphasize for CCM, as we did for
BHI services, that while the CCM codes do not explicitly count time
spent by the billing practitioner, they are valued to include work
performed by the billing practitioner, especially complex CCM. We
emphasize that the practitioner billing for CCM must remain involved in
ongoing oversight, management, collaboration and reassessment as
appropriate to bill CCM services. If there is little oversight by the
billing practitioner or a lack of clinical integration between a third
party providing CCM and the billing practitioner, we do not believe
that the CCM service elements are actually being furnished and
therefore, in such cases, the practitioner should not bill for CCM.
Finally, we note that activities undertaken as part of
participation in MIPS or an APM under the Quality Payment Program may
support the ability of a practitioner to meet our final requirements
for the continuity of care document(s) and the electronic care plan.
Comment: Several commenters recommended that we define the proposed
term ``timely'' for the creation and transmission of care plan and care
[[Page 80250]]
transitions health information. Several commenters believed that
``timely'' implies a time period of 30 to 90 days, or believed some
third party vendors would interpret the term in this manner.
Response: Our proposal of the term ``timely'' originated from the
use of this term in the CPT prefatory language for Care Management
services, which includes, for example, ``provide timely access and
management for follow-up after an emergency department visit'' and
``timely access to clinical information.'' We do not believe we should
specify a timeframe, because it would vary for individual patients and
CCM service elements, we are not aware of any clinical standards
referencing specific times, and we are seeking to allow appropriate
flexibility in how CCM is furnished. We note that dictionary meanings
of the term ``timely'' include quickly; soon; promptly; occurring at a
suitable time; done or occurring at a favorable or useful time;
opportune. ``Timely'' does not necessarily imply speed, and means doing
something at the most appropriate moment. Therefore we believe
``timely'' is an appropriate term to use to govern how quickly the
health information in question is transmitted or available. We note
that even the current requirements for use of specific electronic
technology do not necessarily impact how quickly the health information
in question is used to inform care, and addition of the word ``timely''
implies more regarding actual use of the information. We are monitoring
CCM uptake and diffusion through claims analysis and are pursuing
claims-based outcomes analyses, to help inform whether the service is
being provided as intended and improving health outcomes. We believe
these evaluation activities will help us assess moving forward whether
health information is being shared or made available timely enough
under our revised CCM payment policies.
As we stated in the CY 2017 proposed rule, the policy changes for
CCM health IT use are not intended to undermine the importance of
interoperability or electronic data exchange. These changes are driven
by concerns that we have not applied similar requirements to other PFS
services specifically, including various other care management
services, and that such requirements create disparities between CCM
services and other PFS services. We believe that other CMS initiatives
may be better mechanisms to incentivize increased use and
interoperability of health information systems than conditions of
payment assigned to particular services under the PFS. We anticipate
that these CCM policy changes will improve practitioners' capacity to
invest in the best tools for managing the care of Medicare
beneficiaries.
c. Beneficiary Receipt of Care Plan
We proposed to simplify the current requirement to provide the
beneficiary with a written or electronic copy of the care plan, by
instead adopting the CPT language specifying more simply that a copy of
the care plan must be given to the patient or caregiver. While we
believe beneficiaries should and must be provided a copy of the care
plan, and that practitioners may choose to provide the care plan in
hard copy or electronic form in accordance with patient preferences, we
do not believe it is necessary to specify the format of the care plan
that must be provided as a condition of CCM payment. Additionally, we
recognize that there may be times that sharing the care plan with the
caregiver (in a manner consistent with applicable privacy and security
rules and regulations) may be appropriate.
Comment: The commenters who provided comments on this particular
proposal were supportive of it. In particular, several commenters
expressed appreciation for appropriate inclusion of caregivers.
Response: We thank the commenters for their support and are
finalizing as proposed.
d. Beneficiary Consent
We continue to believe that obtaining advance beneficiary consent
to receive CCM services is important to ensure the beneficiary is
informed, educated about CCM services, and is aware of applicable cost
sharing. We also believe that querying the beneficiary about whether
another practitioner is already providing CCM services helps to reduce
the potential for duplicate provision or billing of the services.
However, we believe the consent process could be simplified, and that
it should be left to the practitioner and the beneficiary to decide the
best way to establish consent. Therefore, we proposed to continue to
require billing practitioners to inform the beneficiary of the
currently required information (that is, inform the beneficiary of the
availability of CCM services; inform the beneficiary that only one
practitioner can furnish and be paid for these services during a
calendar month; and inform the beneficiary of the right to stop the CCM
services at any time (effective at the end of the calendar month)).
However, we proposed to specify that the practitioner could document in
the beneficiary's medical record that this information was explained
and note whether the beneficiary accepted or declined CCM services
instead of obtaining a written agreement.
We also proposed to remove the language requiring beneficiary
authorization for the electronic communication of his or her medical
information with other treating providers as a condition of payment for
CCM services, because under federal regulations that implement the
Health Insurance Portability and Accountability Act (HIPAA) Privacy
Rule (45 CFR 164.506), a covered entity is permitted to use or disclose
protected health information for purposes of treatment without patient
authorization. Moreover, if such disclosure is electronic, the HIPAA
Security Rule requires secure transmission (45 CFR 164.312(e)). In
previous regulations we have reminded practitioners that for all
electronic sharing of beneficiary information in the provision of CCM
services, HIPAA Privacy and Security Rule standards apply in the usual
manner (79 FR 67728).
Comment: The commenters were largely supportive of our proposed
policy changes. The commenters were supportive of verbal instead of
written beneficiary consent if a clear requirement remains to
transparently inform the beneficiary about the nature and benefit of
the services, applicable cost sharing, and document that this
information was conveyed; current written agreements qualify; and
practitioners can elect to obtain written consent. Some commenters
believed that obtaining written consent might be preferable as a means
of resolving who is eligible for payment, if more than one practitioner
bills. A few commenters suggested CMS require written educational
materials about CCM, or conduct beneficiary outreach and education.
Response: We appreciate the commenters' support and
recommendations. We are finalizing changes to the beneficiary consent
requirements as proposed and clarifying that a clear requirement
remains to transparently inform the beneficiary about the nature and
benefit of the services, applicable cost sharing, and to document that
this information was conveyed. The final beneficiary consent
requirements do not affect any written agreements that are already in
place for CCM services, and we note that practitioners can still elect
to obtain written consent rather than verbal consent.
e. Documentation
We have heard from practitioners that the requirements to document
certain
[[Page 80251]]
information in a certified EHR format are redundant because the CCM
billing rules already require documentation of core clinical
information in a certified EHR format. Specifically, we already require
structured recording of demographics, problems, medications and
medication allergies, and the creation of a clinical summary record,
using a qualifying certified EHR; and that a full list of problems,
medications and medication allergies in the EHR must inform the care
plan, care coordination and ongoing clinical care. Therefore, we
proposed to no longer specify the use of a qualifying certified EHR to
document communication to and from home- and community-based providers
regarding the patient's psychosocial needs and functional deficits and
to document beneficiary consent. We would continue to require
documentation in the medical record of beneficiary consent (discussed
above) and of communication to and from home- and community-based
providers regarding the patient's psychosocial needs and functional
deficits.
Comment: Many commenters were supportive of these proposals.
Response: We thank the commenters for their support and are
finalizing changes to the documentation requirements as proposed. We
continue to encourage practitioners to utilize health IT solutions for
obtaining and documenting health information from sources external to
their practice, noting that the 2015 edition of ONC certification
criteria (see 80 FR 62601) includes criteria which specifically relate
to obtaining information from non-clinical sources and the capture of
structured data relating to social, psychological, and behavioral
attributes.
f. Summary of Final CCM Policies
We are finalizing changes to the CCM scope of service elements
discussed above that will apply for both complex and non-complex CCM
services beginning in CY 2017. The final CY 2017 service elements for
CCM are summarized in Table 11. We believe these changes 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. For payment of complex CCM services beginning in CY
2017, we are adopting the CPT code descriptors for CPT codes 99487 and
99489 as well as the service elements in Table 11. We are providing
separate payment for complex CCM (CPT 99487, 99489) using the RUC-
recommended payment inputs for those services. We may reconsider the
role of health information technology in CCM service provision in
future years. We anticipate that improved accuracy of payment for CCM
services, and reduced administrative burden associated with billing CCM
services, will contribute to practitioners' capacity to invest in the
best tools for managing the care of Medicare beneficiaries.
Table 11--Summary of CY 2017 Chronic Care Management Service Elements
and Billing Requirements
------------------------------------------------------------------------
------------------------------------------------------------------------
Initiating Visit--Initiation during an AWV, IPPE, or face-to-face E/M
visit (Level 4 or 5 visit not required), for new patients or patients
not seen within 1 year prior to the commencement of chronic care
management (CCM) services............................................
Structured Recording of Patient Information Using Certified EHR
Technology--Structured recording of demographics, problems,
medications and medication allergies using certified EHR technology.
A full list of problems, medications and medication allergies in the
EHR must inform the care plan, care coordination and ongoing clinical
care.................................................................
24/7 Access & Continuity of Care:
Provide 24/7 access to physicians or other qualified
health care professionals or clinical staff including providing
patients/caregivers with a means to make contact with health care
professionals in the practice to address urgent needs regardless
of the time of day or day of week................................
Continuity of care with a designated member of the care
team with whom the beneficiary is able to schedule successive
routine appointments.............................................
Comprehensive Care Management--Care management for chronic conditions
including systematic assessment of the beneficiary's medical,
functional, and psychosocial needs; system-based approaches to ensure
timely receipt of all recommended preventive care services;
medication reconciliation with review of adherence and potential
interactions; and oversight of beneficiary self-management of
medications..........................................................
Comprehensive Care Plan:
Creation, revision and/or monitoring (as per code
descriptors) of an electronic patient-centered care plan based on
a physical, mental, cognitive, psychosocial, functional and
environmental (re)assessment and an inventory of resources and
supports; a comprehensive care plan for all health issues........
Must at least electronically capture care plan
information, and make this information available timely within
and outside the billing practice as appropriate. Share care plan
information electronically (can include fax) and timely within
and outside the billing practice to individuals involved in the
beneficiary's care...............................................
A copy of the plan of care must be given to the patient
and/or caregiver.................................................
Management of Care Transitions:
Management of care transitions between and among health
care providers and settings, including referrals to other
clinicians; follow-up after an emergency department visit; and
follow-up after discharges from hospitals, skilled nursing
facilities or other health care facilities.......................
Create and exchange/transmit continuity of care
document(s) timely with other practitioners and providers........
Home- and Community-Based Care Coordination:
Coordination with home and community based clinical
service providers................................................
Communication to and from home- and community-based
providers regarding the patient's psychosocial needs and
functional deficits must be documented in the patient's medical
record...........................................................
Enhanced Communication Opportunities--Enhanced opportunities for the
beneficiary and any caregiver to communicate with the practitioner
regarding the beneficiary's care through not only telephone access,
but also through the use of secure messaging, Internet, or other
asynchronous non-face-to-face consultation methods...................
Beneficiary Consent:
Inform the beneficiary of the availability of CCM
services; that only one practitioner can furnish and be paid for
these services during a calendar month; and of their right to
stop the CCM services at any time (effective at the end of the
calendar month)..................................................
Document in the beneficiary's medical record that the
required information was explained and whether the beneficiary
accepted or declined the services................................
Medical Decision-Making--Complex CCM services require and include
medical decision-making of moderate to high complexity (by the
physician or other billing practitioner).............................
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[[Page 80252]]
5. Assessment and Care Planning for Patients with Cognitive Impairment
(GPPP6)
For CY 2017 we proposed a G-code that would provide separate
payment to recognize the work of a physician (or other appropriate
billing practitioner) in assessing and creating a care plan for
beneficiaries with cognitive impairment, such as from Alzheimer's
disease or dementia, at any stage of impairment, G0505 (Cognition and
functional assessment using standardized instruments with development
of recorded care plan for the patient with cognitive impairment,
history obtained from patient and/or caregiver, in office or other
outpatient setting or home or domiciliary or rest home). We understand
that a similar code was recently approved by the CPT Editorial Panel
and is scheduled to be included in the CY 2018 CPT code set. We
intended for G0505 to be a temporary code, perhaps for only one year,
to be replaced by the CPT code in CT 2018. We will consider whether to
adopt and establish relative value units for the new CPT code under our
standard process, presumably for CY 2018.
We reviewed the list of service elements that were considered by
the CPT Editorial Panel, and proposed the following as required service
elements of G0505:
Cognition-focused evaluation including a pertinent history
and examination.
Medical decision making of moderate or high complexity
(defined by the E/M guidelines).
Functional assessment (for example, Basic and Instrumental
Activities of Daily Living), including decision-making capacity.
Use of standardized instruments to stage dementia.
Medication reconciliation and review for high-risk
medications, if applicable.
Evaluation for neuropsychiatric and behavioral symptoms,
including depression, including use of standardized instrument(s).
Evaluation of safety (for example, home), including motor
vehicle operation, if applicable.
Identification of caregiver(s), caregiver knowledge,
caregiver needs, social supports, and the willingness of caregiver to
take on caregiving tasks.
Advance care planning and addressing palliative care
needs, if applicable and consistent with beneficiary preference.
Creation of a care plan, including initial plans to
address any neuropsychiatric symptoms and referral to community
resources as needed (for example, adult day programs, support groups);
care plan shared with the patient and/or caregiver with initial
education and support.
The proposed valuation of G0505 (discussed in section II.E.1)
assumed that this code would include services that are personally
performed by the physician (or other appropriate billing practitioner,
such as a nurse practitioner or physician assistant) and would
significantly overlap with services described by certain E/M visit
codes, advance care planning services, and certain psychological or
psychiatric service codes that are currently separately payable under
the PFS. Accordingly, we proposed that G0505 must be furnished by the
physician (or other appropriate billing practitioner) and could not be
billed on the same date of service as CPT codes 90785 (Psytx complex
interactive), 90791 (Psych diagnostic evaluation), 90792 (Psych diag
eval w/med srvcs), 96103 (Psycho testing admin by comp), 96120
(Neuropsych tst admin w/comp), 96127 (Brief emotional/behav assmt),
99201-99215 (Office/outpatient visits new), 99324-99337 (Domicil/r-home
visits new pat), 99341-99350 (Home visits new patient), 99366-99368
(Team conf w/pat by hc prof), 99497 (Advncd care plan 30 min), 99498
(Advncd care plan addl 30 min)), since these codes all reflect face-to-
face services furnished by the physician or other billing practitioner
for related separately billable services that overlap substantially
with G0505. In addition, we proposed to prohibit billing of G0505 with
other care planning services, such as care plan oversight services (CPT
code 99374), home health care and hospice supervision (G0181, G0182),
or our proposed add-on code for comprehensive assessment and care
planning by the billing practitioner for patients requiring CCM
services (GPPP7). We solicited comment on whether there are
circumstances where multiple care planning codes could be furnished
without significant overlap. We proposed to specify that G0505 may
serve as a companion or primary E/M code to the prolonged service codes
(those that are currently separately paid, and those we proposed to
separately pay beginning in 2017), but were interested in public input
on whether there is any overlap among these services. We solicited
comment on how to best delineate the post-service work for G0505 from
the work necessary to provide the prolonged services code.
We did not believe the services described by G0505 would
significantly overlap with proposed or current medically necessary CCM
services (CPT codes 99487, 99489, 99490); TCM services (CPT codes
99495, 99496); or the proposed behavioral health integration service
codes (HCPCS codes GPPP1, GPPP2, GPPP3, GPPPX). Therefore, we proposed
that G0505 could be billed on the same date-of-service or within the
same service period as these codes (CPT codes 99487, 99489, 99490,
99495, 99496, and HCPCS codes GPPP1, GPPP2, GPPP3, and GPPPX). There
may be overlap in the patient population eligible to receive these
services and the population eligible to receive the services described
by G0505, but we believed there would be sufficient differences in the
nature and extent of the assessments, interventions and care planning,
as well as the qualifications of individuals providing the services, to
allow concurrent billing for services that are medically reasonable and
necessary. We solicited public comment on potential overlap between
G0505 and other codes currently paid under the PFS, as well as the
other primary care/cognitive services addressed in this section of the
final rule.
Comment: Many commenters were supportive of the proposal, including
the provisions regarding scope of service elements, conditions of
payment, and overlap with other services under the PFS.
Response: We thank commenters for their support of the proposed
scope of service, conditions of payment, and overlap with other
services under the PFS for G0505. We believe that by improving payment
accuracy by paying separately for this service, practitioners will be
able to accurately assess patients for cognitive impairment,
particularly in early stages.
Comment: We received numerous comments stating that assessment and
staging for dementia is very sensitive and should only be conducted by
neuropsychologists, who would be unable to bill G0505. Commenters were
concerned that untrained professionals conducting assessments for
dementia would lead to errors in diagnosis and inappropriate treatment.
Commenters encouraged CMS to not finalize this code and maintain the
current coding for psychological and neuropsychological assessment or
suggested that CMS remove the bullet points associated with medication
management or medical decision making so that G0505 could be billed by
psychologists.
Response: While we acknowledge and support the work of
psychologists and neuropsychologists in the care of Medicare
beneficiaries, we continue to
[[Page 80253]]
believe that this code describes a distinct PFS service that may be
reasonable and necessary in the diagnosis and treatment of a
beneficiary's illness. We remind interested stakeholders that we
routinely examine the valuation and coding for existing services under
the potentially misvalued code initiative, and that there is a the
process for public nomination of particular codes. If stakeholders have
information to suggest that the current coding for neuropsychological
and psychological testing is inaccurate, we welcome nominations under
the established process.
Comment: A few commenters encouraged CMS to avoid adopting scope of
service elements that are exhaustive as these may create barriers to
utilization, while other commenters made the following recommendations
regarding the scope of service provisions:
Expand scope of service elements related to medication
management.
Include occupational therapy in the scope of service
element pertaining to community resources.
Rewrite ``Creation of a care plan, including initial plans
to address any neuropsychiatric symptoms and referral to community
resources as needed (for example, adult day programs, support groups);
care plan shared with the patient and/or caregiver with initial
education and support'' to include ``identification of caregiver(s),
caregiver knowledge, caregiver needs, social supports, and the
willingness and availability of caregiver to voluntarily take on
caregiving tasks.''
Make sure that non-paid or informal caregivers are
included in care planning and provide resources and support for care
givers so as to improve care givers ability to provide care for the
beneficiary.
Require the inclusion of caregiver names in care plan and
patients medical record, require that caregivers be assessed for stress
and depressive symptoms, as well as care giver skill and education
needs.
State that consultations with the caregiver are
permissible under HIPAA and that such conversations may be necessary in
the development of a care plan.
Specify that any advance care planning is consistent with
beneficiary preference and addresses any palliative care needs of the
patient, and include establishment of durable power of attorney.
Clarify that diagnosis of dementia is not part of the
scope of service by deleting ``cognition focused evaluation including
pertinent history'' from the scope of service.
Clarify that ``functional assessment'' is separate from
decision making assessments, and that this is a non-legal assessment of
competency.
Stipulate that other decision makers should be identified.
Consider deleting ``use of standardized instruments to
stage dementia'' because the care plan is the most important aspect of
the service and many standardized instruments are not very effective at
staging.
Clarify that the care plan address both medical and non-
medical issues, and includes follow-up scheduling for monitoring and
evaluation.
Provide a copy of the written care plan to the patient.
Refer to the care plan as a ``person-centered care plan.''
Include evaluation of medical problems including review of
lab or imaging tests, review of co-morbidities, especially those which
are dependent on self-care, evaluation the risk of falls and
recommendations for fall prevention, evaluation of possible elder
abuse, and documentation of financial issues, as part of the scope of
service.
Response: We appreciate the information provided by commenters on
the best practices associated with furnishing this service and would
encourage stakeholders to adopt any or all of these scope of service
provisions, such as the inclusion of caregivers in care planning. The
scope of service for assessment and care planning service for patients
with cognitive impairment does not prohibit stakeholders from adopting
any additional scope of service provisions which may be beneficial for
the treatment of the patient. However, we do not believe that the
ability to fully furnish this service and establish an appropriate
value for it is contingent on meeting such conditions. Therefore, we do
not believe they should be added to the scope of service. We concur
with commenters on the necessity of avoiding the imposition of overly
burdensome restrictions within the scope of service.
Comment: Some commenters requested that CMS clarify that not all
elements in the scope of service need to be provided by the billing
practitioner and many can be provided by others incident to the billing
practitioner's services. One commenter stated that there are
circumstances where the best practitioner to provide a specific service
element does not work in the same practice as the billing practitioner,
and therefore the billing practitioner should be able to contract out
for provision of some aspects, provided that the billing practitioner
remain in oversight. Other commenters stated that CMS should make G0505
billable by other practitioners, such as occupational therapists, or
community based entities.
Response: G0505 is a service that includes central elements, which
must be performed by the billing practitioner subject to established E/
M guidelines. Only those practitioners eligible to report E/M services
should report this service. Outside of the specified elements, the
regular incident-to rules apply consistent with other E/M services. We
believe that physicians and eligible non-physician practitioners, such
as a nurse practitioners and physician assistants should exclusively
bill for this code.
Comment: Many commenters suggested that CMS expand HCPCS code G0505
or pay separately for similar services furnished to patients with other
advanced or life threatening illnesses.
Response: We appreciate the comments on other conditions that could
benefit from assessment and care planning and will consider these for
future rulemaking. We are finalizing the G0505 code to pay separately
for the assessment and care plan creation for beneficiaries with
cognitive impairment, such as from Alzheimer's disease or dementia, at
any stage of impairment.
Comment: Commenters provided many examples of how CMS could develop
appropriate quality and outreach measures to ensure appropriate
utilization of G0505. Commenters encouraged CMS to closely monitor use
of G0505 for a few years following implementation, so as to ascertain
whether patient eligibility is an issue in uptake for the code.
Response: We appreciate the information on quality and outreach
measures. CMS is engaged in the use of measures to improve quality and
access to care. CMS intends to monitor utilization and will consider
how conditions of payment align with best practices and quality
measures.
Comment: One commenter urged CMS to make the proposed coding and
payment changes available to physicians in total cost of care models,
such as ACOs and bundled payment programs.
Response: Our proposal relates only to payment for services under
the Medicare PFS. We note that the codes and payment amounts that we
finalize for services will be available for billing and payment under
the PFS for CY 2017. In general, we do not address in this final rule,
and instead defer to the policies regarding billing and payment for
these services that are applicable within individual Center for
Medicare &
[[Page 80254]]
Medicaid Innovation models and other programs. However, as our policies
regarding payment for new primary care codes are applicable beginning
in CY 2017, we note that models may need to update their policies to
prevent potential duplication of payment between the PFS and the
models. For example, where CCM services have been excluded from
separate payment under existing models, newly established care
management services (including complex CCM, psychiatric CoCM, and BHI)
may likewise be excluded.
Comment: One commenter stated that many small practices do not have
the infrastructure to support a multi-disciplinary team of
practitioners and urged CMS to allow flexibility for solo and small
group practices to share resources. The commenter also suggested that
CMS offer a one-time incentive for practices to integrate service
elements into workflow. Response: In general, the coding under the PFS
is intended to describe services as they are furnished and are valued
using typical resource costs. We appreciate the concern of commenters
regarding access, and we are eager to hear from stakeholders regarding
concerns related to access for these and other PFS services.
6. Improving Payment Accuracy for Care of People With Disabilities
(GDDD1)
We estimate that about 7 percent of all Medicare beneficiaries have
a potentially disabling mobility-related diagnosis (the Medicare-only
prevalence is 5.5 percent and the prevalence for Medicare-Medicaid dual
eligible beneficiaries is 11 percent), using 2010 Medicare (and for
dual eligible beneficiaries, Medicaid) claims data.
When a beneficiary with a mobility-related disability goes to a
physician or other practitioner's office for an E/M visit, the
resources associated with providing the visit can exceed the resources
required for the typical E/M visit. An E/M visit for a patient with a
mobility-related disability can require more physician and clinical
staff time to provide appropriate care because the patient may require
skilled assistance throughout the visit to carefully move and adjust
his/her body. Furthermore, an E/M visit for a patient with a mobility-
related disability commonly requires specialized equipment such as a
wheel chair accessible scale, floor and overhead lifts, a movable exam
table, padded leg supports, a stretcher and transfer board. The current
E/M visit payment rates, based on an assumption of ``typical''
resources involved in furnishing an E/M visit to a ``typical'' patient,
do not accurately reflect these additional resources associated with
furnishing appropriate care to many beneficiaries with mobility-related
disabilities.
When furnishing E/M services to beneficiaries with mobility-related
disabilities, practitioners face difficult choices in deciding whether
to take the extra time necessary and invest in the required specialized
equipment for these visits even though the payment rate for the service
does not account for either expense; potentially providing less than
optimal care for a beneficiary whose needs exceed the standard
appointment block of time in the standard equipped exam room reflected
in the current E/M visit payment rate; or declining to accept
appointments altogether for beneficiaries who require additional time
and specialized equipment.
Each of these scenarios is potentially problematic. The first two
scenarios suggest that the quality of care for this beneficiary
population might be compromised by assumptions under the PFS regarding
relative resource costs in furnishing services to this population. The
third scenario reflects an obvious access problem for these
beneficiaries. To improve payment accuracy and help ameliorate
potential disparity in access and quality for beneficiaries with
mobility-related disabilities, we proposed to create a new add-on G-
code, effective for CY 2017, to describe the additional services
furnished in conjunction with E/M services to beneficiaries with
disabilities that impair their mobility:
G0501: Resource-intensive services for patients for whom the use of
specialized mobility-assistive technology (such as adjustable height
chairs or tables, patient lifts, and adjustable padded leg supports) is
medically necessary and used during the provision of an office/
outpatient evaluation and management service visit (Add-on code, list
separately in addition to primary procedure).
Effective January 1, 2017, we proposed that this add-on code could
be billed with new and established patient office/outpatient E/M codes
(CPT codes 99201 through 99205, and 99212 through 99215), as well as
transitional care management codes (CPT codes 99495 and 99496), when
the additional resources described by the code are medically necessary
and used in the provision of care. In addition to seeking comment on
this proposal, we are also sought comment on other HCPCS codes that may
be appropriate base codes for this proposed add-on code, including
those describing preventive visits and services. We reminded potential
commenters that the rationale for this proposal is based in large part
on the broad use and lack of granularity in coding for E/M services
relative to other PFS services in conjunction with the additional
resources used.
We received many thoughtful comments on this proposal and thank
commenters for their input. Comments received are summarized below.
Comment: Most commenters agreed with the proposed rule's statement
of disability disparities and discussed a variety challenges that
individuals with disabilities face in accessing the health care system.
Several of these commenters cited evidence of existing challenges for
individuals with mobility-related disabilities, including a lack of
physically accessible equipment within physician offices, barriers to
communication, and a lack of existing tools to recognize, track, and
consistently meet specialized needs. Commenters applauded CMS for
offering a concrete proposal with significant funding to meaningfully
address this problem and noted that 26 years after passage of the
Americans with Disabilities Act, it is alarming that physical and
communication barriers in physicians' and other health care
professionals' offices still exist across the country. However, some
commenters suggested that the root cause and scope of these issues are
not well characterized, and suggested that CMS work with stakeholders
to conduct additional studies and gain information as to the underlying
reasons for barriers to access to care and lower quality scores on
certain measures.
Generally, commenters noted that they appreciate CMS' efforts to
address health disparities based on disability, and some then supported
this proposal as a first step in providing medically necessary services
to patients with disabilities, while others recommended that CMS not
finalize the proposal and raised legal, access, and equity concerns.
Response: We agree with commenters that individuals with
disabilities face additional barriers to access health care, an issue
that contributes to widespread disparities in outcomes. We also agree
with commenters that the underlying reasons for these disparities are
multifaceted and can include payment challenges, physical accessibility
and communication barriers, a lack of awareness among health care
providers in assessing and fully addressing the needs and preferences
of people with disabilities, and others issues. As a result of all
these factors, individuals with disabilities can face challenges in
scheduling appointments, and in
[[Page 80255]]
finding and maintaining a primary care provider, an essential
foundation for accessing the health system.
Although there was near universal agreement among commenters
regarding problems in health care disparities and barriers to access
among individuals with disabilities, there was disagreement about
whether establishing payment for code G0501 as proposed was a good
solution to help solve these problems. While we believe that improving
the payment accuracy of physicians' services is necessary and
appropriate, and can help to address the underlying access issues for
individuals with disabilities, we also acknowledge that implementation
of new or revised payments can result in unanticipated, and potentially
undesirable, consequences. Before implementing payment for code G0501,
we plan to further analyze and address the concerns raised by
commenters. As such, we are not finalizing payment for code G0501 at
this time. We appreciate commenters' insights, and our commitment to
promoting better primary care for people with disabilities remains
strong. Over the next 6 months we will engage with interested
beneficiaries, advocates, and practitioners to continue to explore
improvements in payment accuracy for care of people with disabilities.
We intend to discuss this issue again in future rulemaking.
While we are not finalizing separate payment for code G0501 for CY
2017, we are including the code in the CY 2017 code set as G0501. The
HCPCS code G0501 will not be payable under the Medicare PFS for CY
2017, though practitioners will be able to report the code, should they
be inclined to do so.
a. Soliciting Comment on Other Coding Changes To Improve Payment
Accuracy for Care of People With Disabilities
When furnishing care to a beneficiary with a mobility-related
disability, the current E/M visit payment rates may not fully reflect
the associated resource costs that are being incurred by practitioners.
We recognize that there are other populations for which payment
adjustment may be appropriate. Our proposal regarding beneficiaries
with mobility-related disabilities reflected the discrete nature of the
additional resource costs for this population, the clear lack of
differentiation in resource costs regarding particular kinds of
frequently-furnished services, and the broad recognition of access
problems. We recognize that some physician practices may frequently
furnish services to particular populations for which the relative
resource costs are similarly systemically undervalued and we sought
comment regarding other circumstances where these dynamics can be
discretely observed.
Comment: Multiple commenters suggested additional coding changes to
improve payment accuracy for services for people with disabilities.
Several commenters requested that CMS broaden the scope of G0501 and
the codes with which it may be billed, for example by allowing G0501 to
be billed with preventive services, such as the Initial Preventive
Physical Examination (IPPE) or ``Welcome to Medicare Visit'', the
Annual Wellness Visit, or other preventive services including those
that have been assigned a grade of A or B by the United States
Preventive Services Task Force. One commenter suggested that CMS also
establish payment for a lower-level, lower payment add-on code for use
with patients with a mobility-related disability that may not require
the use of specialized equipment. Commenters also suggested that CMS
establish certain forms of physician payment incentives, which might
more effectively address the accessibility needs of individuals with
disabilities and ultimately reduce healthcare disparities.
Specifically, one commenter suggested CMS incentivize physicians to
establish record-keeping to inquire into patients' accessibility and
accommodation needs, record the needs of their patients, and take
action to meet those needs over time.
Response: We thank commenters for their thoughtful responses. We
reiterate our commitment to addressing disparities for individuals with
disabilities and advancing health equity, and will continue to explore
and revisit potential solutions for overcoming these significant
challenges, including the appropriate changes in payment.
7. Regulation Text
Our current regulations in 42 CFR 410.26(b) provide for an
exception to assign general supervision to CCM services (and similarly,
for the non-face-to-face portion of TCM services), because these are
generally non-face-to-face care management/care coordination services
that would commonly be provided by clinical staff when the billing
practitioner (who is also the supervising practitioner) is not
physically present; and the CPT codes are comprised solely (or in
significant part) of non-face-to-face services provided by clinical
staff. A number of codes that we proposed to establish for separate
payment in CY 2017 under our initiative to improve payment accuracy for
primary care and care management are similar to CCM services, in that a
critical element of the services is non-face-to-face care management/
care coordination services provided by clinical staff or other
qualified individuals when the billing practitioner may not be
physically present. Accordingly, we proposed to amend 42 CFR
410.26(a)(3) and 410.26(b) to better define general supervision and to
assign general supervision not only to CCM services and the non-face-
to-face portion of TCM services, but also to proposed codes G0502,
G0503, G0504, G0507, CPT code 99487, and CPT code 99489. Instead of
adding each of these proposed codes assigned general supervision to the
regulation text on an individual basis, we proposed to revise our
regulation under 42 CFR 410.26(b)(1) to assign general supervision to
the non-face-to-face portion of designated care management services,
and we would designate the applicable services through notice and
comment rulemaking.
We did not receive any public comments on our proposed regulation
text. However we received a number of comments regarding a related
proposal to require behavioral health care managers to be located on
site. Also for psychiatric CoCM services (G0502, G0503 and G0504), we
are finalizing a requirement that the behavioral health care manager is
available to perform his or her duties face-to-face and non-face-to-
face with the beneficiary. We address these issues at length in the BHI
section of this final rule (section II.E.3). Since we are assigning
general supervision to psychiatric CoCM behavioral health care manager
services that may be provided face-to-face with the beneficiary, we are
omitting the phrase ``non-face-to-face portion of'' in ``the non-face-
to-face portion of designated care management services.'' Accordingly,
the final amended regulation text in 42 CFR 410.26(b) assigns general
supervision to ``designated care management services'' that we will
designate through notice and comment rulemaking. The services that we
are newly designating (finalizing) for general supervision in this
final rule are G0502, G0503, G0504, G0507, CPT code 99487 and CPT code
99489. We had initially proposed adding a cross-reference to the
existing definition of ``general supervision'' in current regulations
at Sec. 410.32(b)(3)(i), but to better describe general supervision in
the context of these services, we are specifying at Sec. 410.26(a)(3)
that general supervision means the service is furnished under the
physician's (or other practitioner's)
[[Page 80256]]
overall direction and control, but the physician's (or other
practitioner's) presence is not required during the performance of the
service. At Sec. 410.26(b)(5), we specify that, in general, services
and supplies must be furnished under the direct supervision of the
physician (or other practitioner). Designated care management services
can be furnished under general supervision of the physician (or other
practitioner) when these services or supplies are provided incident to
the services of a physician (or other practitioner). The physician (or
other practitioner) supervising the auxiliary personnel need not be the
same physician (or other practitioner) who is treating the patient more
broadly. However, only the supervising physician (or other
practitioner) may bill Medicare for incident to services.
8. CCM Requirements for Rural Health Clinics (RHCs) and Federally
Qualified Health Centers (FQHCs).
RHCs and FQHCs have been authorized to bill for CCM services since
January 1, 2016, and are paid based on the Medicare PFS national
average non-facility payment rate when CPT code 99490 is billed alone
or with other payable services on a RHC or FQHC claim. The RHC and FQHC
requirements for billing CCM services have generally followed the
requirements for practitioners billing under the PFS, with some
adaptations based on the RHC and FQHC payment methodologies.
To assure that CCM requirements for RHCs and FQHCs are not more
burdensome than those for practitioners billing under the PFS, we
proposed revisions for CCM services furnished by RHCs and FQHCs similar
to the revisions proposed under the section above entitled, ``Reducing
Administrative Burden and Improving Payment Accuracy for Chronic Care
Management (CCM) Services'' for RHCs and FQHCs. Specifically, we
proposed to:
Require that CCM be initiated during an AWV, IPPE, or
comprehensive E/M visit only for new patients or patients not seen
within one year. This would replace the requirement that CCM could only
be initiated during an AWV, IPPE, or comprehensive E/M visit where CCM
services were discussed.
Require 24/7 access to a RHC or FQHC practitioner or
auxiliary personnel with a means to make contact with a RHC or FQHC
practitioner to address urgent health care needs regardless of the time
of day or day of week. This would replace the requirement that CCM
services be available 24/7 with health care practitioners in the RHC or
FQHC who have access to the patient's electronic care plan to address
his or her urgent chronic care needs, regardless of the time of day or
day of the week.
Require timely electronic sharing of care plan information
within and outside the RHC or FQHC, but not necessarily on a 24/7
basis, and expands the circumstances under which transmission of the
care plan by fax is allowed. This would replace the requirement that
the electronic care plan be available on a 24/7 basis to all
practitioners within the RHC or FQHC whose time counts towards the time
requirement for the practice to bill the CCM code, and removes the
restriction on allowing the care plan to be faxed only when the
receiving practitioner or provider can only receive clinical summaries
by fax.
Require that in managing care transitions, the RHC or FQHC
creates, exchanges, and transmits continuity of care document(s) in a
timely manner with other practitioners and providers. This would
replace the requirements that clinical summaries must be created and
formatted according to certified EHR technology, and the requirement
for electronic exchange of clinical summaries by a means other than
fax.
Require that a copy of the care plan be given to the
patient or caregiver. This would remove the description of the format
(written or electronic) and allows the care plan to be provided to the
caregiver when appropriate (and in a manner consistent with applicable
privacy and security rules and regulations).
Require that the RHC or FQHC practitioner documents in the
beneficiary's medical record that all the elements of beneficiary
consent (for example, that the beneficiary was informed of the
availability of CCM services; only one practitioner can furnish and be
paid for these services during a calendar month; the beneficiary may
stop the CCM services at any time, effective at the end of the calendar
month, etc.) were provided, and whether the beneficiary accepted or
declined CCM services. This would replace the requirement that RHCs and
FQHCs obtain a written agreement that these elements were discussed,
and removes the requirement that the beneficiary provide authorization
for the electronic communication of his or her medical information with
other treating providers as a condition of payment for CCM services.
Require that communication to and from home- and
community-based providers regarding the patient's psychosocial needs
and functional deficits be documented in the patient's medical record.
This would replace the requirement to document this patient health
information in a certified EHR format.
We noted that we did not propose an additional payment adjustment
for patients who require extensive assessment and care planning as part
of the initiating visit, as payments for RHC and FQHC services are not
adjusted for length or complexity of the visit.
We stated that we believe these proposed changes would keep the CCM
requirements for RHCs and FQHCs consistent with the CCM requirements
for practitioners billing under the PFS, simplify the provision of CCM
services by RHCs and FQHCs, and improve access to these services
without compromising quality of care, beneficiary privacy, or advance
notice and consent.
We received 31 comments on the proposed revisions to the CCM
requirements for RHCs and FQHCs. The following is a summary of the
comments we received:
Comment: Commenters stated that they support CMS's efforts to
ensure that CCM requirements for RHCs and FQHCs are not more burdensome
than those for practitioners billing under the Medicare PFS.
Response: We appreciate the support of the commenters.
Comment: One commenter sought clarification on the requirements for
initiating CCM with patients that have been seen in the RHC within the
past year. The commenter asked if CCM could be initiated if the patient
had any type of visit within the past year, or if the visit within the
past year had to be an AWV, IPPE, or comprehensive E/M visit.
Response: To initiate CCM with a patient that has been seen in the
RHC or FQHC within the past year, an AWV, IPPE, or comprehensive E/M
visit must have taken place within the past year in the RHC or FQHC
that is billing for the CCM service. No other type of visit would meet
the requirement for initiating CCM services.
Comment: A few commenters were concerned that RHCs and FQHCs were
charging beneficiaries for coinsurance for non-face-to-face services,
and recommended that the copayment be waived or that CMS pursue waivers
of cost-sharing for care coordination codes. One of these commenters
stated that patients are often unwilling to pay the patient share of
the CCM services since rural providers often have already been
[[Page 80257]]
providing similar services without additional cost to the patients.
Response: As previously stated, we do not have the authority to
waive the copayment requirements for CCM services. While many
practitioners, including those in rural areas, have always provided
some care management services, we believe that payment for CCM services
will enable many RHCs and FQHCs to furnish comprehensive and systematic
care coordination services that were previously unavailable or only
sporadically offered.
Comment: A commenter asked for clarification on how claims for
patients in RHCs and FQHCs with pre-existing care management plans
should be handled, and suggested that CMS permit claims for services
for these patients.
Response: We are not entirely clear what this commenter is
suggesting. RHCs and FQHCs that bill for CCM services must develop a
comprehensive care plan that includes all the elements previously
described and also listed in Table 11. When all the requirements for
furnishing CCM services are met, including the development of the
comprehensive care plan, the RHC or FQHC would submit a claim for CCM
payment using CPT code 99490. Only the time spent furnishing CCM
services after CCM is initiated with the patient is counted toward the
minimum 20 minutes required for CCM billing. There is no additional
payment for a pre-existing care plan, and if a comprehensive care plan
that meets the CCM requirements was developed before the initiation of
CCM services, the time spent developing the plan would not be counted
toward the 20 minute minimum requirement.
Comment: A few commenters requested clarification on whether RHCs
and FQHCs could bill the new CCM codes for either complex CCM services
(CPT 99487 and 99489) or the separately billable comprehensive CCM
assessment and care planning (G0506).
Response: As we noted in the proposed rule, we did not propose to
adopt codes to provide for an additional payment for patients who
require extensive assessment or care planning because payments for RHC
and FQHC services are not adjusted for the length or complexity of the
visit. Therefore, the codes identified by the commenters are not
separately billable by an RHC or FQHC.
Comment: A few commenters recommended that CMS allow RHCs and FQHCs
to bill for the new CCM codes, and to allow safety net providers to
bill for preventive services in addition to the all-inclusive rate for
RHCs and the PPS rate for FQHCs. The commenters stated that the payment
structure for RHCs and FQHCs are a disincentive to provide preventative
services in addition to E/M services at the same visit.
Response: RHCs and FQHCs are paid for CCM services when CPT code
99490 is billed either alone or with other payable services on a RHC or
FQHC claim. The RHC and FQHC payment structures and payment for
preventive services is outside the scope of this final rule.
Comment: Several commenters recommended that CMS provide separate
payment for psychiatric collaborative care management services
furnished in RHCs and FQHCs, including CPT codes G0502, G0503, G0504
and G0507. The commenters stated that allowing RHCs and FQHCs to bill
for these services will ensure that their patients who have been
diagnosed with a mental health or substance use disorder have access to
high-quality care tailored to their individual condition and
circumstances.
Response: To be eligible for CCM services, a Medicare beneficiary
must have two or more chronic conditions that are 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. While 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 invite 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.
After considering the comments, we are finalizing as proposed the
revisions to the requirements for CCM services furnished by RHCs and
FQHCs.
F. Improving Payment Accuracy for Services: Diabetes Self-Management
Training (DSMT)
Section 1861(s)(2)(S) of the Act specifies that medical and other
health services include DSMT services as defined in section 1861(qq) of
the Act. DSMT services are intended to educate beneficiaries in the
successful self-management of diabetes. DSMT includes, as applicable,
instructions in self-monitoring of blood glucose; education about diet
and exercise; an insulin treatment plan developed specifically for the
patient who is insulin-dependent; and motivation for patients to use
the new skills for self-management (see 42 CFR 410.144(a)(5)). DSMT
services are reported under HCPCS codes G0108 (Diabetes outpatient
self-management training services, individual, per 30 minutes) and
G0109 (Diabetes outpatient self- management training services, group
session (2 or more), per 30 minutes). The benefit, as specified at 42
CFR 410.141, consists of 1 hour of individual and 9 hours of group
training unless special circumstances warrant more individual training
or no group session is available within 2 months of the date the
training is ordered.
Section 1861(qq) of the Act specifies that DMST services are
furnished by a certified provider, defined as a physician or other
individual or entity that also provides, in addition to DSMT, other
items or services for which payment may be made under Medicare. The
physician, individual or entity that furnishes the training also must
meet certain quality standards. The physician, individual or entity can
meet standards established by us or standards originally established by
the National Diabetes Advisory Board and subsequently revised by
organizations who participated in their establishment, or can be
recognized by an organization that represents individuals with diabetes
as meeting standards for furnishing the services.
We require that all those who furnish DSMT services be accredited
as meeting quality standards by a CMS-approved national accreditation
organization (NAO). In accordance with Sec. 410.144, a CMS-approved
NAO may accredit an individual, physician or entity to meet one of
three sets of DSMT quality standards: CMS quality standards; the
National Standards for Diabetes Self-Management Education Programs
(National Standards); or the standards of an NAO that represents
individuals with diabetes that meet or exceed our quality standards.
Currently, we recognize the American Diabetes Association and the
American Association of Diabetes Educators as approved NAOs, both of
whom follow National Standards. Medicare payment for outpatient DSMT
services is made in accordance with 42 CFR 414.63.
An article titled ``Use of Medicare's Diabetes Self-Management
Training Benefit'' was published in Health Education Behavior on
January 23, 2015. The article noted that only 5 percent of Medicare
beneficiaries with newly diagnosed diabetes used DSMT services. The
article recommended that future research identify barriers to DSMT
access.
In the CY 2017 PFS proposed rule (81 FR 45215), we identified
issues that the
[[Page 80258]]
DSMT community had brought to our attention which may contribute to the
low utilization of these services, and indicated that we plan to
address and clarify those issues through Medicare program instructions
as appropriate. We also solicited public comment as to other access
barriers--including whether Medicare payment for these services is
accurate--to help us identify and address them. We appreciate the many
comments regarding many issues in response to our solicitation.
Comment: Many commenters stated that the payment rates were too low
but did not suggest specific changes in the inputs used to develop
payment rates under the PFS for particular services (specifically, work
RVUs and direct PE inputs). We also received additional comments
identifying multiple other possible barriers to access. These
commenters' recommendations primarily addressed issues related to
regulatory and statutory DSMT requirements, such as: (a) Expanding of
the definition of diabetes to include hemoglobin A1C as one of the
criteria for diagnosing diabetes; (b) modifying the definition of
certified provider to include the certified diabetes educator (CDE) to
permit them to bill for DSMT; (c) allowing physicians and NPPs, other
than the one treating the beneficiary's diabetes, as required by
regulation, to order DSMT services; and, (d) eliminating the copays and
deductible for DSMT services.
Response: We appreciate the comments received and will consider
changes in valuation of these services and other regulatory issues
raised by commenters for future rulemaking. We also appreciate
commenters' feedback on several subregulatory guidelines and other
operational issues that we will consider addressing outside of
rulemaking.
G. Target for Relative Value Adjustments for Misvalued Services
Section 1848(c)(2)(O) of the Act establishes an annual target for
reductions in PFS expenditures resulting from adjustments to relative
values of misvalued codes. Under section 1848(c)(2)(O)(ii) of the Act,
if the estimated net reduction in expenditures for a year as a result
of adjustments to the relative values for misvalued codes is equal to
or greater than the target for that year, reduced expenditures
attributable to such adjustments shall be redistributed in a budget-
neutral manner within the PFS in accordance with the existing budget
neutrality requirement under section 1848(c)(2)(B)(ii)(II) of the Act.
The provision also specifies that the amount by which such reduced
expenditures exceeds the target for a given year shall be treated as a
net reduction in expenditures for the succeeding year, for purposes of
determining whether the target has been met for that subsequent year.
Section 1848(c)(2)(O)(iv) of the Act defines a target recapture amount
as the difference between the target for the year and the estimated net
reduction in expenditures under the PFS resulting from adjustments to
RVUs for misvalued codes. Section 1848(c)(2)(O)(iii) of the Act
specifies that, if the estimated net reduction in PFS expenditures for
the year is less than the target for the year, an amount equal to the
target recapture amount shall not be taken into account when applying
the budget neutrality requirements specified in section
1848(c)(2)(B)(ii)(II) of the Act. Under section 1848(c)(2)(O)(v) of the
Act, the target that applies to calendar years (CYs) 2017 and 2018 is
calculated as 0.5 percent of the estimated amount of expenditures under
the PFS for the year.
In CY 2016 PFS rulemaking, we proposed and finalized a methodology
to implement this statutory provision.
Because the annual target is calculated by measuring changes from
one year to the next, for CY 2016, we considered how to account for
changes in values that are best measured over 3 years, instead of 2
years. As we described in the CY 2016 final rule with comment period
(80 FR 70932), our general valuation process for potentially misvalued,
new, and revised codes was to establish values on an interim final
basis for a year in the PFS final rule with comment period. Then,
during the 60-day period following the publication of the final rule
with comment period, we would accept public comment about those
valuations. In the final rule with comment period for the subsequent
year, we would consider and respond to public comments received on the
interim final values, and make any appropriate adjustments to values
based on those comments. Under that process for revaluing new, revised,
and misvalued codes, we believe the overall change in valuation for
many codes would best be measured across values for 3 years: between
the original value in the first year; the interim final value in the
second year; and the finalized value in the third year. However, the
target calculation for a year would only be comparing changes in RVUs
between 2 years and not among 3 years, so the contribution of a
particular change towards the target for any single year would be
measured against only the preceding year without regard to the overall
change that takes place over 3 years.
For recent years, interim final values for misvalued codes (year 2)
have generally reflected reductions relative to original values (year
1), and for most codes, the interim final values (year 2) are
maintained and finalized (year 3). However, when values for particular
codes have changed between the interim final (year 2) and final values
(year 3) based on public comment, the general tendency has been that
codes increase in the final value (year 3) relative to the interim
final value (year 2), even in cases where the final value (year 3)
represents a decrease from the original value (year 1). Therefore, for
these codes, the year 2 changes compared to year 1 would risk over-
representing the overall reduction, while the year 3 to year 2 changes
would represent an increase in value. We noted that if there were
similar targets in every PFS year, and a similar number of misvalued
code changes made on an interim final basis, the incongruence in
measuring what is really a 3-year change in 2-year increments might not
be particularly problematic since each year's calculation would
presumably include a similar number of codes measured between years 1
and 2 and years 2 and 3.
However, including changes that take place over 3 years generated
challenges in calculating the target for CY 2016. Because there was no
target for CY 2015, any reductions that occurred on an interim final
basis for CY 2015 were not counted toward achievement of a target. If
we had then included any upward adjustments made to these codes based
on public comment as ``misvalued code'' changes for CY 2016, we would
effectively be counting the service-level increases for 2016 (year 3)
relative to 2015 (year 2) against achievement of the target without any
consideration to the service-level changes relative to 2014 (year 1),
even in cases where the overall change in valuation was negative.
Therefore, we proposed and finalized the decision to exclude code-
level input changes for CY 2015 interim final values from the
calculation of the CY 2016 misvalued code target since the misvalued
change occurred over multiple years, including years not applicable to
the misvalued code target provision.
For the CY 2017 final rule, we will be finalizing values (year 3)
for codes that were interim final in CY 2016 (year 2). Unlike codes
that were interim final for CY 2015, the codes that are interim final
for CY 2016 were included as misvalued codes and will fall within the
range of years for which the misvalued code target provision applies.
Thus, overall changes in values for these codes would
[[Page 80259]]
be measured in the target across 3 full years: The original value in
the first year (CY 2015); the interim final value in the second year
(CY 2016); and the finalized value in the third year (CY 2017). The
changes in valuation for these CY 2016 interim final codes were
previously measured and counted towards the target during their initial
change in valuation between years 1 and 2.
As such, we proposed to include changes in values of the CY 2016
interim final codes toward the CY 2017 misvalued code target. We
believe that this is consistent with the approach that we finalized in
the CY 2016 PFS final rule with comment period. The changes in values
of CY 2015 interim final codes were not counted towards the misvalued
code target in CY 2016 since the valuation change occurred over
multiple years, including years not applicable to the misvalued code
target provision. However, both of the changes in valuation for the CY
2016 interim final codes, from year 1 to year 2 (CY 2015 to CY 2016)
and from year 2 to year 3 (CY 2016 to CY 2017), have taken place during
years that occur within the misvalued code target provision. We
therefore believe that any adjustments made to these codes based on
public comment should be considered towards the achievement of the
target for CY 2017, just as any changes in valuation for these same CY
2016 interim final codes previously counted towards the achievement of
the target for CY 2016.
We solicited comments regarding this proposal. We also reminded
commenters that we revised our process for revaluing new, revised and
misvalued codes so that we will be proposing and finalizing values for
most of the misvalued codes during a single calendar year. After this
year, there will be far fewer instances of interim final codes and
changes that are best measured over 3 years.
We refer readers to the regulatory impact analysis section of this
final rule for the net reduction in expenditures relative to the 0.5
percent target for CY 2017, and the resulting adjustment required to be
made to the conversion factor. Additionally, we refer readers to the
public use file that provides a comprehensive description of how the
target is calculated, as well as the estimated impact by code family on
the CMS Web site under the supporting data files for the CY 2017 PFS
final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
The following is summary of the comments we received regarding the
target for relative value adjustments for misvalued services.
Comment: Several commenters expressed support for the CMS estimate
that there would be no target recapture amount by which to reduce
payments made under the PFS in CY 2017.
Response: We appreciate the comments. We remind stakeholders that
the final determination of the target recapture amount is based on
finalized RVUs for the relevant codes. We refer readers to the
regulatory impact analysis section of this final rule for the net
reduction in expenditures relative to the 0.5 percent target for CY
2017, and the resulting adjustment that is required to be made to the
conversion factor.
Comment: One commenter urged CMS to broaden its approach to
counting misvalued code payment adjustments in the final rule. The
commenter stated that CMS was taking a narrow approach to the misvalued
code target.
Response: We finalized our methodology for calculating the
estimated net reduction relative to the misvalued code target in the CY
2016 final rule with comment period (80 FR 70921-70927). For CY 2017,
we proposed a modification to that methodology that only addressed how
changes to interim final codes would be addressed when both first and
second year changes could be counted towards a misvalued code target
since CY 2017 is the first year for that circumstance. We did not make
a proposal on the more general issue of the methodology used to
calculate the net reductions for the misvalued code target, which, as
noted above, was finalized in the CY 2016 PFS final rule with comment
period.
We did not receive any public comments on our proposal to include
changes in values of the CY 2016 interim final codes toward the CY 2017
misvalued code target.
After consideration of comments received, we are finalizing our
proposal to count any adjustments to interim final codes towards the
misvalued code target when both first and second year changes can be
counted towards a misvalued codes target.
H. Phase-In of Significant RVU Reductions
Section 1848(c)(7) of the Act specifies that for services that are
not new or revised codes, if the total RVUs for a service for a year
would otherwise be decreased by an estimated 20 percent or more as
compared to the total RVUs for the previous year, the applicable
adjustments in work, PE, and MP RVUs shall be phased in over a 2-year
period. In the CY 2016 PFS rulemaking, we proposed and finalized a
methodology to implement this statutory provision. To determine which
services are described by new or revised codes for purposes of the
phase-in provision, we apply the phase-in to all services that are
described by the same, unrevised code in both the current and update
year, and exclude codes that describe different services in the current
and update year.
Because the phase-in of significant reductions in RVUs falls within
the budget neutrality requirements specified in section
1848(c)(2)(B)(ii)(II) of the Act, we estimate the total RVUs for a
service prior to the budget-neutrality redistributions that result from
implementing phase-in values. In implementing the phase-in, we consider
a 19 percent reduction as the maximum 1-year reduction for any service
not described by a new or revised code. This approach limits the year
one reduction for the service to the maximum allowed amount (that is,
19 percent), and then phases in the remainder of the reduction.
The statute provides that the applicable adjustments in work, PE,
and MP RVUs shall be phased in over a 2-year period when the RVU
reduction for a code for a year is estimated to be equal to or greater
than 20 percent. Since CY 2016 was the first year in which we applied
the phase-in transition, CY 2017 will be the first year in which a
single code could be subject to RVU reductions greater than 20 percent
for 2 consecutive years.
Under our finalized policy, the only codes that are not subject to
the phase-in are those that are new or revised, which we defined as
those services that are not described by the same, unrevised code in
both the current and update year, or by the same codes that describe
different services in the current and update year. Since CY 2016 was
the first year for which the phase-in provision applied, we did not
address how we would handle codes with values that had been partially
phased in during the first year, but that have a remaining phase-in
reduction of 20 percent or greater.
The significant majority of codes with reductions in RVUs that are
greater than 20 percent in year one would not be likely to meet the 20
percent threshold in a consecutive year. However, in a few cases,
significant changes (for example, in the input costs included in the
valuation of a service) could produce reductions of 20 percent or
greater in consecutive years.
As stated in the CY 2017 PFS proposed rule, we believed that a
consistent methodology regarding the phase-in transition should be
applied to these cases. We proposed to reconsider
[[Page 80260]]
in each year, for all codes that are not new or revised codes and
including codes that were assigned a phase-in value in the previous
year, whether the total RVUs for the service would otherwise be
decreased by an estimated 20 percent or more as compared to the total
RVUs for the previous year. Under this proposed policy, the 19 percent
reduction in total RVUs would continue to be the maximum one-year
reduction for all codes (except those considered new and revised),
including those codes with phase-in values in the previous year. In
other words, for purposes of the 20 percent threshold, every service is
evaluated anew each year, and any applicable phase-in is limited to a
decrease of 19 percent. For example, if we were to adopt a 50 percent
reduction in total RVUs for an individual service, the reduction in any
particular year would be limited to a decrease of 19 percent in total
RVUs. Because we do not set rates 2 years in advance, the phase-in
transition would continue to apply until the year-to-year reduction for
a given code does not meet the 20 percent threshold. We solicited
comments regarding this proposal.
The list of codes subject to the phase-in and the associated
proposed RVUs that result from this methodology is available on the CMS
Web site under downloads for the CY 2017 PFS final rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
The following is summary of the comments we received regarding the
phase-in of significant RVU reductions.
Comment: Many commenters supported the proposal that a 19 percent
reduction in total RVUs would continue to be the maximum one-year
reduction for all codes that are not new or revised. These commenters
urged CMS to finalize the proposal.
Response: We appreciate the support from the commenters.
Comment: Several commenters suggested that CMS should extend the
threshold for triggering the phase-in provision, by using a lower
single-year maximum reduction (such as 10 percent), at a rate different
than what the statute stipulates. The commenters stated that a lower
threshold would provide a greater safeguard against payment cuts and
disruption of services.
Response: Section 1848(c)(7) of the Act requires the phase-in if
the total RVUs for a service for a year would otherwise be decreased by
an estimated 20 percent or larger. We do not believe that we have the
statutory authority to establish a different threshold value for when
the phase-in applies.
Comment: One commenter objected to CMS' decision to exclude from
the phase-in codes with a reduction of 20 percent or more that fall
within a family with significant coding revisions. The commenter
requested that CMS reconsider this policy.
Response: We understand the commenters' concerns. In the CY 2016
final rule with comment period (80 FR 70927-70931), we finalized a
policy to identify services that are not subject to the phase-in
because they are new or revised codes. As we wrote at the time, 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. We continue to believe that this is
the most accurate methodology to use in identifying new and revised
codes for the purposes of the phase-in transition. We also note that we
did not make a proposal to change how we identify services to which the
phase-in does not apply.
Comment: A commenter requested that CMS apply the phase-in policy
to services in the PFS with year-to-year reductions of 20 percent or
more in payment amount due to the statutory cap that requires payment
for the technical component (TC) of certain imaging services furnished
in the office setting to be made the lesser of the PFS or OPPS rates.
The commenter stated that this application would capture the spirit of
the phase-in legislation in dampening the impact of significant payment
reductions on a year to year basis.
Response: Section 1848(c)(7) of the Act requires the phase-in of
reductions of 20 percent or more in the total RVUs for individual
services. The OPPS cap, required under section 1848(b)(4)(A) of the
Act, specifies that if the PFS payment rate for the TC of certain
imaging services exceeds the OPPS payment amount for the services, the
OPPS payment amount must be substituted for the PFS TC payment amount.
The OPPS cap refers to, and requires substitution of, payment rates for
individual imaging services, and not a reduction in the total RVUs for
those services. As such, services that are subject to the OPPS cap are
not subject to the phase-in on that basis.
Comment: One commenter opposed the phase-in proposal. The commenter
stated that the proposal twisted a plain reading of the law to
effectively extend the phase-in period well beyond the 2 years
prescribed by the statute. The commenter questioned why Medicare
beneficiaries should have to pay a higher fee for overvalued services
when identified as such, and pointed out that in the budget-neutral
environment of the fee schedule, the proposal would delay the benefit
of these RVU reductions to the rest of the services listed in the PFS.
Response: We appreciate the concerns raised by the commenter. As we
have addressed over several rulemaking cycles, we are concerned about
the impact of misvalued services in creating distortions in relativity
across the fee schedule. However, we have already finalized through
notice and comment rulemaking and continue to believe that limiting
reductions to 19 percent as the maximum 1-year decrease for all codes
(except those considered new and revised) is the best and most fair way
to apply the phase-in. Additionally, because we do not set rates 2
years in advance, we believe there are significant obstacles to
implementing an alternative methodology. For example, codes may be
reviewed multiple times in a short period of time, and may have further
decreases in total RVUs for a subsequent year due to a variety of
reasons in addition to any change inputs from the initial year phase-
in. These might include supply and equipment price updates in non-
reviewed years, significant changes in specialty mix of practitioners
reporting the service, or changes in other PFS ratesetting policies
which could lead to several consecutive years of RVU reductions. In any
such cases, it would be impractical to identify with certainty what
portion of reductions in code values are due to input changes
established in a prior year versus input or policy changes from the
current year. We also note that all of these circumstances are
relatively rare since it is unusual for changes in code inputs to
result in reductions of greater than 40 percent. Therefore, while we
appreciate the importance of improving payment accuracy as soon as can
be practicable for the reasons stated by the commenter, we also believe
that, on balance, the best and most fair approach to implementing the
required phase-in of RVU reductions over multiple years is to re-
examine eligible codes for the phase-in on an annual basis, in
conjunction with our annual ratesetting.
After consideration of comments received, we are finalizing the
policy as proposed.
[[Page 80261]]
I. Geographic Practice Cost Indices (GPCIs)
1. Background
Section 1848(e)(1)(A) of the Act requires us to develop separate
Geographic Practice Cost Indices (GPCIs) to measure relative cost
differences among localities compared to the national average for each
of the three fee schedule components (that is, work, PE, and
malpractice (MP)). The PFS localities are discussed in section II.E.3.
of this final rule. Although the statute requires that the PE and MP
GPCIs reflect the full relative cost differences, section
1848(e)(1)(A)(iii) of the Act requires that the work GPCIs reflect only
one-quarter of the relative cost differences compared to the national
average. In addition, section 1848(e)(1)(G) of the Act sets a permanent
1.5 work GPCI floor for services furnished in Alaska beginning January
1, 2009, and section 1848(e)(1)(I) of the Act sets a permanent 1.0 PE
GPCI floor for services furnished in frontier states (as defined in
section 1848(e)(1)(I) of the Act) beginning January 1, 2011.
Additionally, section 1848(e)(1)(E) of the Act provided for a 1.0 floor
for the work GPCIs, which was set to expire on March 31, 2015. Section
201 of the MACRA amended the statute to extend the 1.0 floor for the
work GPCIs through CY 2017 (that is, for services furnished no later
than December 31, 2017).
Section 1848(e)(1)(C) of the Act requires us to review and, if
necessary, adjust the GPCIs at least every 3 years. Section
1848(e)(1)(C) of the Act requires that, if more than 1 year has elapsed
since the date of the last previous GPCI adjustment, the adjustment to
be applied in the first year of the next adjustment shall be half of
the adjustment that otherwise would be made. Therefore, since the
previous GPCI update was implemented in CY 2014 and CY 2015, we
proposed to phase in 1/2 of the latest GPCI adjustment in CY 2017.
We have completed a review of the GPCIs and proposed new GPCIs in
this final rule. We also calculate a geographic adjustment factor (GAF)
for each PFS locality. The GAFs are a weighted composite of each area's
work, PE and malpractice expense GPCIs using the national GPCI cost
share weights. While we do not actually use GAFs in computing the fee
schedule payment for a specific service, they are useful in comparing
overall areas costs and payments. The actual effect on payment for any
actual service would deviate from the GAF to the extent that the
proportions of work, PE and MP RVUs for the service differ from those
of the GAF.
As noted above, section 201 of the MACRA extended the 1.0 work GPCI
floor for services furnished through December 31, 2017. Therefore, the
proposed CY 2017 work GPCIs and summarized GAFs reflect the 1.0 work
floor. Additionally, as required by sections 1848(e)(1)(G) and
1848(e)(1)(I) of the Act, the 1.5 work GPCI floor for Alaska and the
1.0 PE GPCI floor for frontier states are permanent, and therefore,
applicable in CY 2017. See Addenda D and E to this final rule for the
CY 2017 GPCIs and summarized GAFs available on the CMS Web site under
the supporting documents section of the CY 2017 PFS final rule located
at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
2. GPCI Update
The proposed updated GPCI values were calculated by a contractor.
There are three GPCIs (work, PE, and MP), and all GPCIs are calculated
relative to the national average for each measure. Additionally, each
of the three GPCIs relies on its own data source(s) and methodology for
calculating its value as described below. Additional information on the
CY 2017 GPCI update may be found in our contractor's draft report,
``Draft Report on the CY 2017 Update of the Geographic Practice Cost
Index for the Medicare Physician Fee Schedule,'' which is available on
our Web site. It is located under the supporting documents section for
the CY 2017 PFS final rule located at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
a. Work GPCIs
The work GPCIs are designed to reflect the relative costs of
physician labor by Medicare PFS locality. As required by statute, the
work GPCI reflects one quarter of the relative wage differences for
each locality compared to the national average.
To calculate the work GPCIs, we use wage data for seven
professional specialty occupation categories, adjusted to reflect one-
quarter of the relative cost differences for each locality compared to
the national average, as a proxy for physicians' wages. Physicians'
wages are not included in the occupation categories used in calculating
the work GPCI because Medicare payments are a key determinant of
physicians' earnings. Including physician wage data in calculating the
work GPCIs would potentially introduce some circularity to the
adjustment since Medicare payments typically contribute to or influence
physician wages. That is, including physicians' wages in the physician
work GPCIs would, in effect, make the indices, to some extent,
dependent upon Medicare payments.
The work GPCI updates in CYs 2001, 2003, 2005, and 2008 were based
on professional earnings data from the 2000 Census. However, for the CY
2011 GPCI update (75 FR 73252), the 2000 data were outdated and wage
and earnings data were not available from the more recent Census
because the ``long form'' was discontinued. Therefore, we used the
median hourly earnings from the 2006 through 2008 Bureau of Labor
Statistics (BLS) Occupational Employment Statistics (OES) wage data as
a replacement for the 2000 Census data. The BLS OES data meet several
criteria that we consider to be important for selecting a data source
for purposes of calculating the GPCIs. For example, the BLS OES wage
and employment data are derived from a large sample size of
approximately 200,000 establishments of varying sizes nationwide from
every metropolitan area and can be easily accessible to the public at
no cost. Additionally, the BLS OES is updated regularly, and includes a
comprehensive set of occupations and industries (for example, 800
occupations in 450 industries). For the CY 2014 GPCI update, we used
updated BLS OES data (2009 through 2011) as a replacement for the 2006
through 2008 data to compute the work GPCIs.
Because of its reliability, public availability, level of detail,
and national scope, we believe the BLS OES data continue to be the most
appropriate source of wage and employment data for use in calculating
the work GPCIs (and as discussed in section II.E.2.b the employee wage
component and purchased services component of the PE GPCI). Therefore,
for the proposed CY 2017 GPCI update, we used updated BLS OES data
(2011 through 2014) as a replacement for the 2009 through 2011 data to
compute the work GPCIs.
b. Practice Expense GPCIs
The PE GPCIs are designed to measure the relative cost difference
in the mix of goods and services comprising practice expenses (not
including malpractice expenses) among the PFS localities as compared to
the national average of these costs. Whereas the physician work GPCIs
(and as discussed later in this section, the MP GPCIs) are comprised of
a single index, the PE GPCIs are comprised of four component indices
(employee wages; purchased services; office rent; and equipment,
supplies and
[[Page 80262]]
other miscellaneous expenses). The employee wage index component
measures geographic variation in the cost of the kinds of skilled and
unskilled labor that would be directly employed by a physician
practice. Although the employee wage index adjusts for geographic
variation in the cost of labor employed directly by physician
practices, it does not account for geographic variation in the cost of
services that typically would be purchased from other entities, such as
law firms, accounting firms, information technology consultants,
building service managers, or any other third-party vendor. The
purchased services index component of the PE GPCI (which is a separate
index from employee wages) measures geographic variation in the cost of
contracted services that physician practices would typically buy. (For
more information on the development of the purchased service index, we
refer readers to the CY 2012 PFS final rule with comment period (76 FR
73084 through 73085)). The office rent index component of the PE GPCI
measures relative geographic variation in the cost of typical physician
office rents. For the medical equipment, supplies, and miscellaneous
expenses component, we believe there is a national market for these
items such that there is not significant geographic variation in costs.
Therefore, the equipment, supplies and other miscellaneous expense cost
index component of the PE GPCI is given a value of 1.000 for each PFS
locality.
For the previous update to the GPCIs (implemented in CY 2014) we
used 2009 through 2011 BLS OES data to calculate the employee wage and
purchased services indices for the PE GPCI. As discussed in section
II.E.2.a., because of its reliability, public availability, level of
detail, and national scope, we continue to believe the BLS OES is the
most appropriate data source for collecting wage and employment data.
Therefore, in calculating the proposed CY 2017 GPCI update, we used
updated BLS OES data (2011 through 2014) as a replacement for the 2009
through 2011 data for purposes of calculating the employee wage
component and purchased service index component of the PE GPCI.
c. Malpractice Expense (MP) GPCIs
The MP GPCIs measure the relative cost differences among PFS
localities for the purchase of professional liability insurance (PLI).
The MP GPCIs are calculated based on insurer rate filings of premium
data for $1 million to $3 million mature claims-made policies (policies
for claims made rather than services furnished during the policy term).
For the CY 2014 GPCI update (seventh update) we used 2011 and 2012
malpractice premium data (78 FR 74382). The proposed CY 2017 MP GPCI
update reflects 2014 and 2015 premium data. Additionally, the proposed
CY 2017 MP GPCI update reflects several proposed technical refinements
to the MP GPCI methodology as discussed later in section 5.
d. GPCI Cost Share Weights
For CY 2017 GPCIs, we proposed to continue to use the current cost
share weights for determining the PE GPCI values and locality GAFs. We
refer readers to the CY 2014 PFS final rule with comment period (78 FR
74382 through 74383), for further discussion regarding the 2006-based
MEI cost share weights revised in CY 2014 that were also finalized for
use in the CY 2014 (seventh) GPCI update.
The GPCI cost share weights for CY 2017 are displayed in Table 12.
Table 12--Cost Share Weights for CY 2017 GPCI Update
------------------------------------------------------------------------
Proposed
Current CY 2017
cost cost
Expense category share share
weight weight
(%) (%)
------------------------------------------------------------------------
Work.............................................. 50.866 50.866
Practice Expense.................................. 44.839 44.839
--Employee Compensation......................... 16.553 16.553
--Office Rent................................... 10.223 10.223
--Purchased Services............................ 8.095 8.095
--Equipment, Supplies, Other.................... 9.968 9.968
Malpractice Insurance............................. 4.295 4.295
---------------------
Total........................................... 100.000 100.000
------------------------------------------------------------------------
e. PE GPCI Floor for Frontier States
Section 10324(c) of the Affordable Care Act added a new
subparagraph (I) under section 1848(e)(1) of the Act to establish a 1.0
PE GPCI floor for physicians' services furnished in frontier states
effective January 1, 2011. In accordance with section 1848(e)(1)(I) of
the Act, beginning in CY 2011, we applied a 1.0 PE GPCI floor for
physicians' services furnished in states determined to be frontier
states. In general, a frontier state is one in which at least 50
percent of the counties are ``frontier counties,'' which are those that
have a population per square mile of less than 6. For more information
on the criteria used to define a frontier state, we refer readers to
the FY 2011 Inpatient Prospective Payment System (IPPS) final rule (75
FR 50160 through 50161). There are no changes in the states identified
as Frontier States for the CY 2017 final rule. The qualifying states
are: Montana, Wyoming, North Dakota, South Dakota, and Nevada. In
accordance with statute, we would apply a 1.0 PE GPCI floor for these
states in CY 2017.
f. Proposed GPCI Update
As explained above in the background section, the periodic review
and adjustment of GPCIs is mandated by section 1848(e)(1)(C) of the
Act. At each update, the proposed GPCIs are published in the PFS
proposed rule to provide an opportunity for public comment and further
revisions in response to comments prior to implementation. As discussed
later in this section, we are finalizing the GPCIs as proposed (except
where we correct technical errors). The final CY 2017 updated GPCIs for
the first and second year of the 2-year transition, along with the
GAFs, are displayed in Addenda D and E to this final rule available on
our Web site under the supporting documents section of the CY 2017 PFS
final rule Web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
3. Payment Locality Discussion
a. Background
The current PFS locality structure was developed and implemented in
1997. There are currently 89 total PFS localities; 34 localities are
statewide areas (that is, only one locality for the entire state).
There are 52 localities in the other 16 states, with 10 states having 2
localities, 2 states having 3 localities, 1 state having 4 localities,
and 3 states having 5 or more localities. The combined District of
Columbia, Maryland, and Virginia suburbs; Puerto Rico; and the Virgin
Islands are the remaining three localities of the total of 89
localities. The development of the current locality structure is
described in detail in the CY 1997 PFS final rule (61 FR 34615) and the
subsequent final rule with comment period (61 FR 59494). We note that
the localities generally represent a grouping of one or more
constituent counties.
Prior to 1992, Medicare payments for physicians' services were made
under the reasonable charge system. Payments were based on the charging
patterns of physicians. This resulted in large differences in payment
for physicians' services among types of services, geographic payment
areas, and physician specialties. Recognizing this, the Congress
replaced the reasonable
[[Page 80263]]
charge system with the Medicare PFS in the Omnibus Budget
Reconciliation Act (OBRA) of 1989, and the PFS went into effect January
1, 1992. Payments under the PFS are based on the relative resources
involved with furnishing services, and are adjusted to account for
geographic variations in resource costs as measured by the GPCIs.
Payment localities originally were established under the reasonable
charge system by local Medicare carriers based on their knowledge of
local physician charging patterns and economic conditions. These
localities changed little between the inception of Medicare in 1967 and
the beginning of the PFS in 1992. Shortly after the PFS took effect, we
undertook a study in 1994 that culminated in a comprehensive locality
revision that was implemented in 1997 (61 FR 59494).
The revised locality structure reduced the number of localities
from 210 to the current 89, and the number of statewide localities
increased from 22 to 34. The revised localities were based on locality
resource cost differences as reflected by the GPCIs. For a full
discussion of the methodology, see the CY 1997 PFS final rule with
comment period (61 FR 59494). The current 89 fee schedule areas are
defined alternatively by state boundaries (for example, Wisconsin),
metropolitan areas (for example, Metropolitan St. Louis, MO), portions
of a metropolitan area (for example, Manhattan), or rest-of-state areas
that exclude metropolitan areas (for example, Rest of Missouri). This
locality configuration is used to calculate the GPCIs that are in turn
used to calculate payments for physicians' services under the PFS.
As stated in the CY 2011 PFS final rule with comment period (75 FR
73261), changes to the PFS locality structure would generally result in
changes that are budget neutral within a state. For many years, before
making any locality changes, we have sought consensus from among the
professionals whose payments would be affected. In recent years, we
have also considered more comprehensive changes to locality
configuration. In 2008, we issued a draft comprehensive report
detailing four different locality configuration options (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/downloads/ReviewOfAltGPCIs.pdf). We refer readers to
the CY 2014 PFS final rule with comment period for further discussion
regarding that report, as well as a discussion about the Institute of
Medicine's empirical study of the Medicare GAFs established under
sections 1848(e) (PFS GPCI) and 1886(d)(3)(E) (IPPS wage index) of the
Act.
The following is a summary of the comments we received regarding
the proposed CY 2017 GPCI update.
Comment: A few commenters including a major specialty society
expressed support for using more current data in calculating all three
GPCIs.
Response: We thank the commenters for their support.
Comment: One commenter expressed support for the elimination of all
geographic adjustment factors under the PFS, except those designed to
achieve a specific public policy goal, such as to encourage physicians
to practice in underserved areas. Another commenter opposed any
decrease in the GPCI.
Response: As previously discussed, section 1848(e)(1)(A) of the Act
requires us to develop separate GPCIs to measure resource cost
differences among localities compared to the national average for each
of the three GPCI components, and section 1848(e)(1)(C) of the Act
requires us to review and, if necessary, adjust the GPCIs at least
every 3 years; and based on new data, GPCI values may increase or
decrease.
Comment: A few commenters expressed concern regarding payment for
rural localities and recommended that CMS monitor how the GPCI
calculation changes affect the sustainability of health services in
rural communities. One commenter requested that CMS consider the
ongoing data issues regarding the GPCIs raised by stakeholders in the
Midwest, and establish 1.0 work and PE GPCI values for Wisconsin and
Iowa.
Response: As discussed previously in this section, we are required
to update the GPCIs at least every 3 years to reflect the relative cost
differences of operating a medical practice in each locality compared
to the national average costs. Additionally, as previously discussed in
this section, sections 1848(e)(1)(G) and 1848(e)(1)(I) of the Act
established the permanent 1.5 work GPCI floor for Alaska and the
permanent 1.0 PE GPCI floor for frontier States. We do not otherwise
have the authority to establish similar GPCI floors or other policies
that do not take into consideration the differences in physicians'
resource costs among localities.
Comment: One commenter supported the continuation of the 1.0 PE
GPCI floor for frontier states.
Response: As previously discussed, beginning January 1, 2011
section 1848(e)(1)(I) of the Act set a permanent 1.0 PE GPCI floor for
services furnished in frontier states (as defined in section
1848(e)(1)(I) of the Act).
Comment: Several commenters stated their objection to the use of
residential rents as a proxy for physician office space costs, and
stated that CMS should collect commercial rent data and use it either
as the basis for measuring geographic differences in physician office
rents or, if this is not feasible, use it to validate the residential
rents as a proxy. A few commenters requested that CMS provide a
specific explanation on the barriers to gaining better commercial rent
data.
Response: Because Medicare is a national program, and section
1848(e)(1)(A) of the Act requires us to establish GPCIs to measure
relative cost differences among localities compared to the national
average, we believe it is important to use the best data that is
available on a nationwide basis, that is regularly updated, and retains
consistency area-to-area, year-to-year. Since there is currently no
national data source available for physician office or other comparable
commercial rents, we continue to use county-level residential rent data
from the American Community Survey (ACS) as a proxy for the relative
cost differences in commercial office rents. The ACS is administered by
the United States Census Bureau, which is a leading source of national,
robust, quality, publicly available data. We agree that a commercial
data source for office rent that provided for adequate representation
of urban and rural areas nationally would be preferable to a
residential rent proxy. We have previously discussed in the CY 2005, CY
2008, and CY 2011 (69 FR 66262, 72 FR 66376, and 75 FR 73257,
respectively) final rules that we recognize that apartment rents may
not be a perfect proxy for physician office rent. We have also
conducted exhaustive searches for reliable commercial rent data sources
that are publicly available in the past and have not found any reliable
data that meets our accuracy needs, and we continue to conduct such
searches. With regards to suggestion that CMS should collect commercial
rent data, we note that we discussed this issue in the CY 2012 PFS
final rule with comment period (76 FR 73088) and stated with reference
to surveying physicians directly to gather data to compute office rent,
we note that the development and implementation of a survey could take
several years. Additionally, we have historically not sought direct
survey data from physicians related to the GPCI to avoid issues of
circularity and self-reporting bias. In the CY 2011 PFS final rule with
comment period (75 FR 73259), we
[[Page 80264]]
solicited public comments regarding the benefits of utilizing physician
cost reports to potentially achieve greater precision in measuring the
relative cost difference among Medicare localities. We also asked for
comments regarding the administrative burden of requiring physicians to
routinely complete these cost reports and whether this should be
mandatory for physicians' practices. We did not receive any feedback
related to that comment solicitation during the open public comment
period for the CY 2011 final rule with comment period. We continue to
have concerns that physician cost reports could be prohibitively
expensive, and as well about the administrative burden this approach
would place on physician's office staff. We reiterate that the GPCIs
are not an absolute measure of practice costs, rather they are a
measure of the relative cost differences for each of the three GPCI
components. The U.S. Census Bureau is a federal agency that specializes
in data collection, accuracy, and reliability, and we continue to
believe that where such a publicly available resource exists that can
provide useful data to assess geographic cost differences in office
rent, even though it is a proxy for the exact data we seek, that we
should utilize that available resource. Therefore, given its national
representation, reliability, high response rate and frequent updates,
we continue to believe the ACS residential rent data is the most
appropriate data source available at this time for the purposes of
calculating the rent index of the PE GPCI.
Comment: One commenter stated that it objects to the 8 percent
weight that the rent expense category has been given by CMS in
calculating the PE GPCI, and stated that office rent should be given a
much larger weight to more accurately reflect its impact on physician
practice expenses, and CMS should commit resources to update this data
since it is based on 10-year old data from the 2006 AMA Physician
Practice Information Survey (AMA PPIS).
Response: We would like to clarify that the office rent expense
category has a cost share weight of 10.223 percent, not 8 percent as
indicated by the commenter. The MEI cost share weights were derived
from data collected by the AMA on the AMA PPIS. CMS has previously
stated that we believe the AMA PPIS is a reliable data source, however
the AMA PPIS is not an ongoing data source that is regularly published.
We continued to use the AMA PPIS data source in the CY 2014 revisions
to the MEI which have not been further updated since, and therefore, as
discussed above, the 2006-based MEI cost share weights finalized for
use in the CY 2014 (seventh) GPCI update, were proposed for the CY 2017
(eighth) GPCI update. The AMA is no longer conducting the AMA PPIS
survey, and CMS' Office of the Actuary continues to look into viable
options for updating the MEI cost share weights going forward. In the
CY 2014 PFS final rule with comment period (78 FR 74275), we stated
that we continue to investigate possible data sources to use for the
purpose of rebasing the MEI in the future.
Comment: A few commenters expressed concern with the use of
unrelated proxy data for physician wages in geographic adjustment. The
commenters expressed concern about GPCI proxy inputs that result in
downward payment adjustments, which they believe do not reflect the
actual cost of physician practices. The commenters stated that better
data exist for measuring the real physician compensation rates, such as
recruitment compensation surveys and wages for physicians employed at
federally qualified health centers. The commenters also stated that
MedPAC studies have confirmed that the data sources currently relied
upon for geographic adjustment bear no correlation to physician
earnings. One commenter also stated that CMS has acknowledged that the
proxies utilized for the purposes of geographic adjustment have never
been validated and there never has been a new data source utilized in
the twenty years since the fee schedule was implemented. The commenters
urged CMS to undertake the necessary studies to identify reference
occupations that will accurately reflect the higher input costs of
rural physician earnings, and implement the resulting corrections to
the geographic adjustment of the fee schedule as soon as possible.
Response: We appreciate the comments regarding the professional
occupations used to determine the relative cost differences in
physician earnings for purposes of calculating the work GPCI. In
consideration of the ongoing concerns regarding the reference
occupations and other proxy data used to calculate the GPCIs, we also
note that in the past we received comments suggesting the use of survey
data to determine GPCI values, and stated that we would continue to
consider the possibility of establishing a physician cost report and
requiring a sufficiently large sample of physicians in each locality to
report data on actual costs incurred. However we also stated that we
believed that a physician cost report could take years to develop and
implement, and could be prohibitively expensive (75 FR 73259). We
solicited public comment regarding the potential benefits to be gained
from establishing a physician cost report and whether this approach is
appropriate to achieve potentially greater precision in measuring the
relative cost differences in physicians' practices among PFS
localities. We also solicited public comments on the potential
administrative burden of requiring physicians to routinely complete and
submit a cost report. We did not receive any feedback specifically
related to that comment solicitation (76 FR 73088). As noted previously
in this section, physicians' wages are not included in the occupation
categories (reference occupations) used in calculating the work GPCI
because Medicare payments are a key determinant of physicians'
earnings. We have long maintained that including physician wage data in
calculating the work GPCIs would potentially introduce some circularity
to the adjustment since Medicare payments typically contribute to
physician wages. In other words, including physicians' wages in the
physician work GPCI would, in effect, make the indices, to some extent,
dependent upon Medicare payments, which in turn are impacted by the
indices. We reiterate that the work GPCI is not an absolute measure of
physician earnings; rather it is a measure of the relative wage
differences for each locality as compared to the national average;
additionally, the work GPCI reflects only one quarter of those relative
wage differences consistent with the statutory requirement as discussed
previously in this section.
Comment: We received a few comments on the PFS locality structure
that were not within the scope of the CY 2017 proposed rule. For
example, several commenters requested that Prince William and Loudoun
counties in Virginia be changed from the Rest of Virginia locality into
the DC + MD/VA Suburbs locality. Another commenter stated that it
believes large cuts to rural and rest-of-State areas should be avoided
or minimized, but locality boundaries with large payment differences
should not be in the middle of urban areas, because they create payment
cliffs where payment can change by up to eight percent if an office
location is moved across a street or down a block. The commenter stated
that CMS should act quickly to create locality definitions that are not
constrained by county boundaries, and advocated implementing locality
[[Page 80265]]
definition changes based on Metropolitan Statistical Areas.
Response: We appreciate the suggestions for revisions to the PFS
locality structure. As discussed above, we did not propose changes to
the PFS locality structure; we note that the update to the California
Fee Schedule Areas discussed later in this section is the result of a
statutory requirement. Additionally, we would like to note that, absent
statutory provisions like those that pertain to California, changes to
the locality configuration within a state would lead to significant
redistributions in payments within that state. It has been our
practice, and we have stated in previous rulemaking (72 FR 38139, and
73 FR 38513), that we have not considered making changes to localities
without the support of a State medical association(s) to demonstrate
consensus for the change among the professionals whose payments would
be affected (with some increasing and some decreasing). Also, we would
like to clarify that, just as the localities under the Fee Schedule
areas used in the PFS are comprised of one or more constituent
counties, so are Metropolitan Statistical Areas. Therefore the concept
of a payment cliff between neighboring counties as described by the
commenter would not necessarily be mitigated by a change from PFS fee
schedule areas to Metropolitan Statistical Areas.
After consideration of the public comments received regarding the
proposed CY 2017 GPCI data update, we are finalizing as proposed.
b. California Locality Update to the Fee Schedule Areas Used for
Payment Under Section 220(h) of the Protecting Access to Medicare Act
(1) General Discussion and Legislative Change
Section 220(h) of the PAMA added a new section 1848(e)(6) to the
Act, that modifies the fee schedule areas used for payment purposes in
California beginning in CY 2017.
Currently, the fee schedule areas used for payment in California
are based on the revised locality structure that was implemented in
1997 as previously discussed. Beginning in CY 2017, section
1848(e)(6)(A)(i) of the Act requires that the fee schedule areas used
for payment in California must be Metropolitan Statistical Areas (MSAs)
as defined by the Office of Management and Budget (OMB) as of December
31 of the previous year; and section 1848(e)(6)(A)(ii) of the Act
requires that all areas not located in an MSA must be treated as a
single rest-of-state fee schedule area. The resulting modifications to
California's locality structure would increase its number of localities
from 9 under the current locality structure to 27 under the MSA-based
locality structure.
However, section 1848(e)(6)(D) of the Act defines transition areas
as the fee schedule areas for 2013 that were the rest-of-state
locality, and locality 3, which was comprised of Marin County, Napa
County, and Solano County. Section 1848(e)(6)(B) of the Act specifies
that the GPCI values used for payment in a transition area are to be
phased in over 6 years, from 2017 through 2021, using a weighted sum of
the GPCIs calculated under the new MSA-based locality structure and the
GPCIs calculated under the current PFS locality structure. That is, the
GPCI values applicable for these areas during this transition period
are a blend of what the GPCI values would have been under the current
locality structure, and what the GPCI values would be under the MSA-
based locality structure. For example, in the first year, CY 2017, the
applicable GPCI values for counties that were previously in rest-of-
state or locality 3 and are now in MSAs are a blend of 1/6 of the GPCI
value calculated for the year under the MSA-based locality structure,
and 5/6 of the GPCI value calculated for the year under the current
locality structure. The proportions shift by 1/6 in each subsequent
year so that, by CY 2021, the applicable GPCI values for counties
within transition areas are a blend of 5/6 of the GPCI value for the
year under the MSA-based locality structure, and 1/6 of the GPCI value
for the year under the current locality structure. Beginning in CY
2022, the applicable GPCI values for counties in transition areas are
the values calculated under the new MSA-based locality structure. For
the sake of clarity, we reiterate that this incremental phase-in is
only applicable to those counties that are in transition areas that are
now in MSAs, which are only some of the counties in the 2013 California
rest-of state locality and locality 3.
Additionally, section 1848(e)(6)(C) of the Act establishes a hold
harmless for transition areas beginning with CY 2017 whereby the
applicable GPCI values for a year under the new MSA-based locality
structure may not be less than what they would have been for the year
under the current locality structure. There are a total of 58 counties
in California, 50 of which are in transition areas as defined in
section 1848(e)(6)(D) of the Act. Therefore, 50 counties in California
are subject to the hold harmless provision. The other 8 counties, which
are metropolitan counties that are not defined as transition areas, are
not held harmless for the impact of the new MSA-based locality
structure, and may therefore potentially experience slight decreases in
their GPCI values as a result of the provisions in section 1848(e)(6)
of the Act, insofar as the locality in which they are located now newly
includes data from adjacent counties that decreases their GPCI values
relative to those that would have applied had the new data not been
incorporated. Therefore, the GPCIs for these eight counties under the
MSA-based locality structure may be less than they would have been
under the current GPCI structure. The eight counties that are not
within transition areas are: Orange; Los Angeles; Alameda; Contra
Costa; San Francisco; San Mateo; Santa Clara; and Ventura counties.
We emphasize that while transition areas are held harmless from the
impact of the GPCI changes using the new MSA-based locality structure,
because we proposed other updates for CY 2017 as part of the eighth
GPCI update, including the use of updated data, transition areas would
still be subject to impacts resulting from those other updates. Table
13 illustrates using GAFs, for CY 2017, the isolated impact of the MSA-
based locality changes and hold-harmless for transition areas required
by section 1848(e)(6) of the Act, the impact of the use of updated data
for GPCIs, and the combined impact of both of these changes.
[[Page 80266]]
Table 13--Impact on California GAFs as a Result of Section 1848(e)(6) of the Act and Updated Data by Fee
Schedule Area
[Sorted alphabetically by locality name]
----------------------------------------------------------------------------------------------------------------
Combined
2017 GAF % change % change impact of
Medicare fee schedule area Transition 2016 w/o due to new 2017 GAF w/ due to PAMA and
area GAF 1848(e)(6) GPCI data 1848(e)(6) 1848(e)(6) new GPCI
data (%)
----------------------------------------------------------------------------------------------------------------
Bakersfield.................... 1 1.036 1.031 -0.48 1.031 0.00 -0.48
Chico.......................... 1 1.036 1.031 -0.48 1.031 0.00 -0.48
El Centro...................... 1 1.036 1.031 -0.48 1.031 0.00 -0.48
Fresno......................... 1 1.036 1.031 -0.48 1.031 0.00 -0.48
Hanford-Corcoran............... 1 1.036 1.031 -0.48 1.031 0.00 -0.48
Los Angeles-Long Beach-Anaheim 0 1.092 1.090 -0.18 1.091 0.09 -0.09
(Los Angeles Cnty)............
Los Angeles-Long Beach-Anaheim 0 1.111 1.104 -0.63 1.101 -0.27 -0.90
(Orange Cnty).................
Madera......................... 1 1.036 1.031 -0.48 1.031 0.00 -0.48
Merced......................... 1 1.036 1.031 -0.48 1.031 0.00 -0.48
Modesto........................ 1 1.036 1.031 -0.48 1.031 0.00 -0.48
Napa........................... 1 1.137 1.128 -0.79 1.128 0.00 -0.79
Oxnard-Thousand Oaks-Ventura... 0 1.089 1.083 -0.55 1.083 0.00 -0.55
Redding........................ 1 1.036 1.031 -0.48 1.031 0.00 -0.48
Rest of California............. 1 1.036 1.031 -0.48 1.031 0.00 -0.48
Riverside-San Bernardino- 1 1.036 1.031 -0.48 1.032 0.10 -0.39
Ontario.......................
Sacramento-Roseville-Arden- 1 1.036 1.031 -0.48 1.031 0.00 -0.48
Arcade........................
Salinas........................ 1 1.036 1.031 -0.48 1.033 0.19 -0.29
San Diego-Carlsbad............. 1 1.036 1.031 -0.48 1.035 0.39 -0.10
San Francisco-Oakland-Hayward 0 1.124 1.125 0.09 1.142 1.51 1.60
(Alameda/Contra Costa Cnty)
San Francisco-Oakland-Hayward 1 1.137 1.128 -0.79 1.129 0.09 -0.70
(Marin Cnty)..................
San Francisco-Oakland-Hayward 0 1.191 1.194 0.25 1.175 -1.59 -1.34
(San Francisco Cnty)..........
San Francisco-Oakland-Hayward 0 1.182 1.187 0.42 1.171 -1.35 -0.93
(San Mateo Cnty)..............
San Jose-Sunnyvale-Santa Clara 1 1.036 1.031 -0.48 1.053 2.13 1.64
(San Benito Cnty).............
San Jose-Sunnyvale-Santa Clara 0 1.175 1.176 0.09 1.175 -0.09 0.00
(Santa Clara Cnty)............
San Luis Obispo-Paso Robles- 1 1.036 1.031 -0.48 1.031 0.00 -0.48
Arroyo Grande.................
Santa Cruz-Watsonville......... 1 1.036 1.031 -0.48 1.042 1.07 0.58
Santa Maria-Santa Barbara...... 1 1.036 1.031 -0.48 1.036 0.48 0.00
Santa Rosa..................... 1 1.036 1.031 -0.48 1.037 0.58 0.10
Stockton-Lodi.................. 1 1.036 1.031 -0.48 1.031 0.00 -0.48
Vallejo-Fairfield.............. 1 1.137 1.128 -0.79 1.128 0.00 -0.79
Visalia-Porterville............ 1 1.036 1.031 -0.48 1.031 0.00 -0.48
Yuba City...................... 1 1.036 1.031 -0.48 1.031 0.00 -0.48
----------------------------------------------------------------------------------------------------------------
Note: the Los Angeles-Long Beach-Anaheim; San Francisco-Oakland-Hayward; and San Jose-Sunnyvale-Santa Clara
Medicare localities are represented at a sub-locality level for the purpose of demonstrating the variation of
the GAF within the locality. The variation in the Los-Angeles-Long Beach-Anaheim locality exists only in CY
2017 and results from the two-year 50/50 phase in of the GPCI. The GAF variation in San Francisco-Oakland-
Hayward and San Jose-Sunnyvale-Santa Clara results from the localities containing both transition area and non-
transition area counties. For the remainder of Medicare localities, the GAF is consistent throughout the
entire locality.
Additionally, for the purposes of calculating budget neutrality and
consistent with the PFS budget neutrality requirements as specified
under section 1848(c)(2)(B)(ii)(II) of the Act, we proposed to start by
calculating the national GPCIs as if the current localities are still
applicable nationwide; then for the purposes of payment in California,
we override the GPCI values with the values that are applicable for
California consistent with the requirements of section 1848(e)(6) of
the Act. This approach is consistent with the implementation of the
GPCI floor provisions that have previously been implemented--that is,
as an after-the-fact adjustment that is implemented for purposes of
payment after both the GPCIs and PFS budget neutrality have already
been calculated.
(2) Operational Considerations
As discussed above, under section 1848(e)(6) of the Act, counties
that were previously in the rest-of-state locality or locality 3 and
are now in MSAs would have their GPCI values under the new MSA-based
locality structure phased in gradually, in increments of one-sixth over
6 years. Section 1848(e)(1)(C) of the Act requires that, if more than 1
year has elapsed since the date of the last previous GPCI adjustment,
the adjustment to be applied in the first year of the next adjustment
shall be 1/2 of the adjustment that otherwise would be made. While
section 1848(e)(6)(B) of the Act establishes a blended phase-in for the
MSA-based GPCI values, it does not explicitly state whether or how that
provision is to be reconciled with the requirement at section
1848(e)(1)(C) of
[[Page 80267]]
the Act. We believe that since section 1848(e)(6)(A) of the Act
requires that we must make the change to MSA-based fee schedule areas
for California GPCIs notwithstanding the preceding provisions of
section 1848(e) of the Act, and subject to the succeeding provisions of
section 1848(e)(6) of the Act, that applying the two-year phase-in
specified by the preceding provisions simultaneously with the six-year
phase-in would undermine the incremental 6-year phase-in specified in
section 1848(e)(6)(B) of the Act. Therefore, we proposed that the
requirement at section 1848(e)(1)(C) of the Act to phase in 1/2 of the
adjustment in year 1 of the GPCI update would not apply to counties
that were previously in the rest-of-state or locality 3 and are now in
MSAs, and therefore, are subject to the blended phase-in as described
above. Since section 1848(e)(6)(B) of the Act provides for a gradual
phase in of the GPCI values under the new MSA-based locality structure,
specifically in one-sixth increments over 6 years, if we were to also
apply the requirement to phase in 1/2 of the adjustment in year 1 of
the GPCI update then the first year increment would effectively be one-
twelfth. We note that this issue is only of concern if more than 1 year
has elapsed since the previous GPCI update, and would only be
applicable through CY 2021 since, beginning in CY 2022, the GPCI values
for such areas in an MSA would be fully based on the values calculated
under the new MSA-based locality structure for California.
As previously stated, the resulting modifications to California's
locality structure increase its number of localities from 9 under the
current locality structure to 27 under the MSA-based locality
structure. However, both the current localities and the MSA-based
localities are comprised of various component counties, and in some
localities only some of the component counties are subject to the
blended phase-in and hold harmless provisions required by section
1848(e)(6)(B) and (C) of the Act. Therefore, the application of these
provisions may produce differing GPCI values among counties within the
same fee schedule area under the MSA-based locality structure. For
example, the MSA-based San Jose-Sunnyvale-Santa Clara locality, is
comprised of 2 constituent counties--San Benito County, and Santa Clara
County. San Benito County is in a transition area (2013 rest-of-state),
while Santa Clara County is not. Hence, although the counties are in
the same MSA, the requirements of section 1848(e)(6)(B) and (C) of the
Act may produce differing GPCI values for each county. To address this
issue, we proposed to assign a unique locality number to the counties
that would be impacted in the aforementioned manner. As a result,
although the modifications to California's locality structure increase
the number of localities from 9 under the current locality structure to
27 under the MSA-based locality structure, for purposes of payment, the
actual number of localities under the MSA-based locality structure
would be 32 to account for instances where unique locality numbers are
needed as described above. Additionally, while the fee schedule area
names are consistent with the MSAs designated by OMB, we proposed to
maintain 2-digit locality numbers to correspond to the existing fee
schedule areas. Pursuant to the implementation of the new MSA-based
locality structure for California, the total number of PFS localities
would increase from 89 to 112. Table 14 displays the current fee
schedule areas in California, and Table 15 displays the MSA-based fee
schedule areas in California required by section 1848(e)(6) of the Act.
Additional information on the California locality update may be found
in our contractor's draft report, ``Draft Report on the CY 2017 Update
of the Geographic Practice Cost Index for the Medicare Physician Fee
Schedule,'' which is available on the CMS Web site. It is located under
the supporting documents section of the CY 2017 PFS final rule located
at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
Table 14--Current Fee Schedule Areas in California
[Sorted alphabetically by locality name]
------------------------------------------------------------------------
Locality number Fee schedule area Counties
------------------------------------------------------------------------
26.................. Anaheim/Santa Ana....... Orange.
18.................. Los Angeles............. Los Angeles.
03.................. Marin/Napa/Solano....... Marin, Napa, And Solano.
07.................. Oakland/Berkley......... Alameda and Contra
Costa.
05.................. San Francisco........... San Francisco.
06.................. San Mateo............... San Mateo.
09.................. Santa Clara............. Santa Clara.
17.................. Ventura................. Ventura.
99.................. Rest of State........... All Other Counties.
------------------------------------------------------------------------
Table 15--MSA-Based Fee Schedule Areas in California
[Sorted alphabetically by locality name]
----------------------------------------------------------------------------------------------------------------
New
Current locality number locality Fee schedule area Counties Transition area
number (MSA name)
----------------------------------------------------------------------------------------------------------------
99................................ 54 Bakersfield, CA....... Kern................ YES.
99................................ 55 Chico, CA............. Butte............... YES.
99................................ 71 El Centro, CA......... Imperial............ YES.
99................................ 56 Fresno, CA............ Fresno.............. YES.
99................................ 57 Hanford-Corcoran, CA.. Kings............... YES.
18................................ 18 Los Angeles-Long Beach- Los Angeles......... NO.
Anaheim, CA (Los
Angeles County).
26................................ 26 Los Angeles-Long Beach- Orange.............. NO.
Anaheim, CA (Orange
County).
99................................ 58 Madera, CA............ Madera.............. YES.
99................................ 59 Merced, CA............ Merced.............. YES.
99................................ 60 Modesto, CA........... Stanislaus.......... YES.
3................................. 51 Napa, CA.............. Napa................ YES.
17................................ 17 Oxnard-Thousand Oaks- Ventura............. NO.
Ventura, CA.
99................................ 61 Redding, CA........... Shasta.............. YES.
99................................ 75 Rest of State......... All Other Counties.. YES.
99................................ 62 Riverside-San Riverside, And San YES.
Bernardino-Ontario, Bernardino.
CA.
99................................ 63 Sacramento--Roseville- El Dorado, Placer, YES.
-Arden-Arcade, CA. Sacramento, And
Yolo.
99................................ 64 Salinas, CA........... Monterey............ YES.
99................................ 72 San Diego-Carlsbad, CA San Diego........... YES.
[[Page 80268]]
7................................. 7 San Francisco-Oakland- Alameda, Contra NO.
Hayward, CA (Alameda Costa.
County/Contra Costa
County).
3................................. 52 San Francisco-Oakland- Marin............... YES.
Hayward, CA (Marin
County).
5................................. 5 San Francisco-Oakland- San Francisco....... NO.
Hayward, CA (San
Francisco County).
6................................. 6 San Francisco-Oakland- San Mateo........... NO.
Hayward, CA (San
Mateo County).
99................................ 65 San Jose-Sunnyvale- San Benito.......... YES.
Santa Clara, CA (San
Benito County).
9................................. 9 San Jose-Sunnyvale- Santa Clara......... NO.
Santa Clara, CA
(Santa Clara County).
99................................ 73 San Luis Obispo-Paso San Luis Obispo..... YES.
Robles-Arroyo Grande,
CA.
99................................ 66 Santa Cruz- Santa Cruz.......... YES.
Watsonville, CA.
99................................ 74 Santa Maria-Santa Santa Barbara....... YES.
Barbara, CA.
99................................ 67 Santa Rosa, CA........ Sonoma.............. YES.
99................................ 73 Stockton-Lodi, CA..... San Joaquin......... YES.
3................................. 53 Vallejo-Fairfield, CA. Solano.............. YES.
99................................ 69 Visalia-Porterville, Tulare.............. YES.
CA.
99................................ 70 Yuba City, CA......... Sutter, and Yuba.... YES.
----------------------------------------------------------------------------------------------------------------
We received few comments regarding the California locality update
to the fee schedule areas used for payment under section 220(h) of
PAMA.
Comment: One commenter stated that it supports the proposed
California payment locality implementation plan. The commenter stated
that based on its analysis the calculations are accurate except for a
few errors. Specifically, the commenter stated that the CY 2016 GAFs
for 3 fee schedule areas [Los Angeles-Long Beach-Anaheim (Orange
County), San Francisco-Oakland-Hayward (Alameda/Contra Costa County),
and San Francisco-Oakland-Hayward (San Francisco County)] in Table 13
of the proposed rule (81 FR 46221 through 46222) were incorrect. The
commenter also requested that all of the 2016 GAFs in the table be
reported to three decimal places to avoid confusion with rounding.
Additionally, the commenter indicated that Sierra County in California
was missing from the CY 2017 Proposed GPCI County Data File in the CY
2017 Proposed Rule GPCI Public Use Files available on our Web site
under the supporting documents section of the CY 2017 PFS proposed rule
Web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
Response: We thank the commenter for its support of our proposed
California payment locality implementation plan. With regard to the
errors noted by the commenter, we thank the commenter for bringing this
issue to our attention. We agree that the CY 2016 GAFs for Los Angeles-
Long Beach-Anaheim (Orange County), San Francisco-Oakland-Hayward
(Alameda/Contra Costa County), and San Francisco-Oakland-Hayward (San
Francisco County) were incorrect in Table 13 of the proposed rule, and
have been corrected in Table 13 in this final rule. We have also
updated all of the 2016 GAFs in Table 13 to reflect 3 decimal places as
to avoid confusion with rounding as requested. Additionally, we note
that while the GAFs for these 3 fee schedule areas were incorrect in
Table 13 of the proposed rule, the GAF values were correct in Addendum
D to the proposed rule available on our Web site under the supporting
documents section of the CY 2017 PFS Proposed Rule Web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html. Moreover, GAF values are an analysis
tool, and are not used to determine service level payment.
Additionally, we note Sierra County was omitted from the CY 2017
Proposed GPCI County Data File because we removed counties with 0 total
RVUs in 2014. However, for the final rule we have revised the file to
include all counties, even those with 0 total RVUs in 2014. The updated
file can be viewed in the CY 2017 Final GPCI County Data File in the CY
2017 Final Rule GPCI Public use files available on our Web site.
Comment: One commenter requested that CMS implement the California
locality update requirement in a manner that does not require the
Medicare Administrative Contractor (MAC) for California to make changes
to the enrollment process for physician groups in California or changes
in the way that physician groups submit claims to the MAC.
Response: While we note that there are several internal
administrative burdens that result from the implementation of the
California locality update, we do not believe there should be related
burden on practitioners, and California practitioners will continue to
follow the existing process for submitting claims.
After consideration of the public comments received regarding the
proposed California payment locality implementation plan, we are
finalizing as proposed.
4. Update to the Methodology for Calculating GPCIs in the U.S.
Territories
In calculating GPCIs within U.S. states, we use county-level wage
data from the Bureau of Labor Statistics (BLS) Occupational Employment
Statistics Survey (OES), county-level residential rent data from the
American Community Survey (ACS), and malpractice insurance premium data
from state departments of insurance. In calculating GPCIs for the U.S.
territories, we currently use three distinct methodologies--one for
Puerto Rico, another for the Virgin Islands, and a third for the
Pacific Islands (Guam, American Samoa, and Northern Marianas Islands).
These three methodologies were adopted at different times based
primarily on the data that were available at the time they were
adopted. At present, because Puerto Rico is the only territory where
county-level BLS OES, county-level ACS, and malpractice premium data
are available, it is the only territory for which we use territory-
specific data to calculate GPCIs. For the Virgin Islands, because
county-level wage and rent data are not available, and insufficient
malpractice premium data are available, CMS has set the work, PE, and
MP GPCI values for the Virgin Islands payment locality at the national
average of 1.0 even though, like Puerto Rico, the Virgin Islands is its
[[Page 80269]]
own locality and county-level BLS OES data are available for the Virgin
Islands. For the U.S. territories in the Pacific Ocean, we currently
crosswalk GPCIs from the Hawaii locality for each of the three GPCIs,
and incorporate no local data from these territories into the GPCI
calculations even though county-level BLS OES data does exist for Guam,
but not for American Samoa or the Northern Mariana Islands.
As noted above, currently Puerto Rico is the only territory for
which we calculate GPCIs using the territory-specific information
relative to data from the U.S. States. For several years stakeholders
in Puerto Rico have raised concerns regarding the applicability of the
proxy data in Puerto Rico relative to their applicability in the U.S.
states. We believe that these concerns may be consistent across island
territories, but lack of available, appropriate data has made it
difficult to quantify such variation in costs. For example, some
stakeholders previously indicated that shipping and transportation
expenses increase the cost of acquiring medical equipment and supplies
in islands and territories relative to the mainland. While we have
previously attempted to locate data sources specific to geographic
variation in such shipping costs, we found no comprehensive national
data source for this information (we refer readers to 78 FR 74387
through 74388 for the detailed discussion of this issue). Therefore, we
have not been able to quantify variation in costs specific to island
territories in the calculation of the GPCIs.
For all the island territories other than Puerto Rico, the lack of
comprehensive data about unique costs for island territories has had
minimal impact on GPCIs because we have used either the Hawaii GPCIs
(for the Pacific territories) or used the unadjusted national averages
(for the Virgin Islands). In an effort to provide greater consistency
in the calculation of GPCIs given the lack of comprehensive data
regarding the validity of applying the proxy data used in the States in
accurately accounting for variability of costs for these island
territories, we proposed to treat the Caribbean Island territories (the
Virgin Islands and Puerto Rico) in a consistent manner. We proposed to
do so by assigning the national average of 1.0 to each GPCI index for
both Puerto Rico and the Virgin Islands. We did not propose any changes
to the GPCI methodology for the Pacific Island territories (Guam,
American Samoa, and Northern Marianas Islands) where we already
consistently assign the Hawaii GPCI values for each of the three GPCIs.
Additional information on the Proposed Update to the Methodology for
Calculating GPCIs in the U.S. Territories may be found in our
contractor's draft report, ``Draft Report on the CY 2017 Update of the
Geographic Practice Cost Index for the Medicare Physician Fee
Schedule,'' which is available on our Web site. It is located under the
supporting documents section of the CY 2017 PFS final rule located at
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
The following is a summary of the comments we received regarding
the proposed update to the methodology for calculating GPCIs in the
U.S. territories.
Comment: Several commenters expressed support for CMS' proposal to
assign the national average of 1.0 to each GPCI in Puerto Rico, stating
that the physicians in Puerto Rico who treat patients enrolled in fee-
for-service Medicare will be reimbursed in a manner that more closely
aligns with the manner in which physicians in the other U.S.
territories are reimbursed, and better reflects the cost of practicing
medicine in Puerto Rico. Other commenters supporting the proposal also
suggested that there has been a need for revision of Medicare payment
in Puerto Rico, and that the territories of the U.S. have not been
treated similarly even though the territories are much alike. Another
commenter stated that the existing fee schedule for Puerto Rico does
not correlate with the cost of caring for patients, and that the
proposed policy is long overdue. Some commenters also stated that
increasing the GPCI's for Puerto Rico is an important and necessary
first step in trying to salvage Puerto Rico's deteriorated health
system.
Response: We thank the commenters for their support.
Comment: A few commenters requested that CMS consider raising the
GPCI values in Puerto Rico to 1.25.
Response: We proposed assigning the national average of 1.0 to each
GPCI index for both Puerto Rico and the Virgin Islands, in an effort to
provide greater consistency in the calculation of GPCIs among these
island territories, given the lack of information on the validity of
applying the proxy data used in the States to accurately account for
variability of costs in these territories as compared to the national
average costs. Ultimately we proposed to treat the Caribbean Island
territories (the Virgin Islands and Puerto Rico) in a consistent manner
by assigning the national average of 1.0 to each GPCI index. We do not
believe that it would be appropriate to raise the value to 1.25 in the
absence of data demonstrating that would be an accurate reflection of
costs in those territories relative to national average costs.
Comment: We received several comments that are outside of the scope
of the Physician Fee Schedule, requesting that CMS explore every option
to determine whether a one-time correction can be made to the Medicare
Advantage (MA) regulatory cycle so that the per-person monthly payment
to Puerto Rico MA Plans in CY 2017 will reflect the increase to the
fee-for-service spending in the territory as a result of the proposed
GPCI increase. Some commenters stated that it is imperative that CMS
see that the increased physician fees reach the actual providers and
are not diverted away from patient care by third parties such as
Medicare Advantage Organizations. Some commenters requested that CMS
clarify that the new GPCIs will be incorporated into the MA benchmarks
in CY 2018.
Response: We appreciate the concerns raised by the commenters.
Consistent with the statute, we published the final CY 2017 Rate
Announcement for Medicare Advantage on April 4, 2016. Medicare
Advantage actuarial bids and benefit packages for 2017 have been
approved by CMS and sponsors have begun marketing plan to
beneficiaries. Thus, a change in to CY 2017 benchmark would be
disruptive to beneficiaries. In future years, including CY 2018, we
will follow our normal process for calculating rates. This process
incorporates historical Fee for Service expenditures, which would
include any updates to Fee for Service payment rates, such as an
adjustment to the Puerto Rico GPCI. CMS will not be making any
adjustments to CY 2017 Medicare Advantage rates as a result of this
final rule. Finally, we note that according to the statute, we are
prohibited from interfering or directing the contracting between
Medicare Advantage Organizations (MAOs) and contracted providers. As
such, we are not permitted to dictate to MAOs how any increase in
payment rates can be spent, including on provider rates.
Comment: One commenter suggested that if the MA benchmark cannot be
adjusted for CY 2017 that CMS should postpone the applicability of the
GPCI change in Puerto Rico until CY 2018 when such an effect is also
reflected in the MA benchmarks.
Response: We do not agree that the proposal to update to the
methodology for calculating GPCIs in the U.S. territories, which will
provide greater consistency in the calculation of GPCIs for these
areas, should be delayed based on when the MA benchmarks will
[[Page 80270]]
reflect the increases as a result of this policy.
After consideration of the public comments received regarding our
proposal to treat the Caribbean Island territories (the Virgin Islands
and Puerto Rico) in a consistent manner, by assigning the national
average of 1.0 to each GPCI index for both Puerto Rico and the Virgin
Islands, we are finalizing as proposed.
5. Refinement to the MP GPCI Methodology
In the process of calculating MP GPCIs for the purposes of this
final rule, we identified several technical refinements to the
methodology that yield improvements over the current method. We also
proposed refinements that conform to our proposed methodology for
calculating the GPCIs for the U.S. Territories described above.
Specifically, we proposed modifications to the methodology to account
for missing data used in the calculation of the MP GPCI. Under the
methodology used in the CY 2014 GPCI update (78 FR 74380 through
74391), we first calculated the average premiums by insurer and
specialty, then imputed premium values for specialties for which we did
not have specific data, before adjusting the specialty-specific premium
data by market share weights. We proposed to revise our methodology to
instead calculate the average premiums for each specialty using issuer
market share for only available companies. This proposed methodological
improvement would reduce potential bias resulting from large amounts of
imputation, an issue that is prevalent for insurers that only write
policies for ancillary specialties for which premiums tend to be low.
The current method would impute the low premiums for ancillary
specialties across the remaining specialties, and generally greater
imputation leads to less accuracy. Additional information on the MP
GPCI methodology, and the proposed refinement to the MP GPCI
methodology may be found in our contractor's draft report, ``Draft
Report on the CY 2017 Update of the Geographic Practice Cost Index for
the Medicare Physician Fee Schedule,'' which is available on our Web
site. It is located under the supporting documents section of the CY
2017 PFS final rule located at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
We did not receive any comments regarding the proposed technical
refinements to the MP GPCI methodology, and we are finalizing as
proposed.
J. 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, 2016 (Pub. L. 114-113) amended section 1848(b) of
the Act by adding new paragraph (b)(9). Effective for services
furnished on or after January 1, 2017, section 1848(b)(9)(A) of the Act
reduces by 20 percent the payment amounts under the PFS for the
technical component (TC) (including the TC portion of a global
services) of imaging services that are X-rays taken using film. The
reduction is made prior to any other adjustment under this section and
without application of this new paragraph.
Section 1848(b)(9) of the Act allows for the implementation of the
payment reduction through appropriate mechanisms which may include use
of modifiers. In accordance with section 1848(c)(2)(B)(v)(X), the
adjustments under section 1848(b)(9)(A) of the Act are exempt from
budget neutrality.
To implement this provision, in the CY 2017 PFS proposed rule (81
FR 46224), we proposed to establish a new modifier to be used on claims
that include imaging services that are X-rays (including the imaging
portion of a service) taken using film. Since the display of the
proposed rule, modifier FX has been established for that purpose.
Effective January 1, 2017, the modifier must be used on claims for X-
rays that are taken using film. The use of this modifier will result in
a 20 percent reduction for the X-ray service, as specified under
section 1848(b)(9)(A) of the Act.
The proposed rule preamble stated that the applicable HCPCS codes
describing imaging services that are X-ray services could be found on
the PFS Web site. However, we did not intend this to indicate that we
would be developing or displaying an exhaustive list of applicable
codes. Instead, we intended to refer to the several lists of PFS
imaging codes, including those that describe imaging services that are
X-rays.
Comment: Many commenters commented on the merits of the statutory
provision. The commenters stated that the reduction of Medicare film-
based x-ray payments by 20 percent will have unintended consequences on
patient care.
Response: We believe our proposal would implement the required
statutory provision and we do not believe that we have the authority to
alter the application of the provision based on these comments.
Comment: An overwhelming majority of the commenters requested CMS
implement an alternative policy to improve quality of imaging services.
The recommended policy would require registered radiologic technicians
to perform all Medicare film or digital radiography procedures. Other
commenters countered this recommended alternative by stating that it
would exclude otherwise qualified professionals who have undergone
education to acquire limited scope licenses or certification programs
demonstrating As Low As Reasonably Achievable (ALARA) safety practices
by either a third party, vendor training, or another didactic course
deemed acceptable by any of the four accreditation organizations. One
commenter also referenced 35 states that have an entry level
certification for X-ray technicians and that throughout the US, there
are x-ray technicians and limited scope X-ray machine operators that
are also licensed and certified.
Response: We appreciate commenters' interests in standards that
might improve quality of care for Medicare beneficiaries, but we did
not propose a policy regarding standards for radiologic technicians in
the proposed rule. Also, as previously stated, we do not believe we
have the authority to implement conditions of payment regarding
radiologic technicians as an alternative to the adjustments required by
the statutory provision.
Comment: A commenter recommended that a financial incentive be
provided for physicians to convert to digital machines as had been done
in the case of electronic medical records.
Response: The legislation does not authorize any financial
incentive in the form of increased payment, but provides an incentive
to use digital images to avoid the 20 percent reduction that applies to
imaging services that are X-rays taken using film.
Comment: One commenter requested that in the absence of a
meaningful opportunity to comment on the list of codes for which the
policy applies, the provision should be limited to traditional
diagnostic X-ray procedures only. Two commenters presented separate
lists of codes for which the payment reduction should apply. One
commenter also provided codes that should be explicitly excluded from
the payment reduction, for example, radiographic-fluoroscopic, vascular
and mammography X-ray imaging services, radioscopic, radioscopic and
radiography services provided in a
[[Page 80271]]
single examination. Other commenters also provided a list of procedures
that should be excluded. The commenter also requested that we publish
the list of applicable codes as soon as possible.
Response: As previously stated, we did not publish an exhaustive
list of applicable codes, and previously intended to point to existing
lists of PFS imaging services. We believe that physicians and non-
physician practitioners are in the best position to determine whether a
particular imaging service is an X-ray taken using film.
Comment: One commenter suggested that if at least half of the
number of discrete X-ray exposures required for the radiographic exam
are captured using a DR detector, then the examination should be
considered as digital and the payment differential should not be
applied. Another commenter requested that we clarify that the law only
applies (and requires use of a modifier) to sites that use X-ray as a
single method for image capture. The commenter also seeks clarification
that if a site uses both X-ray film and electronic capture of images
and maintains digital archives, by a picture archiving communication
system or other electronic method, that the site is not required to
report the modifier.
Response: At this time, in accordance with the statute, we are
requiring the FX modifier to be used whenever an imaging service is an
X-ray taken using film. As stated, the statute requires that if an
imaging service is an X-ray taken using film, a reduction in payment is
to occur. The statutory requirement applies at the service level, not
based on where the service is furnished or the method used to store
images. There is no provision for an exception to the payment reduction
based on the availability of various technologies or the use of certain
image archiving technology at a particular site.
After consideration of the public comments we received, we are
finalizing the establishment of new modifier ``FX'' to be reported on
claims for imaging services that are X-rays that are taken using film.
Beginning January 1, 2017, claims for imaging services that are X-
rays taken using film must include the modifier ``FX.''
The use of this modifier will result in a 20 percent reduction for
the X-ray service, as specified under section 1848(b)(9)(A) of the Act.
K. Procedures Subject to the Multiple Procedure Payment Reduction
(MPPR) and the OPPS Cap
Effective January 1, 2012, we implemented an MPPR of 25 percent on
the professional component (PC) of advanced imaging services. The
reduction applies when multiple imaging procedures are furnished by the
same physician (or physician in the same group practice) to the same
patient, in the same session, on the same day. Full payment is made for
the PC of the highest priced procedure. Payment for the PC of
subsequent services is reduced by 25 percent.
Section 502(a)(2)(A) of Division O, Title V of the Consolidated
Appropriations Act, 2016 (Pub. L. 114-113, enacted on December 18,
2015) added a new section 1848(b)(10) of the Act which revises the
payment reduction from 25 percent to 5 percent, effective January 1,
2017. Section 502(a)(2)(B) added a new subclause at section
1848(c)(2)(B)(v)(XI) which exempts the reduced expenditures
attributable to the revised 5 percent MMPR on the PC of imaging from
the PFS budget neutrality provision. We proposed to implement these
provisions for services furnished on or after January 1, 2017. We refer
readers to section VI.C of this final rule regarding the necessary
adjustment to the proposed PFS conversion factor to account for the
mandated exemption from PFS budget neutrality.
We note that the lists of services for the upcoming calendar year
that are subject to the MPPR on diagnostic cardiovascular services,
diagnostic imaging services, diagnostic ophthalmology services, and
therapy services; and the list of procedures that meet the definition
of imaging under section 5102(b) of the Deficit Reduction Act (DRA),
and therefore, are subject to the OPPS cap, are displayed in the public
use files for the PFS proposed and final rules for each year. The
public use files for CY 2017 are available on our Web site under
downloads for the CY 2017 PFS final rule with comment period at http://www.cms.gov/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html.
Comment: Commenters supported the proposal to implement the
statutory provision.
Response: We our finalizing our CY 2017 proposal to revise the MPPR
on the PC of diagnostic imaging services.
L. Valuation of Specific Codes
1. Background: Process for Valuing New, Revised, and Potentially
Misvalued Codes
Establishing valuations for newly created and revised CPT codes is
a routine part of maintaining the PFS. Since inception of the PFS, it
has also been a priority to revalue services regularly to make sure
that the payment rates reflect the changing trends in the practice of
medicine and current prices for inputs used in the PE calculations.
Initially, this was accomplished primarily through the 5-year review
process, which resulted in revised work RVUs for CY 1997, CY 2002, CY
2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY
2011. Under the 5-year review process, revisions in RVUs were proposed
and finalized via rulemaking. In addition to the 5-year reviews,
beginning with CY 2009, CMS and the RUC have identified a number of
potentially misvalued codes each year using various identification
screens, as discussed in section II.D.4 of this final 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 proposed rule, the new process is applicable to all codes,
except for new codes that describe truly new services. For CY 2017, we
proposed new values in the CY 2017 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
[[Page 80272]]
values for those codes in the CY 2017 proposed rule.
We considered public comments received during the 60-day public
comment period for the proposed rule before establishing final values
in this 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 are
not aware of any new codes that describe such wholly new services.
Therefore, we are not establishing any code values on an interim final
basis. However, we remind stakeholders that we continually review
stakeholder information regarding the valuation of codes under the
potentially misvalued code initiative and, under our existing process,
could consider proposing any particular changes as early as CY 2018
rulemaking.
2. Methodology for Proposing Work RVUs
We conduct a review of each code identified in this section and
review the current work RVU (if any), RUC-recommended work RVU,
intensity, time to furnish the preservice, intraservice, and
postservice activities, as well as other components of the service that
contribute to the value. Our review of recommended work RVUs and time
inputs generally includes, but is not limited to, a review of
information provided by the RUC, HCPAC (Health Care Professionals
Advisory Committee), and other public commenters, medical literature,
and comparative databases, as well as a comparison with other codes
within the PFS, consultation with other physicians and health care
professionals within CMS and the federal government, as well as
Medicare claims data. We also assess the methodology and data used to
develop the recommendations submitted to us by the RUC and other public
commenters and the rationale for the recommendations. In the CY 2011
PFS final rule with comment period (75 FR 73328 through 73329), we
discussed a variety of methodologies and approaches used to develop
work RVUs, including survey data, building blocks, crosswalks to key
reference or similar codes, and magnitude estimation (see the CY 2011
PFS final rule with comment period for more information). When
referring to a survey, unless otherwise noted, we mean the surveys
conducted by specialty societies as part of the formal RUC process. The
building block methodology is used to construct, or deconstruct, the
work RVU for a CPT code based on component pieces of the code.
Components used in the building block approach may include
preservice, intraservice, or postservice time and post-procedure
visits. When referring to a bundled CPT code, the building block
components could be the CPT codes that make up the bundled code and the
inputs associated with those codes. Magnitude estimation refers to a
methodology for valuing work that determines the appropriate work RVU
for a service by gauging the total amount of work for that service
relative to the work for a similar service across the PFS without
explicitly valuing the components of that work. In addition to these
methodologies, we have frequently utilized an incremental methodology
in which we value a code based upon its incremental difference between
another code or another family of codes. The statute specifically
defines the work component as the resources in time and intensity
required in furnishing the service. Also, the published literature on
valuing work has recognized the key role of time in overall work. For
particular codes, we refine the work RVUs in direct proportion to the
changes in the best information regarding the time resources involved
in furnishing particular services, either considering the total time or
the intraservice time.
Several years ago, to aid in the development of preservice time
recommendations for new and revised CPT codes, the RUC created
standardized preservice time packages. The packages include preservice
evaluation time, preservice positioning time, and preservice scrub,
dress and wait time. Currently there are six preservice time packages
for services typically furnished in the facility setting, reflecting
the different combinations of straightforward or difficult procedure,
straightforward or difficult patient, and without or with sedation/
anesthesia. Currently, there are three preservice time packages for
services typically furnished in the nonfacility setting, reflecting
procedures without and with sedation/anesthesia care.
We have developed several standard building block methodologies to
value services appropriately when they have common billing patterns. In
cases where a service is typically furnished to a beneficiary on the
same day as an E/M service, we believe that there is overlap between
the two services in some of the activities furnished during the
preservice evaluation and postservice time. Our longstanding
adjustments have reflected a broad assumption that at least one-third
of the work time in both the preservice evaluation and postservice
period is duplicative of work furnished during the E/M visit.
Accordingly, in cases where we believe that the RUC has not
adequately accounted for the overlapping activities in the recommended
work RVU and/or times, we adjust the work RVU and/or times to account
for the overlap. The work RVU for a service is the product of the time
involved in furnishing the service multiplied by the intensity of the
work. Preservice evaluation time and postservice time both have a long-
established intensity of work per unit of time (IWPUT) of 0.0224, which
means that 1 minute of preservice evaluation or postservice time
equates to 0.0224 of a work RVU.
Therefore, in many cases when we remove 2 minutes of preservice
time and 2 minutes of postservice time from a procedure to account for
the overlap with the same day E/M service, we also remove a work RVU of
0.09 (4 minutes x 0.0224 IWPUT) if we do not believe the overlap in
time has already been accounted for in the work RVU. The RUC has
recognized this valuation policy and, in many cases, now addresses the
overlap in time and work when a service is typically furnished on the
same day as an E/M service.
We note that many commenters and stakeholders have expressed
concerns with our ongoing adjustment of work RVUs based on changes in
the best information we have regarding the time resources involved in
furnishing individual services. We are particularly concerned with the
RUC's and various specialty societies' objections to our approach given
the significance of their recommendations to our process for valuing
services and since much of the information we have used to make the
adjustments is derived from their survey process. As explained in the
CY 2016 PFS final rule with comment period (80 FR 70933), we recognize
that adjusting work RVUs for changes in time is not always a
straightforward process, so we apply various methodologies to identify
several potential work values for individual codes. However, we want to
reiterate that we are statutorily obligated to consider both time and
intensity in establishing work RVUs for PFS services.
We have observed that for many codes reviewed by the RUC, final
recommended work RVUs appear to be incongruous with recommended
assumptions regarding the resource costs in time. This is the case for
a significant portion of codes for which we have recently established
or proposed work RVUs that are based on
[[Page 80273]]
refinements to the RUC-recommended values. When we have adjusted work
RVUs to account for significant changes in time, we begin by looking at
the change in the time in the context of the RUC-recommended work RVU.
When the recommended work RVUs do not appear to account for significant
changes in time, we employ the different approaches to identify
potential values that reconcile the recommended work RVUs with the
recommended time values. Many of these methodologies, such as survey
data, building blocks, crosswalks to key reference or similar codes,
and magnitude estimation have long been used in developing work RVUs
under the PFS. In addition to these, we sometimes use the relationship
between the old time values and the new time values for particular
services to identify alternative work RVUs based on changes in time
components.
In so doing, rather than ignoring the RUC-recommended value, we are
using the recommended values as a starting reference and then applying
one of these several methodologies to account for the reductions in
time that we believe have not otherwise been reflected in the RUC-
recommended value. When we believe that such changes in time have
already been accounted for in the RUC recommendation, then we do not
make such adjustments. Likewise, we do not arbitrarily apply time
ratios to current work RVUs to calculate proposed work RVUs. We use the
ratios to identify potential work RVUs and consider these work RVUs as
potential options relative to the values developed through other
options.
We clarify that we are not implying that the decrease in time as
reflected in survey values must equate to a one-to-one or linear
decrease in newly valued work RVUs. Instead, we believe that, since the
two components of work are time and intensity, 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 has
appeared to disregard or dismiss the changes in time, without a
persuasive explanation of why such a change should not be accounted for
in the overall work of the service, then we generally use one of the
aforementioned referenced methodologies to identify potential work
RVUs, including the methodologies intended to account for the changes
in the resources involved in furnishing the procedure.
Several commenters, including the RUC, in general have objected to
our use of these methodologies and deemed our actions in adjusting the
recommended work RVUs as inappropriate. We received several specific
comments regarding this issue in response to the CY 2016 PFS final rule
with comment period and those comments are summarized below.
Comment: Several commenters, including the RUC, stated that our
methodology for adjusting work RVUs appears to be contrary to the
statute.
Response: We disagree with these comments. Since section
1848(c)(1)(A) of the Act explicitly identifies time as one of the two
types of resources that encompass the work component of the PFS
payment, we do not believe that our use of the aforementioned
methodologies to adjust the work RVU to account for the changes in
time, which is one of the resources involved, is inconsistent with the
statutory requirements related to the maintenance of work RVUs, and we
have regularly used these and other methodologies in developing values
for PFS services. In selecting which methodological approach will best
determine the appropriate value for a service, we consider the current
and recommended work and time values, as well as the intensity of the
service, all relative to other services. In our review of RUC
recommended values, we have observed that the RUC also uses a variety
of methodologies to develop work RVUs for individual codes, and
subsequently validates the results of these approaches through
magnitude estimation or crosswalk to established values for other
codes.
Comment: Several commenters, including the RUC, stated that we
could not take one element of the services that has changed such as
intra-service time, and apply an overall ratio for reduction to the
work RVU based on changes to time, as that renders the value no longer
resource-based in comparison to the RUC-recommended values.
Response: We disagree with the commenters and continue to believe
that the use of time ratios is one of several reasonable methods for
identifying potential work RVUs for particular PFS services,
particularly when the alternative values do not account for information
that suggests the amount of time involved in furnishing the service has
changed significantly. We reiterate that, consistent with the statute,
we are required to value the work RVU based on the relative resources
involved in furnishing the service, which include time and intensity.
When our review of recommended values determines that changes in the
resource of time have been unaccounted for in a recommended RVU, then
we believe we have the obligation to account for that change in
establishing work RVUs since the statute explicitly identifies time as
one of the two elements of the work RVUs. We recognize that it would
not be appropriate to develop work RVUs solely based on time given that
intensity is also an element of work, but in applying the time ratios
we are using derived intensity measures based on current work RVUs for
individual procedures. Were we to disregard intensity altogether, the
work RVUs for all services would be developed based solely on time
values and that is definitively not the case. Furthermore, we reiterate
that we use time ratios to identify potential work RVUs, and then use
other methods (including estimates of work from CMS medical personnel
and crosswalks to key reference or similar codes) to validate these
RVUs. We also disagree with several commenters' implications that a
work RVU developed through such estimation methods is only resource-
based through the RUC process.
Comment: Several commenters, including the RUC, stated that our
inconsistent use of the time ratio methodology has rendered it
ineffective for valuation purposes and that by choosing the starting
base work value and/or physician time at random, we are essentially
reverse engineering the work value we want under the guise of a
standard algorithm.
Response: We do not choose a starting base work value and/or
physician time at random as suggested by the commenters. We use the RUC
recommended values or the existing values as the base values;
essentially, we are taking one of those values and applying adjustments
to account for the change in time that based on our analysis of the RUC
recommendation, we determine has not been properly accounted for to
determine an appropriate work RVU. In circumstances where adjustments
to time and the corresponding work RVU are relatively congruent or
persuasively explained, our tendency has been to use those values as
recommended. Where the RUC recommendations do not account for changes
in time, we have made changes to RUC-recommended values to account for
the changes in time.
Comment: Commenters, including the RUC, also stated that the use of
time ratio methodologies distills the valuation of the service into a
basic formula with the only variable being either the new total
physician time or the new intra-service physician time, and that these
methodologies are based
[[Page 80274]]
on the incorrect assumption that the per minute physician work
intensity established is permanent regardless of when the service was
last valued. Other commenters have suggested that previous assumed
times are inaccurate.
Response: We agree with commenters that per minute intensity for a
given service may change over time. If we believed that the per-minute
intensity for a given service were immutable, then a reverse-building
block approach to revaluation based on new time data could be
appropriate. However, we have not applied such an approach specifically
because we agree that the per-minute intensity of work is not
necessarily static over time or even necessarily during the course of a
procedure. Instead, we utilize time ratios to identify potential values
that account for changes in time and compare these values to other PFS
services for estimates of overall work. When the values we develop
reflect a similar derived intensity, we agree that our values are the
result of our assessment that the relative intensity of a given service
has remained similar.
Regarding the validity of comparing new times to the old times, we,
too, hope that time estimates have improved over many years especially
when many years have elapsed since the last time the service in
question was valued. However, we also believe that our operating
assumption regarding the validity of the pre-existing values as a point
of comparison is critical to the integrity of the relative value system
as currently constructed. Pre-existing times are a very important
element in the allocation of indirect PE RVUs by specialty, and had the
previously recommended times been overestimated, the specialties that
furnish such services would be benefitting from these times in the
allocation of indirect PE RVUs. As long time observers of the RUC
process, we also recognize that the material the RUC uses to develop
overall work recommendations includes the data from the surveys about
time. We have previously stated concerns regarding the validity of much
of the RUC survey data. However, we believe additional kinds of concern
would be warranted if the RUC itself were operating under the
assumption that its pre-existing data were typically inaccurate.
We understand stakeholders' concerns regarding how best to consider
changes in time in improving the accuracy of work RVUs and have
considered all of the issues raised by commenters. In conjunction with
our review of recommended code values for CY 2017, we conducted a
preliminary analysis to identify general tendencies in the relationship
between changes in time and changes in work RVUs for CY 2014 and CY
2015. We looked at services for which there were no coding changes to
simplify the analysis. The intent of this preliminary analysis was to
examine commenters' beliefs that CMS is only considering time when
making refinements to RUC recommended work values. For CY 2014, we
found that in the aggregate, the average difference between the RUC
recommended intraservice time and existing intraservice time was -17
percent, but the average difference between the RUC recommended work
RVU and existing work RVU was only -4 percent. However, the average
difference between the CMS refined work RVU and existing work RVU was -
7 percent. For CY 2015, the average difference between the RUC
recommended intraservice time and existing intraservice time was -17
percent, but the average difference between the RUC recommended work
RVU and existing work RVU was 1 percent, and the average difference
between the CMS refined work RVU and existing work RVU was -6 percent.
This preliminary analysis demonstrates that we are not making
refinements solely in consideration of time, if that were the case, the
changes in the work RVU values that we adopted would be comparable to
the changes in the time that we adopted, but that is not the case.
We believe that we should account for efficiencies in time when the
recommended work RVU does not account for those efficiencies, otherwise
relativity across the PFS can be significantly skewed over periods of
time. For example, if when a code is first valued, a physician was
previously able to do only 5 procedures per day, but due to new
technologies, the same physician can now do 10 procedures per day,
resource costs in time have empirically been lessened, and we believe
that relative reduction in resources involved in furnishing that
service should be accounted for in the assignment of work RVUs for that
service, since the statute explicitly identifies time as one of the two
components of work. Of course, if more resource intensive technology
has allowed for the increased efficiency in furnishing the procedure,
then the nonfacility PE RVUs for the service should also be adjusted to
account for this change. Additionally, we believe it may be that the
intensity per minute of the procedure may have changed with the greater
efficiency in time. Again, that is why we do not generally reduce work
RVUs in strict proportion to changes in time. We understand that
intensity is not entirely linear, and that data related to time as
obtained in the RUC survey instrument may improve over time, and that
the number of survey respondents may improve over time. However, we
also understand time as a tangible resource cost in furnishing PFS
services, and a cost that by statute, is one of the two kinds of
resources to be considered as part of the work RVU.
Therefore, in the proposed rule, we stated that we were interested
in receiving comments on whether, within the statutory confines, there
are alternative suggestions as to how changes in time should be
accounted for when it is evident that the survey data and/or the RUC
recommendation regarding the overall work RVU does not reflect
significant changes in the resource costs of time for codes describing
PFS services. We solicited comment on potential alternatives, including
the application of the reverse building block methodology, to making
the adjustments that would recognize overall estimates of work in the
context of changes in the resource of time for particular services.
The following is a summary of the comments we received in response
to our solicitation regarding potential alternatives, including the
application of the reverse building block methodology, to making the
adjustments that would recognize overall estimates of work in the
context of changes in the resource of time for particular services.
Comment: One commenter stated that it continues to support CMS in
its efforts to adjust work RVUs commensurate with changes in intra-
service and total time, as well as post-operative visits despite RUC
recommendations to the contrary. The commenter agreed with our changes
and encouraged CMS to continue to identify and address such
incongruities. The commenter stated that it is routine to encounter
recommended decreases in physician time and/or post-procedure visits
combined with RUC recommendations to maintain or increase the work
RVUs. The commenter agreed that when physician time decreases,
physician work should decrease comparatively, absent a compelling
argument that the intensity of the service has increased sufficiently
to offset the decrease in physician time. The commenter did not have
alternative suggestions for how CMS should make these adjustments, and
believes the approaches that CMS has taken are reasonable and
defensible.
Another commenter stated that it appreciates that CMS provided
[[Page 80275]]
information about how it reviews recommendations for work RVUs that
come from the RUC. Additionally, one commenter stated appreciation for
the consideration and effort that CMS gives in valuing the work RVUs
for a service. The commenter stated that the accuracy of RVU estimates
has improved as a result of CMS' various validation processes for
collecting data and its consideration of feedback from the RUC and
public commenters. The commenter stated that CMS should account for
efficiencies in the resource costs of time when the recommended work
RVU does not account for emerging efficiencies, such as advances in
surgical techniques, and that by considering time in these situations,
CMS will be able to effectively adjust both emerging technological
trends and their impact on resource costs needed to deliver care to
beneficiaries.
Response: We appreciate the commenters' support for our ongoing
adjustment of work RVUs based on changes in the best information we
have regarding the time resources involved in furnishing individual
services. We also agree that CMS should account for efficiencies in the
resource costs of time, as indicated by one commenter, and will
endeavor to do so when we consider the work RVU and how the effect of
advancements such as emerging technology and improvements in surgical
techniques impact the resource costs of time.
Comment: A few commenters, including the RUC, stated that all
adjustments to work RVUs should be solely based on the resources
involved in performing each procedure or service. The commenters stated
that all adjustments to work RVUs should either be work neutral to the
family or result in budget neutral adjustment to the conversion factor,
and that broadly redistributing work RVUs would distort the relative
value system and create unintended consequences.
Response: We agree that adjustments to work RVUs should be based on
the resources involved with each procedure or service, and consistent
with the statute, the work RVUs should reflect the relative resources
costs of time and intensity. We also agree with the commenter regarding
how changes in work RVUs affect PFS relativity. We have a long-standing
practice of making an adjustment to the CF to account for increases or
decreases in work RVUs across the PFS instead of scaling the work RVUs
to maintain overall relativity. The practical effect of a positive
adjustment to the CF is that the value of a single work RVU is greater
than it previously had been. In other words, the relative value of the
other work RVUs has increased, across the PFS, whenever we apply a
positive budget neutrality adjustment to the CF to account for an
overall decrease in work RVUs.
Comment: A few commenters, including the RUC, stated that they
appreciate CMS agreeing with the RUC's assertion that the usage of time
ratios to reduce work RVUs is typically not appropriate, as often a
change in physician time coincides with a change in the physician work
intensity per minute. The commenters stated that CMS acknowledges that
physician work intensity per minute is typically not linear and also
that making reductions in RVUs in strict proportion to changes in time
is inappropriate.
Response: We do not agree with the commenters' characterization of
our statements, and believe it misinterprets our view on this matter.
We specifically stated in the CY 2017 proposed rule that we are not
implying that the decrease in time as reflected in survey values must
necessarily equate to a one-to-one or linear decrease in newly valued
work RVUs, given that intensity for any given procedure may change over
several years or within the intraservice period. Nevertheless, we
believe that since the two components of work are time and intensity,
that absent an obvious or explicitly stated rationale for why the
relative intensity of a given procedure has specifically increased or
that the reduction in time is disproportionally from less-intensive
portions of the procedure, that significant decreases in time should
generally be reflected in decreases to work RVUs.
Comment: A few commenters, including the RUC, stated that they
wanted to remind CMS of the Agency's and the RUC's longstanding
position that treating all components of physician time as having
identical intensity is incorrect, and inconsistently applying this
treatment to only certain services under review creates inherent
payment disparities in a payment system that is based on relative
valuation. The commenters stated that when physician times are updated
in the fee schedule, the ratio of intra-service time to total time, the
number and level of bundled post-operative visits, the length of pre-
service, and the length of immediate post-service time may all
potentially change for the same service. These changing components of
physician time result in the physician work intensity per minute often
changing when physician time also changes, and the commenters
recommended that CMS always account for these nuanced variables. A few
commenters also stated that the RUC recommendations now explicitly
state when physician time has changed and address whether and to what
magnitude these changes in time impact the work involved.
Response: We appreciate the commenters' feedback. We understand
that not all components of physician time have identical intensity and
are mindful of this point when we are determining what the appropriate
work RVU values should be. We also agree that the nuanced variables
involved in the changing components of physician time must be accounted
for, and it is our goal to do so when determining the appropriate
valuation. We appreciate when the RUC recommendations provide as much
detailed information regarding the recommended valuations as possible,
including thorough discussions regarding physician time changes and how
the RUC believes such changes should or should not impact the work
involved, and we consider that information when conducting our review
of each code.
Comment: A few commenters stated that CMS places undue emphasis on
time and not enough emphasis on intensity or whether a value is
appropriately ranked in the Medicare fee schedule. The commenters
stated that CMS ignores compelling evidence that work has changed if
the time has not also changed, and that CMS uses codes as supporting
references for new lower values that make no clinical sense. The
commenters urged CMS to always consider all elements of relative work
in every review, including time, relative intensity and relative work.
Response: We disagree with commenters' statement that CMS ignores
compelling evidence that work has changed if the time has not also
changed. As previously stated, we are not making refinements solely in
consideration of time, and if that were the case, changes in work RVU
values that we adopted would consistently be comparable to the changes
in the time that we adopted, and that is not the case. It is our
practice to consider all elements of the relative work when we are
reviewing and determining work RVU valuations. Additionally, our review
of recommended work RVUs and time inputs generally includes review of
various sources such as information provided by the RUC, other public
commenters, medical literature, and comparative databases.
Comment: A few commenters, including the RUC, stated that they do
not agree with any suggested methodology to use a reverse building
block methodology to systematically
[[Page 80276]]
reduce work RVUs for services. The commenters stated that any purely
formulaic approach should never be used as the primary methodology to
value services, and that it is highly inappropriate due to the fact
that magnitude estimation was used to establish work RVUs for services.
Response: We note that a formulaic approach is not being used as
the primary methodology to value services. Instead, we use various
methodologies to identify values to consider relative to other PFS
services. We reiterate that we use the RUC-recommended values or the
existing values as the base values. We then apply adjustments to the
RUC-recommended values where, for example, the RUC's recommendations do
not account for changes in time.
Comment: Another commenter stated that the establishment of a time
formula or use of reverse building block methodology as the primary
method for valuation would completely disregard the possibility that
physicians actually get better at what they do in favor of the
erroneous conclusion that physicians only find new ways to cut corners.
The commenter provided an example to demonstrate why time alone does
not create value, and it is instead just one component of valuation.
The commenter described an example of two watchmakers that make watches
at different rates--one makes two watches per day, the other makes four
watches per day. Each watch involves the same number of gears,
sprockets, jewels, and escapements. One watchmaker is faster than the
other: More focused, more experienced, more agile, and able to
accomplish fastidious work more efficiently. At the end of one workday,
the first watchmaker has two finished watches on the bench, while the
other has four. The commenter questioned that if the watches are
identical, why should the faster (better) watchmaker be paid half the
price for each watch?
Response: We understand some stakeholders' interest in the
maintenance of work RVUs regardless of efficiencies gained. The work
RVU is not a measure of our appreciation for the work ethic of the
physician. Instead, the work RVU reflects the time and intensity of a
particular service relative to others on the PFS. For this reason, we
do not agree with the implication that we should ignore efficiencies in
time, and instead believe that we are obligated to recognize when
efficiencies change the relative resource costs involved in particular
procedures. Of course, such efficiencies can occur as physicians become
more proficient and can therefore complete a service or procedure in
less time. We believe that time is a tangible resource, particularly
the time of a physician or other practitioner paid on the PFS, and the
statute specifically identifies it as such.
Comment: A few commenters urged CMS to always enlist the assistance
of medical officers familiar with procedures under review to examine
CMS staff recommendations that reject the RUC recommendation.
Similarly, a few commenters also urged CMS to work with the RUC to
ensure that the robust discussions and key points that are discussed
during RUC meetings are transferred to CMS in a way that is meaningful
to staff to develop the proposed relative value recommendations.
Response: We note that the values proposed by CMS are developed
through consultation with, and input from CMS staff including medical
officers, who often attend RUC meetings as observers, and therefore,
have had the opportunity to listen to the discussions that take place
and key points that are raised during the RUC meetings.
Comment: One commenter stated that the recent rejections of RUC
recommendations by CMS to instead reduce the work RVUs for almost every
code, even if only by one or two percent, are illogical.
Response: We do not agree with the suggestion that we reject the
RUC-recommended values for most codes. Furthermore, given the numerical
specificity of the RUC-recommended values and that so many PFS services
reviewed under the misvalued code initiative are high-volume, we do not
believe that relatively minor adjustments are unimportant or illogical
because a minor adjustment to the work RVU of a high-volume code may
have a significant dollar impact. However, we would be interested to
know if stakeholders generally agree that the RUC-recommended values
represent only rough estimates, and because of that belief, minor
refinements would be considered illogical, as indicated by the
commenter.
Comment: A few commenters stated that they are concerned with the
CMS trend to discredit intensity when assigning work RVUs to
procedures. These commenters stated that intensity is a key factor when
specialties are making work RVU recommendations and needs to remain an
equal force along with time in the relative value system. One commenter
stated that it is concerned that CMS is repeatedly ignoring intensity
discussions and picking arbitrary crosswalks to justify lowering work
RVU values. One commenter stated that by placing the same value on
clearly different services that vary both in intensity and in types of
patients treated, CMS ignores its statutory requirement to consider
time and intensity in the valuation of services. One commenter stated
that CMS does not mention how it considers, weights or measures
intensity, and there is no validity to the assumption that reduced time
equals less work. The commenter stated that it found no published
evidence supporting this, and states that if the same amount of work is
performed for a shorter period of time, it is logical that the
intensity of work per unit of time increases. The commenter stated that
CMS must be transparent and demonstrate why current intensity
measurements are not appropriate, and if there is a more accurate way
to measure intensity, this must be clearly elucidated with evidence for
superiority of the alternative proposal.
Response: We disagree that we discredit intensity when we establish
work RVUs for procedures. We reiterate that we use RUC-recommended
values or existing values, which we understand to incorporate an
assessment of intensity, as the base values, and then subsequently
apply adjustments as necessary. Additionally, as we have previously
stated, we recognize that it would not be appropriate to develop work
RVUs solely based on time given that intensity is also an element of
work. Additionally, if we were to disregard intensity altogether, the
work RVUs for all services would be developed solely based on time
values, and that is absolutely not the case. We have previously stated
that in cases where the RUC's recommendations do not account for
changes in time, but do provide a persuasive explanation regarding why
the time has drastically changed but the work RVU value has remained
the same, our tendency has been to use those values as recommended.
When the RUC's recommendations do not account for changes in time, and
provide no explanation as to why this is appropriate, we have made
changes to the RUC-recommended values to account for changes in time.
We also disagree that we ignore the statutory requirement to
consider time and intensity in the valuation of services. Based on the
assessments of CMS medical officers and other reviewers, as well as
upon consideration of the survey results, and the rationales in the
recommendations, we make determinations about the overall work
valuations. We acknowledge that the degree to which intensity varies
among different procedures is a relatively subjective assessment, and
we understand that sometimes stakeholders
[[Page 80277]]
may have a different perspective in cases where the intensities of
procedures differ. We recognize that the IWPUT measure is a derived
value with specific uses for quantifying intensity. However, the
limited way in which that derived value is used under the RUC valuation
process, we believe reflects a general consensus that there are not
widely accepted metrics for intensity. As a part of recommendations for
misvalued codes, we welcome any information from stakeholders for us to
more objectively measure intensity.
Comment: A few commenters stated that they are concerned with the
current implied methodology that the 25th survey percentile is the
ceiling for RUC recommendations, and stated that if codes are
continually sent forth for re-survey and the 25th percentile is the
ceiling, a built in reduction is applied to all surveyed codes just by
the nature of surveying the codes, regardless of other factors.
Response: We disagree with commenters' statement that the 25th
survey percentile is the ceiling for RUC recommendations. We note that,
as previously stated in the CY 2011 final rule with comment period (75
FR 73328), we had concerns that surveys conducted on existing codes
produced predictable results, and upon clinical review of a number of
these situations, we were concerned over the validity of the survey
results since the survey values often were very close to the current
code values. Increasingly, the RUC is choosing to recommend the 25th
percentile survey value, potentially responding to the same concern we
have identified, rather than recommending the median survey value that
had historically been the most commonly used. We reiterate that this
does not designate the 25th percentile as the ceiling, rather suggests
that in many instances the 25th percentile is the most appropriate
since it is more frequently being identified through the RUC process as
the recommended value.
Comment: One commenter stated that the time data obtained through
the RUC survey process based on subjective physician perceptions of
time, may not be the most accurate data available on intraoperative
time. The commenter stated that CMS should be open to reviewing
additional sources of objective validated time data, and that such
sources might include peer reviewed and published studies of
comparative surgery times amongst different procedures in the same
institution using standardized metrics. Another commenter stated that
if CMS seeks specific information to substantiate time and intensity
changes associated with services, they should specify these clearly so
stakeholders can provide the necessary data detailing changes over
time.
Response: As previously discussed, our review of work RVUs and time
inputs utilizes information from various resources. It 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 comparison with other codes with the
PFS, consultation with other physicians and health care professionals
within CMS and the federal government, as well as Medicare claims data.
Additionally, 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. However, we
continue to seek information regarding the best sources of objective,
routinely-updated, auditable, and robust data regarding the resource
costs of furnishing PFS services.
We thank the commenters for their feedback. We did not receive any
comments regarding specific potential alternatives to making the
adjustments that would recognize overall estimates of work in the
context of changes in the resource of time for particular services as
requested. However, we appreciate the commenters' sharing their
concerns and suggestions and will continue to consider them as we
continue examining the valuation of services, and as we explore the
best way to address these issues.
3. Requests for Refinement Panel
Consistent with the policy finalized in the CY 2016 PFS final rule
with comment period, we have retained the Refinement Panel process for
use with codes with interim final values where additional input by the
panel is likely to add value as a supplement to notice and comment
rulemaking. Because there are no codes with interim final values in
this final rule, the refinement panel is not necessary for CY 2017. We
note that many commenters requested inclusion of codes with proposed
values for a refinement panel. While these requests are not consistent
with our established process, given the number of requests we received,
we are addressing them here. Many commenters appear to believe that
that the purpose of the refinement panel process was to serve as a kind
of ``appeals'' or reconsideration process outside of notice and comment
rulemaking and that we have effectively eliminated a useful appeals
process. We understand that the refinement panel has been perceived as
an appeals process by many stakeholders. However, as we have previously
clarified, the purpose of the refinement panel process was to assist us
in reviewing the public comments on CPT codes with interim final work
RVUs and to consider more fully the interests of the specialty
societies who provide input on RVU work time and intensity with the
budgetary and redistributive effects that could occur if we accepted
extensive increases in work RVUs across a broad range of services. From
our perspective, the objective of the refinement panel has long been to
provide a needed venue for stakeholders to present any new clinical
information that was not available at the time of the RUC valuation for
interim final values in order that we arrive at the most appropriate
final valuation, especially since the initial values for such codes
were generally established approximately 2 months prior to being used
for Medicare payment. In recent years, we have continually observed
that the material presented to the refinement panel largely raised and
discussed issues and perspective already included as part of the RUC
meetings and considered by us.
We believe that our new process, in which we propose the vast
majority of code values in the proposed rule for public comment on
those proposed values prior to their taking effect, provides
stakeholders and the public with several opportunities to present data
or information that might affect code valuation. We believe that this
is generally consistent with the purpose of the rulemaking process and
reflects our efforts to increase transparency and accountability to the
public. We also note that we continue to seek new information that is
relevant to valuation of particular services, including those with
values recently finalized, for use in future rulemaking. We believe
that notice and comment rulemaking provides the most appropriate means
for valuing services under the PFS. We note that in several instances
in this final rule, thoughtful and informative comments have helped us
to finalize values for CY 2017 that we believe are improved from those
we had proposed. In many cases, these changes reflect the RUC-
recommended value. Therefore, we urge commenters to review this
information and continue to consider how we might continue to improve
the notice and comment rulemaking process rather than establish a
process outside of notice and comment rulemaking.
Table 27 contains a list of codes for which we proposed work RVUs;
this includes all RUC recommendations received by February 10, 2016,
and
[[Page 80278]]
codes for which we established interim final values in the CY 2016 PFS
final rule with comment period. When the proposed work RVUs vary from
those recommended by the RUC or for which we do not have RUC
recommendations, we address those codes in the portions of this section
that are dedicated to particular codes. The final work RVUs and work
time and other payment information for all CY 2017 payable codes are
available on the CMS Web site under downloads for the CY 2017 PFS final
rule at http://www.cms.gov/physicianfeesched/downloads/.
4. Methodology for Proposing the Direct PE Inputs To Develop PE RVUs
a. Background
On an annual basis, the RUC provides us with recommendations
regarding PE inputs for new, revised, and potentially misvalued codes.
We review the RUC-recommended direct PE inputs on a code by code basis.
Like our review of recommended work RVUs, our review of recommended
direct PE inputs generally includes, but is not limited to, a review of
information provided by the RUC, HCPAC, and other public commenters,
medical literature, and comparative databases, as well as a comparison
with other codes within the PFS, consultation with physicians and
health care professionals within CMS and the federal government, as
well as Medicare claims data. We also assess the methodology and data
used to develop the recommendations submitted to us by the RUC and
other public commenters and the rationale for the recommendations. When
we determine that the RUC'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 across codes, as well as
refinements that are specific to particular services. Table 28 details
our finalized refinements of the RUC's direct PE recommendations at the
code-specific level. In this final rule, we address several refinements
that are common across codes, and refinements to particular codes are
addressed in the portions of this section that are dedicated to
particular codes. We note that for each refinement, we indicate the
proposed impact on direct costs for that service. We note that, on
average, in any case where the impact on the direct cost for a
particular refinement is $0.32 or less, the refinement has no impact on
the proposed PE RVUs. This calculation 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 28 result in changes under the
$0.32 threshold and are unlikely to result in a change to the proposed
RVUs.
We also note that the final direct PE inputs for CY 2017 are
displayed in the CY 2017 direct PE input database, available on the CMS
Web site under the downloads for the CY 2017 final rule at www.cms.gov/PhysicianFeeSched/. The inputs displayed there have also been used in
developing the final CY 2017 PE RVUs as displayed in Addendum B.
b. Common Refinements
(1) Changes in Work Time
Some direct PE inputs are directly affected by revisions in work
time. Specifically, changes in the intraservice portions of the work
time and changes in the number or level of postoperative visits
associated with the global periods result in corresponding changes to
direct PE inputs. The direct PE input recommendations generally
correspond to the work time values associated with services. We believe
that inadvertent discrepancies between work time values and direct PE
inputs should be refined or adjusted in the establishment of proposed
direct PE inputs to resolve the discrepancies.
(2) Equipment Time
Prior to CY 2010, the RUC did not generally provide CMS with
recommendations regarding equipment time inputs. In CY 2010, in the
interest of ensuring the greatest possible degree of accuracy in
allocating equipment minutes, we requested that the RUC provide
equipment times along with the other direct PE recommendations, and we
provided the RUC with general guidelines regarding appropriate
equipment time inputs. We continue to appreciate the RUC's willingness
to provide us with these additional inputs as part of its PE
recommendations.
In general, the equipment time inputs correspond to the service
period portion of the clinical labor times. We have clarified this
principle over several years of rulemaking, indicating that we consider
equipment time as the time within the intraservice period when a
clinician is using the piece of equipment plus any additional time that
the piece of equipment is not available for use for another patient due
to its use during the designated procedure. For those services for
which we allocate cleaning time to portable equipment items, because
the portable equipment does not need to be cleaned in the room where
the service is furnished, we do not include that cleaning time for the
remaining equipment items, as those items and the room are both
available for use for other patients during that time. In addition,
when a piece of equipment is typically used during follow-up post-
operative visits included in the global period for a service, the
equipment time would also reflect that use.
We believe that certain highly technical pieces of equipment and
equipment rooms are less likely to be used during all of the preservice
or postservice tasks performed by clinical labor staff on the day of
the procedure (the clinical labor service period) and are typically
available for other patients even when one member of the clinical staff
may be occupied with a preservice or postservice task related to the
procedure. We also note that we believe these same assumptions would
apply to inexpensive equipment items that are used in conjunction with
and located in a room with non-portable highly technical equipment
items since any items in the room in question would be available if the
room is not being occupied by a particular patient. For additional
information, we refer readers to our discussion of these issues in the
CY 2012 PFS final rule with comment period (76 FR 73182) and the CY
2015 PFS final rule with comment period (79 FR 67639).
(3) Standard Tasks and Minutes for Clinical Labor Tasks
In general, the preservice, intraservice, and postservice clinical
labor minutes associated with clinical labor inputs in the direct PE
input database reflect the sum of particular tasks described in the
information that accompanies the RUC-recommended direct PE inputs,
commonly called the ``PE worksheets.'' For most of these described
tasks, there are a standardized number of minutes, depending on the
type of procedure, its typical setting, its global period, and the
other procedures with which it is typically reported. The RUC sometimes
recommends a number of minutes either greater than or less
[[Page 80279]]
than the time typically allotted for certain tasks. In those cases, we
review the deviations from the standards and any rationale provided for
the deviations. When we do not accept the RUC-recommended exceptions,
we refine the proposed direct PE inputs to conform to the standard
times for those tasks. In addition, in cases when a service is
typically billed with an E/M service, we remove the preservice clinical
labor tasks to avoid duplicative inputs and to reflect the resource
costs of furnishing the typical service.
In general, clinical labor tasks fall into one of the categories on
the PE worksheets. In cases where tasks cannot be attributed to an
existing category, the tasks are labeled ``other clinical activity.''
We believe that continual addition of new and distinct clinical labor
tasks each time a code is reviewed under the misvalued code initiative
is likely to degrade relativity between newly reviewed services and
those with already existing inputs. This is because codes more recently
reviewed would be more likely to have a greater number of clinical
labor tasks as a result of the general tendency to increase the number
of clinical labor tasks. To mitigate the potential negative impact of
these additions, we review these tasks to determine whether they are
fully distinct from existing clinical labor tasks, typically included
for other clinically similar services under the PFS, and thoroughly
explained in the recommendation. For those tasks that do not meet these
criteria, we do not accept these newly recommended clinical labor
tasks.
(4) Recommended Items That Are Not Direct PE Inputs
In some cases, the PE worksheets included with the RUC
recommendations include items that are not clinical labor, disposable
supplies, or medical equipment or that cannot be allocated to
individual services or patients. We have addressed these kinds of
recommendations in previous rulemaking (78 FR 74242), and we do not use
items included in these recommendations as direct PE inputs in the
calculation of PE RVUs.
(5) New Supply and Equipment Items
The RUC generally recommends the use of supply and equipment items
that already exist in the direct PE input database for new, revised,
and potentially misvalued codes. Some recommendations, however, include
supply or equipment items that are not currently in the direct PE input
database. In these cases, the RUC has historically recommended that a
new item be created and has facilitated our pricing of that item by
working with the specialty societies to provide us copies of sales
invoices. For CY 2017, we received invoices for several new supply and
equipment items. Tables 30 and 31 detail the invoices received for new
and existing items in the direct PE database. As discussed in section
II.A. of this final rule, we encourage stakeholders to review the
prices associated with these new and existing items to determine
whether these prices appear to be accurate. Where prices appear
inaccurate, we encourage stakeholders to provide invoices or other
information to improve the accuracy of pricing for these items in the
direct PE database during the 60-day public comment period for this
final 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 30 and 31 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 2017 are
available on the CMS Web site under downloads for the CY 2017 PFS final
rule at http://www.cms.gov/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html.
4. Specialty-Mix Assumptions for Proposed Malpractice RVUs
The final CY 2017 malpractice crosswalk table is displayed in the
public use files for the PFS final rule. The public use files for CY
2017 are available on the CMS Web site under downloads for the CY 2017
PFS final rule at http://www.cms.gov/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html. The table lists
the CY 2017 HCPCS codes and their respective source codes used to set
the final CY 2017 MP RVUs where the
[[Page 80280]]
source code for this calculation deviates from the source code for the
utilization otherwise used for purposes of PFS ratesetting. The MP RVUs
for all PFS services and the utilization crosswalk used to identify the
source codes for all other codes are reflected in Addendum B on the CMS
Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
5. Valuation of Specific Codes
(1) Anesthesia Services Furnished in Conjunction With Lower
Gastrointestinal (GI) Procedures (CPT Codes 00740 and 00810)
CPT codes 00740 and 00810 are used to report anesthesia furnished
in conjunction with lower gastrointestinal (GI) procedures. In the CY
2016 PFS proposed rule (80 FR 41686), we discussed that in reviewing
Medicare claims data, a separate anesthesia service is typically
reported more than 50 percent of the time that various colonoscopy
procedures are reported. We discussed that given the significant change
in the relative frequency with which anesthesia codes are reported with
colonoscopy services, we believed the relative values of the anesthesia
services should be reexamined. We proposed to identify CPT codes 00740
and 00810 as potentially misvalued and sought public comment regarding
valuation for these services.
The RUC recommended maintaining the base unit value of 5 as an
interim base value for both CPT code 00740 and 00810 on an interim
basis, due to their concerns about the specialty societies' surveys.
The RUC suggested that the typical patient vignettes used in the
surveys for both CPT codes 00740 and 00810 were not representative of
current typical practice and recommended that the codes be resurveyed
with updated vignettes. We stated in the CY 2017 proposed rule that we
believed it premature to propose any changes to the valuation of CPT
codes 00740 and 00810, continued to believe that these services are
potentially misvalued, and sought additional input from stakeholders
for consideration during future rulemaking.
Comment: Commenters were supportive of CMS' proposal to maintain
the current values for CPT codes 00740 and 00810 for CY 2017. One
commenter requested that CMS ensure that reimbursement for anesthesia
services remains adequate to compensate providers for the cost of
furnishing these services. Commenters also stated that due to greater
complexity of furnishing anesthesia services compared to moderate
sedation, payment for anesthesia services should not be lower than the
values established for moderate sedation.
One commenter stated that CMS' perception that these codes are
misvalued is related to the distinction between screening, diagnostic,
and therapeutic endoscopies. The commenter further stated that there
are no differences in the clinical risk and anesthesia preparation
regardless of the indication for these procedures and suggested that
the current base unit value of 5 units for CPT codes 00740 and 00810 is
appropriate and should be maintained. Another commenter stated that the
frequency of use of separate anesthesia services concurrent with
colonoscopy procedures is not due to any potential misvaluation, but
rather due to changes in Medicare coverage and payment policies that
encourage Medicare beneficiaries to undergo screening colonoscopies.
Response: We appreciate the information provided by commenters. We
continue to encourage feedback from interested parties and specialty
societies, all of which we will take under consideration for future
rulemaking.
(2) Soft Tissue Localization (CPT Codes 10035 and 10036)
In the CY 2016 PFS final rule with comment period, we established
the RUC-recommended work value as interim final for CPT codes 10035 and
10036. We also made standard refinements to remove duplicative clinical
labor and utilize standard equipment time formulas for the PACS
workstation proxy (ED050).
Comment on the CY 2016 PFS final rule with comment period: A
commenter stated that the clinical labor task ``Review/read X-ray, lab,
and pathology reports'' occurs during the preservice period, and it is
a separate activity than ``Review examination with interpreting MD'',
which occurs during the service period.
Response in the CY 2017 PFS proposed rule: We continued to believe
that the clinical labor was duplicative with the clinical labor for
``Review examination with interpreting MD'' because we believed that
the two descriptors detailed the same clinical labor activity taking
place, rather than two separate and distinct tasks.
In the CY 2017 proposed rule, we proposed to maintain our previous
refinement to 0 minutes for this clinical labor task for CPT codes
10035 and 10036. We also proposed to maintain the interim final work
RVUs for CPT codes 10035 and 10036.
We did not receive any comments in response to our proposed
valuation on CPT codes 10035 and 10036 and we are finalizing the
clinical labor task and work RVUs as proposed.
(3) Removal of Nail Plate (CPT Code 11730)
We identified CPT code 11730 through a screen of high expenditures
by specialty. The HCPAC recommended a work RVU of 1.10. We believed the
recommendation for this service overestimates the work involved in
performing this procedure, specifically given the decrease in physician
intraservice and total time concurrently recommended by the HCPAC. We
believed that a work RVU of 1.05, which corresponds to the 25th
percentile of the survey results, more accurately represents the time
and intensity of furnishing the service. To further support the
validity of the use of the 25th percentile of the survey, we identified
two crosswalk codes, CPT code 20606 (Arthrocentesis, aspiration and/or
injection, intermediate joint or bursa), with a work RVU of 1.00, and
CPT code 50389 (Removal of nephrostomy tube, requiring fluoroscopic
guidance), with a work RVU of 1.10, both of which have identical
intraservice times, similar total times and similar intensity. We noted
that our proposed work RVU of 1.05 for CPT code 11730 falls halfway
between the work RVUs for these two crosswalk codes. CPT code 11730 may
be reported with add-on CPT code 11732 to report performance of the
same procedure for each additional nail plate procedure.
Since CPT code 11732 was not reviewed by the HCPAC for CY 2017, we
proposed a new work value to maintain the consistency of this add-on
code with the base code, CPT code 11730. We proposed to remove 2
minutes from the physician intraservice time to maintain consistency
with the HCPAC-recommended reduction of 2 minutes from the physician
intraservice time period for the base code. We are using a crosswalk
from the value for CPT code 77001 (Fluoroscopic guidance for central
venous access device placement, replacement (catheter only or
complete), or removal (includes fluoroscopic guidance for vascular
access and catheter manipulation, any necessary contrast injections
through access site or catheter with related venography radiologic
supervision and interpretation, and radiographic documentation of final
catheter position) (List separately in addition to code for primary
procedure)), which has similar physician intraservice and total time
values; therefore, we proposed a
[[Page 80281]]
work RVU of 0.38 for CPT code 11732. As further support for this
proposal, we noted that this proposed RVU reduction is similar to the
value obtained by subtracting the incremental difference in the current
and recommended work RVUs for the base code from the current value of
CPT code 11732.
We proposed to use the HCPAC-recommended direct PE inputs for CPT
code 11730. We proposed to apply some of the HCPAC-recommended
refinements for CPT code 11730 to CPT code 11732, including the removal
of the penrose drain (0.25 in x 4 in), lidocaine 1%-2% inj (Xylocaine),
applicator (cotton-tipped, sterile) and silver sulfadiazene cream
(Silvadene), as well as the reduction of the swab-pad, alcohol from 2
to 1. In addition, we proposed not to include the recommended supply
items ``needle, 30g, and syringe, 10-12ml'' since other similar items
are present, and we believe inclusion of these additional supply items
would be duplicative. For clinical labor, we proposed to assign 8
minutes to ``Assist physician in performing procedure'' to maintain a
reduction that is proportionate to that recommended for CPT code 11730.
For the supply item ``ethyl chloride spray,'' we believed that the
listed input price of $4.40 per ounce overestimates the cost of this
supply item, and we solicited comment on the accuracy of this supply
item price. Finally, we proposed to add two equipment items as was done
in the base code, basic instrument pack and mayo stand, and proposed to
adjust the times for all pieces of equipment to eight minutes to
reflect the clinical service period time.
Comment: A commenter states that the work for CPT code 11730 has
not changed since the previous recommendation, thus maintenance of a
work RVU of 1.10 is proper.
Response: We continue to believe that the HCPAC-recommended
reduction in intraservice and total time supports a reduction in our
estimation of the physician work value of furnishing this service.
Comment: The HCPAC stated that it did not support the proposed
decrease in the work RVU for CPT code 11732.
Response: We welcome any additional input as to the appropriate
valuation of CPT code 11732. At this time, we continue to believe that
a work RVU of 0.38 is appropriate, considering its relationship to CPT
code 11730. We proposed values for CPT code 11732 based on its being an
add-on code for CPT code 11730. We remind commenters and stakeholders
that they may nominate this code family as potentially misvalued if
they believe that both codes should be evaluated through the standard
process, which would involve use of physician survey data and input
from the HCPAC for both codes. We are finalizing work RVUs of 1.05 for
CPT code 11730 and 0.38 for CPT code 11732, as well as the proposed PE
refinements.
(4) Bone Biopsy Excisional (CPT Code 20245)
In CY 2014, CPT code 20245 was identified by the RUC's 10-Day
Global Post-Operative Visits Screen.
For CY 2017, the RUC recommended a work RVU of 6.50 for CPT code
20245, including a change in global period from 10 to 0 days. We
disagreed with this value given the significant reductions in the
intraservice time, total time, and the change in the office visits
assuming the change in global period. The intraservice and total times
were decreased by approximately 33 and 53 percent respectively; while
the elimination of three post-operative visits (one CPT code 99214 and
two CPT code 99213 visits) alone would reduce the overall work RVU by
at least 38 percent under the reverse building block methodology. We
also note that the RUC-recommended work RVU of 6.50 only represents a
27 percent reduction relative to the previous work RVU of 8.95. To
develop a work RVU for this service, we used a crosswalk from CPT code
19298 (Placement of radiotherapy after loading brachytherapy catheters
(multiple tube and button type) into the breast for interstitial
radioelement application following (at the time of or subsequent to)
partial mastectomy, includes imaging guidance), since we believe the
codes share similar intensity and total time and the same intraservice
time of 60 minutes. Therefore, for CY 2017, we proposed a work RVU of
6.00 for CPT code 20245.
Comments: Several commenters, including the RUC, stated their
objection to the proposed crosswalk, indicating that it underestimated
the total time by 10 minutes and the physician work involved in
furnishing the service. Commenters recommended CMS accept the RUC-
recommended work RVU of 6.50.
The RUC also noted the current time of CPT code 20245 was based on
a survey of 35 individuals more than 15 years ago and due to the
previous flawed survey, the resulting IWPUT was almost zero. Given
these discrepancies, the surveyed time of 60 minutes better reflects an
appropriate level of intensity and complexity (IWPUT= 0.071) for this
service relative to other 0-day global procedures.
Another commenter stated concern that the values proposed by CMS
have been arrived at using methodologies that are not consistent with
the RUC-recommended values, and therefore, are not appropriately
relative to other similar services.
Response: Thank you for your comments. We present the information
in Table 16 to illustrate the differences between the CMS crosswalked
code and the additional RUC comparator codes.
Table 16--Crosswalk for CPT Code 20245
----------------------------------------------------------------------------------------------------------------
Intra-service
CPT code Descriptor time Total time Work RVU
----------------------------------------------------------------------------------------------------------------
20245........................... Bone Biopsy Excisional........ 60 160 * 6.50
19298........................... Place Breast Rad Tube/Cath.... 60 169 6.00
36247........................... Ins Cath ABDL/-Ext Art 3RD.... 60 131 6.29
43262........................... Endocholangiopancreatograp.... 60 138 6.60
----------------------------------------------------------------------------------------------------------------
* RUC recommended value.
Although the total times for CPT codes 19298 and 20245 are not
identical, we continue to believe it is a more accurate comparison than
the additional codes submitted by the RUC, which have 22-29 minutes
less total time.
We note that according to the most recent survey, respondents
lowered the work RVU of the 25th percentile, which we typically accept,
from 6.06 RVUs to 4.94 RVUs when the code was revalued with a 0-day
global period.
For CY 2017, we are finalizing the work RVU of 6.00 for CPT code
20245.
[[Page 80282]]
(5) Insertion of Spinal Stability Distractive Device (CPT Codes 22867,
22868, 22869, and 22870)
For CY 2016, the CPT Editorial Panel converted two Category III
codes to Category I codes describing the insertion of an interlaminar/
interspinous process stability device (CPT codes 22867 and 22869) and
developed two corresponding add-on codes (CPT codes 22868 and 22870).
The RUC recommended a work RVU of 15.00 for CPT code 22867, 4.00 for
CPT code 22868, 7.39 for CPT code 22869, and 2.34 for CPT code 22870.
We believe that the RUC recommendations for CPT codes 22867 and
22869 overestimate the work involved in furnishing these services. We
believe that a crosswalk to CPT code 36832 (Revision, open,
arteriovenous fistula; without thrombectomy, autogenous or
nonautogenous dialysis graft (separate procedure)), which has a work
RVU of 13.50 is a more accurate comparison. CPT code 36832 is similar
in total time, work intensity, and number of visits to CPT code 22867.
This crosswalk is supported by the ratio between total time and work in
the key reference service, CPT code 63047 (Laminectomy, facetectomy and
foraminotomy (unilateral or bilateral with decompression of spinal
cord, cauda equina and/or nerve root[s], [eg, spinal or lateral recess
stenosis]), single vertebral segment; lumbar). Therefore, we proposed a
work RVU of 13.50 for CPT code 22867. For CPT code 22869, we believed
that CPT code 29881 (Arthroscopy, knee, surgical; with meniscectomy
(medial OR lateral, including any meniscal shaving) including
debridement/shaving of articular cartilage (chondroplasty), same or
separate compartment(s), when performed) is an appropriate crosswalk
based on clinical similarity, as well as intensity and total time. CPT
code 29881 has a work RVU of 7.03; therefore, we proposed a work RVU of
7.03 for CPT code 22869. We proposed the RUC-recommended work RVU for
CPT codes 22868 and 22870 without refinement.
Comment: Several commenters disagreed with our proposed valuation
of the work RVU for CPT codes 22867 and 22869. They stated that the RUC
crosswalk for each of these codes, respectively, is either identical to
or a better match than the proposed CMS crosswalk.
Response: We recognize that the RUC crosswalk of CPT code 29915 for
CPT code 22867 has a total time that is more similar to the new code
than the crosswalk we proposed (CPT code 36832). We consider multiple
factors when identifying appropriate crosswalk codes. We note that
RUC's crosswalk, CPT code 29915, had very low service utilization, 355
in 2015, and was last reviewed by CMS and the RUC in April 2010. CPT
code 36832, in contrast, had service utilization of 21,529 in 2015, and
was most recently reviewed in October 2013. We considered the
combination of these factors in choosing a crosswalk and determining a
proposed work RVU. Commenters did not present any additional clinical
information or data about this code that would lead us to reconsider
our proposed valuation; therefore, we are finalizing the work RVU of
13.50 for CPT code 22867.
With regard to CPT code 22869, we disagree that the RUC crosswalk
to CPT code 29880 is a closer comparison than CPT code 29881. The
intraservice time for the newly created CPT code 22869 (43 minutes) is
between that of the RUC recommended crosswalk CPT code 29880 (45
minutes) and the CMS crosswalk CPTcode 29881 (40 minutes). Total time
for CPT code 29881, however, is identical to total time for CPT code
22869 (194 minutes), whereas the RUC recommended crosswalk CPT code
29880 has a higher total time (199 minutes). We continue to believe,
therefore, that our crosswalk is appropriate and we are finalizing the
proposed work RVU of 7.03 for CPT code 22869.
(6) Biomechanical Device Insertion (CPT Codes 22853, 22854, and 22859)
For CY 2016, the CPT Editorial Panel established three new Category
I add-on codes and deleted one code to provide a more detailed
description of the placement and attachment of biomechanical spinal
devices. For CPT code 22853, the RUC recommended a work RVU of 4.88.
For CPT codes 22854 and 22859, the RUC-recommended work RVUs are 5.50
and 6.00, respectively.
In reviewing the code descriptors, descriptions of work and
vignettes associated with CPT codes 22854 and 22859, we concluded that
the two procedures, in addition to having identical work time, contain
many clinical similarities and do not have quantifiable differences in
overall intensity. Therefore, we proposed the RUC-recommended work RVU
of 5.50 for both CPT code 22854 and CPT code 22859. We believe that the
RUC-recommended work RVU of 4.88 for CPT code 22853 overestimates the
work in the procedure relative to the other codes in the family. We
proposed a work RVU of 4.25 for CPT code 22853 based a crosswalk from
CPT code 37237 (Transcatheter placement of an intravascular stent(s)
(except lower extremity artery(s) for occlusive disease, cervical
carotid, extracranial vertebral or intrathoracic carotid, intracranial,
or coronary), open or percutaneous, including radiological supervision
and interpretation and including all angioplasty within the same
vessel, when performed; each additional artery (List separately in
addition to code for primary procedure)), which is similar in time and
intensity to the work described by CPT code 22853.
Comment: Several commenters disagreed with our proposed valuation
of the work RVU of 4.25 for CPT code 22853 rather than the RUC-
recommended work RVU of 4.88. They requested clarification regarding
our crosswalk for this new code to CPT code 37237 instead of the RUC-
recommended crosswalk of CPT code 57267.
Response: We take many factors into consideration when valuing a
work RVU for a new code. We note that CPT code 57267 and CPT code 37237
have identical intraservice times and very similar total work times. We
note that CPT code 37237 was most recently valued in April 2013,
whereas the RUC crosswalk CPT code 57267 was last reviewed in 2004. We
continue to believe that CPT code 37237 is an appropriate crosswalk for
valuing the new CPT code 22859. Therefore, we are finalizing our
proposed work RVU of 4.25 for CPT code 22853.
Comment: We received several comments objecting to our proposed
work RVU of 5.50 for CPT code 22859, which is identical to the work RVU
proposed by the RUC and accepted by CMS for CPT code 22854. Commenters
provided detailed descriptions of the two procedures in an effort to
demonstrate the higher intensity required by CPT code 22859 compared
with CPT code 22854, thereby justifying the RUC-recommended work RVU of
6.00 for CPT code 22859. Several commenters expressed confusion about
the descriptors for all three of the new CPT codes (CPT codes 22853,
22854, and 22859), in general, and stated their concern that the code
descriptors do not clearly differentiate the work involved in
furnishing the services.
Response: While we are somewhat persuaded by commenters' detailed
descriptions of the two procedures and the higher intensity of work
involved in furnishing CPT code 22859 compared with CPT code 22854, we
are concerned about a substantive disagreement between the RUC and
survey respondents about the intensities of work involved in furnishing
the services described by these new codes. The RUC and the survey
respondents valued the
[[Page 80283]]
relative intensities of the two codes in the reverse order. The survey
results indicated a work RVU of 8.16 (with 25th percentile of 7.0) for
CPT code 22854 and a work RVU of 8.0 (with 25th percentile of 6.0) for
CPT code 22859. The RUC reviewed the survey results and agreed that
respondents overvalued the work involved in performing CPT code 22854.
The RUC-recommended work RVU for CPT code 22854, which we are accepting
as recommended, was established through a crosswalk to CPT code 37234.
We agree that this is an appropriate crosswalk and valuation of this
service. For CPT code 22859, the RUC also believed that the survey
recommended work RVU of 8.0 was overvalued. The RUC recommended the
25th percentile of survey results, with a work RVU of 6.0. We find it
difficult to reconcile the conflicting valuations by the survey and the
RUC of the absolute and relative intensity of these new codes.
In addition to the survey results and RUC recommendations, we
reviewed the descriptors of these codes and agree with commenters who
found them vague and unclear. We share the concern of stakeholders who
indicated that the lack of differentiation in the codes may lead to
inconsistent use and reporting.
Given the disagreement between the RUC and survey respondents
regarding the order and level of intensity of these services, along
with confusion about the code descriptors, we find that valuing the
services of 22854 and 22859 differently from each another is difficult
to justify. Therefore, we are finalizing our proposed work RVU of 5.50
for CPT code 22859.
(7) Repair Flexor Tendon (CPT Codes 26356, 26357, and 26358)
In the CY 2016 PFS final rule with comment period, we established
an interim final work RVU of 9.56 for CPT code 26356 after considering
both its similarity in time to CPT code 25607 (Open treatment of distal
radial extra-articular fracture) and the recommended reduction in time
relative to the current times assumed for this procedure. We
established an interim final work RVU of 10.53 for CPT code 26357 based
on a direct crosswalk from CPT code 27654 (Repair, secondary, Achilles
tendon, with or without graft), as we believed that this work RVU
better reflected the changes in time for this procedure. For the last
code in the family, we established an interim final work RVU of 12.13
for CPT code 26358, based on the RUC-recommended increment of 1.60 work
RVUs relative to CPT code 26357.
Comment on the CY 2016 PFS final rule with comment period: We
received several comments regarding the interim final work values for
this family of codes. One commenter stated that it was inappropriate to
use time ratios to evaluate CPT code 26356 as it was last valued in
1995, noting that there was an anomalous relationship between the
current work RVU and the imputed time components in the RUC database.
This commenter also pointed out that when the previous time was
developed, fabrication of a splint was considered to be part of the
intraservice work, while in the current survey instrument, the
fabrication of the splint is considered to be part of the postservice
work since it is a dressing. This commenter urged CMS to adopt the RUC
recommendations. A different commenter agreed that the CMS crosswalk to
CPT code 25607 was an appropriate crosswalk for CPT code 26356 and
supported the CMS work RVU of 9.56.
Response in the CY 2017 PFS proposed rule: We appreciate the
support from the commenter. We continue to believe that our crosswalk
for this code is an appropriate choice, due to our estimate of overall
work between CPT code 26356 and CPT code 25607. We appreciate the
commenters' concerns regarding the time ratio methodologies and have
responded to these concerns about our methodology in section II.L of
this final rule. Although we note the commenter's statement about how
the service period in which fabrication of a splint takes place may
have evolved over time, we do not agree that this task would be
responsible for a decrease in intraservice survey time, as the
postservice survey time for CPT code 26356 remained unchanged at 30
minutes. If the decrease in intraservice time had been due to the shift
of splinting from the intraservice period to the postservice period,
then we would have expected to see an increase in the postservice
period minutes. However, they remained exactly the same in the
physician survey for CPT 26356. As we wrote earlier in this section, we
believe in the validity of using pre-existing time values as a point of
comparison, and we believe that we should account for efficiencies in
time when the recommended work RVU does not account for those
efficiencies. After consideration of comments received, we proposed to
maintain CPT code 26356 at its current work RVU of 9.56 for CY 2017.
Comment on the CY 2016 PFS final rule with comment period: Several
commenters disagreed with the work RVU for CPT code 26357. One
commenter stated that the CMS crosswalk to CPT code 27654 had less
total time and resulted in an inappropriately lower derived intensity.
This commenter urged CMS to adopt the RUC-recommended work value.
Another commenter stated that a better crosswalk for CPT code 26357
would be CPT code 25608 (Open treatment of distal radial intra-
articular fracture or epiphyseal separation), the next code in the same
upper extremity family that CMS used for the initial crosswalk. This
commenter stated that the CMS crosswalk for CPT code 26357 created a
rank order anomaly in terms of intensity within this family, and that
the commenter's suggested crosswalk would create two pairs of matched
codes, survey CPT codes 26356/26357 with crosswalk CPT codes 25607/
25608.
Response in the CY 2017 PFS proposed rule: We appreciate the
suggested crosswalk from the commenters, and we agree that the choice
of the initial CMS crosswalk creates a rank order anomaly within the
family in terms of intensity. As a result, after consideration of
comments received, we proposed to instead value CPT code 26357 at the
25th percentile survey work RVU of 11.00 for CY 2017. This valuation
corrects the anomalous intensity within the Repair Flexor Tendon family
of codes, and preserves the RUC-recommended increment between CPT codes
26356 and 26357.
Comment on the CY 2016 PFS final rule with comment period: The
commenters agreed that the RUC-recommended increment of 1.60 was
appropriate for the work RVU of CPT code 26358 when added to the work
RVU of CPT code 26357. However, commenters stated that this increment
of 1.60 should be added to the RUC-recommended work value for CPT code
26357, and not the CMS refined value from the CY 2016 PFS final rule
with comment period.
Response in the CY 2017 PFS proposed rule: We also continue to
believe that the increment of 1.60 is appropriate for the work RVU of
CPT code 26358. After consideration of comments received, we therefore
proposed to set the work RVU for this code at 12.60 for CY 2017, based
on the increment of 1.60 from CPT code 26357's proposed work RVU of
11.00.
In the CY 2017 proposed rule, we proposed to maintain the current
direct PE inputs for all three codes.
The following is a summary of the comments we received regarding
our proposed valuation of the Repair Flexor Tendon codes:
[[Page 80284]]
Comment: One commenter expressed support for the proposed work RVU
for the flexor tendon codes.
Response: We appreciate the support from the commenters.
After consideration of comments received, we are finalizing our
proposed valuation of the Repair Flexor Tendon codes.
(8) Closed Treatment of Pelvic Ring Fracture (CPT Codes 27197 and
27198)
For CY 2017, the CPT Editorial Panel deleted CPT codes 27193 and
27194 and replaced them with new CPT codes 27197 and 27198. The RUC
recommended a work RVU of 5.50 for CPT code 27193, and a work RVU of
9.00 for CPT code 27198. We proposed to change the global period for
these services from 90 days to 0 days because these codes typically
represent emergent procedures with which injuries beyond pelvic ring
fractures are likely to occur; we believe it is typical that multiple
practitioners would be involved in providing post-operative care and it
is likely that a practitioner furnishing a different procedure is more
likely to be providing the majority of post-operative care. If other
practitioners are typically furnishing care in the post-surgery period,
we believe that the six post-service visits included in CPT code 27197,
and the seven post-service visits included in CPT code 27198, would
likely not occur. This is similar to our CY 2016 review and valuation
of CPT codes 21811 (Open treatment of rib fracture(s) with internal
fixation, includes thoracoscopic visualization when performed,
unilateral; 1-3 ribs), 21812 (Open treatment of rib fracture(s) with
internal fixation, includes thoracoscopic visualization when performed,
unilateral; 4-6 ribs), and 21813 (Open treatment of rib fracture(s)
with internal fixation, includes thoracoscopic visualization when
performed, unilateral; 7 or more ribs). In our valuation of those
codes, we determined that a 0-day, rather than a 90-day global period
was preferable, in part because those codes describe rib fractures that
would typically occur along with other injuries, and the patient would
likely already be receiving post-operative care because of the other
injuries. We believe that the same rationale applies here. To establish
a work RVU for CPT code 27197, we proposed crosswalking this code to
CPT code 65800 (Paracentesis of anterior chamber of eye (separate
procedure); with removal of aqueous), due to its identical intraservice
time and similar total time, after removing the work associated with
postoperative visits, and its similar level of intensity. Therefore, we
proposed a work RVU of 1.53 for CPT code 27197. For CPT code 27198, we
proposed crosswalking this code to CPT code 93452 (Left heart
catheterization including intraprocedural injection(s) for left
ventriculography, imaging supervision and interpretation, when
performed) which has an identical intraservice time and similar total
time, after removing the work associated with post-operative visits
from CPT code 27198. We proposed a work RVU of 4.75 for CPT code 27198.
Comment: Some commenters stated that the new coding for these
services was designed, in part, to address the appropriateness of a 90-
day global period by differentiating between higher energy and lower
energy fractures. According to these commenters, the CPT Editorial
Panel redefined these codes as treating injuries from higher energy and
more unstable posterior pelvic ring injuries, and added a parenthetical
directing physicians to use E/M billing for closed treatment of
isolated lower energy fractures. These commenters say that the new
coding clarifies when to use E/M coding for these services and when to
bill these two codes. They state that these codes should thus remain
valued with 90-day global periods while less complicated fractures will
be billed with E/M coding.
Response: We took into consideration many factors when determining
the appropriate global period of this service. While we understand that
the new coding was partly designed to address the appropriateness of a
90-day global period, we continue to believe that a 0-day, rather than
a 90-day, global period is more appropriate for this code, since we
believe that the patient would likely already be receiving post-
operative care because of other injuries. We also believe that the
practitioner who performs the original procedure may not typically be
performing the follow-up care, and shifting to a 0-day global period
will allow the appropriate practitioner to report the follow up care,
when appropriate.
Comment: A commenter stated that assigning a 0-day global period to
this code will cause these codes to be different from all other closed
fracture codes, which the commenter believes will lead to confusion for
physicians and rank order anomalies.
Response: The commenter did not present sufficient information to
explain why the variation in global periods for these kinds of services
would uniquely cause rank order anomalies. We agree that it is
preferable that codes for similar procedures have similar global
periods; however, other factors specific to each code are taken into
consideration when determining the appropriate global period. In the
case of CPT codes 27197 and 27198, we continue to believe that the
emergent nature inherent with the injuries considered typical would
mean that other physicians would typically perform follow-up care. For
detailed guidance on billing global surgical procedures, we direct
readers to the Medicare Claims Processing Manual, Pub. 100-04; billing
requirements and adjudication of claims requirements for global
surgeries are under chapter 12, sections 40.2 and 40.4. We also note
that if this procedure is billed concurrently with another procedure
that is valued with a 10-day or 90-day global period, that the follow
up visits associated with the latter procedure would occur as part of
that package, while follow-up visits for these two codes would be
reported using E/M coding.
Comment: A commenter states that, for procedures valued as part of
a 90-day global period, the physician who is performing the primary
portion of the treatment is obligated to follow the patient throughout
the entire global period and furnish follow-up care.
Response: We understand the commenter's perspective that the
treating physician is obligated to provide follow-up care within the
global period; however, we do not believe that this necessitates the
valuation of every surgical procedure with a 10-day or 90-day global
period. While the treating physician would ideally provide follow-up
care for these codes were they to be assigned 90-day global periods, we
continue to believe that this would be an atypical situation for these
types of treatments and for these types of injuries. We note that the
assignment of a global period occurs in the process of evaluation of
codes and we take into consideration factors specific to each
procedure. There may be many instances when codes with similar
procedures have different global periods. We are finalizing as proposed
the work RVUs of 1.53 for CPT code 27197 and 4.75 for CPT code 27198,
as well as an assignment of 0-day global periods.
(9) Bunionectomy (CPT Codes 28289, 28291, 28292, 28295, 28296, 28297,
28298, and 28299)
The RUC identified CPT code 28293 as a 90-day global service with
more than 6 office visits and CPT codes 28290-28299 as part of the
family of services. In October 2015, the CPT Editorial Panel created
two new CPT codes (28291, 28295), deleted CPT codes 28290, 28293, and
28294 and revised CPT codes 28289, 28292, 28296,
[[Page 80285]]
28297, 28298 and 28299 based on the rationale that more accurate
descriptions of the services needed to be developed.
For CPT codes 28289, 28292, 28296, 28297, 28298, and 28299, the RUC
recommended and we proposed work RVUs of 6.90, 7.44, 8.25, 9.29, 7.75,
and 9.29 respectively. For CPT code 28291, the RUC recommended a work
RVU of 8.01 based on the 25th percentile of the survey. We believed the
recommendation for this service overestimates the overall work involved
in performing this procedure given the decrease in intraservice time,
total time, and post-operative visits when compared to deleted
predecessor CPT code 28293. Due to similarity in intraservice and total
times, we believed a direct crosswalk of the work RVUs for CPT code
65780 (Ocular surface reconstruction; amniotic membrane
transplantation, multiple layers) to CPT code 28291 more accurately
reflects the time and intensity of furnishing the service. Therefore,
for CY 2017, we proposed a work RVU of 7.81 for CPT code 28291.
For CPT code 28295, the RUC recommended a work RVU of 8.57 based on
the 25th percentile of the survey. We believed the recommendation for
this service overestimates the work involved in performing this
procedure given the similarity in the intensity of the services and
identical intraservice and total times as CPT code 28296. Therefore, we
proposed a direct RVU crosswalk from CPT code 28296 to CPT code 28295.
For CY 2017, we proposed a work RVU of 8.25 for CPT code 28295.
Comments: A few commenters, including the RUC, objected to the
proposed work RVUs for CPT codes 28291 and 28295. Commenters noted that
deleted CPT code 28293 was marked by the RUC as ``not to use for
validation of physician work''. The RUC noted the previous time was
based on Harvard time and when reviewed in 1995, the RUC maintained the
physician work and Harvard time because there was no compelling
evidence to revise the value at that time.
The RUC acknowledged that the deleted CPT code 28293 had 30 minutes
more intra-service time and a higher work RVU of 11.48 compared to the
recommended work RVU of 8.01 for CPT code 28291. However, the RUC
stated the differences in the physician work, time, intensity and the
actual new service as described in CPT code 28291 were appropriately
accounted for in its recommendation.
The RUC also stated disagreement with the proposed crosswalk of
work RVUs from CPT code 28291 to CPT code 65780. The RUC stated it
compared the family and relative ranking and believed CPT code 28291
was more complex and intense than CPT code 28298. The relative
difference in work and complexity was reviewed and correctly ranked by
the survey respondents at the 25th percentile, which corresponds with
the RUC-recommended value.
One commenter stated that CPT code 28293 was deleted and a new CPT
code was established because the two procedures were no longer
synonymous. Also, the slight decrease in the intraoperative intensity
with the new value is barely measurable, and therefore, the commenter
does not agree with CMS that a work RVU of 7.81 is a more accurate
valuation.
One commenter stated that CPT code 28295 is more intense than CPT
code 28296 because CPT code 28295 requires separate areas of
dissection. With CPT code 28296, the osteotomy and soft tissue
procedure are performed at the same anatomic location. The commenter
stated this nuance in complexity is the rationale for separate codes
and is similar to the rationale for separate cervical versus lumbar
spine codes or artery versus vein codes for vascular work.
Response: We appreciate additional information offered by the
commenters. After consideration of comments received, we agreed with
the additional information provided by commenters and are finalizing
the RUC-recommend work RVUs of 6.90, 8.01, 7.44, 8.57, 8.25, 9.29, 7.75
and 9.29 for CPT codes 28289, 28291, 28292, 28295, 28296, 28297, 28298
and 28299; respectively.
(10) Endotracheal Intubation (CPT Code 31500)
In the CY 2016 PFS final rule with comment period (80 FR 70914), we
identified CPT code 31500 as potentially misvalued. The specialty
societies surveyed this code, and after reviewing the survey responses
(which included increases in time) the RUC recommended a work RVU of
3.00 for CPT code 31500. After reviewing the RUC's recommendation, we
proposed a work RVU of 2.66, based on a direct crosswalk to CPT code
65855 (Trabeculoplasty by laser surgery), which has similar intensity
and service times.
Comment: Commenters requested that CMS finalize the RUC-recommended
work RVU of 3.00 instead of CMS' proposed 2.66 work RVUs. The RUC
stated that the surveyed median intraservice time is 10 minutes,
representing a doubling of the current intraservice time of 5 minutes.
Commenters also disagreed with CMS' proposed crosswalk from CPT code
65855. The RUC stated that given the emergent nature of the services
reported with CPT code 31500, there are few relevant physician work and
time-based comparisons within the resource-based relative value scale
(RBRVS).
Response: We appreciate commenters' feedback on our proposal. As
pointed out by the commenters, the survey data shows increased
intraservice and total times for these services. We agree with
commenters that due to the emergent nature of these services, there are
few relevant physician work and time-based comparisons for this
service. Therefore, due to the emergent nature of these services and
service time increases, for CY 2017, we are finalizing a work RVU of
3.00 for CPT code 31500.
(11) Flexible Laryngoscopy (CPT Codes 31572, 31573, 31574, 31575,
31576, 31577, 31578, and 31579)
After we identified CPT codes 31575 and 31579 as potentially
misvalued (80 FR 70912-70914), the RUC referred the entire flexible
laryngoscopy family of codes back to the CPT Editorial Panel for
revision and the addition of several codes representing new technology
within this family of services. At the May 2015 CPT meeting, the CPT
Editorial Panel added three new codes to describe laryngoscopy with
ablation or destruction of lesion and therapeutic injection. Based on
the survey results, the time resources involved in furnishing the
procedures described by this code family experienced a significant
reduction in the intraservice period, yet the recommended work RVUs
were not similarly reduced. Therefore, in reviewing the recommended
values for this family of codes we looked for a rationale for increased
intensity and absent such rationale, proposed to adjust the recommend
work RVUs to account for significant changes in time.
For CPT code 31575, we disagreed with the RUC-recommended work RVU
of 1.00, and we instead proposed a work RVU of 0.94. We looked at the
total time ratio for CPT code 31575, which is decreasing from 28
minutes to 24 minutes, and applied this ratio of 0.86 times the current
work RVU of 1.10 to derive our proposed work RVU of 0.94. We supported
this value for CPT code 31575 through a crosswalk to CPT code 64405
(Injection, anesthetic agent; greater occipital nerve), which shares 5
minutes of intraservice time and also has a work RVU of 0.94.
We agreed with the RUC that CPT code 31575 serves as the base code
for the rest of the Flexible Laryngoscopy family. As a result, we
proposed to
[[Page 80286]]
maintain the same RUC-recommended increments for the rest of the codes
in this family, measuring the increments from CPT code 31575's refined
work RVU of 0.94 instead of the RUC-recommended work RVU of 1.00. This
meant that each of the work RVUs for the codes in the rest of the
family decreased by 0.06 when compared to the RUC-recommended value. We
therefore proposed a work RVU of 1.89 for CPT code 31576, a work RVU of
2.19 for CPT code 31577, a work RVU of 2.43 for CPT code 31578, a work
RVU of 3.01 for CPT code 31572, a work RVU of 2.43 for CPT code 31573,
a work RVU of 2.43 for CPT code 31574, and a work RVU of 1.88 for CPT
code 31579.
Regarding the direct PE inputs, we proposed to use refined clinical
labor time for ``Obtain vital signs'' for CPT codes 31577 and 31579
from 3 minutes to 2 minutes. We believe that this extra clinical labor
time is duplicative, as these codes are typically performed with a same
day E/M service. Each procedure is only allotted a maximum of 5 minutes
for obtaining vital signs, and since 3 minutes are already included in
the E/M code, we proposed to reduce the time to 2 minutes for these
services. Similarly, we proposed to remove the 3 minutes of clinical
labor time for ``Clean room/equipment by physician staff'' from CPT
codes 31575, 31577, and 31579. These procedures are typically reported
with a same day E/M service, making the clinical labor minutes for
cleaning the room in these procedure codes duplicative of the time
already included in the E/M codes.
For CPT code 31572, we proposed to remove the ``laser tip, diffuser
fiber'' supply (SF030) and replace it with the ``laser tip, bare
(single use)'' supply (SF029) already present in our direct PE
database. We believe that the invoice for SF030 submitted with the RUC
recommendation is not current enough to establish a new price for this
supply; as a result, we substituted the SF029 supply for this input. We
welcomed the submission of new invoices to accurately price the
diffuser fiber with laser tip.
We also proposed to make significant changes to the prices of
several of the supplies and equipment related to Flexible Laryngoscopy,
as well as to the prices of scopes more broadly. We proposed to set the
price of the disposable biopsy forceps supply (SD318) at $26.84, based
on the submission of an invoice with a price of $536.81 for a unit size
of 20. In our search for additional information regarding scope inputs,
we obtained a quote from a vendor listing the current price for several
equipment items related to the use of scopes. Since we believe that the
prices in vendor quotes would typically be equal to or higher than
prices actually paid by practitioners, we are updating the prices in
our direct PE database to reflect this new information. As part of this
process, we proposed to increase the price of the ``light source,
xenon'' (EQ167) from $6,723.33 to $7,000 to reflect current pricing
information. We also proposed to adjust the price of the ``fiberscope,
flexible, rhinolaryngoscopy'' (ES020) from $6,301.93 to $4,250.00.
In accordance with the wider proposal that we made involving the
use of scope equipment, we proposed to separate the scopes used in
these procedures from the scope video systems. In the course of
researching different kinds of scopes, we obtained vendor pricing for
two different types of scopes used in these procedures. We proposed to
price the ``rhinolaryngoscope, flexible, video, non-channeled'' (ES063)
at $8,000 and the ``rhinolaryngoscope, flexible, video, channeled''
(ES064) at $9,000 in accordance with our vendor quotes. We proposed to
use the non-channeled scope for CPT codes 31575, 31579, and 31574 and
the channeled scope for CPT codes 31576, 31577, 31578, 31572, and 31573
in accordance with the RUC-recommended video systems that stipulated
channeled versus non-channeled scope procedures.
We believe that the ``Video-flexible laryngoscope system'' listed
in the recommendations is not a new form of equipment, but rather
constitutes a version of the existing ``video system, endoscopy''
equipment (ES031). We did not add a new equipment item to our direct PE
database; instead, we proposed to use the submitted invoices to update
the price of the ES031 endoscopy video system. As the equipment code
for ES031 indicates, we proposed to define the endoscopy video system
as containing a processor, digital capture, monitor, printer, and cart.
We proposed to price ES031 at $15,045.00; this reflected a price of
$2,000.00 for the monitor, $9,000.00 for the processor, $1,750.00 for
the cart, and $2,295.00 for the printer. These prices were obtained
from our vendor invoice, with the exception of the printer, which is a
crosswalk to the ``video printer, color (Sony medical grade)''
equipment (ED036).
We did not agree that there is a need for multiple different video
systems for this collection of Flexible Laryngoscopy codes based on our
understanding of the clinical differences among the codes. In keeping
with this understanding, we proposed to use the same existing ``video
system, endoscopy'' equipment (ES031) for the remaining codes in the
family that included RUC recommendations for new equipment items named
``Video-flexible channeled laryngoscope system'' and ``Video-flexible
laryngoscope stroboscopy system.'' For CPT codes 31576, 31577, 31578,
31572, and 31573, we proposed to replace the Video-flexible channeled
laryngoscope system with the existing endoscopy video system (ES031)
along with a channeled flexible video rhinolaryngoscope (ES064). For
CPT code 31579, we proposed to rename the RUC-recommended ``Video-
flexible laryngoscope stroboscopy system'' to the shortened
``stroboscopy system'' (ES065) and assign it a price of $19,100.00.
This reflected the price of the StrobeLED Stroboscopy system included
on the submitted invoice. We proposed to treat the stroboscopy system
as a scope accessory, which was included along with the ``video system,
endoscopy'' equipment (ES031) and the ``rhinolaryngoscope, flexible,
video, non-channeled'' (ES063) for CPT code 31579. When the price of
the scope, the scope video system, and the stroboscopy system were
summed together, the total proposed equipment price was $42,145.00.
We proposed to refine the recommended equipment times for several
equipment items to conform to changes in clinical labor time. These
are: The fiberoptic headlight (EQ170), the suction and pressure cabinet
(EQ234), the reclining exam chair with headrest (EF008), and the basic
instrument pack (EQ137). We proposed to use the standard equipment time
formula for scope accessories for the endoscopy video system (ES031)
and the stroboscopy scope accessory system (ES065). We also proposed to
refine the equipment time for the channeled and non-channeled flexible
video rhinolaryngoscopes to use the standard equipment time formula for
scopes. For this latter pair of two new equipment items, this proposal
resulted in small increases to their respective equipment times.
The following is a summary of the comments we received regarding
our proposed valuation of the Flexible Laryngoscopy codes:
Comment: Several commenters disagreed with the proposed work RVU
for CPT code 31575. Commenters stated that the use of a work/time ratio
was inconsistent with the methodology of magnitude estimation, and that
reducing work RVUs by mathematical formula can arbitrarily manipulate
intensities without allowing input from survey
[[Page 80287]]
recommendations provided by experts who perform the service. Commenters
indicated their disapproval for a reverse building block methodology
that assumes that if times for individual services change, work values
must also change.
Response: We continue to believe that the use of these
methodologies, including the use of time ratios, is an appropriate
process for code valuation when recommended work RVUs do not appear to
account for significant changes in time. As we stated earlier in our
discussion on this topic in this final rule, we use time ratios to
identify potential work RVUs and consider these work RVUs as potential
options relative to the values developed through other methodologies
for code valuation. We continue to believe that the decrease in total
time for CPT code 31575 from 28 minutes to 24 minutes was not accounted
for in the recommended work RVU, and as a result we proposed a work RVU
of 0.94, supported by a crosswalk to CPT code 64405. We continue to
believe that this valuation for CPT code 31575 more accurately captures
the reduction in physician work caused by the decrease in the time
required to perform the procedure, noting again that the statute
specifically defines the work component as the resources in time and
intensity required in furnishing the service. We believe that our
crosswalk to CPT code 64405, which has very similar time and intensity
values to CPT code 31575 at the same work RVU of 0.94, supports our
valuation for this service.
Comment: Several commenters objected to the application of the work
RVU increment to the rest of the codes in this family, measuring the
increments from CPT code 31575's refined work RVU of 0.94 instead of
the RUC-recommended work RVU of 1.00. Commenters stated that these
codes were reviewed individually, not incrementally, and the use of an
increment to reduce the work RVU of each code in the family by 0.06 was
inappropriate. Commenters disagreed with the notion that when a base
code's value is modified or reduced all other codes in the family
should be reduced accordingly.
Response: We review codes individually for valuation. When we apply
an increment from a base code to the rest of a code family, we do so
only after reviewing each code individually and determining that the
RUC-recommended relativity between the codes in the family is correct.
For this particular family of codes, we stated our belief that the
relativity between the codes in the family was accurate, and that the
increment between the codes should be maintained after adjusting the
work RVU for the base code (CPT code 31575) to account for its
significant decrease in time. As we detailed in our discussion of code
valuation methodologies earlier in this final rule, we use a variety of
different methods, such as survey data, building blocks, crosswalks to
key reference or similar codes, time ratios, and increments between
codes within the same family. In our review of RUC-recommended values,
we have observed that the RUC also uses a variety of methodologies to
develop work RVUs for individual codes, and subsequently validates the
results of these approaches through magnitude estimation or crosswalk
to established values for other codes. We continue to believe that the
use of an incremental methodology is the most accurate way to value
this particular code family because it maintains the appropriate
relativity among the Flexible Laryngoscopy codes.
Comment: One commenter disagreed with our refinement to remove the
clinical labor time for ``Clean room/equipment by physician staff''
from the three codes in this family performed with a same day E/M
service. The commenter stated that the clinical staff have to clean the
equipment for procedure not used during the E/M service. According to
the commenter, they clean that equipment separately and are assisting
the physician during the entire procedure.
Response: In response to the commenter, we investigated this issue
and determined that in the past we have sometimes provided 1 minute of
clinical labor time for cleaning additional equipment beyond what would
be cleaned during the E/M visit. As a result, we are restoring 1 minute
of clinical labor time for ``Clean room/equipment by physician staff''
for CPT codes 31575, 31577, and 31579.
Comment: One commenter stated that there was a lack of clarity
regarding the removal of the laser tip, diffuser fiber supply (SF030)
from CPT code 31572. The commenter stated that the commenter supplied
an invoice for the fibers, believed the invoice price was accurate, and
believed the invoice should be utilized to set the price for this item.
Response: We continue to believe that the invoice for SF030
submitted with the RUC recommendation, which dates from 2009, is not
current enough to establish a new price for this supply. We are
continuing to maintain the laser tip, bare (single use) supply (SF029)
in its place for CPT code 31572. As we discuss in the PE section of
this final rule (II.A), we have concerns that the pricing for the laser
tip, diffuser fiber supply has become outdated, and we are requesting
the submission of additional current pricing information. We are
maintaining the current pricing for this supply at $850 pending the
submission of additional data.
We note as well that there were many comments addressing our
proposal to reclassify scope equipment, as well as the proper pricing
of the scope equipment utilized in this family of codes. These comments
are summarized with responses in the PE section of this final rule
(II.A).
After consideration of comments received, we are finalizing the
work RVUs of the codes in the Flexible Laryngoscopy family at the
proposed values. We are also finalizing the proposed direct PE inputs,
with the exception of the refinement to the ``Clean room/equipment by
physician staff'' clinical labor detailed above.
(12) Laryngoplasty (CPT Codes 31580, 31584, 31587, 31551-31554, 31591,
and 31592)
CPT code 31588 (Laryngoplasty, not otherwise specified (e.g., for
burns, reconstruction after partial laryngectomy)) was identified as
potentially misvalued based on the RUC's 90-Day Global Post-Operative
Visits screen. When this code family was reviewed by the RUC, it was
determined that some codes in the family required revision to reflect
the typical patient before a survey could be conducted and the code
family was referred to the CPT Editorial Panel for revision. At its
October 2015 meeting, the CPT Editorial Panel approved the creation of
six new codes, revision of three codes, and deletion of three codes.
For CPT codes 31580, 31587, 31551, 31552, 31553, 31554, and 31592, CMS
proposed the RUC-recommended work RVUs.
For CPT code 31584, the RUC recommended a work RVU of 20.00. We
believed that the 25th percentile of the survey, which is a work RVU of
17.58, better represents the time and intensity involved with
furnishing this service based on a comparison with and assessment of
the overall intensity of other codes with similar instraservice and
total time. This value is also supported by a crosswalk code of CPT
code 42844 (Radical resection of tonsil, tonsillar pillars, and/or
retromolar trigone; closure with local flap (e.g., tongue, buccal)),
which has identical intraservice time and identical total time.
Therefore, we proposed a work RVU of 17.58 for CPT code 31584.
[[Page 80288]]
Comment: Several commenters requested that we provide an
explanation for our proposed work RVU of 17.58 for the revised CPT code
31584 instead of the RUC-recommended work RVU of 20.00. They stated
that the modified code now represents the combination of two previously
separate CPT codes (the existing CPT code 31584 combined with CPT code
31600) and that the work RVU should better reflect the sum of the total
time for these combined procedures. Commenters further noted that the
proposed work RVU of 17.58 is lower, even, than the existing work RVU
for CPT code 31584. A commenter requested that CMS consider two
additional codes for comparison: CPT code 37660 and CPT code 43280.
Response: We take multiple factors into account when valuing a
service that replaces two previously separate codes. We consider the
efficiencies of combining two services, as reflected in the adjustment
upwards of the intra-service and total time for this code. We also
review the code description and identify a value that is consistent
with other, similar, 90-day global codes. Our valuation is above the
median work RVU for a group of 28 codes with similar intraservice and
total time. Commenters have not provided any additional information
that would suggest this code should be valued differently from other
90-day global codes with similar time and intensity.
We reviewed the two additional codes that commenters recommended as
comparisons. We note that CPT code 43280 (work RVU of 18.1) was most
recently valued in 1997 and that for low-volume code CPT code 37660,
physician intensity is considerably higher than that for CPT code
31584, suggesting a poor reference for comparing the work involved in
furnishing the service. For these reasons, we do not believe this code
is an appropriate comparison for CPT code 31584 and we are finalizing
our work RVU of 17.58 for CPT code 31584.
For CPT code 31591, the RUC recommended a work RVU of 15.60. We
believed that the 25th percentile of the survey, which is a work RVU of
13.56, better represents the time and intensity involved with
furnishing this service based on a comparison of the overall intensity
of other codes with similar instraservice and total time. The 25th
percentile of the survey is additionally bracketed by two crosswalk
codes that we estimate have slightly lower and slighter higher overall
intensities, CPT code 36819 (Arteriovenous anastomosis, open; by upper
arm basilic vein transposition), which has a work RVU of 13.29, and CPT
code 49654 (Laparoscopy, surgical, repair, incisional hernia (includes
mesh insertion, when performed); reducible), which has a work RVU of
13.76; both of these codes have identical intraservice time and similar
total time. Therefore, we proposed a work RVU of 13.56 for CPT code
31591.
Comment: Several commenters disagreed with our proposed work RVU of
13.56 for CPT code 31591, stating that the RUC-recommended work RVU of
15.60 better reflects the work required to perform the procedure.
Response: In developing our proposed valuation, we looked at other
90-day global codes with identical intraservice time and similar total
time (between 275 and 335), and we note that the median work RVU of the
resulting values (reflecting 33 codes) is 13.76. We chose the 25th
percentile of the survey because of its closeness to the median work
RVU of comparable services. We recognize that the RUC's crosswalk to
CPT code 58544, with a work RVU of 15.60, has a lower total time than
the codes we used as comparisons, but we note that this code has very
low utilization, with 103 procedures billed in 2015. We continue to
believe that two codes bracketing the 25th percentile of the work RVU
for CPT code 31591 (CPT codes 36819 and 49654), as noted in the CY2017
PFS proposed rule, provide a better reference for valuing the new code,
and that a work RVU of 13.56 adequately represents the time and
intensity involved with furnishing the service. Therefore, we are
finalizing our proposed work RVU of 13.56 for CPT code 31591.
Additionally, the RUC forwarded invoices provided by a medical
specialty society for the video-flexible laryngoscope system used in
these services. We discussed our proposed changes to the items included
in equipment item ES031 (video system, endoscopy) in the CY 2017
proposed rule (81 FR 46247). Consistent with those proposed changes, we
proposed to add a Nasolaryngoscope, non-channeled, to the list of
equipment items used for CPT codes 31580, 31584, 31587, 31551-31554,
31591, and 31592, along with the modified equipment item ES031.
Comment: We received several comments, including from the RUC,
about our proposal to implement a separate pricing approach for
equipment inputs for this family of codes. Commenters requested a delay
in implementing our approach until the RUC convened a PE subcommittee
and provided CMS with specific recommendations for these codes.
Response: We appreciate the commenters' interests in making certain
that there is appropriate opportunity for stakeholders to provide
feedback and recommendations on the reclassification and pricing of
scopes. Because these codes are currently under review, however, we
believe that they should be valued according to a scheme that
accurately describes the scope equipment typically used in the
services. We continue to believe that our proposed classification
system for scopes is the more proper methodology to use for valuation
of these codes for the CY 2017. Please refer to II.A of the final rule
for additional discussion on the new pricing process.
(13) Closure of Left Atrial Appendage With Endocardial Implant (CPT
Code 33340)
The CPT Editorial Panel deleted category III CPT code 0281T
(Percutaneous transcatheter closure of the left atrial appendage with
implant, including fluoroscopy, transseptal puncture, catheter
placement(s), left atrial angiography, left atrial appendage
angiography, radiological supervision and interpretation) and created
new CPT code 33340 to describe percutaneous transcatheter closure of
the left atrial appendage with implant. The RUC recommended a work RVU
of 14.00. We proposed a work RVU of 13.00 for CPT code 33340, which is
the minimum survey result. Based on our clinical judgment and that the
key reference codes discussed in the RUC recommendations have higher
intraservice and total service times than the median survey results for
CPT code 33340, we stated in the CY 2017 proposed rule that we believe
a work RVU of 13.00 would more accurately represent the work value for
this service.
Comment: We received several comments, including from the RUC.
Commenters noted inaccuracies in CMS' description of the RUC
recommendations including descriptions of the relationship between the
RUC-recommended work RVU, survey results, and service times for the two
key reference codes. Commenters requested that CMS finalize the RUC-
recommended work RVU of 14.00.
Response: We appreciate the commenters' feedback and acknowledge
that we inadvertently mischaracterized the RUC's recommendations
related to this service. We agree that the survey results showed a 25th
percentile survey result of 19.88 and that during the RUC meeting, this
code was referred to the facilitation committee whereby the RUC
identified two comparable codes with
[[Page 80289]]
14.00 work RVUs, which the RUC factored into its analysis and
recommended valuation for this service. After consideration of the
comments, we are finalizing the RUC-recommended work RVU of 14.00 for
CPT code 33340.
(14) Valvuloplasty (CPT Codes 33390 and 33391)
The CPT Editorial Panel created new codes to describe valvuloplasty
procedures and deleted existing CPT code 33400 (Valvuloplasty, aortic
valve; open, with cardiopulmonary bypass). New CPT code 33390
represents a simple valvuloplasty procedure and new CPT code 33391
describes a more complex valvuloplasty procedure. We proposed to use
the RUC-recommended values for CPT code 33390. For CPT code 33391, the
RUC recommended a work RVU of 44.00, the 25th percentile survey result.
The RUC estimated that approximately 70 percent of the services
previously reported using CPT code 33400 would be reported using CPT
code 33391, with 30 percent reported using new CPT code 33390.
Therefore, the typical service previously reported with CPT code 33400
ought to now be reported with CPT code 33391. Compared to deleted CPT
code 33400, the survey results for CPT code 33391 showed similar median
intraservice times and decreased total times. Therefore, we proposed a
work RVU of 41.50 for CPT code 33391, which is the current value of CPT
code 33400. Given that the typical service should remain consistent
between the two codes, we stated that we believe the work RVUs should
remain consistent as well.
Comment: Commenters disagreed with CMS' proposed valuation of CPT
code 33391, citing increased intensity and complexity of the
procedures. Commenters noted that more complex patients are undergoing
valvuloplasty (for instance, adult cardiac patients) when historically
these patients would have received aortic valve replacements.
Response: As discussed in the CY 2017 proposed rule, the deleted
CPT code 33400 is being replaced with two CPT codes that identify
simple and complex procedures. The RUC's utilization crosswalk suggests
that approximately 70 percent of the services that would previously
have been reported using the combined code (CPT code 33400) would now
be reported with CPT code 33391, the complex procedure. Based on the
RUC's utilization crosswalk, the complex procedure would be the typical
procedure reported under the combined code (CPT code 33400). The survey
data for the complex procedure (CPT code 33391) showed similar median
intraservice times and decreased total times compared to CPT code
33400. Therefore, for CY 2017, we are finalizing a work RVU of 35.00
for CPT code 33390 and a work RVU of 41.50 for CPT code 33391.
(15) Mechanochemical Vein Ablation (MOCA) (CPT Codes 36473 and 36474)
At the October 2015 CPT meeting, the CPT Editorial Panel
established two Category I codes for reporting venous mechanochemical
ablation, CPT codes 36473 and 36474. We proposed the RUC-recommended
work RVU of 3.50 for CPT code 36473. For CPT code 36474, we proposed a
work RVU of 1.75 and stated that we believed the RUC-recommended work
RVU of 2.25 does not accurately reflect the typical work involved in
furnishing this procedure. The specialty society survey showed that
this add-on code has half the work of the base code (CPT code 36473).
This value is supported by the ratio between work and time in the key
reference service (CPT code 36476: Endovenous ablation therapy of
incompetent vein, extremity, inclusive of all imaging guidance and
monitoring, percutaneous, radiofrequency; second and subsequent veins
treated in a single extremity, each through separate access sites (List
separately in addition to code for primary procedure)).
The RUC-recommended direct PE inputs for CPT codes 36473 and 36474
included inputs for an ultrasound room (EL015). Based on the clinical
nature of these procedures, we stated in our proposal that we do not
believe that an ultrasound room would typically be used to furnish
these procedures. We proposed to remove inputs for the ultrasound room
and subsequently include a portable ultrasound (EQ250), power table
(EF031), and light (EF014). The RUC also recommended that the
ultrasound machine be allocated clinical staff time based on the PACS
workstation formula. We stated that we did not believe that an
ultrasound machine would be used like a PACS workstation, as images are
generated and reviewed in real time. Therefore, we proposed to remove
all direct PE inputs associated with the PACS workstation.
Comment: We received several comments, including from the RUC.
Commenters disagreed with CMS' proposed work RVU of 1.75 for CPT code
36474 and requested that CMS finalize the RUC's recommendation of 2.25
work RVUs. The RUC disagreed with CMS' rationale for the proposed work
RVU for CPT code 36474. The RUC stated that the ratio between CMS'
proposed physician time and physician work for the survey code is
0.058, whereas that same ratio for the key reference code used by the
RUC is 0.0883, and that the divergent ratios between the two services
are not comparable.
Response: The commenters recommended that we accept the RUC-
recommended ratio of 36 percent between the RUC-recommended work RVUs
for CPT codes 36473 and 36474. We disagree. The RUC survey reported 79
minutes of total time for CPT code 36473 and 30 minutes of total time
for CPT code 36474, a decrease of greater than 50 percent between the
base code and the add-on code. As discussed in the proposed rule, our
proposed work RVU of 1.75 for CPT code 36474 is supported by the ratio
between work and time in the key reference service. The RUC
recommendations made reference to two identical sets of services that
use differing mechanisms for ablating the vein (radiofrequency
procedures reported with CPT codes 36475 and 36476 (work RVUs of 5.30
and 2.65); laser procedures reported with CPT codes 36478 and 36479
(work RVUs of 5.30 and 2.65)). Both key reference code sets have a work
RVU ratio of 50 percent (5.30 versus 2.65) between the base codes and
the add-on codes. Therefore, for CY 2017, we are finalizing a work RVU
of 3.50 for CPT code 36473 and a work RVU of 1.75 for CPT code 36474.
Comment: Commenters requested that CMS restore the direct PE inputs
for the ultrasound room, which includes the PACS workstation.
Commenters stated that the PACS workstation is needed for these
procedures to store and make images available for future use.
Response: Commenters suggested that the ultrasound room was
necessary for this procedure since the ultrasound room includes a PACS
workstation that would allow for storage of the images and subsequent
future use. As we discussed in the proposed rule, during the typical
procedure, the images would be used in real time rather than being
stored for subsequent interpretation. Further, the ultrasound room
would not be typically used during these procedures. Our proposal
included a portable ultrasound that allows for use of the images during
the course of the procedure.
Comment: One commenter requested that CMS include an additional
direct PE input for a ClariVein catheter for both CPT codes 36473 and
36474, and included invoices related to this item. The commenter
suggested that an additional catheter is necessary to prevent
contamination during treatment of subsequent vessels if the catheter
[[Page 80290]]
used in an initial vessel were reused in a subsequent vessel.
Response: The invoice data submitted by the commenter appears to be
applicable to the ClariVein catheters in some instances and in others
to the ClariVein kits. Our review of the ClariVein kits indicated that
the ClariVein catheters are part of the ClariVein kits. Because we lack
clear product data regarding the cost of the ClariVein kits versus the
ClariVein catheters and whether the catheters are included in the price
of the kits, for CY 2017, we are finalizing our proposed direct PE
inputs for the ClariVein kits for CPT codes 36473 and 36474 without
modification. We welcome additional feedback from stakeholders
regarding the product data and costs for the ClariVein catheters and
ClariVein kits for consideration in future rulemaking.
(16) Dialysis Circuit (CPT Codes 36901, 36902, 36903, 36904, 36905,
36906, 36907, 36908, 36909)
In January 2015, a CPT/RUC workgroup identified the following CPT
codes as being frequently reported together in various combinations:
35475 (Transluminal balloon angioplasty, percutaneous; brachiocephalic
trunk or branches, each vessel), 35476 (Transluminal balloon
angioplasty, percutaneous; venous), 36147 (Introduction of needle and/
or catheter, arteriovenous shunt created for dialysis (graft/fistula);
initial access with complete radiological evaluation of dialysis
access, including fluoroscopy, image documentation and report), 36148
(Introduction of needle and/or catheter, arteriovenous shunt created
for dialysis (graft/fistula); additional access for therapeutic
intervention), 37236 (Transcatheter placement of an intravascular
stent(s) (except lower extremity artery(s) for occlusive disease,
cervical carotid, extracranial vertebral or intrathoracic carotid,
intracranial, or coronary), open or percutaneous, including
radiological supervision and interpretation and including all
angioplasty within the same vessel, when performed; initial artery),
37238 (Transcatheter placement of an intravascular stent(s), open or
percutaneous, including radiological supervision and interpretation and
including angioplasty within the same vessel, when performed; initial
vein), 75791 (Angiography, arteriovenous shunt (eg, dialysis patient
fistula/graft), complete evaluation of dialysis access, including
fluoroscopy, image documentation and report (includes injections of
contrast and all necessary imaging from the arterial anastomosis and
adjacent artery through entire venous outflow including the inferior or
superior vena cava), radiological supervision and interpretation),
75962 (Transluminal balloon angioplasty, peripheral artery other than
renal, or other visceral artery, iliac or lower extremity, radiological
supervision and interpretation), and 75968 (Transluminal balloon
angioplasty, each additional visceral artery, radiological supervision
and interpretation). These codes are frequently reported together for
both dialysis circuit services and transluminal angioplasty services.
At the October 2015 CPT Editorial Panel meeting, the panel approved the
creation of nine new codes and deletion of four existing codes used to
describe bundled dialysis circuit intervention services, and the
creation of four new codes and deletion of 13 existing codes used to
describe bundled percutaneous transluminal angioplasty services (see
discussion of the latter code family in the next section). The Dialysis
Circuit family of codes overlaps with the Open and Percutaneous
Transluminal Angioplasty family of codes (CPT codes 37246-37249), as
they are both being constructed from the same set of frequently
reported together codes. We reviewed these two families of codes
concurrently to maintain relativity between these clinically similar
procedures based upon the same collection of deleted codes.
For CPT code 36901, we proposed a work RVU of 2.82 instead of the
RUC-recommended work RVU of 3.36. When we compared CPT code 36901
against other codes in the RUC database, we found that the RUC-
recommended work RVU of 3.36 would be the highest value in the database
among the 32 0-day global codes with 25 minutes of intraservice time.
Generally speaking, we are particularly skeptical of RUC-recommended
values for newly ``bundled'' codes that appear not to recognize the
full resource overlap between predecessor codes. Since the recommended
values would establish a new highest value when compared to other
services with similar time, we believed it likely that the recommended
value for the new code does not reflect the efficiencies in time. Of
course, were there compelling evidence for this valuation accompanying
the recommendation, we would consider such information. We also noted
that the reference code selected by the survey participants, CPT code
36200 (Introduction of catheter, aorta), has a higher intraservice time
and total time, but a lower work RVU of 3.02 We believe that there are
more accurate CPT codes that can serve as a reference for CPT code
36901. As a result, we proposed to crosswalk CPT code 36901 to CPT code
44388 (Colonoscopy through stoma; diagnostic). CPT code 44388 has a
work RVU of 2.82, and we believe it is a more accurate crosswalk for
valuation due to its similar overall intensity and shared intraservice
time of 25 minutes with 36901 and similar total time of 65 minutes.
We proposed a work RVU of 4.24 for CPT code 36902 instead of the
RUC-recommended work RVU of 4.83. The RUC-recommended work RVU is based
upon a direct crosswalk to CPT code 43253 (Esophagogastroduodenoscopy,
flexible, transoral), which shares the same 40 minutes of intraservice
time with CPT code 36902. However, CPT code 43253 has significantly
longer total time than CPT code 36902, 104 minutes against 86 minutes,
which we believe reduces its utility for comparison. We instead
proposed to crosswalk the work RVU for CPT code 36902 from CPT code
44408 (Colonoscopy through stoma), which has a work RVU of 4.24. In
addition to our assessment that the two codes share similar
intensities, CPT code 44408 also shares 40 minutes of intraservice time
with CPT code 36902 but has only 95 minutes of total time and matches
the duration of the procedure under review more closely than the RUC-
recommended crosswalk to CPT code 43253. We also note that the RUC-
recommended work increment between CPT codes 36901 and 36902 was 1.47,
and by proposing a work RVU of 4.24 for CPT code 36902, we would
maintain a very similar increment of 1.42. As a result, we proposed a
work RVU of 4.24 for CPT code 36902, based on this direct crosswalk to
CPT code 44408. For CPT code 36903, we proposed a work RVU of 5.85
instead of the RUC-recommended work RVU of 6.39. The RUC-recommended
value is based on a direct crosswalk to CPT code 52282
(Cystourethroscopy, with insertion of permanent urethral stent). Like
the previous pair of RUC-recommended crosswalk codes, CPT code 52282
shares the same intraservice time of 50 minutes with CPT code 36903,
but has substantially longer total time (120 minutes against 96
minutes) which we believe limits its utility as a crosswalk. We
proposed a work RVU of 5.85 based on maintaining the RUC-recommended
work RVU increment of 3.03 as compared to CPT code 36901 (proposed at a
work RVU of 2.82), the base code for this family of related procedures.
We also point to CPT code 44403 (Colonoscopy through stoma; with
endoscopic mucosal resection) as a reference point for this value. CPT
code
[[Page 80291]]
44403 has a work RVU of 5.60, but also lower intraservice time (45
minutes as compared to 50 minutes) and total time (92 minutes as
compared to 96 minutes) in relation to CPT code 36903, suggesting that
a work RVU a bit higher than 5.60 would be an accurate valuation.
Therefore, we proposed a work RVU of 5.85 for CPT code 36903, based on
an increment of 3.03 from the work RVU of CPT code 36901.
We proposed a work RVU of 6.73 instead of the RUC-recommended work
RVU of 7.50 for CPT code 36904. Our proposed value comes from a direct
crosswalk from CPT code 43264 (Endoscopic retrograde
cholangiopancreatography), which shares the same intraservice time of
60 minutes with CPT code 36904 and has a higher total time. We also
looked to the intraservice time ratio between CPT codes 36901 and
36904; this works out to 60 minutes divided by 25 minutes, for a ratio
of 2.4, and a suggested work RVU of 6.77 (derived from 2.4 times CPT
code 36901's work RVU of 2.82). This indicates that our proposed work
RVU of 6.73 maintains relativity within the Dialysis Circuit family. As
a result, we proposed a work RVU of 6.73 for CPT code 36904, based on a
direct crosswalk to CPT code 43264.
We proposed a work RVU of 8.46 instead of the RUC-recommended work
RVU of 9.00 for CPT code 36905. We looked at the intraservice time
ratio between CPT codes 36901 and 36905 as one potential method for
valuation, which is a 1:3 ratio (25 minutes against 75 minutes) for
this case. This means that one potential value for CPT code 36905 would
be triple the work RVU of CPT code 36901, or 2.82 times 3, which
results in a work RVU of 8.46. We also investigated preserving the RUC-
recommended work RVU increment between CPT code 36901 and 36905, which
was an increase of 5.64. When this increment is added to the work RVU
of 2.82 for CPT code 36901, it also resulted in a work RVU of 8.46 for
CPT code 36905. Therefore, we proposed a work RVU of 8.46 for CPT code
36905, based on both the intraservice time ratio with CPT code 36901
and the RUC-recommended work increment with the same code.
For CPT code 36906, we proposed a work RVU of 9.88 instead of the
RUC-recommended work RVU of 10.42. We based the proposed value upon the
RUC-recommended work RVU increment between CPT codes 36901 and 36906,
which is 7.06. When added to the work RVU of 2.82 for CPT code 36901,
the work RVU for CPT code 36906 would be 9.88. We are supporting this
value through the use of two crosswalks that both share the same 90
minutes of intraservice time with 36906. These are CPT code 31546
(Laryngoscopy, direct, with submucosal removal of non-neoplastic
lesion(s) of vocal cord) at a work RVU of 9.73 and CPT code 61623
(Endovascular temporary balloon arterial occlusion, head or neck) at a
work RVU of 9.95.
The final three codes in the Dialysis Circuit family are all add-on
codes, which make comparisons difficult to the global 0-day codes that
make up the rest of the family. We proposed a work RVU of 2.48 instead
of the RUC-recommended work RVU of 3.00 for CPT code 36907. Due to the
difficulty of comparing CPT code 36907 with the non-add-on codes in the
rest of the Dialysis Circuit family, we looked instead to compare the
value to the add-on codes in the Open and Percutaneous Transluminal
Angioplasty family of codes (CPT codes 37246-37249). As we stated
previously, both of these groups of new codes are being constructed
from the same set of frequently reported together codes. We reviewed
these two families of codes together to maintain relativity across the
two families, and so that we could compare codes that shared the same
global period.
We proposed the RUC-recommended work RVUs for all four codes in the
Open and Percutaneous Transluminal Angioplasty family of codes. As a
result, we compared CPT code 36907 with the RUC-recommended work RVU of
2.97 for CPT code 37249, which is also an add-on code. These procedures
should be clinically very similar, since both of them are performing
percutaneous transluminal angioplasty on a central vein, and both of
them are add-on procedures. We looked at the intraservice time ratio
between these two codes, which was a comparison between 25 minutes for
CPT code 36907 against 30 minutes for CPT code 37249. This produces a
ratio of 0.83, and a proposed work RVU of 2.48 for CPT code 36907 when
multiplied with the RUC-recommended work RVU of 2.97 for CPT code
37249. We noted as well that the intensity was markedly higher for CPT
code 36907 as compared to CPT code 37249 when using the RUC-recommended
work values, which did not make sense since CPT code 36907 would
typically be a clinically less intense procedure. Using the
intraservice time ratio results in the two codes having exactly the
same intensity. As a result, we therefore proposed a work RVU of 2.48
for CPT code 36907, based on this intraservice time ratio with the RUC-
recommended work RVU of CPT code 37249.
For CPT code 36908, we disagree with the RUC-recommended work RVU
of 4.25, and we instead proposed a work RVU of 3.73. We did not
consider the RUC work value of 4.25 to be accurate for CPT code 36908,
as this was higher than our proposed work value for CPT code 36902
(4.24), and we did not believe that an add-on code should typically
have a higher work value than a similar non-add-on code with the same
intraservice time. We identified two appropriate crosswalks for valuing
CPT code 36908: CPT code 93462 (Left heart catheterization by
transseptal puncture through intact septum or by transapical puncture)
and CPT code 37222 (Revascularization, endovascular, open or
percutaneous, iliac artery). Both of these codes share the same
intraservice time as CPT code 36908, and both of them also have the
same work RVU of 3.73, which results in these codes also sharing the
same intensity since they are all add-on codes. We therefore proposed a
work value of 3.73 for CPT code 36908, based on a direct crosswalk to
CPT codes 93462 and 37222.
Finally, we proposed a work RVU of 3.48 for CPT code 36909 instead
of the RUC-recommended work RVU of 4.12. The RUC-recommended value
comes from a direct crosswalk from CPT code 38746 (Thoracic
lymphadenectomy by thoracotomy). We compared the RUC-recommended work
RVU for this procedure to other add-on codes with 30 minutes of
intraservice time and found that the recommended work RVU of 4.12 would
overestimate the overall intensity of this service relative to those
with similar times. In reviewing the range of these codes, we believed
that a more appropriate crosswalk is to CPT code 61797 (Stereotactic
radiosurgery (particle beam, gamma ray, or linear accelerator)) at a
work RVU of 3.48. We believed that this value is more accurate when
compared to other add-on procedures with 30 minutes of intraservice
time across the PFS. As a result, we proposed a work RVU of 3.48 for
CPT code 36909 based on a direct crosswalk from CPT code 61797.
We proposed to use the RUC-recommended direct PE inputs for these
nine codes with several refinements. We did not propose to include the
recommended additional preservice clinical labor for CPT codes 36904,
36905, and 36906. The preservice work description is identical for all
six of the global 0-day codes in this family; there is no justification
given in the RUC recommendations as to why the second three codes need
additional clinical labor time beyond the minimal preservice clinical
labor assigned to the
[[Page 80292]]
first three codes. We do not believe that the additional staff time
would be typical. Patient care already would have been coordinated
ahead of time in the typical case, and the need for unscheduled
dialysis or other unusual circumstances would be discussed prior to the
day of the procedure. We therefore proposed to refine the preservice
clinical labor for CPT codes 36904, 36905, and 36906 to match the
preservice clinical labor of CPT codes 36901, 36902, and 36903.
We proposed to refine the L037D clinical labor for ``Prepare and
position patient/monitor patient/set up IV'' from 5 minutes to 3
minutes for CPT codes 36901-36906. The RUC recommendation included a
written justification for additional clinical labor time beyond the
standard 2 minutes for this activity, stating that the extra time is
needed to prepare the patient's arm for the procedure. We agreed that
extra time may be needed for this activity as compared to the default
standard of 2 minutes; however, we proposed to assign 1 extra minute
for preparing the patient's arm, resulting in a total of 3 minutes for
this task. We did not believe that 3 extra minutes would be typically
needed for arm positioning.
We proposed to remove the ``kit, for percutaneous thrombolytic
device (Trerotola)'' supply (SA015) from CPT codes 36904, 36905, and
36906. We believed that this thrombolytic device kit and the
``catheter, thrombectomy-Fogarty'' (SD032) provide essentially the same
supply, and the use of only one of them would be typical in these
procedures. We believed that each of these supplies can be used
individually for thrombectomy procedures. We proposed to remove the
SA015 supply and retain the SD032 supply, and we solicited additional
comment and information regarding the use of these two supplies.
We also proposed to remove the recommended supply item ``covered
stent (VIABAHN, Gore)'' (SD254) and replace it with the ``stent,
vascular, deployment system, Cordis SMART'' (SA103) for CPT codes 36903
and 36906. The Cordis SMART vascular stent was previously used in the
past for CPT code 37238, which is the deleted code for transcatheter
placement of an intravascular stent that CPT codes 36903 and 36906 are
replacing. We did not have a stated rationale as to the need for this
supply substitution, and therefore, we did not believe it would be
appropriate to replace the current items with a significantly higher-
priced item without additional information.
We also proposed to refine the quantity of the ``Hemostatic patch''
(SG095) from 2 to 1 for CPT codes 36904, 36905, and 36906. This supply
was not included in any of the deleted base codes out of which the new
codes are being constructed, and while we agreed that the use of a
single hemostatic patch has become common clinical practice, we did not
agree that CPT codes 36904-36906 would typically require a second
patch. As a result, we proposed to refine the SG095 supply quantity
from 2 to 1 for CPT codes 36904-36906, which also matches the supply
quantity for CPT codes 36901-36903.
Included in the RUC recommendation for the Dialysis Circuit family
of codes were a series of invoices for a ``ChloraPrep applicator (26
ml)'' supply. We solicited comments regarding whether the Betadine
solution has been replaced by a Chloraprep solution in the typical case
for these procedures. We also solicited comments regarding whether the
``ChloraPrep applicator (26 ml)'' detailed on the submitted invoices is
the same supply as the SH098 ``chlorhexidine 4.0% (Hibiclens)''
applicator currently in the direct PE database.
Finally, we also solicited comments about the use of guidewires for
these procedures. We requested feedback about which guidewires would be
typically used for these procedures, and which guidewires are no longer
clinically necessary.
The following is a summary of the comments we received regarding
our proposed valuation of the Dialysis Circuit codes. Due to the large
number of comments we received for this code family, we will first
summarize the comments related to general code valuation, followed by
the comments related to specific work RVUs, and finally the comments
related to direct PE inputs.
Comment: Several commenters stated that the cumulative impact of
reimbursement reductions for the Dialysis Circuit family of codes in
physician work and practice expense would be quite dramatic. The
commenters compared the total RVU of the old codes against the total
RVU of the newly created codes and found a decrease of roughly 20-30
percent. Commenters expressed concern that if the proposed rates were
to be implemented, many outpatient access centers that focus on
providing care for ESRD patients might no longer be able to operate.
Response: We share the concern of the commenters in maintaining
access to care for Medicare beneficiaries. We believe that improved
payment accuracy under the PFS generally facilitates access to
reasonable and necessary physicians' services.
We note that a change in overall RVUs for particular services,
regardless of the magnitude of the change, may reflect improved
accuracy. For example, comparing the summed total RVU of CPT codes
36147, 36148, 36870, and 37238 against the total RVU of CPT code 36906
is an accurate method to describe the services taking place under the
coding schema effective for 2016 and 2017, respectively. Through the
bundling of these frequently reported services, it is reasonable to
expect that the new coding system will achieve savings via elimination
of duplicative assumption of the resources involved in furnishing
particular servicers. For example, a practitioner would not be carrying
out the full preservice work four separate times for CPT codes 36147,
36148, 36870, and 37238, but preservice times were assigned to each of
the codes under the old coding. We believe the new coding assigns a
more accurate preservice time and thus reflects efficiencies in
resource costs that existed regardless of how the services were
previously reported.
Comment: Several commenters objected to the crosswalk codes used by
CMS for proposed work valuation. Commenters stated that comparing the
Dialysis Circuit codes to colonoscopy or endoscopic retrograde
cholangiopancreatography (ERCP) codes was inappropriate, as it
undervalued the technical skill and judgment necessary to furnish the
services. In other words, the crosswalks chosen by CMS were invalid due
to the differences in the procedures in question, with the Dialysis
Circuit codes being more intensive procedures than the CMS crosswalks.
Response: We disagree with the commenters that the choice of
crosswalk codes is inappropriate for work valuation. We believe that,
generally speaking, codes with similar intensity and time values are
broadly comparable across the PFS, as the fee schedule is based upon a
relative value system. For the Dialysis Circuit codes in particular, we
provided a specific rationale for each crosswalk detailing why we
believed it to be an appropriate selection. Regarding the statement
from the commenters that colonoscopy codes, such as CPT code 44388, are
inappropriate for use as crosswalks in this family of codes, we note
that the RUC-recommended work RVU for CPT code 36901 was based upon a
direct crosswalk to the work RVU of a colonoscopy code (CPT code
45378). We continue to believe that the crosswalks for this family of
codes are appropriate
[[Page 80293]]
choices, since they share highly similar intensity and time values with
the reviewed codes.
Comment: Some commenters disagreed with the use of time ratios for
work valuation. These commenters stated that the use of direct
crosswalks based only on intraservice time comparison or ratios of
intraservice time inappropriately discounted the variation in technical
skill, judgment, and risk inherent to these procedures.
Response: We continue to believe that the use of these
methodologies, including the use of time ratios, is an appropriate
process for identifying potential values for particular codes,
especially when the recommended work RVUs do not appear to account for
significant changes in time. As we stated earlier in our discussion on
this topic in this final rule, we use time ratios to identify potential
work RVUs and consider these work RVUs as potential options relative to
the values developed through other methodologies for code valuation. We
continue to believe our valuation for the Dialysis Circuit codes
accurately captures the reduction in physician work caused by the
efficiencies gained in both time and intensity through the bundling
together of frequently reported services.
Comment: One commenter disagreed with the use of CMS comparisons
between the RUC-recommended work RVUs for the Dialysis Circuit codes
and the work RVU for other codes with similar time values in the rest
of the fee schedule, particularly for CPT code 36901. The commenter
stated that whether or not CPT code 36901 had the highest work RVU
among other 0-day global codes with 25 minutes of intra-service time
was irrelevant. The commenter pointed out that some code must be the
highest value because the RBRVS represents a range of services of
varying intensity. The commenter stated that CMS' reasoning undervalued
the importance of work intensity in favor of the more easily
quantifiable time variable, which was clinically inaccurate and
contradictory to the principles of the relative value system.
Response: We disagree with the commenter about the invalidity of
comparing newly created codes to existing codes with similar time
values on the PFS. While it is true that there must be a highest value
for any particular subset of codes, we believe the best approach in
establishing work RVUs for codes is to compare the service to other
services with similar times and identify codes with similar overall
intensities. As we wrote in the proposed rule with regards to CPT code
36901, we have reservations with RUC-recommended values for newly
``bundled'' codes that appear not to recognize the full resource
overlap between predecessor codes. Since the recommended values would
establish a new highest value when compared to other services with
similar time, we believe it likely that the recommended value for the
new code does not reflect the efficiencies gained through bundling. We
believe that these comparisons to other codes with similar time values
and intensities are an important tool in helping to maintain relativity
across the fee schedule.
Comment: A commenter disagreed with the CMS valuation for these
codes based on a clinical rationale pertaining to how the services are
defined. The commenter stated that the dialysis access circuit is
defined as originating in the artery adjacent to the arterial
anastomosis and including all venous outflow (whether single or
multiple veins) to the axillary-subclavian vein junction. While several
different arteries and veins may be included in this definition, from a
functional perspective it is a single ``vessel''. The commenter stated
that because of this greater propensity for multiple lesions in these
procedures, it is appropriate to define the access vessel as CPT has
done and allow reporting of only a single angioplasty or stent in that
entire conduit. However, the commenter reported that the survey built
on the ``typical patient'' (51 percent of the cases) was unable to
recognize the additional work of additional angioplasty or stent for
the Dialysis Circuit family of codes, even though multiple or arterial
lesions occur with significant frequency. Because the coding structure
of the Dialysis Circuit family does not include a code for ``additional
vessels'', the valuation of the codes needs to incorporate the resource
cost of patient cases where multiple or arterial lesions occur. The
commenter contended that this problem with the survey methodology
affected the work intensity of these codes, and justifies a higher
intensity for these procedures.
Response: We share the commenter's concerns with the survey data
collected by the RUC. This is why we have long employed different
approaches to identify potential values for work RVUs, such as time
ratios, building blocks, and crosswalks to key reference or similar
codes, in addition to the recommended survey data. We also note that
our methodology generally values services based on assumptions
regarding the typical case, not occasional complications that may
require additional work when they occur. For the particular case of the
Dialysis Circuit family of codes, we do not agree with the commenter
that the single ``vessel'' classification of these procedures supports
a higher intensity compared to other related codes. These codes have
been defined by CPT in a similar fashion to the lower extremity
revascularization codes, in which the code is only billed a single time
regardless of the number of lesions or number of stents placed. Due to
the similarity with these existing codes located elsewhere in the PFS,
we do not believe that it would be appropriate to value the Dialysis
Circuit codes differently.
Comment: Several commenters suggested that there was compelling
evidence for the higher RUC-recommended work RVUs because the vignette
developed by the CPT Editorial Panel does not accurately reflect the
typical ESRD patient. Commenters stated that the vignette for the
Dialysis Circuit codes significantly underestimated the age of the
typical patient, and may have led survey respondents to report less
time. According to commenters, the frail and elderly ESRD patients that
constitute the typical patients for these procedures are much sicker
than the typical patient in other codes on the PFS, and this serves to
justify valuing these codes at a higher intensity.
Response: We appreciate the submission of additional information
regarding the patient population for these codes. We recognize that
some services may require additional work due to an unusually difficult
patient population. However, we do not agree at this time that the
Dialysis Circuit family of codes has a uniquely different patient
population that justifies an increase in valuation over other
comparable codes on the PFS. We note that for CPT code 36901, the RUC
recommended a work RVU of 3.36 based on a direct crosswalk to CPT code
45378, a flexible colonoscopy code. Our proposed work RVU of 2.82 for
the same code was based on a direct crosswalk to CPT code 44388, which
is another colonoscopy code. The patient population for these two
crosswalk codes is similar, and both codes share similar time and
intensity. We believe that our crosswalk code is a more appropriate
choice given the time values and the efficiencies gained from bundling.
However, based on this recommended crosswalk code, we believe that the
RUC considers the patient population for CPT code 45378 to be
appropriate for comparison to CPT code 36901, and that the reviewed
code does not possess an unusually resource-intensive patient
population. This same
[[Page 80294]]
pattern holds true for the other codes in the Dialysis Circuit family,
which were valued using similar comparisons to established codes with
typical patient populations.
Comment: One commenter suggested that the difficulties posed by the
patient population for the Dialysis Circuit codes were not sufficiently
reflected in the RUC recommendations. The commenter stated that the
patients receiving dialysis circuit services are extremely sick, and
every step in the process of caring for those patients is more complex
than those involved in caring for the average Medicare patient. The
commenter stated that CMS underestimated the amount of time required to
perform specific tasks and assumes that those tasks can be performed by
individuals with lower levels of training and credentials than are used
in typical practice. The commenter requested a series of direct PE
refinements to this family of codes, many of which went above the
original RUC recommendations, including clinical labor times
significantly above the usual standards and using clinical labor
staffing types outside the normal range. The commenter stated an
intention to present data to support the recommendations at a later
date.
Response: We appreciate the additional information provided by the
commenter about this family of codes. We emphasize that we do not
believe that the RUC need be the exclusive source of information used
in valuation of PFS services, and we are supportive of the submission
of additional data that can aid in the process of determining the
resources that are typically used to furnish these services. Because we
did not receive data from the commenter to support these increases
above the RUC recommendations, we are not incorporating these changes
into the Dialysis Circuit codes at this time. However, we urge
interested stakeholders to consider submitting robust data regarding
costs for these and other services.
We are also seeking information on how to reconcile situations
where we have multiple sets of recommendations from the RUC and from
other PFS stakeholders, both for this specific case and for the
situation more broadly, given the need to maintain relativity among PFS
services.
The following comments address the proposed work valuation of
individual codes in the family.
Comment: A commenter contended that the proposed work RVU of 2.82
undervalues CPT code 36901. The commenter stated that compelling
evidence regarding CPT's inaccurate description of the typical ESRD
patient as 45 years old led to lower survey times and hence the ``new
highest value'' problem mentioned by CMS. The commenter recommended
that CMS should finalize the RUC work RVU of 3.36, or barring that,
should finalize a work RVU of 3.02 based on a direct crosswalk to CPT
code 36200. The commenter stated that this code is very similar
clinically in work and intensity to CPT code 36901.
Response: We summarized and responded to the general issues
surrounding patient populations above. We disagree with the commenter
that CPT code 36200 is a more appropriate choice for a crosswalk code
for CPT code 36901. CPT code 36200 has 5 additional minutes of
intraservice time (30 minutes as compared to 25 minutes) and 25
additional minutes of total time (91 minutes as compared to 66
minutes). In addition to this substantial difference in time values,
the intensity of CPT code 36200 is also significantly lower than CPT
code 36901. If we were to adopt the recommended crosswalk to a work RVU
of 3.02, the intensity of CPT code 36901 would be 50 percent higher
than the intensity CPT code 36200. Since we are statutorily obligated
to base our valuation on time and intensity, we believe that this makes
CPT code 36200 an inferior choice for a crosswalk code when compared to
our choice of CPT code 44388, which shares very similar time and
intensity with CPT code 36901.
Comment: A commenter stated that CPT code 36902 should have a
higher increment in work RVU from CPT code 36901 because it included
work unable to be accounted for in a survey on the typical patient. The
commenter indicated that according to published literature, more than
one stenosis is present requiring angioplasty in 20-30 percent of
dialysis access cases. A higher increment in work RVU from CPT code
36901 to 36902 would reflect the work of additional angioplasty on
separate stenoses and arterial angioplasty that occurs in some cases,
but cannot be reflected in a ``typical'' 51 percent case vignette. The
commenter requested that CMS adopt the RUC-recommended work RVU for CPT
code 36902.
Response: We generally establish RVUs for services based on the
typical case. If a particular patient case requires treatment outside
the defined dialysis circuit code descriptor, then additional catheter
placement and imaging may be reported, assuming that all of the proper
requirements for separate billing are met. We do not believe that it
would be appropriate to increase the work RVU for CPT code 36902 based
on these non-typical situations.
Comment: A commenter stated that the CMS proposed work RVU of 5.85
undervalues the work involved in the services described by CPT code
36903, based on the belief that the CPT patient vignette does not
reflect the typical patient and that ``additional vessel'' angioplasty
or stenting work is included in CPT code 36903 but was not able to be
captured in a survey utilizing the ``typical'' patient.
Response: We addressed these issues in previous comment responses.
We continue to believe that the proposed work RVU for CPT code 36903 is
accurate.
Comment: A commenter disagreed with the proposed work RVUs for CPT
codes 36904 and 36905. The commenter suggested that CMS should use time
ratios from the base code in the family, CPT code 36901, starting from
a work RVU of 3.02 instead of the proposed work RVU of 2.82. The
commenter suggested that this would produce work RVUs for CPT codes
36904 and 36905 almost identical to the RUC-recommended values, which
the commenter urged CMS to adopt.
Response: We agree with the commenter that the use of time ratios
is one potential method to use in the process of determining code
valuation. However, since we stated previously that we believe our
proposed work RVU of 2.82 is more accurate for CPT code 36901 than the
commenter's suggestion of 3.02, we do not believe that applying the
same time ratios provides a rationale for adopting the RUC-recommended
work RVUs for CPT codes 36904 and 36905.
Comment: A commenter disagreed with CMS' proposed work RVU of 9.88
for CPT code 36906 based upon the RUC-recommended increment of 7.06
from CPT code 36901. The commenter stated that the RUC value was well
supported as the 25th percentile survey result and the survey times for
the code were adversely impacted by CPT errors in the code descriptor
and RUC survey limitations.
Response: We do not agree that the RUC's work valuation for CPT
code 36906 maintains relativity within the fee schedule. We believe
that the increment between CPT code 36901 and 36906 maintains
relativity within the Dialysis Circuit family of codes, which is why we
proposed to use it for valuation. However, we believe that the
recommended work RVU for CPT code 36906 insufficiently accounted for
the efficiencies in resource use achieved through bundling together its
predecessor codes. We continue to
[[Page 80295]]
believe that the proposed work RVU of 9.88, bracketed between
crosswalks to CPT codes 31546 and 61623, provides the most accurate
valuation for this service.
Comment: A commenter disagreed with the proposed work RVU of 2.48
for CPT code 36907, and stated that the work RVU should be identical to
CPT code 37249 at a value of 2.97. The commenter stated these two
services are clinically identical, and the CMS contention that CPT code
36907 would typically be a clinically less intense procedure is not
correct. According to the commenter, the intensity involved in both of
these add-on codes is the work and risk of crossing the central venous
stenosis and performing intervention within the thorax where
complications could be severe. The commenter stated that there is no
difference in this work intensity based upon the direction of
approach--from the dialysis access or from a native (femoral) vein.
Both require advancing a long wire from the access site through the
stenosis, superior and inferior vena cava, and right atrium, which is
needed no matter which direction one is approaching the lesion. As a
result, the commenter suggested that CPT code 36907 should have the
same work RVU as CPT code 37249.
Response: While we agree with the commenter that these two services
are clinically similar procedures, we do not agree with the commenter
that the work between the two is identical. In particular, we believe
that the difference in the intraservice time (25 minutes for CPT code
36907 against 30 minutes for CPT code 37249) should be accounted for in
the work valuation, as the former code takes 20 percent less time to
perform. We note as well that under our proposed valuation, these two
codes have exactly the same intensity, with the difference in the work
value occurring solely as a result of the decreased time required to
perform CPT code 36907. Since time is one of the resources we are
obligated to use for code valuation, we believe that the proposed
values for these two codes are more accurate than setting both of them
to the same work RVU.
Comment: One commenter supported the proposed work RVUs of 3.73 for
CPT code 36908 and 3.48 for CPT code 36909.
Response: We appreciate the support from the commenter.
The following comments address the proposed direct PE inputs for
the Dialysis Circuit family of codes.
Comment: Several commenters urged CMS to accept the recommended
additional preservice clinical labor for CPT codes 36904, 36905, and
36906. Commenters stated that the patient presentation and the
requisite preservice clinical labor is inherently different for CPT
codes 36904-36906 when compared with CPT codes 36901-36903. Commenters
indicated that the latter group are elective procedures, which are
scheduled and planned well in advance of the procedure and performed on
days that do not conflict with the patient's dialysis schedule. In
contrast, the former group are urgent procedures typically done when a
patient presents to their dialysis treatment with a thrombosed access.
According to the commenters, the urgent nature of these procedures, the
need for additional preoperative testing because of missed dialysis,
and the need for arranging unscheduled dialysis treatment requires
additional preservice time for the procedural staff.
Response: We disagree with the commenters. We continue to note that
the preservice work description is identical for all six of the 0-day
global codes in this family. Generally speaking, we also typically
provide less preservice clinical labor time for emergent procedures,
not more preservice clinical labor time, as there is no time for these
tasks to be performed. We continue to believe that all six of these
codes are most accurately valued by sharing the same preservice
clinical labor times.
Comment: Several commenters stated that the recommended 5 minutes
of clinical labor for ``Prepare and position patient/monitor patient/
set up IV'' were reasonable because these cases are done on the upper
extremity using portable c-arm fluoroscopy. According to commenters,
the additional time includes prepping and positioning the arm, applying
appropriate shielding to the patient's torso, positioning the c-arm
unit, and then positioning other radiation shielding devices.
Commenters stated that each of these activities requires more time in
the arm, which typically must be extended to the side to be accessible
for access and imaging; this is different from procedures done in the
long plane of the body including the torso and legs. The commenters
stated that 5 minutes is a more accurate reflection of the required
clinical labor time than the proposed 3 minutes.
Response: We continue to believe that additional time may be needed
for this activity as compared to the default standard of 2 minutes.
However, we maintain that the commenter's request for 3 additional
minutes (for a total of 5 minutes) would not typically be required for
arm positioning, as this additional clinical labor time is generally
not included in similar procedures. We do not agree that the additional
tasks described by the commenters would require the requested 5 minutes
of clinical labor time, and we are maintaining our proposed value of 3
minutes.
Comment: Several commenters opposed the CMS proposal to remove the
``kit, for percutaneous thrombolytic device (Trerotola)'' supply
(SA015) from the RUC recommended supplies for CPT code 36904, 36905,
and 36906, under the belief that only one device would typically be
used in these procedures. Commenters indicated that this understanding
was incorrect. According to the commenters, a mechanical thrombectomy
device and a Fogarty thrombectomy balloon serve different purposes and
both are necessary to perform a dialysis access thrombectomy.
Commenters provided lengthy clinical rationales to support their point
of view, which can be summarized as follows: ``The Fogarty balloon is
small and highly compliant allowing it to be pulled through the artery
and into the access without damaging the vessels. The thrombectomy
device cannot be used safely for this function. This device is larger
so risks pushing the fibrin plug into the artery if passed across the
arterial anastomosis from the access--risking distal arterial
embolization. The device is also much more rigid being made from metal
and with irregular shape that risks damaging the endothelium of the
artery causing arterial injury.'' As a result, commenters requested
that the listed devices ``catheter, thrombectomy-Fogarty'' (SD032) and
``kit, for percutaneous thrombolytic device (Trerotola)'' supply
(SA015) both remain in the supply list for these codes.
Response: We appreciated the detailed presentation of additional
clinical information regarding the use of the percutaneous thrombolytic
device kit from the commenters. After review of the comments and the
contents of the kit, we believe that its inclusion in these three
procedures is appropriate. According to the device literature, the kit
contains a rotor for macerating the clot, a catheter for removing the
clot, and a sheath for introducing the device. We will therefore
restore the SA015 supply to CPT codes 36904, 36905, and 36906. However,
we are removing the Fogarty catheter (SD032) and 1 of the 2 vascular
sheaths (SD136), as these are contained within the kit. The literature
for the percutaneous thrombolytic device kit clearly stipulates that
there is no need for additional catheters to remove the clot, which
makes the
[[Page 80296]]
Fogarty catheter a duplicative supply which can be removed.
Comment: Several commenters disagreed with the CMS proposal to
remove the recommended supply item ``covered stent (VIABAHN, Gore)''
(SD254) and replace it with the ``stent, vascular, deployment system,
Cordis SMART'' (SA103) for CPT codes 36903 and 36906. Commenters stated
that covered stents are the only stent devices that are FDA approved
and supported by evidence from randomized controlled trials for use in
dialysis access procedures. They are typically used in recurrent or
elastic stenosis in dialysis access and have become the standard of
care for these interventions. One commenter stated that Braid Forbes
Health Research analyzed stent use in CPT code 37238 using CMS OPPS
claims data, and found that the covered stent (VIABAHN, Gore), was used
67.5 percent of the time and the SA103, stent, vascular, deployment
system, Cordis SMART, was used 32.5 percent of the time. Commenters
stressed that bare metal stents, such as the Cordis SMART, are not
indicated for use in the Dialysis Circuit procedures.
Response: We appreciate the submission of this additional clinical
information regarding the use of stents for these procedures. After
consideration of the comments, we are restoring the covered stent
(VIABAHN, Gore) (SD254) to CPT codes 36903 and 36906 as originally
recommended. Because we are including the SD254 covered stent, we are
not adding the stent, vascular, deployment system, Cordis SMART (SA103)
supply to these procedures.
Comment: Several commenters disagreed with the CMS proposal to
reduce the quantity of the Hemostatic patch (SG095) from 2 to 1 for CPT
codes 36904, 36905, and 36906. Commenters stated that two hemostatic
patches are necessary in these procedures because they require two
separate cannulations and sheaths. At the end of the case, both sheath
sites are removed and covered with a hemostatic patch which aids in
preventing bleeding and maintaining sterility. The commenters stressed
that because there are two access sites, two hemostatic patches are
required, one to cover each site.
Response: We appreciate the additional clinical information
submitted by the commenters. In response to this information, we are
finalizing inclusion of the second Hemostatic patch (SG095) to CPT
codes 36904, 36905, and 36906, as recommended by the RUC.
Comment: In response to the CMS solicitation of feedback regarding
the Chloraprep applicator (26 ml) supply, commenters indicated that
Chloraprep solution has replaced Betadine solution when performing
sterile preparation of the dialysis access circuit due to its greater
efficacy as preoperative skin prep. Commenters indicated that this
supply was most accurately represented by the submitted invoice.
Another commenter stated that studies have shown that preparation of
central venous sites with a 2% aqueous chlorhexidine gluconate (in 70%
alcohol) is superior for skin site preparation to either 10% povidone-
iodine or 70% alcohol alone, and that in 2002, the CDC recommended that
2% chlorhexidine be used for skin antisepsis prior to catheter
insertion. One commenter recommended that CMS replace the Betadine
povidone soln (SJ041) with two units of swab, patient prep, 3.0 ml
(Chloraprep) supply (SJ088) in the inputs for CPT codes 36901-36906.
Response: We appreciate the submission of additional clinical
information regarding the Chloraprep supply from the commenters. We
agree with the recommended supply substitution, and we are therefore
removing 60 ml of the Betadine solution (SJ041) and replacing it with
two units of the swab, patient prep, 3.0 ml (Chloraprep) supply (SJ088)
for CPT codes 36901-36906. We will add the Chloraprep applicator (26
ml) supply to the direct PE input database at a price of $8.48 based on
an average of the three submitted invoices; it is not currently
assigned to any codes. We also agree that it is a distinct supply from
the ``chlorhexidine 4.0% (Hibiclens)'' (SH098) supply already located
in the direct PE database.
Comment: Several commenters provided additional information
regarding the use of guidewires in these procedures. Commenters stated
that the three wires used in the Dialysis Circuit codes are the minimum
required for these interventions and frequently additional wires would
be needed in more complicated cases or in cases in which more than one
access must be used. Commenters stated that the guidewires submitted
are the bare minimum needed for the typical case.
Response: We appreciate the additional information from the
commenters regarding the use of guidewires. We proposed to use the RUC-
recommended quantities for these supplies, and we are not finalizing
any changes.
Comment: One commenter stated that vascular procedures involving
fluoroscopy or radiography require the use of a radio-opaque ruler
(SD249) to accurately size or locate tributaries and lesions beneath
the skin. The commenter indicated that some of the base procedure codes
(CPT codes 36903 and 36906) include this supply, while it is missing
from CPT codes 36902 and 36905 and should be included.
Response: Based upon recommendations from the RUC and specialties,
we believe that the use of this supply is typical in stent procedures
such as CPT codes 36903 and 36906. It was included in CPT code 37238,
which is a predecessor code for these two procedures. However, the
radio-opaque ruler does not appear to be typical in the other dialysis
codes and we do not believe that it would be typically required in the
non-stent procedures, as it was not included in any of the other
predecessor codes.
Comment: One commenter requested that CMS include additional
miscellaneous supplies that were missing or underrepresented in the
cost inputs. These supplies were not included in the RUC
recommendations for these codes. The commenter also requested
increasing the quantity of each category of gloves to 3 and the
quantity of gowns to 3 for each of the base codes (CPT codes 36901-
36906) to more accurately reflect the typical use of these items in the
dialysis circuit procedures.
Response: We believe the supplies as recommended are typical for
these procedures. We also believe the proposed number of gloves and
gowns would be sufficient for the typical case; we currently do not
have any data to suggest that there is a need for additional gloves or
gowns in these procedures. The remainder of the additional
miscellaneous items appear to be new supplies with no included
invoices. Many of these new items may have analogous supplies already
present in our direct PE database. For the others, we will consider
pricing them if invoices are submitted as part of our normal process
for updating supply and equipment costs.
After consideration of comments received, we are finalizing the
work RVUs for the Dialysis Circuit codes as proposed. We are also
finalizing the proposed direct PE inputs, with the refinements detailed
above.
(17) Open and Percutaneous Transluminal Angioplasty (CPT Codes 37246,
37247, 37248, and 37249)
In January 2015, a CPT/RUC workgroup identified the following CPT
codes as being frequently reported together in various combinations:
35475 (Transluminal balloon angioplasty, percutaneous; brachiocephalic
trunk or
[[Page 80297]]
branches, each vessel), 35476 (Transluminal balloon angioplasty,
percutaneous; venous), 36147 (Introduction of needle and/or catheter,
arteriovenous shunt created for dialysis (graft/fistula); initial
access with complete radiological evaluation of dialysis access,
including fluoroscopy, image documentation and report), 36148
(Introduction of needle and/or catheter, arteriovenous shunt created
for dialysis (graft/fistula); additional access for therapeutic
intervention), 37236 (Transcatheter placement of an intravascular
stent(s) (except lower extremity artery(s) for occlusive disease,
cervical carotid, extracranial vertebral or intrathoracic carotid,
intracranial, or coronary), open or percutaneous, including
radiological supervision and interpretation and including all
angioplasty within the same vessel, when performed; initial artery),
37238 (Transcatheter placement of an intravascular stent(s), open or
percutaneous, including radiological supervision and interpretation and
including angioplasty within the same vessel, when performed; initial
vein), 75791 (Angiography, arteriovenous shunt (eg, dialysis patient
fistula/graft), complete evaluation of dialysis access, including
fluoroscopy, image documentation and report (includes injections of
contrast and all necessary imaging from the arterial anastomosis and
adjacent artery through entire venous outflow including the inferior or
superior vena cava), radiological supervision and interpretation),
75962 (Transluminal balloon angioplasty, peripheral artery other than
renal, or other visceral artery, iliac or lower extremity, radiological
supervision and interpretation), and 75968 (Transluminal balloon
angioplasty, each additional visceral artery, radiological supervision
and interpretation).
At the October 2015 CPT Editorial Panel meeting, the panel approved
the creation of four new codes and deletion of 13 existing codes used
to describe bundled percutaneous transluminal angioplasty services. The
Open and Percutaneous Transluminal Angioplasty family of codes overlaps
with the Dialysis Circuit family of codes (CPT codes 36901-36909), as
they are both being constructed from the same set of frequently
reported together codes. We reviewed these two families of codes
concurrently to maintain relativity between these clinically similar
procedures based upon the same collection of deleted codes. After
consideration of these materials, we proposed to accept the RUC-
recommended work RVU for CPT codes 37246, 37247, 37248, and 37249.
For the clinical labor direct PE inputs, we proposed to use the
RUC-recommend inputs with several refinements. Our proposed inputs
refined the recommended clinical labor time for ``Prepare and position
patient/monitor patient/set up IV'' from 5 minutes to 3 minutes for CPT
codes 37246 and 37248. The RUC recommendation included a written
justification for additional clinical labor time beyond the standard 2
minutes for this activity, stating that the extra time was needed to
move leads out of X-ray field, check that X-ray is not obstructed and
that there is no risk of collision of X-ray equipment with patient. As
we wrote for the same clinical labor activity in the Dialysis Circuit
family, we agreed that extra time might be needed for this activity as
compared to the default standard of 2 minutes; however, we assigned 1
extra minute for the additional positioning tasks, resulting in a total
of 3 minutes for this task. We did not believe that 3 extra minutes
would be typically needed for preparation of the X-ray. The equipment
times for the angiography room (EL011) and the PACS workstation (ED050)
were also refined to reflect this change in clinical labor.
We proposed to remove the ``drape, sterile, femoral'' supply
(SB009) and replace it with a ``drape, sterile, fenestrated 16in x
29in'' supply (SB011) for CPT codes 37246 and 37248. The two base codes
out of which these new codes are being constructed, CPT codes 35471 and
35476, both made use of the SB011 fenestrated sterile drape supply, and
there was no rationale provided for the switch to the SB009 femoral
sterile drape in the two new codes. We solicited comment on the use of
sterile drapes for these procedures, and what rationale there was to
support the use of the SB009 femoral sterile drape as typical for these
new procedures.
The following is a summary of the comments we received regarding
our proposed valuation of the Open and Percutaneous Transluminal
Angioplasty codes.
Comment: One commenter disagreed with the CMS proposed value of 3
minutes for the ``Prepare and position patient/monitor patient/set up
IV'' clinical labor task. The commenter stated that the recommended 5
minutes of time was needed to move leads out of X-ray field, check that
X-ray is not obstructed and that there is no risk of collision of X-ray
equipment with patient. The commenter also indicated that the patient's
arm needs to be positioned on an arm board, and requested time for this
activity.
Recommended: We continue to believe that additional time may be
needed for this activity as compared to the default standard of 2
minutes. However, we maintain that the commenter's request for 3
additional minutes (for a total of 5 minutes) would not typically be
required for preparing the X-ray and conducting arm positioning. We do
not agree that the additional tasks described by the commenters would
require the requested 5 minutes of clinical labor time, and we are
maintaining our proposed value of 3 minutes.
Comment: Several commenters objected to the proposed replacement of
the ``drape, sterile, femoral'' supply (SB009) with the ``drape,
sterile, fenestrated 16in x 29in'' supply (SB011) for CPT codes 37246
and 37248. Commenters stated that the vast majority of these new
procedures will be performed from a femoral or jugular approach and
will utilize a standard femoral drape. According to the commenters, the
fenestrated drape provides a limited sterile field (16x29in) which does
not allow room for sterile manipulation of wires and catheters as they
extend away from the entry into the vascular system. With the creation
of the new dialysis access circuit CPT code family, commenters
indicated that the use of extremity access and fenestrated drapes would
become much less typical for the new angioplasty code set.
Response: We appreciate the presentation of additional clinical
information from the commenters regarding the sterile drape most
appropriate for these procedures. As a result, we are finalizing
inclusion of the sterile femoral drape supply (SB009) to CPT codes
37246 and 37248. We will therefore not be adding the fenestrated drape
supply (SB011) to these procedures.
After consideration of comments received, we are finalizing the
proposed work RVUs for the four codes in the family. We are also
finalizing the proposed direct PE inputs, with the refinement to the
sterile femoral drape detailed above.
(18) Esophagogastric Fundoplasty Trans-Oral Approach (CPT Code 43210)
For CY 2016, the CPT Editorial Panel established CPT code 43210 to
describe trans-oral esophagogastric fundoplasty. The RUC recommended a
work RVU of 9.00 and for CY 2016, we established an interim final work
RVU of 7.75 for CPT code 43210. We noted that a work RVU of 7.75, which
corresponds to the 25th
[[Page 80298]]
percentile of the survey, more accurately reflected the resources used
in furnishing this service.
Comment on the CY 2016 PFS final rule with comment period:
Commenters urged CMS to accept the RUC-recommended work RVU of 9.00 for
CPT code 43210. The commenters believed that the RUC-recommended value
compared well with the key reference service, CPT code 43276
(Endoscopic retrograde cholangiopancreatography (ERCP); with removal
and exchange of stent(s), biliary or pancreatic duct, including pre-
and post-dilation and guide wire passage, when performed, including
sphincterotomy, when performed, each stent exchanged), which has a work
RVU of 8.94 and an intraservice time of 60 minutes. Commenters believed
that due to similar intraservice times and intensities, that CPT code
43210 should be valued nearly identically to CPT code 43276. Some
commenters also stated that to maintain relativity within the upper GI
code families, CPT code 43210 should not have a lower work RVU than CPT
code 43276 since the majority of survey participants indicated that CPT
code 43210 is more complex than CPT code 43276. Additionally, one
commenter noted that an esophagogastroduodenoscopy (EGD) is used twice
during this service, before and after fundoplication. The commenter
stated that because this is a multi-stage procedure, other EGD codes
are not comparable. The commenter also pointed out that this technology
has a small number of users and urged CMS to accept the RUC-recommended
work RVU of 9.00 until there is additional utilization, and to consider
reviewing this code again in subsequent years.
Response in the CY 2017 PFS proposed rule: We referred this code to
the CY 2016 multi-specialty refinement panel for further review, which
recommended we accept the RUC-recommended value of 9.00 work RVUs.
There are four ERCP codes with 60 minutes of intraservice time, three
of which have work RVUs of less than 7.00 and only one of the four
codes has a work RVU higher than 7.75 RVUs (8.94). Based on our
estimate of overall work for this service, we continue to believe that
the 25th percentile of the survey more accurately reflects the relative
resource costs associated with this service. Therefore, for CY 2017, we
proposed a work RVU of 7.75 for CPT code 43210.
The following is a summary of the comments we received regarding
our proposed valuation of CPT code 43210:
Comment: Commenters indicated that the survey results were limited
since this is a new technology. Commenters requested that CMS finalize
the RUC-recommended work RVU of 9.00, with the understanding that the
service will be reviewed again in the near future with more robust
survey data as the technology continues to be adopted. Commenters
disagreed with CMS' comparison to other EGD codes for purposes of
establishing the work RVU, due to differences in the inherent clinical
procedural steps involved with this code, including that EGD is used
more than once (pre- and post-fundoplication) to ensure successful
completion of the procedure.
Response: While it may be true that multiple EGDs may be performed
during this procedure, the surveyees are familiar with the service and
we assume included this information in their proposed time and work
recommendations. However, the values recommended by the survey and the
RUC are not consistent with other codes with similar times and
intensities. We noted in the CY 2016 interim final rule that CPT code
43240 (Drainage of cyst of the esophagus, stomach, and/or upper small
bowel using an endoscope) has 10 minutes more intraservice time and a
work RVU of 7.25. Therefore, we are finalizing for CY 2017 a work RVU
of 7.75 for CPT code 43210.
(19) Esophageal Sphincter Augmentation (CPT Codes 43284 and 43285)
In October 2015, the CPT Editorial Panel created two new codes to
describe laparoscopic implantation and removal of a magnetic bead
sphincter augmentation device used for treatment of gastroesophageal
reflux disease (GERD). The RUC noted that the specialty societies
conducted a targeted survey of the 145 physicians who have been trained
to furnish these services and who are the only physicians who have
performed these procedures. They noted that only 18 non-conflicted
survey responses were received despite efforts to follow up and that
nine physicians had no experience in the past 12 months with the
procedure. The RUC agreed with the specialty society that the expertise
of those responding was sufficient to consider the survey; however,
neither the RUC nor the specialty society used the survey results as
the primary basis for their recommended value.
For CPT code 43284, the RUC recommended a work RVU of 10.13. We
compared this code to CPT code 43180 (Esophagoscopy, rigid, transoral
with diverticulectomy of hypopharynx or cervical esophagus (e.g.,
Zenker's diverticulum), with cricopharyngeal myotomy, includes use of
telescope or operating microscope and repair, when performed), which
has a work RVU of 9.03 and has identical intraservice time and similar
total time. We stated in the proposed rule that we believe the overall
intensity of these procedures is similar; therefore, we proposed a work
RVU of 9.03 for CPT code 43284.
For CPT code 43285, the RUC recommended a work RVU of 10.47. We
used the increment between the RUC-recommended work RVU for this code
and CPT code 43284 (0.34 RVUs) to develop our proposed work RVU of 9.37
for CPT code 43285.
Comment: We received many comments on our proposal from various
stakeholders including practitioners, manufacturers, the RUC, and
medical specialty societies representing various surgical specialties.
For CPT code 43284, commenters indicated that CMS' proposed crosswalk
from CPT code 43180 was inadequate with regard to time and complexity
of the services. Commenters stated that CPT code 43180 has 10 minutes
less immediate post-service time and one less post-operative visit.
Some commenters stated that it appears that the difference between the
specialty society median survey total time for 43284 and the total time
for CMS' proposed crosswalk from CPT code 43180 was too great to
discount. Commenters also disagreed that CPT code 43284 and CMS'
proposed crosswalk from CPT code 43180 had similar complexity
considering that one of the procedures was performed on a natural
orifice with endoscopy versus a procedure with a surgical incision.
Commenters indicated that management of surgical patients with
incisions necessitates a more thorough evaluation of the body than an
endoscopic procedure.
For CPT code 43285, commenters noted that although CPT code 47562
(the RUC-recommended crosswalk) requires more intraservice time than
the aggregate survey median time for CPT code 43285, the median
intraservice time may be understated because of the number of people
without experience, and suggested that the total time for CPT codes
43285 and 47562 is nearly identical and both require similar work and
intensity. Commenters stated that only 18 non-conflicted survey
responses were received despite the efforts of the specialty societies,
and that nine physicians had no experience with the procedure in the
past 12 months. Commenters also noted that the RUC recommendations used
the specialty society survey times, but provided a crosswalk for work
RVU valuation.
[[Page 80299]]
Many commenters expressed additional concerns about the specialty
society survey data, indicating that the survey median and 25th
percentile work RVUs were inconsistent with the total physician work
for services reported with CPT codes 43284 and 43285. Commenters stated
that to accept the results of the survey is to essentially state that
the opinions of inexperienced surgeons is adequate to determine the
value of a surgical procedure and lacked input from surgeons
experienced in performing the procedure. Commenters suggested that CMS
maintain carrier pricing for services reported with CPT codes 43284 and
43285 while the specialty societies conduct new surveys that include
data from surgeons experienced with the procedures. Some commenters
suggested that the work of CPT codes 43284 and/or 43285 is more similar
to fundoplication procedures reported with CPT code 43280 (a work RVU
of 18.10). Other commenters suggested valuations for these procedures
ranging from 14 to 17 work RVUs, stating that the services reported
with CPT codes 43284 and 43285 were slightly less complicated than
fundoplication procedures, but more complex than the valuations
reflected in the survey results, RUC recommendations, and CMS proposed
values.
Response: We appreciate the feedback received from stakeholders
regarding valuation of these services. After considering the comments
received, for CY 2017, we are finalizing the RUC-recommended values for
CPT codes 43284 (a work RVU of 10.13) and 43285 (a work RVU of 10.47).
We recognize commenters' concerns regarding the specialty society
survey data and believe these codes may be potentially misvalued. We
look forward to receiving feedback from interested parties and
specialty societies regarding accurate valuation of these services for
consideration during future rulemaking.
(20) Percutaneous Biliary Procedures Bundling (CPT Codes 47531, 47532,
47533, 47534, 47535, 47536, 47537, 47538, 47539, 47540, 47541, 47542,
47543, and 47544)
This group of fourteen codes was reviewed by the RUC at the April
2015 meeting. We established interim final values for this group of
codes during the CY 2016 PFS rulemaking cycle, and subsequently
received updated RUC recommendations from the October 2015 meeting for
the CY 2017 PFS rulemaking cycle. Our proposals for these codes
incorporated both the updated RUC recommendations, as well as public
comments received as part of the interim final status of these
procedures.
We received several comments regarding the CMS refinements to the
work values for this family of codes in the CY 2016 final rule with
comment period. The relevance of many of these comments has been
diminished by the new series of RUC recommendations for work values
that we received as a result of the October 2015 meeting. Given that we
proposed the updated RUC-recommended work RVUs for CPT codes 47531,
47532, 47533, 47534, 47535, 47536, 47537, 47538, 47539, 47540, 47542,
47543, and 47544, we solicited additional comments relative to these
proposed values. We agreed that the second round of physician surveys
conducted for the October 2015 RUC meeting more accurately captured the
work and time required to perform these procedures. The one exception
was CPT code 47541; the survey times for this procedure were identical
as conducted for the April and October 2015 RUC meetings, yet the RUC
recommendation increased from a work RVU of 5.61 in April to a work RVU
of 7.00 in October. Given that the time values for the procedure
remained unchanged between the two surveys, we do not understand why
the work RVU would have increased by nearly 1.50 in the intervening
months. Since this code also has an identical intraservice time (60
minutes) and total time (121 minutes) as CPT code 47533, we do not
agree that it should be valued at a substantially higher rate compared
to a medically similar procedure within the same code family. We
therefore proposed to crosswalk the work value of CPT code 47541 to the
work value of CPT code 47533, and we proposed a work RVU of 5.63 for
both procedures.
We also note that many of the codes in the Percutaneous Biliary
Procedures family were previously included in Appendix G, and were
valued under the assumption that moderate sedation was typically
performed on the patient. As part of the changes for services
previously valued with moderate sedation as inherent, we are removing a
portion of the work RVU and preservice work time from CPT codes 47532,
47533, 47534, 47535, 47536, 47538, 47539, 47540, and 47541. For
example, we proposed a work value for CPT code 47541 with a 0.25
reduction from 5.63 to 5.38, and a 10 minute reduction in its
preservice work time from 33 minutes to 23 minutes, to reflect the work
that will now be reported separately using the new moderate sedation
codes. CPT codes 47542, 47533, and 47544 also were valued with moderate
sedation; however, as add-on codes, they are not subject to alterations
in their work RVUs or work times since the moderate sedation code with
work RVUs and work time (99152) will only be billed once for each base-
code and not additionally with the add-on codes. These changes are
reflected in Appendix B and the work time file posted to the web; see
section II.D for more details.
For the direct PE inputs, we did not propose to include the
recommended L051A clinical labor for ``Sedate/apply anesthesia'' and
the L037D for ``Assist Physician in Performing Procedure'' for CPT
codes 47531 and 47537. As we wrote in the CY 2016 final rule with
comment period (80 FR 71053), we believe that this clinical labor
describes activities associated with moderate sedation, and moderate
sedation is not typical for these procedures. We also proposed to
refine the L037D clinical labor for ``Clean room/equipment by physician
staff'' from 6 minutes to 3 minutes for all of the codes in this
family. Three minutes is the standard for this clinical labor activity,
and we continued to maintain that the need for additional clinical
labor time for this cleaning activity would not be typical for these
procedures.
Comment on the CY 2016 PFS final rule with comment period: One
commenter disagreed with our refinement to replace supply item
``catheter, balloon, PTA'' (SD152) with supply item ``catheter, balloon
ureteral (Dowd)'' (SD150). The commenter stated that a Dowd catheter is
designed and FDA approved for use in the prostatic urethra by
retrograde placement through the penile urethra, and it is not designed
for use in an antegrade ureteral dilation procedure. The commenter
stated that this replacement is inappropriate. The updated RUC
recommendations for this family of codes also restored the balloon PTA
catheter.
Response in the CY 2017 PFS proposed rule: We proposed again to
replace the recommended supply item ``catheter, balloon, PTA'' (SD152)
with supply item ``catheter, balloon ureteral (Dowd)'' (SD150). We
believed that the use of this ureteral balloon catheter, which is
specifically designed for catheter and image guidance procedures, would
be more typical than the use of a PTA balloon catheter. While we
recognize that the Dowd catheter is not FDA approved, it is our
understanding that the PTA balloon catheter has also not been FDA
approved for use in these procedures. We were uncertain if the
commenter was requesting that we should no longer include catheters
that lack FDA approval in the direct PE database; this
[[Page 80300]]
would preclude the use of most of the catheters in our direct PE
database. We solicited additional comment on the use of FDA approved
catheters; in the meantime, we continued our long-standing practice of
using the catheters in the direct PE database without explicit regard
to FDA approval in particular procedures.
We also proposed to remove the recommended supply item ``stone
basket'' (SD315) from CPT code 47543 and add it to CPT code 47544.
Based on the code descriptors, we believed that the stone basket was
intended to be included in CPT code 47544 and was erroneously listed
under CPT code 47543. We solicited comments from the public to help
clarify this issue.
We noted again that many of the codes in the Percutaneous Biliary
Procedures family were previously included in Appendix G, and as part
of the change in moderate sedation reporting, we removed some of the
recommended direct PE inputs related to moderate sedation from CPT
codes 47532, 47533, 47534, 47535, 47536, 47538, 47539, 47540, and
47541. We removed the L051A clinical labor time for ``Sedate/apply
anesthesia'', ``Assist Physician in Performing Procedure (CS)'', and
``Monitor pt. following moderate sedation''. We also removed the
conscious sedation pack (SA044) supply, and some or all of the
equipment time for the stretcher (EF018), the mobile instrument table
(EF027), the 3-channel ECG (EQ011), and the IV infusion pump (EQ032).
These changes are reflected in the public use files posted to the web;
see section II.D for more details.
The following is a summary of the comments we received regarding
our proposed valuation of the Percutaneous Biliary Procedures codes.
Comment: Several commenters disagreed with the proposed work RVU of
5.45 for CPT code 47541. Commenters stated that although CPT codes
47541 and 47533 share similar time values, the patient population for
CPT code 47541 is more complex with post-surgical anatomy and atypical
problems. Therefore, the commenters stated that the direct crosswalk
creates a sharp rank order anomaly within the family, and requested
that CMS adopt the RUC-recommended work RVU.
Response: We agree with the commenters that the proposed work RVU
for CPT code 47541 has the potential to create an anomalous
relationship between the services in this family of codes. After
considering the comments, we are finalizing a work RVU of 6.75 for CPT
code 47541, which is the RUC-recommended work RVU of 7.00 after
removing 0.25 RVUs to account for the fact that moderate sedation will
now be billed separately for this service.
Comment: One commenter requested 2 minutes for the clinical labor
task ``Sedate/apply anesthesia'' and 15 minutes for the clinical labor
task ``Assist Physician in Performing Procedure'' for CPT codes 47531
and 47537. The commenter agreed with CMS that moderate sedation was not
typical for either procedure, but stated that the 2 minutes was for the
RN to administer the pre-procedure prophylactic antibiotics and the 15
minutes for assisting the physician was unrelated to moderate sedation.
Response: We disagree with the commenter that the clinical labor
time for these tasks would be typical for CPT codes 47531 and 47537.
For the 2 minutes of apply anesthesia time, we do not agree that this
clinical labor time should be assigned when the clinical staff is
performing an entirely different activity. We have not assigned
clinical labor time in this way in the past, and the request for 2
minutes related to administering pre-procedure prophylactic antibiotics
was never discussed in the recommendations for these procedures.
For the 15 minutes of assist physician time, the commenter did not
provide a justification for why an additional staff member would be
needed or what the staff member would be doing. CPT codes 47531 and
47537 already contain two clinical staff members, one technician to
assist the physician and another technician to acquire images, plus a
circulator. The other codes in the Percutaneous Biliary Procedures
family previously had a third RN clinical staff member to administer
the sedation to the patient, before moderate sedation was split off
into its own separate procedure codes. However, CPT codes 47531 and
47537 do not typically require sedation, and we do not agree that this
additional clinical staff member would be required to perform the
procedures.
Comment: Several commenters again objected to the proposed
replacement of the recommended supply item ``catheter, balloon, PTA''
(SD152) with supply item ``catheter, balloon ureteral (Dowd)'' (SD150).
Commenters stated that this would not reflect the practice patterns of
the Interventional Radiology community, as it is atypical and even
quite rare to use ureteral balloon dilatation catheters in the biliary
tree. The commenters provided information regarding the size of uretal
balloon catheters, indicating that the maximum diameter is 8mm (Bard)
or 7mm (Cook Medical). According to commenters, these sizes are
frequently inadequate to treat the wide variety of pathologies in the
biliary tree where often balloon sizes up to 12 mm are required. As a
result, the commenters stated that the change of the balloon catheter
supply item does not accurately represents the actual supplies utilized
in real practice, nor does the Dowd ureteral balloon catheter satisfy
the clinical need performed during the procedure.
Response: We appreciate the additional clinical information
supplied by the commenters regarding the current use of balloon
catheters. However, although commenters stated that Bard catheters and
Cook Medical catheters are frequently too small to treat some of the
wide variety of pathologies that occur in the biliary tree, commenters
did not indicate what size balloon catheter would be typically used for
these particular procedures in the Percutaneous Biliary Procedures, or
provide a specific rationale for why the catheter we proposed (the Dowd
ureteral balloon catheter) would not be appropriate for these
procedures. We note again that we are required to assess resources
based on the typical case, and the commenters did not provide data to
indicate that the proposed Dowd catheter would be inadequate in the
typical case for these procedures in question, only that it may be
insufficient for certain pathologies in the biliary tree. We continue
to believe that the Dowd ureteral balloon catheter, which is
specifically designed for catheter and image guidance procedures, would
be more typical than the use of a PTA balloon catheter.
Comment: One commenter indicated that the stone basket supply
(SD315) had indeed been incorrectly assigned to CPT code 47543, and
thanked CMS for moving it to CPT code 47544 where it was intended.
Response: We appreciate the response from the commenter.
After consideration of comments received, we are finalizing our
proposed work RVUs for the Percutaneous Biliary Procedures family of
codes, with the one change to a work RVU of 6.75 for CPT code 47541. We
are finalizing our proposed direct PE inputs without refinement.
(21) Percutaneous Image Guided Sclerotherapy (CPT Code 49185)
For CY 2016, we established an interim final work RVU of 2.35 for
CPT code 49185 based on a crosswalk from CPT code 62305 (Myelography
via lumbar injection, including radiological supervision and
interpretation; 2 or more regions (e.g., lumbar/thoracic,
[[Page 80301]]
cervical/thoracic, lumbar/cervical, lumbar/thoracic/cervical)); which
we believed accurately reflected the time and intensity involved in
furnishing services reported with CPT code 49185. We also requested
stakeholder input on the price of sclerosing solution (supply item
SH062) as the volume of the solution in this procedure (300 mL) is much
higher than other CPT codes utilizing sclerosing solution (between 1
and 10 mL).
Comment on the CY 2016 PFS final rule with comment period: In
response to the CY 2016 PFS final rule with comment period (80 FR
71054), commenters disagreed with CMS' crosswalk from CPT code 62305.
Commenters suggested that the RUC's recommended crosswalk from CPT code
31622 (Bronchoscopy, rigid or flexible, including fluoroscopic
guidance, when performed; diagnostic, with cell washing, when performed
(separate procedure)) was a more appropriate comparison due to the
similarity of the services. Commenters requested that CPT code 49185 be
referred to the refinement panel. The requests did not meet the
requirements related to new clinical information for referral to the
refinement panel. We continue to believe that for CPT code 49185 a
crosswalk from the value of CPT code 62305 is accurate due to
similarities in overall work.
Commenters also stated that the procedure reported with CPT code
49185 required a separate clinical labor staff type. The commenter
noted that, due to the inclusion of this additional individual, the
L037D clinical labor and additional gloves were appropriate to include
in the procedure. The commenter did not provide any evidence for this
claim.
Response in the CY 2017 PFS proposed rule: We continue to believe
that this additional use of clinical staff would not be typical for CPT
code 49185. This procedure does not involve moderate sedation, and
therefore, we do not believe that there would be a typical need for a
third staff member. Additionally, we did not receive any information
regarding the sclerosing solution (supply item SH062) that supports
maintaining an input of 300 mL, which far exceeds the volume associated
with other CPT codes.
Therefore, for CY 2017, we proposed a work RVU of 2.35 for CPT code
49185. We sought stakeholder feedback regarding why a different work
RVU or crosswalk would more accurately reflect the resources involved
in furnishing this service. We also proposed to maintain our direct PE
refinements from the CY 2016 PFS final rule with comment period, but
proposed to refine the direct practice expense inputs for the
sclerosing solution (supply item SH062) from 300 mL to 10 mL, which is
the highest level associated with other CPT codes utilizing sclerosing
solution.
The following is a summary of the comments we received regarding
our proposed valuation of CPT code 49185.
Comment: Commenters requested that CMS use the RUC-recommended
crosswalk from CPT code 31622 instead of the CMS-proposed crosswalk
from CPT code 62305. Commenters stated that CMS' crosswalk undervalues
the services, the RUC-recommended crosswalk has analougous clinical
activities during the procedure, as well as a similar risk, and the
intensity of work involved for services reported with CMS' comparison
code is less than during sclerotherapy. Commenters suggested that the
sclerotherapy procedure includes inherent risks and challenges that are
not adequately accounted for in CMS' proposed crosswalk.
Response: We disagree with commenters that the RUC's recommended
crosswalk from CPT code 31622 has analogous clinical activities
compared to CMS' proposed crosswalk from CPT code 62305. CMS' crosswalk
code refers to a procedure with injection, drainage, and aspiration,
which has more clinical similarity to CPT code 49185 than the RUC's
recommended crosswalk from 31622, which is used to report a broncoscopy
procedure. We continue to believe that a work RVU of 2.35 is an
appropriate valuation for services reported using CPT code 49185 and we
maintain that CPT code 62305 is an accurate crosswalk, since CPT codes
49185 and 62305 have similar service times. Therefore, for CY 2017, we
are finalizing a work RVU of 2.35 for CPT code 49185.
Comment: Commenters disagreed with CMS' proposal to include a
direct PE input of 10 mL of sclerosing solution (supply item SH062) and
requested that CMS accept the RUC's recommendation to include 300 ml of
sclerosing solution as part of the direct PE inputs for this procedure.
One commenter indicated that other services that utilize sclerosing
solution are used to describe injection of sclerosant into vascular
structures which tend to be relatively small in size, and therefore,
use a much smaller volume. Another commenter stated that for this
procedure, the sclerosing solution is injected and drained three
separate times, equating to 100 mL per injection, and that use of
lesser volumes of sclerosant or less than three administrations of the
sclerosant during the procedure would allow for more frequent
recurrence necessitating additional procedures.
Response: We appreciate the commenters' feedback regarding the
direct PE inputs for CPT code 49185. We inadvertently included the RUC-
recommended quantity of 300 mL for the sclerosing solution (supply item
SH062) in developing the proposed rates for this code. For CY 2017, we
are finalizing the RUC-recommended direct PE inputs, including 300 mL
of sclerosing solution. We welcome stakeholder feedback regarding the
appropriate PE inputs for this procedure for consideration for CY 2018,
including volume and pricing of the sclerosing agent.
(22) Genitourinary Procedures (CPT Codes 50606, 50705, and 50706)
In the CY 2016 PFS final rule with comment period, we established
as interim final the RUC-recommended work RVUs for all three codes. We
did not receive any comments on the work values for these codes, and we
proposed to maintain all three at their current work RVUs.
The RUC recommended the inclusion of ``room, angiography'' (EL011)
for this family of codes. As we discussed in the CY 2016 PFS final rule
with comment period, we did not believe that an angiography room would
be used in the typical case for these procedures, and we therefore
replaced the recommended equipment item ``room, angiography'' with
equipment item ``room, radiographic-fluoroscopic'' (EL014) for all
three codes on an interim final basis. We also stated our belief that
since the predecessor procedure codes generally did not include an
angiography room and we did not have a reason to believe that the
procedure would have shifted to an angiography room in the course of
this coding change, we did not believe that the use of an angiography
room would be typical for these procedures.
Comment on the CY 2016 PFS final rule with comment period: Several
commenters disagreed with the CMS substitution of the fluoroscopic room
in place of the angiography room. The commenters stated that all three
of these procedures were previously reported using CPT code 53899
(Unlisted procedure, urinary system) which does not have any PE inputs,
and the RUC recommendations included as a reference CPT code 50387
(Removal and replacement of externally accessible transnephric ureteral
stent), which includes an angiography room. The commenters suggested
that CPT code 50387 was an example of a predecessor code that included
the use of an angiography room, along with other
[[Page 80302]]
codes that are being bundled together to create the new Genitourinary
codes.
Response in the CY 2017 PFS proposed rule: We did not agree with
the commenters' implication that because CPT code 50387 was an
appropriate reference code for use in valuation, that it necessarily
would have previously been used to describe services that are now
reported under CPT codes 50606, 50705, or 50706. Our perspective was
consistent with the RUC-recommended utilization crosswalk for the three
new codes, which did not suggest that the services were previously
reported using 50706. We did not believe that use of one particular
code for reference in developing values for another necessarily meant
that the all of the same equipment would be used for both services.
We did not believe that these codes described the same clinical
work either. CPT code 50387 is for the ``Removal and replacement of
externally accessible transnephric ureteral stent'' while CPT code
50606 describes an ``Endoluminal biopsy of ureter and/or renal
pelvis'', CPT code 50705 refers to ``Ureteral embolization or
occlusion'', and CPT code 50706 details ``Balloon dilation, ureteral
stricture.'' Additionally, the codes do not have the same global
periods, which makes comparisons between CPT code 50387 and CPT codes
506060, 50705, and 50706 even more difficult. We noted that while the
commenter stated that CPT code 50387 was provided as a reference for
these procedures, 50387 is not listed as a reference for any of these
three codes, or mentioned at all in the codes' respective summary of
recommendations. However, we acknowledged that among the procedures
that are provided as references, many of them included the use of an
angiography room, such as CPT code 36227 (Selective catheter placement,
external carotid artery) and CPT code 37233 (Revascularization,
endovascular, open or percutaneous, tibial/peroneal artery, unilateral,
each additional vessel). Therefore, we agreed that the use of the
angiography room in these procedures, or at least some of its component
parts, might be warranted.
Comment on the CY 2016 PFS final rule with comment period: A
commenter stated that the substitution of the fluoroscopic room for the
angiography room was clinically unjustified. The commenter stated that
the angiography room was needed for these procedures to carry out 3-
axis rotational imaging (so as to avoid rolling the patient), ensure
sterility, and avoid unacceptable radiation exposure to physicians,
their staff, and their patients. The commenter indicated that the only
piece of equipment listed in the angiography room that would not be
typically utilized for these procedures is the Provis Injector. All of
the other items were used for these Genitourinary procedures. The
commenter urged CMS to restore the angiography room to these
procedures.
Response in the CY 2017 PFS proposed rule: We agreed that it is
important to provide equipment that is medically reasonable and
necessary. Our concern with the use of the angiography room for these
codes was that we did not believe all of the equipment would be
typically necessary to furnish the procedure. For example, the
commenter agreed that the Provis Injector would not be required for
these Genitourinary codes. Therefore, we proposed to remove the
angiography room from these three procedures and add in its place the
component parts that make up the room. Table 17 detailed these
components:
Table 17--Angiography Room (EL011) Components
------------------------------------------------------------------------
Component
-------------------------------------------------------------------------
100 KW at 100 kV (DIN6822) generator
C-arm single plane system, ceiling mounted, integrated multispace
T motorized rotation, multiple operating modes
Real-time digital imaging
40 cm image intensifier at 40/28/20/14cm
30 x 38 image intensifier dynamic flat panel detector
Floor-mounted patient table with floating tabletop designed for
angiographic exams and interventions (with peistepping for image
intensifiers 13in+)
18 in TFT monitor
Network interface (DICOM)
Careposition: radiation free positioning of collimators
Carewatch: acquisition and monitoring of configurable dose area product
Carefilter: Cu-prefiltration
DICOM HIS/RIS
Control room interface
Injector, Provis
Shields, lower body and mavig
Leonardo software
Fujitsu-Siemens high performance computers
Color monitors
Singo modules for dynamic replay and full format images
Prepared for internal networking and Siemens remote servicing, both
hardware and software
------------------------------------------------------------------------
We included all of the above components except the Provis Injector,
as commenters indicated that its use would not be typical for these
procedures. We welcomed additional comments regarding if these or other
components were typically used in these Genitourinary procedures. We
lacked pricing information for these components; we therefore proposed
to include each of these components in the direct PE input database at
a price of $0.00 and we solicited invoices from the public for their
costs to be able to price these items for use in developing final PE
RVUs for CY 2017.
We also noted that we believed that this issue illustrated a
potentially broad problem with our use of equipment ``rooms'' in the
direct PE input database. For most services, we only include equipment
items that are used and unavailable for other uses due to their use
during the services described by a particular code. However, for items
included in equipment ``rooms,'' we allocate costs regardless of
whether the individual items that comprise the room are actually used
in the particular service.
To maintain relativity among different kinds of procedures, we were
interested in obtaining more information specifying the exact resources
used in furnishing services described by different codes. We hoped to
address this subject in greater detail in future rulemaking.
The following is a summary of the comments we received regarding
our proposed valuation of the Genitourinary codes:
Comment: Many commenters objected to the removal of the angiography
room from these codes and its replacement with the component parts of
the room. Commenters stated that it was misguided to unbundle the
components of the angiography room when one equipment item within the
room is not utilized. They indicated that there are numerous cases
where an equipment room is used despite the fact that not every item in
the room is needed for a service, because in practice the rooms are
configured for the most typical type of procedure performed within the
room and it would not be efficient or realistic to remove items from a
room when a less typical service is needed. For the specific case of
the Provis Injector equipment, commenters stated it could not be used
elsewhere and there was no way to create a separate angiography room
for nonvascular procedures that did not require the injector.
Commenters did not generally agree with the CMS proposal to price
all of the components of the angiography room at $0.00 pending invoices
from the public regarding their individual cost. Commenters stated that
the resource cost of the angiography room components was clearly not
$0.00, since the equipment in total costs over $1.3 million. Commenters
stated that it was
[[Page 80303]]
not realistic to submit 21 separate invoices during the 60 day comment
period, and furthermore that the components of the angiography room are
typically not sold separately.
Response: We appreciate the feedback from commenters regarding the
difficulties involved in pricing the components for the angiography
room. We have longstanding issues with the equipment rooms as they are
currently constituted, due to our belief that all of the components of
the room may not typically be used in performing the procedure in
question. We continue to believe that these three codes do not make use
of all of the components of the angiography room, and we believe that
this code family serves as a clear example of the problems in
relativity associated with the use of ``rooms'' as equipment items for
a limited set of services under the PFS. However, we agree with the
commenters that it is not likely that the components of the angiography
room do not have a price. Therefore, while we continue to seek invoices
for more detailed pricing information, we are restoring the angiography
room (EL011) equipment to these three codes, with an equipment time of
47 minutes for CPT code 50606, 62 minutes for CPT code 50705, and 62
minutes for CPT code 50706, in each case consistent with the equipment
time in CY 2016. We intend to continue to consider the use of equipment
``rooms'' more broadly for future rulemaking.
After consideration of comments received, we are finalizing our
work values for the three Genitourinary codes as proposed. We are
finalizing the proposed direct PE inputs as well, with the changes to
the angiography room as detailed above.
(23) Electromyography Studies (CPT Code 51784)
We identified CPT code 51784 as potentially misvalued through a
screen of high expenditure services by specialty. This family also
includes CPT code 51785 (Needle electromyography studies (EMG) of anal
or urethral sphincter, any technique) but was not included in this
survey. Both services have 0-day global periods. The RUC recommended a
work RVU of 0.75 for CPT code 51784. We believe that this service is
more accurately valued without a global period, since that is more
consistent with other diagnostic services, and specifically, with all
the other diagnostic electromyography services. We proposed to
eliminate the global period and proposed the RUC-recommended work RVU
of 0.75 for CY 2017. We also proposed to change the global period for
CPT code 51785 from 0-day to no global period, to be consistent with
the global period for CPT code 51784. Additionally, we proposed to add
CPT code 51785 to the list of potentially misvalued codes to update the
value of the service considering the change in global period, and to
maintain consistency with CPT code 51784.
Comment: A commenter supported CMS' proposal to accept the RUC-
recommended work value. The commenter requested that CMS indicate any
global period changes and requests for codes as part of the family when
CMS initially nominates a code or reviews the RUC level of interest
(LOI) prior to distribution.
Another commenter, while supporting our acceptance of the RUC-
recommended work RVU for CPT code 51784, did not support adding CPT
code 51785 to the potentially misvalued code list as that code was
addressed recently when the new CPT codes were created for urodynamic
testing procedures.
Response: We appreciate commenters' perspectives. We note that CPT
code 51785 has not been valued since January 2003, at the same RUC
meeting wherein CPT code 51784 was valued. We encourage stakeholders to
submit the entire code family when submitting codes for inclusion on
the list of potentially misvalued codes.
Comment: One commenter stated that there is no difference in the
work value of CPT code 51784 whether it has a 0-day global period
versus an XXX global period, and should not be considered as
potentially misvalued.
Response: We note that CPT code 51784 was identified as potentially
misvalued through a screen of high expenditure services by specialty.
In the standard process of code valuation, CMS decided to change the
global period to XXX, indicating no global period, so that the code is
more closely aligned with other similar services.
Comment: One commenter did not agree that CMS should accept the
RUC-recommended work values, stating that the RUC-recommended work RVU
underestimates the work involved in furnishing this service.
Response: We remind commenters and stakeholders that disagree with
CMS values, including those based on RUC recommendations, that in
addition to submitting comments on our proposed rules, they may also
nominate codes as potentially misvalued through the public nomination
process. After consideration of comments, we are finalizing the work
and global period changes as proposed.
(24) Cystourethroscopy (CPT Code 52000)
In the CY 2016 PFS final rule with comment period, CMS identified
CPT code 52000 through the screen for high expenditure services. We
stated in the CY 2017 proposed rule that the RUC-recommended work RVU
of 1.75 for CPT code 52000 is higher than the work RVUs for all 0-day
global codes with 10 minutes of intraservice time and we did not
believe that the overall intensity of this service was greater than all
of the other codes. Instead, we proposed that this code compares
favorably to CPT code 58100 (Endometrial sampling (biopsy) with or
without endocervical sampling (biopsy), without cervical dilation, any
method (separate procedure)), which has a work RVU of 1.53, and has
identical intraservice time and similar total time. Therefore, we
proposed a work RVU of 1.53 for CPT code 52000, using a direct
crosswalk to CPT code 58100.
Comment: Commenters requested that CMS finalize the RUC-recommended
work RVU of 1.75 for this procedure. Commenters stated that the RUC-
recommended crosswalk codes were a more accurate comparison of
physician work, time, and intensity for procedures reported with CPT
code 52000.
Response: The RUC-recommended work RVU of 1.75 is higher than the
work RVUs associated with all other codes with 0-day global periods and
10 minutes of intraservice time, and we continue to believe that the
work and intensity of this service is similar to other CPT codes with
10 minutes of intraservice time. Therefore, we are finalizing a work
RVU of 1.53 for CPT code 52000.
(25) Biopsy of Prostate (CPT Code 55700)
In the CY 2016 PFS final rule with comment period, CMS identified
CPT code 55700 as potentially misvalued based on the high expenditure
by specialty screen.
The RUC subsequently reviewed this code for physician work and
practice expense and recommended a work RVU of 2.50 based on the 25th
percentile of the survey. We believed the RUC-recommended work RVU
overestimates the work involved in furnishing this service given the
reduction in total service time; specifically, the reduction in
preservice and postservice times. The RUC recommendation also appears
overvalued when compared to similar 0-day global services with 15
minutes of intraservice time and comparable total times. To develop a
proposed work RVU, we crosswalked the work RVUs
[[Page 80304]]
for this code from CPT code 69801 (Labyrinthotomy, with perfusion of
vestibuloactive drug(s), transcanal), noting similar levels of
intensity, similar total times, and identical intraservice times.
Therefore, we proposed a work RVU of 2.06 for CPT code 55700.
Comments: A few commenters, including the RUC, noted the RUC
compared CPT code 55700 to other 0-day global services with 15 minutes
of intraservice time and stated that the RUC-recommended value was
appropriate. The RUC noted that the overall work of the surveyed code
was similar to services: CPT code 93503 (Insertion and placement of
flow directed catheter (eg, Swan-Ganz) for monitoring purposes) (work
RVU = 2.91, intraservice time of 15 minutes) and CPT code 36556
(Insertion of non-tunneled centrally inserted central venous catheter;
age 5 years or older) (work RVU = 2.50, intraservice time of 15
minutes). The RUC determined that these services required the same
intra-service time, comparable physician work and intensity and
recommended CMS accept the RUC-recommended work RVU of 2.50.
Additionally, the RUC continued to urge specialty societies to submit
invoices for new equipment.
Response: We appreciate additional information offered by the
commenters. After consideration of comments received, we agree with the
additional information provided by commenters and are finalizing the
RUC-recommended work RVU of 2.50.
(26) Laparoscopic Radical Prostatectomy (CPT Code 55866)
In the CY 2016 PFS final rule with comment period, we established
an interim final work RVU of 21.36 for CPT code 55866 based on a direct
crosswalk to CPT code 55840 (Prostatectomy, retropubic radical, with or
without nerve sparing). We stated that we believed these codes were
medically similar procedures with nearly identical time values, and we
did not believe that the difference in intensity between CPT code 55840
and CPT code 55866 was significant enough to warrant the RUC-
recommended difference of 5.50 work RVUs. We also compared CPT code
55866 to the work RVU of 25.18 for CPT code 55845, and stated our
belief that, in general, a laparoscopic procedure would not require
greater resources than an open procedure.
Comment on the CY 2016 PFS final rule with comment period: Several
commenters disagreed with the statement that a laparoscopic procedure,
such as CPT code 55866, would generally require fewer resources than an
open procedure, such as CPT code 55840. Commenters stated that
developing the skill necessary to perform a minimally invasive
laparoscopic surgery requires a greater degree of experience and
specialized training than that required to perform an open
prostatectomy. Commenters indicated that this level of practitioner
skill should be reflected in the work RVU for the procedure, as
intensity is based in part upon skill, mental effort, and psychological
stress.
Response in the CY 2017 PFS proposed rule: We agreed with the
commenters that skill and technique, as well as mental effort and
psychological stress on the part of the practitioner contribute to the
overall intensity of the furnishing a given service, and therefore, are
one of the two components in determining code-level work RVUs. However,
we did not believe that relative increases in requisite skill or
technique can be considered alone. Although the development of new
technology (such as robotic assistance) may create a greater burden of
knowledge on the part of the practitioner, it can also make procedures
faster, safer, and easier to perform. This means that there may be
reductions in time for such a procedure (which is the other component
of the work RVU), but also that the mental effort and psychological
stress for a given procedure may be mitigated by the improvements in
safety. Therefore, we did not agree that a newer procedure that
includes additional technology and requires greater training would
inherently be valued at a higher rate than an older and potentially
more invasive procedure.
Comment on the CY 2016 PFS final rule with comment period: A
commenter stated that CPT code 55866 describes two very different
procedures in one code. The descriptor for the code states ``includes
robotic assistance when performed'', and the procedure is performed
differently depending on whether or not the robotic assistance is
included. The commenter indicated that the vast majority of radical
prostatectomies are performed with the robot, and although the outcomes
are the same in both cases, the procedures are completely different.
Response in the CY 2017 PFS proposed rule: We agreed with the
commenter that the descriptor includes the possibility for confusion,
especially on the part of the survey respondents. Valuing this code
based on the typical case is difficult when the procedure differs
depending on the inclusion or exclusion of robotic assistance. We
suggested that valuation might be improved if the CPT Editorial Panel
were to consider further revisions to this code to describe the two
cases of laparoscopic radical prostatectomy: With and without robotic
assistance.
Comment on the CY 2016 PFS final rule with comment period: One
commenter stated that the application of the phase-in transition for
facility-only codes like CPT code 55866 would have a particularly
egregious impact in the second year of the transition. The commenter
urged CMS to ensure that its implementation of the phase-in transition
does not undermine the protections created by the statute.
Response in the CY 2017 PFS proposed rule: Please see sections II.G
and II.H for a discussion of the phase-in transition and its
implementation in its second year.
Comment on the CY 2016 PFS final rule with comment period: Several
commenters requested that CMS refer CPT code 55866 to the refinement
panel for review. At the refinement panel, the presenters brought up
new evidence in the form of a study published in 2016 describing
discharge data for radical laparoscopic prostatectomies. The presenters
stated that there were many more people included in this study as
opposed to the 30 respondents in the survey data, and that on average
the robotic procedure took 90 minutes longer than the open procedure.
The additional time needed to perform the procedure, as indicated by
this new study's results, was presented as a new rationale as to why
CMS should accept the RUC-recommended work RVU.
Response in the CY 2017 PFS proposed rule: CPT code 55866 was
referred to the CY 2016 Multi-Specialty Refinement Panel per the
request of commenters. The outcome of the refinement panel was a median
work RVU of 26.80, the same value as the RUC recommended in the
previous rulemaking cycle. After consideration of the comments and the
results of the refinement panel, we proposed for CY 2017 to maintain
the interim final work RVU of 21.36 for CPT code 55866. We were
interested in the results of the study mentioned at the refinement
panel, and we stated that we would consider incorporating this data
into the valuation of this code, including, if appropriate, adjustments
to the work times used in PFS ratesetting. We also solicited that the
study be submitted through the public comment process so that we could
allow it proper consideration along with other information submitted by
the public, rather than using the results of a single study to propose
valuations. We were also curious about the time values
[[Page 80305]]
regarding the duration of CPT code 55866. One of the members of the
refinement panel stated that on average the robotic procedure took 90
minutes longer than the open procedure. This was not what was indicated
by the survey data from the RUC recommendations, which had the two
procedures valued at virtually identical times (same intraservice time,
6 minutes difference total time). We therefore solicited comment on
whether the times included in this study were more accurate than the
time reflected in the RUC surveys.
The following is a summary of the comments we received regarding
our proposed valuation of CPT code 55866:
Comment: One commenter agreed that the code descriptor for CPT code
55866 might have caused confusion by the RUC survey respondents. The
commenter stated that they were encouraged by the CMS comments that the
valuation might be improved if the CPT Editorial Panel were to consider
further revisions to this code to describe a laparoscopic radical
prostatectomy with and without robotic assistance. The commenter
requested a strong statement from CMS urging the CPT Editorial Panel to
create two unique codes: One for laparoscopic radical prostatectomy and
one for robotic radical prostatectomy.
Response: We believe that there are potential problems with CPT
code 55866 as it is currently described and with the corresponding RUC
recommendation. Commenters presented data suggesting that there are
significant differences between the robotic and non-robotic versions of
the procedure in the length of time required to perform the operation.
However, the same data also suggests that the non-robotic version of
the laparoscopic radical prostatectomy has become comparatively rare.
Given the information presented by commenters, we believe that
valuation might be improved with further revisions to this code.
However, we note that we do not direct the work of the CPT Editorial
Panel, and we also note the comparative rarity of the non-robotic
version of the procedure.
Comment: Several commenters referenced a study entitled ``Robot-
assisted versus Open Radical Prostatectomy: A Contemporary Analysis of
an All-payer Discharge Database'' by J.L. Leow, S.L. Chang, and
colleagues. This study was published in February 2016, and it detailed
how university investigators analyzed more than 600,000 men undergoing
radical prostatectomy in the United States from 2003-2013, which showed
that the robotic approach took on average 90 minutes longer than an
open radical prostatectomy. Commenters noted how this contrasted to the
RUC survey data that had only 32 respondents and recommended an
intraservice time equal to an open radical prostatectomy (180 minutes).
The commenters presented the study data in favor of demonstrating how
the robotic approach to radical prostatectomy detailed in CPT code
55866 takes significantly more time to perform than the open approach
detailed in the CMS crosswalk code 55840. Commenters recommended that
CMS adopt the RUC-recommended work RVU of 26.80 based on this new
clinical evidence contained in the study.
Response: We appreciate the submission of this additional clinical
information from the commenters. We have had longstanding interest in
using robust data sources regarding the resource costs of PFS services,
and we believe that the use of such additional outside data sources can
improve the accuracy of the valuation of services. However, we do note
that the cited study was not specifically designed to measure
intraoperative times and did not use the same ``skin to skin''
definition of intraservice time typically used in the development of
times included in PFS ratesetting.
In this case of the particular comment, we note the potential
logical dissonance of the commenter urging us to adopt the RUC-
recommended work value derived from the RUC survey by citing
alternative data that calls into question the accuracy of the time data
from the same RUC survey. In other words, we are troubled with the idea
that we should consider survey data as valid for work while rejecting
its validity for time, given that time is one of the two elements of
overall work.
Despite these concerns, we agree that the study presents additional
data indicating that there is a significant difference between the open
and robotic-assisted forms of laparoscopic radical prostatectomy, and
that the robotic form described by CPT code 55866 likely takes a longer
time to perform. Based on this presentation of additional clinical
evidence, we agree with the commenters that the recommended work RVU of
26.80 is a more appropriate value for this procedure.
After consideration of comments received, we are finalizing a work
RVU of 26.80 for CPT code 55866.
(27) Hysteroscopy (CPT Codes 58555, 58558, 58559, 58560, 58561, 58562,
and 58563)
During CY 2016 PFS rulemaking, we identified CPT code 58558 as a
potentially misvalued code via the high expenditure specialty screen.
CPT codes 58559-58563 were also included in the RUC's January 2016
review of this family of codes.
For CPT code 58555, the RUC recommended a work RVU of 3.07. We
proposed that the 25th percentile survey result, a work RVU of 2.65,
accurately reflects the resources involved in furnishing this service.
We stated that this value is bracketed by two crosswalk codes, CPT code
43191 (Esophagoscopy, rigid, transoral; diagnostic, including
collection of specimen(s) by brushing or washing when performed
(separate procedure)), which has a work RVU of 2.49, and CPT code 31295
(Nasal/sinus endoscopy, surgical; with dilation of maxillary sinus
ostium (for example, balloon dilation), transnasal or via canine
fossa), which has a work RVU of 2.70. CPT codes 43191 and 31295 have
identical intraservice times and similar total times when compared with
CPT code 58555.
For CPT code 58558, the RUC recommended a work RVU of 4.37.
However, we believed that a direct crosswalk from CPT code 36221 (Non-
selective catheter placement, thoracic aorta, with angiography of the
extracranial carotid, vertebral, and/or intracranial vessels,
unilateral or bilateral, and all associated radiological supervision
and interpretation, includes angiography of the cervicocerebral arch,
when performed), which has a work RVU of 4.17, and identical
intraservice time, and similar total time, more accurately reflects the
time and intensity of furnishing this service. Our proposed work RVU
was additionally supported by using an increment between this code and
the base code for this family, CPT code 58555. The increment between
the RUC-recommended values for these two codes is 1.3. That increment
added to the proposed work RVU of 2.65 for the base code, CPT code
58555, results in a work RVU of 3.95. Therefore, we proposed a work RVU
of 4.17 RVUs for CPT code 58558.
For CPT code 58559, the RUC recommended a work RVU of 5.54.
However, we believed that a direct crosswalk from CPT code 52315
(Cystourethroscopy, with removal of foreign body, calculus, or ureteral
stent from urethra or bladder (separate procedure); complicated), which
has a work RVU of 5.20, a similar intraservice
[[Page 80306]]
time, and similar total time as compared with CPT code 58559 more
accurately reflects the time and intensity of furnishing this service.
This proposed value was additionally supported by using an increment
between CPT code 58559 and the base code for this family, CPT code
58555. The increment between the RUC recommended values for the two
codes is 2.47. That increment added to the proposed value for the base
code, CPT code 58555, would result in a work RVU of 5.12. Therefore, we
proposed a work RVU of 5.20 for CPT code 58559.
For CPT code 58560, the RUC recommended a work RVU of 6.15. We
stated in the proposed rule that we believe that a direct crosswalk
from CPT code 52351 (Cystourethroscopy, with ureteroscopy and/or
pyeloscopy; diagnostic), which has a work RVU of 5.75 and which has
more intraservice time and very similar total time, more accurately
reflects the time and intensity of furnishing this service. Our
proposal further supported this value by using an increment between CPT
code 58560 and the base code for this family, CPT code 58555. We stated
that the increment between the RUC recommended values for the two codes
is 3.08. That increment added to the proposed value for the base code,
CPT code 58555, would result in a work RVU of 5.73. Therefore, we
proposed a work RVU of 5.75 for CPT code 58560.
For CPT code 58561, the RUC recommended a work RVU of 7.00. We
stated in the proposed rule that we believe that a direct crosswalk
from CPT code 35475 (Transluminal balloon angioplasty, percutaneous;
brachiocephalic trunk or branches, each vessel), which has a work RVU
of 6.60 and which has similar intraservice and total times, more
accurately reflected the time and intensity of furnishing this service.
We also noted that our proposal was further supported by using an
increment between CPT code 58561 and the base code for this family, CPT
code 58555. The increment between the RUC recommended values for the
two codes is 3.93. That increment added to the proposed value for the
base code, CPT code 58555, would result in a work RVU of 6.58.
Therefore, we proposed a work RVU of 6.60 for CPT code 58561.
For CPT code 58562, the RUC recommended a work RVU of 4.17.
However, we believed that a direct crosswalk of the work RVUs for CPT
code 15277 (Application of skin substitute graft to face, scalp,
eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or
multiple digits, total wound surface area greater than or equal to 100
sq cm; first 100 sq cm wound surface area, or 1% of body area of
infants and children), which has a work RVU of 4.00 and which has
identical intraservice time and similar total time, more accurately
reflects the time and intensity of furnishing this service. The RUC
also used this code as one of its supporting codes for its
recommendation. This value is additionally supported by using an
increment between CPT code 58562 and the base code for this family, CPT
code 58555. The increment between the RUC recommended values for the
two codes is 1.10. That increment added to the proposed value for the
base code, CPT code 58555, results in a work RVU of 3.75. Therefore, we
proposed a work RVU of 4.00 for CPT code 58562.
For CPT code 58563, the RUC recommended a work RVU of 4.62.
However, we believed that a direct crosswalk of the work RVUs for CPT
code 33962 (Extracorporeal membrane oxygenation (ECMO)/extracorporeal
life support (ECLS) provided by physician; reposition peripheral
(arterial and/or venous) cannula(e), open, 6 years and older (includes
fluoroscopic guidance, when performed)), which has a work RVU of 4.47
and that has identical intraservice time and similar total time, more
accurately reflects the resources involved in furnishing this service.
This value is additionally supported by using an increment between CPT
code 58563 and the base code for this family, CPT code 58555. The
increment between the RUC recommended values for the two codes is 1.55.
That increment added to the proposed value for the base code, CPT code
58555), results in a work RVU of 4.20. We note that CPT code 58563 has
the same instraservice time and the same total time as CPT code 58558;
however, we agreed that the intensity would be slightly higher for this
service. Therefore, we proposed a work RVU of 4.47 for CPT code 58562.
The RUC submitted invoices for two new equipment items used in
furnishing CPT code 58558, the hysteroscopic fluid management system
and the hysteroscopic resection system. We proposed to use these
invoice prices for the hysteroscopic fluid management system, which
totaled $14,698.38. The hysteroscopic resection system included the
price of the hysteroscope, as well as other items necessary for tissue
removal. However, we generally price endoscopes separately and not as a
part of a system. To maintain consistency, we proposed not to include
the hysteroscope from the Resection System. Instead, we proposed to
update the equipment item ``endoscope, rigid, hysteroscopy'' (ES009)
with the invoice price, $6,207.50. We did not propose to include the
sterilization tray from the hysteroscopic resection system because we
believe this tray has generally been characterized as an indirect
practice expense. For the hysteroscopic resection system, we proposed
to include the hysteroscopic tissue remover ($18,375), the sheath
($1,097.25), and the calibration device ($300), and created a new
equipment item code, priced at $19,857.50 in the proposed direct PE
input database. We did not propose to include the calibration device
since the submitted price was not documented with a paid invoice.
Comment: Commenters, including the RUC, disagreed with CMS'
proposed refinements to the work RVUs for these procedures, and
requested that CMS finalize the RUC-recommended work values for these
codes. Commenters suggested that these procedures are more complex in
cases where it is more difficult to find and feed the scopes through
the cervix. Commenters suggested that it appeared as though CMS used a
time to work ratio to value these services, stating further that, for
example, CPT code 58555 requires a forced dilation of a natural
orifice, very small in size and can be difficult to identify in a post-
menopausal patient or a patient with prior cervical surgery. Commenters
suggested that the CMS crosswalk codes are for a natural orifice that
might not require any dilation or only a 10% dilation, and the orifice
is consistently the same with little variation among patients.
Response: While we appreciate the commenters' feedback, we do not
consider forced or difficult dilation as described by the commenter to
be typical based on the RUC's clinical vignette and that the difficulty
of forced dilation at the time of surgery can often be offset by
preoperative cervical ripening. Therefore, we are finalizing the
following work RVUs for each code in this family.
CPT code 58555, 2.65 work RVUs;
CPT code 58558, 4.17 work RVUs;
CPT code 58559, 5.20 work RVUs;
CPT code 58560, 5.75 work RVUs;
CPT code 58561, 6.60 work RVUs;
CPT code 58562, 4.00 work RVUs; and
CPT code 58563, 4.47 work RVUs.
Comment: Regarding the direct PE inputs for CPT code 58558, one
commenter requested that CMS add a procedure kit and update the prices
for these supplies to reflect the cost of providing this procedure in
the physician office setting. The commenter also submitted invoices
related to other direct PE inputs for this code, including invoices for
the incisor blade and the procedure kit, which the commenter
[[Page 80307]]
indicated includes inflow tubing, outflow tubing, and the non-sterile
components of jumper cables and a tissue trap.
Response: We appreciate the feedback we received regarding the
direct PE inputs for CPT code 58558. We agree with the addition of the
hysteroscopic procedure kit and are creating a new supply item
``hysteroscopic fluid management tubing set'' using a single invoice
price of $320. Additionally, we note that we inadvertently did not
remove the existing direct PE inputs related to suction, which we
proposed to replace with the hysteroscopic fluid management system.
Therefore, we are removing direct PE inputs for the following items:
Supply item SD009: Canister, suction;
Supply item SD031: Catheter, suction; and
Equipment item EQ235: Suction machine (Gomco).
The commenter also included an additional invoice for the incision
instrument. Based on this new information, we are renaming this new
supply item, ``hysteroscopic tissue removal device,'' with a final
price of $629.00, which is the simple average of the two invoice prices
we have received for this supply item ($599 and $659 respectively).
Additionally, we note that our proposed summary price for the
hysteroscopic resection system was added incorrectly. The correct price
is $19,772.25. We are also modifying the equipment title to ensure
clarity of items included in the hysteroscopic resection system
(control unit, footpiece, handpiece, sheath and calibration device).
(28) Intracranial Endovascular Intervention (CPT Codes 61645, 61650,
and 61651)
For CY 2016, we established an interim final work RVU of 15.00 for
CPT code 61645, 10.00 for CPT code 61650 and 4.25 for CPT code 61651.
The RUC-recommended values for CPT codes 61645, 61650 and 61651 were
17.00, 12.00 and 5.50, respectively. We valued CPT code 61645 by
applying the ratio between the RUC-recommended reference code, CPT code
37231 (revascularization, endovascular, open or percutaneous, tibial,
peroneal artery, unilateral, initial vessel; with transluminal stent
placement(s) and atherectomy, includes angioplasty within the same
vessel, when performed), to the work and time for CPT code 61645. We
valued CPT code 61650 based on a crosswalk to CPT code 37221
(revascularization, endovascular, open or percutaneous, iliac artery,
unilateral, initial vessel; with transluminal stent placement(s),
includes angioplasty within the same vessel, when performed), due to
similar intensity and intraservice time. We valued CPT code 61651 based
on a crosswalk to CPT code 37223 (revascularization, endovascular, open
or percutaneous, iliac artery, each additional ipsilateral iliac
vessel; with transluminal stent placement(s), includes angioplasty
within the same vessel, when performed (list separately in addition to
the code for primary procedure)), due to similar intraservice time and
intensity.
Both CPT codes 61645 and 61650 included postservice work time
associated with a level 3 inpatient hospital visit. In the CY 2016 PFS
final rule with comment period, we stated that we believe that for the
typical patient, these services would be considered hospital outpatient
services, not inpatient services. As a result, the intraservice time of
the hospital observation care service was valued in the immediate
postservice time. We refined the work time for CPT code 61645 by
removing 55 minutes of work time associated with CPT code 99233, and
added 30 minutes of time to the immediate postservice time. Therefore,
the total time for CPT code 61645 was reduced to 241 minutes and the
immediate postservice time increased to 83 minutes. We also removed the
inpatient visit from CPT code 61650, which reduced the total time to
206 minutes and increased the postservice time to 75 minutes.
Comment on the CY 2016 PFS final rule with comment period:
Commenters disagreed with our categorization of these codes as
typically outpatient. Commenters stated that according to Medicare
claims data, the predecessor codes were performed primarily on an
inpatient basis. Additionally, commenters pointed out that the new
codes would typically be performed on acute stroke patients. Commenters
also said as the new codes are inpatient-only, the CMS reductions in
work and time based on the assumption of outpatient status are flawed
and suggested we accept the RUC-recommended values. Commenters also
requested that these codes be referred to the refinement panel.
Response in the CY 2017 PFS proposed rule: For CY 2016, we valued
CPT codes 61645, 61650, and 61651 based on comparisons to CPT codes
37231, 37221, and 37223, respectively. We continue to believe that
these crosswalks are appropriate comparisons based on intensity and
intraservice time, and because no persuasive information was presented
at the refinement panel that indicated that these comparisons are not
accurate. Therefore, for CY 2017, we proposed work RVUs of 15.00 for
CPT code 61645, 10.00 for CPT code 61650, and 4.25 for CPT code 61651.
We also proposed time inputs based on our refinements of the RUC
recommendations, including removing the time associated with a hospital
inpatient visit (CPT code 99233) from the intraservice work time, and
adding 30 minutes to the immediate postservice time for both CPT codes
61645 and 61650.
We do not believe that 0-day global codes should include post-
operative visits; rather, if global codes require post-operative
visits, they are more appropriately assigned 10- or 90-day global
periods based on our current criteria. Our policy has been to remove
the visit from the post-operative period and the associated minutes
from the total time while adding 30 minutes to the immediate
postservice period without necessarily making an adjustment to the work
RVU (see the CY 2010 PFS proposed rule, 74 FR 33557; also see the CY
2011 PFS proposed rule, 75 FR 40072). We solicited comment on the
inclusion of post-operative visits in valuation of codes with 0-day
global periods. Both CPT codes 61645 and 61650 are assigned 0-day
global periods, and the refinements we proposed reflected changes to
more appropriately value these codes with 0-day global periods.
The following is a summary of the comments we received regarding
our proposed valuations for the intracranial endovascular intervention
family:
Comment: Commenters, including the RUC, requested that CMS finalize
the RUC-recommended work RVUs for CPT codes 61645, 61650 and 61651. The
RUC suggested that evaluating the actual physician work performed in
the inpatient setting is more accurate than applying a crosswalk to a
CPT code that is performed predominantly in the outpatient setting. As
examples, the RUC noted that CPT code 61645 would not be performed in
the outpatient setting, and CPT codes 61650 and 61651 would be
performed in the intensive care unit. For CPT codes 61645 and 61650,
commenters also expressed concern about CMS' proposed refinements to
remove the time associated with a postservice visit from each code and
subsequently adding 30 minutes to the immediate postservice period for
each of these codes. The RUC suggested that these CMS refinements
artificially reduced the total work time for CPT codes 61645 and 61650.
[[Page 80308]]
Response: We continue to believe that our crosswalks for each of
these codes accurately reflect the physician work involved in these
procedures due to similarities in intensity and intraservice time. For
example, our proposed work RVU of 15.00 for CPT code 61645 would be the
highest work value among comparable codes with similar intraservice
times. We note that we identified three CPT codes with similar
intraservice times (CPT codes 33955, 33956, and 33988) that had higher
work RVUs than our proposed work RVU of 15.00, but these three CPT
codes are used to report extracorporeal membrane oxygenation or
extracorporeal life support services (ECMO/ECLS) procedures, which we
do not believe are comparable to the CPT codes in this family.
Regarding physician time for CPT codes 61645 and 61650, as we
discussed in the proposed rule, we do not believe that 0-day global
codes should include post-operative visits; rather, if global codes
require post-operative visits, they are more appropriately assigned 10-
or 90-day global periods based on our current criteria. Our policy has
been to remove the visit from the post-operative period and the
associated minutes from the total time while adding 30 minutes to the
immediate postservice period without necessarily making an adjustment
to the work RVU (see the CY 2010 PFS proposed rule, 74 FR 33557; also
see the CY 2011 PFS proposed rule, 75 FR 40072).
Therefore, for CY 2017, we are finalizing a work RVU of 15.00 for
CPT code 61645, a work RVU of 10.00 for CPT code 61650, and a work RVU
of 4.25 for CPT code 61651.
(29) Epidural Injections (CPT Codes 62320, 62321, 62322, 62323, 62324,
62325, 62326, and 62327)
We proposed the RUC-recommended work RVU for all eight of the codes
in this family.
We proposed to remove the 10-12mL syringes (SC051) and the RK
epidural needle (SC038) from all eight of the codes in this family. We
stated that these supplies were duplicative, as they are included in
the epidural tray (SA064). As an alternative, we raised the possibility
of removing the epidural tray and replacing it with the individual
supply components used in each procedure; we solicited public comment
on either the inclusion of the epidural tray or its individual
components for this family of codes.
The following is a summary of the comments we received regarding
our proposed valuation of the Epidural Injection codes:
Comment: A few commenters expressed their support for the proposed
work values.
Response: We appreciate the support from the commenters.
Comment: Several commenters disagreed with the proposed removal of
the 10-12mL syringes (SC051) and the RK epidural needle (SC038) due to
the CMS belief that they are duplicative of the supplies in the
epidural tray (SA064). Commenters stated that although there are three
syringes listed in the epidural tray, none of the syringes in the tray
are the 10-12mL syringe. In addition, none of the needles currently
listed in the epidural tray (SA064) are an epidural needle. As a
result, commenters indicated that there was no reason to replace the
epidural tray with its individual components.
Response: We appreciate this clarification from the commenters
regarding the components that make up the epidural tray. Taking this
information into account, we are restoring the 10-12mL syringes (SC051)
and the RK epidural needle (SC038) to all eight of the codes in this
family.
After consideration of comments received, we are finalizing the
proposed work RVUs for the Epidural Injection codes. We are also
finalizing the proposed direct PE inputs, with the addition of the 10-
12mL syringes and the RK epidural needle detailed above.
(30) Endoscopic Decompression of Spinal Cord (CPT Code 62380)
For CY 2016, the CPT Editorial Panel created CPT code 62380 to
describe the endoscopic decompression of neural elements. The RUC
recommended a work RVU of 10.47 based on a crosswalk to CPT code 47562
(Laparoscopy, surgical; cholecystectomy) with a higher intraservice
time than reflected in the survey data. Since we believe CPT codes
62380 and 47562 are similar in intensity, we believe using the same
work RVU as the crosswalk code overestimates the work involved in
furnishing CPT code 62380. Reference CPT code 49507 (Repair initial
inguinal hernia, age 5 years or older; incarcerated or strangulated)
has a work RVU of 9.09 and has similar intensity and an identical
intraservice time compared to CPT code 62380. Therefore, we proposed a
work RVU of 9.09 for CPT code 62380.
Comment: Some commenters reiterated that the RUC-recommended direct
crosswalk to CPT code 47562 is appropriate since this code has a
similar physician time, and the IWPUT of the RUC-recommended work RVU
is 0.085, a comparable valuation when compared with other spinal
decompression procedures. The RUC agreed that the intensity of CPT code
62380 was greater, which offsets the 10 minute difference in
intraservice time between the two codes. The RUC indicated that the
difference in intensity between these procedures is based on CPT code
62380 involving decompression about neural elements and the spinal
cord, where the opportunity for complications and for loss of function
is high. One commenter indicated that CMS' proposed work RVU would fall
below the minimum survey results.
A few commenters expressed concerns about the structure of the CPT
code descriptors and RUC-recommended valuations. Commenters suggested
that the CPT Editorial Panel and the RUC did not take certain
indications into account such as differences between the physician work
required for endoscopic tubular microdiscectomy compared to lumbar
spinal stenosis decompression and posterior cervical posterior
laminoforaminotomy. Commenters indicated that the specialty society
survey data was inadequate due to the inexperience of the survey
respondents, with others suggesting that the survey times were not
reflective of some practitioners' experience or patient complexity.
The commenters indicated that the current RUC recommendations for
full endoscopic tubular endoscopic surgery are based on limited
experience among survey respondents with lumbar microdiscectomy, and
insufficient experience with lumbar spinal stenosis decompression and
posterior cervical foraminotomy without fusion and are invalid for
these indications. Commenters requested that the current CPT codes and
valuations for full endoscopic lumbar spinal stenosis decompression and
posterior cervical foraminotomy without fusion remain unchanged until
further RUC survey data are examined. Some commenters suggested
alternative crosswalks including CPT code 61548 (Hypophysectomy or
excision of pituitary tumor, transnasal or transseptal approach,
nonstereotactic) with a work RVU of 23.37, CPT code 63030 (Laminotomy
(hemilaminectomy), with decompression of nerve root(s), including
partial facetectomy, foraminotomy and/or excision of herniated
intervertebral disc; 1 interspace, lumbar) with a work RVU of 13.18,
and CPT code 63056 (Transpedicular approach with decompression of
spinal cord, equina and/or nerve root(s) (e.g., herniated
intervertebral disc), single segment;
[[Page 80309]]
lumbar (including transfacet, or lateral extraforaminal approach)
(e.g., far lateral herniated intervertebral disc)) with a work RVU of
21.86.
Response: As discussed above, commenters raised multiple concerns
about the accuracy of the survey results, the RUC's recommended
valuation of this service, and our subsequent proposed refinements.
Therefore, at this time, we are finalizing contractor pricing for CPT
code 62380. We note that the summary of recommendations (SOR) included
with the RUC recommendations indicated that the expert panel reviewing
the survey data for this procedure believed the survey median and 25th
percentile work RVU were inconsistent with the physician work as it
related to other major open spine procedures. Subsequently, the RUC
recommended a work RVU of 10.47 based on a crosswalk from CPT code
47562 (Laparoscopy, surgical; cholecystectomy). The RUC noted that
procedures reported with CPT code 62380 have ten minutes less
intraoperative time compared to the RUC's recommended crosswalk from
CPT code 62380, but suggested that the physician work of endoscopic
decompression in the small disc interspace near the spinal nerve roots
of the cauda equina is more complex and will require more post-
discharge office work for required imaging to confirm stabilization and
for physical therapy orders and monitoring.
We note that based on the RUC's utilization crosswalk, services
that will be reported in CY 2017 with CPT code 62380 are currently
reported using either CPT code 22899 (Unlisted procedure, spine) or CPT
code 0275T (Percutaneous laminotomy/laminectomy (interlaminar approach)
for decompression of neural elements, (with or without ligamentous
resection, discectomy, facetectomy and/or foraminotomy), any method,
under indirect guidance (e.g., fluoroscopic, CT), with or without the
use of an endoscope, single or multiple levels, unilateral or
bilateral; lumbar)), which are both contractor priced for CY 2016. We
welcome feedback from interested parties and specialty societies
regarding valuation of this service for consideration in future
rulemaking.
(31) Paravertebral Block Injection (CPT Codes 64461, 64462, and 64463)
In CY 2015, the CPT Editorial Panel created three new codes to
describe paravertebral block injections at single or multiple levels,
as well as for continuous infusion for the administration of local
anesthetic for post-operative pain control and thoracic and abdominal
wall analgesia. For the CY 2016 PFS final rule with comment period, we
established the RUC-recommended work RVUs of 1.75 and 1.10 as interim
final for CPT codes 64461 and 64462, respectively. For CPT code 64463,
we utilized a direct crosswalk from three other injection codes (CPT
codes 64416 (Injection, anesthetic agent; brachial plexus, continuous
infusion by catheter (including catheter placement), 64446 (Injection,
anesthetic agent; sciatic nerve, continuous infusion by catheter
(including catheter placement), and 64449 (Injection, anesthetic agent;
lumbar plexus, posterior approach, continuous infusion by catheter
(including catheter placement)), which all had a work RVU of 1.81, as
we believed this crosswalk more accurately reflected the work involved
in furnishing this service.
Comment on the CY 2016 PFS final rule with comment period: We
received comments from the RUC stating CPT code 64463 was more
comparable to CPT code 64483 (Injection(s), anesthetic agent and/or
steroid, transforaminal epidural, with imaging guidance (fluoroscopy or
CT); lumbar or sacral, single), which has a work RVU of 1.90 and
requires the same physician work and time to perform. The RUC
recommended we accept a work RVU of 1.90, which is the 25th percentile
of the survey. Another commenter stated that our interim final work RVU
for CPT code 64463 was inappropriate since imaging guidance is not part
of our comparison codes. The commenter advocated for us to accept the
survey respondent's selection of CPT code 64483 as the most appropriate
comparison code and assign a work RVU of 1.90.
Response in the CY 2017 PFS proposed rule: After reviewing and
considering the comments, we stated we continued to believe that CPT
codes 64416, 64446, and 64449, all of which have 20 minutes of
intraservice time, are better crosswalks to CPT code 64463, which also
has 20 minutes of intraservice time and a similar total time. In
contrast, the crosswalk code recommended by commenters, CPT 64483, only
has 15 minutes of intraservice time. Therefore, for CY 2017 we proposed
a work RVU of 1.81 for CPT code 64463.
The following is a summary of the comments we received regarding
our proposed valuations for the Paravertebral Block Injection family:
Comment: One commenter stated that CMS based its decision on an
inappropriate comparison of CPT code 64463 with codes that describe
continuous peripheral nerve blocks that do not include imaging
guidance. The commenter stated that the imaging component included in
CPT code 64463 was justification for at least the 0.09 difference
between the RUC recommendation and the CMS proposed value. The
commenter offered CPT code 47000 (Biopsy of liver, needle;
percutaneous), which has identical intraservice time and a work RVU of
1.90 as a comparator code.
Response: We appreciate the additional information offered by the
commenters and we agree with the commenter's statement that the image
guidance component of this service was justification for the 0.09
difference between the RUC recommendation and the CMS proposed value.
After review and consideration of the comments, we are finalizing the
RUC-recommended work RVUs of 1.75, 1.10 and 1.90 for CPTs code 64461,
64462 and 64463, respectively for CY 2017.
(32) Implantation of Neuroelectrodes (CPT Codes 64553 and 64555)
The RUC identified CPT codes 64553 and 64555 as a site of service
anomaly during the CY 2016 PFS rulemaking cycle. In the Medicare claims
data, these services were typically reported in the nonfacility
setting, yet the survey data were predicated on a facility-based
procedure. We agreed with the RUC that these two codes should be
referred to the CPT Editorial Panel to better define the services, in
particular to investigate the possibility of establishing one code to
describe temporary or testing implantation and another code to describe
permanent implantation. We maintained the CY 2015 work RVUs and direct
PE inputs for these two codes on an interim basis until receiving
updated recommendations from the CPT Editorial Panel and the RUC.
Comment on the CY 2016 PFS final rule with comment period: A
commenter requested that CMS allow practitioners to bill the MACs
separately for a percutaneous electrode kit (SA022) for CPT code 64555.
The commenter stated that without allowing for a separate payment for
the percutaneous electrode kit, the payment for the procedure would be
insufficient to cover the physician's costs.
Response in the CY 2017 PFS proposed rule: We agreed that CPT codes
64553 and 64555 as currently constructed were potentially misvalued
codes, which is why we maintained the CY 2015 work RVUs and direct PE
inputs on an interim basis. We believe that the disposable supplies
furnished incident to the procedure are paid through the nonfacility PE
RVUs. The
[[Page 80310]]
percutaneous electrode kit (SA022) was not previously included in the
direct PE inputs for either of these two services, and since we
proposed to maintain current direct PE inputs pending additional
recommendations, we do not agree that disposable supplies should be
separately payable. We proposed to maintain the interim final work RVUs
and direct PE inputs for these two codes, and we looked forward to
reviewing recommendations regarding these procedures again for future
rulemaking.
Additionally, we were alerted to a discrepancy regarding the times
for these codes in the CY 2016 work time file. Our proposed CY 2017
work time file addressed this discrepancy by reflecting the RUC
recommended times of 155 minutes for CPT code 64553 and 140 minutes for
CPT code 64555.
The following is a summary of the comments we received regarding
our proposed valuation of the Implantation of Neuroelectrodes codes:
Comment: One commenter responded to the CMS request for information
about whether there was a need for separate codes for temporary/testing
and permanent placement for neuroelectrodes. The commenter stated that
it did not support the creation of new separate codes at this time. The
commenter stressed that the current codes account for the work of both
temporary/testing and permanent placement, making the creation of new
codes unwarranted.
Response: We appreciate the submission of this information from the
commenter. We did not receive any comments addressing the proposed
valuation of these codes.
After consideration of comments, we are finalizing the proposed
work RVUs and proposed direct PE inputs for CPT codes 64553 and 64555.
(33) Ocular Reconstruction Transplant (CPT Code 65780)
In CY 2015, the RUC identified CPT code 65780 as potentially
misvalued through a misvalued code screen for 90-day global services
that included more than 6 office visits. The RUC recommended a direct
work RVU crosswalk from CPT code 27829 (Open treatment of distal
tibiofibular joint (syndesmosis) disruption, includes internal
fixation, when performed). After examining comparable codes, we
determined the RUC-recommended work RVU of 8.80 for CPT code 65780
would likely overstate the work involved in the procedure given the
change in intraservice and total times compared to the previous values.
We believed that the ratio of the total times (230/316) applied to the
work RVU (10.73) more accurately reflected the work involved in this
procedure. Therefore, we established an interim final work RVU of 7.81
for CPT code 65780.
Comment on the CY 2016 PFS final rule with comment period: The RUC
and other commenters disagreed with our interim final values based on
objections to our use of time ratios in developing work RVUs for PFS
services.
Response in the CY 2017 PFS proposed rule: We stated that we
appreciate the commenters' concerns and responded to these concerns
about our methodology in section II.L of the CY 2017 proposed rule.
After review of the comments, we continued to consider the work RVU of
7.81 to accurately represent the work involved in CPT code 65780. We
believed this service was similar in overall intensity to CPT code
27766 (Open treatment of medial malleolus fracture, includes internal
fixation, when performed) that has a work RVU of 7.89 and a total time
that more closely approximates that of CPT code 65780.
In the CY 2017 proposed rule, we proposed a work RVU of 7.81 for
CPT code 65780.
We did not receive any comments in response to our proposed
valuation on CPT code 65780; therefore, we are finalizing a work RVU of
7.81 as proposed.
(34) Trabeculoplasty by Laser Surgery (CPT Code 65855)
In CY 2015, the RUC identified CPT code 65855 as potentially
misvalued through the review of 10-day global services with more than
1.5 postoperative visits. The RUC noted that the code was changed from
a 90-day to a 10-day global period when it was last valued in 2000.
However, the descriptor was not updated to reflect that change. CPT
code 65855 describes multiple laser applications to the trabecular
meshwork through a contact lens to reduce intraocular pressure. The
current practice is to perform only one treatment session during a 10-
day period and then wait for the effect on the intraocular pressure.
The descriptor for CPT code 65855 has been revised and removes the
language ``1 or more sessions'' to clarify this change in practice.
The RUC recommended a work RVU of 3.00 for CPT code 65855. While
the RUC-recommended value represents a reduction from the CY 2015 work
RVU of 3.99, we stated that significant reductions in the intraservice
time, the total time, and the change in the office visits represent a
more significant change in the work resources involved in furnishing
the typical service. The intraservice and total times were decreased by
approximately 33 percent while the elimination of two postoperative
visits (CPT code 99212) alone would reduce the overall work RVU by at
least 24 percent under the reverse building block method. However, the
RUC-recommended work RVU only represents a 25 percent reduction
relative to the previous value. To identify potential work RVUs for
this service, we calculated an intraservice time ratio between the CY
2015 intraservice time, 15 minutes, and the RUC-recommended
intraservice time, 10 minutes, and applied this ratio to the current
work RVU of 3.99 to arrive at a work RVU of 2.66 for CPT code 65855,
which we established as interim final for CY 2016.
Comment on the CY 2016 PFS final rule with comment period: A few
commenters, including the RUC, provided explanations as to how the RUC
recommendation had already accounted for the reduction in physician
intraservice time and post-operative visits. Some commenters disagreed
with CMS' interim final values based on objections to CMS' use of time
ratios in developing work RVUs for PFS services.
Response in the CY 2017 PFS proposed rule: We stated that we
appreciated the commenters' concerns regarding the time ratio
methodologies and responded to those concerns about our methodology in
section II.H.2 of the CY 2017 proposed rule. After considering the
explanations provided by commenters through public comments describing
the RUC's methodologies in more detail, we agreed that the proposed
value did not accurately reflect the physician work involved in
furnishing the service.
In the CY 2017 proposed rule, we proposed the RUC-recommended work
RVU value of 3.00 for CPT code 65855.
We did not receive any comments in response to our proposed
valuation on CPT code 65855; therefore, we are finalizing a work RVU of
3.00 as proposed.
Comment: A few commenters stated their support of CMS' decision to
propose the RUC-recommended value for CY 2017 and strongly urged us to
finalize the proposal.
Response: Thank you for your comments. For CY 2017 we are
finalizing the RUC-recommended work RVU of 3.00 for CPT code 65855.
[[Page 80311]]
(35) Glaucoma Surgery (CPT Codes 66170 and 66172)
The RUC identified CPT codes 66170 and 66172 as potentially
misvalued through a screen for 90-day global codes that included more
than six office visits. We believed the RUC-recommended work RVU of
13.94 for CPT code 66170 did not accurately account for the reductions
in time. Specifically, the survey results indicated reductions of 25
percent in intraservice time and 28 percent in total time. These
reductions suggested that the RUC-recommended work RVU for CPT code
66170 overstated the work involved in furnishing the service, since the
recommended value only represented a reduction of approximately seven
percent. We believed that applying the intraservice time ratio, the
ratio between the CY 2015 intraservice time, 60 minutes, and the RUC-
recommended intraservice time, 45 minutes, applied to the current work
RVU, 15.02, resulted in a more appropriate work RVU of 11.27.
Therefore, for CY 2016, we established an interim final work RVU of
11.27 for CPT code 66170.
For CPT code 66172, the RUC recommended a work RVU of 14.81. After
comparing the RUC-recommended work RVU for this code to the work RVU
for similar codes (for example, CPT code 44900 (Incision and drainage
of appendiceal abscess, open) and CPT code 52647 (Laser coagulation of
prostate, including control of postoperative bleeding, complete
(vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or
dilation, and internal urethrotomy are included if performed))), we
believed the RUC-recommended work RVU of 14.81 overstated the work
involved in this procedure. For the same reasons and following the same
valuation methodology utilized above, we applied the intraservice time
ratio between the CY 2015 intraservice time and the survey intraservice
time, 60/90, to the CY 2015 work RVU of 18.86. This resulted in a work
RVU of 12.57 for CPT code 66172. Therefore, for CY 2016, we established
an interim final work RVU of 12.57 for CPT code 66172.
Comment on the CY 2016 PFS final rule with comment period: Several
commenters, including the RUC, objected with our interim final values
based on objections to our use of time ratios in developing work RVUs
for PFS services. Commenters also requested CMS refer CPT codes 66170
and 66172 to the refinement panel.
Response in the CY 2017 PFS proposed rule: We acknowledged
commenters' concerns regarding the time ratio methodologies and
responded to those concerns in section II.H.2 of the CY 2017 proposed
rule (81 FR 46162). CPT codes 66170 and 66172 were referred to the CY
2016 multi-specialty refinement panel per commenters' request. The
outcome of the refinement panel was a median of 13.94 RVUs for CPT code
66170 and 14.84 RVUs for CPT code 66172. Due to the new information
presented to the refinement panel regarding the level of intensity
required to perform millimeter incisions in the eye, we agreed with the
assessment of the refinement panel and proposed a work RVU of 13.94 for
CPT code 66170 and 14.84 for CPT code 66172 for CY 2017.
The following is a summary of the comments we received regarding
our proposed valuations for the Glaucoma Surgery family:
Comments: Several commenters stated their support of CMS' decision
to propose the values recommended by the refinement panel for CPT codes
66170 and 66172. Some commenters, including the RUC, also brought to
our attention discrepancies between our proposal for these codes in the
CY 2017 proposed rule and the work RVUs posted in Addendum B on the CMS
Web site.
Response: For CY 2017, we are finalizing a work RVU of 13.94 for
CPT code 66170 and a work RVU of 14.84 for CPT code 66172. We
appreciate commenters bringing this issue regarding conflicting
information in the CY 2017 PFS proposed rule preamble text and the
public use files published on the CMS Web site. We have corrected this
discrepancy in this final rule and the associated public use files.
(36) Retinal Detachment Repair (CPT Codes 67101, 67105, 67107, 67108,
67110, and 67113)
For CY 2015, the CPT Editorial Panel made several changes to CPT
codes 67101 and 67105. These changes include revising the code
descriptors to exclude ``diathermy'' and ``with or without drainage of
subretinal fluid'' and removing the reference to ``1 or more
sessions.'' The recommended global period also changed from 90 days to
10 days. For CPT code 67101, we proposed the RUC recommended work RVU
of 3.50, which was based on the 25th percentile of the survey. For CPT
code 67105, the RUC recommended a work RVU of 3.84 based on the 25th
percentile of the survey. The RUC also stated that CPT code 67105 was a
more intense procedure, and therefore, it should have a higher work RVU
than CPT code 67101. Currently, CPT code 67101 has a higher work RVU
than CPT code 67105 and according to the surveys, the intraservice and
total times remain higher for CPT code 67101. We do not understand why
the RUC believes that CPT code 67105 is more work than CPT code 67101.
Therefore, we did not propose the RUC-recommended work RVU of 3.50 for
CPT code 67105. We did not find evidence that CPT code 67105 is more
intense than CPT code 67101 and accordingly, proposed a lower work RVU
for CPT code 67105. To value CPT code 67105, we used the RVU ratio
between CPT codes 67101 and 67105. We divided the current work RVU of
8.53 for CPT code 67105, by the current work RVU of 8.80 for CPT code
67101 and multiplied the quotient by the RUC-recommended work RVU of
3.50 for CPT code 67101 to arrive at a work RVU of 3.39. Therefore, for
CY 2017, we proposed a work RVU of 3.39 for CPT code 67105.
CPT codes 67107, 67108, 67110, and 67113 were identified through
the Relative Assessment Workgroup process under the 90-day global post-
operative visit screen in CY 2015. The RUC recommended a work RVU of
16.00 for CPT code 67107, which corresponded to the 25th percentile of
the survey. While the RUC recommendation represented a five percent
reduction from the current work RVU of 16.71, we believed the RUC
recommendation still overvalued the service given the 15 percent
reduction in intraservice time and 25 percent reduction in total time.
We used the intraservice time ratio between the existing and new
time values to identify an interim final work RVU of 14.06. We believed
this value accurately reflected the work involved in this service and
was comparable to other codes that have the same global period and
similar intraservice time and total time. For CY 2016, we established
an interim final work RVU of 14.06 for CPT code 67107. For CPT code
67108, the RUC recommended a work RVU of 17.13 based on the 25th
percentile of the survey, which reflected a 25 percent reduction from
the current work RVU. The survey results reflected a 53 percent
reduction in intraservice time and a 42 percent reduction in total
time. We believed the RUC-recommended work RVU overestimated the work,
given the significant reductions in intraservice time and total time
and does not maintain relativity among the codes in this family. To
determine the appropriate value for this code and maintain relativity
within the family, we preserved the 1.13 work RVU increment recommended
by the RUC between this code and CPT code 67107
[[Page 80312]]
and applied that increment to the interim final work RVU of 14.06 for
CPT code 67107. Therefore, we established an interim final work RVU of
15.19 for CPT code 67108. For CPT code 67110, the RUC recommended
maintaining the current work RVU of 10.25. To maintain appropriate
relativity with the work RVUs established for the other services within
this family, we used the RUC-recommended 5.75 work RVU differential
between CPT code 67107 and CPT code 67110 to establish the CY 2016
interim final work RVU of 8.31 for CPT code 67110. For CPT code 67113,
the RUC recommended and we established an interim final work RVU of
19.00 based on the 25th percentile of the survey.
Comment on the CY 2016 PFS final rule with comment period: We
received several comments disagreeing with our interim final values
based on objections to our use of time ratios in developing work RVUs
for PFS services. Some commenters also stated that by using some RUC-
recommended increments and rejecting others, we have not only
established inconsistencies within the family of codes, but potentially
opened up anomalies across a wide range of services. The RUC also
expressed disagreement with using the recommended work RVU increments
without using the recommended work RVU. Some commenters also stated the
new IWPUT values for these three services are inappropriately low and
pointed to the derived per minute intensity of 0.064 for CPT code 67110
as particularly problematic.
Response in the CY 2017 PFS proposed rule: We disagreed with the
statement about inconsistencies as the codes in this family are valued
relative to one another based on the times and level of physician work
required for each code.
We also stated that generally we do not agree that a low IWPUT
itself indicates overall misvaluation as the validity of the IWPUT as a
measure of intensity depends on the accuracy of the assumptions
regarding the number, level, and work RVUs attributable to visits for
services in the post-operative global period for individual services.
We provided an example where a service with an unrealistic number
or level of postoperative visits may have a very low derived intensity
for the intra-service time. CPT codes 67107, 67108, and 67110 were
referred to the CY 2016 multispecialty refinement panel per commenters'
request. The outcome of the refinement panel was a median work RVU of
16.00, 17.13, and 10.25, respectively. After consideration of the
comments and the results of the refinement panel, we proposed a work
RVU of 16.00, 17.13, and 10.25 for CPT codes 67107, 67108, and 66110,
respectively, for CY 2017.
The following is a summary of the comments we received regarding
our proposed valuations for the Retinal Detachment Repair family:
Comments: A few commenters, including the RUC, noted that CPT codes
67101 and 67105 were last valued by the Harvard study. The RUC stated
that during the Harvard studies, CPT code 67101 was valued higher due
to greater total time. However, now photocoagulation is reported at
vastly higher levels than the cryotherapy procedure, as it is
considered to be a more effective treatment. A few commenters stated
that given the changing nature of the service since the last valuation,
the intensity of CPT code 67105 is now greater and urged CMS to accept
the RUC-recommended values.
For CPT codes 67107, 67108, 67110, and 67113, several commenters
supported CMS' decision to propose the values recommended by the
refinement panel and urged CMS to finalize these proposed values. A few
commenters, including the RUC, brought to our attention discrepancies
between our proposal for these codes and the work RVUs posted in
Addendum B on the CMS Web site.
Response: We note that, according to the surveys, the intraservice
and total times were significantly higher for CPT code 67101 and note
the specialty societies recommended a higher work RVU for CPT code
67101 prior to the RUC meeting. Although commenters state that
photocoagulation (CPT code 67105) is typically billed more frequently
than diathermy (CPT code 67101), we do not believe the utilization rate
of a service in and of itself is reason enough to warrant an increase
in RVUs. Therefore, for CY 2017, we are finalizing a work RVU of 3.50
and 3.39 for CPT codes 67101 and 67105, respectively.
We appreciate commenters bringing to our attention the issue
regarding conflicting information in the CY 2017 PFS proposed rule
preamble text and the public use files published on the CMS Web site.
We have corrected this discrepancy in this final rule and the public
use files.
For CY 2017, we are finalizing a work RVU of 16.00, 17.13, 10.25
and 19.00 for CPT codes 67107, 67108, 66110 and 67113, respectively, in
agreement with the refinement panel recommendations.
(37) Fetal MRI (74712 and 74713)
For CY 2016, we established the RUC-recommended work RVU of 3.00 as
interim final for CPT code 74712. We established an interim final work
RVU of 1.78 for CPT code 74713 based on a refinement of the RUC-
recommended work RVU of 1.85 using the ratio of work to time for both
codes. This proposed value also corresponds to the 25th percentile
survey result.
Comment on the CY 2016 PFS final rule with comment period:
Commenters stated that the work RVU of 1.78 for CPT code 74713 did not
reflect the higher intensity inherent in the procedure's typical
patient. The commenter explained that the typical patient is pregnant
with twins and has a higher likelihood of complications related to
congenital anomalies, as well as of ischemic brain injury with twin
gestations. The commenter further stated that twin gestations are more
difficult to image. Commenters requested that CPT code 74713 be
referred to the multispecialty refinement panel.
Response in the CY 2017 PFS proposed rule: CPT code 74713 was
referred to the CY 2016 multispecialty refinement panel. After
considering the comments and the results of the refinement panel, we
agreed with commenters that an RVU of 1.78 underestimated the work for
CPT code 74713.
In the CY 2017 proposed rule, we proposed a work RVU of 1.85 for
the service for CY 2017.
We did not receive any comments in response to our proposed
valuation on CPT code 74713; therefore, we are finalizing the proposed
work RVU.
(38) Abdominal Aortic Ultrasound Screening (CPT Code 76706)
For CY 2017, the CPT Editorial Panel created a new code, CPT code
76706, to describe abdominal aortic ultrasound screening, currently
described by HCPCS code G0389. The specialties that surveyed CPT code
76706 for the RUC were vascular surgery and radiology, and the direct
PE inputs recommended by the RUC included an ultrasound room. Based on
an analysis of Medicare claims data, the dominant specialties
furnishing the service are family practice and internal medicine. We
believe that these specialties may more typically use a portable
ultrasound device rather than an ultrasound room. Therefore, we
proposed to accept the RUC-recommended work RVU of 0.55, and the RUC-
recommended PE inputs for this service, but we solicited comment
regarding whether or not it would be more accurate to substitute a
portable ultrasound device or possibly a hand-held device for an
ultrasound room for CPT code 76706. We note that while the phase-in of
significant
[[Page 80313]]
reductions in RVUs ordinarily would not apply to new codes, we believe
that it would be appropriate to consider this change from a G-code to a
CPT code to be fundamentally similar to an editorial coding change
since the service is not described differently, and therefore, we
proposed to apply the phase-in to this service by comparing the
previous value of the G-code to the value for the new CPT code.
Comment: One commenter stated that this service should be furnished
by a physician or surgeon that specializes in vascular disease. The
commenter noted that CMS should assign inputs based on which
specialties would more appropriately furnish a given service. Another
commenter disagreed with our statement in the CY 2017 proposed rule
that the dominant specialties furnishing this service are family
practice and internal medicine. The commenter stated that these
specialties are more likely to make use of a portable ultrasound device
rather than an ultrasound room. One commenter says that this service is
underutilized, and CMS should implement policies which support
screening.
Response: We appreciate the commenters' perspectives. We note that,
in evaluating codes in the Medicare Physician Fee Schedule (MPFS), we
price codes based on the typical service. Our review of the Medicare
claims data indicates that the combined utilization for the technical
component of this service and the service billed globally is typically
billed under the PFS by family practice and internal medicine, which is
why we solicited comment on whether the PE inputs for this service
should be revised.
Comment: A commenter supported our decision to apply the phase-in
to this code.
Response: We thank the commenter for the support.
Comment: A commenter agreed with CMS that family practice
physicians typically use a portable ultrasound device rather than an
ultrasound room. The commenter stated that CMS should continue to
include an ultrasound room as a direct PE input, unless other
specialties furnishing the service indicate that they do not typically
make use of an ultrasound room.
One commenter states that abdominal aortic aneurysm screenings are
performed on nonportable machines in either ambulatory or hospital
settings, and therefore, an ultrasound room is appropriate.
Response: We thank the commenters, and we will take this
information regarding the appropriate PE inputs for this service into
consideration for future rulemaking. While the specialty mix of the
practitioners furnishing services can be helpful in identifying typical
PE inputs, we continue to seek definitive information regarding the
most appropriate PE inputs for this code. For CY 2017, we are
finalizing the RUC-recommended work and PE inputs, as proposed.
(39) Fluoroscopic Guidance (CPT Codes 77001, 77002, and 77003)
In the CY 2015 PFS final rule with comment period, CMS indicated
that while CPT codes 77002 and 77003 had been previously classified as
stand-alone codes without global periods, we believe their vignettes
and CPT Manual parentheticals are consistent with an add-on code as has
been established for CPT code 77001. Therefore, the global periods for
CPT codes 77002 and 77003 now reflect an add-on code global period with
modifications to the vignettes and parentheticals.
For CPT code 77001, we proposed the RUC-recommended work RVU of
0.38. We stated that the RUC-recommended work RVUs for CPT codes 77002
and 77003 did not appear to account for the significant decrease in
total times for these codes relative to the current total times. We
noted that these three codes describe remarkably similar services and
have identical intraservice and total times. Based on the identical
times and notable similarity for all three of these codes, we proposed
a work RVU of 0.38 for all three codes.
The following is a summary of the comments we received regarding
our proposed valuation of the Fluoroscopic Guidance codes:
Comment: A few commenters disagreed with the change in the global
period for CPT codes 77002 and 77003 to reflect their status as add-on
codes. The commenters stated that this would imply that the imaging-
related preservice and postservice activities inherent to these image
guidance codes are captured by the base codes with which they are
reported, which simply is not the case. The commenters provided an
example of how reporting of radiation specific information, such as
fluoroscopy time, is not included in the postservice activities of the
base codes.
Response: CPT codes 77002 and 77003 were surveyed under the
assumption that they would be classified as add-on codes, and the RUC
recommendations for both work RVUs and direct PE inputs reflect this
status. We do not believe that it would be appropriate to assign these
codes a different global period after they were surveyed and valued
with the understanding that they would be classified as add-on codes.
Comment: Many commenters disagreed with the proposed work RVU of
0.38 for CPT codes 77002 and 77003. Commenters stated that these two
codes should not share the same work RVU as CPT code 77001, on the
basis that the physician work, intensity and complexity of codes 77002
and 77003 are greater than the first code in the family. Commenters
stated that the intensity and complexity increases in parts of the body
where there are additional anatomy considerations, such as superficial
and deep structures to consider with CPT code 77002, as well as
additional neuro and spinal structures to consider when performing CPT
code 77003. One commenter suggested that there was clinical data
indicating that CPT codes 77002 and 77003 take longer to perform than
CPT code 77001, in contradiction of the RUC survey data that assigned
all three codes identical time values. The commenter stated that this
was likely due to the greater complexity and procedural variability of
the latter two codes. Another commenter recognized that these codes
describe similar services but stressed that they do not describe
identical services, which was especially important for CPT code 77003
as it pertains to spinal procedure and carries more risk than the other
two codes.
Response: We recognize the concerns raised by the commenters in
assigning the same work RVU of 0.38 to the three codes in the
Fluoroscopic Guidance family. We note that even in cases where we
assign the same work RVU, we do not believe that the services are
identical, only that they share the same overall resources in work as
measured in RVUs. We also appreciate the reference to additional
clinical data from one commenter suggesting that CPT codes 77002 and
77003 take longer to perform than CPT code 77001. We have longstanding
concerns about using survey data alone for code valuation, and we are
always interested in investigating additional sources of information to
assist in this process. We encourage future commenters to submit this
data as part of their public comment so that it can be used by CMS as
part of the code valuation process. Based on the submission of this
additional data, we believe that the CPT codes 77002 and 77003 are more
accurately valued at a higher RVU than CPT code 77001.
After consideration of comments received, we are finalizing the
RUC-recommended work RVUs for all three codes in the family, which is
an increase from the proposed work RVU of 0.38 to a work RVU 0.54 for
CPT code
[[Page 80314]]
77002 and to 0.60 for CPT code 77003. We are finalizing the proposed
work RVU of 0.38 for CPT code 77001 without change.
(40) Mammography--Computer Aided Detection Bundling (CPT Codes 77065,
77066 and 77067)
Section 104 of the Medicare, Medicaid, and SCHIP Benefits
Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554)
required us to create separate codes with higher payment amounts for
digital mammography compared to film mammography, which was the
technology considered to be typical at the time. In addition, the
statute required additional payment to be made when computer-aided
detection (CAD) was used.
In CY 2002, we began valuing digital mammography services using
three G-codes, G0202, G0204, and G0206 to describe screening
mammography, unilateral diagnostic mammography, and bilateral
diagnostic mammography, respectively. CMS implemented the requirements
of BIPA section 104(d)(1), which applied to tests furnished in 2001, by
using the work RVUs of the parallel CPT codes, but establishing a fixed
PE RVU rather than using PE RVUs developed under the standard PE
methodology. The fixed amount of PE RVUs for these codes has generally
remained unchanged since implementation of the G-codes that
specifically described digital imaging.
Most mammography services under Medicare have since been billed
with these G-codes when digital mammography was used, and with CPT
codes 77055, 77056, and 77057 when film mammography was used. The use
of CAD has been reported with CPT codes 77051 and 77052. For CY 2017,
the CPT Editorial Panel deleted CPT codes 77051, 77052, 77055, 77056,
77057 and created three new CPT codes, 77065, 77066, and 77067, to
describe mammography services bundled with CAD. For CY 2017, the RUC
recommended work RVUs of 0.81 for CPT code 77065, 1.00 for CPT code
77066, and 0.76 for CPT code 77067, as well as new PE inputs for use in
developing resource-based PE RVUs based on our standard methodologies.
The RUC recommended these inputs and only one medical specialty society
provided us with a set of single invoices to price the equipment used
in furnishing these services.
We reviewed these coding changes and proposed changes to valuation
for these codes for CY 2017. The revised CPT coding mitigates the need
for both separate G-codes and the CAD add-on codes. Based upon these
coding changes and the RUC-recommended input values, overall Medicare
payment for mammography services would be drastically reduced. This is
particularly true for the technical component of these services, which
could possibly be reduced up to 50 percent relative to the PE RVUs
currently used for payment for these services.
Based on our initial review of the recommended inputs for the new
codes, we believed that these changes would likely result in values
more closely related to the relative resources involved in furnishing
these services. However, we recognized that these services,
particularly the preventive screenings, are of particular importance to
the Medicare program and the health of Medicare beneficiaries. We were
concerned that making drastic changes in coding and payment for these
services could be disruptive in ways that could adversely impact
beneficiary access to necessary services. We also recognized that
unlike almost any other high-volume PFS service, the RVUs used for
payment for many years have not been developed through the generally
applicable PFS methodologies, and instead reflect the statutory
directive under section 104 of the BIPA. Similarly, we recognized that
the changes in both coding and valuation are significant changes for
those who provide these services. Therefore, instead of proposing to
simultaneously adopt the revised CPT coding and drastic reductions in
overall payment rates, we believed it was advisable to propose to adopt
the new coding, including the elimination of separate billing for CAD,
for CY 2017 without proposing immediate implementation of the
recommended resource inputs. We anticipated that we would consider the
recommended inputs, including the pricing of the required equipment, as
carefully as possible prior to proposing revised PE values through
subsequent rulemaking.
Therefore, for CPT codes 77065, 77066, and 77067, we proposed to
accept the RUC-recommended work RVUs, but to crosswalk the PE RVUs for
the technical component of the current corresponding G-codes, as we
sought further pricing information for these equipment items.
Since the publication of the proposed rule, we have determined that
for several reasons related to claims processing systems, Medicare
claims systems will be unable to process claims using CPT codes 77065,
77066, and 77067 for CY 2017. However, given the parallel structure of
these new CPT codes, 77065, 77066, and 77067 to existing G-codes G0206,
G0204, and G0202, we anticipate that the claims systems will be fully
capable of processing the appropriate payment policies and prices
discussed below for CPT codes 77065, 77066, and 77067 by using the
existing G-codes. Therefore, for CY 2017, we will operationalize the
new coding rules, including adoption of the new code descriptors for
CPT codes 77065, 77066, and 77067 through use of the three current G-
codes. For the purposes of discussion below, we discuss policies and
payment rates for these three codes using the CPT numbers. Therefore,
in the preamble discussion below, references to the G-codes refer to
the descriptors, policies, and rates for CY 2016 and references to the
new CPT codes refer to the 2017 descriptors, policies and rates that
will be implemented through revisions to the current G-codes. We
anticipate being able to adopt the CPT coding for CY 2018.
In addition to soliciting comment on this proposal, we also
solicited input on rates for these services in the commercial market to
help us understand the potential impacts of any future proposed
revisions to PFS payment rates.
Finally, we noted that by proposing to adopt the new coding for CY
2017, any subsequent significant reduction in RVUs (greater than 20
percent) for the codes would be subject to the statutory phase-in under
section 1848(c)(7).
To help us examine the resource inputs for these services, we
solicited public comment on the list of items recommended as equipment
inputs for mammography services. We also invited commenters to provide
any invoices that would help with future pricing of these items.
Table 18--Recommended Equipment Items for Mammography Services
------------------------------------------------------------------------
# Item description Quantity Purpose
------------------------------------------------------------------------
1............ 2D Selenia 1 Mammography unit and in-
Dimensions room console itself.
Mammography
System.
[[Page 80315]]
2............ Mammo 1 Required for MQSA. The
Accreditation phantom is currently
Phantom. valued into the existing
mammography room.
3............ Phantom Case...... 1 Protects expensive
required phantom from
damage.
4............ Paddle Storage 3 It requires 3 racks to
Rack. hold and prevent damage
to all of the paddles
that are part of the
typical standard
mammography system.
5............ Needle 1 Needed for a full
Localization Kit. functioning mammography
room. Allows for the
performance of needle
localizations. Input is
not separately in the PE
for the mammography
guided procedure codes,
19281-19282, as a fully
functioning mammography
room is needed for those
procedures.
6............ Advanced Workflow 1 Workflow system
Manager System. connecting mammography
room and workstations.
7............ Cenova 2D Tower 1 CAD server, and also used
System. for post-processing.
8............ Image Checker CAD 1 License required for
(9.4) License for using CAD. This is a one-
One FFDM. time fee.
9............ Film Digitizing 1 Digitizes analog films to
System (. digital for comparison
purposes.
10........... Mammography Chair. 1 A special chair needed
for patients who cannot
stand to safely have
their mammogram
performed.
11........... Laser Imager 1 Prints high resolution
Printer. copies of the mammograms
to send to surgeons and
oncologists, and to use
in the OR.
12........... Barcode Scanner... 1 Allows selection of
individual patient file
for interpretation.
13........... MRS V7 SQL 1 MQSA requires that the
Reporting System. facility develop and
maintain a database that
tracks recall rates from
screening, true and
false positive and true
and false negative
rates, sensitivity,
specificity, and cancer
detection rate. A
reporting system is
required to build the
required database and
produce the federally
required quality audit.
Components below needed
for the reporting
system. The reporting
system is currently
valued into the existing
mammography room.
14........... Worksheet Printing 1 Database reports are
Module. required for federal
tracking purposes. This
is used to generate
reports for MQSA.
15........... Site License...... 1 License for site to use
the reporting system.
This is a one-time fee.
16........... Additional 3 Licenses for radiologists
Concurrent User to use the reporting
License. system. A minimum of
three additional
licenses is typical.
17........... Densitometer...... 1 Required for MQSA.
------------------------------------------------------------------------
We also received specialty society recommendations for a new
Equipment Item, a physician PACS mammography workstation. We note that
we discuss physician PACS workstation in section II.A of this rule. The
items that comprise the physician PACS mammography workstation are
listed in Table 19. We requested public comment as to the
appropriateness of this list and if some items are indirect expenses or
belong in other codes. We also invited commenters to provide any
invoices that would help with future pricing of these items.
Table 19--Physician PACS Mammography Workstation
------------------------------------------------------------------------
-------------------------------------------------------------------------
PC Tower.
Monitors 5 MP (mammo) (x2).
3rd & 4th monitor (for speech recognition, etc.).
Admin Monitor (the extra working monitor).
Keyboard & Mouse.
Powerscribe Microphone.
Software--SV APP SYNC 1.3.0.
Software--R2 Cenova.
------------------------------------------------------------------------
We also note that for CY 2015, the CPT Editorial Panel created CPT
codes 77061, 77062, and 77063 to describe unilateral, bilateral, and
screening digital breast tomosynthesis, respectively. CPT code 77063 is
an add-on code to CPT code 77057, the CPT code for screening
mammography. To be consistent with our use of G-codes for digital
mammography, we did not implement two of these three CPT codes for
Medicare purposes. We only adopted CPT code 77063 as an add-on code to
HCPCS code G0202. Instead of adopting stand-alone CPT codes 77061 and
77062, we created a new code, G0279 Diagnostic digital breast
tomosynthesis, as an add-on code to the diagnostic digital mammography
HCPCS codes G0204 and G0206 and assigned it values based on CPT code
77063. Pending revaluation of the mammography codes using direct PE
inputs, we proposed in CY 2017 to maintain the current coding structure
for digital breast tomosynthesis with the technical change that HCPCS
code G0279 be reported with CPT codes 77065 or 77066 as the replacement
codes for HCPCS codes G0204 and G0206.
Comment: Many commenters expressed support for our decision to
prevent a drastic reduction in payment for the technical component of
these services by maintaining the PE RVUs from CMS' digital mammography
coding. A few commenters expressed concern that shifting to our
standard resource-based PE valuation methodology in future rulemaking
would drastically reduce payments. Some commenters agreed that CMS does
not have sufficient pricing data to value digital mammography. One
commenter stated that the RUC-recommended direct PE inputs do not need
to be re-considered, as they include pricing data provided by the
specialty that most frequently furnishes the service.
Response: We will continue to carefully consider the potential
negative impact that our valuation of these services will have on
beneficiary access as we evaluate all relevant sources of data in
future rulemaking, including data provided by the RUC.
Comment: A commenter did not support our intention to seek more
pricing information in the commercial market, stating that commercial
payers are generally more responsive to market incentives to reduce
rather than increase prices.
Response: We refer readers to the CY 2010 PFS final rule with
comment period (74 FR 61743 through 61748) that describes CMS'
methodology in evaluating practice expense. We would consider a variety
of different data sources, pending their availability and
applicability. We believe that having
[[Page 80316]]
more information regarding pricing in the commercial market may help us
to contextualize recommended pricing, as well as potential impact of
significant changes in payment.
Comment: One commenter expressed concern that, despite our
maintenance of PE RVUs and our acceptance of RUC-recommended work RVUs,
these services will still see significant payment reductions.
Response: We are accepting the RUC-recommended work RVUs, which
equal the sum of the base code work RVUs for mammography and for CAD.
The work RVUs for the new mammography coding are therefore not changing
from their current values. Furthermore, as we are retaining the PE RVUs
from the digital mammography G-codes in the new coding, the practice
expense valuation is not changing. Therefore, payment amounts for
mammography services will not see significant reductions for CY 2017.
We expect to revalue these services through our standard code valuation
process in future rulemaking.
Comment: One commenter said that CMS should accept the RUC-
recommended direct PE inputs.
Response: As noted earlier, we did not propose the RUC-recommended
inputs for these three codes for several reasons, including our
concerns that drastic changes in coding and payment for these services
could be disruptive in ways that could adversely affect beneficiary
access to necessary services, and that unlike almost any other high-
volume PFS service, the RVUs used for payment for many years have not
been developed through the generally applicable PFS methodologies.
Therefore, instead of proposing to simultaneously adopt the revised CPT
coding and drastic reductions in overall payment rates, we believed it
was advisable to propose to adopt the new coding, including the
elimination of separate billing for CAD, for CY 2017 without proposing
immediate implementation of the recommended resource inputs.
Comment: One commenter requested clarification regarding if the PE
RVUs were valued using the RUC-recommended direct PE inputs, as these
inputs were posted in Public Use Files (PUFs) for the CY 2017 Proposed
Rule.
Response: We thank the commenter for pointing out that direct PE
inputs were posted for these codes. These inputs were inadvertently
included in the Public Use Files. We reiterate that we are not
implementing PE inputs for these services, and we are instead
crosswalking the PE RVUs from the digital mammography HCPCS codes
G0202, G0204, and G0206, as doing so prevents a drastic reduction in
payments. We included potential direct PE inputs in the text of the CY
2017 proposed rule to facilitate public comment and information in
anticipation of developing updated PE RVUs for these services in future
rulemaking.
Comment: A commenter stated that this coding violates statutory
requirements set forth by BIPA that required the agency to: (1) create
separate codes with higher payment amounts for digital mammography
compared to film mammography and (2) pay separately when computer-aided
detection (CAD) was used.
Response: The BIPA requirements specifically refer to screening and
diagnostic mammography furnished during the period beginning on April
1, 2001, and ending on December 31, 2001. CMS chose to retain the
payment rates for the technical component following this period.
Comment: A number of commenters volunteered to help CMS in pricing
direct PE inputs for these services.
Response: We thank the commenters and seek as much information as
possible regarding appropriate establishment of direct PE inputs for
these services.
Comment: A commenter stated that the potential reductions to the
technical component that we are avoiding would have been based on
flawed methodology, particularly stating that the PE per hour values
used in PE ratesetting methodology is inaccurate as it is based on the
Physician Practice Expense Information Survey (PPIS) from 2007-2008,
which the commenter considers to be flawed. The commenter also stated
that the interest rate applied to high cost capital equipment such as
imaging is inappropriately low, and that the equipment utilization rate
assumption is inappropriately high.
Response: We note that the 90 percent equipment utilization rate
only applies to diagnostic imaging services with equipment priced at $1
million dollars or more. The most recent recommended inputs for these
services do not include imaging equipment priced at $1 million dollars
or more, so the 90 percent equipment utilization would not apply.
However, we would address any application of a different utilization
rate through notice and comment rulemaking when valuing the codes under
our standard PE methodology. As always, we welcome information about
the validity of the assumptions we make in calculation of direct and
indirect costs in terms of PE. We previously noted our interest in
improving PE calculations through incorporation of alternative data
sources and we continue to seek information from interested
stakeholders as to the kinds of data sources that might be available.
For CY 2017, we are finalizing the proposed work RVUs and PE RVUs
associated with CPT codes 77067, 77066 and 77065 for use with HCPCS
codes G0202, G0204, and G0206, respectively.
(41) Radiation Treatment Devices (CPT Codes 77332, 77333, and 77334)
We identified CPT codes 77332, 77333, and 77334 through the high
expenditures by specialty screen. These services represent an
incremental increase of complexity from the simple to the intermediate
to the complex in design of radiation treatment devices. The RUC
recommended no change from the current work RVUs of 0.54 for CPT code
77332, 0.84 for CPT code 77333 and 1.24 for CPT code 77334. We believed
the recommended work RVUs overstate the work involved in furnishing
these services, as they do not sufficiently reflect the degree to which
the RUC concurrently recommended a decrease in intraservice or total
time. For CPT code 77332, we believed the RUC recommendation to
maintain its current value despite a 34 percent decrease in total time
appeared to ignore the change in time. Therefore, we proposed a value
for this code based on a crosswalk from the value from CPT code 93287
(Peri-procedural device evaluation (in person) and programming of
device system parameters before or after a surgery, procedure, or test
with analysis, review and report by a physician or other qualified
health care professional; single, dual, or multiple lead implantable
defibrillator system), due to its identical intraservice time, similar
total time, and similar level of intensity. We therefore proposed a
work RVU of 0.45 for CPT code 77332. We further supported this
valuation with 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), which
has similar physician time and intensity measurements and a work RVU of
0.45. As these codes are designed to reflect an incremental increase in
work value from simple, to intermediate, and complex device designs, we
used an incremental difference methodology to value CPT codes 77333 and
77334. We proposed a work RVU of 0.75 for CPT code 77333, maintaining
its recommended increment from CPT code 77332. For CPT code 77334, we
proposed a work RVU of 1.15, which would maintain its increment from
CPT code 77332.
[[Page 80317]]
Comment: Several commenters did not support CMS' use of CPT code
93287 as a crosswalk code to value CPT code 77332, as it is not a
radiology service.
Response: We appreciate the commenters' concern about using a non-
radiology service to assist in our valuation of this code family. We
note that it is fundamental to the validity of the relative value
system that codes furnished by different kinds of physicians remain
valid relative to each other. We commonly value codes by use of
crosswalks to other codes that are similar in terms of time and
intensity, and this may extend across different mixes of specialties
furnishing each service on the MPFS.
Comment: One commenter did not support CMS' pointing to the RUC's
recommendation of a reduction of total time without a commensurate
reduction in work RVU, as the current time is a CMS/Other source time,
which is not derived from a survey and was assigned over 20 years ago.
Response: We utilize a variety of methodologies and approaches in
developing work RVUs, and we believe that the total time value for this
service is one of several appropriate criteria that can be used to
estimate the overall time and intensity. We believe that the
intraservice and total times listed for this service are valid elements
in allowing us to determine an appropriate work RVU. Furthermore, we
note that the current times assigned to this code have been used to
allocate indirect PE to services furnished by the same specialties, and
use of this value is consistent with code valuation methodology.
Comment: One commenter asked for clarification regarding if CMS is
comparing the total time for CPT code 93287 to the current physician
time of 77332 or to the survey time on which the RUC recommendation was
based. One commenter stated that CMS' characterization of the
intraservice time of crosswalk CPT code 93287 as identical to CPT code
77332 is incorrect; the intraservice time for 77332 is 15 minutes, and
the intraservice time of CPT code 93287 is 13.5 minutes.
Response: We thank the commenter for bringing this to our
attention; our previous statement that the intraservice time of CPT
code 93287 is identical to the RUC-recommended intraservice time is
incorrect. The RUC-recommended intraservice time of 15 minutes is
similar, but not identical to the intraservice time of CPT code 93287
which is 13.5 minutes. We continue to believe that a work RVU of 0.45
is appropriate because we continue to believe the overall work for
these services is approximately the same as 97760. As further support
for our proposed value, we refer to 93016 (Cardiovascular stress test
using maximal or submaximal treadmill or bicycle exercise, continuous
electrocardiographic monitoring, and/or pharmacological stress;
supervision only, without interpretation and report) which has an
intraservice time that is identical to the RUC-recommended intraservice
time for 77332, as well as a similar total time.
Comment: One commenter stated that these codes have XXX global
periods, and therefore, do not have standard pre or post service
packages. These standard pre and post services packages did not exist
at the time that this service was valued, thus the convention of
eliminating pre-service time and applying minimal post-service time to
services with XXX global periods was not applied at that time.
Response: We appreciate the commenter's concerns about standard
time packages not being applied to these codes. We continue to believe,
however, that use of the RUC-recommended time to value the work RVU in
this case is appropriate because we believe that time values are a
critical element of establishing work RVUs.
Comment: A few commenters stated that CMS' proposed reduction in
the work RVUs for CPT codes 77333 and 77334 based on an incremental
relationship with CPT code 77332 is arbitrary, and that a reduction to
the work RVU for CPT code 77332 does not automatically justify a
reduction to the other two family codes.
A commenter supported the use of incremental valuation methodology
in theory but did not believe it is appropriately applied to these
codes, because the commenter believes that the valuation of CPT code
77332, upon which the increments are based, is incorrect.
Response: We refer readers to a discussion of the methodology for
establishing work RVUs in section II.L.2 of this final rule. As
outlined there, we frequently use an incremental methodology to
identify potential work RVUs for particular codes. We note that we are
maintaining the RUC-recommended incremental relationship between these
three codes. This code family is structured to represent simple,
intermediate, and complex procedures, and we seek to maintain that
structure for this code family. Therefore, we are finalizing the work
RVUs as proposed. We provide the information in Table 20 to illustrate
our valuation of CPT code 77332 and its value relative to our crosswalk
codes:
Table 20--Valuation of CPT Code 77332 Relative to Crosswalk Codes
----------------------------------------------------------------------------------------------------------------
HCPCS Description Intra time Total time Work RVU IWPUT
----------------------------------------------------------------------------------------------------------------
77332--Current.................... Treatment devices, .............. 28 .54 .....
design and
construction; simple
(simple block,
simple bolus).
77332--CMS........................ Treatment devices, 15 18 .45 0.012
design and 6
construction; simple
(simple block,
simple bolus).
93287............................. Peri-procedural 13.5 26 .45 0.012
device evaluation & 6
programming.
97760............................. Orthotic management 14 18 .45 0.025
and training. 7
93016............................. Cardiovascular stress 15 19 .45 0.024
test. 0
----------------------------------------------------------------------------------------------------------------
(42) Special Radiation Treatment (CPT Code 77470)
We identified CPT code 77470 through the high expenditures by
specialty screen. We proposed the RUC-recommended work RVU of 2.03.
However, we believe the description of service and vignette describe
different and unrelated treatments being performed by the physician and
clinical staff for a typical patient, and this presents a disparity
between the work RVUs and PE RVUs. We solicited comment on information
that would clarify this apparent disparity to help determine
appropriate PE inputs. In addition, we solicited comment to determine
if creating two G-codes, one that describes the work portion of this
service, and one that describes the PE portion, may be a potentially
more accurate method of valuing and paying for the service or services
described by this code.
[[Page 80318]]
Comment: Some commenters maintained that the clinical labor and
physician work component are related and are necessarily reported
together. Commenters did not approve of CMS suggestion of breaking the
work and PE components of this service into two separate G-codes in
future rulemaking, stating that the CPT descriptor is accurate and
represents the typical patient. Some commenters sought greater
explanation for why CMS believes that the work and PE portions of this
service are unrelated; commenters question if it is because the
vignettes offered for the work and PE describe treatments for two
separate diagnoses. Commenters also questioned if CMS is assuming that
the ``devices'' mentioned in the description of clinical labor
activities overlap with Radiation Treatment Devices codes which are
also being evaluated in this rule. A commenter stated that if CMS is
suggesting that there should be multiple CPT codes for every possible
diagnosis for the use of this code, then that suggestion is
problematic.
Response: According to the description of work provided for this
service, the physician performs cognitive work such as planning,
consideration of test results, and therapeutic treatment contingency
planning that is in addition to what he or she would typically be
performing for most radiation treatments. Meanwhile, the radiation
therapist handles the treatment devices, performs tasks such as
positioning the patient, and helps facilitate the scan of the patient.
We believe that this may describe activities that are fundamentally
disconnected. To illustrate our concern, we offer the example that this
is akin to a physician removing a mole from a patient's hand while the
clinical staff places a cast on the patient's foot; we see no
compelling clinical evidence to indicate that the two tasks are
related. In addition, the disparate diagnoses described by the
vignettes further calls into question the degree to which the work and
PE components are interrelated. While we agree that there should not
separate coding for each possible diagnosis for a particular service,
in trying to accurately assess relative value, we believe that the work
and PE components should be valued under unified assumptions about the
typical service. We are finalizing the RUC-recommended work RVU and PE
inputs as proposed; however, we continue to have serious concerns about
the validity of this coding.
(43) Interstitial Radiation Source Codes (CPT Codes 77778 and 77790)
In the CY 2016 PFS final rule with comment period, we established
an interim final value for CPT code 77790 without a work RVU,
consistent with the RUC's recommendation. We did not use the RUC-
recommended work RVU to establish the interim final values for CPT code
77778. We stated that the specialty society survey included a work time
that was significantly higher than the RUC-recommended work time
without a commensurate change in the work RVU. For CY 2016, we
established the 25th percentile work RVU survey result of 8.00 as
interim final for CPT code 77778 and 0 work RVUs for CPT code 77790.
Comment on the CY 2016 PFS final rule with comment period:
Commenters agreed that the preservice survey times and the RUC-
recommended survey times were inconsistent and explained that this
inconsistency resulted from the RUC's use of preservice packages in
developing recommendations. In addition, commenters stated that because
the work associated with CPT code 77790 (including pre-time
supervision, handling, and loading of radiation seeds into needles) was
bundled into CPT code 77778, that the additional work should be
reflected in the RVU for CPT code 77778. Commenters encouraged us to
accept the RUC-recommended work RVU of 8.78 and requested that CPT code
77778 be referred to the refinement panel.
Response in the CY 2017 PFS proposed rule: We did not refer CPT
code 77778 to the CY 2016 multispecialty refinement panel because
commenters did not provide new clinical information. We continued to
believe that, based on the reduction in total work time, an RVU of 8.00
accurately reflected the work involved in furnishing CPT code 77778.
In the CY 2017 proposed rule, we proposed a work RVU of 8.00 for
CPT code 77778 and 0 work RVUs for CPT code 77790. We also sought
comment on whether we should use time values based on preservice
packages if the recommended work value was based on time values that
were significantly different than those ultimately recommended.
The following is a summary of the comments we received regarding
our proposed valuations for CPT codes 77778 and 77790:
Comment: Some commenters stated that CMS underestimates the
additional work inherent in furnishing CPT code 77778, considering that
it is being bundled with CPT code 77790.
Commenters did not agree with our decision not to accept the RUC-
recommended work RVU of 8.78 and to propose for CY 2017 a work RVU of
8.00, considering the disparity between the survey total time and the
RUC-recommended total time. According to the RUC, the survey
respondents had accurately estimated the work RVU based on magnitude
estimation while overestimating the relatively low intensity pre-
service time involved in performing this service, and this explains the
disparity between the survey time and the RUC-recommended total time.
One commenter noted that the RUC significantly reduced the pre-time
because it did not include work in supervising the ordering of the
isotope. Several commenters stated that CMS routinely accepts and uses
pre-service time packages as recommended by the RUC.
Response: We continue to question how the same survey respondents
that significantly overestimated the total time based on the RUC's
analysis could nonetheless accurately estimate the overall work. We are
also concerned about the specialty society's perspective that the RUC
does not consider the work of supervising the ordering of the isotope
as part of the service, given the survey respondents clearly considered
such work to be described by the code. We believe that it is important
that a particular code clearly describes the work involved in
furnishing a service. While we appreciate the usefulness of pre-time
packages generally, for this particular code, we believe that in this
case the drastic time difference from the survey time value to the RUC-
recommended time value that the pre-time package produces is
problematic, especially since there does not appear to be consensus
regarding which services are included in the code, or which might be
perceived to be separately reportable.
In general we are concerned with using recommended time values that
are disconnected from recommended work RVUs, including in cases where
the recommended work RVU may include elements of work that are not
reflected in the assumptions in time, as appears to be the case for
this code. We reiterate that we believe the statute directs us to
establish work RVUs that reflect the relative resource costs in time
and intensity, so we believe that there should be an identifiable
relationship between time and work RVUs.
To align the time and work associated with this code, we proposed a
reduction of the work RVU from 8.78 to 8.00 as we proposed. However,
upon consideration of comments, we were persuaded that
[[Page 80319]]
the RUC-recommended work RVUs for this service are appropriate,
particularly because the work includes the supervision, handling, and
loading of radiation seeds, and it reflects the bundling with CPT code
77790.
While we are not finalizing a change in the time associated with
this code since we proposed to use the RUC recommended value based on
the pre-service package, we seek additional information regarding the
best approach to valuing work when there is a clear disconnect between
assumptions regarding time described by a code and the time recommended
by the RUC. We understand that pre-service time packages can be a
helpful tool in assigning estimates of time to particular codes
relative to others on the PFS and that these times may be significantly
different than those derived from survey results. However, since the
RUC has repeatedly stated that its recommendations reflect the typical
resources involved in furnishing PFS services, we believe it would be
important for us to be able to identify cases where the recommended
time values reflect the application of particular policies rather than
the best estimate of the actual time involved in furnishing procedures.
(44) Colon Transit Imaging (78264, 78265, 78266)
In establishing CY 2016 interim final values, we accepted the RUC
recommended work RVUs for CPT codes 78265 and 78266. We believed that
the RUC-recommended RVU of 0.80 overestimated the work involved in
furnishing CPT code 78264 and as a result, we established an interim
final work RVU of 0.74 based on a crosswalk to CPT code 78226
(hepatobiliary system imaging, including gallbladder when present), due
to similar intraservice times and intensities.
Comment on the CY 2016 PFS final rule with comment period:
Commenters did not support our interim final work RVU for CPT code
78264. Commenters disagreed with our assessment of CPT code 78264 as
having a higher work RVU and shorter intraservice time relative to the
other codes in the family. One commenter stated that a difference of
two minutes in intraservice time was insignificant and should not be
used as a rationale for revaluing. Another commenter stated that we
should have maintained the RUC-recommended crosswalk of CPT code 78264
to CPT code 78227 (Hepatobiliary system imaging, including gallbladder
when present; with pharmacologic intervention, including quantitative
measurement(s) when performed) due to similarities in service, work and
intensity. Based on these concerns, commenters requested that CPT code
78264 be referred to the refinement panel.
Response in the CY 2017 PFS proposed rule: CPT code 78264 was
referred to the CY 2016 multi-specialty refinement panel for further
review. We calculated the refinement panel results as the median of
each vote. That result for CPT code 78264 was 0.79 RVUs.
In the CY 2017 proposed rule, we proposed a value of 0.79 for CPT
code 78264.
The following is a summary of the comments we received regarding
our proposed valuation of the Colon Transit Imaging codes:
Comment: A commenter recommended that we reexamine the data
associated with these codes to ensure the accuracy of the final values.
Response: We thank the commenter for this input. We continue to
believe that the proposed valuation on CPT code 78264 most accurately
describes the work, time and intensity associated with this service;
therefore, we are finalizing the work RVU as proposed.
(45) Cytopathology Fluids, Washings or Brushings and Cytopathology
Smears, Screening, and Interpretation (CPT Codes 88104, 88106, 88108,
88112, 88160, 88161, and 88162)
In the CY 2016 PFS final rule with comment period, we made a series
of refinements to the recommended direct PE inputs for this family of
codes. We removed the equipment time for the solvent recycling system
(EP038) and the associated clinical labor described by the tasks
``Recycle xylene from stainer'' and ``Order, restock, and distribute
specimen containers and or slides with requisition forms'' due to our
belief that these were forms of indirect PE. This refinement applied to
all seven codes in the family. We also noticed what appeared to be an
error in the quantity of non-sterile gloves (SB022), impermeable staff
gowns (SB027), and eye shields (SM016) assigned to CPT codes 88108 and
88112. The recommended value of these supplies was a quantity of 0.2,
which we believed was intended to be a quantity of 2. We therefore
refined the value of these supplies to 2 for CPT codes 88108 and 88112.
Comment on the CY 2016 PFS final rule with comment period: Several
commenters disagreed with our characterization of the solvent recycling
system and its associated clinical labor tasks as indirect PE.
Commenters stated that the solvent recycling system costs are direct
expenses since they are based on the amount of recycled solvent
allocated to each specimen, with solvents allocated to specific
specimens based on batch size. They indicated that the related clinical
labor tasks are direct PE as they are also based on the amount of
recycled solvent allocated to each specimen. The time for these tasks
varies based on the batch size, which varies by procedure.
Response in the CY 2017 PFS proposed rule: We maintained our
previously stated belief that these are forms of indirect PE, as they
are not allocated to any individual service. Under the established PE
methodology, direct PE inputs are defined as clinical labor, medical
supplies, or medical equipment that are individually allocable to a
particular patient for a particular service. We continue to believe
that a solvent recycling system would be in general use for a lab
practice, and that the associated clinical labor tasks for ordering and
restocking specimen containers can be more accurately described as
administrative activities. We proposed to maintain these refinements
from the previous rulemaking cycle for CPT codes 88104-88162.
Comment on the CY 2016 PFS final rule with comment period: A
commenter indicated that we did not account for the batch size when
considering the supply quantities for CPT codes 88108 and 88112. The
commenter indicated that the practice expense inputs should be assumed
to have a batch size of five for these two codes, and therefore, no
edits should be made. The commenter requested that we restore the
quantity of 0.2 for the gloves, gowns, and eye shields associated with
these procedures. This did not apply to the other codes on the
submitted spreadsheet, which had a batch size of one.
Response in the CY 2017 PFS proposed rule: We appreciated the
assistance of the commenter in clarifying the batch size for these
procedures. As a result, we proposed to refine the supply quantity of
the non-sterile gloves (SB022), impermeable staff gowns (SB027), and
eye shields (SM016) back to the RUC-recommended value of 0.2 for CPT
codes 88108 and 88112.
The following is a summary of the comments we received regarding
our proposed valuation of the Cytopathology Fluids and Cytopathology
Smears codes:
Comment: A few commenters continued to disagree that the proposed
refinements to the direct PE inputs were forms of indirect PE.
Commenters stated that these tasks are direct expenses, as they are
variable based on the volume
[[Page 80320]]
of these services, with the clinical labor and equipment time directly
attributable to the quantity of specimens typically provided from a
typical laboratory. Commenters also stated that these activities were
not captured in the questions asked on the indirect practice expense
cost survey.
Response: We continue to believe that these are administrative
tasks that are more accurately classified as forms of indirect PE
because they are not allocable to an individual service. Whether these
tasks are variable based on the volume of the services is unrelated to
this classification. For example, some services may require additional
time for administrative staff to record electronic health records or
restock inventory than other services, but in all cases these are
defined as indirect PE under the established methodology, as they are
administrative tasks that are not allocated to any individual service.
We disagree that the validity of the practice expense data rests on
whether or not particular questions were asked on the survey. We note
that we understand medical practice and technology often change over
time and the PE survey data is used to capture the relative difference
in practice expenses incurred by various specialties as opposed to
representing a summation of all individual items that incur an expense.
Therefore, we do not believe that inclusion or exclusion of particular
items means that the underlying data are invalid for purposes of
measuring relativity.
Comment: A commenter agreed with the changes to the RUC-recommended
supply quantity of 0.2 for the non-sterile gloves (SB022), impermeable
staff gowns (SB027), and eye shields (SM016) in CPT codes 88108 and
88112.
Response: We appreciate the support from the commenter.
After consideration of comments, we are finalizing the proposed
direct PE inputs for CPT codes 88104, 88106, 88108, 88112, 88160,
88161, and 88162.
(46) Flow Cytometry Interpretation (CPT Codes 88184, 88185, 88187,
88188, and 88189)
The Flow Cytometry Interpretation family of codes is split into a
pair of codes used to describe the technical component of flow
cytometry (CPT codes 88184 and 88185) that do not have a work
component, and a trio of codes (CPT codes 88187, 88188, and 88189) that
do not have direct practice expense inputs, as they are professional
component only services. CPT codes 88184 and 88185 were reviewed by the
RUC in April 2014, and their CMS refined values were included in the CY
2016 PFS final rule with comment period. The full family of codes was
reviewed again at the January 2016 RUC meeting, and new recommendations
were submitted to CMS as part of the CY 2017 PFS rulemaking cycle.
We proposed the RUC-recommended work RVU of 0.74 for CPT code
88187, and the RUC-recommended work RVU of 1.70 for CPT code 88189. For
CPT code 88188, we proposed a work RVU of 1.20 instead of the RUC-
recommended work RVU of 1.40. We arrived at this value by noticing that
there were no comparable codes with no global period in the RUC
database with intraservice time and total time of 30 minutes that had a
work RVU higher than 1.20. The RUC-recommended work RVU of 1.40 would
go beyond the current maximum value and establish a new high, which is
not consistent with our estimation of the overall intensity of this
service relative to the others. As a result, we believe it is more
accurate to crosswalk CPT code 88188 to the work value of the code with
the current highest value, which is CPT code 88120 (Cytopathology, in
situ hybridization (for example, FISH), urinary tract specimen with
morphometric analysis, 3-5 molecular probes) at a work RVU of 1.20. We
believe that CPT code 88120 is crosswalk comparable code since it
shares the identical intraservice time and total time of 30 minutes
with CPT code 88188.
We also noted that the survey increment between CPT codes 88187 and
88188 at the RUC-recommended 25th percentile was 0.40 (between work
RVUs of 1.00 and 1.40), and this increment of 0.40 when added to CPT
code 88187's work RVU of 0.74 would arrive at a value of 1.14. In
addition, the total time for CPT code 88188 decreases from 43 minutes
to 30 minutes, which is a ratio of 0.70, and when this time ratio is
multiplied by CPT code 88188's previous work value of 1.69, the result
would be a new work RVU of 1.18. With this information in mind, we
proposed a work RVU of 1.20 for CPT code 88188 as a result of a direct
crosswalk to CPT code 88120.
For CPT codes 88184 and 88185, which describe the technical
component of flow cytometry, we proposed to use the RUC-recommended
inputs with a series of refinements. However, we believe that the
coding for these two procedures may inhibit accurate valuation. CPT
code 88184 describes the first marker for flow cytometry, while CPT
code 88185 is an add-on code that describes each additional marker. We
believe that it may be more accurate to have a single CPT code that
describes the technical component of flow cytometry on a per patient
case basis, as these two procedures are always performed together and
it is difficult to determine the clinical labor, supplies, and
equipment used in the typical case under the current coding structure.
We solicited comments regarding the public interest in consolidating
these two procedures into a single code used to describe the technical
component of flow cytometry.
Absent such a change in coding, we proposed to refine the clinical
labor time for ``Instrument start-up, quality control functions,
calibration, centrifugation, maintaining specimen tracking, logs and
labeling'' from 15 minutes to 13 minutes for CPT code 88184. We
maintained that 13 minutes for this activity, which is the current time
value, would be typical for the procedure, as CPT code 88182 also uses
13 minutes for the identical clinical labor task. We also proposed to
refine the L054A clinical labor for ``Load specimen into flow
cytometer, run specimen, monitor data acquisition, and data modeling,
and unload flow cytometer'' from 10 minutes to 7 minutes using the same
rationale, a comparison to CPT code 88182.
We proposed to maintain the clinical labor for ``Print out
histograms, assemble materials with paperwork to pathologists Review
histograms and gating with pathologist'' for CPT code 88184 at 2
minutes, as opposed to the RUC-recommended 5 minutes. A clinical labor
time of 2 minutes is standard for this activity; we disagree with the
RUC rationale that reviewing histograms and gating with the pathologist
in this procedure is not similar to other codes. We also note that the
review of histograms with a pathologist is not even described by CPT
code 88184, which again refers to the technical component of flow
cytometry, not the professional component. We also proposed to refine
the L033A clinical labor time for ``Clean room/equipment following
procedure'' from 2 minutes to 1 minute for CPT code 88184. We have
established 1 minute in previous rulemaking (80 FR 70902) as the
standard time for this clinical labor activity in the laboratory
setting.
We proposed to maintain our removal of the clinical labor time for
``Enter data into laboratory information system, multiparameter
analyses and field data entry, complete quality assurance
documentation'' for both CPT code 88182 and CPT code 88184. As we
stated in the CY 2016 PFS final rule with comment period (80 FR 70979),
we have not recognized the laboratory information system as an
equipment
[[Page 80321]]
item that can be allocated to an individual service. We continue to
believe that this is a form of indirect PE, and therefore, we do not
recognize the laboratory information system as a direct PE input, and
we do not consider this task as typically performed by clinical labor
on a per-service basis.
We proposed to maintain the quantity of the ``lysing reagent''
supply (SL089) at 2 ml for CPT code 88185, as opposed to the RUC-
recommended quantity of 3 ml. In our discussions with pathology
specialists who perform flow cytometry, we were informed that the use
of 50-55 ml of the lysing reagent would be typical for an entire
patient case. The RUC recommendation similarly suggested a quantity of
46 ml or 48 ml per patient case. We were also told that the most
typical number of markers used for flow cytometry is 24, consisting of
1 service of CPT code 88184 and 23 services of CPT code 88185. An
investigation of our claims data confirmed this information, indicating
that 24 markers is the most frequent per patient case for flow
cytometry, and the use of more than 20 markers is typical. We believe
that this data supports our refinement of the lysing reagent from a
quantity of 3 ml to a quantity of 2 ml for CPT code 88185, which is
also the current value for the procedure and the RUC-recommended value
from the previous set of recommendations. For the typical case of 24
markers, our value would produce a total lysing reagent quantity of 51
ml (5 ml from the single service of CPT code 88184 and 46 ml from the
23 services of CPT code 88185), which matches with the amount required
for a total per patient case. If we were to adopt the RUC
recommendation, the total lysing reagent quantity would be 74 ml, which
is well in excess of what we believe to be typical for these
procedures.
We also proposed to refine the quantity of the ``antibody, flow
cytometry'' supply (SL186) from quantity 1.6 to quantity 1, which is
also the current value for the supply and the RUC-recommended value
from the previous set of recommendations. We do not agree that more
than one antibody would be typically used for each marker. We are
reaffirming the previous RUC recommendation, and maintaining the
current quantity of 1 antibody for each marker.
We did not agree with the recommended additional time for the
``printer, dye sublimation (photo, color)'' equipment (ED031). We
proposed to maintain the equipment time at 2 minutes for CPT code
88184, and at 1 minute for CPT code 88185. As we stated in the CY 2016
PFS final rule with comment period (80 FR 70979), we proposed to assign
equipment time for the dye sublimation printer to match the clinical
labor time for ``Print out histograms, assemble materials with
paperwork to pathologists.'' We do not believe that it would be typical
for the printer to be in use longer than it takes to accomplish this
clinical labor task.
The following is a summary of the comments we received regarding
our proposed valuation of the Flow Cytometry Interpretation codes. Due
to the large number of comments we received for this code family, we
will first summarize the comments related to the coding structure of
CPT codes 88184 and 88185, followed by the comments related to specific
work RVUs, and finally the comments related to the direct PE inputs.
Comment: Many commenters disagreed with the potential concept of
consolidating CPT codes 88184 and 88185 into a single code used to
describe the technical component of flow cytometry. Commenters stated
that the resources required for the first marker and for each
subsequent marker differ, and with flow cytometry, there is no
``typical case.'' Because the number of markers differ for different
disease states, such as HIV, Lyme disease, and acute leukemias, the
current coding structure is designed to reflect different valuations of
the professional component codes, based on the number of markers that
must be interpreted. Many commenters stressed that this makes one code
for the technical component of flow cytometry infeasible, and strongly
advised against it. One commenter was also concerned that a coding
structure change may exacerbate the undervaluation of these services,
which have been recently reviewed twice by the RUC and resulted in
substantial decreases in the practice expense relative values.
A few commenters supported the possibility of combining CPT codes
88184 and 88185 into a single code. One commenter stated that the
current coding structure does not incentivize the use of less reagents,
and actually penalizes labs that appropriately test fewer markers.
According to this commenter, moving to a single code structure would be
consistent with the vast majority of lab tests, would simplify billing
processes, and may make development of more cost-effective panels
financially desirable. The commenter supported further examination of a
single CPT code and urged that current payment rates should be frozen
while such examination occurs. Another commenter suggested a slightly
different coding structure, one which would collapse the codes into a
series of case rate codes that reflect the procedures: screening,
classification, and monitoring. There was support from one additional
commenter for a three code proposal designed to track this workflow.
Response: We appreciate the detailed responses from the commenters
about the proper coding structure used to describe the technical
component of flow cytometry. We do not intend to finalize any
recommendations regarding the coding structure at this time, but we
will consider this information for future proposals regarding these
services.
Comment: Many commenters made general comments about decreases to
the proposed rates for either the professional or the technical
component of the flow cytometry codes. Commenters stated that there was
no justification for the reduction in payment rates, and that the
decreases would hamper laboratories' ability to offer the flow
cytometry services. One commenter stated that the payment cuts were not
realistic and would result in flow cytometry not being financially
feasible in the less expensive physician-office setting. Another
commenter indicated that further reductions to these codes would result
in an inability to maintain the level of professional services required
to reduce medical errors.
Response: We share the concern of the commenters in ensuring that
payment for Medicare services is based on an accurate assessment of the
relative resource costs involved in furnishing the service. With
regards to the technical component of flow cytometry, most of the
decrease in code valuation is taking place due to a decrease in the
quantity of the lysing reagent supply (SL089). The RUC has agreed that
there was previously an excess of this supply in CPT codes 88184-88185,
and has recommended a decrease of approximately 78 percent in this
supply quantity, from 336 ml to 74 ml, in the typical case of 24
markers. Due to the resource-based nature of the RVU system, this
substantial reduction in supply costs will be reflected in the RVUs for
these procedures. We note that since CY 2016 the phase-in of
significant reductions in RVUs has been in effect; 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,
those decreases are limited to a 19 percent reduction in total RVUs. We
note that the phase-in mechanism allows reductions to be transitioned
in over time rather than instituting large decreases in a single
[[Page 80322]]
rule cycle. Please see section II.H for more information regarding the
phase-in of significant RVU reductions.
Comment: Many commenters disagreed with the proposed work RVU of
1.20 for CPT code 88188. Several commenters took issue with the CMS
statement that there were no comparable codes with no global period in
the RUC database with intra-service time and total time of 30 minutes
that had a work RVU higher than 1.20. These commenters indicated that
there were at least 10 such codes valued over 1.20 RVUs in the 2016 RUC
database (1 XXX and 9 ZZZ add-on global codes), ranging in work value
from 1.38 to 2.40 RVUs, with a median of 1.67. The commenters suggested
that these codes supported the higher RUC-recommended work RVU of 1.40
for CPT code 88188.
Response: We continue to believe that there are no comparable codes
with the same global period with intraservice time and total time of 30
minutes that have a work RVU higher than 30 minutes. When we used the
phrase ``no global period'' to refer to CPT code 88188, we were not
referring to add-on codes with a global period of ZZZ. We have stated
on numerous occasions that we believe the resources required to furnish
add-on codes constitute a separate category, and we typically only
compare add-on codes to other add-on codes. We do not believe that it
is appropriate to compare the work RVU of add-on codes with 30 minutes
of intraservice time to the work RVU of CPT code 88188, which is not an
add-on code.
With regards to non-add on codes, Table 21 lists all 13 codes in
the RUC database with 30 minutes of intraservice time, fewer than 40
minutes of total time, and a global period of XXX:
Table 21: Work RVU of Codes With Comparable Time Values to CPT Code
88188
------------------------------------------------------------------------
Work
HCPCS Descriptor RVU
------------------------------------------------------------------------
77331................................ Special radiation 0.87
dosimetry.
78195................................ Lymph system imaging.... 1.20
78456................................ Acute venous thrombus 1.00
image.
86079................................ Phys blood bank serv 0.94
authrj.
88120................................ Cytp urne 3-5 probes ea 1.20
spec.
88187................................ Flowcytometry/read 2-8.. 0.74
88365................................ Insitu hybridization 0.88
(fish).
88368................................ Insitu hybridization 0.88
manual.
88374................................ M/phmtrc alys ishquant/ 0.93
semiq.
93750................................ Interrogation vad in 0.92
person.
95251................................ Gluc monitor cont phys 0.85
i&r.
97004................................ Ot re-evaluation........ 0.60
97606................................ Neg press wound tx >50 0.60
cm.
------------------------------------------------------------------------
As we stated previously, there are no codes with a work RVU higher
than 1.20, which is where we proposed to value CPT code 88188. We
acknowledge that there are global XXX codes with 30 minutes of
intraservice time that have a work RVU greater than 1.20. However, all
of these codes have at least 40 minutes of total time, which is 33
percent higher at a minimum than the total time for CPT code 88188. We
believe that a crosswalk to CPT code 88120, which shares the identical
time values as CPT 88188, is a more appropriate choice than codes that
have substantially higher total time. In the particular case of CPT
code 88188, we continue to believe that establishing a new maximum work
value above 1.20 would not be consistent with our estimation of the
overall intensity of this service relative to the others on the PFS.
Comment: Some commenters disagreed with the proposed work RVU of
CPT code 88188 based on the work increments between the codes in the
family. These commenters stated that the original recommended work
values had almost identical increments between the three services (0.60
between CPT codes 88187 and 88188, and 0.63 between CPT codes 88188 and
88189); however the median survey results indicated a much greater
physician work increment between CPT codes 88188 and 88189. According
to commenters, the final RUC recommendations were based on the
expertise of the RUC to establish the work increment between CPT codes
88187 and 88188 (0.74) higher than the increment between CPT codes
88188 and 88189 (0.30). In other words, the recommended work increment
between CPT code 88187 (work RVU = 0.74) and CPT code 88188 (work RVU =
1.40) was significantly larger than the work increment between CPT code
88188 (work RVU = 1.40) and CPT code 88189 (work RVU = 1.70). The
commenters stated that the survey results and expert opinion justified
this smaller increment between the final two codes, and the RUC-
recommended work RVU of 1.40 for CPT code 88188.
Response: We disagree that the survey data justifies a smaller
increment between the final two codes. While this is true for the 25th
percentile survey results, the exact opposite is true for the survey
median results, in which the increment between CPT codes 88187 and
88188 is 0.35 and the increment between CPT codes 88188 and 88189 is
0.70. In addition, in the current pre-reviewed version of these codes,
the increment between CPT codes 88187 and 88188 is 0.33, while the
increment between CPT codes 88188 and 88189 is 0.54. We believe that
this suggests the survey data on the work increments is conflicting,
not conclusive, and that the RUC-recommended increments are a departure
from the previous incremental structure of this code family, in which
the second two codes had a larger increment than the first two codes.
We do not agree that the work increments at the survey 25th percentile
are a sufficient justification for adopting the recommended work RVU
for CPT code 88188 due to the additional data regarding work increments
between these codes detailed above.
Comment: Several commenters stated that over the last decade, flow
cytometric analyses have changed through new technological advances
that have led to an increased interpretative sophistication. It is now
typical for the physician to analyze substantially more data than in
the past. According to commenters, with the advent of 5, 6, 8, and 10
color flow cytometry the intensity and complexity of these services has
significantly increased. Commenters stated that this increased
intensity and complexity is reflected in the RUC recommendation for
this service, based on new physician work associated with technological
changes, time, and intensity.
Response: We appreciate this additional information about the
professional interpretation of flow cytometry from the commenters.
However, we note that the RUC-recommended intensity of CPT codes 88187
and 88189 has actually decreased compared to the current pre-reviewed
version of these codes. We believe that this indicates that the same
new technological advances also allow practitioners to analyze data
faster and with fewer errors, which is reflected in the decreased work
RVUs and time values in the RUC recommendations. The only one of the
three codes with a RUC-recommended increase in intensity is CPT code
88188. This increased intensity in the second code creates an anomalous
relationship within the
[[Page 80323]]
family, as the RUC-recommended intensity for CPT code 88188 is equal to
the intensity for CPT code 88189, in contrast to the current pre-
reviewed version of these codes where the three codes have a linear
increase in intensity (IWPUT = 0.39, 0.43, 0.50). We do not understand
why the professional interpretation of 9 to 15 markers would have an
equal intensity to interpreting 16 or more markers. Logic would suggest
that CPT code 88188 should have a lower intensity than CPT code 88189,
which is indeed the case at our proposed work RVU of 1.20. The proposed
value also re-establishes a linear increase in intensity between the
three codes as additional markers are interpreted (IWPUT = 0.37, 0.40,
0.47). We believe that this intensity data offers additional support
for our proposed work RVU.
Comment: One commenter disagreed with the CMS crosswalk to the work
RVU of CPT code 88120, which the commenter suggested was completely
different in step by step work effort, intensity, and complexity. The
commenter stated that CPT code 88120 typically only involves
identifying and quantifying a limited subset molecular probes (for
example, FISH probes for chromosomes 3, 7, 17 and 9p21 loss), using two
to four color signal enumeration to detect aneuploidy staining of
nuclei on slides from isolated cell preparations, usually from
morphologically well-characterized specimens. In contrast, the
commenter stated that for CPT code 88188 the pathologist is required to
integrate multi-parameter diagnostic information on different cell
populations (both abnormal and normal), by assessing cell scatter (size
and shape) along with signal intensity and pattern of staining of cell
surface markers with antibody reagents using four to six (or more)
color fluorescent antibody probes. The pathologist must perform
successive, iterative analyses of 2- and 3-dimensional plots and
histograms and re-gating of identified cell populations (based on size,
shape, relative staining patterns, signal intensity, etc.) to
characterize cell lineage and render a final diagnosis and
interpretation. Due to this clinical rationale, the commenter indicated
that the work and complexity of CPT code 88188 was substantially
greater than CPT code 88120.
Response: We disagree with the commenter that CPT code 88120 is an
inappropriate crosswalk code for CPT code 88188. These codes are both
recently-reviewed pathology codes with identical intraservice time and
total time values within the Cytopathology listing of the CPT manual.
We also note that many of the activities listed by the commenter are
not detailed in the intraservice work description for CPT code 88188,
and may not be needed in the typical case.
The following comments address the proposed direct PE inputs for
the Flow Cytometry family of codes.
Comment: Many commenters disagreed with the proposed time of 13
minutes for the clinical labor activity ``Instrument start-up, quality
control functions, calibration, centrifugation, maintaining specimen
tracking, logs and labeling.'' Commenters stated that the CMS
comparison to CPT code 88182 was not appropriate, as that code uses
older/simpler technology, with CPT code 88184 using 4-6 or more color
channels while CPT code 88182 uses 1-2 channels. Commenters stressed
that these clinical labor tasks are unique to this flow cytometry
service, and they should not be assumed to take the identical time as
other services. Other commenters stated that three instruments must be
run consecutively, and the task includes quality control calibration,
taking a minimum of 13 to 16 minutes in dedicated technical staff time.
Another commenter indicated that the time required to complete these
activities is continually increasing as more regulatory requirements
are added, and that the recently added flow cytometry requirement for
individual antibody lot/shipment testing increased this time
exponentially.
Response: We disagree with the commenters that the identical
clinical labor activity would take longer to perform for CPT code 88184
than it would for CPT code 88182. Both of these procedures use the same
equipment to perform this task, a flow cytometer (EP014) and a
centrifuge (EP007). We do not agree that there is additional clinical
labor time required for using additional color channels in CPT code
88184, as the same equipment is being used to perform the same clinical
labor task as in CPT code 88182. We did not receive data from the
commenters suggesting that regulatory requirements are increasing the
time required to perform this clinical labor task, nor was this
reflected in the RUC recommendations, which continued to recommend the
same unchanged time for this task.
Comment: Many commenters objected to the proposed clinical labor
time of 7 minutes for the ``Load specimen into flow cytometer, run
specimen, monitor data acquisition, and data modeling, and unload flow
cytometer'' activity for CPT code 88184. Commenters stated that the CMS
comparison to the clinical labor time used for this same activity in
CPT code 88182 was not appropriate as CPT code 88184 uses 4-6 color
channel instruments and up, while 88182 uses only 1-2 channels.
According to the commenters, the time it takes for data capture, data
modeling, data acquisition, and computational analysis is exponentially
longer for CPT code 88184 than for CPT code 88182, since additional
colors result in more complicated profiles which are more difficult and
time consuming to evaluate. Another commenter stated that 7 minutes was
wholly inadequate to perform all of these tasks, and that analysis of a
specimen can take 12 to 15 minutes, depending on the complexity of the
case.
Response: We continue to disagree with the commenters that the
identical clinical labor activity would take longer to perform for CPT
code 88184 than it would for CPT code 88182. As we stated in response
to the previous comment, we do not agree that there is additional
clinical labor time required for using additional color channels in CPT
code 88184, as the same equipment is being used to perform the same
clinical labor task as in CPT code 88182. For the same reason, we do
not agree that this clinical labor activity takes 12 to 15 minutes to
perform, since the identical task only requires 7 minutes for CPT code
88182.
Comment: Many commenters opposed the proposed value of 2 minutes
for the clinical labor activity ``Print out histograms, assemble
materials with paperwork to pathologists Review histograms and gating
with pathologist'' for CPT code 88184. Commenters stated that it was
not reasonable to expect that a flow cytometry technologist could print
out histograms, assemble the documents and deliver them to a
pathologist, and review the histograms with a pathologist, all in the
span of a mere 120 seconds. Commenters were concerned that flow
cytometry technologists cannot produce a high-quality product and
ensure its accuracy and completeness for presentation to a pathologist
in the proposed time. One commenter noted that although their specific
procedure for these steps was largely electronic, their workflow
analysis corroborated the RUC's conclusion because it showed that it
took 5 minutes for staff to complete the equivalent activities. Several
other commenters stated that if the time the cyotechnologist takes to
determine exactly which histograms to print is subtracted, then they
could agree with the proposed 2 minutes. Commenters also stated that
printing is not performed all at one time, with 25-30 pages of
information and data printed over a 5 minute time span, and one
[[Page 80324]]
commenter indicated that the process was ``largely electronic'' with
clinical staff not using the equipment for the full duration that it is
in use.
Response: We appreciate the support from several of the commenters.
In responding to the comments for this clinical labor activity and the
equipment time for the dye sublimation printer (ED031), it became clear
that the clinical labor time for printing was not the same as the
equipment time that the printer was in use. Based on the information
from the commenters that printing is not performed all at one time, we
are assigning the full 5 minutes of equipment time for the dye
sublimation printer; however, we are maintaining our proposed 2 minutes
of clinical labor time for ``Print out histograms, assemble materials
with paperwork to pathologists Review histograms and gating with
pathologist'', as commenters have informed us that the clinical staff
do not use the equipment for the full duration that it is in use.
Comment: Several commenters disagreed with the proposed clinical
labor time of 1 minute for ``Clean room/equipment following procedure''
for CPT code 88184. The commenters stated that this time is allocated
over entire patient case, and that it is typical and critical to clean
the equipment between patient cases. The commenters also supplied
details about the cleaning process, regarding how the laboratory
technician cleans the equipment and workspace by decontaminating the
equipment and work bench surfaces, as well as carrying out waste
management after the procedure.
Response: We appreciate the additional information from the
commenters regarding the cleaning of the room. However, the commenters
did not provide a rationale as to why CPT code 88184 requires
additional clinical labor above the standard value of 1 minute for room
cleaning in lab procedures. We continue to believe that the standard
clinical labor time is the most accurate valuation for this clinical
labor task.
Comment: Many commenters requested that CMS restore the clinical
labor time for the ``Enter data into laboratory information system,
multiparameter analyses and field data entry, complete quality
assurance documentation'' activity. Commenters stated that this data
entry is manually entered and must be performed for each individual
patient case. Several commenters indicated that entering test-specific
data takes between five and ten minutes, and entry of client
information and demographics and specimen information takes additional
time that cannot be short-changed. Commenters emphasized that these are
extremely important tasks that require technical skills, and assigning
zero minutes to this critical task was illogical for a service like
flow cytometry. One commenter stated that the current RUC-recommended
value of four minutes was already a gross underestimation of the time
required to complete these activities for the majority of testing, and
suggested that these activities commonly take more than ten minutes to
perform.
Response: We agree with the commenters that entering patient data
into information systems is an important task, and we agree that it
would take more than zero minutes to perform. However, the commenters
did not address our rationale for removing this clinical labor time
from CPT codes 88184 and 88185, which is that this task is indirect PE.
As we stated in the CY 2016 final rule with comment period (80 FR
70979), we have not recognized the laboratory information system as an
equipment item that can be allocated to an individual service. We
continue to believe that this is indirect PE, and therefore, we do not
recognize the laboratory information system as a direct PE input, and
we do not consider this task as typically performed by clinical labor
on a per-service basis.
Comment: One commenter requested the inclusion of additional
cytotechnologist time of 10 minutes for CPT code 88184 and 2 minutes
for CPT code 88185, as well as an additional desktop computer with
monitor (ED021) equipment times of 10 minutes for 88184 and 2 minutes
for 88185. This additional time was intended to reflect the time spent
using the flow cytometry analytics software (EQ380).
Response: We agree with the RUC recommendations that the clinical
labor and equipment time associated with the flow cytometry analytics
software is already accounted for in the recommended clinical labor
inputs. As the recommendations indicate, this time is included as part
of the clinical labor activities ``Accession specimen'', ``Instrument
start-up, quality control functions'', ``Load specimen into flow
cytometer, run specimen'' and ``Print out histograms, assemble
materials with paperwork to pathologists.''
Comment: Many commenters disagreed with the proposed supply
quantity of 2 for the lysing reagent (SL089) in CPT code 88185.
Commenters stated that although they acknowledged that the current
Medicare data showed that a patient case of 24 markers is typical, this
result ignored other relevant pieces of information. The commenters
indicated that an analysis of the 2014 Medicare 5% Sample Carrier
Database showed that over 50 percent of individual providers typically
bill fewer than 20 markers per patient case, and that since these
providers are generally smaller and see fewer annual cases, the
proposed supply quantity of 2 would potentially drive these providers
to consider ceasing their flow cytometry services. The commenter also
stated that these codes are often billed as part of either the Hospital
IPPS or OPPS, which should be factored into the typical number of
markers billed per case. The commenter also stated that the most common
professional component of flow cytometry, CPT code 88189, would be
associated with patient cases that bill for fewer than 24 markers, from
16 to 24.
Response: We reiterate that we establish payment rates based on the
typical case, which the commenters agreed was 24 total markers. We have
historically established payment rates based on the typical service and
do not believe that it would be appropriate or serve the purpose of
relativity to deviate from that practice in this case. We also do not
believe that the payment for these codes under the IPPS or OPPS is a
directly relevant factor in defining the typical case under the
Physician Fee Schedule. We believe that the patient population and
typical case under the IPPS would not necessarily be the same as the
typical case under the PFS. Finally, we agree that CPT code 88189 would
be associated with patient cases that bill for fewer than 24 markers,
as the code descriptor states that it refers to the performance of 16
or more markers. However, we do not believe that this affects the
number of markers in the typical case, which the commenters agreed was
24 for the typical patient.
Comment: A commenter stated that that it opposed putting a number
or cap on markers because there is a wide range of possible markers
required to achieve patient diagnosis.
Response: We agree with the commenter, and we are not establishing
a cap or determining a fixed number of markers to use for these
procedures. As stated previously, however, we are required to establish
payment rates based on the typical case, which our internal data and
commenter feedback has agreed is 24 markers.
Comment: Other commenters disagreed with the CMS proposal for the
lysing reagent based on the supply quantity needed to perform the
procedure. A commenter stated that the 46-48 mL quantity detailed by
CMS in
[[Page 80325]]
the proposed rule was based on a RUC recommendation; however, the RUC's
amount was based on an average of 16 markers, not 24 markers. Although
the commenter agreed that 24 markers reflected a common case, the
commenter stated that it was necessary to consider the amount of lysing
agent for a 24 marker case, not to assume that the 46-48 mL amount
based upon 16 markers also applies to 24 markers. Another commenter
stated that a laboratory using ammonia chloride needs at least 2.5 ml
of lysing reagent for each time that CPT code 88185 is performed.
Response: We did not base our proposal for this supply quantity
upon the RUC recommendation. As we stated in the proposed rule, we were
informed that the use of 50-55 ml of the lysing reagent would be
typical for an entire patient case based on our discussions with
pathology specialists who perform flow cytometry. For the typical case
of 24 markers, our value would produce a total lysing reagent quantity
of 51 ml (5 ml from the single service of CPT code 88184 and 46 ml from
the 23 services of CPT code 88185), which matches with the amount
required for a total per patient case. Since commenters agreed that 24
markers was the typical patient case, we continue to believe that our
proposed quantity of 2 ml is the most accurate value for CPT code
88185.
Comment: Many commenters objected to the proposed supply quantity
of 1 for the flow cytometry antibody (SL186) in CPT codes 88184 and
88185. Commenters stated that although it is standard practice to use a
single antibody multiple times during the analysis, each antibody or
marker can only be billed once per analysis. According to commenters,
multiple use of such antibodies are not reportable or billable, but are
critical to the overall analysis and interpretation of results and are
part of the total cost for each procedure performed. Some commenters
explained that the recommended quantity of 1.6 antibodies per billed
marker was based on averaging together two separate analyses: a survey
of 59 professionals performing flow cytometry that found 1.52
antibodies required per marker, and a customer survey that found 1.87
antibodies per marker. A different commenter stated that its member
laboratories found that under the current four-color process, 1.36
antibodies per marker is necessary. Another commenter stated that while
one antibody is generally used per marker, the required use of controls
for many of these markers for analysis or quality control means that
this value is greater than 1 antibody per marker reported.
Response: We appreciate the additional data presented regarding the
clinical use of the flow cytometry antibody supply. However, we
continue to have reservations regarding the information that we have
received regarding the 1.6 quantity for this supply. Different
commenters recommended different quantities of this supply required to
furnish the procedure, ranging from 1 to 1.36 to 1.52 to 1.6 to 1.87.
We are hesitant to increase the quantity of this supply given the wide-
ranging information that we received from commenters. We are also
concerned that although commenters referenced studies that found
different supply quantities for SL186, commenters did not submit the
data associated with these studies for our review. We would be more
open to the idea of increasing the supply quantity to 1.6 if this data
were supported by clinical data or study. We also note that one
commenter stated that one antibody is ``generally used'' per marker,
which supports our contention that the proposed value of 1 antibody for
CPT codes 88184 and 88185 would be typical. As a result, we are
maintaining a supply quantity of 1 for the flow cytometry antibody
supply, which is also the current value for the supply and the RUC-
recommended value from the previous set of recommendations.
Comment: Several commenters disagreed with the proposed equipment
time for the dye sublimation printer (ED031). Commenters stated that
printing is not performed all at one time, with 25-30 pages of
information and data printed over a 5 minute time span. Commenters
indicated that this time cannot be linked directly to one particular
clinical labor task line, and the printer cannot be used for any other
task during these 5 minutes even while it is not actively printing.
Response: We appreciated the additional information from the
commenters regarding the use of the dye sublimation printer. Due to the
presentation of this new information detailing how the equipment time
for the printer is disassociated from any clinical labor tasks, we will
increase the equipment time to the RUC-recommended 5 minutes for CPT
code 88184 and 2 minutes for CPT code 88185.
After consideration of comments received, we are finalizing the
proposed work RVUs for CPT code 88187, 88188, and 88189. We are also
finalizing the proposed direct PE inputs, with the refinement to the
dye sublimation printer detailed above.
(47) Microslide Consultation (CPT Codes 88321, 88323, and 88325)
CPT codes 88321, 88323, and 88325 were reviewed by the RUC in April
2014 for their direct PE inputs only, and the CMS refined values were
included in the CY 2016 PFS final rule with comment period. The family
of codes was reviewed again at the January 2016 RUC meeting for both
work values and direct PE inputs, and new recommendations were
submitted to CMS as part of the CY 2017 PFS rulemaking cycle.
In the CY 2016 PFS final rule with comment period, we finalized our
proposal to remove many of the inputs for clinical labor, supplies, and
equipment for CPT code 88325. The descriptor for this code did not
state that slide preparation was taking place, and therefore, we
refined the labor, supplies, and equipment inputs to align with the
inputs recommended for CPT code 88321, which also does not include the
preparation of slides. After further discussion with pathologists and
consideration of comments received, we have been persuaded that slide
preparation does take place in conjunction with the service described
by CPT code 88325. In the RUC-recommended direct PE inputs from the
January 2016 meeting, the labor, supplies, and equipment inputs related
to slide preparation were added once again to CPT code 88325. We
proposed to accept these restorations related to slide preparation
without refinement.
Regarding the clinical labor direct PE inputs, we proposed to
assign 1 minute of L037B clinical labor for ``Complete workload
recording logs. Collate slides and paperwork. Deliver to pathologist''
for CPT codes 88323 and 88325. We are maintaining this at the current
value for CPT code 88323, and adding this 1 minute to CPT code 88325
based on our new understanding that slide preparation is undertaken as
part of the service described by this code. We proposed to remove the
clinical labor for ``Assemble and deliver slides with paperwork to
pathologists'' from all three codes, as we believe this clinical labor
is redundant with the labor assigned for ``Complete workload recording
logs.'' We similarly proposed to remove the clinical labor for ``Clean
equipment while performing service'' from CPT codes 88323 and 88325, as
we believe it to be redundant with the clinical labor assigned for
``Clean room/equipment following procedure.''
We proposed to maintain the quantity of the ``stain, hematoxylin''
supply
[[Page 80326]]
(SL135) at 16 ml for CPT codes 88323 and 88325, as opposed to the RUC-
recommended quantity of 32 ml. The RUC recommendation stated that the
hematoxylin supply does not include eosin and should not be redundant;
the stains are not mixed together, but are instead sequential. The
recommendation also made a comparison to the use of the hematoxylin
supply quantity in CPT code 88305. However, we note that CPT code 88305
does not include 8 ml of eosin stain (SL201), but instead 8 gm of eosin
solution (SL063), and these are not the same supply. Therefore we do
not agree that a direct comparison of the supply quantities is the most
accurate way to value these procedures. For CPT codes 88323 and 88325,
we continue to note that the prior supply inputs for these procedures
had quantity 2.4 of the eosin solution (SL063) and quantity 4.8 of the
hematoxylin stain (SL135); in other words, a 1:2 ratio between the
eosin and hematoxylin. We proposed to maintain that 1:2 ratio with 8 ml
of the eosin stain (SL201) and 16 ml of the hematoxylin stain (SL135).
We also proposed to update the use of the eosin solution (sometimes
listed as ``eosin y'') in our supply database. We believe that the
eosin solution supply (SL063), which is measured in grams, reflects an
older process of creating eosin stains by hand. This is in contrast to
the eosin stain supply (SL201), which is measured in milliliters, and
can be ordered in a state that is ready for staining immediately. We do
not believe that the use of eosin solution would reflect typical lab
practice today, with the readily availability for purchase of
inexpensive eosin staining materials. We also note that in the CY 2016
PFS final rule with comment period, we removed 8 gm of the eosin
solution and replaced it with 8 ml of the eosin stain, and this
substitution was accepted without further change in the most recent set
of RUC recommendations. As a result, we proposed to update the price of
the eosin stain supply from $0.044 per ml to $0.068 per ml to reflect
the current cost of the supply. We also proposed to use CPT codes 88323
and 88325 as a model, and replace the use of eosin solution with an
equal quantity of eosin stain for the rest of the codes that make use
of this supply. This applies to 15 other CPT codes: 88302 (Level II--
Surgical pathology, gross and microscopic examination), 88304 (Level
III--Surgical pathology, gross and microscopic examination), 88305
(Level IV--Surgical pathology, gross and microscopic examination),
88307 (Level V--Surgical pathology, gross and microscopic examination),
88309 (Level VI--Surgical pathology, gross and microscopic
examination), 88364 (In situ hybridization (e.g., FISH), per specimen;
each additional single probe stain procedure), 88365 (In situ
hybridization (e.g., FISH), per specimen; initial single probe stain
procedure), 88366 (In situ hybridization (e.g., FISH), per specimen;
each multiplex probe stain procedure), 88367 (Morphometric analysis, in
situ hybridization (quantitative or semi-quantitative), using computer-
assisted technology, per specimen; initial single probe stain
procedure), 88368 (Morphometric analysis, in situ hybridization
(quantitative or semi-quantitative), manual, per specimen; initial
single probe stain procedure), 88369 (Morphometric analysis, in situ
hybridization (quantitative or semi-quantitative), manual, per
specimen; each additional single probe stain procedure), 88373
(Morphometric analysis, in situ hybridization (quantitative or semi-
quantitative), using computer-assisted technology, per specimen; each
additional single probe stain procedure), 88374 (Morphometric analysis,
in situ hybridization (quantitative or semi-quantitative), using
computer-assisted technology, per specimen; each multiplex probe stain
procedure), 88377 (Morphometric analysis, in situ hybridization
(quantitative or semi-quantitative), manual, per specimen; each
multiplex probe stain procedure), and G0416 (Surgical pathology, gross
and microscopic examinations, for prostate needle biopsy, any method).
The following is a summary of the comments we received regarding
our proposed valuation of the Microslide Consultation codes.
Comment: One commenter supported the restoration of the direct PE
inputs related to slide preparation in CPT code 88325 and requested
that CMS update the PE data files for CY 2016 to reflect these changes.
Response: We appreciate the support from the commenter. The
proposed rates for CY 2017 reflected these changes to the direct PE
inputs. However, the RVUs for CY 2016 were unaffected by this proposal,
as has been our longstanding practice for interim final codes.
Comment: Several commenters requested that CMS add an additional 1
minute for the clinical labor activity ``Complete workload recording
logs. Collate slides and paperwork. Deliver to pathologist'' in CPT
code 88321. Commenters stated that this clinical labor task was
accidently left off of the April 2014 RUC recommendation for CPT code
88321, and that it was a necessary task that was not redundant with
other clinical labor activities.
Response: We agree with the commenters that 1 minute of clinical
labor time for this task is an appropriate addition for CPT 88321 to be
consistent with the identical clinical labor task taking place in other
codes in the family.
After consideration of comments received, we are finalizing our
proposed work RVUs for CPT code 88321, 88323, and 88325. We are also
finalizing the proposed direct PE inputs, with the addition of 1 minute
of clinical labor time as detailed above for CPT code 88321. We note as
well that we are finalizing the replacement of eosin solution with
eosin stain, as detailed in the PE section of this final rule (see
section II.A. of this final rule).
(48) Immunohistochemistry (CPT Codes 88341, 88342, 88344, and 88350)
In the CY 2014 PFS final rule with comment period (78 FR 74341), we
assigned a status indicator of I (Not valid for Medicare purposes) to
CPT codes 88342 and 88343 and instead created two G-codes, G0461 and
G0462, to report immunohistochemistry services. We did this, in part,
to avoid creating incentives for overutilization.
For CY 2015, the CPT coding was revised with the creation of two
new CPT codes, 88341 and 88344, the revision of CPT code 88342 and the
deletion of CPT code 88343. In the past for similar procedures in this
family, the RUC recommended a work RVU for the add-on code (CPT code
88364) that was 60 percent of the work RVU for the base code (CPT code
88365). In the CY 2015 PFS final rule with comment period, we stated
that the relative resources involved in furnishing an add-on service in
this family would be reflected appropriately using the same 60 percent
metric and subsequently established an interim final work RVU of 0.42
for CPT code 88341, which was 60 percent of the work RVU of 0.70 for
the base CPT code 88342. In the CY 2016 PFS proposed rule, we revised
the add-on codes from 60 percent to 76 percent of the base code and
subsequently proposed a work RVU of 0.53 for CPT code 88341. However,
we inadvertently published work RVUs for CPT code 88341 in Addendum B
on the CMS Web site without explicitly discussing it in the preamble
text. In the CY 2016 PFS final rule with comment period, we maintained
the CY 2015 work RVU of 0.53 for CPT code 88341 as interim final for CY
2016 and requested public comment. Also, in the CY 2016 PFS final rule
with comment period, we
[[Page 80327]]
established an interim final work RVU of 0.70 for CPT codes 88342 and
88344.
Comment on the CY 2016 PFS final rule with comment period: Several
commenters objected to a standard discount for the physician work
involved in pathology add-on services and urged us to accept the RUC-
recommend work RVU of 0.65 for CPT code 88341.
Response in the CY 2017 PFS proposed rule: We responded to the
comments by stating our appreciation of the commenters' concerns
regarding a standard discount; however, we believed that it was
reasonable to estimate work RVUs for a base and an add-on code, and to
recognize efficiencies between them, by looking at how similar
efficiencies are reflected in work RVUs for other PFS services. Also we
noted that the intravascular codes for which we initially established
our base/add-on code relationship for CPT codes 88346 and 88350 were
deleted in CY 2016 and replaced with two new codes; CPT codes 37252 and
37253. The relationship between CPT codes 37252 and 37253 represents a
20 percent discount for the add-on code as the base CPT code 37252 has
a work RVU of 1.80 and CPT code 37253 has a work RVU of 1.44. As CPT
codes 37252 and 37253 replaced the codes on which our discounts for
base and add-on codes were based (please see the CY 2016 PFS final rule
with comment period (80 FR 70972) for a detailed discussion), we
believed it would be appropriate to maintain the same 20 percent
relationship for CPT codes 88346 and 88350. Therefore, for CY 2017, we
proposed a work RVU of 0.56 for CPT code 88341, which represents 80
percent of the work RVU of 0.70 for the base code. For CY 2016, we
finalized a work RVU of 0.56 for CPT code 88350 which, represented 76
percent of the work RVU of 0.74 for the base code. To maintain
consistency within this code family, for CY 2017 we proposed to revalue
CPT code 88350 using the 20 percent discount discussed above. To value
CPT code 88350, we multiplied the work RVU of 0.74 for CPT code 88346
by 80 percent, and then subtracted the product from 0.74, resulting in
a work RVU of 0.59 for CPT code 88350. For CY 2017, we proposed a work
RVU of 0.59 for CPT code 88350.
The following is a summary of the comments we received regarding
our proposed valuations for the Immunohistochemistry family:
Comments: Several commenters stated concerns regarding the level of
reimbursement these pathology codes would receive if CMS reduced the
work RVUs as proposed. The commenters stated the reduced reimbursement
would force pathologists to decrease the number of technical staff,
which would interfere with pathologists' ability to perform these
services accurately and timely.
The RUC stated the CY 2017 proposed work RVUs for CPT codes 88341
and 88350 do not represent the work involved in furnishing the
procedure and present a rank order anomaly for other services. The RUC
also stated that the services furnished by CPT codes 37252 and 37253,
which we used to establish the relationship between the base code and
the add-on code, are not medically comparable services to CPT codes
88341 and 88350. Additionally, the RUC stated each pathology service
has individual intensities and complexities. Specifically, for
additional immunohistochemistry services represented by add-on CPT
codes 88341 and 88350, each antibody is evaluated separately on
different slides and each additional service is separate and distinct.
Lastly, the RUC stated its approach of evaluating the actual work
associated with each unique base and each unique add-on service is far
more accurate, rational, and responsive to the specific circumstances
than holding codes equal to a fixed discount from the base code.
Applying ratio comparisons and fixed discounts to arrive at a work
relative value will continue to create inter-specialty rank order
anomalies of physician work RVUs.
Another commenter noted there were RUC surveys that evaluated
physician work differentials between the base codes and the add-on
codes for pathology services. The commenter offered CPT codes 88333
(Pathology consultation during surgery; cytologic examination (e.g.,
touch prep, squash prep), initial site) and 88334 (Pathology
consultation during surgery; cytologic examination (e.g., touch prep,
squash prep), each additional site (List separately in addition to code
for primary procedure)) and CPT codes 88331 (Pathology consultation
during surgery; first tissue block, with frozen section(s), single
specimen) and 88332 (Pathology consultation during surgery; each
additional tissue block with frozen section(s) (List separately in
addition to code for primary procedure) as examples for consideration.
Response: We appreciate commenters' concern regarding the level of
reimbursement and will continue to consider input from the medical
community on this issue through evaluation of CPT coding changes and
associated RUC recommendations, as well as feedback received through
public comments, as we value these services through future notice and
comment rulemaking. We also note that the PFS is a relative value
system and, as such, values services across all specialties. We believe
it is important that there are accurate comparisons between codes in
different families.
As discussed in detail in previous proposed and final rules, we
continue to believe the metric we use to value add-on codes relative to
their base codes is appropriate and representative of the work involved
and note that there is no rank order anomaly within this particular
code family. In response to the commenter's statement that there should
be no comparison of intravascular ultrasound services to any pathology
service, we continue to believe any difference in work RVUs for codes
describing different kinds of services should reflect the relative
differences in time and intensity involved in furnishing the services.
Therefore, we believe that it is imperative that we can compare the
assumptions regarding overall work between any two codes, regardless of
their characteristics.
We appreciate commenters' concerns regarding a standard discount,
and we do not consider the use of a particular increment to establish a
new standard. Instead, we reiterate that we believe that it is
reasonable to estimate work RVUs for a base and an add-on code, and to
recognize efficiencies between them, by looking at how similar
efficiencies are reflected in work RVUs for other PFS services. We
appreciate the commenters' concerns regarding the time ratio
methodologies and have responded to these concerns about our
methodology in section II.L of this final rule.
Therefore, for CY 2017 we are finalizing a work RVU of 0.56, 0.70,
0.70, and 0.59 for CPT codes 88341, 88342, 88344 and 88350,
respectively.
(49) Morphometric Analysis (CPT Codes 88364, 88365, 88367, 88368, 88369
and 88373)
For CY 2015, the CPT Editorial Panel revised the code descriptors
for the in situ hybridization procedures, CPT codes 88365, 88367 and
88368, to specify ``each separately identifiable probe per block.''
Additionally, three new add-on codes (CPT codes 88364, 88369 and 88373)
were created to specify ``each additional separately identifiable probe
per slide.'' Some of the add-on codes in this family had RUC-
recommended work RVUs that were 60 percent of the work RVU of the base
procedure. We believed this accurately reflected the resources used in
furnishing these add-on codes and
[[Page 80328]]
subsequently established interim final work RVUs of 0.53 for CPT code
88364 (60 percent of the work RVU of CPT code 88365); 0.53 for CPT code
88369 (60 percent of the work RVU of CPT code 88368); and 0.43 for CPT
code 88373 (60 percent of the work RVU of CPT code 88367).
For CY 2016, the RUC re-reviewed these services due to the
specialty society's initially low survey response rate. In our review
of these codes, we noticed that the latest RUC recommendation was
identical to the RUC recommendation provided for CY 2015. Therefore, we
proposed to retain the CY 2015 work RVUs and work time for CPT codes
88367 and 88368 for CY 2016. For CPT code 88365 we finalized a work RVU
of 0.88 for CY 2016. For CPT codes 88364 and 88369, we increased the
work RVUs for both of these add-on codes from 0.53 to 0.67, which
reflected 76 percent of the work RVUs of the base procedures for these
services. However, we inadvertently omitted the rationale for this
revision to the work RVUs in the preamble to CY 2016 proposed rule.
Consequently, we maintained the CY 2015 interim final values of the
work RVU of 0.67 for CPT codes 88464 and 88369 and sought comment on
these values for CY 2016. For CPT code 88373 we finalized a work RVU of
0.43.
Comment on the CY 2016 PFS final rule with comment period: A few
commenters stated their objection to our use of a standard discount for
pathology add-on services and for suggesting that each service is
separate and unique. Commenters also stated there should be no
comparison of intravascular ultrasound services to morphometric
analysis, immunohistochemistry, immunofluorescence, or any pathology
service.
Response in the CY 2017 PFS proposed rule: In reviewing the RUC
recommended base/add-on relationships between several pathology codes,
we continue to believe the base/add-on code time relationships for
pathology services are appropriate and have not been presented with any
compelling evidence that conflicts with the RUC-recommended
relationships. However, as we stated above, the intravascular codes we
initially examined in revaluing CPT codes 88364 and 88369 were deleted
in CY 2016 and replaced with CPT codes 37252 and 37253. For the reasons
stated above we continue to believe this 20 percent discount
relationship between the base and add-on code accurately reflects the
work involved in furnishing these services. Therefore, for CY 2017, we
are proposing a work RVU of 0.70 for CPT codes 88364 and 88369 which
represents a 20 percent discount from the base code. As the
relationship between the base code and add-on code now represents a 20
percent difference we are proposing to revalue CPT code 88373 at 0.58
work RVUs.
In the CY 2017 proposed rule, we proposed a work RVU of 0.58 for
CPT code 88373.
The following is a summary of the comments we received regarding
our proposed valuation of the Morphometric Analysis codes:
Comments: The RUC stated appreciation for the proposed increase in
work RVUs for CPT codes 88364 and 88369 although it stated the increase
still does not represent the proper work RVU for the work involved and
presents a rank order anomaly relative to other services. The RUC,
along with other commenters, stated the services described by CPT codes
37252 and 37253 are not comparable medical services to those furnished
by CPT codes 88364 and 88369, and there should be no comparison of
intravascular ultrasound services to any pathology services.
The RUC also stated that although some medical procedures and
services may present efficiencies between base and add-on services,
this is not the case for CPT codes 88364 and 88369, as each pathology
service is individual so that any rational comparison of the physician
work of intravascular ultrasound services with pathology services is
impossible. The RUC also stated that no pathology add-on service can be
presumed to have a discount in physician work from the base service.
Another commenter stated for CPT code 88373, it is irrational to
assume that second and subsequent services designated by convention as
``add-on'' services require a reduction in resources relative to the
corresponding initial service.
Another commenter noted that in the CY 2017 proposed rule, CMS
incorrectly stated it was utilizing a RUC recommendation specific to
these codes. According to the CY 2015 Final Rule (79 FR 67548), the
codes on which CMS based its discount were CPT codes 88334, 88335,
88177, and 88172. The commenter states the distinction between the
codes cited in the CY 2015 final rule, CPT codes 88334, 88335, 88177,
88172, and the new add-on codes, CPT codes 88364, 88369 and 88373, is
that the discount factor is specific to services for which a diagnosis
has already been furnished. For the new codes to which CMS applied this
discount, no such corresponding interpretative diagnosis has been made.
The same commenter stated for morphometric codes, the pathologist
is reviewing a second, unique and distinct probe with an entirely
different signal than that of its base code, and the work involved with
these add-on services requires the same level of intensity and time as
their base codes.
The commenter also stated that pathology consultation and
cytopathology evaluation codes were clinically different and are not
valid proxies to identify efficiencies for the new add-on codes.
Response: We do not agree that there are rank order anomalies
within this code family, and we note that this code family was valued
within itself and not in relation to other services within the PFS. In
response to the commenter's statement that there should be no
comparison of intravascular ultrasound services to any pathology
service as discussed above, we continue to believe it is valid to
compare services across the PFS when determining appropriate values.
We also continue to believe that it is reasonable to recognize
efficiencies between them a base and an add-on code. In reviewing the
RUC-recommended base/add-on relationships between several pathology
codes, we continue to believe the base/add-on code time relationships
for pathology services are appropriate and have not been presented with
any persuasive evidence or rationale that conflicts with the RUC-
recommended relationships.
We agree with the commenter that the designation ``add-on'' does
not automatically imply a reduction; however, in the case of these
similar pathology services, we continue to believe using the same
valuation metrics is valid. Therefore, for CY 2017, we are finalizing a
work RVU of 0.70, 0.73, 0.88, 0.70 and 0.58 for CPT codes 88364, 88367,
88368, 88369 and 88373, respectively.
(50) Liver Elastography (CPT Code 91200)
For CY 2016, we received a RUC recommendation of 0.27 work RVUs for
CPT code 91200. After careful review of the recommendation, we
established the RUC-recommended work RVU and direct PE inputs as
interim final for CY 2016.
Comment on the CY 2016 PFS final rule with comment period: A few
commenters requested that we reconsider the level of payment assigned
to this service when furnished in a nonfacility setting, stating that
the
[[Page 80329]]
code met the definition for the potentially misvalued code list as
there is a significant difference in payment between sites of service.
The commenters also asked us to reconsider the assigned 50 percent
utilization rate for the FibroScan equipment in this procedure as the
current utilization rate would translate to over 50 procedures per
week. Instead, the commenters suggested the typical number of
procedures done per week ranges between 15 and 25 and requested we
adopt a 25 percent utilization rate which corresponds to that number of
procedures.
Response in the CY 2017 PFS proposed rule: We refer commenters to
the CY 2016 final rule with comment period (80 FR 71057-71058) where we
discussed and addressed the comparison of the PFS payment amount to the
OPPS payment amount for CPT 91200. For the commenter's statement about
the utilization rate, we have previously addressed the accuracy of
these default assumptions as they apply to particular equipment
resources and particular services. In the CY 2008 PFS proposed rule (72
FR 38132), we discussed the 50 percent utilization assumption and
acknowledged that the default 50 percent usage assumption is unlikely
to capture the actual usage rates for all equipment. However, we stated
that we did not believe that we had strong empirical evidence to
support any alternative approaches. We indicated that we would continue
to monitor the appropriateness of the equipment utilization assumption,
and evaluate whether changes should be proposed in light of the data
available. The commenters did not provide any verifiable data
suggesting a lower utilization rate. Therefore, for CY 2017 we proposed
a work RVU of 0.27 for CPT code 91200, consistent with the CY 2016
interim final value, and we continued to explore and solicit comments
regarding publically available data sources to identify the most
accurate equipment utilization rate assumptions possible. We also noted
that following the publication of the CY 2016 PFS final rule with
comment period (80 FR 70886) there was an inconsistency in the Work
Time file published on the CMS Web site. For CPT code 91200 the RUC
recommended 16 minutes total service time whereas our file reflected 18
minutes total time for the service. For CY 2017, we proposed to update
the Work Time file to reflect the RUC's recommendation, which is 16
minutes for CPT code 91200.
The following is a summary of the comments we received regarding
our proposed valuation of CPT code 91200.
Comment: Many commenters disagreed with the proposed valuation of
CPT code 91200, suggesting that the $34 payment rate in the nonfacility
setting for CY 2016 underestimated the resource cost of the procedure.
Commenters stated that this code is a first-line method used to assess
fibrosis scores in patients with chronic liver disease, especially
those with chronic Hepatitis C, and that the current reimbursement was
not sufficient to cover the cost of providing the service. Some
commenters compared the use of the Fibroscan device in CPT code 91200
to more expensive and more invasive liver biopsies, or compared the
cost of the procedure to the treatment provided in hospital-based
payment systems. Commenters urged CMS to increase the valuation of CPT
code 91200 to encourage providers to adopt the use of the Fibroscan
device.
Response: We remind commenters that we are obligated by statute to
set payment rates based on the resources used to furnish the procedure,
and that as a result pricing for codes on the PFS does not necessarily
mirror pricing for codes under different payment systems. We also note
that we proposed the RUC-recommended work RVU and direct PE inputs for
CPT code 91200 without alteration.
Comment: Many of the commenters also addressed the pricing of the
Fibroscan equipment (ER101). Commenters provided CMS a range of
different prices for this equipment item, individually suggesting that
the equipment costs $120k, $130k, $140k, and $150k. One commenter
supplied an individual invoice for the Fibroscan, including the device
itself along with a CAP option, an S probe, a printer, and shipping/
maintenance costs.
Response: We appreciate the submission of additional information
regarding the proper pricing of the Fibroscan. We encourage more
commenters to include invoices with their comment submissions if they
believe that existing supplies or equipment items are undervalued, as
we have had longstanding reservations about establishing pricing based
on single invoices. In the specific case of the Fibroscan equipment, we
agree that the price should be increased based on the submitted
invoice. We are pricing ER101 at $183,390 based on a combination of the
cost of the Fibroscan itself ($131,950), the CAP option ($22,955), the
S probe ($27,950), and the printer ($495). We note that we do not
typically pay for shipping costs or maintenance costs, as equipment
maintenance costs are built into the equipment cost per minute formula.
We are also changing the name of ER101 from ``Fibroscan'' to
``Fibroscan with printer'' to reflect the fact that this pricing
incorporates a printer.
After consideration of comments received, we are finalizing our
proposed work RVUs and direct PE inputs, with the price increase to the
Fibroscan with printer equipment.
(51) Closure of Paravalvular Leak (CPT Codes 93590, 93591, and 93592)
The CPT Editorial Panel developed three new codes (two base codes
and one add-on code) to describe paravalvular leak closure procedures
that were previously reported using an unlisted code. The RUC
recommended a work RVU of 17.97 for CPT code 93591. We proposed a work
RVU of 14.50 for CPT code 93591, a direct crosswalk from CPT code
37227. We stated in the CY 2017 proposed rule that we believe that a
direct crosswalk to CPT code 37227 accurately reflected the time and
intensity described in CPT code 93591 since CPT code 37227 also
described a transcatheter procedure with similar service times.
To maintain relativity among the codes in this family, we proposed
refinements to the recommended work RVUs for CPT code 93590. The RUC
noted that the additional work associated with CPT code 93590 compared
to CPT code 93591 was due to the addition of a transseptal puncture to
access the mitral valve. The RUC identified a work RVU of 3.73 for a
transseptal puncture. Therefore, for CPT code 93590, we proposed a work
RVU of 18.23 by using our proposed work RVU of 14.50 for CPT code 93591
and adding the value of a transseptal puncture (3.73).
CPT code 93592 is an add-on code used to report placement of
additional occlusion devices for percutaneous transcatheter
paravalvular leak closure, performed in conjunction with either an
initial mitral or aortic paravalvular leak closure. The RUC recommended
a work RVU of 8.00 for this code. In the proposed rule, we stated that
we considered applying the relative increment between CPT codes 93590
and 93591; however, we believed that a direct crosswalk to CPT code
35572, with a work RVU of 6.81, more accurately reflected the time and
intensity of furnishing the service. Therefore, for CPT code 93592, we
proposed a work RVU of 6.81.
Comment: For CPT code 93591, commenters opposed CMS' assertion that
a cardiovascular intervention
[[Page 80330]]
performed in an immobile leg is comparable in intensity and patient
risk to an intervention performed in a beating, moving heart.
Commenters suggested that CMS' proposed crosswalk to CPT code 37227 was
not appropriate since CPT code 37227 is generally performed in an
outpatient setting, while CPT code 93591 is generally performed in a
facility setting due to the intensity and risk associated with the
procedure. Subsequently, commenters suggested that CMS finalize the
RUC-recommended work RVU of 17.97 for CPT code 93591.
For CPT code 93590, commenters, including the RUC, supported CMS'
proposed use of the same building block methodology used in the RUC
recommendations, by proposing to apply a work RVU of 3.73 to the base
code value of 93591. However, commenters suggested that CMS apply the
value of a transeptal puncture to the RUC-recommended value for CPT
code 93591, and therefore, finalize the RUC-recommended work RVU of
21.70 for CPT code 93590.
For CPT code 93592, commenters, including the RUC, disagreed with
CMS' proposed comparison of CPT code 93592 to CPT code 35572 (Harvest
of femoropopliteal vein, 1 segment, for vascular reconstruction
procedure (e.g., aortic valve services)). Commenters stated that CMS's
proposed crosswalk is inappropriate and does not recognize the
intensity and skill level needed to place a device to close a
paravalvular leak in a moving, beating heart, frequently in patients
with heart failure. Commenters stated that CPT code 35572 was only
similar to CPT code 93592 in that both procedures are cardiovascular in
nature. Commenters also stated that surgical harvest of the lower
extremity vein is not clinically similar to the transcatheter
percutaneous structural heart therapies.
Response: We thank the commenters for their feedback on our
proposal. After consideration of the comments received, we are
finalizing the RUC-recommended work RVUs for each of the codes in this
family. Therefore, we are finalizing a work RVU of 21.70 for CPT code
93590, a work RVU of 17.97 for CPT code 93591, and a work RVU of 8.00
for CPT code 93592.
(52) Electroencephalogram (EEG) (CPT Codes 95812, 95813, and 95957)
In February 2016, the RUC submitted recommendations for work and
direct PE inputs for CPT codes 95812, 95813, and 95957. We proposed to
use the RUC-recommended physician work and direct PE inputs for CPT
code 95957 and to use the RUC-recommended work RVUs for CPT codes 95812
and 95813.
In the CY 2016 PFS final rule with comment period (80 FR 70886), we
finalized direct PE input refinements for several clinical labor times
for CPT codes 95812 and 95813. The RUC's February 2016 direct PE
summary of recommendations indicated that the specialty society expert
panel disagreed with CMS' refinements to clinical labor time for these
two codes. The RUC recommended 62 minutes for clinical labor task
``perform procedure'' for CPT code 95812 and 96 minutes for the same
clinical labor task for CPT code 95813, similar to the values
recommended by the RUC in April 2014.
We proposed to maintain the CMS-refined CY 2016 PE inputs for
clinical labor task ``perform procedure'' for CPT codes 95812 (50
minutes) and 95813 (80 minutes), since the RUC's PE summary of
recommendations stated that CPT code 95812 required 50 minutes of
clinical labor time for EEG recording, and CPT code 95813 required 80
minutes of clinical labor time for the same clinical labor task.
We did not receive any comments on our proposals for this family of
codes. Therefore, for CY 2017, we are finalizing our proposed direct PE
inputs for these codes without modifications. We are also finalizing
for CY 2017 work RVUs of 1.08 for CPT code 95812, 1.63 for CPT code
95813, 1.98 for CPT code 95957.
(53) Analysis of Neurostimulator Pulse Generator System (CPT Codes
95971, 95972)
CPT codes 95971 and 95972 were established as interim final
following the CY 2016 final rule with comment period. For CY 2017, we
proposed to maintain their work RVUs and direct PE inputs.
Comment: A commenter expressed support for the proposal to maintain
the current work and PE RVUs, stating that these codes were revalued in
2015 and there was no reason to make any changes.
Response: We appreciate the support from the commenter.
After consideration of comments received, we are finalizing our
proposed work RVUs and proposed direct PE inputs for CPT codes 95971
and 95972.
(54) Patient, Caregiver-focused Health Risk Assessment (CPT Codes 96160
and 96161)
In October 2015, the CPT Editorial Panel created two new PE-only
CPT codes, 96160 (Administration of patient-focused health risk
assessment instrument (e.g., health hazard appraisal) with scoring and
documentation, per standardized instrument) and 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). For CPT code 96160, we
proposed the RUC-recommended direct PE inputs. For CPT code 96161, the
service is furnished to a patient who may not be a Medicare
beneficiary, and therefore, we did not believe the code would be
eligible for Medicare payment. We proposed to assign a procedure status
of I (Not valid for Medicare purposes) for CPT code 96161.
We noted that we believed that CPT code 96160 describes a service
that is frequently reasonable and necessary in the treatment of illness
or injury, such as when there has been a change in health status.
However, when the service described by CPT code 96160 is explicitly
included in another service being furnished, such as the Annual
Wellness Visit (AWV), this code should not be billed separately, much
like other codes that describe services included in codes with broader
descriptions. We also noted that this service should not be billed
separately if furnished as a preventive service as it would describe a
non-covered service. However, we also solicited comment on whether this
service may be better categorized as an add-on code and welcomed
stakeholder input regarding whether or not there are circumstances when
this service might be furnished as a stand-alone service.
Comment: Many commenters recommended that CMS should recognize and
make separate payment for CPT code 96160, as proposed, as well as 96161
using the RUC-recommended values. Several of these commenters argued
that the medical community has recognized that health risk assessment
of caregivers is an integral part of ongoing medical care for patients
with particular needs. These commenters offered several examples where
such an assessment is integral to treating patients, such as:
Assessment of maternal depression in the active care of
infants,
Assessment of parental mental health as part of evaluating
a child's functioning,
Assessment of caretaker conditions as indicated where
atypical parent/child interactions are observed during care,
Assessment of caregivers as part of care management for
adults whose physical or cognitive status renders them incapable of
independent living and dependent on another adult caregiver. Some
examples might be intellectually disabled adults, seriously
[[Page 80331]]
disabled military veterans and adults with significant musculoskeletal
or central nervous system impairments.
Because commenters noted that these assessments were generally
administered during E/M services, they were receptive to making both
CPT codes 96160 and 96161 add-on codes to E/M services.
Response: After considering comments, we believe that CPT codes
96160 and 96161 describe services that, in particular cases, can be
necessary components of services furnished to Medicare beneficiaries.
While we recognize that in many cases we have previously assigned non-
payment indicators to codes that describe interactions with caregivers,
we also note that we have also recognized that in current medical
practice, practitioner interaction with caregivers is an integral part
of treatment for some patients. Accordingly, the descriptions for
several payable codes under the PFS include direct interactions between
practitioners and caregivers.
In developing our proposal regarding the payment disposition of
this code, we noted that it singularly described a service administered
to a caregiver. However, based on public comments, including the
receptivity to our assignment of add-on code status, we understand that
in actual practice, this service is integrated with E/M visits under
particular circumstances. Consequently, we believe the appropriate
payment status for the code should be determined by looking at the
overall service as described by the two codes together. We agree with
commenters, then, that there are circumstances where this service is an
essential part of a service to a Medicare beneficiary. Therefore, we
are assigning an active payment status to both codes for CY 2017. We
are also establishing use of the RUC recommended values for these
codes. We are also assigning 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.
(55) Reflectance Confocal Microscopy (CPT Codes 96931, 96932, 96933,
96934, 96935, and 96936)
For CY 2015, the CPT Editorial Panel established six new Category I
codes to describe reflectance confocal microscopy (RCM) for imaging of
skin. For CPT codes 96931 and 96933, the specialty society and the RUC
agreed that the physician work required for both codes were identical,
and therefore, should be valued the same. The RUC recommended a work
RVU of 0.80 for CPT codes 96931 and 96933 based on the 25th percentile
of the survey. Based on the similarity of the services being performed
in CPT codes 96931 and 96933 and the identical intra-service times of
96931, 96933 and 88305, the key reference code from the survey, we
believe a direct crosswalk from CPT code 88305 to CPT codes 96931 and
96933 would more accurately reflect the work involved in furnishing the
procedure. Therefore, for CY 2017, we proposed a work RVU of 0.75 for
CPT codes 96931 and 96933. In addition, we proposed removing 3 minutes
of preservice time from CPT codes 96931 and 96933 since it is not
included in CPT code 88305 and as a result, we did not believe it was
appropriate in CPT codes 96931 and 96933.
For CPT codes 96934 and 96936, the specialty society and the RUC
agreed that the physician work required for both codes were identical,
and therefore, should be valued the same. In its recommendation, the
RUC stated that it believed the survey respondents somewhat
overestimated the work for CPT code 96934 with the 25th percentile
yielding a work RVU of 0.79. Consequently, the RUC reviewed the survey
results from CPT code 96936 and agreed that the 25th percentile work
RVU of 0.76 accurately accounted for the work involved for the service.
Therefore, the RUC recommended a work RVU of 0.76 for CPT codes 96934
and 96936.
We believe that the incremental difference between the RUC-
recommended values for the base and add-on codes accurately captures
the difference in work between the code pairs. However, because we
valued the base codes differently than the RUC, we proposed values for
the add-on codes that maintain the RUC's 0.04 increment instead of the
RUC-recommended values. Therefore we proposed a work RVU of 0.71 for
CPT codes 96934 and 96936.
We also proposed to reduce the preservice clinical labor for
``Patient clinical information and questionnaire reviewed by
technologist, order from physician confirmed and exam protocoled by
physician'' for CPT codes 96934 and 93936 as this work is performed in
the two base CPT codes 93931 and 93933. We proposed to reduce the
service period clinical labor for ``Prepare and position patient/
monitor patient/set up IV'' from 2 to 1 minute for CPT codes 93934 and
93936 since we believed that less positioning time is needed with
subsequent lesions. We proposed to refine the service period clinical
labor for ``Other Clinical Activity--Review imaging with interpreting
physician'' to zero minutes for CPT codes 96933 and 96936 as these are
interpretation and report only codes and not image acquisition.
Comment: Several commenters, including the RUC, objected to the
proposed valuations for CPT codes 96931, 96933, 96934, and 96936. The
RUC disagreed with pre-service time being removed from a survey code
simply due to a key reference code not also having pre-service time.
The RUC stated CPT codes 96931 and 96933 are distinct procedures from
CPT codes 88305 and the CMS proposal to remove 3 minutes of pre-time
from the base RCM codes was grounded on faulty logic. The RUC stated
its agreement with the specialty society that 3 minutes of preservice
time was necessary for the physician to review clinical history and
referral information. The RUC further stated with the 3 minutes of pre-
service time in its recommendation for the RCM base codes were
appropriately in line with top key reference CPT code 88305 and urged
CMS to accept the survey 25th percentile work RVUs for CPT codes 96931,
96933, 96934, and 96936. Other commenters stated there were very
significant differences in the technologies used and the work involved
between the procedures of CPT code 88305, the key reference code, and
CPT codes 96931 and 96933, with CPT codes 96931 and 96933 being more
complex procedures.
One commenter stated CMS incorrectly removed technician time for
``Other Clinical Activity--Review imaging with interpreting physician''
for CPT codes 96933 and 96936 noting the technician still must review
the imaging with the interpreting physician and urged CMS to accept the
RUC recommendations.
Response: After consideration of comments received, we agree with
the commenters and will finalize the RUC-recommended work RVUs of 0.80,
0.80, 0.76, and 0.76 for CPT codes 96931, 96933, 96934 and 96936;
respectively. We will also restore the 3 minutes of preservice time to
CPT codes 96931 and 96933.
(56) Evaluative Procedures for Physical Therapy and Occupational
Therapy (CPT Codes 97161, 97162, 97163, 97164, 97165, 97166, 97167,
97168)
For CY 2017, the CPT Editorial Panel deleted four CPT codes (97001,
97002, 97003, and 97004) and created eight new CPT codes (97161-97168)
to describe the evaluative procedures furnished by physical therapists
and
[[Page 80332]]
occupational therapists. There are three new codes, stratified by
complexity, to replace a single CPT code 97001, for physical therapy
(PT) evaluation, and three new codes, also stratified by complexity, to
replace a single code CPT code 97003, for occupational therapy (OT)
evaluation, and one new code each to replace the re-evaluation codes
for physical and occupational therapy, CPT codes 97002 and 97004. Table
23 includes the long descriptors and the required components of each of
the eight new CPT codes for the PT and OT services.
The CPT Editorial Panel's creation of the new codes for PT and OT
evaluative procedures grew out of a CPT workgroup that was originally
convened in January 2012 when contemplating major revision of the
Physical Medicine and Rehabilitation CPT section of codes in response
to our nomination of therapy codes as potentially misvalued codes,
including CPT code 97001 (and, as a result, all four codes in the
family) in the CY 2012 PFS proposed rule.
In reviewing the eight new CPT codes for evaluative procedures, the
HCPAC forwarded recommendations for work RVUs and direct PE inputs for
each code. Currently, CPT codes 97001 and 97003 both have a work RVU of
1.20, and CPT codes 97002 and 97004 both have a work RVU of 0.60. These
CPT codes have reflected the same work RVUs since CY 1998 when we
accepted the HCPAC values during CY 1998 rulemaking.
i. Valuation of Evaluation Codes
In the CY 2017 PFS proposed rule, we noted that the HCPAC submitted
work RVU recommendations for each of the six new PT and OT evaluation
codes. These recommendations are intended to be work neutral relative
to the valuation for the previous single evaluation code for PT and OT,
respectively. However, that assessment for each family of codes is
dependent on the accuracy of the utilization forecast for the different
complexity levels within the PT or OT family. As used in this section,
work neutrality is distinct from the budget neutrality that is applied
broadly in the PFS. Specifically, work neutrality is intended to
reflect that despite changes in coding, the overall amount of work RVUs
for a set of services is held constant from one year to the next. For
example, if a service is reported using a single code with a work RVU
of 2.0 for one year but that same service would be reported using two
codes, one for ``simple'' and another for ``complex'' in the subsequent
year valued at 1.0 and 3.0 respectively, work neutrality could only be
attained if exactly half the services were reported using each of the
two new codes. If more than half of the services were reported using
the ``simple'' code, then there would be fewer overall work RVUs. If
more than half of the services were reported using the ``complex''
code, then there would be more overall work RVUs. Therefore, work
neutrality can only be assessed with an understanding of the relative
frequency of how often particular codes will be reported.
The HCPAC recommended a work RVU of 0.75 for CPT code 97161, a work
RVU of 1.18 for CPT code 97162, and a work RVU of 1.5 for CPT code
97163. The PT specialty society projected that the moderate complexity
evaluation code would be reported 50 percent of the time because it is
the typical evaluation, and the CPT codes for the low and high
complexity evaluations are each expected to be billed 25 percent of the
time. The HCPAC-recommended work RVU of 1.18 for CPT code 97162
represents the survey median with 30 minutes of intraservice time, 10
minutes of preservice time, and 15 minutes postservice time. The HCPAC
notes this work value is appropriately ranked between levels 2 and 3 of
the E/M office visit codes for new patients.
The HCPAC recommended a work RVU of 0.88 for CPT code 97165, a work
RVU of 1.20 for CPT code 97166, and a work RVU of 1.70 for CPT code
97167. For the OT codes, work neutrality would be achieved only with a
projected utilization in which the low complexity evaluation is billed
50 percent of the time; the moderate complexity evaluation is billed 40
percent of the time, and the high complexity evaluation only billed 10
percent of the time. For purposes of calculating work neutrality, the
HCPAC recommended assuming that the low complexity code will be most
frequently reported even though the HCPAC-recommended work RVU of 1.20
and 45 minutes of intraservice time for moderate complexity code is
identical to that of the current OT evaluation code. The HCPAC believes
that the work RVU of 1.20 is appropriately ranked between 99202 and
99203, levels 2 and 3 for E/M office visits for new outpatients.
ii. Valuation of Evaluation Codes and Discussion of PAMA
In our review of the HCPAC recommendations, we noted the work
neutrality and the inherent reliance on the utilization assumptions. We
considered the three complexity levels for the PT evaluations and the
three complexity levels for the OT evaluations; and we also considered
the evaluation services described by the codes as a whole. The varying
work RVUs and the dependence on utilization for each complexity level
to ensure work neutrality in the PT and OT code families make it
difficult for us evaluate the HCPAC's recommended values or to predict
with a high degree of certainty whether physical and occupational
therapists will actually bill for these services at the same rate
forecast by their respective specialty societies.
We were concerned that the coding stratification in the PT and OT
evaluation codes may result in upcoding incentives, especially while
physical and occupational therapists gain familiarity and expertise in
the differential coding of the new PT and OT evaluation codes that now
include the typical face-to-face times and new required components that
are not enumerated in the current codes. We were also concerned that
stratified payment rates may provide, in some cases, a payment
incentive to therapists to upcode to a higher complexity level than was
actually furnished to receive a higher payment.
We understood that there may be multiple reasons for the CPT
Editorial Panel to stratify coding for OT and PT evaluation codes based
on complexity. We also noted that the codes will be used by payers in
addition to Medicare, and other payers may have direct interest in
making such differential payment based on complexity of OT and PT
evaluation. Given our concerns regarding appropriate valuation, work
neutrality, and potential upcoding, however, we did not believe that
making different payment based on the reported complexity for these
services is, at current, advantageous for Medicare or Medicare
beneficiaries.
Given the advantages inherent and public interest in using CPT
codes once they become part of the code set, we proposed to adopt the
new CPT codes for use in Medicare for CY 2017. However, given our
concerns about appropriate pricing and payment for the stratified
services, we proposed to price the services described by these
stratified codes as a group instead of individually. To do that, we
proposed to utilize the authority in section 220(f) of the Protecting
Access to Medicare Act (PAMA), which revised section 1848(c)(2)(C) of
the Act to authorize the Secretary to determine RVUs for groups of
services, rather than determining RVUs at the individual service level.
We believed that using this authority instead of proposing to make
payment based on Medicare G-codes will preserve consistency in the code
set
[[Page 80333]]
across payers, thus lessening burden on providers, while retaining
flexibilities that are beneficial to Medicare.
We proposed a work RVU of 1.20 for both the PT and the OT
evaluation groups of services. We proposed this work RVU because we
believed it best represents the typical PT and OT evaluation. This is
the value recommended by the HCPAC for the OT moderate complexity
evaluation and nearly the same work RVU for corresponding PT evaluation
(1.18). Additionally, a work RVU of 1.20 is the long-standing value for
the current evaluation codes, CPT codes 97001 and 97003, and thus,
assures work neutrality without reliance on particular assumptions
about utilization, which we believed was the intent of the HCPAC
recommendation.
Because we proposed to use the same work RVU for the six evaluation
codes, we are not addressing any additional concerns about the
utilization assumptions recommended to us. Because we proposed the same
work values for each code in the family, there will be no ratesetting
impact to work neutrality. As such, we are not revising the utilization
crosswalks as projected by the respective therapy specialties to
achieve work neutrality. However, were we to value each code in the PT
or OT evaluation families individually, we would seek objective data
from stakeholders to support the utilization crosswalks, particularly
those for the OT family in which the low-level complexity evaluation is
depicted as typical and the high complexity is projected to be billed
infrequently at 10 percent of the overall number of OT evaluations.
We proposed to use the direct PE inputs forwarded by the HCPAC
(with the refinements described below) for the moderate complexity PT
and OT evaluations in the development of PE RVUs for the PT and OT
codes as a group of services. For the PT codes, we proposed to use the
recommended inputs for the moderate complexity code for the direct PE
inputs of all three codes based on its assumption as the typical
service. Our proposed direct PE inputs reflect the recommended values
minus 2 minutes of physical therapist assistant (PTA) time in the
service period because we believe that PTA tasks to administer certain
assessment tools are appropriately included as part of the physical
therapist's work and the time of the PTA to explain and score self-
reported outcome measures is not separately included in the clinical
labor of other codes. We proposed to include the recommended four
sheets of laser paper without an association to a specific equipment
item, but we solicited comment regarding the paper's use.
For the OT evaluation codes, we considered proposing to use the
direct PE inputs for the low complexity evaluation because the OT
specialty organization believes it represents the typical OT evaluation
service with a projected 50 percent utilization rate. However, we
proposed to use the moderate-level direct inputs instead, because the
direct PE for this level is based on a vignette that is valued with the
same intraservice time, 45 minutes, as the current code, CPT code
97003. Consequently, we proposed to use the recommended direct PE
inputs for the moderate complexity code for use in developing PE RVUs
for this group of services.
Our proposed direct PE inputs reflect the recommended values minus
2 minutes of occupational therapist assistant (OTA) time in the service
period because we believe that OTA tasks to administer certain
assessment tools are appropriately included as part of the occupational
therapist's work and the time of the OTA to explain and score self-
reported outcome measures is not separately included in the clinical
labor of other codes. We also rounded up the recommended 6.8 minutes to
7 minutes to represent the time the OTA assists the occupational
therapist during the intraservice time period. For the Vision Kit
equipment item, our proposed price reflects the submitted invoice that
clearly defined a kit.
iii. Valuation of Re-evaluation Codes
The recommendations the HCPAC sent to us for the PT and OT re-
evaluation codes are not work neutral. For the new PT re-evaluation
code, CPT code 97164, the HCPAC recommended a work RVU of 0.75 compared
to the work RVU of 0.60 for CPT code 97002. This recommended work RVU
falls between the 25th percentile of the survey and the survey's median
value and was based on a direct crosswalk to CPT code 95992 for
canalith repositioning with 20 minutes intraservice time and 10 minutes
immediate postservice time. The HCPAC supported this 0.15 work RVU
increase based on an anomalous relationship between PT services and E/M
office visit codes for established patients, noting that physician E/M
codes have historically been used as a relative comparison. The HCPAC
stated its recommendation of a work RVU of 0.75 for CPT code 97164
appropriately ranks it between the key reference codes for this
service, CPT codes 99212 and 99213, levels 2 and 3 E/M office-visit
codes for established patients.
The HCPAC provided a work RVU of 0.80 for the OT re-evaluation
code, CPT code 97168, based on the 25th percentile of the survey, which
represents an increase over the current work RVU of 0.60 for CPT code
97004. This work value includes 30 minutes of intraservice time, 5
minutes preservice time, and 10 minutes immediate postservice time. The
HCPAC noted that the increase in work compared to the PT re-evaluation
code (0.75) is because the occupational therapist spends more time
observing and assessing the patient and, in general, the OT patient
typically has more functional and cognitive disabilities. The HCPAC
recommendation notes that the 0.80 work RVU recommendation
appropriately ranks it between the level 1 and 2 E/M office-visit codes
for new patients.
The HCPAC's recommended increases to work RVUs for the PT and OT
re-evaluation codes are not work neutral. We are unclear why the HCPAC
did not maintain work neutrality for the OT and PT re-evaluation codes
since maintaining work neutrality was important to the establishment of
the six new evaluation codes. We proposed to maintain the overall work
RVUs for these services by proposing a work RVU of 0.60 for CPT codes
97164 and 97168, consistent with the work RVUs for the deleted re-
evaluation codes. We solicited comments from stakeholders on whether
there are reasons that the re-evaluation codes should be revalued
without regard to work neutrality.
We proposed the HCPAC-recommended direct PE inputs for CPT code
97164 with a reduction in time for the PTA by 1 minute (from 5 to 4) in
the service period--the line for ``Other Clinical Activity''--because
the time to explain and score the self-reported outcome measure (for
example, Oswestry) is not separately included in the clinical labor of
other codes.
We proposed the HCPAC-recommended direct PE inputs for CPT code
97168 with a reduction in time for the OTA by 1 minute (from 3 to 2) in
the service period--the line for ``Other Clinical Activity''--for the
same reason we proposed to reduce the corresponding line for PTAs--
because the time to explain and score any patient-self-administered
functional and other standardized outcome measure is not separately
included in the clinical labor of other codes.
Because the new CPT code descriptors contain new coding
requirements for each complexity level, we solicited comment from the
PT and
[[Page 80334]]
OT specialty organizations, as well as other stakeholders to clarify
how therapists will be educated to distinguish the required complexity
level components and the selection of the number of elements that
impact the plan of care. For example, for the OT codes, we invited
comment on how to define performance deficits, what process the
occupational therapist uses to identify the number of these performance
deficits that result in activity limitations, and performance factors
needed for each complexity level. For the PT codes, we sought more
information about how the physical therapist differentiates the number
of personal factors that actually affect the plan of care. We were also
interested in understanding more about how the physical therapist
selects the number of elements from any of the body structures and
functions, activity limitations, and participation restrictions to make
sure there is no duplication during the physical therapist's
examination of body systems.
The following is summary of the comments we received:
Comment: Several commenters disagreed with our proposal to accept
the new CPT codes for PT and OT evaluations and re-evaluations and
urged us to keep the current four-code set. A few of these commenters
noted our proposal to accept the stratified code sets for PT and OT
evaluations would increase the administrative burden associated with
documentation and education training of therapists, billers and coders.
Other commenters believed that CMS should first implement the new
complexity-defined CPT code set on a demonstration or pilot project
basis before we apply it nationally. One commenter proposed that,
rather than accepting the new CPT eight-code set with varying
descriptors for each PT and OT complexity level, we adopt just two
codes that both the PT and OT disciplines could use: a code for PT/OT
evaluation and another for PT/OT re-evaluation. Another commenter told
us that ``implementation of the complex scheme for determining the
evaluation level will excessively complicate patient evaluations where
clinicians will require more mental effort to meet the demands of the
documentation with less time and attention directed at treating the
patient.'' One commenter suggested that instead of implementing the
stratified code sets, CMS should develop an alternative coding and
payment model for therapy services and recommended that we create a
value-based payment program, consistent with the Triple Aim of health
care, which includes reliable and valid outcome and quality measures to
demonstrate the outcome and value of therapy.
Response: We thank the commenters for voicing their concerns about
our adoption of the new CPT codes for PT and OT evaluative procedures
and their alternative coding suggestions. However, we note that we do
not have the authority to change CPT code descriptors or use deleted
codes without creating G-codes to do so. We also note that adopting a
demonstration or pilot program is not a typical CMS payment policy
response to the creation of new CPT codes or code sets. After
considering these comments, we continue to believe that our proposal to
adopt the eight new CPT codes for use in Medicare for CY 2017, rather
than retain the current coding structure by creating G-codes, is the
best option given the advantages inherent and public interest in using
the CPT codes once they become part of the code set. As such, we are
finalizing our proposal to adopt new CPT codes 97161-97168 for PT and
OT evaluations and re-evaluations.
Comment: Many commenters objected to our proposal to use the PAMA
authority to price the services described by the stratified sets of PT
and OT evaluation codes as a group instead of individually and asked us
to accept or consider the HCPAC work RVU values for each of these six
evaluation services. Some commenters expressed concern that we ignored
the HCPAC recommendations and proposed to maintain the work RVU of
1.20, since the codes have not been reviewed for this purposes in
nearly 20 years. Other commenters stated that CMS, by valuing the PT
and OT evaluation complexity levels with the same work RVUs, was
failing to appropriately align cost and quality as mandated in the ACA
and MACRA.
Because we proposed the same values, a few commenters were
concerned that we failed to discuss the difference in the PT and OT
evaluation services. These commenters told us that the HCPAC
recommendations included higher work RVUs for the OT services because
they reflected greater intraservice times from the surveys, and these
times led, in part, to the HCPAC's belief that the typical patient
receiving OT services is more complex and intense to treat than the
patient receiving PT services. The HCPAC and the OT specialty society
urged us to consider the increase in work RVUs for the OT evaluative
services, indicating in their comments that while the HCPAC
recommendations for the PT evaluations were work-neutral, those for the
OT evaluations were not. The HCPAC requested that we consider the
difference in PT services versus OT services.
Some commenters presumed that our proposal to value the work the
same for each evaluation complexity level was temporary. Another
commenter expressed hope that we did not intend to equally value the PT
high complexity evaluation the same as the low complexity one in
perpetuity. Several commenters requested that CMS describe our future
plans to revisit these code sets and asked that the future proposal for
these payment amounts be subject to public comment. One of these
commenters that favored keeping the current code structure urged us not
to adopt the new CPT codes until we are ready to differentiate payments
based on the complexity of the provided service.
Some commenters told us that our lack of payment stratification for
the three PT and three OT evaluation codes would likely prompt coding
and billing behavioral change by some therapists and other providers of
therapy services. One of these commenters claimed that assigning the
same work RVU to each evaluation complexity level would cause some
providers not to adhere to the new coding stratification which could
result in inaccurate data on the levels being reported. Another
commenter stated that the lack of payment stratification to reflect the
therapist's time and expertise at each complexity level could signal to
therapists that the accurate coding of evaluations is of diminished
interest to CMS. Other commenters stated that the failure to recognize
payment stratification between the complexity levels would be
detrimental to patient care and the practice of therapy, for example,
by reducing incentives for therapists to thoroughly evaluate patients
with multiple and complex conditions who fall into the high complexity
evaluation.
Response: After a review of the comments, we continue to believe
that using the PAMA RVU authority to value the PT and OT evaluation
codes as a group of services is appropriate. Given our concerns about
appropriate pricing and payment for the PT and OT stratified evaluation
services as described in the CY 2017 proposed rule, we are finalizing
our proposal to use the PAMA authority to value services as groups
rather than individually--valuing each complexity level at 1.2 work
RVUs for the PT and OT family of evaluation codes for CY 2017. We
believe this policy has advantages for the Medicare program. It limits
the incentives for and consequences of
[[Page 80335]]
upcoding by therapists and providers, especially as therapists become
more familiar with the new set of codes. Additionally, the policy
assures work neutrality for these PT and OT code families while
allowing us to collect and analyze utilization data of the complexity
levels for possible future rulemaking.
We understand commenters' concerns about the possibility that the
absence of payment stratification in the complexity levels of the PT
and OT evaluations could have an effect on some therapists' coding
behavior in for these services in CY 2017. However, we are also
concerned with the implication that financial incentives are the
primary drivers for accurate coding for a significant number of
therapists, and if that is the case, we believe that implementing
stratified coding would likely encourage upcoding since that is
consistent with the financial incentives. We believe that the
implementation of these new PT and OT code sets carries with it an
inherent change for the therapists furnishing the services since there
will be three complexity levels to replace just one and each new code
contains newly defined necessary components. We also believe that it is
premature to predict how therapists will code and bill the new
complexity levels before therapists gain familiarity with the new
codes.
Comment: We received several comments on utilization assumptions
inherent to the HCPAC recommendations. Several commenters questioned
why we did not treat the HCPAC-recommended utilization assumptions for
the PT and OT complexity-stratified evaluation code sets as we have
historically treated other codes sets that come to us from the HCPAC or
RUC; that is, using the utilization assumptions provided in the
recommendations. The HCPAC explained that if the assumptions are
overestimated, the HCPAC or RUC will examine and determine whether to
recommend reductions.
We received several comments from stakeholders in response to our
statement in the proposed rule that we would request additional
objective data to support the utilization crosswalks, especially for
the OT codes, if we were to value the codes individually for the PT and
OT evaluation complexity levels. In its comments, the OT specialty
society explained that their frequency estimations of the three
complexity levels were based on the most recent utilization frequency
data from the 2014 Medicare utilization from the five percent sample
file. The OT specialty society also stated that it defined the
complexity levels using certain groups of diagnoses and patient types.
The PT specialty society stated that because its survey process
included a broad cross-section of therapists working in the various
Medicare settings, it believed its utilization projections for the low,
moderate and high complexity evaluation were representative. Many
commenters told us because some therapists may not initially code the
complexity levels correctly, that we would need to consider an entire
year of utilization data to ensure its accuracy.
Response: We appreciate the views expressed and the information
that the commenters forwarded to us. However, we continue to have
concerns that therapists, particularly occupational therapists, will
not bill with the same utilization frequencies forecast by their
specialty societies for the low, moderate, and high complexity
evaluations as described in the CY 2017 proposed rule. In other words,
we are concerned with the possibility that we would establish rates
(including for purposes of PFS budget neutrality) that rely on the
national organizations' assessment of what ought to be billed, but
Medicare spending and subsequent PFS budget neutrality assumptions will
reflect actual billing given the financial incentives inherent in
stratified payment. Should we propose to value the evaluation codes
individually in future rulemaking, we would seek additional objective
data at that time. We agree that an entire year of data is likely
needed to appropriately analyze the utilization of these evaluation
services. We appreciate that our historical practice regarding
significant revision of CPT coding scheme has required us to make
significant assumptions regarding utilization for new codes. We note
that in many cases, we have not accepted the assumptions recommended by
specialty societies and the RUC and that we were not pricing groups of
services together in the past.
Comment: Several commenters expressed concern about the new PT and
OT CPT code descriptors, specifically, that each descriptor includes
minimal coding requirements. Several commenters expressed skepticism
that therapists will be able to report the new codes accurately--one of
these commenters believes the new codes rely on subjective clinical
reasoning and decision making that will lead to further significant
coding and audit concerns for CMS. Several commenters told us that they
believe the true complexity of evaluating patients cannot be solely
based on personal factors, comorbidities, performance deficits, or time
requirements. One of these commenters noted that some patients with
multiple comorbidities and body structures involved are not
complicated, while others with few comorbidities and body structures
involved are deceptively very complex, difficult to diagnose and treat.
Another commenter specifically recommended that each PT and OT
evaluation complexity level should have the same timeframes, as well as
the same component requirements. A few commenters voiced concern about
how CMS and our contractors will note these multiple required
components of each CPT code. One commenter noted that an evaluation may
have characteristics that fall between two complexity levels and told
us that it should be up to the clinician to determine which level is
most appropriate. A few commenters noted that the new detailed
requirements that dictate the level of each code's definition may cause
confusion for physical and occupational therapists, especially as they
begin to navigate the new codes.
Response: We appreciate the commenters' concerns about new code
descriptors that detail the minimal required components for each of the
eight new PT and OT evaluative procedures. We realize that it may take
time to train therapists about the various required components of each
new PT and OT evaluative procedure code and we have addressed this
training in the comment and response below. We also appreciate the
commenters' concern that the evaluative process is likely more complex
than the component parts comprising each code's new coding
requirements; however, as noted in the CY 2017 proposed rule, we
proposed to adopt the new CPT codes for PT and OT evaluative procedures
rather than propose a different coding structure using G-codes. We
would like to clarify for the commenters that were concerned about
``time requirements'' in the new PT and OT CPT code descriptors for
evaluative procedures that these ``typical times'' are included as a
frame of reference and do not represent a minimum coding requirement.
Just as the typical times included for each E/M code represent the
physician face-to-face time with the patient, the typical times in the
new PT and OT CPT codes represent the typical face-to-face time of the
physical or occupational therapist with the patient. Regarding the
commenter's concern about evaluations that fall between two complexity
levels, we would note general coding principles applicable to all
codes--that the therapist should select the evaluation complexity level
that best
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represents the furnished service and for which the medical necessity is
clearly documented.
Comment: Many commenters requested that we delay documentation
requirements for the new PT and OT evaluative procedure codes; several
commenters requested a one year reprieve from application of medical
review and audit requirements; and a few commenters requested that we
delay the implementation of the new CPT codes until CY 2018. Most of
these delay requests, commenters told us, were related to the time
needed to educate therapists about the new codes. Most of these
commenters who asked us not to implement new documentation requirements
also supported payment stratification of the complexity levels for the
PT and OT evaluation complexity levels. Concerned about the proposed
lack of payment stratification, the PT specialty society noted in its
comments that it asked CPT to postpone the codes for CPT 2017, but CPT
denied the request. In its comments, the PT society, along with a few
other stakeholders, also asked CMS to delay implementing the new CPT
codes for CY 2017 ``if there is any way possible that does not disrupt
patient care.''
A few commenters say they will need a delay of six months, at a
minimum, to train therapists, since all new descriptors include various
required elements and the typical time for each PT and OT complexity
level and the re-evaluation codes. The majority of commenters, though,
indicated they would need a year for their educational efforts to be
successful. In addition to therapists, a few commenters told us they
would have to educate coders and billers in the use of the new CPT
codes. A few commenters noted the time to implement these new codes
into their billing systems was too short.
The PT and OT specialty societies each told us about their plans to
educate their therapist members and nonmembers to ensure coding
accuracy. Each therapy association has already begun this training,
some of which will include webinars, self-paced online courses,
frequently asked questions, documentation resources, published
articles, etc.
Some commenters asked CMS to work with various stakeholders and to
either establish guidelines or assist in educating therapists about the
new codes through Open Door Forums, MLN articles, etc. Additionally,
they also wanted to work with CMS on LCDs established by contractors.
One commenter stated that CMS must provide clear guidance regarding the
selection of the appropriate level of evaluation services provided by
physical and occupational therapists and the associated documentation
requirements to ensure consistency and appropriate reporting of these
services.
Several commenters asked us to consider a one-year reprieve from
the payment consequences of medical review and audit requirements that
address lack of documentation to support the complexity level of the
code billed.
Response: We understand that implementing the new code sets for PT
and OT evaluative procedures will require time for therapists to be
educated in their proper use. We would like to remind those requesting
we assist in writing guidelines that the CPT manual PM&R subsections
for PT and OT Evaluations contain official CPT guidelines. We
understand the many requests for delay of new documentation
requirements during the initial year of their use. As such, for CY
2017, we will delay changes to our current manual instructions for
documentation for evaluations and re-evaluations in the Medicare
Benefits Policy Manual (MBPM), chapter 15, section 220.3.
We understand and appreciate that the PT and OT specialty societies
are already underway in their educational efforts of therapists, as it
has been our past experience with the implementation of other CPT codes
and code sets that the leading educational role is assumed by the
specialty societies responsible for the code changes.
Comment: We received many comments objecting to our proposal to
maintain a work RVU of 0.60 for the re-evaluation codes. Many
commenters--including therapy specialty societies and organization
representing therapy providers and private practice physical and
occupational therapists, among other stakeholders--disagreed with our
proposal to maintain the work RVUs for the PT and OT re-evaluation
codes and expressed their disappointment that we did not consider or
accept the HCPAC recommendations for increased work RVUs of 0.75 for PT
(CPT code 97164) and 0.8 for OT (CPT code 97168).
One commenter supported increasing the work RVUs, but suggested
that the PT and OT re-evaluation codes should be equally valued for the
relative work, PE and MP RVUs. This same commenter contended that
because the patients treated by the PT and OT disciplines for hand
rehabilitation are the same; that is, have the same functional and
cognitive deficits, the same time and expertise of both physical and
occupational therapists is required to perform a thorough re-
evaluation. The commenter recommended that both re-evaluations reflect
the 30-minute typical time that is inherent to the OT re-evaluation
code.
Several commenters reminded us that the work RVU recommendations
forwarded to us were not considered work neutral because the HCPAC
accepted the PT and OT specialty societies' beliefs as compelling
evidence that the practice of PT and OT have each significantly changed
over the past two decades.
Some commenters reasoned that we should accept the HCPAC-
recommended work RVUs for these codes, in part, because the PT and OT
specialty societies completed the RUC-HCPAC defined survey process,
including time and intensity of the services.
Comments from the HCPAC, the PT and OT specialty societies, and a
few other stakeholders provided the rationale that the practice of PT
and OT has significantly changed since 1997, including the work of
physical therapists and occupational therapists. Some of their
rationale included: (a) advances in technology has created
opportunities for additional types of treatment approaches; and, (b)
the work RVUs for the PT and OT re-evaluation codes have not kept pace
with the relativity of increases in work RVUs of comparable E/M codes
that have historically been used as comparison: In 1997 the 0.60 work
RVUs for CPT codes 97002 and 97004 was 90 percent of that for CPT code
99213; today, it is just 62 percent. Other rationales included ones
often cited by commenters requesting increases in RVUs, including
increased patient acuity and administrative and reporting burdens.
Response: We appreciate the commenters' remarks and the rationale
forwarded in response to our request for comments. After a careful
consideration of the comments, we agree that modification of our
proposal, to recognize the change in practice since 1997 for the work
of physical and occupational therapists, is appropriate. Because we
believe that PT and OT have similar work, though, we are finalizing the
value of both codes at the same work RVUs by assigning a work RVU of
0.75--the HCPAC-recommended work RVU for the PT re-evaluation and the
PT low complexity evaluation.
We would like to take this opportunity to remind physical and
occupational therapists about our manual instructions regarding the
reporting of a both the evaluation and re-evaluation codes (MBPM,
Chapter 15, section 220). Of note, to be separately payable, the re-
evaluation requires a
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significant change in the patient's condition or functional status that
was not anticipated in the plan of care. The MBPM full definitions
follow in Table 22.
Table 22--Full Definitions for MBPM
----------------------------------------------------------------------------------------------------------------
Therapy service Definition
----------------------------------------------------------------------------------------------------------------
EVALUATION............................. EVALUATION is a separately payable comprehensive service provided by a
clinician, as defined above, that requires professional skills to make
clinical judgments about conditions for which services are indicated
based on objective measurements and subjective evaluations of patient
performance and functional abilities. Evaluation is warranted for
example, for a new diagnosis or when a condition is treated in a new
setting. These evaluative judgments are essential to development of
the plan of care, including goals and the selection of interventions.
RE-EVALUATION.......................... RE-EVALUATION provides additional objective information not included in
other documentation. Re-evaluation is separately payable and is
periodically indicated during an episode of care when the professional
assessment of a clinician indicates a significant improvement, or
decline, or change in the patient's condition or functional status
that was not anticipated in the plan of care. Although some state
regulations and state practice acts require re-evaluation at specific
times, for Medicare payment, re-evaluations must also meet Medicare
coverage guidelines.
----------------------------------------------------------------------------------------------------------------
Comment: We received a few comments regarding our PE proposals in
the CY 2017 proposed rule for the PT and OT evaluation and re-
evaluation codes. In its comments, the PT specialty society, in
response to our PE proposal, explained, per our request, the use of the
4 sheets of paper as supply items in the PT evaluation and re-
evaluation codes. The OT specialty society noted that they accepted the
PE refinements we proposed in the proposed rule.
Response: We appreciate the comments from both the PT and OT
specialty societies. We will finalize the PE input changes as proposed
and include them in the calculation of the final PE RVUs of the PT and
OT evaluation and re-evaluation codes.
After considering the comments, in summary, we are finalizing our
proposals to (a) accept the new CPT codes 97161-97168 for PT and OT
evaluative procedures and (b) use the PAMA smoothing authority to value
the PT and OT complexity level evaluations as groups of services rather
than individually by assigning a work RVU of 1.2 to each complexity
level. We are modifying our proposal for the valuation of the PT and OT
re-evaluation codes and are finalizing a work RVU of 0.75 for each
code. Lastly, we are finalizing the PE inputs as proposed.
iv. Always Therapy Codes
It is important to note that CMS defines the codes for these
evaluative services as ``always therapy.'' This means that they always
represent therapy services regardless of who performs them and always
require a therapy modifier, GP or GO, to signify that the services are
furnished under a PT or OT plan of care, respectively. These codes will
also be subject to the therapy MPPR and to statutory therapy caps.
Table 23--CPT Long Descriptors for Physical Medicine and Rehabilitation
------------------------------------------------------------------------
CPT long descriptors for
New CPT code physical medicine and
rehabilitation
------------------------------------------------------------------------
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.
Typically, 20 minutes are spent
face-to-face with the patient
and/or family.
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.
Typically, 30 minutes are spent
face-to-face with the patient
and/or family.
97163.................................. Physical therapy evaluation:
high complexity, requiring
these components:
A history of present
problem with 3 or more
personal factors and/or
comorbidities that impact the
plan of care;