[Federal Register Volume 81, Number 136 (Friday, July 15, 2016)]
[Proposed Rules]
[Pages 46162-46476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16097]
[[Page 46161]]
Vol. 81
Friday,
No. 136
July 15, 2016
Part II
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 405, 410, 411, et al.
Medicare Program; Revisions to Payment Policies Under the Physician
Fee Schedule and Other Revisions to Part B for CY 2017; Medicare
Advantage Pricing Data Release; Medicare Advantage and Part D Medical
Low Ratio Data Release; Medicare Advantage Provider Network
Requirements; Expansion of Medicare Diabetes Prevention Program Model;
Proposed Rules
Federal Register / Vol. 81 , No. 136 / Friday, July 15, 2016 /
Proposed Rules
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 405, 410, 411, 414, 417, 422, 423, 424, 425, and 460
[CMS-1654-P]
RIN 0938-AS81
Medicare Program; Revisions to Payment Policies Under the
Physician Fee Schedule and Other Revisions to Part B for CY 2017;
Medicare Advantage Pricing Data Release; Medicare Advantage and Part D
Medical Low Ratio Data Release; Medicare Advantage Provider Network
Requirements; Expansion of Medicare Diabetes Prevention Program Model
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
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SUMMARY: This major proposed rule addresses changes to the physician
fee schedule and other Medicare Part B payment policies, such as
changes to the Value Modifier, to ensure that our payment systems are
updated to reflect changes in medical practice and the relative value
of services, as well as changes in the statute. This proposed rule also
includes proposals related to the Medicare Shared Saving Program, and
the release of certain pricing data from Medicare Advantage bids and
medical loss ratio reports from Medicare health and drug plans. In
addition, this rule proposes to expand the Medicare Diabetes Prevention
Program model.
DATES: To be assured consideration, comments must be received at one of
the addresses provided below, no later than 5 p.m. on September 6,
2016.
ADDRESSES: In commenting, please refer to file code CMS-1654-P. Because
of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to www.regulations.gov. Follow the instructions for
``submitting a comment.''
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1654-P, P.O. Box 8013,
Baltimore, MD 21244-8013.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1654-P, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments before the close of the comment period
to either of the following addresses:
a. For delivery in Washington, DC-- Centers for Medicare & Medicaid
Services, Department of Health and Human Services, Room 445-G, Hubert
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC
20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid
Services, Department of Health and Human Services, 7500 Security
Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
please call telephone number (410) 786-7195 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
FOR FURTHER INFORMATION CONTACT:
Jessica Bruton, (410) 786-5991 for issues related to any physician
payment issues not identified below.
Gail Addis, (410) 786-4522, for issues related to diabetes self-
management training.
Jaime Hermansen, (410) 786-2064, for issues related to moderate
sedation coding and anesthesia services.
Jessica Bruton, (410) 786-5991, for issues related to
identification of potentially misvalued services.
Roberta Epps, (410) 786-4503, for issues related to PAMA section
218(a) policy and the transition from traditional x-ray imaging to
digital radiography.
Ken Marsalek, (410) 786-4502, for issues related to telehealth
services.
Ann Marshall, (410) 786-3059, for primary care issues related to
chronic care management (CCM), burden reduction and evaluation and
management services.
Emily Yoder, (410) 786-1804, for primary care issues related to
resource intensive services and other primary care issues.
Lindsey Baldwin, (410) 786-1694, for primary care issues related to
behavioral health integration services.
Geri Mondowney, (410) 786-4584, and Donta Henson, (410) 786-1947,
for issues related to geographic practice cost indices.
Michael Soracoe, (410) 786-6312, for issues related to the target
and phase-in provisions, the practice expense methodology, impacts,
conversion factor, and the valuation of surgical procedures.
Pamela West, (410) 786-2302, for issues related to therapy.
Patrick Sartini, (410) 786-9252, for issues related to malpractice
RVUs, radiation treatment, mammography and other imaging services.
Kathy Bryant, (410) 786-3448, for issues related to collecting data
on resources used in furnishing global services.
Donta Henson, (410) 786-1947, for issues related to pathology and
ophthalmology services.
Corinne Axelrod, (410) 786-5620, for issues related to rural health
clinics or federally qualified health centers for comprehensive care
management services furnished incident to.
Simone Dennis (410) 786-8409, for issues related to FQHC-specific
market basket.
JoAnna Baldwin (410) 786-7205, or Sarah Fulton (410) 786-2749, for
issues related to appropriate use criteria for advanced diagnostic
imaging services.
Erin Skinner (410) 786-0157, for issues related to open payments.
Sean O'Grady (410) 786-2259, or Julie Uebersax (410) 786-9284, for
issues related to release of pricing data from Medicare Advantage bids
and release of medical loss ratio data submitted by Medicare Advantage
organizations and Part D sponsors.
Sara Vitolo (410) 786-5714, for issues related to prohibition on
billing qualified Medicare beneficiary individuals for Medicare cost-
sharing.
Michelle Peterman (410) 786-2591, for issues on the technical
correction for PQRS.
Katie Mucklow (410) 786-0537 or John Spiegel (410) 786-1909, for
issues related to Provider Enrollment Medicare Advantage Program.
Jen Zhu (410) 786-3725, Carlye Burd (410) 786-1972, or Nina Brown
(410)
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786-6103, for issues related to Medicare Diabetes Prevention Program
model expansion.
Rabia Khan or Terri Postma, (410) 786-8084 or [email protected], for
issues related to Medicare Shared Savings Program.
Sabrina Ahmed (410) 786-7499, or Fiona Larbi (410) 786-7224, for
issues related to Value-based Payment Modifier and Physician Feedback
Program.
Lisa Ohrin Wilson (410) 786-8852, or Gabriel Scott (410) 786-3928,
for issues related to physician self-referral updates.
SUPPLEMENTARY INFORMATION:
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following Web
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to
view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
Table of Contents
I. Executive Summary and Background
A. Executive Summary
B. Background
II. Provisions of the Proposed Rule for PFS
A. Determination of Practice Expense Relative Value Units (PE
RVUs)
B. Determination of Malpractice Relative Value Units (MRVUs)
C. Medicare Telehealth Services
D. Potentially Misvalued Services Under the Physician Fee
Schedule
1. Background
2. Progress in Identifying and Reviewing Potentially Misvalued
Codes
3. Validating RVUs of Potentially Misvalued Codes
4. CY 2017 Identification and Review of Potentially Misvalued
Services
5. Valuing Services That Include Moderate Sedation as an
Inherent Part of Furnishing the Procedure
6. Collecting Data on Resources Used in Furnishing Global
Services
E. Improving Payment Accuracy for Primary Care, Care Management
Services, and Patient-Centered Services
F. Improving Payment Accuracy for Preventive Services: Diabetes
Self-Management Training (DSMT)
G. Target for Relative Value Adjustments for Misvalued Services
H. Phase-In of Significant RVU Reductions
I. Geographic Practice Cost Indices (GPCIs)
J. Payment Incentive for the Transition From Traditional X-Ray
Imaging to Digital Radiography and Other Imaging Services
K. Procedures Subject to the Multiple Procedure Payment
Reduction (MPPR) and the OPPS Cap
L. Valuation of Specific Codes
III. Other Provisions of the Proposed Rule for PFS
A. Chronic Care Management (CCM) and Transitional Care
Management (TCM) Supervision Requirements in Rural Health Clinics
(RHCs) and Federally Qualified Health Centers (FQHCs)
B. FQHC-Specific Market Basket
C. Appropriate Use Criteria for Advanced Diagnostic Imaging
Services
D. Reports of Payments or Other Transfers of Value to Covered
Recipients: Solicitation of Public Comments
E. Release of Part C Medicare Advantage Bid Pricing Data and
Part C and Part D Medical Loss Ratio (MLR) Data
F. Prohibition on Billing Qualified Medicare Beneficiary
Individuals for Medicare Cost-Sharing
G. Recoupment or Offset of Payments to Providers Sharing the
Same Taxpayer Identification Number
H. Accountable Care Organization (ACO) Participants Who Report
Physician Quality Reporting System (PQRS) Quality Measures
Separately
I. Medicare Advantage Provider Enrollment
J. Proposed Expansion of the Diabetes Prevention Program (DPP)
Model
K. Medicare Shared Savings Program
L. Value-Based Payment Modifier and Physician Feedback Program
M. Physician Self-referral Updates
IV. Collection of Information Requirements
V. Response to Comments
VI. Regulatory Impact Analysis
Regulations Text
Acronyms
In addition, because of the many organizations and terms to which
we refer by acronym in this proposed rule, we are listing these
acronyms and their corresponding terms in alphabetical order below:
A1c--Hemoglobin A1c
AAA--Abdominal aortic aneurysms
ACO--Accountable care organization
AMA--American Medical Association
ASC--Ambulatory surgical center
ATA--American Telehealth Association
ATRA--American Taxpayer Relief Act (Pub. L. 112-240)
AWV--Annual wellness visit
BBA--Balanced Budget Act of 1997 (Pub. L. 105-33)
BBRA--[Medicare, Medicaid and State Child Health Insurance Program]
Balanced Budget Refinement Act of 1999 (Pub. L. 106-113)
CAD--Coronary artery disease
CAH--Critical access hospital
CBSA--Core-Based Statistical Area
CCM--Chronic care management
CEHRT--Certified EHR technology
CF--Conversion factor
CG--CAHPS--Clinician and Group Consumer Assessment of Healthcare
Providers and Systems
CLFS--Clinical Laboratory Fee Schedule
CoA--Certificate of Accreditation
CoC--Certificate of Compliance
CoR--Certificate of Registration
CNM--Certified nurse-midwife
CP--Clinical psychologist
CPC--Comprehensive Primary Care
CPEP--Clinical Practice Expert Panel
CPT--[Physicians] Current Procedural Terminology (CPT codes,
descriptions and other data only are copyright 2015 American Medical
Association. All rights reserved.)
CQM--Clinical quality measure
CSW--Clinical social worker
CT--Computed tomography
CW--Certificate of Waiver
CY--Calendar year
DFAR--Defense Federal Acquisition Regulations
DHS-- Designated health services
DM-- Diabetes mellitus
DSMT--Diabetes self-management training
eCQM--Electronic clinical quality measures
ED--Emergency Department
EHR--Electronic health record
E/M--Evaluation and management
EMT--Emergency Medical Technician
EP--Eligible professional
eRx--Electronic prescribing
ESRD--End-stage renal disease
FAR--Federal Acquisition Regulations
FDA--Food and Drug Administration
FFS--Fee-for-service
FQHC--Federally qualified health center
FR--Federal Register
GAF--Geographic adjustment factor
GAO--Government Accountability Office
GPCI--Geographic practice cost index
GPO--Group purchasing organization
GPRO--Group practice reporting option
GTR--Genetic Testing Registry
HCPCS--Healthcare Common Procedure Coding System
HHS--[Department of] Health and Human Services
HOPD--Hospital outpatient department
HPSA--Health professional shortage area
IDTF--Independent diagnostic testing facility
IPPE--Initial preventive physical exam
IPPS--Inpatient Prospective Payment System
IQR--Inpatient Quality Reporting
ISO--Insurance service office
IT--Information technology
IWPUT--Intensity of work per unit of time
LCD--Local coverage determination
MA--Medicare Advantage
MAC--Medicare Administrative Contractor
MACRA--Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L.
114-10)
MAP--Measure Applications Partnership
MAPCP--Multi-payer Advanced Primary Care Practice
MAV--Measure application validity [process]
MCP--Monthly capitation payment
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MedPAC--Medicare Payment Advisory Commission
MEI--Medicare Economic Index
MFP--Multi-Factor Productivity
MIPPA--Medicare Improvements for Patients and Providers Act (Pub. L.
110-275)
MMA--Medicare Prescription Drug, Improvement and Modernization Act
of 2003 (Pub. L. 108-173, enacted on December 8, 2003)
MP--Malpractice
MPPR--Multiple procedure payment reduction
MRA--Magnetic resonance angiography
MRI--Magnetic resonance imaging
MSA--Metropolitan Statistical Areas
MSPB--Medicare Spending per Beneficiary
MU--Meaningful use
NCD--National coverage determination
NCQDIS--National Coalition of Quality Diagnostic Imaging Services
NP--Nurse practitioner
NPI--National Provider Identifier
NPP--Nonphysician practitioner
NQS--National Quality Strategy
OACT--CMS's Office of the Actuary
OBRA '89--Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-
239)
OBRA '90--Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-
508)
OES--Occupational Employment Statistics
OMB--Office of Management and Budget
OPPS--Outpatient prospective payment system
OT--Occupational therapy
PA--Physician assistant
PAMA--Protecting Access to Medicare Act of 2014 (Pub. L. 113-93)
PC--Professional component
PCIP--Primary Care Incentive Payment
PE--Practice expense
PE/HR--Practice expense per hour
PEAC--Practice Expense Advisory Committee
PECOS--Provider Enrollment, Chain, and Ownership System
PFS--Physician Fee Schedule
PLI--Professional Liability Insurance
PMA--Premarket approval
PPM--Provider-Performed Microscopy
PQRS--Physician Quality Reporting System
PPIS--Physician Practice Expense Information Survey
PT--Physical therapy
PT--Proficiency Testing
PT/INR--Prothrombin Time/International Normalized Ratio
PY--Performance year
QA--Quality Assessment
QC--Quality Control
QCDR--Qualified clinical data registry
QRUR--Quality and Resources Use Report
RBRVS--Resource-based relative value scale
RFA--Regulatory Flexibility Act
RHC--Rural health clinic
RIA--Regulatory impact analysis
RUC--American Medical Association/Specialty Society Relative (Value)
Update Committee
RUCA--Rural Urban Commuting Area
RVU--Relative value unit
SBA--Small Business Administration
SGR--Sustainable growth rate
SIM--State Innovation Model
SLP--Speech-language pathology
SMS--Socioeconomic Monitoring System
SNF--Skilled nursing facility
TAP--Technical Advisory Panel
TC--Technical component
TIN--Tax identification number
UAF--Update adjustment factor
UPIN--Unique Physician Identification Number
USPSTF--United States Preventive Services Task Force
VBP--Value-based purchasing
VM--Value-Based Payment Modifier
Addenda Available Only Through the Internet on the CMS Web Site
The PFS Addenda along with other supporting documents and tables
referenced in this proposed rule are available through the Internet on
the CMS Web site at 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, ``PFS Federal
Regulations Notices'' for a chronological list of PFS Federal Register
and other related documents. For the CY 2017 PFS Proposed Rule, refer
to item CMS-1654-P. Readers who experience any problems accessing any
of the Addenda or other documents referenced in this rule and posted on
the CMS Web site identified above should contact Jessica Bruton at
(410) 786-5991.
CPT (Current Procedural Terminology) Copyright Notice
Throughout this proposed rule, we use CPT codes and descriptions to
refer to a variety of services. We note that CPT codes and descriptions
are copyright 2015 American Medical Association. All Rights Reserved.
CPT is a registered trademark of the American Medical Association
(AMA). Applicable Federal Acquisition Regulations (FAR) and Defense
Federal Acquisition Regulations (DFAR) apply.
I. Executive Summary and Background
A. Executive Summary
1. Purpose
This major proposed rule proposes to revise payment polices under
the Medicare Physician Fee Schedule (PFS) and make other policy changes
related to Medicare Part B payment. These changes would be applicable
to services furnished in CY 2017. In addition, this proposed rule
includes proposals related to: the Medicare Shared Savings Program and
release of pricing data submitted to CMS by Medicare Advantage (MA)
organizations; and medical loss ratio reports submitted by MA plans and
Part D plans. These additional proposals are addressed in section III.
of this proposed rule.
2. Summary of the Major Provisions
The statute requires us to establish payments under the PFS based
on national uniform relative value units (RVUs) that account for the
relative resources used in furnishing a service. The statute requires
that RVUs be established for three categories of resources: work,
practice expense (PE); and malpractice (MP) expense; and, that we
establish by regulation each year's payment amounts for all physicians'
services paid under the PFS, incorporating geographic adjustments to
reflect the variations in the costs of furnishing services in different
geographic areas. In this major proposed rule, we are proposing to
establish RVUs for CY 2017 for the PFS, and other Medicare Part B
payment policies, to ensure that our payment systems are updated to
reflect changes in medical practice and the relative value of services,
as well as changes in the statute. In addition, this proposed rule
includes discussions and proposals regarding:
Potentially Misvalued PFS Codes.
Telehealth Services.
Establishing Values for New, Revised, and Misvalued
Codes.
Target for Relative Value Adjustments for Misvalued
Services.
Phase-in of Significant RVU Reductions.
Chronic Care Management (CCM) and Transitional Care
Management (TCM) Supervision Requirements in Rural Health Clinics
(RHCs) and Federally Qualified Health Centers (FQHCs).
FQHC-Specific Market Basket.
Appropriate Use Criteria for Advanced Diagnostic
Imaging Services.
Reports of Payments or Other Transfers of Value to
Covered Recipients: Solicitation of Public Comments.
Release of Part C Medicare Advantage Bid Pricing Data
and Part C and Part D Medical Loss Ratio (MLR) Data.
Prohibition on Billing Qualified Medicare Beneficiary
Individuals for Medicare Cost-Sharing.
Recoupment or Offset of Payments to Providers Sharing
the Same Taxpayer Identification Number.
Accountable Care Organization (ACO) Participants Who
Report Physician Quality Reporting System (PQRS) Quality Measures
Separately.
Medicare Advantage Provider Enrollment.
Proposed Expansion of the Diabetes Prevention Program
(DPP) Model.
Medicare Shared Savings Program.
Value-Based Payment Modifier and the Physician Feedback
Program.
Physician Self-referral Updates.
3. Summary of Costs and Benefits
The statute requires that annual adjustments to PFS RVUs may not
cause annual estimated expenditures to differ by more than $20 million
from what
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they would have been had the adjustments not been made. If adjustments
to RVUs would cause expenditures to change by more than $20 million, we
must make adjustments to preserve budget neutrality. These adjustments
can affect the distribution of Medicare expenditures across
specialties. In addition, several changes proposed in this proposed
rule would affect the specialty distribution of Medicare expenditures.
When considering the combined impact of proposed work, PE, and MP RVU
changes, the projected payment impacts would be small for most
specialties; however, the impact would be larger for a few specialties.
We have determined that this major proposed rule is economically
significant. For a detailed discussion of the economic impacts, see
section VI. of this proposed rule.
B. Background
Since January 1, 1992, Medicare has paid for physicians' services
under section 1848 of the Social Security Act (the Act), ``Payment for
Physicians' Services.'' The system relies on national relative values
that are established for work, PE, and MP, which are adjusted for
geographic cost variations. These values are multiplied by a conversion
factor (CF) to convert the RVUs into payment rates. The concepts and
methodology underlying the PFS were enacted as part of the Omnibus
Budget Reconciliation Act of 1989 (Pub. L. 101-239, enacted on December
19, 1989) (OBRA '89), and the Omnibus Budget Reconciliation Act of 1990
(Pub. L. 101-508, enacted on November 5, 1990) (OBRA '90). The final
rule published on November 25, 1991 (56 FR 59502) set forth the first
fee schedule used for payment for physicians' services.
We note that throughout this major proposed rule, unless otherwise
noted, the term ``practitioner'' is used to describe both physicians
and nonphysician practitioners (NPPs) who are permitted to bill
Medicare under the PFS for services furnished to Medicare
beneficiaries.
1. Development of the Relative Values
a. Work RVUs
The work RVUs established for the initial fee schedule, which was
implemented on January 1, 1992, were developed with extensive input
from the physician community. A research team at the Harvard School of
Public Health developed the original work RVUs for most codes under a
cooperative agreement with the Department of Health and Human Services
(HHS). In constructing the code-specific vignettes used in determining
the original physician work RVUs, Harvard worked with panels of
experts, both inside and outside the federal government, and obtained
input from numerous physician specialty groups.
As specified in section 1848(c)(1)(A) of the Act, the work
component of physicians' services means the portion of the resources
used in furnishing the service that reflects physician time and
intensity. We establish work RVUs for new, revised and potentially
misvalued codes based on our review of information that generally
includes, but is not limited to, recommendations received from the
American Medical Association/Specialty Society Relative Value Update
Committee (RUC), the Health Care Professionals Advisory Committee
(HCPAC), the Medicare Payment Advisory Commission (MedPAC), and other
public commenters; medical literature and comparative databases; as
well as a comparison of the work for other codes within the Medicare
PFS, and consultation with other physicians and health care
professionals within CMS and the federal government. We also assess the
methodology and data used to develop the recommendations submitted to
us by the RUC and other public commenters, and the rationale for their
recommendations. In the CY 2011 PFS final rule with comment period (75
FR 73328 through 73329), we discussed a variety of methodologies and
approaches used to develop work RVUs, including survey data, building
blocks, crosswalk to key reference or similar codes, and magnitude
estimation. More information on these issues is available in that rule.
b. Practice Expense RVUs
Initially, only the work RVUs were resource-based, and the PE and
MP RVUs were based on average allowable charges. Section 121 of the
Social Security Act Amendments of 1994 (Pub. L. 103-432, enacted on
October 31, 1994), amended section 1848(c)(2)(C)(ii) of the Act and
required us to develop resource-based PE RVUs for each physicians'
service beginning in 1998. We were required to consider general
categories of expenses (such as office rent and wages of personnel, but
excluding malpractice expenses) comprising PEs. The PE RVUs continue to
represent the portion of these resources involved in furnishing PFS
services.
Originally, the resource-based method was to be used beginning in
1998, but section 4505(a) of the Balanced Budget Act of 1997 (Pub. L.
105-33, enacted on August 5, 1997) (BBA) delayed implementation of the
resource-based PE RVU system until January 1, 1999. In addition,
section 4505(b) of the BBA provided for a 4-year transition period from
the charge-based PE RVUs to the resource-based PE RVUs.
We established the resource-based PE RVUs for each physicians'
service in a final rule, published on November 2, 1998 (63 FR 58814),
effective for services furnished in CY 1999. Based on the requirement
to transition to a resource-based system for PE over a 4-year period,
payment rates were not fully based upon resource-based PE RVUs until CY
2002. This resource-based system was based on two significant sources
of actual PE data: the Clinical Practice Expert Panel (CPEP) data; and
the AMA's Socioeconomic Monitoring System (SMS) data. (These data
sources are described in greater detail in the CY 2012 final rule with
comment period (76 FR 73033).
Separate PE RVUs are established for services furnished in facility
settings, such as a hospital outpatient department (HOPD) or an
ambulatory surgical center (ASC), and in nonfacility settings, such as
a physician's office. The nonfacility RVUs reflect all of the direct
and indirect PEs involved in furnishing a service described by a
particular HCPCS code. The difference, if any, in these PE RVUs
generally results in a higher payment in the nonfacility setting
because in the facility settings some costs are borne by the facility.
Medicare's payment to the facility (such as the outpatient prospective
payment system (OPPS) payment to the HOPD) would reflect costs
typically incurred by the facility. Thus, payment associated with those
facility resources is not made under the PFS.
Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L.
106-113, enacted on November 29, 1999) (BBRA) directed the Secretary of
Health and Human Services (the Secretary) to establish a process under
which we accept and use, to the maximum extent practicable and
consistent with sound data practices, data collected or developed by
entities and organizations to supplement the data we normally collect
in determining the PE component. On May 3, 2000, we published the
interim final rule (65 FR 25664) that set forth the criteria for the
submission of these supplemental PE survey data. The criteria were
modified in response to comments received, and published in the Federal
Register (65 FR 65376) as part of a November 1, 2000 final rule. The
PFS final rules published
[[Page 46166]]
in 2001 and 2003, respectively, (66 FR 55246 and 68 FR 63196) extended
the period during which we would accept these supplemental data through
March 1, 2005.
In the CY 2007 PFS final rule with comment period (71 FR 69624), we
revised the methodology for calculating direct PE RVUs from the top-
down to the bottom-up methodology beginning in CY 2007. We adopted a 4-
year transition to the new PE RVUs. This transition was completed for
CY 2010. In the CY 2010 PFS final rule with comment period, we updated
the practice expense per hour (PE/HR) data that are used in the
calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010,
we began a 4-year transition to the new PE RVUs using the updated PE/HR
data, which was completed for CY 2013.
c. Malpractice RVUs
Section 4505(f) of the BBA amended section 1848(c) of the Act to
require that we implement resource-based MP RVUs for services furnished
on or after CY 2000. The resource-based MP RVUs were implemented in the
PFS final rule with comment period published November 2, 1999 (64 FR
59380). The MP RVUs are based on commercial and physician-owned
insurers' malpractice insurance premium data from all the states, the
District of Columbia, and Puerto Rico. For more information on MP RVUs,
see section II.B.2. of this proposed rule.
d. Refinements to the RVUs
Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no
less often than every 5 years. Prior to CY 2013, we conducted periodic
reviews of work RVUs and PE RVUs independently. We completed five-year
reviews of work RVUs that were effective for calendar years 1997, 2002,
2007, and 2012.
Although refinements to the direct PE inputs initially relied
heavily on input from the RUC Practice Expense Advisory Committee
(PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to
the use of the updated PE/HR data in CY 2010 have resulted in
significant refinements to the PE RVUs in recent years.
In the CY 2012 PFS final rule with comment period (76 FR 73057), we
finalized a proposal to consolidate reviews of work and PE RVUs under
section 1848(c)(2)(B) of the Act and reviews of potentially misvalued
codes under section 1848(c)(2)(K) of the Act into one annual process.
In addition to the five-year reviews, beginning for CY 2009, CMS
and the RUC have identified and reviewed a number of potentially
misvalued codes on an annual basis based on various identification
screens. This annual review of work and PE RVUs for potentially
misvalued codes was supplemented by the amendments to section 1848 of
the Act, as enacted by section 3134 of the Affordable Care Act, which
requires the agency to periodically identify, review and adjust values
for potentially misvalued codes.
e. Application of Budget Neutrality to Adjustments of RVUs
As described in section VI.C. of this proposed rule, in accordance
with section 1848(c)(2)(B)(ii)(II) of the Act, if revisions to the RVUs
cause expenditures for the year to change by more than $20 million, we
make adjustments to ensure that expenditures did not increase or
decrease by more than $20 million.
2. Calculation of Payments Based on RVUs
To calculate the payment for each service, the components of the
fee schedule (work, PE, and MP RVUs) are adjusted by geographic
practice cost indices (GPCIs) to reflect the variations in the costs of
furnishing the services. The GPCIs reflect the relative costs of work,
PE, and MP in an area compared to the national average costs for each
component.
RVUs are converted to dollar amounts through the application of a
CF, which is calculated based on a statutory formula by CMS's Office of
the Actuary (OACT). The formula for calculating the Medicare fee
schedule payment amount for a given service and fee schedule area can
be expressed as:
Payment = [(RVU work x GPCI work) + (RVU PE x GPCI PE) + (RVU MP x GPCI
MP)] x CF.
3. Separate Fee Schedule Methodology for Anesthesia Services
Section 1848(b)(2)(B) of the Act specifies that the fee schedule
amounts for anesthesia services are to be based on a uniform relative
value guide, with appropriate adjustment of an anesthesia conversion
factor, in a manner to ensure that fee schedule amounts for anesthesia
services are consistent with those for other services of comparable
value. Therefore, there is a separate fee schedule methodology for
anesthesia services. Specifically, we establish a separate conversion
factor for anesthesia services and we utilize the uniform relative
value guide, or base units, as well as time units, to calculate the fee
schedule amounts for anesthesia services. Since anesthesia services are
not valued using RVUs, a separate methodology for locality adjustments
is also necessary. This involves an adjustment to the national
anesthesia CF for each payment locality.
4. Most Recent Changes to the Fee Schedule
Section 220(d) of the Protecting Access to Medicare Act of 2014
(Pub. L. 113-93, enacted on April 1, 2014) (PAMA) added a new
subparagraph (O) to section 1848(c)(2) of the Act to establish an
annual target for reductions in PFS expenditures resulting from
adjustments to relative values of misvalued codes. If the estimated net
reduction in expenditures for a year is equal to or greater than the
target for that year, the provision specifies that reduced expenditures
attributable to such adjustments shall be redistributed in a budget-
neutral manner within the PFS. The provision specifies that the amount
by which such reduced expenditures exceed the target for a given year
shall be treated as a reduction in expenditures for the subsequent year
for purposes of determining whether the target for the subsequent year
has been met. The provision also specifies that an amount equal to the
difference between the target and the estimated net reduction in
expenditures, called the target recapture amount, shall not be taken
into account when applying the budget neutrality requirements specified
in section 1848(c)(2)(B)(ii)(II) of the Act. The PAMA amendments
originally made the target provisions applicable for CYs 2017 through
2020 and set the target for reduced expenditures at 0.5 percent of
estimated expenditures under the PFS for each of those 4 years.
Subsequently, section 202 of the Achieving a Better Life Experience
Act of 2014 (Division B of Pub. L. 113-295, enacted December 19, 2014)
(ABLE) accelerated the application of the target, amending section
1848(c)(2)(O) of the Act to specify that target provisions apply for
CYs 2016, 2017, and 2018; and setting a 1 percent target for reduced
expenditures for CY 2016 and a 0.5 percent target for CYs 2017 and
2018. The implementation of the target legislation was finalized in the
CY 2016 PFS final rule with comment period, and proposed revisions are
discussed in section II.G. of this proposed rule.
Section 1848(c)(7) of the Act, as added by section 220(e) of the
PAMA, specified that for services that are not new or revised codes, if
the total RVUs for a service for a year would otherwise be decreased by
an estimated 20 percent or more as compared to the total RVUs for the
previous year, the applicable
[[Page 46167]]
adjustments in work, PE, and MP RVUs shall be phased in over a 2-year
period. Section 220(e) of the PAMA required the phase-in of RVU
reductions of 20 percent or more to begin for 2017. Section 1848(c)(7)
of the Act was later amended by section 202 of the ABLE Act to require
instead that the phase-in must begin in CY 2016. The implementation of
the phase-in legislation was finalized in the CY 2016 PFS final rule
with comment period and proposed revisions in this year's rulemaking
are discussed in section II.H. of this proposed rule.
II. Provisions of the Proposed Rule for PFS
A. Determination of Practice Expense (PE) Relative Value Units (RVUs)
1. Overview
Practice expense (PE) is the portion of the resources used in
furnishing a service that reflects the general categories of physician
and practitioner expenses, such as office rent and personnel wages, but
excluding malpractice expenses, as specified in section 1848(c)(1)(B)
of the Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use
a resource-based system for determining PE RVUs for each physicians'
service. We develop PE RVUs by considering the direct and indirect
practice resources involved in furnishing each service. Direct expense
categories include clinical labor, medical supplies, and medical
equipment. Indirect expenses include administrative labor, office
expense, and all other expenses. The sections that follow provide more
detailed information about the methodology for translating the
resources involved in furnishing each service into service-specific PE
RVUs. We refer readers to the CY 2010 PFS final rule with comment
period (74 FR 61743 through 61748) for a more detailed explanation of
the PE methodology.
2. Practice Expense Methodology
a. Direct Practice Expense
We determine the direct PE for a specific service by adding the
costs of the direct resources (that is, the clinical staff, medical
supplies, and medical equipment) typically involved with furnishing
that service. The costs of the resources are calculated using the
refined direct PE inputs assigned to each CPT code in our PE database,
which are generally based on our review of recommendations received
from the RUC and those provided in response to public comment periods.
For a detailed explanation of the direct PE methodology, including
examples, we refer readers to the Five-Year Review of Work Relative
Value Units under the PFS and Proposed Changes to the Practice Expense
Methodology proposed notice (71 FR 37242) and the CY 2007 PFS final
rule with comment period (71 FR 69629).
b. Indirect Practice Expense per Hour Data
We use survey data on indirect PEs incurred per hour worked in
developing the indirect portion of the PE RVUs. Prior to CY 2010, we
primarily used the practice expense per hour (PE/HR) by specialty that
was obtained from the AMA's Socioeconomic Monitoring Surveys (SMS). The
AMA administered a new survey in CY 2007 and CY 2008, the Physician
Practice Expense Information Survey (PPIS). The PPIS is a
multispecialty, nationally representative, PE survey of both physicians
and nonphysician practitioners (NPPs) paid under the PFS using a survey
instrument and methods highly consistent with those used for the SMS
and the supplemental surveys. The PPIS gathered information from 3,656
respondents across 51 physician specialty and health care professional
groups. We believe the PPIS is the most comprehensive source of PE
survey information available. We used the PPIS data to update the PE/HR
data for the CY 2010 PFS for almost all of the Medicare-recognized
specialties that participated in the survey.
When we began using the PPIS data in CY 2010, we did not change the
PE RVU methodology itself or the manner in which the PE/HR data are
used in that methodology. We only updated the PE/HR data based on the
new survey. Furthermore, as we explained in the CY 2010 PFS final rule
with comment period (74 FR 61751), because of the magnitude of payment
reductions for some specialties resulting from the use of the PPIS
data, we transitioned its use over a 4-year period from the previous PE
RVUs to the PE RVUs developed using the new PPIS data. As provided in
the CY 2010 PFS final rule with comment period (74 FR 61751), the
transition to the PPIS data was complete for CY 2013. Therefore, PE
RVUs from CY 2013 forward are developed based entirely on the PPIS
data, except as noted in this section.
Section 1848(c)(2)(H)(i) of the Act requires us to use the medical
oncology supplemental survey data submitted in 2003 for oncology drug
administration services. Therefore, the PE/HR for medical oncology,
hematology, and hematology/oncology reflects the continued use of these
supplemental survey data.
Supplemental survey data on independent labs from the College of
American Pathologists were implemented for payments beginning in CY
2005. Supplemental survey data from the National Coalition of Quality
Diagnostic Imaging Services (NCQDIS), representing independent
diagnostic testing facilities (IDTFs), were blended with supplementary
survey data from the American College of Radiology (ACR) and
implemented for payments beginning in CY 2007. Neither IDTFs, nor
independent labs, participated in the PPIS. Therefore, we continue to
use the PE/HR that was developed from their supplemental survey data.
Consistent with our past practice, the previous indirect PE/HR values
from the supplemental surveys for these specialties were updated to CY
2006 using the Medicare Economic Index (MEI) to put them on a
comparable basis with the PPIS data.
We also do not use the PPIS data for reproductive endocrinology and
spine surgery since these specialties currently are not separately
recognized by Medicare, nor do we have a method to blend the PPIS data
with Medicare-recognized specialty data.
Previously, we established PE/HR values for various specialties
without SMS or supplemental survey data by crosswalking them to other
similar specialties to estimate a proxy PE/HR. For specialties that
were part of the PPIS for which we previously used a crosswalked PE/HR,
we instead used the PPIS-based PE/HR. We continue previous crosswalks
for specialties that did not participate in the PPIS. However,
beginning in CY 2010 we changed the PE/HR crosswalk for portable X-ray
suppliers from radiology to IDTF, a more appropriate crosswalk because
these specialties are more similar to each other for work time.
For registered dietician services, the resource-based PE RVUs have
been calculated in accordance with the final policy that crosswalks the
specialty to the ``All Physicians'' PE/HR data, as adopted in the CY
2010 PFS final rule with comment period (74 FR 61752) and discussed in
more detail in the CY 2011 PFS final rule with comment period (75 FR
73183). We have incorporated the available utilization data for
interventional cardiology, which became a recognized Medicare specialty
during 2014. We finalized the use of a proxy PE/HR value for
interventional cardiology in the CY 2016 final rule with comment period
(80 FR 70892), as there are no PPIS data for this specialty, by
crosswalking the PE/HR for from
[[Page 46168]]
Cardiology, since the specialties furnish similar services in the
Medicare claims data.
c. Allocation of PE to Services
To establish PE RVUs for specific services, it is necessary to
establish the direct and indirect PE associated with each service.
(1) Direct Costs
The relative relationship between the direct cost portions of the
PE RVUs for any two services is determined by the relative relationship
between the sum of the direct cost resources (that is, the clinical
staff, medical supplies, and medical equipment) typically involved with
furnishing each of the services. The costs of these resources are
calculated from the refined direct PE inputs in our PE database. For
example, if one service has a direct cost sum of $400 from our PE
database and another service has a direct cost sum of $200, the direct
portion of the PE RVUs of the first service would be twice as much as
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
Section II.A.2.b. of this proposed rule describes the current data
sources for specialty-specific indirect costs used in our PE
calculations. We allocated the indirect costs to the code level on the
basis of the direct costs specifically associated with a code and the
greater of either the clinical labor costs or the work RVUs. We also
incorporated the survey data described earlier in the PE/HR discussion.
The general approach to developing the indirect portion of the PE RVUs
is as follows:
For a given service, we used the direct portion of the PE
RVUs calculated as previously described and the average percentage that
direct costs represent of total costs (based on survey data) across the
specialties that furnish the service to determine an initial indirect
allocator. That is, the initial indirect allocator is calculated so
that the direct costs equal the average percentage of direct costs of
those specialties furnishing the service. For example, if the direct
portion of the PE RVUs for a given service is 2.00 and direct costs, on
average, represented 25 percent of total costs for the specialties that
furnished the service, the initial indirect allocator would be
calculated so that it equals 75 percent of the total PE RVUs. Thus, in
this example, the initial indirect allocator would equal 6.00,
resulting in a total PE RVUs of 8.00 (2.00 is 25 percent of 8.00 and
6.00 is 75 percent of 8.00).
Next, we added the greater of the work RVUs or clinical
labor portion of the direct portion of the PE RVUs to this initial
indirect allocator. In our example, if this service had work RVUs of
4.00 and the clinical labor portion of the direct PE RVUs was 1.50, we
would add 4.00 (since the 4.00 work RVUs are greater than the 1.50
clinical labor portion) to the initial indirect allocator of 6.00 to
get an indirect allocator of 10.00. In the absence of any further use
of the survey data, the relative relationship between the indirect cost
portions of the PE RVUs for any two services would be determined by the
relative relationship between these indirect cost allocators. For
example, if one service had an indirect cost allocator of 10.00 and
another service had an indirect cost allocator of 5.00, the indirect
portion of the PE RVUs of the first service would be twice as great as
the indirect portion of the PE RVUs for the second service.
Next, we incorporated the specialty-specific indirect PE/
HR data into the calculation. In our example, if, based on the survey
data, the average indirect cost of the specialties furnishing the first
service with an allocator of 10.00 was half of the average indirect
cost of the specialties furnishing the second service with an indirect
allocator of 5.00, the indirect portion of the PE RVUs of the first
service would be equal to that of the second service.
(3) Facility and Nonfacility Costs
For procedures that can be furnished in a physician's office, as
well as in a hospital or other facility setting, we establish two PE
RVUs: Facility, and nonfacility. The methodology for calculating PE
RVUs is the same for both the facility and nonfacility RVUs, but is
applied independently to yield two separate PE RVUs. In calculating the
PE RVUs for services furnished in a facility, we do not include
resources that would generally not be provided by physicians when
furnishing the service. For this reason, the facility PE RVUs are
generally lower than the nonfacility PE RVUs. Medicare makes a separate
payment to the facility for its costs of furnishing a service.
(4) Services With Technical Components (TCs) and Professional
Components (PCs)
Diagnostic services are generally composed of two components: A
professional component (PC) and a technical component (TC). The PC and
TC may be furnished independently or by different providers, or they
may be furnished together as a ``global'' service. When services have
separately billable PC and TC components, the payment for the global
service equals the sum of the payment for the TC and PC. To achieve
this we use a weighted average of the ratio of indirect to direct costs
across all the specialties that furnish the global service, TCs, and
PCs; that is, we apply the same weighted average indirect percentage
factor to allocate indirect expenses to the global service, PCs, and
TCs for a service. (The direct PE RVUs for the TC and PC sum to the
global.)
(5) PE RVU Methodology
For a more detailed description of the PE RVU methodology, we refer
readers to the CY 2010 PFS final rule with comment period (74 FR 61745
through 61746). We also direct interested readers to the file called
``Calculation of PE RVUs under Methodology for Selected Codes'' which
is available on our Web site under downloads for the CY 2017 PFS
proposed rule at 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 PFS codes.
(a) Setup File
First, we create a setup file for the PE methodology. The setup
file contains the direct cost inputs, the utilization for each
procedure code at the specialty and facility/nonfacility place of
service level, and the specialty-specific PE/HR data calculated from
the surveys.
(b) Calculate the Direct Cost PE RVUs
Sum the costs of each direct input.
Step 1: Sum the direct costs of the inputs for each service.
Step 2: Calculate the aggregate pool of direct PE costs for the
current year. We set the aggregate pool of PE costs equal to the
product of the ratio of the current aggregate PE RVUs to current
aggregate work RVUs and the proposed aggregate work RVUs.
Step 3: Calculate the aggregate pool of direct PE costs for use in
ratesetting. This is the product of the aggregate direct costs for all
services from Step 1 and the utilization data for that service.
Step 4: Using the results of Step 2 and Step 3, calculate a direct
PE scaling factor to ensure that the aggregate pool of direct PE costs
calculated in Step 3 does not vary from the aggregate pool of direct PE
costs for the current year. Apply the scaling factor to the direct
costs for each service (as calculated in Step 1).
Step 5: Convert the results of Step 4 to an RVU scale for each
service. To do this, divide the results of Step 4 by the CF. Note that
the actual value of the CF used in this calculation does not
[[Page 46169]]
influence the final direct cost PE RVUs, as long as the same CF is used
in Step 2 and Step 5. Different CFs will result in different direct PE
scaling factors, but this has no effect on the final direct cost PE
RVUs since changes in the CFs and changes in the associated direct
scaling factors offset one another.
(c) Create the Indirect Cost PE RVUs
Create indirect allocators.
Step 6: Based on the survey data, calculate direct and indirect PE
percentages for each physician specialty.
Step 7: Calculate direct and indirect PE percentages at the service
level by taking a weighted average of the results of Step 6 for the
specialties that furnish the service. Note that for services with TCs
and PCs, the direct and indirect percentages for a given service do not
vary by the PC, TC, and global service.
We use an average of the 3 most recent years of available Medicare
claims data to determine the specialty mix assigned to each code. As we
stated in the CY 2016 final rule with comment period (80 FR 70894), we
believe that the 3-year average will mitigate the need to use dominant
or expected specialty instead of the claims data. Because we are
incorporating CY 2015 claims data for use in the CY 2017 proposed
rates, we believe that the proposed PE RVUs associated with the CY 2017
PFS proposed rule provide a first opportunity to determine whether
service-level overrides of claims data are necessary. Currently, in the
development of PE RVUs we apply only the overrides that also apply to
the MP RVU calculation. Since the proposed PE RVUs include a new year
of claims into the 3 year average for the first time, we are seeking
comment on the proposed CY 2017 PFS rates and whether or not the
incorporation of a new year of utilization data into a three year
average mitigates the need for alternative service-level overrides such
as a claims-based approach (dominant specialty) or stakeholder-
recommended approach (expected specialty) in the development of PE (and
MP) RVUs for low-volume codes. Prior year RVUs are available at several
locations on the PFS Web site located at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
Step 8: Calculate the service level allocators for the indirect PEs
based on the percentages calculated in Step 7. The indirect PEs are
allocated based on the three components: The direct PE RVUs; the
clinical labor PE RVUs; and the work RVUs.
For most services the indirect allocator is: Indirect PE percentage
* (direct PE RVUs/direct percentage) + work RVUs.
There are two situations where this formula is modified:
If the service is a global service (that is, a service
with global, professional, and technical components), then the indirect
PE allocator is: Indirect percentage (direct PE RVUs/direct percentage)
+ clinical labor PE RVUs + work RVUs.
If the clinical labor PE RVUs exceed the work RVUs (and
the service is not a global service), then the indirect allocator is:
Indirect PE percentage (direct PE RVUs/direct percentage) + clinical
labor PE RVUs. (Note: For global services, the indirect PE allocator is
based on both the work RVUs and the clinical labor PE RVUs. We do this
to recognize that, for the PC service, indirect PEs will be allocated
using the work RVUs, and for the TC service, indirect PEs will be
allocated using the direct PE RVUs and the clinical labor PE RVUs. This
also allows the global component RVUs to equal the sum of the PC and TC
RVUs.)
For presentation purposes, in the examples in the download file
called ``Calculation of PE RVUs under Methodology for Selected Codes'',
the formulas were divided into two parts for each service.
The first part does not vary by service and is the
indirect percentage (direct PE RVUs/direct percentage).
The second part is either the work RVU, clinical labor PE
RVU, or both depending on whether the service is a global service and
whether the clinical PE RVUs exceed the work RVUs (as described earlier
in this step).
Apply a scaling adjustment to the indirect allocators.
Step 9: Calculate the current aggregate pool of indirect PE RVUs by
multiplying the result of step 8 by the average indirect PE percentage
from the survey data.
Step 10: Calculate an aggregate pool of indirect PE RVUs for all
PFS services by adding the product of the indirect PE allocators for a
service from Step 8 and the utilization data for that service.
Step 11: Using the results of Step 9 and Step 10, calculate an
indirect PE adjustment so that the aggregate indirect allocation does
not exceed the available aggregate indirect PE RVUs and apply it to
indirect allocators calculated in Step 8. Calculate the indirect
practice cost index.
Step 12: Using the results of Step 11, calculate aggregate pools of
specialty-specific adjusted indirect PE allocators for all PFS services
for a specialty by adding the product of the adjusted indirect PE
allocator for each service and the utilization data for that service.
Step 13: Using the specialty-specific indirect PE/HR data,
calculate specialty-specific aggregate pools of indirect PE for all PFS
services for that specialty by adding the product of the indirect PE/HR
for the specialty, the work time for the service, and the specialty's
utilization for the service across all services furnished by the
specialty.
Step 14: Using the results of Step 12 and Step 13, calculate the
specialty-specific indirect PE scaling factors.
Step 15: Using the results of Step 14, calculate an indirect
practice cost index at the specialty level by dividing each specialty-
specific indirect scaling factor by the average indirect scaling factor
for the entire PFS.
Step 16: Calculate the indirect practice cost index at the service
level to ensure the capture of all indirect costs. Calculate a weighted
average of the practice cost index values for the specialties that
furnish the service. (Note: For services with TCs and PCs, we calculate
the indirect practice cost index across the global service, PCs, and
TCs. Under this method, the indirect practice cost index for a given
service (for example, echocardiogram) does not vary by the PC, TC, and
global service.)
Step 17: Apply the service level indirect practice cost index
calculated in Step 16 to the service level adjusted indirect allocators
calculated in Step 11 to get the indirect PE RVUs.
(d) Calculate the Final PE RVUs
Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs
from Step 17 and apply the final PE budget neutrality (BN) adjustment.
The final PE BN adjustment is calculated by comparing the sum of steps
5 and 17 of to the proposed aggregate work RVUs scaled by the ratio of
current aggregate PE and work RVUs. This adjustment ensures that all PE
RVUs in the PFS account for the fact that certain specialties are
excluded from the calculation of PE RVUs but included in maintaining
overall PFS budget neutrality. (See ``Specialties excluded from
ratesetting calculation'' later in this section.)
(e) Setup File Information
Specialties excluded from ratesetting calculation: For the
purposes of calculating the PE RVUs, we exclude certain specialties,
such as certain nonphysician practitioners paid at a percentage of the
PFS and low-volume specialties, from the calculation. These specialties
are included for the purposes of calculating the BN adjustment. They
are displayed in Table 1.
[[Page 46170]]
Table 1--Specialties Excluded From Ratesetting Calculation
------------------------------------------------------------------------
Specialty code Specialty description
------------------------------------------------------------------------
49................................ Ambulatory surgical center.
50................................ Nurse practitioner.
51................................ Medical supply company with
certified orthotist.
52................................ Medical supply company with
certified prosthetist.
53................................ Medical supply company with
certified prosthetist-orthotist.
54................................ Medical supply company not included
in 51, 52, or 53.
55................................ Individual certified orthotist.
56................................ Individual certified prosthetist.
57................................ Individual certified prosthetist-
orthotist.
58................................ Medical supply company with
registered pharmacist.
59................................ Ambulance service supplier, e.g.,
private ambulance companies,
funeral homes, etc.
60................................ Public health or welfare agencies.
61................................ Voluntary health or charitable
agencies.
73................................ Mass immunization roster biller.
74................................ Radiation therapy centers.
87................................ All other suppliers (e.g., drug and
department stores).
88................................ Unknown supplier/provider specialty.
89................................ Certified clinical nurse specialist.
96................................ Optician.
97................................ Physician assistant.
A0................................ Hospital.
A1................................ SNF.
A2................................ Intermediate care nursing facility.
A3................................ Nursing facility, other.
A4................................ HHA.
A5................................ Pharmacy.
A6................................ Medical supply company with
respiratory therapist.
A7................................ Department store.
B2................................ Pedorthic personnel.
B3................................ Medical supply company with
pedorthic personnel.
------------------------------------------------------------------------
Crosswalk certain low volume physician specialties:
Crosswalk the utilization of certain specialties with relatively low
PFS utilization to the associated specialties.
Physical therapy utilization: Crosswalk the utilization
associated with all physical therapy services to the specialty of
physical therapy.
Identify professional and technical services not
identified under the usual TC and 26 modifiers: Flag the services that
are PC and TC services but do not use TC and 26 modifiers (for example,
electrocardiograms). This flag associates the PC and TC with the
associated global code for use in creating the indirect PE RVUs. For
example, the professional service, CPT code 93010 (Electrocardiogram,
routine ECG with at least 12 leads; interpretation and report only), is
associated with the global service, CPT code 93000 (Electrocardiogram,
routine ECG with at least 12 leads; with interpretation and report).
Payment modifiers: Payment modifiers are accounted for in
the creation of the file consistent with current payment policy as
implemented in claims processing. For example, services billed with the
assistant at surgery modifier are paid 16 percent of the PFS amount for
that service; therefore, the utilization file is modified to only
account for 16 percent of any service that contains the assistant at
surgery modifier. Similarly, for those services to which volume
adjustments are made to account for the payment modifiers, time
adjustments are applied as well. For time adjustments to surgical
services, the intraoperative portion in the work time file is used;
where it is not present, the intraoperative percentage from the payment
files used by contractors to process Medicare claims is used instead.
Where neither is available, we use the payment adjustment ratio to
adjust the time accordingly. Table 2 details the manner in which the
modifiers are applied.
Table 2--Application of Payment Modifiers to Utilization Files
----------------------------------------------------------------------------------------------------------------
Modifier Description Volume adjustment Time adjustment
----------------------------------------------------------------------------------------------------------------
80, 81, 82........................... Assistant at Surgery... 16%.................... Intraoperative portion.
AS................................... Assistant at Surgery-- 14% (85% * 16%)........ Intraoperative portion.
Physician Assistant.
50 or LT and RT...................... Bilateral Surgery...... 150%................... 150% of work time.
51................................... Multiple Procedure..... 50%.................... Intraoperative portion.
52................................... Reduced Services....... 50%.................... 50%.
53................................... Discontinued Procedure. 50%.................... 50%.
54................................... Intraoperative Care Preoperative + Preoperative +
only. Intraoperative Intraoperative
Percentages on the portion.
payment files used by
Medicare contractors
to process Medicare
claims.
55................................... Postoperative Care only Postoperative Postoperative portion.
Percentage on the
payment files used by
Medicare contractors
to process Medicare
claims.
[[Page 46171]]
62................................... Co-surgeons............ 62.5%.................. 50%.
66................................... Team Surgeons.......... 33%.................... 33%.
----------------------------------------------------------------------------------------------------------------
We also make adjustments to volume and time that correspond to
other payment rules, including special multiple procedure endoscopy
rules and multiple procedure payment reductions (MPPRs). We note that
section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments
for multiple imaging procedures and multiple therapy services from the
BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These
MPPRs are not included in the development of the RVUs.
For anesthesia services, we do not apply adjustments to volume
since we use the average allowed charge when simulating RVUs;
therefore, the RVUs as calculated already reflect the payments as
adjusted by modifiers, and no volume adjustments are necessary.
However, a time adjustment of 33 percent is made only for medical
direction of two to four cases since that is the only situation where a
single practitioner is involved with multiple beneficiaries
concurrently, so that counting each service without regard to the
overlap with other services would overstate the amount of time spent by
the practitioner furnishing these services.
Work RVUs: The setup file contains the work RVUs from this
proposed rule.
(6) Equipment Cost Per Minute
The equipment cost per minute is calculated as:
(1/(minutes per year * usage)) * price * ((interest rate/(1 - (1/((1 +
interest rate) [supcaret] life of equipment)))) + maintenance)
Where:
minutes per year = maximum minutes per year if usage were continuous
(that is, usage = 1); generally 150,000 minutes.
usage = variable, see discussion below.
price = price of the particular piece of equipment.
life of equipment = useful life of the particular piece of
equipment.
maintenance = factor for maintenance; 0.05.
interest rate = variable, see discussion below.
Usage: We currently use an equipment utilization rate assumption of
50 percent for most equipment, with the exception of expensive
diagnostic imaging equipment, for which we use a 90 percent assumption
as required by section 1848(b)(4)(C) of the Act.
Stakeholders have often suggested that particular equipment items
are used less frequently than 50 percent of the time in the typical
setting and that CMS should reduce the equipment utilization rate based
on these recommendations. We appreciate and share stakeholders'
interest in using the most accurate assumption regarding the equipment
utilization rate for particular equipment items. However, we believe
that absent robust, objective, auditable data regarding the use of
particular items, the 50 percent assumption is the most appropriate
within the relative value system. We welcome the submission of data
that illustrates an alternative rate.
Maintenance: This factor for maintenance was proposed and finalized
during rulemaking for CY 1998 PFS (62 FR 33164).
We continue to investigate potential avenues for determining
equipment maintenance costs across a broad range of equipment items.
Interest Rate: In the CY 2013 PFS final rule with comment period
(77 FR 68902), we updated the interest rates used in developing an
equipment cost per minute calculation. The interest rate was based on
the Small Business Administration (SBA) maximum interest rates for
different categories of loan size (equipment cost) and maturity (useful
life). The interest rates are listed in Table 3. (See 77 FR 68902 for a
thorough discussion of this issue.) We are not proposing any changes to
these interest rates for CY 2017.
Table 3--SBA Maximum Interest Rates
------------------------------------------------------------------------
Useful
Price life Interest
(years) rate (%)
------------------------------------------------------------------------
<$25K........................................... <7 7.50
$25K to $50K.................................... <7 6.50
>$50K........................................... <7 5.50
<$25K........................................... 7+ 8.00
$25K to $50K.................................... 7+ 7.00
>$50K........................................... 7+ 6.00
------------------------------------------------------------------------
d. Proposed Changes to Direct PE Inputs for Specific Services
This section focuses on specific PE inputs. The direct PE inputs
are included in the CY 2017 direct PE input database, which is
available on our Web site under downloads for the CY 2017 PFS proposed
rule at 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 had been become typically used in furnishing imaging
services. However, since we did not receive any invoices for the PACS
system prior to that year's proposed rule, we were unable to determine
the appropriate pricing to use for the inputs. For CY 2015, we
finalized our proposal to remove the film supply and equipment items,
and to create a new equipment item as a proxy for the PACS workstation
as a direct expense (79 FR 67561-67563). We used the price associated
with ED021 (computer, desktop, w-monitor) to price the new item, ED050
(PACS Workstation Proxy), pending receipt of invoices to facilitate
pricing specific to the PACS workstation. Subsequent to establishing
payment rates for CY 2015, we received information from several
stakeholders regarding pricing for items related to the digital
acquisition and storage of images. We received invoices from one
stakeholder that facilitated a proposed price update for the PACS
workstation in the CY 2016 PFS proposed rule, and we updated the price
for the PACS workstation to $5,557 in the CY 2016 PFS final rule with
comment period (80 FR 70899).
In addition to the workstation used by the clinical staff acquiring
the images and furnishing the TC of the services, a stakeholder also
submitted more detailed information regarding a workstation used by the
practitioner interpreting the image in furnishing the PC of many of
these services.
As we stated in the CY 2015 PFS final rule with comment period (79
FR 67563), we generally believe that workstations used by these
practitioners
[[Page 46172]]
are more accurately considered indirect costs associated with the PC of
the service. However, we understand that the professional workstations
for interpretation of digital images are similar in principle to some
of the previous film inputs incorporated into the global and technical
components of the codes, such as the view box equipment. Given that the
majority of these services are reported globally in the nonfacility
setting, we believe it is appropriate to include these costs as direct
inputs for the associated HCPCS codes. Based on our established
methodology in which single codes with professional and technical
components are constructed by assigning work RVUs exclusively to the
professional component and direct PE inputs exclusively to the
technical components, these costs would be incorporated into the PE
RVUs of the global and technical component of the HCPCS code.
We stated in the CY 2016 PFS final rule with comment period that
the costs of the professional workstation may be analogous to costs
related to the use of film previously incorporated as direct PE inputs
for these services. We also solicited comments on whether including the
professional workstation as a direct PE input for these codes would be
appropriate, given that the resulting PE RVUs would be assigned to the
global and technical components of the codes. Commenters responded by
indicating their approval of the concept of a professional PACS
workstation used for interpretation of digital images. We received
invoices for the pricing of a professional PACS workstation, as well as
additional invoices for the pricing of a mammography-specific version
of the professional PACS workstation. The RUC also included these new
equipment items in its recommendations for the CY 2017 PFS rulemaking
cycle.
Based on our analysis of submitted invoices, we are proposing to
price the professional PACS workstation (ED053) at $14,616.93. We are
not proposing a change in price for the current technical PACS
workstation (ED050), which will remain at a price of $5,557.00.
The price of the professional PACS workstation is based upon
individual invoices submitted for the cost of a PC Tower ($1531.52), a
pair of 3 MP monitors ($10,500.00 in total), a keyboard and mouse
($84.95), a UPS power backup devices for TNP ($1098.00), and a switch
for PACS monitors/workstations ($1402.46).
We are proposing to add the professional PACS workstation to many
CPT codes in the 70000 series that use the current technical PACS
workstation (ED050) and include professional work for which such a
workstation would be used. We are not proposing to add the equipment
item to add-on codes since the base codes would include minutes for the
item. We are also not proposing to add the item to codes that are
therapeutic in nature, as the professional PACS workstation is intended
for use in diagnostic services. We are therefore not proposing to add
the item to codes in the Radiation Therapy section (77261 through
77799) or the Nuclear Medicine Cardiology section (78414-78499). We
also are not proposing to add the item to image guidance codes where
the dominant provider is not a radiologist (77002, 77011, 77071, 77077,
and 77081) according to the most recent year of claims data, since we
believe a single workstation would be more typical in those cases. We
have identified approximately 426 codes to which we are proposing to
add a professional PACS workstation. Please see Table 4 for the full
list of affected codes.
For the professional PACS workstation, we are proposing to assign
equipment time equal to the intraservice work time plus half of the
preservice work time associated with the codes, since the work time
generally reflects the time associated with the professional
interpretation. We are proposing half of the preservice work time for
the professional PACS workstation, as we do not believe that the
practitioner would typically spend all of the preservice work period
using the equipment. For older codes that do not have a breakdown of
physician work time by service period, and only have an overall
physician work time, we are proposing to use half the total work time
as an approximation of the intraservice work time plus one half of the
preservice work time. In our review of services that contained an
existing PACS workstation and had a breakdown of physician work time,
we found that half of the total time was a reasonable approximation for
the value of intraservice work time plus one half of preservice work
time where no such breakdown existed. We also considered using an
equipment time formula of the physician intraservice time plus 1 minute
(as a stand-in for the physician preservice work time). We are seeking
public comment on the most accurate equipment time formula for the
professional PACS workstation.
We are seeking public comment on the proposed list of codes that
would incorporate either the professional PACS workstation. We are
interested in public comment on the codes for which a professional PACS
workstation should be included, and whether one of these professional
workstations should be included for codes outside the 70000 series. In
cases within the 70000 series where radiologists are not the typical
specialty reporting the code, such as CPT codes 77002 and 77011, we are
asking whether it would be appropriate to add one of the professional
PACS workstations to these services.
Table 4--Codes With Professional PACS Workstation in the Proposed Direct
PE Input Database
------------------------------------------------------------------------
HCPCS ED053 minutes
------------------------------------------------------------------------
70015................................................... 12
70030................................................... 3
70100................................................... 3
70110................................................... 4
70120................................................... 3
70130................................................... 4
70134................................................... 4
70140................................................... 3
70150................................................... 4
70160................................................... 3
70190................................................... 3
70200................................................... 4
70210................................................... 3
70220................................................... 4
70240................................................... 3
70250................................................... 4
70260................................................... 7
70300................................................... 2
70310................................................... 3
70320................................................... 3
70328................................................... 3
70330................................................... 22
70332................................................... 6
70336................................................... 20
70350................................................... 3
70355................................................... 5
70360................................................... 3
70370................................................... 4
70371................................................... 9
70380................................................... 3
70390................................................... 5
70450................................................... 12
70460................................................... 15
70470................................................... 18
70480................................................... 13
70481................................................... 13
70482................................................... 14
70490................................................... 13
70491................................................... 13
70492................................................... 14
70540................................................... 14
70542................................................... 19
70543................................................... 19
70544................................................... 13
70545................................................... 18
70546................................................... 18
70547................................................... 13
70548................................................... 20
70549................................................... 25
70551................................................... 21
70552................................................... 23
70553................................................... 28
70554................................................... 43
71010................................................... 4
71015................................................... 3
[[Page 46173]]
71020................................................... 4
71021................................................... 4
71022................................................... 4
71023................................................... 5
71030................................................... 4
71034................................................... 5
71035................................................... 3
71100................................................... 5
71101................................................... 4
71110................................................... 4
71111................................................... 5
71120................................................... 3
71130................................................... 3
71250................................................... 18
71260................................................... 17
71270................................................... 13
71275................................................... 28
71550................................................... 15
71551................................................... 30
71552................................................... 28
71555................................................... 33
72020................................................... 3
72040................................................... 4
72050................................................... 6
72052................................................... 6
72070................................................... 4
72072................................................... 3
72074................................................... 3
72080................................................... 3
72081................................................... 6
72082................................................... 7
72083................................................... 8
72084................................................... 9
72100................................................... 4
72110................................................... 6
72114................................................... 6
72120................................................... 4
72125................................................... 18
72126................................................... 12
72127................................................... 12
72128................................................... 18
72129................................................... 12
72130................................................... 12
72131................................................... 18
72132................................................... 12
72133................................................... 12
72141................................................... 23
72142................................................... 26
72146................................................... 23
72147................................................... 26
72148................................................... 23
72149................................................... 26
72156................................................... 28
72157................................................... 28
72158................................................... 28
72159................................................... 31
72170................................................... 5
72190................................................... 3
72191................................................... 28
72192................................................... 12
72193................................................... 12
72194................................................... 12
72195................................................... 30
72196................................................... 26
72197................................................... 30
72198................................................... 28
72200................................................... 3
72202................................................... 3
72220................................................... 3
72240................................................... 19
72255................................................... 18
72265................................................... 18
72270................................................... 23
72275................................................... 36
72285................................................... 9
72295................................................... 9
73000................................................... 3
73010................................................... 3
73020................................................... 3
73030................................................... 5
73040................................................... 6
73050................................................... 3
73060................................................... 4
73070................................................... 3
73080................................................... 4
73085................................................... 6
73090................................................... 3
73092................................................... 3
73100................................................... 4
73110................................................... 4
73115................................................... 6
73120................................................... 4
73130................................................... 4
73140................................................... 3
73200................................................... 18
73201................................................... 11
73202................................................... 12
73206................................................... 35
73218................................................... 25
73219................................................... 25
73220................................................... 30
73221................................................... 23
73222................................................... 23
73223................................................... 35
73225................................................... 31
73501................................................... 4
73502................................................... 5
73503................................................... 6
73521................................................... 5
73522................................................... 6
73523................................................... 7
73525................................................... 6
73551................................................... 4
73552................................................... 5
73560................................................... 4
73564................................................... 6
73565................................................... 4
73580................................................... 6
73590................................................... 4
73592................................................... 3
73600................................................... 4
73610................................................... 4
73615................................................... 6
73620................................................... 4
73630................................................... 4
73650................................................... 3
73660................................................... 3
73700................................................... 18
73701................................................... 11
73702................................................... 12
73706................................................... 35
73718................................................... 20
73719................................................... 25
73720................................................... 30
73721................................................... 23
73722................................................... 24
73723................................................... 32
73725................................................... 33
74000................................................... 4
74010................................................... 3
74020................................................... 4
74022................................................... 4
74150................................................... 14
74160................................................... 17
74170................................................... 21
74174................................................... 33
74175................................................... 28
74176................................................... 25
74177................................................... 28
74178................................................... 33
74181................................................... 15
74182................................................... 28
74183................................................... 35
74185................................................... 33
74210................................................... 5
74220................................................... 5
74230................................................... 12
74240................................................... 7
74241................................................... 7
74245................................................... 9
74246................................................... 7
74247................................................... 18
74249................................................... 9
74250................................................... 5
74251................................................... 33
74260................................................... 6
74261................................................... 43
74262................................................... 48
74263................................................... 42
74270................................................... 7
74280................................................... 23
74283................................................... 19
74290................................................... 4
74400................................................... 18
74410................................................... 6
74415................................................... 6
74430................................................... 4
74440................................................... 5
74455................................................... 4
74485................................................... 6
74710................................................... 4
74712................................................... 68
74740................................................... 5
75557................................................... 45
75559................................................... 58
75561................................................... 50
75563................................................... 66
75571................................................... 13
75572................................................... 25
75573................................................... 38
75574................................................... 35
75600................................................... 6
75605................................................... 11
75625................................................... 11
75630................................................... 13
75635................................................... 50
75658................................................... 13
75705................................................... 20
75710................................................... 11
75716................................................... 13
75726................................................... 11
[[Page 46174]]
75731................................................... 11
75733................................................... 13
75736................................................... 11
75741................................................... 13
75743................................................... 16
75746................................................... 11
75756................................................... 11
75791................................................... 33
75809................................................... 5
75820................................................... 7
75822................................................... 11
75825................................................... 11
75827................................................... 11
75831................................................... 11
75833................................................... 14
75840................................................... 11
75842................................................... 14
75860................................................... 11
75870................................................... 11
75872................................................... 11
75880................................................... 7
75885................................................... 14
75887................................................... 14
75889................................................... 11
75891................................................... 11
75893................................................... 6
75901................................................... 11
75902................................................... 13
75962................................................... 6
75966................................................... 13
75978................................................... 6
75984................................................... 8
75989................................................... 12
76000................................................... 3
76010................................................... 3
76080................................................... 6
76098................................................... 3
76100................................................... 6
76101................................................... 6
76102................................................... 6
76120................................................... 5
76376................................................... 8
76380................................................... 10
76390................................................... 28
76506................................................... 10
76536................................................... 12
76604................................................... 9
76700................................................... 14
76705................................................... 11
76770................................................... 13
76775................................................... 11
76776................................................... 13
76800................................................... 14
76801................................................... 18
76805................................................... 18
76811................................................... 35
76813................................................... 23
76815................................................... 8
76816................................................... 18
76817................................................... 13
76818................................................... 35
76819................................................... 28
76820................................................... 13
76821................................................... 13
76825................................................... 45
76826................................................... 11
76830................................................... 13
76831................................................... 30
76856................................................... 13
76857................................................... 10
76870................................................... 10
76872................................................... 20
76873................................................... 40
76881................................................... 18
76885................................................... 20
76886................................................... 15
76936................................................... 71
76942................................................... 19
76970................................................... 8
77012................................................... 11
77014................................................... 9
77021................................................... 53
77053................................................... 5
77054................................................... 5
77058................................................... 50
77059................................................... 55
77072................................................... 3
77074................................................... 5
77075................................................... 6
77076................................................... 12
77084................................................... 15
78012................................................... 8
78013................................................... 13
78014................................................... 13
78015................................................... 31
78016................................................... 49
78018................................................... 29
78070................................................... 13
78071................................................... 18
78072................................................... 23
78075................................................... 38
78102................................................... 18
78103................................................... 22
78104................................................... 20
78135................................................... 48
78140................................................... 40
78185................................................... 16
78190................................................... 40
78195................................................... 30
78201................................................... 16
78202................................................... 20
78205................................................... 20
78206................................................... 25
78215................................................... 13
78216................................................... 22
78226................................................... 13
78227................................................... 18
78230................................................... 19
78231................................................... 23
78232................................................... 28
78258................................................... 27
78261................................................... 21
78262................................................... 25
78264................................................... 13
78265................................................... 18
78266................................................... 23
78278................................................... 18
78290................................................... 18
78291................................................... 31
78300................................................... 15
78305................................................... 22
78306................................................... 11
78315................................................... 11
78320................................................... 24
78579................................................... 8
78580................................................... 13
78582................................................... 15
78597................................................... 13
78598................................................... 13
78600................................................... 16
78601................................................... 18
78605................................................... 21
78606................................................... 22
78607................................................... 29
78610................................................... 10
78630................................................... 24
78635................................................... 36
78645................................................... 32
78647................................................... 15
78650................................................... 40
78660................................................... 16
78700................................................... 17
78701................................................... 18
78707................................................... 22
78708................................................... 32
78709................................................... 40
78710................................................... 21
78740................................................... 30
78761................................................... 20
78800................................................... 28
78801................................................... 32
78802................................................... 24
78803................................................... 43
78804................................................... 35
78805................................................... 25
78806................................................... 23
78807................................................... 37
79440................................................... 24
G0389................................................... 9
767X1................................................... 13
------------------------------------------------------------------------
(2) Standardization of Clinical Labor Tasks
As we noted in the CY 2015 PFS rule (79 FR 67640-67641), we
continue to work on revisions to the direct PE input database to
provide the number of clinical labor minutes assigned for each task for
every code in the database instead of only including the number of
clinical labor minutes for the preservice, service, and postservice
periods for each code. In addition to increasing the transparency of
the information used to set PE RVUs, this improvement would allow us to
compare clinical labor times for activities associated with services
across the PFS, which we believe is important to maintaining the
relativity of the direct PE inputs. This information would facilitate
the identification of the usual numbers of minutes for clinical labor
tasks and the identification of exceptions to the usual values. It
would also allow for greater transparency and consistency in the
assignment of equipment minutes based on clinical labor times. Finally,
we believe that the
[[Page 46175]]
information can be useful in maintaining standard times for particular
clinical labor tasks that can be applied consistently to many codes as
they are valued over several years, similar in principle to the use of
physician preservice time packages. We believe such standards would
provide greater consistency among codes that share the same clinical
labor tasks and could improve relativity of values among codes. For
example, as medical practice and technologies change over time, changes
in the standards could be updated at once for all codes with the
applicable clinical labor tasks, instead of waiting for individual
codes to be reviewed.
In the following paragraphs, we address a series of issues related
to clinical labor tasks, particularly relevant to services currently
being reviewed under the misvalued code initiative.
(a) Clinical Labor Tasks Associated With Digital Imaging
In the CY 2015 PFS rule, we noted that the RUC recommendation
regarding inputs for digital imaging services indicated that, as each
code is reviewed under the misvalued code initiative, the clinical
labor tasks associated with digital technology (instead of film) would
need to be addressed. When we reviewed that recommendation, we did not
have the capability of assigning standard clinical labor times for the
hundreds of individual codes since the direct PE input database did not
previously allow for comprehensive adjustments for clinical labor times
based on particular clinical labor tasks. Therefore, consistent with
the recommendation, we proposed to remove film-based supply and
equipment items but maintain clinical labor minutes that were assigned
based on film technology.
As noted in the paragraphs above, we continue to improve the direct
PE input database by specifying for each code the minutes associated
with each clinical labor task. Once completed, this work would allow
adjustments to be made to minutes assigned to particular clinical labor
tasks related to digital technology that occur in multiple codes,
consistent with the changes that were made to individual supply and
equipment items. In the meantime, we believe it would be appropriate to
establish standard times for clinical labor tasks associated with all
digital imaging services for purposes of reviewing individual services
at present, and for possible broad-based standardization once the
changes to the direct PE input database facilitate our ability to
adjust time across services. During the CY 2016 PFS rulemaking cycle,
we proposed appropriate standard minutes for five different clinical
labor tasks associated with services that use digital imaging
technology. In the CY 2016 PFS final rule with comment period (80 FR
70901), we finalized appropriate standard minutes for four of those
five activities, which are listed in Table 5.
Table 5--Clinical Labor Tasks Associated With Digital Imaging Technology
------------------------------------------------------------------------
Typical
Clinical labor task minutes
------------------------------------------------------------------------
Availability of prior images confirmed..................... 2
Patient clinical information and questionnaire reviewed by 2
technologist, order from physician confirmed and exam
protocoled by radiologist.................................
Review examination with interpreting MD.................... 2
Exam documents scanned into PACS. Exam completed in RIS 1
system to generate billing process and to populate images
into Radiologist work queue...............................
------------------------------------------------------------------------
We did not finalize standard minutes for the activity
``Technologist QC's images in PACS, checking for all images, reformats,
and dose page.'' We agreed with commenters that this task may require a
variable length of time depending on the number of images to be
reviewed. We stated that it may be appropriate to establish several
different standard times for this clinical labor task for a low/medium/
high quantity of images to be reviewed, in the same fashion that the
clinical labor assigned to clean a surgical instrument package has two
different standard times depending on the use of a basic pack (10
minutes) or a medium pack (30 minutes). We solicited public comment and
feedback on this subject, with the anticipation of including a proposal
in the CY 2017 proposed rule.
We received many comments suggesting that this clinical labor
activity should not have a standard time value. Commenters stated that
the number of minutes varies significantly for different imaging
modalities; and the time is not simply based on the quantity of images
to be reviewed, but also the complexity of the images. The commenters
recommended that time for this clinical labor activity should be
assigned on a code by code basis. We agree with the commenters that the
amount of clinical labor needed to check images in a PACS workstation
may vary depending on the service. However, we do not believe that this
precludes the possibility of establishing standards for clinical labor
tasks as we have done in the past by creating multiple standard times,
for example, those assigned to cleaning different kinds of scopes. We
continue to believe that the use of clinical labor standards provides
greater consistency among codes that share the same clinical labor
tasks and can improve relativity of values among codes. We are
proposing to establish a range of appropriate standard minutes for the
clinical labor activity Technologist QCs images in PACS, checking for
all images, reformats, and dose page. These standard minutes will be
applied to new and revised codes that make use of this clinical labor
activity when they are reviewed by us for valuation. We are proposing 2
minutes as the standard for the simple case, 3 minutes as the standard
for the intermediate case, and 4 minutes as the standard for the
complex case. We are proposing the simple case of 2 minutes as the
standard for the typical procedure code involving routine use of
imaging. These values are based upon a review of the existing minutes
assigned for this clinical labor activity; we have determined that 2
minutes is the duration for most services and a small number of codes
with more complex forms of digital imaging have higher values. We are
proposing to use 2 minutes for services involving routine x-rays
(simple), 3 minutes for services involving CTs and MRIs (intermediate),
and 4 minutes for the most highly complex services which would exceed
these more typical cases. We are soliciting comments regarding the most
accurate category--simple, intermediate, or complex for existing codes,
and in particular what criteria
[[Page 46176]]
might be used to identify complex cases systematically.
(b) Pathology Clinical Labor Tasks
As with the clinical labor tasks associated with digital imaging,
many of the currently assigned times for the specialized clinical labor
tasks associated with pathology services are not consistent across
codes. In reviewing past RUC recommendations for pathology services, we
have not identified information that supports the judgment that the
same tasks take significantly more or less time depending on the
individual service for which they are performed, especially given the
high degree of specificity with which the tasks are described. We
continue to believe that, in general, a clinical labor task will tend
to take the same amount of time to perform as the same clinical labor
task when it is performed in a clinically similar service.
Therefore, we developed standard times for clinical labor tasks
that we have used in finalizing direct PE inputs in recent years,
starting in the CY 2012 PFS final rule with comment period (76 FR
73213). These times were based on our review and assessment of the
current times included for these clinical labor tasks in the direct PE
input database. We proposed in the CY 2016 PFS proposed rule to
establish standard times for a list of 17 clinical labor tasks related
to pathology services, and solicited public feedback regarding our
proposed standards. Many commenters stated in response to our proposal
that they did not support the standardization of clinical labor
activities across pathology services. Commenters stated that
establishing a single standard time for each clinical labor task was
infeasible due to the differences in batch size or number of blocks
across different pathology procedures. Several commenters indicated
that it might be possible to standardize across codes with the same
batch sizes, and urged us to consider pathology-specific details, such
as batch size and block number, in the creation of any future standard
times for clinical labor tasks related to pathology services.
As we stated in the CY 2016 PFS proposed rule, we developed the
proposed standard times based on our review and assessment of the
current times included for these clinical labor tasks in the direct PE
input database. We believe that, generally speaking, clinical labor
tasks with the same description are comparable across different
pathology procedures. We believe this to be true based on the
comparability of clinical labor tasks in non-pathology services, as
well as the high degree of specificity with which most pathology tasks
are described relative to clinical labor tasks associated with other
PFS services. We concurred with commenters that accurate clinical labor
times for pathology codes may be dependent on the number of blocks or
batch size typically used for each individual service. However, we also
believe that it is appropriate and feasible to establish ``per block''
standards or standards varied by batch size assumptions for many
clinical labor activities that would be comparable across a wide range
of individual services. We have received detailed information regarding
batch size and number of blocks during review of individual pathology
services on an intermittent basis in the past. We requested regular
submission of these details on the PE worksheets supplied by the RUC as
part of the review process for pathology services, as a means to assist
in the determination of the most accurate direct PE inputs.
We also stated our belief that many of the clinical labor
activities for which we proposed to establish standard times were tasks
that do not depend on number of blocks or batch size. Clinical labor
activities such as ``Clean room/equipment following procedure'' and
``Dispose of remaining specimens'' would typically remain standard
across different services without varying by block number or batch
size, with the understanding that additional time may be required above
the standard value for a clinical labor task that is part of an
unusually complex or difficult service. As a result, we ultimately
finalized standard times for 6 of the 17 proposed clinical labor
activities in the CY 2016 final rule with comment period (80 FR 70902).
We have listed the finalized standard times in Table 6. We are
currently proposing no further action on the remaining 11 clinical
labor activities pending further action by the RUC (see below).
Table 6--Standard Times for Clinical Labor Tasks Associated With
Pathology Services
------------------------------------------------------------------------
Standard clinical
Clinical labor task labor time
(minutes)
------------------------------------------------------------------------
Accession specimen/prepare for examination........... 4
Assemble and deliver slides with paperwork to 0.5
pathologists........................................
Assemble other light microscopy slides, open nerve 0.5
biopsy slides, and clinical history, and present to
pathologist to prepare clinical pathologic
interpretation......................................
Clean room/equipment following procedure (including 1
any equipment maintenance that must be done after
the procedure)......................................
Dispose of remaining specimens, spent chemicals/other 1
consumables, and hazardous waste....................
Prepare, pack and transport specimens and records for 1
in-house storage and external storage (where
applicable).........................................
------------------------------------------------------------------------
We remain committed to the process of establishing standard
clinical labor times for tasks associated with pathology services. This
may include establishing standards on a per-block or per-batch basis,
as we indicated during the previous rulemaking cycle. However, we are
aware that the PE Subcommittee of the RUC is currently working to
standardize the pathology clinical labor activities they use in making
their recommendations. We believe the RUC's efforts to narrow the
current list of several hundred pathology clinical labor tasks to a
more manageable number through the consolidation of duplicative or
highly similar activities into a single description may serve PFS
relativity and facilitate greater transparency in PFS ratesetting. We
also believe that the RUC's standardization of pathology clinical labor
tasks would facilitate our capacity to establish standard times for
pathology clinical labor tasks in future rulemaking. Therefore, we are
not proposing any additional change to clinical labor tasks associated
with pathology services at this time.
(3) Equipment Recommendations for Scope Systems
During our routine reviews of direct PE input recommendations, we
have regularly found unexplained inconsistencies involving the use of
scopes and the video systems associated with them. Some of the scopes
include video systems bundled into the
[[Page 46177]]
equipment item, some of them include scope accessories as part of their
price, and some of them are standalone scopes with no other equipment
included. It is not always clear which equipment items related to
scopes fall into which of these categories. We have also frequently
found anomalies in the equipment recommendations, with equipment items
that consist of a scope and video system bundle recommended along with
a separate scope video system. Based on our review, the variations do
not appear to be consistent with the different code descriptions.
To promote appropriate relativity among the services and facilitate
the transparency of our review process, during review of recommended
direct PE inputs for the CY 2017 PFS proposed rule, we developed a
structure that separates the scope and the associated video system as
distinct equipment items for each code. Under this approach, we are
proposing standalone prices for each scope, and separate prices for the
video systems that are used with scopes. We would define the scope
video system as including: (1) A monitor; (2) a processor; (3) a form
of digital capture; (4) a cart; and (5) a printer. We believe that
these equipment components represent the typical case for a scope video
system. Our model for this system is the ``video system, endoscopy
(processor, digital capture, monitor, printer, cart)'' equipment item
(ES031), which we are proposing to re-price as part of this separate
pricing approach. We obtained current pricing invoices for the
endoscopy video system as part of our investigation of these issues
involving scopes, which we are proposing to use for this re-pricing. We
understand that there may be other accessories associated with the use
of scopes; we are proposing to separately price any scope accessories,
and individually evaluate their inclusion or exclusion as direct PE
inputs for particular codes as usual under our current policy based on
whether they are typically used in furnishing the services described by
the particular codes.
We are also proposing standardizing refinements to the way scopes
have been defined in the direct PE input database. We believe that
there are four general types of scopes: Non-video scopes; flexible
scopes; semi-rigid scopes, and rigid scopes. Flexible scopes, semi-
rigid scopes, and rigid scopes would typically be paired with one of
the video scope systems, while the non-video scopes would not. The
flexible scopes can be further divided into diagnostic (or non-
channeled) and therapeutic (or channeled) scopes. We are proposing to
identify for each anatomical application: (1) A rigid scope; (2) a
semi-rigid scope; (3) a non-video flexible scope; (4) a non-channeled
flexible video scope; and (5) a channeled flexible video scope. We are
proposing to classify the existing scopes in our direct PE database
under this classification system, to improve the transparency of our
review process and improve appropriate relativity among the services.
We plan to propose input prices for these equipment items through
future rulemaking.
We have proposed these changes only for the reviewed codes that
make use of scopes; this applies to the codes in the Flexible
Laryngoscopy family (CPT codes 31575, 31576, 31577, 31578, 315X1,
315X2, 315X3, 31579) (see section II.L) and the Laryngoplasty family
(CPT codes 31580, 31584, 31587, 315Y1, 315Y2, 315Y3, 315Y4, 315Y5,
315Y6) (see section II.L) along with updated prices for the equipment
items related to scopes utilized by these services. We are also
soliciting comment on this separate pricing structure for scopes, scope
video systems, and scope accessories, which we could consider proposing
to apply to other PFS codes in future rulemaking.
(4) Technical Corrections to Direct PE Input Database
Subsequent to the publication of the CY 2016 PFS final rule with
comment period, stakeholders alerted us to several clerical
inconsistencies in the direct PE database. We propose to correct these
inconsistencies as described below and reflected in the CY 2017 direct
PE input database displayed on our Web site under downloads for the CY
2017 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
For CY 2017, we are proposing the following technical corrections:
For CPT codes 72081-72084, a stakeholder informed us that
the equipment time for the PACS workstation (ED050) should be equal to
the clinical labor during the service period; the equipment time
formula we used for these codes for CY 2016 erroneously included 4
minutes of preservice clinical labor. We agree with the stakeholder
that the PACS workstation should use the standard equipment time
formula for a PACS workstation for these codes. As a result, we are
proposing to refine the ED050 equipment time to 21 minutes for CPT code
72081, 36 minutes for CPT code 72082, 44 minutes for CPT code 72083,
and 53 minutes for CPT code 72084 to reflect the clinical labor time
associated with these codes. This same commenter also indicated that a
number of clinical labor activities had been entered in the database in
the incorrect service period for CPT codes 37215, 50432, 50694, and
72081. These clinical labor activities were incorrectly listed in the
``postservice'' period instead of the ``service post'' period. We are
proposing to make these technical corrections as well so that the
minutes are assigned to the appropriate service period within the
direct PE input database.
Another stakeholder alerted us that Ileoscopy codes 44380,
44381 and 44382 did not include the direct PE input equipment item
called the Gomco suction machine (EQ235) and indicated that this
omission appeared to be inadvertent. We agree that it was. We have
included the item EQ235 in the proposed direct PE input database for
CPT code 44380 at a time of 29 minutes, for CPT code 44381 at a time of
39 minutes, and to CPT code 44382 at a time of 34 minutes.
The PE RVUs displayed in Addendum B on our Web site were calculated
with the inputs displayed in the CY 2017 direct PE input database.
(5) Restoration of Inputs
Several of the PE worksheets included in the RUC recommendations
for CY 2016 contained time for the equipment item ``xenon light
source'' (EQ167). Because there appeared to be two special light
sources already present (the fiberoptic headlight and the endoscope
itself) in the services for which this equipment item was recommended
by the RUC, we believed that the use of only one of these light sources
would be typical and removed the xenon light equipment time. In the CY
2016 PFS final rule with comment period, we restored the xenon light
(EQ167) and removed the fiberoptic headlight (EQ170) with the same
number of equipment minutes for CPT codes 30300, 31295, 31296, 31297,
and 92511.
We received comments expressing approval for the restoration of the
xenon light. However, the commenters also stated that the two light
sources were not duplicative, but rather, both a headlight and a xenon
light source are required concurrently for otolaryngology procedures
when scopes are utilized. The commenters requested that the fiberoptic
headlight be restored to these codes.
We agree with the commenters that the use of both light sources
would be typical for these procedures. We are therefore proposing to
add the fiberoptic headlight (EQ170) to CPT codes 30300,
[[Page 46178]]
31295, 31296, 31297, and 92511 at the same number of equipment minutes
as the xenon light (EQ167).
(6) Updates to Prices for Existing Direct PE Inputs
In the CY 2011 PFS final rule with comment period (75 FR 73205), we
finalized a process to act on public requests to update equipment and
supply price and equipment useful life inputs through annual rulemaking
beginning with the CY 2012 PFS proposed rule. For CY 2017, we are
proposing the following price updates for existing direct PE inputs:
Several commenters wrote to discuss the price of the Antibody
Estrogen Receptor monoclonal (SL493). We received information including
three invoices with new pricing information regarding the SL493 supply.
We are proposing to use this information to propose for the supply item
SL493 a price of $14.00 per test, which is the average price based on
the invoices that we received in total for the item.
We are also proposing to update the price for two supplies in
response to the submission of new invoices. The proposed price for
``antigen, venom'' supply (SH009) reflects an increase from $16.67 to
$20.14 per milliliter, and the proposed price for ``antigen, venom,
tri-vespid'' supply (SH010) reflects an increase from $30.22 to $44.05
per milliliter.
We routinely accept public submission of invoices as part of our
process for developing payment rates for new, revised, and potentially
misvalued codes. Often these invoices are submitted in conjunction with
the RUC recommended values for the codes. For CY 2017, we note that
some stakeholders have submitted invoices for new, revised, or
potentially misvalued codes since the February deadline established for
code valuation recommendations. To be included a given year's proposed
rule, we generally need to receive invoices by the same February
deadline. Of course, we will consider invoices submitted as public
comments during the comment period following the publication of the
proposed rule, and will consider any invoices received after February
and/or outside of the public comment process as part of our established
annual process for requests to update supply and equipment prices.
B. Determination of Malpractice Relative Value Units (RVUs)
1. Overview
Section 1848(c) of the Act requires that each service paid under
the PFS be composed of three components: Work, PE, and malpractice
expense (MP). As required by section 1848(c)(2)(C)(iii) of the Act,
beginning in CY 2000, MP RVUs are resource based. Malpractice RVUs for
new codes after 1991 were extrapolated from similar existing codes or
as a percentage of the corresponding work RVU. Section 1848(c)(2)(B)(i)
of the Act also requires that we review, and if necessary adjust, RVUs
no less often than every 5 years. In the CY 2015 PFS final rule with
comment period, we implemented the third review and update of MP RVUs.
For a comprehensive discussion of the third review and update of MP
RVUs see the CY 2015 proposed rule (79 FR 40349 through 40355) and
final rule with comment period (79 FR 67591 through 67596).
To determine MP RVUs for individual PFS services, our MP
methodology uses three primary kinds of data: Specialty-level risk
factors based on the collection of specialty-specific MP premium data
that represent the actual expense incurred by practitioners to obtain
MP insurance; Medicare claims data to determine service level risk
factors based on a weighted average risk factors of the specialties
that furnish each service, and the higher of the work RVU or clinical
labor RVU to adjust the service level risk factor for the intensity and
complexity of the service. Prior to CY 2016, MP RVUs were only updated
once every 5 years, except in the case of new and revised codes.
As explained in the CY 2011 PFS final rule with comment period (75
FR 73208), MP RVUs for new and revised codes effective before the next
5-year review of MP RVUs were determined either by a direct crosswalk
from a similar source code or by a modified crosswalk to account for
differences in work RVUs between the new/revised code and the source
code. For the modified crosswalk approach, we adjust (or scale) the MP
RVU for the new/revised code to reflect the difference in work RVU
between the source code and the new/revised work RVU (or, if greater,
the difference in the clinical labor portion of the fully implemented
PE RVU) for the new code. For example, if the proposed work RVU for a
revised code were 10 percent higher than the work RVU for its source
code, the MP RVU for the revised code would be increased by 10 percent
over the source code MP RVU. Under this approach the same risk factor
is applied for the new/revised code and source code, but the work RVU
for the new/revised code is used to adjust the MP RVUs for risk.
In the CY 2016 PFS final rule with comment period (80 FR 70906
through 70910), we finalized a policy to begin conducting annual MP RVU
updates to reflect changes in the mix of practitioners providing
services (using Medicare claims data), and to adjust MP RVUs for risk
for intensity and complexity (using the work RVU or clinical labor
RVU). We also finalized a policy to modify the specialty mix assignment
methodology (for both MP and PE RVU calculations) to use an average of
the 3 most recent years of data instead of a single year of data. We
stated that under this approach, the specialty-specific risk factors
would continue to be updated through notice and comment rulemaking
every 5 years using updated premium data, but would remain unchanged
between the 5-year reviews.
For CY 2016, we did not propose to discontinue our current approach
for determining MP RVUs for new/revised codes. For the new and revised
codes for which we proposed work RVUs and PE inputs, we also published
the proposed MP crosswalks used to determine their MP RVUs. We address
comments regarding valuation of new and revised codes in section II.L
of this proposed rule, which makes clear the codes with interim final
values for CY 2016 have newly proposed values for CY 2017, all of which
are again open for comment. The MP crosswalks for new and revised codes
with interim final values were established in the CY 2016 PFS final
rule with comment period; we will respond to comments regarding these
interim final values in the CY 2017 PFS final rule.
2. Updating Specialty Specific Risk Factors
The proposed CY 2017 GPCI update (eighth update), discussed in
section II.E of this proposed rule, reflects updated MP premium data,
collected for the purpose of proposing updates to the MP GPCIs. While
we could use the updated MP premium data obtained for the purposes of
the proposed eighth GPCI update to propose updates to the specialty
risk factors used in the calculation of MP RVUs, this would not be
consistent with the policy we previously finalized in the CY 2016 PFS
final rule with comment period. In that rule, we indicated that the
specialty-specific risk factors would continue to be updated through
notice and comment rulemaking every 5 years using updated premium data,
but would remain unchanged between the 5-year reviews. Additionally,
consistent with the statutory requirement at section 1848(e)(1)(C) of
the Act, only \1/2\ of the adjustment to MP GPCIs would be applied for
CY 2017 based on the new
[[Page 46179]]
MP premium data. As such, we do not think it would be appropriate to
propose to update the specialty risk factors for CY 2017 based on the
updated MP premium data that is reflected in the proposed CY 2017 GPCI
update. Therefore, we are not currently proposing to update the
specialty-risk factors based on the new premium data collected for the
purposes of the 3-year GPCI update for CY 2017 at this time. However,
we seek comment on whether we should consider doing so, perhaps as
early as for 2018, prior to the fourth review and update of MP RVUs
that must occur no later than CY 2020.
C. Medicare Telehealth Services
1. Billing and Payment for Telehealth Services
Several conditions must be met for Medicare to make payments for
telehealth services under the PFS. The service must be on the list of
Medicare telehealth services and meet all of the following additional
requirements:
The service must be furnished via an interactive
telecommunications system.
The service must be furnished by a physician or other
authorized practitioner.
The service must be furnished to an eligible telehealth
individual.
The individual receiving the service must be located in a
telehealth originating site.
When all of these conditions are met, Medicare pays a facility fee
to the originating site and makes a separate payment to the distant
site practitioner furnishing the service.
Section 1834(m)(4)(F)(i) of the Act defines Medicare telehealth
services to include consultations, office visits, office psychiatry
services, and any additional service specified by the Secretary, when
furnished via a telecommunications system. We first implemented this
statutory provision, which was effective October 1, 2001, in the CY
2002 PFS final rule with comment period (66 FR 55246). We established a
process for annual updates to the list of Medicare telehealth services
as required by section 1834(m)(4)(F)(ii) of the Act in the CY 2003 PFS
final rule with comment period (67 FR 79988).
As specified at Sec. 410.78(b), we generally require that a
telehealth service be furnished via an interactive telecommunications
system. Under Sec. 410.78(a)(3), an interactive telecommunications
system is defined as multimedia communications equipment that includes,
at a minimum, audio and video equipment permitting two-way, real-time
interactive communication between the patient and distant site
physician or practitioner.
Telephones, facsimile machines, and stand-alone electronic mail
systems do not meet the definition of an interactive telecommunications
system. An interactive telecommunications system is generally required
as a condition of payment; however, section 1834(m)(1) of the Act
allows the use of asynchronous ``store-and-forward'' technology when
the originating site is part of a federal telemedicine demonstration
program in Alaska or Hawaii. As specified in Sec. 410.78(a)(1),
asynchronous store-and-forward is the transmission of medical
information from an originating site for review by the distant site
physician or practitioner at a later time.
Medicare telehealth services may be furnished to an eligible
telehealth individual notwithstanding the fact that the practitioner
furnishing the telehealth service is not at the same location as the
beneficiary. An eligible telehealth individual is an individual
enrolled under Part B who receives a telehealth service furnished at a
telehealth originating site.
Practitioners furnishing Medicare telehealth services are reminded
that these services are subject to the same non-discrimination laws as
other services, including the effective communication requirements for
persons with disabilities of section 504 of the Rehabilitation Act and
language access for persons with limited English proficiency, as
required under Title VI of the Civil Rights Act of 1964. For more
information, see 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 Office of Federal Rural Health
Policy (FORHP) of the Health Resources and Services Administration
(HRSA) (78 FR 74811). Defining ``rural'' to include geographic areas
located in rural census tracts within MSAs allows for broader inclusion
of sites within HPSAs as telehealth originating sites. Adopting the
more precise definition of ``rural'' for this purpose expands access to
health care services for Medicare beneficiaries located in rural areas.
HRSA has developed a Web site tool to provide assistance to potential
originating sites to determine their geographic status. To access this
tool, see the CMS Web site at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
An entity participating in a federal telemedicine demonstration
project that has been approved by, or received funding from, the
Secretary as of December 31, 2000 is eligible to be an originating site
regardless of its geographic location.
Effective January 1, 2014, we also changed our policy so that
geographic status for an originating site would be established and
maintained on an annual basis, consistent with other telehealth payment
policies (78 FR 74400). Geographic status for Medicare telehealth
originating sites for each calendar year is now based upon the status
of the area as of December 31 of the prior calendar year.
For a detailed history of telehealth payment policy, see 78 FR
74399.
2. Adding Services to the List of Medicare Telehealth Services
As noted previously, in the December 31, 2002 Federal Register (67
FR 79988), we established a process for adding services to or deleting
services from the list of Medicare telehealth services. This process
provides the public with an ongoing opportunity to submit requests for
adding services. Under this process, we assign any qualifying request
to make additions to the list of telehealth services to one of two
categories. Revisions to criteria that
[[Page 46180]]
we use to review requests in the second category were finalized in the
November 28, 2011 Federal Register (76 FR 73102). The two categories
are:
Category 1: Services that are similar to professional
consultations, office visits, and office psychiatry services that are
currently on the list of telehealth services. In reviewing these
requests, we look for similarities between the requested and existing
telehealth services for the roles of, and interactions among, the
beneficiary, the physician (or other practitioner) at the distant site
and, if necessary, the telepresenter, a practitioner who is present
with the beneficiary in the originating site. We also look for
similarities in the telecommunications system used to deliver the
proposed service; for example, the use of interactive audio and video
equipment.
Category 2: Services that are not similar to the current
list of telehealth services. Our review of these requests includes an
assessment of whether the service is accurately described by the
corresponding code when furnished via telehealth and whether the use of
a telecommunications system to deliver the service produces
demonstrated clinical benefit to the patient. Submitted evidence should
include both a description of relevant clinical studies that
demonstrate the service furnished by telehealth to a Medicare
beneficiary improves the diagnosis or treatment of an illness or injury
or improves the functioning of a malformed body part, including dates
and findings, and a list and copies of published peer reviewed articles
relevant to the service when furnished via telehealth. Our evidentiary
standard of clinical benefit does not include minor or incidental
benefits.
Some examples of clinical benefit include the following:
Ability to diagnose a medical condition in a patient
population without access to clinically appropriate in-person
diagnostic services.
Treatment option for a patient population without access
to clinically appropriate in-person treatment options.
Reduced rate of complications.
Decreased rate of subsequent diagnostic or therapeutic
interventions (for example, due to reduced rate of recurrence of the
disease process).
Decreased number of future hospitalizations or physician
visits.
More rapid beneficial resolution of the disease process
treatment.
Decreased pain, bleeding, or other quantifiable symptom.
Reduced recovery time.
For the list of telehealth services, see the CMS Web site at
https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/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 proposals for
additions to the CY 2017 telehealth list. Of the requests received, we
found that four services were sufficiently similar to ESRD-related
services currently on the telehealth list to qualify on a category 1
basis. Therefore, we propose to add the following services to the
telehealth list on a category 1 basis for CY 2017:
CPT codes 90967 (End-stage renal disease (ESRD) related
services for dialysis less than a full month of service, per day; for
patients younger than 2 years of age; 90968 (End-stage renal disease
(ESRD) related services for dialysis less than a full month of service,
per day; for patients 2-11 years of age; 90969 (End-stage renal disease
(ESRD) related services for dialysis less than a full month of service,
per day; for patients 12-19 years of age); and 90970 (End-stage renal
disease (ESRD) related services for dialysis less than a full month of
service, per day; for patients 20 years of age and older).
As we indicated in the CY 2015 final rule (80 FR 41783) for the
ESRD-related services (CPT codes 90963-90966) added to the telehealth
list for CY 2016, the required clinical examination of the catheter
access site must be furnished face-to-face ``hands on'' (without the
use of an interactive telecommunications system) by a physician, CNS,
NP, or PA. This requirement also applies to CPT codes 90967-90970.
While we did not receive a specific request, we also propose to add
two advance care planning services to the telehealth list. We have
determined that these services are similar to the annual wellness
visits (HCPCS codes G0438 & G0439) currently on the telehealth list:
CPT codes 99497 (advance care planning including the
explanation and discussion of advance directives such as standard forms
(with completion of such forms, when performed), by the physician or
other qualified health care professional; first 30 minutes, face-to-
face with the patient, family member(s), or surrogate); and 99498
(advance care planning including the explanation and discussion of
advance directives such as standard forms (with completion of such
forms, when performed), by the physician or other qualified health care
professional; each additional 30 minutes (list separately in addition
to code for primary procedure)).
We also received requests to add services to the telehealth list
that do not meet our criteria for Medicare telehealth services. We are
not proposing to add the following procedures for the reasons noted:
a. Observation Care: CPT codes--
99217 (observation care discharge day management (this
code is to be utilized to report all services provided to a patient on
discharge from ``observation status'' if the discharge is on other than
the initial date of ``observation status.'' To report services to a
patient designated as ``observation status'' or ``inpatient status''
and discharged on the same date, use the codes for observation or
inpatient care services [including admission and discharge services,
99234-99236 as appropriate.]));
99218 (initial observation care, per day, for the
evaluation and management
[[Page 46181]]
of a patient which requires these three key components: A detailed or
comprehensive history; a detailed or comprehensive examination; and
medical decision making that is straightforward or of low complexity.
Counseling and coordination of care with other physicians, other
qualified health care professionals, or agencies are provided
consistent with the nature of the problem(s) and the patient's and
family's needs. Usually, the problem(s) requiring admission to
``observation status'' are of low severity. Typically, 30 minutes are
spent at the bedside and on the patient's hospital floor or unit);
99219 (initial observation care, per day, for the
evaluation and management of a patient, which requires these three key
components: A comprehensive history; a comprehensive examination; and
medical decision making of moderate complexity. Counseling and
coordination of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and family's needs. Usually, the
problem(s) requiring admission to ``observation status'' are of
moderate severity. Typically, 50 minutes are spent at the bedside and
on the patient's hospital floor or unit);
99220 (initial observation care, per day, for the
evaluation and management of a patient, which requires these three key
components: A comprehensive history; a comprehensive examination; and
medical decision making of high complexity. Counseling and coordination
of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and family's needs. Usually, the
problem(s) requiring admission to ``observation status'' are of high
severity. Typically, 70 minutes are spent at the bedside and on the
patient's hospital floor or unit);
99224 (subsequent observation care, per day, for the
evaluation and management of a patient, which requires at least two of
these three key components: Problem focused interval history; problem
focused examination; medical decision making that is straightforward or
of low complexity. Counseling and coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and family's needs. Usually, the patient is stable, recovering, or
improving. Typically, 15 minutes are spent at the bedside and on the
patient's hospital floor or unit);
99225 (subsequent observation care, per day, for the
evaluation and management of a patient, which requires at least two of
these three key components: An expanded problem focused interval
history; an expanded problem focused examination; medical decision
making of moderate complexity. Counseling and coordination of care with
other physicians, other qualified health care professionals, or
agencies are provided consistent with the nature of the problem(s) and
the patient's and family's needs. Usually, the patient is responding
inadequately to therapy or has developed a minor complication.
Typically, 25 minutes are spent at the bedside and on the patient's
hospital floor or unit);
99226 (subsequent observation care, per day, for the
evaluation and management of a patient, which requires at least two of
these three key components: A detailed interval history; a detailed
examination; medical decision making of high complexity. Counseling and
coordination of care with other physicians, other qualified health care
professionals, or agencies are provided consistent with the nature of
the problem(s) and the patient's and family's needs. Usually, the
patient is unstable or has developed a significant complication or a
significant new problem. Typically, 35 minutes are spent at the bedside
and on the patient's hospital floor or unit);
99234 (observation or inpatient hospital care, for the
evaluation and management of a patient including admission and
discharge on the same date, which requires these three key components:
A detailed or comprehensive history; a detailed or comprehensive
examination; and medical decision making that is straightforward or of
low complexity. Counseling and coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and family's needs. Usually the presenting problem(s) requiring
admission are of low severity. Typically, 40 minutes are spent at the
bedside and on the patient's hospital floor or unit);
99235 (observation or inpatient hospital care, for the
evaluation and management of a patient including admission and
discharge on the same date, which requires these three key components:
A comprehensive history; a comprehensive examination; and medical
decision making of moderate complexity. Counseling and coordination of
care with other physicians, other qualified health care professionals,
or agencies are provided consistent with the nature of the problem(s)
and the patient's and family's needs. Usually the presenting problem(s)
requiring admission are of moderate severity. Typically, 50 minutes are
spent at the bedside and on the patient's hospital floor or unit);
99236 (observation or inpatient hospital care, for the
evaluation and management of a patient including admission and
discharge on the same date, which requires these three key components:
A comprehensive history; a comprehensive examination; and medical
decision making of high complexity. Counseling and coordination of care
with other physicians, other qualified health care professionals, or
agencies are provided consistent with the nature of the problem(s) and
the patient's and family's needs. Usually the presenting problem(s)
requiring admission are of high severity. Typically, 55 minutes are
spent at the bedside and on the patient's hospital floor or unit);
The request to add these observation services referenced various
studies supporting the use of observation units. The studies indicated
that observation units provide safe, cost effective care to patients
that need ongoing evaluation and treatment beyond the emergency
department visit by having reduced hospital admissions, shorter lengths
of stay, increased safety and reduced cost. Additional studies cited
indicated that observation units reduce the work load on emergency
department physicians, and reduce emergency department overcrowding.
In the CY 2005 PFS proposed rule (69 FR 47510), we considered a
request but did not propose to add the observation CPT codes 99217-
99220 to the list of Medicare telehealth services on a category two
basis for the reasons described in that rule. The most recent request
did not include any information that would cause us to question the
previous evaluation under the category one criterion, which has not
changed, regarding the significant differences in patient acuity
between these services and services on the telehealth list. (69 FR
66277) While the request included evidence of the general benefits of
observation units, it did not include specific information
demonstrating that the services described by these codes provided
clinical benefit when furnished via telehealth, which is necessary for
us to consider these codes on a category two basis. Therefore, we are
not proposing to add these services to the list of approved telehealth
services.
[[Page 46182]]
b. Emergency Department Visits: CPT Codes--
99281 (emergency department visit for the evaluation and
management of a patient, which requires these three key components: A
problem focused history; a problem focused examination; and
straightforward medical decision making. Counseling and coordination of
care with other physicians, other qualified health care professionals,
or agencies are provided consistent with the nature of the problem(s)
and the patient's and family's needs. Usually, the presenting
problem(s) are self-limited or minor);
99282 (emergency department visit for the evaluation and
management of a patient, which requires these three key components: An
expanded problem focused history; an expanded problem focused
examination; and medical decision making of low complexity. Counseling
and coordination of care with other physicians, other qualified health
care professionals, or agencies are provided consistent with the nature
of the problem(s) and the patient's and family's needs. Usually, the
presenting problem(s) are of low to moderate severity);
99283 (emergency department visit for the evaluation and
management of a patient, which requires these three key components: An
expanded problem focused history; an expanded problem focused
examination; and medical decision making of moderate complexity.
Counseling and coordination of care with other physicians, other
qualified health care professionals, or agencies are provided
consistent with the nature of the problem(s) and the patient's and
family's needs. Usually, the presenting problem(s) are of moderate
severity);
99284 (emergency department visit for the evaluation and
management of a patient, which requires these three key components: A
detailed history; a detailed examination; and medical decision making
of moderate complexity. Counseling and coordination of care with other
physicians, other qualified health care professionals, or agencies are
provided consistent with the nature of the problem(s) and the patient's
and family's needs. Usually, the presenting problem(s) are of high
severity, and require urgent evaluation by the physician, or other
qualified health care professionals but do not pose an immediate
significant threat to life or physiologic function); and
99285 (emergency department visit for the evaluation and
management of a patient, which requires these three key components
within the constraints imposed by the urgency of the patient's clinical
condition and mental status: A comprehensive history; a comprehensive
examination; and medical decision making of high complexity. Counseling
and coordination of care with other physicians, other qualified health
care professionals, or agencies are provided consistent with the nature
of the problem(s) and the patient's and family's needs. Usually, the
presenting problem(s) are of high severity and pose an immediate
significant threat to life or physiologic function).
In the CY 2005 PFS proposed rule (69 FR 47510), we considered a
request but did not propose to add the emergency department visit CPT
codes 99281-99285 to the list of Medicare telehealth services for the
reasons described in that rule.
The current request to add the emergency department E/M services
stated that the codes are similar to outpatient visit codes (CPT codes
99201-99215) that have been on the telehealth list since CY 2002. As we
noted in the CY 2005 PFS final rule, while the acuity of some patients
in the emergency department might be the same as in a physician's
office; we believe that, in general, more acutely ill patients are more
likely to be seen in the emergency department, and that difference is
part of the reason there are separate codes describing evaluation and
management visits in the Emergency Department setting. The practice of
emergency medicine often requires frequent and fast-paced patient
reassessments, rapid physician interventions, and sometimes the
continuous physician interaction with ancillary staff and consultants.
This work is distinctly different from the pace, intensity, and acuity
associated with visits that occur in the office or outpatient setting.
Therefore, we are not proposing to add these services to the list of
approved telehealth services on a category one basis.
The requester did not provide any studies supporting the clinical
benefit of managing emergency department patients with telehealth which
is necessary for us to consider these codes on a category two basis.
Therefore, we are not proposing to add these services to the list of
approved telehealth services on a category two basis.
Many requesters of additions to the telehealth list urged us to
consider the potential value of telehealth for providing beneficiaries
access to needed expertise. We note that if clinical guidance or advice
is needed in the emergency department setting, a consultation may be
requested from an appropriate source, including consultations that are
currently included on the list of telehealth services.
c. Critical Care Evaluation and Management: CPT Codes--
99291 (critical care, evaluation and management of the
critically ill or critically injured patient; first 30-74 minutes); and
99292 (critical care, evaluation and management of the critically ill
or critically injured patient; each additional 30 minutes (list
separately in addition to code for primary service).
We previously considered and rejected adding these codes to the
list of Medicare telehealth services in the CY 2009 PFS final rule (74
FR 69744) on a category 1 basis because, due to the acuity of
critically ill patients, we did not believe critical care services are
similar to any services on the current list of Medicare telehealth
services. In that rule, we said that critical care services must be
evaluated as category 2 services. Because we considered critical care
services under category 2, we needed to evaluate whether these are
services for which telehealth can be an adequate substitute for a face-
to-face encounter, based on the category 2 criteria at the time of that
request. We had no evidence suggesting that the use of telehealth could
be a reasonable surrogate for the face-to-face delivery of this type of
care.
The American Telemedicine Association (ATA) submitted a new request
for CY 2016 that cited several studies to support adding these services
on a category 2 basis. To qualify under category 2, we would need
evidence that the service furnished via telehealth is still described
accurately by the requested code and produces a clinical benefit for
the patient via telehealth. However, in reviewing the information
provided by the ATA and a study titled, ``Impact of an Intensive Care
Unit Telemedicine Program on Patient Outcomes in an Integrated Health
Care System,'' published July 2014 in JAMA Internal Medicine, which
found no evidence that the implementation of ICU telemedicine
significantly reduced mortality rates or hospital length of stay, which
could be indicators of clinical benefit. Therefore, we stated that we
do not believe that the submitted evidence demonstrates a clinical
benefit to patients. Therefore, we did not propose to add these
services on a category 2 basis to the list of Medicare telehealth
services for CY 2016 (80 FR 71061).
This year, requesters cited additional studies to support adding
critical care
[[Page 46183]]
services on a category 2 basis. Eight of the studies dealt with
telestroke and one with teleneurology. Telestroke is an approach that
allows a neurologist to provide remote treatment to vascular stroke
victims. Teleneurology offers consultations for neurological problems
from a remote location. It may be initiated by a physician or a
patient, for conditions such as headaches, dementia, strokes, multiple
sclerosis and epilepsy.
However, according to the literature, the management of stroke via
telehealth requires more than a single practitioner and is distinct
from the work described by the E/M codes. One additional study cited
involved pediatric patients, while another noted that the Department of
Defense has used telehealth to provide critical care services to
hospitals in Guam for many years. Another reference study indicated
that consulting intensivists thought that telemedicine consultations
were superior to telephone consultations. In all of these cases, we
believe the evidence demonstrates that interaction between these
patients and distant site practitioners can have clinical benefit.
However, we do not agree that the kinds of services described in the
study are those that are included in the critical care E/M codes. We
note that CPT guidance makes clear that a variety of other services are
bundled into the payment rates for critical care, including gastric
intubations and vascular access procedures among others We do not
believe these kinds of services are furnished via telehealth. Public
comments, included cited studies, can be viewed at https://www.regulations.gov/#!documentDetail;D=CMS-2015-0081-0002. Therefore,
we are not proposing to add these services to the list of Medicare
telehealth services for CY 2017.
However, we are persuaded by the requests that we recognize the
potential benefit of critical care consultation services that are
furnished remotely. We note that there are currently codes on the
telehealth list that could be reported when consultation services are
furnished to critically ill patients. But in consideration of these
public requests, we recognize that there may be greater resource costs
involved in furnishing these services relative to the existing
telehealth consultation codes. We also agree with the requesters that
there may be potential benefits of remote care by specialists for these
patients. For these reasons, we think it would be advisable to create a
coding distinction between telehealth consultations for critically ill
patients relative to telehealth consultations for other hospital
patients. Such a coding distinction would allow us to recognize the
additional resource costs in terms of time and intensity involved in
furnishing such services under the conditions where remote, intensive
consultation is required to provide access to appropriate care for the
critically ill patient. We recognize that the current set of codes may
not adequately describe such services because current E/M coding
presumes that the services are occurring in-person, in which case the
expert care would be furnished in a manner described by the current
codes for critical care.
Therefore, we are proposing to make payment through new codes,
initial and subsequent, used to describe critical care consultations
furnished via telehealth. This coding would provide a mechanism to
report an intensive telehealth consultation service, initial or
subsequent, for the critically ill patient under the circumstance when
a qualified health care professional has in-person responsibility for
the patient but the patient benefits from additional services from a
distant-site consultant specially trained in providing critical care
services. We propose limiting these services to once per day per
patient. Like the other telehealth consultations, these services would
be valued relative to existing E/M services (see Section II.L.2.b for
proposed code valuations).
More details on the new coding (GTTT1 and GTTT2) and proposed
valuation for these services are discussed in section II.L. of this
proposed rule and the proposed RVUs for this service are included in
Addendum B of this proposed rule. Like the other telehealth
consultation codes, we are proposing that these services would be added
to the telehealth list and would be subject to the geographic and other
statutory restrictions that apply to telehealth services.
We request comment on this proposal, specifically as to whether the
use of new coding would create a helpful distinction between telehealth
consultations for critically ill patients relative to telehealth
consultations for other hospital patients. We are also specifically
interested in comments on how these services would be distinguished
from existing critical care services and examples of different
scenarios when each code would be appropriate. Such comments will help
us to refine provider communication materials.
d. Psychological Testing: CPT Codes--
96101 (psychological testing (includes psychodiagnostic
assessment of emotionality, intellectual abilities, personality and
psychopathology, e.g., MMPI, Rorschach, WAIS), per hour of the
psychologist's or physician's time, both face-to-face time
administering tests to the patient and time interpreting these test
results and preparing the report);
96102 psychological testing (includes psychodiagnostic
assessment of emotionality, intellectual abilities, personality and
psychopathology, e.g., MMPI and WAIS), with qualified health care
professional interpretation and report, administered by technician, per
hour of technician time, face-to-face);
96118 Neuropsychological testing (e.g., Halstead-Reitan
neuropsychological battery, Wechsler memory scales and Wisconsin card
sorting test), per hour of the psychologist's or physician's time, both
face-to-face time administering tests to the patient and time
interpreting these test results and preparing the report); and,
96119 Neuropsychological testing (e.g., Halstead-Reitan
neuropsychological battery, Wechsler memory scales and Wisconsin card
sorting test), with qualified health care professional interpretation
and report, administered by technician, per hour of technician time,
face-to-face).
Requesters indicated that there is nothing in the Minnesota
Multiphasic Personality Inventory (MMPI), the Rorschach inkblot test,
the Wechsler Adult Intelligence Scale (WAIS), the Halstead-Reitan
Neuropsychological Battery and Allied Procedures, or the Wisconsin Card
Sorting Test (WCST), that cannot be done via telehealth nor is
different than neurological tests done for Parkinson's disease, seizure
medication side effects, gait assessment, nor any of the many
neurological examinations done via telehealth with the approved
outpatient office visit and inpatient visit CPT codes currently on the
telehealth list. As an example, requesters indicated that the MPPI is
administered by a computer, which generates a report that is
interpreted by the clinical psychologist, and that the test requires no
interaction between the clinician and the patient.
We previously considered the request to add these codes to the
Medicare telehealth list in the CY 2015 final rule (79 FR 67600). We
decided not to add these codes, indicating that these services are not
similar to other services on the telehealth list because they require
close observation of how a patient responds. We noted that the
requesters did not submit evidence supporting the clinical benefit of
furnishing these services via telehealth so that we could evaluate them
on a
[[Page 46184]]
category 2 basis. While we acknowledge that requesters believe that
some of these tests require minimal, if any, interaction between the
clinician and patient, we disagree. We continue to believe that
successful completion of the tests listed as examples in these codes
require the clinical psychologist to closely observe the patient's
response, which cannot be performed via telehealth. Some patient
responses, for example, sweating and fine tremors, may be missed when
the patient and examiner are not in the same room. Therefore, we are
not proposing to add these services to the list of Medicare telehealth
services for CY 2017.
e. Physical and Occupational Therapy and Speech-Language Pathology
Services: CPT Codes--
92507 (treatment of speech, language, voice,
communication, and auditory processing disorder; individual); and,
92508 (treatment of speech, language, voice, communication, and
auditory processing disorder; group, 2 or more individuals); 92521
(evaluation of speech fluency (e.g., stuttering, cluttering)); 92522
(evaluation of speech sound production (e.g., articulation,
phonological process, apraxia, dysarthria)); 92523 (evaluation of
speech sound production (e.g., articulation, phonological process,
apraxia, dysarthria); with evaluation of language comprehension and
expression (e.g., receptive and expressive language)); 92524
(behavioral and qualitative analysis of voice and resonance);
(evaluation of oral and pharyngeal swallowing function); 92526
(treatment of swallowing dysfunction or oral function for feeding);
92610 (evaluation of oral and pharyngeal swallowing function); CPT
codes 97001 (physical therapy evaluation); 97002 (physical therapy re-
evaluation); 97003 (occupational therapy evaluation); 97004
(occupational therapy re-evaluation); 97110 (therapeutic procedure, 1
or more areas, each 15 minutes; therapeutic exercises to develop
strength and endurance, range of motion and flexibility); 97112
(therapeutic procedure, 1 or more areas, each 15 minutes; neuromuscular
reeducation of movement, balance, coordination, kinesthetic sense,
posture, or proprioception for sitting or standing activities); 97116
(therapeutic procedure, 1 or more areas, each 15 minutes; gait training
(includes stair climbing)); 97532 (development of cognitive skills to
improve attention, memory, problem solving (includes compensatory
training), direct (one-on-one) patient contact, each 15 minutes); 97533
(sensory integrative techniques to enhance sensory processing and
promote adaptive responses to environmental demands, direct (one-on-
one) patient contact, each 15 minutes); 97535 (self-care/home
management training (e.g., activities of daily living (adl) and
compensatory training, meal preparation, safety procedures, and
instructions in use of assistive technology devices/adaptive equipment)
direct one-on-one contact, each 15 minutes); 97537 (community/work
reintegration training (e.g., shopping, transportation, money
management, avocational activities or work environment/modification
analysis, work task analysis, use of assistive technology device/
adaptive equipment), direct one-on-one contact, each 15 minutes); 97542
(wheelchair management (e.g., assessment, fitting, training), each 15
minutes); 97750 (physical performance test or measurement (e.g.,
musculoskeletal, functional capacity), with written report, each 15
minutes); 97755 (assistive technology assessment (e.g., to restore,
augment or compensate for existing function, optimize functional tasks
and maximize environmental accessibility), direct one-on-one contact,
with written report, each 15 minutes); 97760 Orthotic(s) management and
training (including assessment and fitting when not otherwise
reported), upper extremity(s), lower extremity(s) and/or trunk, each 15
minutes); 97761 (prosthetic training, upper and lower extremity(s),
each 15 minutes); and 97762 (checkout for orthotic/prosthetic use,
established patient, each 15 minutes).
The statute defines who is an authorized practitioner of telehealth
services. Physical therapists, occupational therapists and speech-
language pathologists are not authorized practitioners of telehealth
under section 1834(m)(4)(E) of the Act, as defined in section
1842(b)(18)(C) of the Act. Because the above services are predominantly
furnished by physical therapists, occupational therapists and speech-
language pathologists, we do not believe it would be appropriate to add
them to the list of telehealth services at this time. One requester
suggested that we can add telehealth practitioners without legislation,
as evidenced by the addition of nutritional professionals. However, we
do not believe we have such authority and note that nutritional
professionals are included as practitioners in the definition at
section 1834(b)(18)(C)(vi) of the Act, and thus, are within the
statutory definition of telehealth practitioners. Therefore, we are not
proposing to add these services to the list of Medicare telehealth
services for CY 2017.
In summary, we propose to add the following codes to the list of
Medicare telehealth services beginning in CY 2017 on a category 1
basis:
ESRD-related services 90967 through 90970. The required
clinical examination of the catheter access site must be furnished
face-to-face ``hands on'' (without the use of an interactive
telecommunications system) by a physician, CNS, NP, or PA.
Advance care planning (CPT codes 99497 and 99498).
Telehealth Consultations for a Patient Requiring Critical
Care Services (GTTT1 and GTTT2)
We remind all interested stakeholders that we are currently
soliciting public requests to add services to the list of Medicare
telehealth services. To be considered during PFS rulemaking for CY
2018, these requests must be submitted and received by December 31,
2016. Each request to add a service to the list of Medicare telehealth
services must include any supporting documentation the requester wishes
us to consider as we review the request. For more information on
submitting a request for an addition to the list of Medicare telehealth
services, including where to mail these requests, we refer readers to
the CMS Web site at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
4. Place of Service (POS) Code for Telehealth Services
CMS has received multiple requests from various stakeholders to
establish a POS code to identify services furnished via telehealth.
These requests have come from other payers, but may also be related to
confusion concerning whether to use the POS where the distant site
physician is located or the POS where the patient is located. The
process for establishing POS codes, is managed by the POS Workgroup
within CMS, is available for use by all payers, and is not contingent
upon Medicare PFS rulemaking. However, if such a POS code were to be
created, in order to make it valid for use in Medicare, we would have
to determine the appropriate payment rules associated with the code.
Therefore, we are proposing how a POS code for telehealth would be used
under the PFS with the expectation that, if such a code is available,
it would be used as early as January 1, 2017. We propose that the
physicians or practitioners furnishing telehealth services would be
required to report the telehealth POS code to
[[Page 46185]]
indicate that the billed service is furnished as a telehealth service
from a distant site.
Our proposed requirement for physicians and practitioners to use
the telehealth POS code to report that telehealth services were
furnished from a distant site would improve payment accuracy and
consistency in telehealth claims submission. Currently, for services
furnished via telehealth, we have instructed practitioners to report
the POS code that would have been reported had the service been
furnished in person. However, some practitioners use the POS where they
are located when the service is furnished, while others use the POS
corresponding to the patient's location.
Under the PFS, the POS code determines whether a service is paid
using the facility or non-facility practice expense relative value
units (PE RVUs). The facility rate is paid when a service is furnished
in a location where Medicare is making a separate facility payment to
an entity other than the physician or practitioner that is intended to
reflect the facility costs associated with the service (clinical staff,
supplies and equipment). We note that in accordance with section
1834(m)(2)(B) of the Act, the payment amount for the telehealth
facility fee paid to the originating site is a national fee, paid
without geographic or site of service adjustments that generally are
made for payments to different kinds of Medicare providers and
suppliers. In the case of telehealth services, we believe that facility
costs (clinical staff, supplies, and equipment) associated with the
provision of the service would generally be incurred by the originating
site, where the patient is located, and not by the practitioner at the
distant site. And, by statute, the Medicare pays a fee to the site that
hosts the patient. This is analogous to the circumstances under which
the facility PE RVUs are used to pay for services under the PFS.
Therefore, we are proposing to use the facility PE RVUs to pay for
telehealth services reported by physicians or practitioners with the
telehealth POS code. We note that there are only three codes on the
telehealth list with a difference greater than 1.0 PE RVUs between the
facility PE RVUs and the non-facility PE RVUs. The remainder of the
physician payments for telehealth services would be unchanged by this
proposal. We do not anticipate that this proposal would result in a
significant change in the total payment for the majority of services on
the telehealth list. Moreover, many practitioners already use a
facility POS when billing for telehealth services (those that report
the POS of the originating site where the beneficiary is located). The
proposed policy to use the telehealth POS code for telehealth services
would not affect payment for telehealth services for these
practitioners.
The POS code for telehealth would not apply to originating sites
billing the facility fee. Originating sites are not furnishing a
service via telehealth since the patient is physically present in the
facility. Accordingly, the originating site would continue to use the
POS code that applies to the type of facility where the patient is
located.
We are also proposing a change to our regulation at Sec.
414.22(b)(5)(i)(A) that addresses the PE RVUs used in different
settings. These proposed revisions would improve clarity regarding our
current and proposed policies. Specifically, we are proposing to amend
this section to specify that the facility PE RVUs are paid for
practitioner services furnished via telehealth under Sec. 410.78. In
addition, we are proposing a change to resolve any potential ambiguity
and clarify that payment under the PFS is made at the facility rate
(facility PE RVUs) when services are furnished in a hospital but for
which the hospital is not being paid. Finally, to streamline the
existing regulation, we are also proposing to delete Sec. 414.32 of
our regulation that refers to the calculating of payments for certain
services prior to 2002.
This proposed change is aligned with regulatory changes being
proposed in the ``Medicare Program: Hospital Outpatient Prospective
Payment and Ambulatory Surgical Center Payment Systems and Quality
Reporting Programs; Organ Procurement Organization Reporting and
Communication; Transplant Outcome Measures and Documentation
Requirements; Electronic Health Record (EHR) Incentive Programs;
Payment to Certain Off-Campus Provider-Based Departments'' proposed
rule to implement section 603 of the Bipartisan Budget Act of 2015. In
that proposed rule, we discuss payment rates for services furnished to
patients in off-campus provider-based departments.
D. Potentially Misvalued Services Under the Physician Fee Schedule
1. Background
Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a
periodic review, not less often than every 5 years, of the RVUs
established under the PFS. Section 1848(c)(2)(K) of the Act requires
the Secretary to periodically identify potentially misvalued services
using certain criteria and to review and make appropriate adjustments
to the relative values for those services. Section 1848(c)(2)(L) to the
Act also requires the Secretary to develop a process to validate the
RVUs of certain potentially misvalued codes under the PFS, using the
same criteria used to identify potentially misvalued codes, and to make
appropriate adjustments.
As discussed in section II.B. of this proposed rule, each year we
develop appropriate adjustments to the RVUs taking into account
recommendations provided by the American Medical Association/Specialty
Society Relative Value Scale Update Committee (RUC), the Medicare
Payment Advisory Commission (MedPAC), and others. For many years, the
RUC has provided us with recommendations on the appropriate relative
values for new, revised, and potentially misvalued PFS services. We
review these recommendations on a code-by-code basis and consider these
recommendations in conjunction with analyses of other data, such as
claims data, to inform the decision-making process as authorized by the
law. We may also consider analyses of work time, work RVUs, or direct
PE inputs using other data sources, such as Department of Veteran
Affairs (VA), National Surgical Quality Improvement Program (NSQIP),
the Society for Thoracic Surgeons (STS), and the Physician Quality
Reporting System (PQRS) databases. In addition to considering the most
recently available data, we also assess the results of physician
surveys and specialty recommendations submitted to us by the RUC for
our review. We also consider information provided by other
stakeholders. We conduct a review to assess the appropriate RVUs in the
context of contemporary medical practice. We note that section
1848(c)(2)(A)(ii) of the Act authorizes the use of extrapolation and
other techniques to determine the RVUs for physicians' services for
which specific data are not available and requires us to take into
account the results of consultations with organizations representing
physicians who provide the services. In accordance with section 1848(c)
of the Act, we determine and make appropriate adjustments to the RVUs.
In its March 2006 Report to the Congress (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'
[[Page 46186]]
services, as well as for other health care services that physicians
order, such as hospital services. In that same report MedPAC postulated
that physicians' services under the PFS can become misvalued over time.
MedPAC stated, ``When a new service is added to the physician fee
schedule, it may be assigned a relatively high value because of the
time, technical skill, and psychological stress that are often required
to furnish that service. Over time, the work required for certain
services would be expected to decline as physicians become more
familiar with the service and more efficient in furnishing it.'' We
believe services can also become overvalued when PE declines. This can
happen when the costs of equipment and supplies fall, or when equipment
is used more frequently than is estimated in the PE methodology,
reducing its cost per use. Likewise, services can become undervalued
when physician work increases or PE rises.
As MedPAC noted in its March 2009 Report to Congress (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 any RVU with the periodic review described
in section 1848(c)(2)(B) of the Act. Section 1848(c)(2)(K)(iii)(V) of
the Act specifies that the Secretary may make appropriate coding
revisions (including using existing processes for consideration of
coding changes) that may include consolidation of individual services
into bundled codes for payment under the physician fee schedule.
2. Progress in Identifying and Reviewing Potentially Misvalued Codes
To fulfill our statutory mandate, we have identified and reviewed
numerous potentially misvalued codes as specified in section
1848(c)(2)(K)(ii) of the Act, and we plan to continue our work
examining potentially misvalued codes in these areas over the upcoming
years. As part of our current process, we identify potentially
misvalued codes for review, and request recommendations from the RUC
and other public commenters on revised work RVUs and direct PE inputs
for those codes. The RUC, through its own processes, also identifies
potentially misvalued codes for review. Through our public nomination
process for potentially misvalued codes established in the CY 2012 PFS
final rule with comment period, other individuals and stakeholder
groups submit nominations for review of potentially misvalued codes as
well.
Since CY 2009, as a part of the annual potentially misvalued code
review and Five-Year Review process, we have reviewed over 1,671
potentially misvalued codes to refine work RVUs and direct PE inputs.
We have assigned appropriate work RVUs and direct PE inputs for these
services as a result of these reviews. A more detailed discussion of
the extensive prior reviews of potentially misvalued codes is included
in the CY 2012 PFS final rule with comment period (76 FR 73052 through
73055). In the CY 2012 PFS final rule with comment period, we finalized
our policy to consolidate the review of physician work and PE at the
same time (76 FR 73055 through 73958), and established a process for
the annual public nomination of potentially misvalued services.
In the CY 2013 PFS final rule with comment period, we built upon
the work we began in CY 2009 to review potentially misvalued codes that
have not been reviewed since the implementation of the PFS (so-called
``Harvard-valued codes''). In CY 2009, we requested recommendations
from the RUC to aid in our review of Harvard-valued codes that had not
yet been reviewed, focusing first on high-volume, low intensity codes
(73 FR 38589). In the fourth Five-Year Review (76 FR 32410), we
requested recommendations from the RUC to aid in our review of Harvard-
valued codes with annual utilization of greater than 30,000. In the CY
2013 PFS final rule with comment period, we identified specific
Harvard-valued services with annual allowed charges that total at least
$10,000,000 as potentially misvalued. In addition to the Harvard-valued
codes, in the CY 2013 PFS final rule with comment period we finalized
for review a list of potentially misvalued codes that have stand-alone
PE (codes with physician work and no listed work time and codes with no
physician work that have listed work time).
In the CY 2016 PFS final rule with comment period, we finalized for
review a list of potentially misvalued services, which included eight
codes in the neurostimulators analysis-programming family (CPT 95970-
95982). We also finalized as potentially misvalued 103 codes identified
through
[[Page 46187]]
our screen of high expenditure services across specialties.
3. Validating RVUs of Potentially Misvalued Codes
Section 1848(c)(2)(L) of the Act requires the Secretary to
establish a formal process to validate RVUs under the PFS. The Act
specifies that the validation process may include validation of work
elements (such as time, mental effort and professional judgment,
technical skill and physical effort, and stress due to risk) involved
with furnishing a service and may include validation of the pre-, post-
, and intra-service components of work. The Secretary is directed, as
part of the validation, to validate a sampling of the work RVUs of
codes identified through any of the 16 categories of potentially
misvalued codes specified in section 1848(c)(2)(K)(ii) of the Act.
Furthermore, the Secretary may conduct the validation using methods
similar to those used to review potentially misvalued codes, including
conducting surveys, other data collection activities, studies, or other
analyses as the Secretary determines to be appropriate to facilitate
the validation of RVUs of services.
In the CY 2011 PFS proposed rule (75 FR 40068) and CY 2012 PFS
proposed rule (76 FR 42790), we solicited public comments on possible
approaches, methodologies, and data sources that we should consider for
a validation process. A summary of the comments along with our
responses are included in the CY 2011 PFS final rule with comment
period (75 FR 73217) and the CY 2012 PFS final rule with comment period
(73054 through 73055).
We contracted with two outside entities to develop validation
models for RVUs.
Given the central role of time in establishing work RVUs and the
concerns that have been raised about the current time values used in
rate setting, we contracted with the Urban Institute to develop
empirical time estimates based on data collected from several health
systems with multispecialty group practices. The Urban Institute
collected data by directly observing the delivery of services and
through the use of electronic health records for services selected by
the contractor in consultation with CMS and is using this data to
produce objective time estimates. We expect the final Urban Institute
report will be made available on the CMS Web site later this summer.
The second contract is with the RAND Corporation, which used
available data to build a validation model to predict work RVUs and the
individual components of work RVUs, time and intensity. The model
design was informed by the statistical methodologies and approach used
to develop the initial work RVUs and to identify potentially misvalued
procedures under current CMS and RUC processes. RAND consulted with a
technical expert panel on model design issues and the test results. The
RAND report is available under downloads on the Web site for the CY
2015 PFS Final Rule with Comment Period at 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 proposals related to this data
collection requirement are discussed in section II.D.6. Also, the data
from this project would provide information that would allow the time
for these services to be included in the model for validating RVUs.
4. CY 2017 Identification and Review of Potentially Misvalued Services
a. 0-day Global Services That Are Typically Billed With an Evaluation
and Management (E/M) Service With Modifier 25
Because routine E/M is included in the valuation of codes with 0-,
10-, and 90-day global periods, Medicare only makes separate payment
for E/M services that are provided in excess of those considered
included in the global procedure. In such cases, the physician would
report the additional E/M service with Modifier 25, which is defined as
a significant, separately identifiable E/M service performed by the
same physician on the day of a procedure above and beyond other
services provided or beyond the usual preservice and postservice care
associated with the procedure that was performed. Modifier 25 allows
physicians to be paid for E/M services that would otherwise be denied
as bundled.
In reviewing misvalued codes, both CMS and the RUC have often
considered how frequently particular codes are reported with E/M codes
to account for potential overlap in resources. Some stakeholders have
expressed concern with this policy especially with regard to the
valuation of 0-day global services that are typically billed with a
separate E/M service with the use of Modifier 25. For example, when we
established our valuation of the osteopathic manipulation services,
described by CPT codes 98925-98929, we did so with the understanding
that these codes are usually reported with E/M codes.
Medicare claims data for CY 2015 show that 19 percent of the codes
that describe 0-day global services were billed over 50 percent of the
time with an E/M with Modifier 25. Since routine E/M is included in the
valuation of 0-day global services, we believe that the routine billing
of separate E/M services may indicate a possible problem with the
valuation of the bundle, which is intended to include all the routine
care associated with the service.
We believe that reviewing the procedure codes typically billed with
an E/M with Modifier 25 as potentially misvalued may be one avenue to
improve valuation of these services. To develop the CY 2017 proposed
list of potentially misvalued services in this category, we identified
0-day global codes billed with an E/M 50 percent of the time or more,
on the same day of service, with the same physician and same
beneficiary. To prioritize review of these potentially misvalued
services, we are identifying the codes that have not been reviewed in
the last 5 years, and with greater than 20,000 allowed services. Table
7 lists the 83 codes that meet these review criteria and we are
proposing these as potentially misvalued for CY 2017. We request public
input on additional ways to address appropriate valuations for all
services that are typically billed with an E/M with Modifier 25.
[[Page 46188]]
Table 7--0-Day Global Services That Are Typically Billed With an
Evaluation and Management (E/M) Service With Modifier 25
------------------------------------------------------------------------
HCPCS Long descriptor
------------------------------------------------------------------------
11000............................ Removal of inflamed or infected skin,
up to 10% of body surface.
11100............................ Biopsy of single growth of skin or
tissue.
11300............................ Shaving of 0.5 centimeters or less
skin growth of the trunk, arms, or
legs.
11301............................ Shaving of 0.6 centimeters to 1.0
centimeters skin growth of the
trunk, arms, or legs.
11302............................ Shaving of 1.1 to 2.0 centimeters
skin growth of the trunk, arms, or
legs.
11305............................ Shaving of 0.5 centimeters or less
skin growth of scalp, neck, hands,
feet, or genitals.
11306............................ Shaving of 0.6 centimeters to 1.0
centimeters skin growth of scalp,
neck, hands, feet, or genitals.
11307............................ Shaving of 1.1 to 2.0 centimeters
skin growth of scalp, neck, hands,
feet, or genitals.
11310............................ Shaving of 0.5 centimeters or less
skin growth of face, ears, eyelids,
nose, lips, or mouth.
11311............................ Shaving of 0.6 centimeters to 1.0
centimeters skin growth of face,
ears, eyelids, nose, lips, or mouth.
11312............................ Shaving of 1.1 to 2.0 centimeters
skin growth of face, ears, eyelids,
nose, lips, or mouth.
11740............................ Removal of blood accumulation between
nail and nail bed.
11755............................ Biopsy of finger or toe nail.
11900............................ Injection of up to 7 skin growths.
11901............................ Injection of more than 7 skin
growths.
12001............................ Repair of wound (2.5 centimeters or
less) of the scalp, neck, underarms,
trunk, arms or legs.
12002............................ Repair of wound (2.6 to 7.5
centimeters) of the scalp, neck,
underarms, genitals, trunk, arms or
legs.
12004............................ Repair of wound (7.6 to 12.5
centimeters) of the scalp, neck,
underarms, genitals, trunk, arms or
legs.
12011............................ Repair of wound (2.5 centimeters or
less) of the face, ears, eyelids,
nose, lips, or mucous membranes.
12013............................ Repair of wound (2.6 to 5.0
centimeters) of the face, ears,
eyelids, nose, lips, or mucous
membranes.
17250............................ Application of chemical agent to
excessive wound tissue.
20526............................ Injection of carpal tunnel.
20550............................ Injections of tendon sheath,
ligament, or muscle membrane.
20551............................ Injections of tendon attachment to
bone.
20552............................ Injections of trigger points in 1 or
2 muscles.
20553............................ Injections of trigger points in 3 or
more muscles.
20600............................ Aspiration or injection of small
joint or joint capsule.
20604............................ Arthrocentesis, aspiration or
injection, small joint or bursa
(e.g., fingers, toes); with
ultrasound guidance, with permanent
recording and reporting.
20605............................ Aspiration or injection of medium
joint or joint capsule.
20606............................ Arthrocentesis, aspiration or
injection, intermediate joint or
bursa (e.g., temporomandibular,
acromioclavicular, wrist, elbow or
ankle, olecranon bursa); with
ultrasound guidance, with permanent
recording and reporting.
20610............................ Aspiration or injection of large
joint or joint capsule.
20611............................ Arthrocentesis, aspiration or
injection, major joint or bursa
(e.g., shoulder, hip, knee,
subacromial bursa); with ultrasound
guidance, with permanent recording
and reporting.
20612............................ Aspiration or injection of cysts.
29105............................ Application of long arm splint
(shoulder to hand).
29125............................ Application of non-moveable, short
arm splint (forearm to hand).
29515............................ Application of short leg splint (calf
to foot).
29540............................ Strapping of ankle or foot.
29550............................ Strapping of toes.
30901............................ Simple control of nose bleed.
30903............................ Complex control of nose bleed.
31231............................ Diagnostic examination of nasal
passages using an endoscope.
31238............................ Control of nasal bleeding using an
endoscope.
31500............................ Emergent insertion of breathing tube
into windpipe cartilage using an
endoscope.
31575............................ Diagnostic examination of voice box
using flexible endoscope.
31579............................ Examination to assess movement of
vocal cord flaps using an endoscope.
31645............................ Aspiration of lung secretions from
lung airways using an endoscope.
32551............................ Removal of fluid from between lung
and chest cavity, open procedure.
32554............................ Removal of fluid from chest cavity.
40490............................ Biopsy of lip.
43760............................ Change of stomach feeding, accessed
through the skin.
45300............................ Diagnostic examination of rectum and
large bowel using an endoscope.
46600............................ Diagnostic examination of the anus
using an endoscope.
51701............................ Insertion of temporary bladder
catheter.
51702............................ Insertion of indwelling bladder
catheter.
51703............................ Insertion of indwelling bladder
catheter.
56605............................ Biopsy of external female genitals.
57150............................ Irrigation of vagina or application
of drug to treat infection.
57160............................ Fitting and insertion of vaginal
support device.
58100............................ Biopsy of uterine lining.
64405............................ Injection of anesthetic agent,
greater occipital nerve.
64418............................ Injection of anesthetic agent, collar
bone nerve.
64455............................ Injections of anesthetic or steroid
drug into nerve of foot.
65205............................ Removal of foreign body in external
eye, conjunctiva.
65210............................ Removal of foreign body in external
eye, conjunctiva or sclera.
65222............................ Removal of foreign body, external
eye, cornea with slit lamp
examination.
67515............................ Injection of medication or substance
into membrane covering eyeball.
67810............................ Biopsy of eyelid.
67820............................ Removal of eyelashes by forceps.
[[Page 46189]]
68200............................ Injection into conjunctiva.
69100............................ Biopsy of ear.
69200............................ Removal of foreign body from ear
canal.
69210............................ Removal of impact ear wax, one ear.
69220............................ Removal of skin debris and drainage
of mastoid cavity.
92511............................ Examination of the nose and throat
using an endoscope.
92941............................ Insertion of stent, removal of plaque
or balloon dilation of coronary
vessel during heart attack, accessed
through the skin.
92950............................ Attempt to restart heart and lungs.
98925............................ Osteopathic manipulative treatment to
1-2 body regions.
98926............................ Osteopathic manipulative treatment to
3-4 body regions.
98927............................ Osteopathic manipulative treatment to
5-6 body regions.
98928............................ Osteopathic manipulative treatment to
7-8 body regions.
98929............................ Osteopathic manipulative treatment to
9-10 body regions.
G0168............................ Wound closure utilizing tissue
adhesive(s) only.
G0268............................ Removal of impacted cerumen (one or
both ears) by physician on same date
of service as audiologic function
testing.
------------------------------------------------------------------------
b. End-Stage Renal Disease Home Dialysis Services (CPT Codes 90963
Through 90970)
In the CY 2004 PFS final rule with comment period (68 FR 63216), we
established new Level II HCPCS G-codes for end-stage renal disease
(ESRD) services and established payment for those codes through monthly
capitation payment (MCP) rates. For ESRD center-based patients, payment
for the G-codes varied based on the age of the beneficiary and the
number of face-to-face visits furnished each month (for example, 1
visit, 2-3 visits and 4 or more visits). We believed that many
physicians would provide 4 or more visits to center-based ESRD patients
and a small proportion will provide 2-3 visits or only one visit per
month. Under the MCP methodology, to receive the highest payment, a
physician would have to provide at least four ESRD-related visits per
month. However, payment for home dialysis MCP services only varied by
the age of beneficiary. Although we did not initially specify a
frequency of required visits for home dialysis MCP services, we stated
that we expect physicians to provide clinically appropriate care to
manage the home dialysis patient.
The CPT Editorial Panel created new CPT codes to replace the G-
codes for monthly ESRD-related services, and we accepted the new codes
for use under the PFS in CY 2009. The CPT codes created were 90963-
90966 for monthly ESRD-related services for home dialysis patient and
CPT codes 90967-90970 for dialysis with less than a full month of
services.
In a GAO report titled ``END-STAGE RENAL DISEASE Medicare Payment
Refinements Could Promote Increased Use of Home Dialysis'' dated
October 2015, 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.
In the report, the GAO noted that CMS intended for the existing
payment structure to create an incentive for physicians to prescribe
home dialysis, because the monthly payment rate for managing the
dialysis care of home patients, which requires a single in-person
visit, was approximately equal to the rate for managing and providing
two to three visits to ESRD center-based patients. However, GAO found
that, in 2013, the rate of $237 for managing home patients was lower
than the average payment of $266 and maximum payment of $282 for
managing ESRD center-based patients. The GAO stated that this
difference in payment rates may discourage physicians from prescribing
home dialysis.
Physician associations and other physicians GAO interviewed stated
that the visits with home patients are often longer and more
comprehensive than in-center visits; this is in part because physicians
may conduct visits with individual home patients in a private setting,
but they may be able to more easily visit multiple in-center patients
on a single day as they receive dialysis. The physician associations
GAO interviewed also said that they may spend a similar amount of time
outside of visits to manage the care of home patients and that they are
required to provide at least one visit per month to perform a complete
assessment of the patient.
It is important to note that, as stated in the CY 2011 PFS final
rule with comment period (75 FR 73296), we believe that furnishing
monthly face-to-face visits is an important component of high quality
medical care for ESRD patients being dialyzed at home and generally
would be consistent with the current standards of medical practice.
However, we also acknowledged that extenuating circumstances may arise
that make it difficult for the MCP physician (or NPP) to furnish a
visit to a home dialysis patient every month. Therefore, we allow
Medicare contractors the discretion to waive the requirement for a
monthly face-to-face visit for the home dialysis MCP service on a case-
by-case basis, for example, when the MCP physician's (or NPP's) notes
indicate that the MCP physician (or NPP) actively and adequately
managed the care of the home dialysis patient throughout the month.
The GAO recommended, and we agreed, that CMS examine Medicare
policies for monthly payments to physicians to manage the care of
dialysis patients and revise them if necessary to ensure that these
policies are consistent with our goal of encouraging the use of home
dialysis among patients for whom it is appropriate. Therefore, we are
proposing to identify CPT codes 90963 through 90970 as potentially
misvalued codes based on the volume of claims submitted for these
services relative to those submitted for facility ESRD services.
[[Page 46190]]
c. Direct PE Input Discrepancies
i. Appropriate Direct PE Inputs Involved in Procedures Involving
Endoscopes
Stakeholders have raised concerns about potential inconsistencies
with the inputs and the prices related to endoscopic procedures in the
direct PE database. Upon review, we noted that there are 45 different
pieces of endoscope related-equipment and 25 different pieces of
endoscope related-supplies that are currently associated with these
services. Relative to other kinds of equipment items in the direct PE
input, these items are much more varied and used for many fewer
services. Given the frequency with which individual codes can be
reviewed and the importance of standardizing inputs for purposes of
maintaining relativity across PFS services, we believe that this
unusual degree of variation is likely to result in code misvaluation.
To facilitate efficient review of this particular kind of misvaluation,
and because we believe that stakeholders will prefer the opportunity to
contribute to such standardization, we request that stakeholders like
the RUC review and make recommendations on the appropriate endoscopic
equipment and supplies typically provided in all endoscopic procedures
for each anatomical body region, along with their appropriate prices.
ii. Appropriate Direct PE Inputs in the Facility Post-Service Period
When Post-Operative Visits Are Excluded
We identified a potential inconsistency in instances where there
are direct PE inputs included in the facility postservice period even
though post-operative visit is not included in a service. We identified
13 codes that are affected by this issue and we are unclear if the
discrepancy is caused by inaccurate direct PE inputs or inaccurate
post-operative data in the work time file. We request that stakeholders
including the RUC review these discrepancies and provide their
recommendations on the appropriate direct PE inputs for the codes
listed in Table 8.
Table 8--Codes That Have Direct PE Inputs in the Facility Postservice
Period When Post-Operative Visits Are Excluded
------------------------------------------------------------------------
CPT Code Long descriptor
------------------------------------------------------------------------
21077............................. Impression and preparation of eye
socket prosthesis.
21079............................. Impression and custom preparation of
temporary oral prosthesis.
21080............................. Impression and custom preparation of
permanent oral prosthesis.
21081............................. Impression and custom preparation of
lower jaw bone prosthesis.
21082............................. Impression and custom preparation of
prosthesis for roof of mouth
enlargement.
21083............................. Impression and custom preparation of
roof of mouth prosthesis.
21084............................. Impression and custom preparation of
speech aid prosthesis.
28636............................. Insertion of hardware to foot bone
dislocation with manipulation,
accessed through the skin.
28666............................. Insertion of hardware to toe joint
dislocation with manipulation,
accessed through the skin.
43652............................. Incision of vagus nerves of stomach
using an endoscope.
46900............................. Chemical destruction of anal
growths.
47570............................. Connection of gall bladder to bowel
using an endoscope.
66986............................. Exchange of lens prosthesis.
------------------------------------------------------------------------
d. Insertion and Removal of Drug Delivery Implants--CPT Codes 11981 and
11983
Stakeholders have urged CMS to create new coding describing the
insertion and removal of drug delivery implants for buprenorphine
hydrochloride, formulated as a 4 rod, 80 mg, long acting subdermal drug
implant for the treatment of opioid addiction. These stakeholders have
suggested that current coding that describes insertion and removal of
drug delivery implants is too broad and that new coding is needed to
account for specific additional resource costs associated with
particular treatment. We are identifying existing CPT codes 11981
(Insertion, non-biodegradable drug delivery implant), 11982 (Removal,
non-biodegradable drug delivery implant), and 11983 (Removal with
reinsertion, non-biodegradable drug delivery implant) as potentially
misvalued codes and are seeking comment and information regarding
whether the current resource inputs in work and practice expense for
these codes appropriately account for variations in the service
relative to which devices and related drugs are inserted and removed.
5. Valuing Services That Include Moderate Sedation as an Inherent Part
of Furnishing the Procedure
The CPT manual identifies more than 400 diagnostic and therapeutic
procedures (listed in Appendix G) for which the CPT Editorial Committee
has determined that moderate sedation is an inherent part of furnishing
the procedure. In developing RVUs for these services, we include the
resource costs associated with moderate sedation in the valuation since
the CPT codes include moderate sedation as an inherent part of the
procedure. Therefore, only the procedure code is currently reported
when furnishing the service. Endoscopic procedures constitute a
significant portion of the services identified in Appendix G. In the CY
2015 PFS proposed rule (79 FR 40349), we noted that it appeared that
practice patterns for endoscopic procedures were changing, with
anesthesia increasingly being separately reported for these procedures,
meaning that the resource costs associated with sedation were no longer
incurred by the practitioner reporting the Appendix G procedure. We
indicated that, in order to reflect apparent changes in medical
practice, we were considering establishing a uniform approach to the
appropriate valuation of all Appendix G services for which moderate
sedation is no longer inherent, rather than addressing the issue at the
procedure level as individual codes are revalued. We solicited public
comment on approaches to the appropriate valuation of these services.
In the CY 2016 PFS proposed rule (80 FR 41707), we again solicited
public comment and recommendations on approaches to address the
appropriate valuation of moderate sedation related to Appendix G
services. In response to our comment solicitation, the CPT Editorial
Panel created CPT codes for separately reporting moderate sedation
services in association with the elimination of Appendix G from the CPT
Manual for CY 2017. This coding change would provide for payment for
[[Page 46191]]
moderate sedation services only in cases where it is furnished. In
addition to providing recommended values for the new codes used to
separately report moderate sedation, the RUC has also provided a
methodology for revaluing all services previously identified in
Appendix G, without moderate sedation, in order to make appropriate
corresponding adjustments for the procedural services. The RUC
recommended this methodology to address moderate sedation valuation
generally instead of recommending that it be addressed as individual
codes are reviewed. The RUC's recommended methodology would remove work
RVUs for moderate sedation from Appendix G codes based on a code-level
assessment of whether the procedures are typically performed on
straightforward patients or more difficult patients. Based on its
recommended methodology, the RUC is recommending removal of fewer RVUs
from each of the procedural services than it recommends for valuing the
moderate sedation services. If we were to use the RUC-recommended
values for both the moderate sedation codes and the Appendix G
procedural codes without refinement, overall payments for these
procedures, when moderate sedation is furnished, would increase
relative to the current payment.
We direct readers to section II.L. of this proposed rule, which
includes more details regarding our proposed valuation of the new
moderate sedation codes and our proposed uniform methodology for
revaluation of the procedural codes previously identified in Appendix
G. We believe that the RVUs assigned under the PFS should reflect the
overall resource costs of PFS services, regardless of how many codes
are used to report the services. Therefore, our proposed methodology
for valuation of Appendix G procedural services would maintain current
resource assumptions for the procedures when furnished with moderate
sedation and redistribute the RVUs associated with moderate sedation
(previously included in Appendix G procedural codes) to other PFS
services. We believe that our proposed uniform methodology for
revaluation of Appendix G services without moderate sedation is
consistent with our general principle that the overall resource costs
for the procedures do not change based solely on changes in coding.
We also note that stakeholders presented information to CMS
regarding specialty group survey data for physician work. The
stakeholders shared survey results for physician work involved in
furnishing moderate sedation that demonstrated a significant bimodal
distribution between procedural services furnished by
gastroenterologists (GI) and procedural services furnished by other
specialties. Since we believe that gastroenterologists furnish the
highest volume of services previously identified in Appendix G, and
services primarily furnished by gastroenterologists prompted the
concerns that led to our identification of changes in medical practice
and potentially duplicative payment for these codes, we have addressed
the variations between the GI and other specialties in our review of
the new moderate sedation CPT codes and their recommended values. We
again direct readers to section II.L. of this proposed rule where we
discuss our proposal to augment the new CPT codes for moderate sedation
with an endoscopy-specific moderate sedation code, as well as proposed
valuations reflecting the differences in the physician survey data
between GI and other specialties.
6. Collecting Data on Resources Used in Furnishing Global Services
a. Background
(1) Current Payment Policy for Global Packages
Under the PFS, certain services, such as surgery, are valued and
paid for as part of global packages that include the procedure and the
services typically furnished in the periods immediately before and
after the procedure. For each of these global packages, we establish a
single PFS payment that includes payment for particular services that
we assume to be typically furnished during the established global
period. There are three primary categories of global packages that are
labeled based on the number of post-operative days included in the
global period: 0-day; 10-day; and 90-day. The 0-day global packages
include the surgical procedure and the pre-operative and post-operative
services furnished by the physician on the day of the service. The 10-
day global packages include these services and, in addition, visits
related to the procedure during the 10 days following the day of the
procedure. The 90-day global packages include the same services as the
0-day global codes plus the pre-operative services furnished one day
prior to the procedure and post-operative services during the 90 days
immediately following the day of the procedure. Section 40.1 of Chapter
12 of the Claims Processing Manual (Pub. 100-04) defines the global
surgical package to include the following services related to the
surgery when furnished during the global period by the same physician
or another practitioner in the same group practice:
Pre-operative Visits: Pre-operative visits after the
decision is made to operate beginning with the day before the day of
surgery for major procedures and the day of surgery for minor
procedures;
Intra-operative Services: Intra-operative services that
are normally a usual and necessary part of a surgical procedure;
Complications Following Surgery: All additional medical or
surgical services required of the surgeon during the post-operative
period of the surgery because of complications that do not require
additional trips to the operating room;
Post-operative Visits: Follow-up visits during the post-
operative period of the surgery that are related to recovery from the
surgery;
Post-surgical Pain Management: By the surgeon;
Supplies: Except for those identified as exclusions; and
Miscellaneous Services: Items such as dressing changes;
local incisional care; removal of operative pack; removal of cutaneous
sutures and staples, lines, wires, tubes, drains, casts, and splints;
insertion, irrigation and removal of urinary catheters, routine
peripheral intravenous lines, nasogastric and rectal tubes; and changes
and removal of tracheostomy tubes.
In the CY 2015 PFS proposed and final rules we extensively
discussed the problems with accurate valuation of 10-and 90-day global
packages. Our concerns included the fact that we do not use actual data
on services furnished in order to update the rates, questions regarding
the accuracy of our current assumptions about typical services, whether
we will be able to adjust values on a regular basis to reflect changes
in the practice of medicine and health care delivery, and how our
global payment policies affect what services are actually furnished (79
FR 67582 through 67585). In finalizing a policy to transform all 10-day
and 90-day global codes to 0-day global codes in CY 2017 and CY 2018,
respectively, to improve the accuracy of valuation and payment for the
various components of global packages, including pre- and post-
operative visits and the procedure itself, we stated that we were
adopting this policy because we believe it is critical that PFS payment
rates be based upon RVUs that reflect the resource costs of furnishing
the services. We also stated our belief that transforming all 10- and
90-day global codes to 0-day global packages would:
[[Page 46192]]
Increase the accuracy of PFS payment by setting payment
rates for individual services that more closely reflect the typical
resources used in furnishing the procedures;
Avoid potentially duplicative or unwarranted payments when
a beneficiary receives post-operative care from a different
practitioner during the global period;
Eliminate disparities between the payment for E/M services
in global periods and those furnished individually;
Maintain the same-day packaging of pre- and post-operative
physicians' services in the 0-day global packages; and
Facilitate the availability of more accurate data for new
payment models and quality research.
(2) Data Collection and Revaluation of Global Packages Required by
MACRA
Section 523(a) of the Medicare Access and CHIP Reauthorization Act
of 2015 (MACRA) (Pub. L. 114-10, enacted April 16, 2015) prohibits the
Secretary from implementing the policy, described above, that would
have transformed all 10-day and 90-day global surgery packages to 0-day
global packages.
Section 1848(c)(8)(B) of the Act, which was also added by section
523(a) of the MACRA, requires us to collect data to value surgical
services. Section 1848(c)(8)(B)(i) of the Act requires us to develop,
through rulemaking, a process to gather information needed to value
surgical services from a representative sample of physicians, and
requires that the data collection begin no later than January 1, 2017.
The collected information must include the number and level of medical
visits furnished during the global period and other items and services
related to the surgery and furnished during the global period, as
appropriate. This information must be reported on claims at the end of
the global period or in another manner specified by the Secretary.
Section 1848(c)(8)(B)(ii) of the Act requires that, every 4 years, we
reassess the value of this collected information; and allows us to
discontinue the collection of this information if the Secretary
determines that we have adequate information from other sources to
accurately value global surgical services. Section 1848(c)(8)(B)(iii)
of the Act specifies that the Inspector General shall audit a sample of
the collected information to verify its accuracy. Section 1848(c)(9) of
the Act (added by section 523(b) of the MACRA) authorizes the
Secretary, through rulemaking, to delay up to 5 percent of the PFS
payment for services for which a physician is required to report
information under section 1848(c)(8)(B)(i) of the Act until the
required information is reported.
Section 1848(c)(8)(C) of the Act, which was also added by section
523(a) of the MACRA, requires that, beginning in CY 2019, we must use
the information collected as appropriate, along with other available
data, to improve the accuracy of valuation of surgical services under
the PFS.
(3) Public Input
As noted above, section 1848(c)(8)(C) of the Act mandates that we
use the collected data to improve the accuracy of valuation of surgery
services beginning in 2019. We described in the CY 2015 PFS final rule
(79 FR 67582 through 67591) the limitations and difficulties involved
in the appropriate valuation of the global packages, especially when
the resources and the related values assigned to the component services
are not defined. To gain input from stakeholders on implementation of
this data collection, we sought comment on various aspects of this task
in the CY 2016 proposed rule (80 FR 41707 through 41708). We solicited
comments from the public regarding the kinds of auditable, objective
data (including the number and type of visits and other services
furnished during the post-operative period by the practitioner
furnishing the procedure) needed to increase the accuracy of the values
for surgical services. We also solicited comment on the most efficient
means of acquiring these data as accurately and efficiently as
possible. For example, we sought information on the extent to which
individual practitioners or practices may currently maintain their own
data on services, including those furnished during the post-operative
period, and how we might collect and objectively evaluate those data
for use in increasing the accuracy of the values beginning in CY 2019.
We received many comments regarding potential methods of valuing
the individual components of the global surgical package. A large
number of comments expressed strong support for our proposal to hold an
open door forum or town hall meetings with the public. Toward this end,
we held a national listening session on January 20, 2016. Prior to the
listening session, the topics for which guidance was being sought were
sent electronically to those who registered for the session and made
available on our Web site. The topics were:
Mechanisms for capturing the types of services typically
furnished during the global period.
Determining the representative sample for the claims-based
data collection.
Determining whether we should collect data on all surgical
services or, if not, which services should be sampled.
Potential for designing data collection elements to
interface with existing infrastructure used to track follow-up visits
within the global period.
Consideration of use of 5 percent withhold until required
information is furnished.
The 658 participants in the national listening session provided
valuable information on this task. A written transcript and an audio
recording of this session are available at https://www.cms.gov/Outreach-and-Education/Outreach/NPC/National-Provider-Calls-and-Events-Items/2016-01-20-MACRA.html.
We considered both the comments submitted on the CY 2016 PFS
proposed rule and the input provided at the listening session as we
developed this proposal for data collection. When relevant, we discuss
this stakeholder input below without distinguishing between comments on
the proposed rule and input provided at the national listening session.
b. Data Collection Required To Accurately Value Global Packages
Resource-based valuation of individual physicians' services is a
critical foundation for Medicare payment to physicians. It is essential
that the RVUs under the PFS be based as closely and accurately as
possible on the actual resources involved in furnishing the typical
occurrence of specific services to make appropriate payment and
preserve relativity among services. For global surgical packages, this
requires using objective data on all of the resources used to furnish
the services that are included in the package. Not having such data for
some components may significantly skew relativity and create
unwarranted payment disparities within the PFS.
The current valuations for many services valued as global packages
are based upon the total package as a unit rather than by determining
the resources used in furnishing the procedure and each additional
service/visit and summing the results. As a result, we do not have the
same level of information about the components of global packages as we
do for other services. To value global packages accurately and
[[Page 46193]]
relative to other procedures, we need accurate information about the
resources--work, PEs and malpractice--used in furnishing the procedure,
similar to what is used to determine RVUs for all services. In addition
we need the same information on the post-operative services furnished
in the global period (and pre-operative services the day before for 90-
day global packages). Public comments about our proposal to value all
global services as 0-day global services and pay separately for
additional post-operative services when furnished indicated that there
were no reliable data available on the value of the underlying
procedure that did not also incorporate the value of the post-operative
services, reinforcing our view that more data are needed across the
board.
While we believe that most of the services furnished in the global
period are visits for follow-up care, we do not have accurate
information on the number and level of visits typically furnished
because those billing for global services are not required to submit
claims for post-operative visits. A May 2012 Office of Inspector
General (OIG) report, entitled Cardiovascular Global Surgery Fees Often
Did Not Reflect the Number of Evaluation and Management Services
Provided (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 entitled
``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 rate-setting. Specifically,
Medicare claims data is a primary driver in the allocation of indirect
PE RVUs and MP RVUs across the codes used by particular specialties,
and in making overall budget neutrality and relativity adjustments. In
most cases, a claim must be filed for all visits. Such claims provide
information such as the place of service, the type and, if relevant,
the level of the service, the date of the service, and the specialty of
the practitioner furnishing the services. Because we have not required
claims reporting of visits included in global surgical packages, we do
not have any of this information for the services bundled in the
package.
In addition to the lack of information about the number and level
of visits actually furnished, the current global valuations rely on
crosswalks to E/M visits, based upon the assumption that the resources,
including work, used in furnishing pre- and post-operative visits are
similar to those used in furnishing E/M visits. We are unaware of any
studies or surveys that verify this assertion. Although we generally
value global packages using the same direct PE inputs as are used for
the E/M services, for services for which the RUC recommendations
include specific PE inputs in addition to those typically included for
E/M services, we generally use the additional inputs in the global
package valuation. Of note, when a visit included in a global package
would use fewer resources than a comparable E/M service, the RUC
generally does not include recommendations to decrease the PE inputs of
the visit included in the global package, and we have not generally
made comparable reductions. Another inconsistency with our current
global package valuation approach is that even though we effectively
assume that the E/M codes are appropriate for valuing pre- and post-
operative services, the indirect PE inputs used for calculating
payments for global services are based upon the specialty mix
furnishing the global service, not the specialty mix of the physicians
furnishing the E/M services, resulting in a different valuation for the
E/M services contained in global packages than for separately billable
E/M services. There is a critical need to obtain complete information
if we are to value global packages accurately and in a way that
preserves relativity across the fee schedule.
To meet the requirement under section 1848(c)(8)(B)(i) of the Act,
we develop, through rulemaking, a process to gather information needed
to value surgical services. Therefore, we are proposing a rigorous data
collection effort that we believe would provide us the data needed to
accurately value the 4,200 codes with a 10- or 90-day global period.
Using our authority under sections 1848(c)(2)(M) and (c)(8)(B)(i) of
the Act, we propose to gather the data needed to determine how to best
structure global packages with post-operative care that is typically
delivered days, weeks or months after the procedure and whether there
are some procedures for which accurate valuation for packaged post-
operative care is not possible. Finally, we believe these data would
provide useful information to assess the resources used in furnishing
pre- and post-operative care. To accurately do so, we need to know the
volume and costs of the resources typically used. Although it may not
be possible to gather all the necessary data and to complete the
analysis required to re-value all of the codes currently valued as 10-
or 90-day global packages by January 1, 2019, we believe the proposed
data collection would provide the foundation for such valuations and
would allow us to re-value, as appropriate, the surgical services on a
flow basis, starting in rulemaking for CY 2019.
We are proposing a three-pronged approach to collect timely and
accurate data on the frequency of, and inputs involved in furnishing,
global services including the procedure and the pre-operative visits,
post-operative visits, and other services for which payment is included
in the global surgical payment. By analyzing these data, we would not
only have the most comprehensive information available on the resources
used in furnishing these services, but also would be able to determine
the appropriate packages for such services. Specifically, the effort
would include:
Comprehensive claims-based reporting about the number and
level of pre- and post-operative visits furnished for 10- and 90-day
global services.
A survey of a representative sample of practitioners about
the activities involved in and the resources used in providing a number
of pre- and post-operative visits during a specified, recent period of
time, such as two weeks.
A more in-depth study, including direct observation of the
pre- and post-operative care delivered in a small number of sites,
including some ACOs.
This work is critical to understanding and characterizing the work
and other resources involved in furnishing services throughout the
current global periods assigned to specific surgical procedures. The
information collected and analyzed through the activities would be the
first comprehensive look at the volume and level of services in a
global period, and the activities and inputs involved in furnishing
global services. The data from these activities would ultimately inform
our revaluation of global surgical packages.
[[Page 46194]]
(1) Statutory Authority for Data Collection
As described above, section 1848(c)(8)(B)(i) of the Act requires us
to develop, through rulemaking, a process to gather information needed
to value surgical services from a representative sample of physicians.
The statute requires that the collected information include the number
and level of medical visits furnished during the global period and
other items and services related to the surgery and furnished during
the global period, as appropriate.
In addition, section 1848(c)(2)(M) of the Act, which was added to
the Act by section 220 of the PAMA, authorizes the Secretary to collect
or obtain information on resources directly or indirectly related to
furnishing services for which payment is made under the PFS. Such
information may be collected or obtained from any eligible professional
or any other source. Information may be collected or obtained from
surveys of physicians, other suppliers, providers of services,
manufacturers, and vendors. That section also authorizes the Secretary
to collect information through any other mechanism determined
appropriate. When using information gathered under this authority, the
statute requires the Secretary to disclose the information source and
discuss the use of such information in the determination of relative
values through notice and comment rulemaking.
As described above, to gain all the information that is needed to
determine the appropriate packages for global services and to revalue
those services, we need to conduct a comprehensive study on the
resources used in furnishing such services. Through such a study, we
would have much more robust data to use in valuation than has been
typically available. We anticipate that such efforts would inform how
to more regularly collect data on the resources used in furnishing
physicians' services. To the extent that such mechanisms prove
valuable, they may be used to collect data for valuing other services.
To achieve this significant data collection, we are proposing to
collect data under the authority of both section 1848(c)(8)(B) and
(c)(2)(M) of the Act.
(2) Claims-Based Data Collection
This section describes our proposal for claims-based data
collection that would be applicable to 10- and 90-day global services
furnished on or after January 1, 2017, including who would be required
to report, what they would be required to report, and how reports would
be submitted.
(a) Information To Be Reported
A key element of claims-based reporting is using codes that
appropriately reflect the services furnished. In response to the
comment solicitation in the CY 2016 PFS proposed rule and in the
January 2016 listening session, we received numerous recommendations
for the information to be reported on claims. The most frequently
recommended approach was for practitioners to report the existing CPT
code for follow-up visits included in the surgical package (CPT 99024--
Postoperative follow-up visit, normally included in the surgical
package, to indicate that an E/M service was performed during a
postoperative period for a reason(s) related to the original
procedure). Others suggested using this code for outpatient visits and
using length of stay data for estimating the number of inpatient visits
during the global period. In response to our concerns that CPT code
99024 would provide only the number of visits and not the level of
visits as required by the statute, one commenter suggested using
modifiers in conjunction with CPT code 99024 to indicate the level of
the visit furnished. Others recommended using existing CPT codes for E/
M visits to report post-operative care. One commenter suggested that
CMS analyze data from a sample of large systems and practices that are
using electronic health records that require entry of some CPT code for
every visit to capture the number of post-operative visits. After
noting that the documentation requirements and PEs required for post-
operative visits differ from those of E/M visits outside the global
period, one commenter encouraged us to develop a separate series of
codes to capture the work of the post-operative services and to
measure, not just estimate, the number and complexity of visits during
the global period.
Other commenters opposed the use of a new set of codes or the use
of modifiers to report post-operative visits. Commenters also noted
several issues for us to consider in developing data collection
mechanisms, including that many post-operative services do not have CPT
codes to bill separately, that surgeons perform a wide range of
collaborative care services, and that patient factors, including
disease severity and comorbidities, influence what post-operative care
is furnished.
To assist us in determining appropriate coding for claims-based
reporting, we added a task to the RAND contract for developing a model
to validate the RVUs in the PFS, which was awarded in response to a
requirement in the Affordable Care Act. Comments that we received on
RAND's report suggested the models did not adequately address global
surgery services due to the lack of available data on included visits.
Therefore, we modified the RAND contract to include the development of
G-codes that could be used to collect data about post-surgical follow-
up visits on Medicare claims for valuing global services under MACRA
and so that this time could be included in the model for validating
RVUs.
To inform its work, RAND conducted interviews with surgeons and
other physicians/non-physician practitioners (NPP) who provide post-
operative care. A technical expert panel (TEP), convened by RAND,
reviewed the findings of the interviews and provided input on how to
best capture care provided in the post-operative period on claims.
In summarizing the input from the interviews and the TEP, RAND
indicated that several considerations were important in developing a
claims-based method for capturing post-operative services. First, a
simple system to facilitate reporting was needed. Since it was reported
that a majority of post-operative visits are straightforward, RAND
found that a key for any proposed system is identifying the smaller
number of complex post-operative visits. Another consideration for RAND
was not using the existing CPT E/M structure to capture postoperative
care because of concerns that E/M codes are inadequately designed to
capture the full scope of post-operative care and that using such codes
might create confusion. Another consideration was that the TEP was most
enthusiastic about a set of codes that used site of care, time, and
complexity to report visits. RAND also believed it was important to
distinguish--particularly in the inpatient setting--between
circumstances where a surgeon is providing primary versus secondary
management of a patient. Finally, a mechanism for reporting the
postoperative care occurs outside of in-person visits and by clinical
staff was needed. RAND noted that in the inpatient setting in
particular, surgeons spend considerable time reviewing test results and
coordinating care with other practitioners.
After reviewing various approaches, RAND recommended a set of time-
based, post-operative visit codes that could be used for reporting care
provided during the post-operative period.
[[Page 46195]]
The recommended codes are distinguished by the setting of care and
whether they are furnished by a physician/NPP or by clinical staff. All
codes are intended to be reported in 10-minute increments. A copy of
the report is available available on the CMS Web site under downloads
for the CY 2017 PFS proposed rule with comment period at http://www.cms.gov/physicianfeesched/downloads/.
Based upon the work done by RAND, we are proposing the following
codes be used for reporting on claims the services actually furnished
but not paid separately because they are part of global packages. No
separate payment would be made for these codes.
TABLE 9--Proposed Global Service Codes
------------------------------------------------------------------------
------------------------------------------------------------------------
Inpatient...................... GXXX1 Inpatient visit,
typical, per 10
minutes, included in
surgical package.
GXXX2 Inpatient visit,
complex, per 10
minutes, included in
surgical package.
GXXX3 Inpatient visit,
critical illness, per
10 minutes, included
in surgical package.
Office or Other Outpatient..... GXXX4 Office or other
outpatient visit,
clinical staff, per
10 minutes, included
in surgical package.
GXXX5 Office or other
outpatient visit,
typical, per 10
minutes, included in
surgical package.
GXXX6 Office or other
outpatient visit,
complex, per 10
minutes, included in
surgical package.
Via Phone or Internet.......... GXXX7 Patient interactions
via electronic means
by physician/NPP, per
10 minutes, included
in surgical package.
GXXX8 Patient interactions
via electronic means
by clinical staff,
per 10 minutes,
included in surgical
package.
------------------------------------------------------------------------
(i) Coding for Inpatient Global Service Visits
Our coding proposal includes three codes for reporting inpatient
pre- and post-operative visits that distinguish the intensity involved
in furnishing the services. The typical inpatient visit would be
reported using HCPCS code GXXX1, Inpatient visit, typical, per 10
minutes, included in surgical package. The activities listed in Table
10 are those that RAND recommended to be reported as a typical visit.
Under our proposal, visits that involve any combination or number of
the services listed in Table 10 would be reported using GXXX1. Based on
the findings from the interviews and the TEP, RAND reports that the
vast majority of inpatient post-operative visits would be expected to
be reported using GXXX1.
Table 10--Activities Included in Typical Visit (GXXX1 & GXXX5)
------------------------------------------------------------------------
-------------------------------------------------------------------------
Review vitals, laboratory or pathology results, imaging, progress notes
Take interim patient history and evaluate post-operative progress
Assess bowel function
Conduct patient examination with a specific focus on incisions and
wounds, post-surgical pain, complications, fluid and diet intake
Manage medications (for example, wean pain medications)
Remove stitches, sutures, and staples
Change dressings
Counsel patient and family in person or via phone
Write progress notes, post-operative orders, prescriptions, and
discharge summary
Contact/coordinate care with referring physician or other clinical staff
Complete forms or other paperwork
------------------------------------------------------------------------
Inpatient pre- and post-operative visits that are more complex than
typical visits but do not qualify as critical illness visits would be
coded using GXXX2 (Inpatient visit, complex, per 10 minutes, included
in surgical package). To report this code, the practitioner would be
required to furnish services beyond those included in a typical visit
and have documentation that indicates what services were provided that
exceeded those included in a typical visit. Some circumstances that
might merit the use of the complex visit code are secondary management
of a critically ill patient where another provider such as an
intensivist is providing the primary management, primary management of
a particularly complex patient such as a patient with numerous
comorbidities or high likelihood of significant decline or death,
management of a significant complication, or complex procedures outside
of the operating room (For example, significant debridement at the
bedside).
The highest level of inpatient pre- and post-operative visits,
critical illness visits (GXXX3--Inpatient visit, critical illness, per
10 minutes, included in surgical package) would be reported when the
physician is providing primary management of the patient at a level of
care that would be reported using critical care codes if it occurred
outside of the global period. This involves acute impairment of one or
more vital organ systems such that there is a high probability of
imminent or life threatening deterioration in the patient's condition.
Similar to how time is now counted for the existing CPT critical
care codes, all time spent engaged in work directly related to the
individual patient's care would count toward the time reported with the
inpatient visit codes; this includes time spent at the immediate
bedside or elsewhere on the floor or unit, such as time spent with the
patient and family members, reviewing test results or imaging studies,
discussing care with other staff, and documenting care.
(ii) Coding for Office and Other Outpatient Global Services Visits
Our proposal includes three codes that would be used for reporting
post-operative visits in the office or other outpatient settings. For
these three codes, time would be defined as the face-to-face time with
patient, which reflects the current rules for time-based outpatient
codes.
Under our proposal, GXXX4 (Office or other outpatient visit,
clinical staff, per 10 minutes, included in surgical package) would be
used for visits in which the clinical care is provided by clinical
staff.
GXXX5 (Office or other outpatient visit, typical, per 10 minutes,
included in surgical package) would be used for reporting any
combination of activities in Table 10. Based on the findings from the
interviews and the TEP, RAND reports that the vast majority of office
or other outpatient visits would be expected to be reported using the
GXXX5 code.
Accordingly, we would expect the office or other outpatient visit
code, complex, GXXX6 (Office or other outpatient visit, complex, per 10
minutes, included in surgical package), to be used infrequently.
Examples of when it might be used include management of a particularly
complex patient such as a patient with numerous comorbidities or high
likelihood of dying, management of a significant complication, or
management or discussion of a complex diagnosis (For
[[Page 46196]]
example, new cancer diagnosis, high risk of mortality). Practitioners
would include documentation in the medical record as to what services
were provided that exceeded those included in a typical visit.
Only face-to-face time spent by the practitioner with the patient
and their family members would count toward the time reported with the
office visit codes. Therefore, even though the codes for both inpatient
and outpatient settings use the same time increment, the services that
are included differ by setting, consistent with the variation in
existing coding conventions.
(iii) Coding for Services Furnished Via Electronic Means
Services that are provided via phone, the internet, or other
electronic means outside the context of a face-to-face visit would be
reported using GXXX7 when furnished by a practitioner and GXXX8 when
furnished by clinical staff. We are proposing that practitioners would
not report these services if they are furnished the day before, the day
of, or the day after a visit as we believe these would be included in
the pre- and post-service activities in the typical visit. However, we
are proposing that these codes be used to report non-face-to-face
services provided by clinical staff prior to the primary procedure
since global surgery codes are typically valued with assumptions
regarding pre-service clinical labor time. Given that some
practitioners have indicated that services they furnish commonly
include activities outside the face-to-face service, we believe it is
important to capture information about those activities in both the
pre- and post-service periods. We believe these requirements to report
on clinical labor time are consistent with and no more burdensome than
those used to report clinical labor time associated with chronic care
management services, which similarly describe care that takes place
over more than one patient encounter.
In addition, for services furnished via interactive
telecommunications that meet the requirements of a Medicare telehealth
service visit, the appropriate global service G-code for the services
should be reported with the GT modifier to indicate that the service
was furnished ``via interactive audio and video telecommunications
systems.''
(iv) Benefits of G-Codes
One commenter indicated that the documentation requirements and PEs
for post-operative visits differ from those of other E/M visits, and
encouraged us to develop a separate series of codes to capture the work
of the post-operative services and to measure, not just estimate, the
number and complexity of visits during the global period. Others
opposed the use of a new set of codes or the use of modifiers to
collect information on post-operative visits. After considering the
RAND report, the comments and other stakeholder input that we have
received, and our needs for data to fulfill our statutory mandate and
to value surgical services appropriately, we are proposing this new set
of codes because we believe it provides us the most robust data upon
which to determine the most appropriate way and amounts to pay for PFS
surgical services. We believe that the codes being proposed would
provide data of the kind that can reasonably collected through claims
data and that reflect what we believe are key issues in the post-
operative care where the service is provided, who furnishes the
service, its relative complexity, and the time involved in the service.
We seek public comments about all aspects of these codes, including
the nature of the services described, the time increment, and any other
areas of interest to stakeholders. We are particularly interested in
any pre- or post-operative services furnished that could not be
appropriately captured by these codes. Although RAND developed this set
of codes to collect data on post-operative services, we are proposing
to also use such codes to collect data on pre-operative services. We
are seeking comments on whether the codes discussed above are
appropriate for collecting data on pre-operative services or whether
additional codes should be added to distinguish in the data collected
the resources used for pre-operative services from those used for post-
operative services. We also seek comment on any activities that should
be added to the list of activities in Table 10 to reflect typical pre-
operative visit activities.
(v) Alternative Approach to Coding
As noted above, many stakeholders expressed strong support for the
use of CPT code 99024 (Postoperative follow-up visit, normally included
in the surgical package, to indicate that an evaluation and management
service was performed during a postoperative period for a reason(s)
related to the original procedure) to collect data on post-operative
care. Stakeholders suggest that practitioners are familiar with this
existing CPT code and the burden on practitioners would be minimized by
only having to report that a visit occurred, not the level of the
visit. We do not believe that this code alone would provide the
information that we need for valuing surgical services nor do we
believe it alone can meet the statutory requirement that we collect
data on the number and level of visits because it does not provide any
information beyond the number of visits. Although we are proposing to
use the G-codes detailed above to measure pre- and post-operative
visits, given the strong support that many stakeholders have for the
use of CPT code 99024, we are soliciting comments specifically on how
we could use this code to capture the statutorily required data on the
number and level of visits and the data that we would need to value
global services in the future.
Some have suggested using CPT code 99024 with modifiers to indicate
to which of the existing levels of E/M codes the visit corresponds. As
outlined in the RAND report, E/M visits may not accurately capture what
drives greater complexity in post-operative visits. E/M billing
requirements are built upon complexity in elements such as medical
history, review of systems, family history, social history, and how
many organ systems are examined. In the context of a post-operative
visit, many of these elements may be irrelevant. RAND also noted that
there was significant concern from interviewees and the expert panel
about documentation that is required for reporting E/M codes.
Specifically, they argued that documentation requirements for surgeons
to support the relevant E/M visit code would place undue administrative
burden on surgeons. RAND reported that many surgeons currently use
minimal documentation when they provide a postoperative visit.
Moreover, to value surgical packages accurately we need to understand
the activities involved in furnishing post-operative care and as
discussed above, we lack information that would demonstrate that
activities involved in post-operative care are similar to those in E/M
services. In addition, the use of modifiers to report levels of
services is more difficult to operationalize than using unique HCPCS
codes. However, we would be interested in whether, and if so, why,
practitioners would find it easier to report CPT code 99024 with
modifiers corresponding to the proposed G-code levels rather than the
new G-codes, as proposed. We are also seeking comment on whether
practitioners would find it difficult to use this for pre-operative
visits since the CPT code descriptor specifically defines it as a
``post-operative follow-up'' service.
[[Page 46197]]
We are also seeking comment on whether time of visits could alone
be a proxy for the level of visit. If pre- and post-operative care
varies only by the time the practitioner spends care so that time could
be a proxy for complexity of the service, then we could use the
reporting of CPT code 99024 in 10-minute increments to meet the
statutory requirement of collecting claims-based data on the number and
level of visits. In addition to comments on whether time is an accurate
proxy for level of visit, we are seeking comment on the feasibility and
desirability of reporting CPT 99024 in 10-minute increments.
c. Reporting of Claims
We propose that the G-codes detailed above would be reported for
services related to and within 10- and 90-day global periods for
procedures furnished on or after January 1, 2017. Services related to
the procedure furnished following recovery and otherwise within the
relevant global period would be required to be reported. These codes
would be included on claims filed through the usual process. Through
this mechanism, we would collect all of the information reported on a
claim for services, including information about the practitioner,
service furnished, date of service, and the units of service. By not
imposing special reporting requirements on the reporting of these
codes, we intend to allow practitioners the flexibility to report the
services on a rolling basis as they are furnished or to report all of
the services on one claim once all have been furnished, as long as the
filed claims meet the requirements for filing claims. As with all other
claims, we would expect the patient's medical record to include
documentation of the services furnished. Documentation that would be
expected is an indication that a visit occurred or a service was
furnished and sufficient information to determine that the appropriate
G-code was reported.
We are not proposing any special requirements for inclusion of
additional data on claims that could be used for linking the post-
operative care furnished to a particular service. To use the data
reported on post-operative visits for analysis and valuation, we will
link the data reported on post-operative care to the related procedure
using date of service, practitioner, beneficiary, and diagnosis. We
believe this approach to matching will allow us to accurately link the
preponderance of G-codes to the related procedure. However, we solicit
comment on the extent to which post-operative care may not be
appropriately linked to related procedures whether we should consider
using additional variables to link these aspects of the care, and
whether additional data should be required to be reported to enable a
higher percentage of matching.
d. Special Provisions for Teaching Physicians
We are seeking comment on whether special provisions are needed to
capture the pre- and post-operative services provided by residents in
teaching settings. If the surgeon is present for the key portion of the
visit, should the surgeon report the joint time spent by the resident
and surgeon with the patient? If the surgeon is not present for the key
portion of the visit, should the resident report the service? If we
value services without accounting for services provided by residents
that would otherwise be furnished by the surgeon in non-teaching
settings, subsequent valuations based upon the data we collect may
underestimate the resources used, particularly for the types of
surgeries typically furnished in teaching facilities. However, there is
also a risk of overvaluing services if the reporting includes services
that are provided by residents when those services would otherwise be
furnished by a physician other than the surgeon, such as a hospitalist
or intensivist, and as such, should not be valued in the global
package.
e. Who Reports
In both the comments on the CY 2016 proposed rule and in the
national listening session, there was a great deal of discussion
regarding the challenges that we are likely to encounter in obtaining
adequate data to support appropriate valuation. Some indicated that a
broad sample and significant cooperation from physicians would be
necessary to understand what is happening as part of the global
surgical package. One commenter suggested that determining a
representative sample would be difficult and, due to the variability
related to the patient characteristics, it would be easier to have all
practitioners report. Many suggested that we conduct an extensive
analysis across surgical specialties with a sample that is
representative of the entire physician community and covers the broad
spectrum of the various types of physician practice to avoid problems
that biased or inadequate data collection would cause. Suggestions of
factors to account for in selecting a sample include specialty,
practice size (including solo practices), practice setting, volume of
claims, urban, rural, type of surgery, and type of health care delivery
systems. Another commenter pointed out that small sample sizes may lead
to unreliable data. On the other hand, some commenters stated that
requiring all practitioners to report this information is unreasonable
and would be an insurmountable burden. A participant acknowledged that
it would be difficult for practitioners to report on only certain
procedures, while another stated that this would not be an
administrative burden.
After considering the input of stakeholders, we are proposing that
any practitioner who furnishes a procedure that is a 10- or 90-day
global report the pre- and post-operative services furnished on a claim
using the codes proposed above. We agree with stakeholders that it is
necessary to obtain data from a broad, representative sample across
specialties, geographic location, and practice size, practice model,
patient acuity, and differing practice patterns. However, as we
struggled to develop a sampling approach that would result in
statistically reliable and valid data, it became apparent that we do
not have adequate information about how post-operative care is
delivered, how it varies and, more specifically, what drives variation
in post-operative care. In its work to develop the coding used for its
study, RAND found a range of opinions on what drives variation in post-
operative care. (The report is available on the CMS Web site under
downloads for the CY 2017 PFS proposed rule with comment period at
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 have concerns about whether a sample
could provide sufficient volume to value accurately the global package,
except in the case of a few high-volume procedures.
In addition to concerns about achieving an appropriate, sufficient,
and unbiased representative sample of practitioners, we have
significant operational concerns with collecting data from a limited
sample of practitioners or on a limited sample of services. These
include how to gain sufficient information on practitioners to
sufficiently stratify the sample, how to identify the practitioners who
must report, determining which services, and for those who practice in
multiple settings and/or with multiple groups in which settings the
practitioner would report. Establishing the rules to govern
[[Page 46198]]
which post-operative care should be reported for which procedures would
be challenging for us to develop for a random sample and difficult for
physicians to apply.
With the limited time between the issuance of the CY 2017 PFS final
rule with comment period and the beginning of reporting on January 1st,
it would be challenging to make sure that affected practitioners are
aware of the requirement to report and have an ability to determine
which post-operative care to report. If, instead, we require all
practitioners to report, we can take a uniform approach to notifying
practitioners. The national medical and coding organizations are
routinely relied upon by practitioners for information on new coding
and billing requirements and play a major role in the expeditious
adoption of new coding or billing requirements. Similarly, adjustments
to software used for medical records and coding are made by national
organizations. We have concerns that if this requirement is only
applied to a small segment of practitioners that these organizations
will not be able to ensure that the affected practitioners are aware
and easily able to comply with the requirements.
The more robust the reported data, the more accurate our ultimate
valuations can be. Given the importance of data on visits in accurate
valuations for global packages, we believe that collecting data on all
pre- and post-operative visits in the global period is the best way to
accurately value surgical procedures with global packages.
We recognize that reporting of all pre- and post-operative visits
would require submission of additional claims by those practitioners
furnishing global services, but we believe the benefits of accurate
data for valuation of services merits the imposition of this
requirement. By using the claims system to report the data, we believe
the additional burden is minimized. Stakeholders have reported that
many practitioners are already required by their practice or health
care system to report a code for each visit for internal control
purposes and some of these systems already submit claims for these
services, which are denied. For these practices, the additional burden
would be minimal. We believe that requiring only some physicians to
report this information, or requiring reporting for only some services,
could actually be more burdensome to physicians than requiring this
information from all physicians on all services because of the
additional steps necessary to determine whether a report is required
for a particular service and adopting a mechanism to assure that data
is collected and reported when required. Moreover, we believe the
challenges with implementing a limited approach at the practice level
as compared to a requirement for all global services would result in
less reliable data being reported.
As we analyze the data collected and make decisions about
valuations, we would reassess the data needed and what should be
required from whom. Under section 1848(c)(8)(B)(ii) of the Act, we are
required to reassess every 4 years whether continued collection of
these data is needed. However, we can modify through rulemaking what
data is collected at any time, as appropriate. By collecting data on
all procedures with a 10- or 90-day global package, we would have the
information to assess whether the post-operative care furnished varies
by factors such as specialty, geography, practice setting, and practice
size, and thus, the information needed for a selection of a
representative sample. By initially collecting information from all
practitioners that furnish surgical services, we believe we would be
able to reduce required reporting in the future if we find that
adequate information can be obtained by selective reporting. Without
the broader set of data we would not be able to evaluate the
variability of pre- and post-operative care in order to identify a
useful targeted data collection.
While section 1848(c)(8)(B) of the Act requires us to collect data
from a representative sample of physicians on the number and level of
visits provided during the global period, it does not prohibit us from
collecting data from a broad set of physicians. In addition, section
1848(c)(2)(M) of the Act authorizes the collection of data from a wide
range of physicians. Given the benefits of more robust data, including
avoiding sample bias, obtaining more accurate data, and facilitating
operational simplicity, we believe collecting data on all post-
operative care initially is the best way to undertake an accurate
valuation of surgical services in the future.
(1) Survey of Practitioners
We agree with commenters that we need more information than is
currently provided on claims and that we should utilize a number of
different data sources and collection approaches to collect the data
needed to assess and revalue global surgery services. In addition to
the claims-based reporting, we are proposing to survey a large,
representative sample of practitioners and their clinical staff in
which respondents would report information about approximately 20
discrete pre-operative and post-operative visits and other global
services like care coordination and patient training. The proposed
survey would produce data on a large sample of pre-operative and post-
operative visits and is being designed so that we could analyze the
data collected in conjunction with the claims-based data that we would
be collecting. We expect to obtain data from approximately 5,000
practitioners.
We have contracted with RAND to develop and, if our proposal is
finalized, conduct this survey. RAND would also assist us in analyzing
data collected under this survey and the claims-based data. While the
primary data collection would be via a survey instrument, RAND would
conduct semi-structured interviews and direct observations of data in a
small number of pilot sites to inform survey design, validate survey
results, and collect information that is not conducive to survey-based
reporting.
Our proposed sampling approach would sample practitioners rather
than for procedures or visits to streamline survey data collection and
minimize respondent burden. Specifically, we propose to representative
and random sample from a frame of providers who billed Medicare for
more than a minimum threshold of surgical procedures with a 10- or 90-
day global period (for example, 200 procedures) in the most recent
available prior year of claims data. We expect to survey approximately
5,000 practitioners, stratified by specialty, geography, and practice
type. Based upon preliminary analysis we believe this number of
participants will allow us to collect information on post-operative
care following the full range of CPT level-2 surgical procedure code
groups. A smaller sample size would reduce the precision of estimates
from the survey and more importantly risk missing important differences
in post-operative care for specific specialties or following different
types of surgical procedures. We expect a response rate in excess of 50
percent.
We are not proposing that respondents report on the entire period
of post-operative care for individual patients, as a 90-day follow-up
window (for surgeries currently with a 90-day global period) is too
long to implement practically in this study setting and would be more
burdensome to practitioners. Instead, we propose to collect information
on a range of different post-operative services resulting from
surgeries furnished by
[[Page 46199]]
the in-sample practitioner prior to or during a fixed reporting period.
Each sampled practitioner will be assigned to a specified and brief
(for example, 2-week) reporting period. Given the proposed overall data
collection period, the selected sample of providers will be randomly
divided into 6 subsets within each specialty, each of which will be
assigned to a specified reporting period. Practitioners will be asked
to describe 20 post-operative visits furnished to Medicare
beneficiaries or other patients during the reporting period. The
information collected through the survey instrument, which will be
developed based upon direct observation and discussions in a small
number of pilot sites, will include contextual information to describe
the background for the post-operative care, including, for example:
Procedure codes(s) and date of service for procedure upon
which the global period is based.
Procedure place of service (type).
Whether or not there were complications during or after
the procedure.
The number in sequence of the follow-up visit (for
example, the first visit after the procedure).
The survey instrument will also collect information on the visit in
question including, for example:
Which level of visit using the finalized no-pay codes.
Specific pre-service, face-to-face, and post-service
activities furnished during the visit.
Times for each activity.
Identify who performed each activity (physician or other
practitioner).
PE components used during the visit, for example supplies
like surgical dressings and clinical staff time.
Finally, the instrument will ask respondents to report other prior
or anticipated care furnished to the patient by the practice outside of
the context of a post-operative visit, for example non-face-to-face
services.
The survey approach will complement the claims data collection by
collecting detailed information on the activities, time, intensity, and
resources involved in delivering global services. The resulting visit-
level survey data would allow us to explore in detail the variation in
activities, time, intensity, and resources associated with global
services within and between physicians and procedures, and would help
to validate the information gathered through claims. A summary of the
work that RAND would be doing is available on the CMS Web site under
downloads for the CY 2017 PFS proposed rule with comment period at
http://www.cms.gov/physicianfeesched/downloads/.
(2) Required Participation in Data Collection
Using the authority we are provided under sections 1848(c)(8) and
1848(c)(2)(M) of the Act, we are proposing to require all practitioners
who furnish a 10- or 90-day global service to submit a claim(s)
providing information on all services furnished within the relevant
global service period in the form and manner described below, beginning
with surgical or procedural services furnished on or after January 1,
2017. We are also proposing to require participation by practitioners
selected for the broad-based survey through which we are proposing to
gather additional data needed to value surgical services, such as the
clinical labor and equipment involved that cannot be efficiently
collected on claim (see below).
Given the importance of the proposed survey effort, making sure
that we get valid data is critical. By eliminating the bias that would
be associated with using only data reported voluntarily, we believe we
will get more accurate and representative data. In addition to the
potential bias inherent in voluntary surveys, we are concerned that
relying on voluntary data reporting would limit the adequacy of the
volume of data we obtain, will require more effort to recruit
participation, and may make it impossible to obtain data for valuation
for CY 2019 as required by the statute.
Based on our previous experience with requesting voluntary
cooperation in data collection activity, voluntary participation poses
a significant challenge in data collection. Specifically, the Urban
Institute's work (under contract with us) to validate work RVUs by
conducting direct observation of the time it took to furnish certain
elements of services paid under the physician fee schedule provides
evidence of this challenge. (See https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/RVUs-Validation-Urban-Interim-Report.pdf for an interim report that describes
challenges in securing participation in voluntary data collection.)
Similarly, we routinely request invoices on equipment and supplies that
are used in furnishing services and often receive no more than one
invoice. These experiences support the idea that mandatory
participation in data collection activities is essential if we are to
collect valid and unbiased data.
Section 1848(a)(9) of the Act authorizes us, through rulemaking, to
withhold payment of up to 5 percent of the payment for services on
which the practitioner is required to report under section
1848(c)(8)(B)(i) of the Act until the practitioner has completed the
required reporting. Some commenters opposed the imposition of this
payment withhold, and others said it was too large of a penalty. While
we believe this is a way to encourage practitioners to report on claims
the information we propose to require on care that is furnished in the
global period, we are not proposing to implement this option at this
time. We believe that requiring physicians to report the information on
claims, combined with the incentive to report complete information so
that we can make appropriate revisions when we revalue payments for
global surgical services, would result in compliance with the reporting
requirements. However, we note that if we find that compliance with
required claims-based reporting is not acceptable, we would consider in
future rulemaking imposing up to a 5 percent payment withhold as
authorized by the statute.
Consistent with the requirements of section 1848(c)(2)(M) of the
Act, should the data collected under this requirement be used to
determine RVUs, we will disclose the information source and discuss the
use of such information in such determination of relative values
through future notice and comment rulemaking.
(3) Data Collection From Accountable Care Organizations (ACOs)
We are particularly interested in knowing whether physicians and
practices affiliated with ACOs expend greater time and effort in
providing post-operative global services in keeping with their goal of
improving care coordination for their assigned beneficiaries. ACOs are
organizations in which practitioners and hospitals voluntarily come
together to provide high-quality and coordinated care for their
patients. Because such organizations share in the savings realized by
Medicare, their incentive is to minimize post-operative visits while
maintaining high quality post-operative care for patients. In addition,
we believe that such organizations offer us the opportunity to gain
more in-depth information about delivery of surgical services.
We propose to collect primary data on the activities and resources
involved in delivering services in and around surgical events in the
ACO context by surveying a small number of ACOs (Pioneer and Next
Generation ACOs).
[[Page 46200]]
Similar to the approach of the more general practitioner survey, this
effort would begin with an initial phase of primary data collection
using a range of methodologies in a small number of ACOs; development,
piloting, and validation of an additional survey module specific to
ACOs. A survey of practitioners participating in approximately 4 to 6
ACOs using the survey instrument along with the additional ACO-specific
module will be used to collect data from on pre- and post-operative
visits.
(4) Conclusion
We recognize that the some of the data collection activity proposed
here varies greatly from how the data is currently gathered to support
PFS valuations for global surgery services. However, we believe the
proposed claims-based data collection is generally consistent with how
claims data is reported for other kinds of services paid under the PFS.
We believe that the authority and requirements included in the statute
through the MACRA and PAMA were intended to expand and enhance data
that might be available to enhance the accuracy of PFS payments.
Because these are new approaches to collecting data and in an area--
global surgery--where very little data has previously been collected,
we cannot describe exactly how this information would be used in
valuing services. What is clear is that the claims-based data would
provide information parallel to the kinds of claims-data used in
developing RVUs for other PFS services and that by collecting these
data, we would know far more than we do now about how post-operative
care is delivered and gain insight to support appropriate packaging and
valuation. We would include any revaluation proposals based on these
data in subsequent notice and comment rulemaking.
E. Improving Payment Accuracy for Primary Care, Care Management, and
Patient-Centered Services
1. Overview
In recent years, we have undertaken ongoing efforts to support
primary care and patient-centered care management within the PFS as
part of HHS' broader efforts to achieve better care, smarter spending
and healthier people through delivery system reform. We have recognized
the need to improve payment accuracy for primary care and patient-
centered care management over several years, especially beginning in
the CY 2012 PFS proposed rule (76 FR 42793) and continuing in each
subsequent year of rulemaking. In the CY 2012 proposed rule, we
acknowledged the limitations of the current code set that describes
evaluation & management (E/M) services within the PFS. For example, E/M
services represent a high proportion of PFS expenditures but have not
been recently revalued to account for significant changes in the
disease burden of the Medicare patient population and changes in health
care practice that are underway, to meet the current population's
health care needs. These trends in the Medicare population and health
care practice have been widely recognized in the provider community and
by health services researchers and policymakers alike.\1\ We believe
the focus of the health care system has shifted to delivery system
reforms, such as patient-centered medical homes, clinical practice
improvement, and increased investment in primary and comprehensive care
management/coordination services for chronic and other conditions. This
shift requires centralized management of patient needs and extensive
care coordination among practitioners and providers (often on a non-
face-to-face basis across an extended period of time). In contrast, the
current CPT code set is designed with an overall orientation to pay for
discrete services and procedural care as opposed to ongoing primary
care, care management and coordination, and cognitive services. It
includes thousands of separately paid, individual codes, most of which
describe highly specialized procedures and diagnostic tests, while
there are relatively few codes that describe care management and
cognitive services. Further, in the past, we have not recognized as
separately payable many existing CPT codes that describe care
management and cognitive services, viewing them as bundled and paid as
part of other services including the broadly drawn E/M codes that
describe face-to-face visits billed by physicians and practitioners in
all specialties.
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\1\ See, for example, 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.
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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 Merit-Based Incentive Payment System
(MIPS) and Alternative Payment Models (APMs) incentives under The
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L.
114-10, enacted April 16, 2015), since MIPS and many APMs will adopt
and build on PFS coding, RVUs and PFS payment as their foundation.
In CY 2013, we began by focusing on post-discharge care management
and transition of beneficiaries back into the community, establishing
new codes to pay separately for transitional care management (TCM)
services. Next we finalized new coding and separate payment beginning
in CY 2015 for chronic care management (CCM) services provided by
clinical staff. Most recently, in the CY 2016 PFS proposed rule (80 FR
41708 through 41711), we solicited public comments on three additional
policy areas of consideration: (1) Improving payment for the
professional work of care management
[[Page 46201]]
services through coding that would more accurately describe and value
the work of primary care and other cognitive specialties for complex
patients (for example, monthly timed services including care
coordination, patient/caregiver education, medication management,
assessment and integration of data, care planning); (2) establishing
separate payment for collaborative care, particularly, how we might
better value and pay for robust inter-professional consultation,
between primary care physicians and psychiatrists (developing codes to
describe and provide payment for the evidence-based psychiatric
collaborative care model (CoCM), and between primary care physicians
and other (non-mental health) specialists; and (3) assessing whether
current PFS payment for CCM services is adequate and whether we should
reduce the administrative burden associated with furnishing and billing
these services.
In the CY 2016 PFS final rule with comment period (80 FR 70919
through 70921), we summarized the many public comments we received in
response to last year's comment solicitation. Instead of the specific
policies we sought comment on, several commenters recommended an
overhaul and complete revaluation of the E/M codes through a major
research initiative akin to that undertaken when the PFS was first
established. Many other commenters recommended that, until a major
research initiative could be conducted to fully address the
deficiencies in the current E/M code set, CMS should make separate
payment under Medicare for a number of existing CPT codes to improve
payment in the areas in which we solicited comments, including the
codes used to describe complex CCM services (CPT codes 99487 and
99489). Other commenters also suggested that care management services
may be beneficial to a number of other patient populations in addition
to those transitioning into the community from an inpatient setting and
those with multiple chronic conditions.
Also in response to our CY 2016 comment solicitation, the AMA
restructured its existing CPT/RUC workgroup on these issues and
convened the relevant individual specialty societies to develop new CPT
coding that would address these issues. We understand that these
efforts are ongoing, and that at this time, two sets of new codes are
scheduled to be included in the CY 2018 CPT code set in response to our
2016 comment solicitation. One is a set of new codes describing
services furnished under the psychiatric CoCM and the other is a code
for assessment and care planning services for patients with cognitive
impairment. Several stakeholders have urged us to facilitate Medicare
payment for these and other new primary care, care management, and
cognitive services sooner than CY 2018 by proposing payment using G-
codes for CY 2017.
In response to our comment solicitation in the CY 2016 proposed
rule, MedPAC commented that the PFS is an ill-suited payment mechanism
for primary care and cognitive care generally. MedPAC recommended that
Congress replace the expired Primary Care Incentive Payment (PCIP) with
a capitated payment mechanism and expressed preference for codes like
CCM that are beneficiary-centered and do not pay for each distinct care
coordination activity.
Finally, many public commenters recommended a number of
modifications to the current CCM payment rules. According to many
commenters, current payment does not cover the cost of furnishing these
services, and therefore, the codes are underutilized. As referenced in
section II.E.3 on improving access and payment for CCM services, our
assessment of claims data for CY 2015 for CPT code 99490 suggests that
CCM services may be underutilized relative to the intended eligible
patient population.
After considering the commenters' perspective and recommendations,
as well as monitoring the ongoing efforts at the AMA/RUC and CPT to
respond with new/revised coding, for CY 2017 we are proposing a number
of changes to coding and payment policies under the PFS. These
proposals are intended to accomplish the following:
Improve payment for care management services provided in
the care of beneficiaries with behavioral health conditions (including
services for substance use disorder treatment) through new coding,
including three codes used to describe services furnished as part of
the psychiatric CoCM and one to address behavioral health integration
more broadly.
Improve payment for cognition and functional assessment,
and care planning for beneficiaries with cognitive impairment.
Adjust payment for routine visits furnished to
beneficiaries whose care requires additional resources due to their
mobility-related disabilities.
Recognize for Medicare payment the additional CPT codes
within the Chronic Care Management family (for Complex CCM services)
and adjust payment for the visit during which CCM services are
initiated (the initiating CCM visit) to reflect resources associated
with the assessment for, and development of, a new care plan.
Recognize for Medicare payment CPT codes for non-face-to-
face Prolonged E/M services by the physician (or other billing
practitioner) that are currently bundled, and increase payment rates
for face-to-face prolonged E/M services by the physician (or other
billing practitioner) based on existing RUC recommended values.
We are aware that CPT has approved a code to describe assessment
and care planning for patients with cognitive impairment; however, it
will not be ready in time for valuation in CY 2017. Therefore, we are
proposing to make payment using a G-code (GPPP6--see below) for this
service in 2017. We are also aware that CPT has approved three codes
that describe services furnished consistent with the psychiatric CoCM,
but that they will also not be ready in time for valuation in CY 2017.
We discuss these services in more detail in the next section of this
proposed rule. To facilitate separate payment for these services
furnished to Medicare beneficiaries during CY 2017, we are proposing to
make payment through the use of three G-codes (GPPP1, GPPP2, and
GPPP3--see below) that parallel the new CPT codes, as well as a fourth
G-code (GPPPX--see below) to describe services furnished using a
broader application of behavioral health integration in the primary
care setting. We intend for these to be temporary codes (for perhaps
only one year) and will consider whether to adopt and establish values
for the new CPT codes under our standard process, presumably for CY
2018. While we recognize that there may be overlap in the patient
populations for the proposed new G-codes, we note that time spent by a
practitioner or clinical staff cannot be counted more than once for any
code (or assigned to more than one patient), consistent with PFS coding
conventions.
Proposed payment for services described by new coding are as
follows (please note that the descriptions included for GPPP1, GPPP2,
and GPPP3 are from Current Procedural Terminology (CPT[supreg])
Copyright 2016 American Medical Association (and will be effective as
part of CPT codes January 1, 2018). All rights reserved):
GPPP1: Initial psychiatric collaborative care management,
first 70 minutes in the first calendar month of behavioral health care
manager activities, in consultation with a psychiatric consultant, and
directed by the treating physician or other qualified
[[Page 46202]]
health care professional, with the following required elements:
++ Outreach to and engagement in treatment of a patient directed by
the treating physician or other qualified health care professional;
++ Initial assessment of the patient, including administration of
validated rating scales, with the development of an individualized
treatment plan;
++ Review by the psychiatric consultant with modifications of the
plan if recommended;
++ Entering patient in a registry and tracking patient follow-up
and progress using the registry, with appropriate documentation, and
participation in weekly caseload consultation with the psychiatric
consultant; and
++ Provision of brief interventions using evidence-based techniques
such as behavioral activation, motivational interviewing, and other
focused treatment strategies.
GPPP2: Subsequent psychiatric collaborative care
management, first 60 minutes in a subsequent month of behavioral health
care manager activities, in consultation with a psychiatric consultant,
and directed by the treating physician or other qualified health care
professional, with the following required elements:
++ Tracking patient follow-up and progress using the registry, with
appropriate documentation;
++ Participation in weekly caseload consultation with the
psychiatric consultant;
++ Ongoing collaboration with and coordination of the patient's
mental health care with the treating physician or other qualified
health care professional and any other treating mental health
providers;
++ Additional review of progress and recommendations for changes in
treatment, as indicated, including medications, based on
recommendations provided by the psychiatric consultant;
++ Provision of brief interventions using evidence-based techniques
such as behavioral activation, motivational interviewing, and other
focused treatment strategies;
++ Monitoring of patient outcomes using validated rating scales;
and relapse prevention planning with patients as they achieve remission
of symptoms and/or other treatment goals and are prepared for discharge
from active treatment.
GPPP3: Initial or subsequent psychiatric collaborative
care management, each additional 30 minutes in a calendar month of
behavioral health care manager activities, in consultation with a
psychiatric consultant, and directed by the treating physician or other
qualified health care professional (List separately in addition to code
for primary procedure) (Use GPPP3 in conjunction with GPPP1, GPPP2).
GPPPX: Care management services for behavioral health
conditions, at least 20 minutes of clinical staff time, directed by a
physician or other qualified health care professional time, per
calendar month.
GPPP6: Cognition and functional assessment using
standardized instruments with development of recorded care plan for the
patient with cognitive impairment, history obtained from patient and/or
caregiver, by the physician or other qualified health care professional
in office or other outpatient setting or home or domiciliary or rest
home.
GPPP7: Comprehensive assessment of and care planning by
the physician or other qualified health care professional for patients
requiring chronic care management services, including assessment during
the provision of a face-to-face service (billed separately from monthly
care management services) (Add-on code, list separately in addition to
primary service).
GDDD1: Resource-intensive services for patients for whom
the use of specialized mobility-assistive technology (such as
adjustable height chairs or tables, patient lifts, and adjustable
padded leg supports) is medically necessary and used during the
provision of an office/outpatient evaluation and management visit (Add-
on code, list separately in addition to primary procedure).
Additionally, we are aware that other codes are being developed
through the CPT process. We have noted with interest that the CPT
Editorial Panel and AMA/RUC restructured the former Chronic Care
Coordination Workgroup to establish a new Emerging CPT and RUC Issues
Workgroup that we hope will continue to consider the issues raised in
this section of our CY 2017 proposed rule. We are continuing to
consider possible additional codes for CCM services that would describe
the time of the physician or other billing practitioner. We also remain
interested in whether there should be changes under the PFS to reflect
additional models of inter-professional collaboration for health
conditions, in addition to those we are proposing for behavioral health
integration.
For additional details on the coding and proposed valuation related
to these proposals, see section II.L of this proposed rule for
Valuation of Specific Codes. We note that the development of coding for
these and other kinds of services across the PFS is typically an
iterative process that responds to changes in medical practice and may
be best refined over several years, with PFS rulemaking and the
development of CPT codes as important parts of that process. Thus, we
anticipate continuing the multi-year process of implementing
initiatives designed to improve payment for, and recognize long-term
investment in, primary care, care management and cognitive services,
and patient-centered services.
2. Non-Face-To-Face Prolonged Evaluation & Management (E/M) Services
In public comments to the CY 2016 PFS proposed rule, many
commenters recommended that CMS should establish separate payment for
non-face-to-face prolonged E/M service codes that we currently consider
to be ``bundled'' under the PFS (CPT codes 99358, 99359). The CPT
descriptors are:
CPT code 99358 (Prolonged evaluation and management
service before and/or after direct patient care, first hour); and
CPT code 99359 (Prolonged evaluation and management
service before and/or after direct patient care, each additional 30
minutes (List separately in addition to code for prolonged service).
Commenters believed that separate payment for these existing CPT
codes would provide a means for physicians and other billing
practitioners to receive payment that more appropriately accounts for
time that they spend providing non-face-to-face care. We agree that
these codes would provide a means to recognize the additional resource
costs of physicians and other practitioners when they spend an
extraordinary amount of time outside the in-person office visit caring
for the individual needs of their patients. And we believe that doing
so in the context of the ongoing changes in health care practice to
meet the current population's health care needs would be beneficial for
Medicare beneficiaries and consistent with our overarching goals
related to patient-centered care.
These non-face-to-face prolonged service codes are broadly
described (although they include only time spent personally by the
physician or other billing practitioner) and have a relatively high
time threshold (the time counted must be beyond the usual service time
for the primary or companion E/M code that is also billed). We believe
this makes them sufficiently distinct from the other codes we propose
to pay in CY 2017 as part of our
[[Page 46203]]
primary care/care management/cognitive care initiative described in
this section of our proposed rule. Accordingly, beginning in CY 2017 we
propose to recognize CPT codes 99358 and 99359 for separate payment
under the PFS. We note that time could not be counted more than once
towards the provision of CPT codes 99358 or 99359 and any other PFS
service. See section II.L for a discussion of our proposed valuation of
CPT codes 99358 and 99359.
We propose to require the services to be furnished on the same day
by the same physician or other billing practitioner as the companion E/
M code. However, in reviewing the CPT guidance for CPT codes 99358 and
99359, we noted that CPT codes 99358 and 99359 should not be reported
during the same service period as complex CCM services (CPT codes
99487, 99489) or TCM services (CPT codes 99495, 99496). One reason for
excluding TCM and complex CCM services from concurrent billing would be
that, like prolonged services, TCM and complex CCM services include
substantial non-face-to-face work by the billing physician or other
practitioner (an E/M visit and/or medical decision-making of moderate
or high complexity). However, the CPT prolonged service with patient
contact codes are billable on the same day an E/M service is furnished,
and the CPT prolonged service codes without direct patient contact are
services furnished during a single day that are directly related to a
discrete face-to-face service. In contrast, TCM and CCM codes are
billed monthly and focused on a broader episode of patient care. We are
seeking public input on the intersection of the prolonged service codes
with CCM and TCM services. We are also seeking public comment on the
potential intersection of the prolonged service CPT codes 99358 and
99359 with proposed code GPPP7 (Comprehensive assessment of and care
planning for patients requiring CCM services). Specifically, we are
seeking comment regarding how distinctions among these services can be
clearly delineated, including how the prolonged time can be clearly
distinguished from typical pre- and post-service time, which is
continued to be bundled with other codes. For all of these services, we
have concerns that there may potentially be program integrity risks as
the same non-face-to-face activities could be undertaken to meet the
billing requirements for any of the above. We are seeking public
comment to help us identify the full extent of program integrity
considerations, as well as options for mitigating program integrity
risks associated with these and other potentially overlapping codes.
3. Establishing Separate Payment for Behavioral Health Integration
(BHI)
a. Psychiatric Collaborative Care Model (CoCM)
In the CY 2016 PFS final rule with comment period (80 FR 70920), we
stated that we believed the care and management for Medicare
beneficiaries with behavioral health conditions may include extensive
discussion, information sharing and planning between a primary care
physician and a specialist. We refer to this practice broadly as
``Behavioral Health Integration'' (BHI). In CY 2016 rulemaking, we
described that in recent years, many randomized controlled trials have
established an evidence base for an approach to caring for patients
with behavioral health conditions called the psychiatric Collaborative
Care Model (CoCM). A specific model for BHI, CoCM typically is provided
by a primary care team, consisting of a primary care provider and a
care manager who works in collaboration with a psychiatric consultant,
such as a psychiatrist. Care is directed by the primary care team and
includes structured care management with regular assessments of
clinical status using validated tools and modification of treatment as
appropriate. The psychiatric consultant provides regular consultations
to the primary care team to review the clinical status and care of
patients and to make recommendations. As we previously noted, several
resources have been published that describe the psychiatric CoCM in
greater detail and assess the impact of the model, including pieces
from the University of Washington (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, we expressed that we were particularly interested in
comments on how coding under the PFS might facilitate appropriate
valuation of the services furnished under the model. We also solicited
comments to assist us in considering refinements to coding and payment
to address this model in particular relative to current coding and
payment policies, as well as information related to various
requirements and aspects of these services.
After consideration of the comments, we are proposing to begin
making separate payment for services furnished using the psychiatric
CoCM beginning January 1, 2017. We are aware that CPT, recognizing the
need for new coding for services under this model of care, has approved
three codes to describe psychiatric collaborative care that is
consistent with this model, but the codes will not be ready in time for
valuation in CY 2017. Current CPT coding does not accurately describe
or facilitate appropriate payment for the treatment of Medicare
beneficiaries under this model of care. For example, under current
Medicare payment policy, there is no payment made specifically for
regular monitoring of patients using validated clinical rating scales
or for regular psychiatric caseload review and consultation that does
not involve face-to-face contact with the patient. We believe that
these resources are directly involved in furnishing ongoing care
management services to specific patients with specific needs, but they
are not appropriately recognized under current coding and payment
mechanisms. Because PFS valuation is based on the relative resource
costs of the PFS services furnished to Medicare beneficiaries, we
believe that appropriate coding for these services for CY 2017 will
facilitate accurate payment for these and other PFS services.
Therefore, we are proposing separate payment for services under the
psychiatric CoCM using three new G-codes, as detailed above: GPPP1,
GPPP2, and GPPP3, which would parallel the CPT codes that are being
created to report these services. We intend for these to be temporary
codes (for perhaps only one year) and will consider whether to adopt
and establish values for the new CPT codes under our standard process,
presumably for CY 2018.
Services in the psychiatric CoCM are provided under the direction
of a treating physician or other qualified health care professional
during a calendar month. These services are provided when a patient has
a diagnosed psychiatric disorder that requires a behavioral health care
assessment; establishing, implementing, revising, or monitoring a care
plan; and provision of brief interventions. The diagnosis may be either
pre-existing or made by the billing practitioner. These services are
reported by the treating physician or other qualified health care
[[Page 46204]]
professional and include the services of the treating physician or
other qualified health care professional, the behavioral health care
manager (see description below) who furnishes services incident to
services of the treating physician or other qualified health care
professional, and the psychiatric consultant (see description below)
whose consultative services are furnished incident to services of the
treating physician or other qualified health care professional.
Patients who are appropriate candidates to participate in the
psychiatric CoCM may have newly diagnosed conditions, need help in
engaging in treatment, have not responded to standard care delivered in
a non-psychiatric setting, or require further assessment and engagement
prior to consideration of referral to a psychiatric care setting.
Patients are treated under this model for an episode of care, defined
as beginning when the behavioral health care manager engages in care of
the patient under the appropriate supervision of the treating physician
and ending with:
The attainment of targeted treatment goals, which
typically results in the discontinuation of care management services
and continuation of usual follow-up with the treating physician or
other qualified healthcare professional; or
Failure to attain targeted treatment goals culminating in
referral to a psychiatric care provider for ongoing treatment; or
Lack of continued engagement with no psychiatric
collaborative care management services provided over a consecutive six
month calendar period (break in episode).
A new episode of care starts after a break in episode of six
calendar months or more.
The treating physician or other qualified health care professional
directs the behavioral health care manager and continues to oversee the
patient's care, including prescribing medications, providing treatments
for medical conditions, and making referrals to specialty care when
needed. Medically necessary E/M and other services may be reported
separately by the treating physician or other qualified health care
professional, or other physicians or practitioners, during the same
calendar month. Time spent by the treating physician or other qualified
health care professional on activities for services reported separately
may not be included in the services reported using GPPP1, GPPP2, and
GPPP3. The behavioral health care manager under this model of care is a
member of the treating physician or other qualified health care
professional's clinical staff with formal education or specialized
training in behavioral health (which could include a range of
disciplines, for example, social work, nursing, and psychology) who
provides care management services, as well as an assessment of needs,
including the administration of validated rating scales,\2\ the
development of a care plan, provision of brief interventions, ongoing
collaboration with the treating physician or other qualified health
care professional, maintenance of a registry,\3\ all in consultation
with a psychiatric consultant. The behavioral health care manager
furnishes these services both face-to-face and non-face-to-face, and
consults with the psychiatric consultant minimally on a weekly basis.
We would expect that the behavioral health care manager would be on-
site at the location where the treating physician or other qualified
health care professional furnishes services to the beneficiary.
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\2\ For example, see https://aims.uw.edu/resource-library/measurement-based-treatment-target.
\3\ For example, see https://aims.uw.edu/collaborative-care/implementation-guide/plan-clinical-practice-change/identify-population-based.
---------------------------------------------------------------------------
The behavioral health care manager may or may not be a professional
who meets all the requirements to independently furnish and report
services to Medicare. If otherwise eligible, then that individual may
report separate services furnished a beneficiary receiving the services
described by GPPP1, GPPP2, GPPP3, and GPPPX in the same calendar month.
These could include: psychiatric evaluation (90791, 90792),
psychotherapy (90832, 90833, 90834, 90836, 90837, 90838), psychotherapy
for crisis (90839, 90840), family psychotherapy (90846, 90847),
multiple family group psychotherapy (90849), group psychotherapy
(90853), smoking and tobacco use cessation counseling (99406, 90407),
and alcohol or substance abuse structured screening and brief
intervention services (99408, 99409). Time spent by the behavioral
health care manager on activities for services reported separately may
not be included in the services reported using time applied to GPPP1,
GPPP2, and GPPP3.
The psychiatric consultant involved in the ``incident to'' care
furnished under this model is a medical professional trained in
psychiatry and qualified to prescribe the full range of medications.
The psychiatric consultant advises and makes recommendations, as
needed, for psychiatric and other medical care, including psychiatric
and other medical diagnoses, treatment strategies including appropriate
therapies, medication management, medical management of complications
associated with treatment of psychiatric disorders, and referral for
specialty services, that are communicated to the treating physician or
other qualified health care professional, typically through the
behavioral health care manager. The psychiatric consultant does not
typically see the patient or prescribe medications, except in rare
circumstances, but can and should facilitate a referral to a
psychiatric care provider when clinically indicated.
In the event that the psychiatric consultant furnishes services to
the beneficiary directly in the calendar month described by other
codes, such as E/M services or psychiatric evaluation (90791, 90792),
the services may be reported separately by the psychiatric consultant.
Time spent by the psychiatric consultant on activities for services
reported separately may not be included in the services reported using
GPPP1, GPPP2, and GPPP3.
We also note that, although the psychiatric CoCM has been studied
extensively in the setting of specific behavioral health conditions
(for example, depression), we received persuasive comments last year
recommending that we not specify particular diagnoses required for use
of the codes for several reasons, including that: there may be overlap
in behavioral health conditions; there are concerns that there could be
modification of diagnoses to fit within payment rules which could skew
the accuracy of submitted diagnosis code data; and for many patients
for whom specialty care is not available, or who choose for other
reasons to remain in primary care, primary care treatment will be more
effective if it is provided within a model of integrated care that
includes care management and psychiatric consultation.
(1) General Behavioral Health Integration (BHI)
We recognize that the psychiatric CoCM is prescriptive and that
much of its demonstrated success may be attributable to adherence to a
set of elements and guidelines of care as described in the preceding
paragraphs. Therefore, we are proposing the use of these codes to pay
accurately for this specific model of care for the benefit of Medicare
beneficiaries, given its wide-spread adoption and recognized
effectiveness. However, we note that PFS coding, in general, does not
dictate how physicians practice medicine and believe that it should,
instead, reflect the practice of medicine. We also recognize that there
are primary care practices that are incurring, or may
[[Page 46205]]
incur, resource costs inherent to treatment of patients with similar
conditions based on other models of BHI that may benefit beneficiaries
with behavioral health conditions (see, for example, the approach
described at http://www.integration.samhsa.gov/integrated-care-models.)
These models of care include resource costs associated with care
managers and consultants that are not accurately characterized by the
descriptions in the preceding paragraphs. However, these costs are also
not included as direct PE inputs in other PFS services, such as E/M
codes. In its comment regarding the psychiatric CoCM, MedPAC noted its
preference for beneficiary-centered treatment that would allow for
flexibility in addressing patient needs, rather than approaches that
are tied to a particular model of care. MedPAC also urged CMS not to
make separate payment for each care management activity.
Therefore, to recognize the resource costs associated with
furnishing behavioral health care management services to Medicare
beneficiaries under related but different models of care without paying
for each activity separately, we are also proposing to make payment
using a new G-code that describes care management for beneficiaries
with diagnosed behavioral health conditions under a broader application
of integration in the primary care setting. We believe that for this
subset of Medicare beneficiaries, the resources associated with
medically necessary care management services are not otherwise
adequately reflected under the PFS. The proposed code is GPPPX (Care
management services for behavioral health conditions, at least 20
minutes of clinical staff time, directed by a physician or other
qualified health care professional time, per calendar month). We note
that we expect this coding to be refined over time as we receive more
information about other behavioral health care models being used and
how they are implemented.
We are seeking stakeholder input on whether we should consider
requiring a longer duration of time for this code or an add-on to the
code that would allow, for example, additional 20 minute increments. In
addition, while we recognize that services inherent to models of BHI
provided under this code may range in resource costs, we hope that
appropriate payment for these services will lead to appropriate use of
BHI models of care, which, in turn, will inform further refinement of
the valuation in the future. For additional information on proposed
valuation of these codes, see section II.L of this proposed rule.
(2) Initiating Visit for Proposed BHI Codes (GPPP1, GPPP2, GPPP3, and
GPPPX)
Similar to CCM services (see section II.E.4), we propose to require
an initiating visit for the BHI codes (both the psychiatric CoCM model
and the general BHI code), that would be billable separately from the
services themselves. We propose that the same services that can serve
as the initiating visit for CCM services (see section II.E.3 of this
proposed rule) can serve as the initiating visit for the proposed BHI
codes. The initiating visit would establish the beneficiary's
relationship with the billing practitioner (most aspects of the BHI
services would be furnished incident to the billing practitioner's
professional services), ensure the billing treating physician or other
qualified health care professional assesses the patient prior to
initiating other care management processes, and provides an opportunity
to obtain beneficiary consent (discussed below). We welcome public
comment on the types of services that are appropriate for an initiating
visit for the BHI codes, and within what timeframe the initiating visit
should be conducted prior to furnishing BHI services.
(3) Beneficiary Consent
Commenters to the CY 2016 PFS proposed rule indicated that they did
not believe a specific patient consent for BHI services is necessary
and, in fact, that requiring special informed consent for these
services may reduce access due to stigma associated with behavioral
health conditions. Instead, the commenters recommended requiring a more
general consent prior to initiating these services whereby the
beneficiary gives the initiating physician or practitioner permission
to consult with relevant specialists, which would include conferring
with a psychiatric consultant. Accordingly, we propose to require a
general beneficiary consent to consult with relevant specialists prior
to initiating these services, recognizing that applicable rules
continue to apply regarding privacy. The proposed general consent would
encompass conferring with a psychiatric consultant when furnishing the
psychiatric CoCM codes (GPPP1, GPPP2, and GPPP3) or the broader BHI
code (GPPPX). Similar to the proposed beneficiary consent process for
CCM services (see section II.E.4 of this proposed rule), we propose
that the billing practitioner must document in the beneficiary's
medical record that the beneficiary's consent was obtained to consult
with relevant specialists including a psychiatric consultant, and that,
as part of the consent, the beneficiary is informed that there is
beneficiary cost-sharing, including potential deductible and
coinsurance amounts, for both in-person and non-face-to-face services
that are provided. We welcome stakeholder comments on this proposal.
We recognize that special informed consent can also be helpful in
cases when a particular service is limited to being billed by a single
practitioner for a particular beneficiary. We do not believe that there
are circumstances where it would reasonable for multiple practitioners
to be reporting these codes during the same month. However, we are not
proposing a formal limit at this time. We are seeking comment on
whether such a limitation would be beneficial or whether there are
circumstances under which a beneficiary might reasonably receive BHI
services from more than one practitioner during a given month.
In recent months, many stakeholders have advised that we should
waive the applicable Part B coinsurance for services such as those
included in our proposed BHI codes. However, we currently lack
statutory authority to waive the coinsurance for services such as
these.
4. Reducing Administrative Burden and Improving Payment Accuracy for
Chronic Care Management (CCM) Services
Beginning in CY 2015, we implemented separate payment for chronic
care management (CCM) services under CPT code 99490 (Chronic care
management services, at least 20 minutes of clinical staff time
directed by a physician or other qualified health professional, per
calendar month, with the following required elements:
Multiple (two or more) chronic conditions expected to last
at least 12 months, or until the death of the patient;
Chronic conditions place the patient at significant risk
of death, acute exacerbation/decompensation, or functional decline;
Comprehensive care plan established, implemented, revised,
or monitored.
We finalized a proposal to make separate payment for CCM services
as one initiative in a series of initiatives designed to improve
payment for, and encourage long-term investment in, care management
services (79 FR 67715). In particular, we sought to address an issue
raised to us by the physician community, which asserted that the care
management included in many of the existing E/M services, such as
office visits, does not adequately describe the
[[Page 46206]]
typical non-face-to-face care management work required by certain
categories of beneficiaries (78 FR 43337). We began to re-examine how
Medicare should pay under the PFS for non-face-to-face care management
services that were bundled into the PFS payment for face-to-face E/M
visits, being included in the pre- and post-encounter work (78 FR
43337). In proposing separate payment for CCM, we acknowledged that,
even though we had previously considered non-face-to-face care
management services as bundled into the payment for face-to-face E/M
visits, the E/M office/outpatient visit CPT codes may not reflect all
the services and resources required to furnish comprehensive,
coordinated care management for certain categories of beneficiaries. We
stated that we believed that the resources required to furnish complex
chronic care management services to beneficiaries with multiple (that
is, two or more) chronic conditions were not adequately reflected in
the existing E/M codes. Medical practice and patient complexity
required physicians, other practitioners and their clinical staff to
spend increasing amounts of time and effort managing the care of
comorbid beneficiaries outside of face-to-face E/M visits, for example
complex and multidisciplinary care modalities that involve regular
physician development and/or revision of care plans; subsequent report
of patient status; review of laboratory and other studies;
communication with other health care professionals not employed in the
same practice who are involved in the patient's care; integration of
new information into the care plan; and/or adjustments of medical
therapy.
Therefore, in the CY 2014 PFS final rule with comment period, we
established a separate payment under the PFS for CPT code 99490 (78 FR
43341 through 43342). We sought to include a relatively broad eligible
patient population within the code descriptor, established a moderate
payment amount, and established bundled payment for concurrently new
CPT codes that were reserved for beneficiaries requiring ``complex''
CCM services (base CPT code 99487 and its add-on code 99489) (79 FR
67716 through 67719). We stated that we would evaluate the services
reported under CPT code 99490 to assess whether the service is targeted
to the right population and whether the payment amount is appropriate
(79 FR 67719). We remind stakeholders that CMS did not limit the
eligible population to any particular list of chronic conditions other
than the language in the CPT code descriptor. Accordingly, one or more
of the chronic conditions being managed through CCM services could be
chronic mental health or behavioral health conditions or chronic
cognitive disorders, as long as the chronic conditions meet the
eligibility language in the CPT code descriptor for CCM services and
the billing practitioner meets all of Medicare's requirements to bill
the code including comprehensive, patient-centered care planning for
all health conditions (see Table 11).
In finalizing separate payment for CPT code 99490, we considered
whether we should develop standards to ensure that physicians and other
practitioners billing the service would have the capability to fully
furnish the service (79 FR 67721). We sought to make certain that the
new PFS code(s) would provide beneficiary access to appropriate care
management services that are characteristic of advanced primary care,
such as patient support for chronic diseases to achieve health goals;
24/7 patient access to care and health information; receipt of
preventive care; patient, family and caregiver engagement; and timely
coordination of care through electronic health information exchange.
Accordingly, we established a set of scope of service elements and
payment rules in addition to or in lieu of those established in CPT
guidance (in the CPT code descriptor and CPT prefatory language), that
the physician or nonphysician practitioner must satisfy to fully
furnish CCM services and report CPT code 99490 (78 FR 74414 through
74427, 79 FR 67715 through 67730, and 80 FR 14854). We established
requirements to furnish a preceding qualifying visit, obtain advance
written beneficiary consent, use certified electronic health record
(EHR) technology to furnish certain elements of the service, share the
care plan and clinical summaries electronically, document specified
activities, and other items summarized in Table 11. For the CCM service
elements for which we required use of a certified EHR, the billing
practitioner must use, at a minimum, technology meeting the edition(s)
of certification criteria that is acceptable for purposes of the EHR
Incentive Programs as of December 31st of the calendar year preceding
each PFS payment year. (For the CY 2017 PFS payment year, this would
mean technology meeting the 2014 edition of certification criteria).
These elements and requirements for separately payable CCM services are
extensive and generally exceed those required for payment of codes
describing procedures, diagnostic tests, or other E/M services under
the PFS. In addition, both CPT guidance and our rules specify that only
a single practitioner who assumes the care management role for a given
beneficiary can bill CPT code 99490 per service period (calendar
month). Because the new CCM service closely overlapped with several
Medicare demonstration models of advanced primary care (the Multi-Payer
Advanced Primary Care Practice (MAPCP) demonstration and the
Comprehensive Primary Care Initiative (CPCI)), we provided that
practitioners participating in one of these two initiatives could not
be paid for CCM services furnished to a beneficiary attributed by the
initiative to their practice (79 FR 67729).
Given the non-face-to-face nature of CCM services, we also sought
to ensure that beneficiaries would receive advance notice that Part B
cost sharing applies since we currently have no legislative authority
to ``waive'' cost sharing for this service. Also since only one
practitioner can bill for CCM each service period, we believed the
beneficiary notice requirement would help prevent duplicate payment to
multiple practitioners.
Since the establishment of CPT code 99490 for separate payment of
CCM services, in a number of forums and in public comments to the CY
2016 PFS final rule (80 FR 70921), many practitioners have stated that
the service elements and billing requirements are burdensome, redundant
and prevent them from being able to provide the services to
beneficiaries who could benefit from them. Stakeholders have stated
that CPT 99490 is underutilized because it is underpaid relative to the
resources involved in furnishing the services, especially given the
extensive Medicare rules for payment, and they have suggested a number
of potential changes to our current payment rules. Stakeholders
continue to believe that many of the CCM payment rules are duplicative
of other statutory and regulatory provisions, and to recommend that we
reduce the rules and expand CCM coding and payment to distinguish among
different levels of patient complexity. We also note that section 103
of the MACRA requires CMS to assess and report to Congress (no later
than December 31, 2017) on access to CCM services by underserved rural
and racial and ethnic minority populations and to conduct an outreach/
education campaign that is underway.
Our assessment of claims data for CY 2015 for CPT code 99490
suggests that
[[Page 46207]]
CCM services may indeed be underutilized considering the number of
eligible Medicare beneficiaries. Our analysis of Medicare claims data
indicates that for CY 2015, approximately 275,000 unique Medicare
beneficiaries received the service an average of 3 times each, totaling
$37 million in allowed charges. Since CPT code 99490 describes a
minimum of 20 minutes of clinical staff time spent furnishing CCM
services during a month and does not have a time limit, and since we
currently do not separately pay the other codes in the CCM family of
CPT codes (which would provide us with utilization data on the number
of patients requiring longer service times during a billing period), we
do not know how often patients required more than 20 minutes of CCM
services per month. We also do not know their relative complexity,
other than meeting the acuity criteria in the CPT code descriptor. We
also have no way to know the relative complexity of the CCM services
furnished to beneficiaries.
In light of this stakeholder feedback and our mandate under MACRA
section 103 to encourage and report on access to CCM services, we are
proposing several changes in the payment rules for CCM services. Our
primary goal and statutory mandate is to pay as accurately as possible
for services furnished to Medicare beneficiaries based on the relative
resources required to furnish PFS services, including CCM services. In
so doing, we also expect to facilitate beneficiaries' access to
reasonable and necessary CCM services that improve health outcomes.
First, for CY 2017 we are proposing to more appropriately recognize and
pay for the other codes in the CPT family of CCM services (CPT codes
99487 and 99489 describing complex CCM), consistent with our general
practice to price services according to their relative ranking within a
given family of services. We direct the reader to section II.L of this
proposed rule for a discussion of proposed valuation for base CPT code
99487 and its add-on CPT code 99489. The CPT code descriptors are:
CPT code 99487--Complex chronic care management services,
with the following required elements:
++ Multiple (two or more) chronic conditions expected to last at
least 12 months, or until the death of the patient;
++ Chronic conditions place the patient at significant risk of
death, acute exacerbation/decompensation, or functional decline;
++ Establishment or substantial revision of a comprehensive care
plan;
++ Moderate or high complexity medical decision making;
++ 60 minutes of clinical staff time directed by a physician or
other qualified health care professional, per calendar month.
CPT code 99489--Each additional 30 minutes of clinical
staff time directed by a physician or other qualified health care
professional, per calendar month (List separately in addition to code
for primary procedure).
As CPT provides, less than 60 minutes of clinical staff time in the
service period could not be reported separately, and similarly, less
than 30 minutes in addition to the first 60 minutes of complex CCM in a
service period could not be reported. We would require 60 minutes of
services for reporting CPT code 99487 and 30 additional minutes for
each unit of CPT code 99489.
We propose to adopt the CPT provision that CPT codes 99487, 99489,
99490 may only be reported once per service period (calendar month) and
only by the single practitioner who assumes the care management role
with a particular beneficiary for the service period. That is, a given
beneficiary would be classified as eligible to receive either complex
or non-complex CCM during a given service period (calendar month), not
both, and only one professional claim could be submitted to the PFS for
CCM for that service period by one practitioner.
Except for differences in the CPT code descriptors, we propose to
require the same CCM service elements for CPT codes 99487, 99489 and
99490. In other words, all the requirements in Table 11 would apply
whether the code being billed for the service period is CPT code 99487
(plus 99489 if applicable) or CPT code 99490. These three codes would
differ in the amount of clinical staff service time provided; the
complexity of medical decision-making as defined in the E/M guidelines
(determined by the problems addressed by the reporting practitioner
during the month); and the nature of care planning that was performed
(establishment or substantial revision of the care plan for complex CCM
versus establishment, implementation, revision or monitoring of the
care plan for non-complex CCM). Billing practitioners could consider
identifying beneficiaries who require complex CCM services using
criteria suggested in CPT guidance (such as number of illnesses, number
of medications or repeat admissions or emergency department visits) or
the profile of typical patients in the CPT prefatory language, but
these would not comprise Medicare conditions of eligibility for complex
CCM.
We are proposing several changes to our current scope of service
elements for CCM, and are proposing that the same scope of service
elements, as amended, would apply to all codes used to report CCM
services beginning in 2017 (i.e., CPT codes 99487, 99489 and 99490). In
particular, we are proposing changes in the requirements for the
initiating visit, 24/7 access to care and continuity of care, format
and sharing of the care plan and clinical summaries, beneficiary
receipt of the care plan, beneficiary consent, and documentation. In
Table 11, we summarize the current scope of service elements and
payment rules for CCM and indicate whether we are proposing to retain,
remove or revise each element.
a. Initiating Visit
As provided in the CY 2014 PFS final rule with comment period (78
FR 74425) and subregulatory guidance (available at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/Payment_for_CCM_Services_FAQ.pdf), CCM must be initiated by the billing
practitioner during a ``comprehensive'' E/M visit, annual wellness
visit (AWV) or initial preventive physical exam (IPPE). This face-to-
face, initiating visit is not part of the CCM service and can be
separately billed to the PFS, but is required before CCM services can
be provided directly or under other arrangements. The billing
practitioner must discuss CCM with the patient at this visit. While
informed patient consent does not have to be obtained during this
visit, the visit is an opportunity to obtain the required consent. The
face-to-face visit included in transitional care management (TCM)
services (CPT 99495 and 99496) qualifies as a ``comprehensive'' visit
for CCM initiation. Levels 2 through 5 E/M visits (CPT 99212 through
99215) also qualify; CMS does not require the practice to initiate CCM
during a level 4 or 5 E/M visit. However CPT codes that do not involve
a face-to-face visit by the billing practitioner or are not separately
payable by Medicare (such as CPT 99211, anticoagulant management,
online services, telephone and other E/M services) do not qualify as
initiating visits. If the practitioner furnishes a ``comprehensive'' E/
M, AWV, or IPPE and does not discuss CCM with the patient at that
visit, that visit cannot count as the initiating visit for CCM.
We continue to believe that we should require an initiating visit
in advance of furnishing CCM services, separate from the services
themselves, because a face-to-face visit establishes the beneficiary's
relationship with the billing practitioner
[[Page 46208]]
(most aspects of the CCM services are furnished incident to the billing
practitioner's professional services). The initiating visit also
ensures collection of comprehensive health information to inform the
care plan. We continue to believe that the types of face-to-face
services that qualify as an initiating visit for CCM are appropriate.
We are not proposing to change the kinds of visits that can qualify as
initiating CCM visits. However we are proposing to require the
initiating visit only for new patients or patients not seen within one
year instead of for all beneficiaries receiving CCM services. We
believe this will allow practitioners with existing relationships with
patients who have been seen relatively recently to initiate CCM
services without furnishing a potentially unnecessary E/M visit. We are
seeking public comment on whether a period of time shorter than one
year would be more appropriate.
We are also proposing for CY 2017 to create a new add-on G-code
that would improve payment for visits that qualify as initiating visits
for CCM services. The code would be billable for beneficiaries who
require extensive face-to-face assessment and care planning by the
billing practitioner (as opposed to clinical staff), through an add-on
code to the initiating visit, GPPP7 (Comprehensive assessment of and
care planning by the physician or other qualified health care
professional for patients requiring chronic care management services
(billed separately from monthly care management services) (Add-on code,
list separately in addition to primary service). We propose that when
the billing practitioner initiating CCM personally performs extensive
assessment and care planning outside of the usual effort described by
the billed E/M code (or AWV or IPPE code), the practitioner could bill
GPPP7 in addition to the E/M code for the initiating visit (or in
addition to the AWV or IPPE), and in addition to the CCM CPT code 99490
(or proposed 99487 and 99489) if all requirements to bill for CCM
services are also met. See section II.L for proposed valuation of
GPPP7.
The code GPPP7 would account specifically for additional work of
the billing practitioner in personally performing a face-to-face
assessment of a beneficiary requiring CCM services, and personally
performing CCM care planning (the care planning could be face-to-face
and/or non-face-to-face) that is not already reflected in the
initiating visit itself (nor in the monthly CCM service code). We
believe GPPP7 might be particularly appropriate to bill when the
initiating visit is a less complex visit (such as a level 2 or 3 E/M
visit), although GPPP7 could be billed along with higher level visits
if the billing practitioner's effort and time exceeded the usual effort
described by the initiating visit code. It could also be appropriate to
bill GPPP7 when the initiating visit addresses problems unrelated to
CCM, and the billing practitioner does not consider the CCM-related
work he or she performs in determining what level of initiating visit
to bill. We believe that this proposal will more appropriately
recognize the relative resource costs for the work of the billing
practitioner in initiating CCM services, specifically for extensive
work assessing the beneficiary and establishing the CCM care plan that
is reasonable and necessary, and that is not accounted for in the
billed initiating visit or in the unit of the CCM service itself that
is billed for a given service period. In addition, we believe this
proposal will help ensure that the billing practitioner personally
performs and meaningfully contributes to the establishment of the CCM
care plan when the patient's complexity warrants it.
Consistent with general coding guidance, the work that is reported
under GPPP7 (including time) could not also be reported under or
counted towards the reporting of any other billed code, including any
of the monthly CCM services codes. The care plan that the practitioner
must create in order to bill GPPP7 would be subject to the same
requirements as the care plan included in the monthly CCM services,
namely it must be an electronic patient-centered care plan based on a
physical, mental, cognitive, psychosocial, functional and environmental
(re)assessment and an inventory of resources and supports; a
comprehensive care plan for all health issues. This would distinguish
it from the more limited care plan included in the BHI codes GPPP1,
GPPP2, GPPP3 or GPPPX which focus on behavioral health issues, or the
care plan included in GPPP6 which focuses on cognitive status. We are
seeking public input on potential overlap among these codes and further
clinical input as to how the assessments and care planning that is
included in them would differ.
Finally, although not part of our proposals for 2017, we have noted
with interest a recent CPT coding proposal for a code that would
potentially identify and separately pay for monthly CCM work that is
personally performed by the billing physician or other practitioner. We
will continue to follow any CPT developments in this area.
b. 24/7 Access to Care and Continuity of Care
We propose several revisions to the scope of service elements of
24/7 Access to care and Continuity of Care. We continue to believe
these elements are important aspects of CCM services, but that it would
be appropriate to improve alignment with CPT provisions and remove the
requirement for the care plan to be available remotely to individuals
providing CCM services after hours. Studies have shown that after-hours
care is best implemented as part of a larger practice approach to
access and continuity (see for example, the peer-review article
available at 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 recognize that some models of care require more significant
investment in practice infrastructure than others, for example
resources in staffing or health information technology. In addition, we
believe there is room to reduce the administrative complexity of our
current payment rules for CCM services to accommodate a range of
potential care models. In re-examining what should be included in the
CCM scope of service elements for 24/7 Access to Care and Continuity of
Care, we believe the CPT language adequately and more appropriately
describes the services that should, at a minimum, be included in these
service elements. Therefore, we propose to adopt the CPT language for
these two elements. For 24/7 Access to Care, the scope of service
element would be to provide 24/7 access to physicians or other
qualified health care professionals or clinical staff including
providing patients/caregivers with a means to make contact with health
care professionals in the practice to address urgent needs regardless
of the time of day or day of week. We believe
[[Page 46209]]
the CPT language more accurately reflects the potential role of
clinical staff or call-sharing services in addressing after-hours care
needs than our current language does. In addition, the 24/7 access
would be for ``urgent'' needs rather than ``urgent chronic care
needs,'' because we believe after-hours services typically would and
should address any urgent needs and not only those explicitly related
to the beneficiary's chronic conditions.
We recognize that health information systems that include remote
access to the care plan or the full EHR after hours, or a feedback loop
that communicates back to the primary care physician and others
involved in the beneficiary's care regarding after-hours care or advice
provided, are extremely helpful (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 continue to support and encourage the use
of interoperable EHRs or remote access to the care plan in providing
the CCM service elements of 24/7 Access to Care, Continuity of Care,
and Management of Care Transitions. However, adoption of such
technology would be optimal not only for CCM services, but also for a
number of other PFS services and procedures (including various other
care management services), and we have not required adoption of any
certified or non-certified health information technology as a condition
of payment for any other PFS service. We note that there are incentives
under other Medicare programs to adopt such information technology, and
are concerned that imposing EHR-related requirements at the service
level as a condition of PFS payment could create disparities between
these services and others under the fee schedule. Lastly, we recognize
that not all after-hours care warrants follow-up or a feedback loop
with the practitioner managing the beneficiary's care overall, and that
under particular circumstances feedback loops can be achieved through
oral, telephone or other less sophisticated communication methods.
Therefore at this time, we propose to remove the requirement that the
individuals providing CCM after hours must have access to the
electronic care plan. This proposal reflects our understanding that
flexibility in how practices can provide the requisite 24/7 access to
care, as well as continuity of care and management of care transitions,
for their CCM patients can facilitate appropriate access to these
services for Medicare beneficiaries. This proposal is not intended to
undermine the significance of standardized communication methods as
part of effective care. Instead, we recognize that other CMS
initiatives may be better mechanisms to incentivize increased
interoperability of health information systems than conditions of
payment assigned to particular services under the PFS. We also
anticipate that improved accuracy of payment for care management
services and reduced administrative burden associated with billing for
them will contribute to practitioners' capacity to invest in the best
tools for managing the care of Medicare beneficiaries.
For Continuity of Care, we currently require the ability to obtain
successive routine appointments ``with the practitioner or a designated
member of the care team,'' while CPT only references successive routine
appointments ``with a designated member of the care team.'' We do not
believe there is any practical difference between these two phrases and
therefore are proposing to omit the words ``practitioner or'' from our
requirement. The billing practitioner is a member of the CCM care team,
so the CPT language already allows for successive routine appointments
either with the billing practitioner or another appropriate member of
the CCM care team.
c. Electronic Care Plan
Based on review of extensive public comment and stakeholder
feedback, we have come to believe that we should not require
individuals providing the beneficiary with the required 24/7 access to
care for urgent needs to have access to the care plan as a condition of
CCM payment. As discussed above, we believe that in general, provision
of effective after-hours care of the beneficiary would require access
to the care plan, if not the full EHR. However, we have heard from
rural and other practices that remote access to the care plan is not
always necessary or possible because urgent care needs after-hours are
often referred to a practitioner or care team member who established
the care plan or is familiar with the beneficiary. In some instances,
the care plan does not need to be available in order to address urgent
patient needs after business hours. In addition, we have not required
the use of any certified or non-certified health information technology
in the provision of any other PFS services (including various other
care management services). We are concerned that imposing EHR-related
requirements at the service level as a condition of PFS payment could
distort the relative valuation of services priced under the fee
schedule. Therefore, we propose to change the CCM service element to
require timely electronic sharing of care plan information within and
outside the billing practice, but not necessarily on a 24/7 basis, and
to allow transmission of the care plan by fax.
We acknowledge that it is best for practitioners and providers to
have access to care plan information any time they are providing
services to beneficiaries who require CCM services. This proposal is
not intended to undermine the significance of electronic communication
methods other than fax transmission in providing effective, continuous
care. On the contrary, we believe that fax transmission, while commonly
used, is much less efficient and secure than other methods of
communicating patient health information, and we encourage
practitioners to adopt and use electronic technologies other than fax
for transmission and exchange of the CCM care plan. We continue to
believe the best means of exchange of all relevant patient health
information is through standardized electronic means. However, we
recognize that other CMS initiatives may be better mechanisms to
incentivize increased interoperability of health information systems
than conditions of payment assigned to particular services under the
PFS. We believe our proposal would still allow timely availability of
health information within and outside the practice for purposes of
providing CCM, and would simplify the rules governing provision of the
service and improve access to the service. These proposed revisions
would better align the service with appropriate CPT prefatory language,
which may reduce unnecessary administrative complexity for
practitioners in navigating the differences between CPT guidance and
Medicare rules.
d. Clinical Summaries
The CCM scope of service element Management of Care Transitions
includes a requirement for the creation and electronic transmission and
exchange of continuity of care documents referred to as ``clinical
summaries'' (see Table 11). We patterned our requirements regarding
clinical summaries after the EHR Incentive Program requirement that an
eligible professional who transitions their patient to another setting
of care or provider of care, or refers their patient to another
provider of care, should
[[Page 46210]]
provide a summary care record for each transition of care or referral.
This clinical summary includes demographics, the medication list,
medication allergy list, problem list, and a number of other data
elements if the practitioner knows them. As a condition of CCM payment,
we required standardized content for clinical summaries (that they must
be created/formatted according to certified EHR technology). For the
exchange/transport function, we did not require the use of a specific
tool or service to exchange/transmit clinical summaries, as long as
they are transmitted electronically (this can include fax only when the
receiving practitioner or provider can only receive by fax).
Based on review of extensive public comment and stakeholder
feedback, we have come to believe that we should not require the use of
any specific electronic technology in managing a beneficiary's care
transitions as a condition of payment for CCM services. Instead we are
proposing more simply to require the billing practitioner to create and
exchange/transmit continuity of care document(s) timely with other
practitioners and providers. To avoid confusion with the requirements
of the EHR Incentive Programs, and since we would no longer require
standardized content for the CCM continuity of care document(s), we
would refer to them as continuity of care documents instead of clinical
summaries. We would no longer specify how the billing practitioner must
transport or exchange these document(s), as long as it is done timely
and consistent with the Care Transitions Management scope of service
element. We welcome public input on how we should refer to these
document(s), noting that CPT does not provide model language specific
to CCM services. The proposed term ``continuity of care document(s)''
draws on CPT prefatory language for TCM services, which CPT provides
may include ``obtaining and reviewing the discharge information (for
example, discharge summary, as available, or continuity of care
document).''
Again, this proposal is not intended to undermine the significance
of a standardized, electronic format and means of exchange (other than
fax) of all relevant patient health information, for achieving timely,
seamless care across settings especially after discharge from a
facility. On the contrary, we believe that fax transmission, while
commonly used, is much less efficient and secure than other methods of
communicating patient health information, and we encourage
practitioners to adopt and use electronic technologies other than fax
for transmission and exchange of continuity of care documents in
providing CCM services. We continue to believe the best means of
exchange of all relevant patient health information is through
standardized electronic means. However, as we discussed above regarding
the CCM care plan, we have not applied similar requirements to other
PFS services specifically (including various other care management
services) and have concerns about how doing so may create disparities
between these services and others under the PFS. We also recognize that
other CMS initiatives may be better mechanisms to incentivize increased
interoperability of health information systems than conditions of
payment assigned to particular services under the PFS. However, we also
anticipate that our proposals will contribute to practitioners'
capacity to invest in the best tools for managing the care of Medicare
beneficiaries.
e. Beneficiary Receipt of Care Plan
We propose to simplify the current requirement to provide the
beneficiary with a written or electronic copy of the care plan, by
instead adopting the CPT language specifying more simply that a copy of
the care plan must be given to the patient or caregiver. While we
believe beneficiaries should and must be provided a copy of the care
plan, and that practitioners may choose to provide the care plan in
hard copy or electronic form in accordance with patient preferences, we
do not believe it is necessary to specify the format of the care plan
that must be provided as a condition of CCM payment. Additionally, we
recognize that there may be times that sharing the care plan with the
caregiver (in a manner consistent with applicable privacy and security
rules and regulations) may be appropriate.
f. Beneficiary Consent
We continue to believe that obtaining advance beneficiary consent
to receive CCM services is important to ensure the beneficiary is
informed, educated about CCM services, and is aware of applicable cost
sharing. We also believe that querying the beneficiary about whether
another practitioner is already providing CCM services helps to reduce
the potential for duplicate provision or billing of the services.
However, we believe the consent process could be simplified, and that
it should be left to the practitioner and the beneficiary to decide the
best way to establish consent. Therefore, we propose to continue to
require billing practitioners to inform the beneficiary of the
currently required information (that is, inform the beneficiary of the
availability of CCM services; inform the beneficiary that only one
practitioner can furnish and be paid for these services during a
calendar month; and inform the beneficiary of the right to stop the CCM
services at any time (effective at the end of the calendar month)).
However, we propose to specify that the practitioner could document in
the beneficiary's medical record that this information was explained
and note whether the beneficiary accepted or declined CCM services
instead of obtaining a written agreement.
We also propose to remove the language requiring beneficiary
authorization for the electronic communication of his or her medical
information with other treating providers as a condition of payment for
CCM services, because under the Health Insurance Portability and
Accountability Act (HIPAA) Privacy Rule (45 CFR 164.506), a covered
entity is permitted to use or disclose protected health information for
purposes of treatment without patient authorization. Moreover, if such
disclosure is electronic, the HIPAA Security Rule requires secure
transmission (45 CFR 164.312(e)). In previous regulations we have
reminded practitioners that for all electronic sharing of beneficiary
information in the provision of CCM services, HIPAA Privacy and
Security Rule standards apply in the usual manner (79 FR 67728).
g. Documentation
We have heard from practitioners that the requirements to document
certain information in a certified EHR format are redundant because the
CCM billing rules already require documentation of core clinical
information in a certified EHR format. Specifically, we already require
structured recording of demographics, problems, medications and
medication allergies, and the creation of a clinical summary record,
using a qualifying certified EHR; and that a full list of problems,
medications and medication allergies in the EHR must inform the care
plan, care coordination and ongoing clinical care. Therefore, we
propose to no longer require the use of a qualifying certified EHR to
document communication to and from home- and community-based providers
regarding the patient's psychosocial needs and functional deficits and
to document beneficiary consent. We would continue to require
documentation in the medical record of beneficiary consent (discussed
above) and of communication to and from home- and community-based
providers
[[Page 46211]]
regarding the patient's psychosocial needs and functional deficits.
In summary, we believe our proposed changes would retain elements
of the CCM service that are most characteristic of the changes in
medical practice toward advanced primary care, while eliminating
redundancy, simplifying provision of the services, and improving access
without compromising quality of care and beneficiary privacy or advance
notice and consent. We also anticipate that improved accuracy of
payment for care management services and reduced administrative burden
associated with billing for these services will contribute to
practitioners' capacity to invest in the best tools for managing the
care of Medicare beneficiaries.
g. CCM Requirements for Rural Health Clinics (RHCs) and Federally
Qualified Health Centers (FQHCs)
RHCs and FQHCs have been authorized to bill for CCM services since
January 1, 2016, and are paid based on the Medicare PFS national
average non-facility payment rate when CPT code 99490 is billed alone
or with other payable services on a RHC or FQHC claim. The RHC and FQHC
requirements for billing CCM services have generally followed the
requirements for practitioners billing under the PFS, with some
adaptations based on the RHC and FQHC payment methodologies.
To assure that CCM requirements for RHCs and FQHCs are not more
burdensome than those for practitioners billing under the PFS, we are
proposing revisions for CCM services furnished by RHCs and FQHCs
similar to the revisions proposed under the section above entitled,
``Reducing Administrative Burden and Improving Payment Accuracy for
Chronic Care Management (CCM) Services'' for RHCs and FQHCs.
Specifically, we propose to:
Require that CCM be initiated during an AWV, IPPE, or
comprehensive E/M visit only for new patients or patients not seen
within one year. This would replace the requirement that CCM could only
be initiated during an AWV, IPPE, or comprehensive E/M visit where CCM
services were discussed.
Require 24/7 access to a RHC or FQHC practitioner or
auxiliary staff with a means to make contact with a RHC or FQHC
practitioner to address urgent health care needs regardless of the time
of day or day of week. This would replace the requirement that CCM
services be available 24/7 with health care practitioners in the RHC or
FQHC who have access to the patient's electronic care plan to address
his or her urgent chronic care needs, regardless of the time of day or
day of the week.
Require timely electronic sharing of care plan information
within and outside the RHC or FQHC, but not necessarily on a 24/7
basis, and allow transmission of the care plan by fax. This would
replace the requirement that the electronic care plan be available on a
24/7 basis to all practitioners within the RHC or FQHC whose time
counts towards the time requirement for the practice to bill the CCM
code, and removes the restriction on allowing the care plan to be
faxed.
Require that in managing care transitions, the RHC or FQHC
creates, exchanges, and transmits continuity of care document(s) in a
timely manner with other practitioners and providers. This would
replace the requirements that clinical summaries must be created and
formatted according to certified EHR technology, and the requirement
for electronic exchange of clinical summaries by a means other than
fax.
Require that a copy of the care plan be given to the
patient or caregiver. This would remove the description of the format
(written or electronic) and allows the care plan to be provided to the
caregiver when appropriate (and in a manner consistent with applicable
privacy and security rules and regulations).
Require that the RHC or FQHC practitioner documents in the
beneficiary's medical record that all the elements of beneficiary
consent (for example, that the beneficiary was informed of the
availability of CCM services; only one practitioner can furnish and be
paid for these services during a calendar month; the beneficiary may
stop the CCM services at any time, effective at the end of the calendar
month, etc.) were provided, and whether the beneficiary accepted or
declined CCM services. This would replace the requirement that RHCs and
FQHCs obtain a written agreement that these elements were discussed,
and removes the requirement that the beneficiary provide authorization
for the electronic communication of his or her medical information with
other treating providers as a condition of payment for CCM services.
Require that communication to and from home- and
community-based providers regarding the patient's psychosocial needs
and functional deficits be documented in the patient's medical record.
This would replace the requirement to document this patient health
information in a certified EHR format.
We note that we are not proposing an additional payment adjustment
for patients who require extensive assessment and care planning as part
of the initiating visit, as payments for RHC and FQHC services are not
adjusted for length or complexity of the visit.
We believe these proposed changes would keep the CCM requirements
for RHCs and FQHCs consistent with the CCM requirements for
practitioners billing under the PFS, simplify the provision of CCM
services by RHCs and FQHCs, and improve access to these services
without compromising quality of care, beneficiary privacy, or advance
notice and consent.
Table 11--Chronic Care Management (CCM) Scope of Service Elements and Billing Requirements
----------------------------------------------------------------------------------------------------------------
CCM Scope of service element/billing Propose to Propose to
requirement retain remove Proposed revision
----------------------------------------------------------------------------------------------------------------
Initiating Visit--Initiation during an AWV, ............... ............... Initiation during an AWV, IPPE,
IPPE, or face-to-face E/M visit for all or face-to-face E/M visit
patients (Level 4 or 5 visit not required). (Level 4 or 5 visit not
required) for new patients or
patients not seen within 1
year.
Structured Recording of Patient Information ............... ............... Structured Recording of Patient
Using Certified EHR Technology--Structured Information Using Certified
recording of demographics, problems, EHR Technology--Structured
medications, medication allergies, and the recording of demographics,
creation of a structured clinical summary problems, medications and
record, using certified EHR technology. A medication allergies using
full list of problems, medications and certified EHR technology. A
medication allergies in the EHR must inform full list of problems,
the care plan, care coordination and ongoing medications and medication
clinical care. allergies in the EHR must
inform the care plan, care
coordination and ongoing
clinical care.
[[Page 46212]]
24/7 Access to Care--Access to care ............... ............... Provide 24/7 access to
management services 24/7 (providing the physicians or other qualified
beneficiary with a means to make timely health professionals or
contact with health care practitioners in clinical staff including
the practice who have access to the providing patients/caregivers
patient's electronic care plan to address with a means to make contact
his or her urgent chronic care needs with health care professionals
regardless of the time of day or day of the in the practice to address
week). urgent needs regardless of the
time of day or day of week.
Continuity of Care--Continuity of care with a ............... ............... Continuity of care with a
designated practitioner or member of the designated member of the care
care team with whom the beneficiary is able team with whom the beneficiary
to get successive routine appointments. is able to schedule successive
routine appointments.
Comprehensive Care Management--Care X ............... ...............................
management for chronic conditions including
systematic assessment of the beneficiary's
medical, functional, and psychosocial needs;
system-based approaches to ensure timely
receipt of all recommended preventive care
services; medication reconciliation with
review of adherence and potential
interactions; and oversight of beneficiary
self-management of medications.
Electronic Comprehensive Care Plan--Creation X ............... ...............................
of an electronic patient-centered care plan
based on a physical, mental, cognitive,
psychosocial, functional and environmental
(re)assessment and an inventory of resources
and supports; a comprehensive care plan for
all health issues.
Electronic Sharing of Care Plan--Must at ............... ............... Must at least electronically
least electronically capture care plan capture care plan information,
information; make this information available and make this information
on a 24/7 basis to all practitioners within available timely within and
the practice whose time counts towards the outside the billing practice
time requirement for the practice to bill as appropriate. Share care
the CCM code; and share care plan plan information
information electronically (by fax in electronically (can include
extenuating circumstance) as appropriate fax) and timely within and
with other practitioners and providers. outside the billing practice
to individuals involved in the
beneficiary's care.
Beneficiary Receipt of Care Plan--Provide the ............... ............... A copy of the plan of care must
beneficiary with a written or electronic be given to the patient or
copy of the care plan. caregiver.
Documentation of care plan provision to ............... X ...............................
beneficiary-- Document provision of the care
plan as required to the beneficiary using
certified EHR technology.
Management of Care Transitions............... ............... ............... Management of Care Transitions
Management of care transitions Management of care
between and among health care providers and transitions between and among
settings, including referrals to other health care providers and
clinicians; follow-up after an emergency settings, including referrals
department visit; and follow-up after to other clinicians; follow-up
discharges from hospitals, skilled nursing after an emergency department
facilities or other health care facilities. visit; and follow-up after
Format clinical summaries according discharges from hospitals,
to certified EHR technology (content skilled nursing facilities or
standard). other health care facilities.
Not required to use a specific tool Create and exchange/
or service to exchange/transmit clinical transmit continuity of care
summaries, as long as they are transmitted document(s) timely with other
electronically (by fax in extenuating practitioners and providers.
circumstance).
Home- and Community-Based Care Coordination-- X ............... ...............................
Coordination with home and community based
clinical service providers.
Documentation of Home- and Community-Based ............... ............... Communication to and from home-
Care Coordination--Communication to and from and community-based providers
home- and community-based providers regarding the patient's
regarding the patient's psychosocial needs psychosocial needs and
and functional deficits must be documented functional deficits must be
in the patient's medical record using documented in the patient's
certified EHR technology. medical record.
[[Page 46213]]
Enhanced Communication Opportunities-- X ............... ...............................
Enhanced opportunities for the beneficiary
and any caregiver to communicate with the
practitioner regarding the beneficiary's
care through not only telephone access, but
also through the use of secure messaging,
Internet, or other asynchronous non-face-to-
face consultation methods.
Beneficiary Consent-- ............... ............... Inform the beneficiary
Inform the beneficiary of the of the availability of CCM
availability of CCM services and obtain his services.
or her written agreement to have the Inform the beneficiary
services provided, including authorization that only one practitioner can
for the electronic communication of his or furnish and be paid for these
her medical information with other treating services during a calendar
providers. month.
Inform the beneficiary of the right Inform the beneficiary
to stop the CCM services at any time of the right to stop the CCM
(effective at the end of the calendar month) services at any time
and the effect of a revocation of the (effective at the end of the
agreement on CCM services. calendar month).
Inform the beneficiary that only one Document in the
practitioner can furnish and be paid for beneficiary's medical record
these services during a calendar month. that the required information
Document the beneficiary's written was explained and whether the
consent and authorization using certified beneficiary accepted or
EHR technology. declined the services.
----------------------------------------------------------------------------------------------------------------
5. Assessment and Care Planning for Patients With Cognitive Impairment
For CY 2017 we are proposing a G-code that would provide separate
payment to recognize the work of a physician (or other appropriate
billing practitioner) in assessing and creating a care plan for
beneficiaries with cognitive impairment, GPPP6 (Cognition and
functional assessment using standardized instruments with development
of recorded care plan for the patient with cognitive impairment,
history obtained from patient and/or caregiver, in office or other
outpatient setting or home or domiciliary or rest home). We understand
that a similar code was recently approved by the CPT Editorial Panel
and is scheduled to be included in the CY 2018 CPT code set. We intend
for GPPP6 to be a temporary code (perhaps for only one-year) and will
consider whether to adopt and establish relative value units for the
new CPT code under our standard process, presumably for CY 2018.
We reviewed the list of service elements that were proposed at CPT,
and are proposing the following as required service elements of GPPP6:
Cognition-focused evaluation including a pertinent history
and examination.
Medical decision making of moderate or high complexity
(defined by the E/M guidelines).
Functional assessment (for example, Basic and Instrumental
Activities of Daily Living), including decision-making capacity.
Use of standardized instruments to stage dementia.
Medication reconciliation and review for high-risk
medications, if applicable.
Evaluation for neuropsychiatric and behavioral symptoms,
including depression, including use of standardized instrument(s).
Evaluation of safety (for example, home), including motor
vehicle operation, if applicable.
Identification of caregiver(s), caregiver knowledge,
caregiver needs, social supports, and the willingness of caregiver to
take on caregiving tasks.
Advance care planning and addressing palliative care
needs, if applicable and consistent with beneficiary preference.
Creation of a care plan, including initial plans to
address any neuropsychiatric symptoms and referral to community
resources as needed (for example, adult day programs, support groups);
care plan shared with the patient and/or caregiver with initial
education and support.
The proposed valuation of GPPP6 (discussed in section II.E.1)
assumes that this code would include services that are personally
performed by the physician (or other appropriate billing practitioner)
and would significantly overlap with services described by certain E/M
visit codes, advance care planning services, and certain psychological
or psychiatric service codes that are currently separately payable
under the PFS. Accordingly, we propose that GPPP6 must be furnished by
the physician (or other appropriate billing practitioner) and could not
be billed on the same date of service as CPT codes 90785 (Psytx complex
interactive), 90791 (Psych diagnostic evaluation), 90792 (Psych diag
eval w/med srvcs), 96103 (Psycho testing admin by comp), 96120
(Neuropsych tst admin w/comp), 96127 (Brief emotional/behav assmt),
99201-99215 (Office/outpatient visits new), 99324-99337 (Domicil/r-home
visits new pat), 99341-99350 (Home visits new patient), 99366-99368
(Team conf w/pat by hc prof), 99497 (Advncd care plan 30 min), 99498
(Advncd care plan addl 30 min)), since these codes all reflect face-to-
face services provided by the physician or other billing practitioner
for related services that are separately payable. In addition, we are
proposing to prohibit billing of GPPP6 with other care planning
services, such as care plan oversight services (CPT code 99374), home
health care and hospice supervision (G0181, G0182), or our proposed
add-on code for comprehensive assessment and care planning by the
billing practitioner for patients requiring CCM services (GPPP7). We
are seeking comment on whether there are circumstances where multiple
care planning codes could be furnished without significant overlap. We
propose to specify that GPPP6 may serve as a companion or primary E/M
code to the prolonged service codes (those that are currently
separately paid, and those we propose to separately pay beginning in
2017), but are interested in
[[Page 46214]]
public input on whether there is any overlap among these services. We
are seeking comment on how to best delineate the post-service work for
GPPP6 from the work necessary to provide the prolonged services code.
We do not believe the services described by GPPP6 would
significantly overlap with proposed or current medically necessary CCM
services (CPT codes 99487, 99489, 99490); TCM services (99495, 99496);
or the proposed behavioral health integration service codes (GPPP1,
GPPP2, GPPP3, GPPPX). Therefore we propose that GPPP6 could be billed
on the same date-of-service or within the same service period as these
codes (CPT codes 99487, 99489, 99490, 99495, 99496, GPPP1, GPPP2,
GPPP3, GPPPX). There may be overlap in the patient population eligible
to receive these services and the population eligible to receive the
services described by GPPP6, but we believe there would be sufficient
differences in the nature and extent of the assessments, interventions
and care planning, as well as the qualifications of individuals
providing the services, to allow concurrent billing for services that
are medically reasonable and necessary. We welcome public comment on
potential overlap between GPPP6 and existing PFS billing codes, as well
as the other primary care/cognitive services addressed in this section
of the proposed rule.
6. Improving Payment Accuracy for Care of People With Disabilities
a. Background
People with disabilities face significant challenges accessing the
health care system. Medicare beneficiaries who are under age 65 with
disabilities are three times more likely to report having difficulties
finding a doctor who accepts Medicare than beneficiaries age 65 and
older.\4\ When able to find a Medicare participating physician, people
with disabilities report worse experiences than people without
disabilities on many quality measures, including those related to
patient-centered care and patient safety based on data from the
National Healthcare Disparities Report, produced by the Agency for
Healthcare Research and Quality (AHRQ).\5\ The reasons for these access
and quality disparities are multifaceted and may include a range of
payment challenges, accessibility issues with equipment and facilities,
communication obstacles, and sometimes lack of practitioner
understanding of how to assess and fully address the needs and
preferences of people with disabilities. The Equity Plan for Improving
Quality in Medicare, released last fall by CMS, highlights many
challenges in achieving better outcomes for people with disabilities.
---------------------------------------------------------------------------
\4\ The Henry J Kaiser Family Foundation. 2010. ``Medicare and
Nonelderly People with Disabilities.''
\5\ National Healthcare Disparities Report, 2013. May 2014.
Agency for Healthcare Research and Quality, Rockville, MD. The
National Healthcare Disparities Report summarizes health care
quality and access among various racial, ethnic, and income groups
and other priority populations, such as residents of rural areas and
people with disabilities.
---------------------------------------------------------------------------
One way to help improve access to high-quality physicians' services
for people with disabilities is to ensure Medicare Physician Fee
Schedule payments are based on the accurate relative resource costs of
services furnished to people with disabilities.
As described in section I.B. of this proposed rule, PFS payments
are required to be based on the relative resources involved in
furnishing a service. To determine the relative resources required to
furnish a service described by a specific HCPCS code, CMS considers the
``typical'' Medicare service described by that code, and identifies the
resources involved in that scenario. This approach assumes that while
practitioners might incur greater or fewer costs in furnishing any
specific service to any particular beneficiary, RVUs are allocated
appropriately based on a ``typical'' Medicare case-mix.
For HCPCS codes that describe narrowly-defined procedures and
tests, PFS payment rates based on the typical resources may be accurate
for most kinds of practitioners and many beneficiaries, because the
granularity of coding corresponds with practitioners' use of resources
based on the specific medical needs of their patients. However, the
HCPCS codes that describe the office/outpatient E/M services are
broadly defined, so the typical service billed using one of those HCPCS
codes matches a much smaller percentage of all the services billed
using that HCPCS code. Medicare payment rates for these kinds of
services under the PFS do not vary by the population being served, or
by the particular practitioner furnishing the services. Payment for
these kinds of service vary only based on the delineations among the
level of visits, despite the reality that adequately serving certain
patients requires much greater resources in ways that are generally not
reflected in the described differentiation between visit levels.
For example, the same codes and rates are used to pay for routine
care of all patients, including furnishing care to patients with
disabilities that often require greater resources relating to
equipment, clinical staff, and physician time relative to the resource
costs associated with providing the same kind of care to other Medicare
beneficiaries. Thus, the payment rate for the code may not accurately
reflect the resources involved in providing the service to certain
categories of beneficiaries. For these reasons, the resources involved
in furnishing care, including and especially routine care of both acute
and chronic illness, to beneficiaries with disabilities may be
routinely and systematically underestimated under PFS payment made on
the basis of the broadly described visit codes. This effectively
reduces overall payment relative to resource needs for practitioners
who more frequently serve such patients, which could negatively impact
access or quality of care for beneficiaries with disabilities.
b. Establishing a HCPCS G-Code To Improve Payment Accuracy for Care of
People With Mobility-Related Disabilities
We estimate that about 7 percent of all Medicare beneficiaries have
a potentially disabling mobility-related diagnosis (the Medicare-only
prevalence is 5.5 percent and the prevalence for Medicare-Medicaid dual
eligible beneficiaries is 11 percent), using 2010 Medicare (and for
dual eligible beneficiaries, Medicaid) claims data.
When a beneficiary with a mobility-related disability goes to a
physician or other practitioner's office for an E/M visit, the
resources associated with providing the visit can exceed the resources
required for the typical E/M visit. An E/M visit for a patient with a
mobility-related disability can require more physician and clinical
staff time to provide appropriate care because the patient may require
skilled assistance throughout the visit to carefully move and adjust
his/her body. Furthermore, an E/M visit for a patient with a mobility-
related disability commonly requires specialized equipment such as a
wheel chair accessible scale, floor and overhead lifts, a movable exam
table, padded leg supports, a stretcher and transfer board. The current
E/M visit payment rates, based on an assumption of ``typical''
resources involved in furnishing an E/M visit to a ``typical'' patient,
do not accurately reflect these additional resources associated with
furnishing appropriate care to many beneficiaries with mobility-related
disabilities.
When furnishing E/M services to beneficiaries with mobility-related
[[Page 46215]]
disabilities, practitioners face difficult choices in deciding whether
to take the extra time necessary and invest in the required specialized
equipment for these visits even though the payment rate for the service
does not account for either expense; potentially providing less than
optimal care for a beneficiary whose needs exceed the standard
appointment block of time in the standard equipped exam room reflected
in the current E/M visit payment rate; or declining to accept
appointments altogether for beneficiaries who require additional time
and specialized equipment.
Each of these scenarios is potentially problematic. The first two
scenarios suggest that the quality of care for this beneficiary
population might be compromised by assumptions under the PFS regarding
relative resource costs in furnishing services to this population. The
third scenario reflects an obvious access problem for these
beneficiaries. To improve payment accuracy and help ameliorate
potential disparity in access and quality for beneficiaries with
mobility-related disabilities, we propose to create a new add-on G-
code, effective for CY 2017, to describe the additional services
furnished in conjunction with E/M services to beneficiaries with
disabilities that impair their mobility:
GDDD1: Resource-intensive services for patients for whom
the use of specialized mobility-assistive technology (such as
adjustable height chairs or tables, patient lifts, and adjustable
padded leg supports) is medically necessary and used during the
provision of an office/outpatient evaluation and management service
visit (Add-on code, list separately in addition to primary procedure).
Effective January 1, 2017, we propose that this add-on code could
be billed with new and established patient office/outpatient E/M codes
(CPT codes 99201 through 99205, and 99212 through 99215), as well as
transitional care management codes (CPT codes 99495 and 99496), when
the additional resources described by the code are medically necessary
and used in the provision of care. In addition to seeking comment on
this proposal, we are also seeking comment on other HCPCS codes that
may be appropriate base codes for this proposed add-on code, including
those describing preventive visits and services. We remind potential
commenters that the rationale for this proposal is based in large part
on the broad use and lack of granularity in coding for E/M services
relative to other PFS services in conjunction with the additional
resources used.
The proposed inputs and valuation for this code are detailed in
section II.L of this proposed rule.
c. Soliciting Comment on Other Coding Changes To Improve Payment
Accuracy for Care of People With Disabilities
When furnishing care to a beneficiary with a mobility-related
disability, the current E/M visit payment rates may not fully reflect
the associated resource costs that are being incurred by practitioners.
We recognize that there are other populations for which payment
adjustment may be appropriate. Our proposal regarding beneficiaries
with mobility-related disabilities reflects the discrete nature of the
additional resource costs for this population, the clear lack of
differentiation in resource costs regarding particular kinds of
frequently-furnished services, and the broad recognition of access
problems. We recognize that some physician practices may frequently
furnish services to particular populations for which the relative
resource costs are similarly systemically undervalued and we seek
comment regarding other circumstances where these dynamics can be
discretely observed.
7. Supervision for Requirements for Non-Face-to-Face Care Management
Services
Our current regulations in Sec. 410.26(b) provide for an exception
to allow general supervision of CCM services (and similarly, for the
non-face-to-face portion of TCM services), because these are non-face-
to-face care management/care coordination services that would commonly
be provided by clinical staff when the billing practitioner, and hence,
the supervising physician, is not physically present; and the CPT codes
are comprised solely (or largely) of non-face-to-face services provided
by clinical staff. A number of codes that we are proposing to establish
for separate payment in CY 2017 under our initiative to improve payment
accuracy for primary care and care management are similar to CCM
services in that a critical element of the services is non-face-to-face
care management/care coordination services provided by clinical staff
when the billing practitioner may not be physically present.
Accordingly, we are proposing to amend Sec. 410.26(a)(3) and Sec.
410.26 (b) to better define general supervision and to allow general
supervision not only for CCM services and the non-face-to-face portion
of TCM services, but also for proposed codes GPPP1, GPPP2, GPPP3,
GPPPX, CPT code 99487, and CPT code 99489. Instead of adding each of
these proposed codes requiring general supervision to the regulation
text on an individual basis, we propose to revise our regulation under
paragraph (b)(1) of Sec. 410.26 to allow general supervision of the
non-face-to-face portion of designated care management services, and we
would designate the applicable services through notice and comment
rulemaking.
F. Improving Payment Accuracy for Services: Diabetes Self-Management
Training (DSMT)
Section 1861(s)(2)(S) of the Act specifies that medical and other
health services include DSMT services as defined in section 1861(qq) of
the Act. DSMT services are intended to educate beneficiaries in the
successful self-management of diabetes. DSMT includes, as applicable,
instructions in self-monitoring of blood glucose; education about diet
and exercise; an insulin treatment plan developed specifically for the
patient who is insulin-dependent; and motivation for patients to use
the new skills for self-management (see Sec. 410.144(a)(5)). DSMT
services are reported under HCPCS codes G0108 (Diabetes outpatient
self-management training services, individual, per 30 minutes) and
G0109 (Diabetes outpatient self- management training services, group
session (2 or more), per 30 minutes). The benefit, as specified at
Sec. 410.141, consists of 1 hour of individual and 9 hours of group
training unless special circumstances warrant more individual training
or no group session is available within 2 months of the date the
training is ordered.
Section 1861(qq) of the Act specifies that DMST services are
furnished by a certified provider, defined as a physician or other
individual or entity that also provides, in addition to DSMT, other
items or services for which payment may be made under Medicare. The
physician, individual or entity that furnishes the training also must
meet certain quality standards. The physician, individual or entity can
meet standards established by us or standards originally established by
the National Diabetes Advisory Board and subsequently revised by
organizations who participated in their establishment, or can be
recognized by an organization that represents individuals with diabetes
as meeting standards for furnishing the services.
We require that all those who furnish DSMT services be accredited
as meeting quality standards by a CMS-approved national accreditation
organization (NAO). In accordance with Sec. 410.144, a CMS-approved
NAO may accredit an
[[Page 46216]]
individual, physician or entity to meet one of three sets of DSMT
quality standards: CMS quality standards; the National Standards for
Diabetes Self-Management Education Programs (National Standards); or
the standards of an NAO that represents individuals with diabetes that
meet or exceed our quality standards. Currently, we recognize the
American Diabetes Association and the American Association of Diabetes
Educators as approved NAOs, both of whom follow National Standards.
Medicare payment for outpatient DSMT services is made in accordance
with Sec. 414.63.
An article titled ``Use of Medicare's Diabetes Self-Management
Training Benefit'' was published in the Health Education Behavior on
January 23, 2015. The article noted that only 5 percent of Medicare
beneficiaries with newly diagnosed diabetes used DSMT services. The
article recommended that future research identify barriers to DSMT
access.
We understand there are a number of issues that may contribute to
the low utilization of these services. Some of the issues that have
been brought to our attention by the DSMT community and NAOs are:
Concerns that claims have been rejected or denied because
of confusion about the credentials of the individuals who furnish DSMT
services. In entities following the National Standards, the credentials
of the educators actually providing the training are determined by the
NAO and are not to be determined by the Medicare Administrative
Contractor. Many individuals who actually furnish DSMT services, such
as registered nurses and pharmacists, do not qualify to enroll in
Medicare as certified providers, as that term is defined at section
1861(qq)(2)(A) of the Act, and codified in our regulations at Sec.
410.140 as approved entit(ies).
Questions about when individual (rather than group) DSMT
services are available. As noted above, the benefit consists of 1 hour
of individual and 9 hours of group training unless special
circumstances warrant more individual training or no group session is
available within 2 months of the date the training is ordered. The
special circumstances are when the beneficiary's physician or qualified
NPP documents in the beneficiary's medical record that the beneficiary
has special needs resulting from conditions such as severe vision,
hearing, or language limitations that would hinder effective
participation in a group training session. In all cases, however, the
physician or NPP must order individual training.
Concerns that the Medicare Benefit Policy Manual, Chapter
15, section 300 does not clarify the settings and locations in which
DSMT services may be provided. As a result, some providers (and perhaps
some Medicare contractors) are confused. In regard to this issue, we
note that a forthcoming manual update will reiterate the guidance we
provided to the DSMT community, including the NAOs, in a response to
their letter requesting clarification regarding the settings and
locations in which DSMT services can be provided. The manual update
will clarify that: (a) In the case of DSMT services furnished by an
entity that submits professional claims to the A/B Medicare
Administrative Contractor (MAC), such as a physician's office or an
RD's practice, DSMT services may be furnished at alternate locations
used by the entity as a practice location; and (b) when the DSMT
services are furnished by an entity that is a hospital outpatient
department (HOPD), these DSMT services must be furnished in the
hospital (including a provider-based department) and cannot be
furnished at alternate non-hospital locations. We plan to address and
clarify the above issues through Medicare program instructions as
appropriate. We also recognize the possibility that Medicare payment
for these services may not fully reflect the resources required to
provide them and this may be contributing to relatively low
utilization. There may also be other barriers to access of which we are
not aware. We are seeking public comment on such barriers to help us
identify and address them. We also seek comment and information on
whether Medicare payment for these services is accurate. In particular,
we would appreciate information on the time and intensity of services
provided, and on the services and supplies that should be included in
the calculation of practice expenses. We will consider this information
to determine whether to propose an update to resource inputs used to
develop payment rates for these services in future rulemaking.
G. Target for Relative Value Adjustments for Misvalued Services
Section 1848(c)(2)(O) of the Act establishes an annual target for
reductions in PFS expenditures resulting from adjustments to relative
values of misvalued codes. Under section 1848(c)(2)(O)(ii) of the Act,
if the estimated net reduction in expenditures for a year as a result
of adjustments to the relative values for misvalued codes is equal to
or greater than the target for that year, reduced expenditures
attributable to such adjustments shall be redistributed in a budget-
neutral manner within the PFS in accordance with the existing budget
neutrality requirement under section 1848(c)(2)(B)(ii)(II) of the Act.
The provision also specifies that the amount by which such reduced
expenditures exceeds the target for a given year shall be treated as a
net reduction in expenditures for the succeeding year, for purposes of
determining whether the target has been met for that subsequent year.
Section 1848(c)(2)(O)(iv) of the Act defines a target recapture amount
as the difference between the target for the year and the estimated net
reduction in expenditures under the PFS resulting from adjustments to
RVUs for misvalued codes. Section 1848(c)(2)(O)(iii) of the Act
specifies that, if the estimated net reduction in PFS expenditures for
the year is less than the target for the year, an amount equal to the
target recapture amount shall not be taken into account when applying
the budget neutrality requirements specified in section
1848(c)(2)(B)(ii)(II) of the Act. Under section 1848(c)(2)(O)(v) of the
Act, the target that applies to calendar years (CYs) 2017 and 2018 is
calculated as 0.5 percent of the estimated amount of expenditures under
the PFS for the year.
In CY 2016 PFS rulemaking, we proposed and finalized a methodology
to implement this statutory provision.
Because the annual target is calculated by measuring changes from
one year to the next, for CY 2016, we considered how to account for
changes in values that are best measured over 3 years, instead of 2
years. As we described in the CY 2016 final rule with comment period
(80 FR 70932), our general valuation process for potentially misvalued,
new, and revised codes was to establish values on an interim final
basis for a year in the PFS final rule with comment period. Then,
during the 60-day period following the publication of the final rule
with comment period, we would accept public comment about those
valuations. In the final rule with comment period for the subsequent
year, we would consider and respond to public comments received on the
interim final values, and make any appropriate adjustments to values
based on those comments. Under that process for revaluing new, revised,
and misvalued codes, we believe the overall change in valuation for
many codes would best measured across values for 3 years: Between the
original value in the first year; the interim final value in the second
year; and the finalized value in the third year. However, the target
calculation for a year would only be comparing changes in RVUs between
2 years and not among 3 years, so the
[[Page 46217]]
contribution of a particular change towards the target for any single
year would be measured against only the preceding year without regard
to the overall change that takes place over 3 years.
For recent years, interim final values for misvalued codes (year 2)
have generally reflected reductions relative to original values (year
1), and for most codes, the interim final values (year 2) are
maintained and finalized (year 3). However, when values for particular
codes have changed between the interim final (year 2) and final values
(year 3) based on public comment, the general tendency has been that
codes increase in the final value (year 3) relative to the interim
final value (year 2), even in cases where the final value (year 3)
represents a decrease from the original value (year 1). Therefore, for
these codes, the year 2 changes compared to year 1 would risk over-
representing the overall reduction, while the year 3 to year 2 changes
would represent an increase in value. We noted that if there were
similar targets in every PFS year, and a similar number of misvalued
code changes made on an interim final basis, the incongruence in
measuring what is really a 3-year change in 2-year increments might not
be particularly problematic since each year's calculation would
presumably include a similar number of codes measured between years 1
and 2 and years 2 and 3.
However, including changes that take place over 3 years generated
challenges in calculating the target for CY 2016. Because there was no
target for CY 2015, any reductions that occurred on an interim final
basis for CY 2015 were not counted toward achievement of a target. If
we had then included any upward adjustments made to these codes based
on public comment as ``misvalued code'' changes for CY 2016, we would
effectively be counting the service-level increases for 2016 (year 3)
relative to 2015 (year 2) against achievement of the target without any
consideration to the service-level changes relative to 2014 (year 1),
even in cases where the overall change in valuation was negative.
Therefore, we proposed and finalized the decision to exclude code-
level input changes for CY 2015 interim final values from the
calculation of the CY 2016 misvalued code target since the misvalued
change occurred over multiple years, including years not applicable to
the misvalued code target provision.
For the CY 2017 final rule with comment period, we will be
finalizing values (year 3) for codes that were interim final in CY 2016
(year 2). Unlike codes that were interim final for CY 2015, the codes
that are interim final for CY 2016 were included as misvalued codes and
will fall within the range of years for which the misvalued code target
provision applies. Thus, overall changes in values for these codes
would be measured in the target across 3 full years: The original value
in the first year (CY 2015); the interim final value in the second year
(CY 2016); and the finalized value in the third year (CY 2017). The
changes in valuation for these CY 2016 interim final codes were
previously measured and counted towards the target during their initial
change in valuation between years 1 and 2.
As such, we are proposing to include changes in values of the CY
2016 interim final codes toward the CY 2017 misvalued code target. We
believe that this is consistent with the approach that we finalized in
last year's final rule with comment period. The changes in values of CY
2015 interim final codes were not counted towards the misvalued code
target in CY 2016 since the valuation change occurred over multiple
years, including years not applicable to the misvalued code target
provision. However, both of the changes in valuation for the CY 2016
interim final codes, from year 1 to year 2 (CY 2015 to CY 2016) and
from year 2 to year 3 (CY 2016 to CY 2017), have taken place during
years that occur within the misvalued code target provision. We
therefore believe that any adjustments made to these codes based on
public comment should be considered towards the achievement of the
target for CY 2017, just as any changes in valuation for these same CY
2016 interim final codes previously counted towards the achievement of
the target for CY 2016.
We seek public comments regarding this proposal. We also remind
commenters that we have revised our process for revaluing new, revised
and misvalued codes so that we will be proposing and finalizing values
for most of the misvalued codes during a single calendar year. After
this year, there will be far fewer instances of interim final codes and
changes that are best measured over 3 years far.
We refer readers to the regulatory impact analysis section of this
proposed rule for our estimate of the proposed net reduction in
expenditures relative to the 0.5 percent target for CY 2017, and the
resulting adjustment required to be made to the conversion factor.
Additionally, we refer readers to the public use file that provides a
comprehensive description of how the target is calculated as well as
the estimated impact by code family on the CMS Web site under the
supporting data files for the CY 2017 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
H. Phase-In of Significant RVU Reductions
Section 1848(c)(7) of the Act specifies that for services that are
not new or revised codes, if the total RVUs for a service for a year
would otherwise be decreased by an estimated 20 percent or more as
compared to the total RVUs for the previous year, the applicable
adjustments in work, PE, and MP RVUs shall be phased in over a 2-year
period.
In the CY 2016 PFS rulemaking, we proposed and finalized a
methodology to implement this statutory provision. To determine which
services are described by new or revised codes for purposes of the
phase-in provision, we apply the phase-in to all services that are
described by the same, unrevised code in both the current and update
year, and exclude codes that describe different services in the current
and update year.
Because the phase-in of significant reductions in RVUs falls within
the budget neutrality requirements specified in section
1848(c)(2)(B)(ii)(II) of the Act, we estimate the total RVUs for a
service prior to the budget-neutrality redistributions that result from
implementing phase-in values. In implementing the phase-in, we consider
a 19 percent reduction as the maximum 1-year reduction for any service
not described by a new or revised code. This approach limits the year
one reduction for the service to the maximum allowed amount (that is,
19 percent), and then phases in the remainder of the reduction.
The statute provides that the applicable adjustments in work, PE,
and MP RVUs shall be phased in over a 2-year period when the RVU
reduction for a code for a year is estimated to be equal to or greater
than 20 percent. Since CY 2016 was the first year in which we applied
the phase-in transition, CY 2017 will be the first year in which a
single code could be subject to RVU reductions greater than 20 percent
for 2 consecutive years.
Under our finalized policy, the only codes that are not subject to
the phase-in are those that are new or revised, which we defined as
those services that are not described by the same, unrevised code in
both the current and update year, or by the same codes that describe
different services in the current and update year. Since CY 2016 was
the first year for which the phase-in provision applied, we did not
address how we would handle codes with
[[Page 46218]]
values that had been partially phased in during the first year, but
that have a remaining phase-in reduction of 20 percent or greater.
The significant majority of codes with reductions in RVUs that are
greater than 20 percent in year one would not be likely to meet the 20
percent threshold in a consecutive year. However, in a few cases,
significant changes (for example, in the input costs included in the
valuation of a service) could produce reductions of 20 percent or
greater in consecutive years.
We believe that a consistent methodology regarding the phase-in
transition should be applied to these cases. We propose to reconsider
in each year, for all codes that are not new or revised codes and
including codes that were assigned a phase-in value in the previous
year, whether the total RVUs for the service would otherwise be
decreased by an estimated 20 percent or more as compared to the total
RVUs for the previous year. Under this proposed policy, the 19 percent
reduction in total RVUs would continue to be the maximum one-year
reduction for all codes (except those considered new and revised),
including those codes with phase-in values in the previous year. In
other words, for purposes of the 20 percent threshold, every service is
evaluated anew each year, and any applicable phase-in is limited to a
decrease of 19 percent. For example, if we were to adopt a 50 percent
reduction in total RVUs for an individual service, the reduction in any
particular year would be limited to a decrease of 19 percent in total
RVUs. Because we do not set rates 2 years in advance, the phase-in
transition continues to apply until the year-to-year reduction for a
given code does not meet the 20 percent threshold.
We are soliciting comments regarding this proposal.
The list of codes proposed to be subject to the phase-in and the
associated proposed RVUs that result from this methodology are
available on the CMS Web site under downloads for the CY 2017 PFS
proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
I. Geographic Practice Cost Indices (GPCIs)
1. Background
Section 1848(e)(1)(A) of the Act requires us to develop separate
Geographic Practice Cost Indices (GPCIs) to measure relative cost
differences among localities compared to the national average for each
of the three fee schedule components (that is, work, PE, and
malpractice (MP)). The PFS localities are discussed in section II.E.3.
of this proposed rule. Although the statute requires that the PE and MP
GPCIs reflect the full relative cost differences, section
1848(e)(1)(A)(iii) of the Act requires that the work GPCIs reflect only
one-quarter of the relative cost differences compared to the national
average. In addition, section 1848(e)(1)(G) of the Act sets a permanent
1.5 work GPCI floor for services furnished in Alaska beginning January
1, 2009, and section 1848(e)(1)(I) of the Act sets a permanent 1.0 PE
GPCI floor for services furnished in frontier states (as defined in
section 1848(e)(1)(I) of the Act) beginning January 1, 2011.
Additionally, section 1848(e)(1)(E) of the Act provided for a 1.0 floor
for the work GPCIs, which was set to expire on March 31, 2015. Section
201 of the MACRA amended the statute to extend the 1.0 floor for the
work GPCIs through CY 2017 (that is, for services furnished no later
than December 31, 2017).
Section 1848(e)(1)(C) of the Act requires us to review and, if
necessary, adjust the GPCIs at least every 3 years. Section
1848(e)(1)(C) of the Act requires that, if more than 1 year has elapsed
since the date of the last previous GPCI adjustment, the adjustment to
be applied in the first year of the next adjustment shall be half of
the adjustment that otherwise would be made. Therefore, since the
previous GPCI update was implemented in CY 2014 and CY 2015, we are
proposing to phase in 1/2 of the latest GPCI adjustment in CY 2017.
We have completed a review of the GPCIs and are proposing new GPCIs
in this proposed rule. We also calculate a geographic adjustment factor
(GAF) for each PFS locality. The GAFs are a weighted composite of each
area's work, PE and malpractice expense GPCIs using the national GPCI
cost share weights. While we do not actually use GAFs in computing the
fee schedule payment for a specific service, they are useful in
comparing overall areas costs and payments. The actual effect on
payment for any actual service would deviate from the GAF to the extent
that the proportions of work, PE and MP RVUs for the service differ
from those of the GAF.
As noted above, section 201 of the MACRA extended the 1.0 work GPCI
floor for services furnished through December 31, 2017. Therefore, the
proposed CY 2017 work GPCIs and summarized GAFs reflect the 1.0 work
floor. Additionally, as required by sections 1848(e)(1)(G) and
1848(e)(1)(I) of the Act, the 1.5 work GPCI floor for Alaska and the
1.0 PE GPCI floor for frontier states are permanent, and therefore,
applicable in CY 2017. See Addenda D and E to this proposed rule for
the proposed CY 2017 GPCIs and summarized GAFs available on the CMS Web
site under the supporting documents section of the CY 2017 PFS proposed
rule located at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/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
through comparison to a national average for each. Additionally, each
of the three GPCIs relies on its own data source(s) and methodology for
calculating its value as described below. Additional information on the
CY 2017 GPCI update may be found in our contractor's draft report,
``Draft Report on the CY 2017 Update of the Geographic Practice Cost
Index for the Medicare Physician Fee Schedule,'' which is available on
our Web site. It is located under the supporting documents section for
the CY 2017 PFS proposed rule located at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/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.
[[Page 46219]]
The work GPCI updates in CYs 2001, 2003, 2005, and 2008 were based
on professional earnings data from the 2000 Census. However, for the CY
2011 GPCI update (75 FR 73252), the 2000 data were outdated and wage
and earnings data were not available from the more recent Census
because the ``long form'' was discontinued. Therefore, we used the
median hourly earnings from the 2006 through 2008 Bureau of Labor
Statistics (BLS) Occupational Employment Statistics (OES) wage data as
a replacement for the 2000 Census data. The BLS OES data meet several
criteria that we consider to be important for selecting a data source
for purposes of calculating the GPCIs. For example, the BLS OES wage
and employment data are derived from a large sample size of
approximately 200,000 establishments of varying sizes nationwide from
every metropolitan area and can be easily accessible to the public at
no cost. Additionally, the BLS OES is updated regularly, and includes a
comprehensive set of occupations and industries (for example, 800
occupations in 450 industries). For the CY 2014 GPCI update, we used
updated BLS OES data (2009 through 2011) as a replacement for the 2006
through 2008 data to compute the work GPCIs.
Because of its reliability, public availability, level of detail,
and national scope, we believe the BLS OES continues to be the most
appropriate source of wage and employment data for use in calculating
the work GPCIs (and as discussed in section II.E.2.b the employee wage
component and purchased services component of the PE GPCI). Therefore,
for the proposed CY 2017 GPCI update, we used updated BLS OES data
(2011 through 2014) as a replacement for the 2009 through 2011 data to
compute the work GPCIs.
b. Practice Expense GPCIs
The PE GPCIs are designed to measure the relative cost difference
in the mix of goods and services comprising practice expenses (not
including malpractice expenses) among the PFS localities as compared to
the national average of these costs. Whereas the physician work GPCIs
(and as discussed later in this section, the MP GPCIs) are comprised of
a single index, the PE GPCIs are comprised of four component indices
(employee wages; purchased services; office rent; and equipment,
supplies and other miscellaneous expenses). The employee wage index
component measures geographic variation in the cost of the kinds of
skilled and unskilled labor that would be directly employed by a
physician practice. Although the employee wage index adjusts for
geographic variation in the cost of labor employed directly by
physician practices, it does not account for geographic variation in
the cost of services that typically would be purchased from other
entities, such as law firms, accounting firms, information technology
consultants, building service managers, or any other third-party
vendor. The purchased services index component of the PE GPCI (which is
a separate index from employee wages) measures geographic variation in
the cost of contracted services that physician practices would
typically buy. (For more information on the development of the
purchased service index, we refer readers to the CY 2012 PFS final rule
with comment period (76 FR 73084 through 73085)). The office rent index
component of the PE GPCI measures relative geographic variation in the
cost of typical physician office rents. For the medical equipment,
supplies, and miscellaneous expenses component, we believe there is a
national market for these items such that there is not significant
geographic variation in costs. Therefore, the equipment, supplies and
other miscellaneous expense cost index component of the PE GPCI is
given a value of 1.000 for each PFS locality.
For the previous update to the GPCIs (implemented in CY 2014) we
used 2009 through 2011 BLS OES data to calculate the employee wage and
purchased services indices for the PE GPCI. As discussed in section
II.E.2.a., because of its reliability, public availability, level of
detail, and national scope, we continue to believe the BLS OES is the
most appropriate data source for collecting wage and employment data.
Therefore, in calculating the proposed CY 2017 GPCI update, we used
updated BLS OES data (2011 through 2014) as a replacement for the 2009
through 2011 data for purposes of calculating the employee wage
component and purchased service index of the PE GPCI.
c. Malpractice Expense (MP) GPCIs
The MP GPCIs measure the relative cost differences among PFS
localities for the purchase of professional liability insurance (PLI).
The MP GPCIs are calculated based on insurer rate filings of premium
data for $1 million to $3 million mature claims-made policies (policies
for claims made rather than services furnished during the policy term).
For the CY 2014 GPCI update (seventh update) we used 2011 and 2012
malpractice premium data (78 FR 74382). The proposed CY 2017 MP GPCI
update reflects 2014 and 2015 premium data. Additionally, the proposed
CY 2017 MP GPCI update reflects several proposed technical refinements
to the MP GPCI methodology as discussed later in section 5.
d. GPCI Cost Share Weights
For the proposed CY 2017 GPCIs, we are continuing to use the
current cost share weights for determining the PE GPCI values and
locality GAFs. We refer readers to the CY 2014 PFS final rule with
comment period (78 FR 74382 through 74383), for further discussion
regarding the 2006-based MEI cost share weights revised in CY 2014 that
were also finalized for use in the CY 2014 (seventh) GPCI update.
The proposed GPCI cost share weights for CY 2017 are displayed in
Table 12.
Table 12--Proposed Cost Share Weights for CY 2017 GPCI Update
------------------------------------------------------------------------
Proposed CY
Current cost 2017 cost
Expense category share weight share weight
(%) (%)
------------------------------------------------------------------------
Work.................................... 50.866 50.866
Practice Expense........................ 44.839 44.839
--Employee Compensation............. 16.553 16.553
--Office Rent....................... 10.223 10.223
--Purchased Services................ 8.095 8.095
--Equipment, Supplies, Other........ 9.968 9.968
Malpractice Insurance................... 4.295 4.295
Total............................... 100.000 100.000
------------------------------------------------------------------------
[[Page 46220]]
e. PE GPCI Floor for Frontier States
Section 10324(c) of the Affordable Care Act added a new
subparagraph (I) under section 1848(e)(1) of the Act to establish a 1.0
PE GPCI floor for physicians' services furnished in frontier states
effective January 1, 2011. In accordance with section 1848(e)(1)(I) of
the Act, beginning in CY 2011, we applied a 1.0 PE GPCI floor for
physicians' services furnished in states determined to be frontier
states. In general, a frontier state is one in which at least 50
percent of the counties are ``frontier counties,'' which are those that
have a population per square mile of less than 6. For more information
on the criteria used to define a frontier state, we refer readers to
the FY 2011 Inpatient Prospective Payment System (IPPS) final rule (75
FR 50160 through 50161). There are no changes in the states identified
as Frontier States for the CY 2017 proposed rule. The qualifying states
are: Montana, Wyoming, North Dakota, South Dakota, and Nevada. In
accordance with statute, we would apply a 1.0 PE GPCI floor for these
states in CY 2017.
f. Proposed GPCI Update
As explained above in the background section, the periodic review
and adjustment of GPCIs is mandated by section 1848(e)(1)(C) of the
Act. At each update, the proposed GPCIs are published in the PFS
proposed rule to provide an opportunity for public comment and further
revisions in response to comments prior to implementation. The proposed
CY 2017 updated GPCIs for the first and second year of the 2-year
transition, along with the GAFs, are displayed in Addenda D and E to
this proposed rule available on our Web site under the supporting
documents section of the CY 2017 PFS proposed rule Web page at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/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 proposed rule (61 FR 34615) and
the subsequent final rule with comment period (61 FR 59494). We note
that the localities generally represent a grouping of one or more
constituent counties.
Prior to 1992, Medicare payments for physicians' services were made
under the reasonable charge system. Payments were based on the charging
patterns of physicians. This resulted in large differences in payment
for physicians' services among types of services, geographic payment
areas, and physician specialties. Recognizing this, the Congress
replaced the reasonable charge system with the Medicare PFS in the
Omnibus Budget Reconciliation Act (OBRA) of 1989, and the PFS went into
effect January 1, 1992. Payments under the PFS are based on the
relative resources involved with furnishing services, and are adjusted
to account for geographic variations in resource costs as measured by
the GPCIs.
Payment localities originally were established under the reasonable
charge system by local Medicare carriers based on their knowledge of
local physician charging patterns and economic conditions. These
localities changed little between the inception of Medicare in 1967 and
the beginning of the PFS in 1992. Shortly after the PFS took effect, we
undertook a study in 1994 that culminated in a comprehensive locality
revision that was implemented in 1997 (61 FR 59494).
The revised locality structure reduced the number of localities
from 210 to the current 89, and the number of statewide localities
increased from 22 to 34. The revised localities were based on locality
resource cost differences as reflected by the GPCIs. For a full
discussion of the methodology, see the CY 1997 PFS final rule with
comment period (61 FR 59494). The current 89 fee schedule areas are
defined alternatively by state boundaries (for example, Wisconsin),
metropolitan areas (for example, Metropolitan St. Louis, MO), portions
of a metropolitan area (for example, Manhattan), or rest-of-state areas
that exclude metropolitan areas (for example, Rest of Missouri). This
locality configuration is used to calculate the GPCIs that are in turn
used to calculate payments for physicians' services under the PFS.
As stated in the CY 2011 PFS final rule with comment period (75 FR
73261), changes to the PFS locality structure would generally result in
changes that are budget neutral within a state. For many years, before
making any locality changes, we have sought consensus from among the
professionals whose payments would be affected. In recent years, we
have also considered more comprehensive changes to locality
configuration. In 2008, we issued a draft comprehensive report
detailing four different locality configuration options (https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/downloads/ReviewOfAltGPCIs.pdf). We refer readers to
the CY 2014 PFS final rule with comment period for further discussion
regarding that report, as well as a discussion about the Institute of
Medicine's empirical study of the Medicare GAFs established under
sections 1848(e) (PFS GPCI) and 1886(d)(3)(E) (IPPS wage index) of the
Act.
b. California Locality Update to the Fee Schedule Areas Used for
Payment Under Section 220(h) of the Protecting Access to Medicare Act
(1) General Discussion and Legislative Change
Section 220(h) of the PAMA added a new section 1848(e)(6) to the
Act, that modifies the fee schedule areas used for payment purposes in
California beginning in CY 2017.
Currently, the fee schedule areas used for payment in California
are based on the revised locality structure that was implemented in
1997 as previously discussed. Beginning in CY 2017, section
1848(e)(6)(A)(i) of the Act requires that the fee schedule areas used
for payment in California must be Metropolitan Statistical Areas (MSAs)
as defined by the Office of Management and Budget (OMB) as of December
31 of the previous year; and section 1848(e)(6)(A)(ii) of the Act
requires that all areas not located in an MSA must be treated as a
single rest-of-state fee schedule area. The resulting modifications to
California's locality structure would increase its number of localities
from 9 under the current locality structure to 27 under the MSA-based
locality structure.
However, section 1848(e)(6)(D) of the Act defines transition areas
as the fee schedule areas for 2013 that were the rest-of-state
locality, and locality 3, which was comprised of Marin county, Napa
county, and Solano county. Section 1848(e)(6)(B) specifies that the
GPCI values used for payment in a transition area are to be phased in
over 6 years, from 2017 through 2021, using a weighted sum of the GPCIs
calculated under the new MSA-based locality structure and the GPCIs
calculated under the current PFS locality structure. That is, the GPCI
values applicable for
[[Page 46221]]
these areas during this transition period are a blend of what the GPCI
values would have been under the current locality structure, and what
the GPCI values would be under the MSA-based locality structure. For
example, in the first year, CY 2017, the applicable GPCI values for
counties that were previously in rest-of-state or locality 3 and are
now in MSAs are a blend of 1/6 of the GPCI value calculated for the
year under the MSA-based locality structure, and 5/6 of the GPCI value
calculated for the year under the current locality structure. The
proportions shift by 1/6 in each subsequent year so that, by CY 2021,
the applicable GPCI values for counties within transition areas are a
blend of 5/6 of the GPCI value for the year under the MSA-based
locality structure, and 1/6 of the GPCI value for the year under the
current locality structure. Beginning in CY 2022, the applicable GPCI
values for counties in transition areas are the values calculated under
the new MSA-based locality structure. For the sake of clarity, we
reiterate that this incremental phase-in is only applicable to those
counties that are in transition areas that are now in MSAs, which are
only some of the counties in the 2013 California rest-of state locality
and locality 3.
Additionally, section 1848(e)(6)(C) of the Act establishes a hold
harmless for transition areas beginning with CY 2017 whereby the
applicable GPCI values for a year under the new MSA-based locality
structure may not be less than what they would have been for the year
under the current locality structure. There are a total of 58 counties
in California, 50 of which are in transition areas as defined in
section 1848(e)(6)(D) of the Act. Therefore, 50 counties in California
are subject to the hold harmless provision. The other 8 counties, which
are metropolitan counties that are not defined as transition areas, are
not held harmless for the impact of the new MSA-based locality
structure, and may therefore potentially experience slight decreases in
their GPCI values as a result of the provisions in section 1848(e)(6)
of the Act, insofar as the locality in which they are located now newly
includes data from adjacent counties that decreases their GPCI values
relative to those that would have applied had the new data not been
incorporated. Therefore, the GPCIs for these eight counties under the
MSA-based locality structure may be less than they would have been
under the current GPCI structure. The eight counties that are not
within transition areas are: Orange; Los Angeles; Alameda; Contra
Costa; San Francisco; San Mateo; Santa Clara; and Ventura counties.
We emphasize that while transition areas are held harmless from the
impact of the GPCI changes using the new MSA-based locality structure,
because we are proposing other updates for CY 2017 as part of the
eighth GPCI update, including the use of updated data, transition areas
would still be subject to impacts resulting from those other updates.
Table 13 illustrates using GAFs, for CY 2017, the isolated impact of
the MSA-based locality changes and hold-harmless for transition areas
required by section 1848(e)(6) of the Act, the impact of the proposed
use of updated data for GPCIs, and the combined impact of both of these
proposed changes.
Table 13--Impact on California GAFs as a Result of Section 1848(e)(6) of the Act and Proposed Updated Data by Fee Schedule Area
[Sorted alphabetically by locality name]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Combined
Transition 2016 2017 GAF w/o % Change due 2017 GAF w/ % Change due impact of PAMA
Medicare fee schedule area area GAF 1848(e)(6) to new GPCI 1848(e)(6) to 1848(e)(6) and new GPCI
data data (%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Bakersfield........................................ 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Chico.............................................. 1 1.04 1.031 -0.50 1.031 0.00 -0.50
El Centro.......................................... 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Fresno............................................. 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Hanford-Corcoran................................... 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Los Angeles-Long Beach-Anaheim (Los Angeles County) 0 1.09 1.09 -0.20 1.091 0.10 -0.10
Los Angeles-Long Beach-Anaheim (Orange County)..... 0 1.09 1.104 1.10 1.101 -0.30 0.80
Madera............................................. 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Merced............................................. 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Modesto............................................ 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Napa............................................... 1 1.14 1.128 -0.80 1.128 0.00 -0.80
Oxnard-Thousand Oaks-Ventura....................... 0 1.09 1.083 -0.60 1.083 0.00 -0.60
Redding............................................ 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Rest Of California................................. 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Riverside-San Bernardino-Ontario................... 1 1.04 1.031 -0.50 1.032 0.10 -0.40
Sacramento-Roseville-Arden-Arcade.................. 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Salinas............................................ 1 1.04 1.031 -0.50 1.033 0.20 -0.30
San Diego-Carlsbad................................. 1 1.04 1.031 -0.50 1.035 0.40 -0.10
San Francisco-Oakland-Hayward (Alameda/Contra Costa 0 1.18 1.125 -4.80 1.142 1.50 -3.40
County)...........................................
San Francisco-Oakland-Hayward (Marin County)....... 1 1.14 1.128 -0.80 1.129 0.10 -0.70
San Francisco-Oakland-Hayward (San Francisco 0 1.18 1.194 1.00 1.175 -1.60 -0.60
County)...........................................
San Francisco-Oakland-Hayward (San Mateo County)... 0 1.18 1.187 0.40 1.171 -1.30 -0.90
San Jose-Sunnyvale-Santa Clara (San Benito County). 1 1.04 1.031 -0.50 1.053 2.10 1.60
San Jose-Sunnyvale-Santa Clara (Santa Clara County) 0 1.18 1.176 0.10 1.175 -0.10 0.00
[[Page 46222]]
San Luis Obispo-Paso Robles-Arroyo Grande.......... 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Santa Cruz-Watsonville............................. 1 1.04 1.031 -0.50 1.042 1.10 0.60
Santa Maria-Santa Barbara.......................... 1 1.04 1.031 -0.50 1.036 0.50 0.00
Santa Rosa......................................... 1 1.04 1.031 -0.50 1.037 0.60 0.10
Stockton-Lodi...................................... 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Vallejo-Fairfield.................................. 1 1.14 1.128 -0.80 1.128 0.00 -0.80
Visalia-Porterville................................ 1 1.04 1.031 -0.50 1.031 0.00 -0.50
Yuba City.......................................... 1 1.04 1.031 -0.50 1.031 0.00 -0.50
--------------------------------------------------------------------------------------------------------------------------------------------------------
Additionally, for the purposes of calculating budget neutrality and
consistent with the PFS budget neutrality requirements as specified
under section 1848(c)(2)(B)(ii)(II) of the Act, we are proposing to
start by calculating the national GPCIs as if the current localities
are still applicable nationwide; then for the purposes of payment in
California, we will override the GPCI values with the values that are
applicable for California consistent with the requirements of section
1848(e)(6) of the Act. This approach is consistent with the
implementation of the GPCI floor provisions that have previously been
implemented--that is, as an after-the-fact adjustment that is
implemented for purposes of payment after both the GPCIs and PFS budget
neutrality have already been calculated.
(2) Proposed Operational Considerations
As discussed above, under section 1848(e)(6) of the Act, counties
that were previously in the rest-of-state locality or locality 3 and
are now in MSAs would have their GPCI values under the new MSA-based
locality structure phased in gradually, in increments of one-sixth over
6 years. Section 1848(e)(1)(C) of the Act requires that, if more than 1
year has elapsed since the date of the last previous GPCI adjustment,
the adjustment to be applied in the first year of the next adjustment
shall be 1/2 of the adjustment that otherwise would be made. While
section 1848(e)(6)(B) of the Act establishes a blended phase-in for the
MSA-based GPCI values, it does not explicitly state whether or how that
provision is to be reconciled with the requirement at section
1848(e)(1)(C) of the Act. We believe that since section 1848(e)(6)(A)
of the Act requires that we must make the change to MSA-based fee
schedule areas for California GPCIs notwithstanding the preceding
provisions of section 1848(e) of the Act, and subject to the succeeding
provisions of section 1848(e)(6) of the Act, that applying the two-year
phase-in specified by the preceding provisions simultaneously with the
six-year phase-in would undermine the incremental 6-year phase-in
specified in section 1848(e)(6)(B) of the Act. Therefore, we are
proposing that the requirement at section 1848(e)(1)(C) of the Act to
phase in \1/2\ of the adjustment in year 1 of the GPCI update would not
apply to counties that were previously in the rest-of-state or locality
3 and are now in MSAs, and therefore, are subject to the blended phase-
in as described above. Since section 1848(e)(6)(B) of the Act provides
for a gradual phase in of the GPCI values under the new MSA-based
locality structure, specifically in one-sixth increments over 6 years,
if we were to also apply the requirement to phase in 1/2 of the
adjustment in year 1 of the GPCI update then the first year increment
would effectively be one-twelfth. We note that this issue is only of
concern if more than 1 year has elapsed since the previous GPCI update,
and would only be applicable through CY 2021 since, beginning in CY
2022, the GPCI values for such areas in an MSA would be fully based on
the values calculated under the new MSA-based locality structure for
California.
As previously stated, the resulting modifications to California's
locality structure increase its number of localities from 9 under the
current locality structure to 27 under the MSA-based locality
structure. However, both the current localities and the MSA-based
localities are comprised of various component counties, and in some
localities only some of the component counties are subject to the
blended phase-in and hold harmless provisions required by section
1848(e)(6)(B) and (C) of the Act. Therefore, the application of these
provisions may produce differing GPCI values among counties within the
same fee schedule area under the MSA-based locality structure. For
example, the MSA-based San Jose-Sunnyvale-Santa Clara locality, is
comprised of 2 constituent counties--San Benito county, and Santa Clara
county. San Benito County is in a transition area (2013 rest-of-state),
while Santa Clara county is not. Hence, although the counties are in
the same MSA, the requirements of section 1848(e)(6)(B) and (C) of the
Act may produce differing GPCI values for each county. To address this
issue, we propose to assign a unique locality number to the counties
that would be impacted in the aforementioned manner. As a result,
although the modifications to California's locality structure increase
the number of localities from 9 under the current locality structure to
27 under the MSA-based locality structure, for purposes of payment, the
actual number of localities under the MSA-based locality structure
would be 32 to account for instances where unique locality numbers are
needed as described above. Additionally, while the fee schedule area
names are consistent with the MSAs designated by OMB, we are proposing
to maintain 2-digit locality numbers to correspond to the existing fee
schedule areas. Pursuant to the implementation of the new MSA-based
locality structure for California, the total number of PFS localities
would increase from 89 to 112. Table 14 displays the current fee
schedule areas in California, and Table 15 displays the MSA-based fee
schedule areas in California required by section 1848(e)(6) of the Act.
Additional information on the California locality update may be found
in our contractor's draft report, ``Draft Report on the CY 2017 Update
of the Geographic Practice Cost Index for the Medicare Physician Fee
Schedule,'' which is available on the CMS Web site.
[[Page 46223]]
It is located under the supporting documents section of the CY 2017 PFS
proposed rule located at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/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]
----------------------------------------------------------------------------------------------------------------
Proposed new
Current locality number locality Fee schedule area Counties Transition area
number (MSA name)
----------------------------------------------------------------------------------------------------------------
99............................... 54 Bakersfield, CA..... Kern................ YES.
99............................... 55 Chico, CA........... Butte............... YES.
99............................... 71 El Centro, CA....... Imperial............ YES.
99............................... 56 Fresno, CA.......... Fresno.............. YES.
99............................... 57 Hanford-Corcoran, CA Kings............... YES.
18............................... 18 Los Angeles-Long Los Angeles......... NO.
Beach-Anaheim, CA
(Los Angeles
County).
26............................... 26 Los Angeles-Long Orange.............. NO.
Beach-Anaheim, CA
(Orange County).
99............................... 58 Madera, CA.......... Madera.............. YES.
99............................... 59 Merced, CA.......... Merced.............. YES.
99............................... 60 Modesto, CA......... Stanislaus.......... YES.
3................................ 51 Napa, CA............ Napa................ YES.
17............................... 17 Oxnard-Thousand Oaks- Ventura............. NO.
Ventura, CA.
99............................... 61 Redding, CA......... Shasta.............. YES.
99............................... 75 REST OF STATE....... All Other Counties.. YES.
99............................... 62 Riverside-San Riverside, and San YES.
Bernardino-Ontario, Bernardino.
CA.
99............................... 63 Sacramento--Rosevill El Dorado, Placer, YES.
e--Arden-Arcade, CA. Sacramento, and
Yolo.
99............................... 64 Salinas, CA......... Monterey............ YES.
99............................... 72 San Diego-Carlsbad, San Diego........... YES.
CA.
7................................ 7 San Francisco- Alameda, Contra NO.
Oakland-Hayward, CA Costa.
(Alameda County/
Contra Costa
County).
3................................ 52 San Francisco- Marin............... YES.
Oakland-Hayward, CA
(Marin County).
5................................ 5 San Francisco- San Francisco....... NO.
Oakland-Hayward, CA
(San Francisco
County).
6................................ 6 San Francisco- San Mateo........... NO.
Oakland-Hayward, CA
(San Mateo County).
99............................... 65 San Jose-Sunnyvale- San Benito.......... YES.
Santa Clara, CA
(San Benito County).
9................................ 9 San Jose-Sunnyvale- Santa Clara......... NO.
Santa Clara, CA
(Santa Clara
County).
99............................... 73 San Luis Obispo-Paso San Luis Obispo..... YES.
Robles-Arroyo
Grande, CA.
99............................... 66 Santa Cruz- Santa Cruz.......... YES.
Watsonville, CA.
99............................... 74 Santa Maria-Santa Santa Barbara....... YES.
Barbara, CA.
99............................... 67 Santa Rosa, CA...... Sonoma.............. YES.
99............................... 73 Stockton-Lodi, CA... San Joaquin......... YES.
3................................ 53 Vallejo-Fairfield, Solano.............. YES.
CA.
99............................... 69 Visalia-Porterville, Tulare.............. YES.
CA.
99............................... 70 Yuba City, CA....... Sutter, and Yuba.... YES.
----------------------------------------------------------------------------------------------------------------
4. Proposed Update to the Methodology for Calculating GPCIs in the U.S.
Territories
In calculating GPCIs within U.S. states, we use county-level wage
data from the Bureau of Labor Statistics (BLS) Occupational Employment
Statistics Survey (OES), county-level residential rent data from the
American Community Survey (ACS), and malpractice insurance premium data
from state departments of insurance. In calculating GPCIs for the U.S.
territories, we currently use three distinct methodologies--one for
Puerto Rico, another for the Virgin Islands, and a third for the
Pacific Islands (Guam, American Samoa, and Northern Marianas Islands).
These three methodologies were adopted at different times based
primarily on the data that were available at the time they were
adopted. At present, because Puerto Rico is the only territory where
county-level BLS OES, county-level ACS, and malpractice premium data
are available, it is the only territory for which we use territory-
specific data to calculate GPCIs. For the Virgin Islands, because
county-level wage and rent data are not available, and insufficient
malpractice premium data are available, CMS has set the work, PE, and
MP GPCI values for the Virgin Islands payment locality at the national
average of 1.0 even though,
[[Page 46224]]
like Puerto Rico, the Virgin Islands is its own locality and county-
level BLS OES data are available for the Virgin Islands. For the U.S.
territories in the Pacific Ocean, we currently crosswalk GPCIs from the
Hawaii locality for each of the three GPCIs, and incorporate no local
data from these territories into the GPCI calculations even though
county-level BLS OES data does exist for Guam, but not for American
Samoa or the Northern Mariana Islands.
As noted above, currently Puerto Rico is the only territory for
which we calculate GPCIs using the territory-specific information
relative to data from the U.S. States. For several years stakeholders
in Puerto Rico have raised concerns regarding the applicability of the
proxy data in Puerto Rico relative to their applicability in the U.S.
states. We believe that these concerns may be consistent across island
territories, but lack of available, appropriate data has made it
difficult to quantify such variation in costs. For example, some
stakeholders previously indicated that shipping and transportation
expenses increase the cost of acquiring medical equipment and supplies
in islands and territories relative to the mainland. While we have
previously attempted to locate data sources specific to geographic
variation in such shipping costs, we found no comprehensive national
data source for this information (we refer readers to 78 FR 74387
through 74388 for the detailed discussion of this issue). Therefore, we
have not been able to quantify variation in costs specific to island
territories in the calculation of the GPCIs.
For all the island territories other than Puerto Rico, the lack of
comprehensive data about unique costs for island territories has had
minimal impact on GPCIs because we have used either the Hawaii GPCIs
(for the Pacific territories) or used the unadjusted national averages
(for the Virgin Islands). In an effort to provide greater consistency
in the calculation of GPCIs given the lack of comprehensive data
regarding the validity of applying the proxy data used in the States in
accurately accounting for variability of costs for these island
territories, we are proposing to treat the Caribbean Island territories
(the Virgin Islands and Puerto Rico) in a consistent manner. We propose
to do so by assigning the national average of 1.0 to each GPCI index
for both Puerto Rico and the Virgin Islands. We are not proposing any
changes to the GPCI methodology for the Pacific Island territories
(Guam, American Samoa, and Northern Marianas Islands) where we already
consistently assign the Hawaii GPCI values for each of the three GPCIs.
Additional information on the Proposed Update to the Methodology for
Calculating GPCIs in the U.S. Territories may be found in our
contractor's draft report, ``Draft Report on the CY 2017 Update of the
Geographic Practice Cost Index for the Medicare Physician Fee
Schedule,'' which is available on our Web site. It is located under the
supporting documents section of the CY 2017 PFS proposed rule located
at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
5. Proposed Refinement to the MP GPCI Methodology
In the process of calculating MP GPCIs for the purposes of this
proposed rule, we identified several technical refinements to the
methodology that yield improvements over the current method. We are
also proposing refinements that conform to our proposed methodology for
calculating the GPCIs for the U.S. Territories described above.
Specifically, we are proposing modifications to the methodology to
account for missing data used in the calculation of the MP GPCI. Under
the methodology used in the CY 2014 GPCI update (78 FR 74380 through
74391), we first calculated the average premiums by insurer and
specialty, then imputed premium values for specialties for which we did
not have specific data, before adjusting the specialty-specific premium
data by market share weights. We are proposing to revise our
methodology to instead calculate the average premiums for each
specialty using issuer market share for only available companies. This
proposed methodological improvement would reduce potential bias
resulting from large amounts of imputation, an issue that is prevalent
for insurers that only write policies for ancillary specialties for
which premiums tend to be low. The current method would impute the low
premiums for ancillary specialties across the remaining specialties,
and generally greater imputation leads to less accuracy. Additional
information on the MP GPCI methodology, and the proposed refinement to
the MP GPCI methodology may be found in our contractor's draft report,
``Draft Report on the CY 2017 Update of the Geographic Practice Cost
Index for the Medicare Physician Fee Schedule,'' which is available on
our Web site. It is located under the supporting documents section of
the CY 2017 PFS proposed rule located at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
J. Payment Incentive for the Transition From Traditional X-Ray Imaging
to Digital Radiography and Other Imaging Services
Section 502(a)(1) of the Consolidated Appropriations Act of 2016
(H.R. 2029) amended section 1848(b) of the Act by establishing new
paragraph (b)(9). Effective for services furnished beginning January 1,
2017, section 1848(b)(9)(A) of the Act reduces by 20 percent the
payment amounts under the PFS for the technical component (TC)
(including the TC portion of a global service) of imaging services that
are X-rays taken using film. The reduction is made prior to any other
adjustment under this section and without application of this new
paragraph.
Section 1848(b)(9)(B) of the Act provides for a 7 percent reduction
in payments for imaging services made under the PFS that are X-rays
(including the X-ray component of a packaged service) taken using
computed radiology furnished during CY 2018, 2019, 2020, 2021, or 2022,
and for a 10 percent reduction for such imaging services taken using
computed radiology furnished during CY 2023 or a subsequent year.
Computed radiology technology is defined for purposes of this paragraph
as cassette-based imaging, which utilizes an imaging plate to create
the image involved. Section 1848(b)(9) of the Act also requires
implementation of the reductions in payment for X-rays through
appropriate mechanisms, which can include the use of modifiers. In
accordance with section 1848(c)(2)(B)(v)(X), the adjustments under
section 1848(b)(9)(A) of the Act are exempt from budget neutrality.
In this section of the rule, we discuss the proposed implementation
of the reduction in payment for X-rays taken using film provided for in
section 1848(b)(9)(A) of the Act. Because the required reductions in
PFS payment for imaging services (including the imaging portion of a
service) that are X-rays taken using computed radiography technology
does not apply for CY 2017, we will address implementation of section
1848(b)(9)(B) of the Act in future rulemaking.
To implement the provisions of sections 1848(b)(9)(A) of the Act
relating to the PFS payment reduction for X-rays taken using film that
are furnished during CY 2017 or subsequent years, in this proposed
rule, we are proposing to establish a new modifier (modifier ``XX'') to
be used on claims, as allowed under the section 1848(b)(9)(D) of the
Act. The list of CY 2017 applicable HCPCS codes describing imaging
services that are X-ray services are on
[[Page 46225]]
the CMS Web site under downloads for the CY 2017 PFS proposed rule with
comment period at http://www.cms.gov/physicianfeesched/downloads/. We
are proposing that, beginning January 1, 2017, this modifier would be
required on claims for X-rays that are taken using film. The modifier
would be required on claims for the technical component of the X-ray
service, including when the service is billed globally, since the PFS
payment adjustment is made to the technical component regardless of
whether it is billed globally or separately using the -TC modifier. The
use of this proposed modifier to indicate an X-ray taken using film
would result in a 20-percent reduction for the technical component of
the X-ray service, as specified under section 1848(b)(9)(A) of the Act
that would be exempt from budget neutrality as specified under section
1848(c)(2)(B)(v)(X) of the Act.
K. Procedures Subject to the Multiple Procedure Payment Reduction
(MPPR) and the OPPS Cap
Effective January 1, 2012, we implemented an MPPR of 25 percent on
the professional component (PC) of advanced imaging services. The
reduction applies when multiple imaging procedures are furnished by the
same physician (or physician in the same group practice) to the same
patient, in the same session, on the same day. Full payment is made for
the PC of the highest priced procedure. Payment for the PC of
subsequent services is reduced by 25 percent.
Section 502(a)(2)(A) of the Consolidated Appropriations Act, 2016
(Pub. L. 114-113, enacted on December 18, 2015) added a new section
1848(b)(10) of the Act which revises the payment reduction from 25
percent to 5 percent, effective January 1, 2017. Section 502(a)(2)(B)
added a new subclause at section 1848(c)(2)(B)(v)(XI) which exempts the
reduced expenditures attributable to the revised 5 percent MMPR on the
PC of imaging from the PFS budget neutrality provision. We propose to
implement these provisions for services furnished on or after January
1, 2017. We refer readers to section VI.C of this proposed rule
regarding the necessary adjustment to the proposed PFS conversion
factor to account for the mandated exemption from PFS budget
neutrality.
We note that the lists of services for the upcoming calendar year
that are subject to the MPPR on diagnostic cardiovascular services,
diagnostic imaging services, diagnostic ophthalmology services, and
therapy services; and the list of procedures that meet the definition
of imaging under section 5102(b) of the DRA, and therefore, are subject
to the OPPS cap, are displayed in the public use files for the PFS
proposed and final rules for each year. The public use files for CY
2017 are available on our Web site under downloads for the CY 2017 PFS
proposed rule with comment period at http://www.cms.gov/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html.
L. Valuation of Specific Codes
1. Background: Process for Valuing New, Revised, and Potentially
Misvalued Codes
Establishing valuations for newly created and revised CPT codes is
a routine part of maintaining the PFS. Since inception of the PFS, it
has also been a priority to revalue services regularly to make sure
that the payment rates reflect the changing trends in the practice of
medicine and current prices for inputs used in the PE calculations.
Initially, this was accomplished primarily through the 5-year review
process, which resulted in revised work RVUs for CY 1997, CY 2002, CY
2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY
2011. Under the 5-year review process, revisions in RVUs were proposed
and finalized via rulemaking. In addition to the 5-year reviews,
beginning with CY 2009, CMS and the RUC have identified a number of
potentially misvalued codes each year using various identification
screens, as discussed in section II.B.5. of this proposed rule.
Historically, when we received RUC recommendations, our process had
been to establish interim final RVUs for the potentially misvalued
codes, new codes, and any other codes for which there were coding
changes in the final rule with comment period for a year. Then, during
the 60-day period following the publication of the final rule with
comment period, we accepted public comment about those valuations. For
services furnished during the calendar year following the publication
of interim final rates, we paid for services based upon the interim
final values established in the final rule with comment period. In the
final rule with comment period for the subsequent year, we considered
and responded to public comments received on the interim final values,
and typically made any appropriate adjustments and finalized those
values.
In the CY 2015 PFS final rule with comment period, we finalized a
new process for establishing values for new, revised and potentially
misvalued codes. Under the new process, we include proposed values for
these services in the proposed rule, rather than establishing them as
interim final in the final rule with comment period. Beginning with
this CY 2017 proposed rule, the new process will be applicable to all
codes, except for new codes that describe truly new services. For CY
2017, we are proposing new values in this proposed rule for the vast
majority of new, revised, and potentially misvalued codes for which we
received complete RUC recommendations by February 10, 2016. To complete
the transition to this new process, for codes where we established
interim final values in the CY 2016 PFS final rule with comment period,
we reviewed the comments received during the 60-day public comment
period following release of the CY 2016 PFS final rule with comment
period, and are re-proposing values for those codes in this CY 2017
proposed rule.
We will consider public comments received during the 60-day public
comment period for this proposed rule before establishing final values
in the final rule with comment period, and adopt interim final values
only in the case of wholly new services for which there are no
predecessor codes or values and for which we do not receive
recommendations in time to propose values. Recommendations regarding
any new or revised codes received after February 10th will be
considered in the next year's proposed rule (that is, CY 2018 PFS
rulemaking).
2. Methodology for Proposing Work RVUs
We conduct a review of each code identified in this section and
review the current work RVU (if any), RUC-recommended work RVU,
intensity, time to furnish the preservice, intraservice, and
postservice activities, as well as other components of the service that
contribute to the value. Our review of recommended work RVUs and time
inputs generally includes, but is not limited to, a review of
information provided by the RUC, HCPAC (Health Care Professionals
Advisory Committee), and other public commenters, medical literature,
and comparative databases, as well as a comparison with other codes
within the PFS, consultation with other physicians and health care
professionals within CMS and the federal government, as well as
Medicare claims data. We also assess the methodology and data used to
develop the recommendations submitted to us by the RUC and other public
commenters and the rationale for the recommendations. In the CY 2011
PFS final rule with comment period (75
[[Page 46226]]
FR 73328 through 73329), we discussed a variety of methodologies and
approaches used to develop work RVUs, including survey data, building
blocks, crosswalks to key reference or similar codes, and magnitude
estimation (see the CY 2011 PFS final rule with comment period for more
information). When referring to a survey, unless otherwise noted, we
mean the surveys conducted by specialty societies as part of the formal
RUC process. The building block methodology is used to construct, or
deconstruct, the work RVU for a CPT code based on component pieces of
the code.
Components used in the building block approach may include
preservice, intraservice, or postservice time and post-procedure
visits. When referring to a bundled CPT code, the building block
components could be the CPT codes that make up the bundled code and the
inputs associated with those codes. Magnitude estimation refers to a
methodology for valuing work that determines the appropriate work RVU
for a service by gauging the total amount of work for that service
relative to the work for a similar service across the PFS without
explicitly valuing the components of that work. In addition to these
methodologies, we have frequently utilized an incremental methodology
in which we value a code based upon its incremental difference between
another code or another family of codes. The statute specifically
defines the work component as the resources in time and intensity
required in furnishing the service. Also, the published literature on
valuing work has recognized the key role of time in overall work. For
particular codes, we refine the work RVUs in direct proportion to the
changes in the best information regarding the time resources involved
in furnishing particular services, either considering the total time or
the intraservice time.
Several years ago, to aid in the development of preservice time
recommendations for new and revised CPT codes, the RUC created
standardized preservice time packages. The packages include preservice
evaluation time, preservice positioning time, and preservice scrub,
dress and wait time. Currently there are six preservice time packages
for services typically furnished in the facility setting, reflecting
the different combinations of straightforward or difficult procedure,
straightforward or difficult patient, and without or with sedation/
anesthesia. Currently, there are three preservice time packages for
services typically furnished in the nonfacility setting, reflecting
procedures without and with sedation/anesthesia care.
We have developed several standard building block methodologies to
value services appropriately when they have common billing patterns. In
cases where a service is typically furnished to a beneficiary on the
same day as an E/M service, we believe that there is overlap between
the two services in some of the activities furnished during the
preservice evaluation and postservice time. Our longstanding
adjustments have reflected a broad assumption that at least one-third
of the work time in both the preservice evaluation and postservice
period is duplicative of work furnished during the E/M visit.
Accordingly, in cases where we believe that the RUC has not
adequately accounted for the overlapping activities in the recommended
work RVU and/or times, we adjust the work RVU and/or times to account
for the overlap. The work RVU for a service is the product of the time
involved in furnishing the service multiplied by the intensity of the
work. Preservice evaluation time and postservice time both have a long-
established intensity of work per unit of time (IWPUT) of 0.0224, which
means that 1 minute of preservice evaluation or postservice time
equates to 0.0224 of a work RVU.
Therefore, in many cases when we remove 2 minutes of preservice
time and 2 minutes of postservice time from a procedure to account for
the overlap with the same day E/M service, we also remove a work RVU of
0.09 (4 minutes x 0.0224 IWPUT) if we do not believe the overlap in
time has already been accounted for in the work RVU. The RUC has
recognized this valuation policy and, in many cases, now addresses the
overlap in time and work when a service is typically furnished on the
same day as an E/M service.
We note that many commenters and stakeholders have expressed
concerns with our ongoing adjustment of work RVUs based on changes in
the best information we have regarding the time resources involved in
furnishing individual services. We are particularly concerned with the
RUC's and various specialty societies' objections to our approach given
the significance of their recommendations to our process for valuing
services and since much of the information we have used to make the
adjustments is derived from their survey process. As explained in the
CY 2016 PFS final rule with comment period (80 FR 70933), we recognize
that adjusting work RVUs for changes is not always a straightforward
process, so we apply various methodologies to identify several
potential work values for individual codes. However, we want to
reiterate that we are statutorily obligated to consider both time and
intensity in establishing work RVUs for PFS services.
We have observed that for many codes reviewed by the RUC, final
recommended work RVUs appear to be incongruous with recommended
assumptions regarding the resource costs in time. This is the case for
a significant portion of codes for which we have recently established
or proposed work RVUs that are based on refinements to the RUC-
recommended values. When we have adjusted work RVUs to account for
significant changes in time, we begin by looking at the change in the
time in the context of the RUC-recommended work RVU. When the
recommended work RVUs do not appear to account for significant changes
in time, we employ the different approaches to identify potential
values that reconcile the recommended work RVUs with the recommended
time values. Many of these methodologies, such as survey data, building
blocks, crosswalks to key reference or similar codes, and magnitude
estimation have long been used in developing work RVUs under the PFS.
In addition to these we sometimes use the relationship between the old
time values and the new time values for particular services to identify
alternative work RVUs based on changes in time components.
In so doing, rather than ignoring the RUC-recommended value, we are
using the recommended values as a starting reference and then applying
one of these several methodologies to account for the reductions in
time that we believe have not otherwise been reflected in the RUC
recommended value. When we believe that such changes in time have
already been accounted for in the RUC recommendation, then we do not
make such adjustments. Likewise, we do not arbitrarily apply time
ratios to current work RVUs to calculate proposed work RVUs. We use the
ratios to identify potential work RVUs and consider these work RVUs as
potential options relative to the values developed through other
options.
We want to make it clear that we are not implying that the decrease
in time as reflected in survey values must equate to a one-to-one or
linear decrease in newly valued work RVUs. Instead, we believe that
since the two components of work are time and intensity that absent an
obvious or explicitly stated rationale for why the relative intensity
of a given procedure has increased, that significant decreases in time
should be reflected in decreases
[[Page 46227]]
to work RVUs. If the RUC recommendation has appeared to disregard or
dismiss the changes in time, without a persuasive explanation of why
such a change should not be accounted for in the overall work of the
service, then we generally use one of the aforementioned referenced
methodologies to identify potential work RVUs, including the
methodologies intended to account for the changes in the resources
involved in furnishing the procedure.
Several commenters, including the RUC, in general have objected to
our use of these methodologies and deemed our actions in adjusting the
recommended work RVUs as inappropriate. We received several specific
comments regarding this issue in response to the CY 2016 PFS final rule
with comment period, those comments are summarized below.
Comment: Several commenters, including the RUC, stated that our
methodology for adjusting work RVUs appears to be contrary to the
statute.
Response: We disagree with these comments. Since section
1848(c)(1)(A) of the Act explicitly identifies time as one of the two
types of resources that encompass the work component of the PFS
payment, we do not believe that our use of the aforementioned
methodologies to adjust the work RVU to account for the changes in
time, which is one of the resources involved, is inconsistent with the
statutory requirements related to the maintenance of work RVUs, and we
have regularly used these and other methodologies in developing values
for PFS services. In selecting which methodological approach will best
determine the appropriate value for a service, we consider the current
and recommended work and time values, as well as the intensity of the
service, all relative to other services. In our review of RUC
recommended values, we have observed that the RUC also uses a variety
of methodologies to develop work RVUs for individual codes, and
subsequently validates the results of these approaches through
magnitude estimation or crosswalk to established values for other
codes.
Comment: Several commenters, including the RUC, stated that we
could not take one element of the services that has changed such as
intra-service time, and apply an overall ratio for reduction to the
work RVU based on changes to time, as that renders the value no longer
resource-based in comparison to the RUC-recommended values.
Response: We disagree with the commenters. We continue to believe
that the use of time ratios is one of several reasonable methods for
identifying potential work RVUs for particular PFS services,
particularly when the alternative values do not account for information
that suggests the amount of time involved in furnishing the service has
changed significantly. We reiterate that, consistent with the statute,
we are required to value the work RVU based on the relative resources
involved in furnishing the service, which include time and intensity.
When our review of recommended values determines that changes in the
resource of time have been unaccounted for in a recommended RVU, then
we believe we have the obligation to account for that change in
establishing work RVUs since the statute explicitly identifies time as
one of the two elements of the work RVUs. We recognize that it would
not be appropriate to develop work RVUs solely based on time given that
intensity is also an element of work, but in applying the time ratios
we are using derived intensity measures based on current work RVUs for
individual procedures. Were we to disregard intensity altogether, the
work RVUs for all services would be developed based solely on time
values and that is definitively not the case. Furthermore, we reiterate
that we use time ratios to identify potential work RVUs, and then use
other methods (including estimates of work from CMS medical personnel
and crosswalks to key reference or similar codes) to validate these
RVUs. We also disagree with several commenters' implications that a
work RVU developed through such estimation methods is only resource-
based through the RUC process.
Comment: Several commenters, including the RUC, stated that our
inconsistent use of the time ratio methodology has rendered it
ineffective for valuation purposes and that by choosing the starting
base work value and/or physician time at random, we are essentially
reverse engineering the work value we want under the guise of a
standard algorithm.
Response: We do not choose a starting base work value and/or
physician time at random as suggested by the commenters. We use the RUC
recommended values or the existing values as the base values;
essentially, we are taking one of those values and applying adjustments
to account for the change in time that based on our analysis of the RUC
recommendation, we determine has not been properly accounted for to
determine an appropriate work RVU. In circumstances where adjustments
to time and the corresponding work RVU are relatively congruent or
persuasively explained, our tendency has been to use those values as
recommended. Where the RUC recommendations do not account for changes
in time, we have made changes to RUC-recommended values to account for
the changes in time.
Comment: Commenters, including the RUC, also stated that the use of
time ratio methodologies distills the valuation of the service into a
basic formula with the only variable being either the new total
physician time or the new intra-service physician time, and that these
methodologies are based on the incorrect assumption that the per minute
physician work intensity established is permanent regardless of when
the service was last valued. Other commenters have suggested that
previous assumed times are inaccurate.
Response: We agree with commenters that per minute intensity for a
given service may change over time. If we believed that the per-minute
intensity for a given service were immutable, then a reverse-building
block approach to revaluation based on new time data could be
appropriate. However, we have not applied such an approach specifically
because we agree that the per-minute intensity of work is not
necessarily static over time or even necessarily during the course of a
procedure. Instead, we utilize time ratios to identify potential values
that account for changes in time and compare these values to other PFS
services for estimates of overall work. When the values we develop
reflect a similar derived intensity, we agree that our values are the
result of our assessment that the relative intensity of a given service
has remained similar.
Regarding the validity of comparing new times to the old times, we,
too, hope that time estimates have improved over many years especially
when many years have elapsed since the last time the service in
question was valued. However, we also believe that our operating
assumption regarding the validity of the pre-existing values as a point
of comparison is critical to the integrity of the relative value system
as currently constructed. Pre-existing times are a very important
element in the allocation of indirect PE RVUs by specialty, and had the
previously recommended times been overestimated, the specialties that
furnish such services would be benefitting from these times in the
allocation of indirect PE RVUs. As long time observers of the RUC
process, we also recognize that the material the RUC uses to develop
overall work recommendations includes the data
[[Page 46228]]
from the surveys about time. We have previously stated concerns
regarding the validity of much of the RUC survey data. However, we
believe additional kinds of concern would be warranted if the RUC
itself were operating under the assumption that its pre-existing data
were typically inaccurate.
We understand stakeholders' concerns regarding how best to consider
changes in time in improving the accuracy of work RVUs and have
considered all of the issues raised by commenters. In conjunction with
our review of recommended code values for CY 2017, we conducted a
preliminary analysis to identify general tendencies in the relationship
between changes in time and changes in work RVUs for CY 2014 and CY
2015. We looked at services for which there were no coding changes to
simplify the analysis. The intent of this preliminary analysis was to
examine commenters' beliefs that CMS is only considering time when
making refinements to RUC recommended work values. For CY 2014, we
found that in the aggregate, the average difference between the RUC
recommended intraservice time and existing intraservice time was -17
percent, but the average difference between the RUC recommended work
RVU and existing work RVU was only -4 percent. However, the average
difference between the CMS refined work RVU and existing work RVU was -
7 percent. For CY 2015, the average difference between the RUC
recommended intraservice time and existing intraservice time was -17
percent, but the average difference between the RUC recommended work
RVU and existing work RVU was 1 percent, and the average difference
between the CMS refined work RVU and existing work RVU was -6 percent.
This preliminary analysis demonstrates that we are not making
refinements solely in consideration of time, if that were the case, the
changes in the work RVU values that we adopted would be comparable to
the changes in the time that we adopted, but that is not the case.
We believe that we should account for efficiencies in time when the
recommended work RVU does not account for those efficiencies, otherwise
relativity across the PFS can be significantly skewed over periods of
time. For example, if when a code is first valued, a physician was
previously able to do only 5 procedures per day, but due to new
technologies, the same physician can now do 10 procedures per day,
resource costs in time have empirically been lessened, and we believe
that relative reduction in resources involved in furnishing that
service should be accounted for in the assignment of work RVUs for that
service, since the statute explicitly identifies time as one of the two
components of work. Of course, if more resource intensive technology
has allowed for the increased efficiency in furnishing the procedure,
then the nonfacility PE RVUs for the service should also be adjusted to
account for this change. Additionally, we believe it may be that the
intensity per minute of the procedure may have changed with the greater
efficiency in time. Again, that is why we do not generally reduce work
RVUs in strict proportion to changes in time. We understand that
intensity is not entirely linear, and that data related to time as
obtained in the RUC survey instrument may improve over time, and that
the number of survey respondents may improve over time. However, we
also understand time as a tangible resource cost in furnishing PFS
services, and a cost that by statute, is one of the two kinds of
resources to be considered as part of the work RVU.
Therefore, we are interested in receiving comments on whether,
within the statutory confines, there are alternative suggestions as to
how changes in time should be accounted for when it is evident that the
survey data and/or the RUC recommendation regarding the overall work
RVU does not reflect significant changes in the resource costs of time
for codes describing PFS services. We are also seeking comment on
potential alternatives, including the application of the reverse
building block methodology, to making the adjustments that would
recognize overall estimates of work in the context of changes in the
resource of time for particular services.
Table 16 contains a list of codes for which we are proposing work
RVUs; this includes all RUC recommendations received by February 10,
2016, and codes for which we established interim final values in the CY
2016 PFS final rule with comment period. When the proposed work RVUs
vary from those recommended by the RUC or for which we do not have RUC
recommendations, we address those codes in the portions of this section
that are dedicated to particular codes. The proposed work RVUs and
other payment information for all proposed CY 2017 payable codes are
available in Addendum B. Addendum B is available on the CMS Web site
under downloads for the CY 2017 PFS proposed rule with comment period
at http://www.cms.gov/physicianfeesched/downloads/. The proposed time
values for all CY 2017 codes are listed in a file called ``CY 2017 PFS
Proposed Work Time,'' available on the CMS Web site under downloads for
the CY 2017 PFS proposed rule with comment period at http://www.cms.gov/physicianfeesched/downloads/.
3. Methodology for Proposing the Direct PE Inputs To Develop PE RVUs
a. Background
On an annual basis, the RUC provides us with recommendations
regarding PE inputs for new, revised, and potentially misvalued codes.
We review the RUC-recommended direct PE inputs on a code by code basis.
Like our review of recommended work RVUs, our review of recommended
direct PE inputs generally includes, but is not limited to, a review of
information provided by the RUC, HCPAC, and other public commenters,
medical literature, and comparative databases, as well as a comparison
with other codes within the PFS, consultation with physicians and
health care professionals within CMS and the federal government, as
well as Medicare claims data. We also assess the methodology and data
used to develop the recommendations submitted to us by the RUC and
other public commenters and the rationale for the recommendations. When
we determine that the RUC recommendations appropriately estimate the
direct PE inputs (clinical labor, disposable supplies, and medical
equipment) required for the typical service, consistent with the
principles of relativity, and reflect our payment policies, we use
those direct PE inputs to value a service. If not, we refine the
recommended PE inputs to better reflect our estimate of the PE
resources required for the service. We also confirm whether CPT codes
should have facility and/or nonfacility direct PE inputs and refine the
inputs accordingly.
Our review and refinement of RUC-recommended direct PE inputs
includes many refinements that are common across codes as well as
refinements that are specific to particular services. Table 16 details
our proposed refinements of the RUC's direct PE recommendations at the
code-specific level. In this proposed rule, we address several
refinements that are common across codes, and refinements to particular
codes are addressed in the portions of this section that are dedicated
to particular codes. We note that for each refinement, we indicate the
proposed impact on direct costs for that service. We note that, on
average, in any case where the impact on the direct cost for a
particular refinement is $0.32 or less, the refinement has no impact on
the proposed PE RVUs. This calculation
[[Page 46229]]
considers both the impact on the direct portion of the PE RVU, as well
as the impact on the indirect allocator for the average service. We
also note that nearly half of the proposed refinements listed in Table
16 result in changes under the $0.32 threshold and are unlikely to
result in a change to the proposed RVUs.
We also note that the proposed direct PE inputs for CY 2017 are
displayed in the proposed CY 2017 direct PE input database, available
on the CMS Web site under the downloads for the CY 2017 proposed rule
at www.cms.gov/PhysicianFeeSched/. The inputs displayed there have also
been used in developing the proposed CY 2017 PE RVUs as displayed in
Addendum B.
b. Common Refinements
(1) Changes in Work Time
Some direct PE inputs are directly affected by revisions in work
time. Specifically, changes in the intraservice portions of the work
time and changes in the number or level of postoperative visits
associated with the global periods result in corresponding changes to
direct PE inputs. The direct PE input recommendations generally
correspond to the work time values associated with services. We believe
that inadvertent discrepancies between work time values and direct PE
inputs should be refined or adjusted in the establishment of proposed
direct PE inputs to resolve the discrepancies.
(2) Equipment Time
Prior to CY 2010, the RUC did not generally provide CMS with
recommendations regarding equipment time inputs. In CY 2010, in the
interest of ensuring the greatest possible degree of accuracy in
allocating equipment minutes, we requested that the RUC provide
equipment times along with the other direct PE recommendations, and we
provided the RUC with general guidelines regarding appropriate
equipment time inputs. We continue to appreciate the RUC's willingness
to provide us with these additional inputs as part of its PE
recommendations.
In general, the equipment time inputs correspond to the service
period portion of the clinical labor times. We have clarified this
principle over several years of rulemaking, indicating that we consider
equipment time as the time within the intraservice period when a
clinician is using the piece of equipment plus any additional time that
the piece of equipment is not available for use for another patient due
to its use during the designated procedure. For those services for
which we allocate cleaning time to portable equipment items, because
the portable equipment does not need to be cleaned in the room where
the service is furnished, we do not include that cleaning time for the
remaining equipment items, as those items and the room are both
available for use for other patients during that time. In addition,
when a piece of equipment is typically used during follow-up post-
operative visits included in the global period for a service, the
equipment time would also reflect that use.
We believe that certain highly technical pieces of equipment and
equipment rooms are less likely to be used during all of the preservice
or postservice tasks performed by clinical labor staff on the day of
the procedure (the clinical labor service period) and are typically
available for other patients even when one member of the clinical staff
may be occupied with a preservice or postservice task related to the
procedure. We also note that we believe these same assumptions would
apply to inexpensive equipment items that are used in conjunction with
and located in a room with non-portable highly technical equipment
items since any items in the room in question would be available if the
room is not being occupied by a particular patient. For additional
information, we refer readers to our discussion of these issues in the
CY 2012 PFS final rule with comment period (76 FR 73182) and the CY
2015 PFS final rule with comment period (79 FR 67639).
(3) Standard Tasks and Minutes for Clinical Labor Tasks
In general, the preservice, intraservice, and postservice clinical
labor minutes associated with clinical labor inputs in the direct PE
input database reflect the sum of particular tasks described in the
information that accompanies the RUC-recommended direct PE inputs,
commonly called the ``PE worksheets.'' For most of these described
tasks, there are a standardized number of minutes, depending on the
type of procedure, its typical setting, its global period, and the
other procedures with which it is typically reported. The RUC sometimes
recommends a number of minutes either greater than or less than the
time typically allotted for certain tasks. In those cases, we review
the deviations from the standards and any rationale provided for the
deviations. When we do not accept the RUC-recommended exceptions, we
refine the proposed direct PE inputs to conform to the standard times
for those tasks. In addition, in cases when a service is typically
billed with an E/M service, we remove the preservice clinical labor
tasks to avoid duplicative inputs and to reflect the resource costs of
furnishing the typical service.
In general, clinical labor tasks fall into one of the categories on
the PE worksheets. In cases where tasks cannot be attributed to an
existing category, the tasks are labeled ``other clinical activity.''
We believe that continual addition of new and distinct clinical labor
tasks each time a code is reviewed under the misvalued code initiative
is likely to degrade relativity between newly reviewed services and
those with already existing inputs. This is because codes more recently
reviewed would be more likely to have a greater number of clinical
labor tasks as a result of the general tendency to increase the number
of clinical labor tasks. To mitigate the potential negative impact of
these additions, we review these tasks to determine whether they are
fully distinct from existing clinical labor tasks, typically included
for other clinically similar services under the PFS, and thoroughly
explained in the recommendation. For those tasks that do not meet these
criteria, we do not accept these newly recommended clinical labor
tasks.
(4) Recommended Items That Are Not Direct PE Inputs
In some cases, the PE worksheets included with the RUC
recommendations include items that are not clinical labor, disposable
supplies, or medical equipment or that cannot be allocated to
individual services or patients. We have addressed these kinds of
recommendations in previous rulemaking (78 FR 74242), and we do not use
items included in these recommendations as direct PE inputs in the
calculation of PE RVUs.
(5) New Supply and Equipment Items
The RUC generally recommends the use of supply and equipment items
that already exist in the direct PE input database for new, revised,
and potentially misvalued codes. Some recommendations, however, include
supply or equipment items that are not currently in the direct PE input
database. In these cases, the RUC has historically recommended that a
new item be created and has facilitated our pricing of that item by
working with the specialty societies to provide us copies of sales
invoices. For CY 2017, we received invoices for several new supply and
equipment items. Tables 16 and 17 detail the invoices received for new
and existing items in the direct PE database. As discussed in section
II.A. of this proposed rule with comment
[[Page 46230]]
period, we encourage stakeholders to review the prices associated with
these new and existing items to determine whether these prices appear
to be accurate. Where prices appear inaccurate, we encourage
stakeholders to provide invoices or other information to improve the
accuracy of pricing for these items in the direct PE database during
the 60-day public comment period for this proposed rule. We expect that
invoices received outside of the public comment period would be
submitted by February 10th of the following year for consideration in
future rulemaking, similar to our new process for consideration of RUC
recommendations.
We remind stakeholders that due to the relativity inherent in the
development of RVUs, reductions in existing prices for any items in the
direct PE database increase the pool of direct PE RVUs available to all
other PFS services. Tables 16 and 17 also include the number of
invoices received, as well as the number of nonfacility allowed
services for procedures that use these equipment items. We provide the
nonfacility allowed services so that stakeholders will note the impact
the particular price might have on PE relativity, as well as to
identify items that are used frequently, since we believe that
stakeholders are more likely to have better pricing information for
items used more frequently. A single invoice may not be reflective of
typical costs and we encourage stakeholders to provide additional
invoices so that we might identify and use accurate prices in the
development of PE RVUs.
In some cases, we do not use the price listed on the invoice that
accompanies the recommendation because we identify publicly available
alternative prices or information that suggests a different price is
more accurate. In these cases, we include this in the discussion of
these codes. In other cases, we cannot adequately price a newly
recommended item due to inadequate information. Sometimes, no
supporting information regarding the price of the item has been
included in the recommendation. In other cases, the supporting
information does not demonstrate that the item has been purchased at
the listed price (for example, vendor price quotes instead of paid
invoices). In cases where the information provided on the item allows
us to identify clinically appropriate proxy items, we might use
existing items as proxies for the newly recommended items. In other
cases, we have included the item in the direct PE input database
without any associated price. Although including the item without an
associated price means that the item does not contribute to the
calculation of the proposed PE RVU for particular services, it
facilitates our ability to incorporate a price once we obtain
information and are able to do so.
(6) Service Period Clinical Labor Time in the Facility Setting
Generally speaking, our proposed inputs do not include clinical
labor minutes assigned to the service because the cost of clinical
labor during the service period for a procedure in the facility setting
is not considered a resource cost to the practitioner since Medicare
makes separate payment to the facility for these costs. We address
proposed code-specific refinements to clinical labor in the individual
code sections.
(7) Procedures Subject to the Multiple Procedure Payment Reduction
(MPPR) and the OPPS Cap
We note that the public use files for the PFS proposed and final
rules for each year display both the services subject to the MPPR lists
on diagnostic cardiovascular services, diagnostic imaging services,
diagnostic ophthalmology services and therapy services and the list of
procedures that meet the definition of imaging under section
1848(b)(4)(B) of the Act, and therefore, are subject to the OPPS cap
for the upcoming calendar year. The public use files for CY 2017 are
available on the CMS Web site under downloads for the CY 2017 PFS
proposed rule with comment period at http://www.cms.gov/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFSFederal-Regulation-Notices.html.
4. Specialty-Mix Assumptions for Proposed Malpractice RVUs
The proposed CY 2017 malpractice crosswalk table is displayed in
the public use files for the PFS proposed and final rules. The public
use files for CY 2017 are available on the CMS Web site under downloads
for the CY 2017 PFS proposed rule with comment period at 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 proposed CY
2017 MP RVUs where the source code for this calculation deviates from
the source code for the utilization otherwise used for purposes of PFS
ratesetting. The proposed MP RVUs for all PFS services and the
utilization crosswalk used to identify the source codes for all other
PFS codes are reflected in Addendum B on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
5. Valuation of Specific Codes
a. CY 2017 Proposed Codes That Were Also CY 2016 Proposed Codes
(1) Soft Tissue Localization (CPT Codes 10035 and 10036)
In the CY 2016 PFS final rule with comment period, we established
the RUC-recommended work value as interim final for CPT codes 10035 and
10036. We also made standard refinements to remove duplicative clinical
labor and utilize standard equipment time formulas for the PACS
workstation proxy (ED050).
Comment: A commenter stated that the clinical labor task ``Review/
read X-ray, lab, and pathology reports'' occurs during the preservice
period, and it is a separate activity than ``Review examination with
interpreting MD'', which occurs during the service period.
Response: We continue to believe that this clinical labor is
duplicative with the clinical labor for Review examination with
interpreting MD because we believe that these two descriptors detail
the same clinical labor activity taking place, rather than two separate
and distinct tasks. We are proposing to maintain our previous
refinement to 0 minutes for this clinical labor task for CPT codes
10035 and 10036.
We are also proposing to maintain the interim final work RVUs for
CPT codes 10035 and 10036.
(2) Repair Flexor Tendon (CPT Codes 26356, 26357, and 26358)
In the CY 2016 PFS final rule with comment period, we established
an interim final work RVU of 9.56 for CPT code 26356 after considering
both its similarity in time to CPT code 25607 (Open treatment of distal
radial extra-articular fracture) and the recommended reduction in time
relative to the current times assumed for this procedure. We
established an interim final work RVU of 10.53 for CPT code 26357 based
on a direct crosswalk from CPT code 27654 (Repair, secondary, Achilles
tendon, with or without graft), as we believed that this work RVU
better reflected the changes in time for this procedure. For the last
code in the family, we established an interim final work RVU of 12.13
for CPT code 26358, based on the RUC recommended increment of 1.60 work
RVUs relative to CPT code 26357.
Comment: We received several comments regarding the interim final
work values for this family of codes.
[[Page 46231]]
One commenter stated that it was inappropriate to use time ratios to
evaluate CPT code 26356 as it was last valued in 1995, noting that
there was an anomalous relationship between the current work RVU and
the imputed time components in the RUC database. This commenter also
pointed out that when the previous time was developed, fabrication of a
splint was considered to be part of the intraservice work, while in the
current survey instrument, the fabrication of the splint is considered
to be part of the postservice work since it is a dressing. This
commenter urged CMS to adopt the RUC recommendations. A different
commenter agreed that the CMS crosswalk to CPT code 25607 was an
appropriate crosswalk for CPT code 26356 and supported the CMS work RVU
of 9.56.
Response: We appreciate the support from the commenter. We continue
to believe that our crosswalk for this code is an appropriate choice,
due to our estimate of overall work between CPT code 26356 and CPT code
25607. We appreciate the commenters' concerns regarding the time ratio
methodologies and have responded to these concerns about our
methodology in section II.L.2 of this proposed rule. Although we note
the commenter's statement about how the service period in which
fabrication of a splint takes place may have evolved over time, we do
not agree that this task would be responsible for a decrease in
intraservice survey time, as the postservice survey time for CPT code
26356 remained unchanged at 30 minutes. If the decrease in intraservice
time had been due to the shift of splinting from the intraservice
period to the postservice period, then we would have expected to see an
increase in the postservice period minutes. However, they remained
exactly the same in the physician survey for CPT 26356. As we wrote
earlier in this section, we believe in the validity of using pre-
existing time values as a point of comparison, and we believe that we
should account for efficiencies in time when the recommended work RVU
does not account for those efficiencies. After consideration of
comments received, we are proposing to maintain CPT code 26356 at its
current work RVU of 9.56 for CY 2017.
Comment: Several commenters disagreed with the work RVU for CPT
code 26357. One commenter stated that the CMS crosswalk to CPT code
27654 had less total time and resulted in an inappropriately lower
intensity. This commenter urged CMS to adopt the RUC-recommended work
value. Another commenter stated that a better crosswalk for CPT code
26357 would be CPT code 25608 (Open treatment of distal radial intra-
articular fracture or epiphyseal separation), the next code in the same
upper extremity family that CMS used for the initial crosswalk. This
commenter stated that the CMS crosswalk for CPT code 26357 created a
rank order anomaly in terms of intensity within this family, and that
the commenter's suggested crosswalk would create two pairs of matched
codes, survey CPT codes 26356/26357 with crosswalk CPT codes 25607/
25608.
Response: We appreciate the suggested crosswalk from the
commenters, and we agree that the choice of the initial CMS crosswalk
creates a rank order anomaly within the family in terms of intensity.
As a result, after consideration of comments received, we are proposing
to instead value CPT code 26357 at the 25th percentile survey work RVU
of 11.00 for CY 2017. This valuation corrects the anomalous intensity
within the Repair Flexor Tendon family of codes, and preserves the RUC-
recommended increment between CPT codes 26356 and 26357.
Comment: The commenters agreed that the RUC-recommended increment
of 1.60 was appropriate for the work RVU of CPT code 26358 when added
to the work RVU of CPT code 26357. However, commenters stated that this
increment of 1.60 should be added to the RUC-recommended work value for
CPT code 26357, and not the CMS refined value from the CY 2016 PFS
final rule with comment period.
Response: We also continue to believe that the increment of 1.60 is
appropriate for the work RVU of CPT code 26358. After consideration of
comments received, we are therefore proposing to set the work RVU for
this code at 12.60 for CY 2017, based on the increment of 1.60 from CPT
code 26357's proposed work RVU of 11.00.
We are proposing to maintain the current direct PE inputs for all
three codes.
(3) Esophagogastric Fundoplasty Trans-Oral Approach (CPT Code 43210)
For CY 2016, the CPT Editorial Panel established CPT code 43210 to
describe trans-oral esophagogastric fundoplasty. The RUC recommended a
work RVU of 9.00 for CPT code 43210. We noted our determination that a
work RVU of 7.75, which corresponds to the 25th percentile survey
result, more accurately reflects the resources used in furnishing the
service associated with CPT code 43210. Therefore, for CY 2016 we
established an interim final work RVU of 7.75 for CPT code 43210.
Comment: A few commenters urged CMS to accept the RUC-recommended
work RVU of 9.00 for CPT code 43210. The commenters believed that the
RUC-recommended value compared well with the key reference service, CPT
code 43276 (Endoscopic retrograde cholangiopancreatography (ERCP); with
removal and exchange of stent(s), biliary or pancreatic duct, including
pre- and post-dilation and guide wire passage, when performed,
including sphincterotomy, when performed, each stent exchanged), which
has a work RVU of 8.94 and an intraservice time of 60 minutes.
Commenters believed that due to similar intra-service times and
intensities, that CPT code 43210 should be valued nearly identically to
CPT code 43276. Some commenters also stated that to maintain relativity
within the upper GI code families, CPT code 43210 should not have a
lower work RVU than CPT code 43276, especially since the majority of
survey participants indicated that CPT code 43210 is ``somewhat more''
complex than CPT code 43276. Additionally, one commenter noted that an
EGD (Esophagogastroduodenoscopy) is used twice during this service,
before and after fundoplication. They stated that because this is a
multi-stage procedure, other EGD codes are not comparable. The
commenter also pointed out that this technology has a small number of
users and urged us to accept the RUC-recommended work RVU of 9.00 until
there is increased volume and then reassess in 2 years. Commenters also
requested refinement panel consideration for this service.
Response: Per the commenters' request, we referred this code to the
CY 2016 multi-specialty refinement panel for further review. The result
of the panel was a recommendation that we accept the RUC-recommended
value of 9.00 work RVUs. However, since there are four ERCP codes with
60 minutes of intraservice time, three of which have work RVUs of less
than 7.00 and only one of the four codes has a work RVU higher than
7.75 RVUs (8.94), based on our estimate of overall work for this
service, we continue to believe that the 25th percentile of the survey
most accurately reflects the relative resource costs associated with
CPT code 43210. Therefore, for CY 2017 we are proposing a work RVU of
7.75 for CPT code 43210.
(4) Percutaneous Biliary Procedures Bundling (CPT Codes 47531, 47532,
47533, 47534, 47535, 47536, 47537, 47538, 47539, 47540, 47541, 47542,
47543, and 47544)
These codes were revalued with new recommendations at the October
2015
[[Page 46232]]
RUC meeting; we will discuss the CY 2016 interim final comments
alongside the new recommendations. Please see section II.L for a
discussion of the CY 2017 proposed code values.
(5) Percutaneous Image Guided Sclerotherapy (CPT Code 49185)
For CY 2016, we established an interim final work RVU of 2.35 for
CPT code 49185 based on a crosswalk from CPT code 62305 (Myelography
via lumbar injection, including radiological supervision and
interpretation; 2 or more regions (e.g., lumbar/thoracic, cervical/
thoracic, lumbar/cervical, lumbar/thoracic/cervical)); which we
believed accurately reflected the time and intensity involved in
furnishing CPT code 49185. We also requested stakeholder input on the
price of supply item SH062 (sclerosing solution) as the volume of the
solution in this procedure (300 mL) is much higher than other CPT codes
utilizing SH062 (between 1 and 10 mL).
Comment: Commenters disagreed with our proposed crosswalk of CPT
code 49185 from CPT code 62305. Commenters believed that the RUC-
recommended crosswalk from CPT code 31622 (Bronchoscopy, rigid or
flexible, including fluoroscopic guidance, when performed; diagnostic,
with cell washing, when performed (separate procedure)) was a more
appropriate comparison due to similarity in service. Commenters
requested that CPT code 49185 be referred to the refinement panel.
Response: The requests did not meet the requirements related to new
clinical information for referral to the refinement panel. After review
of the comments, we continue to believe that a crosswalk of CPT code
49185 from the value for CPT code 62305 is most appropriate due to
similarities in overall work. Therefore, we are proposing a work RVU of
2.35 for CPT code 49185 for CY 2017 and seek additional rationale for
why a different work RVU or crosswalk would more accurately reflect the
resources involved in furnishing this service.
Comment: A commenter stated that the procedure described by CPT
code 49185 involved a separate clinical labor staff type. Due to the
inclusion of this additional individual, the L037D clinical labor and
additional gloves were appropriate to include in the procedure.
Response: The commenter did not provide any evidence for this
claim. We continue to believe that this additional use of clinical
staff would not be typical for CPT code 49185. This procedure does not
involve moderate sedation, and therefore, we do not believe that there
would be a typical need for a third staff member. As a result, we are
proposing to maintain our direct PE refinements from the CY 2016 PFS
final rule with comment period.
Additionally, we did not receive any information regarding SH062
that supports maintaining an input of 300 mL, and as noted above, this
level far exceeds the volume associated with other CPT codes;
therefore, we are proposing to refine the direct practice expense
inputs for SH062 from 300 mL to 10 mL, which is the highest level
associated with other CPT codes utilizing SH062.
(6) Genitourinary Procedures (CPT Codes 50606, 50705, and 50706)
In the CY 2016 PFS final rule with comment period, we established
as interim final the RUC-recommended work RVUs for all three codes. We
did not receive any comments on the work values for these codes, and we
are proposing to maintain all three at their current work RVUs.
The RUC recommended the inclusion of ``room, angiography'' (EL011)
for this family of codes. As we discussed in the CY 2016 PFS final rule
with comment period, we did not believe that an angiography room would
be used in the typical case for these procedures, and we therefore
replaced the recommended equipment item ``room, angiography'' with
equipment item ``room, radiographic-fluoroscopic'' (EL014) for all
three codes on an interim final basis. We also stated our belief that
since the predecessor procedure codes generally did not include an
angiography room and we did not have a reason to believe that the
procedure would have shifted to an angiography room in the course of
this coding change, we did not believe that the use of an angiography
room would be typical for these procedures.
Comment: Several commenters disagreed with the CMS substitution of
the fluoroscopic room in place of the angiography room. The commenters
stated that all three of these procedures were previously reported
using CPT code 53899 (Unlisted procedure, urinary system) which does
not have any PE inputs, and the RUC recommendations included as a
reference CPT code 50387 (Removal and replacement of externally
accessible transnephric ureteral stent), which includes an angiography
room. The commenters suggested that CPT code 50387 was an example of a
predecessor code that included the use of an angiography room, along
with other codes that are being bundled together to create the new
Genitourinary codes.
Response: We do not agree with the commenter's implication that
because CPT code 50387 was an appropriate reference code for use in
valuation, that it necessarily would have previously been used to
describe services that are now reported under CPT codes 50606, 50705,
or 50706. Our perspective is consistent with the RUC-recommended
utilization crosswalk for the three new codes, which did not suggest
that the services were previously reported using 50706. We do not
believe that use of one particular code for reference in developing
values for another necessarily means that the all of the same equipment
would be used for both services.
We do not believe that these codes describe the same clinical work
either. CPT code 50387 is for the ``Removal and replacement of
externally accessible transnephric ureteral stent'' while CPT code
50606 describes an ``Endoluminal biopsy of ureter and/or renal
pelvis'', CPT code 50705 refers to ``Ureteral embolization or
occlusion'', and CPT code 50706 details ``Balloon dilation, ureteral
stricture.'' Additionally, the codes do not have the same global
periods, which makes comparisons between CPT code 50387 and CPT codes
506060, 50705, and 50706 even more difficult. We note that despite the
commenter's claim that CPT code 50387 was provided as a reference for
these procedures, 50387 is not in fact listed as a reference for any of
these three codes, or mentioned at all in the codes' respective summary
of recommendations. However, we acknowledge that among the procedures
that are provided as references, many of them include the use of an
angiography room, such as CPT code 36227 (Selective catheter placement,
external carotid artery) and CPT code 37233 (Revascularization,
endovascular, open or percutaneous, tibial/peroneal artery, unilateral,
each additional vessel). Therefore, we agree that the use of the
angiography room in these procedures, or at least some of its component
parts, may be warranted.
Comment: A commenter stated that the substitution of the
fluoroscopic room for the angiography room was clinically unjustified.
The commenter stated that the angiography room was needed for these
procedures to carry out 3-axis rotational imaging (so as to avoid
rolling the patient), ensure sterility, and avoid unacceptable
radiation exposure to physicians, their staff, and their patients. The
commenter indicated that the only piece of equipment listed in the
angiography room that would not be typically utilized for these
procedures is the Provis Injector. All of the other
[[Page 46233]]
items are used for these Genitourinary procedures. The commenter urged
CMS to restore the angiography room to these procedures.
Response: We agree that it is important to provide equipment that
is medically reasonable and necessary. Our concern with the use of the
angiography room for these codes is that we do not believe all of the
equipment would be typically necessary to furnish the procedure. For
example, the commenter agreed that the Provis Injector would not be
required for these Genitourinary codes. Therefore, we are proposing to
remove the angiography room from these three procedures and add in its
place the component parts that make up the room. Table 16 details these
components:
Table 16--Angiography Room (EL011) Components
------------------------------------------------------------------------
-------------------------------------------------------------------------
100 KW at 100 kV (DIN6822) generator
C-arm single plane system, ceiling mounted, integrated multispace
T motorized rotation, multiple operating modes
real-time digital imaging
40 cm image intensifier at 40/28/20/14cm
30 x 38 image intensifier dynamic flat panel detector
floor-mounted patient table with floating tabletop designed for
angiographic exams and interventions (with peistepping for image
intensifiers 13in+)
18 in TFT monitor
network interface (DICOM)
Careposition: Radiation free positioning of collimators
Carewatch: Acquisition and monitoring of configurable dose area product
Carefilter: Cu-prefiltration
DICOM HIS/RIS
Control room interface
Injector, Provis
Shields, lower body and mavig
Leonardo software
Fujitsu-Siemens high performance computers
Color monitors
Singo modules for dynamic replay and full format images
Prepared for internal networking and Siemens remote servicing, both
hardware and software
------------------------------------------------------------------------
We will include all of the above components except the Provis
Injector, as commenters have indicated that its use would not be
typical for these procedures. We welcome additional comment regarding
if these or other components are typically used in these Genitourinary
procedures. We currently lack pricing information for these components;
we are therefore proposing to include each of these components in the
direct PE input database at a price of $0.00 and we are soliciting
invoices from the public for their costs so that we may be able to
price these items for use in developing final PE RVUs for CY 2017
We also note that we believe that this issue illustrates a
potentially broad problem with our use of equipment ``rooms'' in the
direct PE input database. For most services, we only include equipment
items that are used and unavailable for other uses due to their use
during the services described by a particular code. However, for items
included in equipment ``rooms,'' we allocate costs regardless of
whether the individual items that comprise the room are actually used
in the particular service.
To maintain relativity among different kinds of procedures, we are
interested in obtaining more information specifying the exact resources
used in furnishing services described by different codes. We hope to
address this subject in greater detail in future rulemaking.
(7) Laparoscopic Radical Prostatectomy (CPT code 55866)
In the CY 2016 PFS final rule with comment period, we established
an interim final work RVU of 21.36 for CPT code 55866 based on a direct
crosswalk to CPT code 55840 (Prostatectomy, retropubic radical, with or
without nerve sparing). We stated that we believed these codes were
medically similar procedures with nearly identical time values, and we
did not believe that the difference in intensity between CPT code 55840
and CPT code 55866 was significant enough to warrant the RUC-
recommended difference of 5.50 work RVUs. We also compared CPT code
55866 to the work RVU of 25.18 for CPT code 55845, and stated our
belief that, in general, a laparoscopic procedure would not require
greater resources than an open procedure.
Comment: Several commenters disagreed with the statement that a
laparoscopic procedure, such as CPT code 55866, would generally require
fewer resources than an open procedure, such as CPT code 55840.
Commenters stated that developing the skill necessary to perform a
minimally invasive laparoscopic surgery requires a greater degree of
experience and specialized training than that required to perform an
open prostatectomy. Commenters indicated that this level of
practitioner skill should be reflected in the work RVU for the
procedure, as intensity is based in part upon skill, mental effort, and
psychological stress.
Response: We agree with the commenters that skill and technique as
well as mental effort and psychological stress on the part of the
practitioner contribute to the overall intensity of the furnishing a
given service, and therefore, are one of the two components in
determining code-level work RVUs. However, we do not believe that
relative increases in requisite skill or technique can be considered
alone. Although the development of new technology (such as robotic
assistance) may create a greater burden of knowledge on the part of the
practitioner, it can also make procedures faster, safer, and easier to
perform. This means that there may be reductions in time for such a
procedure (which is the other component of the work RVU), but also that
the mental effort and psychological stress for a given procedure may be
mitigated by the improvements in safety. Therefore, we do not agree
that a newer procedure that includes additional technology and requires
greater training would inherently be valued at a higher rate than an
older and potentially more invasive procedure.
Comment: A commenter stated that CPT code 55866 describes two very
different procedures in one code. The descriptor for the code states
``includes robotic assistance when performed'', and the procedure is
performed differently depending on whether or not the robotic
assistance is included. The commenter indicated that the vast majority
of radical prostatectomies are performed with the robot, and although
the outcomes are the same in both cases, the procedures are completely
different.
Response: We agree with the commenter that the descriptor includes
the possibility for confusion, especially on the part of the survey
respondents. Valuing this code based on the typical case is difficult
when the procedure differs depending on the inclusion or exclusion of
robotic assistance. We would recommend that valuation might be improved
if the CPT Editorial Panel were to consider further revisions to this
code to describe the two cases of laparoscopic radical prostatectomy:
With and without robotic assistance.
Comment: One commenter stated that the application of the phase-in
transition for facility-only codes like CPT code 55866 would have a
particularly egregious impact in the second year of the transition. The
commenter urged CMS to ensure that its implementation of the phase-in
transition does not undermine the protections created by the statute.
Response: Please see Sections II.G and II.H or a discussion of the
phase-in transition and its implementation in its second year.
Comment: Several commenters requested that CMS refer CPT code 55866
to the refinement panel for
[[Page 46234]]
review. At the refinement panel, the presenters brought up new evidence
in the form of a study published in 2016 describing discharge data for
radical laparoscopic prostatectomies. The presenters stated that there
were many more people included in this study as opposed to the 30
respondents in the survey data, and that on average the robotic
procedure took 90 minutes longer than the open procedure. The
additional time needed to perform the procedure, as indicated by this
new study's results, was presented as a new rationale as to why CMS
should accept the RUC-recommended work RVU.
Response: CPT code 55866 was referred to the CY 2016 Multi-
Specialty Refinement Panel per the request of commenters. The outcome
of the refinement panel was a median work RVU of 26.80, the same value
as the RUC recommended in the previous rulemaking cycle. After
consideration of the comments and the results of the refinement panel,
we are proposing for CY 2017 to maintain the interim final work RVU of
21.36 for CPT code 55866. We are interested in the results of the study
mentioned at the refinement panel, and we will consider incorporating
this data into the valuation of this code, including, if appropriate,
adjustments to the work times used in PFS ratesetting. We are also
seeking that the study be submitted through the public comment process
so that we can allow it proper consideration along with other
information submitted by the public, rather than using the results of a
single study to propose valuations. We are also curious about the time
values regarding the duration of CPT code 55866. One of the members of
the refinement panel stated that on average the robotic procedure took
90 minutes longer than the open procedure. This is not what was
indicated by the survey data from the RUC recommendations, which had
the two procedures valued at virtually identical times (same
intraservice time, 6 minutes difference total time). We are therefore
seeking comment on whether the times included in this study are more
accurate than the time reflected in the RUC surveys.
(8) Intracranial Endovascular Intervention (CPT codes 61645, 61650, and
61651)
For CY 2016, we established interim final work RVUs of 15.00 for
CPT code 61645, 10.00 for CPT code 61650 and 4.25 for CPT code 61651.
The RUC-recommended values for CPT codes 61645, 61650 and 61651 were
17.00, 12.00 and 5.50, respectively. We valued CPT code 61645 by
applying the ratio between the RUC-recommended reference code's, CPT
37231 (revascularization, endovascular, open or percutaneous, tibial,
peroneal artery, unilateral, initial vessel; with transluminal stent
placement(s) and atherectomy, includes angioplasty within the same
vessel, when performed), work and time to CPT code 61645. We valued CPT
code 61650 based on a crosswalk to CPT code 37221 (revascularization,
endovascular, open or percutaneous, iliac artery, unilateral, initial
vessel; with transluminal stent placement(s), includes angioplasty
within the same vessel, when performed), due to similar intensity and
intraservice time. We valued CPT code 61651 based on a crosswalk to CPT
code 37223 (revascularization, endovascular, open or percutaneous,
iliac artery, each additional ipsilateral iliac vessel; with
transluminal stent placement(s), includes angioplasty within the same
vessel, when performed (list separately in addition to the code for
primary procedure, due to similar intraservice time and intensity.
Both CPT codes 61645 and 61650 included postservice work time
associated with CPT code 99233 (Subsequent hospital care, per day, for
the evaluation and management of a patient, which requires at least 2
of these 3 key components: A detailed interval history; A detailed
examination; Medical decision making of high complexity. Counseling
and/or coordination of care with other physicians, other qualified
health care professionals, or agencies are provided consistent with the
nature of the problem(s) and the patient's and/or family's needs.
Usually, the patient is unstable or has developed a significant
complication or a significant new problem. Typically, 35 minutes are
spent at the bedside and on the patient's hospital floor or unit). In
the CY 2016 PFS final rule with comment period, we stated that we
believe that for the typical patient, these services would be
considered hospital outpatient services, not inpatient services. As a
result the intraservice time of the hospital observation care service
was valued in the immediate postservice time. We refined the work time
for CPT code 61645 by removing 55 minutes of work time associated with
CPT code 99233, and added 30 minutes of time from CPT code 99233 to the
immediate postservice. Therefore the total time for CPT code 61645 was
reduced to 241 minutes and the immediate postservice time increased to
83 minutes. We also removed the inpatient visit from CPT code 61650,
which reduced the total time to 206 minutes and increased the
postservice time to 75 minutes.
Comment: Commenters disagreed with our categorization of these
codes as outpatient only, and therefore, subject to the 23-hour
outpatient policy. Commenters stated that according to Medicare claims
data, the predecessor codes were performed primarily on an inpatient
basis. Additionally, commenters pointed out that the new codes would
typically be performed on acute stroke patients. Commenters also said
as the new codes are inpatient-only, the CMS reductions in work and
time based on the assumption of outpatient status are flawed; as a
result, commenters suggested we accept the RUC-recommended values.
Commenters also requested that these codes be referred to the
refinement panel.
Response: We valued CPT codes 61645, 61650, and 61651 based on
comparisons to reference CPT codes 37231, 37221, and 37223,
respectively. We continue to believe that these codes are appropriate
comparisons based on intensity and intra-service time because no
persuasive information was presented at the refinement panel that
indicated that these comparisons are not appropriate. Therefore we are
proposing an RVU of 15.00 for CPT code 61645, 10.00 for CPT code 61650,
and 4.25 for CPT code 61651. We are also proposing time inputs based on
our refinements of the RUC recommendations, including removing the time
associated with hospital inpatient visit CPT code 99233 from the
intraservice work time, and adding 30 minutes to the immediate
postservice time for both CPT codes 61645 and 61650.
We are also seeking comment on the inclusion of post-operative
visits in a 0-day global. Both CPT codes 61645 are 0-day global codes,
and the refinements described above reflect changes to more appropriate
value these codes as 0-day codes. We do not believe that 0-day globals
codes should include post-operative visits; rather, if global codes
require post-operative visits, they are more appropriately assigned 10-
or 90-day global periods based on our current criteria. Our policy has
been to remove the visit from the post-operative period and the
associated minutes from the total time while adding 30 minutes to the
immediate postservice period without necessarily making an adjustment
to the work RVU (see the CY 2010 PFS proposed rule, 74 FR 33557; also
see the CY 2011 PFS proposed rule, 75 FR 40072).
[[Page 46235]]
(9) Paravertebral Block Injection (CPT codes 64461, 64462, and 64463)
In CY 2015, the CPT Editorial Panel created three new codes to
describe paravertebral block injections at single or multiple levels,
as well as for continuous infusion for the administration of local
anesthetic for post-operative pain control and thoracic and abdominal
wall analgesia. For the CY 2016 PFS final rule with comment period, we
established the RUC-recommended work RVUs, 1.75 and 1.10, as interim
final for CPT codes 64461 and 64462, respectively.
For CPT code 64463, we utilized a direct crosswalk from three other
injection codes (CPT codes 64416 (Injection, anesthetic agent; brachial
plexus, continuous infusion by catheter (including catheter placement),
64446 (Injection, anesthetic agent; sciatic nerve, continuous infusion
by catheter (including catheter placement), and 64449 (Injection,
anesthetic agent; lumbar plexus, posterior approach, continuous
infusion by catheter (including catheter placement)) which all had a
work RVU of 1.81 as we believed this crosswalk more accurately
reflected the work involved in furnishing this service.
Comment: The RUC stated that CPT code 64463 is more comparable to
CPT code 64483 (Injection(s), anesthetic agent and/or steroid,
transforaminal epidural, with imaging guidance (fluoroscopy or CT);
lumbar or sacral, single), which has a work RVU of 1.90 and requires
the same physician work and time to perform. The RUC recommended we
accept the 25th percentile survey work RVU of 1.90. Another commenter
stated that our value for CPT code 64463 was inappropriate since
imaging guidance is not part of our comparison codes. The commenter
advocated for us to accept the survey respondent's selection of CPT
code 64483 as the most appropriate comparison code and assign a work
RVU of 1.90.
Response: After reviewing and considering the comments, we continue
to believe that CPT codes 64416, 64446, and 64449, all of which have 20
minutes of intraservice time, are better crosswalks to CPT code 64463,
which also has 20 minutes of intraservice time and a similar total
time. In contrast, the crosswalk code recommended by commenters, CPT
64483, only has 15 minutes of intraservice time. Therefore, we are
proposing a work RVU of 1.81 for CPT code 64463 for CY 2017.
(10) Implantation of Neuroelectrodes (CPT codes 64553 and 64555)
The RUC identified CPT codes 64553 and 64555 as a site of service
anomaly during the CY 2016 PFS rulemaking cycle. In the Medicare claims
data, these services were typically reported in the nonfacility
setting, yet the survey data was predicated on a facility-based
procedure. We agreed with the RUC that these two codes should be
referred to the CPT Editorial Panel to better define the services, in
particular to investigate the possibility of establishing one code to
describe temporary or testing implantation and another code to describe
permanent implantation. We maintained the CY 2015 work RVUs and direct
PE inputs for these two codes on an interim basis until receiving
updated recommendations from CPT and the RUC.
Comment: A commenter requested that CMS allow practitioners to bill
the MACs separately for a percutaneous electrode kit (SA022) for CPT
code 64555. The commenter stated that without allowing for a separate
payment for the percutaneous electrode kit, the payment for the
procedure would be insufficient to cover the physician's costs.
Response: We agree that CPT codes 64553 and 64555 as currently
constructed are potentially misvalued codes, which is why we are
maintaining the CY 2015 work RVUs and direct PE inputs on an interim
basis. We believe that the disposable supplies furnished incident to
the procedure are paid through the nonfacility PE RVUs. The
percutaneous electrode kit (SA022) was not previously included in the
direct PE inputs for either of these two services, and since we are
proposing to maintain current direct PE inputs pending additional
recommendations, we do not agree that disposable supplies should be
separately payable. We are proposing to maintain the interim final work
RVUs and direct PE inputs for these two codes, and we look forward to
reviewing recommendations regarding these procedures again for future
rulemaking.
Additionally, we were alerted to a discrepancy regarding the times
for these codes in the CY 2016 work time file. Our proposed CY 2017
work time file addresses this discrepancy by reflecting the RUC
recommended times of 155 minutes for CPT code 64553 and 140 minutes for
CPT code 64555.
(11) Ocular Reconstruction Transplant (CPT code 65780)
In CY 2015, the RUC identified CPT code 65780 as potentially
misvalued through a misvalued code screen for 90-day global services
that included more than 6 office visits. The RUC recommended a direct
work RVU crosswalk from CPT code 27829 (Open treatment of distal
tibiofibular joint (syndesmosis) disruption, includes internal
fixation, when performed). After examining comparable codes, we
determined the RUC-recommended work RVU of 8.80 for CPT code 65780
would likely overstate the work involved in the procedure given the
change in intraservice and total times compared to the previous values.
We believed that the ratio of the total times (230/316) applied to the
work RVU (10.73) more accurately reflected the work involved in this
procedure. Therefore, we established an interim final work RVU of 7.81
for CPT code 65780.
Comment: The RUC and other commenters disagreed with our interim
final values based on objections to our use of time ratios in
developing work RVUs for PFS services.
Response: We appreciate the commenters' concerns and have responded
to these concerns about our methodology in section II.L of this
proposed rule. After review of the comments, we continue to consider
the work RVU of 7.81 to accurately represent the work involved in CPT
code 65780. We believe this service is similar in overall intensity to
CPT code 27766 (Open treatment of medial malleolus fracture, includes
internal fixation, when performed) that has a work RVU of 7.89 and a
total time that more closely approximates that of CPT code 65780.
Therefore, we are proposing a work RVU of 7.81 for CPT code 65780 for
CY 2017.
(12) Trabeculoplasty by Laser Surgery (CPT code 65855)
In CY 2015, the RUC identified CPT code 65855 as potentially
misvalued through the review of 10-day global services with more than
1.5 postoperative visits. The RUC noted that the code was changed from
a 90-day to a 10-day global period when it was last valued in 2000.
However, the descriptor was not updated to reflect that change. CPT
code 65855 describes multiple laser applications to the trabecular
meshwork through a contact lens to reduce intraocular pressure. The
current practice is to perform only one treatment session during a 10-
day period and then wait for the effect on the intraocular pressure.
The descriptor for CPT code 65855 has been revised and removes the
language ``1 or more sessions'' to clarify this change in practice.
[[Page 46236]]
The RUC recommended a work RVU of 3.00 for CPT code 65855. While
the RUC-recommended value represents a reduction from the CY 2015 work
RVU of 3.99, we stated that significant reductions in the intraservice
time, the total time, and the change in the office visits represent a
more significant change in the work resources involved in furnishing
the typical service. The intraservice and total times were decreased by
approximately 33 percent while the elimination of two post-operative
visits (CPT code 99212) alone would reduce the overall work RVU by at
least 24 percent under the reverse building block method. However, the
RUC-recommended work RVU only represents a 25 percent reduction
relative to the previous value. To identify potential work RVUs for
this service, we calculated an intraservice time ratio between the CY
2015 intraservice time, 15 minutes, and the RUC-recommended
intraservice time, 10 minutes, and applied this ratio to the current
work RVU of 3.99 to arrive at a work RVU of 2.66 for CPT code 65855,
which we established as interim final for CY 2016.
Comment: A few commenters, including the RUC, provided explanations
as to how the RUC recommendation had already accounted for the
reduction in physician intra-service time and post-operative visits.
Some commenters disagreed with CMS' interim final values based on
objections to CMS' use of time ratios in developing work RVUs for PFS
services.
Response: We appreciate the commenters' concerns regarding the time
ratio methodologies and have responded to these concerns about our
methodology in section II.H.2 of this proposed rule. After considering
the explanations provided by commenters through public comments
describing the RUC's methodologies in more detail, we agree that the
proposed value did not accurately reflect the physician work involved
in furnishing the service. Therefore, for CY 2017 we are proposing the
RUC-recommended work RVU value of 3.00 for CPT code 65855.
(13) Glaucoma Surgery (CPT codes 66170 and 66172)
The RUC identified CPT codes 66170 and 66172 as potentially
misvalued through a screen for 90-day global codes that included more
than 6 office visits). We believed the RUC-recommended work RVU of
13.94 for CPT code 66170 did not accurately account for the reductions
in time. Specifically, the survey results indicated reductions of 25
percent in intraservice time and 28 percent in total time. These
reductions suggested that the RUC-recommended work RVU for CPT code
66170 overstated the work involved in furnishing the service, since the
recommended value only represented a reduction of approximately seven
percent. We believed that applying the intraservice time ratio, the
ratio between the CY 2015 intraservice time, 60 minutes, and the RUC-
recommended intraservice time, 45 minutes, applied to the current work
RVU, 15.02, resulted in a more appropriate work RVU. Therefore, for CY
2016, we established an interim final work RVU of 11.27 for CPT code
66170.
For CPT code 66172, the RUC recommended a work RVU of 14.81. After
comparing the RUC-recommended work RVU for this code to the work RVU
for similar codes (for example, CPT code 44900 (Incision and drainage
of appendiceal abscess, open) and CPT code 52647 (Laser coagulation of
prostate, including control of postoperative bleeding, complete
(vasectomy, meatotomy, cystourethroscopy, urethral calibration and/or
dilation, and internal urethrotomy are included if performed))), we
believed the RUC-recommended work RVU of 14.81 overstated the work
involved in this procedure. For the same reasons and following the same
valuation methodology utilized above, we applied the intraservice time
ratio between the CY 2015 intraservice time and the survey intraservice
time, 60/90, to the CY 2015 work RVU of 18.86. This resulted in a work
RVU of 12.57 for CPT code 66172. Therefore, for CY 2016, we established
an interim final work RVU of 12.57 for CPT code 66172.
Comment: Several commenters, including the RUC, disagreed with our
interim final values based on objections to our use of time ratios in
developing work RVUs for PFS services. Commenters also requested CMS
refer CPT codes 66170 and 66172 to the refinement panel.
Response: We appreciate the commenters' concerns regarding the time
ratio methodologies and have responded to these concerns in section
II.H.2 of this proposed rule. CPT codes 66170 and 66172 were referred
to the CY 2016 multi-specialty refinement panel per commenters'
request. The outcome of the refinement panel was a median of 13.94 RVUs
for CPT code 66170 and 14.84 RVUs for CPT code 66172. Due to the new
information presented to the refinement panel regarding the level of
intensity required to perform millimeter incisions in the eye, we agree
with the assessment of the refinement panel and therefore, for CY 2017
we are proposing a work RVU of 13.94 for CPT code 66170 and 14.84 for
CPT code 66172.
(14) Retinal Detachment Repair (CPT codes 67107, 67108, 67110, and
67113)
CPT codes 67107, 67108, 67110 and 67113 were identified as
potentially misvalued through a screen for 90-day global post-operative
visits. The RUC recommended a work RVU of 16.00 for CPT code 67107,
which corresponded to the 25th percentile of the survey. While the RUC
recommendation represented a five percent reduction from the current
work RVU of 16.71, we believed the RUC recommendation still overvalued
the service given the 15 percent reduction in intraservice time and 25
percent reduction in total time. We used the intraservice time ratio
between the existing and new time values to identify an interim final
work RVU of 14.06. We believed this value accurately reflected the work
involved in this service and was comparable to other codes that have
the same global period and similar intraservice time and total time.
For CY 2016, we established an interim final work RVU of 14.06 for CPT
code 67107.
For CPT code 67108, the RUC recommended a work RVU of 17.13 based
on the 25th percentile of the survey, which reflected a 25 percent
reduction from the current work RVU. The survey results reflected a 53
percent reduction in intraservice time and a 42 percent reduction in
total time. We believe the RUC-recommended work RVU overestimated the
work, given the significant reductions in intraservice time and total
time and does not maintain relativity among the codes in this family.
To determine the appropriate value for this code and maintain
relativity within the family, we preserved the 1.13 work RVU increment
recommended by the RUC between this code and CPT code 67107 and applied
that increment to the interim final work RVU of 14.06 for CPT code
67107. Therefore, we established an interim final work RVU of 15.19 for
CPT code 67108.
For CPT code 67110, the RUC recommended maintaining the current
work RVU of 10.25. To maintain appropriate relativity with the work
RVUs established for the other services within this family, we used the
RUC-recommended -5.75 RVU differential between CPT code 67107 and CPT
code 67110 to establish the CY 2016 interim final work RVU of 8.31 for
CPT code 67110. For CPT code 67113, the RUC recommended and we
established an interim final work RVU of 19.00 based on the 25th
percentile of the survey.
[[Page 46237]]
Comment: Several commenters, including the RUC, disagreed with our
interim final values based on objections to our use of time ratios in
developing work RVUs for PFS services. Some commenters also stated that
by using some RUC-recommended increments and rejecting others, we have
not only established inconsistencies within the family of codes, but
potentially opened up anomalies across a wide range of services. The
RUC also expressed disagreement with using the recommended work RVU
increments without using the recommended work RVU. Some commenters also
stated the new IWPUT values for these three services are
inappropriately low and pointed to the derived per minute intensity of
0.064 for CPT code 67110 as particularly problematic.
Response: We appreciate the commenters' concerns regarding the time
ratio methodologies and have responded to these concerns in section
II.H.2 of this proposed rule. We disagree with the statement about
inconsistencies as the codes in this family are valued relative to one
another based on the times and level of physician work required for
each code. Also, we generally do not agree that a low IWPUT itself
indicates overall misvaluation as the validity of the IWPUT as a
measure of intensity depends on the accuracy of the assumptions
regarding the number, level, and work RVUs attributable to visits for
services in the post-operative global period for individual services.
For example, a service with an unrealistic number or level of post-
operative visits may have a very low derived intensity for the intra-
service time.
CPT codes 67107, 67108, and 67110 were referred to the CY 2016
multi-specialty refinement panel per commenters' request. The outcome
of the refinement panel was a median of 16.00, 17.13, and 10.25 work
RVUs; respectively. After consideration of the comments and the results
of the refinement panel, we are proposing a work RVU of 16.00, 17.13,
and 10.25 for CPT codes 67107, 67108, and 66110, respectively, for CY
2017.
(15) Fetal MRI (CPT Codes 74712 and 74713)
For CY 2016, we established the RUC-recommended work RVU of 3.00 as
interim final for CPT code 74712. We established an interim final work
RVU of 1.78 for CPT code 74713 based on a refinement of the RUC-
recommended work RVU of 1.85 using the ratio of work to time for both
codes. This proposed value also corresponds to the 25th percentile
survey result.
Comment: Commenters stated that the work RVU of 1.78 for CPT code
74713 did not reflect the higher intensity inherent in the procedure's
typical patient. The commenter explained that the typical patient is
pregnant with twins and has a higher likelihood of complications
related to congenital anomalies, as well as of ischemic brain injury
with twin gestations. The commenter further stated that twin gestations
are more difficult to image. Commenters requested that CPT code 74713
be referred to the multispecialty refinement panel.
Response: CPT code 74713 was referred to the CY 2016 multispecialty
refinement panel. After considering the comments and the results of the
refinement panel, we agree with commenters that an RVU of 1.78
underestimates the work for CPT code 74713. Therefore, we propose a
work RVU of 1.85 for the service for CY 2017.
(16) Interstitial Radiation Source Codes (CPT Codes 77778 and 77790)
In CY 2016 PFS final rule with comment period, we established an
interim final value for CPT code 77790 without a work RVU, consistent
with the RUC's recommendation. We did not use the RUC-recommended work
RVU to establish the interim final values for CPT code 77778. We stated
that the specialty society survey included a work time that was
significantly higher than the RUC-recommended work time without a
commensurate change in RVU. For CY 2016, we established the 25th
percentile work RVU survey result of 8.00 as interim final for CPT code
77778.
Comment: Commenters agreed that the preservice survey times and the
RUC-recommended survey times were inconsistent and explained that this
inconsistency resulted from the RUC's use of preservice packages in
developing recommendations. In addition, commenters stated that because
the work associated with CPT code 77790 (including pre-time
supervision, handling, and loading of radiation seeds into needles) was
bundled into CPT code 77778, that the additional work should be
reflected in the RVU for CPT code 77778. Commenters encouraged us to
accept the RUC-recommended work RVU of 8.78 and requested that CPT code
77778 be referred to the refinement panel.
Response: We did not refer CPT code 77778 to the CY 2016
multispecialty refinement panel because commenters did not provide new
clinical information. We continue to believe that, based on the
reduction in total work time, an RVU of 8.00 accurately reflects the
work involved in furnishing CPT code 77778. Therefore for CY 2017, we
are proposing a work RVU of 8.00 for CPT code 77778 and 0 work RVUs for
CPT code 77790. We are also seeking comment on whether we should use
time values based on preservice packages if the recommended work value
is based on time values that are significantly different than those
ultimately recommended.
(17) Colon Transit Imaging (CPT Codes 78264, 78265, and 78266)
In establishing CY 2016 interim final values, we accepted the RUC-
recommended work RVUs for CPT codes 78265 and 78266. We believed that
the RUC-recommended RVU of 0.80 overestimated the work involved in
furnishing CPT code 78264 and as a result, we established an interim
final work RVU of 0.74 based on a crosswalk to CPT code 78226
(hepatobiliary system imaging, including gallbladder when present), due
to similar intraservice times and intensities.
Comment: Commenters did not support our interim final work RVU for
CPT code 78264. Commenters disagreed with our assessment of CPT code
78264 as having a higher work RVU and shorter intraservice time
relative to the other codes in the family. One commenter stated that a
difference of two minutes in intraservice time was insignificant and
should not be used as a rationale for revaluing. Another commenter
stated that we should have maintained the RUC-recommended crosswalk of
CPT code 78264 to CPT code 78227 (Hepatobiliary system imaging,
including gallbladder when present; with pharmacologic intervention,
including quantitative measurement(s) when performed) due to
similarities in service, work and intensity. Based on these concerns,
commenters requested that CPT code 78264 be referred to the refinement
panel.
Response: CPT code 78264 was referred to the CY 2016 multi-
specialty refinement panel for further review. We calculate the
refinement panel results as the median of each vote. That result for
CPT code 78264 was 0.79 RVUs. After consideration of the comments and
the refinement panel results, we agree that 0.79 accurately captures
the overall work involved in furnishing this service and are proposing
a value of 0.79 for CPT code 78264.
[[Page 46238]]
(18) Cytopathology Fluids, Washings or Brushings and Cytopathology
Smears, Screening, and Interpretation (CPT Codes 88104, 88106, 88108,
88112, 88160, 88161, and 88162)
In the CY 2016 PFS final rule with comment period, we made a series
of refinements to the recommended direct PE inputs for this family of
codes. We removed the equipment time for the solvent recycling system
(EP038) and the associated clinical labor described by the tasks
``Recycle xylene from stainer'' and ``Order, restock, and distribute
specimen containers and or slides with requisition forms'' due to our
belief that these were forms of indirect PE. This refinement applied to
all seven codes in the family. We also noticed what appeared to be an
error in the quantity of non-sterile gloves (SB022), impermeable staff
gowns (SB027), and eye shields (SM016) assigned to CPT codes 88108 and
88112. The recommended value of these supplies was a quantity of 0.2,
which we believed was intended to be a quantity of 2. We therefore
refined the value of these supplies to 2 for CPT codes 88108 and 88112.
Comment: Several commenters disagreed with our characterization of
the solvent recycling system and its associated clinical labor tasks as
indirect PE. Commenters stated that the solvent recycling system costs
are direct expenses since they are based on the amount of recycled
solvent allocated to each specimen, with solvents allocated to specific
specimens based on batch size. They indicated that the related clinical
labor tasks are also forms of direct PE as they are also based on the
amount of recycled solvent allocated to each specimen. The time for
these tasks varies based on the batch size, which varies by procedure.
Response: We maintain our previously stated belief that these are
forms of indirect PE, as they are not allocated to any individual
service. We have defined direct PE inputs as clinical labor, medical
supplies, or medical equipment that are individually allocable to a
particular patient for a particular service. We continue to believe
that a solvent recycling system would be in general use for a lab
practice, and that the associated clinical labor tasks for ordering and
restocking specimen containers can be more accurately described as
administrative activities. We are proposing to maintain these
refinements from the previous rulemaking cycle for CPT codes 88104-
88162.
Comment: A commenter indicated that we did not account for the
batch size when considering the supply quantities for CPT codes 88108
and 88112. The commenter indicated that the practice expense inputs
should be assumed to have a batch size of five for these two codes, and
therefore, no edits should be made. The commenter requested that we
restore the quantity of 0.2 for the gloves, gowns, and eye shields
associated with these procedures. This did not apply to the other codes
on the submitted spreadsheet, which had a batch size of one.
Response: We appreciate the assistance of the commenter in
clarifying the batch size for these procedures. As a result, we are
proposing to refine the supply quantity of the non-sterile gloves
(SB022), impermeable staff gowns (SB027), and eye shields (SM016) back
to the RUC-recommended value of 0.2 for CPT codes 88108 and 88112.
(19) Immunohistochemistry (CPT Codes 88341, 88342, 88344, and 88350)
In the CY 2014 PFS final rule with comment period (78 FR 74341), we
assigned a status indicator of I (Not valid for Medicare purposes) to
CPT codes 88342 and 88343 and instead created two G-codes, G0461 and
G0462, to report immunohistochemistry services. We did this in part to
avoid creating incentives for overutilization. For CY 2015, the CPT
coding was revised with the creation of two new CPT codes, 88341 and
88344, the revision of CPT code 88342 and the deletion of CPT code
88343. In the past for similar procedures in this family, the RUC
recommended a work RVU for the add-on code (CPT code 88364) that was 60
percent of the base code (CPT code 88365). In the CY 2015 PFS final
rule with comment period, we stated that the relative resources
involved in furnishing an add-on service in this family would be
reflected appropriately using the same 60 percent metric and
subsequently established an interim final work RVU of 0.42 for CPT code
88341, which was 60 percent of the work RVU of the base CPT code 88342
(0.70). In the CY 2016 PFS proposed rule, we revised the add-on codes
from 60 percent to 76 percent of the base code and subsequently
revalued CPT code 88341 at 0.53 work RVUs. However, we inadvertently
published work RVUs for CPT code 88341 in Addendum B without explicitly
discussing it in the preamble text. In the CY 2016 PFS final rule with
comment period, we maintained CPT code 88341's CY 2015 work RVU of 0.53
as interim final for CY 2016 and requested public comment. Also, in the
CY 2016 PFS final rule with comment period, we established an interim
final value of 0.70 work RVUs for CPT codes 88342 and 88344.
Comment: Several commenters expressed their opposition to a
standard discount for the physician work involved in pathology add-on
services and urged us to accept the RUC-recommend value of 0.65 RVUs
for CPT code 88341.
Response: We appreciate commenters' concerns regarding a standard
discount; however, we believe that it is reasonable to estimate work
RVUs for a base and an add-on code, and to recognize efficiencies
between them, by looking at how similar efficiencies are reflected in
work RVUs for other PFS services. Also we note that the intravascular
codes for which we initially established our base/add-on code
relationship for CPT codes 88346 and 88350 were deleted in CY 2016 and
replaced with two new codes; CPT codes 37252 and 37253. The
relationship between 37252 and 37253 represents a 20 percent discount
for the add-on code as the base CPT code 37252 has a work RVU of 1.80
and 37523 and work RVU of 1.44. As CPT codes 37252 and 37253 replaced
the codes on which our discounts for base and add-on codes were based
(please see the CY 2016 PFS final rule with comment period (80 FR
70972) for a detailed discussion) we believed it would be appropriate
to maintain the same 20 percent relationship for 88346 and 88350.
Therefore, for CY 2017, we are proposing a work RVU of 0.56 for CPT
code 88341, which represents 80 percent of 0.70, the work RVU of the
base code.
For CY 2016, we finalized a work RVU of 0.56 for CPT code 88350
which represented 76 percent of 0.74, the RVU for the base code. To
maintain consistency within this code family, we are proposing to
revalue CPT code 88350 using the 20 percent discount discussed above.
To value CPT code 88350, we multiplied the work RVU of CPT code 88346,
0.74, by 80 percent, and then subtracted the product from 0.74,
resulting in a work RVU of 0.59 for CPT code 88350. Therefore, for CY
2017, we are proposing a work RVU of 0.59 for CPT code 88350.
A stakeholder has suggested to us that an error was made in the
implementation of direct PE inputs for code 88341 and several other
related codes. This stakeholder stated that when CMS reclassified
equipment code EP112 (Benchmark ULTRA automated slide preparation
system) and EP113 (E-Bar II Barcode Slide Label System) into a single
equipment item, with a price of $150,000 using equipment code EP112,
[[Page 46239]]
the equipment minutes assigned to the E-Bar II Barcode Slide Label
System should have been added into the new EP112 equipment time. The
stakeholder requested that these minutes should be added into the EP112
equipment time; for example, 1 additional minute should be added to CPT
code 88341 for a total of 16 minutes.
We appreciate the additional information, and are soliciting
additional information on this topic through public comment on this
proposed rule to assess whether it would be appropriate to add the
former EP113 minutes into EP112. We are specifically seeking comment
from other stakeholders, including the RUC, since the assigned number
of minutes was originally based on a RUC recommendation. This
information would be potentially relevant for CPT codes 88341
(Immunohistochemistry or immunocytochemistry, per specimen; each
additional single antibody stain procedure), 88342
(Immunohistochemistry or immunocytochemistry, per specimen; initial
single antibody stain procedure), 88344 (Immunohistochemistry or
immunocytochemistry, per specimen; each multiplex antibody stain
procedure), 88360 (Morphometric analysis, tumor immunohistochemistry,
quantitative or semiquantitative, per specimen, each single antibody
stain procedure; manual), and 88361 (Morphometric analysis, tumor
immunohistochemistry, quantitative or semiquantitative, per specimen,
each single antibody stain procedure; using computer-assisted
technology).
(20) Morphometric Analysis (CPT Codes 88364, 88365, 88367, 88368, 88369
and 88373)
For CY 2015, the CPT editorial panel revised the code descriptors
for the in situ hybridization procedures, CPT codes 88365, 88367 and
88368, to specify ``each separately identifiable probe per block.''
Additionally, three new add-on codes (CPT codes 88364, 88369, 88373,)
were created to specify ``each additional separately identifiable probe
per slide.'' Some of the add-on codes in this family had RUC-
recommended work RVUs that were 60 percent of the work RVU of the base
procedure. We believed this accurately reflected the resources used in
furnishing these add-on codes and subsequently established interim-
final work RVUs of 0.53 for code 88364 (60 percent of the work RVU of
CPT code 88365); 0.53 for CPT code 88369 (60 percent of the work RVU of
CPT code 88368); and 0.43 for CPT code 88373 (60 percent of the work
RVU of CPT code 88367).
For CY 2016, the RUC re-reviewed these services due to the
specialty society's initially low survey response rate. In our review
of these codes, we noticed that the latest RUC recommendation was
identical to the RUC recommendation provided for CY 2015. Therefore, we
proposed to retain the CY 2015 work RVUs and work time for CPT codes
88367 and 88368 for CY 2016. For CPT code 88365 we finalized a work RVU
of 0.88.
For CPT codes 88364 and 88369, we increased the work RVUs of these
add-on codes from 0.53 to 0.67, which reflected 76 percent of the work
RVUs of the base procedures for these services. However, we
inadvertently omitted the rationale for this revision to the work RVUs
in the proposed rule. Consequently, we maintained the CY 2015 interim
final values of the work RVU of 0.67 for CPT codes 88464 and 88369 and
sought comment on these values for CY 2016. For CPT code 88373 we
finalized a work RVU of 0.43.
Comment: A few commenters stated their objection to our use of a
standard discount for pathology add-on services and for suggesting that
each service is separate and unique. Commenters also stated there
should be no comparison of intravascular ultrasound services to
morphometric analysis, immunohistochemistry, immunofluorescence, or any
pathology service.
Response: In reviewing the RUC-recommended base/add-on
relationships between several pathology codes, we continue to believe
the base/add-on code time relationships for pathology services are
appropriate and have not been presented with any compelling evidence
that conflicts with the RUC-recommended relationships. However, as we
stated above, the intravascular codes we initially examined in
revaluing CPT codes 88364 and 88369 were deleted in CY 2016 and
replaced with CPT codes 37252 and 37253. For the reasons stated above
we continue to believe this 20 percent discount relationship between
the base and add-on code accurately reflects the work involved in
furnishing these services.
Therefore, for CY 2017, we are proposing a work RVU of 0.70 for CPT
codes 88364 and 88369 which represents a 20 percent discount from the
base code. As the relationship between the base code and add-on code
now represents a 20 percent difference we are proposing to revalue CPT
code 88373 at 0.58 work RVUs. Therefore, for CY 2017 we are proposing a
work RVU of 0.58 for CPT code 88373.
(21) Liver Elastography (CPT Code 91200)
For CY 2016, we received a RUC recommendation of 0.27 RVU for CPT
code 91200. After careful review of the recommendation, we established
the RUC-recommended work RVU and direct PE inputs as interim final for
CY 2016.
Comment: A few commenters requested that we reconsider the level of
payment assigned to this service when furnished in a non-facility
setting, stating that the code met the definition for the potentially
misvalued code list as there is a significant difference in payment
between sites of service. The commenters also asked us to reconsider
the assigned 50 percent utilization rate for the FibroScan equipment in
this procedure as the current utilization rate would translate to over
50 procedures per week. Instead, the commenters suggested the typical
number of procedures done per week ranges between 15 and 25 and
requested we adopt a 25 percent utilization rate which corresponds to
that number of procedures.
Response: We refer commenters to the CY 2016 final rule with
comment period (80 FR 71057-71058) where we discussed and addressed the
comparison of the PFS payment amount to the OPPS payment amount for CPT
91200. For the commenter's statement about the utilization rate, we
have previously addressed the accuracy of these default assumptions as
they apply to particular equipment resources and particular services.
In the CY 2008 PFS proposed rule (72 FR 38132), we discussed the 50
percent utilization assumption and acknowledged that the default 50
percent usage assumption is unlikely to capture the actual usage rates
for all equipment. However, we stated that we did not believe that we
had strong empirical evidence to support any alternative approaches. We
indicated that we would continue to monitor the appropriateness of the
equipment utilization assumption, and evaluate whether changes should
be proposed in light of the data available. The commenters did not
provide any verifiable data suggesting a lower utilization rate.
Therefore, for CY 2017 we are proposing a work RVU of 0.27 for CPT code
91200, consistent with the CY 2016 interim final value, and we continue
to explore and seek comments regarding publicly available data sources
to identify the most accurate equipment utilization rate assumptions
possible. We also note that following the
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publication of the CY 2016 PFS final rule with comment period (80 FR
70886) there was an inconsistency in the Work Time file published on
the CMS Web site. For CPT code 91200 the RUC recommended 16 minutes
total service time whereas our file reflected 18 minutes total time for
the service. For CY 2017, we are proposing to update the Work Time file
to reflect the RUC's recommendation, which is 16 minutes for CPT code
91200.
b. CY 2017 Proposed Codes
(1) Anesthesia Services Furnished in Conjunction with Lower
Gastrointestinal (GI) Procedures (CPT Codes 00740 and 00810)
The anesthesia procedure CPT codes 00740 and 00810 are used for
anesthesia furnished in conjunction with lower gastrointestinal (GI)
procedures. In the CY 2016 PFS proposed rule (80 FR 41686), we
discussed that in reviewing Medicare claims data, a separate anesthesia
service is now reported more than 50 percent of the time that several
types of colonoscopy procedures are reported. We discussed that given
the significant change in the relative frequency with which anesthesia
codes are reported with colonoscopy services, we believe the relative
values of the anesthesia services should be reexamined. We proposed to
identify CPT codes 00740 and 00810 as potentially misvalued and sought
public comment regarding valuation for these services.
The RUC recommended maintaining the base unit value of 5 as an
interim base value for both CPT code 00740 and 00810 on an interim
basis, due to their concerns about the specialty society surveys. The
RUC suggested that the typical patient vignettes used in the surveys
for both CPT codes 00740 and 00810 were not representative of current
typical practice and recommended that the codes be resurveyed with
updated vignettes. We agree that it is premature to propose any changes
to the valuation of CPT codes 00740 and 00810, but continue to believe
that these services are potentially misvalued and look forward to
receiving input from interested parties and specialty societies for
consideration during future notice and comment rulemaking.
(2) Removal of Nail Plate (CPT Code 11730)
We identified CPT code 11730 (Avulsion of nail plate, partial or
complete, simple; single) through a screen of high expenditures by
specialty. The HCPAC recommended a work RVU of 1.10. We believe the
recommendation for this service overestimates the work involved in
performing this procedure, specifically given the decrease in physician
intraservice and total time concurrently recommended by the HCPAC. We
believe that a work RVU of 1.05, which corresponds to the 25th
percentile of the survey results, more accurately represents the time
and intensity of furnishing the service. To further support the
validity of the use of the 25th percentile of the survey, a work RVU of
1.05, we identified two crosswalk CPT codes, 20606 (Arthrocentesis,
aspiration and/or injection, intermediate joint or bursa), with a work
RVU of 1.00, and 50389 (Removal of nephrostomy tube, requiring
fluoroscopic guidance) with a work RVU of 1.10, both of which have
identical intraservice times, similar total times and similar
intensity. We note that our proposed work RVU of 1.05 for CPT code
11730 falls halfway between the work RVUs for these two crosswalk-
codes. CPT Code 11730 may be reported with add-on CPT code 11732 to
report performance of the same procedure for each additional nail plate
procedure.
Since CPT code 11732 was not reviewed by the HCPAC for CY 2017, we
are proposing a new work value to maintain the consistency of this add-
on code with the base code, CPT code 11730. We are proposing to remove
2 minutes from the physician intraservice time to maintain consistency
with the HCPAC-recommended reduction of 2 minutes from the physician
intraservice time period for the base code. We are using a crosswalk
from the value for CPT code 77001 (Fluoroscopic guidance for central
venous access device placement, replacement (catheter only or
complete), or removal (includes fluoroscopic guidance for vascular
access and catheter manipulation, any necessary contrast injections
through access site or catheter with related venography radiologic
supervision and interpretation, and radiographic documentation of final
catheter position) (List separately in addition to code for primary
procedure)), which has similar physician intraservice and total time
values; therefore, we are proposing a work RVU of 0.38 for CPT code
11732. As further support for this proposal, we note that this proposed
RVU reduction is similar to the value obtained by subtracting the
incremental difference in the current and recommended work RVUs for the
base code from the current value of CPT code 11732.
We are proposing to use the HCPAC-recommended direct PE inputs for
CPT code 11730. We are proposing to apply some of HCPAC-recommended
refinements for CPT code 11730 to11732, including the removal of the
penrose drain (0.25in x 4in), lidocaine 1%-2% inj (Xylocaine),
applicator (cotton-tipped, sterile) and silver sulfadiazene cream
(Silvadene), as well as the reduction of the swab-pad, alcohol from 2
to 1. In addition, we are proposing not to include the recommended the
supply items ``needle, 30g, and syringe, 10-12ml'' since other similar
items are present, and we think inclusion of these additional supply
items would be duplicative. For clinical labor, we are proposing to
assign 8 minutes to ``Assist physician in performing procedure'' for to
maintain a reduction that is proportionate to that recommended for
11730. For the supply item ``ethyl chloride spray,'' we believe that
the listed input price of $4.40 per ounce overestimates the cost of
this supply item, and we are seeking comment on the accuracy of this
supply item price. Finally, we are adding two equipment items as was
done in the base code, basic instrument pack and mayo stand, and are
proposing to adjust the times for all pieces of equipment to 8 minutes
to reflect the clinical service period time.
(3) Bone Biopsy Excisional (CPT Code 20245)
In CY 2014, CPT code 20245 was identified by the RUC's 10-Day
Global Post-Operative Visits Screen.
For CY 2017, the RUC recommended a value of 6.50 work RVUs for CPT
code 20245, including a change in global period from 10- to 0- days. We
disagree with this value given the significant reductions in the
intraservice time, total time, and the change in the office visits
assuming the change in global period. The intraservice and total times
were decreased by approximately 33 and 53 percent respectively; while
the elimination of three post-operative visits (one CPT code 99214 and
two CPT code 99213 visits) alone would reduce the overall work RVU by
at least 38 percent under the reverse building block methodology. We
also note that the RUC-recommended work RVU of 6.50 only represents a
27 percent reduction relative to the previous work RVU of 8.95. To
develop a work RVU for this service, we used a crosswalk from CPT code
19298 (Placement of radiotherapy after loading brachytherapy catheters
(multiple tube and button type) into the breast for interstitial
radioelement application following (at the time of or subsequent to)
partial mastectomy, includes imaging guidance), since we believe the
codes share similar intensity and total time and the same intraservice
time of 60 minutes. Therefore, for CY
[[Page 46241]]
2017, we are proposing a work RVU of 6.00 for CPT code 20245.
(4) Insertion of Spinal Stability Distractive Device (CPT Codes 228X1,
228X2, 228X4, and 228X5)
For CY 2016, the CPT Editorial Panel converted two Category III
codes to Category I codes describing the insertion of an interlaminar/
interspinous process stability device (CPT codes 228X1 and 228X4) and
developed two corresponding add-on codes (CPT codes 228X2 and 228X5).
The RUC recommended a work RVU of 15.00 for CPT code 228X1, 4.00 for
CPT code 228X2, 7.39 for CPT code 228X4, and 2.34 for CPT code 228X5.
We believe that the RUC recommendations for CPT codes 228X1 and
228X4 overestimate the work involved in furnishing these services. We
believe that a crosswalk to CPT code 36832 (Revision, open,
arteriovenous fistula; without thrombectomy, autogenous or
nonautogenous dialysis graft (separate procedure)) which has a work RVU
of 13.50 is an accurate comparison. CPT code 36832 is similar in total
time, work intensity, and number of visits to 228X1. This is supported
by the ratio between total time and work in the key reference service,
CPT code 63047 (Laminectomy, facetectomy and foraminotomy (unilateral
or bilateral with decompression of spinal cord, cauda equina and/or
nerve root[s], [e.g., spinal or lateral recess stenosis]), single
vertebral segment; lumbar). Therefore, we are proposing a work RVU of
13.50 for CPT code 228X1. For CPT code 228X4, we believe that CPT code
29881 (Arthroscopy, knee, surgical; with meniscectomy (medial OR
lateral, including any meniscal shaving) including debridement/shaving
of articular cartilage (chondroplasty), same or separate
compartment(s), when performed) is an appropriate crosswalk based on
clinical similarity as well as intensity and total time. CPT code 29881
has an RVU of 7.03; therefore, we are proposing a work RVU of 7.03 for
CPT code 228X4. We are proposing to accept the RUC-recommended work RVU
for CPT codes 228X2 and 228X5 without refinement.
(5) Biomechanical Device Insertion (CPT Codes 22X81, 22X82, and 22X83)
For CY 2016, the CPT Editorial Panel established three new category
I add-on codes and deleted one code to provide a more detailed
description of the placement and attachment of biomechanical spinal
devices. For CPT code 22X81, the RUC recommended a work RVU of 4.88.
For CPT code 22X82, and CPT code 22X83, the recommended work RVUs are
5.50 and 6.00, respectively.
In reviewing the code descriptors, descriptions of work and
vignettes associated with CPT codes 22X82 and 22X83, we determined that
the two procedures, in addition to having identical work time, contain
many clinical similarities and do not have quantifiable differences in
overall intensity. Therefore, we are proposing the RUC-recommended work
RVU of 5.50 for both CPT code 22X82 and CPT code 228X3. We believe that
the RUC-recommended work RVU for CPT code 22X81 overestimates the work
in the procedure relative to the other codes in the family. We are
proposing a work RVU of 4.25 for CPT code 228X1 based a crosswalk from
CPT code 37237 (Transcatheter placement of an intravascular stent(s)
(except lower extremity artery(s) for occlusive disease, cervical
carotid, extracranial vertebral or intrathoracic carotid, intracranial,
or coronary), open or percutaneous, including radiological supervision
and interpretation and including all angioplasty within the same
vessel, when performed; each additional artery (List separately in
addition to code for primary procedure)), which is similar in time and
intensity to the work described by CPT code 22X81.
(6) Closed Treatment of Pelvic Ring Fracture (CPT Codes 271X1 and
271X2)
For CY 2017, the CPT Editorial Panel deleted CPT codes 27193 and
27194 and replaced them with two new codes, 271X1 and 271X2, and the
RUC recommended a work RVU of 5.50 for CPT code 27193, and a work RVU
of 9.00 for CPT code 271X2 to describe closed treatment of pelvic ring
fracture. We are proposing to change the global period for these
services from 90 days to 0 days because these codes typically represent
emergent procedures with which injuries beyond pelvic ring fractures
are likely to occur; we believe it is typical that multiple
practitioners would be involved in providing post-operative care and it
is likely that a practitioner furnishing a different procedure is more
likely to be providing the primary post-operative care. If other
practitioners are typically furnishing care in the post-surgery period,
we believe that the six postservice visits included in CPT code 271X1,
and the seven included in 271X2, would likely not occur. This is
similar to our CY 2016 review and valuation of CPT codes 21811 (Open
treatment of rib fracture(s) with internal fixation, includes
thoracoscopic visualization when performed, unilateral; 1-3 ribs),
21812 (Open treatment of rib fracture(s) with internal fixation,
includes thoracoscopic visualization when performed, unilateral; 4-6
ribs), and 21813 (Open treatment of rib fracture(s) with internal
fixation, includes thoracoscopic visualization when performed,
unilateral; 7 or more ribs). In our valuation of those codes, we
determined that a 0-day, rather than a 90-day global period was
preferable, in part because those codes describe rib fractures that
would typically occur along with other injuries, and the patient would
likely already be receiving post-operative care because of the other
injuries. We believe that the same rationale applies here. To establish
a work RVU for 271X1, we are crosswalking this code to CPT code 65800
(Paracentesis of anterior chamber of eye (separate procedure); with
removal of aqueous), due to its identical intraservice time and similar
total time, after removing the work associated with postoperative
visits, and its similar level of intensity. Therefore, we are proposing
a work RVU of 1.53 for CPT code 271X1. For 271X2, we are crosswalking
to CPT code 93452 (Left heart catheterization including intraprocedural
injection(s) for left ventriculography, imaging supervision and
interpretation, when performed) which has an identical intraservice
time and similar total time after removing the work associated with
postoperative visits from 271X2. We are proposing a work RVU of 4.75
for code 271X2.
(7) Bunionectomy (CPT Codes 28289, 282X1, 28292, 28296, 282X2, 28297,
28298, and 28299)
The RUC identified CPT Code 28293 as a 90-day global service with
more than 6 office visits and CPT codes 28290-28299 as part of the
family of services. In October 2015, the CPT Editorial Panel created
two new CPT codes (282X1, 282X2), deleted CPT codes 28290, 28293, 28294
and revised CPT codes 28289, 28292, 28296, 28297, 28298 and 28299 based
on the rationale that more accurate descriptions of the services needed
to be developed.
For CPT codes 28289, 28292, 28296, 28297, 28298, and 28299 the RUC
recommended and we are proposing work RVUs of 6.90, 7.44, 8.25, 9.29,
7.75, and 9.29 respectively. For CPT code 282X1, the RUC recommended a
work RVU of 8.01 based on the 25th percentile of the survey. We believe
the recommendation for this service overestimates the overall work
involved in performing this procedure given the decrease in
intraservice time, total time, and post-operative visits when compared
to deleted predecessor CPT code 28293. Due to similarity in
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intraservice and total times, we believe a direct crosswalk of the work
RVUs for CPT code 65780 (Ocular surface reconstruction; amniotic
membrane transplantation, multiple layers), to CPT code 282X1 more
accurately reflects the time and intensity of furnishing the service.
Therefore, for CY 2017, we are proposing a work RVU of 7.81 for CPT
code 282X1.
For CPT code 282X2, the RUC recommended a work RVU of 8.57 based on
the 25th percentile of the survey. We believe the recommendation for
this service overestimates the work involved in performing this
procedure given the similarity in the intensity of the services and
identical intraservice and total times as CPT code 28296. Therefore, we
propose a direct RVU crosswalk from CPT code 28296 to CPT code 282X2.
For CY 2017, we are proposing a work RVU of 8.25 for CPT code 282X2.
(8) Endotracheal Intubation (CPT Code 31500)
In the CY 2016 PFS final rule with comment period (80 FR 70914), we
identified CPT code 31500 as potentially misvalued. The specialty
societies surveyed this code, and after reviewing the survey responses,
including increases in time, the RUC recommended an increase in work
RVUs to 3.00 for CPT code 31500. After reviewing the RUC's
recommendation, we are proposing a work RVU of 2.66, based on a direct
crosswalk to CPT code 65855, which has similar intensity and service
times as reflected in the survey data reported by the specialty groups.
(9) Closure of Left Atrial Appendage With Endocardial Implant (CPT Code
333X3)
The CPT Editorial Panel deleted category III code 0281T
(Percutaneous transcatheter closure of the left atrial appendage with
implant, including fluoroscopy, transseptal puncture, catheter
placement(s), left atrial angiography, left atrial appendage
angiography, radiological supervision and interpretation) and created
new CPT code 333X3 to describe percutaneous transcatheter closure of
the left atrial appendage with implant. The RUC recommended a work RVU
of 14.00, which is the 25th percentile survey result. After reviewing
that recommendation, we are proposing a work RVU of 13.00 for CPT code
333X3, which is the minimum survey result. Based on our clinical
judgment and that the key reference codes discussed in the RUC
recommendations have higher intraservice and total service times than
the median survey results for CPT code 333X3, we believe a work RVU of
13.00 more accurately represents the work value for this service.
(10) Valvuloplasty (CPT Codes 334X1 and 334X2)
The CPT Editorial Committee created new codes to describe
valvuloplasty procedures and deleted existing CPT code 33400
(Valvuloplasty, aortic valve; open, with cardiopulmonary bypass). New
CPT code 334X1 represents a simple valvuloplasty procedure and new CPT
code 334X2 describes a more complex valvuloplasty procedure. We are
proposing to use the RUC-recommended values for CPT code 334X1. For CPT
code 334X2, the RUC recommended a work RVU of 44.00, the 25th
percentile survey result. The RUC estimated that approximately 70
percent of the services previously reported using CPT code 33400 would
have been reported using CPT code 334X2 with 30 percent reported using
new CPT code 334X1. Therefore, the typical service previously reported
with 33400 ought to now be reported with 334X2. Compared to deleted CPT
code 33400, the survey results for CPT 334X2 showed the median
intraservice time to be similar but total service time to be decreased.
Therefore, we do not believe the increase recommended by the RUC is
warranted, and we are proposing a work RVU of 41.50 for CPT code 334X2.
This is the current value of CPT code 33400, and given that the typical
service should remain consistent between the two codes, we believe the
work RVU should remain consistent as well.
(11) Dialysis Circuit (CPT Codes 369X1, 369X2, 369X3, 369X4, 369X5,
369X6, 369X7, 369X8, 369X9)
In January 2015, a CPT/RUC workgroup identified the following CPT
codes as being frequently reported together in various combinations:
35475 (Transluminal balloon angioplasty, percutaneous; brachiocephalic
trunk or branches, each vessel), 35476 (Transluminal balloon
angioplasty, percutaneous; venous), 36147 (Introduction of needle and/
or catheter, arteriovenous shunt created for dialysis (graft/fistula);
initial access with complete radiological evaluation of dialysis
access, including fluoroscopy, image documentation and report), 36148
(Introduction of needle and/or catheter, arteriovenous shunt created
for dialysis (graft/fistula); additional access for therapeutic
intervention), 37236 (Transcatheter placement of an intravascular
stent(s) (except lower extremity artery(s) for occlusive disease,
cervical carotid, extracranial vertebral or intrathoracic carotid,
intracranial, or coronary), open or percutaneous, including
radiological supervision and interpretation and including all
angioplasty within the same vessel, when performed; initial artery),
37238 (Transcatheter placement of an intravascular stent(s), open or
percutaneous, including radiological supervision and interpretation and
including angioplasty within the same vessel, when performed; initial
vein), 75791 (Angiography, arteriovenous shunt (e.g., dialysis patient
fistula/graft), complete evaluation of dialysis access, including
fluoroscopy, image documentation and report (includes injections of
contrast and all necessary imaging from the arterial anastomosis and
adjacent artery through entire venous outflow including the inferior or
superior vena cava), radiological supervision and interpretation),
75962 (Transluminal balloon angioplasty, peripheral artery other than
renal, or other visceral artery, iliac or lower extremity, radiological
supervision and interpretation), and 75968 (Transluminal balloon
angioplasty, each additional visceral artery, radiological supervision
and interpretation). These codes are frequently reported together for
both dialysis circuit services and transluminal angioplasty services.
At the October 2015 CPT Editorial Panel meeting, the panel approved the
creation of nine new codes and deletion of four existing codes used to
describe bundled dialysis circuit intervention services, and the
creation of four new codes and deletion of 13 existing codes used to
describe bundled percutaneous transluminal angioplasty services (see
discussion of the latter code family in the next section). The Dialysis
Circuit family of codes overlaps with the Open and Percutaneous
Transluminal Angioplasty family of codes (CPT codes 372X1-372X4), as
they are both being constructed from the same set of frequently
reported together codes. We reviewed these two families of codes
concurrently to maintain relativity between these clinically similar
procedures based upon the same collection of deleted codes.
For CPT code 369X1, we are proposing a work RVU of 2.82 instead of
the RUC-recommended work RVU of 3.36. When we compared CPT code 369X1
against other codes in the RUC database, we found that the RUC-
recommended work RVU of 3.36 would be the highest value in the database
among the 32 0-day global codes with 25 minutes of intraservice time.
Generally speaking, we are particularly skeptical of RUC-recommended
values for newly ``bundled'' codes that appear not to recognize the
full resource
[[Page 46243]]
overlap between predecessor codes. Since the recommended values would
establish a new highest value when compared to other services with
similar time, we believe it likely that the recommended value for the
new code does not reflect the efficiencies in time. Of course, were the
compelling evidence for this valuation accompanying the recommendation,
we would consider such information. We also note that the reference
code selected by the survey participants, CPT code 36200 (Introduction
of catheter, aorta), has a higher intraservice time and total time, but
a lower work RVU of 3.02. We believe that there are more accurate CPT
codes that can serve as a reference for CPT code 369X1. As a result, we
are proposing to crosswalk CPT code 369X1 to CPT code 44388
(Colonoscopy through stoma; diagnostic). CPT code 44388 has a work RVU
of 2.82, and we believe it is a more accurate crosswalk for valuation
due to its similar overall intensity and shared intraservice time of 25
minutes with 369X1 and similar total time of 65 minutes.
We are proposing a work RVU of 4.24 for CPT code 369X2 instead of
the RUC-recommended work RVU of 4.83. The RUC-recommended work RVU is
based upon a direct crosswalk to CPT code 43253
(Esophagogastroduodenoscopy, flexible, transoral) which shares the same
40 minutes of intraservice time with CPT code 369X2. However, CPT code
43253 has significantly longer total time than CPT code 369X2, 104
minutes against 86 minutes, which we believe reduces its utility for
comparison. We are instead proposing to crosswalk the work RVU for CPT
code 369X2 from CPT code 44408 (Colonoscopy through stoma), which has a
work RVU of 4.24. In addition to our assessment that the two codes
share similar intensities, CPT code 44408 also shares 40 minutes of
intraservice time with CPT code 369X2 but has only 95 minutes of total
time and matches the duration of the procedure under review more
closely than the RUC-recommended crosswalk to CPT code 43253. We also
note that the RUC-recommended work increment between CPT codes 369X1
and 369X2 was 1.47, and by proposing a work RVU of 4.24 for CPT code
369X2, we maintain a very similar increment of 1.42. As a result, we
are proposing a work RVU of 4.24 for CPT code 369X2, based on this
direct crosswalk to CPT code 44408.
For CPT code 369X3, we are proposing a work RVU of 5.85 instead of
the RUC-recommended work RVU of 6.39. The RUC-recommended value is
based on a direct crosswalk to CPT code 52282 (Cystourethroscopy, with
insertion of permanent urethral stent). Like the previous pair of RUC-
recommended crosswalk codes, CPT code 52282 shares the same
intraservice time of 50 minutes with CPT code 369X3, but has
substantially longer total time (120 minutes against 96 minutes) which
we believe limits its utility as a crosswalk. We are proposing a work
RVU of 5.85 based on maintaining the RUC-recommended work RVU increment
of 3.03 as compared to CPT code 369X1 (proposed at a work RVU of 2.82),
the base code for this family of related procedures. We also point to
CPT code 44403 (Colonoscopy through stoma; with endoscopic mucosal
resection) as a reference point for this value. CPT code 44403 has a
work RVU of 5.60, but also lower intraservice time (45 minutes as
compared to 50 minutes) and total time (92 minutes as compared to 96
minutes) in relation to CPT code 369X3, suggesting that a work RVU a
bit higher than 5.60 would be an accurate valuation. Therefore, we are
proposing a work RVU of 5.85 for CPT code 369X3, based on an increment
of 3.03 from the work RVU of CPT code 369X1.
We are proposing a work RVU of 6.73 instead of the RUC-recommended
work RVU of 7.50 for CPT code 369X4. Our proposed value comes from a
direct crosswalk from CPT code 43264 (Endoscopic retrograde
cholangiopancreatography), which shares the same intraservice time of
60 minutes with CPT code 369X4 and has a higher total time. We also
looked to the intraservice time ratio between CPT codes 369X1 and
369X4; this works out to 60 minutes divided by 25 minutes, for a ratio
of 2.4, and a suggested work RVU of 6.77 (derived from 2.4 times CPT
code 369X1's work RVU of 2.82). This indicates that our proposed work
RVU of 6.73 maintains relativity within the Dialysis Circuit family. As
a result, we are proposing a work RVU of 6.73 for CPT code 369X4, based
on a direct crosswalk to CPT code 43264.
We are proposing a work RVU of 8.46 instead of the RUC-recommended
work RVU of 9.00 for CPT code 369X5. We looked at the intraservice time
ratio between CPT codes 369X1 and 369X5 as one potential method for
valuation, which is a 1:3 ratio (25 minutes against 75 minutes) for
this case. This means that one potential value for CPT code 369X5 would
be triple the work RVU of CPT code 369X1, or 2.82 times 3, which
results in a work RVU of 8.46. We also investigated preserving the RUC-
recommended work RVU increment between CPT code 369X1 and 369X5, which
was an increase of 5.64. When this increment is added to the work RVU
of 2.82 for CPT code 369X1, it also resulted in a work RVU of 8.46 for
CPT code 369X5. Therefore, we are proposing a work RVU of 8.46 for CPT
code 369X5, based on both the intraservice time ratio with CPT code
369X1 and the RUC-recommended work increment with the same code.
For CPT code 369X6, we are proposing a work RVU of 9.88 instead of
the RUC-recommended work RVU of 10.42. We based the proposed value upon
the RUC-recommended work RVU increment between CPT codes 369X1 and
369X6, which is 7.06. When added to the work RVU of 2.82 for CPT code
369X1, the work RVU for CPT code 369X6 would be 9.88. We are supporting
this value through the use of two crosswalks that both share the same
90 minutes of intraservice time with 369X6. These are CPT code 31546
(Laryngoscopy, direct, with submucosal removal of non-neoplastic
lesion(s) of vocal cord) at a work RVU of 9.73 and CPT code 61623
(Endovascular temporary balloon arterial occlusion, head or neck) at a
work RVU of 9.95.
The final three codes in the Dialysis Circuit family are all add-on
codes, which make comparisons difficult to the global 0-day codes that
make up the rest of the family. We are proposing a work RVU of 2.48
instead of the RUC-recommended work RVU of 3.00 for CPT code 369X7. Due
to the difficulty of comparing CPT code 369X7 with the non-add-on codes
in the rest of the Dialysis Circuit family, we looked instead to
compare the value to the add-on codes in the Open and Percutaneous
Transluminal Angioplasty family of codes (CPT codes 372X1-372X4). As we
stated previously, both of these groups of new codes are being
constructed from the same set of frequently reported together codes. We
reviewed these two families of codes together to maintain relativity
across the two families, and so that we could compare codes that shared
the same global period.
We are proposing the RUC-recommended work RVUs for all four codes
in the Open and Percutaneous Transluminal Angioplasty family of codes.
As a result, we compared CPT code 369X7 with the RUC-recommended work
RVU of 2.97 for CPT code 372X4, which is also an add-on code. These
procedures should be clinically very similar, since both of them are
performing percutaneous transluminal angioplasty on a central vein, and
both of them are add-on procedures. We looked at the intraservice time
ratio between these two codes, which was a comparison between 25
minutes for CPT code 369X7 against 30 minutes for CPT code 372X4.
[[Page 46244]]
This produces a ratio of 0.83, and a proposed work RVU of 2.48 for CPT
code 369X7 when multiplied with the RUC-recommended work RVU of 2.97
for CPT code 372X4. We note as well that the intensity was markedly
higher for CPT code 369X7 as compared to CPT code 372X4 when using the
RUC-recommended work values, which did not make sense since CPT code
369X7 would typically be a clinically less intense procedure. Using the
intraservice time ratio results in the two codes having exactly the
same intensity. As a result, we are therefore proposing a work RVU of
2.48 for CPT code 369X7, based on this intraservice time ratio with the
RUC-recommended work RVU of CPT code 372X4.
For CPT code 369X8, we disagree with the RUC-recommended work RVU
of 4.25, and we are instead proposing a work RVU of 3.73. We do not
consider the RUC work value of 4.25 to be accurate for CPT code 369X8,
as this was higher than our proposed work value for CPT code 369X2
(4.24), and we do not believe that an add-on code should typically have
a higher work value than a similar non-add-on code with the same
intraservice time. We identified two appropriate crosswalks for valuing
CPT code 369X8: CPT code 93462 (Left heart catheterization by
transseptal puncture through intact septum or by transapical puncture)
and CPT code 37222 (Revascularization, endovascular, open or
percutaneous, iliac artery). Both of these codes share the same
intraservice time as CPT code 369X8, and both of them also have the
same work RVU of 3.73, which results in these codes also sharing the
same intensity since they are all add-on codes. We are therefore
proposing a work value of 3.73 for CPT code 369X8, based on a direct
crosswalk to CPT codes 93462 and 37222.
Finally, we are proposing a work RVU of 3.48 for CPT code 369X9
instead of the RUC-recommended work RVU of 4.12. The RUC recommended
value comes from a direct crosswalk from CPT code 38746 (Thoracic
lymphadenectomy by thoracotomy). We compared the RUC-recommended work
RVU for this procedure to other add-on codes with 30 minutes of
intraservice time and found that the recommended work RVU of 4.12 would
overestimate the overall intensity of this service relative to those
with similar times. In reviewing the range of these codes, we believe
that a more appropriate crosswalk is to CPT code 61797 (Stereotactic
radiosurgery (particle beam, gamma ray, or linear accelerator)) at a
work RVU of 3.48. We believe that this value is more accurate when
compared to other add-on procedures with 30 minutes of intraservice
time across the PFS. As a result, we are proposing a work RVU of 3.48
for CPT code 369X9 based on a direct crosswalk from CPT code 61797.
We are proposing to use the RUC-recommended direct PE inputs for
these nine codes with several refinements. We are not proposing to
include the recommended additional preservice clinical labor for CPT
codes 369X4, 369X5, and 369X6. The preservice work description is
identical for all six of the global 0-day codes in this family; there
is no justification given in the RUC recommendations as to why the
second three codes need additional clinical labor time beyond the
minimal preservice clinical labor assigned to the first three codes. We
do not believe that the additional staff time would be typical. Patient
care already would have been coordinated ahead of time in the typical
case, and the need for unscheduled dialysis or other unusual
circumstances would be discussed prior to the day of the procedure. We
are therefore proposing to refine the preservice clinical labor for CPT
codes 369X4, 369X5, and 369X6 to match the preservice clinical labor of
CPT codes 369X1, 369X2, and 369X3.
We are proposing to refine the L037D clinical labor for ``Prepare
and position patient/monitor patient/set up IV'' from 5 minutes to 3
minutes for CPT codes 369X1-369X6. The RUC recommendation included a
written justification for additional clinical labor time beyond the
standard 2 minutes for this activity, stating that the extra time is
needed to prepare the patient's arm for the procedure. We agree that
extra time may be needed for this activity as compared to the default
standard of 2 minutes; however, we are assigning 1 extra minute for
preparing the patient's arm, resulting in a total of 3 minutes for this
task. We do not believe that 3 extra minutes would be typically needed
for arm positioning.
We are proposing to remove the ``kit, for percutaneous thrombolytic
device (Trerotola)'' supply (SA015) from CPT codes 369X4, 369X5, and
369X6. We believe that this thrombolytic device kit and the ``catheter,
thrombectomy-Fogarty'' (SD032) provide essentially the same supply, and
the use of only one of them would be typical in these procedures. We
believe that each of these supplies can be used individually for
thrombectomy procedures. We are proposing to remove the SA015 supply
and retain the SD032 supply, and we seek additional comment and
information regarding the use of these two supplies.
We are also proposing to remove the recommended supply item
``covered stent (VIABAHN, Gore)'' (SD254) and replace it with the
``stent, vascular, deployment system, Cordis SMART'' (SA103) for CPT
codes 369X3 and 369X6. The Cordis SMART vascular stent was previously
used in the past for CPT code 37238, which is the deleted code for
transcatheter placement of an intravascular stent that CPT codes 369X3
and 369X6 are replacing. We do not have a stated rationale as to the
need for this supply substitution, and therefore, we do not believe it
would be appropriate to replace the current items with a significantly
higher-priced item without additional information.
We are also proposing to refine the quantity of the ``Hemostatic
patch'' (SG095) from 2 to 1 for CPT codes 369X4, 369X5, and 369X6. This
supply was not included in any of the deleted base codes out of which
the new codes are being constructed, and while we agree that the use of
a single hemostatic patch has become common clinical practice, we do
not agree that CPT codes 369X4-369X6 would typically require a second
patch. As a result, we are proposing to refine the SG095 supply
quantity from 2 to 1 for CPT codes 369X4-369X6, which also matches the
supply quantity for CPT codes 369X1-369X3.
Included in the RUC recommendation for the Dialysis Circuit family
of codes were a series of invoices for a ``ChloraPrep applicator (26
ml)'' supply. We are soliciting comments regarding whether the Betadine
solution has been replaced by a Chloraprep solution in the typical case
for these procedures. We are also soliciting comments regarding whether
the ``ChloraPrep applicator (26 ml)'' detailed on the submitted
invoices is the same supply as the SH098 ``chlorhexidine 4.0%
(Hibiclens)'' applicator currently in the direct PE database.
Finally, we are also interested in soliciting comments about the
use of guidewires for these procedures. We are requesting feedback
about which guidewires would be typically used for these procedures,
and which guidewires are no longer clinically necessary.
(12) Open and Percutaneous Transluminal Angioplasty (CPT Codes 372X1,
372X2, 372X3, and 372X4)
In January 2015, a CPT/RUC workgroup identified the following CPT
codes as being frequently reported together in various combinations:
35475 (Transluminal balloon angioplasty, percutaneous; brachiocephalic
trunk or branches, each vessel), 35476 (Transluminal balloon
angioplasty,
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percutaneous; venous), 36147 (Introduction of needle and/or catheter,
arteriovenous shunt created for dialysis (graft/fistula); initial
access with complete radiological evaluation of dialysis access,
including fluoroscopy, image documentation and report), 36148
(Introduction of needle and/or catheter, arteriovenous shunt created
for dialysis (graft/fistula); additional access for therapeutic
intervention), 37236 (Transcatheter placement of an intravascular
stent(s) (except lower extremity artery(s) for occlusive disease,
cervical carotid, extracranial vertebral or intrathoracic carotid,
intracranial, or coronary), open or percutaneous, including
radiological supervision and interpretation and including all
angioplasty within the same vessel, when performed; initial artery),
37238 (Transcatheter placement of an intravascular stent(s), open or
percutaneous, including radiological supervision and interpretation and
including angioplasty within the same vessel, when performed; initial
vein), 75791 (Angiography, arteriovenous shunt (e.g., dialysis patient
fistula/graft), complete evaluation of dialysis access, including
fluoroscopy, image documentation and report (includes injections of
contrast and all necessary imaging from the arterial anastomosis and
adjacent artery through entire venous outflow including the inferior or
superior vena cava), radiological supervision and interpretation),
75962 (Transluminal balloon angioplasty, peripheral artery other than
renal, or other visceral artery, iliac or lower extremity, radiological
supervision and interpretation), and 75968 (Transluminal balloon
angioplasty, each additional visceral artery, radiological supervision
and interpretation). At the October 2015 CPT Editorial Panel meeting,
the panel approved the creation of four new codes and deletion of 13
existing codes used to describe bundled percutaneous transluminal
angioplasty services. The Open and Percutaneous Transluminal
Angioplasty family of codes overlaps with the Dialysis Circuit family
of codes (CPT codes 369X1-369X9), as they are both being constructed
from the same set of frequently reported together codes. We reviewed
these two families of codes concurrently to maintain relativity between
these clinically similar procedures based upon the same collection of
deleted codes. After consideration of these materials, we are proposing
to accept the RUC-recommended work RVU for CPT codes 372X1, 372X2,
372X3, and 372X4.
For the clinical labor direct PE inputs, we are proposing to use
the RUC-recommend inputs with several refinements. Our proposed inputs
refine the recommended clinical labor time for ``Prepare and position
patient/monitor patient/set up IV'' from 5 minutes to 3 minutes for CPT
codes 372X1 and 372X3. The RUC recommendation included a written
justification for additional clinical labor time beyond the standard 2
minutes for this activity, stating that the extra time was needed to
move leads out of X-ray field, check that X-ray is not obstructed and
that there is no risk of collision of X-ray equipment with patient. As
we wrote for the same clinical labor activity in the Dialysis Circuit
family, we agree that extra time may be needed for this activity as
compared to the default standard of 2 minutes; however, we are
assigning 1 extra minute for the additional positioning tasks,
resulting in a total of 3 minutes for this task. We do not believe that
3 extra minutes would be typically needed for preparation of the X-ray.
The equipment times for the angiography room (EL011) and the PACS
workstation (ED050) have been refined to reflect this change in
clinical labor.
We are proposing to remove the ``drape, sterile, femoral'' supply
(SB009) and replace it with a ``drape, sterile, fenestrated 16in x
29in'' supply (SB011) for CPT codes 372X1 and 372X3. The two base codes
out of which these new codes are being constructed, CPT codes 35471 and
35476, both made use of the SB011 fenestrated sterile drape supply, and
there was no rationale provided for the switch to the SB009 femoral
sterile drape in the two new codes. We are seeking comment on the use
of sterile drapes for these procedures, and what rationale there is to
support the use of the SB009 femoral sterile drape as typical for these
new procedures.
(13) Percutaneous Biliary Procedures Bundling (CPT Codes 47531, 47532,
47533, 47534, 47535, 47536, 47537, 47538, 47539, 47540, 47541, 47542,
47543, and 47544)
This group of fourteen codes was reviewed by the RUC at the April
2015 meeting. We established interim final values for this group of
codes during the CY 2016 PFS rulemaking cycle, and subsequently
received updated RUC recommendations from the October 2015 meeting for
the CY 2017 PFS rulemaking cycle. Our proposals for these codes
incorporate both the updated RUC recommendations, as well as public
comments received as part of the interim final status of these
procedures.
We received several comments regarding the CMS refinements to the
work values for this family of codes in the CY 2016 final rule with
comment period. The relevance of many of these comments has been
diminished by the new series of RUC recommendations for work values
that we received as a result of the October 2015 meeting. Given that we
are proposing the updated RUC-recommended work RVUs for CPT codes
47531, 47532, 47533, 47534, 47535, 47536, 47537, 47538, 47539, 47540,
47542, 47543, and 47544, we seek additional comments relative to these
proposed values. We agree that the second round of physician surveys
conducted for the October 2015 RUC meeting more accurately captured the
work and time required to perform these procedures. The one exception
is CPT code 47541; the survey times for this procedure were identical
as conducted for the April and October 2015 RUC meetings, yet the RUC
recommendation increased from a work RVU of 5.61 in April to a work RVU
of 7.00 in October. Given that the time values for the procedure
remained unchanged between the two surveys, we do not understand why
the work RVU would have increased by nearly 1.50 in the intervening
months. Since this code also has an identical intraservice time (60
minutes) and total time (121 minutes) as CPT code 47533, we do not
agree that it should be valued at a substantially higher rate compared
to a medically similar procedure within the same code family. We are
therefore proposing to crosswalk the work value of CPT code 47541 to
the work value of CPT code 47533, and we are proposing a work RVU of
5.63 for both procedures.
We also note that many of the codes in the Percutaneous Biliary
Procedures family were previously included in Appendix G, and were
valued under the assumption that moderate sedation was typically
performed on the patient. As part of the initiative to pay separately
for moderate sedation when it is performed, we are removing a portion
of the work RVU and preservice work time from CPT codes 47532, 47533,
47534, 47535, 47536, 47538, 47539, 47540, and 47541. For example, we
are proposing that CPT code 47541 undergoes a 0.25 reduction in its
work RVU from 5.63 to 5.38, and a 10 minute reduction in its preservice
work time from 33 minutes to 23 minutes, to reflect the work that will
now be reported separately using the new moderate sedation codes. CPT
codes 47542, 47533, and 47544 are also included in the moderate
sedation initiative; however, as add-on codes, they are not subject to
alterations in
[[Page 46246]]
their work RVUs or work times since the moderate sedation code with
work RVUs and work time (991X2) will only be billed once for each base-
code and not additionally with the add-on codes. These changes are
reflected in Appendix B and the work time file posted to the Web; see
section II.D for more details.
For the direct PE inputs, we are proposing to remove the L051A
clinical labor for ``Sedate/apply anesthesia'' and the L037D for
``Assist Physician in Performing Procedure'' for CPT codes 47531 and
47537. As we wrote in last year's final rule with comment period (80 FR
71053), we believe that this clinical labor describes activities
associated with moderate sedation, and moderate sedation is not typical
for these procedures. We are also proposing to refine the L037D
clinical labor for ``Clean room/equipment by physician staff'' from 6
minutes to 3 minutes for all of the codes in this family. Three minutes
is the standard for this clinical labor activity, and we continue to
maintain that the need for additional clinical labor time for this
cleaning activity would not be typical for these procedures.
Comment: One commenter disagreed with our refinement to replace
supply item ``catheter, balloon, PTA'' (SD152) with supply item
``catheter, balloon ureteral (Dowd)'' (SD150). The commenter stated
that a Dowd catheter is designed and FDA approved for use in the
prostatic urethra by retrograde placement through the penile urethra,
and it is not designed for use in an antegrade ureteral dilation
procedure. The commenter stated that this replacement is inappropriate.
The updated RUC recommendations for this family of codes also restored
the balloon PTA catheter.
Response: We are proposing again to replace the recommended supply
item ``catheter, balloon, PTA'' (SD152) with supply item ``catheter,
balloon ureteral (Dowd)'' (SD150). We believe that the use of this
ureteral balloon catheter, which is specifically designed for catheter
and image guidance procedures, would be more typical than the use of a
PTA balloon catheter. While we recognize that the Dowd catheter is not
FDA approved, it is our understanding that the PTA balloon catheter has
also not been FDA approved for use in these procedures. We are
uncertain if the commenter was requesting that we should no longer
include catheters that lack FDA approval in the direct PE database;
this would preclude the use of most of the catheters in our direct PE
database. We welcome additional comment on the use of FDA approved
catheters; in the meantime, we will continue our long-standing practice
of using the catheters in the direct PE database without explicit
regard to FDA approval in particular procedures.
We are also proposing to remove the recommended supply item ``stone
basket'' (SD315) from CPT code 47543 and add it to CPT code 47544.
Based on the code descriptors, we believe that the stone basket was
intended to be included in CPT code 47544 and was erroneously listed
under CPT code 47543. We are soliciting comments from the public to
help clarify this issue.
We note again that many of the codes in the Percutaneous Biliary
Procedures family were previously included in Appendix G, and as part
of the initiative to pay separately for moderate sedation when
performed, we are removing some of the recommended direct PE inputs
related to moderate sedation from CPT codes 47532, 47533, 47534, 47535,
47536, 47538, 47539, 47540, and 47541. We are removing the L051A
clinical labor time for ``Sedate/apply anesthesia'', ``Assist Physician
in Performing Procedure (CS)'', and ``Monitor pt. following moderate
sedation''. We are also removing the conscious sedation pack (SA044)
supply, and some or all of the equipment time for the stretcher
(EF018), the mobile instrument table (EF027), the 3-channel ECG
(EQ011), and the IV infusion pump (EQ032). These changes are reflected
in the public use files posted to the web; see section II.D for more
details.
(14) Flexible Laryngoscopy (CPT Codes 31575, 31576, 31577, 31578,
317X1, 317X2, 317X3, and 31579)
After we identified CPT codes 31575 and 31579 as potentially
misvalued in (80 FR 70912-70914) the RUC referred the entire flexible
laryngoscopy family of codes back to CPT for revision and the addition
of several codes representing new technology within this family of
services. At the May 2015 CPT meeting, the Editorial Panel added three
new codes to describe laryngoscopy with ablation or destruction of
lesion and therapeutic injection. Based on the survey results, the time
resources involved in furnishing the procedures described by this code
family experienced a significant reduction in the intraservice period,
yet the recommended work RVUs were not similarly reduced. Therefore, in
reviewing the recommended values for this family of codes we looked for
a rationale for increased intensity and absent such rationale, propose
to adjust the recommend work RVUs to account for significant changes in
time.
For CPT code 31575, we disagree with the RUC-recommended work RVU
of 1.00, and we are instead proposing a work RVU of 0.94. We looked at
the total time ratio for CPT code 31575, which is decreasing from 28
minutes to 24 minutes, and applied this ratio of 0.86 times the current
work RVU of 1.10 to derive our proposed work RVU of 0.94. We are
supporting this value for CPT code 31575 through a crosswalk to CPT
code 64405 (Injection, anesthetic agent; greater occipital nerve),
which shares 5 minutes of intraservice time and also has a work RVU of
0.94.
We agree with the RUC that CPT code 31575 serves as the base code
for the rest of the Flexible Laryngoscopy family. As a result, we are
proposing to maintain the same RUC-recommended increments for the rest
of the codes in this family, measuring the increments from CPT code
31575's refined work RVU of 0.94 instead of the RUC-recommended work
RVU of 1.00. This means that each of the work RVUs for the codes in the
rest of the family has decreased by 0.06 when compared to the RUC-
recommended value. We are therefore proposing a work RVU of 1.89 for
CPT code 31576, a work RVU of 2.19 for CPT code 31577, a work RVU of
2.43 for CPT code 31578, a work RVU of 3.01 for CPT code 317X1, a work
RVU of 2.43 for CPT code 317X2, a work RVU of 2.43 for CPT code 317X3,
and a work RVU of 1.88 for CPT code 31579.
Amongst the direct PE inputs, we are proposing to refine the
clinical labor time for ``Obtain vital signs'' for CPT codes 31577 and
31579 from 3 minutes to 2 minutes. We believe that this extra clinical
labor time is duplicative, as these codes are typically performed with
a same day E/M service. Each procedure is only allotted a maximum of 5
minutes for obtaining vital signs, and since 3 minutes are already
included in the E/M code, we are proposing to reduce the time to 2
minutes for these services. Similarly, we are proposing to remove the 3
minutes of clinical labor time for ``Clean room/equipment by physician
staff'' from CPT codes 31575, 31577, and 31579. These procedures are
typically reported with a same day E/M service, making the clinical
labor minutes for cleaning the room in these procedure codes
duplicative of the time already included in the E/M codes.
For CPT code 317X1, we are proposing to remove the ``laser tip,
diffuser fiber'' supply (SF030) and replace it with the ``laser tip,
bare (single use)'' supply (SF029) already present in our direct PE
database. We
[[Page 46247]]
believe that the invoice for SF030 submitted with the RUC
recommendation is not current enough to establish a new price for this
supply; as a result, we are substituting the SF029 supply for this
input. We welcome the submission of new invoices to accurately price
the diffuser fiber with laser tip.
We are also proposing to make significant changes to the prices of
several of the supplies and equipment related to Flexible Laryngoscopy,
as well as to the prices of scopes more broadly. We are proposing to
set the price of the disposable biopsy forceps supply (SD318) at
$26.84, based on the submission of an invoice with a price of $536.81
for a unit size of 20. In our search for additional information
regarding scope inputs, we obtained a quote from a vendor listing the
current price for several equipment items related to the use of scopes.
Since we believe that the prices in vendor quotes would typically be
equal to or higher than prices actually paid by practitioners, we are
updating the prices in our direct PE database to reflect this new
information. As part of this process, we are proposing to increase the
price of the ``light source, xenon'' (EQ167) from $6,723.33 to $7,000
to reflect current pricing information. We are also proposing to adjust
the price of the ``fiberscope, flexible, rhinolaryngoscopy'' (ES020)
from $6,301.93 to $4,250.00.
In accordance with the wider proposal that we are making involving
the use of scope equipment, we are proposing to separate the scopes
used in these procedures from the scope video systems. In the course of
researching different kinds of scopes, we obtained vendor pricing for
two different types of scopes used in these procedures. We are
proposing to price the ``rhinolaryngoscope, flexible, video, non-
channeled'' (ES063) at $8,000 and the ``rhinolaryngoscope, flexible,
video, channeled'' (ES064) at $9,000 in accordance with our vendor
quotes. We are proposing to use the non-channeled scope for CPT codes
31575, 31579, and 317X3 and the channeled scope for CPT codes 31576,
31577, 31578, 317X1, and 317X2 in accordance with the RUC-recommended
video systems that stipulated channeled versus non-channeled scope
procedures.
We believe that the ``Video-flexible laryngoscope system'' listed
in the recommendations is not a new form of equipment, but rather
constitutes a version of the existing ``video system, endoscopy''
equipment (ES031). We are not adding a new equipment item to our direct
PE database; instead, we are proposing to use the submitted invoices to
update the price of the ES031 endoscopy video system. As the equipment
code for ES031 indicates, we are proposing to define the endoscopy
video system as containing a processor, digital capture, monitor,
printer, and cart. We are proposing to price ES031 at $15,045.00; this
reflects a price of $2,000.00 for the monitor, $9,000.00 for the
processor, $1,750.00 for the cart, and $2,295.00 for the printer. These
prices were obtained from our vendor invoice, with the exception of the
printer, which is a crosswalk to the ``video printer, color (Sony
medical grade)'' equipment (ED036).
We do not agree that there is a need for multiple different video
systems for this collection of Flexible Laryngoscopy codes based on our
understanding of the clinical differences among the codes. In keeping
with this understanding, we are proposing to use the same existing
``video system, endoscopy'' equipment (ES031) for the remaining codes
in the family that included RUC recommendations for new equipment items
named ``Video-flexible channeled laryngoscope system'' and ``Video-
flexible laryngoscope stroboscopy system.'' For CPT codes 31576, 31577,
31578, 317X1, and 317X2, we are proposing to replace the Video-flexible
channeled laryngoscope system with the existing endoscopy video system
(ES031) along with a channeled flexible video rhinolaryngoscope
(ES064). For CPT code 31579, we are proposing to rename the RUC-
recommended ``Video-flexible laryngoscope stroboscopy system'' to the
shortened ``stroboscopy system'' (ES065) and assign it a price of
$19,100.00. This reflects the price of the StrobeLED Stroboscopy system
included on the submitted invoice. We are proposing to treat the
stroboscopy system as a scope accessory, which will be included along
with the ``video system, endoscopy'' equipment (ES031) and the
``rhinolaryngoscope, flexible, video, non-channeled'' (ES063) for CPT
code 31579. When the price of the scope, the scope video system, and
the stroboscopy system are summed together, the total proposed
equipment price is $42,145.00.
We are proposing to refine the recommended equipment times for
several equipment items to conform to changes in clinical labor time.
These are: The fiberoptic headlight (EQ170), the suction and pressure
cabinet (EQ234), the reclining exam chair with headrest (EF008), and
the basic instrument pack (EQ137). We are proposing to use the standard
equipment time formula for scope accessories for the endoscopy video
system (ES031) and the stroboscopy scope accessory system (ES065). We
are also proposing to refine the equipment time for the channeled and
non-channeled flexible video rhinolaryngoscopes to use the standard
equipment time formula for scopes. For this latter pair of two new
equipment items, this proposal results in small increases to their
respective equipment times.
(15) Laryngoplasty (CPT Codes 31580, 31584, 31587, and 315X1-315X6)
CPT code 31588 (Laryngoplasty, not otherwise specified (e.g., for
burns, reconstruction after partial laryngectomy) was identified as
potentially misvalued based on the RUC's 90-Day Global Post-Operative
Visits screen. When this code family was reviewed by the RUC, it was
determined that some codes in the family required revision to reflect
the typical patient before a survey could be conducted and the code
family was referred to the CPT Editorial Panel for revision. At the
October 2015 CPT Editorial Panel meeting, the CPT Editorial Panel
approved the creation of six new codes, revision of three codes, and
deletion of three codes. For CPT codes 31580, 31587, 315X1, 315X2,
315X3, 315X4, and 315X6, CMS is proposing the RUC-recommended work
RVUs.
For CPT code 31584, the RUC recommended a work RVU of 20.00. We
believe that the 25th percentile of the survey, which is a work RVU of
17.58, better represents the time and intensity involved with
furnishing this service based on a comparison with and assessment of
the overall intensity of other codes with similar instraservice and
total time. This value is also supported by a crosswalk code of CPT
code 42844 (Radical resection of tonsil, tonsillar pillars, and/or
retromolar trigone; closure with local flap (e.g., tongue, buccal)),
which has identical intraservice time and identical total time.
Therefore, we are proposing a work value of 17.58 RVUs for CPT code
31584.
For CPT code 315X5, the RUC recommended a work value of 15.60 RVUs.
We believe that the 25th percentile of the survey, which is a work RVU
of 13.56, better represents the time and intensity involved with
furnishing this service based on a comparison of the overall intensity
of other codes with similar instraservice and total time. The 25th
percentile of the survey is additionally bracketed by two crosswalk
codes that we estimate have slightly lower and slighter higher overall
intensities, CPT code 36819
[[Page 46248]]
(Arteriovenous anastomosis, open; by upper arm basilic vein
transposition), which has a work RVU of 13.29, and CPT code 49654
(Laparoscopy, surgical, repair, incisional hernia (includes mesh
insertion, when performed); reducible), which has a work RVU of 13.76;
both of these codes have identical intraservice time and similar total
time. Therefore, we are proposing a work RVU of 13.56 for CPT code
315X5.
Additionally, the RUC forwarded invoices provided by a medical
specialty society for the video-flexible laryngoscope system used in
these services. As discussed in section II.A of this proposed rule, we
have proposed changes to the items included in equipment item ES031
(video system, endoscopy). Consistent with those proposed changes, we
are proposing to add a Nasolaryngoscope, non-channeled, to the list of
equipment items used for CPT codes 31580, 31584, 31587, and 315X1-
315X6, along with the modified equipment item ES031.
(16) Mechanochemical Vein Ablation (MOCA) (CPT Codes 364X1 and 364X2)
At the October 2015 CPT meeting, the CPT Editorial Panel
established two Category I codes for reporting venous mechanochemical
ablation, CPT codes 364X1 and 364X2. We are proposing the RUC-
recommended work RVU of 3.50 for CPT code 364X1. For CPT code 364X2 we
believe that the RUC-recommended work RVU of 2.25 does not accurately
reflect the typical work involved in furnishing this procedure. The
specialty society survey recommended that this add-on code has half the
work of the base code, CPT code 364X1. This value is supported by the
ratio between work and time in the key reference service, CPT code
36476 (Endovenous ablation therapy of incompetent vein, extremity,
inclusive of all imaging guidance and monitoring, percutaneous,
radiofrequency; second and subsequent veins treated in a single
extremity, each through separate access sites (List separately in
addition to code for primary procedure)). Therefore, we are proposing a
work RVU of 1.75 for CPT code 364X2.
The RUC-recommended direct practice expense inputs for CPT codes
364X1 and 364X2 included inputs for an ultrasound room (EL015). Based
on the clinical nature of these procedures, we do not believe that an
ultrasound room would typically be used to furnish these procedures. We
are proposing to remove inputs for the ultrasound room and put in a
portable ultrasound (EQ250), power table (EF031), and light (EF014).
The RUC also recommended that the ultrasound machine be allocated
clinical staff time based on the PACS workstation formula. We do not
believe that an ultrasound machine would be used like a PACS
workstation, as images are generated and reviewed in real time.
Therefore, we are proposing to remove all inputs associated with the
PACS workstation.
(17) Esophageal Sphincter Augmentation (CPT Codes 432X1 and 432X2)
In October 2015, the CPT Editorial Panel created two new codes to
describe laparoscopic implantation and removal of a magnetic bead
sphincter augmentation device used for treatment of gastroesophageal
reflux disease (GERD). The RUC noted that the specialty societies
conducted a targeted survey of the 145 physicians who have been trained
to furnish these services and who are the only physicians who have
performed these procedures. They noted that only 18 non-conflicted
survey responses were received despite efforts to follow up and that
nine physicians had no experience in the past 12 months with the
procedure. The RUC agreed with the specialty society that the expertise
of those responding was sufficient to consider the survey, however,
neither entity used the survey results as the as the primary basis for
their recommended value.
For CPT code 432X1, the RUC recommended a work RVU of 10.13. We
compared this code to CPT code 43180 (Esophagoscopy, rigid, transoral
with diverticulectomy of hypopharynx or cervical esophagus (e.g.,
Zenker's diverticulum), with cricopharyngeal myotomy, includes use of
telescope or operating microscope and repair, when performed), which
has a work RVU of 9.03 and has identical intraservice time and similar
total time. We believe the overall intensity of these procedures is
similar, therefore, we are proposing a work RVU of 9.03 for CPT code
432X1.
For CPT code 432X2, the RUC recommended a work RVU of 10.47. To
value this code, we used the increment between the RUC-recommended work
RVU for this code and CPT code 432X1 (0.34 RVUs) to develop our
proposed work RVU of 9.37 for CPT code 432X2.
(18) Electromyography Studies (CPT Code 51784)
We identified CPT code 51784 as potentially misvalued through a
screen of high expenditure by specialty. This family also includes CPT
code 51785 (Needle electromyography studies (EMG) of anal or urethral
sphincter, any technique) but was not included in this survey. Both
services have 0-day global periods. The RUC recommended a work RVU of
0.75 for CPT code 51784. We believe that this service is more
accurately valued without a global period, since that is more
consistent with other diagnostic services, and specifically, with all
the other diagnostic electromyography services. We are proposing a
change to the global period from 0-day to no global period, and we are
proposing the RUC-recommended work RVU of 0.75 for CY 2017. We are also
proposing to change the global period for CPT code 51785 from 0-day to
no global period, to be consistent with 51784. Additionally, we are
proposing to add CPT code 51785 to the list of potentially misvalued
codes to update the value of the service considering the change in
global period, and to maintain consistency with 51784.
(19) Cystourethroscopy (CPT Code 52000)
In the CY 2016 PFS final rule with comment period, CMS identified
CPT code 52000 through the screen for high expenditure services by
specialty screen. The RUC-recommended work RVUs of 1.75 for CPT code
52000 is larger than the work RVUs for all 0-day global codes with 10
minutes of intraservice time and we do not believe that the overall
intensity of this service is greater than all of the other codes.
Instead, we believe the overall work compares for this code compares
favorably to CPT code 58100 (Endometrial sampling (biopsy) with or
without endocervical sampling (biopsy), without cervical dilation, any
method (separate procedure)), which has a work RVU of 1.53, and has
identical intraservice time and similar total time. Therefore, we are
using a direct crosswalk to CPT code 58100 and are proposing a work RVU
of 1.53 for CPT code 52000.
(20) Biopsy of Prostate (CPT Code 55700)
In the CY 2016 PFS final rule with comment period, CMS identified
CPT code 55700 as potentially misvalued based on the high expenditure
by specialty screen.
The RUC subsequently reviewed this code for physician work and
practice expense and recommended a work RVU of 2.50 based on the 25th
percentile of the survey. We believe the RUC-recommended work RVU
overestimates the work involved in furnishing this service given the
reduction in total service time; specifically, the reduction in
preservice and postservice times. The RUC recommendation also appears
overvalued when compared to similar 0-day global services with 15
minutes of intraservice time and comparable total
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times. To develop a proposed work RVU, we crosswalked the work RVUs for
this code from CPT code 69801 (Labyrinthotomy, with perfusion of
vestibuloactive drug(s), transcanal), noting similar levels of
intensity, similar total times, and identical intraservice times.
Therefore, we are proposing a work RVU of 2.06 for CPT code 55700.
As part of the recommended direct PE inputs for CPT code 55700, the
RUC recommended inclusion of a new equipment item, Biopsy Guide, but we
have not received any invoices to price this item. Given our
longstanding difficulties in acquiring accurate pricing information for
equipment items, we are seeking invoices and public comment for pricing
this equipment prior to adding this new equipment item code.
(21) Hysteroscopy (CPT Codes 58555-58563)
In the CY 2016 PFS proposed rule, we proposed CPT code 58558 as a
potentially misvalued code based on the screen for high expenditure by
specialty screen. This code was reviewed at the January 2016 RUC
meeting and CPT codes 58559-58563 were included in the review as part
of the family.
For CPT code 58555, the RUC recommended a work RVU of 3.07. We
believe that the 25th percentile of the survey, a work RVU of 2.65,
more accurately reflects the resources involved in furnishing this
service. This value is bracketed by two crosswalk codes, CPT code 43191
(Esophagoscopy, rigid, transoral; diagnostic, including collection of
specimen(s) by brushing or washing when performed (separate
procedure)), which has a work RVU of 2.49, and CPT code 31295 (Nasal/
sinus endoscopy, surgical; with dilation of maxillary sinus ostium
(e.g., balloon dilation), transnasal or via canine fossa), which has a
work RVU of 2.70. Compared with CPT code 58555, CPT codes 43191 and
31295 have identical intraservice times and similar total times.
Therefore, we are proposing a work RVU of 2.65 for CPT code 58555.
For CPT code 58558, the RUC recommended a work RVU of 4.37.
However, we believe that a direct crosswalk from CPT code 36221 (Non-
selective catheter placement, thoracic aorta, with angiography of the
extracranial carotid, vertebral, and/or intracranial vessels,
unilateral or bilateral, and all associated radiological supervision
and interpretation, includes angiography of the cervicocerebral arch,
when performed), which has a work RVU of 4.17, and which has identical
intraservice time and very similar total time, more accurately reflects
the time and intensity of furnishing this service. This value is
additionally supported by using an increment between this code and the
base code for this family, CPT code 58555. The increment between the
RUC-recommended values for these two codes is 1.3. That increment added
to the proposed work RVU of 2.65 for the base code, CPT code 58555,
results in a work RVU of 3.95. Therefore, we are proposing a work value
of 4.17 RVUs for CPT code 58558.
For CPT code 58559, the RUC recommended a work RVU of 5.54.
However, we believe that a direct crosswalk of the work RVUs for CPT
code 52315 (Cystourethroscopy, with removal of foreign body, calculus,
or ureteral stent from urethra or bladder (separate procedure);
complicated), which has a work RVU of 5.20 and which has a similar
(slightly higher) intraservice time and similar total time as compared
with CPT code 58589 more accurately reflects the time and intensity of
furnishing this service. This value is additionally supported by using
an increment between CPT code 58559 and the base code for this family,
CPT code 58555. The increment between the RUC recommended values for
the two codes is 2.47. That increment added to the proposed value for
the base code, CPT code 58555 (2.65), results in a work RVU of 5.12.
Therefore, we are proposing a work RVU of 5.20 for CPT code 58559.
For CPT code 58560, the RUC recommended a work RVU of 6.15.
However, we believe that a direct crosswalk of the work RVUs for CPT
code 52351 (Cystourethroscopy, with ureteroscopy and/or pyeloscopy;
diagnostic), which has a work RVU of 5.75 and which has more
intraservice time and very similar total time, more accurately reflects
the time and intensity of furnishing this service. This value is
additionally supported by using an increment between CPT code 58560 and
the base code for this family, CPT code 58555. The increment between
the RUC recommended values for the two codes is 3.08. That increment
added to the proposed value for the base code, CPT code 58555 (2.65),
results in a work RVU of 5.73. Therefore, we are proposing a work RVU
of 5.75 for CPT code 58560.
For CPT code 58561, the RUC recommended a work RVU of 7.00.
However, we believe that a direct crosswalk of the work RVUs for CPT
code 35475 (Transluminal balloon angioplasty, percutaneous;
brachiocephalic trunk or branches, each vessel), which has a work RVU
of 6.60 and which has similar intraservice and total times, more
accurately reflects the time and intensity of furnishing this service.
This value is additionally supported by using an increment between CPT
code 58561 and the base code for this family, CPT code 58555. The
increment between the RUC recommended values for the two codes is 3.93.
That increment added to the proposed value for the base code, CPT code
58555 (2.65), results in a work RVU of 6.58. Therefore, we are
proposing a work RVU of 6.60 for CPT code 58561.
For CPT code 58562, the RUC recommended a work RVU of 4.17.
However, we believe that a direct crosswalk of the work RVUs for CPT
code 15277 (Application of skin substitute graft to face, scalp,
eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or
multiple digits, total wound surface area greater than or equal to 100
sq cm; first 100 sq cm wound surface area, or 1% of body area of
infants and children), which has a work RVU of 4.00 and which has
identical intraservice time and similar total time, more accurately
reflects the time and intensity of furnishing this service. The RUC
also used this code as one of its supporting codes for its
recommendation. This value is additionally supported by using an
increment between CPT code 58562 and the base code for this family, CPT
code 58555. The increment between the RUC recommended values for the
two codes is 1.10. That increment added to the proposed value for the
base code, CPT code 58555 (2.65), results in a work RVU of 3.75.
Therefore, we are proposing a work RVU of 4.00 for CPT code 58562.
For CPT code 58563, the RUC recommended a work RVU of 4.62.
However, we believe that a direct crosswalk of the work RVUs for CPT
code 33962 (Extracorporeal membrane oxygenation (ECMO)/extracorporeal
life support (ECLS) provided by physician; reposition peripheral
(arterial and/or venous) cannula(e), open, 6 years and older (includes
fluoroscopic guidance, when performed)), which has a work RVU of 4.47
and which has identical intraservice time and similar total time, more
accurately reflects the resources involved in furnishing this service.
This value is additionally supported by using an increment between CPT
code 58563 and the base code for this family, CPT code 58555. The
increment between the RUC recommended values for the two codes is 1.55.
That increment added to the proposed value for the base code, CPT code
58555 (2.65), results in a work RVU of 4.20. We note that CPT code
58563 has the same instraservice time and the same total time as CPT
code 58558; however, we agree that the
[[Page 46250]]
intensity would be slightly higher for this service. Therefore, we are
proposing a work RVU of 4.47 for CPT code 58562.
The RUC submitted invoices for two new equipment items used in
furnishing CPT code 58558, the Hysteroscopic Fluid Management System
and the Hysteroscopic Resection System. We are proposing to use these
invoice prices for the Hysteroscopic Fluid Management System, which
totaled $14,698.38. The Hysteroscopic Resection System included the
price of the hysteroscope as well as other items necessary for tissue
removal. However, we generally price endoscopes separately and not as a
part of a system. In order to maintain consistency, we are proposing
not to include the hysteroscope from the Resection System. Instead, we
are proposing to update the equipment item ``endoscope, rigid,
hysteroscopy'' (ES009) with the invoice price, $6,207.50. We are not
proposing to include the sterilization tray from the Hysteroscopic
Resection System because we believe this tray has generally been
characterized as an indirect expense. For the Hysteroscopic Resection
System, we are proposing to include the Hysteroscopic tissue remover
($18,375), the sheath ($1,097.25), and the calibration device ($300),
and creating a new equipment item code, priced at $19,857.50 in the
proposed direct PE input database. We did not propose to include the
calibration device since the submitted price was not documented with a
paid invoice.
(22) Epidural Injections (CPT Codes 623X5, 623X6, 623X7, 623X8, 623X9,
62X10, 62X11, and 62X12)
We are proposing the RUC-recommended work RVU for all eight of the
codes in this family.
We are proposing to remove the 10-12ml syringes (SC051) and the RK
epidural needle (SC038) from all eight of the codes in this family.
These supplies are duplicative, as they are included in the epidural
tray (SA064). As an alternative, we could remove the epidural tray and
replace it with the individual supply components used in each
procedure; we are seeking public comment on either the inclusion of the
epidural tray or its individual components for this family of codes.
(23) Endoscopic Decompression of Spinal Cord (CPT code 630X1)
For CY 2016, the CPT Editorial Panel created CPT code 630X1 to
describe the endoscopic decompression of neural elements. The RUC
recommended a work RVU of 10.47 based on a crosswalk to CPT code 47562
(Laparoscopy, surgical; cholecystectomy) with a higher intraservice
time than reflected in the survey data. Since we believe CPT codes
630X1 and 47562 are similar in intensity, we believe using the same
work RVU as the crosswalk code overestimates the work involved in
furnishing CPT code 630X1. Reference CPT code 49507 (Repair initial
inguinal hernia, age 5 years or older; incarcerated or strangulated)
has a work RVU of 9.09 and has similar intensity and an identical
intraservice time compared to CPT code 630X1. Therefore, we are
proposing a work RVU of 9.09 for CPT code 630X1.
(24) Retinal Detachment Repair (CPT Codes 67101 and 67105)
For CY 2015, the CPT Editorial Panel made several changes to CPT
codes 67101 and 67105. These changes include revising the code
descriptors to exclude ``diathermy'' and ``with or without drainage of
subretinal fluid'' and removing the reference to ``1 or more
sessions''. The recommended global period has also changed from 90 days
to 10 days.
For CPT code 67101 we propose the RUC recommendation of 3.50 work
RVUs, which was based on the 25th percentile of the survey. For CPT
code 67105, the RUC recommended a work RVU of 3.84 based on the 25th
percentile of the survey. The RUC also stated that CPT code 67105 was a
more intense procedure, and therefore, should have a higher work RVU
than CPT code 67101. Currently, CPT code 67101 has a higher work RVU
than CPT code 67105 and according to the surveys the intraservice and
total times remain higher for CPT code 67101. It was not clearly
explained and we do not understand why the RUC believes that CPT code
67105 is more work than CPT code 67101. Therefore we are not proposing
the RUC-recommended work value of 3.50 for CPT code 67105. We do not
find evidence that CPT code 67105 is more intense than CPT code 67101
and accordingly propose a new value for CPT code 67105. To value CPT
code 67105 we used the RVU ratio between 67101 and 67105. We divided
the current work RVU of CPT code 67105 (8.53), by the current work RVU
of CPT code 67101 (8.80) and multiplied the quotient by the RUC-
recommended work RVU for CPT code 67101 (3.50) to arrive at a product
of 3.39 work RVUs.
Therefore, for CY 2017 we are proposing a work RVU of 3.39 for CPT
code 67105.
(25) Abdominal Aortic Ultrasound Screening (CPT Code 767X1)
For CY 2017, the CPT Editorial Panel created a new code, CPT 767X1,
to describe abdominal aortic ultrasound screening, currently described
by HCPCS G-code G0389. The specialties that surveyed CPT code 767X1 for
the RUC were vascular surgery and radiology, and the direct practice
expense inputs recommended by the RUC included an ultrasound room.
Based on an analysis of Medicare claims data, the dominant specialties
furnishing the service are family practice and internal medicine. We
believe that these specialties may more typically use a portable
ultrasound device rather than an ultrasound room. Therefore, we are
proposing to accept the RUC-recommended work value of 0.55, and the
RUC-recommended PE inputs for this service, but we are seeking comment
regarding whether or not it would be more accurate to substitute a
portable ultrasound device or possibly a hand-held device for an
ultrasound room for CPT code 767X1. We note that while the phase-in of
significant reductions in RVUs ordinarily would not apply to new codes,
we believe that it would be appropriate to consider this change from a
G-code to a CPT code to be fundamentally similar to an editorial coding
change since the service is not described differently, and therefore,
we propose to apply the phase-in to this service by comparing the
previous value of the G-code to the value for the new CPT code.
(26) Fluoroscopic Guidance (CPT Codes 77001, 77002, and 77003)
In the CY 2015 PFS final rule with comment period, CMS indicated
that while CPT codes 77002 and 77003 had been previously classified as
stand-alone codes without global periods, we believe their vignettes
and CPT Manual parentheticals are consistent with an add-on code as has
been established for CPT code 77001. Therefore, the global periods for
CPT codes 77002 and 77003 now reflect an add-on code global period with
modifications to the vignettes and parentheticals.
For CPT code 77001, we are proposing the RUC-recommended work RVU
of 0.38. The RUC-recommended work RVUs for CPT codes 77002 and 77003 do
not appear to account for the significant decrease in total times for
these codes relative to the current total times. We note that these
three codes describe remarkably similar services and have identical
intraservice and total times. Based on the identical times and
[[Page 46251]]
notable similarity for all three of these codes, we are proposing a
work RVU of 0.38 for all three codes.
(27) Radiation Treatment Devices (CPT Codes 77332, 77333, and 77334)
We identified CPT codes 77332, 77333, and 77334 through the high
expenditures by specialty screen. These services represent an
incremental increase of complexity from the simple to the intermediate
to the complex in design of radiation treatment devices. The RUC
recommended no change from the current work RVUs for these codes, which
are currently 0.54 for CPT code 77332, 0.84 for CPT code 77333 and 1.24
for CPT code 77334. We believe the recommended work RVUs overstate the
work involved in furnishing these services, as they do not sufficiently
reflect the degree to which the RUC concurrently recommended a decrease
in intraservice or total time. For CPT code 77332, we believe the RUC
recommendation to maintain its current value despite a 34 percent
decrease in total time appears to ignore the change in time. Therefore,
we are proposing a value for this code based on a crosswalk from the
value from CPT code 93287 (Peri-procedural device evaluation (in
person) and programming of device system parameters before or after a
surgery, procedure, or test with analysis, review and report by a
physician or other qualified health care professional; single, dual, or
multiple lead implantable defibrillator system)), due to its identical
intraservice time, similar total time, and similar level of intensity.
We are therefore proposing a work RVU of 0.45 for CPT code 77332. We
are further supporting this valuation with HCPAC code 97760
(Orthotic(s) management and training (including assessment and fitting
when not otherwise reported) upper extremity(s), lower extremity(s)
and/or trunk, each 15 minutes), which has similar physician time and
intensity measurements and a work RVU of 0.45. As these codes are
designed to reflect an incremental increase in work value from simple,
to intermediate, and complex device designs, we used an incremental
difference methodology to value CPT codes 77333 and 77334. We are
proposing a work RVU of 0.75 for CPT code 77333, maintaining its
recommended increment from CPT code 77332, For CPT code 77334, we are
proposing a work RVU of 1.15 which maintains its increment from CPT
code 77332.
(28) Special Radiation Treatment (CPT Code 77470)
We identified CPT code 77470 through the high expenditure charges
by specialty. We are proposing the RUC-recommended work RVU of 2.03.
However, we believe the description of service and vignette describe
different and unrelated treatments being performed by the physician and
clinical staff for a typical patient, and this presents a disparity
between the work RVUs and PE RVUs. We seek public comment on
information that would clarify this apparent disparity to help
determine appropriate PE inputs. In addition, we seek comment to
determine if creating two G-codes, one which describes the work portion
of this service, and one which describes the PE portion, may be a
potentially more accurate method of valuing and paying for the service
or services described by this code.
(29) Flow Cytometry Interpretation (CPT Codes 88184, 88185, 88187,
88188, and 88189)
The Flow Cytometry Interpretation family of codes is split into a
pair of codes used to describe the technical component of flow
cytometry (CPT codes 88184 and 88185), which do not have a work
component, and a trio of codes (CPT codes 88187, 88188, and 88189)
which do not have direct practice expense inputs, as they are
professional component only services. CPT codes 88184 and 88185 were
reviewed by the RUC in April 2014, and their CMS refined values were
included in the CY 2016 PFS final rule with comment period. The full
family of codes was reviewed again at the January 2016 RUC meeting, and
new recommendations were submitted to CMS as part of the CY 2017 PFS
rulemaking cycle.
We are proposing the RUC-recommended work RVU of 0.74 for CPT code
88187, and the RUC-recommended work RVU of 1.70 for CPT code 88189. For
CPT code 88188, we are proposing a work RVU of 1.20 instead of the RUC-
recommended work RVU of 1.40. We arrived at this value by noticing that
there were no comparable codes with no global period in the RUC
database with intraservice time and total time of 30 minutes that had a
work RVU higher than 1.20. The RUC-recommended work RVU of 1.40 would
go beyond the current maximum value and establish a new high, which is
not consistent with our estimation of the overall intensity of this
service relative to the others. As a result, we believe it is more
accurate to crosswalk CPT code 88188 to the work value of the code with
the current highest value, which is CPT code 88120 (Cytopathology, in
situ hybridization (for example, FISH), urinary tract specimen with
morphometric analysis, 3-5 molecular probes) at a work RVU of 1.20. We
believe that CPT code 88120 is crosswalk comparable code since it
shares the identical intraservice time and total time of 30 minutes
with CPT code 88188.
We also noted that the survey increment between CPT codes 88187 and
88188 at the RUC-recommended 25th percentile was 0.40 (between work
RVUs of 1.00 and 1.40), and this increment of 0.40 when added to CPT
code 88187's work RVU of 0.74 would arrive at a value of 1.14. In
addition, the total time for CPT code 88188 decreases from 43 minutes
to 30 minutes, which is a ratio of 0.70, and when this time ratio is
multiplied by CPT code 88188's previous work value of 1.69, the result
would be a new work RVU of 1.18. With this information in mind, we are
proposing a work RVU of 1.20 for CPT code 88188 as a result of a direct
crosswalk to CPT code 88120.
For CPT codes 88184 and 88185, which describe the technical
component of flow cytometry, we are proposing to use the RUC-
recommended inputs with a series of refinements. However, we believe
that the coding for these two procedures may inhibit accurate
valuation. CPT code 88184 describes the first marker for flow
cytometry, while CPT code 88185 is an add-on code that describes each
additional marker. We believe that it may be more accurate to have a
single CPT code that describes the technical component of flow
cytometry on a per patient case basis, as these two procedures are
always performed together and it is difficult to determine the clinical
labor, supplies, and equipment used in the typical case under the
current coding structure. We are soliciting comments regarding the
public interest in consolidating these two procedures into a single
code used to describe the technical component of flow cytometry.
Absent such a change in coding, we are proposing to refine the
clinical labor time for ``Instrument start-up, quality control
functions, calibration, centrifugation, maintaining specimen tracking,
logs and labeling'' from 15 minutes to 13 minutes for CPT code 88184.
We maintain that 13 minutes for this activity, which is the current
time value, would be typical for the procedure, as CPT code 88182 also
uses 13 minutes for the identical clinical labor task. We are also
proposing to refine the L054A clinical labor for
[[Page 46252]]
``Load specimen into flow cytometer, run specimen, monitor data
acquisition, and data modeling, and unload flow cytometer'' from 10
minutes to 7 minutes using the same rationale, a comparison to CPT code
88182.
We are proposing to maintain the clinical labor for ``Print out
histograms, assemble materials with paperwork to pathologists Review
histograms and gating with pathologist'' for CPT code 88184 at 2
minutes, as opposed to the RUC-recommended 5 minutes. A clinical labor
time of 2 minutes is standard for this activity; we disagree with the
RUC rationale that reviewing histograms and gating with the pathologist
in this procedure is not similar to other codes. We also note that the
review of histograms with a pathologist is not even described by CPT
code 88184, which again refers to the technical component of flow
cytometry, not the professional component. We are also proposing to
refine the L033A clinical labor time for ``Clean room/equipment
following procedure'' from 2 minutes to 1 minute for CPT code 88184. We
have established 1 minute in previous rulemaking (80 FR 70902) as the
standard time for this clinical labor activity in the laboratory
setting.
We are proposing to maintain our removal of the clinical labor time
for ``Enter data into laboratory information system, multiparameter
analyses and field data entry, complete quality assurance
documentation'' for both CPT code 88182 and CPT code 88184. As we
stated in last year's final rule with comment period (80 FR 70979), we
have not recognized the laboratory information system as an equipment
item that can be allocated to an individual service. We continue to
believe that this is a form of indirect PE, and therefore, we do not
recognize the laboratory information system as a direct PE input, and
we not consider this task as typically performed by clinical labor on a
per-service basis.
We are proposing to maintain the quantity of the ``lysing reagent''
supply (SL089) at 2 ml for CPT code 88185, as opposed to the RUC-
recommended quantity of 3 ml. In our discussions with pathology
specialists who perform flow cytometry, we were informed that the use
of 50-55 ml of the lysing reagent would be typical for an entire
patient case. The RUC recommendation similarly suggested a quantity of
46 ml or 48 ml per patient case. We were also told that the most
typical number of markers used for flow cytometry is 24, consisting of
1 service of CPT code 88184 and 23 services of CPT code 88185. An
investigation of our claims data confirmed this information, indicating
that 24 markers is the most frequent per patient case for flow
cytometry, and the use of more than 20 markers is typical. We believe
that this data supports our refinement of the lysing reagent from a
quantity of 3 ml to a quantity of 2 ml for CPT code 88185, which is
also the current value for the procedure and the RUC-recommended value
from the previous set of recommendations. For the typical case of 24
markers, our value would produce a total lysing reagent quantity of 51
ml (5 ml from the single service of CPT code 88184 and 46 ml from the
23 services of CPT code 88185), which matches with the amount required
for a total per patient case. If we were to adopt the RUC
recommendation, the total lysing reagent quantity would be 74 ml, which
is well in excess of what we believe to be typical for these
procedures.
We are also proposing to refine the quantity of the ``antibody,
flow cytometry'' supply (SL186) from quantity 1.6 to quantity 1, which
is also the current value for the supply and the RUC-recommended value
from the previous set of recommendations. We do not agree that more
than one antibody would be typically used for each marker. We are
reaffirming the previous RUC recommendation, and maintaining the
current quantity of 1 antibody for each marker.
We are not proposing the recommended additional time for the
``printer, dye sublimation (photo, color)'' equipment (ED031). We are
proposing to maintain the equipment time at 2 minutes for CPT code
88184, and at 1 minute for CPT code 88185. As we stated in the CY 2016
PFS final rule with comment period (80 FR 70979), we are proposing to
assign equipment time for the dye sublimation printer to match the
clinical labor time for ``Print out histograms, assemble materials with
paperwork to pathologists.'' We do not believe that it would be typical
for the printer to be in use longer than it takes to accomplish this
clinical labor task.
(30) Mammography--Computer Aided Detection Bundling (CPT Codes 770X1,
770X2 and 770X3)
Section 104 of the Medicare, Medicaid, and SCHIP Benefits
Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554)
required us to create separate codes with higher payment amounts for
digital mammography compared to film mammography, which was the
technology considered to be typical at the time. In addition, the
statute required additional payment to be made when computer-aided
detection (CAD) was used.
In CY 2002, we began valuing digital mammography services using
three G-codes, G0202, G0204, and G0206 to describe screening
mammography, unilateral diagnostic mammography, and bilateral
diagnostic mammography, respectively. CMS implemented the requirements
of BIPA section 104(d)(1), which applied to tests furnished in 2001, by
using the work RVUs of the parallel CPT codes, but establishing a fixed
PE RVU rather than using PE RVUs developed under the standard PE
methodology. The fixed amount of PE RVUs for these codes has generally
remained unchanged since implementation of the G-codes that
specifically described digital imaging.
Most mammography services under Medicare have since been billed
with these G-codes when digital mammography was used, and with CPT
codes 77055, 77056, and 77057 when film mammography was used. The use
of CAD has been reported with CPT codes 77051 and 77052. For CY 2017,
the CPT Editorial Panel deleted CPT codes 77051, 77052, 77055, 77056,
77057 and created three new CPT codes, 770X1, 770X2, and 770X3, to
describe mammography services bundled with CAD. For CY 2017, the RUC
recommended a work RVU of 0.81 for CPT code 770X1, a work RVU of 1.00
for CPT code 770X2, and a work RVU of 0.76 for CPT code 770X3, as well
as new PE inputs for use in developing resource-based PE RVUs based on
our standard methodologies. The RUC has recommended these inputs and
only one medical specialty society has provided us with a set of single
invoices to price the equipment used in furnishing these services.
We have reviewed these coding changes and recommended changes to
valuation for CY 2017. The revised CPT coding mitigates the need for
both separate G-codes and the CAD add-on codes. Based upon these coding
changes and the recommended input values, overall Medicare payment for
mammography services would be drastically reduced. This is especially
the case for the technical component of these services, which could
possibly be reduced up to 50 percent relative to the PE RVUs currently
used for payment for these services.
Based on our initial review of the recommended inputs for the new
codes, we believe that these changes would likely result in values more
closely related to the relative resources involved in furnishing these
services. However, we recognize that these services, particularly the
preventive
[[Page 46253]]
screenings, are of particular importance to the Medicare program and
the health of the Medicare beneficiaries. We are concerned that making
drastic changes in coding and payment for these services could be
disruptive in ways that could affect beneficiary access to necessary
services. We also recognize that unlike almost any other high-volume
PFS service, the RVUs used for payment for many years have not been
developed through the generally applicable PFS methodologies, and
instead reflect the statutory directive under section 104 of the BIPA.
Similarly, we recognize that the changes in both coding and valuation
are significant changes for those who provide these services.
Therefore, instead of proposing to simultaneously adopt the revised CPT
coding and drastic reductions in overall payment rates, we believe it
is advisable to adopt the new coding, including the elimination of
separate billing for CAD, for CY 2017 without proposing immediate
implementation of the recommended resource inputs. We anticipate that
we will consider the recommended inputs, including the pricing of the
required equipment, as carefully as possible prior to proposing revised
PE values through subsequent rulemaking.
Therefore, for CPT codes 770X1, 770X2, and 770X3, we are proposing
to accept the RUC-recommended work RVUs, but to crosswalk the PE RVUs
for the technical component of the current corresponding G-codes, as we
seek further pricing information for these equipment items.
In addition to seeking comment on this proposal, we are also
seeking comment on rates for these services in the commercial market to
help us understand the potential impacts of any future proposed
revisions to PFS payment rates.
Finally, we note that by adopting the new coding for CY 2017, any
subsequent significant reduction in RVUs (greater than 20 percent) for
the codes would be subject to the statutory phase-in under section
1848(c)(7).
To help us examine the resource inputs for these services, we are
seeking public comment on the list of items recommended as equipment
inputs for mammography services. We also invite commenters to provide
any invoices that would help with future pricing of these items.
Table 17--Recommended Equipment Items for Mammography Services
------------------------------------------------------------------------
# Item description Quantity Purpose
------------------------------------------------------------------------
1.............. 2D Selenia 1 Mammography unit and
Dimensions in-room console
Mammography itself.
System.
2.............. Mammo 1 Required for MQSA.
Accreditation The phantom is
Phantom. currently valued
into the existing
mammography room.
3.............. Phantom Case.... 1 Protects expensive
required phantom
from damage.
4.............. Paddle Storage 3 It requires 3 racks
Rack. to hold and prevent
damage to all of the
paddles that are
part of the typical
standard mammography
system.
5.............. Needle 1 Needed for a full
Localization functioning
Kit. mammography room.
Allows for the
performance of
needle
localizations. Input
is not separately in
the PE for the
mammography guided
procedure codes,
19281-19282, as a
fully functioning
mammography room is
needed for those
procedures.
6.............. Advanced 1 Workflow system
Workflow connecting
Manager System. mammography room and
workstations.
7.............. Cenova 2D Tower 1 CAD server, and also
System. used for post-
processing.
8.............. Image Checker 1 License required for
CAD (9.4) using CAD. This is a
License for One one-time fee.
FFDM.
9.............. Film Digitizing 1 Digitizes analog
System. films to digital for
comparison purposes.
10............. Mammography 1 A special chair
Chair. needed for patients
who cannot stand to
safely have their
mammogram performed.
11............. Laser Imager 1 Prints high
Printer. resolution copies of
the mammograms to
send to surgeons and
oncologists, and to
use in the OR.
12............. Barcode Scanner. 1 Allows selection of
individual patient
file for
interpretation.
13............. MRS V7 SQL 1 MQSA requires that
Reporting the facility develop
System. and maintain a
database that tracks
recall rates from
screening, true and
false positive and
true and false
negative rates,
sensitivity,
specificity, and
cancer detection
rate. A reporting
system is required
to build the
required database
and produce the
federally required
quality audit.
Components below
needed for the
reporting system.
The reporting system
is currently valued
into the existing
mammography room.
14............. Worksheet 1 Database reports are
Printing Module. required for federal
tracking purposes.
This is used to
generate reports for
MQSA.
15............. Site License.... 1 License for site to
use the reporting
system. This is a
one-time fee.
16............. Additional 3 Licenses for
Concurrent User radiologists to use
License. the reporting
system. A minimum of
three additional
licenses is typical.
17............. Densitometer.... 1 Required for MQSA.
------------------------------------------------------------------------
We also received specialty society recommendations for a new
Equipment Item, a physician PACS mammography workstation. We note that
we discuss physician PACS workstation in section II.A of this rule. The
items that comprise the physician PACS mammography workstation are
listed in Table 18. We are requesting public comment as to the
appropriateness of this list and if some items are indirect expenses or
belong in other codes. We also invite commenters to provide any
invoices that would help with future pricing of these items.
Table 18--Physician PACS Mammography Workstation
------------------------------------------------------------------------
-------------------------------------------------------------------------
PC Tower.
Monitors 5 MP (mammo) (x2).
3rd & 4th monitor (for speech recognition, etc.).
Admin Monitor (the extra working monitor).
Keyboard & Mouse.
[[Page 46254]]
Powerscribe Microphone.
Software--SV APP SYNC 1.3.0.
Software--R2 Cenova.
------------------------------------------------------------------------
We also note that for CY 2015, the CPT Editorial Panel created CPT
codes 77061, 77062, and 77063 to describe unilateral, bilateral, and
screening digital breast tomosynthesis, respectively. CPT code 77063 is
an add-on code to 77057, the CPT code for screening mammography. To be
consistent with our use of G codes for digital mammography, we did not
implement two of these three CPT codes for Medicare purposes. We only
adopted CPT code 77063 an add-on code to G0202. Instead of adopting
stand-alone codes 77061 and 77062, we created a new code, G0279
Diagnostic digital breast tomosynthesis, as an add-on code to the
diagnostic digital mammography codes G0204 and G0206 and assigned it
values based on CPT code 77063. Pending revaluation of the mammography
codes using direct PE inputs, we propose to maintain the current coding
structure for digital breast tomosynthesis with the technical change
that G0279 be reported with 770X1 or 770X2 as the replacement codes for
G0204 and G0206.
(31) Microslide Consultation (CPT Codes 88321, 88323, and 88325)
CPT codes 88321, 88323, and 88325 were reviewed by the RUC in April
2014 for their direct PE inputs only, and the CMS refined values were
included in the CY 2016 PFS final rule with comment period. The family
of codes was reviewed again at the January 2016 RUC meeting for both
work values and direct PE inputs, and new recommendations were
submitted to CMS as part of the CY 2017 PFS rulemaking cycle.
In the CY 2016 PFS final rule with comment period, we finalized our
proposal to remove many of the inputs for clinical labor, supplies, and
equipment for CPT code 88325. The descriptor for this code did not
state that slide preparation was taking place, and therefore, we
refined the labor, supplies, and equipment inputs to align with the
inputs recommended for CPT code 88321, which also does not include the
preparation of slides. After further discussion with pathologists and
consideration of comments received, we have been persuaded that slide
preparation does take place in conjunction with the service described
by CPT code 88325. In the RUC-recommended direct PE inputs from the
January 2016 meeting, the labor, supplies, and equipment inputs related
to slide preparation were added once again to CPT code 88325. We are
proposing to accept these restorations related to slide preparation
without refinement.
Regarding the clinical labor direct PE inputs, we are proposing to
assign 1 minute of L037B clinical labor for ``Complete workload
recording logs. Collate slides and paperwork. Deliver to pathologist''
for CPT codes 88323 and 88325. We are maintaining this at the current
value for CPT code 88323, and adding this 1 minute to CPT code 88325
based on our new understanding that slide preparation is undertaken as
part of the service described by this code. We are proposing to remove
the clinical labor for ``Assemble and deliver slides with paperwork to
pathologists'' from all three codes, as we believe this clinical labor
is redundant with the labor assigned for ``Complete workload recording
logs.'' We are similarly proposing to remove the clinical labor for
``Clean equipment while performing service'' from CPT codes 88323 and
88325, as we believe it to be redundant with the clinical labor
assigned for ``Clean room/equipment following procedure.''
We are proposing to maintain the quantity of the ``stain,
hematoxylin'' supply (SL135) at 16 ml for CPT codes 88323 and 88325, as
opposed to the RUC-recommended quantity of 32 ml. The RUC
recommendation stated that the hematoxylin supply does not include
eosin and should not be redundant; the stains are not mixed together,
but are instead sequential. The recommendation also made a comparison
to the use of the hematoxylin supply quantity in CPT code 88305.
However, we note that CPT code 88305 does not include 8 ml of eosin
stain (SL201), but instead 8 gm of eosin solution (SL063), and these
are not the same supply. Therefore we do not agree that a direct
comparison of the supply quantities is the most accurate way to value
these procedures. For CPT codes 88323 and 88325, we continue to note
that the prior supply inputs for these procedures had quantity 2.4 of
the eosin solution (SL063) and quantity 4.8 of the hematoxylin stain
(SL135); in other words, a 1:2 ratio between the eosin and hematoxylin.
We are proposing to maintain that 1:2 ratio with 8 ml of the eosin
stain (SL201) and 16 ml of the hematoxylin stain (SL135).
We are also proposing to update the use of the eosin solution
(sometimes listed as ``eosin y'') in our supply database. We believe
that the eosin solution supply (SL063), which is measured in grams,
reflects an older process of creating eosin stains by hand. This is in
contrast to the eosin stain supply (SL201), which is measured in
milliliters, and can be ordered in a state that is ready for staining
immediately. We do not believe that the use of eosin solution would
reflect typical lab practice today, with the readily availability for
purchase of inexpensive eosin staining materials. We also note that in
the CY 2016 PFS final rule with comment period, we removed 8 gm of the
eosin solution and replaced it with 8 ml of the eosin stain, and this
substitution was accepted without further change in the most recent set
of RUC recommendations. As a result, we are proposing to update the
price of the eosin stain supply from $0.044 per ml to $0.068 per ml to
reflect the current cost of the supply. We are also proposing to use
CPT codes 88323 and 88325 as a model, and replace the use of eosin
solution with an equal quantity of eosin stain for the rest of the
codes that make use of this supply. This applies to 15 other CPT codes:
88302 (Level II--Surgical pathology, gross and microscopic
examination), 88304 (Level III--Surgical pathology, gross and
microscopic examination), 88305 (Level IV--Surgical pathology, gross
and microscopic examination), 88307 (Level V--Surgical pathology, gross
and microscopic examination), 88309 (Level VI--Surgical pathology,
gross and microscopic examination), 88364 (In situ hybridization (e.g.,
FISH), per specimen; each additional single probe stain procedure),
88365 (In situ hybridization (e.g., FISH), per specimen; initial single
probe stain procedure), 88366 (In situ hybridization (e.g., FISH), per
specimen; each multiplex probe stain procedure), 88367 (Morphometric
analysis, in situ hybridization (quantitative or semi-quantitative),
using computer-assisted technology, per specimen; initial single probe
stain procedure), 88368 (Morphometric analysis, in situ hybridization
(quantitative or semi-quantitative), manual, per specimen; initial
single probe stain procedure), 88369 (Morphometric analysis, in situ
hybridization (quantitative or semi-quantitative), manual, per
specimen; each additional single probe stain procedure), 88373
(Morphometric analysis, in situ hybridization (quantitative or semi-
quantitative), using computer-assisted technology, per specimen; each
additional single probe stain procedure), 88374 (Morphometric analysis,
in situ hybridization (quantitative or semi-quantitative),
[[Page 46255]]
using computer-assisted technology, per specimen; each multiplex probe
stain procedure), 88377 (Morphometric analysis, in situ hybridization
(quantitative or semi-quantitative), manual, per specimen; each
multiplex probe stain procedure), and G0416 (Surgical pathology, gross
and microscopic examinations, for prostate needle biopsy, any method).
(32) Closure of Paravalvular Leak (CPT Codes 935X1, 935X2, and 935X3)
The CPT Editorial Committee developed three new codes (two base
codes and one add-on code) to describe paravalvular leak closure
procedures that were previously reported using an unlisted code. The
RUC recommended a work RVU of 17.97 for CPT code 935X2. We are
proposing a work RVU of 14.50 for CPT code 935X2, a direct crosswalk
from CPT code 37227. We believe that a direct crosswalk to CPT code
37227 accurately reflects the time and intensity described in CPT code
935X2 since CPT code 37227 also describes a transcatheter procedure
with similar service times.
To maintain relativity among the codes in this family, we are
proposing refinements to the recommended work RVUs for CPT code 935X1.
The RUC noted the additional work associated with CPT code 935X1
compared to CPT code 935X2 was due to the addition of a transseptal
puncture to access the mitral valve. The RUC identified a work RVU of
3.73 for a transseptal puncture. Therefore, for CPT code 935X1, we are
proposing a work RVU of 18.23 arrived at by using our proposed work RVU
for CPT code 935X2 (14.50) and adding the value of a transseptal
puncture (3.73).
CPT code 935X3 is an add-on code used to report placement of
additional occlusion devices for percutaneous transcatheter
paravalvular leak closure, performed in conjunction with either an
initial mitral or aortic paravalvular leak closure. The RUC recommended
a work RVU of 8.00 for this code. We considered applying the relative
increment between CPT codes 935X1 and 935X2, however, we believe that a
direct crosswalk to CPT code 35572, with a work RVU of 6.81, more
accurately reflects the time and intensity of furnishing the service.
Therefore, for CPT code 935X3, we are proposing a work RVU of 6.81.
(33) Electroencephalogram (EEG) (CPT Codes 95812, 95813, and 95957)
In February 2016, the RUC submitted recommendations for work and
direct PE inputs for CPT codes 95812, 95813, and 95957. We are
proposing to use the RUC-recommended physician work and direct PE
inputs for CPT code 95957 and to use the RUC-recommended work RVUs for
CPT codes 95812 and 95813.
In the CY 2016 PFS final rule with comment period (80 FR 70886), we
finalized direct PE input refinements for several clinical labor times
for CPT codes 95812 and 95813. The RUC's February 2016 PE summary of
recommendations indicated that the specialty society expert panel
disagreed with CMS' refinements to clinical labor time for these two
codes. The RUC recommended 62 minutes for clinical labor task ``perform
procedure'' for CPT code 95812 and 96 minutes for the same clinical
labor task for CPT code 95813, similar to the values recommended by the
RUC in April 2014.
We are proposing to maintain the CMS-refined CY 2016 PE inputs for
clinical labor task ``perform procedure'' for CPT codes 95812 (50
minutes) and 95813 (80 minutes). The PE summary of recommendations
state that CPT code 95812 requires 50 minutes of clinical labor time
for EEG recording, and CPT code 95813 requires 80 minutes of clinical
labor time for the same clinical labor task.
(34) Parent, Caregiver-Focused Health Risk Assessment (CPT Code 961X0)
In October 2015, the CPT Editorial Panel created two new PE-only
codes, 961X0 (Administration of patient-focused health risk assessment
instrument (e.g., health hazard appraisal) with scoring and
documentation, per standardized instrument) and 961X1 (Administration
of caregiver-focused health risk assessment instrument (e.g.,
depression inventory) for the benefit of the patient, with scoring and
documentation, per standardized instrument). For CPT code 961X0, we are
proposing the RUC-recommended direct PE inputs. For CPT code 961X1, the
service is furnished to a patient who may not be a Medicare beneficiary
and thus we do not believe would be eligible for Medicare payment. We
are proposing to assign a procedure status of I (Not valid for Medicare
purposes) for CPT code 961X1.
We note that we believe that this code describes a service that is
frequently reasonable and necessary in the treatment of illness or
injury, such as when there has been a change in health status. However,
when the service described by CPT code 961X0 is explicitly included in
another service being furnished, such as the Annual Wellness Visit
(AWV), this code should not be billed separately, much like other codes
that describe services included in codes with broader descriptions. We
also note that this service should not be billed separately if
furnished as a preventive service as it would describe a non-covered
service. However, we are also seeking comment on whether this service
may be better categorized as an add-on code and welcome stakeholder
input regarding whether or not there are circumstances when this
service might be furnished as a stand-alone service.
(35) Reflectance Confocal Microscopy (CPT Codes 96931, 96932, 96933,
96934, 96935, and 96936)
For CY 2015, the CPT Editorial panel established six new Category I
codes to describe reflectance confocal microscopy (RCM) for imaging of
skin. For CPT codes 96931 and 96933, the specialty society and the RUC
agreed that the physician work required for both codes were identical,
and therefore, should be valued the same. The RUC recommended a work
RVU of 0.80 for CPT codes 96931 and 96933 based on the 25th percentile
of the survey. Based on the similarity of the services being performed
in CPT codes 96931 and 96933 and the identical intra-service times of
96931, 96933 and 88305, the key reference code from the survey, we
believe a direct crosswalk from CPT code 88305 to 96931 and 96933 would
more accurately reflect the work involved in furnishing the procedure.
Therefore, for CY 2017 we are proposing a value of 0.75 RVUs for CPT
codes 96931 and 96933. In addition, we are removing 3 minutes of
preservice time in CPT codes 96931 and 96933 since it is not included
in CPT code 88305 and as a result, we do not believe it is appropriate
in CPT codes 96931 and 96933 either.
For CPT codes 96934 and 96936 the specialty society and the RUC
agreed that the physician work required for both codes were identical,
and therefore, should be valued the same. In its recommendation, the
RUC stated that it believed the survey respondents somewhat
overestimated the work for CPT code 96934 with the 25th percentile
yielding a work RVU of 0.79. Consequently, the RUC reviewed the survey
results from CPT code 96936 and agreed that the 25th percentile work
RVU of 0.76 accurately accounted for the work involved for the service.
Therefore, the RUC recommended a work RVU of 0.76 for CPT codes 96934
and 96936.
We believe that the incremental difference between the RUC-
recommended values for the base and add-on codes accurately captures
the difference in work between the code pairs. However, because we
valued the base codes differently than the RUC, we are proposing values
for the add-on
[[Page 46256]]
codes that maintain the RUC's 0.04 increment instead of the RUC-
recommended values. Therefore we are proposing a work RVU of 0.71 for
CPT codes 96934 and 96936.
We are also proposing to reduce the preservice clinical labor for
Patient clinical information and questionnaire reviewed by
technologist, order from physician confirmed and exam protocoled by
physician CPT codes 96934 and 93936 as this work is performed in the
two CPT base codes 93931 and 93933. The service period clinical labor
for ``Prepare and position patient/monitor patient/set up IV'' was
reduced from 2 to 1 minute for CPT codes 93934 and 93936 since we
believe that less positioning time is needed with subsequent lesions.
The service period clinical labor for ``Other Clinical Activity--Review
imaging with interpreting physician'' was refined to zero minutes for
CPT codes 96933 and 96936 as these are interpretation and report only
codes and not image acquisition.
(36) Evaluative Procedures for Physical Therapy and Occupational
Therapy (CPT Codes 97X61, 97X62, 97X63, 97X64, 97X65, 97X66, 97X67,
97X68)
For CY 2017, the CPT Editorial Panel deleted four CPT codes (97001,
97002, 97003, and 97004) and created eight new CPT codes (97X61-97X68)
to describe the evaluative procedures furnished by physical therapists
and occupational therapists. There are three new codes, stratified by
complexity, to replace a single code, 97001, for physical therapy (PT)
evaluation, three new codes, also stratified by complexity, to replace
a single code, 97003, for occupational therapy (OT) evaluation, and one
new code each to replace the reevaluation codes for physical and
occupational therapy--97002 and 97004. Table 19 includes the long
descriptors and the required components of each of the eight new CPT
codes for the PT and OT services.
The CPT Editorial Panel's creation of the new codes for PT and OT
evaluative procedures grew out of a CPT workgroup that was originally
convened in January 2012 when contemplating major revision of the
Physical Medicine and Rehabilitation CPT section of codes in response
to our nomination of therapy codes as potentially misvalued codes,
including CPT code 97001 (and, as a result, all four codes in the
family) in the CY 2012 PFS proposed rule.
In reviewing the eight new CPT codes for evaluative procedures, the
HCPAC forwarded recommendations for work RVUs and direct PE inputs for
each code. Currently, CPT codes 97001 and 97003 both have a work RVU of
1.20, and CPT codes 97002 and 97004 both have a work RVU of 0.60. These
CPT codes have reflected the same work RVUs since CY 1998 when we
accepted the HCPAC values during CY 1998 rulemaking.
i. Valuation of Evaluation Codes
The HCPAC submitted work RVU recommendations for each of the six
new PT and OT evaluation codes. These recommendations are intended to
be work neutral relative to the valuation for the previous single
evaluation code for PT and OT, respectively. However, that assessment
for each family of codes is dependent on the accuracy of the
utilization forecast for the different complexity levels within the PT
or OT family. As used in this section, work neutrality is distinct from
the budget neutrality that is applied broadly in the PFS. Specifically,
work neutrality is intended to reflect that despite changes in coding,
the overall amount of work RVUs for a set of services is held constant
from one year to the next. For example, if a service is reported using
a single code with a work RVU of 2.0 for one year but that same service
would be reported using two codes, one for ``simple'' and another for
``complex'' in the subsequent year valued at 1.0 and 3.0 respectively,
work neutrality could only be attained if exactly half the services
were reported using each of the two new codes. If more than half of the
services were reported using the ``simple'' code, then there would be
fewer overall work RVUs. If more than half of the services were
reported using the ``complex'' code, then there would be more overall
work RVUs. Therefore, work neutrality can only be assessed with an
understanding of the relative frequency of how often particular codes
will be reported.
The HCPAC recommended a work RVU of 0.75 for CPT code 97X61, a work
RVU of 1.18 for CPT code 97X62, and a work RVU of 1.5 for CPT code
97X63. The PT specialty society projected that the moderate complexity
evaluation code would be reported 50 percent of the time because it is
the typical evaluation, and the CPT codes for the low and high
complexity evaluations are each expected to be billed 25 percent of the
time. The HCPAC-recommended work RVU of 1.18 for CPT code 97X62
represents the survey median with 30 minutes of intraservice time, 10
minutes of preservice time, and 15 minutes postservice time. The HCPAC
notes this work value is appropriately ranked between levels 2 and 3 of
the E/M office visit codes for new patients.
The HCPAC recommended a work RVU of 0.88 for CPT code 97X65, a work
RVU of 1.20 for CPT code 97X66, and a work RVU of 1.70 for CPT code
97X67. For the OT codes, work neutrality would be achieved only with a
projected utilization in which the low-complexity evaluation is billed
50 percent of the time; the moderate-complexity evaluation is billed 40
percent of the time, and the high-complexity evaluation only billed 10
percent of the time. For purposes of calculating work neutrality, the
HCPAC recommended assuming that the low-complexity code will be most
frequently reported even though the HCPAC-recommended work RVU of 1.20
and 45 minutes of intraservice time for moderate complexity code is
identical to that of the current OT evaluation code. The HCPAC believes
that the work RVU of 1.20 is appropriately ranked between 99202 and
99203, levels 2 and 3 for E/M office visits for new outpatients.
ii. Valuation of Evaluation Codes and Discussion of PAMA
In our review of the HCPAC recommendations, we noted the work
neutrality and the inherent reliance on the utilization assumptions. We
considered the three complexity levels for the PT evaluations and the
three complexity levels for the OT evaluations; and we also considered
the evaluation services described by the codes as a whole. The varying
work RVUs and the dependence on utilization for each complexity level
to ensure work neutrality in the PT and OT code families make it
difficult for us evaluate the HCPAC's recommended values or to predict
with a high degree of certainty whether physical and occupational
therapists will actually bill for these services at the same rate
forecast by their respective specialty societies.
We are concerned that the coding stratification in the PT and OT
evaluation codes may result in upcoding incentives, especially while
physical and occupational therapists gain familiarity and expertise in
the differential coding of the new PT and OT evaluation codes that now
include the typical face-to-face times and new required components that
are not enumerated in the current codes. We are also concerned that
stratified payment rates may provide, in some cases, a payment
incentive to therapists to upcode to a higher complexity level than was
actually furnished to receive a higher payment.
We understand that there may be multiple reasons for the CPT
Editorial Panel to stratify coding for OT and PT
[[Page 46257]]
evaluation codes based on complexity. We also note that the codes will
be used by payers in addition to Medicare, and other payers may have
direct interest in making such differential payment based on complexity
of OT and PT evaluation. Given our concerns regarding appropriate
valuation, work neutrality, and potential upcoding, however, we do not
believe that making different payment based on the reported complexity
for these services is, at current, advantageous for Medicare or
Medicare beneficiaries.
Given the advantages inherent and public interest in using CPT
codes once they become part of the code set, we are proposing to adopt
the new CPT codes for use in Medicare for CY 2017. However, given our
concerns about appropriate pricing and payment for the stratified
services, we are proposing to price the services described by these
stratified codes as a group instead of individually. To do that, we are
proposing to utilize the authority in section 220(f) of the Protecting
Access to Medicare Act (PAMA), which revised section 1848(c)(2)(C) of
the Act to authorize the Secretary to determine RVUs for groups of
services, rather than determining RVUs at the individual service level.
We believe that using this authority instead of proposing to make
payment based on Medicare G-codes will preserve consistency in the code
set across payers, thus lessening burden on providers, while retaining
flexibilities that are beneficial to Medicare.
We propose a work RVU of 1.20 for both the PT and the OT evaluation
groups of services. We are proposing this work RVU because we believe
it best represents the typical PT and OT evaluation. This is the value
recommended by the HCPAC for the OT moderate-complexity evaluation and
nearly the same work RVU for corresponding PT evaluation (1.18).
Additionally, 1.20 work RVUs is the long-standing value for the current
evaluation codes, 97001 and 97003, and, thus, assures work neutrality
without reliance on particular assumptions about utilization, which we
believe was the intent of the HCPAC recommendation.
Because we are proposing to use the same work RVU for the six
evaluation codes, we are not addressing any additional concerns about
the utilization assumptions recommended to us. By proposing the same
work values for each code in the family, there will be no ratesetting
impact to work neutrality. As such, we are not revising the utilization
crosswalks as projected by the respective therapy specialties to
achieve work neutrality. However, were we to value each code in the PT
or OT evaluation families individually, we would seek objective data
from stakeholders to support the utilization crosswalks, particularly
those for the OT family in which the low-level complexity evaluation is
depicted as typical and the high-complexity is projected to be billed
infrequently at 10 percent of the overall number of OT evaluations.
We are proposing to use the direct PE inputs forwarded by the HCPAC
(with the refinements described below) for the typical PT evaluation
and also for the typical OT evaluation in the development of PE RVUs
for the PT and OT codes as a group of services. For the PT codes, we
are proposing to use the recommended inputs for the moderate-complexity
code for the direct PE inputs of all three codes based on its
assumption as the typical service. Our proposed direct PE inputs
reflect the recommended values minus 2 minutes of physical therapist
assistant (PTA) time in the service period because we believe that PTA
tasks to administer certain assessment tools are appropriately included
as part of the physical therapist's work and the time of the PTA to
explain and/or score self-reported outcome measures is not separately
included in the clinical labor of other codes. We are proposing to
include the recommended four sheets of laser paper without an
association to a specific equipment item, but we are seeking comment
regarding the paper's use.
For the OT evaluation codes, we considered proposing to use the
direct PE inputs for the low-complexity evaluation because the OT
specialty organization believes it represents the typical OT evaluation
service with a projected 50 percent utilization rate. However, we
propose to use the moderate-level direct inputs instead, because the
direct PE for this level is based on a vignette that is valued with the
same intraservice time, 45 minutes, as the current code, CPT code
97003. Consequently, we propose to use the recommended direct PE inputs
for the moderate-complexity code for use in developing PE RVUs for this
group of services.
Our proposed direct PE inputs reflect the recommended values minus
2 minutes of occupational therapist assistant (OTA) time in the service
period because we believe that OTA tasks to administer certain
assessment tools are appropriately included as part of the occupational
therapist's work and the time of the OTA to explain and/or score self-
reported outcome measures is not separately included in the clinical
labor of other codes. We also rounded up the recommended 6.8 minutes to
7 minutes to represent the time the OTA assists the occupational
therapist during the intraservice time period. For the Vision Kit
equipment item, our proposed price reflects the submitted invoice that
clearly defined a kit.
iii. Valuation of Reevaluation Codes
The recommendations the HCPAC sent to us for the PT and OT
reevaluation codes are not work neutral. For the new PT reevaluation
code, CPT code 97X64, the HCPAC recommended a work RVU of 0.75 compared
to the work RVU of 0.60 for CPT code 97002. This recommended work RVU
falls between the 25th percentile of the survey and the survey's median
value and was based on a direct crosswalk to CPT code 95992 for
canalith repositioning with 20 minutes intraservice time and 10 minutes
immediate postservice time. The HCPAC supported this 0.15 work RVU
increase based on an anomalous relationship between PT services and E/M
office visit codes for established patients, noting that physician E/M
codes have historically been used as a relative comparison. The HCPAC
stated its 0.75 work RVU recommendation for code 97X64 appropriately
ranks it between the key reference codes for this service 99212 and
99213, levels 2 and 3 E/M office-visit codes for established patients.
The HCPAC provided a work RVU of 0.80 for the OT reevaluation code,
CPT code 97X68, based on the 25th percentile of the survey, which
represents an increase over the current work RVU of 0.60 for CPT code
97004. This work value includes 30 minutes of intraservice time, 5
minutes preservice time, and 10 minutes immediate postservice time. The
HCPAC noted that the increase in work compared to the PT reevaluation
code (0.75) is because the occupational therapist spends more time
observing and assessing the patient and, in general, the OT patient
typically has more functional and cognitive disabilities. The HCPAC
recommendation notes that the 0.80 work RVU recommendation
appropriately ranks it between the level 1 and 2 E/M office-visit codes
for new patients.
The HCPAC's recommended increases to work RVUs for the PT and OT
reevaluation codes are not work neutral. We are unclear why the HCPAC
did not maintain work neutrality for the OT and PT reevaluation codes
since maintaining work neutrality was important to the establishment of
the six new evaluation codes. We are proposing to maintain the
[[Page 46258]]
overall work RVUs for these services by proposing 0.60 work RVUs for
CPT codes 97X64 and 97X68, consistent with the work RVUs for the
deleted reevaluation codes. We are seeking comments from stakeholders
on whether there are reasons that the reevaluation codes should be
revalued without regard to work neutrality particularly given the
HCPAC's interest in preserving work neutrality for the new evaluation
codes.
We are proposing the HCPAC-recommended direct PE inputs for CPT
code 97X64 with a reduction in time for the PTA by 1 minute (from 5 to
4) in the service period- the line for ``Other Clinical Activity''--
because the time to explain and score the self-reported outcome measure
(for example, Oswestry) is not separately included in the clinical
labor of other codes.
We are proposing the HCPAC-recommended direct PE inputs for CPT
code 97X68 with a reduction in time for the OTA by 1 minute (from 3 to
2) in the service period--the line for ``Other Clinical Activity''--for
the same reason we reduced the corresponding line for PTAs--because the
time to explain and score any patient-self-administered functional and/
or other standardized outcome measure is not separately included in the
clinical labor of other codes.
Because the new CPT code descriptors contain new coding
requirements for each complexity level, we seek comment from the PT and
OT specialty organizations as well as other stakeholders to clarify how
therapists will be educated to distinguish the required complexity
level components and the selection of the number of elements that
impact the plan of care. For example, for the OT codes, we invite
comment on how to define performance deficits, what process the
occupational therapist uses to identify the number of these performance
deficits that result in activity limitations, and performance factors
needed for each complexity level. For the PT codes, we would like more
information about how the physical therapist differentiates the number
of personal factors that actually affect the plan of care. We would
also be interested in understanding more about how the physical
therapist selects the number of elements from any of the body
structures and functions, activity limitations, and/or participation
restrictions to make sure there is no duplication during the physical
therapist's examination of body systems.
iv. Always Therapy Codes
It is also important to note that CMS defines the codes for these
evaluative services as ``always therapy.'' This means that they always
represent therapy services regardless of who performs them and always
require a therapy modifier, GP or GO, to signify that the services are
furnished under a PT or OT plan of care, respectively. These codes will
also be subject to the therapy MPPR and to statutory therapy caps.
Table 19--CPT Long Descriptors for Physical Medicine and Rehabilitation
------------------------------------------------------------------------
CPT long descriptors for physical
New CPT code medicine and rehabilitation
------------------------------------------------------------------------
97X61.............................. Physical therapy evaluation: Low
complexity, requiring these
components:
A history with no personal
factors and/or comorbidities that
impact the plan of care;
An examination of body
system(s) using standardized tests
and measures addressing 1-2
elements from any of the
following: Body structures and
functions, activity limitations,
and/or participation restrictions;
A clinical presentation
with stable and/or uncomplicated
characteristics; and
Clinical decision making
of low complexity using
standardized patient assessment
instrument and/or measurable
assessment of functional outcome.
Typically, 20 minutes are spent
face-to-face with the patient and/
or family.
97X62.............................. Physical therapy evaluation:
Moderate complexity, requiring
these components:
A history of present
problem with 1-2 personal factors
and/or comorbidities that impact
the plan of care;
An examination of body
systems using standardized tests
and measures in addressing a total
of 3 or more elements from any of
the following: Body structures and
functions, activity limitations,
and/or participation restrictions;
An evolving clinical
presentation with changing
characteristics; and
Clinical decision making
of moderate complexity using
standardized patient assessment
instrument and/or measurable
assessment of functional outcome.
Typically, 30 minutes are spent
face-to-face with the patient and/
or family.
97X63.............................. Physical therapy evaluation: High
complexity, requiring these
components:
A history of present
problem with 3 or more personal
factors and/or comorbidities that
impact the plan of care;
An examination of body
systems using standardized tests
and measures addressing a total of
4 or more elements from any of the
following: Body structures and
functions, activity limitations,
and/or participation restrictions;
A clinical presentation
with unstable and unpredictable
characteristics; and
Clinical decision making
of high complexity using
standardized patient assessment
instrument and/or measurable
assessment of functional outcome.
Typically, 45 minutes are spent
face-to-face with the patient and/
or family.
97X64.............................. Reevaluation of physical therapy
established plan of care,
requiring these components:
An examination including a
review of history and use of
standardized tests and measures is
required; and
Revised plan of care using
a standardized patient assessment
instrument and/or measurable
assessment of functional outcome
Typically, 20 minutes are spent
face-to-face with the patient and/
or family.
97X65.............................. Occupational therapy evaluation,
low complexity, requiring these
components:
An occupational profile
and medical and therapy history,
which includes a brief history
including review of medical and/or
therapy records relating to the
presenting problem;
An assessment(s) that
identifies 1-3 performance
deficits (i.e., relating to
physical, cognitive, or
psychosocial skills) that result
in activity limitations and/or
participation restrictions; and
Clinical decision making
of low complexity, which includes
an analysis of the occupational
profile, analysis of data from
problem-focused assessment(s), and
consideration of a limited number
of treatment options. Patient
presents with no comorbidities
that affect occupational
performance. Modification of tasks
or assistance (e.g., physical or
verbal) with assessment(s) is not
necessary to enable completion of
evaluation component.
Typically, 30 minutes are spent
face-to-face with the patient and/
or family.
[[Page 46259]]
97X66.............................. Occupational therapy evaluation,
moderate complexity, requiring
these components:
An occupational profile
and medical and therapy history,
which includes an expanded review
of medical and/or therapy records
and additional review of physical,
cognitive, or psychosocial history
related to current functional
performance;
An assessment(s) that
identifies 3-5 performance
deficits (i.e., relating to
physical, cognitive, or
psychosocial skills) that result
in activity limitations and/or
participation restrictions; and
Clinical decision making
of moderate analytic complexity,
which includes an analysis of the
occupational profile, analysis of
data from detailed assessment(s),
and consideration of several
treatment options. Patient may
present with comorbidities that
affect occupational performance.
Minimal to moderate modification
of tasks or assistance (e.g.,
physical or verbal) with
assessment(s) is necessary to
enable patient to complete
evaluation component.
Typically, 45 minutes are spent
face-to-face with the patient and/
or family.
97X67.............................. Occupational therapy evaluation,
high complexity, requiring these
components:
An occupational profile
and medical and therapy history,
which includes review of medical
and/or therapy records and
extensive additional review of
physical, cognitive, or
psychosocial history related to
current functional performance;
An assessment(s) that
identify 5 or more performance
deficits (i.e., relating to
physical, cognitive, or
psychosocial skills) that result
in activity limitations and/or
participation restrictions; and
A clinical decision-making
is of high analytic complexity,
which includes an analysis of the
patient profile, analysis of data
from comprehensive assessment(s),
and consideration of multiple
treatment options. Patient
presents with comorbidities that
affect occupational performance.
Significant modification of tasks
or assistance (e.g., physical or
verbal) with assessment(s) is
necessary to enable patient to
complete evaluation component.
Typically, 60 minutes are spent
face-to-face with the patient and/
or family.
97X68.............................. Reevaluation of occupational
therapy established plan of care,
requiring these components:
An assessment of changes
in patient functional or medical
status with revised plan of care;
An update to the initial
occupational profile to reflect
changes in condition or
environment that affect future
interventions and/or goals; and
A revised plan of care. A
formal reevaluation is performed
when there is a documented change
in functional status or a
significant change to the plan of
care is required.
Typically, 30 minutes are spent
face-to-face with the patient and/
or family.
------------------------------------------------------------------------
v. Potentially Misvalued Therapy Codes
Since 2010, in addition to the codes for evaluative services, CMS
has periodically added codes that represent therapy services to the
list of potentially misvalued codes. The current list of 10 therapy
codes was based on the statutory category ``codes that account for the
majority of spending under the physician fee schedule,'' as specified
in section 1848(c)(2)(K)(ii)(VII) of the Act. We understand that the
therapy specialty organizations have pursued the development of coding
changes through the CPT process for these modality and procedures
services. While we understand that, in some cases, it may take several
years to develop appropriate coding revisions, we are, in the meantime,
seeking information regarding appropriate valuation for the existing
codes. See Table 20.
Table 20--Potentially Misvalued Codes Identified Through High
Expenditure by Specialty Screen
------------------------------------------------------------------------
HCPCS code Short descriptor
------------------------------------------------------------------------
97032......................... Electrical stimulation.
97035......................... Ultrasound therapy.
97110......................... Therapeutic exercises.
97112......................... Neuromuscular reeducation.
97113......................... Aquatic therapy/exercises.
97116......................... Gait training therapy.
97140......................... Manual therapy 1/regions.
97530......................... Therapeutic activities.
97535......................... Self care mngment training.
G0283......................... Elec stim other than wound.
------------------------------------------------------------------------
(37) Proposed Valuation of Services Where Moderate Sedation Is an
Inherent Part of the Procedure and Proposed Valuation of Moderate
Sedation Services (CPT Codes 991X1, 991X2, 991X3, 991X4, 991X5, and
991X6; and HCPCS Code GMMM1)
In the CY 2015 PFS proposed rule (79 FR 40349), we noted that it
appeared that practice patterns for endoscopic procedures were
changing. Anesthesia services are increasingly being separately
reported for endoscopic procedures, meaning that resource costs
associated with sedation were no longer incurred by the practitioner
reporting the procedure. Subsequently, in the CY 2016 PFS proposed rule
(80 FR 41707), we sought public comment and recommendations on
approaches to address the appropriate valuation of moderate sedation
related to the approximately 400 diagnostic and therapeutic procedures
for which the CPT Editorial Committee has determined that moderate
sedation is an inherent part of furnishing the service. The CPT
Editorial Committee created separate codes for reporting of moderate
sedation services.
Table 21--Moderate Sedation Codes and Descriptors
------------------------------------------------------------------------
CPT/HCPCS code Descriptor
------------------------------------------------------------------------
991X1.............................. Moderate sedation services provided
by the same physician or other
qualified health care professional
performing the diagnostic or
therapeutic service that the
sedation supports, requiring the
presence of an independent trained
observer to assist in the
monitoring of the patient's level
of consciousness and physiological
status; initial 15 minutes of
intra-service time, patient
younger than 5 years of age.
[[Page 46260]]
991X2.............................. Moderate sedation services provided
by the same physician or other
qualified health care professional
performing the diagnostic or
therapeutic service that the
sedation supports, requiring the
presence of an independent trained
observer to assist in the
monitoring of the patient's level
of consciousness and physiological
status; initial 15 minutes of
intra-service time, patient age 5
years or older.
991X3.............................. Moderate sedation services provided
by a physician or other qualified
health care professional other
than the physician or other
qualified health care professional
performing the diagnostic or
therapeutic service that the
sedation supports; initial 15
minutes of intra-service time,
patient younger than 5 years of
age.
991X4.............................. Moderate sedation services provided
by a physician or other qualified
health care professional other
than the physician or other
qualified health care professional
performing the diagnostic or
therapeutic service that the
sedation supports; initial 15
minutes of intra-service time,
patient age 5 years or older.
991X5.............................. Moderate sedation services provided
by the same physician or other
qualified health care professional
performing the diagnostic or
therapeutic service that the
sedation supports, requiring the
presence of an independent trained
observer to assist in the
monitoring of the patient's level
of consciousness and physiological
status; each additional 15 minutes
of intra-service time (List
separately in addition to code for
primary service).
991X6.............................. Moderate sedation services provided
by a physician or other qualified
health care professional other
than the physician or other
qualified health care professional
performing the diagnostic or
therapeutic service that the
sedation supports; each additional
15 minutes intra-service time
(List separately in addition to
code for primary service).
------------------------------------------------------------------------
For the newly created moderate sedation CPT codes, we are proposing
to use the RUC-recommended work RVUs for CPT codes 991X1, 991X2, 991X3,
and 991X6. CPT codes 991X1 and 991X2 make a distinction between
moderate sedation services furnished to patients younger than 5 years
of age and patients 5 years or older, with CPT codes 991X3 and 991X4
making a similar distinction. The RUC recommendations include a work
RVU increment of 0.25 between CPT code 991X1 and 991X2. For CPT code
991X4, we are proposing a work RVU of 1.65 to maintain the 0.25
increment relative to CPT code 991X3 (a RUC-recommended work RVU of
1.90) and maintain relativity among the CPT codes in this family. We
are proposing to use the RUC-recommended direct PE inputs for all six
codes.
When moderate sedation is reported for Medicare beneficiaries, we
expect that it would most frequently reported using the code that
describes moderate sedation furnished by the same person who also
performs the primary procedure for patients 5 years of age or older.
Under the new coding structure, these services would be reported using
CPT code 991X2. Stakeholders have presented information that
illustrates that the specialty group survey data regarding the work
involved in furnishing the moderate sedation described by CPT code
991X2 showed a significant bimodal distribution between procedural
services furnished by gastroenterologists (GI) and those services
furnished by other specialties. The GI societies' survey data reported
a median valuation of 0.10 work RVUs for moderate sedation furnished by
the same person furnishing the base procedure; all other specialty
groups (combined) reported a median valuation of 0.25 work RVUs. Given
the significant volume of moderate sedation furnished by GI
practitioners and the significant difference in RVUs reported in the
survey data, we are proposing to make payment using a gastrointestinal
(GI) endoscopy-specific moderate sedation code GMMM1 that would be used
in lieu of the new CPT moderate sedation coding used more broadly:
GMMM1: Moderate sedation services provided by the same physician or
other qualified health care professional performing a gastrointestinal
endoscopic service (excluding biliary procedures) that sedation
supports, requiring the presence of an independent trained observer to
assist in the monitoring of the patient's level of consciousness and
physiological status; initial 15 minutes of intra-service time; patient
age 5 years or older.
We are proposing to value GMMM1 at 0.10 work RVUs based on the
median survey result for GI respondents in the survey data. We are
proposing that when moderate sedation services are furnished by the
same practitioner reporting the GI endoscopy procedure, practitioners
would report the sedation services using GMMM1 instead of 991X2. In all
other cases, we propose that practitioners would report moderate
sedation using one of the new moderate sedation CPT codes consistent
with CPT guidance. This would include the full range of codes for those
furnishing moderate sedation with the remaining (non-GI endoscopy) base
procedures as well as for the other circumstances during which moderate
sedation is furnished along with a GI endoscopy (for example, to a
patient under 5 years of age or for a biliary procedure, the
endoscopist furnishing moderate sedation should not use GMMM1, but
instead use the appropriate CPT code; see Table 22 for more information
about when GMMM1 should be used in lieu of the newly created moderate
sedation CPT codes).
In addition to providing recommended values for the new codes used
to separately report moderate sedation, the RUC has provided
recommendations that value the procedural services without moderate
sedation. However, the RUC recommends removing fewer RVUs from the
procedures than it recommends for valuing the sedation services. In
other words, the RUC is recommending that overall payments for these
procedures should be increased now that practitioners will be required
to report the sedation services that were previously included as
inherent parts of the procedures. We believe that if we were to use the
RUC recommendations for re-valuation of the procedural services without
refinement, the RVUs currently attributable to the redundant payment
for sedation services when anesthesia is separately reported would be
used exclusively to increase overall payment for these services. We
refer readers to Section II.D.5. of this proposed rule, which includes
a more extensive discussion of our general principle that overall
resource costs for the procedures including moderate sedation do not
inherently change based solely on changes in coding.
To account for the separate billing of moderate sedation services,
we are proposing to maintain current values for the procedure codes
less the work RVUs associated with the most frequently reported
corresponding moderate sedation code so that practitioners furnishing
the moderate sedation
[[Page 46261]]
services previously considered to be inherent in the procedure will
have no change in overall work RVUs. Since we are proposing 0.10 work
RVUs for moderate sedation for the GI endoscopy procedures, this means
we are proposing a corresponding .10 reduction in work RVUs for these
procedures. For all other Appendix G procedures that currently include
moderate sedation as an inherent part of the procedure, we are
proposing to remove 0.25 work RVUs from the current values.
Table 22 lists the existing work RVUs for each applicable service
and our proposed refined work RVU using the proposed revaluation
methodology described above. Additionally, the table identifies the GI
endoscopic services for which we are proposing that GMMM1 would be used
to report moderate sedation services. This information will be made
available and maintained in the ``downloads'' section of the PFS Web
site at http://www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
Table 22--Proposed Valuations for Endoscopy Services Minus Moderate
Sedation
------------------------------------------------------------------------
Use GMMM1
CY 2017 to report
HCPCS CY 2016 proposed moderate
work RVU work RVU sedation
(Y/N)
------------------------------------------------------------------------
10030.................................. 3.00 2.75 N
19298.................................. 6.00 5.75 N
20982.................................. 7.27 7.02 N
20983.................................. 7.13 6.88 N
22510.................................. 8.15 7.90 N
22511.................................. 7.58 7.33 N
22512.................................. 4.00 4.00 N
22513.................................. 8.90 8.65 N
22514.................................. 8.24 7.99 N
22515.................................. 4.00 4.00 N
22526.................................. 6.10 5.85 N
22527.................................. 3.03 3.03 N
31615.................................. 2.09 1.84 N
31622.................................. 2.78 2.53 N
31623.................................. 2.88 2.63 N
31624.................................. 2.88 2.63 N
31625.................................. 3.36 3.11 N
31626.................................. 4.16 3.91 N
31627.................................. 2.00 2.00 N
31628.................................. 3.80 3.55 N
31629.................................. 4.00 3.75 N
31632.................................. 1.03 1.03 N
31633.................................. 1.32 1.32 N
31634.................................. 4.00 3.75 N
31635.................................. 3.67 3.42 N
31645.................................. 3.16 2.91 N
31646.................................. 2.72 2.47 N
31647.................................. 4.40 4.15 N
31648.................................. 4.20 3.95 N
31649.................................. 1.44 1.44 N
31651.................................. 1.58 1.58 N
31652.................................. 4.71 4.46 N
31653.................................. 5.21 4.96 N
31654.................................. 1.40 1.40 N
31660.................................. 4.25 4.00 N
31661.................................. 4.50 4.25 N
31725.................................. 1.96 1.71 N
32405.................................. 1.93 1.68 N
32550.................................. 4.17 3.92 N
32551.................................. 3.29 3.04 N
32553.................................. 3.80 3.55 N
33010.................................. 2.24 1.99 N
33011.................................. 2.24 1.99 N
33206.................................. 7.39 7.14 N
33207.................................. 8.05 7.80 N
33208.................................. 8.77 8.52 N
33210.................................. 3.30 3.05 N
33211.................................. 3.39 3.14 N
33212.................................. 5.26 5.01 N
33213.................................. 5.53 5.28 N
33214.................................. 7.84 7.59 N
33216.................................. 5.87 5.62 N
33217.................................. 5.84 5.59 N
33218.................................. 6.07 5.82 N
33220.................................. 6.15 5.90 N
33221.................................. 5.80 5.55 N
33222.................................. 5.10 4.85 N
33223.................................. 6.55 6.30 N
33227.................................. 5.50 5.25 N
33228.................................. 5.77 5.52 N
33229.................................. 6.04 5.79 N
33230.................................. 6.32 6.07 N
33231.................................. 6.59 6.34 N
33233.................................. 3.39 3.14 N
33234.................................. 7.91 7.66 N
33235.................................. 10.15 9.90 N
33240.................................. 6.05 5.80 N
33241.................................. 3.29 3.04 N
33244.................................. 13.99 13.74 N
33249.................................. 15.17 14.92 N
33262.................................. 6.06 5.81 N
33263.................................. 6.33 6.08 N
33264.................................. 6.60 6.35 N
33282.................................. 3.50 3.25 N
33284.................................. 3.00 2.75 N
33990.................................. 8.15 7.90 N
33991.................................. 11.88 11.63 N
33992.................................. 4.00 3.75 N
33993.................................. 3.51 3.26 N
35471.................................. 10.05 9.80 N
35472.................................. 6.90 6.65 N
35475.................................. 6.60 6.35 N
35476.................................. 5.10 4.85 N
36010.................................. 2.43 2.18 N
36140.................................. 2.01 1.76 N
36147.................................. 3.72 3.47 N
36148.................................. 1.00 1.00 N
36200.................................. 3.02 2.77 N
36221.................................. 4.17 3.92 N
36222.................................. 5.53 5.28 N
36223.................................. 6.00 5.75 N
36224.................................. 6.50 6.25 N
36225.................................. 6.00 5.75 N
36226.................................. 6.50 6.25 N
36227.................................. 2.09 2.09 N
36228.................................. 4.25 4.25 N
36245.................................. 4.90 4.65 N
36246.................................. 5.27 5.02 N
36247.................................. 6.29 6.04 N
36248.................................. 1.01 1.01 N
36251.................................. 5.35 5.10 N
36252.................................. 6.99 6.74 N
36253.................................. 7.55 7.30 N
36254.................................. 8.15 7.90 N
36481.................................. 6.98 6.73 N
36555.................................. 2.68 2.43 N
36557.................................. 5.14 4.89 N
36558.................................. 4.84 4.59 N
36560.................................. 6.29 6.04 N
36561.................................. 6.04 5.79 N
36563.................................. 6.24 5.99 N
36565.................................. 6.04 5.79 N
36566.................................. 6.54 6.29 N
36568.................................. 1.92 1.67 N
36570.................................. 5.36 5.11 N
36571.................................. 5.34 5.09 N
36576.................................. 3.24 2.99 N
36578.................................. 3.54 3.29 N
36581.................................. 3.48 3.23 N
36582.................................. 5.24 4.99 N
36583.................................. 5.29 5.04 N
36585.................................. 4.84 4.59 N
36590.................................. 3.35 3.10 N
36870.................................. 5.20 4.95 N
37183.................................. 7.99 7.74 N
37184.................................. 8.66 8.41 N
37185.................................. 3.28 3.28 N
37186.................................. 4.92 4.92 N
37187.................................. 8.03 7.78 N
37188.................................. 5.71 5.46 N
37191.................................. 4.71 4.46 N
37192.................................. 7.35 7.10 N
37193.................................. 7.35 7.10 N
37197.................................. 6.29 6.04 N
37211.................................. 8.00 7.75 N
37212.................................. 7.06 6.81 N
37213.................................. 5.00 4.75 N
37214.................................. 2.74 2.49 N
37215.................................. 18.00 17.75 N
37216.................................. 0.00 0.00 N
37218.................................. 15.00 14.75 N
37220.................................. 8.15 7.90 N
37221.................................. 10.00 9.75 N
37222.................................. 3.73 3.73 N
37223.................................. 4.25 4.25 N
37224.................................. 9.00 8.75 N
37225.................................. 12.00 11.75 N
37226.................................. 10.49 10.24 N
37227.................................. 14.50 14.25 N
37228.................................. 11.00 10.75 N
37229.................................. 14.05 13.80 N
37230.................................. 13.80 13.55 N
37231.................................. 15.00 14.75 N
37232.................................. 4.00 4.00 N
37233.................................. 6.50 6.50 N
37234.................................. 5.50 5.50 N
37235.................................. 7.80 7.80 N
37236.................................. 9.00 8.75 N
37237.................................. 4.25 4.25 N
37238.................................. 6.29 6.04 N
37239.................................. 2.97 2.97 N
37241.................................. 9.00 8.75 N
37242.................................. 10.05 9.80 N
[[Page 46262]]
37243.................................. 11.99 11.74 N
37244.................................. 14.00 13.75 N
37252.................................. 1.80 1.80 N
37253.................................. 1.44 1.44 N
43200.................................. 1.52 1.42 Y
43201.................................. 1.82 1.72 Y
43202.................................. 1.82 1.72 Y
43204.................................. 2.43 2.33 Y
43205.................................. 2.54 2.44 Y
43206.................................. 2.39 2.29 Y
43211.................................. 4.30 4.20 Y
43212.................................. 3.50 3.40 Y
43213.................................. 4.73 4.63 Y
43214.................................. 3.50 3.40 Y
43215.................................. 2.54 2.44 Y
43216.................................. 2.40 2.30 Y
43217.................................. 2.90 2.80 Y
43220.................................. 2.10 2.00 Y
43226.................................. 2.34 2.24 Y
43227.................................. 2.99 2.89 Y
43229.................................. 3.59 3.49 Y
43231.................................. 2.90 2.80 Y
43232.................................. 3.69 3.59 Y
43233.................................. 4.17 4.07 Y
43235.................................. 2.19 2.09 Y
43236.................................. 2.49 2.39 Y
43237.................................. 3.57 3.47 Y
43238.................................. 4.26 4.16 Y
43239.................................. 2.49 2.39 Y
43240.................................. 7.25 7.15 Y
43241.................................. 2.59 2.49 Y
43242.................................. 4.83 4.73 Y
43243.................................. 4.37 4.27 Y
43244.................................. 4.50 4.40 Y
43245.................................. 3.18 3.08 Y
43246.................................. 3.66 3.56 Y
43247.................................. 3.21 3.11 Y
43248.................................. 3.01 2.91 Y
43249.................................. 2.77 2.67 Y
43250.................................. 3.07 2.97 Y
43251.................................. 3.57 3.47 Y
43252.................................. 3.06 2.96 Y
43253.................................. 4.83 4.73 Y
43254.................................. 4.97 4.87 Y
43255.................................. 3.66 3.56 Y
43257.................................. 4.25 4.15 Y
43259.................................. 4.14 4.04 Y
43260.................................. 5.95 5.70 N
43261.................................. 6.25 6.00 N
43262.................................. 6.60 6.35 N
43263.................................. 6.60 6.35 N
43264.................................. 6.73 6.48 N
43265.................................. 8.03 7.78 N
43266.................................. 4.17 3.92 N
43270.................................. 4.26 4.01 N
43273.................................. 2.24 2.24 N
43274.................................. 8.58 8.33 N
43275.................................. 6.96 6.71 N
43276.................................. 8.94 8.69 N
43277.................................. 7.00 6.75 N
43278.................................. 8.02 7.77 N
43450.................................. 1.38 1.13 N
43453.................................. 1.51 1.26 N
44360.................................. 2.59 2.49 Y
44361.................................. 2.87 2.77 Y
44363.................................. 3.49 3.39 Y
44364.................................. 3.73 3.63 Y
44365.................................. 3.31 3.21 Y
44366.................................. 4.40 4.30 Y
44369.................................. 4.51 4.41 Y
44370.................................. 4.79 4.69 Y
44372.................................. 4.40 4.30 Y
44373.................................. 3.49 3.39 Y
44376.................................. 5.25 5.15 Y
44377.................................. 5.52 5.42 Y
44378.................................. 7.12 7.02 Y
44379.................................. 7.46 7.36 Y
44380.................................. 0.97 0.87 Y
44381.................................. 1.48 1.38 Y
44382.................................. 1.27 1.17 Y
44384.................................. 2.95 2.85 Y
44385.................................. 1.30 1.20 Y
44386.................................. 1.60 1.50 Y
44388.................................. 2.82 2.72 Y
44388-53............................... 1.41 1.36 Y
44389.................................. 3.12 3.02 Y
44390.................................. 3.84 3.74 Y
44391.................................. 4.22 4.12 Y
44392.................................. 3.63 3.53 Y
44394.................................. 4.13 4.03 Y
44401.................................. 4.44 4.34 Y
44402.................................. 4.80 4.70 Y
44403.................................. 5.60 5.50 Y
44404.................................. 3.12 3.02 Y
44405.................................. 3.33 3.23 Y
44406.................................. 4.20 4.10 Y
44407.................................. 5.06 4.96 Y
44408.................................. 4.24 4.14 Y
44500.................................. 0.49 0.39 Y
45303.................................. 1.50 1.40 Y
45305.................................. 1.25 1.15 Y
45307.................................. 1.70 1.60 Y
45308.................................. 1.40 1.30 Y
45309.................................. 1.50 1.40 Y
45315.................................. 1.80 1.70 Y
45317.................................. 2.00 1.90 Y
45320.................................. 1.78 1.68 Y
45321.................................. 1.75 1.65 Y
45327.................................. 2.00 1.90 Y
45332.................................. 1.86 1.76 Y
45333.................................. 1.65 1.55 Y
45334.................................. 2.10 2.00 Y
45335.................................. 1.14 1.04 Y
45337.................................. 2.20 2.10 Y
45338.................................. 2.15 2.05 Y
45340.................................. 1.35 1.25 Y
45341.................................. 2.22 2.12 Y
45342.................................. 3.08 2.98 Y
45346.................................. 2.91 2.81 Y
45347.................................. 2.82 2.72 Y
45349.................................. 3.62 3.52 Y
45350.................................. 1.78 1.68 Y
45378.................................. 3.36 3.26 Y
45378-53............................... 1.68 1.63 Y
45379.................................. 4.38 4.28 Y
45380.................................. 3.66 3.56 Y
45381.................................. 3.66 3.56 Y
45382.................................. 4.76 4.66 Y
45384.................................. 4.17 4.07 Y
45385.................................. 4.67 4.57 Y
45386.................................. 3.87 3.77 Y
45388.................................. 4.98 4.88 Y
45389.................................. 5.34 5.24 Y
45390.................................. 6.14 6.04 Y
45391.................................. 4.74 4.64 Y
45392.................................. 5.60 5.50 Y
45393.................................. 4.78 4.68 Y
45398.................................. 4.30 4.20 Y
47000.................................. 1.90 1.65 N
47382.................................. 15.22 14.97 N
47383.................................. 9.13 8.88 N
47532.................................. 4.25 4.25 N
47533.................................. 6.00 5.38 N
47534.................................. 8.03 7.60 N
47535.................................. 4.50 3.95 N
47536.................................. 2.88 2.61 N
47538.................................. 6.60 4.75 N
47539.................................. 9.00 8.75 N
47540.................................. 10.75 9.03 N
47541.................................. 5.61 5.38 N
47542.................................. 2.50 2.85 N
47543.................................. 3.07 3.00 N
47544.................................. 4.29 3.28 N
49405.................................. 4.25 4.00 N
49406.................................. 4.25 4.00 N
49407.................................. 4.50 4.25 N
49411.................................. 3.82 3.57 N
49418.................................. 4.21 3.96 N
49440.................................. 4.18 3.93 N
49441.................................. 4.77 4.52 N
49442.................................. 4.00 3.75 N
49446.................................. 3.31 3.06 N
50200.................................. 2.63 2.38 N
50382.................................. 5.50 5.25 N
50384.................................. 5.00 4.75 N
50385.................................. 4.44 4.19 N
50386.................................. 3.30 3.05 N
50387.................................. 2.00 1.75 N
50430.................................. 3.15 2.90 N
50432.................................. 4.25 4.00 N
50433.................................. 5.30 5.05 N
50434.................................. 4.00 3.75 N
50592.................................. 6.80 6.55 N
50593.................................. 9.13 8.88 N
50606.................................. 3.16 3.16 N
50693.................................. 4.21 3.96 N
50694.................................. 5.50 5.25 N
50695.................................. 7.05 6.80 N
50705.................................. 4.03 4.03 N
50706.................................. 3.80 3.80 N
57155.................................. 5.40 5.15 N
66720.................................. 5.00 4.75 N
69300.................................. 6.69 6.44 N
77371.................................. 0.00 0.00 N
77600.................................. 1.56 1.31 N
77605.................................. 2.09 1.84 N
77610.................................. 1.56 1.31 N
77615.................................. 2.09 1.84 N
92920.................................. 10.10 9.85 N
92921.................................. 0.00 0.00 N
92924.................................. 11.99 11.74 N
92925.................................. 0.00 0.00 N
92928.................................. 11.21 10.96 N
92929.................................. 0.00 0.00 N
92933.................................. 12.54 12.29 N
[[Page 46263]]
92934.................................. 0.00 0.00 N
92937.................................. 11.20 10.95 N
92938.................................. 0.00 0.00 N
92941.................................. 12.56 12.31 N
92943.................................. 12.56 12.31 N
92944.................................. 0.00 0.00 N
92953.................................. 0.23 0.01 N
92960.................................. 2.25 2.00 N
92961.................................. 4.59 4.34 N
92973.................................. 3.28 3.28 N
92974.................................. 3.00 3.00 N
92975.................................. 7.24 6.99 N
92978.................................. 0.00 0.00 N
92979.................................. 0.00 0.00 N
92986.................................. 22.85 22.60 N
92987.................................. 23.63 23.38 N
93312.................................. 2.55 2.30 N
93313.................................. 0.51 0.26 N
93314.................................. 2.10 1.85 N
93315.................................. 2.94 2.69 N
93316.................................. 0.85 0.60 N
93317.................................. 2.09 1.84 N
93318.................................. 2.40 2.15 N
93451.................................. 2.72 2.47 N
93452.................................. 4.75 4.50 N
93453.................................. 6.24 5.99 N
93454.................................. 4.79 4.54 N
93455.................................. 5.54 5.29 N
93456.................................. 6.15 5.90 N
93457.................................. 6.89 6.64 N
93458.................................. 5.85 5.60 N
93459.................................. 6.60 6.35 N
93460.................................. 7.35 7.10 N
93461.................................. 8.10 7.85 N
93462.................................. 3.73 3.73 N
93463.................................. 2.00 2.00 N
93464.................................. 1.80 1.80 N
93505.................................. 4.37 4.12 N
93530.................................. 4.22 3.97 N
93561.................................. 0.50 0.25 N
93562.................................. 0.16 0.01 N
93563.................................. 1.11 1.11 N
93564.................................. 1.13 1.13 N
93565.................................. 0.86 0.86 N
93566.................................. 0.86 0.86 N
93567.................................. 0.97 0.97 N
93568.................................. 0.88 0.88 N
93571.................................. 0.00 0.00 N
93572.................................. 0.00 0.00 N
93582.................................. 12.56 12.31 N
93583.................................. 14.00 13.75 N
93609.................................. 0.00 0.00 N
93613.................................. 6.99 6.99 N
93615.................................. 0.99 0.74 N
93616.................................. 1.49 1.24 N
93618.................................. 4.25 4.00 N
93619.................................. 7.31 7.06 N
93620.................................. 11.57 11.32 N
93621.................................. 0.00 0.00 N
93622.................................. 0.00 0.00 N
93624.................................. 4.80 4.55 N
93640.................................. 3.51 3.26 N
93641.................................. 5.92 5.67 N
93642.................................. 4.88 4.63 N
93644.................................. 3.29 3.04 N
93650.................................. 10.49 10.24 N
93653.................................. 15.00 14.75 N
93654.................................. 20.00 19.75 N
93655.................................. 7.50 7.50 N
93656.................................. 20.02 19.77 N
93657.................................. 7.50 7.50 N
94011.................................. 2.00 1.75 N
94012.................................. 3.10 2.85 N
94013.................................. 0.66 0.41 N
96440.................................. 2.37 2.12 N
G0105.................................. 3.36 3.26 Y
G0105-53............................... 1.68 1.63 Y
G0121.................................. 3.36 3.26 Y
G0121-53............................... 1.68 1.63 Y
G0341.................................. 6.98 6.98 N
------------------------------------------------------------------------
(38) Prolonged Evaluation and Management Services (CPT Codes 99354,
99358, and 99359)
We previously received RUC recommendations for face-to-face and
non-face-to-face prolonged E/M services. In response to the CY 2016 PFS
proposed rule, in which we sought comment about improving payment
accuracy for cognitive services, commenters suggested that we consider
making separate payment for CPT codes 99358 and 99359. As reflected in
section II.E, we are proposing to make separate payment for these
services.
We are also proposing values for services in this family of codes
based on the RUC-recommended values, including for CPT code 99354,
which would increase the current work RVU to 2.33. Likewise, we are
proposing to adopt the RUC-recommended work values of 2.10 for CPT code
99358 and of 1.00 for CPT code 99359.
(39) Complex Chronic Care Management Services (CPT Codes 99487 and
99489)
We received RUC recommendations for CPT codes 99487 and 99489
following the October 2012 RUC meeting. For CY 2017, we are proposing
to change the procedure status for CPT codes 99487 and 99489 from B
(bundled) to A (active), see II.E, and are proposing to adopt the RUC-
recommended values for work, 1.00 work RVUs for CPT code 99487 and 0.50
work RVUs for CPT code 99489, as well as direct PE inputs consistent
with the RUC recommendations.
(40) Prostate Biopsy, Any Method (HCPCS Code G0416)
The College of American Pathologists and the American Society of
Cytopathology formed an expert panel to make recommendations at the
October 2015 RUC meeting to determine an appropriate work RVU for HCPCS
code G0416, as they felt that the survey results were invalid. The
panel made several arguments to the RUC in recommending for a higher
work RVU under the RUC's ``compelling evidence'' standard. These
arguments were: (1) That incorrect assumptions were made in previous
valuations; (2) the value of HCPCS code G0416 remained constant while
the code descriptors changed over the years; and (3) the ``anomalous
relationship'' between HCPCS code G0416 and CPT code 88305 (Level IV--
Surgical pathology, gross and microscopic examination). The expert
panel recommended a work RVU of 4.00 based on a crosswalk from CPT code
38240 (Hematopoietic progenitor cell (HPC); allogeneic transplantation
per donor). The RUC agreed.
We believe HCPCS code G0416 should not be valued as a direct
crosswalk from CPT code 38240. Instead we believe CPT code 88305 is the
basis for HCPCS code G0416, and therefore, HCPCS code G0416 should be
valued as such. To value HCPCS code G0416, we used the intra-service
time ratio between HCPCS code G0416 and CPT code 88305 to arrive at a
work RVU of 3.60. To further support this method, we note that the
IWPUT for HCPCS code G0416 with a work RVU of 3.60 is the same as CPT
code 88305. Using the RUC recommended RVU of 4.00 results in a higher
IWPUT, and we do not believe there is a difference in work intensity
between these codes. Therefore for CY 2017, we are proposing a work RVU
of 3.60 for HCPCS code G0416.
(41) Behavioral Health Integration: Psychiatric Collaborative Care
Model (HCPCS Codes GPPP1, GPPP2, and GPPP3) and General Behavioral
Health Integration (HCPCS Code GPPPX)
For CY 2017, we are proposing to establish and make separate
Medicare payment using four new HCPCS G-codes, GPPP1 (Initial
psychiatric collaborative care management, first 70 minutes in the
first calendar month of behavioral health care manager activities, in
consultation with a psychiatric consultant, and directed by the
treating physician or other qualified health care professional), GPPP2
(Subsequent psychiatric collaborative care management, first 60 minutes
in a subsequent month of behavioral health
[[Page 46264]]
care manager activities, in consultation with a psychiatric consultant,
and directed by the treating physician or other qualified health care
professional), GPPP3 (Initial or subsequent psychiatric collaborative
care management, each additional 30 minutes in a calendar month of
behavioral health care manager activities, in consultation with a
psychiatric consultant, and directed by the treating physician or other
qualified health care professional), and GPPPX (Care management
services for behavioral health conditions, at least 20 minutes of
clinical staff time, directed by a physician or other qualified health
care professional time, per calendar month) for collaborative care and
care management for beneficiaries with behavioral health conditions, as
detailed in section II.E of this proposed rule. To value HCPCS codes
GPPP1, GPPP2, and GPPP3, we are proposing to base the portion of the
work RVU that accounts for the work of the treating physician or other
qualified health care professional on a direct crosswalk to the
proposed work values for the complex CCM codes, CPT codes 99487 and
99489. To value the portion of the work RVU that accounts for the
psychiatric consultant, we are estimating ten minutes of psychiatric
consultant time per patient per month and a value of 0.42 work RVUs,
based on the per minute work RVUs for the highest volume codes
typically billed by psychiatrists. Since the behavioral health care
manager in the services described by HCPCS codes GPPP1, GPPP2, and
GPPP3 should have academic with specialized training in behavioral
health, we are proposing a new clinical labor type for the behavioral
health care manager, L057B, at $0.57 per minute, based on the rates for
genetic counselors in the direct PE input database. We are seeking
comment on all aspects of these proposed valuations.
To value HCPCS code GPPPX, we are proposing a work value based on a
direct crosswalk from CPT code 99490 (Chronic care management
services), a work value of 0.61 RVUs. We recognize that the services
described by CPT code 99490 are distinct from those furnished under the
CoCM and we believe that these alsovary based on different kinds of BHI
care. We note that there are relatively few existing codes that
describe these kinds of services over a calendar month. We also believe
that the resources associated with 99490 may vary based on the ways
different practitioners implement the service. Until we have more
information about how these services are typically furnished, we
believe valuation based on the minimum resources would be most
appropriate. To account for the care manager minutes in the direct PE
inputs for HCPCS code GPPPX, we are proposing to use clinical labor
type L045C, which is the labor type for social workers/psychologists
and has a rate of $0.45 per minute.
(42) Resource-Intensive Services (HCPCS Code GDDD1)
As discussed in section II.E, we are proposing to establish payment
for services furnished to patients with mobility-related disabilities,
through a new add-on G-code, to be billable with office/outpatient E/M
and TCM codes. Based on our analysis of the resources typically
involved in furnishing office visits to patients with these needs
(especially including the typical additional practitioner and staff
time), we believe that the physician work and time for HCPCS code GDDD1
is most accurately valued through a direct crosswalk from CPT code
99212 (Level 2 office or other outpatient visit for the evaluation and
management of an established patient). Therefore, we are proposing a
work RVU of 0.48 and a physician time of 16 minutes for HCPCS code
GDDD1. We are seeking comment on whether these work and time values
accurately capture the additional physician work typically involved in
furnishing services to patients with mobility impairments.
We believe that a direct crosswalk to the clinical staff-time
associated with CPT code 99212, which is 27 minutes of LN/LPN/MTA
(L037D) accurately represents the additional clinical staff time
required to furnish an outpatient office visit or TCM to a patient with
a mobility-related disability. We are also proposing to include as
direct practice expense inputs 27 minutes for a stretcher (EF018) and a
high/low table (EF028), and 27 minutes for new equipment inputs
associated with the following: A patient lift system, wheelchair
accessible scale, and padded leg support positioning system. These
items are included in the CY 2017 proposed direct PE input database. We
are seeking comments on whether these inputs are appropriate, and
whether any additional inputs are typically used in treating patients
with mobility-impairments.
(43) Comprehensive Assessment and Care Planning for Patients With
Cognitive Impairment (HCPCS Code GPPP6)
For CY 2017, we are proposing to create and pay separately for new
HCPCS code GPPP6 (Cognition and functional assessment using
standardized instruments with development of recorded care plan for the
patient with cognitive impairment, history face-to-face obtained from
patient and/or caregiver, in office or other outpatient setting or home
or domiciliary or rest home), see II.E for further discussion. Based on
similarities between work intensity and time, we believe that the
physician work and time for this code would be accurately valued by
combining the work RVUs from CPT code 99204 (Level 4 office or other
outpatient visit for the evaluation and management of a new patient)
and half the work RVUs for HCPCS code G0181 (Physician supervision of a
patient receiving Medicare-covered services furnished by a
participating home health agency (patient not present) requiring
complex and multidisciplinary care modalities involving regular
physician development and/or revision of care plans, review of
subsequent reports of patient status, review of laboratory and other
studies, communication (including telephone calls) with other health
care professionals involved in the patient's care, integration of new
information into the medical treatment plan and/or adjustment of
medical therapy, within a calendar month, 30 minutes or more).
Therefore, we are proposing a work RVU of 3.30. For direct practice
expense inputs we are proposing 70 total minutes of time for RN/LPN/MTA
(L037D). We believe this is typical based on information from several
specialty societies representing practitioners who typically furnish
this service and report, it, when appropriate, using E/M codes. We are
seeking comment on these valuation assumptions and would welcome
additional information on the work and direct practice expense
associated with furnishing this service.
(44) Comprehensive Assessment and Care Planning for Patients Requiring
Chronic Care Management (HCPCS Code GPPP7)
For CY 2017 we are proposing to make payment for the resource costs
of comprehensive assessment and care planning for patients requiring
CCM services through HCPCS code GPPP7 as an add-on code to be billed
with the initiating visit for CCM for patients that require extensive
assessment and care planning (see section II.E). In valuing this code,
we believe that a crosswalk to half the work and time values of HCPCS
code G0181 (Physician supervision of a patient receiving Medicare-
covered services provided by a participating home health agency
(patient not present) requiring complex and
[[Page 46265]]
multidisciplinary care modalities involving regular physician
development and/or revision of care plans, review of subsequent reports
of patient status, review of laboratory and other studies,
communication (including telephone calls) with other health care
professionals involved in the patient's care, integration of new
information into the medical treatment plan and/or adjustment of
medical therapy, within a calendar month, 30 minutes or more)
accurately accounts for the time and intensity of the work associated
with furnishing this service over and above the work accounted for as
part of the separately billed initiating visit. Therefore, we are
proposing a work RVU of 0.87 and 29 minutes of physician time. We are
also proposing 36 minutes for a RN/LPN/MTA (L037D) as the only direct
PE input for this service.
(45) Telehealth Consultation for a Patient Requiring Critical Care
Services (HCPCS Codes GTTT1 and GTTT2)
As discussed in section II.C, we are proposing use of HCPCS G-
codes, GTTT1 (Telehealth consultation, critical care, physicians
typically spend 60 minutes communicating with the patient via
telehealth (initial) and GTTT2 (Telehealth consultation, critical care,
physicians typically spend 50 minutes communicating with the patient
via telehealth (subsequent)), to report telehealth consultations for a
patient requiring critical care services. We note that due to limited
coding granularity for high-intensity cognitive services, in the PFS,
we do not believe there is an intuitive crosswalk code for ideal
estimation of the work and time values for GTTT1. In general, we
believe that the overall work for GTTT1 is not as much as 99291
(Critical care, evaluation and management of the critically ill or
critically injured patient; first 30-74 minutes) but that the service
involves more work than G0427 (Telehealth consultation, emergency
department or initial inpatient, typically 70 minutes or more
communicating with the patient via telehealth). We believe that GTTT1
is most accurately valued by a crosswalk to the work RVU and physician
intra-service time of 38240 (Hematopoietic progenitor cell (HPC);
allogeneic transplantation per donor) can therefore serve as an
appropriate crosswalk. Therefore we are proposing a work RVU of 4.0 and
are seeking comment on the accuracy of these assumptions. We do not
believe that direct PE inputs would typically be involved with
furnishing this service from the distant site. For GTTT2 we are
proposing a work RVU of 3.86 based on a crosswalk from G0427. We
believe that G0427 has similar overall work intensity to GTTT2 and has
a similar intraservice time. We also believe that no direct PE inputs
would typically be associated with furnishing this service from the
distant site.
Table 23--Proposed CY 2017 Work RVUs for New, Revised and Potentially Misvalued Codes
----------------------------------------------------------------------------------------------------------------
CMS time
HCPCS Descriptor Current work RVU RUC work RVU CMS work RVU refinement
----------------------------------------------------------------------------------------------------------------
00740............ Anesthesia for upper 0.00.............. 0.00 0.00 No.
gastrointestinal
endoscopic
procedures,
endoscope introduced
proximal to duodenum.
00810............ Anesthesia for lower 0.00.............. 0.00 0.00 No.
intestinal
endoscopic
procedures,
endoscope introduced
distal to duodenum.
10035............ Placement of soft 1.70.............. .............. 1.70 No.
tissue localization
device(s) (e.g.,
clip, metallic
pellet, wire/needle,
radioactive seeds),
percutaneous,
including imaging
guidance; first
lesion.
10036............ Placement of soft 0.85.............. .............. 0.85 No.
tissue localization
device(s) (e.g.,
clip, metallic
pellet, wire/needle,
radioactive seeds),
percutaneous,
including imaging
guidance; each
additional lesion.
11730............ Avulsion of nail 1.10.............. 1.10 1.05 No.
plate, partial or
complete, simple;
single.
11732............ Avulsion of nail 0.44.............. 0.44 0.38 Yes.
plate, partial or
complete, simple;
each additional nail
plate.
20245............ Biopsy, bone, open; 8.95.............. 6.50 6.00 No.
deep (e.g., humerus,
ischium, femur).
20550............ Injection(s); single 0.75.............. 0.75 0.75 No.
tendon sheath, or
ligament,
aponeurosis (e.g.,
plantar ``fascia'').
20552............ Injection(s); single 0.66.............. 0.66 0.66 No.
or multiple trigger
point(s), 1 or 2
muscle(s).
20553............ Injection(s); single 0.75.............. 0.75 0.75 No.
or multiple trigger
point(s), 3 or more
muscles.
228X1............ Insertion of NEW............... 15.00 13.50 No.
interlaminar/
interspinous process
stabilization/
distraction device,
without fusion,
including image
guidance when
performed, with open
decompression,
lumbar; single level.
228X2............ Insertion of NEW............... 4.00 4.00 No.
interlaminar/
interspinous process
stabilization/
distraction device,
without fusion,
including image
guidance when
performed, with open
decompression,
lumbar; second level.
228X4............ Insertion of NEW............... 7.39 7.03 No.
interlaminar/
interspinous process
stabilization/
distraction device,
without open
decompression or
fusion, including
image guidance when
performed, lumbar;
single level.
228X5............ Insertion of NEW............... 2.34 2.34 No.
interlaminar/
interspinous process
stabilization/
distraction device,
without open
decompression or
fusion, including
image guidance when
performed, lumbar;
second level.
[[Page 46266]]
22X81............ Insertion of NEW............... 4.88 4.25 No.
interbody
biomechanical
device(s) (e.g.,
synthetic cage,
mesh) with integral
anterior
instrumentation for
device anchoring
(e.g., screws,
flanges) when
performed to
intervertebral disc
space in conjunction
with interbody
arthrodesis, each
interspace.
22X82............ Insertion of NEW............... 5.50 5.50 No.
intervertebral
biomechanical
device(s) (e.g.,
synthetic cage,
mesh) with integral
anterior
instrumentation for
device anchoring
(e.g., screws,
flanges) when
performed to
vertebral
corpectomy(ies)
(vertebral body
resection, partial
or complete) defect,
in conjunction with
interbody
arthrodesis, each
contiguous defect.
22X83............ Insertion of NEW............... 6.00 5.50 No.
intervertebral
biomechanical
device(s) (e.g.,
synthetic cage,
mesh,
methylmethacrylate)
to intervertebral
disc space or
vertebral body
defect without
interbody
arthrodesis, each
contiguous defect.
26356............ Repair or 9.56.............. .............. 9.56 No.
advancement, flexor
tendon, in zone 2
digital flexor
tendon sheath (e.g.,
no man's land);
primary, without
free graft, each
tendon.
26357............ Repair or 10.53............. .............. 11.00 No.
advancement, flexor
tendon, in zone 2
digital flexor
tendon sheath (e.g.,
no man's land);
secondary, without
free graft, each
tendon.
26358............ Repair or 12.13............. .............. 12.60 No.
advancement, flexor
tendon, in zone 2
digital flexor
tendon sheath (e.g.,
no man's land);
secondary, with free
graft (includes
obtaining graft),
each tendon.
271X1............ Closed treatment of NEW............... 5.50 1.53 Yes.
posterior pelvic
ring fracture(s),
dislocation(s),
diastasis or
subluxation of the
ilium, sacroiliac
joint, and/or
sacrum, with or
without anterior
pelvic ring
fracture(s) and/or
dislocation(s) of
the pubic symphysis
and/or superior/
inferior rami,
unilateral or
bilateral; without
manipulation.
271X2............ Closed treatment of NEW............... 9.00 4.75 Yes.
posterior pelvic
ring fracture(s),
dislocation(s),
diastasis or
subluxation of the
ilium, sacroiliac
joint, and/or
sacrum, with or
without anterior
pelvic ring
fracture(s) and/or
dislocation(s) of
the pubic symphysis
and/or superior/
inferior rami,
unilateral or
bilateral; with
manipulation,
requiring more than
local anesthesia
(i.e., general
anesthesia, moderate
sedation, spinal/
epidural).
28289............ Hallux rigidus 8.31.............. 6.90 6.90 No.
correction with
cheilectomy,
debridement and
capsular release of
the first
metatarsophalangeal
joint.
28292............ Correction, hallux 9.05.............. 7.44 7.44 No.
valgus (bunion),
with or without
sesamoidectomy;
Keller, McBride, or
Mayo type procedure.
28296............ Correction, hallux 8.35.............. 8.25 8.25 No.
valgus (bunion),
with or without
sesamoidectomy; with
metatarsal osteotomy
(e.g., Mitchell,
Chevron, or
concentric type
procedures).
28297............ Correction, hallux 9.43.............. 9.29 9.29 No.
valgus (bunion),
with or without
sesamoidectomy;
Lapidus-type
procedure.
28298............ Correction, hallux 8.13.............. 7.75 7.75 No.
valgus (bunion),
with or without
sesamoidectomy; by
phalanx osteotomy.
28299............ Correction, hallux 11.57............. 9.29 9.29 No.
valgus (bunion),
with or without
sesamoidectomy; by
double osteotomy.
282X1............ Hallux rigidus NEW............... 8.01 7.81 No.
correction with
cheilectomy,
debridement and
capsular release of
the first
metatarsophalangeal
joint; with implant.
282X2............ Correction, hallux NEW............... 8.57 8.25 No.
valgus
(bunionectomy), with
sesamoidectomy, when
performed; with
proximal metatarsal
osteotomy, any
method.
31500............ Intubation, 2.33.............. 3.00 2.66 No.
endotracheal,
emergency procedure.
31575............ Laryngoscopy, 1.10.............. 1.00 0.94 No.
flexible fiberoptic;
diagnostic.
31576............ Laryngoscopy, 1.97.............. 1.95 1.89 No.
flexible fiberoptic;
with biopsy.
31577............ Laryngoscopy, 2.47.............. 2.25 2.19 No.
flexible fiberoptic;
with removal of
foreign body.
31578............ Laryngoscopy, 2.84.............. 2.49 2.43 No.
flexible fiberoptic;
with removal of
lesion.
31579............ Laryngoscopy, 2.26.............. 1.94 1.88 No.
flexible or rigid
fiberoptic, with
stroboscopy.
317X1............ Laryngoscopy, NEW............... 3.07 3.01 No.
flexible; with
ablation or
destruction of
lesion(s) with
laser, unilateral.
[[Page 46267]]
317X2............ Laryngoscopy, NEW............... 2.49 2.43 No.
flexible; with
therapeutic
injection(s) (e.g.,
chemodenervation
agent or
corticosteroid,
injected
percutaneous,
transoral, or via
endoscope channel),
unilateral.
317X3............ Laryngoscopy, NEW............... 2.49 2.43 No.
flexible; with
injection(s) for
augmentation (e.g.,
percutaneous,
transoral),
unilateral.
31580............ Laryngoplasty; for 14.66............. 14.60 14.60 No.
laryngeal web, 2-
stage, with keel
insertion and
removal.
31584............ Laryngoplasty; with 20.47............. 20.00 17.58 No.
open reduction of
fracture.
31587............ Laryngoplasty, 15.27............. 15.27 15.27 No.
cricoid split.
315X1............ Laryngoplasty; for NEW............... 21.50 21.50 No.
laryngeal stenosis,
with graft, without
indwelling stent
placement, younger
than 12 years of age.
315X2............ Laryngoplasty; for NEW............... 20.50 20.50 No.
laryngeal stenosis,
with graft, without
indwelling stent
placement, age 12
years or older.
315X3............ Laryngoplasty; for NEW............... 22.00 22.00 No.
laryngeal stenosis,
with graft, with
indwelling stent
placement, younger
than 12 years of age.
315X4............ Laryngoplasty; for NEW............... 22.00 22.00 No.
laryngeal stenosis,
with graft, with
indwelling stent
placement, age 12
years or older.
315X5............ Laryngoplasty, NEW............... 15.60 13.56 No.
medialization;
unilateral.
315X6............ Cricotracheal NEW............... 25.00 25.00 No.
resection.
333X3............ Percutaneous NEW............... 14.00 13.00 No.
transcatheter
closure of the left
atrial appendage
with endocardial
implant, including
fluoroscopy,
transseptal
puncture, catheter
placement(s), left
atrial angiography,
left atrial
appendage
angiography, when
performed, and
radiological
supervision and
interpretation.
334X1............ Valvuloplasty, aortic NEW............... 35.00 35.00 No.
valve, open, with
cardiopulmonary
bypass; simple
(i.e., valvotomy,
debridement,
debulking and/or
simple commissural
resuspension).
334X2............ Valvuloplasty, aortic NEW............... 44.00 41.50 No.
valve, open, with
cardiopulmonary
bypass; complex
(e.g., leaflet
extension, leaflet
resection, leaflet
reconstruction or
annuloplasty).
364X1............ Partial exchange NEW............... 2.00 2.00 No.
transfusion, blood,
plasma or
crystalloid
necessitating the
skill of a physician
or other qualified
health care
professional,
newborn.
36440............ Push transfusion, 1.03.............. 1.03 1.03 No.
blood, 2 years or
younger.
36450............ Exchange transfusion, 2.23.............. 3.50 3.50 No.
blood; newborn.
36455............ Exchange transfusion, 2.43.............. 2.43 2.43 No.
blood; other than
newborn.
36X41............ Endovenous ablation NEW............... 3.50 3.50 No.
therapy of
incompetent vein,
extremity, inclusive
of all imaging
guidance and
monitoring,
percutaneous,
mechanochemical;
first vein treated.
364X2............ Endovenous ablation NEW............... 2.25 1.75 No.
therapy of
incompetent vein,
extremity, inclusive
of all imaging
guidance and
monitoring,
percutaneous,
mechanochemical;
subsequent vein(s)
treated in a single
extremity, each
through separate
access sites.
369X1............ Introduction of NEW............... 3.36 2.82 No.
needle(s) and/or
catheter(s),
dialysis circuit,
with diagnostic
angiography of the
dialysis circuit,
including all direct
puncture(s) and
catheter
placement(s),
injection(s) of
contrast, all
necessary imaging
from the arterial
anastomosis and
adjacent artery
through entire
venous outflow
including the
inferior or superior
vena cava,
fluoroscopic
guidance, radiologic
supervision and
interpretation and
image documentation
and report.
369X2............ Introduction of NEW............... 4.83 4.24 No.
needle(s) and/or
catheter(s),
dialysis circuit,
with diagnostic
angiography of the
dialysis circuit,
including all direct
puncture(s) and
catheter
placement(s),
injection(s) of
contrast, all
necessary imaging
from the arterial
anastomosis and
adjacent artery
through entire
venous outflow
including the
inferior or superior
vena cava,
fluoroscopic
guidance, radiologic
supervision and
interpretation and
image documentation
and report; with
transluminal balloon
angioplasty,
peripheral dialysis
segment, including
all imaging and
radiological
supervision and
interpretation
necessary to perform
the angioplasty.
[[Page 46268]]
369X3............ Introduction of NEW............... 6.39 5.85 No.
needle(s) and/or
catheter(s),
dialysis circuit,
with diagnostic
angiography of the
dialysis circuit,
including all direct
puncture(s) and
catheter
placement(s),
injection(s) of
contrast, all
necessary imaging
from the arterial
anastomosis and
adjacent artery
through entire
venous outflow
including the
inferior or superior
vena cava,
fluoroscopic
guidance, radiologic
supervision and
interpretation and
image documentation
and report; with
transcatheter
placement of
intravascular
stent(s) peripheral
dialysis segment,
including all
imaging and
radiological
supervision and
interpretation
necessary to perform
the stenting, and
all angioplasty
within the
peripheral dialysis
segment.
369X4............ Percutaneous NEW............... 7.50 6.73 No.
transluminal
mechanical
thrombectomy and/or
infusion for
thrombolysis,
dialysis circuit,
any method,
including all
imaging and
radiological
supervision and
interpretation,
diagnostic
angiography,
fluoroscopic
guidance, catheter
placement(s), and
intraprocedural
pharmacological
thrombolytic
injection(s).
369X5............ Percutaneous NEW............... 9.00 8.46 No.
transluminal
mechanical
thrombectomy and/or
infusion for
thrombolysis,
dialysis circuit,
any method,
including all
imaging and
radiological
supervision and
interpretation,
diagnostic
angiography,
fluoroscopic
guidance, catheter
placement(s), and
intraprocedural
pharmacological
thrombolytic
injection(s); with
transluminal balloon
angioplasty,
peripheral dialysis
segment, including
all imaging and
radiological
supervision and
interpretation
necessary to perform
the angioplasty.
369X6............ Percutaneous NEW............... 10.42 9.88 No.
transluminal
mechanical
thrombectomy and/or
infusion for
thrombolysis,
dialysis circuit,
any method,
including all
imaging and
radiological
supervision and
interpretation,
diagnostic
angiography,
fluoroscopic
guidance, catheter
placement(s), and
intraprocedural
pharmacological
thrombolytic
injection(s); with
transcatheter
placement of an
intravascular
stent(s), peripheral
dialysis segment,
including all
imaging and
radiological
supervision and
interpretation to
perform the stenting
and all angioplasty
within the
peripheral dialysis
circuit.
369X7............ Transluminal balloon NEW............... 3.00 2.48 No.
angioplasty, central
dialysis segment,
performed through
dialysis circuit,
including all
imaging and
radiological
supervision and
interpretation
required to perform
the angioplasty.
369X8............ Transcatheter NEW............... 4.25 3.73 No.
placement of an
intravascular
stent(s), central
dialysis segment,
performed through
dialysis circuit,
including all
imaging and
radiological
supervision and
interpretation
required to perform
the stenting, and
all angioplasty in
the central dialysis
segment.
369X9............ Dialysis circuit NEW............... 4.12 3.48 No.
permanent vascular
embolization or
occlusion (including
main circuit or any
accessory veins),
endovascular,
including all
imaging and
radiological
supervision and
interpretation
necessary to
complete the
intervention.
372X1............ Transluminal balloon NEW............... 7.00 7.00 No.
angioplasty (except
lower extremity
artery(s) for
occlusive disease,
intracranial,
coronary, pulmonary,
or dialysis
circuit), open or
percutaneous,
including all
imaging and
radiological
supervision and
interpretation
necessary to perform
the angioplasty
within the same
artery; initial
artery.
372X2............ Transluminal balloon NEW............... 3.50 3.50 No.
angioplasty (except
lower extremity
artery(s) for
occlusive disease,
intracranial,
coronary, pulmonary,
or dialysis
circuit), open or
percutaneous,
including all
imaging and
radiological
supervision and
interpretation
necessary to perform
the angioplasty
within the same
artery; each
additional artery.
372X3............ Transluminal balloon NEW............... 6.00 6.00 No.
angioplasty (except
dialysis circuit),
open or
percutaneous,
including all
imaging and
radiological
supervision and
interpretation
necessary to perform
the angioplasty
within the same
vein; initial vein.
[[Page 46269]]
372X4............ Transluminal balloon NEW............... 2.97 2.97 No.
angioplasty (except
dialysis circuit),
open or
percutaneous,
including all
imaging and
radiological
supervision and
interpretation
necessary to perform
the angioplasty
within the same
vein; each
additional vein.
41530............ Submucosal ablation 3.50.............. .............. 3.50 No.
of the tongue base,
radiofrequency, 1 or
more sites, per
session.
43210............ Esophagogastroduodeno 7.75.............. .............. 7.75 No.
scopy, flexible,
transoral; with
esophagogastric
fundoplasty, partial
or complete,
includes
duodenoscopy when
performed.
432X1............ Laparoscopy, NEW............... 10.13 9.03 No.
surgical, esophageal
sphincter
augmentation
procedure, placement
of sphincter
augmentation device
(i.e., magnetic
band), including
cruroplasty when
performed.
432X2............ Removal of esophageal NEW............... 10.47 9.37 No.
sphincter
augmentation device.
47531............ Injection procedure 1.80.............. 1.30 1.30 No.
for cholangiography,
percutaneous,
complete diagnostic
procedure including
imaging guidance
(e.g., ultrasound
and/or fluoroscopy)
and all associated
radiological
supervision and
interpretation;
existing access.
47532............ Injection procedure 4.25.............. 4.32 4.25 No.
for cholangiography,
percutaneous,
complete diagnostic
procedure including
imaging guidance
(e.g., ultrasound
and/or fluoroscopy)
and all associated
radiological
supervision and
interpretation; new
access (e.g.,
percutaneous
transhepatic
cholangiogram).
47533............ Placement of biliary 6.00.............. 5.45 5.38 No.
drainage catheter,
percutaneous,
including diagnostic
cholangiography when
performed, imaging
guidance (e.g.,
ultrasound and/or
fluoroscopy), and
all associated
radiological
supervision and
interpretation;
external.
47534............ Placement of biliary 8.03.............. 7.67 7.60 No.
drainage catheter,
percutaneous,
including diagnostic
cholangiography when
performed, imaging
guidance (e.g.,
ultrasound and/or
fluoroscopy), and
all associated
radiological
supervision and
interpretation;
internal-external.
47535............ Conversion of 4.50.............. 4.02 3.95 No.
external biliary
drainage catheter to
internal-external
biliary drainage
catheter,
percutaneous,
including diagnostic
cholangiography when
performed, imaging
guidance (e.g.,
fluoroscopy), and
all associated
radiological
supervision and
interpretation.
47536............ Exchange of biliary 2.88.............. 2.68 2.61 No.
drainage catheter
(e.g., external,
internal-external,
or conversion of
internal-external to
external only),
percutaneous,
including diagnostic
cholangiography when
performed, imaging
guidance (e.g.,
fluoroscopy), and
all associated
radiological
supervision and
interpretation.
47537............ Removal of biliary 1.83.............. 1.84 1.84 No.
drainage catheter,
percutaneous,
requiring
fluoroscopic
guidance (e.g., with
concurrent
indwelling biliary
stents), including
diagnostic
cholangiography when
performed, imaging
guidance (e.g.,
fluoroscopy), and
all associated
radiological
supervision and
interpretation.
47538............ Placement of stent(s) 6.60.............. 4.82 4.75 No.
into a bile duct,
percutaneous,
including diagnostic
cholangiography,
imaging guidance
(e.g., fluoroscopy
and/or ultrasound),
balloon dilation,
catheter exchange(s)
and catheter
removal(s) when
performed, and all
associated
radiological
supervision and
interpretation, each
stent; existing
access.
47539............ Placement of stent(s) 9.00.............. 8.82 8.75 No.
into a bile duct,
percutaneous,
including diagnostic
cholangiography,
imaging guidance
(e.g., fluoroscopy
and/or ultrasound),
balloon dilation,
catheter exchange(s)
and catheter
removal(s) when
performed, and all
associated
radiological
supervision and
interpretation, each
stent; new access,
without placement of
separate biliary
drainage catheter.
[[Page 46270]]
47540............ Placement of stent(s) 10.75............. 9.10 9.03 No.
into a bile duct,
percutaneous,
including diagnostic
cholangiography,
imaging guidance
(e.g., fluoroscopy
and/or ultrasound),
balloon dilation,
catheter exchange(s)
and catheter
removal(s) when
performed, and all
associated
radiological
supervision and
interpretation, each
stent; new access,
with placement of
separate biliary
drainage catheter
(e.g., external or
internal-external).
47541............ Placement of access 5.61.............. 6.82 5.38 No.
through the biliary
tree and into small
bowel to assist with
an endoscopic
biliary procedure
(e.g., rendezvous
procedure),
percutaneous,
including diagnostic
cholangiography when
performed, imaging
guidance (e.g.,
ultrasound and/or
fluoroscopy), and
all associated
radiological
supervision and
interpretation, new
access.
47542............ Balloon dilation of 2.50.............. 2.85 2.85 No.
biliary duct(s) or
of ampulla
(sphincteroplasty),
percutaneous,
including imaging
guidance (e.g.,
fluoroscopy), and
all associated
radiological
supervision and
interpretation, each
duct.
47543............ Endoluminal 3.07.............. 3.00 3.00 No.
biopsy(ies) of
biliary tree,
percutaneous, any
method(s) (e.g.,
brush, forceps, and/
or needle),
including imaging
guidance (e.g.,
fluoroscopy), and
all associated
radiological
supervision and
interpretation,
single or multiple.
47544............ Removal of calculi/ 4.29.............. 3.28 3.28 No.
debris from biliary
duct(s) and/or
gallbladder,
percutaneous,
including
destruction of
calculi by any
method (e.g.,
mechanical,
electrohydraulic,
lithotripsy) when
performed, imaging
guidance (e.g.,
fluoroscopy), and
all associated
radiological
supervision and
interpretation.
49185............ Sclerotherapy of a 2.35.............. .............. 2.35 No.
fluid collection
(e.g., lymphocele,
cyst, or seroma),
percutaneous,
including contrast
injection(s),
sclerosant
injection(s),
diagnostic study,
imaging guidance
(e.g., ultrasound,
fluoroscopy) and
radiological
supervision and
interpretation when
performed.
50606............ Endoluminal biopsy of 3.16.............. .............. 3.16 No.
ureter and/or renal
pelvis, non-
endoscopic,
including imaging
guidance (e.g.,
ultrasound and/or
fluoroscopy) and all
associated
radiological
supervision and
interpretation.
50705............ Ureteral embolization 4.03.............. .............. 4.03 No.
or occlusion,
including imaging
guidance (e.g.,
ultrasound and/or
fluoroscopy) and all
associated
radiological
supervision and
interpretation.
50706............ Balloon dilation, 3.80.............. .............. 3.80 No.
ureteral stricture,
including imaging
guidance (e.g.,
ultrasound and/or
fluoroscopy) and all
associated
radiological
supervision and
interpretation.
51700............ Bladder irrigation, 0.88.............. 0.60 0.60 No.
simple, lavage and/
or instillation.
51701............ Insertion of non- 0.50.............. 0.50 0.50 No.
indwelling bladder
catheter (e.g.,
straight
catheterization for
residual urine).
51702............ Insertion of 0.50.............. 0.50 0.50 No.
temporary indwelling
bladder catheter;
simple (e.g., Foley).
51703............ Insertion of 1.47.............. 1.47 1.47 No.
temporary indwelling
bladder catheter;
complicated (e.g.,
altered anatomy,
fractured catheter/
balloon).
51720............ Bladder instillation 1.50.............. 0.87 0.87 No.
of anticarcinogenic
agent (including
retention time).
51784............ Electromyography 1.53.............. 0.75 0.75 No.
studies (EMG) of
anal or urethral
sphincter, other
than needle, any
technique.
52000............ Cystourethroscopy 2.23.............. 1.75 1.53 No.
(separate procedure).
55700............ Biopsy, prostate; 2.58.............. 2.50 2.06 No.
needle or punch,
single or multiple,
any approach.
55866............ Laparoscopy, surgical 21.36............. .............. 21.36 No.
prostatectomy,
retropubic radical,
including nerve
sparing, includes
robotic assistance,
when performed.
58555............ Hysteroscopy, 3.33.............. 3.07 2.65 No.
diagnostic (separate
procedure).
58558............ Hysteroscopy, 4.74.............. 4.37 4.17 No.
surgical; with
sampling (biopsy) of
endometrium and/or
polypectomy, with or
without D & C.
58559............ Hysteroscopy, 6.16.............. 5.54 5.20 No.
surgical; with lysis
of intrauterine
adhesions (any
method).
58560............ Hysteroscopy, 6.99.............. 6.15 5.75 No.
surgical; with
division or
resection of
intrauterine septum
(any method).
58561............ Hysteroscopy, 9.99.............. 7.00 6.60 No.
surgical; with
removal of
leiomyomata.
[[Page 46271]]
58562............ Hysteroscopy, 5.20.............. 4.17 4.00 No.
surgical; with
removal of impacted
foreign body.
58563............ Hysteroscopy, 6.16.............. 4.62 4.47 No.
surgical; with
endometrial ablation
(e.g., endometrial
resection,
electrosurgical
ablation,
thermoablation).
585X1............ Laparoscopy, NEW............... 14.08 14.08 No.
surgical, ablation
of uterine
fibroid(s) including
intraoperative
ultrasound guidance
and monitoring,
radiofrequency.
61640............ Balloon dilatation of N................. N N No.
intracranial
vasospasm,
percutaneous;
initial vessel.
61641............ Balloon dilatation of N................. N N No.
intracranial
vasospasm,
percutaneous; each
additional vessel in
same vascular family.
61642............ Balloon dilatation of N................. N N No.
intracranial
vasospasm,
percutaneous; each
additional vessel in
different vascular
family.
61645............ Percutaneous arterial 15.00............. .............. 15.00 No.
transluminal
mechanical
thrombectomy and/or
infusion for
thrombolysis,
intracranial, any
method, including
diagnostic
angiography,
fluoroscopic
guidance, catheter
placement, and
intraprocedural
pharmacological
thrombolytic
injection(s).
61650............ Endovascular 10.00............. .............. 10.00 No.
intracranial
prolonged
administration of
pharmacologic
agent(s) other than
for thrombolysis,
arterial, including
catheter placement,
diagnostic
angiography, and
imaging guidance;
initial vascular
territory.
61651............ Endovascular 4.25.............. .............. 4.25 No.
intracranial
prolonged
administration of
pharmacologic
agent(s) other than
for thrombolysis,
arterial, including
catheter placement,
diagnostic
angiography, and
imaging guidance;
each additional
vascular territory.
623X5............ Injection(s), of NEW............... 1.80 1.80 No.
diagnostic or
therapeutic
substance(s) (e.g.,
anesthetic,
antispasmodic,
opioid, steroid,
other solution), not
including neurolytic
substances,
including needle or
catheter placement,
interlaminar
epidural or
subarachnoid,
cervical or
thoracic; without
imaging guidance.
623X6............ Injection(s), of NEW............... 1.95 1.95 No.
diagnostic or
therapeutic
substance(s) (e.g.,
anesthetic,
antispasmodic,
opioid, steroid,
other solution), not
including neurolytic
substances,
including needle or
catheter placement,
interlaminar
epidural or
subarachnoid,
cervical or
thoracic; with
imaging guidance
(i.e., fluoroscopy
or CT).
623X7............ Injection(s), of NEW............... 1.55 1.55 No.
diagnostic or
therapeutic
substance(s) (e.g.,
anesthetic,
antispasmodic,
opioid, steroid,
other solution), not
including neurolytic
substances,
including needle or
catheter placement,
interlaminar
epidural or
subarachnoid, lumbar
or sacral (caudal);
without imaging
guidance.
623X8............ Injection(s), of NEW............... 1.80 1.80 No.
diagnostic or
therapeutic
substance(s) (e.g.,
anesthetic,
antispasmodic,
opioid, steroid,
other solution), not
including neurolytic
substances,
including needle or
catheter placement,
interlaminar
epidural or
subarachnoid, lumbar
or sacral (caudal);
with imaging
guidance (ie,
fluoroscopy or CT).
623X9............ Injection(s), NEW............... 1.89 1.89 No.
including indwelling
catheter placement,
continuous infusion
or intermittent
bolus, of diagnostic
or therapeutic
substance(s) (e.g.,
anesthetic,
antispasmodic,
opioid, steroid,
other solution), not
including neurolytic
substances,
interlaminar
epidural or
subarachnoid,
cervical or
thoracic; without
imaging guidance.
62X10............ Injection(s), NEW............... 2.20 2.20 No.
including indwelling
catheter placement,
continuous infusion
or intermittent
bolus, of diagnostic
or therapeutic
substance(s) (e.g.,
anesthetic,
antispasmodic,
opioid, steroid,
other solution), not
including neurolytic
substances,
interlaminar
epidural or
subarachnoid,
cervical or
thoracic; with
imaging guidance
(ie, fluoroscopy or
CT).
[[Page 46272]]
62X11............ Injection(s), NEW............... 1.78 1.78 No.
including indwelling
catheter placement,
continuous infusion
or intermittent
bolus, of diagnostic
or therapeutic
substance(s) (e.g.,
anesthetic,
antispasmodic,
opioid, steroid,
other solution), not
including neurolytic
substances,
interlaminar
epidural or
subarachnoid, lumbar
or sacral (caudal);
without imaging
guidance.
62X12............ Injection(s), NEW............... 1.90 1.90 No.
including indwelling
catheter placement,
continuous infusion
or intermittent
bolus, of diagnostic
or therapeutic
substance(s) (e.g.,
anesthetic,
antispasmodic,
opioid, steroid,
other solution), not
including neurolytic
substances,
interlaminar
epidural or
subarachnoid, lumbar
or sacral (caudal);
with imaging
guidance (ie,
fluoroscopy or CT).
630X1............ Endoscopic NEW............... 10.47 9.09 No.
decompression of
spinal cord, nerve
root(s), including
laminotomy, partial
facetectomy,
foraminotomy,
discectomy and/or
excision of
herniated
intervertebral disc;
1 interspace, lumbar.
64461............ Paravertebral block 1.75.............. .............. 1.75 No.
(PVB) (paraspinous
block), thoracic;
single injection
site (includes
imaging guidance,
when performed).
64462............ Paravertebral block 1.10.............. .............. 1.10 No.
(PVB) (paraspinous
block), thoracic;
second and any
additional injection
site(s) (includes
imaging guidance,
when performed).
64463............ Paravertebral block 1.81.............. .............. 1.81 No.
(PVB) (paraspinous
block), thoracic;
continuous infusion
by catheter
(includes imaging
guidance, when
performed).
64553............ Percutaneous 2.36.............. .............. 2.36 Yes.
implantation of
neurostimulator
electrode array;
cranial nerve.
64555............ Percutaneous 2.32.............. .............. 2.32 Yes.
implantation of
neurostimulator
electrode array;
peripheral nerve
(excludes sacral
nerve).
64566............ Posterior tibial 0.60.............. .............. 0.60 No.
neurostimulation,
percutaneous needle
electrode, single
treatment, includes
programming.
65778............ Placement of amniotic 1.00.............. .............. 1.00 No.
membrane on the
ocular surface;
without sutures.
65779............ Placement of amniotic 2.50.............. .............. 2.50 No.
membrane on the
ocular surface;
single layer,
sutured.
65780............ Ocular surface 7.81.............. .............. 7.81 No.
reconstruction;
amniotic membrane
transplantation,
multiple layers.
65855............ Trabeculoplasty by 2.66.............. .............. 2.77 No.
laser surgery.
66170............ Fistulization of 11.27............. .............. 11.27 No.
sclera for glaucoma;
trabeculectomy ab
externo in absence
of previous surgery.
66172............ Fistulization of 12.57............. .............. 12.57 No.
sclera for glaucoma;
trabeculectomy ab
externo with
scarring from
previous ocular
surgery or trauma
(includes injection
of antifibrotic
agents).
67101............ Repair of retinal 8.80.............. 3.50 3.50 No.
detachment, 1 or
more sessions;
cryotherapy or
diathermy, including
drainage of
subretinal fluid,
when performed.
67105............ Repair of retinal 8.53.............. 3.84 3.39 No.
detachment, 1 or
more sessions;
photocoagulation,
including drainage
of subretinal fluid,
when performed.
67107............ Repair of retinal 14.06............. .............. 14.06 No.
detachment; scleral
buckling (such as
lamellar scleral
dissection,
imbrication or
encircling
procedure),
including, when
performed, implant,
cryotherapy,
photocoagulation,
and drainage of
subretinal fluid.
67108............ Repair of retinal 15.19............. .............. 15.19 No.
detachment; with
vitrectomy, any
method, including,
when performed, air
or gas tamponade,
focal endolaser
photocoagulation,
cryotherapy,
drainage of
subretinal fluid,
scleral buckling,
and/or removal of
lens by same
technique.
67110............ Repair of retinal 8.31.............. .............. 8.31 No.
detachment; by
injection of air or
other gas (e.g.,
pneumatic
retinopexy).
67113............ Repair of complex 19.00............. .............. 19.00 No.
retinal detachment
(e.g., proliferative
vitreoretinopathy,
stage C-1 or
greater, diabetic
traction retinal
detachment,
retinopathy of
prematurity, retinal
tear of greater than
90 degrees), with
vitrectomy and
membrane peeling,
including, when
performed, air, gas,
or silicone oil
tamponade,
cryotherapy,
endolaser
photocoagulation,
drainage of
subretinal fluid,
scleral buckling,
and/or removal of
lens.
[[Page 46273]]
67227............ Destruction of 3.50.............. .............. 3.50 No.
extensive or
progressive
retinopathy (e.g.,
diabetic
retinopathy),
cryotherapy,
diathermy.
67228............ Treatment of 4.39.............. .............. 4.39 No.
extensive or
progressive
retinopathy (e.g.,
diabetic
retinopathy),
photocoagulation.
70540............ Magnetic resonance 1.35.............. 1.35 1.35 No.
(e.g., proton)
imaging, orbit,
face, and/or neck;
without contrast
material(s).
70542............ Magnetic resonance 1.62.............. 1.62 1.62 No.
(e.g., proton)
imaging, orbit,
face, and/or neck;
with contrast
material(s).
70543............ Magnetic resonance 2.15.............. 2.15 2.15 No.
(e.g., proton)
imaging, orbit,
face, and/or neck;
without contrast
material(s),
followed by contrast
material(s) and
further sequences.
72170............ Radiologic 0.17.............. .............. 0.17 No.
examination, pelvis;
1 or 2 views.
73501............ Radiologic 0.18.............. .............. 0.18 No.
examination, hip,
unilateral, with
pelvis when
performed; 1 view.
73502............ Radiologic 0.22.............. .............. 0.22 No.
examination, hip,
unilateral, with
pelvis when
performed; 2-3 views.
73503............ Radiologic 0.27.............. .............. 0.27 No.
examination, hip,
unilateral, with
pelvis when
performed; minimum
of 4 views.
73521............ Radiologic 0.22.............. .............. 0.22 No.
examination, hips,
bilateral, with
pelvis when
performed; 2 views.
73522............ Radiologic 0.29.............. .............. 0.29 No.
examination, hips,
bilateral, with
pelvis when
performed; 3-4 views.
73523............ Radiologic 0.31.............. .............. 0.31 No.
examination, hips,
bilateral, with
pelvis when
performed; minimum
of 5 views.
73551............ Radiologic 0.16.............. .............. 0.16 No.
examination, femur;
1 view.
73552............ Radiologic 0.18.............. .............. 0.18 No.
examination, femur;
minimum 2 views.
74712............ Magnetic resonance 3.00.............. .............. 3.00 No.
(e.g., proton)
imaging, fetal,
including placental
and maternal pelvic
imaging when
performed; single or
first gestation.
74713............ Magnetic resonance 1.78.............. .............. 1.85 No.
(e.g., proton)
imaging, fetal,
including placental
and maternal pelvic
imaging when
performed; each
additional gestation.
767X1............ Ultrasound, abdominal NEW............... 0.55 0.55 No.
aorta, real time
with image
documentation,
screening study for
abdominal aortic
aneurysm.
77001............ Fluoroscopic guidance 0.38.............. 0.38 0.38 No.
for central venous
access device
placement,
replacement
(catheter only or
complete), or
removal (includes
fluoroscopic
guidance for
vascular access and
catheter
manipulation, any
necessary contrast
injections through
access site or
catheter with
related venography
radiologic
supervision and
interpretation, and
radiographic
documentation of
final catheter
position).
77002............ Fluoroscopic guidance 0.54.............. 0.54 0.38 No.
for needle placement
(e.g., biopsy,
aspiration,
injection,
localization device).
77003............ Fluoroscopic guidance 0.60.............. 0.60 0.38 No.
and localization of
needle or catheter
tip for spine or
paraspinous
diagnostic or
therapeutic
injection procedures
(epidural or
subarachnoid).
770X1............ Fluoroscopic guidance NEW............... 0.81 0.81 No.
for central venous
access device
placement,
replacement
(catheter only or
complete), or
removal (includes
fluoroscopic
guidance for
vascular access and
catheter
manipulation, any
necessary contrast
injections through
access site or
catheter with
related venography
radiologic
supervision and
interpretation, and
radiographic
documentation of
final catheter
position).
770X2............ Fluoroscopic guidance NEW............... 1.00 1.00 No.
for needle placement
(e.g., biopsy,
aspiration,
injection,
localization device).
770X3............ Fluoroscopic guidance NEW............... 0.76 0.76 No.
and localization of
needle or catheter
tip for spine or
paraspinous
diagnostic or
therapeutic
injection procedures
(epidural or
subarachnoid).
77332............ Treatment devices, 0.54.............. 0.54 0.45 No.
design and
construction; simple
(simple block,
simple bolus).
77333............ Treatment devices, 0.84.............. 0.84 0.75 No.
design and
construction;
intermediate
(multiple blocks,
stents, bite blocks,
special bolus).
77334............ Treatment devices, 1.24.............. 1.24 1.15 No.
design and
construction;
complex (irregular
blocks, special
shields,
compensators,
wedges, molds or
casts).
77470............ Special treatment 2.09.............. 2.03 2.03 No.
procedure (e.g.,
total body
irradiation,
hemibody radiation,
per oral or
endocavitary
irradiation).
[[Page 46274]]
77778............ Interstitial 8.00.............. .............. 8.00 No.
radiation source
application,
complex, includes
supervision,
handling, loading of
radiation source,
when performed.
77790............ Supervision, 0.00.............. .............. 0.00 No.
handling, loading of
radiation source.
78264............ Gastric emptying 0.74.............. .............. 0.74 No.
imaging study (e.g.,
solid, liquid, or
both).
78265............ Gastric emptying 0.98.............. .............. 0.98 No.
imaging study (e.g.,
solid, liquid, or
both); with small
bowel transit.
78266............ Gastric emptying 1.08.............. .............. 1.08 No.
imaging study (e.g.,
solid, liquid, or
both); with small
bowel and colon
transit, multiple
days.
88104............ Cytopathology, 0.56.............. .............. 0.56 No.
fluids, washings or
brushings, except
cervical or vaginal;
smears with
interpretation.
88106............ Cytopathology, 0.37.............. .............. 0.37 No.
fluids, washings or
brushings, except
cervical or vaginal;
simple filter method
with interpretation.
88108............ Cytopathology, 0.44.............. .............. 0.44 No.
concentration
technique, smears
and interpretation
(e.g., Saccomanno
technique).
88112............ Cytopathology, 0.56.............. .............. 0.56 No.
selective cellular
enhancement
technique with
interpretation
(e.g., liquid based
slide preparation
method), except
cervical or vaginal.
88160............ Cytopathology, 0.50.............. .............. 0.50 No.
smears, any other
source; screening
and interpretation.
88161............ Cytopathology, 0.50.............. .............. 0.50 No.
smears, any other
source; preparation,
screening and
interpretation.
88162............ Cytopathology, 0.76.............. .............. 0.76 No.
smears, any other
source; extended
study involving over
5 slides and/or
multiple stains.
88184............ Flow cytometry, cell 0.00.............. 0.00 0.00 No.
surface,
cytoplasmic, or
nuclear marker,
technical component
only; first marker.
88185............ Flow cytometry, cell 0.00.............. 0.00 0.00 No.
surface,
cytoplasmic, or
nuclear marker,
technical component
only; each
additional marker.
88187............ Flow cytometry, 1.36.............. 0.74 0.74 No.
interpretation; 2 to
8 markers.
88188............ Flow cytometry, 1.69.............. 1.40 1.20 No.
interpretation; 9 to
15 markers.
88189............ Flow cytometry, 2.23.............. 1.70 1.70 No.
interpretation; 16
or more markers.
88321............ Consultation and 1.63.............. 1.63 1.63 No.
report on referred
slides prepared
elsewhere.
88323............ Consultation and 1.83.............. 1.83 1.83 No.
report on referred
material requiring
preparation of
slides.
88325............ Consultation, 2.50.............. 2.85 2.85 No.
comprehensive, with
review of records
and specimens, with
report on referred
material.
88341............ Immunohistochemistry 0.53.............. .............. 0.56 No.
or
immunocytochemistry,
per specimen; each
additional single
antibody stain
procedure (List
separately in
addition to code for
primary procedure).
88364............ In situ hybridization 0.67.............. .............. 0.70 No.
(e.g., FISH), per
specimen; each
additional single
probe stain
procedure.
88369............ Morphometric 0.67.............. .............. 0.67 No.
analysis, in situ
hybridization
(quantitative or
semi-quantitative),
manual, per
specimen; each
additional single
probe stain
procedure.
91110............ Gastrointestinal 3.64.............. 2.49 2.49 No.
tract imaging,
intraluminal (e.g.,
capsule endoscopy),
esophagus through
ileum, with
interpretation and
report.
91111............ Gastrointestinal 1.00.............. 1.00 1.00 No.
tract imaging,
intraluminal (e.g.,
capsule endoscopy),
esophagus with
interpretation and
report.
91200............ Liver elastography, 0.27.............. .............. 0.27 No.
mechanically induced
shear wave (e.g.,
vibration), without
imaging, with
interpretation and
report.
92132............ Scanning computerized 0.35.............. 0.30 0.30 No.
ophthalmic
diagnostic imaging,
anterior segment,
with interpretation
and report,
unilateral or
bilateral.
92133............ Scanning computerized 0.50.............. 0.40 0.40 No.
ophthalmic
diagnostic imaging,
posterior segment,
with interpretation
and report,
unilateral or
bilateral; optic
nerve.
92134............ Scanning computerized 0.50.............. 0.45 0.45 No.
ophthalmic
diagnostic imaging,
posterior segment,
with interpretation
and report,
unilateral or
bilateral; retina.
92235............ Fluorescein 0.81.............. 0.75 0.75 No.
angiography
(includes multiframe
imaging) with
interpretation and
report.
92240............ Indocyanine-green 1.10.............. 0.80 0.80 No.
angiography
(includes multiframe
imaging) with
interpretation and
report.
92250............ Fundus photography 0.44.............. 0.40 0.40 No.
with interpretation
and report.
922X4............ Fluorescein NEW............... 0.95 0.95 No.
angiography and
indocyanine-green
angiography
(includes multiframe
imaging) performed
at the same patient
encounter with
interpretation and
report, unilateral
or bilateral.
[[Page 46275]]
93050............ Arterial pressure 0.17.............. .............. 0.17 No.
waveform analysis
for assessment of
central arterial
pressures, includes
obtaining
waveform(s),
digitization and
application of
nonlinear
mathematical
transformations to
determine central
arterial pressures
and augmentation
index, with
interpretation and
report, upper
extremity artery,
non-invasive.
935X1............ Percutaneous NEW............... 21.70 18.23 No.
transcatheter
closure of
paravalvular leak;
initial occlusion
device, mitral valve.
935X2............ Percutaneous NEW............... 17.97 14.50 No.
transcatheter
closure of
paravalvular leak;
initial occlusion
device, aortic valve.
935X3............ Percutaneous NEW............... 8.00 6.81 No.
transcatheter
closure of
paravalvular leak;
each additional
occlusion device
(list separately in
addition to code for
primary service).
95144............ Professional services 0.06.............. 0.06 0.06 No.
for the supervision
of preparation and
provision of
antigens for
allergen
immunotherapy,
single dose vial(s)
(specify number of
vials).
95165............ Professional services 0.06.............. 0.06 0.06 No.
for the supervision
of preparation and
provision of
antigens for
allergen
immunotherapy;
single or multiple
antigens (specify
number of doses).
95812............ Electroencephalogram 1.08.............. 1.08 1.08 No.
(EEG) extended
monitoring; 41-60
minutes.
95813............ Electroencephalogram 1.73.............. 1.63 1.63 No.
(EEG) extended
monitoring; greater
than 1 hour.
95957............ Digital analysis of 1.98.............. 1.98 1.98 No.
electroencephalogram
(EEG) (e.g., for
epileptic spike
analysis).
95971............ Electronic analysis 0.78.............. .............. 0.78 No.
of implanted
neurostimulator
pulse generator
system (e.g., rate,
pulse amplitude,
pulse duration,
configuration of
wave form, battery
status, electrode
selectability,
output modulation,
cycling, impedance
and patient
compliance
measurements);
simple spinal cord,
or peripheral (i.e.,
peripheral nerve,
sacral nerve,
neuromuscular)
neurostimulator
pulse generator/
transmitter, with
intraoperative or
subsequent
programming.
95972............ Electronic analysis 0.80.............. .............. 0.80 No.
of implanted
neurostimulator
pulse generator
system (e.g., rate,
pulse amplitude,
pulse duration,
configuration of
wave form, battery
status, electrode
selectability,
output modulation,
cycling, impedance
and patient
compliance
measurements);
complex spinal cord,
or peripheral (i.e,
peripheral nerve,
sacral nerve,
neuromuscular)
(except cranial
nerve)
neurostimulator
pulse generator/
transmitter, with
intraoperative or
subsequent
programming.
961X0............ Administration of NEW............... 0.00 0.00 No.
patient-focused
health risk
assessment
instrument (e.g.,
health hazard
appraisal) with
scoring and
documentation, per
standardized
instrument.
961X1............ Administration of NEW............... 0.00 0.00 No.
caregiver-focused
health risk
assessment
instrument (e.g.,
depression
inventory) for the
benefit of the
patient, with
scoring and
documentation, per
standardized
instrument.
96931............ Reflectance confocal 0.00.............. 0.80 0.75 No.
microscopy (RCM) for
cellular and sub-
cellular imaging of
skin; image
acquisition and
interpretation and
report, first lesion.
96932............ Reflectance confocal 0.00.............. 0.00 0.00 No.
microscopy (RCM) for
cellular and sub-
cellular imaging of
skin; image
acquisition only,
first lesion.
96933............ Reflectance confocal 0.00.............. 0.80 0.75 No.
microscopy (RCM) for
cellular and sub-
cellular imaging of
skin; interpretation
and report only,
first lesion.
96934............ Reflectance confocal 0.00.............. 0.76 0.71 No.
microscopy (RCM) for
cellular and sub-
cellular imaging of
skin; image
acquisition and
interpretation and
report, each
additional lesion.
96935............ Reflectance confocal 0.00.............. 0.00 0.00 No.
microscopy (RCM) for
cellular and sub-
cellular imaging of
skin; image
acquisition only,
each additional
lesion.
96936............ Reflectance confocal 0.00.............. 0.76 0.71 No.
microscopy (RCM) for
cellular and sub-
cellular imaging of
skin; interpretation
and report only,
each additional
lesion.
97X61............ Physical therapy NEW............... 0.75 1.20 Yes.
evaluation; low
complexity.
97X62............ Physical therapy NEW............... 1.18 1.20 No.
evaluation; moderate
complexity.
97X63............ Physical therapy NEW............... 1.50 1.20 Yes.
evaluation; high
complexity.
97X64............ Reevaluation of NEW............... 0.75 0.60 No.
physical therapy
established plan of
care.
[[Page 46276]]
97X65............ Occupational therapy NEW............... 0.88 1.20 Yes.
evaluation; low
complexity.
97X66............ Occupational therapy NEW............... 1.20 1.20 No.
evaluation; moderate
complexity.
97X67............ Occupational therapy NEW............... 1.70 1.20 Yes.
evaluation; high
complexity.
97X68............ Reevaluation of NEW............... 0.80 0.60 No.
occupational therapy
care/established
plan of care.
991X1............ Moderate sedation NEW............... 0.50 0.50 No.
services provided by
the same physician
or other qualified
health care
professional
performing the
diagnostic or
therapeutic service
that the sedation
supports, requiring
the presence of an
independent trained
observer to assist
in the monitoring of
the patient's level
of consciousness and
physiological
status; initial 15
minutes of intra-
service time,
patient younger than
5 years of age.
991X2............ Moderate sedation NEW............... 0.25 0.25 No.
services provided by
the same physician
or other qualified
health care
professional
performing the
diagnostic or
therapeutic service
that the sedation
supports, requiring
the presence of an
independent trained
observer to assist
in the monitoring of
the patient's level
of consciousness and
physiological
status; initial 15
minutes of intra-
service time,
patient age 5 years
or older.
991X3............ Moderate sedation NEW............... 1.90 1.90 No.
services provided by
a physician or other
qualified health
care professional
other than the
physician or other
qualified health
care professional
performing the
diagnostic or
therapeutic service
that the sedation
supports; initial 15
minutes of intra-
service time,
patient younger than
5 years of age.
991X4............ Moderate sedation NEW............... 1.84 1.65 No.
services provided by
a physician or other
qualified health
care professional
other than the
physician or other
qualified health
care professional
performing the
diagnostic or
therapeutic service
that the sedation
supports; initial 15
minutes of intra-
service time,
patient age 5 years
or older.
991X5............ Moderate sedation NEW............... 0.00 0.00 No.
services provided by
the same physician
or other qualified
health care
professional
performing the
diagnostic or
therapeutic service
that the sedation
supports, requiring
the presence of an
independent trained
observer to assist
in the monitoring of
the patient's level
of consciousness and
physiological
status; each
additional 15
minutes of intra-
service time.
991X6............ Moderate sedation NEW............... 1.25 1.25 No.
services provided by
a physician or other
qualified health
care professional
other than the
physician or other
qualified health
care professional
performing the
diagnostic or
therapeutic service
that the sedation
supports; each
additional 15
minutes intra-
service time.
99354............ Prolonged evaluation 1.77.............. .............. 2.33 No.
and management or
psychotherapy
service(s) (beyond
the typical service
time of the primary
procedure) in the
office or other
outpatient setting
requiring direct
patient contact
beyond the usual
service; first hour.
99358............ Prolonged evaluation 2.10.............. .............. 2.10 No.
and management
service before and/
or after direct
patient care; first
hour.
99359............ Prolonged evaluation 1.00.............. .............. 1.00 No.
and management
service before and/
or after direct
patient care; each
additional 30
minutes.
99487............ Complex chronic care 0.00.............. .............. 1.00 No.
management services,
with the following
required elements:
Multiple (two or
more) chronic
conditions expected
to last at least 12
months, or until the
death of the
patient, chronic
conditions place the
patient at
significant risk of
death, acute
exacerbation/
decompensation, or
functional decline,
establishment or
substantial revision
of a comprehensive
care plan, moderate
or high complexity
medical decision
making; 60 minutes
of clinical staff
time directed by a
physician or other
qualified health
care professional,
per calendar month.
[[Page 46277]]
99489............ Complex chronic care 0.00.............. .............. 0.50 No.
management services,
with the following
required elements:
Multiple (two or
more) chronic
conditions expected
to last at least 12
months, or until the
death of the
patient, chronic
conditions place the
patient at
significant risk of
death, acute
exacerbation/
decompensation, or
functional decline,
establishment or
substantial revision
of a comprehensive
care plan, moderate
or high complexity
medical decision
making; 60 minutes
of clinical staff
time directed by a
physician or other
qualified health
care professional,
per calendar month;
each additional 30
minutes of clinical
staff time directed
by a physician or
other qualified
health care
professional, per
calendar month.
G0416............ Surgical pathology, 3.09.............. 4.00 3.60 No.
gross and
microscopic
examinations, for
prostate needle
biopsy, any method.
GDDD1............ Resource-intensive NEW............... .............. 0.48 No.
services for
patients for whom
the use of
specialized mobility-
assistive technology
(such as adjustable
height chairs or
tables, patient
lift, and adjustable
padded leg supports)
is medically
necessary and used
during the provision
of an office/
outpatient E/M visit
(Add-on code, list
separately in
addition to primary
procedure).
GMMM1............ Moderate sedation NEW............... .............. 0.10 No.
services provided by
the same physician
or other qualified
health care
professional
performing a
gastrointestinal
endoscopic service
(excluding biliary
procedures) that the
sedation supports,
requiring the
presence of an
independent trained
observer to assist
in the monitoring of
the patient's level
of consciousness and
physiological
status; initial 15
minutes of intra-
service time.
GPPP1............ Initial psychiatric NEW............... .............. 1.59 No.
collaborative care
management, first 70
minutes in the first
calendar month of
behavioral health
care manager
activities, in
consultation with a
psychiatric
consultant, and
directed by the
treating physician
or other qualified
health care
professional.
GPPP2............ Subsequent NEW............... .............. 1.42 No.
psychiatric
collaborative care
management, first 60
minutes in a
subsequent month of
behavioral health
care manager
activities, in
consultation with a
psychiatric
consultant, and
directed by the
treating physician
or other qualified
health care
professional.
GPPP3............ Initial or subsequent NEW............... .............. 0.71 No.
psychiatric
collaborative care
management, each
additional 30
minutes in a
calendar month of
behavioral health
care manager
activities, in
consultation with a
psychiatric
consultant, and
directed by the
treating physician
or other qualified
health care
professional.
GPPP6............ Cognition and NEW............... .............. 3.30 No.
functional
assessment using
standardized
instruments with
development of
recorded care plan
for the patient with
cognitive
impairment, history
obtained from
patient and/or
caregiver, in office
or other outpatient
setting or home or
domiciliary or rest
home.
GPPP7............ Comprehensive NEW............... .............. 0.87 No.
assessment of and
care planning for
patients requiring
chronic care
management services
(billed separately
from monthly care
management services).
GPPPX............ Care management NEW............... .............. 0.61 No.
services for
behavioral health
conditions, at least
20 minutes of
clinical staff time,
directed by a
physician or other
qualified health
care professional
time, per calendar
month.
GTTT1............ Telehealth NEW............... .............. 4.00 No.
consultation,
critical care,
physicians typically
spend 60 minutes
communicating with
the patient via
telehealth (initial).
GTTT2............ Telehealth NEW............... .............. 3.86 No.
consultation,
critical care,
physicians typically
spend 50 minutes
communicating with
the patient via
telehealth
(subsequent).
----------------------------------------------------------------------------------------------------------------
[[Page 46278]]
Table 24--CY 2016 Proposed Codes With Direct PE Input Recommendations
Accepted Without Refinement
------------------------------------------------------------------------
HCPCS code Description
------------------------------------------------------------------------
00740............................... Anesth upper gi visualize.
00810............................... Anesth low intestine scope.
10030............................... Guide cathet fluid drainage.
11730............................... Removal of nail plate.
19298............................... Place breast rad tube/caths.
20245............................... Bone biopsy excisional.
20550............................... Inj tendon sheath/ligament.
20552............................... Inj trigger point 1/2 muscl.
20553............................... Inject trigger points 3/>.
20982............................... Ablate bone tumor(s) perq.
20983............................... Ablate bone tumor(s) perq.
22510............................... Perq cervicothoracic inject.
22511............................... Perq lumbosacral injection.
22512............................... Vertebroplasty addl inject.
22513............................... Perq vertebral augmentation.
22514............................... Perq vertebral augmentation.
22515............................... Perq vertebral augmentation.
22526............................... Idet single level.
22527............................... Idet 1 or more levels.
228X1............................... Insj stablj dev w/dcmprn.
228X4............................... Insj stablj dev w/o dcmprn.
28289............................... Repair hallux rigidus.
28292............................... Correction of bunion.
28296............................... Correction of bunion.
28297............................... Correction of bunion.
28298............................... Correction of bunion.
28299............................... Correction of bunion.
282X1............................... Corrj halux rigdus w/implt.
31615............................... Visualization of windpipe.
31622............................... Dx bronchoscope/wash.
31623............................... Dx bronchoscope/brush.
31624............................... Dx bronchoscope/lavage.
31625............................... Bronchoscopy w/biopsy(s).
31626............................... Bronchoscopy w/markers.
31627............................... Navigational bronchoscopy.
31628............................... Bronchoscopy/lung bx each.
31629............................... Bronchoscopy/needle bx each.
31632............................... Bronchoscopy/lung bx addl.
31633............................... Bronchoscopy/needle bx addl.
31634............................... Bronch w/balloon occlusion.
31635............................... Bronchoscopy w/fb removal.
31645............................... Bronchoscopy clear airways.
31646............................... Bronchoscopy reclear airway.
31652............................... Bronch ebus samplng 1/2 node.
31653............................... Bronch ebus samplng 3/> node.
31654............................... Bronch ebus ivntj perph les.
32405............................... Percut bx lung/mediastinum.
32550............................... Insert pleural cath.
32553............................... Ins mark thor for rt perq.
333X3............................... Perq clsr tcat l atr apndge.
334X1............................... Valvuloplasty aortic valve.
334X2............................... Valvuloplasty aortic valve.
35471............................... Repair arterial blockage.
35472............................... Repair arterial blockage.
35475............................... Repair arterial blockage.
35476............................... Repair venous blockage.
36010............................... Place catheter in vein.
36140............................... Establish access to artery.
36147............................... Access av dial grft for eval.
36148............................... Access av dial grft for proc.
36200............................... Place catheter in aorta.
36221............................... Place cath thoracic aorta.
36222............................... Place cath carotid/inom art.
36223............................... Place cath carotid/inom art.
36224............................... Place cath carotid art.
36225............................... Place cath subclavian art.
36226............................... Place cath vertebral art.
36227............................... Place cath xtrnl carotid.
36228............................... Place cath intracranial art.
36245............................... Ins cath abd/l-ext art 1st.
36246............................... Ins cath abd/l-ext art 2nd.
36247............................... Ins cath abd/l-ext art 3rd.
36248............................... Ins cath abd/l-ext art addl.
36251............................... Ins cath ren art 1st unilat.
36252............................... Ins cath ren art 1st bilat.
36253............................... Ins cath ren art 2nd+ unilat.
36254............................... Ins cath ren art 2nd+ bilat.
36481............................... Insertion of catheter vein.
36555............................... Insert non-tunnel cv cath.
36557............................... Insert tunneled cv cath.
36558............................... Insert tunneled cv cath.
36560............................... Insert tunneled cv cath.
36561............................... Insert tunneled cv cath.
36563............................... Insert tunneled cv cath.
36565............................... Insert tunneled cv cath.
36566............................... Insert tunneled cv cath.
36568............................... Insert picc cath.
36570............................... Insert picvad cath.
36571............................... Insert picvad cath.
36576............................... Repair tunneled cv cath.
36578............................... Replace tunneled cv cath.
36581............................... Replace tunneled cv cath.
36582............................... Replace tunneled cv cath.
36583............................... Replace tunneled cv cath.
36585............................... Replace picvad cath.
36590............................... Removal tunneled cv cath.
36870............................... Percut thrombect av fistula.
369X7............................... Balo angiop ctr dialysis seg.
369X8............................... Stent plmt ctr dialysis seg.
369X9............................... Dialysis circuit embolj.
37183............................... Remove hepatic shunt (tips).
37184............................... Prim art m-thrmbc 1st vsl.
37185............................... Prim art m-thrmbc sbsq vsl.
37186............................... Sec art thrombectomy add-on.
37187............................... Venous mech thrombectomy.
37188............................... Venous m-thrombectomy add-on.
37191............................... Ins endovas vena cava filtr.
37192............................... Redo endovas vena cava filtr.
37193............................... Rem endovas vena cava filter.
37197............................... Remove intrvas foreign body.
37220............................... Iliac revasc.
37221............................... Iliac revasc w/stent.
37222............................... Iliac revasc add-on.
37223............................... Iliac revasc w/stent add-on.
37224............................... Fem/popl revas w/tla.
37225............................... Fem/popl revas w/ather.
37226............................... Fem/popl revasc w/stent.
37227............................... Fem/popl revasc stnt & ather.
37228............................... Tib/per revasc w/tla.
37229............................... Tib/per revasc w/ather.
37230............................... Tib/per revasc w/stent.
37231............................... Tib/per revasc stent & ather.
37232............................... Tib/per revasc add-on.
37233............................... Tibper revasc w/ather add-on.
37234............................... Revsc opn/prq tib/pero stent.
37235............................... Tib/per revasc stnt & ather.
37236............................... Open/perq place stent 1st.
37237............................... Open/perq place stent ea add.
37238............................... Open/perq place stent same.
37239............................... Open/perq place stent ea add.
37241............................... Vasc embolize/occlude venous.
37242............................... Vasc embolize/occlude artery.
37243............................... Vasc embolize/occlude organ.
37244............................... Vasc embolize/occlude bleed.
37252............................... Intrvasc us noncoronary 1st.
37253............................... Intrvasc us noncoronary addl.
372X2............................... Trluml balo angiop addl art.
372X4............................... Trluml balo angiop addl vein.
43200............................... Esophagoscopy flexible brush.
43201............................... Esoph scope w/submucous inj.
43202............................... Esophagoscopy flex biopsy.
43206............................... Esoph optical endomicroscopy.
43213............................... Esophagoscopy retro balloon.
43215............................... Esophagoscopy flex remove fb.
43216............................... Esophagoscopy lesion removal.
43217............................... Esophagoscopy snare les remv.
43220............................... Esophagoscopy balloon <30 mm.
43226............................... Esoph endoscopy dilation.
43227............................... Esophagoscopy control bleed.
43229............................... Esophagoscopy lesion ablate.
43231............................... Esophagoscop ultrasound exam.
43232............................... Esophagoscopy w/us needle bx.
43235............................... Egd diagnostic brush wash.
43236............................... Uppr gi scope w/submuc inj.
43239............................... Egd biopsy single/multiple.
43245............................... Egd dilate stricture.
43247............................... Egd remove foreign body.
43248............................... Egd guide wire insertion.
43249............................... Esoph egd dilation <30 mm.
43250............................... Egd cautery tumor polyp.
43251............................... Egd remove lesion snare.
43252............................... Egd optical endomicroscopy.
43255............................... Egd control bleeding any.
43270............................... Egd lesion ablation.
432X1............................... Laps esophgl sphnctr agmnt.
432X2............................... Rmvl esophgl sphnctr dev.
43450............................... Dilate esophagus 1/mult pass.
43453............................... Dilate esophagus.
44380............................... Small bowel endoscopy br/wa.
44381............................... Small bowel endoscopy br/wa.
44382............................... Small bowel endoscopy.
44385............................... Endoscopy of bowel pouch.
44386............................... Endoscopy bowel pouch/biop.
44388............................... Colonoscopy thru stoma spx.
44389............................... Colonoscopy with biopsy.
44390............................... Colonoscopy for foreign body.
44391............................... Colonoscopy for bleeding.
44392............................... Colonoscopy & polypectomy.
44394............................... Colonoscopy w/snare.
44401............................... Colonoscopy with ablation.
44404............................... Colonoscopy w/injection.
44405............................... Colonoscopy w/dilation.
45303............................... Proctosigmoidoscopy dilate.
45305............................... Proctosigmoidoscopy w/bx.
[[Page 46279]]
45307............................... Proctosigmoidoscopy fb.
45308............................... Proctosigmoidoscopy removal.
45309............................... Proctosigmoidoscopy removal.
45315............................... Proctosigmoidoscopy removal.
45317............................... Proctosigmoidoscopy bleed.
45320............................... Proctosigmoidoscopy ablate.
45332............................... Sigmoidoscopy w/fb removal.
45333............................... Sigmoidoscopy & polypectomy.
45334............................... Sigmoidoscopy for bleeding.
45335............................... Sigmoidoscopy w/submuc inj.
45338............................... Sigmoidoscopy w/tumr remove.
45340............................... Sig w/tndsc balloon dilation.
45346............................... Sigmoidoscopy w/ablation.
45350............................... Sgmdsc w/band ligation.
45378............................... Diagnostic colonoscopy.
45379............................... Colonoscopy w/fb removal.
45380............................... Colonoscopy and biopsy.
45381............................... Colonoscopy submucous njx.
45382............................... Colonoscopy w/control bleed.
45384............................... Colonoscopy w/lesion removal.
45385............................... Colonoscopy w/lesion removal.
45386............................... Colonoscopy w/balloon dilat.
45388............................... Colonoscopy w/ablation.
45398............................... Colonoscopy w/band ligation.
47000............................... Needle biopsy of liver.
47382............................... Percut ablate liver rf.
47383............................... Perq abltj lvr cryoablation.
49405............................... Image cath fluid colxn visc.
49406............................... Image cath fluid peri/retro.
49407............................... Image cath fluid trns/vgnl.
49411............................... Ins mark abd/pel for rt perq.
49418............................... Insert tun ip cath perc.
49440............................... Place gastrostomy tube perc.
49441............................... Place duod/jej tube perc.
49442............................... Place cecostomy tube perc.
49446............................... Change g-tube to g-j perc.
50200............................... Renal biopsy perq.
50382............................... Change ureter stent percut.
50384............................... Remove ureter stent percut.
50385............................... Change stent via transureth.
50386............................... Remove stent via transureth.
50387............................... Change nephroureteral cath.
50430............................... Njx px nfrosgrm &/urtrgrm.
50432............................... Plmt nephrostomy catheter.
50433............................... Plmt nephroureteral catheter.
50434............................... Convert nephrostomy catheter.
50592............................... Perc rf ablate renal tumor.
50593............................... Perc cryo ablate renal tum.
50693............................... Plmt ureteral stent prq.
50694............................... Plmt ureteral stent prq.
50695............................... Plmt ureteral stent prq.
51702............................... Insert temp bladder cath.
51703............................... Insert bladder cath complex.
51720............................... Treatment of bladder lesion.
51784............................... Anal/urinary muscle study.
55700............................... Biopsy of prostate.
57155............................... Insert uteri tandem/ovoids.
58558............................... Hysteroscopy biopsy.
58559............................... Hysteroscopy lysis.
58560............................... Hysteroscopy resect septum.
58561............................... Hysteroscopy remove myoma.
58563............................... Hysteroscopy ablation.
585X1............................... Laps abltj uterine fibroids.
630X1............................... Ndsc dcmprn 1 ntrspc lumbar.
66720............................... Destruction ciliary body.
67101............................... Repair detached retina.
67105............................... Repair detached retina.
69300............................... Revise external ear.
767X1............................... Us abdl aorta screen aaa.
77332............................... Radiation treatment aid(s).
77333............................... Radiation treatment aid(s).
77334............................... Radiation treatment aid(s).
77470............................... Special radiation treatment.
77600............................... Hyperthermia treatment.
77605............................... Hyperthermia treatment.
77610............................... Hyperthermia treatment.
77615............................... Hyperthermia treatment.
91110............................... Gi tract capsule endoscopy.
91111............................... Esophageal capsule endoscopy.
92132............................... Cmptr ophth dx img ant segmt.
92133............................... Cmptr ophth img optic nerve.
92134............................... Cptr ophth dx img post segmt.
92235............................... Eye exam with photos.
92240............................... Icg angiography.
92250............................... Eye exam with photos.
922X4............................... Fluorescein icg angiography.
92960............................... Cardioversion electric ext.
93312............................... Echo transesophageal.
93314............................... Echo transesophageal.
93451............................... Right heart cath.
93452............................... Left hrt cath w/ventrclgrphy.
93453............................... R&l hrt cath w/ventriclgrphy.
93454............................... Coronary artery angio s&i.
93455............................... Coronary art/grft angio s&i.
93456............................... R hrt coronary artery angio.
93457............................... R hrt art/grft angio.
93458............................... L hrt artery/ventricle angio.
93459............................... L hrt art/grft angio.
93460............................... R&l hrt art/ventricle angio.
93461............................... R&l hrt art/ventricle angio.
93464............................... Exercise w/hemodynamic meas.
93505............................... Biopsy of heart lining.
93566............................... Inject r ventr/atrial angio.
93567............................... Inject suprvlv aortography.
93568............................... Inject pulm art hrt cath.
935X1............................... Perq transcath cls mitral.
935X2............................... Perq transcath cls aortic.
93642............................... Electrophysiology evaluation.
93644............................... Electrophysiology evaluation.
95144............................... Antigen therapy services.
95165............................... Antigen therapy services.
95957............................... Eeg digital analysis.
961X0............................... Pt-focused hlth risk assmt.
961X1............................... Caregiver health risk assmt.
96440............................... Chemotherapy intracavitary.
96931............................... Rcm celulr subcelulr img skn.
96932............................... Rcm celulr subcelulr img skn.
97X64............................... Pt re-eval est plan care.
97X68............................... Ot re-eval est plan care.
991X1............................... Mod sed same phys/qhp <5 yrs.
991X2............................... Mod sed same phys/qhp 5/>yrs.
991X5............................... Mod sed oth phys/qhp 5/>yrs.
G0341............................... Percutaneous islet celltrans.
GMMM1
------------------------------------------------------------------------
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[GRAPHIC] [TIFF OMITTED] TP15JY16.021
[[Page 46302]]
[GRAPHIC] [TIFF OMITTED] TP15JY16.022
[[Page 46303]]
[GRAPHIC] [TIFF OMITTED] TP15JY16.023
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[GRAPHIC] [TIFF OMITTED] TP15JY16.024
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[GRAPHIC] [TIFF OMITTED] TP15JY16.025
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[GRAPHIC] [TIFF OMITTED] TP15JY16.026
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[GRAPHIC] [TIFF OMITTED] TP15JY16.027
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[GRAPHIC] [TIFF OMITTED] TP15JY16.028
[[Page 46309]]
[GRAPHIC] [TIFF OMITTED] TP15JY16.029
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[GRAPHIC] [TIFF OMITTED] TP15JY16.030
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[GRAPHIC] [TIFF OMITTED] TP15JY16.031
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[GRAPHIC] [TIFF OMITTED] TP15JY16.032
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[GRAPHIC] [TIFF OMITTED] TP15JY16.033
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[GRAPHIC] [TIFF OMITTED] TP15JY16.034
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[GRAPHIC] [TIFF OMITTED] TP15JY16.035
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[GRAPHIC] [TIFF OMITTED] TP15JY16.036
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[GRAPHIC] [TIFF OMITTED] TP15JY16.038
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[GRAPHIC] [TIFF OMITTED] TP15JY16.039
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[GRAPHIC] [TIFF OMITTED] TP15JY16.040
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[GRAPHIC] [TIFF OMITTED] TP15JY16.041
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[GRAPHIC] [TIFF OMITTED] TP15JY16.042
[[Page 46323]]
[GRAPHIC] [TIFF OMITTED] TP15JY16.043
[[Page 46324]]
[GRAPHIC] [TIFF OMITTED] TP15JY16.044
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[GRAPHIC] [TIFF OMITTED] TP15JY16.045
[[Page 46326]]
[GRAPHIC] [TIFF OMITTED] TP15JY16.046
[[Page 46327]]
[GRAPHIC] [TIFF OMITTED] TP15JY16.047
[[Page 46328]]
[GRAPHIC] [TIFF OMITTED] TP15JY16.048
[[Page 46329]]
[GRAPHIC] [TIFF OMITTED] TP15JY16.049
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[GRAPHIC] [TIFF OMITTED] TP15JY16.050
[[Page 46331]]
[GRAPHIC] [TIFF OMITTED] TP15JY16.051
[[Page 46332]]
[GRAPHIC] [TIFF OMITTED] TP15JY16.052
[[Page 46333]]
[GRAPHIC] [TIFF OMITTED] TP15JY16.053
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[GRAPHIC] [TIFF OMITTED] TP15JY16.054
[[Page 46335]]
[GRAPHIC] [TIFF OMITTED] TP15JY16.055
[[Page 46336]]
[GRAPHIC] [TIFF OMITTED] TP15JY16.056
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[GRAPHIC] [TIFF OMITTED] TP15JY16.057
[[Page 46338]]
[GRAPHIC] [TIFF OMITTED] TP15JY16.058
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[GRAPHIC] [TIFF OMITTED] TP15JY16.059
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[GRAPHIC] [TIFF OMITTED] TP15JY16.060
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[GRAPHIC] [TIFF OMITTED] TP15JY16.061
[[Page 46342]]
[GRAPHIC] [TIFF OMITTED] TP15JY16.062
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[GRAPHIC] [TIFF OMITTED] TP15JY16.063
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[GRAPHIC] [TIFF OMITTED] TP15JY16.064
[[Page 46345]]
[GRAPHIC] [TIFF OMITTED] TP15JY16.065
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[[Page 46365]]
[GRAPHIC] [TIFF OMITTED] TP15JY16.085
[[Page 46366]]
[GRAPHIC] [TIFF OMITTED] TP15JY16.086
[[Page 46367]]
[GRAPHIC] [TIFF OMITTED] TP15JY16.087
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[GRAPHIC] [TIFF OMITTED] TP15JY16.088
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[GRAPHIC] [TIFF OMITTED] TP15JY16.089
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[[Page 46376]]
Table 26--Invoices Received for Existing Direct PE Inputs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated non-
facility
allowed
CPT/HCPCS codes Item name CMS code Current price Updated price Percent Number of services for
change invoices HCPCS codes
using this
item
--------------------------------------------------------------------------------------------------------------------------------------------------------
19030, 19081, 19082, 19281, 19282, room, digital EL013 168,214.00 362,935.00 116 10 2,294,862
19283, 19284, 77053, 77054, 770X1, mammography.
770X2, 770X3.
31575, 31576, 31577, 31578, 31579, video system, ES031 33,232.50 15,045.00 -55 1 1,497,130
317X1, 317X2, 317X3, 31580, 31584, endoscopy (processor,
31587, 315X1, 315X2, 315X3, 315X4, digital capture,
315X5, 315X6, 190+ other codes. monitor, printer,
cart).
58555, 58562, 58563, 58565......... endoscope, rigid, ES009 4,990.50 6,207.50 24 1 672
hysteroscopy.
88323, 88355, 88380, 88381......... stain, eosin.......... SL201 0.04 0.07 55 5 45,393
88360, 88361....................... Antibody Estrogen SL493 3.19 14.00 339 4 216,208
Receptor monoclonal.
91110.............................. kit, capsule endoscopy SA005 450.00 520.00 16 1 30,464
w-application
supplies (M2A).
91110, 91111....................... video system, capsule ES029 17,000.00 12,450.00 -27 1 30,586
endoscopy (software,
computer, monitor,
printer).
91111.............................. kit, capsule, ESO, SA094 450.00 472.80 5 1 122
endoscopy w-
application supplies
(ESO).
95145, 95146, 95148, 95149......... antigen, venom........ SH009 16.67 20.14 21 4 50,772
95147, 95148, 95149................ antigen, venom, tri- SH010 30.22 44.05 46 3 37,955
vespid.
122 codes.......................... light source, xenon... EQ167 6,723.33 7,000.00 4 1 2,149,616
59 codes........................... fiberscope, flexible, ES020 6,301.93 4,250.00 -33 1 581,924
rhinolaryngoscopy.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Table 27--Invoices Received For New Direct PE Inputs
----------------------------------------------------------------------------------------------------------------
Estimated non-
facility
allowed
CPT/HCPCS codes Item name CMS code Average price Number of services for
invoices HCPCS codes
using this
item
----------------------------------------------------------------------------------------------------------------
31575, 31579, 317X3, 31580, rhinolaryngoscope ES063 8,000.00 1 541,537
31584, 31587, 315X1, 315X2, , flexible,
315X3, 315X4, 315X5, 315X6. video, non-
channeled.
31576, 31577, 31578, 317X1, rhinolaryngoscope ES064 9,000.00 1 756
317X2. , flexible,
video, channeled.
31576, 31577, 31578........... Disposable biopsy SD318 26.84 1 574
forceps.
31579......................... stroboscopy ES065 19,100.00 1 54,466
system.
317X3......................... Voice SJ090 575.00 1 99
Augmentation Gel.
36X41......................... Claravein Kit.... SA122 890.00 1 264
36X41, 364X2.................. Sotradecol SH108 110.20 1 528
Sclerosing Agent.
55700......................... Biopsy Guide..... EQ375 7,000.00 0 85,731
58558......................... BLADE INCSR 2.9MM SF059 599.00 1 2,677
58558......................... Hysteroscopic EQ378 14,698.38 1 2,677
fluid management
system.
58558......................... Hysteroscopic EQ379 19,857.50 1 2,677
Resection System.
770X1, 770X2, 770X3........... PACS Mammography ED054 103,616.47 8 2,274,249
Workstation.
70540, 70542, 70543; over 400 Professional PACS ED053 14,616.93 9 32,571,650
additional codes. Workstation.
[[Page 46377]]
77332......................... knee wedge/foot EQ376 3,290.00 1 48,831
block system.
77333......................... Thermoplastic SD321 23.90 1 3,493
tissue bolus
30X30X0.3cm.
77333......................... water bath, EP120 2,350.00 1 3,493
digital control.
77333, 77334.................. Supine Breast/ EQ377 5,773.15 1 290,969
Lung Board.
77334......................... Urethane Foaming SL519 53.50 1 287,476
Agent.
88184, 88185.................. flow cytometry EQ380 14,000.00 1 1,680,252
analytics
software.
95144, 95165.................. antigen vial SK127 1.50 2 6,464,311
transport
envelope.
961X1......................... Beck Depression SK128 2.26 1 1
Inventory,
Second Edition
(BDI-II).
96416......................... IV infusion pump, EQ381 2384.45 1 117,248
ambulatory.
96931, 96932.................. Imaging Tray..... SA121 34.75 1 5
96931, 96932.................. adhesive ruler... SK125 9.95 1 5
96931, 96932, 96934, 96935.... reflectance ES056 98,500.00 1 9
confocal imaging
system.
97X66, 97X67, 97X68........... environmental ES057 25,000.00 1 115,107
module--bathroom.
97X66, 97X67.................. kit, vision...... ES058 410.00 1 86,912
GDDD1......................... patient lift EF045 2,824.33 3 15,115,789
system.
GDDD1......................... wheelchair EF046 875.92 3 15,115,789
accessible scale.
GDDD1......................... leg positioning EF047 1,076.50 3 15,115,789
system.
----------------------------------------------------------------------------------------------------------------
III. Other Provisions of the Proposed Rule for PFS
A. Chronic Care Management (CCM) and Transitional Care Management (TCM)
Supervision Requirements in Rural Health Clinics (RHCs) and Federally
Qualified Health Centers (FQHCs)
In the CY 2016 PFS final rule with comment period (80 FR 71080
through 71088), we finalized policies for payment of CCM services in
RHCs and FQHCs. Payment for CCM services in RHCs and FQHCs was
effective beginning on January 1, 2016, for RHCs and FQHCs that furnish
a minimum of 20 minutes of qualifying CCM services during a calendar
month to patients with multiple (two or more) chronic conditions that
are expected to last at least 12 months or until the death of the
patient, and that would place the patient at significant risk of death,
acute exacerbation/decompensation, or functional decline. Payment is
made when CPT code 99490 is billed alone or with other payable services
on a RHC or FQHC claim, and the rate is based on the PFS national
average non-facility payment rate. The requirement that RHC or FQHC
services be furnished face-to-face was waived for CCM services
furnished to a RHC or FQHC patient because CCM services are not
required to be furnished face-to-face.
Medicare payment for TCM services furnished by a RHC or FQHC
practitioner was effective January 1, 2013, consistent with the
effective date of payment for TCM services under the PFS (77 FR 68978
through 68994; also, see CMS-Pub. 100-02, Medicare Benefit Policy
Manual, chapter 13, section 110.4).
TCM services are billable only when furnished within 30 days of the
date of the patient's discharge from a hospital (including outpatient
observation or partial hospitalization), skilled nursing facility, or
community mental health center. Communication (direct contact,
telephone, or electronic) with the patient or caregiver must commence
within 2 business days of discharge, and a face-to-face visit must
occur within 14 days of discharge for moderate complexity decision
making (CPT code 99495), or within 7 days of discharge for high
complexity decision making (CPT code 99496). The TCM visit is billed on
the day that the TCM visit takes place, and only one TCM visit may be
paid per beneficiary for services furnished during that 30 day post-
discharge period. If the TCM visit occurs on the same day as another
billable visit, only one visit may be billed. TCM and CCM cannot be
billed during the same time period for the same patient.
In the CY 2016 PFS final rule with comment period (80 FR 71087), we
responded to comments requesting that we make an exception to the
supervision requirements for auxiliary staff furnishing CCM and TCM
services incident to physician services in RHCs and FQHCs (80 FR
71087). Auxiliary staff in RHCs and FQHCs furnish services incident to
a RHC or FQHC visit and include nurses, medical assistants, and other
clinical staff who work under the direct supervision of a RHC or FQHC
practitioner. The commenters suggested that the regulatory language be
amended to be consistent with the provision in Sec. 410.26(b)(5) for
CCM and TCM services under the PFS, which states that services and
supplies furnished incident to CCM and TCM services can be furnished
under general supervision of the physician (or other practitioner) when
they are provided by clinical staff. It further specifies that the
physician (or other practitioner) supervising the auxiliary personnel
need not be the same physician (or other practitioner) upon whose
professional service the incident to service is based, but only the
supervising physician (or other practitioner) may bill Medicare for
incident to services. We responded that due to the differences between
physician offices and RHCs and FQHCs in their models of care and
payment structures, we believe that the direct supervision requirement
for services furnished by auxiliary staff is appropriate for RHCs and
FQHCs, but that we would consider changing this in future rulemaking if
RHCs and FQHCs find that requiring direct supervision presents a
barrier to furnishing CCM services.
Since payment for CCM in RHCs and FQHCs began on January 1, 2016,
some RHCs and FQHCs have informed us that, in their view, the direct
supervision requirement for auxiliary
[[Page 46378]]
staff has limited their ability to furnish CCM services. Specifically,
these RHCs and FQHCs have stated that the direct supervision
requirement has prevented them from entering into contracts with third
party companies to provide CCM services, especially during hours that
they are not open, and that they are unable to meet the CCM
requirements within their current staffing and budget constraints.
To bill for CCM services, RHCs and FQHCs must ensure that there is
access to care management services on a 24 hour a day, 7 day a week
basis. This includes providing the patient with a means to make timely
contact with RHC or FQHC practitioners who have access to the patient's
electronic care plan to address his or her urgent chronic care needs.
The RHC or FQHC must ensure the care plan is available electronically
at all times to anyone within the RHC or FQHC who is providing CCM
services.
Once the RHC or FQHC practitioner has initiated CCM services and
the patient has consented to receiving this service, CCM services can
be furnished by a RHC or FQHC practitioner, or by auxiliary personnel,
as defined in Sec. 410.26(a)(1), which includes nurses, medical
assistants, and other staff working under physician supervision who
meet the requirements to provide incident to services. Auxiliary
personnel in RHCs and FQHCs must furnish services under direct
supervision, which requires that a RHC or FQHC practitioner be present
in the RHC or FQHC and immediately available to furnish assistance and
direction. The RHC or FQHC practitioner does not need to be present in
the room when the service is furnished.
Although many RHCs and FQHCs prefer to furnish CCM and TCM services
utilizing existing staff, some RHCs and FQHCs would like to contract
with a third party to furnish aspects of their CCM and TCM services,
but cannot do so because of the direct supervision requirement. Without
the ability to contract with a third party, these RHCs and FQHCs have
stated that they find it difficult to meet the CCM requirements for 24
hours a day, 7 days a week access to services.
To enable RHCs and FQHCs to effectively contract with third parties
to furnish aspects of CCM and TCM services, we propose to revise Sec.
405.2413(a)(5) and Sec. 405.2415(a)(5) to state that services and
supplies furnished incident to TCM and CCM services can be furnished
under general supervision of a RHC or FQHC practitioner. The proposed
exception to the direct supervision requirement would apply only to
auxiliary personnel furnishing TCM or CCM incident to services, and
would not apply to any other RHC or FQHC services. The proposed
revisions for CCM and TCM services and supplies furnished by RHCs and
FQHCs are consistent with Sec. 410.26(b)(5), which allows CCM and TCM
services and supplies to be furnished by clinical staff under general
supervision when billed under the PFS.
B. FQHC-Specific Market Basket
1. Background
Section 10501(i)(3)(A) of the Affordable Care Act (Pub. L. 111-148
and Pub. L. 111-152) added section 1834(o) of the Act to establish a
payment system for the costs of FQHC services under Medicare Part B
based on prospectively set rates. In the Prospective Payment System
(PPS) for FQHC Final Rule published in the May 2, 2014 Federal Register
(79 FR 25436), we implemented a methodology and payment rates for the
FQHC PPS. The FQHC PPS base payment rate was determined using FQHC cost
report and claims data and was effective for FQHC payments from October
1, 2014, through December 31, 2015 (implementation year). The adjusted
base payment rate for the implementation year was $158.85 (79 FR
25455). When calculating the FQHC PPS payment, the base payment rate is
multiplied by the FQHC geographic adjustment factor (GAF) based on the
location of the FQHC, and adjusted for new patients or when an initial
preventive physical examination or annual wellness visit are furnished.
Beginning on October 1, 2014, FQHCs began to transition to the FQHC PPS
based on their cost reporting periods. As of January 1, 2016, all FQHCs
are paid under the FQHC PPS.
Section 1834(o)(2)(B)(ii) of the Act requires that the payment for
the first year after the implementation year be increased by the
percentage increase in the MEI. Therefore, in CY 2016, the FQHC PPS
base payment rate was increased by the MEI. The MEI was based on 2006
data from the American Medical Association (AMA) for self-employed
physicians and was used in the PFS Sustainable Growth Rate (SGR)
formula to determine the conversion factor for physician service
payments. (See the CY 2014 PFS final rule (78 FR 74264) for a complete
discussion of the 2006-based MEI). Section 1834(o)(2)(B)(ii) of the Act
also requires that beginning in CY 2017, the FQHC PPS base payment rate
will be increased by the percentage increase in a market basket of FQHC
goods and services, or if such an index is not available, by the
percentage increase in the MEI.
For CY 2017, we are proposing to create a 2013-based FQHC market
basket. The proposed market basket uses Medicare cost report (MCR) data
submitted by freestanding FQHCs. In the following discussion, we
provide an overview of the proposed market basket and describe the
methodologies used to determine the cost categories, cost weights, and
price proxies. In addition, we compare the growth rates of the proposed
FQHC market basket to the growth rates of the MEI.
2. Overview of the FQHC Market Basket
The 2013-based FQHC market basket is a fixed-weight, Laspeyres-type
price index. A Laspeyres price index measures the change in price, over
time, of the same mix of goods and services purchased in the base
period. Any changes in the quantity or mix of goods and services (that
is, intensity) purchased over time relative to a base period are not
measured.
The index itself is constructed in three steps. First, a base
period is selected (in this proposed rule, the base period is CY 2013),
total base period costs are estimated for a set of mutually exclusive
and exhaustive cost categories, and the proportion of total costs that
each cost category represents is calculated. These proportions are
called cost weights. Second, each cost category is matched to an
appropriate price or wage variable, referred to as a price proxy. These
price proxies are derived from publicly available statistical series
that are published on a consistent schedule (preferably at least on a
quarterly basis). Finally, the cost weight for each cost category is
multiplied by the established price proxy index level. The sum of these
products (that is, the cost weights multiplied by their price levels)
for all cost categories yields the composite index level of the market
basket for the given time period. Repeating this step for other periods
produces a series of market basket levels over time. Dividing the
composite index level of one period by the composite index level for an
earlier period produces a rate of growth in the input price index over
that timeframe.
As previously noted, the market basket is described as a fixed-
weight index because it represents the change in price over time of a
constant mix (quantity and intensity) of goods and services needed to
furnish FQHC services. The effects on total costs resulting from
changes in the mix of goods and services purchased subsequent to the
base period are not
[[Page 46379]]
measured. For example, a FQHC hiring more nurses to accommodate the
needs of patients would increase the volume of goods and services
purchased by the FQHC, but would not be factored into the price change
measured by a fixed-weight FQHC market basket. Only when the index is
rebased would changes in the quantity and intensity be captured, with
those changes being reflected in the cost weights. Therefore, we rebase
the market baskets periodically so that the cost weights reflect a
current mix of goods and services purchased (FQHC inputs) to furnish
FQHC services.
3. Creating a FQHC Market Basket
In 2015, we began researching the possibility of creating a FQHC
market basket that would be used in place of the MEI to update the FQHC
PPS base payment rate annually. An FQHC market basket should reflect
the cost structures of FQHCs while the MEI reflects the cost structures
of self-employed physician offices. At the time of implementation of
the FQHC PPS, a FQHC market basket had not been developed, and
therefore, the law stipulated that the FQHC PPS base payment rate be
updated by the MEI for the first year after implementation (CY 2016).
In subsequent years, the FQHC PPS base payment rate should be annually
updated by a FQHC market basket, if available.
The MEI cost weights were derived from data collected by the AMA on
the Physician Practice Expense Information Survey (PPIS), since
physicians, unlike other Medicare providers, are not required to
complete and submit a Medicare Cost Report. FQHCs submit expense data
annually on the Medicare Cost Report form CMS-222-92 (OMB No: 0938-
0107), ``Independent Rural Health Clinic and Freestanding Federally
Qualified Health Center Cost Report''; therefore, we were able to
estimate relative cost weights specific to FQHCs. We define a ``major
cost weight'' as one calculated using the Medicare cost reports (for
example, FQHC practitioner compensation). However, the Medicare cost
report data allows multiple methods for reporting detailed expenses,
either in detailed cost center lines or more broadly reported in
general categories of expenses. An alternative data source is used to
disaggregate further residual costs that could not be classified into a
major cost category directly using only the Medicare Cost Report data.
We estimated the cost weights for each year 2009 through 2013 and found
the cost weights from each year to be similar, which provided
confidence in the derived cost weights.
In summary, our research over the past year allowed us to evaluate
the appropriateness of using freestanding FQHC Medicare cost report
data to calculate the major cost weights for a FQHC market basket. We
believe that the proposed methodologies described below create a FQHC
market basket that reflects the cost structure of FQHCs. Therefore, we
believe that the use of this proposed 2013-based FQHC market basket to
update FQHC PPS base payment rate would more accurately reflect the
actual costs and scope of services that FQHCs furnish compared to the
2006-based MEI.
4. Development of Cost Categories and Cost Weights for the Proposed
2013-Based FQHC Market Basket
a. Use of Medicare Cost Report Data
The proposed 2013-based FQHC market basket consists of eight major
cost categories, which were derived from the CY 2013 Medicare cost
reports for freestanding FQHCs. These categories are FQHC-Practitioner
Compensation, Other Clinical Compensation, Non-Health Compensation,
Fringe Benefits, Pharmaceuticals, Fixed Capital, Moveable Capital, and
an All Other (Residual) cost category. The All Other (Residual) cost
category reflects the costs not captured in the other seven cost
categories. The CY 2013 Medicare cost reports include all FQHCs whose
cost reporting period began on or after January 1, 2013, and prior to
or on December 31, 2013. We selected CY 2013 as the base year because
the Medicare cost reports for that year were the most recent, complete
set of Medicare cost report data available for FQHCs at the time of
development of the cost share weights and proposed 2013-based FQHC
market basket. As stated above, we compared the cost share weights from
the MCR for CY 2009 through CY 2013 and the CY 2013 weights were
consistent with the weights from prior years.
We began with all FQHCs with reporting periods in CY 2013 (that is,
between and including January 1, 2013, and December 31, 2013). We then
excluded FQHCs missing ``total costs'' (that is, any FQHC that did not
report expenses on Worksheet A, Column 7, Line 62). This edit removed
83 providers from our analysis. Next, we compared the total Medicare
allowable costs (that is, total costs eligible for reimbursement under
the FQHC PPS) to total costs reported on the Medicare cost report. We
kept FQHCs whose Medicare-allowable costs accounted for 60 percent or
more of total costs to remove FQHCs whose costs were primarily driven
by services not covered under the FQHC benefit. For example, FQHCs that
reported a majority of costs for dental services were excluded from the
sample. This edit removed 33 FQHCs from our analysis. We used the
remaining Medicare cost reports to calculate the costs for the eight
major cost categories (FQHC Practitioner Compensation, Other Clinical
Compensation, Non-Health Compensation, Fringe Benefits,
Pharmaceuticals, Fixed Capital, Moveable Capital, and All Other
(Residual) costs).
The resulting 2013-based FQHC market basket cost weights reflect
Medicare allowable costs. We propose to define Medicare allowable costs
for freestanding FQHC facilities as: Worksheet A, Columns 1 and 2, cost
centers lines 1 through 51 but excluding line 20, which is professional
liability insurance (PLI). We exclude PLI costs from the total Medicare
allowable costs because FQHCs that receive section 330 grant funds also
are eligible to apply for medical malpractice coverage under Federally
Supported Health Centers Assistance Act (FSHCAA) of 1992 (Pub. L. 102-
501) and FSHCAA of 1995 (Pub. L. 104-73 amending section 224 of the
Public Health Service Act). Below we derive the eight major cost
categories.
(1) FQHC Practitioner Compensation: A FQHC practitioner is defined
as one of the following occupations: Physicians, NPs, PAs, CNMs,
Clinical Psychologist (CPs), and Clinical Social Worker (CSWs). Under
certain conditions, a FQHC visit also may be provided by qualified
practitioners of outpatient DSMT and MNT when the FQHC meets the
relevant program requirements for provision of these services. FQHC
Practitioner Compensation costs are derived as the sum of compensation
and other costs as reported on Worksheet A; columns 1 and 2; lines 1,
2, 3, 6, 7, 13, 14. The Medicare cost reports also captures ``Other''
compensation costs (the sum of costs reported on Worksheet A; columns 1
and 2; lines 9, 10, 11, and 15). We allocate a portion of these
compensation costs to FQHC Practitioner compensation by multiplying
this amount by the ratio of FQHC Practitioner compensation costs to the
sum of FQHC Practitioner compensation costs and Other Clinical
compensation costs. We believe that the assumption of distributing the
costs proportionally is reasonable since there is no additional detail
on the specific occupations these compensation costs represent. We also
include a proportion of Fringe Benefit
[[Page 46380]]
costs as described in section III.B.1.a.iv of this proposed rule.
(2) Other Clinical Compensation: Other Clinical Compensation
includes any health-related clinical staff who does not fall under the
definition of a FQHC practitioner from paragraph (1) (FQHC Practitioner
Compensation). Other Clinical Compensation costs are derived as the sum
of compensation and other costs as reported on Worksheet A; columns 1
and 2; lines 4, 5, and 8. Similar to the FQHC Practitioner
compensation, we also allocate a proportion of the ``Other'' Clinical
compensation costs by multiplying this amount by the ratio of Other
Clinical Compensation costs to the sum of FQHC Practitioner
Compensation costs and Other Clinical compensation costs. Given the
ambiguity in the costs reported on these lines, we believe that the
assumption of distributing the costs proportionally is reasonable since
there is no additional detail on the specific occupations these
compensation costs represent. We also include a proportion of Fringe
Benefit costs as described in section III.B.1.a.iv of this proposed
rule.
(3) Non-Health Compensation: Non-Health Compensation includes
compensation costs for Office Staff, Housekeeping & Maintenance, and
Pharmacy. Non-Health Compensation costs are derived as the sum of
compensation costs as reported on Worksheet A; column 1 only for lines
32 and 51; and Worksheet A; both columns 1 and 2 for line 38. We only
use the costs from column 1 for housekeeping and maintenance and
pharmacy since we believe that there are considerable costs other than
compensation that could be reported for these categories. We use the
costs from both column 1 and column 2 for office salaries (line 38)
since only salaries or compensation should be reported on this line. We
also include a proportion of Fringe Benefit costs as described in
section III.B.1.a.iv of this proposed rule.
(4) Fringe Benefits: Worksheet A; columns 1 and 2; line 45 of the
Medicare cost report captures fringe benefits and payroll tax expenses.
We proposed to estimate the fringe benefit cost weight as the fringe
benefits costs divided by total Medicare allowable costs. We propose to
allocate the Fringe Benefits cost weight to the three compensation cost
categories (FQHC practitioner compensation, other clinical
compensation, and non-health compensation) based on their relative
proportions. The fringe benefits ratio is equal to the compensation
cost weight as a percent of the sum of the compensation cost weights
for all three types of workers. These allocation ratios are 46 percent,
14 percent, and 40 percent, respectively. Therefore, we propose to
allocate 46 percent of the fringe benefits cost weight to the FQHC
practitioner cost weight, 14 percent of the fringe benefits cost weight
to the clinical compensation cost weight, and 40 percent of the fringe
benefits cost weight to the non-health compensation cost weight. Table
28 shows the three compensation category cost weights after the fringe
benefit cost weight is allocated for the proposed 2013-based FQHC
market basket.
Table 28--Compensation Category Cost Weights After Fringe Benefits
Allocation
------------------------------------------------------------------------
Before fringe After fringe
Cost category benefits benefits
allocation (%) allocation (%)
------------------------------------------------------------------------
FQHC Practitioner Compensation.......... 26.8 31.8
Other Clinical Compensation............. 8.1 9.5
Non-Health Compensation................. 23.1 27.4
Fringe Benefits (distribute to comp).... 10.7 0.0
------------------------------------------------------------------------
We believe that distributing the fringe benefit expenses reported
on line 45 using the provider-specific compensation ratios is
reasonable.
(5) Pharmaceuticals: Drugs and biologicals that are not usually
self-administered, and certain Medicare-covered preventive injectable
drugs are paid incident to a FQHC visit. Therefore, pharmaceutical
costs include the non-compensation costs reported on Worksheet A,
column 2, for the pharmacy cost center (line 51). We note that
pharmaceutical costs are not included in the MEI since pharmaceutical
costs are paid outside of the PFS.
(6) Fixed Capital: Fixed capital costs are equal to the sum of
costs for rent, interest on mortgage loans, depreciation on buildings
and fixtures, and property tax as reported on Worksheet A; columns 1
and 2; lines 26, 28, 30, and 33.
(7) Moveable Capital: Moveable capital costs are equal to the sum
of costs for depreciation of medical equipment, office equipment, and
other equipment as reported on Worksheet A; column 1 and 2; lines 19,
31, and 39.
(8) All Other (Residual): After estimating the expenses for the
seven cost categories listed above, we summed all remaining costs
together for each FQHC to come up with All Other (Residual) costs. The
costs included in the All Other (Residual) category include all costs
reported for medical supplies, transportation, allowable GME pass
through costs, facility insurance, utilities, office supplies, legal,
accounting, administrative insurance, telephone, housekeeping &
maintenance, nondescript healthcare costs, nondescript facility costs,
and nondescript administrative costs.
Although a cost weight for these categories could be obtained
directly from the costs reported in that cost center's respective line
on the cost report form, some FQHCs reported significant costs in other
(specify), or ``free form,'' lines which made it difficult to determine
the accuracy of these costs. For example, some FQHCs reported costs
only in the free form lines and not in the cost center specific lines,
while other FQHCs reported costs in both the cost center specific lines
and the free form lines. Since a majority of FQHCs used the free form
lines, relying solely on the costs reported in the cost center specific
lines for costs could lead to an inaccurate cost weights in the market
basket. For example, if a FQHC reported all other healthcare costs in
line 21 rather than breaking the healthcare costs into the detailed
cost centers (lines 17 through 20.50), then the cost weight for medical
supplies could be lower than it should be if we did not allocate the
costs reported in the free form lines to medical supplies.
Section III.B.1.b explains the method used to allocate the residual
costs to more detailed cost categories.
After we derived costs for the eight major cost categories for each
FQHC using the Medicare cost report data as previously described, we
addressed data outliers using the following steps. First,
[[Page 46381]]
we divided the costs for each of the eight categories by total Medicare
allowable costs for each FQHC. We then removed those FQHCs whose
derived cost weights fell in the top and bottom 5 percent of provider
specific derived cost weights. Five percent is the standard trim
applied for all CMS market basket cost weights. After these outliers
were removed, we summed the costs for each category across all
remaining FQHCs. We then divided this by the sum of total Medicare
allowable costs across all remaining FQHCs to obtain a cost weight for
the proposed 2013-based FQHC market basket for the given category. See
Table 29 for the resulting cost weights for these major cost categories
that we obtained from the Medicare cost reports.
Table 29--Major Cost Categories as Derived From Medicare Cost Reports
------------------------------------------------------------------------
2013 FQHC
Cost category weight (%)
------------------------------------------------------------------------
FQHC Practitioner Compensation.......................... 26.8
Other Clinical Compensation............................. 8.1
Non-Health Compensation................................. 23.1
Fringe Benefits (distribute to compensation)............ 10.7
Fixed Capital........................................... 4.5
Moveable Capital........................................ 1.7
Non Salary Pharmaceuticals.............................. 5.1
All Other (Residual).................................... 20.1
------------------------------------------------------------------------
Totals may not sum to 100.0% due to rounding.
b. Derivation of Detailed Cost Categories From the All Other (Residual)
Cost Weight
The All Other Residual cost weight was derived from summing all
expenses reported on the Medicare cost report Worksheet A, columns 1
and 2 for medical supplies (line 17), transportation (line 18),
allowable GME pass through costs (line 20.50), facility insurance (line
27), utilities (line 29), office supplies (line 40), legal (line 41),
accounting (line 42), administrative insurance (line 43), telephone
(line 44), non-compensation housekeeping & maintenance (line 32, column
2 only), nondescript healthcare costs (lines 21-23), nondescript
facility costs (lines 34-36), and nondescript administrative costs
(lines 54-56).
To further divide the ``All Other'' residual cost weight (20.1
percent) estimated from the CY 2013 Medicare cost report data into more
detailed cost categories, we propose to use the relative cost shares
from the 2006-based MEI for nine detailed cost categories: Utilities;
Miscellaneous Office Expenses; Telephone; Postage; Medical Equipment;
Medical Supplies; Professional, Scientific, & Technical Services;
Administrative & Facility Services; and Other Services. For example,
the Utilities cost represents 7 percent of the sum of the 2006-based
MEI ``All Other'' cost category weights; therefore, the Utilities cost
weight would represent 7 percent of the proposed 2013-based FQHC market
basket's ``All Other'' cost category (20.066 percent), yielding a
``final'' Utilities proposed cost weight of 1.4 percent in the proposed
2013-based LTCH market basket (7 percent * 20.1 percent = 1.4 percent).
Table 30 shows the cost weight for each matching category from the
2006-based MEI, the percent each cost category represents of the 2006-
based MEI ``All Other'' cost weight, and the resulting proposed 2013-
based FQHC market basket cost weights for detailed cost categories.
Table 30--Proposed Detailed FQHC Cost Category Weights
----------------------------------------------------------------------------------------------------------------
Percent of the
2006-based MEI 2006-based MEI Proposed 2013-
Proposed FQHC detailed cost categories cost weights ``All Other'' based FQHC
(%) cost weight detailed cost
(%) weights (%)
----------------------------------------------------------------------------------------------------------------
Total All Other (Residual)...................................... 17.976 100.000 20.1
Utilities....................................................... 1.266 7.0 1.4
Miscellaneous Office Expenses................................... 2.478 13.8 2.8
Telephone....................................................... 1.501 8.4 1.7
Postage......................................................... 0.898 5.0 1.0
Medical Equipment............................................... 1.978 11.0 2.2
Medical supplies................................................ 1.760 9.8 2.0
Professional, Scientific, & Tech. Services...................... 2.592 14.4 2.9
Administrative & Facility Services.............................. 3.052 17.0 3.4
Other Services.................................................. 2.451 13.6 2.7
----------------------------------------------------------------------------------------------------------------
FQHCs have liberty in how and where certain costs are reported on
the Medicare cost report form. We believe that, given the ambiguity in
how the data are reported for these overhead cost centers on the FQHC
cost report form, relying on the relative shares determined from the
MEI is reasonable. We hope that future cost data from the upcoming
revised FQHC cost report form will allow us to better estimate the
detailed cost weights for these categories directly. All FQHCs will
report costs on the new forms for cost report periods for CY 2016
expenses. For details regarding how the 2006-based MEI cost categories
were derived, see the CY 2011 PFS final rule with comment period (75 FR
73262 through 73267). The following is a description of the types of
expenses included in detailed cost categories derived from the All
Other (Residual) cost category:
Utilities: Includes expenses classified in the fuel, oil
and gas, water and sewage, and electricity industries. These types of
industries are classified in NAICS and include NAICS 2211 (Electric
power generation, transmission, and distribution), 2212 (Natural gas
distribution), and 2213 (Water, sewage, and other systems).
Miscellaneous Office Expense: Includes expenses for office
expenses not reported in other categories, miscellaneous expenses,
included but not limited to, paper (such as paper towels), printing
(such as toner for printers), miscellaneous chemicals (such as soap and
hand sanitizer).
Telephone: Includes expenses classified in NAICS 517
[[Page 46382]]
(Telecommunications) and NAICS 518 (Internet service providers), and
NAICS 515 (Cable and other subscription programming). Telephone
service, which is one component of the Telecommunications expenses,
accounts for the majority of the expenditures in this cost category.
Postage: Includes expenses classified in NAICS 491 (Postal
services) and NAICS 492 (Courier services).
Medical Equipment Expenses: Includes the expenses related
to maintenance contracts, and the leases or rental of medical equipment
used in diagnosis or treatment of patients. It would also include the
expenses for any medical equipment that was purchased in a single year
and not financed.
Medical Supplies Expenses: Includes the expenses related
to medical supplies such as sterile gloves, needles, bandages, specimen
containers, and catheters. We note that the Medical Supply cost
category does not include expenses related to pharmaceuticals (drugs
and biologicals).
Professional, Scientific, & Technical Services: Includes
the expenses for any professional services purchased from an outside
agency or party and could include fees including but not limited to,
legal, marketing, professional association memberships, licensure fees,
journal fees, continuing education.
Administrative & Facility Services: Includes the expenses
for any administrative and facility services purchased from an outside
agency or party and could include fees including but not limited to,
accounting, billing, office management services, security services,
transportation services, landscaping, or professional car upkeep.
Other Services: Includes other service expenses including,
but not limited to, nonresidential maintenance and repair, machinery
repair, janitorial, and security services.
Table 31 shows the proposed cost categories and weights for the
2013-based FQHC market basket. The resulting cost weights include
combining the cost weights derived from the Medicare Cost Report Data
(shown in Table 29), distributing the fringe benefits weight across the
three compensation cost categories (shown in Table 28), and
disaggregating the residual cost weight into detailed cost categories
(shown in Table 30). Additionally, we compare the cost weights of the
proposed 2013-based FQHC market basket to the cost weights in the 2006-
based MEI, where we have grouped the cost weights from the MEI to align
with the FQHC proposed cost categories.
Table 31--Proposed FQHC Market Basket and MEI, Cost Categories, Cost Weights
----------------------------------------------------------------------------------------------------------------
2013 FQHC 2006 MEI
FQHC cost category weight weight MEI cost category
(percent) (percent)
----------------------------------------------------------------------------------------------------------------
FQHC Market Basket............................ 100.0 100.000 MEI.
Total Compensation........................ 68.7 67.419 Total Compensation.
FQHC Practitioner Compensation........ 31.7 50.866 Physician Compensation.
Other Clinical Compensation........... 9.5 6.503 Other Clinical
Compensation.
Non-health Compensation............... 27.4 10.050 Non-health Compensation.
All Other Products........................ 16.1 14.176 All Other Products.
Utilities............................. 1.4 1.266 Utilities.
Miscellaneous Office Expenses......... 2.8 2.478 Miscellaneous Office
Expenses.
Telephone............................. 1.7 1.501 Telephone.
Postage............................... 1.0 0.898 Postage.
Medical Equipment..................... 2.2 1.978 Medical Equipment.
Medical Supplies...................... 2.0 1.760 Medical Supplies.
Professional Liability Insurance...... .............. 4.295 Professional Liability
Insurance.
Pharmaceuticals....................... 5.1 .............. Pharmaceuticals.
All Other Services..................... 9.0 8.095 All Other Services.
Professional, Scientific & Technical 2.9 2.592 Professional, Scientific &
Services. Technical Services.
Administrative & Facility Services.... 3.4 3.052 Administrative & Facility
Services.
Other Services........................ 2.7 2.451 Other Services.
Capital................................... 6.1 10.310 Capital.
Fixed Capital......................... 4.5 8.957 Fixed Capital.
Moveable Capital...................... 1.7 1.353 Moveable Capital.
----------------------------------------------------------------------------------------------------------------
Although the overall cost structure of the MEI, the index currently
used to update the FQHC PPS base payment, is similar to the proposed
FQHC cost structure, there are a few key differences.
First, though total compensation costs in the proposed FQHC market
basket and the MEI are each approximately 67-68 percent of total costs,
non-health compensation accounts for a larger share of compensation
costs in the FQHC setting than in the self-employed physician office.
Likewise, physician compensation accounts for a larger percentage of
costs in the MEI than FQHC practitioner compensation accounts for in
the proposed FQHC market basket.
Second, the proposed FQHC market basket includes a cost category
for pharmaceuticals, while drug costs are excluded from the MEI. Drug
costs are an expense in the FQHC PPS base payment rate since drugs and
biologicals that are not usually self-administered, and certain
Medicare-covered preventive injectable drugs are paid incident to a
visit while drug costs are reimbursed separately under the PFS.
Third, as mentioned previously, PLI expenditures are excluded from
the proposed FQHC market basket since most FQHCs PLI costs are covered
under the Federal Tort Claims Act, while in the MEI the PLI costs are a
significant expense for self-employed physicians. Finally, fixed
capital expenses, which include costs such as office rent and
depreciation, are about half of the share in the FQHC market basket as
they are in the MEI.
c. Selection of Price Proxies for the Proposed 2013-Based FQHC Market
Basket
After establishing the 2013 cost weights for the proposed FQHC
market basket, an appropriate price proxy was selected for each cost
category. The proposed price proxies are chosen from a set of publicly
available price indexes
[[Page 46383]]
that best reflect the rate of price change for each cost category in
the FQHC market basket. All of the proxies for the proposed 2013-based
FQHC market basket are based on indexes published by the Bureau of
Labor Statistics (BLS) and are grouped into one of the following BLS
categories:
Producer Price Indexes: Producer Price Indexes (PPIs)
measure price changes for goods sold in markets other than the retail
market. PPIs are preferable price proxies for goods and services that
businesses purchase as inputs. For example, we are proposing to use a
PPI for prescription drugs, rather than the Consumer Price Index (CPI)
for prescription drugs, because healthcare providers generally purchase
drugs directly from a wholesaler. The PPIs that we are proposing to use
measure price changes at the final stage of production.
Consumer Price Indexes: CPIs measure change in the prices
of final goods and services bought by the typical consumer. Because
they may not represent the price encountered by a producer, we are
proposing to use CPIs only if an appropriate PPI is not available, or
if the expenditures are more like those faced by retail consumers in
general rather than by purchasers of goods at the wholesale level.
Employment Cost Indexes: Employment Cost Indexes (ECIs)
measure the rate of change in employee wage rates and employer costs
for employee benefits per hour worked. These indexes are fixed-weight
indexes and strictly measure the change in wage rates and employee
benefits per hour. Appropriately, they are not affected by shifts in
employment mix.
We evaluate the price proxies using the criteria of reliability,
timeliness, availability, and relevance. Reliability indicates that the
index is based on valid statistical methods and has low sampling
variability. Timeliness implies that the proxy is published regularly,
preferably at least once a quarter. Availability means that the proxy
is publicly available. Finally, relevance means that the proxy is
applicable and representative of the cost category weight to which it
is applied. We believe the proposed PPIs, CPIs, and ECIs selected meet
these criteria.
Table 32 lists all price proxies that we are proposing to use for
the 2013-based FQHC market basket. Below is a detailed explanation of
the price proxies that we are proposing for each cost category weight.
We note that many of the proxies that we are proposing for the 2013-
based FQHC market basket are the same as those used for the 2006-based
MEI.
(1) FQHC Practitioner Compensation: We are proposing to use the ECI
for Total Compensation for Private Industry Workers in Professional and
Related) (BLS series code CIU2010000120000I) to measure price growth of
this category. There is no specific ECI for physicians and, therefore,
similar to the MEI, we are proposing to use an index that is based on
professionals that receive advanced training. We note that the 2006-
based MEI has a separate cost category for Physician Wages and Salaries
and Physician Benefits. For these cost categories, the MEI uses the ECI
for Wages and Salaries and ECI for Benefits for Professional and
Related Occupations.
(2) Other Clinical Compensation: We are proposing to use the ECI
for Total Compensation for all Civilian Workers in Health Care and
Social Assistance (BLS series code CIU1016200000000I) to measure the
price growth of this cost category. This cost category consists of
compensation costs for Nurses, Laboratory Technicians, and all other
health staff not included in the FQHC practitioner compensation
category. Based on the clinical composition of these workers, we
believe that the ECI for health-related workers is an appropriate proxy
to measure compensation price pressures for these workers. The MEI uses
the ECI for Wages and Salaries and benefits for Hospitals.
(3) Non-Health Compensation: We are proposing to use the ECI for
Total Compensation for Private Industry Workers in Office and
Administrative Support (BLS series code CIU2010000220000I) to measure
the price growth of this cost category. The Non-health compensation
cost weight is predominately attributable to administrative and
facility type occupations, as reported in the data from the Medicare
cost reports. We note the MEI has a composite index of four price
proxies, with the majority of the composite index accounted for by
administrative occupations, proxied by the ECI for Wages & Salaries of
Office and Administrative Support (Private).
(4) Utilities: We are proposing to use the CPI for Fuel and
Utilities (BLS series code CUUR0000SAH2) to measure the price growth of
this cost category. This is the same proxy used in the 2006-based MEI.
(5) Miscellaneous Office Expenses: We are proposing to use the CPI
for All Items Less Food and Energy (BLS series code CUUR0000SA0L1E) to
measure the price growth of this cost category. We believe that using
the CPI for All Items Less Food and Energy avoids double counting of
changes in food and energy prices already captured elsewhere in the
market basket. We note the MEI does not have a separate cost category
for miscellaneous office expenses.
(6) Telephone Services: We are proposing to use the CPI for
Telephone Services (BLS series code CUUR0000SEED) to measure the price
growth of this cost category. This is the same price proxy used in the
2006-based MEI.
(7) Postage: We are proposing to use the CPI for Postage (BLS
series code CUUR0000SEEC01) to measure the price growth of this cost
category. This is the same proxy used in the 2006-based MEI.
(8) Medical Equipment: We are proposing to use the PPI Commodities
for Surgical and Medical Instruments (BLS series code WPU1562) as the
price proxy for this category. This is the same proxy used in the
current 2006-based MEI.
(9) Medical Supplies: We are proposing to use a 50/50 blended index
comprised of the PPI Commodities for Medical and Surgical Appliances
and Supplies (BLS series code WPU156301) and the CPI-U for Medical
Equipment and Supplies (BLS series code CUUR0000SEMG). The 50/50 blend
is used in all market baskets where we do not have an accurate split
available. We believe FQHCs purchase the types of supplies contained
within these proxies, including such items as bandages, dressings,
catheters, intravenous equipment, syringes, and other general
disposable medical supplies, via wholesale purchase, as well as at the
retail level. Consequently, we are proposing to combine the two
aforementioned indexes to reflect those modes of purchase. This is the
same proxy used in the 2006-based MEI.
(10) Pharmaceuticals: We are proposing to use the PPI Commodities
for Pharmaceuticals for Human Use, Prescription (BLS series code
WPUSI07003) to measure the price growth of this cost category. We note
the MEI does not have a separate cost category for Pharmaceuticals.
This price proxy is used to measure prices of Pharmaceuticals in other
CMS market baskets, such as 2010-based Inpatient Prospective Payment
System and 2010-based Skilled Nursing Facility market baskets.
(11) Professional, Scientific, & Technical Services: We are
proposing to use the ECI for Total Compensation for Private Industry
Workers in Professional, Scientific, and Technical Services (BLS series
code CIU2015400000000I) to measure the price growth of this cost
category. This
[[Page 46384]]
is the same proxy used in the 2006-based MEI.
(12) Administrative & Facility Services: We are proposing to use
the ECI Total Compensation for Private Industry Workers in Office and
Administrative Support (BLS series code CIU2010000220000I) to measure
the price growth of this cost category. This is the same price proxy
used in the 2006-based MEI.
(13) Other Services: We are proposing to use the ECI for Total
Compensation for Private Industry Workers in Service Occupations (BLS
series code CIU2010000300000I) to measure the price growth of this cost
category. This is the same price proxy used in the 2006-based MEI.
(14) Fixed Capital: We are proposing to use the PPI Industry for
Lessors of Nonresidential Buildings (BLS series code PCU531120531120)
to measure the price growth of this cost category. This is the same
price proxy used in the 2006-based MEI. We believe this is an
appropriate proxy since fixed capital expenses in FQHCs should reflect
inflation for the rental and purchase of business office space.
(15) Moveable Capital: We are proposing to use the PPI Commodities
for Machinery and Equipment (series code WPU11) to measure the price
growth of this cost category as this cost category represents
nonmedical moveable equipment. This is the same proxy used in the 2006-
based MEI.
Table 32 lists the proposed price proxies for each cost category in
the proposed FQHC market basket.
Table 32--Proposed Cost Categories and Price Proxies for the FQHC Market
Basket
------------------------------------------------------------------------
Cost category FQHC price proxies
------------------------------------------------------------------------
FQHC Practitioner Compensation......... ECI--for Total Compensation for
Private Industry Workers in
Professional and Related.
Other Clinical Compensation............ ECI--for Total Compensation for
all Civilian Workers in Health
Care and Social Assistance.
Non-health Compensation................ ECI--for Total Compensation for
Private Industry Workers in
Office and Administrative
Support.
Utilities.............................. CPI-U for Fuels and Utilities.
Miscellaneous Office Expense........... CPI-U for All Items Less Food
And Energy.
Telephone.............................. CPI-U for Telephone.
Postage................................ CP-U for Postage.
Medical Equipment...................... PPI Commodities for Surgical
and Medical Instruments.
Medical supplies....................... Blend: PPI Commodities for
Medical and Surgical
Appliances and Supplies and
CPI for Medical Equipment and
Supplies.
Pharmaceuticals........................ PPI Commodities for
Pharmaceuticals for Human Use,
Prescription.
Professional, Scientific, and Technical ECI--for Total Compensation for
Services. Private Industry Workers in
Professional, Scientific, and
Technical Services.
Administrative & Facility Services..... ECI--for Total Compensation for
Private Industry Workers in
Office and Administrative
Support.
Other Services......................... ECI--for Total compensation for
Private industry workers in
Service Occupations.
Fixed Capital.......................... PPI Industry--for Lessors of
nonresidential buildings.
Moveable Capital....................... PPI Commodities--for Machinery
and Equipment.
------------------------------------------------------------------------
d. Inclusion of Multi-Factor Productivity in the Proposed FQHC Market
Basket
Section 1834(o)(2)(B)(ii) of the Act describes the methods for
determining updates to FQHC PPS payment. After the first year of
implementation, the FQHC PPS base payment rate must be increased by the
percentage increase in the MEI. In subsequent years, the FQHC PPS base
payment rate shall be increased by the percentage increase in a market
basket of FQHC goods and services as established through regulations
or, if not available, the MEI published in the PFS final rule.
The MEI published in the PFS final rule has a productivity
adjustment. The MEI has been adjusted for changes in productivity since
its inception. In the CY 2003 PFS final rule with comment period (67 FR
80019), we implemented a change in the way the MEI was adjusted to
account for changes in productivity. The MEI used for the 2003
physician payment update incorporated changes in the 10-year moving
average of private nonfarm business (economy-wide) multifactor
productivity. Previously, the index incorporated changes in
productivity by adjusting the labor portions of the index by the 10-
year moving average of private nonfarm business (economy-wide) labor
productivity.
In 2012, we convened the MEI Technical Panel to review all aspects
of the MEI including inputs, input weights, price-measurement proxies,
and productivity adjustment. For more information regarding the MEI
Technical Panel, see the CY 2014 PFS final rule with comment period (78
FR 74264). The MEI Technical Panel was asked to review the approach of
adjusting the MEI by the 10-year moving average of private nonfarm
business productivity. As described in the CY 2014 PFS final rule with
comment period (78 FR 74271), the MEI Technical Panel concluded in
Finding 5.1 that ``such an adjustment continues to be appropriate. This
adjustment prevents `double counting' of the effects of productivity
improvements, which would otherwise be reflected in both (i) the
increase in compensation and other input price proxies underlying the
MEI, and (ii) the growth in the number of physician services performed
per unit of input resources, which results from advances in
productivity by individual physician practices.''
We are proposing to include a productivity adjustment similar to
the MEI in the proposed FQHC market basket. We believe that applying a
productivity adjustment is appropriate because this would be consistent
with the MEI, which has an embedded productivity adjustment. We note
that the MEI Technical Panel concluded that a productivity adjustment
is appropriate for the MEI given the type of services performed in
physician's offices. Specifically, the MEI Technical Panel report
states that ``The input price increases within the MEI are reflected in
the price proxies, such as changes in wages and benefits. Wages
increase, in part, due to the ability of workers to increase the amount
of output per unit of input. Absent a productivity
[[Page 46385]]
adjustment in the MEI, physicians would be receiving increased payments
resulting both from their ability to increase their individual outputs
and from the productivity gains already reflected in the wage proxies
used in the index. The productivity adjustment used in the MEI ensures
the productivity gains reflected in increased outputs are not double
counted, or paid for twice. Currently, the productivity adjustment in
the MEI is based on changes in economy-wide productivity based on the
rationale that the price proxy for physician income reflects changes in
economy-wide wages. Implicitly, this assumes physicians can achieve the
same level of productivity as the average general wage earner.'' We
believe that the services performed in FQHC facilities are similar to
those covered by the MEI, and therefore, a productivity adjustment is
appropriate to avoid double counting of the effects of productivity
improvements.
We propose to use the most recent estimate of the 10-year moving
average of changes in annual private nonfarm business (economy-wide)
multifactor productivity (MFP), which is the same measure of MFP used
in the MEI. The BLS publishes the official measure of private nonfarm
business MFP. (See http://www.bls.gov/mfp for the published BLS
historical MFP data). For the final FQHC market basket update, we
propose to use the most recent historical estimate of annual MFP as
published by the BLS. Generally, the most recent historical MFP
estimate is lagged two years from the payment year. Therefore, we
propose to use the 2015 MFP as published by BLS in the CY2017 FQHC
market basket update.
We note that MFP is derived by subtracting the contribution of
labor and capital input growth from output growth. Since at the time of
the proposed rule the 2015 MFP has not been published by BLS, we rely
on a projection of MFP. The projection of MFP is currently produced by
IHS Global Insight (IGI), a national economic forecasting firm with
which CMS contracts to forecast the components of the market basket and
MFP. A complete description of the MFP projection methodology is
available at http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MedicareProgramRatesStats/MarketBasketResearch.html.
Using IGI's first quarter 2016 forecast, the productivity
adjustment for CY 2017 (the 10-year moving average of MFP for the
period ending CY 2015) is projected to be 0.4 percent. If more recent
data are subsequently available (for example, a more recent estimate of
the market basket and MFP adjustment), we would use such data to
determine the CY 2017 increase in the proposed FQHC market basket in
the final rule.
5. CY 2017 Proposed Market Basket Update: Proposed CY 2017 FQHC Market
Basket Update Compared to the MEI Update for CY 2017
For CY 2017, we are proposing to use the proposed 2013-based FQHC
market basket increase factor to update the FQHC PPS base payment rate.
Consistent with CMS practice, we estimated the market basket update for
the FQHC PPS based on the most recent forecast from IGI. Identical to
the MEI, we are proposing to use the update based on the most recent
historical data available at the time of publication of the final rule.
For example, the final CY 2017 FQHC update would be based on the four-
quarter moving-average percent change of the FQHC market basket through
the second quarter of 2016 (based on the final rule's statutory
publication schedule). For the proposed rule, we do not have the second
quarter of 2016 historical data and, therefore, we will use the most
recent projection available.
Based on IGI's first quarter 2016 forecast with historical data
through the fourth quarter of 2015, the projected proposed FQHC market
basket increase factor for CY 2017 would be 1.7 percent. This reflects
a 2.1-percent increase of FQHC input prices and a 0.4-percent
adjustment for productivity. We are also proposing that if more recent
data are subsequently available (for example, a more recent estimate of
the market basket or MFP) we would use such data, to determine the CY
2017 update in the final rule.
For comparison, the 2006-based MEI is projected to be 1.3 percent
in CY 2017; this estimate is based on IGI's first quarter 2016 forecast
(with historical data through the fourth quarter of 2015). Table 33
compares the proposed 2013-based FQHC market basket updates and the
2006-based MEI market basket updates for CY 2017.
Table 33--FQHC Market Basket and MEI, Cost Categories, Cost Weights, MFP, and CY 2017 Update
----------------------------------------------------------------------------------------------------------------
CY 2017 Update
FQHC cost category -------------------------------- MEI cost category
(percent) (percent)
----------------------------------------------------------------------------------------------------------------
FQHC Market Basket............................ 1.7 1.3 MEI.
Productivity adjustment....................... 0.4 0.4 Productivity adjustment.
FQHC Market Basket (unadjusted)............... 2.1 1.7 MEI (unadjusted).
Total Compensation........................ 2.1 2.0 Total Compensation.
FQHC Practitioner Comp................ 1.9 2.0 Physician Compensation.
Other Clinical Compensation........... 1.9 2.0 Other Clinical
Compensation.
Non-health Compensation............... 2.4 2.4 Non-health Compensation.
All Other Products........................ 2.6 -0.6 All Other Products.
Utilities............................. -3.9 -3.9 Utilities.
Miscellaneous Office Expenses......... 2.0 -1.7 Miscellaneous Office
Expenses.
Telephone............................. 0.4 0.4 Telephone.
Postage............................... 0.3 0.3 Postage.
Medical Equipment..................... 1.2 1.2 Medical Equipment.
Medical Supplies...................... -0.4 -0.4 Medical Supplies.
Professional Liability Insurance...... .............. -0.4 Professional Liability
Insurance.
Pharmaceuticals....................... 7.8 .............. Pharmaceuticals.
All Other Services........................ 2.0 2.0 All Other Services.
Professional, Scientific & Technical 1.5 1.5 Professional, Scientific &
Services. Technical Services.
Administrative & Facility Services.... 2.4 2.4 Administrative & Facility
Services.
Other Services........................ 1.9 1.9 Other Services.
Capital................................... 1.6 1.9 Capital.
Fixed Capital......................... 2.1 2.1 Fixed Capital.
Moveable Capital...................... 0.1 0.1 Moveable Capital.
----------------------------------------------------------------------------------------------------------------
[[Page 46386]]
For CY 2017, the proposed 2013-based FQHC market basket update (1.7
percent) is 0.4 percent higher than the 2006-based MEI (1.3 percent).
The 0.4 percentage point difference stems mostly from the inclusion of
pharmaceuticals in the proposed FQHC market basket. Prices for
pharmaceuticals are projected to grow 7.8 percent, faster than the
other components in the market basket. This cost category and
associated price pressures are not included in the MEI.
We propose to update the FQHC PPS base payment rate by 1.7 percent
for CY 2017 based on the proposed 2013-based FQHC market basket. The
proposed FQHC market basket would more accurately reflect the actual
costs and scope of services that FQHCs furnish compared to the 2006-
based MEI. We invite public comment on all aspects of the FQHC market
basket proposals.
C. Appropriate Use Criteria for Advanced Diagnostic Imaging Services
Section 218(b) of the PAMA amended Title XVIII of the Act to add
section 1834(q) of the Act directing us to establish a program to
promote the use of appropriate use criteria (AUC) for advanced
diagnostic imaging services. The CY 2016 PFS final rule with comment
period addressed the initial component of the new Medicare AUC program,
specifying applicable AUC. In that rule we established evidence-based
process and transparency requirements for the development of AUC,
defined provider-led entities (PLEs) and established the process by
which PLEs may become qualified to develop, modify or endorse AUC. The
first list of qualified PLEs are expected to be posted on the CMS Web
site by the end of June 2016 at which time their AUC libraries will be
considered to be specified AUC for purposes of section 1834(q)(2)(A) of
the Act.
This rule proposes requirements and processes for specification of
qualified clinical decision support mechanisms (CDSMs) under the
Medicare AUC program; the initial list of priority clinical areas; and
exceptions to the requirement that ordering professionals consult
specified applicable AUC when ordering applicable imaging services.
1. Background
AUC present information in a manner that links: A specific clinical
condition or presentation; one or more services; and, an assessment of
the appropriateness of the service(s). For purposes of this program,
AUC are a set or library of individual appropriate use criteria. Each
individual criterion is an evidence-based guideline for a particular
clinical scenario. Each scenario in turn starts with a patient's
presenting symptoms and/or condition. Evidence-based AUC for imaging
can assist clinicians in selecting the imaging study that is most
likely to improve health outcomes for patients based on their
individual clinical presentation.
AUC need to be integrated as seamlessly as possible into the
clinical workflow. CDSMs are the electronic portals through which
clinicians would access the AUC during the patient workup. While CDSMs
can be standalone applications that require direct entry of patient
information, they may be more effective when they automatically
incorporate information such as specific patient characteristics,
laboratory results, and lists of co-morbid diseases from Electronic
Health Records (EHRs) and other sources. Ideally, practitioners would
interact directly with the CDSM through their primary user interface,
thus minimizing interruption to the clinical workflow.
Consistent with definitions of CDSM by the Agency for Healthcare
Research and Quality (AHRQ) (http://www.ahrq.gov/professionals/prevention-chronic-care/decision/clinical/index.html), and the Office
of the National Coordinator for Health Information Technology (ONC)
(https://www.healthit.gov/policy-researchers-implementers/clinical-decision-support-cds), within Health IT applications, a CDSM is a
functionality that provides persons involved in care processes with
general and person-specific information, intelligently filtered and
organized, at appropriate times, to enhance health and health care.
2. Previous CDSM Experience
In the CY 2016 PFS final rule with comment period, we included a
discussion of the Medicare Imaging Demonstration (MID), which was
required by section 135(b) of the MIPPA, in addition to independent
experiences of implementing AUC by several healthcare systems and
academic medical centers. Two key aspects of that discussion remain
relevant to the CDSM component of this program. First, AUC, and the
CDSMs through which clinicians access AUC, must be integrated into the
clinical workflow and facilitate, not obstruct, evidence-based care
delivery. For instance, a CDSM external to a provider's primary user
interface could utilize an application program interface (API), a set
of protocols and tools specifying how software components should
interact, to pull relevant information into the decision support
application. By adhering to common interoperability standards, such as
the national standards advanced through certified health IT (see 2015
edition of criteria available in the Federal Register (80 FR 62601) and
described in the Interoperability Standards Advisory at https://www.healthit.gov/standards-advisory), CDSMs could both ensure
integration of patient-specific data from EHRs, and allow clinicians to
optimize the time spent using the tool.
Second, the ideal AUC is an evidence-based guide that starts with a
patient's specific clinical condition or presentation (symptoms) and
assists the clinician in the overall patient workup, treatment, and
follow-up. Imaging would appear as key nodes within the clinical
management decision tree.
Other options outside of certified EHR technology exist to access
AUC through CDSMs. Stand-alone, internet-based CDSMs are available and,
although they will not interact with EHR data, can nonetheless search
for and present AUC relevant to a patient's presenting symptoms or
condition.
In communicating an appropriateness rating to the ordering
practitioner, some CDSMs provide a scale with numeric ratings, some
output a red, yellow, or green light while others provide a dichotomous
yes or no. At this time, we do not believe there is one correct
approach to communicating the level of appropriateness to the ordering
professional. However, section 1834(q)(4)(B) of the Act requires that
information be reported on the claim form as to whether the service
would or would not adhere to the specified AUC consulted through a
particular CDSM, or whether the AUC was not applicable to the service.
We are requesting feedback from commenters regarding how
appropriateness ratings provided by CDSMs could be interpreted and
recorded for the purposes of this program.
There are different views about the comprehensiveness of AUC that
should be accessible within CDSMs. Some stakeholders believe that the
CDSM should contain as comprehensive a collection of AUC as possible,
incorporating individual criteria from across all specified AUC
libraries. The intent would be for ordering professionals to avoid the
frustration, experienced and voiced by many clinicians participating in
the MID, of spending time navigating the CDSM only to find that no
criterion for their patient's specific clinical condition exists.
Other stakeholders believe, based on decades of experience rolling
out AUC in the context of robust quality improvement programs that it
is best to
[[Page 46387]]
start with a CDSM that contains AUC for a few clinical areas where
impact is large and evidence is strong. This would ensure that quality
AUC are developed, and that clinicians and entire care teams could
fully understand the AUC they are using, including when they do not
apply to a particular patient.
As we stated in the CY 2016 PFS final rule with comment period, we
believe there is merit to both approaches, and it has been suggested to
us that the best approach may depend on the particular care setting.
The second, ``focused'' approach may work better for a large health
system that produces and uses its own AUC. The first, ``comprehensive''
approach may in turn work better for a smaller practice with broad
image ordering patterns and fewer resources that wants to simply adopt
and start using a complete AUC system developed elsewhere. We believe a
successful program would allow flexibility, and under section 1834(q)
of the Act, we foresee a number of sets of AUC developed by different
PLEs, and an array of CDSMs from which clinicians may choose.
3. Priority Clinical Areas
We established in the CY 2016 PFS final rule with comment period
that we would identify priority clinical areas through rulemaking, and
that these may be used in the determination of outlier ordering
professionals (a future phase of the Medicare AUC program). The concept
of priority clinical areas allows us to implement an AUC program that
combines the focused and comprehensive approaches to implementation
discussed above. Although potentially large volumes of AUC (as some
PLEs have large libraries of AUC) would become specified across
clinical conditions and advanced imaging technologies, we believe this
rapid and comprehensive roll out of specified AUC should be balanced
with a more focused approach when identifying outlier ordering
professionals. We believe this will provide an opportunity for
physicians and practitioners to become familiar with AUC in identified
priority clinical areas prior to Medicare claims for those services
being part of the input for calculating outlier ordering professionals.
As we describe earlier, CDSMs are the access point for ordering
professionals to consult AUC. We believe the combination of the
comprehensive and focused approaches should be applied to CDSM
requirements as we consider a minimum floor of AUC that must be made
available to ordering professionals through qualified CDSMs. AUC that
reasonably address the entire clinical scope of priority clinical areas
could establish a minimum floor of AUC to be included in qualified
CDSMs, and the number of priority clinical areas could be expanded
through annual rulemaking and in consultation with physicians and other
stakeholders. This allows priority clinical areas to roll out
judiciously, and build over time.
4. Statutory Authority
Section 218(b) of the PAMA added a new section 1834(q) of the Act
entitled, ``Recognizing Appropriate Use Criteria for Certain Imaging
Services,'' which directs the Secretary to establish a new program to
promote the use of AUC. Section 1834(q)(3)(A) of the Act requires the
Secretary to specify qualified CDSMs that could be used by ordering
professionals to consult with specified applicable AUC for applicable
imaging services.
5. Discussion of Statutory Requirements
There are four major components of the AUC program under section
1834(q) of the Act, each with its own implementation date: (1)
Establishment of AUC by November 15, 2015 (section 1834(q)(2)); (2)
identification of mechanisms for consultation with AUC by April 1, 2016
(section 1834(q)(3)); (3) AUC consultation by ordering professionals
and reporting on AUC consultation by furnishing professionals by
January 1, 2017 (section 1834(q)(4)); and (4) annual identification of
outlier ordering professionals for services furnished after January 1,
2017 (section 1834(q)(5)). As we will discuss later in this preamble,
we did not identify mechanisms for consultation by April 1, 2016 and
will not have specified or published the list of qualified CDSMs by
January 1, 2017; therefore, ordering professionals will not be required
to consult CDSMs, and furnishing professionals will not be able to
report information on the consultation, by this date.
a. Establishment of AUC
In the CY 2016 PFS final rule with comment period, we addressed the
first component under section 1834(q)(2) of the Act--the requirements
and process for establishment and specification of applicable AUC,
along with relevant aspects of the definitions under section 1834(q)(1)
of the Act. This included defining the term PLE and finalizing
requirements for the rigorous, evidence-based process by which a PLE
would develop AUC, upon which qualification is based, as provided in
section 1834(q)(2)(B) of the Act and in the CY 2016 PFS final rule with
comment period. Using this process, once a PLE is qualified by CMS, the
AUC that are developed, modified or endorsed by the qualified PLE are
considered to be specified applicable AUC under section 1834(q)(2)(A)
of the Act. We defined the term PLE to include national professional
medical societies, health systems, hospitals, clinical practices and
collaborations of such entities such as the High Value Healthcare
Collaborative or the National Comprehensive Cancer Network. Qualified
PLEs may collaborate with third parties that they believe add value to
their development of AUC, provided such collaboration is transparent.
We expect qualified PLEs to have sufficient infrastructure, resources,
and the relevant experience to develop and maintain AUC according to
the rigorous, transparent, and evidence-based processes detailed in the
CY 2016 PFS final rule with comment period.
A timeline and process was established for PLEs to apply to become
qualified with the first list of qualified PLEs expected to be
published at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/index.html by
June 30, 2016.
b. Mechanism for AUC Consultation
The second major component of the Medicare AUC program is the
specification of qualified CDSMs that could be used by ordering
professionals for consultation with specified applicable AUC under
section 1834(q)(3) of the Act. We envision a CDSM as an interactive
tool that communicates AUC information to the user. Information
regarding the clinical presentation of the patient would be
incorporated into the CDSM from another health IT system or through
data entry by the ordering professional. At a minimum, the tool would
provide immediate feedback to the ordering professional on the
appropriateness of one or more imaging services. Ideally, CDSMs would
be integrated within or seamlessly interoperable with existing health
IT systems and would automatically receive patient data from the EHR or
through an API or other connection. Such integration would minimize
burden on practitioners and avoid duplicate documentation. Also useful
to clinicians would be the ability to switch between CDSMs that can
interoperate based on common standards.
Section 1834(q)(3)(A) of the Act states that the Secretary must
specify qualified CDSMs in consultation with physicians, practitioners,
health care technology experts, and other stakeholders. This
[[Page 46388]]
paragraph authorizes the Secretary to specify mechanisms that could
include: CDS modules within certified EHR technology; private sector
CDSMs that are independent of certified EHR technology; and a CDSM
established by the Secretary. The Secretary does not propose to
establish a CDSM at this time.
All CDSMs must meet the requirements under section 1834(q)(3)(B) of
the Act, which specifies that a mechanism must: Make available to the
ordering professional applicable AUC and the documentation supporting
the appropriateness of the applicable imaging service that is ordered;
where there is more than one applicable appropriate use criterion
specified for an applicable imaging service, indicate the criteria it
uses for the service; determine the extent to which an applicable
imaging service that is ordered is consistent with the applicable AUC;
generate and provide to the ordering professional documentation to
demonstrate that the qualified CDSM was consulted by the ordering
professional; be updated on a timely basis to reflect revisions to the
specification of applicable AUC; meet applicable privacy and security
standards; and perform such other functions as specified by the
Secretary (which may include a requirement to provide aggregate
feedback to the ordering professional). Section 1834(q)(3)(C) of the
Act specifies that the Secretary must publish an initial list of
specified mechanisms no later than April 1, 2016, and that the
Secretary must identify on an annual basis the list of specified
qualified CDSMs.
As we explained in the CY 2016 PFS proposed and final rules with
comment period, implementation of many aspects of the amendments made
by section 218(b) of the PAMA requires consultation with physicians,
practitioners, and other stakeholders, and notice and comment
rulemaking. We continue to believe the PFS calendar year rulemaking
process is the most appropriate and administratively feasible
implementation vehicle. Given the timing of the PFS rulemaking process,
we were not able to include proposals in the PFS proposed rule to begin
implementation in the same year the PAMA was enacted, as we would have
had to interpret and analyze the new statutory language, and develop
proposed plans for implementation in under one month. As we did prior
to the CY 2016 PFS proposed rule when we met extensively with
stakeholders to gain insight and hear their comments and concerns about
the AUC program, we have used the time prior to the CY 2017 PFS
proposed rule to meet with many of the same stakeholders but also a new
group of stakeholders specifically related to CDSMs. In addition, we
are continuing our stepwise approach to implementing this AUC program.
The first phase of the AUC program (specifying AUC including defining
what AUC are and specifying the process for developing them) was
accomplished through last year's CY 2016 PFS final rule with comment
period. For this second phase, we will use this CY 2017 PFS rulemaking
process as the vehicle to establish requirements for CDSMs, and the
process to specify qualified CDSMs, in a transparent manner that allows
for stakeholder and public involvement. Therefore, the final CDSM
requirements and process for CDSMs to become qualified would be
published in the CY 2017 PFS final rule with comment period on or about
November 1, 2016.
c. AUC Consultation and Reporting
The third major component of the AUC program is in section
1834(q)(4) of the Act, Consultation with Applicable Appropriate Use
Criteria. This section establishes, beginning January 1, 2017, the
requirement for an ordering professional to consult with a qualified
CDSM when ordering an applicable imaging service that would be
furnished in an applicable setting and paid for under an applicable
payment system; and for the furnishing professional to include on the
Medicare claim information about the ordering professional's
consultation with a qualified CDSM. The statute distinguishes between
the ordering and furnishing professional, recognizing that the
professional who orders an applicable imaging service is usually not
the same professional who bills Medicare for that service when
furnished. Section 1834(q)(4)(C) of the Act provides for certain
exceptions to the AUC consultation and reporting requirements including
in the case of certain emergency services, inpatient services paid
under Medicare Part A, and ordering professionals who obtain an
exception due to a significant hardship. Section 1834(q)(4)(D) of the
Act specifies that the applicable payment systems for the AUC
consultation and reporting requirements are the PFS, hospital
outpatient prospective payment system, and the ambulatory surgical
center payment systems.
Since a list of qualified CDSMs is not yet available and will not
be available by January 1, 2017, we will not require ordering
professionals to meet this requirement by that date.
d. Identification of Outliers
The fourth component of the AUC program is in section 1834(q)(5) of
the Act, Identification of Outlier Ordering Professionals. The
identification of outlier ordering professionals under this paragraph
facilitates a prior authorization requirement for outlier professionals
beginning January 1, 2020, as specified under section 1834(q)(6) of the
Act. Although we are not proposing to implement these sections in the
CY 2017 PFS proposed rule, we propose below a list of priority clinical
areas which may serve as part of the basis for identifying outlier
ordering professionals.
6. Proposals for Implementation
We propose to amend our regulations at Sec. 414.94, ``Appropriate
Use Criteria for Certain Imaging Services.''
a. Definitions
In Sec. 414.94(b), we propose to codify and add language to
clarify some of the definitions provided in section 1834(q) of the Act,
as well as define terms that were not defined in statute but for which
a definition would be helpful for program implementation. In this
section, we provide a description of the terms we propose to codify to
facilitate understanding and encourage public comment on the AUC
program.
We propose to define CDSM under Sec. 414.94(b) as an interactive,
electronic tool for use by clinicians that communicates AUC information
to the user and assists them in making the most appropriate treatment
decision for a patient's specific clinical condition. A CDSM would
incorporate specified applicable AUC sets from which an ordering
professional could select. A CDSM may be a module within or available
through certified EHR technology (as defined in section 1848(o)(4) of
the Act) or private sector mechanisms independent from certified EHR
technology. If within or available through certified EHR technology, a
qualified CDSM would incorporate relevant patient-specific information
into the assessment of the appropriateness of an applicable imaging
service.
As prescribed in section 1834(q) of the Act and Sec. 414.94(b) of
our regulations, the Medicare AUC program imposes requirements only for
applicable imaging services furnished in applicable settings. Further,
as specified in section 1834(q)(4)(D) of the Act, we propose to amend
our regulation at Sec. 414.94(b) to state that the applicable payment
systems for the Medicare AUC program are the PFS under section
[[Page 46389]]
1848(b) of the Act, the prospective payment system for hospital
outpatient department services under section 1833(t) of the Act, and
the ambulatory surgical center payment systems under section 1833(i) of
the Act. Applicable payment systems are relevant to implementation of
section 1834(q)(4)(B) of the Act, entitled ``Reporting by Furnishing
Professionals.''
We remind readers that in PFS rulemaking for CY 2016 we defined
applicable imaging service in Sec. 414.94(b) as an advanced diagnostic
imaging service as defined in 1834(e)(1)(B) of the Act for which the
Secretary determines (i) One or more applicable appropriate use
criteria apply; (ii) There are one or more qualified clinical decision
support mechanisms listed; and (iii) One or more of such mechanisms is
available free of charge.
b. Priority Clinical Areas
We propose to establish a new Sec. 414.94(e)(5) to set forth the
initial list of priority clinical areas.
To compile this proposed list we performed an analysis of Medicare
claims data using the CMS Chronic Conditions Data Warehouse (CCW) as
the primary data source. The CCW contains 100 percent of Medicare
claims for beneficiaries who are enrolled in the fee-for-service (FFS)
program. Data were derived from the CCW's 2014 Part B non-institutional
claim line file, which includes Part B services furnished during CY
2014. This is the main file containing final action claims data for
non-institutional health care providers, including physicians,
physician assistants, clinical social workers, nurse practitioners,
independent clinical laboratories, and freestanding ambulatory surgical
centers. The Part B non-institutional claim line file contains the
individual line level information from the claim and includes
Healthcare Common Procedure Coding System (HCPCS) code(s), diagnosis
code(s) using the International Classification of Diseases, Ninth
Revision (ICD-9), service dates, and Medicare payment amount. A
publicly available version of this dataset can be downloaded from the
CMS Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/index.html. We encourage stakeholders to review this dataset as a
source that may help inform public comments related to the proposed
priority clinical areas.
In the CY 2016 PFS final rule with comment period, we stated that
when identifying priority clinical areas we may consider factors such
as incidence and prevalence of disease, the volume and variability of
utilization of imaging services, the strength of evidence for their
use, and applicability of the clinical area to the Medicare population
and to a variety of care settings.
Using the 2014 Medicare claims data referenced above, we ranked
ICD-9 codes by the frequency with which they were used as the primary
indication for specific imaging procedures, which in turn were
identified by the volume of individual Current Procedural Terminology
(CPT) codes for which payments were made in 2014. We extracted the top
135 ICD-9 codes from this list and formed clinically-related
categories. Next, we searched manually through an electronic list of
all ICD-9 codes to find others that would plausibly fit into each
clinical grouping. This process required subjective clinical judgment
on whether a particular ICD-9 code should be included in a given
clinical group. The top eight clinical groupings (by volume of
procedures) are what we are proposing as the initial list of priority
clinical areas. The eight clinical areas account for roughly 40 percent
of part B advanced diagnostic imaging services paid for by Medicare in
2014. We are aware that some stakeholders have suggested beginning the
AUC program with no more than five priority clinical areas while others
have suggested a far greater number. We believe the proposed eight
priority clinical areas strike a reasonable balance that allows us to
focus on a significant range and volume of advanced diagnostic imaging
services.
We also considered extracting pulmonary embolism as a separate
priority clinical area from the chest pain grouping based on
stakeholder consultation and feedback. However, we decided not to
identify pulmonary embolism separately, but are asking for public
comment on whether pulmonary embolism should be included as a stand-
alone priority clinical area. Based on our consultations with
physicians, practitioners and other stakeholders, as required by
section 218(b) of the PAMA, we attempted to be inclusive when grouping
ICD-9 codes into cohesive clinical areas. As an example of how we
derived the priority clinical area for low back pain, we grouped
together 10 ICD-9 codes, incorporating six from the top 135 and four
from the manual search of all ICD-9 codes. Included in this grouping
are the ICD-9 codes for displacement of lumbar intervertebral disc
without myelopathy (722.10), degeneration of lumbar of lumbosacral
intervertebral disc (722.52), intervertebral disc disorder with
myelopathy lumbar region (722.73), post-laminectomy syndrome of lumbar
region (722.83), lumbago (724.2), sciatica (724.3), thoracic or
lumbosacral neuritis or radiculitis unspecified (724.4), spinal
stenosis, lumbar region, without neurogenic claudication (724.02),
lumbosacral spondylosis without myelopathy (721.3), and spondylosis
with myelopathy lumbar region (721.42) which resulted in 1,883,617
services. To see all of the priority clinical area groupings of
diagnosis codes, a table is available on the CMS Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/index.html.
Using the above methodology, we developed and are proposing eight
priority clinical areas. These reflect both the significance and the
high prevalence of some of the most disruptive diseases in the Medicare
population.
Table 34--Proposed Priority Clinical Areas With Corresponding Claims Data
----------------------------------------------------------------------------------------------------------------
% Total Total % Total
Proposed priority clinical area Total services services \1\ payments payments/1
----------------------------------------------------------------------------------------------------------------
Chest Pain (includes angina, suspected 4,435,240.00 12 $ 470,395,545 14
myocardial infarction, and suspected pulmonary
embolism)......................................
Abdominal Pain (any locations and flank pain)... 2,973,331.00 8 235,424,592 7
Headache, traumatic and non-traumatic........... 2,107,868.00 6 89,382,087 3
Low back pain................................... 1,883,617.00 5 180,063,352 5
Suspected stroke................................ 1,810,514.00 5 119,574,141 4
Altered mental status........................... 1,782,794.00 5 83,296,007 3
Cancer of the lung (primary or metastatic, 1,114,303.00 3 154,872,814 5
suspected or diagnosed)........................
[[Page 46390]]
Cervical or neck pain........................... 1,045,381.00 3 83,899,299 3
----------------------------------------------------------------------------------------------------------------
\1\ Percentage of 2014 Part B non-institutional claim line file for advanced imaging services from Medicare
claims for beneficiaries who are enrolled in the fee-for-service (FFS) program (source: CMS Chronic Conditions
Data Warehouse).
CMS also engaged the CMS Alliance to Modernize Healthcare (CAMH)
Federally Funded Research and Development Center (FFRDC), the MITRE
Corporation (MITRE), to begin developing efficient and effective
processes for managing current and future health technology
assessments. MITRE generated an independent report that presents a
summary of findings from claims data from the Medicare population and
their utilization of advanced imaging procedures. Coupled with our
internal analysis, this report has assisted in identification of
proposed priority clinical areas for the Medicare AUC program for
advanced diagnostic imaging services. Analysis and methods for this
report are available at https://www.mitre.org/publications/technical-papers/claims-data-analysis-to-define-priority-clinical-areas-for-advanced.
While this year we are proposing priority clinical areas based on
an analysis of claims data alone, we may use a different approach in
future rulemaking cycles. As we provided in Sec. 414.94(e) of our
regulations, we may consider factors other than volume when proposing
priority clinical areas including incidence and prevalence of disease,
variability of use of particular imaging services, strength of evidence
supporting particular imaging services and the applicability of a
clinical area to a variety of care settings and to the Medicare
population.
We encourage public comments on this proposed initial list of
priority clinical areas, including recommendations for other clinical
areas that we should include among our list of priority clinical areas.
In particular, we are interested in comments on the above methodology
or alternate options; whether the proposed priority clinical areas are
appropriate including information on the extent to which these proposed
priority clinical areas may be represented by clinical guidelines or
AUC in the future. Furthermore, we are interested in public comments,
supported by published information, with respect to varying levels of
evidence that exist across as well as within priority clinical areas.
c. CDSM Qualifications and Requirements
We are proposing to add a new Sec. 414.94(g)(1) to our regulations
to establish requirements for qualified CDSMs. Section
1834(q)(3)(A)(iii) of the Act provides relative flexibility for
qualified CDSMs, and states that they may include mechanisms that are
within certified EHR technology, private sector mechanisms that are
independent from certified EHR technology or mechanisms that are
established by the Secretary.
We believe that, at least initially, it is in the best interest of
the program to establish CDSM requirements that are not prescriptive
about specific IT standards. Rather, we are proposing an approach that
focuses on the functionality and capabilities of qualified CDSMs. The
CDSM, EHR and health IT environments are constantly changing and
improving and we want to allow room for growth and innovation. However,
in the future, as more stakeholders and other entities including the
ONC, AHRQ, and relevant standards development organizations come to
consensus regarding standards for CDSMs, then we may consider pointing
to such standards as a requirement for qualified CDSMs under this
program. We believe standards would make it possible to achieve
interoperability, allowing any CDSM to incorporate any standardized AUC
and for sets of AUC to be easily interchangeable among various CDSMs.
We will continue to work with the ONC and AHRQ to facilitate movement
in this direction.
Recent work under the federally-sponsored Clinical Quality
Framework (CQF) initiative has successfully developed an integrated
approach that harmonizes standards for electronic clinical quality
measurement with those that enable shareable clinical decision support
artifacts (for example, AUC). The CQF initiative is working to support
semantically interoperable data exchange for (1) sending patient data
to a service for clinical decision support guidance and receiving
clinical decision support guidance or quality measurement results in
return, and (2) enabling a system to consume and internally execute
decision support artifacts. As this standard is considered sufficiently
mature for widespread adoption, the ONC may consider it for use in
future editions of certification criteria for health IT. While the
current regulation requires no specific standard, the CMS and ONC are
supportive of this approach and additional information can be found at
http://hl7-fhir.github.io/cqif/cqif.html.
Under Sec. 414.94(g)(1), we propose to codify in regulations the
seven requirements for qualified CDSMs set forth in section
1834(q)(3)(B)(ii) of the Act. The Act requires qualified CDSMs to make
available to the ordering professional specified applicable AUC and the
supporting documentation for the applicable imaging service ordered. We
do not interpret this requirement to mean that every qualified CDSM
must make available every specified applicable AUC. In the CY 2016 PFS
final rule with comment period we allowed for the approval of massive
libraries of AUC (resulting from approvals for qualified PLEs with
comprehensive and extensive libraries), yet we expressed our intention
to establish priority clinical areas. While there is a statutory
requirement to consult AUC for each applicable imaging service, we
recognize that ordering professionals may choose to thoroughly improve
their understanding of, and focus their internal quality improvement
(QI) programs on, those priority clinical areas; and these areas will
in turn serve as the basis for future outlier calculations.
Consistent with that approach, we propose to add a requirement in
Sec. 414.94(g)(1)(iii) that qualified CDSMs must make available to
ordering professionals, at a minimum, specified applicable AUC that
reasonably encompass the entire clinical scope of all priority clinical
areas. We encourage and expect some CDSMs, based on the needs of the
professionals they serve, will choose to include a far more
comprehensive set of AUC going above and beyond the minimum set as we
understand many ordering professionals want such comprehensive access
to AUC. When this Medicare AUC program is fully implemented, all
ordering professionals must consult specified applicable AUC through a
qualified
[[Page 46391]]
CDSM for every applicable imaging service that would be furnished in an
applicable setting and paid for under an applicable payment system in
order for payment to be made for the service. However, when identifying
the outlier ordering professionals who will be subject to prior
authorization beginning in 2020, we anticipate focusing on consultation
with specified applicable AUC within priority clinical areas rather
than the universe of specified applicable AUC. The concept of priority
clinical areas will allow us to implement an AUC program that combines
two approaches to implementation allowing clinicians flexibility to
either engage with a rapid rollout of comprehensive specified
applicable AUC or adopt a focused approach to consulting AUC. Thus,
they can choose their approach and select a CDSM and AUC set(s) that
fit their needs and preferences, while being sure that each qualified
CDSM will include AUC that address all priority clinical areas.
We further propose to add a requirement in Sec. 414.94(g)(1)(iv)
of our regulations that qualified CDSMs must be able to incorporate
specified applicable AUC from more than one qualified PLE. We believe
this approach ensures that CDSMs can expand the AUC libraries they can
provide access to in order to represent AUC across all priority
clinical areas (consistent with the requirements under proposed Sec.
414.94(g)(1)(iii)). We do not necessarily expect that a single
qualified PLE will develop AUC addressing every priority clinical area
domain, especially since we believe that over time and through future
rulemaking, the list of priority clinical areas will expand and cross
additional clinical domains. Ensuring that qualified CDSMs are not
limited in their technology to incorporating AUC from only one
qualified PLE will help to ensure that ordering professionals will not
be in a position of consulting a CDSM that cannot offer them access to
AUC that address all priority clinical areas. As stakeholders continue
to advance CDSM technology, we look forward to standards being
developed and widely accepted so that AUC are incorporated in a
standardized format across CDSM platforms. Increasing standardization
in this area will move the industry closer to the goal of
interoperability across CDSMs and EHRs.
We also propose to add a requirement in Sec. 414.94(g)(1)(i) that
specified applicable AUC and related documentation supporting the
appropriateness of the applicable imaging service ordered must be made
available within the qualified CDSM. For example, the ordering
professional would have immediate access to the full appropriate use
criterion, citations supporting the criterion and a summary of key
evidence supporting the criterion.
We propose to add a requirement in Sec. 414.94(g)(1)(ii),
consistent with section 1834(q)(3)(B)(ii)(II) of the Act, that the
qualified CDSM must clearly identify the appropriate use criterion
consulted if the tool makes available more than one criterion relevant
to a consultation for a patient's specific clinical scenario. We
believe this is important since CDSMs that choose to incorporate a
comprehensive AUC library may be offering the ordering professional
access to AUC from multiple qualified PLEs. In such scenarios, it is
important that the ordering professional knows which appropriate use
criterion is being consulted and have the option to choose one over the
other if more than one criterion applies to the scenario.
We propose to add a requirement in Sec. 414.94(g)(1)(v),
consistent with section 1834(q)(3)(B)(ii)(III) of the Act, that the
qualified CDSM must provide to the ordering professional a
determination, for each consultation, of the extent to which an
applicable imaging service is consistent with specified applicable AUC
or a determination of ``not applicable'' when the mechanism does not
contain a criterion that would apply to the consultation. This
determination would communicate the appropriateness of the applicable
imaging service to the ordering professional. In addition to this
determination, we also propose that the CDSM provide the ordering
professional with a determination of ``not applicable'' when the
mechanism does not contain an appropriate use criterion applicable to
that patient's specific clinical scenario.
We propose to add a requirement in Sec. 414.94(g)(1)(vi),
consistent with section 1834(q)(3)(B)(ii)(IV) of the Act, that the
qualified CDSM must generate and provide to the ordering professional
certification or documentation that documents which qualified CDSM was
consulted, the name and NPI of the ordering professional that consulted
the CDSM and whether the service ordered would adhere to applicable
AUC, whether the service ordered would not adhere to such criteria, or
whether such criteria was not applicable for the service ordered. We
propose to require under Sec. 414.94(g)(1)(vi)(A) that this
certification or documentation must be issued each time an ordering
professional consults the qualified CDSM. Since Medicare claims will be
filed only for services that are rendered to beneficiaries, we will not
see CDSM consultation information on the claim form specific to imaging
services that are not ordered. We believe that for the CDSM to be able
to provide meaningful feedback to ordering professionals, information
regarding consultations that do not result in imaging is just as
important as information on consultations that do result in an order
for advanced imaging.
Thus, we propose to require under Sec. 414.94(g)(1)(vi)(B) that
the documentation or certification provided by the qualified CDSM must
include a unique consultation identifier. This would be a unique code
issued by the CDSM that is specific to each consultation by an ordering
professional. This type of unique code may serve as a platform for
future collaboration and aggregation of consultation data across CDSMs.
In addition, at some point in the future, this unique code may assist
in more seamlessly bringing Medicare data together with CDSM clinical
data to maximize quality improvement in clinical practices and to
iteratively improve the AUC itself.
We propose in Sec. 414.94(g)(1)(vii), consistent with section
1834(q)(3)(B)(ii)(V) of the Act, that the specified applicable AUC
content within qualified CDSMs be updated at least every 12 months to
reflect revisions or updates made by qualified PLEs to their AUC sets
or to an individual appropriate use criterion. We propose 12 months as
the maximum acceptable delay for updating content. We believe that in
most cases it will be possible to update AUC content more frequently
than every 12 months, particularly for cloud-based CDSMs. We further
propose in Sec. 414.94(g)(1)(vii)(A) that qualified CDSMs have a
protocol in place to more expeditiously remove AUC that are determined
by the qualified PLE to be potentially dangerous to patients and/or
harmful if followed.
In addition, we propose in Sec. 414.94(g)(1)(vii)(B) that
qualified CDSMs must make available for consultation specified
applicable AUC that address any new priority clinical areas within 12
months of the priority clinical area being finalized by CMS. We believe
this would allow the CDSM sufficient time to incorporate the AUC into
the CDSM. Thus, any new priority clinical areas finalized, for example,
in the CY 2018 PFS final rule with comment period that would be
effective January 1, 2018, would need to be incorporated into a
qualified CDSM by January 1, 2019. To accommodate this time frame, we
would accept a not applicable determination from a CDSM
[[Page 46392]]
for a consultation on a priority clinical area for dates of service
through the 12-month period that ends, in this example, on January 1,
2019. We note that all qualified CDSMs that are approved by June 30,
2017 should be capable of supporting AUC for all priority clinical
areas that are finalized in the CY 2017 PFS final rule with comment
period.
We propose to add a requirement in Sec. 414.94(g)(1)(viii),
consistent with section 1834(q)(3)(B)(ii)(VI) of the Act, that the
qualified mechanism must meet privacy and security standards under
applicable provisions of law. Potentially applicable laws may include
the HIPAA Privacy and Security rules.
We propose to add a requirement in Sec. 414.94(g)(1)(ix),
consistent with section 1834(q)(3)(B)(ii)(VII) of the Act, that
qualified CDSMs must provide ordering professionals aggregate feedback
in the form of an electronic report on an annual basis (at minimum)
regarding their consultations with specified applicable AUC. Our intent
is to require records to be retained in a manner consistent with the
HIPAA Security Rule. To provide such feedback, and to make detailed
consultation information available to ordering professionals,
furnishing professionals (when they have authorized access to the
CDSM), auditors and CMS, we propose in Sec. 414.94(g)(1)(x) that a
qualified CDSM must maintain electronic storage of clinical,
administrative and demographic information of each unique consult for a
minimum of 6 years. We believe CDSMs could fulfill this requirement in
a number of ways, including involving a third party in the storage of
information as well as for providing feedback to ordering
professionals. We recognize that these requirements represent a minimum
floor that clinicians may choose to expand upon in their local QI
programs.
In the event requirements under Sec. 414.94(g)(1) are modified
through rulemaking during the course of a qualified CDSM's 5-year
approval cycle, we propose in Sec. 414.94(g)(1)(xi) that the CDSM
would be required to comply with the modification(s) within 12 months
of the effective date of the modification.
d. Process for CDSMs To Become Qualified and Determination of Non-
Adherence
We propose that CDSMs must apply to CMS to be specified as a
qualified CDSM. We propose that CDSM developers who believe their
mechanisms meet the regulatory requirements must submit an application
to us that documents adherence to each of the requirements to be a
qualified CDSM.
We propose to require in Sec. 414.94(g)(2) that CDSM developers
must submit applications to CMS for review that document adherence to
each of the CDSM requirements. Applications to be specified as a
qualified CDSM must be submitted by January 1 of a year in order to be
reviewed within that year's review cycle. For example, the first
applications would be accepted from the date of publication of the PFS
final rule until January 1, 2017. A determination on whether the
applicants are qualified would be made by June 30, 2017. Applications
must be submitted electronically to [email protected]. This
process and timeline mirror the qualified PLE application and approval
process and timeline. As we did for qualified PLEs, we will post a list
of all applicants that we determine to be qualified CDSMs to our Web
site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/index.html by
June 30. We propose that all qualified CDSMs must reapply every 5 years
and their applications must be received by January 1 during the 5th
year that they are qualified CDSMs. It is important to note that, as
with PLE applications, the application for qualified CDSMs is not a CMS
form; rather it is created by the applicant. A CDSM that is specified
as qualified for the first 5-year cycle beginning on July 1, 2017 would
be required to submit an application for requalification by January 1,
2022. A determination would be made by June 30, 2022, and, if approved,
the second 5-year cycle would begin on July 1, 2022.
An example of our proposed timeline for applications and the
approval cycle is as follows:
Year 1 = July 2017 to June 2018.
Year 2 = July 2018 to June 2019.
Year 3 = July 2019 to June 2020.
Year 4 = July 2020 to June 2021.
Year 5 = July 2021 to June 2022 (reapplication is due by
January 1, 2022).
We believe it is important for us to have the ability to remove
from the list of specified qualified CDSMs a CDSM that we determine
fails to adhere to any of the qualification requirements, including
removal outside of the proposed 5-year cycle. We propose to state under
Sec. 414.94(h) that, at any time, we may remove from the list of
qualified CDSMs a CDSM that fails to meet the criteria to be a
qualified CDSM or consider this information during the requalification
process. Such determinations may be based on public comment or our own
review and we may consult with the National Coordinator for Health
Information Technology or her designee to assess whether a qualified
CDSM continues to adhere to requirements.
We invite comments on how we could streamline and strengthen the
approval process for CDSMs in future program years. For instance, CMS
may consider a testing framework for CDSMs that would validate
adherence to specific standards that enable seamless incorporation of
AUC across CDSMs.
e. Consultation by Ordering Professional and Reporting by Furnishing
Professional
Although we continue to aggressively move forward to implement this
AUC program, ordering professionals will not be expected to consult
qualified CDSMs by January 1, 2017. At the earliest, under this
proposal, the first qualified CDSM(s) will be specified on June 30,
2017. We anticipate that some ordering professionals could be able to
begin consulting AUC through qualified CDSMs very quickly as some may
already be aligned with a qualified CDSM.
We anticipate that furnishing professionals may begin reporting as
early as January 1, 2018. This reporting delay is necessary to allow
time for ordering practitioners who are not already aligned with a
qualified CDSM to research and evaluate the qualified CDSMs so they may
make an informed decision. While there will be further rulemaking next
year, we are announcing this date because the agency expects physicians
and other stakeholders/regulated parties to begin preparing themselves
to begin reporting on that date. We will adopt procedures for capturing
this information on claims forms and the timing of the reporting
requirement through PFS rulemaking for CY 2018.
As we expect to implement the AUC consultation and reporting
requirements under section 1834(q)(4)(A) and (B) of the Act on January
1, 2018, we are interested in receiving feedback from the public to
include a discussion of specific operational considerations that we
should take into account and include in such rulemaking. For example,
commenters could consider alternatives for reporting data on claims and
for seeking exceptions, as discussed below. We also seek information on
the barriers to implementation along this timeline that allows ordering
and furnishing professionals to be prepared to consult AUC and report
consultation information on the claims and whether
[[Page 46393]]
separate rulemaking outside of the payment rule cycle would be
preferred.
Under section 1834(q)(4)(B) of the Act, Medicare claims for
applicable imaging services furnished in applicable settings can only
be paid under the applicable payment systems if certain information is
included on the claim including: Which qualified CDSM was consulted by
the ordering professional for the service; whether the service, based
on the CDSM consultation, adheres to specified applicable AUC, does not
adhere to specified applicable AUC or whether no criteria in the CDSM
were applicable to the patient's clinical scenario; and, the national
provider identifier (NPI) of the ordering professional. This section
further allows payment for these services only if the claim contains
such information beginning January 1, 2017. To develop and
operationalize a meaningful solution to collecting new AUC
consultation-related information on the claims, we must diligently
evaluate our options taking into account the vast number of claims
impacted and the limitations of the legacy claims processing system.
While we could have moved more quickly to establish some sort of AUC
consultation indicator for Medicare claims, any such indicator would
have been a relatively meaningless token. Additionally, in the case of
advanced imaging services, related claims are already required to
append certain HCPCS modifiers and G codes for purposes of proper
payments. In the recent implementation of section 218(a) of the PAMA,
we established a HCPCS modifier for CT services rendered on machines
that do not meet an equipment standard. It is important that we
understand and evaluate how the additional requirements for AUC
reporting would impact the information that is already required for
advanced imaging services. Moving too quickly to satisfy the reporting
requirement could inadvertently result in technical and operational
problems that could cause delays in payments.
Section 1834(q)(4)(C) of the Act includes exceptions that allow
claims to be paid even though they do not include the information about
AUC consultation by the ordering professional. We believe that, unless
a statutory exception applies, an AUC consultation must take place for
every order for an applicable imaging service furnished in an
applicable setting and under an applicable payment system. We further
believe that section 1834(q)(4)(B) of the Act accounts for the
possibility that AUC may not be available in a particular qualified
CDSM to address every applicable imaging service that might be ordered;
and thus, the furnishing professional can meet the requirement to
report information on the ordering professional's AUC consultation by
indicating that AUC is not applicable to the service ordered.
We are considering the mechanisms for appending the AUC
consultation information to various types of Medicare claims and expect
to develop requirements for appending such information in the CY 2018
PFS rulemaking process. Stakeholders interested in sharing feedback
related to reporting and claims processing are welcome to do so as part
of the comment period for this proposed rule. We are particularly
interested in receiving feedback on, for example, whether the
information should be collected using HCPCS level II G codes or HCPCS
modifiers. We will use this feedback to inform CY 2018 rulemaking.
f. Exceptions To Consulting and Reporting Requirements
Section 1834(q)(4)(C) of the Act provides for certain exceptions to
the AUC consultation and reporting requirements under section
1834(q)(4)(B) of the Act. First, the statute provides for an exception
under section 1834(q)(4)(C)(i) of the Act where an applicable imaging
service is ordered for an individual with an emergency medical
condition as defined in section 1867(e)(1) of the Act. We believe this
exception is warranted because there can be situations in which a delay
in action would jeopardize the health or safety of individuals. Though
we believe they occur primarily in the emergency department, these
emergent situations could potentially arise in other settings.
Furthermore, we recognize that most encounters in an emergency
department are not for an emergency medical condition as defined in
section 1867(e)(1) of the Act.
We propose to provide for an exception to the AUC consultation and
reporting requirements under Sec. 414.94(i)(1) for an applicable
imaging service ordered for an individual with an emergency medical
condition as defined in section 1867(e)(1) of the Act. For example, if
a patient, originally determined by the clinician to have an emergency
medical condition prior to ordering an applicable imaging service, is
later determined not to have had an emergency medical condition at that
time, the relevant claims for applicable imaging services would still
qualify for an exception. To meet the exception for an emergency
medical condition as defined in section 1867(e)(1) of the Act, the
clinician only needs to determine that the medical condition manifests
itself by acute symptoms of sufficient severity (including severe pain)
such that the absence of immediate medical attention could reasonably
be expected to result in: Placing the health of the individual (or a
woman's unborn child) in serious jeopardy; serious impairment to bodily
functions; or serious dysfunction of any bodily organ or part. Orders
for advanced imaging services for beneficiaries with an emergency
medical condition as defined under section 1867(e)(1) of the Act are
excepted from the requirement to consult AUC. We intend through the CY
2018 PFS proposed rule to propose more details around how this
exception will be identified on the Medicare claim.
The second exception is under section 1834(q)(4)(ii) of the Act for
applicable imaging services ordered for an inpatient and for which
payment is made under Medicare Part A. We propose to codify this
exception in new Sec. 414.94(i)(2). While we are including this
exception consistent with statute, we note that if payment is made
under Medicare Part A, the service would not be paid under an
applicable payment system, such that the AUC consultation and reporting
requirements under Sec. 414.94 would never apply.
The third exception is under section 1834(q)(4)(iii) of the Act for
applicable imaging services ordered by an ordering professional who the
Secretary determines, on a case-by-case basis and subject to annual
renewal, that consultation with applicable AUC would result in a
significant hardship, such as in the case of a professional practicing
in a rural area without sufficient Internet access. We propose to
codify this exception in new Sec. 414.94(i)(3) by specifying that
ordering professionals who are granted a significant hardship exception
for purposes of the Medicare EHR Incentive Program payment adjustment
under Sec. 495.102(d)(4)(i), (ii), or (iii)(A)(B) of our regulations
would also be granted a significant hardship exception for purposes of
the AUC consultation requirement. We are proposing, to the extent
technically feasible, that the year for which the eligible professional
is excepted from the EHR Incentive Program payment adjustment is the
same year that the ordering professional is excepted from the
requirement to consult AUC through a qualified CDSM. We propose not to
adopt the Meaningful Use significant hardship exception under Sec.
495.102(d)(4)(iv)(C) as an exception for purposes of the AUC
consultation requirement. Therefore, ordering professionals with a
primary specialty of anesthesiology, radiology or
[[Page 46394]]
pathology will not be categorically excepted from AUC consultation
requirements.
We believe there is substantial overlap between the eligible
professionals that would seek a hardship exception under the EHR
Incentive Program and those ordering professionals that would seek a
hardship exception under the AUC program and, as such, this proposal
would be administratively efficient. Using an existing program is the
most efficient and expeditious manner to implement the significant
hardship exception under the Medicare AUC program. We also believe it
is the only administratively feasible option for a national significant
hardship identification process that can be implemented by January 1,
2018, though we intend to revisit this option for years after 2018 as
the current EHR Incentive Program payment adjustment is set to expire
after the 2018 payment year as the Merit-Based Incentive Payment System
takes effect. In addition, below we discuss considerations for a
supplemental process to account for hardships for ordering
professionals that are not eligible to apply for a significant hardship
under the EHR Incentive Program (for example, non-physician
practitioners) and ordering professionals that incur a significant
hardship outside of the EHR Incentive Program application deadline.
The criteria for significant hardships under the EHR Incentive
Program relate to insufficient internet connectivity, practicing for
less than 2 years, practicing at multiple locations with the inability
to control the availability of Certified EHR Technology, lack of face-
to-face interaction with patients or a primary specialty designation of
anesthesiology, radiology or pathology. We believe that most of these
criteria would be relevant to demonstrate a significant hardship for
ordering professionals to consult AUC. Regarding hardship exceptions
for certain specialty designations, based on Medicare claims data for
advanced imaging services from the first 6 months of 2014,
approximately 1.2 percent of those claims were for advanced imaging
services that had been ordered by a professional with one of the three
primary specialty designations. While their combined ordering volume is
small, we do not believe that categorical exclusion of certain
specialties of which the practitioner selected as their primary
specialty designation for Medicare enrollment would necessarily be
appropriate under the AUC program. Since eligible professionals in
these three specialties are categorically excepted from the EHR
Incentive Program payment adjustment, few of them would have applied
for an exception on the other grounds. Therefore, we must consider
another mechanism to evaluate whether ordering practitioners with these
medical specialties experience a significant hardship for purposes of
the AUC program.
We understand that there are differences between the purpose and
timing of significant hardship exceptions for the EHR Incentive Program
and the Medicare AUC program. Foremost, a significant hardship under
the EHR Incentive Program is generally based on a hardship that
occurred in a prior period, impacting meaningful EHR use that would
affect payments in a subsequent calendar year. For example, a
professional that submits an application in March 2017 and qualifies
for the hardship exception under the EHR Incentive Program would be
exempt from the EHR payment adjustment for calendar year 2018. Although
significant hardship exceptions for the EHR payment adjustment year
generally are based on the existence of a hardship in a prior period,
we believe it would be appropriate for these professionals to also
qualify for a significant hardship exception for purposes of the AUC
consultation requirement during calendar year 2018. It is also our
best, most efficient, administratively feasible means of determining
significant hardships for ordering professionals for CY 2018.
We also recognize the possibility that an ordering professional
could suffer a significant hardship during the AUC program year, and
therefore, is immediately unable to consult AUC. In addition, while
again we believe there is significant overlap, there may be
circumstances where an ordering professional is not considered to be an
eligible professional under the EHR Incentive Program (for example, an
ordering professional that is not a physician). We are seeking feedback
from commenters regarding processes that could be put in place to
accommodate ordering professionals with primary specialties that
categorically receive significant hardship exceptions under the EHR
Incentive Program, real-time hardships that arise during a year, and
ordering professionals that are not eligible to apply using the EHR
Incentive Program significant hardship exception process and need to
seek a significant hardship exception for the purposes of the AUC
program. We believe this would involve only a small number of ordering
professionals. To the extent technically feasible, some possibilities
for implementing such hardship exceptions may include Medicare
Administrative Contractors granting hardships on a case-by-case basis
or establishing another mechanism to allow for self-attestation of a
significant hardship for a defined period of time (for example, a
calendar quarter or a calendar year). We intend to propose a process in
the CY 2018 PFS proposed rule.
We invite the public to comment on our proposal for ordering
professionals granted a hardship exception for the EHR Incentive
Program for payment year 2018 to also be granted a hardship exception
to the Medicare AUC program for those years. We propose that the year
the practitioner is excepted from the EHR Incentive Program payment
adjustment is the same year that the practitioner would be excepted
from consulting AUC.
6. Summary
Section 1834(q) of the Act includes rapid timelines for
establishing a Medicare AUC program for advanced diagnostic imaging
services. The number of clinicians impacted by the scope of this
program is massive as it will apply to every physician or other
practitioner who orders or furnishes applicable imaging services. This
crosses almost every medical specialty and could have a particular
impact on primary care physicians since their scope of practice can be
quite broad.
We continue to believe the best implementation approach is one that
is diligent, maximizes the opportunity for public comment and
stakeholder engagement, and allows for adequate advance notice to
physicians and practitioners, beneficiaries, AUC developers, and CDSM
developers. It is for these reasons we are proposing to continue a
stepwise approach, adopted through notice and comment rulemaking. We
propose this second component to the program to specify qualified
CDSMs, identify the initial list of priority clinical areas, and
establish requirements related to CDSMs, as well as consulting and
reporting exceptions. However, we also recognize the importance of
moving expeditiously to accomplish a fully implemented program. Under
this proposal, the first list of qualified CDSMs will be posted no
later than June 30, 2017, allowing ordering professionals to begin
aligning themselves with a qualified CDSM. We anticipate that
furnishing professionals could begin reporting AUC information starting
as early as January 1, 2018, but will provide details in CY 2018 PFS
[[Page 46395]]
rulemaking for how to report that information on claims.
In summary, we propose definitions of terms and processes necessary
to implement the second component of the AUC program. We invite the
public to submit comments on these proposals. We are particularly
seeking comment on the proposed priority clinical areas and the
requirements that must be met by CDSMs to become qualified. We believe
the proposed requirements for qualified CDSMs will allow for
flexibility so mechanisms can continue to reflect innovative concepts
in decision support and develop customer-driven products to ultimately
provide information to the ordering professional in such a manner that
will maximize appropriate ordering of advanced diagnostic imaging while
seamlessly integrating into workflow. As the stakeholders continue to
move to a place of consensus-based standards deemed ready for
deployment, we may become more prescriptive in future requirements for
CDSMs. We also seek comment on the exceptions to the requirements to
consult applicable AUC using CDSMs.
D. Reports of Payments or Other Transfers of Value to Covered
Recipients: Solicitation of Public Comments
1. Background
In the February 8, 2013 Federal Register (78 FR 9458), we published
the ``Transparency Reports and Reporting of Physician Ownership or
Investment Interests'' final rule (Open Payments Final Rule) which
implemented section 1128G of the Act, as added by section 6002 of the
Affordable Care Act. Under section 1128G(a)(1) of the Act,
manufacturers of covered drugs, devices, biologicals, and medical
supplies (applicable manufacturers) are required to submit on an annual
basis information about certain payments or other transfers of value
made to physicians and teaching hospitals (collectively called covered
recipients) during the course of the preceding calendar year. Section
1128G(a)(2) of the Act requires applicable manufacturers and applicable
group purchasing organizations (GPOs) to disclose any ownership or
investment interests in such entities held by physicians or their
immediate family members, as well as information on any payments or
other transfers of value provided to such physician owners or
investors. The Open Payments program creates transparency around the
nature and extent of relationships that exist between drug, device,
biologicals and medical supply manufacturers, and physicians and
teaching hospitals (covered recipients and physician owner or
investors). The implementing regulations are at 42 CFR part 402,
subpart A, and part 403, subpart I.
In addition to the Open Payments final rule, we issued final
regulations in the CY 2015 PFS final rule with comment period (79 FR
67758) that revised the Open Payments regulations. Specifically, we:
(1) Deleted of the definition of ``covered device''; (2) removed the
continuous medical education (CME) exclusion; (3) expanded the marketed
name reporting requirements to biologicals and medical supplies; and
(4) required stock, stock options, and any other ownership interests to
be reported as distinct forms of payment.
Since the publication and implementation of the Open Payments Final
Rule and the CY 2015 PFS, various stakeholders have provided feedback
to us regarding aspects of the Open Payment program. We have identified
areas in the rule that might benefit from revision. In order to
consider the views of all stakeholders, we are soliciting comments to
inform future rulemaking. We do not intend to finalize any requirements
related to Open Payments directly as a result of this proposed rule;
rather, we expect to conduct future rulemaking. We are particularly
interested in receiving comments on the following:
We would like to know if the nature of payment categories
as listed at Sec. 403.904(e)(2) are inclusive enough to facilitate
reporting of all payments or transfers of value to covered recipient
physicians and teaching hospitals. We also seek feedback on further
categorization of reported research payments.
Although there is a 5-year record retention requirement at
Sec. 403.912(e), our regulations are currently silent on how long
applicable manufacturers and applicable GPOs remain obligated to report
on past years of payments or ownership or investment interests. We are
soliciting feedback on how many years an applicable manufacturer or
applicable GPO should continue to monitor and report on past program
years for Open Payments reporting purposes.
We are continuing to refresh all years of program data in
addition to newly submitted payment records. We are interested in
receiving feedback on how many years of Open Payments data is relevant
to our stakeholders to help us determine how many years to continue to
publish and refresh annually on our Web site. In addition, we are
looking for feedback on how many years may be useful or relevant to
Open Payments data users as archive files available for download on our
Web site.
We are seeking feedback on a requirement for all
applicable manufacturers and applicable GPOs as defined in Sec.
403.902 to register each year, regardless of whether the entity will be
reporting payments or other transfers of value, or ownership or
investment interests for the program year. We also seek comment on
requiring applicable manufacturers and applicable GPOs to include the
reason for not reporting any payments or other transfers of value, or
ownership or investment interests.
We are constantly striving to ensure that all published
Open Payments data is valid and reliable. As part of this effort we are
seeking comment on a requirement for applicable manufacturers and
applicable GPOs to pre-vet payment information with covered recipients
and physicians owners or investors before reporting to the Open
Payments system, which we understand is an increasingly common
practice. Specifically, we would like feedback on pre-vetting based on
threshold payment values or random samplings of covered recipients. We
are also interested in hearing how applicable manufacturers and
applicable GPOs are successfully pre-vetting payment or transfer of
value records.
We continue to receive feedback that the current
definition of a covered recipient teaching hospital, as defined at
Sec. 403.902, makes reporting payments or transfers of value difficult
for applicable manufacturers. Section 1128G of the Act is silent on the
definition of a covered recipient teaching hospital. We are soliciting
feedback on the specific hurdles that the current definition presents.
Additionally we would like to receive proposed alternative
operationally feasible definitions or definitional elements of a
covered recipient teaching hospital.
We have heard from stakeholders that verifying receipt of
payments or transfers of value to teaching hospitals is a difficult
process on the recipient end for a various number of reasons (such as
size of hospitals, number of departments, etc.). Without context around
a payment record, teaching hospitals have reported difficulties
verifying payments attributed to them. This leads to payment disputes.
We are seeking feedback on adding a new non-public data element to
assist in review and affirmation of payment records. Some examples
might be hospital contact name or department etc. Would a free form
text field be preferable?
[[Page 46396]]
Should this field be mandatory to facilitate review of any attributed
payments to a teaching hospital?
Some reporting entities have expressed interest to upload
data into the Open Payments system before the end of the calendar year
for which the data is collected. We believe this may increase data
validity and minimize disputes. We solicit feedback on the benefit for
applicable manufacturers and applicable GPOs to report data to CMS
early or ongoing throughout the year.
We recognize that some entities may experience mergers,
acquisitions, corporate organizations and reorganizations, and other
structural corporate changes. We seek feedback on how we might change
our reporting requirements to ensure that industry can properly, and
easily, represent these changes while still monitoring for compliance
with reporting requirements.
We have received feedback from industry that there is
confusion surrounding requirements for reporting ownership and
investment interests. Keeping in mind that these reporting requirements
are statutorily mandated, we solicit feedback on operationally feasible
definitions regarding ownership or investment interests. Specifically,
we would like feedback on the terms ``value or interest'' and ``dollar
amount invested.'' We also solicit comments on additional terms that
may require further clarification to facilitate compliance with
reporting requirements.
We solicit ideas on how to define physician-owned
distributors (PODs) for data reporting purposes, as well as what data
elements PODs should be required to report. We also seek feedback on
what portion of the reported data we should share on our Web site.
From a data collection perspective, we welcome suggestions
on ways to streamline or make the process more efficient, while
facilitating our role in oversight, compliance, and enforcement.
With respect to all solicitations, we are requesting an
estimate of the time and cost burden associated with reporting for
purposes of compliance with the Paperwork Reduction Act.
E. Release of Part C Medicare Advantage Bid Pricing Data and Part C and
Part D Medical Loss Ratio (MLR) Data
1. Background
As part of the annual bidding process required under section
1854(a) of the Act, Medicare Advantage organizations (MAOs) submit bids
for each plan they wish to offer in the upcoming contract year
(calendar year). We refer to each of these bids as a Medicare Advantage
(MA) plan bid. As required by sections 1857(e)(4) and 1860D-12(b)(3)(D)
of the Act, data supporting medical loss ratios (MLR) are submitted
annually to us by MAOs and Part D sponsors, respectively. Using this
authority, we codified the MLR submission requirement in the MLR final
rule for Part C and Part D published in the Federal Register (78 FR
31284) on May 23, 2013.
We are proposing to release to the public MA bid pricing data and
Part C and Part D MLR data on a specific schedule and subject to
specified exclusions. We propose to add contract terms and expand the
basis and scope of our regulations on MA bidding and Part C and Part D
MLR submission to incorporate section 1106(a) of the Act (42 U.S.C.
1306(a)), which authorizes disclosure of information filed with this
agency in accordance with regulations adopted by the agency. (See
Parkridge Hospital, Inc. v. Califano, 625 F.2d 719, 724-25 (6th Cir.
1980). A substantive regulation issued following rulemaking provides
the legal authorization for government officials to disclose commercial
information that would otherwise be required to be kept confidential in
accordance with 18 U.S.C. 1905. See Chrysler Corp. v. Brown, 441 U.S.
281, 306-08 (1979). We note as well that under 45 CFR 401.105(a),\6\ we
have adopted a regulation that permits publication and release of data
that would not be exempt from disclosure under FOIA or prohibited from
disclosure under other law, even if a request has not been submitted.
We further note that because we collect Part D MLR information under
section 1860D-12(b)(3)(D) of the Act, we have the authority to use such
information for purposes of improving public health through research on
the utilization, safety, effectiveness, quality and efficiency of
health care services. We propose to adopt a regulation that clearly
identifies the categories of data from submitted bids and reports of
medical loss ratios that will be released so as to avoid repeating FOIA
analyses and reviews of each request, to standardize the disclosure and
the procedures for disclosure, and in the interest of furthering goals
related to the MA and Part D programs.
---------------------------------------------------------------------------
\6\ The regulation, which implements 42 U.S.C. 1306(a), provides
that the Freedom of Information Act rules shall be applied to every
proposed disclosure of information. If, considering the
circumstances of the disclosure, the information would be made
available in accordance with the Freedom of Information Act rules,
then the information may be disclosed regardless of whether the
requester or beneficiary of the information has a statutory right to
request the information under the Freedom of Information Act, 5
U.S.C. 552, or whether a request has been made.
---------------------------------------------------------------------------
The purposes underlying these proposed data releases include
allowing public evaluation of the MA and Part D programs encouraging
research into these programs and better ways to provide health care,
and reporting to the public regarding federal expenditures and other
statistics involving these programs. In particular, we believe that
facilitating public research using this bid pricing data could lead to
better understanding of the costs and utilization trends in MA and
support future policymaking for the MA program. For example, MA bid
pricing data (which contains actual and projected cost figures) could
be used to understand patterns of health care utilization such as how
projected and actual costs may differ across geographic areas and
different beneficiary populations. Release of MLR data from the MA and
Part D programs could lead to research into how managed care in the
Medicare population differs from and is similar to managed care in
other populations (such as the individual and group markets) where MLR
data is also released publicly; such research could inform future
administration of these programs. Further, we believe that making
certain MA bid pricing data and Part C and Part D MLR data available
publicly aligns with Presidential initiatives to improve management and
transparency of federal information. The President's January 21, 2009,
Memorandum on Transparency and Open Government (74 FR 4685) instructed
federal agencies to take specific actions to implement increased data
transparency and access to federal datasets. Subsequent Presidential
memoranda (including the May 23, 2012 memorandum Building a 21st
Century Digital Government and May 9, 2013 memorandum Making Open and
Machine Readable the New Default for Government Information) further
stated the policy initiative to increase open access to and
interoperability among such government data sets. These memoranda
demonstrate a commitment to making information about government
activities and government spending available to the public and using
the internet as a means of public disclosure in order to eliminate as
many barriers as possible to public access to such information. Our
proposal would promote accountability in the MA and Part D programs, by
making MLR information publicly available for use by beneficiaries who
are making enrollment choices and by allowing the
[[Page 46397]]
public to see whether and how privately-operated MA and Part D plans
administer Medicare--and supplemental--benefits in an effective and
efficient manner. Disclosing MA pricing data would provide the public
with insight as to how public dollars are spent in this aspect of the
Medicare program. Further, we have received requests under FOIA for
data of the type of the pricing data we propose to release here and we
anticipate that, as the MLR Reports from MA and Part D plans are
submitted, we will receive requests for those reports and that data.
These interests, however, must also be balanced with the need to
protect the privacy of individuals, the confidentiality of information
about Medicare beneficiaries, and the proprietary interests of the MA
and Part D plans that submit the information. While transparency in
governmental activities and spending is important, we recognize that
some of the information we collect in the form of MA bid pricing
submissions and Part C and Part D MLR reports should not be publicly
disclosed. We believe that our proposal balances these various
interests and goals, both in carving out from the planned and
authorized releases certain specific data, and (in the case of the MA
bid pricing data) in delaying the release past the point of the
commercial usefulness of the data.
We are seeking to balance protection of the proprietary interests
of MAOs and Part D sponsors with the need to effectively and
transparently administer federal health care programs and to encourage
research into better ways to provide health care. Further, we believe
that adopting a fixed schedule for release of this information and
standardizing releases of this data through this rule, will reduce the
burdens on the public, CMS, and the submitters of the data that are
associated with individual requests for information. Proposing a rule
for these releases provides the opportunity for a fulsome and public
dialogue that is not always the case with individual requests for
information. We encourage commenters to identify and explain additional
uses of the information we propose here to release and to suggest
additional protections from release if commenters disagree with how we
have balanced the competing interests. We hope to receive comments from
all viewpoints to ensure that the lines for releasing and protecting
information are appropriately drawn.
2. MA Bid Submission and Pricing Data
We make monthly prospective payments to MAOs for providing Part C
coverage to Medicare beneficiaries enrolled in their MA plans. As
mandated in section 1854 of the Act, amended by Title II of the
Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA) (Pub. L. 108-173), our payments to MAOs for their MA plan
enrollees are based on bids that MAOs must submit to us no later than
the first Monday in June for the upcoming contract year. Each MA plan
bid is an estimate of the plan's revenue requirement to cover plan
benefits for a projected population. The monthly aggregate bid amount
for an MA plan is composed of estimated benefit expenses (direct
medical expenses), non-benefit expenses (administrative expenses), and
a gain/loss margin (profit) for coverage of original Medicare benefits,
Part C supplemental benefits (if any), and Part D benefits (if any). We
are not proposing to release Part D bid pricing data in this rule.
Also, cost plans operated under section 1876 and section 1833 of the
Act, Program for All Inclusive Care for the Elderly (PACE)
organizations, and Medicare-Medicaid demonstration plans operated under
the Financial Alignment Initiative (https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/FinancialAlignmentInitiative/FinancialModelstoSupportStatesEffortsinCareCoordination.html) do not
submit Part C bids to us so pricing data relating to those plans is not
part of this proposed rule.
Section 1854(a) of the Act requires that MA bid submissions,
including coverage, cost-sharing, and pricing, be in a form and manner
specified by the Secretary. The statute, as specified in paragraphs
(a)(1), (a)(3), and (a)(6), requires that bids include the plan type,
the plan's geographic service area, projected enrollment under the
plan, bid amounts for the provision of Part C benefits, bid amounts for
Part D benefits (if offered by the MA plan), descriptions of
beneficiary cost-sharing liability for each type of benefit, the plan's
use of the beneficiary rebate (if any), and the actuarial basis for
determining the bid pricing amounts. Part C benefits include basic
benefits (that is, the benefits available under Original Medicare Parts
A and B) and non-Medicare supplemental benefits (both mandatory and
optional); supplemental benefits may include benefits not available
under Original Medicare (for example, vision and dental benefits) or
the reduction in cost-sharing obligations of enrollees compared to
Original Medicare.
The regulation at Sec. 422.254 addresses the content of the bid
submission as well but does not specify the form or manner of the
submission. We developed standardized templates for MAOs to populate
and upload to our Health Plan Management System (HPMS) as the bid
submission described in the statute and regulation. These standardized
MA bid submission templates collect the information required under
Sec. 422.254, and organize the information as follows:
Plan Benefit Package (PBP) information (describing the
Part C benefits and cost-sharing for each MA plan);
Service Area information (identifying geographic areas
where an MA plan is to be offered by the MAO);
Plan Crosswalk information (identifying plan
consolidations, terminations, and/or service area changes from one year
to the next); and
The MA bid pricing data for each PBP (that is, each MA
plan). MA bid pricing data is uploaded to HPMS in a template referred
to as the MA Bid Pricing Tool (MA BPT).
Currently, we publicly release information on the Plan Benefit
Package, service area, and plan crosswalks each year. These data sets
can be found on our Web site at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/MCRAdvPartDEnrolData/index.html, under the subpages Benefits-Data, MA-
Contract-Service-Area-by-State-County, and Plan-Crosswalks,
respectively.
In this rule, we propose to release MA bid pricing data, as defined
at proposed Sec. 422.272, which would be implemented as a release of
data housed in the MA BPT for each MA plan subject to specified
exclusions from release (noted in this section of the proposed rule).
The MA BPT is a standardized Excel workbook with multiple worksheets
and special functions built-in (for example, validation features).
There are also separate BPTs used to price two types of MA plans:
Medicare Medical Savings Account plans (the MSA BPT); and End-Stage
Renal Disease-only special needs plans (the ESRD-SNP BPT). The MSA BPT
was first released for calendar year (CY) 2009 bidding, and the ESRD-
SNP BPT was first released for CY 2014 bidding. We maintain and update
these three MA BPT formats under OMB #0938-0944, and release annual
versions every April.
The MA BPT templates can be found on our Web site at https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Bid-Forms-Instructions.html, accompanied
[[Page 46398]]
by instructions on how to populate the tool and a data dictionary for
all data elements. Information pertaining to the MSA BPT and the ESRD-
SNP BPT can be found in the Appendices within the general MA BPT
instructions, which can be found on the Bid-Forms Web site.
Below we describe the general categories of MA bid pricing data
contained in the MA BPT templates, indicating the associated BPT
worksheet. Worksheets 1 through 6 of the MA BPT template collect
information for the development and identification of the revenue
requirements for basic benefits and mandatory supplemental benefits.
Optional supplemental benefits, which enrollees may opt to purchase
separately, are addressed in a separate worksheet. The BPT as a whole
collects the information described in Sec. 422.254(b), (c) and (d) for
coordinated care and private fee-for-service plans and in Sec.
422.254(b) and (e) for MA-MSA plans. The regulation describes the
required bid elements in general terms, which we implemented and
operationalized at a detailed level in the BPT.
a. MA Base Period Experience and Projection Assumptions (MA BPT
Worksheet 1)
MAOs must report base period experience data, which is defined as
claims incurred in the calendar year 2 years prior to the contract year
for which the bid is being submitted, for basic benefits and mandatory
supplemental benefits. For example, for CY 2017 bids (which must be
submitted June 6, 2016), the base period data is for CY 2015. For the
historical period, MAOs report the plan's actual allowed per member per
month (PMPM) cost, unit cost and utilization by service type (for
example, inpatient, outpatient, etc.); cost sharing and net costs are
also reported. MAOs must also report actual enrollment and revenue, as
well as expenses for claims, administration, and gain/loss margin, for
this base period. Finally, MAOs must report the assumptions they use to
project (that is, trend) the base period claims experience to the
contract year for which they are bidding.
b. MA Projected Allowed Costs (MA BPT Worksheet 2)
MAOs provide the projected allowed PMPM costs, unit costs, and
utilization by service type for the contract year, using the claims
experience and projection assumptions described previously; such
information demonstrates the actuarial bases of the bid. Allowed costs
are ``gross'' costs, that is, before the application of any beneficiary
cost sharing. Total projected allowed costs are reported separately for
dual eligible beneficiaries without full Medicare cost-sharing
liability versus other beneficiaries. MAOs may also enter manual rates
and the credibility assumptions used to blend together manual rates
with projected experience.
c. MA Projected Cost Sharing (MA BPT Worksheet 3)
MAOs present the effective value of a plan's level of cost-sharing
by service type, which must include both in-network and out-of-network
cost sharing (copays and coinsurance) and other amounts such as plan
deductibles and the plan's out-of-pocket maximum cost-sharing amount.
d. MA Projected Revenue Requirement (MA BPT Worksheet 4)
MAOs then combine their allowed cost data and cost sharing
information (described in sections III.E.2.b. and c. of this proposed
rule) to calculate the plan's projected revenue requirement, which
consists of benefit costs (direct medical costs) net of cost-sharing,
non-benefit expenses (administrative costs), and gain/loss margin. The
plan's projected revenue requirement is allocated to the following:
Medicare-covered A/B services, prescription drug coverage (if the plan
is an MA-PD plan), and non-Medicare covered services (mandatory
supplemental benefits under the plan).\7\ MAOs report the revenue
requirement separately for dual eligible beneficiaries without full
Medicare cost-sharing liability versus other enrolled beneficiaries.
They also report administrative expenses by category (for example,
direct versus indirect administration) and information related to the
plan's gain/loss (profit) margin.
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\7\ We are not proposing to release any Part D bid pricing data
as part of this proposed rule. Therefore, for any MA-PD bid, the
Part D information underlying the pricing of Part D benefits would
be redacted from any data release under this rule. However, the
amount of beneficiary rebate applied to buy-down the Part D premiums
if any, is included at Sec. 422.264(b)(2) as a use of Part C
dollars, so will be included in the MA bid pricing data release. See
section III.E.3.a.1.
---------------------------------------------------------------------------
MAOs have the option of reporting enrollment, revenue and expense
information related to their plan enrollees with End Stage Renal
Disease (ESRD) on worksheet 4; these costs are otherwise excluded from
bid development. (We have the authority to determine whether and when
it is appropriate to apply the bidding methodology to ESRD MA
enrollees, as set forth at Sec. 422.254(a)(2).) MAOs also have the
option of reporting information related to Medicaid revenue and
expenses for dual eligible beneficiaries.
The plan's expected risk profile (average risk score) is reflected
in the projected revenue requirements (costs) for both A/B and
supplemental bid amounts. That is, the projected costs will reflect the
expected risk profile of that plan's population because the utilization
projections built into the costs projected in the bid reflect the
underlying risk and need for services of the expected enrollees for
that plan. When these projected costs are divided by the plan's
projected risk score for a projected enrollment, the costs become
``standardized.'' Standardized costs have a risk score equal to one,
which means that they reflect the risk profile of the average Medicare
beneficiary.
e. MA BPT Benchmark (Worksheet 5)
The MA BPT illustrates development of the plan-specific A/B
benchmark, based on the service area of the plan and the county rates
(or MA regional rates) applicable to the plan; the benchmark is
identified and calculated using information provided by the plan and
county rate information announced by CMS. See Sec. 422.254 and Sec.
422.258. The service-area level benchmark represents the upper limit
that the federal government will pay PMPM for coverage of A/B benefits
in the defined service area, given the plan's quality rating, prior to
risk adjusting payments. The service-area level benchmark for (non-
regional) plans that cover multiple counties is a weighted average of
the projected plan enrollment and the applicable county ratebook
amounts.
For benchmark development, the MAO reports the following: Projected
enrollment in member months per county; projected average risk score
for the projected enrollment in each county in the plan's service area;
and a plan-level factor for the proportion of beneficiaries with
Medicare as Secondary Payer. Plan-level projected member months and
risk scores are reported separately for dual eligible beneficiaries
without full Medicare cost-sharing liability versus other
beneficiaries.
The MA BPT is programmed to compare the A/B bid amount from the MAO
to the benchmark to determine whether the plan has a beneficiary rebate
(defined at Sec. 422.266) and must submit information required by
Sec. 422.254(d). If the plan A/B bid amount is lower than the plan
benchmark, a percentage of the difference determines the beneficiary
rebate amount (where the percentage is based on the plan's quality
rating). If the bid is greater than benchmark, the plan must charge a
[[Page 46399]]
member premium for coverage of A/B benefits.
f. MA Bid Summary (MA BPT Worksheet 6)
The MA BPT presents a summary of key figures developed in the tool,
including the bid, benchmark, projected risk score, and rebate amount,
to support the final step of bid pricing--development of the
beneficiary premium (if any) for the plan. To determine the premium,
MAOs indicate how the rebate amount will be allocated. Under Sec.
422.266(b), the rebate must be allocated to some combination of MA
mandatory supplemental benefits (defined at Sec. 422.2), which can
include buy down of original Medicare A/B cost-sharing and offering
additional benefits not covered by original Medicare; and buy down of
the Part D basic premium, the Part D supplemental premium, and/or the
Part B premium.
g. Optional Supplemental Benefits (MA BPT Worksheet 7)
MAOs may offer optional supplemental benefits, which plan enrollees
may opt to purchase for a separate, additional premium. MAOs present
the actuarial pricing elements for any optional supplemental benefit
packages to be offered during the contract year, up to a maximum of 5
packages. Not all MA plans offer optional supplemental benefits. MAOs
report projected member months, allowed costs PMPM, cost sharing,
administrative costs and gain/loss margin for each optional
supplemental benefit package. MAOs also report base period experience
for optional supplemental benefits, including revenue, enrollment,
claim expenses, administrative expenses, and gain/loss margin. The
information is reported separately as enrollees must make a separate
election to purchase these benefits, and for coordinated care plans and
private fee-for-service plans they cannot be funded by beneficiary
rebates.
h. MSA BPT and ESRD-SNP BPT
Regarding the MSA BPT and ESRD-SNP BPT, the same general
requirements apply: Submission of base period experience data;
projected allowed costs by service type; projected enrollee cost-
sharing payments; projected revenue requirements (medical,
administrative, and margin); and development of the plan benchmark
against which the bid is compared. Unique to the MSA BPT is development
of the beneficiary deposit amount for the high-deductible plan. Unique
to the ESRD-SNP BPT are service categories such as dialysis and
nephrologist.
i. Additional Documentation
In addition to the categories of data noted in this section of the
proposed rule, MAOs must also submit supporting documentation to
substantiate the actuarial basis of pricing and an actuarial
certification of the bid for their MA BPTs, MSA BPTs, and ESRD-SNP
BPTs, as required at Sec. Sec. 422.254(b)(5) and 422.256(c)(5).
3. Proposed Regulatory Changes for Release of MA Bid Pricing Data
We are proposing to amend our MA regulations to provide for the
release of certain MA bid pricing data. We propose to release to the
public each year, after the first Monday in October, MA bid pricing
data that we accepted or approved for a contract year at least 5 years
prior to the upcoming calendar year, subject to specific exclusions
described in proposed Sec. 422.272(c). We believe this disclosure is
consistent with Presidential directives to make information available
to the public, and with our goals of allowing public evaluation of the
MA program, encouraging research into better ways to provide health
care, and reporting to the public regarding federal expenditures and
other statistics involving this program. For example, MA bid pricing
data (which contains actual and projected cost figures) could be used
to understand patterns of health care utilization such as how projected
and actual costs may differ across geographic areas and different
beneficiary populations, which could inform future bidding and payment
policies. Further, releasing pricing data, particularly in conjunction
with information already released under Sec. 422.504(n), will provide
insight into the use of public funds for the MA program, providing
appropriate transparency about the administration of the program.
We propose to codify the requirements for release of MA bid pricing
data for MA plan bids accepted or approved by us by adding a new Sec.
422.272 to subpart F of part 422. First, we discuss the definition of
MA bid pricing data, then our proposal to release MA bid pricing data
for MA plan bids accepted or approved by us, and the types of
information we propose be excluded from these data releases. Next, we
discuss the specific proposal for the timing of the public data
release. Finally, we solicit public comment on approaches to releasing
more recent MA bid pricing data. We also solicit comment on our goals
and purposes stated above for the release of MA bid pricing data.
(a) Terminology
At Sec. 422.272(a), we propose a definition of MA bid pricing data
to mean the information that MAOs must submit for the annual bid
submission for each MA plan, in a form and manner specified by us.
Specifically, we propose that MA bid pricing data includes the
information described at Sec. 422.254(a)(1) and the information
required for MSA plans at Sec. 422.254(e). We use Sec. 422.254(a)(1)
in our proposed definition because it provides an overview of the
submission requirements in our MA bidding regulations. Specifically,
Sec. 422.254(a)(1) references Sec. 422.254(b), (c), and (d), which
address, respectively, general bid requirements, information required
for coordinated care plans and private fee-for-service plans, and
information on beneficiary rebates. At Sec. 422.272(a)(2), we propose
to include in the definition the information required for bids for MSA
plans, set forth at Sec. 422.254(e), which includes the amount of plan
deductible for the high-deductible plan.
By proposing to define MA bid pricing data at Sec. 422.272(a)
using cross-references to existing regulation at Sec. 422.254(a)(1)
and (e), we are proposing in operational terms that the term encompass
all plan-specific data fields in the MA BPT, the MSA BPT, and the ESRD-
SNP BPT, that is, the figures that MAOs input and those that are
calculated within the BPT. The BPTs also include data that are not
plan-specific, which consist of look-up tables built-in to facilitate
calculations. We do not propose to include these look-up tables as part
of the proposed definition of MA bid pricing data, as they are not
submitted by the MAO. These look-up tables are hidden Excel worksheets
(which can be ``unhidden'' within Excel), and are currently available
to the public in the BPT templates on the CMS Web site at https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Bid-Forms-Instructions.html. Selected data from the look-up tables are reflected
in each MA plan's BPT. For example, there is a look-up table in the
BPTs with the county rates for the contract year and when the MAO
enters a state-county code, the BPT extracts the appropriate rate
amount for the county from the look-up table and populates the
appropriate data field.
Our proposed definition of MA bid pricing data references elements
required at Sec. 422.254(b) and includes information described in
section III.E.2. (MA Bid Pricing Data) of this proposed rule: The
estimated revenue required by an MA plan for providing original
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Medicare benefits and mandatory supplemental health care benefits, if
any (composed of direct medical costs by service type, administrative
costs and return on investment); and the plan pricing of enrollee cost-
sharing for original Medicare benefits and mandatory supplemental
benefits. In addition, the definition references the MA bid pricing
data elements required at Sec. 422.254(c), which include more detail
about the Medicare-covered and supplemental bid amounts such as the
actuarial bases for the bid amounts, projected enrollment, and data
specific to regional MA plans.
Finally, we propose to define MA bid pricing data to include
elements required at Sec. 422.254(d), thus incorporating a reference
to the forms of beneficiary rebate at Sec. 422.266(b). That is, for
plans that bid below the benchmark for their service areas, the term
would include the beneficiary rebate amounts that are allocated in the
BPTs to the uses allowed in law: Reduction of cost-sharing below
original Medicare levels, offering additional benefits not covered by
original Medicare, and reduction of the Part D basic premium, the Part
D supplemental premium, and/or the Part B premium. Unlike the
underlying components of the Part D pricing (that is, pricing
information related to the Part D benefit analogous to the information
included in the MA BPT), we consider beneficiary rebate amounts that
are applied to reduce the Part D basic and supplemental premiums to be
Part C amounts that are part of the MA bid pricing submission, not the
Part D bid pricing submission.
(b) Release of Accepted or Approved MA Bid Pricing Data With a 5 Year
Lag
In Sec. 422.272(b), we propose to authorize the public release of
MA bid pricing data for the MA plan bids that were accepted or approved
by us for a contract year under Sec. 422.256. We propose that the
annual release will contain MA bid pricing data from the final list of
MA plan bids accepted or approved by us for a contract year that is at
least 5 years prior to the upcoming calendar year.
We use the phrase ``accepted or approved'' in the proposed
regulation text because both terms are used in existing regulation when
referring to MA bids. We consider these words to mean the same thing in
the context of MA bid pricing submissions, and we use both words in
proposed Sec. 422.272(b) to mirror existing regulation. For example,
existing Sec. 422.256(b) states that CMS can only accept bids that
meet the standards in that paragraph. However, Sec. 422.256(b)(4)(i)
and (ii) use the phrase ``CMS approves a bid. . . .'' The phrases
``decline to accept'' and ``decline to approve'' are used at Sec.
422.254(a)(5) and Sec. 422.256(a), respectively. In the remainder of
this preamble, we will use the term ``accepted'' to represent the
phrase ``accepted or approved.''
During our annual bid review process, we determine which MAOs must
submit one or more updated versions of the initial MA BPT for one or
more of their MA plans, in response to questions from our bid
reviewers. In addition, as part of the bid pricing submission process,
an MAO may have to adjust its allocation of beneficiary rebate dollars
for some or all of its MA plans that offer Part D and for their
regional PPOs, after we publicly release the Part D national average
bid amount and the final MA regional plan benchmarks. Any reallocation
of rebate dollars results in a revised MA bid, which must be submitted
to us as an updated version of the original submission. Finally, on
occasion an MAO will withdraw an MA plan after we have accepted the
plan bid. For these reasons, we propose that the MA bid pricing data to
be released will only be the data found in the final list of accepted
bids; for operational purposes, this means the final accepted MA BPTs,
MSA BPTs, and ESRD-SNP BPTs, subject to exclusions noted in proposed
paragraph (c).
Finally, in Sec. 422.272(b), we propose to authorize the annual
release of MA bid pricing data for a contract year that is at least 5
years prior to the upcoming calendar year. We believe that 5 years is
an appropriate length of time for the MA bid pricing data to no longer
be competitively sensitive. (The base period data on actual expenses in
the MA BPT, MSA BPT, and ESRD-SNP BPT is 2 years older than the data
for the bidding year--see the description of the MA BPT category MA
Base Period Experience and Projection Assumptions in section III.E.2.
of this proposed rule.) Since this will be an annual release, over time
the public would have the ability to trend bid cost projections across
years, to compare actual costs from the MA BPT with projections from
prior years, and to observe bidding patterns over ever-longer periods
of time.
We are seeking to balance the protection of commercially sensitive
information with our goals to effectively administer federal health
care programs, increase data transparency regarding federal
expenditures, and encourage research into better ways to provide health
care. We propose that a 5-year delay renders multi-year comparisons of
pricing trends less relevant to the current year of MA plan pricing.
The time lag represents a buffer between the development and
implementation of pricing strategies that can be distilled from data
multiple years for and the observed relationship and trend from one
year to the next, thus mitigating possible competitive disadvantage
from the proposed data disclosure. For example, an MAO looking to enter
a new MA market is significantly less likely to gain an unfair
commercial advantage from being able to examine and trend 5-year-old
bid pricing data than if the MAO were able to examine and trend more
recent bid pricing data.
We solicit comment on the proposed 5 year delay for reducing
competitive disadvantages to MAOs. We solicit comments explaining
whether a shorter period would suffice to protect MAOs from competitive
harm associated from the disclosure of confidential commercial
information or if a longer period is necessary to adequately protect
the information and assure the continued submission of accurate data.
(c) Exclusions From Release
In Sec. 422.272(c), we propose that several types of MA bid
pricing information be excluded from the data releases under paragraph
(b). First, we note that we are not proposing to release Part D bid
pricing data in this rule. For this reason, the exclusion from release
at proposed Sec. 422.272(c)(1) is information pertaining to the Part D
prescription drug bid amount for an MA plan offering Part D benefits,
specifically the information required for Part D bid submission at
Sec. 422.254(b)(1)(ii), (c)(3)(ii), and (c)(7). We consider this
exclusion at proposed Sec. 422.272(c)(1) to include the following
amounts in the MA BPT that pertain to the Part D premiums: The Part D
basic premium before and after application of beneficiary rebate
amounts; the Part D supplemental premium before and after application
of beneficiary rebate amounts; the combined MA plus Part D total plan
premium; and the target Part D basic premium.
Regarding Part D bid pricing data, section 1860D-15(f) of the Act
contains protections for data submitted by Part D Sponsors in
accordance with section 1860D-15; these protections would generally
prohibit public release of such data. We propose that the Part D bid
pricing elements listed in this section of the proposed rule, which
appear in the MA bid pricing tools, would be excluded from release.
However, we note that the Part C statute does not establish similar
protections for MA bid pricing data, and we believe that MA
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bid pricing data is not subject to the protections imposed by section
1860D-15 of the Act.
Second, at Sec. 422.272(c)(2), we propose to exclude from release
two categories of additional information that we require to verify the
actuarial bases of the MA plan bids. At paragraph (c)(2)(i), we propose
to exclude from release any narrative information in the MA BPT, MSA
BPT, and ESRD SNP BPT regarding base period factors, manual rates,
cost-sharing methodology, optional supplemental benefits, or other
topics for which narratives are required by us under Sec. 422.254.
These narrative fields provide additional information to allow us to
verify the actuarial bases of the bid, as described at Sec.
422.256(c)(5). For the base period narratives, MAOs are asked to
describe the source of the base period experience data, and any other
utilization adjustment factors, unit cost adjustment factors, and
additive adjustment factors that the MAO applied. For projected allowed
costs, the narrative field captures descriptions of manual rates
including trending assumptions in the manual rates. For projected cost
sharing, the narrative fields contains a description of the methodology
for reflecting the impact of maximum cost-sharing. Finally, for
optional supplemental benefits, there is a general comments field. The
proposed regulation text would also exclude from release any other
narrative fields in the BPT that we may require as the bid submission
process changes over time. We propose to exclude these text fields in
the BPTs. MAOs may populate them with information pertinent to more
than the individual MA plan bid in which the narrative is included,
such as regional or national-level information on an MAO's approach to
cost-sharing methodology or projection factors. For example, MAOs may
provide information on provider contracting, such as the fee schedules.
Further, these explanations and additional information provide insight
into the exercise of actuarial judgment in developing the bids. We
believe that it is reasonable to treat such summary statements of MAO
methodology or strategy as information proprietary to the MAO that
should remain protected from public disclosure. The release of such
information (for example, fee schedules or national pricing strategy)
may provide an unfair commercial advantage to certain entities, such as
new market entrants, and likely would impair the government's ability
to obtain such information in the future, since MAOs have greater
discretion in deciding what written information to share with us and
would likely attempt to avoid sharing fee schedule and pricing strategy
information.
Another category of information that we propose to exclude from
release, at Sec. 422.272(c)(2)(ii), is the supporting documentation
that MAOs submit to us to support the actuarial bases of each MA plan
bid; these materials are collected outside of the BPT templates so this
proposed exclusion would be operationalized by withholding from release
any materials submitted as part of an MA bid that were not part of the
BPT worksheet submission. Supporting documentation for each MA plan bid
can consist of multiple text, spreadsheet, and email files. MAOs submit
the first round of supporting documentation with the initial bid
submission. Subsequently, during the bid review process, our reviewers
may communicate requests for additional supporting documentation, and
in response, MAOs may submit multiple updated versions of an MA plan's
BPT and additional supporting documentation. There are no standard
formats for supporting documentation. A range of files (Word, Adobe,
Excel, and email formats) may be uploaded for each of the MA plan bids,
and there is no way to identify clearly which data elements in any of
the supporting documentation for an MA plan bid applies to the final
accepted version of the bid. Supporting documentation often links a
particular plan bid to an MAO's broader pricing approaches, such as
financial arrangements with providers, and we believe that such
analytical information at a regional or national level could be
commercially sensitive information in a way that the cost and
enrollment estimates in the BPT are not, since such strategic pricing
and contracting information could provide an unfair commercial
advantage to certain entities, such as new market entrants, who would
not need to release such strategic information. We also are concerned
whether release of supporting documentation could have a chilling
effect on the scope of information provided by MAOs for future bidding
and our ability to accurately evaluate bids. We rely on MAOs to provide
detailed explanations of the bids in order for CMS to fully understand
the judgment calls underlying the assumptions reflected in the bids. If
MAOs believe that the explanations and additional information are not
protected from disclosure, they may provide less information and less
explanation. In order to preserve the access we have, we are proposing
to protect this information.
Third, at Sec. 422.272(c)(3), we propose to exclude from release
any information identifying Medicare beneficiaries and other
individuals. We believe that this identifying information should be
excluded from a public data release to protect the privacy of
individuals, including but not limited to protecting the
confidentiality of information about Medicare beneficiaries. Regarding
Medicare beneficiaries, we propose to exclude from release any MA bid
pricing data element that is based on fewer than 11 Medicare
beneficiaries as we believe that this threshold establishes the point
at which individual-level data can be discerned. Following our
longstanding data release policy for protecting individually
identifiable information, in the event that data fields in an MA BPT,
MSA BPT, or ESRD SNP BPT are populated with fewer than 11 MA plan
members (or 132 member months, assuming each individual is counted for
12 months), we would suppress all of those data fields in the public
release file for that MA plan bid under our proposed rule. We are not
proposing to build this threshold into the regulation text, however, as
we believe that technology and the ability to reverse-engineer data to
identify beneficiaries may change over time. We may revisit this
threshold as we administer the data releases proposed here (and in
other Medicare contexts) and will make adjustments as necessary to
ensure that we do not disclose data that could be used to identify
beneficiaries. For example, data fields with member months, utilizers,
and utilization per 1,000 could be populated based on fewer than 11 MA
plan members and would be suppressed from the release under this
proposed rule. Protection of information that could identify Medicare
beneficiaries, particularly in the context of their receipt of health
care services, is a long-standing principle of ours in the context of
the Medicare program. Incorporating this principle and the necessary
protection of this data into this proposal to disclose information is
appropriate.
Regarding other individuals, we require the names and contact
information of certifying actuaries and MA plan contacts in the MA bid
submission, that is, in certain fields in the MA BPT, MSA BPT, and
ESRD-SNP BPT, and we also require the names and contact information in
the actuarial certifications submitted by actuaries who prepared the
bids. We propose to exclude this information from the release that we
propose to implement. The actuarial certification consists of
standardized language that we
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developed for the purpose of bidding; for example, the language notes
that the actuary is a member of the American Academy of Actuaries,
federal law and CMS guidance regarding MA bids were followed, the data
and assumptions used in the development of the bid are reasonable, and
Actuarial Standards of Practice were applied. (Certifying actuaries may
choose whether to append additional language.) We do not believe that
these bid certification paragraphs represent information that serves
the goals for this proposed release of MA bid pricing data (for
example, to inform research and public evaluation of the MA program and
to be transparent about spending). In addition, identifying specific
individuals who have worked on a bid for an MAO appears an unnecessary
intrusion into the personal privacy of these individuals. In sum, we
propose to not release any information identifying individual actuaries
or their associated certification paragraphs, to protect individual
names and to not expend resources separating names from each of the
hundreds of identical or similar paragraphs of attestation language.
Finally, at Sec. 422.272(c)(4), we propose to exclude from release
bid review correspondence between us (including our contractors) and
the MAO, and internal bid review reports (for example, bid desk review
documentation housed in the HPMS Bid Desk Review module, which supports
the automated aspects of bid review). First, bid review correspondence
(emails) often involves follow-up questions requesting clarification of
supporting documentation, so our concerns described above regarding the
release of supporting documentation apply to bid review correspondence.
Second, it would not be operationally feasible to determine which set
of bid review emails between our reviewers and MAOs and which internal
bid review reports pertain to the final accepted/approved bid for an MA
plan, which is the data we propose to release.
(d) Timing of MA Bid Pricing Data Release
At Sec. 422.272(d), we propose the timing of the release of MA bid
pricing data as provided in paragraph (b) and limited by the exclusions
in paragraph (c). We propose that the annual release would occur after
the first Monday in October. We selected the first Monday in October as
the date after which the release could occur each year because the
annual bidding cycle has come to a close at this point and we have
completed the approval of MA plan bids for the upcoming contract year
(calendar year). For example, after the first Monday in October 2016,
the bids for contract year 2017 have been accepted; thus, a public
release in December 2016 or January 2017 would be a release of the
final accepted MA bid pricing data for a contract year not more recent
than 2012.
Under this example, our December 2016 release of MA bid pricing
data under this proposed rule may include the following: (1) The
accepted MA BPT worksheets for 2012 in their entirety, subject to the
exceptions Sec. 422.272(c); (2) the accepted MSA BPT worksheets for
2012 in their entirety, subject to the same exceptions; (3) accepted MA
BPTs for 2006 through 2011, subject to the same exceptions; and (4) MSA
BPTs for 2009 through 2011 (as 2009 was the first year this BPT was
used), subject to the same exceptions, because these years are more
than 5 years prior to 2017. However, under the example of a December
2016 release, we would not release any Part C pricing data for ESRD-
SNPs because the ESRD-SNP BPT was used for the first time for contract
year 2014; the first time that data from accepted ESRD-SNP BPTs could
be released under this proposal is after the first Monday in October
2018.
While we propose to authorize release of this data after the first
Monday in October each year, we are not committing to a specific date
for each annual release. We will provide details on each year's release
schedule through sub-regulatory communications. We anticipate that as
the release process becomes more standardized over the years, we will
be able to release these files closer to the proposed regulatory
timeline. In addition, we intend that the first time we implement a
public release MA bid submission data, we may release data for multiple
contract years that meet the criterion of at least 5 years prior to the
upcoming calendar year.
As mentioned in the Background (section III.E.1), in crafting this
proposal to release MA bid pricing data, we are seeking to balance
proprietary interests with our mission to effectively administer
federal health care programs and increase data transparency. We are
soliciting comments on the approach we are proposing for the public
release of MA bid pricing data based on a 5-year lag in the data, and
whether that is the appropriate timeframe to apply to this data
release. We also seek comment on the scope of the proposed release of
BPT worksheets and data elements. We are particularly interested in
whether of the MA bid pricing data we are proposing to release contains
proprietary information, and if so, are requesting detailed
explanations of good cause for its redaction from public availability
and suggestions for what safeguards might be implemented to
appropriately protect those portions of the data. Detailed explanations
should contain specific examples which show how this information
disclosure could cause substantial competitive harm to MAOs. Specific
examples should (1) cite the particular information proposed to be
released and explain how that information differs from publicly
available data; (2) point to the particular entity or entity type that
could gain an unfair competitive advantage from the information
release; and (3) fully explain the mechanism by which the release of
that particular information would create an unfair competitive
advantage for that particular entity. Similarly, we are interested in
comments that our proposed scope for release is too narrow and
unnecessarily protects data that is not confidential and should not be
protected. We are soliciting comments and explanations that show how
the data is not confidential, could not be used to create unfair
competitive disadvantage, and that its release would not have a
chilling effect on the nature and scope of the data that we currently
receive from MAOs in the bid submissions. As noted above, we view this
rulemaking as the opportunity to solicit wide ranging comments on this
issue in order to chart the wisest course for release of pricing data
in support of our goals.
4. Proposed Technical Change
We propose to amend Sec. 422.250 on the basis and scope of the MA
program to add a reference to section 1106 of the Act. As discussed in
the Background (section E.1.), section 1106(a) of the Act (42 U.S.C.
1306(a)) provides us the authority to enact regulations that would
enable the agency to release information filed with this agency.
5. Other Approaches To Release of MA Bid Pricing Data
We are also considering whether to release MA bid pricing data for
years more recent than the 5-year data lag proposal. In 2011, an
academic researcher submitted a request to CMS for certain data
elements regarding the 2009 MA Base Period Experience in the 2011 MA
bid pricing submissions. We rejected the request under Exemption 4 to
the FOIA, 5 U.S.C. 552(b)(4), which exempts from disclosure trade
secrets and confidential or privileged commercial or financial
information that is obtained from a person. In a 2013 opinion, Biles v.
Dep't of Health and Human Services, 931 F. Supp. 2d 211 (D.D.C. 2013),
the U.S. District Court for
[[Page 46403]]
the District of Columbia ordered the release of the requested bid
information, rejecting HHS's argument that release would cause
substantial competitive harm to the private companies that submit bid
data to CMS. The court remarked that the HHS statements about
substantial competitive harm were conclusory. As a result of this
ruling, we released the requested data to the academic researcher (and
the public) at https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/DataRequests.html. In light of this
litigation, as well as anticipated additional requests for more recent
MA bid pricing data, we are soliciting public comments on a range of
approaches we could implement to release data more recent than the
proposal we are currently setting forth for consideration.
For example, we are considering whether to release MA bid pricing
data on a shorter timeframe than the proposed 5-year lagged timeframe,
which could be as recent as MA bid pricing data from the previously-
concluded MA contract year. We are also seeking comment as to whether
the relationship between the passage of time and commercial sensitivity
of the bid data changes more rapidly for some MA bid pricing data
elements than others. If commenters believe this to be the case, we are
seeking the submission of detailed analysis that sets forth which data
elements meet this standard and why.
If unfair competitive harm is included as a rationale for us to
consider in withholding some or all elements of more recent MA bid
pricing data from release, either to external researchers subject to
some limitations in redisclosure of the data or the public at large, we
seek evidence of this competitive harm linked to particular bid data
elements, and a fulsome discussion as to how each of the elements
identified could be used by a competitor to directly harm a competing
MAO. See section III.E.3.d above for detail on what a fulsome
discussion would include, in our explanation of ``specific examples.''
If there are commercially sensitive data elements in the MA bids, we
also seek comment as to whether there are safeguards that might be
appropriately implemented to protect those identified data elements,
while still allowing releases of more recent data.
Finally, we are seeking comment regarding to whom we should release
more recent MA bid pricing data. Specifically, should such a release be
made fully available to the public at large, or only to researchers who
have studies approved through an application process and who are
subject to our long-standing data sharing procedures. If we were to
release MA bid pricing data for years more recent than the 5 year
lagged data we propose here, we also seek comment on whether to use the
existing policies for the release of Part D prescription drug event
(PDE) data at Sec. 423.505(m) and Part C encounter data at Sec.
422.310(f)(2). We also seek comment on whether research results from
the analysis of MA bid pricing data should be subject to additional
restrictions, such as a prohibition of publication of MA bid pricing
data at the plan level or prohibitions on the identification of the
applicable MAO that submitted the data. We seek comment on whether
external researchers should be able to use MA bid pricing data for
commercial purposes rather than to produce research that could be
useful to us in our administration of the Medicare program generally.
We are considering limiting conditions of this type as means to release
as much data while protecting what should be protected.
As discussed in section III.E.3.d above, we are seeking comment on
our proposal that 5 years is an appropriate length of time for the MA
bid pricing data we are proposing to release to no longer be
competitively sensitive. In addition, in setting forth this section
III.E.5 discussion, we are also soliciting comments on how we can best
serve the needs of the public through the sharing of MA bid pricing
data that is less than 5 years old while at the same time addressing
the concerns of MAOs that we appropriately guard against the potential
misuse of data in ways that would undermine protections put in place to
ensure nondisclosure of proprietary data. The purpose of this
solicitation is to both inform our decision-making process about the 5-
year threshold proposed above, as well as to inform future policy
development.
6. Background on Part C and Part D Medical Loss Ratio Data
Section 1103 of Title I, Subpart B of the Health Care and Education
Reconciliation Act (Pub. L. 111-152) amends section 1857(e) of the Act
to add medical loss ratio (MLR) requirements to Medicare Part C. An MLR
is expressed as a percentage, generally representing the percentage of
revenue used for patient care rather than for such other items as
administrative expenses or profit. Because section 1860D-12(b)(3)(D) of
the Act incorporates by reference the requirements of section 1857(e)
of the Act, these MLR requirements also apply to the Part D program. In
the May 23, 2013 final rule (78 FR 31284), we codified the MLR
requirements for MAOs and Part D sponsors in the regulations at part
422, subpart X, and part 423, subpart X.
For contracts beginning in 2014 or later, MAOs, cost plans, and
Part D sponsors are required to report their MLRs and are subject to
financial and other penalties for a failure to meet the statutory
requirement that they have an MLR of at least 85 percent (see Sec.
422.2410 and Sec. 423.2410). The statute imposes several levels of
sanctions for failure to meet the 85 percent minimum MLR requirement,
including remittance of funds to CMS, a prohibition on enrolling new
members, and ultimately contract termination. The minimum MLR
requirement in section 1857(e)(4) of the Act creates incentives for
MAOs and Part D sponsors to reduce administrative costs, such as
marketing costs, profits, and other uses of the funds earned by plan
sponsors, and helps to ensure that taxpayers and enrolled beneficiaries
receive value from Medicare health plans.
Under the regulations at Sec. 422.2410 and Sec. 422.2460, with
respect to MAOs, and Sec. 423.2410 and Sec. 423.2460, with respect to
Part D sponsors, for each contract year, each MAO and Part D sponsor is
required to submit a report to us, in a timeframe and manner that we
specify, which includes the data needed to calculate and verify the MLR
and remittance amount, if any, for each contract. The information that
MAOs and Part D sponsors report to us includes incurred claims for
medical services and prescription drug costs, expenditures on
activities that improve health care quality, taxes, licensing and
regulatory fees, non-claims costs, and revenue.
We have developed a standardized MLR Report template, called the
MLR Report, for MAOs and Part D sponsors to populate with the data used
to calculate the MLR and remittance amount owed to us under Sec.
422.2410 and Sec. 423.2410, if any. The MLR Report is a standardized
Excel workbook with three worksheets and special functions built in
(for example, validation features). We maintain and update the MLR
Report data collection format under OMB #0938-1232.
For each contract year beginning in 2014 or later, MAOs and Part D
sponsors are required to enter their MLR data and upload their MLR
Reports to our Health Plan Management System (HPMS). Based on the data
entered by the MAO or Part D sponsor, the Report calculates the MLR for
the contract. An MA or Part D contract's MLR is increased by a
credibility factor if the contract's experience for the contract
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year is partially credible in actuarial terms, as provided at Sec.
422.2440 and Sec. 423.2440. Finally, we also require MAOs and Part D
sponsors to include in their MLR Reports a detailed description of the
methods used to allocate expenses, including how each specific expense
meets the criteria for the expense category to which it was assigned.
The MLR Report is on our Web site at https://www.cms.gov/Medicare/Medicare-Advantage/Plan-Payment/medicallossratio.html, accompanied by
instructions on how to populate the Report.
Below we describe the categories of Part C and Part D MLR data
submitted in the MLR Reports:
Revenue. MAOs and Part D sponsors must report revenue
received under the contract. The MLR Report includes separate lines for
MAOs and Part D sponsors to report the amounts of revenue received,
such as beneficiary premiums; MA plan payments (based on A/B bids); MA
rebates; Part D direct subsidies; federal reinsurance subsidies; Low
Income Premium Subsidy Amounts; risk corridor payments; and MSA
enrollee deposits (see Sec. 422.2420(c)(1) and Sec. 423.2420(c)(1)).
Claims. MAOs and Part D sponsors must report incurred
claims for clinical services and prescription drug costs, including
categories such as the following: Direct claims paid to providers
(including under capitation contracts with physicians) for covered
services; for an MA contract that includes MA-PD plans, or a Part D
contract, the MLR Report must include drug costs provided to all
enrollees under the contract; liability and reserves for claims
incurred during the contract year; paid and accrued medical incentive
pools and bonuses; reserves for contingent benefits and the medical or
Part D claim portion of lawsuits; MA rebate amounts that are used to
reduce enrollees' Part B premiums; total fraud reduction expenses and
total claim payment recoveries as a result of fraud reduction efforts;
MSA enrollee deposits; and direct and indirect remuneration (see Sec.
422.2420(b) and Sec. 423.2420(b)).
Federal and State Taxes and Licensing or Regulatory Fees.
The MLR Report includes MAOs and Part D sponsors' outlays for taxes and
fees, such as federal income taxes and other federal taxes; state
income, excise, business, and other taxes; state premium taxes;
allowable community benefit expenditures; and licensing and regulatory
fees (see Sec. 422.2420(c)(2) and Sec. 423.2420(c)(2)).
Health Care Quality Improvement Expenses Incurred. MAOs
and Part D sponsors must enter their expenditures for health care
quality improvement. Expenditures are categorized separately depending
on the primary purpose of the activity. Quality improvement expenses
are reported in categories such as: (1) Expenses for improving health
outcomes through the implementation of activities such as quality
reporting, effective case management, care coordination, chronic
disease management, and medication and care compliance initiatives; (2)
expenses for implementing activities to prevent hospital readmissions;
(3) expenses for activities primarily designed to improve patient
safety, reduce medical errors, and lower infection and mortality rates;
(4) expenses for activities primarily designed to implement, promote,
and increase wellness and health activities; (5) expenditures to
enhance the use of health care data to improve quality, transparency,
and outcomes and support meaningful use of health information
technology; or (6) allowable ICD-10 implementation costs (see Sec.
422.2430(a)(1) and Sec. 423.2430(a)(1)).
Non-Claims Costs. MAOs and Part D sponsors must report
expenditures for non-claims costs, such as administrative fees, direct
sales salaries and benefits, brokerage fees and commissions, regulatory
fines and penalties, cost containment expenses not included as quality
improvement expenses, all other claims adjustment expenses, non-
allowable community benefit expenditures, and non-allowable ICD-10
implementation costs (see Sec. 422.2430(b) and Sec. 423.2430(b)).
Employer Group Waiver Plan (EGWP) Reporting Methodology.
We only apply the MLR requirement to the Medicare-funded portion of
EGWPs. MLR Reports submitted for MA or Part D contracts that include
EGWPs must specify the percentage of the contract's total revenue that
was funded by Medicare. The MLR Report must also identify the
methodology that the MAO or Part D sponsor used to determine the
Medicare-funded portion of the EGWP (see Sec. 422.2420 and Sec.
423.2420).
Total Member Months. MAOs and Part D sponsors must report
all member months across all plans under the contract (see Sec.
422.2440 and Sec. 423.2440).
Plan-Specific Data. MAOs and Part D sponsors enter a list
of all of the plans offered under the contract, and the member months
associated with each plan entered. They must provide additional details
about each plan that is listed, including whether the plan is a Special
Needs Plan for beneficiaries who are dually eligible for both Medicare
and Medicaid (D-SNP); whether the plan's defined service area includes
counties in one of the territories; and plan-level cost and revenue
information for D-SNPs in territories (see Sec. 422.2420(a) and Sec.
423.2420(a)).
Medical Loss Ratio Numerator. This is a calculated field
that is the sum of all amounts reported as claims or as health care
quality improvement expenses in the MLR Report (see Sec. 422.2420(b)
and Sec. 423.2420(b)).
Medical Loss Ratio Denominator. This field is calculated
by taking the contract's total revenue and deducting the sum of the
reported licensing or regulatory fees, federal and state taxes, and
allowable community benefit expenditures (see Sec. 422.2420(c) and
Sec. 423.2420(c)).
Credibility Adjustment. An MAO or Part D sponsor may add a
credibility adjustment to a contract's MLR if the contract's experience
is partially credible, as determined by us (see Sec. 422.2440(d) and
Sec. 423.2440(d)). If a contract receives a credibility adjustment
(determined by the number of total member months under the contract),
this field is populated by a percentage that represents the credibility
adjustment factor (see Sec. 422.2440(a) and Sec. 423.2440(a)).
Unadjusted MLR. This is a calculated field that reflects
the MLR for an MA or Part D contract before application of the
credibility adjustment (see Sec. 422.2440 and Sec. 423.2440).
Adjusted MLR. This is a calculated field that represents
the MLR after the application of the credibility adjustment factor (see
Sec. 422.2440(a) and Sec. 423.2440(a)).
Remittance Amount Due to CMS for the Contract Year. The
MLR Report includes any amounts that the MAO or Part D sponsor must
remit to us. The MLR Report identifies the amount of the remittance
that is allocated to Parts A and B, and the amount allocated to Part D
(see Sec. 422.2410(c) and Sec. 423.2410(c)).
7. Proposed Regulatory Changes for Release of MLR Data
a. Proposed Addition of Sec. 422.2490 and Sec. 423.2490 Authorizing
Release of Part C and Part D Medical Loss Ratio Data
We are proposing to add new contract requirements, codified in new
regulations at Sec. Sec. 422.504 and 422.2490 of part 422, with
respect to Part C MLR data, and Sec. Sec. 423.505 and 423.2490 of part
423, with respect to Part D MLR data, to authorize release to the
public by CMS of certain MLR data submitted by MAOs and Part D
sponsors. We propose to define Part C MLR data at Sec. 422.2490(a),
and Part D MLR data at
[[Page 46405]]
Sec. 423.2490(a), as the data the MAOs and Part D sponsors submit to
us in their annual MLR Reports, as required under existing Sec.
422.2460 and Sec. 423.2460. At Sec. 422.2490(b) and Sec.
423.2490(b), we propose certain exclusions to the definitions of Part C
MLR data and Part D MLR data, respectively. Finally, we propose at
Sec. 422.2490(c) and Sec. 423.2490(c) to release the Part C MLR data
and Part D MLR data, respectively, for each contract for each contract
year, no earlier than 18 months after the end of the applicable
contract year.
Generally, the MLR for each MA and Part D contract reflects the
ratio of costs (numerator) to revenues (denominator) for all enrollees
under the contract. For an MA contract, the MLR reflects the percentage
of revenue received under the contract spent on incurred claims for all
enrollees, prescription drug costs for those enrollees in MA plans
under the contract offering the Part D benefit, quality initiatives
that meet the requirements at Sec. 422.2430, and amounts spent to
reduce Part B premiums. The MLR for a Part D contract reflects the
percentage of revenue received under the contract spent on incurred
claims for all enrollees for Part D prescription drugs, and on quality
initiatives that meet the requirements at Sec. 423.2430. The
percentage of revenue that is used for other items such as
administration, marketing, and profit is excluded from the numerator of
the MLR (see Sec. 422.2401 and Sec. 423.2401; Sec. 422.2420(b)(4)
and Sec. 423.2420(b)(4); Sec. 422.2430(b) and Sec. 423.2430(b)).
As discussed in section III.F.1. of this proposed rule, our
proposed release of Part C and Part D MLR data is in keeping with
Presidential initiatives to improve federal management of information
resources by increasing data transparency and access to federal
datasets. In proposing this release, we are also seeking to align with
current disclosures of MLR data that issuers of commercial health plans
submit each year as required by section 2718 of the Public Health
Service Act. We have published similar commercial MLR data on our Web
site at https://www.cms.gov/CCIIO/Resources/Data-Resources/mlr.html.
The MLR data that we propose to release will enable enrollees,
consumers, regulators, and others to see how much of plan sponsors'
revenue is used to pay for services, quality improving activities, and
Part B premium rebates versus how much is used to pay for ``non-
claims,'' or administrative expenses, incurred by the plan sponsor. We
believe that the release of this data will facilitate public evaluation
of the MA and Part D programs by providing insight into the efficiency
of health insurers' operations. In addition, we believe that our
proposed policy for the release of certain MLR data will provide
beneficiaries with information that can be used to assess the relative
value of Medicare health and drug plans.
b. Exclusions From the Release of Part C and Part D MLR Data
For the purpose of this data release under proposed Sec. 422.2490
and Sec. 423.2490, we would exclude four categories of information
from the release of Part C and Part D MLR data, as described at
proposed Sec. 422.2490(b) and Sec. 423.2490(b), respectively. First,
at Sec. 422.2490(b)(1) and Sec. 423.2490(b)(1), we propose to exclude
from release any narrative information that MAOs and Part D sponsors
submit to support the amounts that they include in their MLR Reports,
such as descriptions of the methods used to allocate expenses. MAOs and
Part D sponsors are required to describe the methods they used to
allocate expenses, including incurred claims, quality improvement
expenses, federal and state taxes and licensing or regulatory fees, and
other non-claims costs. A detailed description of each expense element
should be provided, including how each specific expense meets the
criteria for the type of expense in which it is categorized. We believe
that descriptions of expense allocation methods should be excluded
because MAOs and Part D sponsors may be required to provide information
that is pertinent to more than the individual MA or Part D contract for
which the MLR Report is being submitted (see, for example, Sec.
422.2420(d)(1)(ii) and Sec. 423.2420(d)(1)(ii), which requires that
expenditures that benefit multiple contracts, or contracts other than
those being reported, be reported on a pro rata share), such as an
MAO's or Part D sponsor's proprietary approach to setting payment rates
in contracts with providers, or its strategies for investing in
activities that improve health quality. We are concerned that MAOs and
Part D sponsors would be reluctant to submit narrative descriptions
that include information that they regard as proprietary if they know
that it will be disclosed to the public, which could impair our ability
to assess the accuracy of their allocation methods.
Second, at Sec. 422.2490(b)(2) and Sec. 423.2490(b)(2), we
propose to exclude from release any plan-level information that MAOs
and Part D sponsors submit in their MLR Reports. Some of the plan-level
data in MAO's and Part D sponsors' MLR Reports is also included in
their plan bids as base period experience data, such as plan IDs, plan
member months, and Medicaid per member per month gain/loss. As
discussed in our proposal to release certain MA bid pricing data, we
believe bid data would no longer be competitively sensitive after 5
years; however, we do not believe that bid data becomes no longer
competitively sensitive within the 18-month timeframe for our proposed
release of MLR data. Therefore, we will exclude from our proposed
release plan-level data that is included as base period experience data
in plan bids. We also propose to exclude the plan-level information
submitted in MLR Reports because we do not regard it as relevant to the
purposes of our proposed release of Part C and Part D MLR data, which
include giving the public access to data that can be used to evaluate
the efficiency of MAOs and Part D sponsors and providing enrollees with
information that can be used to compare the relative value of health
plans. For example, our proposed release would exclude MAOs' and Part D
sponsors' responses to questions in the MLR Report that ask whether
each plan under a contract is a Special Needs Plan for beneficiaries
who are dually eligible for both Medicare and Medicaid (D-SNP), or
whether the plan's defined service area includes counties in one of the
territories.
Third, at Sec. 422.2490(b)(3) and Sec. 423.2490(b)(3), we propose
to exclude from release any information identifying Medicare
beneficiaries or other individuals. This exclusion is proposed for the
same reason we propose to exclude similar information from MA bid
submission data that will be released; we believe that it is important
to protect the privacy of individuals identified in these submissions,
particularly Medicare beneficiaries. Protection of information that
could identify Medicare beneficiaries, particularly in the context of
their receipt of health care services, is a long-standing principle of
ours in the context of the Medicare program. Incorporating this
principle and the necessary protection of this data into this proposal
to disclose information is appropriate. With respect to Medicare
beneficiaries, we propose to exclude from release any information (that
is, data elements) in an MLR Report for a contract if the total number
of beneficiaries under the contract is fewer than 11, as we believe
that this threshold establishes the point at which individual-level
data can be discerned. Following our longstanding data release policy
for protecting
[[Page 46406]]
individually identifiable information, if a data field in the MLR
Report for an MA or Part D contract is calculated based on figures
associated with fewer than 11 enrollees (or 132 member months, assuming
each individual is counted for 12 months), we would suppress all the
data from such fields in the public release file for that contract. We
are not proposing to build this threshold into the regulation text,
however, as we believe that as technology changes and the ability to
reverse-engineer data to identify beneficiaries may change over time.
We may revisit this threshold as we administer the data releases
proposed here (and in other Medicare contexts) and will make
adjustments as necessary to ensure that we do not disclose data that
could be used to identify beneficiaries.
Regarding other individuals, we require that MAOs and Part D
sponsors provide in their MLR Reports the names and contact information
of individuals who can answer questions about the data submitted in an
MLR Report. We propose to exclude this information from release. We do
not believe that the release of this information serves the purposes of
our proposed release of certain MLR data, which are to provide the
public with data that can be used to evaluate MA and Part D contracts'
efficiency, and to provide beneficiaries with information that can be
used to compare the relative value of Medicare plans. Further, release
of this identifying and contact information appears to be an
unnecessary intrusion into information about private individuals.
Fourth, at Sec. 422.2490(b)(4) and Sec. 423.2490(b)(4), we
propose to exclude from release any MLR review correspondence. In the
course of the MLR review process, our reviewers may engage in
correspondence with MAOs and Part D sponsors in order to validate
amounts included in their MLR Reports. Such correspondence may include
requests for evidence of amounts reported to us. Responses to these
requests could include competitively-sensitive information, such as
MAOs' and Part D sponsors' negotiated rates of reimbursement. Release
of this correspondence could cause MAOs to be less forthcoming in the
information provided to CMS, which would impede the ability of the
agency to verify the information submitted by MAOs and Part D sponsors.
c. Timing of Release of Part C and Part D MLR Data
We are proposing to release the MLR data specified in this rule for
each MA and Part D contract on an annual basis no earlier than 18
months after the end of the contract year to which the MLR data
applies. We are proposing to follow the commercial MLR approach in
making the data we receive in MLR Reports available to the public. For
Part C and Part D MLR reporting, the data is due about 12 months after
the end of the contract year. After we receive MAOs' and Part D
sponsors' MLR Reports, we anticipate that it will take up to six months
for us to review and finalize the data submitted by MAOs and Part D
sponsors.
We believe that our proposed release of contract-level MLR data
strikes the appropriate balance between safeguarding information that
could be commercially sensitive or proprietary and providing enrollees
of health plans, consumers, regulators, and others with a measure that
can be used to evaluate health insurers' efficiency. The Part C MLR
data and Part D MLR data that we propose to release is aggregated at
the contract level. Costs in the MLR numerator are aggregated across
providers, beneficiaries, and sites of service. Costs and revenues are
further aggregated across all plans under the contract. We do not
believe that there is a realistic possibility that the MLR data that we
propose to release could be disaggregated or reverse engineered to
reveal commercially sensitive or proprietary information. We seek
comment on this point and on our analysis of the commercial sensitivity
of this information.
We believe the availability of the Part C MLR data and Part D MLR
data we are proposing to release will provide beneficiaries a measure
by which they can compare the relative value of Medicare products. Our
proposed release of MLR data will permit enrollees of health plans,
consumers, regulators, and others to take into consideration MLRs when
evaluating health insurers' efficiency.
We also believe the availability of MLR data will enhance the
competitive nature of the MA and Part D programs. The proposed access
to data will support potential plan sponsors in evaluating their
participation in the Part C and D programs and will facilitate the
entry into new markets of existing plan sponsors. In knowing historical
MLR data, new business partners might emerge, and better business
decisions might be made by existing partners. As a result, we believe
that releasing Part C and Part D MLR data as proposed is both necessary
and appropriate for the effective operation of these programs.
We seek comment on the release of Part C MLR data and Part D MLR
data as outlined above. We solicit comment on whether the Part C MLR
data and Part D MLR data we propose to release contain proprietary
information, and if so, what safeguards might be appropriate to protect
those data, such as recommended fields to be redacted, the minimum
length of time that such data remains commercially sensitive, and any
suggestions for publishing aggregations of Part C MLR data and Part D
MLR data in lieu of publishing the MLR data as submitted by MAOs and
Part D sponsors. We invite commenters to provide analysis and
explanations to support comments that information should be protected
for a longer--or shorter--period of time so that we may properly
evaluate our proposal in adopting a final rule. Analysis and
explanations should (1) cite the particular information proposed to be
released and explain how that information differs from publicly
available data; (2) point to the particular entity or entity type that
could gain an unfair competitive advantage from the information
release; and (3) fully explain the mechanism by which the release of
that particular information would create an unfair competitive
advantage for that particular entity.
We also solicit comment on whether MLR data that is associated
single-plan contracts is more commercially sensitive than MLR data that
is associated with contracts that include multiple plans, and if so,
whether we should take any protective measures when releasing the MLR
data for single-plan contracts, such as redacting data fields that
could be used to identify the contract, withholding the MLR data for
all single-plan contracts and instead publishing a data set consisting
of figures that have been averaged across all single-plan contracts, or
by releasing a more limited data set for single-plan contracts.
8. Proposed Technical Changes
We are proposing to amend Sec. 422.2400, which identifies the
basis and scope of the MLR regulations for MAOs, and Sec. 423.2400,
which identifies the basis and scope of the MLR regulations for Part D
sponsors, to add a reference to section 1106 of the Act, which governs
the release of information gathered in the course of administering our
programs under the Act.
F. Prohibition on Billing Qualified Medicare Beneficiary Individuals
for Medicare Cost-Sharing
We remind all Medicare providers (including providers of services
defined in section 1861 of the Act and
[[Page 46407]]
physicians) that federal law prohibits them from collecting Medicare
Part A and Medicare Part B deductibles, coinsurance, or copayments,
from beneficiaries enrolled in the Qualified Medicare Beneficiaries
(QMB) program (a Medicaid program which helps certain low-income
individuals with Medicare cost-sharing liability). In July 2015, we
released a study finding that confusion and inappropriate balance
billing persist notwithstanding laws prohibiting Medicare cost-sharing
charges for QMB individuals, Access to Care Issues Among Qualified
Medicare Beneficiaries (QMB) (``Access to Care'') https://www.cms.gov/Medicare-Medicaid-Coordination/Medicare-and-Medicaid-Coordination/Medicare-Medicaid-Coordination-Office/Downloads/Access_to_Care_Issues_Among_Qualified_Medicare_Beneficiaries.pdf.
These findings underscore the need to re-educate providers about
proper billing practices for QMB enrollees.
In 2013, approximately 7 million Medicare beneficiaries were
enrolled in the QMB program. State Medicaid programs are liable to pay
Medicare providers who serve QMB individuals for the Medicare cost-
sharing. However, as permitted by federal law, states can limit
provider payment for Medicare cost-sharing to the lesser of the
Medicare cost-sharing amount, or the difference between the Medicare
payment and the Medicaid rate for the service. Regardless, Medicare
providers must accept the Medicare payment and Medicaid payment (if
any, and including any permissible Medicaid cost sharing from the
beneficiary) as payment in full for services rendered to a QMB
individual. Medicare providers who violate these billing prohibitions
are violating their Medicare Provider Agreement and may be subject to
sanctions. (See sections 1902(n)(3); 1905(p); 1866(a)(1)(A); 1848(g)(3)
of the Act.)
Providers should take steps to educate themselves and their staff
about QMB billing prohibitions and to exempt QMB individuals from
impermissible Medicare cost-sharing billing and related collection
efforts. For more information about these requirements, steps to
identify QMB patients and ways to promote compliance, see https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/se1128.pdf.
Given that original Medicare providers may also serve Medicare
Advantage enrollees, we note that the CY 2017 Medicare Advantage Call
Letter reiterates the billing prohibitions applicable to dual eligible
beneficiaries (including QMBs) enrolled in Medicare Advantage plans and
the responsibility of plans to adopt certain measures to protect dual
eligible beneficiaries from unauthorized charges under Sec.
422.504(g). (See pages 181-183 at https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Downloads/Announcement2017.pdf).
G. Recoupment or Offset of Payments to Providers Sharing the Same
Taxpayer Identification Number
1. Overview and Background
Medicare payments to providers and suppliers may be offset or
recouped, in whole or in part, by a Medicare contractor if the Medicare
contractor or CMS has determined that a provider or supplier has been
overpaid. Historically, we have used the Medicare provider billing
number or National Provider Identifier (NPI) to recoup overpayments
from Medicare providers and suppliers until these debts were paid in
full or eligible for referral to the Department of Treasury (Treasury)
for further collection action under the Debt Collection Improvement Act
of 1996 and the Digital Accountability and Transparency Act of 2014.
Once an overpayment is referred to Treasury, the Treasury's Debt
Management Services uses various tools to collect the debt, including
offset of federal payments against entities that share the same
provider Taxpayer Identification Number (TIN). Hence, Treasury has the
ability to collect our overpayments using the provider TIN and we pay a
fee for every collection made.
On March 23, 2010, the Affordable Care Act (ACA) was enacted.
Section 6401(a)(6) of the Affordable Care Act established a new section
1866(j)(6) of the Act. Section 1866j(6) of the Act allows the Secretary
to make any necessary adjustments to the payments to an applicable
provider of services or supplier to satisfy any amount due from an
obligated provider of services or supplier. The statute defines an
applicable provider of services or supplier (applicable provider) as a
provider of services or supplier that has the same taxpayer
identification number as the one assigned to the obligated provider of
services or supplier. The statute defines the obligated provider of
services or supplier (obligated provider) as a provider of services or
supplier that owes a past-due overpayment to the Medicare program. For
purposes of this provision, the applicable and obligated providers must
share a TIN, but may possess a different billing number or National
Provider Identifier (NPI) number than one another.
For example, a health care system may own a number of hospital
providers and these providers may share the same TIN while having
different NPI or Medicare billing numbers. If one of the hospitals in
this system receives a demand letter for a Medicare overpayment, then
that hospital (Hospital A) will be considered the obligated provider
while its sister hospitals (Hospitals B and C) will be considered the
applicable providers. This authority allows us to recoup the
overpayment of the obligated provider, Hospital A, against any or all
of the applicable providers, Hospitals B and C, with which it, Hospital
A, shares a TIN.
2. Provisions of the Proposed Regulations
If CMS or a Medicare contractor has decided to put into effect an
offset or recoupment, then Sec. 405.373(a) requires the Medicare
contractor to notify the provider or supplier in writing of its
intention to fully or partially offset or recoup payment and the
reasons for the offset or recoupment. Currently, the written demand
letter sent by the Medicare contractor to a provider or supplier serves
as notification of the overpayment and intention to recoup or offset if
the obligated provider, Hospital A, fails to repay the overpayment in a
timely manner.
With the passage of section 1866(j)(6) of the Act, the requirements
in Sec. 405.373(a) could be interpreted to require the Medicare
contractor to provide notification to both the obligated provider,
Hospital A, and the applicable provider, Hospital B, of its intention
to recoup or offset payment. Because we don't think it is necessary to
provide separate notice to both the obligated provider and the
applicable provider, we propose to amend the notice requirement in
Sec. 405.373. Specifically, we propose to create a new paragraph (f)
in Sec. 405.373 to state that Sec. 405.373(a) does not apply in
instances where the Medicare Administrative Contractor intends to
offset or recoup payments to the applicable provider of services or
supplier to satisfy an amount due from an obligated provider of
services or supplier when the applicable and obligated provider of
services or supplier share the same Taxpayer Identification Number.
Before the effective date of this rule, we intend to notify all
potentially affected Medicare providers of the implementation of
section 1866j(6) of the Act through Medicare Learning Network (MLN) or
MLN Connects Provider eNews article(s), an update to
[[Page 46408]]
the current Internet Only Manual instructions including, the Medicare
Financial Management Manual, and the addition of clarifying language in
the demand letters issued to obligated providers. We believe these
actions would provide adequate notice to providers and suppliers
sharing a TIN, if they choose, provide the opportunity to implement a
tracking system of Medicare overpayments on the corporate level for the
affected providers. We also believe these actions are sufficient
because of Treasury's analogous practice of offsetting using a TIN
without furnishing notice to all potentially affected providers and
suppliers. It has been a long standing practice for Treasury to offset
federal payments using the TIN and Treasury currently does not issue a
notice of intent to recoup or offset to applicable providers and
suppliers when Treasury recoups CMS overpayments.
Additionally, in our review of Sec. 405.373(a) and (b), we propose
to replace the terms intermediary and carrier with the term Medicare
Administrative Contractor as intermediaries and carriers no longer
exist.
H. Accountable Care Organization (ACO) Participants Who Report
Physician Quality Reporting System (PQRS) Quality Measures Separately
The Affordable Care Act gives the Secretary authority to
incorporate reporting requirements and incentive payments from certain
Medicare programs into the Shared Savings Program, and to use
alternative criteria to determine if payments are warranted.
Specifically, section 1899(b)(3)(D) of the Act affords the Secretary
discretion to incorporate reporting requirements and incentive payments
related to the physician quality reporting initiative (PQRI), under
section 1848 of the Act, including such requirements and such payments
related to electronic prescribing, electronic health records, and other
similar initiatives under section 1848, and permits the Secretary to
use alternative criteria than would otherwise apply (under section 1848
of the Act) for determining whether to make such payments.
Current Shared Savings Program regulations at Sec. 425.504(c) do
not allow eligible professionals (EPs) billing through the Taxpayer
Identification Number (TIN) of an Accountable Care Organization (ACO)
participant to participate in PQRS outside of the Shared Savings
Program, and these EPs and the ACO participants through which they bill
may not independently report for purposes of the PQRS apart from the
ACO. This policy was designed to ease reporting burden for individual
EPs and group practices and promote integration of providers and
suppliers within the ACO in order to help achieve the Shared Savings
Program goals of improving quality and coordination of care. While over
98 percent of ACOs satisfactorily report their quality data annually,
if an ACO fails to satisfy the PQRS reporting requirements, the
individual EPs and group practices participating in that ACO will
receive the PQRS payment adjustment along with the automatic VM
downward payment adjustment.
We are proposing to amend the regulation at Sec. 425.504 to permit
EPs that bill under the TIN of an ACO participant to report separately
for purposes of the 2018 PQRS payment adjustment when the ACO fails to
report on behalf of the EPs who bill under the TIN of an ACO
participant. Specifically, we are proposing to remove the requirement
at Sec. 425.504(c)(2) so that, for purposes of the reporting period
for the 2018 PQRS payment adjustment (that is, January 1, 2016, through
December 31, 2016), EPs who bill under the TIN of an ACO participant
have the option of reporting separately as individual EPs or group
practices. If the ACO fails to satisfactorily report on behalf of such
EPs or group practices, we are proposing to consider this separately
reported data for purposes of determining whether the EPs or group
practices are subject to the 2018 PQRS payment adjustment. We are also
proposing to amend Sec. 425.504(c)(2) to apply only for purposes of
the 2016 payment adjustment. We propose at Sec. 425.504(d) the revised
requirements for the 2017 and 2018 PQRS payment adjustment under the
Shared Savings Program. We discuss the proposed changes for the 2017
PQRS payment adjustment under the Shared Savings Program in more detail
later in this section.
We note that the registration deadline for participating in the
PQRS Group Practice Reporting Option (GPRO) is June 30 of the
applicable reporting period. Since affected EPs are not able to
register for the PQRS GPRO by the applicable deadline for the 2018 PQRS
payment adjustment, we propose that such EPs would not need to register
for the PQRS GPRO for the 2018 PQRS payment adjustment, but rather mark
the data as group data in their submission. Thus, we are proposing to
eliminate a registration process for groups submitting data using third
party entities. When groups submit data utilizing third party entities,
such as a qualified registry, QCDR, direct EHR product, or EHR data
submission vendor, we are able to obtain group information from the
third party entity and discern whether the data submitted represents
group submission or individual submission once the data is submitted.
In addition, we propose that an affected EP may utilize the secondary
reporting period either as an individual EP using one of the registry,
qualified clinical data registry (QCDR), direct Electronic Health
Record (EHR) product, or EHR data submission vendor reporting options
or as a group practice using one of the registry, QCDR, direct EHR
product, or EHR data submission vendor reporting options. We note that
this would exclude, for individual EPs, the claims reporting option
and, for group practices, the Web Interface and certified survey vendor
reporting options.
Furthermore, we recognize that certain EPs are similarly situated
with regard to the 2017 PQRS payment adjustment, which will be applied
beginning on January 1, 2017. We believe it is appropriate and
consistent with our stated policy goals to afford these EPs the benefit
of this proposed policy change. Accordingly, as noted above,we are
proposing to permit EPs that bill through the TIN of an ACO participant
to report separately for purposes of the 2017 PQRS payment adjustment
if the ACO failed to report on behalf of the EPs who bill under the TIN
of an ACO participant. Specifically, we are proposing to remove the
requirements at Sec. 425.504(c)(2) so that, for purposes of the
reporting period for the 2017 PQRS payment adjustment, EPs who bill
under the TIN of an ACO participant have the option of reporting
separately as individual EPs or group practices. As noted above, we are
proposing to amend Sec. 425.504(c)(2) to apply only for purposes of
the 2016 payment adjustment. We propose at Sec. 425.504(d) the revised
requirements for the 2017 and 2018 PQRS payment adjustment under the
Shared Savings Program.
The previously established reporting period for the 2017 PQRS
payment adjustment is January 1, 2015, through December 31, 2015. To
allow affected EPs that participate in an ACO to report separately for
purposes of the 2017 PQRS payment adjustment, we are proposing at Sec.
414.90(j)(1)(ii) to establish a secondary PQRS reporting period for the
2017 PQRS payment adjustment for individual EPs or group practices who
bill under the TIN of an ACO participant if the ACO failed to report on
behalf of such individual EPs or group practices during the previously
established reporting period for the
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2017 PQRS payment adjustment. This option is limited to EPs that bill
through the TIN of an ACO participant in an ACO that failed to
satisfactorily report on behalf of its EPs and would not be available
to EPs that failed to report for purposes of PQRS outside the Shared
Savings Program.
In addition, we propose that these affected EPs may utilize the
secondary reporting period either as an individual EP using the
registry, QCDR, direct EHR product, or EHR data submission vendor
reporting options or as a group practice using one of the registry,
QCDR, direct EHR product, or EHR data submission vendor reporting
options. We note that this would exclude, for individual EPs, the
claims reporting option and, for group practices, the Web Interface and
certified survey vendor reporting options.
We note that the registration deadline for the participating in the
PQRS GPRO is June 30 of the applicable reporting period. Since the
applicable deadline for the 2017 PQRS payment adjustment has passed, we
propose that such EPs would not need to register for the PQRS GPRO for
the 2017 PQRS payment adjustment, but rather would be able to report as
a group practice via the registry, QCDR, direct EHR product, or EHR
data submission vendor reporting options. Therefore, we propose at
Sec. 414.90(j)(4)(v) that sections Sec. 414.90(j)(8)(ii), (iii), and
(iv) would apply to affected EPs reporting as individuals using this
secondary reporting period for the 2017 PQRS payment adjustment. In
addition, we propose at Sec. 414.90(j)(7)(viii) that sections Sec.
414.90(j)(9)(ii), (iii), and (iv) would apply to affected EPs reporting
as group practices using this secondary reporting period for the 2017
PQRS payment adjustment. Further, we propose at Sec. 414.90(k)(4)(ii)
that Sec. 414.90(k)(5) would apply to affected EPs reporting as
individuals or group practices using this secondary reporting period
for the 2017 PQRS payment adjustment.
We are also proposing that the secondary reporting period for the
2017 PQRS payment adjustment would coincide with the reporting period
for the 2018 PQRS payment adjustment (that is, January 1, 2016 through
December 31, 2016). In addition, for operational reasons and to
minimize any additional burden on affected EPs (who are already
required to report for CY 2016 for purposes of the 2018 PQRS payment
adjustment), we propose to assess the individual EP or group practice's
2016 data using the applicable satisfactory reporting requirements for
the 2018 PQRS payment adjustment (including, but not limited to, the
applicable PQRS measure set). We invite comment on any 2018
requirements that may need to be modified when applied for purposes of
the 2017 PQRS payment adjustment,
As a result, individual EP or group practice 2016 data could be
used with respect to the secondary reporting period for the 2017
payment adjustment or for the 2018 payment adjustment or for both
payment adjustments if the ACO in which the affected EPs participate
failed to report for purposes of the applicable payment adjustment. We
believe this change to our program rules is necessary for affected
individual EPs and group practices to be able to take advantage of the
additional flexibility proposed at section III.K.1.e. for the Shared
Savings Program. If an affected individual EP or group practice decides
to use the secondary reporting period for the 2017 payment adjustment,
it is important to note that this EP or group practice should expect to
receive a PQRS payment adjustment for services furnished in 2017 until
CMS is able to determine that the EP or group practice satisfactorily
reported for purposes of the 2017 PQRS payment adjustment. First, we
would need to process the data submitted for 2016. Second, we would
need to determine whether or not the individual EP or group practice
met the applicable satisfactory reporting requirements for the 2018
PQRS payment adjustment. Third, we would need to update the individual
EP or group practice's status so that the EP or group practice stops
receiving a negative payment adjustment on claims for services
furnished in 2017 and reprocess all claims that were previously paid.
In addition, as discussed further in section III.L. of this proposed
rule, the EP or group practice would also avoid the automatic downward
VM adjustment, but would not qualify for an upward adjustment since the
ACO failed to report.
Since EPs and group practices taking advantage of this secondary
reporting period for the 2017 PQRS payment adjustment will have missed
the deadline for submitting an informal review request for the 2017
PQRS payment adjustment, we propose the informal review submission
periods for these EPs or group practices would occur during the 60 days
following the release of the PQRS feedback reports for the 2018 PQRS
payment adjustment.
We request comments on these proposals.
I. Medicare Advantage Provider Enrollment
1. Background
a. General Overview
The Medicare program is the primary payer of health care for
approximately 54 million beneficiaries and enrollees. Section 1802(a)
of the Act permits beneficiaries to obtain health services from any
individual or organization qualified to participate in the Medicare
program. Providers and suppliers furnishing items or services must
comply with all applicable Medicare requirements stipulated in the Act
and codified in the regulations. These requirements are meant to
promote quality care while protecting the integrity of the program. As
a major component of our fraud prevention activities, we have increased
our efforts to prevent unqualified individuals or organizations from
enrolling in Medicare.
The term ``provider of services'' is defined in section 1861 of the
Act as a hospital, a critical access hospital (CAH), a skilled nursing
facility (SNF), a comprehensive outpatient rehabilitation facility
(CORF), a home health agency (HHA), or a hospice. The term ``supplier''
is defined in section 1861(d) of the Act as, unless context otherwise
requires, a physician or other practitioner, facility or other entity
(other than a provider of services) that furnishes items or services
under title XVIII of the Act. Other supplier categories may include,
for example, physicians, nurse practitioners, and physical therapists.
Providers and suppliers that fit into these statutorily defined
categories may enroll in Medicare if they meet the proper screening and
enrollment requirements. This proposed rule would require MA
organization providers and suppliers to be enrolled in Medicare in an
approved status. We generally refer to an ``approved status'' as a
status whereby a provider or supplier is enrolled in, and is not
revoked from, the Medicare program. For example, a provider or supplier
that has submitted an application, but has not completed the enrollment
process with their respective Medicare Administrative Contractor (MAC),
is not enrolled in an approved status. The submission of an enrollment
application does not deem a provider or supplier enrolled in an
approved status. A provider or supplier that is currently revoked from
Medicare is not in an approved status. Out-of network or non-contract
providers and suppliers are not required to enroll in
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Medicare to meet the requirements of this proposed rule.
b. Background
To receive payment for a furnished Medicare Part A or Part B
service or item, or to order, certify, or prescribe certain Medicare
services, items, and drugs, a provider or supplier must enroll in
Medicare. The enrollment process requires the provider or supplier to
complete, sign, and submit to its assigned Medicare contractor the
appropriate Form CMS-855 enrollment application. The CMS-855
application form captures information about the provider or supplier
that is needed for CMS or its contractors to screen the provider or
supplier and determine whether the provider or supplier meets all
Medicare requirements. This screening prior to enrollment helps to
ensure that unqualified individuals and entities do not bill Medicare
and that the Medicare Trust Funds are accordingly protected. Data
collected and verified during the enrollment process generally
includes, but is not limited to: (1) Basic identifying information (for
example, legal business name, tax identification number); (2) state
licensure information; (3) practice locations; and (4) information
regarding ownership and management control.
We strive to further strengthen its provider and supplier
enrollment process to prevent and deter problematic providers and
suppliers from entering the Medicare program. This includes, but is not
limited to, enhancing its program integrity monitoring systems and
revising its provider and supplier enrollment regulations in 42 CFR
424, subpart P, and elsewhere as needed. With authority granted by the
Act, including provisions in the Affordable Care Act and Medicare
Access and CHIP Reauthorization Act, we have revised our provider and
supplier enrollment regulations by issuing the following:
In the February 2, 2011 Federal Register (76 FR 5861), we
published a final rule with comment period titled, ``Medicare,
Medicaid, and Children's Health Insurance Programs; Additional
Screening Requirements, Application Fees, Temporary Enrollment
Moratoria, Payment Suspensions and Compliance Plans for Providers and
Suppliers.'' This final rule with comment period implemented major
Affordable Care Act provisions, including the following:
++ A requirement that institutional providers and suppliers must
submit application fees as part of the Medicare, Medicaid, and CHIP
provider and supplier enrollment processes.
++ Establishment of Medicare, Medicaid, and CHIP provider and
supplier risk-based enrollment screening categories and corresponding
screening requirements.
++ Authority that enabled imposition of temporary moratoria on the
enrollment of new Medicare, Medicaid, and CHIP providers and suppliers
of a particular type (or the establishment of new practice locations of
a particular type) in a geographic area.
In the April 27, 2012 Federal Register (77 FR 25284), we
published a final rule titled, ``Medicare and Medicaid Programs;
Changes in Provider and Supplier Enrollment, Ordering and Referring,
and Documentation Requirements and Changes in Provider Agreements.''
The rule implemented another major Affordable Care Act provision and
required, among other things, that providers and suppliers that order
or certify certain items or services be enrolled in or validly opted-
out of the Medicare program.
++ This requirement was expanded to include prescribers of Medicare
Part D drugs in the final rule published in the May 23, 2014 Federal
Register (79 FR 29844) titled, ``Medicare Program; Contract Year 2015
Policy and Technical Changes to the Medicare Advantage and the Medicare
Prescription Drug Benefit Programs.''
Through improved processes and systems, since March 2011 we have:
Saved over $927 million by revoking Medicare Part A and B
providers and suppliers that did not comply with Medicare requirements;
Avoided over $2.4 billion in costs by preventing further
billing from revoked and deactivated Medicare Part A and B providers
and suppliers;