[Federal Register Volume 81, Number 136 (Friday, July 15, 2016)]
[Proposed Rules]
[Pages 46161-46476]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16097]



[[Page 46161]]

Vol. 81

Friday,

No. 136

July 15, 2016

Part II





Department of Health and Human Services





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Centers for Medicare & Medicaid Services





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42 CFR Parts 405, 410, 411, et al.





 Medicare Program; Revisions to Payment Policies Under the Physician 
Fee Schedule and Other Revisions to Part B for CY 2017; Medicare 
Advantage Pricing Data Release; Medicare Advantage and Part D Medical 
Low Ratio Data Release; Medicare Advantage Provider Network 
Requirements; Expansion of Medicare Diabetes Prevention Program Model; 
Proposed Rules

Federal Register / Vol. 81 , No. 136 / Friday, July 15, 2016 / 
Proposed Rules

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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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
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    The behavioral health care manager may or may not be a professional 
who meets all the requirements to independently furnish and report 
services to Medicare. If otherwise eligible, then that individual may 
report separate services furnished a beneficiary receiving the services 
described by GPPP1, GPPP2, GPPP3, and GPPPX in the same calendar month. 
These could include: psychiatric evaluation (90791, 90792), 
psychotherapy (90832, 90833, 90834, 90836, 90837, 90838), psychotherapy 
for crisis (90839, 90840), family psychotherapy (90846, 90847), 
multiple family group psychotherapy (90849), group psychotherapy 
(90853), smoking and tobacco use cessation counseling (99406, 90407), 
and alcohol or substance abuse structured screening and brief 
intervention services (99408, 99409). Time spent by the behavioral 
health care manager on activities for services reported separately may 
not be included in the services reported using time applied to GPPP1, 
GPPP2, and GPPP3.
    The psychiatric consultant involved in the ``incident to'' care 
furnished under this model is a medical professional trained in 
psychiatry and qualified to prescribe the full range of medications. 
The psychiatric consultant advises and makes recommendations, as 
needed, for psychiatric and other medical care, including psychiatric 
and other medical diagnoses, treatment strategies including appropriate 
therapies, medication management, medical management of complications 
associated with treatment of psychiatric disorders, and referral for 
specialty services, that are communicated to the treating physician or 
other qualified health care professional, typically through the 
behavioral health care manager. The psychiatric consultant does not 
typically see the patient or prescribe medications, except in rare 
circumstances, but can and should facilitate a referral to a 
psychiatric care provider when clinically indicated.
    In the event that the psychiatric consultant furnishes services to 
the beneficiary directly in the calendar month described by other 
codes, such as E/M services or psychiatric evaluation (90791, 90792), 
the services may be reported separately by the psychiatric consultant. 
Time spent by the psychiatric consultant on activities for services 
reported separately may not be included in the services reported using 
GPPP1, GPPP2, and GPPP3.
    We also note that, although the psychiatric CoCM has been studied 
extensively in the setting of specific behavioral health conditions 
(for example, depression), we received persuasive comments last year 
recommending that we not specify particular diagnoses required for use 
of the codes for several reasons, including that: there may be overlap 
in behavioral health conditions; there are concerns that there could be 
modification of diagnoses to fit within payment rules which could skew 
the accuracy of submitted diagnosis code data; and for many patients 
for whom specialty care is not available, or who choose for other 
reasons to remain in primary care, primary care treatment will be more 
effective if it is provided within a model of integrated care that 
includes care management and psychiatric consultation.
(1) General Behavioral Health Integration (BHI)
    We recognize that the psychiatric CoCM is prescriptive and that 
much of its demonstrated success may be attributable to adherence to a 
set of elements and guidelines of care as described in the preceding 
paragraphs. Therefore, we are proposing the use of these codes to pay 
accurately for this specific model of care for the benefit of Medicare 
beneficiaries, given its wide-spread adoption and recognized 
effectiveness. However, we note that PFS coding, in general, does not 
dictate how physicians practice medicine and believe that it should, 
instead, reflect the practice of medicine. We also recognize that there 
are primary care practices that are incurring, or may

[[Page 46205]]

incur, resource costs inherent to treatment of patients with similar 
conditions based on other models of BHI that may benefit beneficiaries 
with behavioral health conditions (see, for example, the approach 
described at 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,

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the equipment minutes assigned to the E-Bar II Barcode Slide Label 
System should have been added into the new EP112 equipment time. The 
stakeholder requested that these minutes should be added into the EP112 
equipment time; for example, 1 additional minute should be added to CPT 
code 88341 for a total of 16 minutes.
    We appreciate the additional information, and are soliciting 
additional information on this topic through public comment on this 
proposed rule to assess whether it would be appropriate to add the 
former EP113 minutes into EP112. We are specifically seeking comment 
from other stakeholders, including the RUC, since the assigned number 
of minutes was originally based on a RUC recommendation. This 
information would be potentially relevant for CPT codes 88341 
(Immunohistochemistry or immunocytochemistry, per specimen; each 
additional single antibody stain procedure), 88342 
(Immunohistochemistry or immunocytochemistry, per specimen; initial 
single antibody stain procedure), 88344 (Immunohistochemistry or 
immunocytochemistry, per specimen; each multiplex antibody stain 
procedure), 88360 (Morphometric analysis, tumor immunohistochemistry, 
quantitative or semiquantitative, per specimen, each single antibody 
stain procedure; manual), and 88361 (Morphometric analysis, tumor 
immunohistochemistry, quantitative or semiquantitative, per specimen, 
each single antibody stain procedure; using computer-assisted 
technology).
(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,

[[Page 46245]]

percutaneous; venous), 36147 (Introduction of needle and/or catheter, 
arteriovenous shunt created for dialysis (graft/fistula); initial 
access with complete radiological evaluation of dialysis access, 
including fluoroscopy, image documentation and report), 36148 
(Introduction of needle and/or catheter, arteriovenous shunt created 
for dialysis (graft/fistula); additional access for therapeutic 
intervention), 37236 (Transcatheter placement of an intravascular 
stent(s) (except lower extremity artery(s) for occlusive disease, 
cervical carotid, extracranial vertebral or intrathoracic carotid, 
intracranial, or coronary), open or percutaneous, including 
radiological supervision and interpretation and including all 
angioplasty within the same vessel, when performed; initial artery), 
37238 (Transcatheter placement of an intravascular stent(s), open or 
percutaneous, including radiological supervision and interpretation and 
including angioplasty within the same vessel, when performed; initial 
vein), 75791 (Angiography, arteriovenous shunt (e.g., dialysis patient 
fistula/graft), complete evaluation of dialysis access, including 
fluoroscopy, image documentation and report (includes injections of 
contrast and all necessary imaging from the arterial anastomosis and 
adjacent artery through entire venous outflow including the inferior or 
superior vena cava), radiological supervision and interpretation), 
75962 (Transluminal balloon angioplasty, peripheral artery other than 
renal, or other visceral artery, iliac or lower extremity, radiological 
supervision and interpretation), and 75968 (Transluminal balloon 
angioplasty, each additional visceral artery, radiological supervision 
and interpretation). At the October 2015 CPT Editorial Panel meeting, 
the panel approved the creation of four new codes and deletion of 13 
existing codes used to describe bundled percutaneous transluminal 
angioplasty services. The Open and Percutaneous Transluminal 
Angioplasty family of codes overlaps with the Dialysis Circuit family 
of codes (CPT codes 369X1-369X9), as they are both being constructed 
from the same set of frequently reported together codes. We reviewed 
these two families of codes concurrently to maintain relativity between 
these clinically similar procedures based upon the same collection of 
deleted codes. After consideration of these materials, we are proposing 
to accept the RUC-recommended work RVU for CPT codes 372X1, 372X2, 
372X3, and 372X4.
    For the clinical labor direct PE inputs, we are proposing to use 
the RUC-recommend inputs with several refinements. Our proposed inputs 
refine the recommended clinical labor time for ``Prepare and position 
patient/monitor patient/set up IV'' from 5 minutes to 3 minutes for CPT 
codes 372X1 and 372X3. The RUC recommendation included a written 
justification for additional clinical labor time beyond the standard 2 
minutes for this activity, stating that the extra time was needed to 
move leads out of X-ray field, check that X-ray is not obstructed and 
that there is no risk of collision of X-ray equipment with patient. As 
we wrote for the same clinical labor activity in the Dialysis Circuit 
family, we agree that extra time may be needed for this activity as 
compared to the default standard of 2 minutes; however, we are 
assigning 1 extra minute for the additional positioning tasks, 
resulting in a total of 3 minutes for this task. We do not believe that 
3 extra minutes would be typically needed for preparation of the X-ray. 
The equipment times for the angiography room (EL011) and the PACS 
workstation (ED050) have been refined to reflect this change in 
clinical labor.
    We are proposing to remove the ``drape, sterile, femoral'' supply 
(SB009) and replace it with a ``drape, sterile, fenestrated 16in x 
29in'' supply (SB011) for CPT codes 372X1 and 372X3. The two base codes 
out of which these new codes are being constructed, CPT codes 35471 and 
35476, both made use of the SB011 fenestrated sterile drape supply, and 
there was no rationale provided for the switch to the SB009 femoral 
sterile drape in the two new codes. We are seeking comment on the use 
of sterile drapes for these procedures, and what rationale there is to 
support the use of the SB009 femoral sterile drape as typical for these 
new procedures.
(13) Percutaneous Biliary Procedures Bundling (CPT Codes 47531, 47532, 
47533, 47534, 47535, 47536, 47537, 47538, 47539, 47540, 47541, 47542, 
47543, and 47544)
    This group of fourteen codes was reviewed by the RUC at the April 
2015 meeting. We established interim final values for this group of 
codes during the CY 2016 PFS rulemaking cycle, and subsequently 
received updated RUC recommendations from the October 2015 meeting for 
the CY 2017 PFS rulemaking cycle. Our proposals for these codes 
incorporate both the updated RUC recommendations, as well as public 
comments received as part of the interim final status of these 
procedures.
    We received several comments regarding the CMS refinements to the 
work values for this family of codes in the CY 2016 final rule with 
comment period. The relevance of many of these comments has been 
diminished by the new series of RUC recommendations for work values 
that we received as a result of the October 2015 meeting. Given that we 
are proposing the updated RUC-recommended work RVUs for CPT codes 
47531, 47532, 47533, 47534, 47535, 47536, 47537, 47538, 47539, 47540, 
47542, 47543, and 47544, we seek additional comments relative to these 
proposed values. We agree that the second round of physician surveys 
conducted for the October 2015 RUC meeting more accurately captured the 
work and time required to perform these procedures. The one exception 
is CPT code 47541; the survey times for this procedure were identical 
as conducted for the April and October 2015 RUC meetings, yet the RUC 
recommendation increased from a work RVU of 5.61 in April to a work RVU 
of 7.00 in October. Given that the time values for the procedure 
remained unchanged between the two surveys, we do not understand why 
the work RVU would have increased by nearly 1.50 in the intervening 
months. Since this code also has an identical intraservice time (60 
minutes) and total time (121 minutes) as CPT code 47533, we do not 
agree that it should be valued at a substantially higher rate compared 
to a medically similar procedure within the same code family. We are 
therefore proposing to crosswalk the work value of CPT code 47541 to 
the work value of CPT code 47533, and we are proposing a work RVU of 
5.63 for both procedures.
    We also note that many of the codes in the Percutaneous Biliary 
Procedures family were previously included in Appendix G, and were 
valued under the assumption that moderate sedation was typically 
performed on the patient. As part of the initiative to pay separately 
for moderate sedation when it is performed, we are removing a portion 
of the work RVU and preservice work time from CPT codes 47532, 47533, 
47534, 47535, 47536, 47538, 47539, 47540, and 47541. For example, we 
are proposing that CPT code 47541 undergoes a 0.25 reduction in its 
work RVU from 5.63 to 5.38, and a 10 minute reduction in its preservice 
work time from 33 minutes to 23 minutes, to reflect the work that will 
now be reported separately using the new moderate sedation codes. CPT 
codes 47542, 47533, and 47544 are also included in the moderate 
sedation initiative; however, as add-on codes, they are not subject to 
alterations in

[[Page 46246]]

their work RVUs or work times since the moderate sedation code with 
work RVUs and work time (991X2) will only be billed once for each base-
code and not additionally with the add-on codes. These changes are 
reflected in Appendix B and the work time file posted to the Web; see 
section II.D for more details.
    For the direct PE inputs, we are proposing to remove the L051A 
clinical labor for ``Sedate/apply anesthesia'' and the L037D for 
``Assist Physician in Performing Procedure'' for CPT codes 47531 and 
47537. As we wrote in last year's final rule with comment period (80 FR 
71053), we believe that this clinical labor describes activities 
associated with moderate sedation, and moderate sedation is not typical 
for these procedures. We are also proposing to refine the L037D 
clinical labor for ``Clean room/equipment by physician staff'' from 6 
minutes to 3 minutes for all of the codes in this family. Three minutes 
is the standard for this clinical labor activity, and we continue to 
maintain that the need for additional clinical labor time for this 
cleaning activity would not be typical for these procedures.
    Comment: One commenter disagreed with our refinement to replace 
supply item ``catheter, balloon, PTA'' (SD152) with supply item 
``catheter, balloon ureteral (Dowd)'' (SD150). The commenter stated 
that a Dowd catheter is designed and FDA approved for use in the 
prostatic urethra by retrograde placement through the penile urethra, 
and it is not designed for use in an antegrade ureteral dilation 
procedure. The commenter stated that this replacement is inappropriate. 
The updated RUC recommendations for this family of codes also restored 
the balloon PTA catheter.
    Response: We are proposing again to replace the recommended supply 
item ``catheter, balloon, PTA'' (SD152) with supply item ``catheter, 
balloon ureteral (Dowd)'' (SD150). We believe that the use of this 
ureteral balloon catheter, which is specifically designed for catheter 
and image guidance procedures, would be more typical than the use of a 
PTA balloon catheter. While we recognize that the Dowd catheter is not 
FDA approved, it is our understanding that the PTA balloon catheter has 
also not been FDA approved for use in these procedures. We are 
uncertain if the commenter was requesting that we should no longer 
include catheters that lack FDA approval in the direct PE database; 
this would preclude the use of most of the catheters in our direct PE 
database. We welcome additional comment on the use of FDA approved 
catheters; in the meantime, we will continue our long-standing practice 
of using the catheters in the direct PE database without explicit 
regard to FDA approval in particular procedures.
    We are also proposing to remove the recommended supply item ``stone 
basket'' (SD315) from CPT code 47543 and add it to CPT code 47544. 
Based on the code descriptors, we believe that the stone basket was 
intended to be included in CPT code 47544 and was erroneously listed 
under CPT code 47543. We are soliciting comments from the public to 
help clarify this issue.
    We note again that many of the codes in the Percutaneous Biliary 
Procedures family were previously included in Appendix G, and as part 
of the initiative to pay separately for moderate sedation when 
performed, we are removing some of the recommended direct PE inputs 
related to moderate sedation from CPT codes 47532, 47533, 47534, 47535, 
47536, 47538, 47539, 47540, and 47541. We are removing the L051A 
clinical labor time for ``Sedate/apply anesthesia'', ``Assist Physician 
in Performing Procedure (CS)'', and ``Monitor pt. following moderate 
sedation''. We are also removing the conscious sedation pack (SA044) 
supply, and some or all of the equipment time for the stretcher 
(EF018), the mobile instrument table (EF027), the 3-channel ECG 
(EQ011), and the IV infusion pump (EQ032). These changes are reflected 
in the public use files posted to the web; see section II.D for more 
details.
(14) Flexible Laryngoscopy (CPT Codes 31575, 31576, 31577, 31578, 
317X1, 317X2, 317X3, and 31579)
    After we identified CPT codes 31575 and 31579 as potentially 
misvalued in (80 FR 70912-70914) the RUC referred the entire flexible 
laryngoscopy family of codes back to CPT for revision and the addition 
of several codes representing new technology within this family of 
services. At the May 2015 CPT meeting, the Editorial Panel added three 
new codes to describe laryngoscopy with ablation or destruction of 
lesion and therapeutic injection. Based on the survey results, the time 
resources involved in furnishing the procedures described by this code 
family experienced a significant reduction in the intraservice period, 
yet the recommended work RVUs were not similarly reduced. Therefore, in 
reviewing the recommended values for this family of codes we looked for 
a rationale for increased intensity and absent such rationale, propose 
to adjust the recommend work RVUs to account for significant changes in 
time.
    For CPT code 31575, we disagree with the RUC-recommended work RVU 
of 1.00, and we are instead proposing a work RVU of 0.94. We looked at 
the total time ratio for CPT code 31575, which is decreasing from 28 
minutes to 24 minutes, and applied this ratio of 0.86 times the current 
work RVU of 1.10 to derive our proposed work RVU of 0.94. We are 
supporting this value for CPT code 31575 through a crosswalk to CPT 
code 64405 (Injection, anesthetic agent; greater occipital nerve), 
which shares 5 minutes of intraservice time and also has a work RVU of 
0.94.
    We agree with the RUC that CPT code 31575 serves as the base code 
for the rest of the Flexible Laryngoscopy family. As a result, we are 
proposing to maintain the same RUC-recommended increments for the rest 
of the codes in this family, measuring the increments from CPT code 
31575's refined work RVU of 0.94 instead of the RUC-recommended work 
RVU of 1.00. This means that each of the work RVUs for the codes in the 
rest of the family has decreased by 0.06 when compared to the RUC-
recommended value. We are therefore proposing a work RVU of 1.89 for 
CPT code 31576, a work RVU of 2.19 for CPT code 31577, a work RVU of 
2.43 for CPT code 31578, a work RVU of 3.01 for CPT code 317X1, a work 
RVU of 2.43 for CPT code 317X2, a work RVU of 2.43 for CPT code 317X3, 
and a work RVU of 1.88 for CPT code 31579.
    Amongst the direct PE inputs, we are proposing to refine the 
clinical labor time for ``Obtain vital signs'' for CPT codes 31577 and 
31579 from 3 minutes to 2 minutes. We believe that this extra clinical 
labor time is duplicative, as these codes are typically performed with 
a same day E/M service. Each procedure is only allotted a maximum of 5 
minutes for obtaining vital signs, and since 3 minutes are already 
included in the E/M code, we are proposing to reduce the time to 2 
minutes for these services. Similarly, we are proposing to remove the 3 
minutes of clinical labor time for ``Clean room/equipment by physician 
staff'' from CPT codes 31575, 31577, and 31579. These procedures are 
typically reported with a same day E/M service, making the clinical 
labor minutes for cleaning the room in these procedure codes 
duplicative of the time already included in the E/M codes.
    For CPT code 317X1, we are proposing to remove the ``laser tip, 
diffuser fiber'' supply (SF030) and replace it with the ``laser tip, 
bare (single use)'' supply (SF029) already present in our direct PE 
database. We

[[Page 46247]]

believe that the invoice for SF030 submitted with the RUC 
recommendation is not current enough to establish a new price for this 
supply; as a result, we are substituting the SF029 supply for this 
input. We welcome the submission of new invoices to accurately price 
the diffuser fiber with laser tip.
    We are also proposing to make significant changes to the prices of 
several of the supplies and equipment related to Flexible Laryngoscopy, 
as well as to the prices of scopes more broadly. We are proposing to 
set the price of the disposable biopsy forceps supply (SD318) at 
$26.84, based on the submission of an invoice with a price of $536.81 
for a unit size of 20. In our search for additional information 
regarding scope inputs, we obtained a quote from a vendor listing the 
current price for several equipment items related to the use of scopes. 
Since we believe that the prices in vendor quotes would typically be 
equal to or higher than prices actually paid by practitioners, we are 
updating the prices in our direct PE database to reflect this new 
information. As part of this process, we are proposing to increase the 
price of the ``light source, xenon'' (EQ167) from $6,723.33 to $7,000 
to reflect current pricing information. We are also proposing to adjust 
the price of the ``fiberscope, flexible, rhinolaryngoscopy'' (ES020) 
from $6,301.93 to $4,250.00.
    In accordance with the wider proposal that we are making involving 
the use of scope equipment, we are proposing to separate the scopes 
used in these procedures from the scope video systems. In the course of 
researching different kinds of scopes, we obtained vendor pricing for 
two different types of scopes used in these procedures. We are 
proposing to price the ``rhinolaryngoscope, flexible, video, non-
channeled'' (ES063) at $8,000 and the ``rhinolaryngoscope, flexible, 
video, channeled'' (ES064) at $9,000 in accordance with our vendor 
quotes. We are proposing to use the non-channeled scope for CPT codes 
31575, 31579, and 317X3 and the channeled scope for CPT codes 31576, 
31577, 31578, 317X1, and 317X2 in accordance with the RUC-recommended 
video systems that stipulated channeled versus non-channeled scope 
procedures.
    We believe that the ``Video-flexible laryngoscope system'' listed 
in the recommendations is not a new form of equipment, but rather 
constitutes a version of the existing ``video system, endoscopy'' 
equipment (ES031). We are not adding a new equipment item to our direct 
PE database; instead, we are proposing to use the submitted invoices to 
update the price of the ES031 endoscopy video system. As the equipment 
code for ES031 indicates, we are proposing to define the endoscopy 
video system as containing a processor, digital capture, monitor, 
printer, and cart. We are proposing to price ES031 at $15,045.00; this 
reflects a price of $2,000.00 for the monitor, $9,000.00 for the 
processor, $1,750.00 for the cart, and $2,295.00 for the printer. These 
prices were obtained from our vendor invoice, with the exception of the 
printer, which is a crosswalk to the ``video printer, color (Sony 
medical grade)'' equipment (ED036).
    We do not agree that there is a need for multiple different video 
systems for this collection of Flexible Laryngoscopy codes based on our 
understanding of the clinical differences among the codes. In keeping 
with this understanding, we are proposing to use the same existing 
``video system, endoscopy'' equipment (ES031) for the remaining codes 
in the family that included RUC recommendations for new equipment items 
named ``Video-flexible channeled laryngoscope system'' and ``Video-
flexible laryngoscope stroboscopy system.'' For CPT codes 31576, 31577, 
31578, 317X1, and 317X2, we are proposing to replace the Video-flexible 
channeled laryngoscope system with the existing endoscopy video system 
(ES031) along with a channeled flexible video rhinolaryngoscope 
(ES064). For CPT code 31579, we are proposing to rename the RUC-
recommended ``Video-flexible laryngoscope stroboscopy system'' to the 
shortened ``stroboscopy system'' (ES065) and assign it a price of 
$19,100.00. This reflects the price of the StrobeLED Stroboscopy system 
included on the submitted invoice. We are proposing to treat the 
stroboscopy system as a scope accessory, which will be included along 
with the ``video system, endoscopy'' equipment (ES031) and the 
``rhinolaryngoscope, flexible, video, non-channeled'' (ES063) for CPT 
code 31579. When the price of the scope, the scope video system, and 
the stroboscopy system are summed together, the total proposed 
equipment price is $42,145.00.
    We are proposing to refine the recommended equipment times for 
several equipment items to conform to changes in clinical labor time. 
These are: The fiberoptic headlight (EQ170), the suction and pressure 
cabinet (EQ234), the reclining exam chair with headrest (EF008), and 
the basic instrument pack (EQ137). We are proposing to use the standard 
equipment time formula for scope accessories for the endoscopy video 
system (ES031) and the stroboscopy scope accessory system (ES065). We 
are also proposing to refine the equipment time for the channeled and 
non-channeled flexible video rhinolaryngoscopes to use the standard 
equipment time formula for scopes. For this latter pair of two new 
equipment items, this proposal results in small increases to their 
respective equipment times.
(15) Laryngoplasty (CPT Codes 31580, 31584, 31587, and 315X1-315X6)
    CPT code 31588 (Laryngoplasty, not otherwise specified (e.g., for 
burns, reconstruction after partial laryngectomy) was identified as 
potentially misvalued based on the RUC's 90-Day Global Post-Operative 
Visits screen. When this code family was reviewed by the RUC, it was 
determined that some codes in the family required revision to reflect 
the typical patient before a survey could be conducted and the code 
family was referred to the CPT Editorial Panel for revision. At the 
October 2015 CPT Editorial Panel meeting, the CPT Editorial Panel 
approved the creation of six new codes, revision of three codes, and 
deletion of three codes. For CPT codes 31580, 31587, 315X1, 315X2, 
315X3, 315X4, and 315X6, CMS is proposing the RUC-recommended work 
RVUs.
    For CPT code 31584, the RUC recommended a work RVU of 20.00. We 
believe that the 25th percentile of the survey, which is a work RVU of 
17.58, better represents the time and intensity involved with 
furnishing this service based on a comparison with and assessment of 
the overall intensity of other codes with similar instraservice and 
total time. This value is also supported by a crosswalk code of CPT 
code 42844 (Radical resection of tonsil, tonsillar pillars, and/or 
retromolar trigone; closure with local flap (e.g., tongue, buccal)), 
which has identical intraservice time and identical total time. 
Therefore, we are proposing a work value of 17.58 RVUs for CPT code 
31584.
    For CPT code 315X5, the RUC recommended a work value of 15.60 RVUs. 
We believe that the 25th percentile of the survey, which is a work RVU 
of 13.56, better represents the time and intensity involved with 
furnishing this service based on a comparison of the overall intensity 
of other codes with similar instraservice and total time. The 25th 
percentile of the survey is additionally bracketed by two crosswalk 
codes that we estimate have slightly lower and slighter higher overall 
intensities, CPT code 36819

[[Page 46248]]

(Arteriovenous anastomosis, open; by upper arm basilic vein 
transposition), which has a work RVU of 13.29, and CPT code 49654 
(Laparoscopy, surgical, repair, incisional hernia (includes mesh 
insertion, when performed); reducible), which has a work RVU of 13.76; 
both of these codes have identical intraservice time and similar total 
time. Therefore, we are proposing a work RVU of 13.56 for CPT code 
315X5.
    Additionally, the RUC forwarded invoices provided by a medical 
specialty society for the video-flexible laryngoscope system used in 
these services. As discussed in section II.A of this proposed rule, we 
have proposed changes to the items included in equipment item ES031 
(video system, endoscopy). Consistent with those proposed changes, we 
are proposing to add a Nasolaryngoscope, non-channeled, to the list of 
equipment items used for CPT codes 31580, 31584, 31587, and 315X1-
315X6, along with the modified equipment item ES031.
(16) Mechanochemical Vein Ablation (MOCA) (CPT Codes 364X1 and 364X2)
    At the October 2015 CPT meeting, the CPT Editorial Panel 
established two Category I codes for reporting venous mechanochemical 
ablation, CPT codes 364X1 and 364X2. We are proposing the RUC-
recommended work RVU of 3.50 for CPT code 364X1. For CPT code 364X2 we 
believe that the RUC-recommended work RVU of 2.25 does not accurately 
reflect the typical work involved in furnishing this procedure. The 
specialty society survey recommended that this add-on code has half the 
work of the base code, CPT code 364X1. This value is supported by the 
ratio between work and time in the key reference service, CPT code 
36476 (Endovenous ablation therapy of incompetent vein, extremity, 
inclusive of all imaging guidance and monitoring, percutaneous, 
radiofrequency; second and subsequent veins treated in a single 
extremity, each through separate access sites (List separately in 
addition to code for primary procedure)). Therefore, we are proposing a 
work RVU of 1.75 for CPT code 364X2.
    The RUC-recommended direct practice expense inputs for CPT codes 
364X1 and 364X2 included inputs for an ultrasound room (EL015). Based 
on the clinical nature of these procedures, we do not believe that an 
ultrasound room would typically be used to furnish these procedures. We 
are proposing to remove inputs for the ultrasound room and put in a 
portable ultrasound (EQ250), power table (EF031), and light (EF014). 
The RUC also recommended that the ultrasound machine be allocated 
clinical staff time based on the PACS workstation formula. We do not 
believe that an ultrasound machine would be used like a PACS 
workstation, as images are generated and reviewed in real time. 
Therefore, we are proposing to remove all inputs associated with the 
PACS workstation.
(17) Esophageal Sphincter Augmentation (CPT Codes 432X1 and 432X2)
    In October 2015, the CPT Editorial Panel created two new codes to 
describe laparoscopic implantation and removal of a magnetic bead 
sphincter augmentation device used for treatment of gastroesophageal 
reflux disease (GERD). The RUC noted that the specialty societies 
conducted a targeted survey of the 145 physicians who have been trained 
to furnish these services and who are the only physicians who have 
performed these procedures. They noted that only 18 non-conflicted 
survey responses were received despite efforts to follow up and that 
nine physicians had no experience in the past 12 months with the 
procedure. The RUC agreed with the specialty society that the expertise 
of those responding was sufficient to consider the survey, however, 
neither entity used the survey results as the as the primary basis for 
their recommended value.
    For CPT code 432X1, the RUC recommended a work RVU of 10.13. We 
compared this code to CPT code 43180 (Esophagoscopy, rigid, transoral 
with diverticulectomy of hypopharynx or cervical esophagus (e.g., 
Zenker's diverticulum), with cricopharyngeal myotomy, includes use of 
telescope or operating microscope and repair, when performed), which 
has a work RVU of 9.03 and has identical intraservice time and similar 
total time. We believe the overall intensity of these procedures is 
similar, therefore, we are proposing a work RVU of 9.03 for CPT code 
432X1.
    For CPT code 432X2, the RUC recommended a work RVU of 10.47. To 
value this code, we used the increment between the RUC-recommended work 
RVU for this code and CPT code 432X1 (0.34 RVUs) to develop our 
proposed work RVU of 9.37 for CPT code 432X2.
(18) Electromyography Studies (CPT Code 51784)
    We identified CPT code 51784 as potentially misvalued through a 
screen of high expenditure by specialty. This family also includes CPT 
code 51785 (Needle electromyography studies (EMG) of anal or urethral 
sphincter, any technique) but was not included in this survey. Both 
services have 0-day global periods. The RUC recommended a work RVU of 
0.75 for CPT code 51784. We believe that this service is more 
accurately valued without a global period, since that is more 
consistent with other diagnostic services, and specifically, with all 
the other diagnostic electromyography services. We are proposing a 
change to the global period from 0-day to no global period, and we are 
proposing the RUC-recommended work RVU of 0.75 for CY 2017. We are also 
proposing to change the global period for CPT code 51785 from 0-day to 
no global period, to be consistent with 51784. Additionally, we are 
proposing to add CPT code 51785 to the list of potentially misvalued 
codes to update the value of the service considering the change in 
global period, and to maintain consistency with 51784.
(19) Cystourethroscopy (CPT Code 52000)
    In the CY 2016 PFS final rule with comment period, CMS identified 
CPT code 52000 through the screen for high expenditure services by 
specialty screen. The RUC-recommended work RVUs of 1.75 for CPT code 
52000 is larger than the work RVUs for all 0-day global codes with 10 
minutes of intraservice time and we do not believe that the overall 
intensity of this service is greater than all of the other codes. 
Instead, we believe the overall work compares for this code compares 
favorably to CPT code 58100 (Endometrial sampling (biopsy) with or 
without endocervical sampling (biopsy), without cervical dilation, any 
method (separate procedure)), which has a work RVU of 1.53, and has 
identical intraservice time and similar total time. Therefore, we are 
using a direct crosswalk to CPT code 58100 and are proposing a work RVU 
of 1.53 for CPT code 52000.
(20) Biopsy of Prostate (CPT Code 55700)
    In the CY 2016 PFS final rule with comment period, CMS identified 
CPT code 55700 as potentially misvalued based on the high expenditure 
by specialty screen.
    The RUC subsequently reviewed this code for physician work and 
practice expense and recommended a work RVU of 2.50 based on the 25th 
percentile of the survey. We believe the RUC-recommended work RVU 
overestimates the work involved in furnishing this service given the 
reduction in total service time; specifically, the reduction in 
preservice and postservice times. The RUC recommendation also appears 
overvalued when compared to similar 0-day global services with 15 
minutes of intraservice time and comparable total

[[Page 46249]]

times. To develop a proposed work RVU, we crosswalked the work RVUs for 
this code from CPT code 69801 (Labyrinthotomy, with perfusion of 
vestibuloactive drug(s), transcanal), noting similar levels of 
intensity, similar total times, and identical intraservice times. 
Therefore, we are proposing a work RVU of 2.06 for CPT code 55700.
    As part of the recommended direct PE inputs for CPT code 55700, the 
RUC recommended inclusion of a new equipment item, Biopsy Guide, but we 
have not received any invoices to price this item. Given our 
longstanding difficulties in acquiring accurate pricing information for 
equipment items, we are seeking invoices and public comment for pricing 
this equipment prior to adding this new equipment item code.
(21) Hysteroscopy (CPT Codes 58555-58563)
    In the CY 2016 PFS proposed rule, we proposed CPT code 58558 as a 
potentially misvalued code based on the screen for high expenditure by 
specialty screen. This code was reviewed at the January 2016 RUC 
meeting and CPT codes 58559-58563 were included in the review as part 
of the family.
    For CPT code 58555, the RUC recommended a work RVU of 3.07. We 
believe that the 25th percentile of the survey, a work RVU of 2.65, 
more accurately reflects the resources involved in furnishing this 
service. This value is bracketed by two crosswalk codes, CPT code 43191 
(Esophagoscopy, rigid, transoral; diagnostic, including collection of 
specimen(s) by brushing or washing when performed (separate 
procedure)), which has a work RVU of 2.49, and CPT code 31295 (Nasal/
sinus endoscopy, surgical; with dilation of maxillary sinus ostium 
(e.g., balloon dilation), transnasal or via canine fossa), which has a 
work RVU of 2.70. Compared with CPT code 58555, CPT codes 43191 and 
31295 have identical intraservice times and similar total times. 
Therefore, we are proposing a work RVU of 2.65 for CPT code 58555.
    For CPT code 58558, the RUC recommended a work RVU of 4.37. 
However, we believe that a direct crosswalk from CPT code 36221 (Non-
selective catheter placement, thoracic aorta, with angiography of the 
extracranial carotid, vertebral, and/or intracranial vessels, 
unilateral or bilateral, and all associated radiological supervision 
and interpretation, includes angiography of the cervicocerebral arch, 
when performed), which has a work RVU of 4.17, and which has identical 
intraservice time and very similar total time, more accurately reflects 
the time and intensity of furnishing this service. This value is 
additionally supported by using an increment between this code and the 
base code for this family, CPT code 58555. The increment between the 
RUC-recommended values for these two codes is 1.3. That increment added 
to the proposed work RVU of 2.65 for the base code, CPT code 58555, 
results in a work RVU of 3.95. Therefore, we are proposing a work value 
of 4.17 RVUs for CPT code 58558.
    For CPT code 58559, the RUC recommended a work RVU of 5.54. 
However, we believe that a direct crosswalk of the work RVUs for CPT 
code 52315 (Cystourethroscopy, with removal of foreign body, calculus, 
or ureteral stent from urethra or bladder (separate procedure); 
complicated), which has a work RVU of 5.20 and which has a similar 
(slightly higher) intraservice time and similar total time as compared 
with CPT code 58589 more accurately reflects the time and intensity of 
furnishing this service. This value is additionally supported by using 
an increment between CPT code 58559 and the base code for this family, 
CPT code 58555. The increment between the RUC recommended values for 
the two codes is 2.47. That increment added to the proposed value for 
the base code, CPT code 58555 (2.65), results in a work RVU of 5.12. 
Therefore, we are proposing a work RVU of 5.20 for CPT code 58559.
    For CPT code 58560, the RUC recommended a work RVU of 6.15. 
However, we believe that a direct crosswalk of the work RVUs for CPT 
code 52351 (Cystourethroscopy, with ureteroscopy and/or pyeloscopy; 
diagnostic), which has a work RVU of 5.75 and which has more 
intraservice time and very similar total time, more accurately reflects 
the time and intensity of furnishing this service. This value is 
additionally supported by using an increment between CPT code 58560 and 
the base code for this family, CPT code 58555. The increment between 
the RUC recommended values for the two codes is 3.08. That increment 
added to the proposed value for the base code, CPT code 58555 (2.65), 
results in a work RVU of 5.73. Therefore, we are proposing a work RVU 
of 5.75 for CPT code 58560.
    For CPT code 58561, the RUC recommended a work RVU of 7.00. 
However, we believe that a direct crosswalk of the work RVUs for CPT 
code 35475 (Transluminal balloon angioplasty, percutaneous; 
brachiocephalic trunk or branches, each vessel), which has a work RVU 
of 6.60 and which has similar intraservice and total times, more 
accurately reflects the time and intensity of furnishing this service. 
This value is additionally supported by using an increment between CPT 
code 58561 and the base code for this family, CPT code 58555. The 
increment between the RUC recommended values for the two codes is 3.93. 
That increment added to the proposed value for the base code, CPT code 
58555 (2.65), results in a work RVU of 6.58. Therefore, we are 
proposing a work RVU of 6.60 for CPT code 58561.
    For CPT code 58562, the RUC recommended a work RVU of 4.17. 
However, we believe that a direct crosswalk of the work RVUs for CPT 
code 15277 (Application of skin substitute graft to face, scalp, 
eyelids, mouth, neck, ears, orbits, genitalia, hands, feet, and/or 
multiple digits, total wound surface area greater than or equal to 100 
sq cm; first 100 sq cm wound surface area, or 1% of body area of 
infants and children), which has a work RVU of 4.00 and which has 
identical intraservice time and similar total time, more accurately 
reflects the time and intensity of furnishing this service. The RUC 
also used this code as one of its supporting codes for its 
recommendation. This value is additionally supported by using an 
increment between CPT code 58562 and the base code for this family, CPT 
code 58555. The increment between the RUC recommended values for the 
two codes is 1.10. That increment added to the proposed value for the 
base code, CPT code 58555 (2.65), results in a work RVU of 3.75. 
Therefore, we are proposing a work RVU of 4.00 for CPT code 58562.
    For CPT code 58563, the RUC recommended a work RVU of 4.62. 
However, we believe that a direct crosswalk of the work RVUs for CPT 
code 33962 (Extracorporeal membrane oxygenation (ECMO)/extracorporeal 
life support (ECLS) provided by physician; reposition peripheral 
(arterial and/or venous) cannula(e), open, 6 years and older (includes 
fluoroscopic guidance, when performed)), which has a work RVU of 4.47 
and which has identical intraservice time and similar total time, more 
accurately reflects the resources involved in furnishing this service. 
This value is additionally supported by using an increment between CPT 
code 58563 and the base code for this family, CPT code 58555. The 
increment between the RUC recommended values for the two codes is 1.55. 
That increment added to the proposed value for the base code, CPT code 
58555 (2.65), results in a work RVU of 4.20. We note that CPT code 
58563 has the same instraservice time and the same total time as CPT 
code 58558; however, we agree that the

[[Page 46250]]

intensity would be slightly higher for this service. Therefore, we are 
proposing a work RVU of 4.47 for CPT code 58562.
    The RUC submitted invoices for two new equipment items used in 
furnishing CPT code 58558, the Hysteroscopic Fluid Management System 
and the Hysteroscopic Resection System. We are proposing to use these 
invoice prices for the Hysteroscopic Fluid Management System, which 
totaled $14,698.38. The Hysteroscopic Resection System included the 
price of the hysteroscope as well as other items necessary for tissue 
removal. However, we generally price endoscopes separately and not as a 
part of a system. In order to maintain consistency, we are proposing 
not to include the hysteroscope from the Resection System. Instead, we 
are proposing to update the equipment item ``endoscope, rigid, 
hysteroscopy'' (ES009) with the invoice price, $6,207.50. We are not 
proposing to include the sterilization tray from the Hysteroscopic 
Resection System because we believe this tray has generally been 
characterized as an indirect expense. For the Hysteroscopic Resection 
System, we are proposing to include the Hysteroscopic tissue remover 
($18,375), the sheath ($1,097.25), and the calibration device ($300), 
and creating a new equipment item code, priced at $19,857.50 in the 
proposed direct PE input database. We did not propose to include the 
calibration device since the submitted price was not documented with a 
paid invoice.
(22) Epidural Injections (CPT Codes 623X5, 623X6, 623X7, 623X8, 623X9, 
62X10, 62X11, and 62X12)
    We are proposing the RUC-recommended work RVU for all eight of the 
codes in this family.
    We are proposing to remove the 10-12ml syringes (SC051) and the RK 
epidural needle (SC038) from all eight of the codes in this family. 
These supplies are duplicative, as they are included in the epidural 
tray (SA064). As an alternative, we could remove the epidural tray and 
replace it with the individual supply components used in each 
procedure; we are seeking public comment on either the inclusion of the 
epidural tray or its individual components for this family of codes.
(23) Endoscopic Decompression of Spinal Cord (CPT code 630X1)
    For CY 2016, the CPT Editorial Panel created CPT code 630X1 to 
describe the endoscopic decompression of neural elements. The RUC 
recommended a work RVU of 10.47 based on a crosswalk to CPT code 47562 
(Laparoscopy, surgical; cholecystectomy) with a higher intraservice 
time than reflected in the survey data. Since we believe CPT codes 
630X1 and 47562 are similar in intensity, we believe using the same 
work RVU as the crosswalk code overestimates the work involved in 
furnishing CPT code 630X1. Reference CPT code 49507 (Repair initial 
inguinal hernia, age 5 years or older; incarcerated or strangulated) 
has a work RVU of 9.09 and has similar intensity and an identical 
intraservice time compared to CPT code 630X1. Therefore, we are 
proposing a work RVU of 9.09 for CPT code 630X1.
(24) Retinal Detachment Repair (CPT Codes 67101 and 67105)
    For CY 2015, the CPT Editorial Panel made several changes to CPT 
codes 67101 and 67105. These changes include revising the code 
descriptors to exclude ``diathermy'' and ``with or without drainage of 
subretinal fluid'' and removing the reference to ``1 or more 
sessions''. The recommended global period has also changed from 90 days 
to 10 days.
    For CPT code 67101 we propose the RUC recommendation of 3.50 work 
RVUs, which was based on the 25th percentile of the survey. For CPT 
code 67105, the RUC recommended a work RVU of 3.84 based on the 25th 
percentile of the survey. The RUC also stated that CPT code 67105 was a 
more intense procedure, and therefore, should have a higher work RVU 
than CPT code 67101. Currently, CPT code 67101 has a higher work RVU 
than CPT code 67105 and according to the surveys the intraservice and 
total times remain higher for CPT code 67101. It was not clearly 
explained and we do not understand why the RUC believes that CPT code 
67105 is more work than CPT code 67101. Therefore we are not proposing 
the RUC-recommended work value of 3.50 for CPT code 67105. We do not 
find evidence that CPT code 67105 is more intense than CPT code 67101 
and accordingly propose a new value for CPT code 67105. To value CPT 
code 67105 we used the RVU ratio between 67101 and 67105. We divided 
the current work RVU of CPT code 67105 (8.53), by the current work RVU 
of CPT code 67101 (8.80) and multiplied the quotient by the RUC-
recommended work RVU for CPT code 67101 (3.50) to arrive at a product 
of 3.39 work RVUs.
    Therefore, for CY 2017 we are proposing a work RVU of 3.39 for CPT 
code 67105.
(25) Abdominal Aortic Ultrasound Screening (CPT Code 767X1)
    For CY 2017, the CPT Editorial Panel created a new code, CPT 767X1, 
to describe abdominal aortic ultrasound screening, currently described 
by HCPCS G-code G0389. The specialties that surveyed CPT code 767X1 for 
the RUC were vascular surgery and radiology, and the direct practice 
expense inputs recommended by the RUC included an ultrasound room. 
Based on an analysis of Medicare claims data, the dominant specialties 
furnishing the service are family practice and internal medicine. We 
believe that these specialties may more typically use a portable 
ultrasound device rather than an ultrasound room. Therefore, we are 
proposing to accept the RUC-recommended work value of 0.55, and the 
RUC-recommended PE inputs for this service, but we are seeking comment 
regarding whether or not it would be more accurate to substitute a 
portable ultrasound device or possibly a hand-held device for an 
ultrasound room for CPT code 767X1. We note that while the phase-in of 
significant reductions in RVUs ordinarily would not apply to new codes, 
we believe that it would be appropriate to consider this change from a 
G-code to a CPT code to be fundamentally similar to an editorial coding 
change since the service is not described differently, and therefore, 
we propose to apply the phase-in to this service by comparing the 
previous value of the G-code to the value for the new CPT code.
(26) Fluoroscopic Guidance (CPT Codes 77001, 77002, and 77003)
    In the CY 2015 PFS final rule with comment period, CMS indicated 
that while CPT codes 77002 and 77003 had been previously classified as 
stand-alone codes without global periods, we believe their vignettes 
and CPT Manual parentheticals are consistent with an add-on code as has 
been established for CPT code 77001. Therefore, the global periods for 
CPT codes 77002 and 77003 now reflect an add-on code global period with 
modifications to the vignettes and parentheticals.
    For CPT code 77001, we are proposing the RUC-recommended work RVU 
of 0.38. The RUC-recommended work RVUs for CPT codes 77002 and 77003 do 
not appear to account for the significant decrease in total times for 
these codes relative to the current total times. We note that these 
three codes describe remarkably similar services and have identical 
intraservice and total times. Based on the identical times and

[[Page 46251]]

notable similarity for all three of these codes, we are proposing a 
work RVU of 0.38 for all three codes.
(27) Radiation Treatment Devices (CPT Codes 77332, 77333, and 77334)
    We identified CPT codes 77332, 77333, and 77334 through the high 
expenditures by specialty screen. These services represent an 
incremental increase of complexity from the simple to the intermediate 
to the complex in design of radiation treatment devices. The RUC 
recommended no change from the current work RVUs for these codes, which 
are currently 0.54 for CPT code 77332, 0.84 for CPT code 77333 and 1.24 
for CPT code 77334. We believe the recommended work RVUs overstate the 
work involved in furnishing these services, as they do not sufficiently 
reflect the degree to which the RUC concurrently recommended a decrease 
in intraservice or total time. For CPT code 77332, we believe the RUC 
recommendation to maintain its current value despite a 34 percent 
decrease in total time appears to ignore the change in time. Therefore, 
we are proposing a value for this code based on a crosswalk from the 
value from CPT code 93287 (Peri-procedural device evaluation (in 
person) and programming of device system parameters before or after a 
surgery, procedure, or test with analysis, review and report by a 
physician or other qualified health care professional; single, dual, or 
multiple lead implantable defibrillator system)), due to its identical 
intraservice time, similar total time, and similar level of intensity. 
We are therefore proposing a work RVU of 0.45 for CPT code 77332. We 
are further supporting this valuation with HCPAC code 97760 
(Orthotic(s) management and training (including assessment and fitting 
when not otherwise reported) upper extremity(s), lower extremity(s) 
and/or trunk, each 15 minutes), which has similar physician time and 
intensity measurements and a work RVU of 0.45. As these codes are 
designed to reflect an incremental increase in work value from simple, 
to intermediate, and complex device designs, we used an incremental 
difference methodology to value CPT codes 77333 and 77334. We are 
proposing a work RVU of 0.75 for CPT code 77333, maintaining its 
recommended increment from CPT code 77332, For CPT code 77334, we are 
proposing a work RVU of 1.15 which maintains its increment from CPT 
code 77332.
(28) Special Radiation Treatment (CPT Code 77470)
    We identified CPT code 77470 through the high expenditure charges 
by specialty. We are proposing the RUC-recommended work RVU of 2.03. 
However, we believe the description of service and vignette describe 
different and unrelated treatments being performed by the physician and 
clinical staff for a typical patient, and this presents a disparity 
between the work RVUs and PE RVUs. We seek public comment on 
information that would clarify this apparent disparity to help 
determine appropriate PE inputs. In addition, we seek comment to 
determine if creating two G-codes, one which describes the work portion 
of this service, and one which describes the PE portion, may be a 
potentially more accurate method of valuing and paying for the service 
or services described by this code.
(29) Flow Cytometry Interpretation (CPT Codes 88184, 88185, 88187, 
88188, and 88189)
    The Flow Cytometry Interpretation family of codes is split into a 
pair of codes used to describe the technical component of flow 
cytometry (CPT codes 88184 and 88185), which do not have a work 
component, and a trio of codes (CPT codes 88187, 88188, and 88189) 
which do not have direct practice expense inputs, as they are 
professional component only services. CPT codes 88184 and 88185 were 
reviewed by the RUC in April 2014, and their CMS refined values were 
included in the CY 2016 PFS final rule with comment period. The full 
family of codes was reviewed again at the January 2016 RUC meeting, and 
new recommendations were submitted to CMS as part of the CY 2017 PFS 
rulemaking cycle.
    We are proposing the RUC-recommended work RVU of 0.74 for CPT code 
88187, and the RUC-recommended work RVU of 1.70 for CPT code 88189. For 
CPT code 88188, we are proposing a work RVU of 1.20 instead of the RUC-
recommended work RVU of 1.40. We arrived at this value by noticing that 
there were no comparable codes with no global period in the RUC 
database with intraservice time and total time of 30 minutes that had a 
work RVU higher than 1.20. The RUC-recommended work RVU of 1.40 would 
go beyond the current maximum value and establish a new high, which is 
not consistent with our estimation of the overall intensity of this 
service relative to the others. As a result, we believe it is more 
accurate to crosswalk CPT code 88188 to the work value of the code with 
the current highest value, which is CPT code 88120 (Cytopathology, in 
situ hybridization (for example, FISH), urinary tract specimen with 
morphometric analysis, 3-5 molecular probes) at a work RVU of 1.20. We 
believe that CPT code 88120 is crosswalk comparable code since it 
shares the identical intraservice time and total time of 30 minutes 
with CPT code 88188.
    We also noted that the survey increment between CPT codes 88187 and 
88188 at the RUC-recommended 25th percentile was 0.40 (between work 
RVUs of 1.00 and 1.40), and this increment of 0.40 when added to CPT 
code 88187's work RVU of 0.74 would arrive at a value of 1.14. In 
addition, the total time for CPT code 88188 decreases from 43 minutes 
to 30 minutes, which is a ratio of 0.70, and when this time ratio is 
multiplied by CPT code 88188's previous work value of 1.69, the result 
would be a new work RVU of 1.18. With this information in mind, we are 
proposing a work RVU of 1.20 for CPT code 88188 as a result of a direct 
crosswalk to CPT code 88120.
    For CPT codes 88184 and 88185, which describe the technical 
component of flow cytometry, we are proposing to use the RUC-
recommended inputs with a series of refinements. However, we believe 
that the coding for these two procedures may inhibit accurate 
valuation. CPT code 88184 describes the first marker for flow 
cytometry, while CPT code 88185 is an add-on code that describes each 
additional marker. We believe that it may be more accurate to have a 
single CPT code that describes the technical component of flow 
cytometry on a per patient case basis, as these two procedures are 
always performed together and it is difficult to determine the clinical 
labor, supplies, and equipment used in the typical case under the 
current coding structure. We are soliciting comments regarding the 
public interest in consolidating these two procedures into a single 
code used to describe the technical component of flow cytometry.
    Absent such a change in coding, we are proposing to refine the 
clinical labor time for ``Instrument start-up, quality control 
functions, calibration, centrifugation, maintaining specimen tracking, 
logs and labeling'' from 15 minutes to 13 minutes for CPT code 88184. 
We maintain that 13 minutes for this activity, which is the current 
time value, would be typical for the procedure, as CPT code 88182 also 
uses 13 minutes for the identical clinical labor task. We are also 
proposing to refine the L054A clinical labor for

[[Page 46252]]

``Load specimen into flow cytometer, run specimen, monitor data 
acquisition, and data modeling, and unload flow cytometer'' from 10 
minutes to 7 minutes using the same rationale, a comparison to CPT code 
88182.
    We are proposing to maintain the clinical labor for ``Print out 
histograms, assemble materials with paperwork to pathologists Review 
histograms and gating with pathologist'' for CPT code 88184 at 2 
minutes, as opposed to the RUC-recommended 5 minutes. A clinical labor 
time of 2 minutes is standard for this activity; we disagree with the 
RUC rationale that reviewing histograms and gating with the pathologist 
in this procedure is not similar to other codes. We also note that the 
review of histograms with a pathologist is not even described by CPT 
code 88184, which again refers to the technical component of flow 
cytometry, not the professional component. We are also proposing to 
refine the L033A clinical labor time for ``Clean room/equipment 
following procedure'' from 2 minutes to 1 minute for CPT code 88184. We 
have established 1 minute in previous rulemaking (80 FR 70902) as the 
standard time for this clinical labor activity in the laboratory 
setting.
    We are proposing to maintain our removal of the clinical labor time 
for ``Enter data into laboratory information system, multiparameter 
analyses and field data entry, complete quality assurance 
documentation'' for both CPT code 88182 and CPT code 88184. As we 
stated in last year's final rule with comment period (80 FR 70979), we 
have not recognized the laboratory information system as an equipment 
item that can be allocated to an individual service. We continue to 
believe that this is a form of indirect PE, and therefore, we do not 
recognize the laboratory information system as a direct PE input, and 
we not consider this task as typically performed by clinical labor on a 
per-service basis.
    We are proposing to maintain the quantity of the ``lysing reagent'' 
supply (SL089) at 2 ml for CPT code 88185, as opposed to the RUC-
recommended quantity of 3 ml. In our discussions with pathology 
specialists who perform flow cytometry, we were informed that the use 
of 50-55 ml of the lysing reagent would be typical for an entire 
patient case. The RUC recommendation similarly suggested a quantity of 
46 ml or 48 ml per patient case. We were also told that the most 
typical number of markers used for flow cytometry is 24, consisting of 
1 service of CPT code 88184 and 23 services of CPT code 88185. An 
investigation of our claims data confirmed this information, indicating 
that 24 markers is the most frequent per patient case for flow 
cytometry, and the use of more than 20 markers is typical. We believe 
that this data supports our refinement of the lysing reagent from a 
quantity of 3 ml to a quantity of 2 ml for CPT code 88185, which is 
also the current value for the procedure and the RUC-recommended value 
from the previous set of recommendations. For the typical case of 24 
markers, our value would produce a total lysing reagent quantity of 51 
ml (5 ml from the single service of CPT code 88184 and 46 ml from the 
23 services of CPT code 88185), which matches with the amount required 
for a total per patient case. If we were to adopt the RUC 
recommendation, the total lysing reagent quantity would be 74 ml, which 
is well in excess of what we believe to be typical for these 
procedures.
    We are also proposing to refine the quantity of the ``antibody, 
flow cytometry'' supply (SL186) from quantity 1.6 to quantity 1, which 
is also the current value for the supply and the RUC-recommended value 
from the previous set of recommendations. We do not agree that more 
than one antibody would be typically used for each marker. We are 
reaffirming the previous RUC recommendation, and maintaining the 
current quantity of 1 antibody for each marker.
    We are not proposing the recommended additional time for the 
``printer, dye sublimation (photo, color)'' equipment (ED031). We are 
proposing to maintain the equipment time at 2 minutes for CPT code 
88184, and at 1 minute for CPT code 88185. As we stated in the CY 2016 
PFS final rule with comment period (80 FR 70979), we are proposing to 
assign equipment time for the dye sublimation printer to match the 
clinical labor time for ``Print out histograms, assemble materials with 
paperwork to pathologists.'' We do not believe that it would be typical 
for the printer to be in use longer than it takes to accomplish this 
clinical labor task.
(30) Mammography--Computer Aided Detection Bundling (CPT Codes 770X1, 
770X2 and 770X3)
    Section 104 of the Medicare, Medicaid, and SCHIP Benefits 
Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554) 
required us to create separate codes with higher payment amounts for 
digital mammography compared to film mammography, which was the 
technology considered to be typical at the time. In addition, the 
statute required additional payment to be made when computer-aided 
detection (CAD) was used.
    In CY 2002, we began valuing digital mammography services using 
three G-codes, G0202, G0204, and G0206 to describe screening 
mammography, unilateral diagnostic mammography, and bilateral 
diagnostic mammography, respectively. CMS implemented the requirements 
of BIPA section 104(d)(1), which applied to tests furnished in 2001, by 
using the work RVUs of the parallel CPT codes, but establishing a fixed 
PE RVU rather than using PE RVUs developed under the standard PE 
methodology. The fixed amount of PE RVUs for these codes has generally 
remained unchanged since implementation of the G-codes that 
specifically described digital imaging.
    Most mammography services under Medicare have since been billed 
with these G-codes when digital mammography was used, and with CPT 
codes 77055, 77056, and 77057 when film mammography was used. The use 
of CAD has been reported with CPT codes 77051 and 77052. For CY 2017, 
the CPT Editorial Panel deleted CPT codes 77051, 77052, 77055, 77056, 
77057 and created three new CPT codes, 770X1, 770X2, and 770X3, to 
describe mammography services bundled with CAD. For CY 2017, the RUC 
recommended a work RVU of 0.81 for CPT code 770X1, a work RVU of 1.00 
for CPT code 770X2, and a work RVU of 0.76 for CPT code 770X3, as well 
as new PE inputs for use in developing resource-based PE RVUs based on 
our standard methodologies. The RUC has recommended these inputs and 
only one medical specialty society has provided us with a set of single 
invoices to price the equipment used in furnishing these services.
    We have reviewed these coding changes and recommended changes to 
valuation for CY 2017. The revised CPT coding mitigates the need for 
both separate G-codes and the CAD add-on codes. Based upon these coding 
changes and the recommended input values, overall Medicare payment for 
mammography services would be drastically reduced. This is especially 
the case for the technical component of these services, which could 
possibly be reduced up to 50 percent relative to the PE RVUs currently 
used for payment for these services.
    Based on our initial review of the recommended inputs for the new 
codes, we believe that these changes would likely result in values more 
closely related to the relative resources involved in furnishing these 
services. However, we recognize that these services, particularly the 
preventive

[[Page 46253]]

screenings, are of particular importance to the Medicare program and 
the health of the Medicare beneficiaries. We are concerned that making 
drastic changes in coding and payment for these services could be 
disruptive in ways that could affect beneficiary access to necessary 
services. We also recognize that unlike almost any other high-volume 
PFS service, the RVUs used for payment for many years have not been 
developed through the generally applicable PFS methodologies, and 
instead reflect the statutory directive under section 104 of the BIPA. 
Similarly, we recognize that the changes in both coding and valuation 
are significant changes for those who provide these services. 
Therefore, instead of proposing to simultaneously adopt the revised CPT 
coding and drastic reductions in overall payment rates, we believe it 
is advisable to adopt the new coding, including the elimination of 
separate billing for CAD, for CY 2017 without proposing immediate 
implementation of the recommended resource inputs. We anticipate that 
we will consider the recommended inputs, including the pricing of the 
required equipment, as carefully as possible prior to proposing revised 
PE values through subsequent rulemaking.
    Therefore, for CPT codes 770X1, 770X2, and 770X3, we are proposing 
to accept the RUC-recommended work RVUs, but to crosswalk the PE RVUs 
for the technical component of the current corresponding G-codes, as we 
seek further pricing information for these equipment items.
    In addition to seeking comment on this proposal, we are also 
seeking comment on rates for these services in the commercial market to 
help us understand the potential impacts of any future proposed 
revisions to PFS payment rates.
    Finally, we note that by adopting the new coding for CY 2017, any 
subsequent significant reduction in RVUs (greater than 20 percent) for 
the codes would be subject to the statutory phase-in under section 
1848(c)(7).
    To help us examine the resource inputs for these services, we are 
seeking public comment on the list of items recommended as equipment 
inputs for mammography services. We also invite commenters to provide 
any invoices that would help with future pricing of these items.

     Table 17--Recommended Equipment Items for Mammography Services
------------------------------------------------------------------------
       #         Item description     Quantity            Purpose
------------------------------------------------------------------------
1..............  2D Selenia                     1  Mammography unit and
                  Dimensions                        in-room console
                  Mammography                       itself.
                  System.
2..............  Mammo                          1  Required for MQSA.
                  Accreditation                     The phantom is
                  Phantom.                          currently valued
                                                    into the existing
                                                    mammography room.
3..............  Phantom Case....               1  Protects expensive
                                                    required phantom
                                                    from damage.
4..............  Paddle Storage                 3  It requires 3 racks
                  Rack.                             to hold and prevent
                                                    damage to all of the
                                                    paddles that are
                                                    part of the typical
                                                    standard mammography
                                                    system.
5..............  Needle                         1  Needed for a full
                  Localization                      functioning
                  Kit.                              mammography room.
                                                    Allows for the
                                                    performance of
                                                    needle
                                                    localizations. Input
                                                    is not separately in
                                                    the PE for the
                                                    mammography guided
                                                    procedure codes,
                                                    19281-19282, as a
                                                    fully functioning
                                                    mammography room is
                                                    needed for those
                                                    procedures.
6..............  Advanced                       1  Workflow system
                  Workflow                          connecting
                  Manager System.                   mammography room and
                                                    workstations.
7..............  Cenova 2D Tower                1  CAD server, and also
                  System.                           used for post-
                                                    processing.
8..............  Image Checker                  1  License required for
                  CAD (9.4)                         using CAD. This is a
                  License for One                   one-time fee.
                  FFDM.
9..............  Film Digitizing                1  Digitizes analog
                  System.                           films to digital for
                                                    comparison purposes.
10.............  Mammography                    1  A special chair
                  Chair.                            needed for patients
                                                    who cannot stand to
                                                    safely have their
                                                    mammogram performed.
11.............  Laser Imager                   1  Prints high
                  Printer.                          resolution copies of
                                                    the mammograms to
                                                    send to surgeons and
                                                    oncologists, and to
                                                    use in the OR.
12.............  Barcode Scanner.               1  Allows selection of
                                                    individual patient
                                                    file for
                                                    interpretation.
13.............  MRS V7 SQL                     1  MQSA requires that
                  Reporting                         the facility develop
                  System.                           and maintain a
                                                    database that tracks
                                                    recall rates from
                                                    screening, true and
                                                    false positive and
                                                    true and false
                                                    negative rates,
                                                    sensitivity,
                                                    specificity, and
                                                    cancer detection
                                                    rate. A reporting
                                                    system is required
                                                    to build the
                                                    required database
                                                    and produce the
                                                    federally required
                                                    quality audit.
                                                    Components below
                                                    needed for the
                                                    reporting system.
                                                    The reporting system
                                                    is currently valued
                                                    into the existing
                                                    mammography room.
14.............  Worksheet                      1  Database reports are
                  Printing Module.                  required for federal
                                                    tracking purposes.
                                                    This is used to
                                                    generate reports for
                                                    MQSA.
15.............  Site License....               1  License for site to
                                                    use the reporting
                                                    system. This is a
                                                    one-time fee.
16.............  Additional                     3  Licenses for
                  Concurrent User                   radiologists to use
                  License.                          the reporting
                                                    system. A minimum of
                                                    three additional
                                                    licenses is typical.
17.............  Densitometer....               1  Required for MQSA.
------------------------------------------------------------------------

    We also received specialty society recommendations for a new 
Equipment Item, a physician PACS mammography workstation. We note that 
we discuss physician PACS workstation in section II.A of this rule. The 
items that comprise the physician PACS mammography workstation are 
listed in Table 18. We are requesting public comment as to the 
appropriateness of this list and if some items are indirect expenses or 
belong in other codes. We also invite commenters to provide any 
invoices that would help with future pricing of these items.

            Table 18--Physician PACS Mammography Workstation
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
PC Tower.
Monitors 5 MP (mammo) (x2).
3rd & 4th monitor (for speech recognition, etc.).
Admin Monitor (the extra working monitor).
Keyboard & Mouse.

[[Page 46254]]

 
Powerscribe Microphone.
Software--SV APP SYNC 1.3.0.
Software--R2 Cenova.
------------------------------------------------------------------------

    We also note that for CY 2015, the CPT Editorial Panel created CPT 
codes 77061, 77062, and 77063 to describe unilateral, bilateral, and 
screening digital breast tomosynthesis, respectively. CPT code 77063 is 
an add-on code to 77057, the CPT code for screening mammography. To be 
consistent with our use of G codes for digital mammography, we did not 
implement two of these three CPT codes for Medicare purposes. We only 
adopted CPT code 77063 an add-on code to G0202. Instead of adopting 
stand-alone codes 77061 and 77062, we created a new code, G0279 
Diagnostic digital breast tomosynthesis, as an add-on code to the 
diagnostic digital mammography codes G0204 and G0206 and assigned it 
values based on CPT code 77063. Pending revaluation of the mammography 
codes using direct PE inputs, we propose to maintain the current coding 
structure for digital breast tomosynthesis with the technical change 
that G0279 be reported with 770X1 or 770X2 as the replacement codes for 
G0204 and G0206.
(31) Microslide Consultation (CPT Codes 88321, 88323, and 88325)
    CPT codes 88321, 88323, and 88325 were reviewed by the RUC in April 
2014 for their direct PE inputs only, and the CMS refined values were 
included in the CY 2016 PFS final rule with comment period. The family 
of codes was reviewed again at the January 2016 RUC meeting for both 
work values and direct PE inputs, and new recommendations were 
submitted to CMS as part of the CY 2017 PFS rulemaking cycle.
    In the CY 2016 PFS final rule with comment period, we finalized our 
proposal to remove many of the inputs for clinical labor, supplies, and 
equipment for CPT code 88325. The descriptor for this code did not 
state that slide preparation was taking place, and therefore, we 
refined the labor, supplies, and equipment inputs to align with the 
inputs recommended for CPT code 88321, which also does not include the 
preparation of slides. After further discussion with pathologists and 
consideration of comments received, we have been persuaded that slide 
preparation does take place in conjunction with the service described 
by CPT code 88325. In the RUC-recommended direct PE inputs from the 
January 2016 meeting, the labor, supplies, and equipment inputs related 
to slide preparation were added once again to CPT code 88325. We are 
proposing to accept these restorations related to slide preparation 
without refinement.
    Regarding the clinical labor direct PE inputs, we are proposing to 
assign 1 minute of L037B clinical labor for ``Complete workload 
recording logs. Collate slides and paperwork. Deliver to pathologist'' 
for CPT codes 88323 and 88325. We are maintaining this at the current 
value for CPT code 88323, and adding this 1 minute to CPT code 88325 
based on our new understanding that slide preparation is undertaken as 
part of the service described by this code. We are proposing to remove 
the clinical labor for ``Assemble and deliver slides with paperwork to 
pathologists'' from all three codes, as we believe this clinical labor 
is redundant with the labor assigned for ``Complete workload recording 
logs.'' We are similarly proposing to remove the clinical labor for 
``Clean equipment while performing service'' from CPT codes 88323 and 
88325, as we believe it to be redundant with the clinical labor 
assigned for ``Clean room/equipment following procedure.''
    We are proposing to maintain the quantity of the ``stain, 
hematoxylin'' supply (SL135) at 16 ml for CPT codes 88323 and 88325, as 
opposed to the RUC-recommended quantity of 32 ml. The RUC 
recommendation stated that the hematoxylin supply does not include 
eosin and should not be redundant; the stains are not mixed together, 
but are instead sequential. The recommendation also made a comparison 
to the use of the hematoxylin supply quantity in CPT code 88305. 
However, we note that CPT code 88305 does not include 8 ml of eosin 
stain (SL201), but instead 8 gm of eosin solution (SL063), and these 
are not the same supply. Therefore we do not agree that a direct 
comparison of the supply quantities is the most accurate way to value 
these procedures. For CPT codes 88323 and 88325, we continue to note 
that the prior supply inputs for these procedures had quantity 2.4 of 
the eosin solution (SL063) and quantity 4.8 of the hematoxylin stain 
(SL135); in other words, a 1:2 ratio between the eosin and hematoxylin. 
We are proposing to maintain that 1:2 ratio with 8 ml of the eosin 
stain (SL201) and 16 ml of the hematoxylin stain (SL135).
    We are also proposing to update the use of the eosin solution 
(sometimes listed as ``eosin y'') in our supply database. We believe 
that the eosin solution supply (SL063), which is measured in grams, 
reflects an older process of creating eosin stains by hand. This is in 
contrast to the eosin stain supply (SL201), which is measured in 
milliliters, and can be ordered in a state that is ready for staining 
immediately. We do not believe that the use of eosin solution would 
reflect typical lab practice today, with the readily availability for 
purchase of inexpensive eosin staining materials. We also note that in 
the CY 2016 PFS final rule with comment period, we removed 8 gm of the 
eosin solution and replaced it with 8 ml of the eosin stain, and this 
substitution was accepted without further change in the most recent set 
of RUC recommendations. As a result, we are proposing to update the 
price of the eosin stain supply from $0.044 per ml to $0.068 per ml to 
reflect the current cost of the supply. We are also proposing to use 
CPT codes 88323 and 88325 as a model, and replace the use of eosin 
solution with an equal quantity of eosin stain for the rest of the 
codes that make use of this supply. This applies to 15 other CPT codes: 
88302 (Level II--Surgical pathology, gross and microscopic 
examination), 88304 (Level III--Surgical pathology, gross and 
microscopic examination), 88305 (Level IV--Surgical pathology, gross 
and microscopic examination), 88307 (Level V--Surgical pathology, gross 
and microscopic examination), 88309 (Level VI--Surgical pathology, 
gross and microscopic examination), 88364 (In situ hybridization (e.g., 
FISH), per specimen; each additional single probe stain procedure), 
88365 (In situ hybridization (e.g., FISH), per specimen; initial single 
probe stain procedure), 88366 (In situ hybridization (e.g., FISH), per 
specimen; each multiplex probe stain procedure), 88367 (Morphometric 
analysis, in situ hybridization (quantitative or semi-quantitative), 
using computer-assisted technology, per specimen; initial single probe 
stain procedure), 88368 (Morphometric analysis, in situ hybridization 
(quantitative or semi-quantitative), manual, per specimen; initial 
single probe stain procedure), 88369 (Morphometric analysis, in situ 
hybridization (quantitative or semi-quantitative), manual, per 
specimen; each additional single probe stain procedure), 88373 
(Morphometric analysis, in situ hybridization (quantitative or semi-
quantitative), using computer-assisted technology, per specimen; each 
additional single probe stain procedure), 88374 (Morphometric analysis, 
in situ hybridization (quantitative or semi-quantitative),

[[Page 46255]]

using computer-assisted technology, per specimen; each multiplex probe 
stain procedure), 88377 (Morphometric analysis, in situ hybridization 
(quantitative or semi-quantitative), manual, per specimen; each 
multiplex probe stain procedure), and G0416 (Surgical pathology, gross 
and microscopic examinations, for prostate needle biopsy, any method).
(32) Closure of Paravalvular Leak (CPT Codes 935X1, 935X2, and 935X3)
    The CPT Editorial Committee developed three new codes (two base 
codes and one add-on code) to describe paravalvular leak closure 
procedures that were previously reported using an unlisted code. The 
RUC recommended a work RVU of 17.97 for CPT code 935X2. We are 
proposing a work RVU of 14.50 for CPT code 935X2, a direct crosswalk 
from CPT code 37227. We believe that a direct crosswalk to CPT code 
37227 accurately reflects the time and intensity described in CPT code 
935X2 since CPT code 37227 also describes a transcatheter procedure 
with similar service times.
    To maintain relativity among the codes in this family, we are 
proposing refinements to the recommended work RVUs for CPT code 935X1. 
The RUC noted the additional work associated with CPT code 935X1 
compared to CPT code 935X2 was due to the addition of a transseptal 
puncture to access the mitral valve. The RUC identified a work RVU of 
3.73 for a transseptal puncture. Therefore, for CPT code 935X1, we are 
proposing a work RVU of 18.23 arrived at by using our proposed work RVU 
for CPT code 935X2 (14.50) and adding the value of a transseptal 
puncture (3.73).
    CPT code 935X3 is an add-on code used to report placement of 
additional occlusion devices for percutaneous transcatheter 
paravalvular leak closure, performed in conjunction with either an 
initial mitral or aortic paravalvular leak closure. The RUC recommended 
a work RVU of 8.00 for this code. We considered applying the relative 
increment between CPT codes 935X1 and 935X2, however, we believe that a 
direct crosswalk to CPT code 35572, with a work RVU of 6.81, more 
accurately reflects the time and intensity of furnishing the service. 
Therefore, for CPT code 935X3, we are proposing a work RVU of 6.81.
(33) Electroencephalogram (EEG) (CPT Codes 95812, 95813, and 95957)
    In February 2016, the RUC submitted recommendations for work and 
direct PE inputs for CPT codes 95812, 95813, and 95957. We are 
proposing to use the RUC-recommended physician work and direct PE 
inputs for CPT code 95957 and to use the RUC-recommended work RVUs for 
CPT codes 95812 and 95813.
    In the CY 2016 PFS final rule with comment period (80 FR 70886), we 
finalized direct PE input refinements for several clinical labor times 
for CPT codes 95812 and 95813. The RUC's February 2016 PE summary of 
recommendations indicated that the specialty society expert panel 
disagreed with CMS' refinements to clinical labor time for these two 
codes. The RUC recommended 62 minutes for clinical labor task ``perform 
procedure'' for CPT code 95812 and 96 minutes for the same clinical 
labor task for CPT code 95813, similar to the values recommended by the 
RUC in April 2014.
    We are proposing to maintain the CMS-refined CY 2016 PE inputs for 
clinical labor task ``perform procedure'' for CPT codes 95812 (50 
minutes) and 95813 (80 minutes). The PE summary of recommendations 
state that CPT code 95812 requires 50 minutes of clinical labor time 
for EEG recording, and CPT code 95813 requires 80 minutes of clinical 
labor time for the same clinical labor task.
(34) Parent, Caregiver-Focused Health Risk Assessment (CPT Code 961X0)
    In October 2015, the CPT Editorial Panel created two new PE-only 
codes, 961X0 (Administration of patient-focused health risk assessment 
instrument (e.g., health hazard appraisal) with scoring and 
documentation, per standardized instrument) and 961X1 (Administration 
of caregiver-focused health risk assessment instrument (e.g., 
depression inventory) for the benefit of the patient, with scoring and 
documentation, per standardized instrument). For CPT code 961X0, we are 
proposing the RUC-recommended direct PE inputs. For CPT code 961X1, the 
service is furnished to a patient who may not be a Medicare beneficiary 
and thus we do not believe would be eligible for Medicare payment. We 
are proposing to assign a procedure status of I (Not valid for Medicare 
purposes) for CPT code 961X1.
    We note that we believe that this code describes a service that is 
frequently reasonable and necessary in the treatment of illness or 
injury, such as when there has been a change in health status. However, 
when the service described by CPT code 961X0 is explicitly included in 
another service being furnished, such as the Annual Wellness Visit 
(AWV), this code should not be billed separately, much like other codes 
that describe services included in codes with broader descriptions. We 
also note that this service should not be billed separately if 
furnished as a preventive service as it would describe a non-covered 
service. However, we are also seeking comment on whether this service 
may be better categorized as an add-on code and welcome stakeholder 
input regarding whether or not there are circumstances when this 
service might be furnished as a stand-alone service.
(35) Reflectance Confocal Microscopy (CPT Codes 96931, 96932, 96933, 
96934, 96935, and 96936)
    For CY 2015, the CPT Editorial panel established six new Category I 
codes to describe reflectance confocal microscopy (RCM) for imaging of 
skin. For CPT codes 96931 and 96933, the specialty society and the RUC 
agreed that the physician work required for both codes were identical, 
and therefore, should be valued the same. The RUC recommended a work 
RVU of 0.80 for CPT codes 96931 and 96933 based on the 25th percentile 
of the survey. Based on the similarity of the services being performed 
in CPT codes 96931 and 96933 and the identical intra-service times of 
96931, 96933 and 88305, the key reference code from the survey, we 
believe a direct crosswalk from CPT code 88305 to 96931 and 96933 would 
more accurately reflect the work involved in furnishing the procedure. 
Therefore, for CY 2017 we are proposing a value of 0.75 RVUs for CPT 
codes 96931 and 96933. In addition, we are removing 3 minutes of 
preservice time in CPT codes 96931 and 96933 since it is not included 
in CPT code 88305 and as a result, we do not believe it is appropriate 
in CPT codes 96931 and 96933 either.
    For CPT codes 96934 and 96936 the specialty society and the RUC 
agreed that the physician work required for both codes were identical, 
and therefore, should be valued the same. In its recommendation, the 
RUC stated that it believed the survey respondents somewhat 
overestimated the work for CPT code 96934 with the 25th percentile 
yielding a work RVU of 0.79. Consequently, the RUC reviewed the survey 
results from CPT code 96936 and agreed that the 25th percentile work 
RVU of 0.76 accurately accounted for the work involved for the service. 
Therefore, the RUC recommended a work RVU of 0.76 for CPT codes 96934 
and 96936.
    We believe that the incremental difference between the RUC-
recommended values for the base and add-on codes accurately captures 
the difference in work between the code pairs. However, because we 
valued the base codes differently than the RUC, we are proposing values 
for the add-on

[[Page 46256]]

codes that maintain the RUC's 0.04 increment instead of the RUC-
recommended values. Therefore we are proposing a work RVU of 0.71 for 
CPT codes 96934 and 96936.
    We are also proposing to reduce the preservice clinical labor for 
Patient clinical information and questionnaire reviewed by 
technologist, order from physician confirmed and exam protocoled by 
physician CPT codes 96934 and 93936 as this work is performed in the 
two CPT base codes 93931 and 93933. The service period clinical labor 
for ``Prepare and position patient/monitor patient/set up IV'' was 
reduced from 2 to 1 minute for CPT codes 93934 and 93936 since we 
believe that less positioning time is needed with subsequent lesions. 
The service period clinical labor for ``Other Clinical Activity--Review 
imaging with interpreting physician'' was refined to zero minutes for 
CPT codes 96933 and 96936 as these are interpretation and report only 
codes and not image acquisition.
(36) Evaluative Procedures for Physical Therapy and Occupational 
Therapy (CPT Codes 97X61, 97X62, 97X63, 97X64, 97X65, 97X66, 97X67, 
97X68)
    For CY 2017, the CPT Editorial Panel deleted four CPT codes (97001, 
97002, 97003, and 97004) and created eight new CPT codes (97X61-97X68) 
to describe the evaluative procedures furnished by physical therapists 
and occupational therapists. There are three new codes, stratified by 
complexity, to replace a single code, 97001, for physical therapy (PT) 
evaluation, three new codes, also stratified by complexity, to replace 
a single code, 97003, for occupational therapy (OT) evaluation, and one 
new code each to replace the reevaluation codes for physical and 
occupational therapy--97002 and 97004. Table 19 includes the long 
descriptors and the required components of each of the eight new CPT 
codes for the PT and OT services.
    The CPT Editorial Panel's creation of the new codes for PT and OT 
evaluative procedures grew out of a CPT workgroup that was originally 
convened in January 2012 when contemplating major revision of the 
Physical Medicine and Rehabilitation CPT section of codes in response 
to our nomination of therapy codes as potentially misvalued codes, 
including CPT code 97001 (and, as a result, all four codes in the 
family) in the CY 2012 PFS proposed rule.
    In reviewing the eight new CPT codes for evaluative procedures, the 
HCPAC forwarded recommendations for work RVUs and direct PE inputs for 
each code. Currently, CPT codes 97001 and 97003 both have a work RVU of 
1.20, and CPT codes 97002 and 97004 both have a work RVU of 0.60. These 
CPT codes have reflected the same work RVUs since CY 1998 when we 
accepted the HCPAC values during CY 1998 rulemaking.
i. Valuation of Evaluation Codes
    The HCPAC submitted work RVU recommendations for each of the six 
new PT and OT evaluation codes. These recommendations are intended to 
be work neutral relative to the valuation for the previous single 
evaluation code for PT and OT, respectively. However, that assessment 
for each family of codes is dependent on the accuracy of the 
utilization forecast for the different complexity levels within the PT 
or OT family. As used in this section, work neutrality is distinct from 
the budget neutrality that is applied broadly in the PFS. Specifically, 
work neutrality is intended to reflect that despite changes in coding, 
the overall amount of work RVUs for a set of services is held constant 
from one year to the next. For example, if a service is reported using 
a single code with a work RVU of 2.0 for one year but that same service 
would be reported using two codes, one for ``simple'' and another for 
``complex'' in the subsequent year valued at 1.0 and 3.0 respectively, 
work neutrality could only be attained if exactly half the services 
were reported using each of the two new codes. If more than half of the 
services were reported using the ``simple'' code, then there would be 
fewer overall work RVUs. If more than half of the services were 
reported using the ``complex'' code, then there would be more overall 
work RVUs. Therefore, work neutrality can only be assessed with an 
understanding of the relative frequency of how often particular codes 
will be reported.
    The HCPAC recommended a work RVU of 0.75 for CPT code 97X61, a work 
RVU of 1.18 for CPT code 97X62, and a work RVU of 1.5 for CPT code 
97X63. The PT specialty society projected that the moderate complexity 
evaluation code would be reported 50 percent of the time because it is 
the typical evaluation, and the CPT codes for the low and high 
complexity evaluations are each expected to be billed 25 percent of the 
time. The HCPAC-recommended work RVU of 1.18 for CPT code 97X62 
represents the survey median with 30 minutes of intraservice time, 10 
minutes of preservice time, and 15 minutes postservice time. The HCPAC 
notes this work value is appropriately ranked between levels 2 and 3 of 
the E/M office visit codes for new patients.
    The HCPAC recommended a work RVU of 0.88 for CPT code 97X65, a work 
RVU of 1.20 for CPT code 97X66, and a work RVU of 1.70 for CPT code 
97X67. For the OT codes, work neutrality would be achieved only with a 
projected utilization in which the low-complexity evaluation is billed 
50 percent of the time; the moderate-complexity evaluation is billed 40 
percent of the time, and the high-complexity evaluation only billed 10 
percent of the time. For purposes of calculating work neutrality, the 
HCPAC recommended assuming that the low-complexity code will be most 
frequently reported even though the HCPAC-recommended work RVU of 1.20 
and 45 minutes of intraservice time for moderate complexity code is 
identical to that of the current OT evaluation code. The HCPAC believes 
that the work RVU of 1.20 is appropriately ranked between 99202 and 
99203, levels 2 and 3 for E/M office visits for new outpatients.
ii. Valuation of Evaluation Codes and Discussion of PAMA
    In our review of the HCPAC recommendations, we noted the work 
neutrality and the inherent reliance on the utilization assumptions. We 
considered the three complexity levels for the PT evaluations and the 
three complexity levels for the OT evaluations; and we also considered 
the evaluation services described by the codes as a whole. The varying 
work RVUs and the dependence on utilization for each complexity level 
to ensure work neutrality in the PT and OT code families make it 
difficult for us evaluate the HCPAC's recommended values or to predict 
with a high degree of certainty whether physical and occupational 
therapists will actually bill for these services at the same rate 
forecast by their respective specialty societies.
    We are concerned that the coding stratification in the PT and OT 
evaluation codes may result in upcoding incentives, especially while 
physical and occupational therapists gain familiarity and expertise in 
the differential coding of the new PT and OT evaluation codes that now 
include the typical face-to-face times and new required components that 
are not enumerated in the current codes. We are also concerned that 
stratified payment rates may provide, in some cases, a payment 
incentive to therapists to upcode to a higher complexity level than was 
actually furnished to receive a higher payment.
    We understand that there may be multiple reasons for the CPT 
Editorial Panel to stratify coding for OT and PT

[[Page 46257]]

evaluation codes based on complexity. We also note that the codes will 
be used by payers in addition to Medicare, and other payers may have 
direct interest in making such differential payment based on complexity 
of OT and PT evaluation. Given our concerns regarding appropriate 
valuation, work neutrality, and potential upcoding, however, we do not 
believe that making different payment based on the reported complexity 
for these services is, at current, advantageous for Medicare or 
Medicare beneficiaries.
    Given the advantages inherent and public interest in using CPT 
codes once they become part of the code set, we are proposing to adopt 
the new CPT codes for use in Medicare for CY 2017. However, given our 
concerns about appropriate pricing and payment for the stratified 
services, we are proposing to price the services described by these 
stratified codes as a group instead of individually. To do that, we are 
proposing to utilize the authority in section 220(f) of the Protecting 
Access to Medicare Act (PAMA), which revised section 1848(c)(2)(C) of 
the Act to authorize the Secretary to determine RVUs for groups of 
services, rather than determining RVUs at the individual service level. 
We believe that using this authority instead of proposing to make 
payment based on Medicare G-codes will preserve consistency in the code 
set across payers, thus lessening burden on providers, while retaining 
flexibilities that are beneficial to Medicare.
    We propose a work RVU of 1.20 for both the PT and the OT evaluation 
groups of services. We are proposing this work RVU because we believe 
it best represents the typical PT and OT evaluation. This is the value 
recommended by the HCPAC for the OT moderate-complexity evaluation and 
nearly the same work RVU for corresponding PT evaluation (1.18). 
Additionally, 1.20 work RVUs is the long-standing value for the current 
evaluation codes, 97001 and 97003, and, thus, assures work neutrality 
without reliance on particular assumptions about utilization, which we 
believe was the intent of the HCPAC recommendation.
    Because we are proposing to use the same work RVU for the six 
evaluation codes, we are not addressing any additional concerns about 
the utilization assumptions recommended to us. By proposing the same 
work values for each code in the family, there will be no ratesetting 
impact to work neutrality. As such, we are not revising the utilization 
crosswalks as projected by the respective therapy specialties to 
achieve work neutrality. However, were we to value each code in the PT 
or OT evaluation families individually, we would seek objective data 
from stakeholders to support the utilization crosswalks, particularly 
those for the OT family in which the low-level complexity evaluation is 
depicted as typical and the high-complexity is projected to be billed 
infrequently at 10 percent of the overall number of OT evaluations.
    We are proposing to use the direct PE inputs forwarded by the HCPAC 
(with the refinements described below) for the typical PT evaluation 
and also for the typical OT evaluation in the development of PE RVUs 
for the PT and OT codes as a group of services. For the PT codes, we 
are proposing to use the recommended inputs for the moderate-complexity 
code for the direct PE inputs of all three codes based on its 
assumption as the typical service. Our proposed direct PE inputs 
reflect the recommended values minus 2 minutes of physical therapist 
assistant (PTA) time in the service period because we believe that PTA 
tasks to administer certain assessment tools are appropriately included 
as part of the physical therapist's work and the time of the PTA to 
explain and/or score self-reported outcome measures is not separately 
included in the clinical labor of other codes. We are proposing to 
include the recommended four sheets of laser paper without an 
association to a specific equipment item, but we are seeking comment 
regarding the paper's use.
    For the OT evaluation codes, we considered proposing to use the 
direct PE inputs for the low-complexity evaluation because the OT 
specialty organization believes it represents the typical OT evaluation 
service with a projected 50 percent utilization rate. However, we 
propose to use the moderate-level direct inputs instead, because the 
direct PE for this level is based on a vignette that is valued with the 
same intraservice time, 45 minutes, as the current code, CPT code 
97003. Consequently, we propose to use the recommended direct PE inputs 
for the moderate-complexity code for use in developing PE RVUs for this 
group of services.
    Our proposed direct PE inputs reflect the recommended values minus 
2 minutes of occupational therapist assistant (OTA) time in the service 
period because we believe that OTA tasks to administer certain 
assessment tools are appropriately included as part of the occupational 
therapist's work and the time of the OTA to explain and/or score self-
reported outcome measures is not separately included in the clinical 
labor of other codes. We also rounded up the recommended 6.8 minutes to 
7 minutes to represent the time the OTA assists the occupational 
therapist during the intraservice time period. For the Vision Kit 
equipment item, our proposed price reflects the submitted invoice that 
clearly defined a kit.
iii. Valuation of Reevaluation Codes
    The recommendations the HCPAC sent to us for the PT and OT 
reevaluation codes are not work neutral. For the new PT reevaluation 
code, CPT code 97X64, the HCPAC recommended a work RVU of 0.75 compared 
to the work RVU of 0.60 for CPT code 97002. This recommended work RVU 
falls between the 25th percentile of the survey and the survey's median 
value and was based on a direct crosswalk to CPT code 95992 for 
canalith repositioning with 20 minutes intraservice time and 10 minutes 
immediate postservice time. The HCPAC supported this 0.15 work RVU 
increase based on an anomalous relationship between PT services and E/M 
office visit codes for established patients, noting that physician E/M 
codes have historically been used as a relative comparison. The HCPAC 
stated its 0.75 work RVU recommendation for code 97X64 appropriately 
ranks it between the key reference codes for this service 99212 and 
99213, levels 2 and 3 E/M office-visit codes for established patients.
    The HCPAC provided a work RVU of 0.80 for the OT reevaluation code, 
CPT code 97X68, based on the 25th percentile of the survey, which 
represents an increase over the current work RVU of 0.60 for CPT code 
97004. This work value includes 30 minutes of intraservice time, 5 
minutes preservice time, and 10 minutes immediate postservice time. The 
HCPAC noted that the increase in work compared to the PT reevaluation 
code (0.75) is because the occupational therapist spends more time 
observing and assessing the patient and, in general, the OT patient 
typically has more functional and cognitive disabilities. The HCPAC 
recommendation notes that the 0.80 work RVU recommendation 
appropriately ranks it between the level 1 and 2 E/M office-visit codes 
for new patients.
    The HCPAC's recommended increases to work RVUs for the PT and OT 
reevaluation codes are not work neutral. We are unclear why the HCPAC 
did not maintain work neutrality for the OT and PT reevaluation codes 
since maintaining work neutrality was important to the establishment of 
the six new evaluation codes. We are proposing to maintain the

[[Page 46258]]

overall work RVUs for these services by proposing 0.60 work RVUs for 
CPT codes 97X64 and 97X68, consistent with the work RVUs for the 
deleted reevaluation codes. We are seeking comments from stakeholders 
on whether there are reasons that the reevaluation codes should be 
revalued without regard to work neutrality particularly given the 
HCPAC's interest in preserving work neutrality for the new evaluation 
codes.
    We are proposing the HCPAC-recommended direct PE inputs for CPT 
code 97X64 with a reduction in time for the PTA by 1 minute (from 5 to 
4) in the service period- the line for ``Other Clinical Activity''--
because the time to explain and score the self-reported outcome measure 
(for example, Oswestry) is not separately included in the clinical 
labor of other codes.
    We are proposing the HCPAC-recommended direct PE inputs for CPT 
code 97X68 with a reduction in time for the OTA by 1 minute (from 3 to 
2) in the service period--the line for ``Other Clinical Activity''--for 
the same reason we reduced the corresponding line for PTAs--because the 
time to explain and score any patient-self-administered functional and/
or other standardized outcome measure is not separately included in the 
clinical labor of other codes.
    Because the new CPT code descriptors contain new coding 
requirements for each complexity level, we seek comment from the PT and 
OT specialty organizations as well as other stakeholders to clarify how 
therapists will be educated to distinguish the required complexity 
level components and the selection of the number of elements that 
impact the plan of care. For example, for the OT codes, we invite 
comment on how to define performance deficits, what process the 
occupational therapist uses to identify the number of these performance 
deficits that result in activity limitations, and performance factors 
needed for each complexity level. For the PT codes, we would like more 
information about how the physical therapist differentiates the number 
of personal factors that actually affect the plan of care. We would 
also be interested in understanding more about how the physical 
therapist selects the number of elements from any of the body 
structures and functions, activity limitations, and/or participation 
restrictions to make sure there is no duplication during the physical 
therapist's examination of body systems.
iv. Always Therapy Codes
    It is also important to note that CMS defines the codes for these 
evaluative services as ``always therapy.'' This means that they always 
represent therapy services regardless of who performs them and always 
require a therapy modifier, GP or GO, to signify that the services are 
furnished under a PT or OT plan of care, respectively. These codes will 
also be subject to the therapy MPPR and to statutory therapy caps.

 Table 19--CPT Long Descriptors for Physical Medicine and Rehabilitation
------------------------------------------------------------------------
                                      CPT long descriptors for physical
            New CPT code                 medicine and rehabilitation
------------------------------------------------------------------------
97X61..............................  Physical therapy evaluation: Low
                                      complexity, requiring these
                                      components:
                                      A history with no personal
                                      factors and/or comorbidities that
                                      impact the plan of care;
                                      An examination of body
                                      system(s) using standardized tests
                                      and measures addressing 1-2
                                      elements from any of the
                                      following: Body structures and
                                      functions, activity limitations,
                                      and/or participation restrictions;
                                      A clinical presentation
                                      with stable and/or uncomplicated
                                      characteristics; and
                                      Clinical decision making
                                      of low complexity using
                                      standardized patient assessment
                                      instrument and/or measurable
                                      assessment of functional outcome.
                                     Typically, 20 minutes are spent
                                      face-to-face with the patient and/
                                      or family.
97X62..............................  Physical therapy evaluation:
                                      Moderate complexity, requiring
                                      these components:
                                      A history of present
                                      problem with 1-2 personal factors
                                      and/or comorbidities that impact
                                      the plan of care;
                                      An examination of body
                                      systems using standardized tests
                                      and measures in addressing a total
                                      of 3 or more elements from any of
                                      the following: Body structures and
                                      functions, activity limitations,
                                      and/or participation restrictions;
                                      An evolving clinical
                                      presentation with changing
                                      characteristics; and
                                      Clinical decision making
                                      of moderate complexity using
                                      standardized patient assessment
                                      instrument and/or measurable
                                      assessment of functional outcome.
                                     Typically, 30 minutes are spent
                                      face-to-face with the patient and/
                                      or family.
97X63..............................  Physical therapy evaluation: High
                                      complexity, requiring these
                                      components:
                                      A history of present
                                      problem with 3 or more personal
                                      factors and/or comorbidities that
                                      impact the plan of care;
                                      An examination of body
                                      systems using standardized tests
                                      and measures addressing a total of
                                      4 or more elements from any of the
                                      following: Body structures and
                                      functions, activity limitations,
                                      and/or participation restrictions;
                                      A clinical presentation
                                      with unstable and unpredictable
                                      characteristics; and
                                      Clinical decision making
                                      of high complexity using
                                      standardized patient assessment
                                      instrument and/or measurable
                                      assessment of functional outcome.
                                     Typically, 45 minutes are spent
                                      face-to-face with the patient and/
                                      or family.
97X64..............................  Reevaluation of physical therapy
                                      established plan of care,
                                      requiring these components:
                                      An examination including a
                                      review of history and use of
                                      standardized tests and measures is
                                      required; and
                                      Revised plan of care using
                                      a standardized patient assessment
                                      instrument and/or measurable
                                      assessment of functional outcome
                                     Typically, 20 minutes are spent
                                      face-to-face with the patient and/
                                      or family.
97X65..............................  Occupational therapy evaluation,
                                      low complexity, requiring these
                                      components:
                                      An occupational profile
                                      and medical and therapy history,
                                      which includes a brief history
                                      including review of medical and/or
                                      therapy records relating to the
                                      presenting problem;
                                      An assessment(s) that
                                      identifies 1-3 performance
                                      deficits (i.e., relating to
                                      physical, cognitive, or
                                      psychosocial skills) that result
                                      in activity limitations and/or
                                      participation restrictions; and
                                      Clinical decision making
                                      of low complexity, which includes
                                      an analysis of the occupational
                                      profile, analysis of data from
                                      problem-focused assessment(s), and
                                      consideration of a limited number
                                      of treatment options. Patient
                                      presents with no comorbidities
                                      that affect occupational
                                      performance. Modification of tasks
                                      or assistance (e.g., physical or
                                      verbal) with assessment(s) is not
                                      necessary to enable completion of
                                      evaluation component.
                                     Typically, 30 minutes are spent
                                      face-to-face with the patient and/
                                      or family.

[[Page 46259]]

 
97X66..............................  Occupational therapy evaluation,
                                      moderate complexity, requiring
                                      these components:
                                      An occupational profile
                                      and medical and therapy history,
                                      which includes an expanded review
                                      of medical and/or therapy records
                                      and additional review of physical,
                                      cognitive, or psychosocial history
                                      related to current functional
                                      performance;
                                      An assessment(s) that
                                      identifies 3-5 performance
                                      deficits (i.e., relating to
                                      physical, cognitive, or
                                      psychosocial skills) that result
                                      in activity limitations and/or
                                      participation restrictions; and
                                      Clinical decision making
                                      of moderate analytic complexity,
                                      which includes an analysis of the
                                      occupational profile, analysis of
                                      data from detailed assessment(s),
                                      and consideration of several
                                      treatment options. Patient may
                                      present with comorbidities that
                                      affect occupational performance.
                                      Minimal to moderate modification
                                      of tasks or assistance (e.g.,
                                      physical or verbal) with
                                      assessment(s) is necessary to
                                      enable patient to complete
                                      evaluation component.
                                     Typically, 45 minutes are spent
                                      face-to-face with the patient and/
                                      or family.
97X67..............................  Occupational therapy evaluation,
                                      high complexity, requiring these
                                      components:
                                      An occupational profile
                                      and medical and therapy history,
                                      which includes review of medical
                                      and/or therapy records and
                                      extensive additional review of
                                      physical, cognitive, or
                                      psychosocial history related to
                                      current functional performance;
                                      An assessment(s) that
                                      identify 5 or more performance
                                      deficits (i.e., relating to
                                      physical, cognitive, or
                                      psychosocial skills) that result
                                      in activity limitations and/or
                                      participation restrictions; and
                                      A clinical decision-making
                                      is of high analytic complexity,
                                      which includes an analysis of the
                                      patient profile, analysis of data
                                      from comprehensive assessment(s),
                                      and consideration of multiple
                                      treatment options. Patient
                                      presents with comorbidities that
                                      affect occupational performance.
                                      Significant modification of tasks
                                      or assistance (e.g., physical or
                                      verbal) with assessment(s) is
                                      necessary to enable patient to
                                      complete evaluation component.
                                     Typically, 60 minutes are spent
                                      face-to-face with the patient and/
                                      or family.
97X68..............................  Reevaluation of occupational
                                      therapy established plan of care,
                                      requiring these components:
                                      An assessment of changes
                                      in patient functional or medical
                                      status with revised plan of care;
                                      An update to the initial
                                      occupational profile to reflect
                                      changes in condition or
                                      environment that affect future
                                      interventions and/or goals; and
                                      A revised plan of care. A
                                      formal reevaluation is performed
                                      when there is a documented change
                                      in functional status or a
                                      significant change to the plan of
                                      care is required.
                                     Typically, 30 minutes are spent
                                      face-to-face with the patient and/
                                      or family.
------------------------------------------------------------------------

v. Potentially Misvalued Therapy Codes
    Since 2010, in addition to the codes for evaluative services, CMS 
has periodically added codes that represent therapy services to the 
list of potentially misvalued codes. The current list of 10 therapy 
codes was based on the statutory category ``codes that account for the 
majority of spending under the physician fee schedule,'' as specified 
in section 1848(c)(2)(K)(ii)(VII) of the Act. We understand that the 
therapy specialty organizations have pursued the development of coding 
changes through the CPT process for these modality and procedures 
services. While we understand that, in some cases, it may take several 
years to develop appropriate coding revisions, we are, in the meantime, 
seeking information regarding appropriate valuation for the existing 
codes. See Table 20.

      Table 20--Potentially Misvalued Codes Identified Through High
                     Expenditure by Specialty Screen
------------------------------------------------------------------------
          HCPCS code                        Short descriptor
------------------------------------------------------------------------
97032.........................  Electrical stimulation.
97035.........................  Ultrasound therapy.
97110.........................  Therapeutic exercises.
97112.........................  Neuromuscular reeducation.
97113.........................  Aquatic therapy/exercises.
97116.........................  Gait training therapy.
97140.........................  Manual therapy 1/regions.
97530.........................  Therapeutic activities.
97535.........................  Self care mngment training.
G0283.........................  Elec stim other than wound.
------------------------------------------------------------------------

(37) Proposed Valuation of Services Where Moderate Sedation Is an 
Inherent Part of the Procedure and Proposed Valuation of Moderate 
Sedation Services (CPT Codes 991X1, 991X2, 991X3, 991X4, 991X5, and 
991X6; and HCPCS Code GMMM1)
    In the CY 2015 PFS proposed rule (79 FR 40349), we noted that it 
appeared that practice patterns for endoscopic procedures were 
changing. Anesthesia services are increasingly being separately 
reported for endoscopic procedures, meaning that resource costs 
associated with sedation were no longer incurred by the practitioner 
reporting the procedure. Subsequently, in the CY 2016 PFS proposed rule 
(80 FR 41707), we sought public comment and recommendations on 
approaches to address the appropriate valuation of moderate sedation 
related to the approximately 400 diagnostic and therapeutic procedures 
for which the CPT Editorial Committee has determined that moderate 
sedation is an inherent part of furnishing the service. The CPT 
Editorial Committee created separate codes for reporting of moderate 
sedation services.

            Table 21--Moderate Sedation Codes and Descriptors
------------------------------------------------------------------------
           CPT/HCPCS code                         Descriptor
------------------------------------------------------------------------
991X1..............................  Moderate sedation services provided
                                      by the same physician or other
                                      qualified health care professional
                                      performing the diagnostic or
                                      therapeutic service that the
                                      sedation supports, requiring the
                                      presence of an independent trained
                                      observer to assist in the
                                      monitoring of the patient's level
                                      of consciousness and physiological
                                      status; initial 15 minutes of
                                      intra-service time, patient
                                      younger than 5 years of age.

[[Page 46260]]

 
991X2..............................  Moderate sedation services provided
                                      by the same physician or other
                                      qualified health care professional
                                      performing the diagnostic or
                                      therapeutic service that the
                                      sedation supports, requiring the
                                      presence of an independent trained
                                      observer to assist in the
                                      monitoring of the patient's level
                                      of consciousness and physiological
                                      status; initial 15 minutes of
                                      intra-service time, patient age 5
                                      years or older.
991X3..............................  Moderate sedation services provided
                                      by a physician or other qualified
                                      health care professional other
                                      than the physician or other
                                      qualified health care professional
                                      performing the diagnostic or
                                      therapeutic service that the
                                      sedation supports; initial 15
                                      minutes of intra-service time,
                                      patient younger than 5 years of
                                      age.
991X4..............................  Moderate sedation services provided
                                      by a physician or other qualified
                                      health care professional other
                                      than the physician or other
                                      qualified health care professional
                                      performing the diagnostic or
                                      therapeutic service that the
                                      sedation supports; initial 15
                                      minutes of intra-service time,
                                      patient age 5 years or older.
991X5..............................  Moderate sedation services provided
                                      by the same physician or other
                                      qualified health care professional
                                      performing the diagnostic or
                                      therapeutic service that the
                                      sedation supports, requiring the
                                      presence of an independent trained
                                      observer to assist in the
                                      monitoring of the patient's level
                                      of consciousness and physiological
                                      status; each additional 15 minutes
                                      of intra-service time (List
                                      separately in addition to code for
                                      primary service).
991X6..............................  Moderate sedation services provided
                                      by a physician or other qualified
                                      health care professional other
                                      than the physician or other
                                      qualified health care professional
                                      performing the diagnostic or
                                      therapeutic service that the
                                      sedation supports; each additional
                                      15 minutes intra-service time
                                      (List separately in addition to
                                      code for primary service).
------------------------------------------------------------------------

    For the newly created moderate sedation CPT codes, we are proposing 
to use the RUC-recommended work RVUs for CPT codes 991X1, 991X2, 991X3, 
and 991X6. CPT codes 991X1 and 991X2 make a distinction between 
moderate sedation services furnished to patients younger than 5 years 
of age and patients 5 years or older, with CPT codes 991X3 and 991X4 
making a similar distinction. The RUC recommendations include a work 
RVU increment of 0.25 between CPT code 991X1 and 991X2. For CPT code 
991X4, we are proposing a work RVU of 1.65 to maintain the 0.25 
increment relative to CPT code 991X3 (a RUC-recommended work RVU of 
1.90) and maintain relativity among the CPT codes in this family. We 
are proposing to use the RUC-recommended direct PE inputs for all six 
codes.
    When moderate sedation is reported for Medicare beneficiaries, we 
expect that it would most frequently reported using the code that 
describes moderate sedation furnished by the same person who also 
performs the primary procedure for patients 5 years of age or older. 
Under the new coding structure, these services would be reported using 
CPT code 991X2. Stakeholders have presented information that 
illustrates that the specialty group survey data regarding the work 
involved in furnishing the moderate sedation described by CPT code 
991X2 showed a significant bimodal distribution between procedural 
services furnished by gastroenterologists (GI) and those services 
furnished by other specialties. The GI societies' survey data reported 
a median valuation of 0.10 work RVUs for moderate sedation furnished by 
the same person furnishing the base procedure; all other specialty 
groups (combined) reported a median valuation of 0.25 work RVUs. Given 
the significant volume of moderate sedation furnished by GI 
practitioners and the significant difference in RVUs reported in the 
survey data, we are proposing to make payment using a gastrointestinal 
(GI) endoscopy-specific moderate sedation code GMMM1 that would be used 
in lieu of the new CPT moderate sedation coding used more broadly: 
GMMM1: Moderate sedation services provided by the same physician or 
other qualified health care professional performing a gastrointestinal 
endoscopic service (excluding biliary procedures) that sedation 
supports, requiring the presence of an independent trained observer to 
assist in the monitoring of the patient's level of consciousness and 
physiological status; initial 15 minutes of intra-service time; patient 
age 5 years or older.
    We are proposing to value GMMM1 at 0.10 work RVUs based on the 
median survey result for GI respondents in the survey data. We are 
proposing that when moderate sedation services are furnished by the 
same practitioner reporting the GI endoscopy procedure, practitioners 
would report the sedation services using GMMM1 instead of 991X2. In all 
other cases, we propose that practitioners would report moderate 
sedation using one of the new moderate sedation CPT codes consistent 
with CPT guidance. This would include the full range of codes for those 
furnishing moderate sedation with the remaining (non-GI endoscopy) base 
procedures as well as for the other circumstances during which moderate 
sedation is furnished along with a GI endoscopy (for example, to a 
patient under 5 years of age or for a biliary procedure, the 
endoscopist furnishing moderate sedation should not use GMMM1, but 
instead use the appropriate CPT code; see Table 22 for more information 
about when GMMM1 should be used in lieu of the newly created moderate 
sedation CPT codes).
    In addition to providing recommended values for the new codes used 
to separately report moderate sedation, the RUC has provided 
recommendations that value the procedural services without moderate 
sedation. However, the RUC recommends removing fewer RVUs from the 
procedures than it recommends for valuing the sedation services. In 
other words, the RUC is recommending that overall payments for these 
procedures should be increased now that practitioners will be required 
to report the sedation services that were previously included as 
inherent parts of the procedures. We believe that if we were to use the 
RUC recommendations for re-valuation of the procedural services without 
refinement, the RVUs currently attributable to the redundant payment 
for sedation services when anesthesia is separately reported would be 
used exclusively to increase overall payment for these services. We 
refer readers to Section II.D.5. of this proposed rule, which includes 
a more extensive discussion of our general principle that overall 
resource costs for the procedures including moderate sedation do not 
inherently change based solely on changes in coding.
    To account for the separate billing of moderate sedation services, 
we are proposing to maintain current values for the procedure codes 
less the work RVUs associated with the most frequently reported 
corresponding moderate sedation code so that practitioners furnishing 
the moderate sedation

[[Page 46261]]

services previously considered to be inherent in the procedure will 
have no change in overall work RVUs. Since we are proposing 0.10 work 
RVUs for moderate sedation for the GI endoscopy procedures, this means 
we are proposing a corresponding .10 reduction in work RVUs for these 
procedures. For all other Appendix G procedures that currently include 
moderate sedation as an inherent part of the procedure, we are 
proposing to remove 0.25 work RVUs from the current values.
    Table 22 lists the existing work RVUs for each applicable service 
and our proposed refined work RVU using the proposed revaluation 
methodology described above. Additionally, the table identifies the GI 
endoscopic services for which we are proposing that GMMM1 would be used 
to report moderate sedation services. This information will be made 
available and maintained in the ``downloads'' section of the PFS Web 
site at 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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                                                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 C