[Federal Register Volume 82, Number 139 (Friday, July 21, 2017)]
[Proposed Rules]
[Pages 33950-34203]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14639]



[[Page 33949]]

Vol. 82

Friday,

No. 139

July 21, 2017

Part II





 Department of Health and Human Services





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 Centers for Medicare & Medicaid Services





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42 CFR Parts 405, 410, 414, et al.





 Medicare Program; Revisions to Payment Policies Under the Physician 
Fee Schedule and Other Revisions to Part B for CY 2018; Medicare Shared 
Savings Program Requirements; and Medicare Diabetes Prevention Program; 
Proposed Rule

  Federal Register / Vol. 82 , No. 139 / Friday, July 21, 2017 / 
Proposed Rules  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Parts 405, 410, 414, 424, and 425

[CMS-1676-P]
RIN 0938-AT02


Medicare Program; Revisions to Payment Policies Under the 
Physician Fee Schedule and Other Revisions to Part B for CY 2018; 
Medicare Shared Savings Program Requirements; and Medicare Diabetes 
Prevention Program

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Proposed rule.

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SUMMARY: This major proposed rule addresses changes to the Medicare 
physician fee schedule (PFS) and other Medicare Part B payment 
policies.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 5 p.m. on September 11, 
2017. (See the SUPPLEMENTARY INFORMATION section of this final rule 
with comment period for a list of provisions open for comment.)

ADDRESSES: In commenting, please refer to file code CMS-1676-P. Because 
of staff and resource limitations, we cannot accept comments by 
facsimile (FAX) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
    1. Electronically. You may submit electronic comments on this 
regulation to www.regulations.gov. Follow the instructions for 
``submitting a comment.''
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-1676-P, P.O. Box 8016, 
Baltimore, MD 21244-8013.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-1676-P, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. If you prefer, you may deliver (by hand or 
courier) your written comments before the close of the comment period 
to either of the following addresses:
    a. For delivery in Washington, DC--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, Room 445-G, Hubert 
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 
20201.
    (Because access to the interior of the Hubert H. Humphrey Building 
is not readily available to persons without federal government 
identification, commenters are encouraged to leave their comments in 
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing 
by stamping in and retaining an extra copy of the comments being 
filed.)
    b. For delivery in Baltimore, MD--Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
please call telephone number (410) 786-7195 in advance to schedule your 
arrival with one of our staff members. Comments mailed to the addresses 
indicated as appropriate for hand or courier delivery may be delayed 
and received after the comment period.

FOR FURTHER INFORMATION CONTACT: 
    Jamie Hermansen, (410) 786-2064, for issues related to the 
valuation of anesthesia services and any physician payment issues not 
identified below.
    Lindsey Baldwin, (410) 786-1694, and Emily Yoder, (410) 786-1804, 
for issues related to telehealth services and primary care.
    Roberta Epps, (410) 786-4503, for issues related to PAMA section 
218(a) policy and transition from traditional X-ray imaging to digital 
radiography.
    Isadora Gil, (410) 786-4532, for issues related to the valuation of 
cardiovascular services, bone marrow services, surgical respiratory 
services, dermatological procedures, and payment rates for nonexcepted 
items and services furnished by nonexcepted off-campus provider-based 
departments of a hospital.
    Donta Henson, (410) 786-1947, for issues related to ophthalmology 
services.
    Tourette Jackson, (410) 786-4735, for issues related to the 
valuation of musculoskeletal services, allergy and clinical immunology 
services, endocrinology services, genital surgical services, nervous 
system services, INR monitoring services, injections and infusions, and 
chemotherapy services.
    Ann Marshall, (410) 786-3059, for issues related to primary care, 
chronic care management (CCM), and evaluation and management (E/M) 
services.
    Geri Mondowney, (410) 786-4584, for issues related to malpractice 
RVUs.
    Patrick Sartini, (410) 786-9252, for issues related to the 
valuation of imaging services and malpractice RVUs.
    Michael Soracoe, (410) 786-6312, for issues related to the practice 
expense methodology, impacts, conversion factor, and valuation of 
pathology and surgical procedures.
    Pamela West, (410) 786-2302, for issues related to therapy 
services.
    Corinne Axelrod, (410) 786-5620, for issues related to rural health 
clinics or federally qualified health centers.
    Felicia Eggleston, (410) 786-9287, for issues related to DME 
infusion drugs.
    Rasheeda Johnson, (410) 786-3434, for issues related to initial 
data collection and reporting periods for the clinical laboratory fee 
schedule.
    Edmund Kasaitis, (410) 786-0477, for issues related to biosimilars.
    JoAnna Baldwin, (410) 786-7205, or Sarah Fulton, (410) 786-2749, 
for issues related to appropriate use criteria for advanced diagnostic 
imaging services.
    Alesia Hovatter, (410) 786-6861, for issues related to PQRS.
    Alexandra Mugge, (410) 786-4457, or Elizabeth Holland, (410) 786-
1309, for issues related to the EHR incentive program.
    Rabia Khan or Terri Postma, (410) 786-8084 or [email protected], for 
issues related to the Medicare Shared Savings Program.
    Kimberly Spalding Bush, (410) 786-3232, or Fiona Larbi, (410) 786-
7224, for issues related to Value-based Payment Modifier and Physician 
Feedback Program.
    Wilbert Agbenyikey, (410) 786-4399, for issues related to MACRA 
patient relationship categories and codes.
    Carlye Burd, (410) 786-1972, or Albert Wesley, (410) 786-4204, for 
issues related to diabetes prevention program.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
II. Provisions of the Proposed Rule for PFS
    A. Background
    B. Determination of Practice Expense Relative Value Units (PE 
RVUs)
    C. Determination of Malpractice Relative Value Units (MRVUs)
    D. Medicare Telehealth Services
    E. Potentially Misvalued Services Under the PFS
    F. Implementation of Reduced Payment for Film-Based Imaging 
Services
    G. Proposed Payment Rates Under the Medicare PFS for Nonexcepted 
Items and Services Furnished by Nonexcepted Off-Campus Provider-
Based Departments of a Hospital

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    H. Proposed Valuation of Specific Codes
    I. Evaluation & Management (E/M) Guidelines and Care Management 
Services
III. Other Provisions of the Proposed Rule
    A. New Care Coordination Services and Payment for Rural Health 
Clinics (RHCs) and Federally Qualified Health Centers (FQHCs)
    B. Payment for DME Infusion Drugs
    C. Solicitation of Public Comments on Initial Data Collection 
and Reporting Periods for Clinical Laboratory Fee Schedule
    D. Solicitation of Public Comments on Biosimilars
    E. Appropriate Use Criteria for Advanced Diagnostic Imaging 
Services
    F. Physician Quality Reporting System Criteria for Satisfactory 
Reporting for Individual EPs and Group Practices for the 2018 PQRS 
Payment Adjustment
    G. Medicare EHR Incentive Program
    H. Medicare Shared Savings Program
    I. Value-Based Payment Modifier and Physician Feedback Program
    J. MACRA Patient Relationship Categories and Codes
    K. Medicare Diabetes Prevention Program
IV. Collection of Information Requirements
V. Response to Comments
VI. Regulatory Impact Analysis
Regulations Text

Acronyms

    In addition, because of the many organizations and terms to which 
we refer by acronym in this final rule, we are listing these acronyms 
and their corresponding terms in alphabetical order below:

A1c Hemoglobin A1c
AAA Abdominal aortic aneurysms
ACO Accountable care organization
AMA American Medical Association
ASC Ambulatory surgical center
ATA American Telehealth Association
ATRA American Taxpayer Relief Act (Pub. L. 112-240)
AWV Annual wellness visit
BBA Balanced Budget Act of 1997 (Pub. L. 105-33)
BBRA [Medicare, Medicaid and State Child Health Insurance Program] 
Balanced Budget Refinement Act of 1999 (Pub. L. 106-113)
BLS Bureau of Labor Statistics
CAD Coronary artery disease
CAH Critical access hospital
CBSA Core-Based Statistical Area
CCM Chronic care management
CEHRT Certified EHR technology
CF Conversion factor
CG-CAHPS Clinician and Group Consumer Assessment of Healthcare 
Providers and Systems
CLFS Clinical Laboratory Fee Schedule
CoA Certificate of Accreditation
CoC Certificate of Compliance
CoR Certificate of Registration
CNM Certified nurse-midwife
CP Clinical psychologist
CPC Comprehensive Primary Care
CPEP Clinical Practice Expert Panel
CPT [Physicians] Current Procedural Terminology (CPT codes, 
descriptions and other data only are copyright 2015 American Medical 
Association. All rights reserved.)
CQM Clinical quality measure
CSW Clinical social worker
CT Computed tomography
CW Certificate of Waiver
CY Calendar year
DFAR Defense Federal Acquisition Regulations
DHS Designated health services
DM Diabetes mellitus
DSMT Diabetes self-management training
eCQM Electronic clinical quality measures
ED Emergency Department
EHR Electronic health record
E/M Evaluation and management
EMT Emergency Medical Technician
EP Eligible professional
eRx Electronic prescribing
ESRD End-stage renal disease
FAR Federal Acquisition Regulations
FDA Food and Drug Administration
FFS Fee-for-service
FQHC Federally qualified health center
FR Federal Register
FSHCAA Federally Supported Health Centers Assistance Act
GAF Geographic adjustment factor
GAO Government Accountability Office
GPCI Geographic practice cost index
GPO Group purchasing organization
GPRO Group practice reporting option
GTR Genetic Testing Registry
HCPCS Healthcare Common Procedure Coding System
HHS [Department of] Health and Human Services
HOPD Hospital outpatient department
HPSA Health professional shortage area
IDTF Independent diagnostic testing facility
IPPE Initial preventive physical exam
IPPS Inpatient Prospective Payment System
IQR Inpatient Quality Reporting
ISO Insurance service office
IT Information technology
IWPUT Intensity of work per unit of time
LCD Local coverage determination
MA Medicare Advantage
MAC Medicare Administrative Contractor
MACRA Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L. 
114-10)
MAP Measure Applications Partnership
MAPCP Multi-payer Advanced Primary Care Practice
MAV Measure application validity [process]
MCP Monthly capitation payment
MedPAC Medicare Payment Advisory Commission
MEI Medicare Economic Index
MFP Multi-Factor Productivity
MIPPA Medicare Improvements for Patients and Providers Act (Pub. L. 
110-275)
MMA Medicare Prescription Drug, Improvement and Modernization Act of 
2003 (Pub. L. 108-173, enacted on December 8, 2003)
MP Malpractice
MPPR Multiple procedure payment reduction
MRA Magnetic resonance angiography
MRI Magnetic resonance imaging
MSA Metropolitan Statistical Areas
MSPB Medicare Spending per Beneficiary
MU Meaningful use
NCD National coverage determination
NCQDIS National Coalition of Quality Diagnostic Imaging Services
NP Nurse practitioner
NPI National Provider Identifier
NPP Nonphysician practitioner
NQS National Quality Strategy
OACT CMS's Office of the Actuary
OBRA '89 Omnibus Budget Reconciliation Act of 1989 (Pub. L. 101-239)
OBRA '90 Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508)
OES Occupational Employment Statistics
OMB Office of Management and Budget
OPPS Outpatient prospective payment system
OT Occupational therapy
PA Physician assistant
PAMA Protecting Access to Medicare Act of 2014 (Pub. L. 113-93)
PAMPA Patient Access and Medicare Protection Act (Pub. L. 114-115)
PC Professional component
PCIP Primary Care Incentive Payment
PE Practice expense
PE/HR Practice expense per hour
PEAC Practice Expense Advisory Committee
PECOS Provider Enrollment, Chain, and Ownership System
PFS Physician Fee Schedule
PLI Professional Liability Insurance
PMA Premarket approval
PPM Provider-Performed Microscopy
PQRS Physician Quality Reporting System
PPIS Physician Practice Expense Information Survey
PPS Prospective Payment System
PT Physical therapy
PT Proficiency Testing
PT/INR Prothrombin Time/International Normalized Ratio
PY Performance year
QA Quality Assessment
QC Quality Control
QCDR Qualified clinical data registry
QRUR Quality and Resources Use Report
RBRVS Resource-based relative value scale
RFA Regulatory Flexibility Act
RHC Rural health clinic
RIA Regulatory impact analysis
RUC American Medical Association/Specialty Society Relative Value 
Scale Update Committee
RUCA Rural Urban Commuting Area
RVU Relative value unit
SBA Small Business Administration
SGR Sustainable growth rate
SIM State Innovation Model
SLP Speech-language pathology
SMS Socioeconomic Monitoring System
SNF Skilled nursing facility
TAP Technical Advisory Panel
TC Technical component
TIN Tax identification number
TCM Transitional Care Management
UAF Update adjustment factor
UPIN Unique Physician Identification Number
USPSTF United States Preventive Services Task Force
VBP Value-based purchasing
VM Value-Based Payment Modifier

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Addenda Available Only Through the Internet on the CMS Web site

    The PFS Addenda along with other supporting documents and tables 
referenced in this proposed rule are available on the CMS Web site at 
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 2018 PFS Proposed Rule, refer to item 
CMS-1676-P. Readers with questions related to accessing any of the 
Addenda or other supporting documents referenced in this proposed rule 
and posted on the CMS Web site identified above should contact Jamie 
Hermansen at (410) 786-2064.

CPT (Current Procedural Terminology) Copyright Notice

    Throughout this proposed rule, we use CPT codes and descriptions to 
refer to a variety of services. We note that CPT codes and descriptions 
are copyright 2016 American Medical Association. All Rights Reserved. 
CPT is a registered trademark of the American Medical Association 
(AMA). Applicable Federal Acquisition Regulations (FAR) and Defense 
Federal Acquisition Regulations (DFAR) apply.

I. Executive Summary

A. Purpose

    This major proposed rule proposes to revise payment polices under 
the Medicare PFS and make other policy changes related to Medicare Part 
B payment, applicable to services furnished in CY 2018. In addition, 
this proposed rule includes proposals related to payment policy changes 
that are addressed in section III. of this proposed rule.
1. Summary of the Major Provisions
    The statute requires us to establish payments under the PFS based 
on national uniform relative value units (RVUs) that account for the 
relative resources used in furnishing a service. The statute requires 
that RVUs be established for three categories of resources: Work, 
practice expense (PE); and malpractice (MP) expense; and, that we 
establish by regulation each year's payment amounts for all physicians' 
services paid under the PFS, incorporating geographic adjustments to 
reflect the variations in the costs of furnishing services in different 
geographic areas. In this major proposed rule, we are proposing to 
establish RVUs for CY 2018 for the PFS, and other Medicare Part B 
payment policies, to ensure that our payment systems are updated to 
reflect changes in medical practice and the relative value of services, 
as well as changes in the statute. In addition, this proposed rule 
includes discussions and proposals regarding:
     Potentially Misvalued Codes.
     Telehealth Services.
     Establishing Values for New, Revised, and Misvalued Codes.
     Establishing Payment Rates under the PFS for Nonexcepted 
Items and Services Furnished by Nonexcepted Off-Campus Provider-Based 
Departments of a Hospital.
     Evaluation & Management (E/M) Guidelines and Care 
Management Services.
     Care Coordination Services and Payment for Rural Health 
Clinics (RHCs) and Federally Qualified Health Centers (FQHCs).
     Payment for DME Infusion Drugs.
     Solicitation of Public Comments on Initial Data Collection 
and Reporting Periods for Clinical Laboratory Fee Schedule.
     Solicitation of Public Comments on Payment for Biosimilar 
Biological Products under Section 1847A of the Act.
     Appropriate Use Criteria for Advanced Diagnostic Imaging 
Services.
     PQRS Criteria for Satisfactory Reporting for Individual 
EPs and Group Practices for the 2018 PQRS Payment Adjustment.
     Medicare EHR Incentive Program.
     Medicare Shared Savings Program.
     Value-Based Payment Modifier and the Physician Feedback 
Program.
     MACRA Patient Relationship Categories and Codes.
     Medicare Diabetes Prevention Program.
2. Summary of Costs and Benefits
    We have determined that this major proposed rule is economically 
significant. For a detailed discussion of the economic impacts, see 
section VI. of this proposed rule.

II. Provisions of the Proposed Rule for PFS

A. Background

    Since January 1, 1992, Medicare has paid for physicians' services 
under section 1848 of the Act, ``Payment for Physicians' Services.'' 
The PFS relies on national relative values that are established for 
work, PE, and MP, which are adjusted for geographic cost variations. 
These values are multiplied by a conversion factor (CF) to convert the 
RVUs into payment rates. The concepts and methodology underlying the 
PFS were enacted as part of the Omnibus Budget Reconciliation Act of 
1989 (Pub. L. 101-239, enacted on December 19, 1989) (OBRA '89), and 
the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508, enacted 
on November 5, 1990) (OBRA '90). The final rule published on November 
25, 1991 (56 FR 59502) set forth the first fee schedule used for 
payment for physicians' services.
    We note that throughout this major proposed rule, unless otherwise 
noted, the term ``practitioner'' is used to describe both physicians 
and nonphysician practitioners (NPPs) who are permitted to bill 
Medicare under the PFS for services furnished to Medicare 
beneficiaries.
1. Development of the Relative Values
a. Work RVUs
    The work RVUs established for the initial fee schedule, which was 
implemented on January 1, 1992, were developed with extensive input 
from the physician community. A research team at the Harvard School of 
Public Health developed the original work RVUs for most codes under a 
cooperative agreement with the Department of Health and Human Services 
(HHS). In constructing the code-specific vignettes used in determining 
the original physician work RVUs, Harvard worked with panels of 
experts, both inside and outside the federal government, and obtained 
input from numerous physician specialty groups.
    As specified in section 1848(c)(1)(A) of the Act, the work 
component of physicians' services means the portion of the resources 
used in furnishing the service that reflects physician time and 
intensity. We establish work RVUs for new, revised and potentially 
misvalued codes based on our review of information that generally 
includes, but is not limited to, recommendations received from the 
American Medical Association/Specialty Society Relative Value Scale 
Update Committee (RUC), the Health Care Professionals Advisory 
Committee (HCPAC), the Medicare Payment Advisory Commission (MedPAC), 
and other public commenters; medical literature and comparative 
databases; as well as a comparison of the work for other codes within 
the Medicare PFS, and consultation with other physicians and health 
care professionals within CMS and the federal government. We also 
assess the methodology and data used to develop the recommendations

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submitted to us by the RUC and other public commenters, and the 
rationale for their recommendations. In the CY 2011 PFS final rule with 
comment period (75 FR 73328 through 73329), we discussed a variety of 
methodologies and approaches used to develop work RVUs, including 
survey data, building blocks, crosswalk to key reference or similar 
codes, and magnitude estimation. More information on these issues is 
available in that rule.
b. Practice Expense RVUs
    Initially, only the work RVUs were resource-based, and the PE and 
MP RVUs were based on average allowable charges. Section 121 of the 
Social Security Act Amendments of 1994 (Pub. L. 103-432, enacted on 
October 31, 1994), amended section 1848(c)(2)(C)(ii) of the Act and 
required us to develop resource-based PE RVUs for each physicians' 
service beginning in 1998. We were required to consider general 
categories of expenses (such as office rent and wages of personnel, but 
excluding malpractice expenses) comprising PEs. The PE RVUs continue to 
represent the portion of these resources involved in furnishing PFS 
services.
    Originally, the resource-based method was to be used beginning in 
1998, but section 4505(a) of the Balanced Budget Act of 1997 (Pub. L. 
105-33, enacted on August 5, 1997) (BBA) delayed implementation of the 
resource-based PE RVU system until January 1, 1999. In addition, 
section 4505(b) of the BBA provided for a 4-year transition period from 
the charge-based PE RVUs to the resource-based PE RVUs.
    We established the resource-based PE RVUs for each physicians' 
service in a final rule, published on November 2, 1998 (63 FR 58814), 
effective for services furnished in CY 1999. Based on the requirement 
to transition to a resource-based system for PE over a 4-year period, 
payment rates were not fully based upon resource-based PE RVUs until CY 
2002. This resource-based system was based on two significant sources 
of actual PE data: The Clinical Practice Expert Panel (CPEP) data; and 
the AMA's Socioeconomic Monitoring System (SMS) data. These data 
sources are described in greater detail in the CY 2012 final rule with 
comment period (76 FR 73033).
    Separate PE RVUs are established for services furnished in facility 
settings, such as a hospital outpatient department (HOPD) or an 
ambulatory surgical center (ASC), and in nonfacility settings, such as 
a physician's office. The nonfacility RVUs reflect all of the direct 
and indirect PEs involved in furnishing a service described by a 
particular HCPCS code. The difference, if any, in these PE RVUs 
generally results in a higher payment in the nonfacility setting 
because in the facility settings some costs are borne by the facility. 
Medicare's payment to the facility (such as the outpatient prospective 
payment system (OPPS) payment to the hospital outpatient department 
(HOPD)) would reflect costs typically incurred by the facility. Thus, 
payment associated with those facility resources is not made under the 
PFS.
    Section 212 of the Balanced Budget Refinement Act of 1999 (Pub. L. 
106-113, enacted on November 29, 1999) (BBRA) directed the Secretary of 
Health and Human Services (the Secretary) to establish a process under 
which we accept and use, to the maximum extent practicable and 
consistent with sound data practices, data collected or developed by 
entities and organizations to supplement the data we normally collect 
in determining the PE component. On May 3, 2000, we published the 
interim final rule (65 FR 25664) that set forth the criteria for the 
submission of these supplemental PE survey data. The criteria were 
modified in response to comments received, and published in the Federal 
Register (65 FR 65376) as part of a November 1, 2000 final rule. The 
PFS final rules published in 2001 and 2003, respectively, (66 FR 55246 
and 68 FR 63196) extended the period during which we would accept these 
supplemental data through March 1, 2005.
    In the CY 2007 PFS final rule with comment period (71 FR 69624), we 
revised the methodology for calculating direct PE RVUs from the top-
down to the bottom-up methodology beginning in CY 2007. We adopted a 4-
year transition to the new PE RVUs. This transition was completed for 
CY 2010. In the CY 2010 PFS final rule with comment period, we updated 
the practice expense per hour (PE/HR) data that are used in the 
calculation of PE RVUs for most specialties (74 FR 61749). In CY 2010, 
we began a 4-year transition to the new PE RVUs using the updated PE/HR 
data, which was completed for CY 2013.
c. Malpractice RVUs
    Section 4505(f) of the BBA amended section 1848(c) of the Act to 
require that we implement resource-based MP RVUs for services furnished 
on or after CY 2000. The resource-based MP RVUs were implemented in the 
PFS final rule with comment period published November 2, 1999 (64 FR 
59380). The MP RVUs are based on commercial and physician-owned 
insurers' malpractice insurance premium data from all the states, the 
District of Columbia, and Puerto Rico. For more information on MP RVUs, 
see section II.C. of this proposed rule.
d. Refinements to the RVUs
    Section 1848(c)(2)(B)(i) of the Act requires that we review RVUs no 
less often than every 5 years. Prior to CY 2013, we conducted periodic 
reviews of work RVUs and PE RVUs independently. We completed five-year 
reviews of work RVUs that were effective for calendar years 1997, 2002, 
2007, and 2012.
    Although refinements to the direct PE inputs initially relied 
heavily on input from the RUC Practice Expense Advisory Committee 
(PEAC), the shifts to the bottom-up PE methodology in CY 2007 and to 
the use of the updated PE/HR data in CY 2010 have resulted in 
significant refinements to the PE RVUs in recent years.
    In the CY 2012 PFS final rule with comment period (76 FR 73057), we 
finalized a proposal to consolidate reviews of work and PE RVUs under 
section 1848(c)(2)(B) of the Act and reviews of potentially misvalued 
codes under section 1848(c)(2)(K) of the Act into one annual process.
    In addition to the 5-year reviews, beginning for CY 2009, CMS and 
the RUC have identified and reviewed a number of potentially misvalued 
codes on an annual basis based on various identification screens. This 
annual review of work and PE RVUs for potentially misvalued codes was 
supplemented by the amendments to section 1848 of the Act, as enacted 
by section 3134 of the Affordable Care Act, that require the agency to 
periodically identify, review and adjust values for potentially 
misvalued codes.
e. Application of Budget Neutrality to Adjustments of RVUs
    As described in section VI.C. of this proposed rule, in accordance 
with section 1848(c)(2)(B)(ii)(II) of the Act, if revisions to the RVUs 
cause expenditures for the year to change by more than $20 million, we 
make adjustments to ensure that expenditures do not increase or 
decrease by more than $20 million.
2. Calculation of Payments Based on RVUs
    To calculate the payment for each service, the components of the 
fee schedule (work, PE, and MP RVUs) are adjusted by geographic 
practice cost indices (GPCIs) to reflect the variations in the costs of 
furnishing the services.

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The GPCIs reflect the relative costs of work, PE, and MP in an area 
compared to the national average costs for each component.
    RVUs are converted to dollar amounts through the application of a 
conversion factor (CF), which is calculated based on a statutory 
formula by CMS's Office of the Actuary (OACT). The formula for 
calculating the Medicare PFS payment amount for a given service and fee 
schedule area can be expressed as:

Payment = [(RVU work x GPCI work) + (RVU PE x GPCI PE) + (RVU MP x GPCI 
MP)] x CF
3. Separate Fee Schedule Methodology for Anesthesia Services
    Section 1848(b)(2)(B) of the Act specifies that the fee schedule 
amounts for anesthesia services are to be based on a uniform relative 
value guide, with appropriate adjustment of an anesthesia conversion 
factor, in a manner to ensure that fee schedule amounts for anesthesia 
services are consistent with those for other services of comparable 
value. Therefore, there is a separate fee schedule methodology for 
anesthesia services. Specifically, we establish a separate conversion 
factor for anesthesia services and we utilize the uniform relative 
value guide, or base units, as well as time units, to calculate the fee 
schedule amounts for anesthesia services. Since anesthesia services are 
not valued using RVUs, a separate methodology for locality adjustments 
is also necessary. This involves an adjustment to the national 
anesthesia CF for each payment locality.

B. Determination of Proposed Practice Expense (PE) Relative Value Units 
(RVUs)

1. Overview
    Practice expense (PE) is the portion of the resources used in 
furnishing a service that reflects the general categories of physician 
and practitioner expenses, such as office rent and personnel wages, but 
excluding malpractice expenses, as specified in section 1848(c)(1)(B) 
of the Act. As required by section 1848(c)(2)(C)(ii) of the Act, we use 
a resource-based system for determining PE RVUs for each physicians' 
service. We develop PE RVUs by considering the direct and indirect 
practice resources involved in furnishing each service. Direct expense 
categories include clinical labor, medical supplies, and medical 
equipment. Indirect expenses include administrative labor, office 
expense, and all other expenses. The sections that follow provide more 
detailed information about the methodology for translating the 
resources involved in furnishing each service into service-specific PE 
RVUs. We refer readers to the CY 2010 PFS final rule with comment 
period (74 FR 61743 through 61748) for a more detailed explanation of 
the PE methodology.
2. Practice Expense Methodology
a. Direct Practice Expense
    We determine the direct PE for a specific service by adding the 
costs of the direct resources (that is, the clinical staff, medical 
supplies, and medical equipment) typically involved with furnishing 
that service. The costs of the resources are calculated using the 
refined direct PE inputs assigned to each CPT code in our PE database, 
which are generally based on our review of recommendations received 
from the RUC and those provided in response to public comment periods. 
For a detailed explanation of the direct PE methodology, including 
examples, we refer readers to the 5 Year Review of Work Relative Value 
Units under the PFS and Proposed Changes to the Practice Expense 
Methodology proposed notice (71 FR 37242) and the CY 2007 PFS final 
rule with comment period (71 FR 69629).
b. Indirect Practice Expense per Hour Data
    We use survey data on indirect PEs incurred per hour worked in 
developing the indirect portion of the PE RVUs. Prior to CY 2010, we 
primarily used the practice expense per hour (PE/HR) by specialty that 
was obtained from the AMA's Socioeconomic Monitoring Surveys (SMS). The 
AMA administered a new survey in CY 2007 and CY 2008, the Physician 
Practice Expense Information Survey (PPIS). The PPIS is a 
multispecialty, nationally representative, PE survey of both physicians 
and nonphysician practitioners (NPPs) paid under the PFS using a survey 
instrument and methods highly consistent with those used for the SMS 
and the supplemental surveys. The PPIS gathered information from 3,656 
respondents across 51 physician specialty and health care professional 
groups. We believe the PPIS is the most comprehensive source of PE 
survey information available. We used the PPIS data to update the PE/HR 
data for the CY 2010 PFS for almost all of the Medicare-recognized 
specialties that participated in the survey.
    When we began using the PPIS data in CY 2010, we did not change the 
PE RVU methodology itself or the manner in which the PE/HR data are 
used in that methodology. We only updated the PE/HR data based on the 
new survey. Furthermore, as we explained in the CY 2010 PFS final rule 
with comment period (74 FR 61751), because of the magnitude of payment 
reductions for some specialties resulting from the use of the PPIS 
data, we transitioned its use over a 4-year period from the previous PE 
RVUs to the PE RVUs developed using the new PPIS data. As provided in 
the CY 2010 PFS final rule with comment period (74 FR 61751), the 
transition to the PPIS data was complete for CY 2013. Therefore, PE 
RVUs from CY 2013 forward are developed based entirely on the PPIS 
data, except as noted in this section.
    Section 1848(c)(2)(H)(i) of the Act requires us to use the medical 
oncology supplemental survey data submitted in 2003 for oncology drug 
administration services. Therefore, the PE/HR for medical oncology, 
hematology, and hematology/oncology reflects the continued use of these 
supplemental survey data.
    Supplemental survey data on independent labs from the College of 
American Pathologists were implemented for payments beginning in CY 
2005. Supplemental survey data from the National Coalition of Quality 
Diagnostic Imaging Services (NCQDIS), representing independent 
diagnostic testing facilities (IDTFs), were blended with supplementary 
survey data from the American College of Radiology (ACR) and 
implemented for payments beginning in CY 2007. Neither IDTFs, nor 
independent labs, participated in the PPIS. Therefore, we continue to 
use the PE/HR that was developed from their supplemental survey data.
    Consistent with our past practice, the previous indirect PE/HR 
values from the supplemental surveys for these specialties were updated 
to CY 2006 using the Medicare Economic Index (MEI) to put them on a 
comparable basis with the PPIS data.
    We also do not use the PPIS data for reproductive endocrinology and 
spine surgery since these specialties currently are not separately 
recognized by Medicare, nor do we have a method to blend the PPIS data 
with Medicare-recognized specialty data.
    Previously, we established PE/HR values for various specialties 
without SMS or supplemental survey data by crosswalking them to other 
similar specialties to estimate a proxy PE/HR. For specialties that 
were part of the PPIS for which we previously used a crosswalked PE/HR, 
we instead used the PPIS-based PE/HR. We use crosswalks for specialties 
that did not participate in the PPIS. These crosswalks have been 
generally established through notice and

[[Page 33955]]

comment rulemaking and are available in the file called ``CY 2018 PFS 
Proposed Rule PE/HR'' on the CMS Web site under downloads for the CY 
2018 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
c. Allocation of PE to Services
    To establish PE RVUs for specific services, it is necessary to 
establish the direct and indirect PE associated with each service.
(1) Direct Costs
    The relative relationship between the direct cost portions of the 
PE RVUs for any two services is determined by the relative relationship 
between the sum of the direct cost resources (that is, the clinical 
staff, medical supplies, and medical equipment) typically involved with 
furnishing each of the services. The costs of these resources are 
calculated from the refined direct PE inputs in our PE database. For 
example, if one service has a direct cost sum of $400 from our PE 
database and another service has a direct cost sum of $200, the direct 
portion of the PE RVUs of the first service would be twice as much as 
the direct portion of the PE RVUs for the second service.
(2) Indirect Costs
    We allocate the indirect costs to the code level on the basis of 
the direct costs specifically associated with a code and the greater of 
either the clinical labor costs or the work RVUs. We also incorporate 
the survey data described earlier in the PE/HR discussion (see section 
II.B.2.b of this proposed rule). The general approach to developing the 
indirect portion of the PE RVUs is as follows:
     For a given service, we use the direct portion of the PE 
RVUs calculated as previously described and the average percentage that 
direct costs represent of total costs (based on survey data) across the 
specialties that furnish the service to determine an initial indirect 
allocator. That is, the initial indirect allocator is calculated so 
that the direct costs equal the average percentage of direct costs of 
those specialties furnishing the service. For example, if the direct 
portion of the PE RVUs for a given service is 2.00 and direct costs, on 
average, represent 25 percent of total costs for the specialties that 
furnish the service, the initial indirect allocator would be calculated 
so that it equals 75 percent of the total PE RVUs. Thus, in this 
example, the initial indirect allocator would equal 6.00, resulting in 
a total PE RVU of 8.00 (2.00 is 25 percent of 8.00 and 6.00 is 75 
percent of 8.00).
     Next, we add the greater of the work RVUs or clinical 
labor portion of the direct portion of the PE RVUs to this initial 
indirect allocator. In our example, if this service had a work RVU of 
4.00 and the clinical labor portion of the direct PE RVU was 1.50, we 
would add 4.00 (since the 4.00 work RVUs are greater than the 1.50 
clinical labor portion) to the initial indirect allocator of 6.00 to 
get an indirect allocator of 10.00. In the absence of any further use 
of the survey data, the relative relationship between the indirect cost 
portions of the PE RVUs for any two services would be determined by the 
relative relationship between these indirect cost allocators. For 
example, if one service had an indirect cost allocator of 10.00 and 
another service had an indirect cost allocator of 5.00, the indirect 
portion of the PE RVUs of the first service would be twice as great as 
the indirect portion of the PE RVUs for the second service.
     Next, we incorporated the specialty-specific indirect PE/
HR data into the calculation. In our example, if, based on the survey 
data, the average indirect cost of the specialties furnishing the first 
service with an allocator of 10.00 was half of the average indirect 
cost of the specialties furnishing the second service with an indirect 
allocator of 5.00, the indirect portion of the PE RVUs of the first 
service would be equal to that of the second service.
(3) Facility and Nonfacility Costs
    For procedures that can be furnished in a physician's office, as 
well as in a facility setting, where Medicare makes a separate payment 
to the facility for its costs in furnishing a service, we establish two 
PE RVUs: Facility, and nonfacility. The methodology for calculating PE 
RVUs is the same for both the facility and nonfacility RVUs, but is 
applied independently to yield two separate PE RVUs. In calculating the 
PE RVUs for services furnished in a facility, we do not include 
resources that would generally not be provided by physicians when 
furnishing the service. For this reason, the facility PE RVUs are 
generally lower than the nonfacility PE RVUs.
(4) Services With Technical Components and Professional Components
    Diagnostic services are generally comprised of two components: A 
professional component (PC) and a technical component (TC). The PC and 
TC may be furnished independently or by different providers, or they 
may be furnished together as a global service. When services have 
separately billable PC and TC components, the payment for the global 
service equals the sum of the payment for the TC and PC. To achieve 
this, we use a weighted average of the ratio of indirect to direct 
costs across all the specialties that furnish the global service, TCs, 
and PCs; that is, we apply the same weighted average indirect 
percentage factor to allocate indirect expenses to the global service, 
PCs, and TCs for a service. (The direct PE RVUs for the TC and PC sum 
to the global.)
(5) PE RVU Methodology
    For a more detailed description of the PE RVU methodology, we refer 
readers to the CY 2010 PFS final rule with comment period (74 FR 61745 
through 61746). We also direct interested readers to the file called 
``Calculation of PE RVUs under Methodology for Selected Codes'' which 
is available on our Web site under downloads for the CY 2018 PFS 
proposed rule at 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 in this proposed rule for individual codes.
(a) Setup File
    First, we create a setup file for the PE methodology. The setup 
file contains the direct cost inputs, the utilization for each 
procedure code at the specialty and facility/nonfacility place of 
service level, and the specialty-specific PE/HR data calculated from 
the surveys.
(b) Calculate the Direct Cost PE RVUs
    Sum the costs of each direct input.
    Step 1: Sum the direct costs of the inputs for each service.
    Step 2: Calculate the aggregate pool of direct PE costs for the 
current year. We set the aggregate pool of PE costs equal to the 
product of the ratio of the current aggregate PE RVUs to current 
aggregate work RVUs and the proposed aggregate work RVUs.
    Step 3: Calculate the aggregate pool of direct PE costs for use in 
ratesetting. This is the product of the aggregate direct costs for all 
services from Step 1 and the utilization data for that service.
    Step 4: Using the results of Step 2 and Step 3, use the conversion 
factor to calculate a direct PE scaling adjustment to ensure that the 
aggregate pool of direct PE costs calculated in Step 3 does not vary 
from the aggregate pool of direct PE costs for the current year. Apply 
the scaling adjustment to the direct costs for each service (as 
calculated in Step 1).

[[Page 33956]]

    Step 5: Convert the results of Step 4 to a RVU scale for each 
service. To do this, divide the results of Step 4 by the conversion 
factor (CF). Note that the actual value of the CF used in this 
calculation does not influence the final direct cost PE RVUs as long as 
the same CF is used in Step 4 and Step 5. Different CFs would result in 
different direct PE scaling adjustments, but this has no effect on the 
final direct cost PE RVUs since changes in the CFs and changes in the 
associated direct scaling adjustments offset one another.
(c) Create the Indirect Cost PE RVUs
    Create indirect allocators.
    Step 6: Based on the survey data, calculate direct and indirect PE 
percentages for each physician specialty.
    Step 7: Calculate direct and indirect PE percentages at the service 
level by taking a weighted average of the results of Step 6 for the 
specialties that furnish the service. Note that for services with TCs 
and PCs, the direct and indirect percentages for a given service do not 
vary by the PC, TC, and global service.
    We generally use an average of the 3 most recent years of available 
Medicare claims data to determine the specialty mix assigned to each 
code. Prior to implementing that policy, we used the most recent year 
of available claims data to determine the specialty mix assigned to 
each code.
    Under either of these approaches, codes with low Medicare service 
volume require special attention since billing or enrollment 
irregularities for a given year can result in significant changes in 
specialty mix assignment. Prior to adopting the 3-year average of data, 
for low-volume services (fewer than 100 Medicare allowed services), we 
assigned the values associated with the specialty that most frequently 
reported the service in the most recent claims data (dominant 
specialty). For some time, stakeholders, including the RUC, have 
requested that we use a recommended ``expected'' specialty for all low 
volume services instead of the information contained in the claims 
data. Currently, in the development of PE RVUs we use ``expected 
specialty'' overrides for only several dozen services based on several 
code-specific policies we established in prior rulemaking. As we stated 
in the CY 2016 final rule with comment period (80 FR 70894), we hoped 
that the 3-year average would mitigate the need to use dominant or 
expected specialty instead of the specialty identified using claims 
data. Because we incorporated CY 2015 claims data for use in the CY 
2017 proposed rates, we believe that the finalized PE RVUs associated 
with the CY 2017 PFS final rule provided a first opportunity to 
determine whether service-level overrides of claims data are necessary.
    Although we believe that the use of the 3-year average of claims 
data to determine specialty mix has led to an improvement in the 
stability of PE and MP RVUs from year to year, after reviewing the RVUs 
for low volume services, we continue to see possible distortions and 
wide variability from year to year in PE and MP RVUs for low volume 
services. Several stakeholders have suggested that CMS implement 
service-level overrides based on the expected specialty in order to 
determine the specialty mix for these low volume procedures. The RUC 
previously supplied us with a list of nearly 2,000 lower volume codes 
and their suggested specialty overrides. After reviewing the finalized 
PE RVUs for the CY 2017 PFS final rule, we agree that the use of 
service-level overrides for low volume services would help mitigate 
annual fluctuations and provide greater stability in the valuation of 
these services. While the use of the 3-year average of claims data to 
determine specialty mix has helped to mitigate some of the year-to-year 
variability for low volume services, it has not fully mitigated what 
appear to be anomalies for many of these lower volume codes.
    We are, therefore, proposing to use the most recent year of claims 
data to determine which codes are low volume for the coming year (those 
that have fewer than 100 allowed services in the Medicare claims data). 
For codes that fall into this category, instead of assigning specialty 
mix based on the specialties of the practitioners reporting the 
services in the claims data, we are proposing to instead use the 
expected specialty that we identify on a list. For CY 2018, we are 
proposing to use a list that was developed based on our medical review 
of the list most recently recommended by the RUC, in addition to our 
own proposed expected specialty for certain other low-volume codes for 
which we have historically used expected specialty assignments. We 
would display this list as part of the annual set of data files we make 
available as part of notice and comment rulemaking. We propose to 
consider recommendations from the RUC and other stakeholders on changes 
to this list on an annual basis.
    We are also proposing to apply these service-level overrides for 
both PE and MP, rather than one or the other category. We believe that 
this would simplify the implementation of service-level overrides for 
PE and MP, and would also address stakeholder concerns about the year-
to-year variability for low volume services. We are soliciting public 
comment on the proposal to use service-level overrides to determine the 
specialty mix for low volume procedures, as well as on the proposed 
list of expected specialty overrides itself, which is largely based on 
the recommendations submitted by the RUC last year. The proposed list 
of expected specialty assignments for individual low volume services is 
available on our Web site under downloads for the CY 2018 PFS proposed 
rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. Services for 
which the specialty is automatically assigned based on previously 
finalized policies under our established methodology (for example, 
``always therapy'' services) would be unaffected by this proposal.
    Step 8: Calculate the service level allocators for the indirect PEs 
based on the percentages calculated in Step 7. The indirect PEs are 
allocated based on the three components: the direct PE RVUs; the 
clinical labor PE RVUs; and the work RVUs.
    For most services the indirect allocator is: indirect PE percentage 
* (direct PE RVUs/direct percentage) + work RVUs.
    There are two situations where this formula is modified:
     If the service is a global service (that is, a service 
with global, professional, and technical components), then the indirect 
PE allocator is: indirect percentage (direct PE RVUs/direct percentage) 
+ clinical labor PE RVUs + work RVUs.
     If the clinical labor PE RVUs exceed the work RVUs (and 
the service is not a global service), then the indirect allocator is: 
indirect PE percentage (direct PE RVUs/direct percentage) + clinical 
labor PE RVUs.
    (Note: For global services, the indirect PE allocator is based on 
both the work RVUs and the clinical labor PE RVUs. We do this to 
recognize that, for the PC service, indirect PEs would be allocated 
using the work RVUs, and for the TC service, indirect PEs would be 
allocated using the direct PE RVUs and the clinical labor PE RVUs. This 
also allows the global component RVUs to equal the sum of the PC and TC 
RVUs.)
    For presentation purposes, in the examples in the download file 
called ``Calculation of PE RVUs under Methodology for Selected Codes'', 
the formulas were divided into two parts for each service.

[[Page 33957]]

     The first part does not vary by service and is the 
indirect percentage (direct PE RVUs/direct percentage).
     The second part is either the work RVU, clinical labor PE 
RVU, or both depending on whether the service is a global service and 
whether the clinical PE RVUs exceed the work RVUs (as described earlier 
in this step).
    Apply a scaling adjustment to the indirect allocators.
    Step 9: Calculate the current aggregate pool of indirect PE RVUs by 
multiplying the result of Step 8 by the average indirect PE percentage 
from the survey data.
    Step 10: Calculate an aggregate pool of indirect PE RVUs for all 
PFS services by adding the product of the indirect PE allocators for a 
service from Step 8 and the utilization data for that service.
    Step 11: Using the results of Step 9 and Step 10, calculate an 
indirect PE adjustment so that the aggregate indirect allocation does 
not exceed the available aggregate indirect PE RVUs and apply it to 
indirect allocators calculated in Step 8.
    Calculate the indirect practice cost index.
    Step 12: Using the results of Step 11, calculate aggregate pools of 
specialty-specific adjusted indirect PE allocators for all PFS services 
for a specialty by adding the product of the adjusted indirect PE 
allocator for each service and the utilization data for that service.
    Step 13: Using the specialty-specific indirect PE/HR data, 
calculate specialty-specific aggregate pools of indirect PE for all PFS 
services for that specialty by adding the product of the indirect PE/HR 
for the specialty, the work time for the service, and the specialty's 
utilization for the service across all services furnished by the 
specialty.
    Step 14: Using the results of Step 12 and Step 13, calculate the 
specialty-specific indirect PE scaling factors.
    Step 15: Using the results of Step 14, calculate an indirect 
practice cost index at the specialty level by dividing each specialty-
specific indirect scaling factor by the average indirect scaling factor 
for the entire PFS.
    Step 16: Calculate the indirect practice cost index at the service 
level to ensure the capture of all indirect costs. Calculate a weighted 
average of the practice cost index values for the specialties that 
furnish the service. (Note: For services with TCs and PCs, we calculate 
the indirect practice cost index across the global service, PCs, and 
TCs. Under this method, the indirect practice cost index for a given 
service (for example, echocardiogram) does not vary by the PC, TC, and 
global service.)
    Step 17: Apply the service level indirect practice cost index 
calculated in Step 16 to the service level adjusted indirect allocators 
calculated in Step 11 to get the indirect PE RVUs.
(d) Calculate the Final PE RVUs
    Step 18: Add the direct PE RVUs from Step 5 to the indirect PE RVUs 
from Step 17 and apply the final PE budget neutrality (BN) adjustment. 
The final PE BN adjustment is calculated by comparing the sum of steps 
5 and 17 to the proposed aggregate work RVUs scaled by the ratio of 
current aggregate PE and work RVUs. This adjustment ensures that all PE 
RVUs in the PFS account for the fact that certain specialties are 
excluded from the calculation of PE RVUs but included in maintaining 
overall PFS budget neutrality. (See ``Specialties excluded from 
ratesetting calculation'' later in this proposed rule.)
    Step 19: Apply the phase-in of significant RVU reductions and its 
associated adjustment. Section 1848(c)(7) of the Act specifies that for 
services that are not new or revised codes, if the total RVUs for a 
service for a year would otherwise be decreased by an estimated 20 
percent or more as compared to the total RVUs for the previous year, 
the applicable adjustments in work, PE, and MP RVUs shall be phased in 
over a 2-year period. In implementing the phase-in, we consider a 19 
percent reduction as the maximum 1-year reduction for any service not 
described by a new or revised code. This approach limits the year one 
reduction for the service to the maximum allowed amount (that is, 19 
percent), and then phases in the remainder of the reduction. To comply 
with section 1848(c)(7) of the Act, we adjust the PE RVUs to ensure 
that the total RVUs for all services that are not new or revised codes 
decrease by no more than 19 percent, and then apply a relativity 
adjustment to ensure that the total pool of aggregate PE RVUs remains 
relative to the pool of work and MP RVUs. For a more detailed 
description of the methodology for the phase-in of significant RVU 
changes, we refer readers to the CY 2016 PFS final rule with comment 
period (80 FR 70927 through 70931).
(e) Setup File Information
     Specialties excluded from ratesetting calculation: For the 
purposes of calculating the PE RVUs, we exclude certain specialties, 
such as certain NPPs paid at a percentage of the PFS and low-volume 
specialties, from the calculation. These specialties are included for 
the purposes of calculating the BN adjustment. They are displayed in 
Table 1.

       TABLE 1--Specialties Excluded From Ratesetting Calculation
------------------------------------------------------------------------
      Specialty code                   Specialty description
------------------------------------------------------------------------
49.......................  Ambulatory surgical center.
50.......................  Nurse practitioner.
51.......................  Medical supply company with certified
                            orthotist.
52.......................  Medical supply company with certified
                            prosthetist.
53.......................  Medical supply company with certified
                            prosthetist[dash]orthotist.
54.......................  Medical supply company not included in 51,
                            52, or 53.
55.......................  Individual certified orthotist.
56.......................  Individual certified prosthetist.
57.......................  Individual certified
                            prosthetist[dash]orthotist.
58.......................  Medical supply company with registered
                            pharmacist.
59.......................  Ambulance service supplier, e.g., private
                            ambulance companies, funeral homes, etc.
60.......................  Public health or welfare agencies.
61.......................  Voluntary health or charitable agencies.
73.......................  Mass immunization roster biller.
74.......................  Radiation therapy centers.
87.......................  All other suppliers (e.g., drug and
                            department stores).
88.......................  Unknown supplier/provider specialty.
89.......................  Certified clinical nurse specialist.
96.......................  Optician.

[[Page 33958]]

 
97.......................  Physician assistant.
A0.......................  Hospital.
A1.......................  SNF.
A2.......................  Intermediate care nursing facility.
A3.......................  Nursing facility, other.
A4.......................  HHA.
A5.......................  Pharmacy.
A6.......................  Medical supply company with respiratory
                            therapist.
A7.......................  Department store.
B2.......................  Pedorthic personnel.
B3.......................  Medical supply company with pedorthic
                            personnel.
------------------------------------------------------------------------

     Crosswalk certain low volume physician specialties: 
Crosswalk the utilization of certain specialties with relatively low 
PFS utilization to the associated specialties.
     Physical therapy utilization: Crosswalk the utilization 
associated with all physical therapy services to the specialty of 
physical therapy.
     Identify professional and technical services not 
identified under the usual TC and 26 modifiers: Flag the services that 
are PC and TC services but do not use TC and 26 modifiers (for example, 
electrocardiograms). This flag associates the PC and TC with the 
associated global code for use in creating the indirect PE RVUs. For 
example, the professional service, CPT code 93010 (Electrocardiogram, 
routine ECG with at least 12 leads; interpretation and report only), is 
associated with the global service, CPT code 93000 (Electrocardiogram, 
routine ECG with at least 12 leads; with interpretation and report).
     Payment modifiers: Payment modifiers are accounted for in 
the creation of the file consistent with current payment policy as 
implemented in claims processing. For example, services billed with the 
assistant at surgery modifier are paid 16 percent of the PFS amount for 
that service; therefore, the utilization file is modified to only 
account for 16 percent of any service that contains the assistant at 
surgery modifier. Similarly, for those services to which volume 
adjustments are made to account for the payment modifiers, time 
adjustments are applied as well. For time adjustments to surgical 
services, the intraoperative portion in the work time file is used; 
where it is not present, the intraoperative percentage from the payment 
files used by contractors to process Medicare claims is used instead. 
Where neither is available, we use the payment adjustment ratio to 
adjust the time accordingly. Table 2 details the manner in which the 
modifiers are applied.

                         Table 2--Application of Payment Modifiers to Utilization Files
----------------------------------------------------------------------------------------------------------------
             Modifier                     Description             Volume adjustment           Time adjustment
----------------------------------------------------------------------------------------------------------------
80,81,82..........................  Assistant at Surgery...  16%........................  Intraoperative
                                                                                           portion.
AS................................  Assistant at Surgery--   14% (85% * 16%)............  Intraoperative
                                     Physician Assistant.                                  portion.
50 or LT and RT...................  Bilateral Surgery......  150%.......................  150% of work time.
51................................  Multiple Procedure.....  50%........................  Intraoperative
                                                                                           portion.
52................................  Reduced Services.......  50%........................  50%.
53................................  Discontinued Procedure.  50%........................  50%.
54................................  Intraoperative Care      Preoperative +               Preoperative +
                                     only.                    Intraoperative Percentages   Intraoperative
                                                              on the payment files used    portion.
                                                              by Medicare contractors to
                                                              process Medicare claims.
55................................  Postoperative Care only  Postoperative Percentage on  Postoperative portion.
                                                              the payment files used by
                                                              Medicare contractors to
                                                              process Medicare claims.
62................................  Co-surgeons............  62.5%......................  50%.
66................................  Team Surgeons..........  33%........................  33%.
----------------------------------------------------------------------------------------------------------------

    We also make adjustments to volume and time that correspond to 
other payment rules, including special multiple procedure endoscopy 
rules and multiple procedure payment reductions (MPPRs). We note that 
section 1848(c)(2)(B)(v) of the Act exempts certain reduced payments 
for multiple imaging procedures and multiple therapy services from the 
BN calculation under section 1848(c)(2)(B)(ii)(II) of the Act. These 
MPPRs are not included in the development of the RVUs.
    For anesthesia services, we do not apply adjustments to volume 
since we use the average allowed charge when simulating RVUs; 
therefore, the RVUs as calculated already reflect the payments as 
adjusted by modifiers, and no volume adjustments are necessary. 
However, a time adjustment of 33 percent is made only for medical 
direction of two to four cases since that is the only situation where a 
single practitioner is involved with multiple beneficiaries 
concurrently, so that counting each service without regard to the 
overlap with other services would overstate the amount of time spent by 
the practitioner furnishing these services.
     Work RVUs: The setup file contains the work RVUs from this 
proposed rule.
(6) Equipment Cost per Minute
    The equipment cost per minute is calculated as:

(1/(minutes per year * usage)) * price * ((interest rate/(1-(1/((1 + 
interest rate)[supcaret] life of equipment)))) + maintenance)

Where:


[[Page 33959]]


minutes per year = maximum minutes per year if usage were continuous 
(that is, usage=1); generally 150,000 minutes.
usage = variable, see discussion in this proposed rule.
price = price of the particular piece of equipment.
life of equipment = useful life of the particular piece of 
equipment.
maintenance = factor for maintenance; 0.05.
interest rate = variable, see discussion in this proposed rule.

    Usage: We currently use an equipment utilization rate assumption of 
50 percent for most equipment, with the exception of expensive 
diagnostic imaging equipment, for which we use a 90 percent assumption 
as required by section 1848(b)(4)(C) of the Act.
    Stakeholders have often suggested that particular equipment items 
are used less frequently than 50 percent of the time in the typical 
setting and that CMS should reduce the equipment utilization rate based 
on these recommendations. We appreciate and share stakeholders' 
interest in using the most accurate assumption regarding the equipment 
utilization rate for particular equipment items. However, we believe 
that absent robust, objective, auditable data regarding the use of 
particular items, the 50 percent assumption is the most appropriate 
within the relative value system. We welcome the submission of data 
that illustrates an alternative rate.
    Maintenance: This factor for maintenance was finalized in the CY 
1998 PFS final rule with comment period (62 FR 33164). We continue to 
investigate potential avenues for determining equipment maintenance 
costs across a broad range of equipment items.
    Interest Rate: In the CY 2013 PFS final rule with comment period 
(77 FR 68902), we updated the interest rates used in developing an 
equipment cost per minute calculation (see 77 FR 68902 for a thorough 
discussion of this issue). The interest rate was based on the Small 
Business Administration (SBA) maximum interest rates for different 
categories of loan size (equipment cost) and maturity (useful life). We 
are not proposing any changes to these interest rates for CY 2018. The 
interest rates are listed in Table 3.

                   Table 3--SBA Maximum Interest Rates
------------------------------------------------------------------------
                                                           Interest rate
               Price                     Useful life            (%)
------------------------------------------------------------------------
<$25K.............................  <7 Years............            7.50
$25K to $50K......................  <7 Years............            6.50
>$50K.............................  <7 Years............            5.50
<$25K.............................  7+ Years............            8.00
$25K to $50K......................  7+ Years............            7.00
>$50K.............................  7+ Years............            6.00
------------------------------------------------------------------------

3. Changes to Direct PE Inputs for Specific Services
    This section focuses on specific PE inputs. The direct PE inputs 
are included in the CY 2018 direct PE input database, which is 
available on the CMS Web site under downloads for the CY 2018 PFS 
proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
(a) PE Inputs for Digital Imaging Services
    In the CY 2017 PFS final rule (81 FR 80179 through 80184), we 
finalized our proposal to add a professional PACS workstation (ED053) 
used for interpretation of digital images to a series of CPT codes and 
to address costs related to the use of film that had previously been 
incorporated as direct PE inputs for these services. We finalized the 
following criteria for the inclusion of a professional PACS 
workstation:
     We did not add the professional PACS workstation to any 
code that currently lacks a technical PACS workstation (ED050) or lacks 
a work RVU. We continue to believe that procedures that do not include 
a technical workstation, or do not have physician work, would not 
require a professional workstation.
     We did not add the professional PACS workstation to add-on 
codes. Because the base codes include equipment minutes for the 
professional PACS workstation, we continue to believe it would be 
duplicative to add additional equipment time for the professional PACS 
workstation in the add-on code.
     We also did not add the professional PACS workstation to 
image guidance codes where the dominant provider is not a radiologist 
according to the most recent year of claims data, because we believe a 
single technical PACS workstation would be more typical in those cases.
     We agreed with commenters that because the clinical 
utility of the PACS workstation is not necessarily limited to 
diagnostic services, there may be therapeutic codes where it would be 
reasonable to assume its use to be typical. Based on information 
provided by commenters and our own medical review, we stated that we 
believe that the use of the professional PACS workstation is typical 
for many of the specific codes that were identified. We added the 
workstation to many of the therapeutic codes requested by commenters, 
specifically CPT codes listed outside the 70000 series, where we agreed 
that use of the professional PACS workstation was typical.
     For CPT codes in the 80000 and 90000 series, we expressed 
our concerns about whether it is appropriate to include the technical 
PACS workstation in many of these services. PACS workstations were 
created for imaging purposes, but many of these services that include a 
technical PACS workstation do not appear to make use of imaging. 
Although we did not remove the technical PACS workstation from these 
codes at that time, we did not believe that a professional PACS 
workstation should be added to these procedures.
    Prior to the publication of this CY 2018 PFS proposed rule, a 
stakeholder expressed concern about our decision not to include the 
professional PACS workstation in a series of vascular ultrasound codes 
that use technical PACS workstations. The stakeholder indicated that 
the vascular ultrasound codes in question do make use of a professional 
PACS workstation, and that the dominant specialty provider requirement 
(that is, that the code's dominant specialty provider being diagnostic 
radiology) would exclude codes for which the professional PACS 
workstation is typical based on a mistaken assumption. The stakeholder 
stated that to furnish vascular ultrasound services following the 
transition from film to digital imaging, both a technical and a 
professional PACS workstation are required, regardless of whether the 
practitioner furnishing the service is a radiologist, cardiologist, 
neurologist, or vascular surgeon.
    We appreciate the submission of this additional information 
regarding the use of the professional PACS workstation in vascular 
ultrasound codes. Therefore, we seek comments regarding whether or not 
the use of the professional PACS workstation would be typical in the 
following list of CPT and HCPCS codes. The codes brought to our 
attention by the stakeholder are CPT codes 93880, 93882, 93886, 93888, 
93890, 93892, 93893, 93922, 93923, 93924, 93925, 93926, 93930, 93931, 
93965, 93970, 93971, 93975, 93976, 93978, 93979, 93980, 93981, 93990, 
and 76706, and HCPCS code G0365. We will consider information submitted 
in comments to determine whether the professional

[[Page 33960]]

PACS workstation should be included as a direct PE input for these 
codes.
(2) Standardization of Clinical Labor Tasks
    As we noted in the CY 2015 PFS final rule with comment period (79 
FR 67640-67641), we continue to make improvements to the direct PE 
input database to provide the number of clinical labor minutes assigned 
for each task for every code in the database instead of only including 
the number of clinical labor minutes for the preservice, service, and 
postservice periods for each code. In addition to increasing the 
transparency of the information used to set PE RVUs, this improvement 
would allow us to compare clinical labor times for activities 
associated with services across the PFS, which we believe is important 
to maintaining the relativity of the direct PE inputs. This information 
would facilitate the identification of the usual numbers of minutes for 
clinical labor tasks and the identification of exceptions to the usual 
values. It would also allow for greater transparency and consistency in 
the assignment of equipment minutes based on clinical labor times. 
Finally, we believe that the information can be useful in maintaining 
standard times for particular clinical labor tasks that can be applied 
consistently to many codes as they are valued over several years, 
similar in principle to the use of physician preservice time packages. 
We believe such standards would provide greater consistency among codes 
that share the same clinical labor tasks and could improve relativity 
of values among codes. For example, as medical practice and 
technologies change over time, changes in the standards could be 
updated simultaneously for all codes with the applicable clinical labor 
tasks, instead of waiting for individual codes to be reviewed.
    In the following paragraphs, we address a series of issues related 
to clinical labor tasks, particularly relevant to services currently 
being reviewed under the misvalued code initiative.
a. Preservice Clinical Labor for 0-Day and 10-Day Global Services
    Several years ago, the RUC's PE Subcommittee reviewed the 
preservice clinical labor times for CPT codes with 0-day and 10-day 
global periods. The RUC concluded that these codes are assumed to have 
no preservice clinical staff time (standard time of 0 minutes) unless 
the specialty can provide evidence that the preservice time is 
appropriate. In other words, for minor procedures, it is assumed that 
there is no clinical staff time typically spent preparing for the 
specific procedure prior to the patient's arrival. However, we note 
that for CY 2018, 41 of the 53 reviewed codes with 0-day or 10-day 
global periods include preservice clinical labor of some kind, 
suggesting that it is typical for clinical staff to prepare for the 
procedure prior to the patient's arrival. As we review misvalued codes, 
we believe that the general adherence to values that we have 
established as standards supports relativity within the PFS. Because 77 
percent of the reviewed codes for the current calendar year deviate 
from the ``standard,'' we are seeking comment on the value and 
appropriate application of the standard in our review of RUC 
recommendations in future rulemaking. In reviewing the inputs included 
in the direct PE inputs database, we found that for the 1,142 total 0-
day global codes, 741 of them had preservice clinical labor of some 
kind (65 percent). We also noticed a general correlation between 
preservice clinical labor time and the recent review. We are seeking 
comment specifically on whether the standard preservice clinical labor 
time of 0 minutes should be consistently applied for 0-day and 10-day 
global codes in future rulemaking.
b. Obtain Vital Signs Clinical Labor
    The direct PE inputs for each CPT code paid under the PFS include 
minutes assigned to a series of standard clinical labor tasks assumed 
to be typical for the service in question. The minutes assigned to each 
of these tasks for each CPT code have been developed over several 
decades, and what was previously considered to be a standard value in 
the review of the codes has changed over time. Because each year we 
perform a detailed review of all of the inputs for only several hundred 
of the over 7,000 CPT codes paid under the PFS, valuation for 
individual services can be influenced by shifts in review standards 
over time rather than purely based on changes in practice.
    For example, we traditionally assigned a clinical labor time of 3 
minutes for the ``Obtain vital signs'' clinical labor activity, based 
on the amount of time typically required to check a patient's vitals. 
Over time, that number of minutes has increased as codes are reviewed. 
For example, many of the reviewed codes for the current CY 2018 
rulemaking cycle have a recommended clinical labor time of 5 minutes 
for ``Obtain vital signs,'' based on the understanding that these 
services are measuring two additional vital signs: The patient's height 
and weight. We do not have any reason to believe that measuring a 
patient's height and weight is only typical for services described by 
recently reviewed codes. Instead, we believe that the review standards 
have changed, perhaps in conjunction with changes in medical practice, 
and that the change in the minutes assigned for the ``Obtain vital 
signs'' task for newer-reviewed services is detrimental to relativity 
among PFS services.
    Therefore, to preserve relativity among the PFS codes, we are 
proposing to assign 5 minutes of clinical labor time for all codes that 
include the ``Obtain vital signs'' task, regardless of the date of last 
review. We are proposing to assign this 5 minutes of clinical labor 
time for all codes that include at least 1 minute previously assigned 
to this task. We are also proposing to update the equipment times of 
the codes with this clinical labor task accordingly to match the 
changes in clinical labor time. For codes that were not recently 
reviewed and for which we lacked a breakdown of how the equipment time 
was derived from the clinical labor tasks, we could not determine if 
the equipment time included time assigned for the ``Obtain vital 
signs'' task. In these cases, we are proposing to adjust the equipment 
time of any equipment item that matched the clinical labor time of the 
full service period to match the change in the ``Obtain vital signs'' 
clinical labor time. The proposed list of all codes affected by these 
proposed vital signs changes to direct PE inputs is available on the 
CMS Web site under downloads for the CY 2018 PFS proposed rule at 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
c. Establishment of Clinical Labor Activity Codes
    Historically, the RUC has submitted a ``PE worksheet'' that details 
the recommended direct PE inputs for our use in developing PE RVUs. The 
format of the PE worksheet has varied over time and among the medical 
specialties developing the recommendations. These variations have made 
it difficult for both the RUC's development and our review of code 
values for individual codes. Beginning for the CY 2019 PFS rulemaking 
cycle, we understand that the RUC intends to mandate the use of a new 
PE worksheet for purposes of their recommendation development process 
that standardizes the clinical labor tasks and assigns them a clinical 
labor activity code. We believe the RUC's use of the new PE worksheet 
in developing and submitting recommendations to us would, in turn, help 
us to simplify and standardize the hundreds of different clinical labor 
tasks

[[Page 33961]]

currently listed in our direct PE database.
    To help facilitate this transition to the new clinical labor 
activity codes, we have developed a crosswalk to link the old clinical 
labor tasks to the new clinical labor activity codes. Our crosswalk is 
for informational purposes only, and would not change either the direct 
PE input values or the PE RVUs for codes. Instead, we hope that the 
crosswalk would help us to translate the sprawling, existing data set 
into a condensed version that would significantly improve the 
standardization of clinical labor recommendations and improve the 
ability of commenters to identify concerns with our proposed valuation. 
For CY 2018 rulemaking, we are displaying two versions of the Labor 
Task Detail public use file: One version with the old listing of 
clinical labor tasks, and one with the same tasks as described by the 
new listing of clinical labor activity codes. These lists are available 
on the CMS Web site under downloads for the CY 2018 PFS proposed rule 
at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
(3) Equipment Recommendations for Scope Systems
    During our routine reviews of direct PE input recommendations, we 
have regularly found unexplained inconsistencies involving the use of 
scopes and the video systems associated with them. Some of the scopes 
include video systems bundled into the equipment item, some of them 
include scope accessories as part of their price, and some of them are 
standalone scopes with no other equipment included. It is not always 
clear which equipment items related to scopes fall into which of these 
categories. We have also frequently found anomalies in the equipment 
recommendations, with equipment items that consist of a scope and video 
system bundle recommended, along with a separate scope video system. 
Based on our review, the variations do not appear to be consistent with 
the different code descriptions.
    To promote appropriate relativity among the services and facilitate 
the transparency of our review process, during review of recommended 
direct PE inputs for the CY 2017 PFS proposed rule, we developed a 
structure that separates the scope and the associated video system as 
distinct equipment items for each code. Under this approach, we 
proposed standalone prices for each scope, and separate prices for the 
video systems that are used with scopes. We proposed to define the 
scope video system as including: (1) A monitor; (2) a processor; (3) a 
form of digital capture; (4) a cart; and (5) a printer. We believe that 
these equipment components represent the typical case for a scope video 
system. Our model for this system was the ``video system, endoscopy 
(processor, digital capture, monitor, printer, cart)'' equipment item 
(ES031), which we proposed to re-price as part of this separate pricing 
approach. We obtained current pricing invoices for the endoscopy video 
system as part of our investigation of these issues involving scopes, 
which we proposed to use for this re-pricing. We understand that there 
may be other accessories associated with the use of scopes; we proposed 
to separately price any scope accessories, and individually evaluate 
their inclusion or exclusion as direct PE inputs for particular codes 
as usual under our current policy based on whether they are typically 
used in furnishing the services described by the particular codes.
    We also proposed standardizing refinements to the way scopes have 
been defined in the direct PE input database. We believe that there are 
four general types of scopes: non-video scopes; flexible scopes; semi-
rigid scopes, and rigid scopes. Flexible scopes, semi-rigid scopes, and 
rigid scopes would typically be paired with one of the scope video 
systems, while the non-video scopes would not. The flexible scopes can 
be further divided into diagnostic (or non-channeled) and therapeutic 
(or channeled) scopes. We proposed to identify for each anatomical 
application: (1) A rigid scope; (2) a semi-rigid scope; (3) a non-video 
flexible scope; (4) a non-channeled flexible video scope; and (5) a 
channeled flexible video scope. We proposed to classify the existing 
scopes in our direct PE database under this classification system, to 
improve the transparency of our review process and improve appropriate 
relativity among the services. We planned to propose input prices for 
these equipment items through future rulemaking.
    We proposed these changes only for the reviewed codes for CY 2017 
that made use of scopes, along with updated prices for the equipment 
items related to scopes utilized by these services. But, we did not 
propose to apply these policies to codes with inputs reviewed prior to 
CY 2017. We also solicited comment on this separate pricing structure 
for scopes, scope video systems, and scope accessories, which we could 
consider proposing to apply to other codes in future rulemaking. In 
response to comments, we finalized the addition of a digital capture 
device to the endoscopy video system (ES031) in the CY 2017 PFS final 
rule. We finalized our proposal to price the system at $33,391, based 
on component prices of $9,000 for the processor, $18,346 for the 
digital capture device, $2,000 for the monitor, $2,295 for the printer, 
and $1,750 for the cart. We also finalized a price of $16,843.87 for 
the stroboscopy system scope accessory (ES065). We did not finalize 
price increases for a series of other scopes and scope accessories, as 
the invoices submitted for these components indicated that they are 
different forms of equipment with different product IDs and different 
prices. We did not receive any data to indicate that the equipment on 
the newly submitted invoices was more typical in its use than the 
equipment that we were currently using for pricing.
    We did not make further changes to existing scope equipment in CY 
2017 in order to allow the RUC's PE Subcommittee the opportunity to 
provide feedback. However, we believe there was some miscommunication 
on this point, as the RUC's PE Subcommittee workgroup that was created 
to address scope systems stated that no further action was required 
following the finalization of our proposal. We are making further 
proposals to continue clarifying scope equipment inputs, and seek 
comments regarding the new set of scope proposals. We welcome feedback 
from all stakeholders, including practitioners with direct experience 
in the use of scope equipment.
    We are seeking comment on several potential categories of scope 
system PE inputs. We are considering creating a single scope equipment 
code for each of the five categories detailed in this proposed rule: 
(1) A rigid scope; (2) a semi-rigid scope; (3) a non-video flexible 
scope; (4) a non-channeled flexible video scope; and (5) a channeled 
flexible video scope. Under the current classification system, there 
are many different scopes in each category depending on the medical 
specialty furnishing the service and the part of the body affected. We 
believe that the variation between these scopes is not significant 
enough to warrant maintaining these distinctions, and we believe that 
creating and pricing a single scope equipment code for each category 
would help provide additional clarity. We are seeking public comment on 
the merits of this potential scope organization, as well as any pricing 
information regarding these five new scope categories.

[[Page 33962]]

    For CY 2018, we are proposing two minor changes to PE inputs 
related to scopes. We are proposing to add an LED light source into the 
cost of the scope video system (ES031), which would remove the need for 
a separate light source in these procedures. If this proposal were to 
be finalized, we would remove the equipment time for the separate light 
source from CPT codes that include the scope video system. We are also 
proposing an increase to the price of the scope video system of 
$1,000.00 to cover the expense of miscellaneous small equipment 
associated with the system that falls below the threshold of individual 
equipment pricing as scope accessories (such as cables, microphones, 
foot pedals, etc.) We seek comments on the inclusion of the LED light 
in the scope video system, and the appropriate pricing of the system 
with the inclusion of these additional equipment items.
    We anticipate adopting detailed changes to scope systems at the 
code level through rulemaking for CY 2019, because we believe that 
additional feedback from expert stakeholders will improve the details 
of the proposed changes. We are not proposing any additional pricing 
changes to scope equipment for CY 2018 due to the proposed 
reorganization into a single type of scope equipment for each of the 
five scope categories. However, we would consider updating prices for 
these equipment items through the public request process for price 
updates, or based on information submitted as part of RUC 
recommendations.
(4) Clarivein Kit for Mechanochemical Vein Ablation
    In the CY 2017 PFS final rule, we finalized work RVUs and direct PE 
inputs for two new codes related to mechanochemical vein ablation, CPT 
codes 36473 and 36474. Following the publication of the final rule, 
stakeholders contacted CMS and requested that a Clarivein kit supply 
item (SA122) be added to the direct PE inputs for CPT code 36474, the 
add-on code for ablation of subsequent veins. They stated that the 
Clarivein kit was accidentally omitted from the RUC recommendations, 
and that an additional kit is necessary to perform the service 
described by the add-on procedure. We are soliciting comment regarding 
the use of multiple kits during procedures described by the base and 
add-on codes to determine whether or not this supply should be included 
as a direct PE input for CPT code 36474 for CY 2018.
(5) Removal of Oxygen From Non-Moderate Sedation Post-Procedure 
Monitoring
    After finalizing the creation of separately billable codes for 
moderate sedation during the CY 2017 PFS final rule, we received 
additional recommendations to remove the oxygen gas supply item (SD084) 
from a series of CPT codes that were previously valued with moderate 
sedation as an inherent part of the procedure. Because oxygen gas is 
included in the moderate sedation pack contained within the separately 
billed moderate sedation codes, we believe that the continued inclusion 
of the oxygen gas in these codes is a duplicative supply. We are 
therefore proposing to remove the oxygen gas from the following codes 
(see Table 4):

    Table 4--CY 2018 Proposed Removal of Oxygen (SD084) From Non-Moderate Sedation Post-Procedure Monitoring
----------------------------------------------------------------------------------------------------------------
                                                                                      Current
                     HCPCS                                    NF/F                   (liters)          Cost
----------------------------------------------------------------------------------------------------------------
31622.........................................  NF..............................              90           -0.27
31625.........................................  NF..............................             105           -0.32
31626.........................................  NF..............................             135           -0.41
31627.........................................  NF..............................             150           -0.45
31628.........................................  NF..............................             120           -0.36
31629.........................................  NF..............................             105           -0.32
31632.........................................  NF..............................              54           -0.16
31633.........................................  NF..............................              60           -0.18
31645.........................................  NF..............................             175           -0.53
31652.........................................  NF..............................             180           -0.54
31653.........................................  NF..............................             225           -0.68
31654.........................................  NF..............................              90           -0.27
52647.........................................  NF..............................              10           -0.03
52648.........................................  NF..............................              10           -0.03
90870.........................................  NF..............................             198           -0.59
----------------------------------------------------------------------------------------------------------------

(6) Technical Corrections to Direct PE Input Database and Supporting 
Files
    Subsequent to the publication of the CY 2017 PFS final rule, 
stakeholders alerted us to several clerical inconsistencies in the 
direct PE database. We are proposing to correct these inconsistencies 
as described in this proposed rule and reflected in the CY 2018 
proposed direct PE input database displayed on the CMS Web site under 
downloads for the CY 2018 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    For CY 2018, we are proposing to address the following 
inconsistencies:
     For CY 2018, we are proposing to make direct PE changes 
for CPT code 96416 (Chemotherapy administration, intravenous infusion 
technique; initiation of prolonged chemotherapy infusion (more than 8 
hours), requiring use of a portable or implantable pump) to improve 
payment accuracy, in response to a stakeholder inquiry regarding the 
use of the ambulatory IV pump equipment for this service. We are 
proposing to add 6 additional minutes of RN/OCN clinical labor (L056A), 
4 minutes for the ``Review charts by chemo nurse regarding course of 
treatment & obtain chemotherapy-related medical hx'' task, and 2 
minutes for the ``Greet patient and provide gowning'' task. We are 
proposing to add 1 quantity of the IV infusion set supply (SC018) and 
proposing to lower the quantity from 2 to 1 of the 20 ml syringe supply 
(SC053). We are proposing to add 1800 minutes for the new ambulatory IV 
pump equipment, and we are proposing to increase the equipment time of 
the medical recliner chair (EF009) from 83 minutes to 89 minutes to 
match the increase in RN/OCN clinical labor. For CY 2018, these

[[Page 33963]]

proposed direct PE changes would be used to calculate the PE RVU for 
CPT code 96416. We seek comments on these proposed direct PE 
refinements.
     We propose to correct an anomaly in the postservice work 
time for CPT code 91200 (Liver elastography, mechanically induced shear 
wave (e.g., vibration), without imaging, with interpretation and 
report) by changing it from 5 minutes to 3 minutes, which also results 
in a refinement in the total work time for the code from 18 minutes to 
16 minutes.
     In the process of making updates to our direct PE 
database, we discovered a series of discrepancies between the finalized 
direct PE inputs and the values entered into the database from previous 
calendar years. To reconcile these discrepancies, we are proposing the 
following direct PE refinements:

                                           Table 5--Direct PE Database Data Discrepancies and Proposed Changes
--------------------------------------------------------------------------------------------------------------------------------------------------------
              HCPCS                     Input code       Input code description            NF/F                 Old             New            Cost
--------------------------------------------------------------------------------------------------------------------------------------------------------
11307............................  SF033..............  scalpel with blade,       NF                                   1               2            0.69
                                                         surgical (#10-20).
11311............................  SG056..............  gauze, sterile 4in x 4in  NF                                   1               2            0.80
                                                         (10 pack uou).
11311............................  SH046..............  lidocaine 1% w-epi inj    NF                                  10               4           -0.38
                                                         (Xylocaine w-epi).
11719............................  L037D..............  Greet patient, provide    NF                                   1               3            0.74
                                                         gowning, ensure
                                                         appropriate medical
                                                         records are available.
11719............................  L037D..............  Provide pre-service       NF                                   1               2            0.37
                                                         education/obtain
                                                         consent.
11719............................  L037D..............  Prepare room, equipment,  NF                                   1               2            0.37
                                                         supplies.
11719............................  L037D..............  Clean room/equipment by   NF                                   1               3            0.74
                                                         physician staff.
17312............................  SL097..............  OCT Tissue-Tek..........  NF                                   8               6           -0.12
17313............................  SF004..............  blade, microtome........  NF                                   1               0           -1.72
17313............................  SF044..............  blade, surgical, super-   NF                                   0               1            4.17
                                                         sharp.
17313............................  SG056..............  gauze, sterile 4in x 4in  NF                                   3               0           -2.39
                                                         (10 pack uou).
17313............................  SG088..............  tape, foam, elastic, 2in  NF                                  10               8           -0.01
                                                         (Microfoam).
17314............................  SG056..............  gauze, sterile 4in x 4in  NF                                   2               0           -1.60
                                                         (10 pack uou).
17314............................  SL097..............  OCT Tissue-Tek..........  NF                                   8               6           -0.12
17315............................  SL078..............  histology freezing spray  NF                                   0             0.2            0.29
                                                         (Freeze-It).
19283............................  L043A..............  Service total costs.....  NF                                  55              54           -0.43
19286............................  L051B..............  Service total costs.....  NF                                  30              31            0.51
19286............................  EL015..............  room, ultrasound,         NF                                  19              20            1.40
                                                         general.
19286............................  EQ168..............  light, exam.............  NF                                  19              20            0.00
23333............................  L037D..............  Post service total costs  F                                   63              90            9.99
28045............................  SC029..............  needle, 18-27g..........  NF                                   2               1           -0.09
32405............................  L041B..............  Service total costs.....  NF                                  52              57            2.05
37765............................  L037D..............  Service total costs.....  NF                                  91              94            1.11
37766............................  L037D..............  Service total costs.....  NF                                 121             124            1.11
45171............................  SJ052..............  swab, procto 16in.......  F                                    2               3            0.12
45172............................  L037D..............  Service total costs.....  F                                    6              12            2.22
45172............................  SJ052..............  swab, procto 16in.......  F                                    2               3            0.12
52214............................  SH047..............  lidocaine 1%-2% inj       NF                                   1              50            1.72
                                                         (Xylocaine).
72120............................  EL012..............  room, basic radiology...  NF                                  16              17            0.48
72148............................  L047A..............  Service total costs.....  NF                                  47              49            0.84
74230............................  L041B..............  Technologist QC's images  NF                                   0               2            0.82
                                                         in PACS, checking for
                                                         all images, reformats,
                                                         and dose page.
91013............................  EF023..............  table, exam.............  NF                                   0               9            0.03
91013............................  EF015..............  mayo stand..............  NF                                   0               9            0.01
91013............................  EQ235..............  suction machine (Gomco).  NF                                   0               9            0.02
91013............................  EQ181..............  manometry system          NF                                   0               9            1.15
                                                         (computer, transducers,
                                                         catheter).
91013............................  EQ339..............  manometry accessory       NF                                   0               9            0.05
                                                         cable.
91013............................  ED050..............  PACS Workstation Proxy..  NF                                   0               9            0.20
91132............................  EQ019..............  EGG monitoring system...  NF                                  22              30            0.83
92227............................  EL006..............  lane, screening (oph)...  NF                                  12               0           -1.07
92227............................  EL005..............  lane, exam (oph)........  NF                                   0              12            1.15
93017............................  L051A..............  Preservice total costs..  NF                                  15               5           -5.10
95819............................  SG079..............  tape, surgical paper 1in  NF                                   6              42            0.07
                                                         (Micropore).
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The proposed PE RVUs displayed in Addendum B on our Web site were 
calculated with the inputs displayed in the CY 2018 proposed direct PE 
input database.
(7) Updates to Prices for Existing Direct PE Inputs
    In the CY 2011 PFS final rule with comment period (75 FR 73205), we 
finalized a process to act on public requests to update equipment and 
supply price and equipment useful life inputs through annual 
rulemaking, beginning with the CY 2012 PFS proposed rule. For CY 2018, 
we are proposing the following price updates for existing direct PE 
inputs.
    We are proposing to update the price of thirteen supplies and one 
equipment item in response to the public submission of invoices. For 
the details of these proposed price updates, please refer to section 
II.H, of this proposed rule, Table 14: Invoices Received for Existing 
Direct PE Inputs.
    We are not proposing to update the price of the blood warmer 
(EQ072), the cell separator system (EQ084), or the photopheresor system 
(EQ206) equipment items. The only pricing information that we received 
for these three equipment items was an invoice that included a hand-
written price over redacted information. We were unable to verify the 
accuracy of this invoice. We are also not proposing to update the price 
of the DNA image analyzer (ACIS) (EP001) equipment item, due to the

[[Page 33964]]

inclusion of many components on the submitted invoice that are not part 
of the price of the DNA image analyzer. We were unable to determine 
which of these components were included in the cost of the DNA image 
analyzer, and which of these components were unrelated types of 
equipment. To price these equipment items accurately, we believe that 
we need additional information. We continue to use the current price 
for these equipment items pending the submission of additional pricing 
information. We welcome the submission of updated pricing information 
regarding these equipment items through valid invoices from commenters 
and other stakeholders.
    We are also proposing to change the name of the ED050 equipment 
from the ``PACS Workstation Proxy'' to the ``Technologist PACS 
workstation.'' In the CY 2017 final rule (81 FR 80180-80182), we 
finalized a policy to add a professional PACS workstation (ED053) to 
the list of approved equipment items, and we believe that renaming 
ED050 to the technologist PACS workstation would help to alleviate 
potential confusion between the two PACS workstations.
    We routinely accept public submission of invoices as part of our 
process for developing payment rates for new, revised, and potentially 
misvalued codes. Often these invoices are submitted in conjunction with 
the RUC-recommended values for the codes. For CY 2018, we note that 
some stakeholders have submitted invoices for new, revised, or 
potentially misvalued codes after the February 10th deadline 
established for code valuation recommendations. To be included in a 
given year's proposed rule, we generally need to receive invoices by 
the same February 10th deadline. However, we would consider invoices 
submitted as public comments during the comment period following the 
publication of the proposed rule, and would consider any invoices 
received after February or outside of the public comment process as 
part of our established annual process for requests to update supply 
and equipment prices.
4. Adjustment to Allocation of Indirect PE for Some Office-Based 
Services
    As we explain in section II.B.2.c.(2) of this proposed rule, we 
allocate indirect costs for each code on the basis of the direct costs 
specifically associated with a code and the greater of either the 
clinical labor costs or the work RVUs. Indirect expenses include 
administrative labor, office expense, and all other expenses. For PFS 
services priced in both the facility and non-facility settings, the 
difference in indirect PE RVUs between the settings is driven by 
differences in direct PE inputs for those settings since the other 
allocator of indirect PE, the work RVU, does not differ between 
settings. For most services, the direct PE input costs are higher in 
the nonfacility setting than in the facility setting. As a result, 
indirect PE RVUs allocated to these services are higher in the 
nonfacility setting than in the facility setting. When direct PE inputs 
for a service are very low, however, the allocation of indirect PE RVUs 
is almost exclusively based on work RVUs, which results in a very small 
(or no) site of service differential between the total PE RVUs in the 
facility and nonfacility setting.
    Some stakeholders have suggested that for codes in which direct PE 
inputs for a service are very low, this allocation methodology does not 
allow for a site of service differential that accurately reflects the 
relative indirect costs involved in furnishing services in nonfacility 
settings. Among the services most affected by this anomaly are the 
primary therapy and counseling services available to Medicare 
beneficiaries for treatment of behavioral health conditions, including 
substance use disorders. For example, for the most commonly reported 
psychotherapy service (CPT code 90834), the difference between the 
nonfacility and facility PE RVUs is only 0.02 RVUs, which seems 
unlikely to represent the difference in relative resource costs in 
terms of administrative labor, office expense, and all other expenses 
incurred by the billing practitioner for 45 minutes of psychotherapy 
services when furnished in the office setting versus the facility 
setting.
    We agree with these stakeholders that the site of service 
differential for these services that is produced by our PE methodology 
seems unlikely to reflect the relative resource costs for the 
practitioners furnishing these services in nonfacility settings. For 
example, we believe the 0.02 RVUs, which translates to approximately 
$0.72, would be unlikely to reflect the relative administrative labor, 
office rent, and other overhead involved in furnishing the 45 minute 
psychotherapy service in a nonfacility setting. Consequently, we 
believe it would be appropriate to modify the existing methodology for 
allocating indirect PE RVUs in order to better reflect the relative 
indirect PE resources involved in furnishing these kinds of services in 
the nonfacility setting.
    In examining the range of services furnished in the nonfacility 
setting that are most affected by this circumstance, we identified 
HCPCS codes that describe face-to-face services, have work RVUs greater 
than zero, and are priced in both the facility and nonfacility setting. 
From among these codes, we further selected those with the lowest ratio 
between nonfacility PE RVUs and work RVUs. We selected 0.4 as an 
appropriate threshold based on several factors, including the range of 
nonfacility PE RVU to work RVU ratios among the codes identified. Based 
on these criteria, there were fewer than 50 codes that we identified 
with a ratio of less than 0.4 nonfacility PE RVUs for each work RVU, 
most of which are primarily furnished by behavioral health 
professionals, for a potential modification to our indirect PE 
allocation methodology.
    In considering how to address the anomaly and ensure that an 
appropriate number of indirect PE RVUs are allocated to these services 
in the nonfacility setting, we looked at the indirect, nonfacility PE 
RVU for the most commonly billed physician office visit, CPT code 
99213, which is billed by a wide range of physicians and non-physician 
practitioners under the PFS. We believe that the indirect PE costs 
allocated to services reported with CPT code 99213, including 
administrative labor and office rent, would be common for a broad range 
of physicians and non-physician practitioners across the PFS. We 
recognize that the services we seek to address are primarily furnished 
by behavioral health professionals who may be unlikely to incur some of 
the costs incurred by other practitioners furnishing a broader range of 
medical services. For instance, a practitioner furnishing a broader 
range of primary care services likely requires separate office and 
examination room space, and storage for disposable medical supplies and 
equipment. Some costs, however, such as those for office staff and 
records maintenance, would be analogous.
    We looked at the relationship between indirect PE and work RVUs for 
CPT code 99213 as a marker because that is the most commonly and 
broadly reported PFS code that describes face-to-face office-based 
services. We compared the relationship between indirect PE and work 
RVUs for the set of HCPCS codes that we identified using the criteria 
discussed above and found that for the significant majority of codes, 
that ratio was at least 0.4 nonfacility PE RVUs for each work RVU. We 
believe the 0.4 nonfacility PE RVUs can serve as an appropriate marker 
that appropriately reflects the relative resources involved in 
furnishing these services.

[[Page 33965]]

    For the fewer than 50 outlier codes identified using the criteria 
above, we believe it would be appropriate to establish a minimum 
nonfacility indirect PE RVU that would be a better reflection the 
resources involved in furnishing these services. We propose to set the 
nonfacility indirect PE RVUs for these codes using the indirect PE RVU 
to work RVU ratio for the most commonly furnished office-based, face-
to-face service (CPT 99213) as a marker. Specifically, for each of 
these outlier codes, we propose to compare the ratio between indirect 
PE RVUs and work RVUs that result from the preliminary application of 
the standard methodology to the ratio for the marker code, CPT code 
99213. Our proposed change in the methodology would then increase the 
allocation of indirect PE RVUs to the outlier codes to at least one 
quarter of the difference between the two ratios. We believe this 
approach reflects a reasonable minimum allocation of indirect PE RVUs, 
but we do not currently have empirical data that would be useful in 
establishing a more precise number.
    In developing the proposed PE RVUs for CY 2018, we propose to 
implement only one quarter of this proposed minimum value for 
nonfacility indirect PE for the outlier codes. We recognize that this 
change in the PE methodology could have a significant impact on the 
allocation of indirect PE RVUs across all PFS services. In making 
significant changes to the PE methodology in previous years, we have 
implemented such changes using 4 year transitions, based largely on 
concerns that some specialties experience significant payment 
reductions with changes in PE relativity, and a transition period 
allows for a more gradual adjustment for affected practitioners. Under 
the approach we are proposing, we estimate that approximately $40 
million, or approximately 0.04 percent of total PFS allowed charges, 
would shift within the PE methodology for each year of the proposed 4-
year transition, including for CY 2018. We also note that we are 
proposing to exclude the codes directly subject to this proposed change 
from the misvalued code target calculation because the proposed change 
is a methodological change to address an anomaly produced by our 
indirect PE allocation process as opposed to a change to address 
misvalued codes. The PE RVUs displayed in Addendum B on our Web site 
were calculated with the one quarter of the indirect PE adjustment 
factor implemented.

C. Determination of Malpractice Relative Value Units (RVUs)

1. Overview
    Section 1848(c) of the Act requires that each service paid under 
the PFS be composed of three components: work, PE, and malpractice (MP) 
expense. As required by section 1848(c)(2)(C)(iii) of the Act, 
beginning in CY 2000, MP RVUs are resource based. Section 
1848(c)(2)(B)(i) of the Act also requires that we review, and if 
necessary adjust, RVUs no less often than every 5 years. In the CY 2015 
PFS final rule with comment period, we implemented the third review and 
update of MP RVUs. For a comprehensive discussion of the third review 
and update of MP RVUs see the CY 2015 proposed rule (79 FR 40349 
through 40355) and final rule with comment period (79 FR 67591 through 
67596).
    To determine MP RVUs for individual PFS services, our MP 
methodology is composed of three factors: (1) Specialty-level risk 
factors derived from data on specialty-specific MP premiums incurred by 
practitioners, (2) service level risk factors derived from Medicare 
claims data of the weighted average risk factors of the specialties 
that furnish each service, and (3) an intensity/complexity of service 
adjustment to the service level risk factor based on either the higher 
of the work RVU or clinical labor RVU. Prior to CY 2016, MP RVUs were 
only updated once every 5 years, except in the case of new and revised 
codes.
    As explained in the CY 2011 PFS final rule with comment period (75 
FR 73208), MP RVUs for new and revised codes effective before the next 
5-year review of MP RVUs were determined either by a direct crosswalk 
from a similar source code or by a modified crosswalk to account for 
differences in work RVUs between the new/revised code and the source 
code. For the modified crosswalk approach, we adjusted (or scaled) the 
MP RVU for the new/revised code to reflect the difference in work RVU 
between the source code and the new/revised work RVU (or, if greater, 
the difference in the clinical labor portion of the fully implemented 
PE RVU) for the new code. For example, if the proposed work RVU for a 
revised code were 10 percent higher than the work RVU for its source 
code, the MP RVU for the revised code would be increased by 10 percent 
over the source code MP RVU. Under this approach, the same risk factor 
was applied for the new/revised code and source code, but the work RVU 
for the new/revised code was used to adjust the MP RVUs for risk.
    In the CY 2016 PFS final rule with comment period (80 FR 70906 
through 70910), we finalized a policy to begin conducting annual MP RVU 
updates to reflect changes in the mix of practitioners providing 
services (using Medicare claims data), and to adjust MP RVUs for risk, 
intensity and complexity (using the work RVU or clinical labor RVU). We 
also finalized a policy to modify the specialty mix assignment 
methodology (for both MP and PE RVU calculations) to use an average of 
the 3 most recent years of data instead of a single year of data. Under 
this approach, for new and revised codes, we generally assign a 
specialty risk factor to individual codes based on the same utilization 
assumptions we make regarding specialty mix we use for calculating PE 
RVUs and for PFS budget neutrality. We continue to use the work RVU or 
clinical labor RVU to adjust the MP RVU for each code for intensity and 
complexity. In finalizing this policy, we stated that the specialty-
specific risk factors would continue to be updated through notice and 
comment rulemaking every 5 years using updated premium data, but would 
remain unchanged between the 5-year reviews.
    In CY 2017, we finalized the eighth GPCI update, which reflected 
updated MP premium data. We did not propose to use the updated MP 
premium data to propose updates for CY 2017 to the specialty risk 
factors used in the calculation of MP RVUs because it was inconsistent 
with the policy we previously finalized in the CY 2016 PFS final rule 
with comment period, whereby we indicated that the specialty-specific 
risk factors would continue to be updated through notice and comment 
rulemaking every 5 years using updated premium data, but would remain 
unchanged between the 5-year reviews. However, we solicited comment on 
whether we should consider doing so, perhaps as early as for CY 2018, 
prior to the fourth review and update of MP RVUs that must occur no 
later than CY 2020. After consideration of the comments received, we 
stated that we would consider the possibility of using the updated MP 
data to update the specialty risk factors used in the calculation of 
the MP RVUs prior to the next 5-year update in future rulemaking (81 FR 
80191 through 80192). Since MP premium data are used to update both the 
MP GPCIs and the MP RVUs, going forward we believe it would be logical 
to align the update of MP premium data used to determine the MP RVUs 
with the update of the MP GPCI. Section 1848(e)(1)(C) of the Act 
requires us to review and, if necessary, adjust the

[[Page 33966]]

GPCIs at least every 3 years. The next review of the GPCIs must occur 
by CY 2020.
    We propose to use the most recent data for the proposed MP RVUs for 
CY 2018 and to align the update of MP premium data and MP GPCIs to once 
every 3 years. We are seeking comment on these proposals, and we are 
also seeking comment on methodologies and sources that we might use to 
improve the next update of MP premium data.
2. Methodology for the Proposed Revision of Resource Based Malpractice 
RVUs
a. General Discussion
    The proposed MP RVUs were calculated based on updated malpractice 
premium data obtained from state insurance rate filings by a CMS 
contractor. The methodology used in calculating the proposed CY 2018 
review and update of resource based MP RVUs largely parallels the 
process used in the CY 2015 update. The calculation requires using 
information on specialty-specific malpractice premiums linked to 
specific services based upon the relative risk factors of the various 
specialties that furnish a particular service. Because malpractice 
premiums vary by state and specialty, the malpractice premium 
information must be weighted geographically and by specialty. 
Accordingly, the proposed MP RVUs are based upon four data sources: CY 
2014 and CY 2015 malpractice premium data; CY 2016 and 2017 Medicare 
payment and utilization data; CY 2017 geographic practice cost indices 
(GPCIs), and CY 2018 proposed work and clinical labor RVUs.
    Similar to the previous update, we calculated the proposed MP RVUs 
using specialty-specific malpractice premium data because they 
represent the actual expense incurred by practitioners to obtain 
malpractice insurance. We obtained malpractice premium data exclusively 
from the most recently available data published in the 2014 and 2015 
Market Share Reports accessed from the National Association of 
Insurance Commissioners (NAIC) Web site. We used information obtained 
from malpractice insurance rate filings with effective dates in 2014 
and 2015. These were the most current data available during our data 
collection process. We collected malpractice insurance premium data 
from all 50 States, and the District of Columbia, and Puerto Rico. Rate 
filings were not available in American Samoa, Guam or the Virgin 
Islands. Premiums were for $1 million/$3 million, mature, claims-made 
policies (policies covering claims made, rather than those covering 
services furnished, during the policy term). A $1 million/$3 million 
liability limit policy means that the most that would be paid on any 
claim is $1 million and the most that the policy would pay for claims 
over the timeframe of the policy is $3 million. We made adjustments to 
the premium data to reflect mandatory surcharges for patient 
compensation funds (funds to pay for any claim beyond the statutory 
amount, thereby limiting an individual physician's liability in cases 
of a large suit) in states where participation in such funds is 
mandatory.
    We included premium information for all physician and NPP 
specialties, and all risk classifications available in the collected 
rate filings. Although we collected premium data from all states, the 
District of Columbia, and Puerto Rico, not all specialties had distinct 
premium data in the rate filings from all states. Additionally, for 
some specialties, MP premiums were not available from the rate filings 
in any state. Therefore, for specialties for which there were not 
premium data for at least 35 states, and specialties for which there 
were not distinct premium data in the rate filings, we crosswalked the 
specialty to a similar specialty, either conceptually or by available 
premium data, for which we did have sufficient and reliable data. These 
specialties and the specialty data that we propose to use are shown in 
Table 6.
    For example, for radiation oncology, data were only available from 
23 states, and therefore this specialty does not meet our 35-state 
threshold, which determines whether or not a specialty is deemed to 
have premium data sufficient to construct a unique risk factor. 
However, based on the 23 states' worth of rate filings for radiation 
oncology, the resource costs for the premiums suggests a similar, 
though slightly lesser average than that of the premiums for diagnostic 
radiology. We developed the proposed MP RVUs for radiation oncology by 
crosswalking the risk factor for diagnostic radiology as a similar 
specialty with similar premium data. We are seeking comment as to the 
appropriateness of this and the other crosswalks used in developing MP 
RVUs.
    For the proposed CY 2018 MP RVU update, sufficient and reliable 
premium data were available for 43 specialty types, representing over 
76 percent of allowed Medicare PFS services, which we used to develop 
specialty specific malpractice risk factors. (See Table 8 for a list of 
these specialties.)

                        Table 6--Proposed Crosswalk of Specialties to Similar Specialties
----------------------------------------------------------------------------------------------------------------
                                                                    Crosswalk
        Specialty code              Medicare specialty name      specialty code        Crosswalk specialty
----------------------------------------------------------------------------------------------------------------
12............................  Osteopathic Manipulative                     03  Allergy/Immunology.
                                 Medicine.
15............................  Speech Language Pathology......              03  Allergy/Immunology.
17............................  Hospice and Palliative Care....              03  Allergy/Immunology.
19............................  Oral Surgery (Dentist only)....              24  Plastic and Reconstructive
                                                                                  Surgery.
23............................  Sports Medicine................              01  General Practice.
27............................  Geriatric Psychiatry...........              26  Psychiatry.
32............................  Anesthesiology Assistant.......              05  Anesthesiology.
35............................  Chiropractic...................              03  Allergy/Immunology.
36............................  Nuclear Medicine...............              30  Diagnostic Radiology.
40............................  Hand Surgery...................              20  Orthopedic Surgery.
41............................  Optometry......................              03  Allergy/Immunology.
42............................  Certified Nurse Midwife........              16  Obstetrics & Gynecology.
43............................  Certified Registered Nurse                   05  Anesthesiology.
                                 Anesthetist (CRNA).
48............................  Podiatry.......................              07  Dermatology.
62............................  Psychologist...................              03  Allergy/Immunology.
64............................  Audiologist....................              03  Allergy/Immunology.
65............................  Physical Therapist in Private                03  Allergy/Immunology.
                                 Practice.
67............................  Occupational Therapist in                    03  Allergy/Immunology.
                                 Private Practice.
68............................  Psychologist, Clinical.........              03  Allergy/Immunology.

[[Page 33967]]

 
76............................  Peripheral Vascular Disease....              77  Vascular Surgery.
79............................  Addiction Medicine.............              03  Allergy/Immunology.
80............................  Licensed Clinical Social Worker              03  Allergy/Immunology.
81............................  Critical Care (Intensivists)...              29  Pulmonary Disease.
85............................  Maxillofacial Surgery..........              24  Plastic and Reconstructive
                                                                                  Surgery.
86............................  Neuropsychiatry................              26  Psychiatry.
89............................  Certified Clinical Nurse                     01  General Practice.
                                 Specialist.
92............................  Radiation Oncology.............              30  Diagnostic Radiology.
94............................  Interventional Radiology.......              30  Diagnostic Radiology.
97............................  Physician Assistant............              03  Allergy/Immunology.
98............................  Gynecological Oncology.........              02  General Surgery.
C0............................  Sleep Medicine.................              01  General Practice.
----------------------------------------------------------------------------------------------------------------

b. Steps for Calculating Malpractice RVUs
    Calculation of the proposed MP RVUs conceptually follows the 
specialty-weighted approach used in the CY 2015 final rule with comment 
period (79 FR 67591). The specialty-weighted approach bases the MP RVUs 
for a given service upon a weighted average of the risk factors of all 
specialties furnishing the service. This approach ensures that all 
specialties furnishing a given service are accounted for in the 
calculation of the MP RVUs. The steps for calculating the proposed MP 
RVUs are described below.
    Step (1): Compute a preliminary national average premium for each 
specialty.
    Insurance rating area malpractice premiums for each specialty are 
mapped to the county level. The specialty premium for each county is 
then multiplied by its share of the total U.S. population (from the 
U.S. Census Bureau's 2014 American Community (ACS) estimates). This is 
in contrast to the method used for creating national average premiums 
for each specialty in the 2015 update; in that update, specialty 
premiums were weighted by the total RVU per county, rather than by the 
county share of the total U.S. population. We refer readers to the PFS 
2016 Final Rule with comment period (80 FR 70909) for a discussion of 
why we have adopted a weighting method based on share of total U.S. 
population. This calculation is then divided by the average MP GPCI 
across all counties for each specialty to yield a normalized national 
average premium for each specialty. The specialty premiums are 
normalized for geographic variation so that the locality cost 
differences (as reflected by the GPCIs) would not be counted twice. 
Without the geographic variation adjustment, the cost differences among 
fee schedule areas would be reflected once under the methodology used 
to calculate the MP RVUs and again when computing the service specific 
payment amount for a given fee schedule area.
    Step (2): Determine which premium class(es) to use within each 
specialty.
    Some specialties had premium rates that differed for surgery, 
surgery with obstetrics, and non-surgery. These premium classes are 
designed to reflect differences in risk of professional liability and 
the cost of malpractice claims if they occur. To account for the 
presence of different classes in the malpractice premium data and the 
task of mapping these premiums to procedures, we calculated distinct 
risk factors for surgical, surgical with obstetrics, and nonsurgical 
procedures. However, the availability of data by surgery and non-
surgery varied across specialties. Consistent with the CY 2015 MP RVU 
update, because no single approach accurately addressed the variability 
in premium class among specialties, we employed several methods for 
calculating average premiums by specialty. These methods are discussed 
below.
    (a) Substantial Data for Each Class: For 10 out of 86 specialties, 
we determined that there were sufficient data for surgery and non-
surgery premiums, as well as sufficient differences in rates between 
classes. These specialties are listed in Table 7. Therefore, we 
calculated a national average surgical premium and non-surgical 
premium. We note that, unlike in the CY 2015 MP RVU update, for CY 
2018, there were no specialties that fell under the ``unspecified 
dominates'' specialty/surgery class scenario, therefore we have omitted 
that surgical class category.
    (b) Major Surgery Dominates: For 9 surgical specialties, rate 
filings that included non-surgical premiums were relatively rare. For 
most of these surgical specialties, the rate filings did not include an 
``unspecified'' premium. When it did, the unspecified premium was lower 
than the major surgery rate. For these surgical specialties, we 
calculated only a surgical premium and used the premium for major 
surgery for all procedures furnished by this specialty.
    (c) Blend All Available: For the remaining specialties, there was 
wide variation across the rate filings in terms of whether or not 
premium classes were reported and which categories were reported. 
Because there was no clear strategy for these remaining specialties, we 
blended the available rate information into one general premium rate. 
For these specialties, we developed a weighted average ``blended'' 
premium at the national level, according to the percentage of work RVUs 
correlated with the premium classes within each specialty. For example, 
the surgical premiums for a given specialty were weighted by that 
specialty's work RVUs for surgical services; the nonsurgical premiums 
were weighted by the work RVUs for non-surgical services and the 
unspecified premiums were weighted by all work RVUs for the specialty 
type.
    The three methods for calculating premiums by specialty type are 
summarized in Table 7. (See Table 8: ``Proposed Risk Factors by 
Specialty Type'' for the specialty names associated with the specialty 
codes listed in Table 7.)

    Table 7--Proposed Premium Calculation Approach by Specialty Type
------------------------------------------------------------------------
                  Method                      Medicare specialty codes
------------------------------------------------------------------------
(a) Substantial Data for Each Class (10)..  01, 04, 08, 09, 13, 16, 18,
                                             34, 72, 93.
(b) Major Surgery Dominates (9)...........  02, 14, 20, 24, 28, 33, 77,
                                             78, 91.

[[Page 33968]]

 
(c) Blend all Available (24)..............  03, 05, 06, 07, 10, 11, 22,
                                             25, 26, 29, 30, 37, 38, 39,
                                             44, 46, 50, 66, 71, 82, 83,
                                             84, 90, 99.
------------------------------------------------------------------------

    Step (3): Calculate a risk factor for each specialty.
    The relative differences in national average premiums between 
specialties are expressed in our methodology as a specialty risk 
factor. These risk factors are an index calculated by dividing the 
national average premium for each specialty by the national average 
premium for the specialty with the lowest premiums for which we had 
sufficient and reliable data, allergy and immunology. For specialties 
with sufficient surgical and non-surgical premium data, we calculated 
both a surgical and non-surgical risk factor. For specialties with rate 
filings that distinguished surgical premiums with obstetrics, we 
calculated a separate surgical with obstetrics risk factor. For all 
other specialties we calculated a single risk factor and applied the 
specialty risk factor to both surgery and non-surgery services.
    We note that for determining the risk factor for suppliers of TC-
only services in the CY 2015 update, we updated the premium data for 
independent diagnostic testing facilities (IDTFs) that we used in the 
CY 2010 update. These data were obtained from a survey conducted by the 
Radiology Business Management Association (RBMA) in 2009; we ultimately 
used these data to calculate an updated TC specialty risk factor. We 
applied the updated TC specialty risk factor to suppliers of TC-only 
services. In the CY 2015 final rule with comment period (79 FR 67595), 
RBMA voluntarily submitted updated MP premium information collected 
from independent diagnostic testing facilities (IDTFs) in 2014, and 
requested that we use the data for calculating the CY 2015 MP RVUs for 
TC services. We declined to utilize the data and stated that we believe 
further study is necessary and we would consider this matter and 
propose any changes through future rulemaking. We believe that data for 
a broader set of technical component services are needed, and seek 
comment on appropriate, comparable data sources for such information. 
We also seek comment on whether the data for IDTFs are comparable and 
appropriate as a proxy for the broader set of TC services. We endeavor 
to, in the next update of specialty risk factors, collect more data 
across a broader set of the technical component services, not just for 
radiology (as is currently reflected in the RBMA data), but data for 
services performed by other non-physician practitioners including 
cytotechnologists, and cardiovascular technologists. In the interim, 
for CY 2018, we propose to assign a TC risk factor of 1.0, which 
corresponds to the lowest physician specialty risk factor.
    We assigned the risk factor of 1.0 to the TC services because we do 
not have comparable professional liability premium data for the full 
range of clinicians that furnish these services. In lieu of 
comprehensive, comparable data, we used 1.0 as the default minimum risk 
factor, though we seek information on the best available data sources 
for use in the next update, as well as empirical information that would 
support assignment of an alternative risk factor for these services. 
Table 8 shows the proposed risk factors by specialty type.

                                Table 8--Proposed Risk Factors by Specialty Type
----------------------------------------------------------------------------------------------------------------
                                                                                   Non-surgical    Surgical risk
               Specialty code                      Medicare specialty name          risk factor       factor
----------------------------------------------------------------------------------------------------------------
01.........................................  General Practice...................            1.80            3.72
01.........................................  General Practice w/OB..............  ..............            4.30
02.........................................  General Surgery....................  ..............            6.75
03.........................................  Allergy/Immunology.................            1.00            1.00
04.........................................  Otolaryngology.....................            1.53            4.08
05.........................................  Anesthesiology.....................            2.58            2.58
06.........................................  Cardiovascular Disease (Cardiology)            1.90            1.90
07.........................................  Dermatology........................            2.77            2.77
08.........................................  Family Practice....................            1.67            3.74
08.........................................  Family Practice w/OB...............  ..............            4.31
09.........................................  Interventional Pain Management.....            2.08            2.97
10.........................................  Gastroenterology...................            2.40            2.40
11.........................................  Internal Medicine..................            2.70            2.70
12.........................................  Osteopathic Manipulative Medicine..            1.00            1.00
13.........................................  Neurology..........................            2.46           13.02
14.........................................  Neurosurgery.......................  ..............           10.66
15.........................................  Speech Language Pathology..........            1.00            1.00
16.........................................  Obstetrics & Gynecology............            1.59            4.52
16.........................................  Obstetrics & Gynecology w/OB.......  ..............            8.67
17.........................................  Hospice and Palliative Care........            1.00            1.00
18.........................................  Ophthalmology......................            1.03            2.16
19.........................................  Oral Surgery (Dentist only)........  ..............            4.93
20.........................................  Orthopedic Surgery.................  ..............            6.22
22.........................................  Pathology..........................            1.60            1.60
23.........................................  Sports Medicine....................            1.80            3.72
24.........................................  Plastic and Reconstructive Surgery.  ..............            4.93
25.........................................  Physical Medicine and                          1.49            1.49
                                              Rehabilitation.
26.........................................  Psychiatry.........................            1.27            1.27
27.........................................  Geriatric Psychiatry...............            1.27            1.27
28.........................................  Colorectal Surgery (Proctology)....  ..............            4.19
29.........................................  Pulmonary Disease..................            1.82            1.82
30.........................................  Diagnostic Radiology...............            2.82            2.82
32.........................................  Anesthesiology Assistant...........            2.58            2.58
33.........................................  Thoracic Surgery...................  ..............            6.06
34.........................................  Urology............................            1.66            2.97

[[Page 33969]]

 
35.........................................  Chiropractic.......................            1.00            1.00
36.........................................  Nuclear Medicine...................            2.82            2.82
37.........................................  Pediatric Medicine.................            1.82            1.82
38.........................................  Geriatric Medicine.................            1.52            1.52
39.........................................  Nephrology.........................            1.56            1.56
40.........................................  Hand Surgery.......................  ..............            6.22
41.........................................  Optometry..........................            1.00            1.00
42.........................................  Certified Nurse Midwife............            1.59            4.52
42.........................................  Certified Nurse Midwife w/OB.......  ..............            8.67
43.........................................  Certified Registered Nurse                     2.58            2.58
                                              Anesthetist (CRNA).
44.........................................  Infectious Disease.................            2.03            2.03
46.........................................  Endocrinology......................            1.75            1.75
48.........................................  Podiatry...........................            2.77            2.77
50.........................................  Nurse Practitioner.................            1.95            1.95
62.........................................  Psychologist.......................            1.00            1.00
64.........................................  Audiologist........................            1.00            1.00
65.........................................  Physical Therapist in Private                  1.00            1.00
                                              Practice.
66.........................................  Rheumatology.......................            1.58            1.58
67.........................................  Occupational Therapist in Private              1.00            1.00
                                              Practice.
68.........................................  Psychologist, Clinical.............            1.00            1.00
71.........................................  Registered Dietitian or Nutrition              1.37            1.37
                                              Professional.
72.........................................  Pain Management....................            2.65            3.65
76.........................................  Peripheral Vascular Disease........  ..............            6.67
77.........................................  Vascular Surgery...................  ..............            6.67
78.........................................  Cardiac Surgery....................  ..............            6.87
79.........................................  Addiction Medicine.................            1.00            1.00
80.........................................  Licensed Clinical Social Worker....            1.00            1.00
81.........................................  Critical Care (Intensivists).......            1.82            1.82
82.........................................  Hematology.........................            1.77            1.77
83.........................................  Hematology-Oncology................            1.85            1.85
84.........................................  Preventive Medicine................            1.15            1.15
85.........................................  Maxillofacial Surgery..............  ..............            4.93
86.........................................  Neuropsychiatry....................            1.27            1.27
89.........................................  Certified Clinical Nurse Specialist            1.80            3.72
90.........................................  Medical Oncology...................            1.82            1.82
91.........................................  Surgical Oncology..................  ..............            4.32
92.........................................  Radiation Oncology.................            2.82            2.82
93.........................................  Emergency Medicine.................            2.29            5.03
94.........................................  Interventional Radiology...........            2.82            2.82
97.........................................  Physician Assistant................            1.95            1.95
98.........................................  Gynecological Oncology.............  ..............            6.75
99.........................................  Undefined Physician type...........            1.95            1.95
C0.........................................  Sleep Medicine.....................            1.80            3.72
----------------------------------------------------------------------------------------------------------------

    Step (4): Calculate malpractice RVUs for each HCPCS code.
    Resource-based MP RVUs were calculated for each HCPCS code that has 
work or PE RVUs. The first step was to identify the percentage of 
services furnished by each specialty for each respective HCPCS code. 
This percentage was then multiplied by each respective specialty's risk 
factor as calculated in Step 3. The products for all specialties for 
the HCPCS code were then added together, yielding a specialty-weighted 
service specific risk factor reflecting the weighted malpractice costs 
across all specialties furnishing that procedure. The service specific 
risk factor was multiplied by the greater of the work RVU or PE 
clinical labor index for that service to reflect differences in the 
complexity and risk-of-service between services.
    Low volume service codes: As we discussed in section II.B. of this 
proposed rule, we are proposing to use a list of expected specialties 
instead of the claims-based specialty mix for low volume services in 
order to address stakeholder concerns about the year to year 
variability in PE and MP RVUs for low volume services. We are 
soliciting comments on the proposal to use these service-level 
overrides to determine the specialty for low volume procedures, as well 
as on the list of overrides itself. The proposed list of codes and 
expected specialties is available on our Web site under downloads for 
the CY 2018 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. In previous MP RVU updates, as discussed in the CY 2015 
final rule with comment period (79 FR 40354), we assigned specialty for 
low volume services based on dominant specialty. As discussed in the CY 
2012 final rule with comment period (76 FR 73187 through 73189), we 
applied an additional list of service-level overrides for purposes of 
calculating MP RVUs for a number of cardiothoracic surgery codes. 
Therefore, we note that there are certain codes for which we have 
previously applied expected specialty overrides for purposes of 
calculating MP RVUs based on assumptions regarding low Medicare volume. 
Because we are consolidating policies for low volume service expected 
specialty overrides into a single list for PE and MP, and because we do 
not believe that there is a reason to assume different specialties for 
purposes of calculating PE RVUs than for MP RVUs for any particular 
code, we

[[Page 33970]]

are also proposing to assign the specialty mix solely based on the 
claims data for any code that does not meet the low volume threshold of 
99 allowed services or fewer in the previous year, for the purposes of 
calculating MP RVUs.
    Given that we now annually recalibrate MP RVUs based on claims 
data, and in light of our proposed introduction of the service-level 
specialty override for low volume services, we believe that there would 
no longer be a need to apply service-level MP crosswalks in order to 
assign a specialty-mix risk factor. Contingent on finalizing this 
proposal, we are also proposing to eliminate general use of an MP-
specific specialty-mix crosswalk for new and revised codes. However, we 
would continue to consider, in conjunction with annual recommendations, 
specific recommendations from the public and the RUC regarding 
specialty mix assignments for new and revised codes, particularly in 
cases where coding changes are expected to result in differential 
reporting of services by specialty, or where the new or revised code is 
expected to be low-volume. Absent such information, we would derive the 
specialty mix assumption for the first year for a new or revised code 
from the specialty mix used for purposes of ratesetting. In subsequent 
years when claims data are available, we would assign the specialty 
based on claims data unless the service does not exceed the low volume 
threshold (99 or fewer allowed services). If the service is low volume, 
we would assign the expected specialty, establishing a new expected 
specialty through rulemaking as needed, which is consistent with our 
approach for developing PE RVUs.
    Step (5): Rescale for budget neutrality.
    The statute requires that changes to fee schedule RVUs must be 
budget neutral. Thus, the last step is to adjust for relativity by 
rescaling the proposed MP RVUs so that the total proposed resource 
based MP RVUs are equal to the total current resource based MP RVUs 
scaled by the ratio of current aggregate MP and work RVUs. This scaling 
is necessary in order to maintain the work RVUs for individual services 
from year to year while also maintaining the overall relationship among 
work, PE, and MP RVUs.
    The proposed resource based MP RVUs are shown in Addendum B, which 
is available on the CMS Web site under the downloads section of the CY 
2018 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
    Because a different share of the resources involved in furnishing 
PFS services is reflected in each of the three fee schedule components, 
implementation of the resource based MP RVU update will have much 
smaller payment effects than implementing updates of resource based 
work RVUs and resource based PE RVUs. On average, work represents about 
50.9 percent of payment for a service under the fee schedule, PE about 
44.8 percent, and MP about 4.3 percent. Therefore, a 25 percent change 
in PE RVUs or work RVUs for a service would result in a change in 
payment of about 11 to 13 percent. In contrast, a corresponding 25 
percent change in MP values for a service would yield a change in 
payment of only about one percent. Estimates of the effects on payment 
by specialty type can be found in section VI. of this proposed rule.
    Additional information on our proposed methodology for updating the 
MP RVUs may be found in our contractor's report, ``Interim Report on 
Malpractice RVUs for the CY 2018 PFS Proposed Rule,'' which is 
available on the CMS Web site under the downloads section of the CY 
2018 PFS proposed rule located at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
    We are seeking comments on these proposals for calculating the MP 
RVUs for CY 2018.

C. Medicare Telehealth Services

1. Billing and Payment for Telehealth Services
    Several conditions must be met for Medicare to make payments for 
telehealth services under the PFS. The service must be on the list of 
Medicare telehealth services and meet all of the following additional 
requirements:
     The service must be furnished via an interactive 
telecommunications system.
     The service must be furnished by a physician or other 
authorized practitioner.
     The service must be furnished to an eligible telehealth 
individual.
     The individual receiving the service must be located in a 
telehealth originating site.
    When all of these conditions are met, Medicare pays a facility fee 
to the originating site and makes a separate payment to the distant 
site practitioner furnishing the service.
    Section 1834(m)(4)(F)(i) of the Act defines Medicare telehealth 
services to include professional consultations, office visits, office 
psychiatry services, 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

[[Page 33971]]

telehealth services to the Medicare Administrative Contractors (MACs) 
that process claims for the service area where their distant site is 
located. Section 1834(m)(2)(A) of the Act requires that a practitioner 
who furnishes a telehealth service to an eligible telehealth individual 
be paid an amount equal to the amount that the practitioner would have 
been paid if the service had been furnished without the use of a 
telecommunications system.
    Originating sites, which can be one of several types of sites 
specified in the statute where an eligible telehealth individual is 
located at the time the service is being furnished via a 
telecommunications system, are paid a facility fee under the PFS for 
each Medicare telehealth service. The statute specifies both the types 
of entities that can serve as originating sites and the geographic 
qualifications for originating sites. For geographic qualifications, 
our regulation at Sec.  410.78(b)(4) limits originating sites to those 
located in rural health professional shortage areas (HPSAs) or in a 
county that is not included in a metropolitan statistical area (MSA).
    Historically, we have defined rural HPSAs to be those located 
outside of MSAs. Effective January 1, 2014, we modified the regulations 
regarding originating sites to define rural HPSAs as those located in 
rural census tracts as determined by the Federal Office of Rural Health 
Policy of the Health Resources and Services Administration (HRSA) (78 
FR 74811). Defining ``rural'' to include geographic areas located in 
rural census tracts within MSAs allows for broader inclusion of sites 
within HPSAs as telehealth originating sites. Adopting the more precise 
definition of ``rural'' for this purpose expands access to health care 
services for Medicare beneficiaries located in rural areas. HRSA has 
developed a Web site tool to provide assistance to potential 
originating sites to determine their geographic status. To access this 
tool, see our Web site at https://www.cms.gov/MedicareMedicare-General-Information/Telehealth/index.html.
    An entity participating in a federal telemedicine demonstration 
project that has been approved by, or received funding from, the 
Secretary as of December 31, 2000 is eligible to be an originating site 
regardless of its geographic location.
    Effective January 1, 2014, we also changed our policy so that 
geographic status for an originating site would be established and 
maintained on an annual basis, consistent with other telehealth payment 
policies (78 FR 74400). Geographic status for Medicare telehealth 
originating sites for each calendar year is now based upon the status 
of the area as of December 31 of the prior calendar year.
    For a detailed history of telehealth payment policy, see 78 FR 
74399.
2. Adding Services to the List of Medicare Telehealth Services
    As noted previously, in the CY 2003 PFS final rule with comment 
period (67 FR 79988), we established a process for adding services to 
or deleting services from the list of Medicare telehealth services. 
This process provides the public with an ongoing opportunity to submit 
requests for adding services. Under this process, we assign any 
qualifying request to make additions to the list of telehealth services 
to one of two categories. Revisions to criteria that we use to review 
requests in the second category were finalized in the CY 2012 PFS final 
rule with comment period (76 FR 73102). The two categories are:
     Category 1: Services that are similar to professional 
consultations, office visits, and office psychiatry services that are 
currently on the list of telehealth services. In reviewing these 
requests, we look for similarities between the requested and existing 
telehealth services for the roles of, and interactions among, the 
beneficiary, the physician (or other practitioner) at the distant site 
and, if necessary, the telepresenter, a practitioner who is present 
with the beneficiary in the originating site. We also look for 
similarities in the telecommunications system used to deliver the 
service; for example, the use of interactive audio and video equipment.
     Category 2: Services that are not similar to the current 
list of telehealth services. Our review of these requests includes an 
assessment of whether the service is accurately described by the 
corresponding code when furnished via telehealth and whether the use of 
a telecommunications system to furnish the service produces 
demonstrated clinical benefit to the patient. Submitted evidence should 
include both a description of relevant clinical studies that 
demonstrate the service furnished by telehealth to a Medicare 
beneficiary improves the diagnosis or treatment of an illness or injury 
or improves the functioning of a malformed body part, including dates 
and findings, and a list and copies of published peer reviewed articles 
relevant to the service when furnished via telehealth. Our evidentiary 
standard of clinical benefit does not include minor or incidental 
benefits.
    Some examples of clinical benefit include the following:
     Ability to diagnose a medical condition in a patient 
population without access to clinically appropriate in-person 
diagnostic services.
     Treatment option for a patient population without access 
to clinically appropriate in-person treatment options.
     Reduced rate of complications.
     Decreased rate of subsequent diagnostic or therapeutic 
interventions (for example, due to reduced rate of recurrence of the 
disease process).
     Decreased number of future hospitalizations or physician 
visits.
     More rapid beneficial resolution of the disease process 
treatment.
     Decreased pain, bleeding, or other quantifiable symptom.
     Reduced recovery time.
    The list of telehealth services, including the proposed additions 
described below, is included in the Downloads section to this proposed 
rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    Requests to add services to the list of Medicare telehealth 
services must be submitted and received no later than December 31 of 
each calendar year to be considered for the next rulemaking cycle. For 
example, qualifying requests submitted before the end of CY 2017 will 
be considered for the CY 2019 proposed rule. Each request to add a 
service to the list of Medicare telehealth services must include any 
supporting documentation the requester wishes us to consider as we 
review the request. Because we use the annual PFS rulemaking process as 
a vehicle for making changes to the list of Medicare telehealth 
services, requesters should be advised that any information submitted 
is subject to public disclosure for this purpose. For more information 
on submitting a request for an addition to the list of Medicare 
telehealth services, including where to mail these requests, see our 
Web site at https://www.cms.gov/Medicare/Medicare-General-Information/Telehealth/index.html.
3. Submitted Requests To Add Services to the List of Telehealth 
Services for CY 2018
    Under our existing policy, we add services to the telehealth list 
on a category 1 basis when we determine that they are similar to 
services on the existing telehealth list for the roles of, and 
interactions among, the beneficiary, physician (or other practitioner) 
at the distant site and, if necessary, the telepresenter. As we stated 
in the CY

[[Page 33972]]

2012 final rule with comment period (76 FR 73098), we believe that the 
category 1 criteria not only streamline our review process for publicly 
requested services that fall into this category, but also expedite our 
ability to identify codes for the telehealth list that resemble those 
services already on this list.
    We received several requests in CY 2016 to add various services as 
Medicare telehealth services effective for CY 2018. The following 
presents a discussion of these requests, and our proposals for 
additions to the CY 2018 telehealth list. Of the requests received, we 
found that three services were sufficiently similar to services 
currently on the telehealth list to qualify on a category 1 basis. 
Therefore, we are proposing to add the following services to the 
telehealth list on a category 1 basis for CY 2018:
     HCPCS code G0296 (Counseling visit to discuss need for 
lung cancer screening using low dose ct scan (ldct) (service is for 
eligibility determination and shared decision making))
    We found that the service described by HCPCS code G0296 is 
sufficiently similar to office visits currently on the telehealth list. 
We believe that all the components of this service, which include 
assessment of the patient's risk for lung cancer, shared decision 
making, and counseling on the risks and benefits of LDCT, can be 
furnished via interactive telecommunications technology.
     CPT codes 90839 and 90840 (Psychotherapy for crisis; first 
60 minutes) and (Psychotherapy for crisis; each additional 30 minutes 
(List separately in addition to code for primary service))
    We are proposing to add CPT codes 90839 and 90840 on a Category 1 
basis. We found that these services are sufficiently similar to the 
psychotherapy services currently on the telehealth list, even though 
these codes describe patients requiring more urgent care and 
psychotherapeutic interventions to minimize the potential for 
psychological trauma. However, we did identify one specific element of 
the services as described in the CPT prefatory language that we 
concluded may or may not be able to be furnished via telehealth, 
depending on the circumstances of the particular service. The CPT 
prefatory language specifies that the treatment described by these 
codes requires, ``mobilization of resources to defuse the crisis and 
restore safety.'' In many cases, we believe that a distant site 
practitioner would have access (via telecommunication technology, 
presumably) to the resources at the originating site that would allow 
for the kind of mobilization required to restore safety. However, we 
also believe that it would be possible that a distant site practitioner 
would not have access to such resources. Therefore we are proposing to 
add the codes to the telehealth list with the explicit condition of 
payment that the distant site practitioner be able to mobilize 
resources at the originating site to defuse the crisis and restore 
safety, when applicable, when the codes are furnished via telehealth. 
``Mobilization of resources'' is a description used in the CPT 
prefatory language. We believe the critical element of ``mobilizing 
resources'' is the ability to communicate with and inform staff at the 
originating site to the extent necessary to restore safety. We solicit 
comment on whether our assumption that the remote practitioner is able 
to mobilize resources at the originating site to defuse the crisis and 
restore safety is valid.
    Although we did not receive specific requests, we are also 
proposing to add four additional services to the telehealth list based 
on our review of services. All four of these codes are add-on codes 
that describe additional elements of services currently on the 
telehealth list and would only be considered telehealth services when 
billed as an add-on to codes already on the telehealth list. The four 
codes are:
     CPT code 90785 (Interactive complexity (List separately in 
addition to the code for primary procedure))
     CPT codes 96160 and 96161 (Administration of patient-
focused health risk assessment instrument (e.g., health hazard 
appraisal) with scoring and documentation, per standardized instrument) 
and (Administration of caregiver-focused health risk assessment 
instrument (e.g., depression inventory) for the benefit of the patient, 
with scoring and documentation, per standardized instrument))
     HCPCS code G0506 (Comprehensive assessment of and care 
planning for patients requiring chronic care management services (list 
separately in addition to primary monthly care management service))
    In the case of CPT codes 96160 and 96161, and HCPCS code G0506, we 
recognize that these services may not necessarily be ordinarily 
furnished in-person with a physician or billing practitioner. 
Ordinarily, services that are typically not considered to be face-to-
face services do not need to be on the list of Medicare telehealth 
services; however, these services would only be considered Medicare 
telehealth services when billed with a base code that is also on the 
telehealth list and would not be considered Medicare telehealth 
services when billed with codes not on the Medicare telehealth list. We 
believe that by adding these services to the telehealth list it will be 
administratively easier for practitioners who report these services in 
association with a visit code that is furnished via telehealth as both 
the base code and the add-on code would be reported with the telehealth 
place of service.
    We also received requests to add services to the telehealth list 
that do not meet our criteria for Medicare telehealth services. We are 
not proposing to add the following procedures for physical, 
occupational, and speech therapy, initial hospital care, and online E/M 
by physician/qualified healthcare professional to the telehealth list, 
or changing the requirements for ESRD procedure codes furnished via 
telehealth, for the reasons noted in the paragraphs that follow.
a. Physical and Occupational Therapy and Speech-Language Pathology 
Services: CPT Codes--
     CPT code 97001: Now deleted and reported as CPT code 97161 
(Physical therapy evaluation: low complexity, requiring these 
components: A history with no personal factors and/or comorbidities 
that impact the plan of care; An examination of body system(s) using 
standardized tests and measures addressing 1-2 elements from any of the 
following: Body structures and functions, activity limitations, and/or 
participation restrictions; A clinical presentation with stable and/or 
uncomplicated characteristics; and Clinical decision making of low 
complexity using standardized patient assessment instrument and/or 
measurable assessment of functional outcome.)
     CPT code 97002: Now deleted and reported as CPT code 97162 
(Physical therapy evaluation: moderate complexity, requiring these 
components: A history of present problem with 1-2 personal factors and/
or comorbidities that impact the plan of care; An examination of body 
systems using standardized tests and measures in addressing a total of 
3 or more elements from any of the following: Body structures and 
functions, activity limitations, and/or participation restrictions; An 
evolving clinical presentation with changing characteristics; and 
Clinical decision making of moderate complexity using standardized 
patient assessment instrument and/or measurable assessment of 
functional outcome)
     CPT code 97003: Now deleted and reported as CPT code 97165 
(Occupational therapy evaluation, low

[[Page 33973]]

complexity, requiring these components: An occupational profile and 
medical and therapy history, which includes a brief history including 
review of medical and/or therapy records relating to the presenting 
problem; An assessment(s) that identifies 1-3 performance deficits 
(i.e., relating to physical, cognitive, or psychosocial skills) that 
result in activity limitations and/or participation restrictions; and 
Clinical decision making of low complexity, which includes an analysis 
of the occupational profile, analysis of data from problem-focused 
assessment(s), and consideration of a limited number of treatment 
options. Patient presents with no comorbidities that affect 
occupational performance. Modification of tasks or assistance (e.g., 
physical or verbal) with assessment(s) is not necessary to enable 
completion of evaluation component)
     CPT code 97004: Now deleted and reported as CPT code 97166 
(Occupational therapy evaluation, moderate complexity, requiring these 
components: An occupational profile and medical and therapy history, 
which includes an expanded review of medical and/or therapy records and 
additional review of physical, cognitive, or psychosocial history 
related to current functional performance; An assessment(s) that 
identifies 3-5 performance deficits (i.e., relating to physical, 
cognitive, or psychosocial skills) that result in activity limitations 
and/or participation restrictions; and Clinical decision making of 
moderate analytic complexity, which includes an analysis of the 
occupational profile, analysis of data from detailed assessment(s), and 
consideration of several treatment options. Patient may present with 
comorbidities that affect occupational performance. Minimal to moderate 
modification of tasks or assistance (e.g., physical or verbal) with 
assessment(s) is necessary to enable patient to complete evaluation 
component))
     CPT code 97110 (Therapeutic procedure, 1 or more areas, 
each 15 minutes; therapeutic exercises to develop strength and 
endurance, range of motion and flexibility)
     CPT code 97112 (Therapeutic procedure, 1 or more areas, 
each 15 minutes; neuromuscular reeducation of movement, balance, 
coordination, kinesthetic sense, posture, and/or proprioception for 
sitting and/or standing activities)
     CPT code 97116 (Therapeutic procedure, 1 or more areas, 
each 15 minutes; gait training (includes stair climbing))
     CPT code 97535 (Self-care/home management training (e.g., 
activities of daily living (ADL) and compensatory training, meal 
preparation, safety procedures, and instructions in use of assistive 
technology devices/adaptive equipment) direct one-on-one contact, each 
15 minutes)
     CPT code 97750 (Physical performance test or measurement 
(e.g., musculoskeletal, functional capacity), with written report, each 
15 minutes)
     CPT code 97755 (Assistive technology assessment (e.g., to 
restore, augment or compensate for existing function, optimize 
functional tasks and/or maximize environmental accessibility), direct 
one-on-one contact, with written report, each 15 minutes).
     CPT code 97760 (Orthotic(s) management and training 
(including assessment and fitting when not otherwise reported), upper 
extremity(s), lower extremity(s) and/or trunk, each 15 minutes).
     CPT code 97761 (Prosthetic training, upper and/or lower 
extremity(s), each 15 minutes).
     CPT code 97762 (Checkout for orthotic/prosthetic use, 
established patient, each 15 minutes).
    In section 1834(m)(4)(E) of the Act, the statute specifies the 
types of practitioners who may furnish and bill for Medicare telehealth 
services as those practioners under section 1842(b)(18)(C) of the Act. 
Physical therapists, occupational therapists and speech-language 
pathologists are not among the practitioners identified in section 
1842(b)(18)(C) of the Act. We stated in the CY 2017 PFS final rule (81 
FR 80198) that because these services are predominantly furnished by 
physical therapists, occupational therapists and speech-language 
pathologists, we did not believe it would be appropriate to add them to 
the list of telehealth services at this time. In an ensuing submission 
for 2018, the original requester suggested that we might propose these 
services to be added to the list so that they can be furnished via 
telehealth when furnished by eligible distant site practitioners. We 
considered that possibility; however, since the majority of the codes 
are furnished by therapy professionals over 90 percent of the time, we 
believe that adding therapy services to the telehealth list that 
explicitly describe the services of the kinds of professionals not 
included on the statutory list of distant site practitioners could 
result in confusion about who is authorized to furnish and bill for 
these services when furnished via telehealth. We also note that several 
of these services, such as CPT code 97761, require directly physically 
manipulating the beneficiary, which is not possible to do through 
telecommunications technology. Therefore, we are not proposing to add 
these codes to the list of Medicare telehealth services.
b. Initial Hospital Care Services: CPT Codes--
     CPT code 99221 (Initial hospital care, per day, for the 
evaluation and management of a patient, which requires these 3 key 
components: A detailed or comprehensive history; A detailed or 
comprehensive examination; and Medical decision making that is 
straightforward or of low complexity. Counseling and/or coordination of 
care with other physicians, other qualified health care professionals, 
or agencies are provided consistent with the nature of the problem(s) 
and the patient's and/or family's needs. Usually, the problem(s) 
requiring admission are of low severity.)
     CPT code 99222 (Initial hospital care, per day, for the 
evaluation and management of a patient, which requires these 3 key 
components: A comprehensive history; A comprehensive examination; and 
Medical decision making of moderate complexity. Counseling and/or 
coordination of care with other physicians, other qualified health care 
professionals, or agencies are provided consistent with the nature of 
the problem(s) and the patient's and/or family's needs. Usually, the 
problem(s) requiring admission are of moderate severity.)
     CPT code 99223 (Initial hospital care, per day, for the 
evaluation and management of a patient, which requires these 3 key 
components: A comprehensive history; A comprehensive examination; and 
Medical decision making of high complexity. Counseling and/or 
coordination of care with other physicians, other qualified health care 
professionals, or agencies are provided consistent with the nature of 
the problem(s) and the patient's and/or family's needs. Usually, the 
problem(s) requiring admission are of high severity.)
    We previously considered a request to add these codes to the 
telehealth list. As we stated in the CY 2011 PFS final rule with 
comment period (75 FR 73315), while initial inpatient consultation 
services are currently on the list of approved telehealth services, 
there are no services on the current list of telehealth services that 
resemble initial hospital care for an acutely ill patient by the 
admitting practitioner who has ongoing responsibility for the patient's

[[Page 33974]]

treatment during the hospital course. Therefore, consistent with prior 
rulemaking, we are not proposing initial hospital care services be 
added to the Medicare telehealth services list on a category 1 basis.
    The initial hospital care codes describe the first visit of the 
hospitalized patient by the admitting practitioner who may or may not 
have seen the patient in the decision-making phase regarding 
hospitalization. Based on the description of the services for these 
codes, we believe it is critical that the initial hospital visit by the 
admitting practitioner be conducted in person to ensure that the 
practitioner with ongoing treatment responsibility comprehensively 
assesses the patient's condition upon admission to the hospital through 
a thorough in-person examination. Additionally, the requester submitted 
no additional research or evidence that the use of a telecommunications 
system to furnish the service produces demonstrated clinical benefit to 
the patient; therefore, we also are not proposing to add initial 
hospital care services to the Medicare telehealth services list on a 
category 2 basis.
    We note that Medicare beneficiaries who are being treated in the 
hospital setting can receive reasonable and necessary E/M services 
using other HCPCS codes that are currently on the Medicare telehealth 
list including those for subsequent hospital care, initial and followup 
telehealth inpatient and emergency department consultations, as well as 
initial and followup critical care telehealth consultations.
    Therefore, we do not propose to add the initial hospital care 
services to the list of Medicare telehealth services for CY 2018.
c. Online E/M by physician/QHP: CPT Code--
     CPT code 99444 (Online evaluation and management service 
provided by a physician or other qualified health care professional who 
may report evaluation and management services provided to an 
established patient or guardian, not originating from a related E/M 
service provided within the previous 7 days, using the Internet or 
similar electronic communications network)
    As we indicated in the CY 2016 final rule with comment period (80 
FR 71061), CPT code 99444 is assigned a status indicator of ``N'' (Non-
covered service). Under section 1834(m)(2)(A) of the Act, Medicare pays 
the physician or practitioner furnishing a telehealth service an amount 
equal to the amount that would have been paid if the service was 
furnished without the use of a telecommunications system. Because CPT 
code 99444 is currently non-covered, there would be no Medicare payment 
if this service were furnished without the use of a telecommunications 
system. Because this code is a non-covered service for which no 
Medicare payment may be made under the PFS, we do not propose to add 
online E/M services to the list of Medicare telehealth services for CY 
2018.
d. Monthly Capitation Payment (MCP) for ESRD-Related Services for Home 
Dialysis, by Age: CPT Codes--
     CPT codes 90963 (End-stage renal disease (ESRD) related 
services for home dialysis per full month, for patients younger than 2 
years of age to include monitoring for the adequacy of nutrition, 
assessment of growth and development, and counseling of parents); 90964 
(End-stage renal disease (ESRD) related services for home dialysis per 
full month, for patients 2- 11 years of age to include monitoring for 
the adequacy of nutrition, assessment of growth and development, and 
counseling of parents); 90965 (End-stage renal disease (ESRD) related 
services for home dialysis per full month, for patients 12-19 years of 
age to include monitoring for the adequacy of nutrition, assessment of 
growth and development, and counseling of parents); and 90966 (End-
stage renal disease (ESRD) related services for home dialysis per full 
month, for patients 20 years of age and older)
     90967 (End-stage renal disease (ESRD) related services for 
dialysis less than a full month of service, per day; for patients 
younger than 2 years of age); 90968 (End-stage renal disease (ESRD) 
related services for dialysis less than a full month of service, per 
day; for patients 2-11 years of age); and 90969 (End-stage renal 
disease (ESRD) related services for dialysis less than a full month of 
service, per day; for patients 12-19 years of age); and 90970 (End-
stage renal disease (ESRD) related services for dialysis less than a 
full month of service, per day; for patients 20 years of age and 
older).
    In the CY 2004 PFS final rule (68 FR 63216), we established G-codes 
for ESRD monthly capitation payments (MCPs), which were replaced by CPT 
codes in CY 2009 (73 FR 69898). The services described by CPT codes 
90963 through 90966 were added to the Medicare telehealth list in CY 
2005 (69 FR 66276) and CPT codes 90967 through 90970 were added to the 
Medicare telehealth list in the CY 2017 PFS final rule (81 FR 80194); 
however, we specified that the required clinical examination of the 
vascular access site must be furnished face-to-face ``hands on'' 
(without the use of an interactive telecommunications system) by a 
physician, clinical nurse specialist (CNS), nurse practitioner (NP), or 
physician assistant (PA). The American Telemedicine Association (ATA) 
submitted a new request for CY 2018 requesting that we allow telehealth 
coverage of ESRD procedure codes without in-person exam of the catheter 
access site monthly. Our current policy reflects our understanding that 
evaluation of the integrity and functionality of the access site is a 
critical element of the services described by the codes and that this 
element cannot be performed via telecommunications technology. The 
requester did not submit evidence to support the assertation that 
effective examination of the access site can be executed via 
telecommunications technology. Therefore, for CY 2018, we are not 
proposing any changes to the policy requiring that the MCP practitioner 
must furnish at least one face-to-face encounter with the home dialysis 
patient per month for clinical examination of the catheter access site. 
However, we are interested in more information about current clinically 
accepted care practices and to what extent telecommunications 
technology can be used to examine the access site. We are also 
interested in information about the clinical standards of care 
regarding the frequency of the evaluation of the access site.
    In summary, we are proposing to add the following codes to the list 
of Medicare telehealth services beginning in CY 2018 on a category 1 
basis:
     HCPCS code G0296 (Counseling visit to discuss need for 
lung cancer screening using low dose CT scan (ldct) (service is for 
eligibility determination and shared decision making)).
     HCPCS code G0506 (Comprehensive assessment of and care 
planning for patients requiring chronic care management services (list 
separately in addition to primary monthly care management service)).
     CPT code 90785 (Interactive complexity (List separately in 
addision to the code for primary procedure)).
     CPT codes 90839 and 90840 (Psychotherapy for crisis; first 
60 minutes) and (Psychotherapy for crisis; each additional 30 minutes 
(List separately in addition to code for primary procedure)).
     CPT codes 96160 and 96161 (Administration of patient-
focused health risk assessment instrument (e.g., health hazard 
appraisal) with scoring and documentation, per standardized

[[Page 33975]]

instrument) and (Administration of caregiver-focused health risk 
assessment instrument (e.g., depression inventory) for the benefit of 
the patient, with scoring and documentation, per standardized 
instrument).
4. Elimination of the Required Use of the GT Modifier on Professional 
Claims
    Medicare has required distant site practitioners to report one of 
two longstanding HCPCS modifiers when reporting telehealth services. 
Current guidance instructs practitioners to submit claims for 
telehealth services using the appropriate CPT or HCPCS code for the 
professional service along with the telehealth modifier GT (via 
interactive audio and video telecommunications systems). For federal 
telemedicine demonstration programs in Alaska or Hawaii, practitioners 
are instructed to submit claims using the appropriate CPT or HCPCS code 
for the professional service along with the telehealth modifier GQ if 
telehealth services are performed ``via an asynchronous 
telecommunications system.'' By coding and billing these modifiers with 
a service code, practitioners are certifying that both the broad and 
code-specific telehealth requirements have been met.
    In the CY 2017 PFS final rule (81 FR 80201), we finalized payment 
policies regarding Medicare's use of a new Place of Service (POS) Code 
describing services furnished via telehealth. The new POS code became 
effective January 1, 2017, and we believe its use is redundant with the 
requirements to apply the GT modifier for telehealth services. We did 
not propose to implement a change to the modifier requirements during 
CY 2017 rulemaking because at the time of the CY 2017 PFS proposed 
rule, we did not know whether the telehealth POS code would be made 
effective for January 1, 2017. However, we noted in the CY 2017 PFS 
final rule that, like the modifiers, use of the telehealth POS code 
certifies that the service meets the telehealth requirements.
    Because a valid POS code is required on professional claims for all 
services, and the appropriate reporting of the telehealth POS code 
serves to indicate both the provision of the service via telehealth and 
certification that the requirements have been met, we believe that it 
is unnecessary to also require the distant site practitioner report the 
GT modifier on the claim. Therefore, we are proposing to eliminate the 
required use of the GT modifier on professional claims. Because 
institutional claims do not use a POS code, we propose for distant site 
practitioners billing under CAH Method II to continue to use the GT 
modifier on institutional claims. For purposes of the federal 
telemedicine demonstration programs in Alaska or Hawaii, we propose to 
retain the GQ modifier to maintain the distinction between synchronous 
and asynchronous telehealth services, as reflected in statute.
5. Comment Solicitation on Medicare Telehealth Services
    We have received numerous requests from stakeholders to expand 
access to telehealth services. As noted above, Medicare payment for 
telehealth services is restricted by statute, which establishes the 
services initially eligible for Medicare telehealth and limits the use 
of telehealth by defining both eligible originating sites (the location 
of the beneficiary) and the distant site practitioners who may furnish 
and bill for telehealth services. Originating sites are limited both by 
geography and provider setting. We have the authority to add to the 
list of eligible services based on our annual process, but cannot 
change the limitations relating to geography, patient setting, or type 
of furnishing practitioner because these requirements are specified in 
statute. For CY 2018, we are seeking information regarding ways that we 
might further expand access to telehealth services within the current 
statutory authority and pay appropriately for services that take full 
advantage of communication technologies.
6. Comment Solicitation on Remote Patient Monitoring
    In addition to the broad comment solicitation regarding Medicare 
telehealth services, we are also specifically seeking comment on 
whether to make separate payment for CPT codes that describe remote 
patient monitoring. We note that remote patient monitoring services 
would generally not be considered Medicare telehealth services as 
defined under section 1834(m) of the Act. Rather, like the 
interpretation by a physician of an actual electrocardiogram or 
electroencephalogram tracing that has been transmitted electronically, 
these services involve the interpretation of medical information 
without a direct interaction between the practitioner and beneficiary. 
As such, they are paid under the same conditions as in-person 
physicians' services with no additional requirements regarding 
permissible originating sites or use of the telehealth place of service 
code.
    We are particularly interested in comments regarding CPT code 99091 
(Collection and interpretation of physiologic data (e.g., ECG, blood 
pressure, glucose monitoring) digitally stored and/or transmitted by 
the patient and/or caregiver to the physician or other qualified health 
care professional, qualified by education, training, licensure/
regulation (when applicable) requiring a minimum of 30 minutes of 
time). This code is currently assigned a procedure status of B 
(bundled). As with many other bundled codes, we currently assign RVUs 
for this code based on existing RUC recommendations, even though we 
have considered the services described by the code to be bundled with 
other services. In addition to comments on the payment status and 
valuation for this code (the RUC-recommended value, specifically) we 
are seeking information about the circumstances under which this code 
might be reported for separate payment, including how to differentiate 
the time related to these services from other services, including care 
management services. For example, PFS payment for analysis of patient-
generated health data is considered included in chronic care management 
(CCM) services (CPT codes 99487, 99489, and 99490) to the extent that 
this activity is medically necessary and performed as part of CCM (see 
the CY 2015 PFS final rule (79 FR 67727), CY 2016 PFS final rule (81 FR 
80244), and the CMS FAQ available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/Payment_for_CCM_Services_FAQ.pdf.). We also seek comment from 
beneficiaries and beneficiary advocacy organizations on the value of 
such services and what protections might be necessary to assure that 
beneficiaries are properly informed that they are receiving a remote 
monitoring service, since beneficiaries would be required to pay 
standard cost sharing for such services. Finally, regarding CPT code 
99091, we are seeking available information regarding potential 
utilization assumptions we might make for the service for purposes of 
PFS ratesetting, were we to make it payable for CY 2018 or in the 
future; since making such asumptions would be necessary to implement 
separate payment. We note that since the PFS is a budget neutral 
system, any increase in payment made for particular services would 
result in decreases in payment for other services, and the degree of 
that decrease would depend, in large part, on the utilization 
assumptions.
    We are also seeking comment on other existing codes that describe 
extensive use of communications technology for

[[Page 33976]]

consideration for future rulemaking, including CPT code 99090 (Analysis 
of clinical data stored in computers (e.g., ECGs, blood pressures, 
hematologic data)). CPT code 99090 is also assigned a procedure status 
of B (bundled). However, we do not have RUC recommended values for this 
service, and therefore, currently do not assign RVUs.

E. Proposed Potentially Misvalued Services Under the Physician Fee 
Schedule

1. Background
    Section 1848(c)(2)(B) of the Act directs the Secretary to conduct a 
periodic review, not less often than every 5 years, of the RVUs 
established under the PFS. Section 1848(c)(2)(K) of the Act requires 
the Secretary to periodically identify potentially misvalued services 
using certain criteria and to review and make appropriate adjustments 
to the relative values for those services. Section 1848(c)(2)(L) to the 
Act also requires the Secretary to develop a process to validate the 
RVUs of certain potentially misvalued codes under the PFS, using the 
same criteria used to identify potentially misvalued codes, and to make 
appropriate adjustments.
    As discussed in section II.H. of this proposed rule, each year we 
develop appropriate adjustments to the RVUs taking into account 
recommendations provided by the American Medical Association/Specialty 
Society Relative Value Scale Update Committee (RUC), the Medicare 
Payment Advisory Commission (MedPAC), and others. For many years, the 
RUC has provided us with recommendations on the appropriate relative 
values for new, revised, and potentially misvalued PFS services. We 
review these recommendations on a code-by-code basis and consider these 
recommendations in conjunction with analyses of other data, such as 
claims data, to inform the decision-making process as authorized by 
law. We may also consider analyses of work time, work RVUs, or direct 
PE inputs using other data sources, such as Department of Veteran 
Affairs (VA), National Surgical Quality Improvement Program (NSQIP), 
the Society for Thoracic Surgeons (STS), and the Physician Quality 
Reporting System (PQRS) databases. In addition to considering the most 
recently available data, we assess the results of physician surveys and 
specialty recommendations submitted to us by the RUC for our review. We 
also consider information provided by other stakeholders. We conduct a 
review to assess the appropriate RVUs in the context of contemporary 
medical practice. We note that section 1848(c)(2)(A)(ii) of the Act 
authorizes the use of extrapolation and other techniques to determine 
the RVUs for physicians' services for which specific data are not 
available and requires us to take into account the results of 
consultations with organizations representing physicians who provide 
the services. In accordance with section 1848(c) of the Act, we 
determine and make appropriate adjustments to the RVUs.
    In its March 2006 Report to the Congress (http://www.medpac.gov/documents/reports/Mar06_EntireReport.pdf?sfvrsn=0), MedPAC discussed 
the importance of appropriately valuing physicians' services, noting 
that misvalued services can distort the market for physicians' 
services, as well as for other health care services that physicians 
order, such as hospital services. In that same report MedPAC postulated 
that physicians' services under the PFS can become misvalued over time. 
MedPAC stated, ``When a new service is added to the physician fee 
schedule, it may be assigned a relatively high 0l value because of the 
time, technical skill, and psychological stress that are often required 
to furnish that service. Over time, the work required for certain 
services would be expected to decline as physicians become more 
familiar with the service and more efficient in furnishing it.'' We 
believe services can also become overvalued when PE declines. This can 
happen when the costs of equipment and supplies fall, or when equipment 
is used more frequently than is estimated in the PE methodology, 
reducing its cost per use. Likewise, services can become undervalued 
when physician work increases or PE rises.
    As MedPAC noted in its March 2009 Report to Congress (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

[[Page 33977]]

(including using existing processes for consideration of coding 
changes) that may include consolidation of individual services into 
bundled codes for payment under the physician fee schedule.
2. Progress in Identifying and Reviewing Potentially Misvalued Codes
    To fulfill our statutory mandate, we have identified and reviewed 
numerous potentially misvalued codes as specified in section 
1848(c)(2)(K)(ii) of the Act, and we plan to continue our work 
examining potentially misvalued codes in these areas over the upcoming 
years. As part of our current process, we identify potentially 
misvalued codes for review, and request recommendations from the RUC 
and other public commenters on revised work RVUs and direct PE inputs 
for those codes. The RUC, through its own processes, also identifies 
potentially misvalued codes for review. Through our public nomination 
process for potentially misvalued codes established in the CY 2012 PFS 
final rule with comment period, other individuals and stakeholder 
groups submit nominations for review of potentially misvalued codes as 
well.
    Since CY 2009, as a part of the annual potentially misvalued code 
review and Five-Year Review process, we have reviewed approximately 
1,700 potentially misvalued codes to refine work RVUs and direct PE 
inputs. We have assigned appropriate work RVUs and direct PE inputs for 
these services as a result of these reviews. A more detailed discussion 
of the extensive prior reviews of potentially misvalued codes is 
included in the CY 2012 PFS final rule with comment period (76 FR 73052 
through 73055). In the CY 2012 PFS final rule with comment period (76 
FR 73055 through 73958), we finalized our policy to consolidate the 
review of physician work and PE at the same time, and established a 
process for the annual public nomination of potentially misvalued 
services.
    In the CY 2013 PFS final rule with comment period, we built upon 
the work we began in CY 2009 to review potentially misvalued codes that 
have not been reviewed since the implementation of the PFS (so-called 
``Harvard-valued codes''). In CY 2009 (73 FR 38589), we requested 
recommendations from the RUC to aid in our review of Harvard-valued 
codes that had not yet been reviewed, focusing first on high-volume, 
low intensity codes. In the fourth Five-Year Review (76 FR 32410), we 
requested recommendations from the RUC to aid in our review of Harvard-
valued codes with annual utilization of greater than 30,000. In the CY 
2013 PFS final rule with comment period, we identified specific 
Harvard-valued services with annual allowed charges that total at least 
$10,000,000 as potentially misvalued. In addition to the Harvard-valued 
codes, in the CY 2013 PFS final rule with comment period we finalized 
for review a list of potentially misvalued codes that have stand-alone 
PE (codes with physician work and no listed work time and codes with no 
physician work that have listed work time).
    In the CY 2016 PFS final rule with comment period, we finalized for 
review a list of potentially misvalued services, which included eight 
codes in the neurostimulators analysis-programming family (CPT 95970-
95982). We also finalized as potentially misvalued 103 codes identified 
through our screen of high expenditure services across specialties.
    In the CY 2017 PFS final rule, we finalized for review a list of 
potentially misvalued services, which included eight codes in the end-
stage renal disease home dialysis family (CPT codes 90963-90970). We 
also finalized as potentially misvalued 19 codes identified through our 
screen for 0-day global services that are typically billed with an 
evaluation and management (E/M) service with modifier 25.
3. CY 2018 Identification and Review of Potentially Misvalued Services
    In the CY 2012 PFS final rule with comment period (76 FR 73058), we 
finalized a process for the public to nominate potentially misvalued 
codes. The public and stakeholders may nominate potentially misvalued 
codes for review by submitting the code with supporting documentation 
by February 10 of each year. Supporting documentation for codes 
nominated for the annual review of potentially misvalued codes may 
include the following:
     Documentation in peer reviewed medical literature or other 
reliable data that there have been changes in physician work due to one 
or more of the following: technique, knowledge and technology, patient 
population, site-of-service, length of hospital stay, and work time.
     An anomalous relationship between the code being proposed 
for review and other codes.
     Evidence that technology has changed physician work.
     Analysis of other data on time and effort measures, such 
as operating room logs or national and other representative databases.
     Evidence that incorrect assumptions were made in the 
previous valuation of the service, such as a misleading vignette, 
survey, or flawed crosswalk assumptions in a previous evaluation.
     Prices for certain high cost supplies or other direct PE 
inputs that are used to determine PE RVUs are inaccurate and do not 
reflect current information.
     Analyses of work time, work RVU, or direct PE inputs using 
other data sources (for example: Department of Veteran Affairs (VA) 
National Surgical Quality Improvement Program (NSQIP), the Society for 
Thoracic Surgeons (STS) National Database, and the Physician Quality 
Reporting System (PQRS) databases).
     National surveys of work time and intensity from 
professional and management societies and organizations, such as 
hospital associations.
    We evaluate the supporting documentation submitted with the 
nominated codes and assess whether the nominated codes appear to be 
potentially misvalued codes appropriate for review under the annual 
process. In the following year's PFS proposed rule, we publish the list 
of nominated codes and indicate whether we are proposing each nominated 
code as a potentially misvalued code. The public has the opportunity to 
comment on these and all other proposed potentially misvalued codes. In 
that year's final rule, we finalize our list of potentially misvalued 
codes.
    After we issued the CY 2017 PFS final rule, we received a 
nomination and supporting documentation for one code to be considered 
as potentially misvalued. We evaluated the supporting documentation for 
this nominated code to ascertain whether the submitted information 
demonstrated that the code should be proposed as potentially misvalued.
    CPT code 27279 (Arthrodesis, sacroiliac joint, percutaneous or 
minimally invasive (indirect visualization), with image guidance, 
includes obtaining bone graft when performed, and placement of 
transfixing device) was nominated for review as a potentially misvalued 
code because the current work RVU is potentially undervalued and 
stakeholders recommend that it should be increased to 14.23. We are 
proposing this code as a potentially misvalued code. In the CY 2017 PFS 
final rule, we noted that some assertions regarding appropriate values 
for the dialysis vascular access codes newly created in CY 2017 (CPT 
codes 36901 through 36909) did not include data that would warrant 
increases to the work RVUs. However, we urged interested stakeholders 
to consider

[[Page 33978]]

submitting robust data regarding costs for these and other services (81 
FR 80294). We have continued to receive feedback from stakeholders 
regarding the work valuation of these codes. Stakeholders have 
expressed concerns regarding the typical patient for these procedures 
as reflected in the information included in the RUC recommendations for 
CY 2017 and the importance of appropriate payment for ensuring access 
to care for Medicare beneficiaries. Therefore, we are seeking 
additional comment and continuing to request robust data regarding the 
potentially misvalued work RVUs for CPT codes 36901 through 36909 and 
considering alternate work valuations for CY 2018, such as the RUC-
recommended work RVUs from CY 2017, or other potential values based on 
submission of data through the public comment process. We note that the 
RUC recommended work RVUs for these services are displayed in the CY 
2017 PFS final rule (81 FR 80290 through 80296). We have received 
conflicting information about the direct PE inputs for CPT codes 88184 
(Flow cytometry, cell surface, cytoplasmic, or nuclear marker, 
technical component only; first marker) and 88185 (Flow cytometry, cell 
surface, cytoplasmic, or nuclear marker, technical component only; each 
additional marker (List separately in addition to code for first 
marker)), and we are proposing these codes as potentially misvalued so 
that they can be reviewed again because some stakeholders have 
suggested the clinical labor and supplies that were previously 
finalized are no longer accurate.
    We have received information suggesting that the work RVUs for 
emergency department visits may not appropriately reflect the full 
resources involved in furnishing these services. Specifically, 
stakeholders have expressed concerns that the work RVUs for these 
services have been undervalued given the increased acuity of the 
patient population and the heterogeneity of the sites, such as 
freestanding and off-campus emergency departments, where emergency 
department visits are furnished. We are, therefore, seeking comment on 
whether CPT codes 99281-99385 (Emergency department visits for the 
evaluation and management of a patient) should be reviewed under the 
misvalued code initiative.
    For over a decade, CMS has collaborated with the RUC to regularly 
prioritize codes for review by using the categories specified in the 
statute or as determined appropriate. We generally have referred to 
these categories as ``misvalued code screens.'' To supplement ongoing 
RUC identification of potentially misvalued codes through established 
screens, CMS regularly uses PFS rulemaking to identify other screens 
for use in identifying potentially misvalued codes. For example, in 
recent years, CMS has prioritized the following screens:
     Codes with low work RVUs commonly billed in multiple units 
per single encounter.
     Codes with high volume and low work RVUs.
     Codes with site-of-service-anomalies.
     E/M codes.
     PFS high expenditure services.
     Services with standalone PE procedure time.
     Services with anomalous time.
     Contractor Medical Director identified potentially 
misvalued codes.
     Codes with higher total Medicare payments in office than 
in hospital or ASC.
     Publicly nominated potentially misvalued codes.
     0-day global services that are typically billed with an 
evaluation and management (E/M) service with modifier 25.
    Although we are not proposing a new screen for CY 2018, we continue 
to believe that it is important to prioritize codes for review under 
the misvalued code initiative. As a result, we are seeking public 
comment on the best approach for developing screens, as well as what 
particular new screens we might consider. We will consider these 
comments for future rulemaking.

F. Payment Incentive for the Transition From Traditional X-Ray Imaging 
to Digital Radiography and Other Imaging Services

    Section 502(a)(1) of Division O, Title V of the Consolidated 
Appropriations Act of 2016 (Pub. L. 114-113) amended section 1848(b) of 
the Act by establishing a new paragraph (9) of subsection (b). Section 
1848(b)(9)(B) of the Act provides for a 7 percent reduction in payments 
for the technical component (TC) for imaging services made under the 
PFS that are X-rays (including the technical component portion of a 
global service) taken using computed radiography technology furnished 
during CYs 2018, 2019, 2020, 2021, or 2022, and for a 10 percent 
reduction for the technical component of such imaging services 
furnished during CY 2023 or a subsequent year. Computed radiography 
technology is defined for purposes of this paragraph as cassette-based 
imaging that utilizes an imaging plate to create the image involved. 
Section 1848(b)(9) of the Act also requires implementation of the 
reduction in payments through appropriate mechanisms, which can include 
the use of modifiers. In accordance with section 1848(c)(2)(B)(v)(X) of 
the Act, the adjustments under section 1848(b)(9)(A) of the Act are 
exempt from the budget neutrality requirement.
    We stated in the CY 2017 PFS proposed rule that because the 
required reductions in PFS payment for the TC of imaging services 
(including the TC portion of a global service) that are X-rays taken 
using computed radiography technology did not apply for CY 2017, we 
would address implementation of section 1848(b)(9)(B) of the Act in 
future rulemaking. Therefore, to implement the provisions of section 
1848(b)(9)(B) of the Act relating to the payment reduction for the TC 
(including the TC portion of a global service) of X-rays taken using 
computed radiography technology during CY 2018 or subsequent years, we 
are proposing to establish a new modifier to be used on claims for 
these services.
    We are proposing that beginning January 1, 2018, this modifier 
would be required to be used when reporting imaging services for which 
payment is made under the PFS that are X-rays (including the X-ray 
component of a packaged service) taken using computed radiography 
technology. The modifier would be required on claims for the technical 
component of the X-ray service, including when the service is billed 
globally because the PFS payment adjustment is made to the technical 
component regardless of whether it is billed globally, or billed 
separately using the TC modifier. The modifier must be used to report 
the specific services that are subject to the payment reduction and 
accurate use is subject to audit. The use of this proposed modifier to 
indicate an X-ray taken using computed radiography would result in a 7 
percent reduction for CYs 2018 through 2022 and a 10 percent reduction 
for CY 2023 or a subsequent calendar year to the payments for the TC 
for such imaging services furnished as specified under section 
1848(b)(9)(B) of the Act.

G. Proposed Payment Rates Under the Medicare Physician Fee Schedule for 
Nonexcepted Items and Services Furnished by Nonexcepted Off-Campus 
Provider-Based Departments of a Hospital

1. Background
    Sections 1833(t)(1)(B)(v) and (t)(21) of the Act require that 
certain items and services furnished by certain off-campus

[[Page 33979]]

provider-based departments (PBDs) (collectively referenced here as 
nonexcepted items and services furnished by nonexcepted off-campus 
PBDs) shall not be considered covered OPD services for purposes of 
payment under the OPPS, and payment for those nonexcepted items and 
services furnished on or after January 1, 2017 shall be made under the 
applicable payment system. In the CY 2017 OPPS/ASC final rule with 
comment period (81 FR 79713), we finalized the PFS as the ``applicable 
payment system'' for most nonexcepted items and services furnished by 
off-campus PBDs.
    As part of that discussion, we indicated that, in response to 
public comments received on the proposed payment policies for 
nonexcepted items and services, we would issue an interim final rule 
with comment period (the CY 2017 interim final rule, 81 FR 79720 
through 79729) to establish payment policies under the PFS for 
nonexcepted items and services furnished on or after January 1, 2017. 
In the following paragraphs, we propose the payment policies under the 
PFS for nonexcepted items and services furnished during CY 2018. The CY 
2017 interim final rule can be found on the Internet at https://www.gpo.gov/fdsys/pkg/FR-2016-11-14/pdf/2016-26515.pdf. We anticipate 
responding to public comments and finalizing the CY 2017 interim final 
rule in future PFS rulemaking.
2. Payment Mechanism
    Coding and payment policies under the PFS have long recognized the 
differences between the portions of services for which direct costs 
generally are incurred by practitioners and the portions of services 
for which direct costs generally are incurred by facilities. At 
present, the coding and RVUs established for particular groups of 
services under the PFS generally reflect such direct cost differences. 
As described in section II.B of this proposed rule, we establish 
separate nonfacility and facility RVUs for many HCPCS codes describing 
particular services paid under the PFS. For many other services, we 
establish separate RVUs for the professional component and the 
technical component of the service described by the same HCPCS code. 
For other services, we establish RVUs for the different HCPCS codes 
that segregate and describe the discrete professional and technical 
aspects of particular services.
    Because hospitals with nonexcepted off-campus PBDs that furnish 
nonexcepted items and services are likely to furnish a broader range of 
services than other provider or supplier types for which there is a 
separately valued technical component under the PFS, for CY 2017, we 
established a new set of payment rates under the PFS that reflected the 
relative resource costs of furnishing the technical component of a 
broad range of services to be paid under the PFS specific to the off-
campus PBD of a hospital with packaging (bundling) rules that are 
unique to the hospital outpatient setting under the OPPS.
    In principle, the coding and billing mechanisms required to make 
appropriate payment to hospitals for nonexcepted items and services 
furnished by nonexcepted off-campus PBDs are parallel to those used to 
make payment for the technical component services for a range of 
supplier types paid under the PFS. That is, payments to hospitals are 
made for the technical aspect of services, while physicians and other 
practitioners report the professional aspect of these same services. In 
some cases, the entities reporting the technical aspect of services use 
the same coding that is used by the individuals reporting the 
professional services. In other cases, different coding applies. We are 
proposing to maintain this mechanism for CY 2018.
3. Establishment of Payment Rates
    Using the relativity among OPPS payments to establish rates for the 
nonexcepted items and services furnished by nonexcepted off-campus PBDs 
and billed by hospitals under the PFS was only one aspect of 
establishing the necessary relativity of these services under the PFS 
more broadly. It was necessary to estimate the relativity of these 
services compared to PFS services furnished in other settings. For CY 
2017, we used our best estimate of the more general relativity between 
the technical component of PFS services furnished in nonexcepted off-
campus PBDs and all other PFS services furnished in other settings 
using the limited information available to us at that time. As 
described in the CY 2017 interim final rule (81 FR 79722 through 
79726), we estimated that for CY 2017, scaling the OPPS payment rates 
by 50 percent would strike an appropriate balance that avoided 
potentially underestimating the relative resources involved in 
furnishing services in nonexcepted off-campus PBDs as compared to the 
services furnished in other settings for which payment was made under 
the PFS. Specifically, we established site-specific rates under the PFS 
for the technical component of the broad range of nonexcepted items and 
services furnished by nonexcepted off-campus PBDs to be paid under the 
PFS that was based on the OPPS payment amount for the same items and 
services, scaled downward by 50 percent. We called this adjustment the 
``PFS Relativity Adjuster.'' The PFS Relativity Adjuster refers to the 
percentage of the OPPS payment amount paid under the PFS for a 
nonexcepted item or service to the non-excepted off-campus PBD under 
this policy.
a. Methodology for Establishing CY 2017 PFS Relativity Adjuster
    In developing the CY 2017 interim final rule, we began by analyzing 
hospital outpatient claims data from January 1 through August 26, 2016, 
that contained the ``PO'' modifier signifying that they were billed by 
an off-campus department of a hospital paid under the OPPS other than a 
remote location, a satellite facility, or a dedicated emergency 
department (ED). We noted that the use of the ``PO'' modifier was a new 
mandatory reporting requirement for CY 2016. We limited our analysis to 
those claims billed on the 13X Type of Bill because those claims were 
used for Medicare Part B billing under the OPPS. We then identified the 
top (most frequently billed) 25 major codes that were billed by claim 
line; that is, items and services that were separately payable or 
conditionally packaged. Specifically, we restricted our analysis to 
codes with OPPS status indicators ``J1'', ``J2'', ``Q1'', ``Q2'', 
``Q3'', ``S'', ``T'', or ``V''. We did not include separately payable 
drugs or biologicals in this analysis because those drugs or 
biologicals were not paid under the PFS under the CY 2017 interim final 
rule. As such, under the CY 2017 interim final rule, the PFS Relativity 
Adjuster did not apply to separately payable drugs and biologicals 
furnished by a nonexcepted PBD. Similarly, we excluded codes assigned 
an OPPS status indicator ``A'' because the services described by those 
codes were already paid at a rate under a fee schedule other than the 
OPPS and payment for those nonexcepted items and services was not 
changed by the rates established under the CY 2017 interim final rule. 
Next, for the same major codes (or analogous codes in the rare instance 
that different coding applies under the OPPS than the PFS), we compared 
the CY 2016 payment rate under the OPPS to a CY 2016 payment rate under 
the PFS attributable to the nonprofessional relative resource costs 
involved in furnishing the services.
    The most frequently billed service with the ``PO'' modifier was 
described by HCPCS code G0463 (Hospital outpatient clinic visit for 
assessment and management of a patient), which is paid under APC 5012; 
the total number

[[Page 33980]]

of CY 2016 claim lines for that service was approximately 6.7 million 
as of August 2016. In CY 2016, the OPPS payment rate for APC 5012 was 
$102.12. Because there were multiple CPT codes (CPT codes 99201 through 
99215) used under the PFS for billing that service, an exact comparison 
between the $102.12 OPPS payment rate for APC 5012 and the payment rate 
for a single CPT code billed under the PFS was not possible. However, 
for purposes of the analysis, we examined the difference between the 
nonfacility payment rates and the facility payment rates under the PFS 
for CPT codes 99213 and 99214, which were the billing codes for a Level 
III and a Level IV office visit. While we did not have data to 
precisely determine the equivalent set of PFS visit codes to use for 
the comparison, we believed that, based on the distribution of services 
billed for the visit codes under the PFS and the distribution of the 
visit codes under the OPPS from the last time period the CPT codes were 
used under the OPPS in CY 2014, those two codes provided reliable 
points of comparison. For CPT code 99213, the difference between the 
nonfacility payment rate and the facility payment rate under the PFS in 
CY 2016 was $21.86, which was 21 percent of the OPPS payment rate for 
APC 5012 of $102.12. For CPT code 99214, the difference between the 
nonfacility payment rate and the facility payment rate under the PFS in 
CY 2016 was $29.02, which was 28 percent of the OPPS payment rate for 
APC 5012. However, we recognized that, due to the more extensive 
packaging that occurred under the OPPS for services provided along with 
clinic visits relative to the more limited packaging that occurred 
under the PFS for office visits, those payment rates were not entirely 
comparable.
    We then assessed the next 24 major codes most frequently billed on 
the 13X claim form by hospitals. We removed HCPCS code 36591 
(Collection of blood specimen from a completely implantable venous 
access device) because, under current PFS policies, the code is used 
only to pay separately under the PFS when no other service was on the 
claim. We also removed HCPCS code G0009 (Administration of Pneumococcal 
Vaccine) because there was no payment for the code under the PFS. For 
the remaining 22 major codes most frequently billed, we estimated the 
amount that would have been paid to the physician in the office setting 
under the PFS for practice expenses not associated with the 
professional component of the service. As indicated in Table 9, this 
amount reflected (1) the difference between the PFS nonfacility payment 
rate and the PFS facility rate, (2) the technical component, or (3) in 
instances where payment would have been made only to the facility or 
only to the physician, the full nonfacility rate. This estimate ranged 
from zero percent to 137.8 percent of the OPPS payment rate for a code. 
Overall, the average (weighted by claim line volume times rate) of the 
nonfacility payment rate estimate for the PFS compared to the estimate 
for the OPPS for the 22 remaining major codes was 45 percent.

Table 9--Comparison of CY 2016 OPPS Payment Rate to CY 2016 PFS Payment Rate for Top Hospital Codes Billed Using
                                               the ``PO'' Modifier
----------------------------------------------------------------------------------------------------------------
                                                                    CY 2016
                                                                applicable PFS   Col (5) as a
 HCPCS code   Code description    Total claim    CY 2016 OPPS      technical      percent of      PFS estimate
                                     lines       payment rate   payment amount       OPPS
                                                                    estimate
(1)           (2).............             (3)             (4)             (5)                  (6)
----------------------------------------------------------------------------------------------------------------
96372.......  Injection                338,444          $42.31          $25.42            60.1  Single rate paid
               beneath the                                                                       exclusively to
               skin or into                                                                      either
               muscle for                                                                        practitioner or
               therapy,                                                                          facility: Full
               diagnosis, or                                                                     nonfacility
               prevention.                                                                       rate.
71020.......  X-ray of chest,          333,203           60.80           16.83            27.7  Technical
               2 views, front                                                                    component: Full
               and side.                                                                         nonfacility
                                                                                                 rate.
93005.......  Routine                  318,099           55.94            8.59            15.4  Technical
               electrocardiogr                                                                   component: Full
               am (EKG) with                                                                     nonfacility
               tracing using                                                                     rate.
               at least 12
               leads.
96413.......  Infusion of              254,704          280.27          136.41            48.7  Single rate paid
               chemotherapy                                                                      exclusively to
               into a vein up                                                                    either
               to 1 hour.                                                                        practitioner or
                                                                                                 facility: Full
                                                                                                 nonfacility
                                                                                                 rate.
93798.......  Physician                203,926          103.92           11.10            10.7  Nonfacility
               services for                                                                      rate--Facility
               outpatient                                                                        rate.
               heart
               rehabilitation
               with continuous
               EKG monitoring
               per session.
96375.......  Injection of             189,140           42.31           22.56            53.3  Single rate paid
               different drug                                                                    exclusively to
               or substance                                                                      either
               into a vein for                                                                   practitioner or
               therapy,                                                                          facility: Full
               diagnosis, or                                                                     nonfacility
               prevention.                                                                       rate.
93306.......  Ultrasound               179,840          416.80          165.77            39.8  Technical
               examination of                                                                    component: Full
               heart including                                                                   nonfacility
               color-depicted                                                                    rate.
               blood flow
               rate,
               direction, and
               valve function.
77080.......  Bone density             155,513          100.69           31.15            30.9  Technical
               measurement                                                                       component: Full
               using dedicated                                                                   nonfacility
               X-ray machine.                                                                    rate.
77412.......  Radiation                137,241          194.35          267.86           137.8  Technical
               treatment                                                                         component (Full
               delivery.                                                                         nonfacility
                                                                                                 rate) based on
                                                                                                 weighted
                                                                                                 averages for
                                                                                                 the following
                                                                                                 PFS codes:
                                                                                                 G6011; G6012;
                                                                                                 G6013; and
                                                                                                 G6014.

[[Page 33981]]

 
90853.......  Group                    123,282           69.65            0.36             0.5  Nonfacility
               psychotherapy.                                                                    rate--Facility
                                                                                                 rate.
96365.......  Infusion into a          122,641          173.18           69.82            40.3  Nonfacility
               vein for                                                                          rate--Facility
               therapy,                                                                          rate.
               prevention, or
               diagnosis up to
               1 hour.
20610.......  Aspiration and/          106,769          223.76           13.96             6.2  Nonfacility
               or injection of                                                                   rate--Facility
               large joint or                                                                    rate.
               joint capsule.
11042.......  Removal of skin           99,134          225.55           54.78            24.3  Nonfacility
               and tissue                                                                        rate--Facility
               first 20 sq cm                                                                    rate.
               or less.
96367.......  Infusion into a           98,930           42.31           30.79            72.8  Single rate paid
               vein for                                                                          exclusively to
               therapy                                                                           either
               prevention or                                                                     practitioner or
               diagnosis                                                                         facility: Full
               additional                                                                        nonfacility
               sequential                                                                        rate.
               infusion up to
               1 hour.
93017.......  Exercise or drug-         96,312          220.35           39.74            18.0  Technical
               induced heart                                                                     component: Full
               and blood                                                                         nonfacility
               vessel stress                                                                     rate.
               test with EKG
               tracing and
               monitoring.
77386.......  Radiation                 81,925          505.51          347.30            68.7  Technical
               therapy                                                                           component:
               delivery.                                                                         Nonfacility
                                                                                                 rate for CPT
                                                                                                 code G6015
                                                                                                 (analogous code
                                                                                                 used under the
                                                                                                 PFS).
78452.......  Nuclear medicine          79,242        1,108.46          412.82            37.2  Technical
               study of                                                                          component: Full
               vessels of                                                                        nonfacility
               heart using                                                                       rate.
               drugs or
               exercise
               multiple
               studies.
74177.......  CT scan of                76,393          347.72          220.20            63.3  Technical
               abdomen and                                                                       component: Full
               pelvis with                                                                       nonfacility
               contrast.                                                                         rate.
71260.......  CT scan chest             75,052          236.86          167.21            70.6  Technical
               with contrast.                                                                    component: Full
                                                                                                 nonfacility
                                                                                                 rate.
71250.......  CT scan chest...          74,570          112.49          129.61           115.2  Technical
                                                                                                 component: Full
                                                                                                 nonfacility
                                                                                                 rate.
73030.......  X-ray of                  71,330           60.80           19.33            31.8  Technical
               shoulder,                                                                         component: Full
               minimum of 2                                                                      nonfacility
               views.                                                                            rate.
90834.......  Psychotherapy,            70,524          125.04            0.36             0.3  Nonfacility
               45 minutes with                                                                   rate--Facility
               patient and/or                                                                    rate.
               family member.
----------------------------------------------------------------------------------------------------------------
Weighted Average (claim line volume*rate) of the PFS payment compared to OPPS payment for the   45%
 22 major codes:
----------------------------------------------------------------------------------------------------------------

    As noted with the clinic visits, we recognized that there were 
limitations to our data analysis, including that OPPS payment rates 
include the costs of packaged items or services billed with the 
separately payable code, and therefore the comparison to rates under 
the PFS was not a one-to-one comparison. Also, we included only a 
limited number of services, and noted that additional services may have 
different patterns than the services described. After considering the 
payment differentials for major codes billed by off-campus departments 
of hospitals with the ``PO'' modifier and based on the data limitations 
of our analysis, we adopted, with some exceptions noted below, a set of 
PFS payment rates that were based on a 50-percent PFS Relativity 
Adjuster to the OPPS payment rates (inclusive of packaging) for 
nonexcepted items and services furnished by nonexcepted off-campus PBDs 
in the CY 2017 interim final rule. Generally speaking, we arrived at 
the 50 percent PFS Relativity Adjuster by examining the 45-percent 
comparison noted above, the ASC payment rate--which was roughly 55 
percent of the OPPS payment rate on average--and the payment rate 
differential for the large number of OPPS and PFS evaluation and 
management services, as described above. We recognized that the 
equivalent PFS nonfacility rates may be higher or lower on a code-
specific basis than the rates that result from applying the overall PFS 
Relativity Adjuster to the OPPS payment rates on a code specific basis. 
However, we believed that, on the whole, the percentage reduction did 
not underestimate the overall relativity between the OPPS and the PFS 
based on the limited data that was available. We were concerned, 
however, that the 50 percent PFS Relativity Adjuster might overestimate 
PFS nonfacility payments relative to OPPS payments. For example, if we 
were able at the time to sufficiently estimate the effect of the 
packaging differences between the OPPS and PFS, we suspected that the 
equivalent portion of PFS payments for evaluation and management codes, 
and for PFS services on average, would likely have been less than 50 
percent for the same services. We considered the 50 percent PFS 
Relativity Adjuster for CY 2017 to be a transitional policy until such 
time that we had more precise data to better

[[Page 33982]]

identify and value nonexcepted items and services furnished by 
nonexcepted off-campus PBDs and billed by hospitals.
    We established several significant exceptions to the application of 
the 50 percent PFS Relativity Adjuster. For example, we did not apply 
the 50 percent PFS Relativity Adjuster to services that are currently 
paid under the OPPS based on payment rates from other Medicare fee 
schedules (including the PFS) on an institutional claim. The items and 
services that are assigned status indicator ``A'' in Addendum B to the 
CY 2017 OPPS/ASC final rule with comment period (available on the CMS 
Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices-Items/CMS-1656-FC.html) continue to be reported on an 
institutional claim and paid under the PFS, the CLFS, or the Ambulance 
Fee Schedule (ASC) without a payment reduction. Similarly, drugs and 
biologicals that are separately payable under the OPPS (identified by 
status indicator ``G'' or ``K'' in Addendum B to the CY 2017 OPPS/ASC 
final rule with comment period) are paid in accordance with section 
1847A of the Act (that is, typically ASP + 6 percent), consistent with 
payment rules in the physician office setting. Drugs and biologicals 
that are unconditionally packaged under the OPPS and are not separately 
payable (that is, those drugs and biologicals assigned status indicator 
of ``N'' in Addendum B to the CY 2017 OPPS/ASC final rule with comment 
period) are bundled into the PFS payment and are not separately paid to 
hospitals billing for nonexcepted items and services furnished by 
nonexcepted off-campus PBDs. The full range of exceptions and 
adjustments to the otherwise applicable OPPS payment rate that were 
adopted in the new PFS site-of-service payment rates in the CY 2017 
interim final rule can be found on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Downloads/CMS-1656-FC-2017-OPPS-Status-Indicator.zip.
    All nonexcepted items and services furnished by nonexcepted off-
campus PBDs and billed by a hospital on an institutional claim with 
modifier ``PN'' (Nonexcepted service provided at an off-campus, 
outpatient, provider-based department of a hospital) are currently paid 
under the PFS at the rate established in the CY 2017 interim final 
rule. Specifically, nonexcepted off campus PBDs must report modifier 
``PN'' on each UB-04 claim line to indicate a nonexcepted item or 
service, and otherwise continue to bill as they currently do. Further 
billing instructions on the PN modifier can be found in the January 
2017 OPPS Quarterly Update (transmittal 3685, Change Request 9930) 
released December 22, 2016, available on the CMS Web site at https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/Downloads/R3685CP.pdf.
b. PFS Relativity Adjuster
    As noted in the CY 2017 interim final rule, we considered the CY 
2017 50 percent PFS Relativity Adjuster to be a transitional policy 
until such time that we had more precise data to better identify and 
value nonexcepted items and services furnished by nonexcepted off-
campus PBDs and billed by hospitals. At present, we do not have more 
precise data than were available when we established the PFS Relativity 
Adjuster in the CY 2017 interim final rule, and we do not anticipate 
having such data until after the end of CY 2017, at the earliest. 
However, in developing a proposed policy for CY 2018, we have continued 
to explore options for modifying the calculation of the CY 2018 PFS 
Relativity Adjuster.
    There is no consensus among stakeholders regarding the appropriate 
PFS Relativity Adjuster. Many stakeholders have suggested that making 
separate facility fee payments to hospitals under the PFS for all 
services that are separately paid under the OPPS itself undermines 
site-neutral payment because practitioners are only paid a single 
combined fee for many services when furnished in an office setting, 
while there are two separate fees (professional and facility) paid when 
the service is furnished in the hospital setting. We acknowledge that 
there are many cases where single fees are paid to practitioners for 
services furnished in an office setting while fees for comparable 
services when furnished in the hospital setting are paid to both the 
professional and facility entities. However, we do not agree that this 
necessarily means that overall payment cannot be site neutral. We point 
out that the sum of the professional and the facility portions of 
payment for a service furnished in a nonexcepted off-campus PBD or in a 
different institutional setting could be equivalent to a single fee 
paid to the professional in the office setting. In the case of some 
services, in fact, the single payment made under the PFS at the 
nonfacility rate exceeds the sum of the separate payments Medicare 
makes to the professional at the facility rate under the PFS and to the 
facility under the OPPS. We also note that there are many separately 
reportable services under the PFS (for example, the vast majority of 
services described by add-on codes) for which separate payment is made 
to physician offices but no separate payment is made under either the 
OPPS or under the site-specific PFS payments made to hospitals billing 
for nonexcepted items and services furnished by nonexcepted off-campus 
PBDs. For these reasons, we believe that the overall total payment made 
for services is more relevant to the goal of site neutrality than the 
quantity of individual payments made. Nonetheless, we continue to 
recognize and share stakeholders' concerns regarding the importance of 
equivalent overall payment for services, regardless of setting.
    In considering the appropriate PFS Relativity Adjuster for CY 2018, 
we continue to believe that claims data from CY 2017, which are not yet 
available, are needed to guide potential changes to our general 
approach. In the absence of such data, however, we have continued to 
consider the appropriate PFS Relativity Adjuster based on the 
information that is available. In the analysis we used to establish the 
PFS Relativity Adjuster for CY 2017, we attempted to identify the 
appropriate value by comparing OPPS and PFS payment rates for services 
frequently reported in PBDs and described by the same codes under the 
two payment systems. As we acknowledged in the CY 2017 interim final 
rule, that data analysis did not include the most frequently billed 
service furnished in nonexcepted off-campus hospital PBDs, outpatient 
visits. Outpatient visits are reported using a single code under the 
OPPS and by one of ten different codes under the PFS.
    Consistent with our previously stated concern that the PFS 
Relativity Adjuster for CY 2017 might be too small, generally resulting 
in greater overall payments to hospitals for services furnished by 
nonexcepted off-campus PBDs than would otherwise be paid under the PFS 
in the non-facility setting, we believe it is appropriate to propose 
changing the PFS Relativity Adjuster in order to ensure that payment 
made to these nonexcepted PBDs better aligns with these services that 
are the most frequently furnished in this setting.
    For CY 2018, we propose to revise the PFS Relativity Adjuster for 
nonexcepted items and services furnished by nonexcepted off-campus PBDs 
to be 25 percent of the OPPS payment rate. We arrived at this proposed 
PFS Relativity Adjuster by making a code-level comparison for the 
service most

[[Page 33983]]

commonly billed in the off-campus PBD setting under the OPPS: A clinic 
visit reported using HCPCS code G0463. In order to determine the 
analogous payment for the technical aspects of this service under the 
PFS in nonfacility settings, we compared the CY 2017 OPPS national 
payment rate for HCPCS code G0463 ($102.12) to the difference between 
the nonfacility and facility PFS payment amounts under the PFS using CY 
2017 rates for the weighted average of outpatient visits (CPT codes 
99201-99205 and CPT codes 99211-99215) billed by physicians and other 
professionals in an outpatient hospital place of service.
    This proposed 25 percent PFS Relativity Adjuster is based solely on 
the comparison for the visit services that reflect greater than 50 
percent of services billed in off-campus PBDs. We continue to recognize 
that the comparison between the OPPS and PFS rates for other services 
varies greatly, and that there are other factors, including the 
specific mix of services furnished by non-excepted PBDs, policies 
related to packaging of codes under OPPS, and payment adjustments like 
MPPRs and bundling under the PFS that rely on empirical information 
about whether or not codes are billed on the same day, that contribute 
to the differences in aggregate payment amounts for a broader range of 
services. However, for CY 2018, as for CY 2017, we must set the PFS 
Relativity Adjuster prior to studying the CY 2017 claims data that 
might allow us to consider and incorporate many more factors, including 
the ones stated above. When we established the 50 percent PFS 
Relativity Adjuster for CY 2017, we stated that we did so with the goal 
of ensuring adequate payment but remained concerned that the resulting 
reduction was too small. For CY 2018, we are focused on ensuring that 
we do not overestimate the appropriate overall payments for these 
services. Until we are able to study claims data, we believe that the 
comparison between PFS and OPPS payment for the most common services 
furnished in off-campus PBDs, outpatient visits, is a better proxy than 
our previous approach.
    We welcome stakeholder input with regard to this analysis and the 
resulting rate. We also request comment on whether we should adopt a 
different PFS Relativity Adjuster, such as 40 percent, that represents 
a relative middle ground between the CY 2017 PFS Relativity Adjuster, 
selected to ensure adequate payment to hospitals and our proposed CY 
2018 PFS Relativity Adjuster, selected to ensure that hospitals are not 
paid more than others would be paid through the PFS nonfacility rate. 
We intend to continue to study this issue and welcome comments 
regarding potential future refinements to payment rates for non-
excepted items and services furnished by non-excepted off-campus PBDs 
as we gain more experience with these new site-of-service PFS rates.
    Finally, we note that for CY 2018, as in recent years, the proposed 
annual update to OPPS payments exceeds the proposed annual update to 
PFS payments. Because we are proposing to make a single, across-the-
board and, by necessity, imprecise adjustment to OPPS payment rates to 
establish PFS payment rates for nonexcepted items and services 
furnished by nonexcepted off-campus PBDs, we expect that the actual 
difference between OPPS and PFS payment rates for nonexcepted items and 
services furnished by nonexcepted off-campus PBDs falls in a range 
which includes our proposed PFS Relativity Adjuster (that is, the 
actual differential may differ from our proposed PFS Relativity 
Adjuster). As such, taking into account the differential between the 
OPPS and PFS annual updates by making an adjustment to the PFS 
Relativity Adjuster our proposal for CY 2018 would presume a level of 
precision in our estimates that is simply not present in our analysis. 
Therefore, we will not adjust our proposal to reflect the relative 
updates to PFS and OPPS between CY 2017 and CY 2018, and instead note 
that the differential between the OPPS and PFS payment update for CY 
2018 is a factor that suggests that the proposed PFS Relativity 
Adjuster may overestimate PFS nonfacility payment relative to OPPS 
payments; in future years, we intend to more precisely account for any 
differential between these two update factors.
c. Geographic Adjustments
    For CY 2017, we established class-specific geographic practice cost 
indices (GPCIs) under the PFS exclusively used to adjust these site-
specific, technical component rates for nonexcepted items and services 
furnished in nonexcepted off-campus PBDs. These class-specific GPCIs 
are parallel to the geographic adjustments made under the OPPS based on 
the hospital wage index. We believed it was appropriate to adopt the 
hospital wage index areas for purposes of geographic adjustment because 
non-excepted off-campus PBDs are still considered to be part of a 
hospital, and the PFS payments to these entities will be limited to the 
subset of PFS services furnished by hospitals. We also believed it was 
appropriate, as an initial matter for CY 2017, to adopt the actual wage 
index values for these hospitals in addition to the wage index areas. 
The PFS GPCIs that would otherwise currently apply are not based on the 
hospital wage index areas. For CY 2018, we are proposing to continue 
using the authority under section 1848(e)(1)(B) of the Act to maintain 
a class-specific set of GPCIs for these site-specific technical 
component rates that are based both on the hospital wage index areas 
and the hospital wage index value themselves. For purposes of payment 
to hospitals, this means that the geographic adjustments used under the 
OPPS continue to apply.
d. Coding Consistency
    For most services, the same HCPCS codes are used to describe 
services paid under both the PFS and the OPPS. There are two notable 
exceptions that describe high-volume services. The first is the set of 
codes that describe evaluation and management (E/M) services which are 
reported under the PFS using the 5 levels of CPT codes describing new 
or established patient visits (for a total of 10 codes). However, since 
CY 2014, these visits have been reported under the OPPS using the 
single HCPCS code G0463 (Hospital Outpatient Clinic Visit) (see 78 FR 
75042). We are proposing to maintain the current PFS payment rate for 
HCPCS code G0463 based on the OPPS payment rate modified by the PFS 
Relativity Adjuster.
    The second is a set of radiation treatment delivery and imaging 
guidance services that are reported using different codes under the PFS 
and the OPPS. CMS established HCPCS Level II G codes to describe 
radiation treatment delivery services when furnished in the physician 
office setting (see 79 FR 67666 through 67667). However, these HCPCS G 
codes are not recognized under the OPPS; rather, CPT codes are used to 
describe these services when furnished in the HOPD. Both sets of codes 
were implemented for CY 2015 and were maintained for CY 2016. Under the 
PFS, there is a particular statutory provision under section 
1848(c)(2)(K) of the Act that required maintenance of the CY 2016 
coding and payment inputs for these services for CY 2017 and also for 
CY 2018. Accordingly, the proposed CY 2018 PFS rates for these services 
are calculated based on the maintenance of the CY 2016 coding and 
payment inputs. Because non-excepted items and services furnished by a 
nonexcepted off-campus PBD are paid under the PFS, and we are required 
to maintain the CY 2016 coding and payment inputs for these services 
under

[[Page 33984]]

the CY 2018 PFS, we are proposing to maintain payment amounts for 
nonexcepted items and services furnished by a nonexcepted off-campus 
PBD consistent with the payments that would be made to other facilities 
under the PFS. That is, nonexcepted off-campus PBDs submitting claims 
for these nonexcepted items and services will continue to bill the 
HCPCS G codes established under the PFS to describe radiation treatment 
delivery services. Under this proposal, the nonexcepted off-campus PBD 
must append modifier PN to each applicable claim line for these 
nonexcepted items and services, even though the PFS Relativity Adjuster 
will not apply. The payment amount for these services would be set to 
reflect the technical component rate for the code under the PFS.
4. OPPS Payment Adjustments
    In the CY 2017 interim final rule, we adopted the packaging payment 
rates and multiple procedure payment reduction (MPPR) percentage that 
applied under the OPPS to establish the PFS payment rates for 
nonexcepted items and services furnished by nonexcepted off-campus PBDs 
and billed by hospitals. That is, the claims processing logic that was 
used for payments under the OPPS for comprehensive APCs (C-APCs), 
conditionally and unconditionally packaged items and services, and 
major procedures, was incorporated into the newly established PFS 
rates. We continue to believe it is necessary to incorporate the OPPS 
payment policies for C-APCs, packaged items and services, and the MPPR 
in order to maintain the integrity of the PFS Relativity Adjuster 
because the adjuster is intended in part to account for the 
methodological differences between the OPPS and the PFS rates that 
would otherwise apply. We also direct interested stakeholders to 
related proposed policies under the OPPS, since prospective changes in 
the applicable adjustments and policies would generally apply to non-
excepted items and services furnished by nonexcepted off-campus PBDs 
for CY 2018. We are interested in comments regarding the applicability 
of particular prospective OPPS adjustments to non-excepted items and 
services.
    In order to apply these OPPS payment policies and adjustments to 
non-excepted items and services, we propose that hospitals continue to 
bill on an institutional claim form that will pass through the 
Outpatient Code Editor and into the OPPS PRICER for calculation of 
payment. This approach will yield data based on claims for non-excepted 
items and services furnished by nonexcepted off-campus PBDs, which can 
be used to refine PFS payment rates for these services in future years.
    There were several OPPS payment adjustments that we did not adopt 
in the CY 2017 interim final rule, including, but not limited to, 
outlier payments, the rural sole community hospital (SCH) adjustment, 
the cancer hospital adjustments, transitional outpatient payments, the 
hospital outpatient quality reporting payment adjustment, and the 
inpatient hospital deductible cap to the cost-sharing liability for a 
single hospital outpatient service. We believed these payment 
adjustments were expressly authorized for, and should be limited to, 
hospitals that are paid under the OPPS for covered OPD services in 
accordance with section 1833(t) of the Act. We continue to believe that 
these policies should not apply to non-excepted items and services 
furnished by nonexcepted off-campus PBDs, and are not proposing that 
they apply for CY 2018.
5. Partial Hospitalization Services
    With respect to partial hospitalization programs (PHP) (intensive 
outpatient psychiatric day treatment programs furnished to patients as 
an alternative to inpatient psychiatric hospitalization or as a 
stepdown to shorten an inpatient stay and transition a patient to a 
less intensive level of care), section 1861(ff)(3)(A) of the Act 
specifies that a PHP is a program furnished by a hospital, to its 
outpatients, or by a CMHC. In the CY 2017 OPPS/ASC proposed rule (81 FR 
45690), in the discussion of the proposed implementation of section 603 
of Public Law 114-74, we noted that because CMHCs also furnish PHP 
services and are ineligible to be provider-based to a hospital, a 
nonexcepted off-campus PBD would be eligible for PHP payment if the 
entity enrolls and bills as a CMHC for payment under the OPPS. We 
further noted that a hospital may choose to enroll a nonexcepted off-
campus PBD as a CMHC, provided it meets all Medicare requirements and 
conditions of participation.
    Commenters expressed concern that without a clear payment mechanism 
for PHP services furnished by nonexcepted off-campus PBDs, access to 
partial hospitalization services would be limited, and pointed out the 
critical role PHPs play in the continuum of mental health care. Many 
commenters believed that Congress did not intend for partial 
hospitalization services to no longer be paid for by Medicare when such 
services are furnished by nonexcepted off-campus PBDs. Several 
commenters disagreed with the notion of enrolling as a CMHC in order to 
receive payment for PHP services. These commenters stated that 
hospital-based PHPs and CMHCs are inherently different in structure, 
operation, and payment, and noted that the conditions of participation 
for hospital departments and CMHCs are different. Several commenters 
requested that CMS find a mechanism to pay hospital-based PHPs in 
nonexcepted off-campus PBDs.
    Because we shared the commenters' concerns, in the CY 2017 OPPS/ASC 
final rule with comment period and the CY 2017 interim final rule (81 
FR 79727), we adopted payment for partial hospitalization items and 
services furnished by nonexcepted off-campus hospital-based PBDs under 
the PFS. When billed in accordance with the CY 2017 interim final rule, 
these partial hospitalization services are paid at the CMHC per diem 
rate for APC 5853, for providing three or more partial hospitalization 
services per day (81 FR 79727).
    In the CY 2017 OPPS/ASC proposed rule (81 FR 45681), the CY 2017 
OPPS/ASC final rule with comment period, and the CY 2017 interim final 
rule (81 FR 79727), we noted that when a beneficiary receives 
outpatient services in an off-campus department of a hospital, the 
total Medicare payment for those services is generally higher than when 
those same services are provided in a physician's office. Similarly, 
when partial hospitalization services are provided in a hospital-based 
PHP, Medicare pays more than when those same services are provided by a 
CMHC. Our rationale for adopting the CMHC per diem rate for APC 5853 as 
the PFS payment amount for nonexcepted off-campus PBDs providing PHP 
services is because CMHCs are freestanding entities that are not part 
of a hospital, but they provide the same PHP services as hospital-based 
PHPs (81 FR 79727). This is similar to the differences between 
freestanding entities paid under the PFS that furnish other services 
also provided by hospital-based entities. Similar to other entities 
currently paid for their technical component services under the PFS, we 
believe CMHCs would typically have lower cost structures than hospital-
based PHPs, largely due to lower overhead costs and other indirect 
costs such as administration, personnel, and security. We believe that 
paying for nonexcepted hospital-based partial hospitalization services 
at the lower CMHC per diem rate aligns with section 603 of Pubic Law 
114-74, while also preserving access to PHP services. In addition, 
nonexcepted off-campus PBDs will not be required to enroll as CMHCs

[[Page 33985]]

in order to bill and be paid for providing partial hospitalization 
services. However, a nonexcepted off-campus PBD that wishes to provide 
PHP services may still enroll as a CMHC if it chooses to do so and 
meets the relevant requirements. Finally, we recognize that because 
hospital-based PHPs are providing partial hospitalization services in 
the hospital outpatient setting, they can offer benefits that CMHCs do 
not have, such as an easier patient transition to and from inpatient 
care, and easier sharing of health information between the PHP and the 
inpatient staff. We are not proposing to require these PHPs to enroll 
as CMHCs but instead we are proposing to continue to pay non-excepted 
off-campus PBDs providing PHP items and services under the PFS. 
Further, we are proposing to continue to adopt the CMHC per diem rate 
for APC 5853 as the PFS payment amount for nonexcepted off-campus PBDs 
providing three or more PHP services per day in CY 2018.
6. Supervision Rules
    The supervision rules that apply for hospitals continue to apply 
for nonexcepted off-campus PBDs that furnish nonexcepted items and 
services. The amendments made by section 603 of the Bipartisan Budget 
Act of 2015 (Pub. L. 114-74, enacted November 2, 2015) did not change 
the status of these PBDs, only the status of, and payment mechanism 
for, the services they furnish. These supervision requirements are 
specified in Sec.  410.27.
7. Beneficiary Cost-Sharing
    Under the PFS, the beneficiary copayment is generally 20 percent of 
the fee schedule amount, unless there is an applicable exception in 
accordance with the statute. All cost-sharing rules that apply under 
the PFS in accordance with section 1848(g) of the Act and section 
1866(a)(2)(A) of the Act continue to apply for all nonexcepted items 
and services furnished by nonexcepted off-campus PBDs, regardless of 
the cost-sharing obligation under the OPPS.
8. CY 2019 and Future Years
    We continue to believe the amendments made to the statute by 
section 603 of the Bipartisan Budget Act of 2015 intended to eliminate 
the Medicare payment incentive for hospitals to purchase physician 
offices, convert them to off-campus PBDs, and bill under the OPPS for 
items and services they furnish there. Therefore, we continue to 
believe the payment policy under this provision should ultimately 
equalize payment rates between nonexcepted off-campus PBDs and 
physician offices to the greatest extent possible, while allowing 
nonexcepted off-campus PBDs to bill in a straight-forward way for 
services they furnish.
    We note that a full year of claims data regarding the mix of 
services reported using the ``PN'' modifier (from CY 2017) will first 
be available for use in PFS ratesetting for CY 2019. Under the current 
methodology, we would expect to use that data in order to ensure that 
Medicare payment to hospitals billing for non-excepted items and 
services furnished by nonexcepted off-campus PBDs under the PFS would 
reflect the relative resources involved in furnishing the items and 
services relative to other PFS services. We recognize that under our 
current approach, the payment rates would not be equal on a procedure-
by-procedure basis, application of the PFS Relativity Adjuster would 
move toward equalizing payment rates in the aggregate between physician 
offices and nonexcepted off-campus PBDs to the extent appropriate. 
Therefore, for certain specialties, service lines, and nonexcepted off-
campus PBD types, total Medicare payments for the same services might 
be either higher or lower when furnished by a nonexcepted off-campus 
PBD rather than in a physician office.
    Depending on the mix of services for particular off-campus PBDs, we 
remain concerned that such specialty-specific patterns in payment 
differentials could result in continued incentives for hospitals to buy 
certain types of physician offices and convert them to nonexcepted off-
campus PBDs; these are the incentives we believe Congress intended to 
avoid. However, continuing a policy similar to the one we are proposing 
in this proposed rule would allow hospitals to continue billing through 
a facility claim form and would allow for continuation of the packaging 
rules and cost report-based relative payment rate determinations under 
OPPS, which we believe are preferable to using the current valuation 
methodologies under the PFS that are not well-suited for nonexcepted 
items and services furnished by nonexcepted off-campus PBDs. Therefore, 
for CY 2019 and for future years, we intend to examine the claims data 
in order to determine not only the appropriate PFS Relativity 
Adjuster(s), but also to determine whether additional adjustments to 
the methodology are appropriate--especially with the goal of attaining 
site neutral payments to promote a level playing field under Medicare 
between physician office settings and nonexcepted off-campus PBD 
settings, without regard to the kinds of services furnished by 
particular off-campus PBDs. We solicit comments on potential changes to 
our methodology that would better account for these specialty-specific 
patterns.

H. Proposed Valuation of Specific Codes

1. Background: Process for Valuing New, Revised, and Potentially 
Misvalued Codes
    Establishing valuations for newly created and revised CPT codes is 
a routine part of maintaining the PFS. Since inception of the PFS, it 
has also been a priority to revalue services regularly to make sure 
that the payment rates reflect the changing trends in the practice of 
medicine and current prices for inputs used in the PE calculations. 
Initially, this was accomplished primarily through the 5-year review 
process, which resulted in revised work RVUs for CY 1997, CY 2002, CY 
2007, and CY 2012, and revised PE RVUs in CY 2001, CY 2006, and CY 
2011. Under the 5-year review process, revisions in RVUs were proposed 
and finalized via rulemaking. In addition to the 5-year reviews, 
beginning with CY 2009, CMS and the RUC have identified a number of 
potentially misvalued codes each year using various identification 
screens, as discussed in section II.E.4 of this proposed rule. 
Historically, when we received RUC recommendations, our process had 
been to establish interim final RVUs for the potentially misvalued 
codes, new codes, and any other codes for which there were coding 
changes in the final rule for a year. Then, during the 60-day period 
following the publication of the final rule, we accepted public comment 
about those valuations. For services furnished during the calendar year 
following the publication of interim final rates, we paid for services 
based upon the interim final values established in the final rule. In 
the final rule with comment period for the subsequent year, we 
considered and responded to public comments received on the interim 
final values, and typically made any appropriate adjustments and 
finalized those values.
    In the CY 2015 PFS final rule with comment period, we finalized a 
new process for establishing values for new, revised and potentially 
misvalued codes. Under the new process, we include proposed values for 
these services in the proposed rule, rather than establishing them as 
interim final in the final rule with comment period. Beginning with the 
CY 2017 PFS proposed rule, the new process was applicable to all codes, 
except for new codes that describe truly new services.

[[Page 33986]]

For CY 2017, we proposed new values in the CY 2017 PFS proposed rule 
for the vast majority of new, revised, and potentially misvalued codes 
for which we received complete RUC recommendations by February 10, 
2016. To complete the transition to this new process, for codes where 
we established interim final values in the CY 2016 PFS final rule with 
comment period, we reviewed the comments received during the 60-day 
public comment period following release of the CY 2016 PFS final rule 
with comment period, and re-proposed values for those codes in the CY 
2017 PFS proposed rule.
    We considered public comments received during the 60-day public 
comment period for the proposed rule before establishing final values 
in the CY 2017 PFS final rule. As part of our established process we 
will adopt interim final values only in the case of wholly new services 
for which there are no predecessor codes or values and for which we do 
not receive recommendations in time to propose values. For CY 2017, we 
were not aware of any new codes that described such wholly new 
services. Therefore, we did not establish any code values on an interim 
final basis.
2. Methodology for Proposing Work RVUs
    We conduct a review of each code identified in this section and 
review the current work RVU (if any), RUC-recommended work RVU, 
intensity, time to furnish the preservice, intraservice, and 
postservice activities, as well as other components of the service that 
contribute to the value. Our reviews of recommended work RVUs and time 
inputs have generally included, but have not been limited to, a review 
of information provided by the RUC, the Health Care Professionals 
Advisory Committee (HCPAC), and other public commenters, medical 
literature, and comparative databases, as well as a comparison with 
other codes within the PFS, consultation with other physicians and 
health care professionals within CMS and the federal government, as 
well as Medicare claims data. We have also assessed the methodology and 
data used to develop the recommendations submitted to us by the RUC and 
other public commenters and the rationale for the recommendations. In 
the CY 2011 PFS final rule with comment period (75 FR 73328 through 
73329), we discussed a variety of methodologies and approaches used to 
develop work RVUs, including survey data, building blocks, crosswalks 
to key reference or similar codes, and magnitude estimation (see the CY 
2011 PFS final rule with comment period (75 FR 73328 through 73329) for 
more information). When referring to a survey, unless otherwise noted, 
we mean the surveys conducted by specialty societies as part of the 
formal RUC process. We have used the building block methodology to 
construct, or deconstruct, the work RVU for a CPT code based on 
component pieces of the code.
    Components that we have used in the building block approach may 
have included preservice, intraservice, or postservice time and post-
procedure visits. When referring to a bundled CPT code, the building 
block components could be the CPT codes that make up the bundled code 
and the inputs associated with those codes. Magnitude estimation refers 
to a methodology for valuing work that determines the appropriate work 
RVU for a service by gauging the total amount of work for that service 
relative to the work for a similar service across the PFS without 
explicitly valuing the components of that work. In addition to these 
methodologies, we have frequently utilized an incremental methodology 
in which we value a code based upon its incremental difference between 
another code and another family of codes. The statute specifically 
defines the work component as the resources in time and intensity 
required in furnishing the service. Also, the published literature on 
valuing work has recognized the key role of time in overall work. For 
particular codes, we have refined the work RVUs in direct proportion to 
the changes in the best information regarding the time resources 
involved in furnishing particular services, either considering the 
total time or the intraservice time.
    Several years ago, to aid in the development of preservice time 
recommendations for new and revised CPT codes, the RUC created 
standardized preservice time packages. The packages include preservice 
evaluation time, preservice positioning time, and preservice scrub, 
dress and wait time. Currently there are preservice time packages for 
services typically furnished in the facility setting (for example: 
Preservice time packages reflecting the different combinations of 
straightforward or difficult procedure, and straightforward or 
difficult patient). Currently, there are three preservice time packages 
for services typically furnished in the nonfacility setting.
    We developed several standard building block methodologies to value 
services appropriately when they have common billing patterns. In cases 
where a service is typically furnished to a beneficiary on the same day 
as an E/M service, we believe that there is overlap between the two 
services in some of the activities furnished during the preservice 
evaluation and postservice time. Our longstanding adjustments have 
reflected a broad assumption that at least one-third of the work time 
in both the preservice evaluation and postservice period is duplicative 
of work furnished during the E/M visit. Accordingly, in cases where we 
have believed that the RUC has not adequately accounted for the 
overlapping activities in the recommended work RVU and/or times, we 
have adjusted the work RVU and/or times to account for the overlap. The 
work RVU for a service is the product of the time involved in 
furnishing the service multiplied by the intensity of the work. 
Preservice evaluation time and postservice time both have a long-
established intensity of work per unit of time (IWPUT) of 0.0224, which 
means that 1 minute of preservice evaluation or postservice time 
equates to 0.0224 of a work RVU.
    Therefore, in many cases when we have removed 2 minutes of 
preservice time and 2 minutes of postservice time from a procedure to 
account for the overlap with the same day E/M service, we have also 
removed a work RVU of 0.09 (4 minutes x 0.0224 IWPUT) if we have not 
believed the overlap in time had already been accounted for in the work 
RVU. The RUC has recognized this valuation policy and, in many cases, 
now addresses the overlap in time and work when a service is typically 
furnished on the same day as an E/M service.
    We note that many commenters and stakeholders have expressed 
concerns with our ongoing adjustment of work RVUs based on changes in 
the best information we have had regarding the time resources involved 
in furnishing individual services. We have been particularly concerned 
with the RUC's and various specialty societies' objections to our 
approach given the significance of their recommendations to our process 
for valuing services and since much of the information we have used to 
make the adjustments is derived from their survey process. We are 
statutorily obligated to consider both time and intensity in 
establishing work RVUs for PFS services. As explained in the CY 2016 
PFS final rule with comment period (80 FR 70933), we recognize that 
adjusting work RVUs for changes in time is not always a straightforward 
process, so we have applied various methodologies to identify several 
potential work values for individual codes.

[[Page 33987]]

    We have observed that for many codes reviewed by the RUC, 
recommended work RVUs have appeared to be incongruous with recommended 
assumptions regarding the resource costs in time. This has been the 
case for a significant portion of codes for which we have recently 
established or proposed work RVUs that are based on refinements to the 
RUC-recommended values. When we have adjusted work RVUs to account for 
significant changes in time, we have begun by looking at the change in 
the time in the context of the RUC-recommended work RVU. When the 
recommended work RVUs have not appeared to account for significant 
changes in time, we have employed the different approaches to identify 
potential values that reconcile the recommended work RVUs with the 
recommended time values. Many of these methodologies, such as survey 
data, building block, crosswalks to key reference or similar codes, and 
magnitude estimation have long been used in developing work RVUs under 
the PFS. In addition to these, we have sometimes used the relationship 
between the old time values and the new time values for particular 
services to identify alternative work RVUs based on changes in time 
components.
    In so doing, rather than ignoring the RUC-recommended value, we 
have used the recommended values as a starting reference and then 
applied one of these several methodologies to account for the 
reductions in time that we believe had not otherwise been reflected in 
the RUC-recommended value. When we have believed that such changes in 
time have already been accounted for in the RUC recommendation, then we 
have not made such adjustments. Likewise, we have not arbitrarily 
applied time ratios to current work RVUs to calculate proposed work 
RVUs. We have used the ratios to identify potential work RVUs and 
considered these work RVUs as potential options relative to the values 
developed through other options.
    We do not imply that the decrease in time as reflected in survey 
values must equate to a one-to-one or linear decrease in newly valued 
work RVUs. Instead, we have believed that, since the two components of 
work are time and intensity, absent an obvious or explicitly stated 
rationale for why the relative intensity of a given procedure has 
increased, significant decreases in time should be reflected in 
decreases to work RVUs. If the RUC recommendation had appeared to 
disregard or dismiss the changes in time, without a persuasive 
explanation of why such a change should not be accounted for in the 
overall work of the service, then we have generally used one of the 
aforementioned referenced methodologies to identify potential work 
RVUs, including the methodologies intended to account for the changes 
in the resources involved in furnishing the procedure.
    Several stakeholders, including the RUC, in general have objected 
to our use of these methodologies and deemed our actions in adjusting 
the recommended work RVUs as inappropriate; other stakeholders have 
also expressed concerns with CMS refinements to RUC recommended values 
in general. In the CY 2017 PFS final rule (81 FR 80272 through 80277) 
we responded in detail to several comments that we received regarding 
this issue. In the CY 2017 PFS proposed rule, we requested comments 
regarding potential alternatives to making adjustments that would 
recognize overall estimates of work in the context of changes in the 
resource of time for particular services; however, we did not receive 
any specific potential alternatives as requested.
    In developing proposed values for new, revised, and potentially 
misvalued codes for CY 2018, we considered the lack of alternative 
approaches to making the adjustments, especially since many 
stakeholders have routinely urged us to propose and finalize the RUC 
recommended values. We also considered the RUC's consistent reassurance 
that these kinds of concerns (regarding changes in time, for example) 
had already been considered, and either incorporated or dismissed, as 
part of the development of their recommended values. These have led us 
to shift our approach to reviewing RUC recommendations, especially as 
we believe that the majority of practitioners paid under the PFS, 
though not necessarily those in any particular specialty, would prefer 
CMS rely more heavily on RUC recommended values in establishing payment 
rates under the PFS.
    For CY 2018, we have generally proposed RUC-recommended work RVUs 
for new, revised, and potentially misvalued codes. We are proposing 
these values based on our understanding that the RUC generally 
considers the kinds of concerns we have historically raised regarding 
appropriate valuation of work RVUs. During our review of these 
recommended values, however, we identified some concerns similar to 
those we have recognized in prior years. Given the relative nature of 
the PFS and our obligation to ensure that the RVUs reflect relative 
resource use, we have included descriptions of potential approaches we 
might have taken in developing work RVUs that differ from the RUC 
recommended values. We are seeking comment on both the RUC-recommended 
values as well as the alternatives considered.
    Table 10 contains a list of codes for which we proposed work RVUs; 
this includes all codes for which we received RUC recommendations by 
February 10, 2017. The proposed work RVUs, work time and other payment 
information for all proposed CY 2018 payable codes are available on the 
CMS Web site under downloads for the CY 2018 PFS proposed rule at 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. Table 10 also 
contains the CPT code descriptors for all proposed, new, revised, and 
potentially misvalued codes discussed in this section.
3. Methodology for Proposing the Direct PE Inputs To Develop PE RVUs
a. Background
    On an annual basis, the RUC provides us with recommendations 
regarding PE inputs for new, revised, and potentially misvalued codes. 
We review the RUC-recommended direct PE inputs on a code by code basis. 
Like our review of recommended work RVUs, our review of recommended 
direct PE inputs generally includes, but is not limited to, a review of 
information provided by the RUC, HCPAC, and other public commenters, 
medical literature, and comparative databases, as well as a comparison 
with other codes within the PFS, and consultation with physicians and 
health care professionals within CMS and the federal government, as 
well as Medicare claims data. We also assess the methodology and data 
used to develop the recommendations submitted to us by the RUC and 
other public commenters and the rationale for the recommendations. When 
we determine that the RUC's recommendations appropriately estimate the 
direct PE inputs (clinical labor, disposable supplies, and medical 
equipment) required for the typical service, are consistent with the 
principles of relativity, and reflect our payment policies, we use 
those direct PE inputs to value a service. If not, we refine the 
recommended PE inputs to better reflect our estimate of the PE 
resources required for the service. We also confirm whether CPT codes 
should have facility and/or nonfacility direct PE inputs and refine the 
inputs accordingly.
    Our review and refinement of RUC-recommended direct PE inputs 
includes many refinements that are common

[[Page 33988]]

across codes, as well as refinements that are specific to particular 
services. Table 11 details our proposed refinements of the RUC's direct 
PE recommendations at the code-specific level. In this proposed rule, 
we address several refinements that are common across codes, and 
refinements to particular codes are addressed in the portions of this 
section that are dedicated to particular codes. We note that for each 
refinement, we indicate the proposed impact on direct costs for that 
service. We note that, on average, in any case where the impact on the 
direct cost for a particular refinement is $0.30 or less, the 
refinement has no impact on the proposed PE RVUs. This calculation 
considers both the impact on the direct portion of the PE RVU, as well 
as the impact on the indirect allocator for the average service. We 
also note that nearly half of the proposed refinements listed in Table 
11 result in changes under the $0.30 threshold and are unlikely to 
result in a change to the proposed RVUs.
    We also note that the proposed direct PE inputs for CY 2018 are 
displayed in the CY 2018 direct PE input database, available on the CMS 
Web site under the downloads for the CY 2018 PFS proposed rule at 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html. The inputs 
displayed there have also been used in developing the proposed CY 2018 
PE RVUs as displayed in Addendum B.
b. Common Refinements
(1) Changes in Work Time
    Some direct PE inputs are directly affected by revisions in work 
time. Specifically, changes in the intraservice portions of the work 
time and changes in the number or level of postoperative visits 
associated with the global periods result in corresponding changes to 
direct PE inputs. The direct PE input recommendations generally 
correspond to the work time values associated with services. We believe 
that inadvertent discrepancies between work time values and direct PE 
inputs should be refined or adjusted in the establishment of proposed 
direct PE inputs to resolve the discrepancies.
(2) Equipment Time
    Prior to CY 2010, the RUC did not generally provide CMS with 
recommendations regarding equipment time inputs. In CY 2010, in the 
interest of ensuring the greatest possible degree of accuracy in 
allocating equipment minutes, we requested that the RUC provide 
equipment times along with the other direct PE recommendations, and we 
provided the RUC with general guidelines regarding appropriate 
equipment time inputs. We continue to appreciate the RUC's willingness 
to provide us with these additional inputs as part of its PE 
recommendations.
    In general, the equipment time inputs correspond to the service 
period portion of the clinical labor times. We have clarified this 
principle over several years of rulemaking, indicating that we consider 
equipment time as the time within the intraservice period when a 
clinician is using the piece of equipment plus any additional time that 
the piece of equipment is not available for use for another patient due 
to its use during the designated procedure. For those services for 
which we allocate cleaning time to portable equipment items, because 
the portable equipment does not need to be cleaned in the room where 
the service is furnished, we do not include that cleaning time for the 
remaining equipment items, as those items and the room are both 
available for use for other patients during that time. In addition, 
when a piece of equipment is typically used during follow-up post-
operative visits included in the global period for a service, the 
equipment time would also reflect that use.
    We believe that certain highly technical pieces of equipment and 
equipment rooms are less likely to be used during all of the preservice 
or postservice tasks performed by clinical labor staff on the day of 
the procedure (the clinical labor service period) and are typically 
available for other patients even when one member of the clinical staff 
may be occupied with a preservice or postservice task related to the 
procedure. We also note that we believe these same assumptions would 
apply to inexpensive equipment items that are used in conjunction with 
and located in a room with non-portable highly technical equipment 
items since any items in the room in question would be available if the 
room is not being occupied by a particular patient. For additional 
information, we refer readers to our discussion of these issues in the 
CY 2012 PFS final rule with comment period (76 FR 73182) and the CY 
2015 PFS final rule with comment period (79 FR 67639).
(3) Standard Tasks and Minutes for Clinical Labor Tasks
    In general, the preservice, intraservice, and postservice clinical 
labor minutes associated with clinical labor inputs in the direct PE 
input database reflect the sum of particular tasks described in the 
information that accompanies the RUC-recommended direct PE inputs, 
commonly called the ``PE worksheets.'' For most of these described 
tasks, there are a standardized number of minutes, depending on the 
type of procedure, its typical setting, its global period, and the 
other procedures with which it is typically reported. The RUC sometimes 
recommends a number of minutes either greater than or less than the 
time typically allotted for certain tasks. In those cases, we review 
the deviations from the standards and any rationale provided for the 
deviations. When we do not accept the RUC-recommended exceptions, we 
refine the proposed direct PE inputs to conform to the standard times 
for those tasks. In addition, in cases when a service is typically 
billed with an E/M service, we remove the preservice clinical labor 
tasks to avoid duplicative inputs and to reflect the resource costs of 
furnishing the typical service.
    We refer readers to section II.B. of this proposed rule for more 
information regarding the collaborative work of CMS and the RUC in 
improvements in standardizing clinical labor tasks.
(4) Recommended Items that are not Direct PE Inputs
    In some cases, the PE worksheets included with the RUC 
recommendations include items that are not clinical labor, disposable 
supplies, or medical equipment or that cannot be allocated to 
individual services or patients. We have addressed these kinds of 
recommendations in previous rulemaking (78 FR 74242), and we do not use 
items included in these recommendations as direct PE inputs in the 
calculation of PE RVUs.
(5) New Supply and Equipment Items
    The RUC generally recommends the use of supply and equipment items 
that already exist in the direct PE input database for new, revised, 
and potentially misvalued codes. Some recommendations, however, include 
supply or equipment items that are not currently in the direct PE input 
database. In these cases, the RUC has historically recommended that a 
new item be created and has facilitated our pricing of that item by 
working with the specialty societies to provide us copies of sales 
invoices. For CY 2018, we received invoices for several new supply and 
equipment items. Tables 13 and 14 detail the invoices received for new 
and existing items in the direct PE database. As discussed in section 
II.B. of this proposed rule, we encourage stakeholders to review the 
prices associated with these new and existing

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items to determine whether these prices appear to be accurate. Where 
prices appear inaccurate, we encourage stakeholders to provide invoices 
or other information to improve the accuracy of pricing for these items 
in the direct PE database during the 60-day public comment period for 
this proposed rule. We expect that invoices received outside of the 
public comment period would be submitted by February 10th of the 
following year for consideration in future rulemaking, similar to our 
new process for consideration of RUC recommendations.
    We remind stakeholders that due to the relativity inherent in the 
development of RVUs, reductions in existing prices for any items in the 
direct PE database increase the pool of direct PE RVUs available to all 
other PFS services. Tables 13 and 14 also include the number of 
invoices received, as well as the number of nonfacility allowed 
services for procedures that use these equipment items. We provide the 
nonfacility allowed services so that stakeholders will note the impact 
the particular price might have on PE relativity, as well as to 
identify items that are used frequently, since we believe that 
stakeholders are more likely to have better pricing information for 
items used more frequently. A single invoice may not be reflective of 
typical costs and we encourage stakeholders to provide additional 
invoices so that we might identify and use accurate prices in the 
development of PE RVUs.
    In some cases, we do not use the price listed on the invoice that 
accompanies the recommendation because we identify publicly available 
alternative prices or information that suggests a different price is 
more accurate. In these cases, we include this in the discussion of 
these codes. In other cases, we cannot adequately price a newly 
recommended item due to inadequate information. Sometimes, no 
supporting information regarding the price of the item has been 
included in the recommendation. In other cases, the supporting 
information does not demonstrate that the item has been purchased at 
the listed price (for example, vendor price quotes instead of paid 
invoices). In cases where the information provided on the item allows 
us to identify clinically appropriate proxy items, we might use 
existing items as proxies for the newly recommended items. In other 
cases, we have included the item in the direct PE input database 
without any associated price. Although including the item without an 
associated price means that the item does not contribute to the 
calculation of the proposed PE RVU for particular services, it 
facilitates our ability to incorporate a price once we obtain 
information and are able to do so.
(6) Service Period Clinical Labor Time in the Facility Setting
    Generally speaking, our proposed inputs did not include clinical 
labor minutes assigned to the service period because the cost of 
clinical labor during the service period for a procedure in the 
facility setting is not considered a resource cost to the practitioner 
since Medicare makes separate payment to the facility for these costs. 
We address proposed code-specific refinements to clinical labor in the 
individual code sections.
(7) Procedures Subject to the Multiple Procedure Payment Reduction 
(MPPR) and the OPPS Cap
    We note that the public use files for the PFS proposed and final 
rules for each year display both the services subject to the MPPR lists 
on diagnostic cardiovascular services, diagnostic imaging services, 
diagnostic ophthalmology services and therapy services and the list of 
procedures that meet the definition of imaging under section 
1848(b)(4)(B) of the Act, and therefore, are subject to the OPPS cap 
for the upcoming calendar year. The public use files for CY 2018 are 
available on the CMS Web site under downloads for the CY 2018 PFS 
proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html For more 
information regarding the history of the MPPR policy, we refer readers 
to the CY 2014 PFS final rule (78 FR 74261-74263). For more information 
regarding the history of the OPPS cap, we refer readers to the CY 2007 
PFS final rule (71 FR 69659-69662).
4. Proposed Valuation of Specific Codes for CY 2018
(1) Anesthesia Services for Gastrointestinal (GI) Procedures (CPT codes 
007X1, 007X2, 008X1, 008X2, and 008X3)
    In the CY 2016 PFS proposed rule (80 FR 41686), we discussed that 
in reviewing Medicare claims data, a separate anesthesia service is 
typically reported more than 50 percent of the time that various 
colonoscopy procedures are reported. We discussed that given the 
significant change in relative frequency with which anesthesia codes 
are reported with colonoscopy services, we believed the relative values 
of the anesthesia services should be reexamined and proposed to 
identify CPT codes 00740 (Anesth upper gi visualize) and 00810 (Anesth 
low intestine scope) as potentially misvalued. For CY 2018, the CPT 
Editorial Panel is deleting CPT codes 00740 and 00810 and creating new 
codes for anesthesia services furnished in conjunction with and in 
support of gastrointestinal endoscopic procedures: Two codes for upper 
GI procedures (007X1 and 007X2), two codes for lower GI procedures 
(008X1 and 008X2), and one code for upper and lower GI procedures 
(008X3).
    For CY 2018, we are proposing the RUC-recommended base units 
without refinement for CPT codes 007X1 (5.00 base units), 007X2 (6.00 
base units), 008X1 (4.00 base units), 008X2 (4.00 base units) and 008X3 
(5.00 base units). We considered 3.00 base units (the 25th percentile 
survey result) for CPT code 008X2 (Anesthesia for lower intestinal 
endoscopic procedures, endoscope introduced distal to duodenum; 
screening colonoscopy), based on our comparison of the surveyed post-
induction anesthesia-intensity allocation for CPT code 008X2 to codes 
with similar allocations (CPT code 01382 (Anesth dx knee arthroscopy)). 
We found that CPT code 01382, which was also valued with 3.00 base 
units, had similar allocations compared to the survey results for CPT 
code 008X2. We are seeking comment on our proposed and alternative 
value for CPT code 008X2.
(2) Acne Surgery (CPT code 10040)
    CPT code 10040 was identified as potentially misvalued on a screen 
of Harvard-valued codes with utilization over 30,000 in CY 2014. We are 
proposing the RUC-recommended work RVU of 0.91 for CPT code 10040 and 
the RUC-recommended work time values. We considered using the current 
number of 0.5 post-procedure office visits of CPT code 99212 (Office/
outpatient visit est) rather than the RUC-recommended number of 1.0 
post-procedure office visits. For CPT code 10040, the RUC states that 
it is a low intensity service that can be performed by a nurse under a 
physician's supervision, and that the average number of office visits 
in the follow-up period of acne surgery is 0.4. We are seeking public 
comments regarding the typical number of postoperative visits for this 
code, considering there have been no changes made to the code 
descriptor and we have not found evidence of changes to the typical 
patient population.
    We are proposing the RUC-recommended direct PE inputs for CPT code 
10040 without refinement. We considered refinements to the clinical

[[Page 33990]]

labor for ``Assist physician in performing procedure'' from 10 minutes 
to 3 minutes. CPT code 10040 previously used about one third of the 
intraservice work time for this clinical labor activity (5 minutes out 
of 14 minutes), and the RUC-recommended value of 10 minutes would have 
increased this to 100 percent of the intraservice work time without 
rationale for the change. We considered 3 minutes for this clinical 
labor activity, which is about one third of the intraservice work time 
(3 minutes out of 10 minutes) and would have maintained the current 
ratio between clinical labor time and work time.
    For CY 2018, we are proposing the RUC-recommended work RVUs and 
direct PE inputs for CPT code 10040 and are seeking comment on our 
proposed and alternative values.
(3) Muscle Flaps (CPT codes 15734, 15736, 15738, 157X1, and 157X2)
    CPT codes 15732 and 15736 were identified via a screen of high 
level E/M visits included in their global periods. This screen 
identified that a CPT code 99214 office visit was included for CPT 
codes 15732 and 15736 but not included in the other codes in this 
family. During the review process for this family of codes, CPT code 
15732 was deleted and replaced with two new codes, CPT codes 157X1 and 
157X2, to better differentiate and describe the work of large muscle 
flaps performed on patients with head and neck cancer depending on the 
site where the service was performed.
    For CY 2018, we are proposing the RUC-recommended work RVUs for CPT 
codes 15734 (a work RVU of 23.00), 15736 (a work RVU of 17.04), 15738 
(a work RVU of 19.04), 157X1 (a work RVU of 13.50), and 157X2 (a work 
RVU of 15.68). For CPT code 157X1, we considered a work RVU of 12.03, 
crosswalking to CPT code 36830 (Creation of arteriovenous fistula by 
other than direct arteriovenous anastomosis (separate procedure); 
nonautogenous graft (eg, biological collagen, thermoplastic graft)). We 
have concerns because the RUC-recommended work RVU of 13.50 would 
represent nearly double the intensity of CPT codes 15734 through 15738, 
as well as nearly double the intensity of deleted CPT code 15732. The 
RUC-recommended work RVU for CPT code 157X1 is also based on a direct 
crosswalk to CPT code 36832 (Revision, open, arteriovenous fistula; 
without thrombectomy, autogenous or nonautogenous dialysis graft 
(separate procedure)), which has the same intraservice time, but with 
20 additional minutes of total time. We considered a potential 
crosswalk to another code in the same family, CPT code 36830, which 
also shares the same intraservice time with CPT code 157X1 but differs 
by only 8 minutes of total time. However, we seek comment on whether 
the RUC recommendation is appropriate given the significant variation 
in intensity among these services.
    We considered a work RVU of 14.63 for CPT code 157X2 (survey 25th 
percentile), crosswalking to CPT code 36833 (Revision, open, 
arteriovenous fistula; with thrombectomy, autogenous or nonautogenous 
dialysis graft (separate procedure)), which has the same intraservice 
time, 1 minute of additional total time, and a work RVU of 14.50. We 
are seeking comment on the effect that an alternative work RVU of 14.50 
would have on relativity among the codes in this family.
    We considered refining the clinical labor time for ``Check 
dressings & wound/home care instructions'' for CPT code 157X1 from 10 
minutes to 5 minutes. We are seeking comment on the typical time input 
for checking dressings, and whether removing and replacing dressings, 
would typically take place during the intraservice or postservice 
period.
    We are also seeking comments regarding the use of the new ``plate, 
surgical, mini-compression, 4 hole'' (SD189) supply included in CPT 
code 157X1, including whether use of this supply would be typical, and 
if so, whether it should be included in the work description. We note 
that SD189 is mentioned in the direct PE recommendations, but the 
supply does not appear in the work description. In the work 
description, the fixation screws are applied to the orbital rim and 
lateral nasal wall, not the surgical plate.
(4) Application of Rigid Leg Cast (CPT code 29445)
    CPT code 29445 appeared on a high growth screen of all services 
with total Medicare utilization of 10,000 or more that increased by at 
least 100 percent from 2008 through 2013. This screen also indicated 
that the code was last surveyed more than 10 years previously, and that 
the dominant specialty had changed during that time.
    For CY 2018, we are proposing the RUC-recommended work RVU of 1.78 
for CPT code 29445. For the direct PE inputs, we are proposing to 
refine the clinical labor time for ``Check dressings & wound/home care 
instructions'' from 5 minutes to 3 minutes. We believe that the 
additional 2 minutes of clinical labor time that we are proposing to 
remove would take place during the monitoring time following the 
procedure and be accounted for in that clinical labor time.
    We also considered refining the clinical labor time for ``Remove 
cast'' from 22 minutes to 11 minutes: 1 minute for room prep, 10 
minutes for assisting the physician, and 0 minutes for the additional 
activities described in the RUC recommendations, which would have only 
taken place during the initial casting. We have concerns that the RUC-
recommended clinical labor regarding the ``remove cast'' task is based 
only on an initial visit where a new cast would be applied and 22 
minutes may be an appropriate length of time. However, the RUC 
recommendations suggest that four to twelve cast changes are common for 
patients, and we are seeking comment on whether the initial application 
of a new cast would be typical for CPT code 29445. We reviewed the 
Medicare claims data for CPT code 29445 and found that three or more 
castings took place for 52 percent of beneficiaries, which suggests 
that three or more castings may be the typical case. A single casting 
only took place for 30 percent of services reported with CPT code 
29445.
(5) Strapping Multi-Layer Compression (CPT codes 29580 and 29581)
    The RUC reviewed CPT code 29580 since it appeared on the screen for 
high expenditure services and reviewed CPT code 29581 as part of this 
family of codes. For CY 2018, the CPT Editorial Panel is deleting two 
additional codes in the family: CPT codes 29582 (Application of multi-
layer compression system; thigh and leg, including ankle and foot, when 
performed) and 29583 (Application of multi-layer compression system; 
upper arm and forearm).
    For CY 2018, we are proposing the RUC-recommended work RVUs for CPT 
code 29580 (a work RVU of 0.55) and CPT code 29581 (a work RVU of 
0.60).
    However, we are concerned about the changes in preservice time 
reflected in the specialty surveys compared to the RUC-recommended work 
RVUs. For instance, for CPT code 29580, we considered a work RVU of 
0.46, crosswalking to CPT code 98925 (Osteopathic manipulative 
treatment (OMT); 1-2 body regions involved)), which has a work RVU of 
0.46 and shares a similar intraservice time. Compared to the specialty 
survey times, the RUC recommended a slight decrease (9 minutes) in 
preservice time for CPT code 29580, with the intraservice and immediate 
postservice times remaining unchanged.

[[Page 33991]]

    For CPT code 29581, we considered a work RVU of 0.5 by using the 
RUC-recommended work RVU increment between CPT codes 29580 and 29581 
(+0.05), added to the work RVU we considered for CPT code 29580 (0.46), 
and crosswalking to CPT code 97597 (Debridement (eg, high pressure 
waterjet with/without suction, sharp selective debridement with 
scissors, scalpel and forceps), open wound, (eg, fibrin, devitalized 
epidermis and/or dermis, exudate, debris, biofilm), including topical 
application(s), wound assessment, use of a whirlpool, when performed 
and instruction(s) for ongoing care, per session, total wound(s) 
surface area; first 20 sq cm or less)), which has similar intraservice 
and total times to the RUC-recommended services times for CPT code 
29581. We are seeking comment on whether a work RVU of 0.51 would 
improve relativity among the codes in this family.
    For CY 2018, we are proposing the RUC-recommended work RVUs for CPT 
codes 29580 and 29581 and are seeking comment on whether the 
alternative values we considered would be more appropriate.
(6) Resection Inferior Turbinate (CPT Code 30140)
    CPT code 30140 was identified as potentially misvalued on a screen 
of Harvard-valued codes with utilization over 30,000 in CY 2014. During 
the review process, the RUC re-surveyed the code as a 0-day global 
period, based on the presence of a negative intensity value in the 
initial survey and highly variable postoperative office visits.
    For CY 2018, we are proposing the RUC-recommended work RVU of 3.00 
for CPT code 30140 as a 0-day global code. We also considered a work 
RVU of 2.68 for CPT code 30140 and are seeking comment on changes in 
practice patterns since the code was previously reviewed, service times 
of comparable services, and whether a work RVU of 2.68 would better 
maintain relativity among similar codes. We note that the RUC-
recommended work RVU of 3.0 nearly doubles the derived intensity of the 
code as currently valued. We note that the RUC recommendations 
referenced services that had similar service times to CPT code 30140 
(CPT code 31240 (Nasal/sinus endoscopy, surgical; with concha bullosa 
resection), with a work RVU of 2.61; and CPT code 31295 (Nasal/sinus 
endoscopy, surgical; with dilation of maxillary sinus ostium (eg, 
balloon dilation), transnasal or via canine fossa), with a work RVU of 
2.70).
    We note that the initial survey for CPT code 30140 as a 90-day 
global resulted in a RUC-recommended work RVU of 3.57, while the second 
survey for the code as a 0-day global resulted in a RUC-recommended 
work RVU of 3.00, despite the removal of two postoperative office 
visits of CPT code 99212 and a half discharge visit of CPT code 99238. 
These removed postoperative visits have a total work RVU of 2.58, which 
is notably higher than the difference in the RUC-recommended work RVU 
between the two surveys.
    We are also proposing to create equipment codes for three new 
equipment items based on invoices submitted with the RUC 
recommendations for CPT code 30140. We are proposing to create three 
new equipment codes based on the invoices submitted for this code 
family: the 2mm reusable shaver blade (EQ383) at a price of $790, the 
microdebrider handpiece (EQ384) at a price of $4,760, and the 
microdebrider console (EQ385) at a price of $9,034.
(7) Control Nasal Hemorrhage (CPT Codes 30901, 30903, 30905, and 30906)
    For CY 2018, we are proposing the RUC-recommended work RVUs for CPT 
codes 30901 (a work RVU of 1.10), 30903 (a work RVU of 1.54), 30905 (a 
work RVU of 1.97), and 30906 (a work RVU of 2.45). We are also 
proposing to use the RUC-recommended direct PE inputs for CPT codes 
30901, 30903, 30905, and 30906, with standard refinements to the 
equipment times to account for patient monitoring times. We noted that 
as part of its recommendation, the RUC informed us that the specialty 
societies presented evidence stating that the 1995 valuations for these 
services factored in excessive times, specifically to account for 
infection control procedures that were necessary at that time due to 
the prevalence of HIV/AIDS. The specialty societies also noted that 
increased availability and use of blood thinner medications compared to 
those available in 1995, has increased the difficulty and intensity of 
these procedures. We are seeking additional information regarding the 
presumption that the relative resource intensity of these services, 
specifically, would be affected by the commercial availability of 
additional blood thinner medications. We believe that blood thinner 
medications were widely available before 1995 when these codes were 
last valued. Additionally, we seek comments on the prevalence of HIV/
AIDS and whether the work related to infection control procedures would 
be relative across many PFS services or specifically related to nasal 
hemorrhage control procedures.
    For CPT code 30901 (Control nasal hemorrhage, anterior, simple 
(limited cautery and/or packing) any method), we considered a work RVU 
of 1.00 (the 25th percentile survey result), crosswalking to CPT code 
20606 (Drain/inj joint/bursa w/us), which has similar service times. 
The median survey total time (24 minutes) dropped by 2 minutes (from 
preservice time), to 24 minutes compared to the existing total time. 
The difference in total time reflected a small decrease in preservice 
time, with no change in intraservice time (10 minutes). Among codes 
with similar service times, we found only three codes that had a higher 
work RVU than the RUC-recommended value.
    For CPT code 30903 (Control nasal hemorrhage, anterior, complex 
(extensive cautery and/or packing) any method), we considered a work 
RVU of 1.30 (the 25th percentile survey result), which would have been 
further supported by CPT codes 36584 and 51710 which have similar 
service times to the median survey results. The RUC recommended a 
decreased total time of 39 minutes compared to the existing total time 
(70 minutes), with intraservice time dropping from 30 to 15 minutes.
    For CPT code 30905 (Control nasal hemorrhage, posterior, with 
posterior nasal packs and/or cautery, any method; initial), we 
considered a work RVU of 1.73, using the RUC-recommended work RVU 
increment between CPT code 30903 and CPT code 30905 (0.43), added to 
the work RVU we considered for CPT code 30903 (1.30), and crosswalking 
to CPT code 45321 (Proctosigmoidoscopy volvul), which has similar 
service times. The surveyed intraservice time dropped from 48 minutes 
to 20 minutes. The RUC recommendations indicated that surveyed service 
times for CPT code 30905 are longer than for CPT code 30903 since the 
service is performed to control an arterial posterior bleed. According 
to the specialty society, arterial posterior bleeds are more difficult 
to treat and require a more extensive procedure in comparison to 
services reported with CPT code 30903. We considered using the RUC-
recommended work RVU increment between CPT code 30903 and CPT code 
30905 (0.43), added to the work RVU we considered for CPT code 30903 
(1.30), resulting in a work RVU of 1.73. We are seeking comment on 
whether a work RVU of 1.73 would potentially affect relativity among 
the codes in this family.

[[Page 33992]]

    For CPT code 30906 (Control nasal hemorrhage, posterior, with 
posterior nasal packs and/or cautery, any method; subsequent), we 
considered a work RVU of 2.21, using the RUC-recommended work RVU 
increment between CPT codes 30905 and 30906 (0.48), added to the work 
RVU we considered for CPT code 30905 (1.73), and crosswalking to 
services with similar service times (CPT codes 19281 (Perq device 
breast 1st imag), 51727 (Cystometrogram w/up), 49185 (Sclerotx fluid 
collection), and 62305 (Myelography lumbar injection)). The surveyed 
median intraservice time dropped from 60 minutes to 30 minutes. We are 
seeking comment on whether a work RVU of 2.21 would potentially improve 
relativity among the codes in this family.
    Given the RUC's consensus for CY 2018, we are proposing the RUC-
recommended work RVUs for each code in this family and seeking comment 
on whether our alternative values would be more appropriate.
(8) Nasal Sinus Endoscopy (CPT Codes 31254, 31255, 31256, 31267, 31276, 
31287, 31288, 31295, 31296, 31297, 31XX1, 31XX2, 31XX3, 31XX4, and 
31XX5)
    In October 2016, the CPT Editorial Panel created five new codes 
(CPT codes 31XX1, 31XX2, 31XX3, 31XX4 and 31XX5) and revised CPT codes 
31238, 31254, 31255, 31276, 31287, 31288, 31296, and 31297. CPT codes 
31XX2--31XX5 are newly bundled services representing services that are 
frequently reported together. CPT code 31XX1 represents a new service. 
The RUC reviewed this family of codes at their January 2017 meeting. 
For CY 2018, we are proposing the RUC-recommended work RVUs for all 15 
CPT codes in this family as follows: 4.27 for CPT code 31254, 5.75 for 
CPT code 31255, 3.11 for CPT code 31256, 4.68 for CPT code 31267, 6.75 
for CPT code 31276, 3.50 for CPT code 31287, 4.10 for CPT code 31288, 
2.70 for CPT code 31295, 3.10 for CPT code 31296, 2.44 for CPT code 
31297, 8.00 for CPT code 31XX1, 9.00 for CPT code 31XX2, 8.00 for CPT 
code 31XX3, 8.48 for CPT code 31XX4, and 4.50 for CPT code 31XX5.
    For CPT code 31296, we considered a work RVU of 2.82, supported by 
a crosswalk to CPT code 36901 (Intro cath dialysis circuit) with an 
intraservice time of 25 minutes and total time of 66 minutes, similar 
to the service times for CPT code 31296. We are concerned about the 
decrease in service time compared to the work RVU and we seek comment 
on whether or not a work RVU of 2.82 might improve relativity with 
other PFS services.
    For CPT code 31256, we considered a work RVU of 2.80, supported by 
a crosswalk to CPT code 43231 (Esophagoscopy, flexible, transoral; with 
endoscopic ultrasound examination), which has 30 minutes of 
intraservice time and 81 minutes of total time, similar to the RUC-
recommended service times. We are concerned about the difference in 
total time between CPT code 31256 and the RUC-recommended crosswalk to 
CPT code 43247. CPT code 43247 has 30 minutes intraservice time and 58 
minutes total time), and CPT code 31256 (30 minutes intraservice time 
and 83 minutes total time).
    For CPT code 31254, we note the RUC's explanation that this service 
is more intense than the functional endoscopic sinus surgery on the 
maxillary or sphenoid sinuses due to the risk of major complications 
such as injury to the eye muscles, bleeding into the eye or brain fluid 
leak and, consequently, that the RUC concluded that it should be valued 
higher than either CPT code 31256 or CPT code 31287. Since CPT code 
31256 has the same total time (30 minutes) and intraservice time (30 
minutes) as CPT code 31254, we considered whether the incremental 
difference recommended by the RUC between these two codes (work RVU of 
1.16) would reflect the intensity of the service. We considered a work 
RVU of 2.80 for CPT code 31256, and also considered an alternative work 
RVU of 3.97 for CPT code 31254.
    For CPT code 31287, we considered a work RVU of 3.19 based on the 
difference between the RUC-recommended work RVU for the maxillary sinus 
surgery (CPT code 31256) and the sphenoid sinus surgery (CPT code 
31287) (difference = 0.28) added to the work RVU that we considered for 
the base code (CPT code 31256, a work RVU of 2.80). We note that the 
magnitude of decreases in service times are greater than those for the 
work RVU, which potentially could affect relativity among PFS services.
    For CPT code 31255, we considered a work RVU of 5.30, based on a 
crosswalk to CPT codes 36475 (Endovenous rf 1st vein) and 36478 
(Endovenous laser 1st vein) since both of these services have the same 
intraservice times, total times, and work RVUs). We note that there are 
several CPT codes with similar total and intraservice times that have 
lower work RVUs than the crosswalk to CPT code 36246 (Ins cath abd/l-
ext art 2nd) noted by the RUC, which has 45 minutes intraservice and 96 
minutes total time, has work RVU of 5.02; CPT code 36475 (Endovenous rf 
1st vein) has 94 minutes intraservice and 94 minutes total time and has 
work RVU of 5.30).
    For CPT code 31276 (Nasal/sinus endoscopy, surgical; with frontal 
sinus exploration, including removal of tissue from frontal sinus, when 
performed), we considered a work RVU of 6.30, which is similar to other 
functional endoscopic surgeries. We note that the services reported 
with CPT code 31276 are the most intense and complex of the functional 
endoscopic surgeries due to the risks of working in the narrow confines 
in the frontal recess. However, we have concerns that a crosswalk to 
CPT code 52352 (Cystourethroscopy, with ureteroscopy and/or pyeloscopy; 
with removal or manipulation of calculus (ureteral catheterization is 
included)), and we seek comment on whether the RUC-recommended decrease 
in service times is appropriate since CPT code 52352 has 20 minutes 
more total time than CPT code 31276.
    For CPT 31XX1 (nasal/sinus endoscopy, surgical; with ligation of 
Sphenopalatine artery), we have concerns and seek comment regarding the 
accuracy and applicability of the surveys as the RUC indicated that the 
specialty society did not use the survey instrument that contains 
questions about the number and types of visits and that this service 
requires a half day discharge day management as the patients typically 
stay overnight to be monitored for further bleeding. We seek comment on 
whether inclusion of a half day discharge day visit is typical for this 
service since services assigned 0-day global periods do not typically 
include discharge visits. We considered reducing the total time from 
142 minutes to 123 minutes by removing the half day discharge. Using 
the alternative total time of 123 minutes, we found services with 
similar total and intraservice time (60 minutes) and total time (123 
minutes).
    We considered a work RVU of 7.30 for CPT code 31XX1, supported by a 
direct crosswalk to CPT code 36253 (Superselective catheter placement 
(one or more second order or higher renal artery branches) renal artery 
and any accessory renal artery(s) for renal angiography, including 
arterial puncture, catheterization, fluoroscopy, contrast injection(s), 
image postprocessing, permanent recording of images, and radiological 
supervision and interpretation, including pressure gradient 
measurements when performed, and flush aortogram when performed; 
unilateral), since CPT code 36253 has a similar total time compared to 
our alternative total time.
    For CPT code 31XX3, we considered a work RVU of 7.30, based on a 
crosswalk to CPT code 36253 (Superselective catheter placement (one

[[Page 33993]]

or more second order or higher renal artery branches) renal artery and 
any accessory renal artery(s) for renal angiography, including arterial 
puncture, catheterization, fluoroscopy, contrast injection(s), image 
postprocessing, permanent recording of images, and radiological 
supervision and interpretation, including pressure gradient 
measurements when performed, and flush aortogram when performed; 
unilateral). We have similar concerns regarding the service times for 
this service, including the cited reference codes, compared to the 
recommended work RVU. We are seeking comment on whether a work RVU of 
7.30 for CPT code 31XX3 would improve consistency among the combined 
CPT codes in this family.
    CPT code 31XX4 is a new code representing a combination of the 
services previously described by CPT codes 31255 and 31288. We note the 
changes in overall service times compared to other codes in this family 
and other PFS services. We considered a work RVU of 7.85 for CPT code 
31XX4, crosswalking to CPT code 93461 (R&l hrt art/ventricle angio), 
which has identical intraservice times. We are seeking comment on the 
effect that this alternative work RVU might have on consistency and 
rank order compared to the other bundled codes in this family.
    CPT code 31XX5 represents a combination of CPT codes 31296 and 
31297. We have concerns about the use of CPT codes 47532 and 58558, 
which were used by the RUC as comparison codes, due to differences in 
both intraservice and total time compared to the service times for CPT 
code 31XX5. We considered a work RVU of 4.10 for CPT code 31XX5, 
crosswalking to CPT code 44406 (Colonoscopy w/ultrasound), which has 
similar service times.
    For CY 2018, we are proposing the RUC-recommended work RVUs for 
each code in this family and are seeking comment on our alternative 
values.
    Regarding the recommended direct PE inputs, we are concerned about 
one of the supply items used in furnishing services for several CPT 
codes in this family:, ``sinus surgery balloon (maxillary, frontal, or 
sphenoid) kit'' (SA106). In the current recommendations, half of one 
kit (each kit has sufficient supply for two sinuses) is included in the 
practice expense inputs for CPT codes 31295, 31296, and 31297. The new 
CPT code 31XX5 has one full kit, reflecting a service consisting of two 
sinuses, according to the RUC's explanation. The price of the full kit 
(two sinuses) of this disposable supply is $2599.06. Our analysis of 
2016 Medicare claims data indicates that 48 percent of the time one of 
the three CPT codes (31295, 31296, and 31297) is billed, it is reported 
on a claim with either one or both of the other codes. Ten percent of 
the time one of the three CPT codes is billed, it is reported on a 
claim with both of the other two codes. Effectively, 10 percent of 
claims reporting these CPT codes are being paid for three sinuses.
    We are seeking comments on the number of units of this supply item 
that are used for each service. We welcome suggestions about improved 
methodologies for identifying the quantity of this disposable supply 
used during these procedures and will continue to monitor utilization 
and reporting of these services.
    In reviewing the RUC recommendations for this family of CPT codes, 
we note that CPT codes in this family are subject to the standard 
payment adjustment for multiple surgeries. In our analysis of the 
claims data, we noted that the average number of HCPCS codes in this 
family reported together on a claim line is approximately 2.89. In 
addition, about 15 percent of claims have two of the newly bundled CPT 
codes reported together on a claim line. We are concerned about the 
frequency with which the nasal sinus endoscopy CPT codes in this family 
are billed together. We are seeking comments on whether we should 
consider the endobase code adjustments as a better approach to 
adjusting payment for these services instead of the current multiple 
procedure reduction. For additional information about the payment 
adjustment under the special rule for multiple endoscopic services, we 
refer readers to the Medicare Claims Processing Manual, Chapter 23 
(available on the CMS Web site at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c23.pdf.).
    We note that in developing the utilization crosswalk we use for 
purposes of PFS ratesetting, for this complex set of newly bundled 
codes, we adopted ratios that differ significantly from the ratios 
accompanying the RUC recommendations to better account for the 
reductions in overall reporting frequency. We direct readers to the 
file called ``CY 2017 Analytic Crosswalk to CY 2018'' on the CMS Web 
site under downloads for the CY 2018 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
(9) Tracheostomy (CPT Codes 31600, 31601, 31603, 31605, and 31610)
    CPT code 31600 was identified as part of a screen of high 
expenditure services with Medicare allowed charges of $10 million or 
more that had not been recently reviewed. CPT codes 31601, 31603, 
31605, and 31610 were added and reviewed as part of the code family.
    We are proposing the RUC-recommended work RVUs for all five codes 
in this family. We are proposing a work RVU of 5.56 for CPT code 31600, 
a work RVU of 8.00 for CPT code 31601, a work RVU of 6.00 for CPT code 
31603, a work RVU of 6.45 for CPT code 31605, and a work RVU of 12.00 
for CPT code 31610.
    We considered a work RVU of 6.50 for CPT code 31601. We seek 
comment on the effect that this alternative value would have on 
relativity compared to other PFS services, especially since the survey 
data does not suggest an increase in the time required to perform the 
procedure.
    We considered a work RVU of 4.77 for CPT code 31605, based on the 
survey 25th percentile from the combined survey total. We also 
considered an intraservice work time of 15 minutes, based on the median 
intraservice work time from the combined survey total for CPT code 
31605. We are seeking comments on the methodology used to determine the 
RUC-recommended work RVU and intraservice work time. We are concerned 
that the number of respondents (20) is below the threshold typically 
required for submission of a survey, and the effect of using survey 
results only from physicians who had personal experience performing the 
procedure (20 respondents). CPT code 31605 has a lower intraservice and 
total time, but a higher work RVU than comparable codes under the PFS. 
We note that the next highest 0-day global code with 20 minutes of 
intraservice time is CPT code 16035 (Escharotomy; initial incision) at 
a work RVU of 3.74. All other 0-day global codes with a work RVU of 
6.45 or greater have at least 40 minutes of intraservice time. We are 
seeking comment on the effect that an alternative work RVU of 4.77 
would have on the relativity of this service compared to other services 
in this family of codes and compared to other PFS services, taking into 
account that CPT code 31605 describes a difficult and dangerous life-
threatening emergency procedure.
    We considered a work RVU of 6.50 for CPT code 31610 based on a 
direct crosswalk to CPT code 31601 (Incision of windpipe). We 
understand that the RUC considered the possibility of

[[Page 33994]]

recommending this code be assigned a 0-day global period based on 
concerns about negative derived intensity. We share the RUC's concerns 
with the current construction of CPT code 31610, particularly with the 
242 minutes of work time included in the postoperative visits, which is 
an unusually large amount for a procedure with only 45 minutes of 
intraservice time. We did not identify any other comparable codes under 
the PFS with 45 minutes of intraservice time and more than 300 minutes 
of total time. We seek comment on whether the unusual volume of 
physician work time included in the postoperative visits for CPT code 
31610 contributed to the negative derived intensity reported by the 
survey data. Considering that the other codes in this family have 0-day 
global periods, we considered and are seeking comment on whether a 0-
day global period should be assigned to CPT code 31610. Removal of the 
postoperative E/M visits from CPT code 31610 would result in an 
intraservice time of 45 minutes and a total time of 125 minutes, 
similar to CPT code 31601 with 45 minutes of intraservice time and 135 
minutes of total time.
    We are proposing the RUC-recommended direct PE inputs for all five 
CPT codes in this family without refinements. As discussed earlier, we 
considered a 0-day global period for CPT code 31610, which would also 
have resulted in removal of the clinical labor associated with the 
postoperative E/M visits, along with the supplies and equipment 
utilized during those visits.
    While we remain concerned about the global period assigned to CPT 
code 31610 and the changes in service times reflected in the specialty 
surveys compared to the RUC-recommended work RVUs, for CY 2018, we are 
proposing the RUC-recommended work RVUs and direct PE inputs for each 
code in this family and are seeking comment on our proposed and 
alternative values.
(10) Bronchial Aspiration of Tracheobronchial Tree (CPT Codes 31645 and 
31646)
    CPT code 31645 was identified as potentially misvalued on a screen 
of Harvard-valued codes with utilization over 30,000 in CY 2014. CPT 
code 31646 was added for review as part of the family of codes, and 
both were revised to reflect recent changes in how the services are 
typically performed. For CY 2018, we are proposing the RUC-recommended 
work RVU of 2.88 for CPT code 31645 and the RUC-recommended work RVU of 
2.78 for CPT code 31646.
    We considered a work RVU of 2.72 for CPT code 31645, crosswalking 
to CPT code 45347 (Sigmoidoscopy, flexible; with placement of 
endoscopic stent). We have concerns regarding the decrease in 
intraservice and total time compared to the current values (we also 
believe that it is important to note how these related codes have been 
affected by the creation of separately billable codes for moderate 
sedation (see CY 2017 PFS final rule (81 FR 80339)). The RUC-
recommended values CPT code 31645 higher than CPT code 31622 
(Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when 
performed; diagnostic, with cell washing, when performed), which is the 
base procedure for this wider group of codes. We agree that CPT code 
31645 should be valued at a higher work RVU than CPT code 31622, 
however, we are seeking comment on whether the work of moderate 
sedation was inadvertently included in the development of the 
recommended work RVU. We note that as part of the CY 2017 PFS final 
rule (81 FR 80339), we finalized separate payment for moderate 
sedation.
    Following the creation of separately billable codes for moderate 
sedation, CPT code 31622 is currently valued at a work RVU of 2.53, not 
2.78 as it was previously valued, and we do not believe it would be 
appropriate to continue to value CPT code 31645 as though moderate 
sedation was still an inherent part of the work of this service. As a 
result, we considered a direct crosswalk to CPT code 45347, which has 
the same intraservice time and 8 additional minutes of total time, at a 
work RVU of 2.72.
    We considered a work RVU of 2.53 for CPT code 31646, crosswalking 
to CPT code 31622 (Dx bronchoscope/wash). The RUC recommendation for 
CPT code 31646 indicated that the code was comparable to CPT code 
31622, since they share the same intraservice time and similar total 
time, and that the recommended work RVU of 2.78 for CPT code 31646 was 
equal to the work RVU of CPT code 31622 before the CY 2017 changes to 
reporting of moderate sedation. We agree with the survey participants 
that these two codes are comparable to one another, but have concerns 
about valuation of CPT code 31646 using a cross reference to a code 
that included moderate sedation. We considered crosswalking CPT code 
31646 (Bronchoscopy reclear airway) using the current CY 2017 valuation 
for CPT code 31622 (a work RVU of 2.53).
    For the direct PE inputs, we are proposing to remove the oxygen gas 
(SD084) from CPT code 31645. This supply is included in the separately 
billable moderate sedation codes, and we are proposing to remove the 
oxygen gas as recommended by the RUC's PE Subcommittee as part of the 
removal of oxygen from non-moderate sedation post-procedure monitoring 
codes. We are proposing to remove the equipment time for the IV 
infusion pump (EQ032) from CPT code 31645. We do not agree that there 
would typically be a need for a separate infusion pump in CPT code 
31645, as the infusion pump is contained in the separately reportable 
moderate sedation codes. We are also proposing to remove the equipment 
time for the CO2 respiratory profile monitor (EQ004) and the 
mobile instrument table (EF027) from CPT code 31645. These equipment 
items are not contained in the current composition of the code, and 
there was no rationale provided in the RUC recommendations for their 
inclusion. As a result, we do not believe that their use would be 
typical for CPT code 31645.
    We are proposing to increase the equipment time for the flexible 
bronchoscopy fiberscope (ES017) for CPT code 31645 consistent with 
standard equipment times for scopes. We are also proposing to increase 
the equipment time for the Gomco suction machine (EQ235) and the power 
table (EF031) consistent with standard equipment times for non-highly 
technical equipment.
    For CY 2018, we are proposing the RUC-recommended work RVUs for 
both codes in this family and are seeking comment on whether we should 
finalize refined values consistent with the implementation of 
separately billable codes for moderate sedation.
(11) Cryoablation of Pulmonary Tumor (CPT Codes 32998 and 32X99)
    For CY 2018, the CPT Editorial Panel modified the descriptor for 
CPT code 32998 (Ablation therapy for reduction or eradication of 1 or 
more pulmonary tumor(s) including pleura or chest wall when involved by 
tumor extension, percutaneous, including imaging guidance when 
performed, unilateral; radiofrequency) to include imaging guidance. In 
addition, the panel deleted Category III CPT Code 0304T and replaced it 
with a new CPT code 32X99, to describe ablation therapy for reduction 
of pulmonary tumor using cryoablation with imaging guidance. For CY 
2018, we are proposing the RUC-recommended work RVUs for CPT codes 
32998 (a work RVU of 9.03) and 32X99 (a work RVU of 9.03).
    However, we have concerns about the descriptions of the codes and 
the recommended valuations assuming that imaging guidance is inherent 
to the

[[Page 33995]]

procedure. Based on our analysis of claims data from 2014, existing CPT 
code 32998 is currently reported with one of the three imaging guidance 
codes (CPT codes 76940, 77013, or 77022) less than 50 percent of the 
time. We seek comment on whether there is additional information that 
would help explain why the codes are being bundled despite what is 
reflected in the Medicare claims data. We considered a work RVU of 7.69 
for CPT code 32998, that included approximately one half the value of 
the imaging guidance in the new codes that describe the work of both 
the procedure and the image guidance (that is, the sum of the current 
work RVU for CPT code 32998 and one-half of the work RVU for CPT code 
77013 (the imaging guidance code most frequently billed with CPT code 
32998 according to 2014 claims data)). We applied the same general 
rationale regarding the use of imaging guidance for new CPT code 32X99. 
Since the RUC recommended identical work RVUs for these codes, we also 
considered a work RVU of 7.69 for CPT 32X99.
    For CPT codes 32998 and 32X99, we are proposing to use the RUC-
recommended direct PE inputs with standard refinements.
    For CY 2018, we are proposing the RUC-recommended work RVUs and 
direct PE inputs for both codes and are seeking comment on our proposed 
and alternative values.
(12) Artificial Heart System Procedures (CPT Codes 339X1, 339X2, and 
339X3)
    For CY 2018, the CPT Editorial Panel deleted Category III CPT Codes 
0051T through 0053T and created CPT codes 339X1, 339X2, and 339X3 to 
report artificial heart system procedures. We are proposing the RUC-
recommended work RVU of 49.00 for CPT code 339X1, and proposing to 
assign contractor-priced status to CPT codes 339X2 and 339X3 as 
recommended by the RUC.
    We considered assigning contractor-priced status for CPT code 
339X1. We have concerns regarding the accuracy of the RUC-recommended 
work valuation for CPT code 339X1, due to its low utilization and the 
resulting difficulties in finding enough practitioners with direct 
experience of the procedure for the specialty societies to survey. We 
seek comment on the sufficiency of the survey data, especially since 
new technologies and those with lower utilization are typically 
contractor-priced. For CY 2018, we are proposing the RUC-recommended 
work RVUs for CPT code 339X1. We are seeking comment on alternative 
pricing for this CPT code 339X1.
    We are not proposing any direct PE inputs, as we did not receive 
RUC-recommended PE information for CPT codes 339X1, 339X2, and 339X3. 
These three codes will be placed on the RUC's new technology list and 
will be re-reviewed by the RUC in 3 years.
(13) Endovascular Repair Procedures (CPT Codes 34X01, 34X02, 34X03, 
34X04, 34X05, 34X06, 34X07, 34X08, 34X09, 34X10, 34X11, 34X12, 34X13, 
34812, 34X15, 34820, 34833, 34834, 34X19, and 34X20)
    The CPT/RUC joint workgroup on codes recommended in October 2015 to 
bundle endovascular abdominal aortic aneurysm repair (EVAR) codes 
together with radiologic supervision and interpretation codes, since 
these codes were typically reported together at least 50 percent of the 
time. The CPT Editorial Panel bundled these services together in 
September 2016, creating 16 new codes, revising four existing codes, 
and deleting 14 other codes related to endovascular repair procedures.
    We are proposing the RUC-recommended work RVUs for all 20 codes in 
this family. We are proposing a work RVU of 23.71 for CPT code 34X01, a 
work RVU of 36.00 for CPT code 34X02, a work RVU of 26.52 for CPT code 
34X03, a work RVU of 45.00 for CPT code 34X04, a work RVU of 29.58 for 
CPT code 34X05, a work RVU of 45.00 for CPT code 34X06, a work RVU of 
22.28 for CPT code 34X07, a work RVU of 36.50 for CPT code 34X08, a 
work RVU of 6.50 for CPT code 34X09, a work RVU of 15.00 for CPT code 
34X10, a work RVU of 6.00 for CPT code 34X11, a work RVU of 12.00 for 
CPT code 34X12, a work RVU of 2.50 for CPT code 34X13, a work RVU of 
4.13 for CPT code 34812, a work RVU of 5.25 for CPT code 34X15, a work 
RVU of 7.00 for CPT code 34820, a work RVU of 8.16 for CPT code 34833, 
a work RVU of 2.65 for CPT code 34834, a work RVU of 6.00 for CPT code 
34X19, and a work RVU of 7.19 for CPT code 34X20.
    We are also proposing the RUC-recommended direct PE inputs without 
refinement for all 20 codes in the family.
    We considered a work RVU of 32.00 for CPT code 34X02 based on the 
survey 25th percentile, and further supported with a crosswalk to CPT 
code 48000 (Placement of drains, peripancreatic, for acute 
pancreatitis), which has the same intraservice time of 120 minutes and 
a work RVU of 31.95. When we compared the RUC-recommended work RVU to 
similar codes valued under the PFS, we were unable to find any 90-day 
global services with 120 minutes of intraservice time and approximately 
677 minutes of total time that had a work RVU greater than 36.00.
    We considered a work RVU of 40.00 for CPT code 34X04 based on the 
survey 25th percentile, crosswalking to CPT code 33534 (Coronary artery 
bypass, using arterial graft(s); 2 coronary arterial grafts) which has 
a work RVU of 39.88. CPT code 33534 has 193 minutes of intraservice 
time, but a lower total time of 717 minutes. When we compared the RUC-
recommended work RVU for CPT code 34X04 to similar codes paid under the 
PFS, we were unable to find any 90-day global services with 180 minutes 
of intraservice time and approximately 737 minutes of total time that 
had a work RVU greater than 45.00.
    We considered a work RVU of 40.00 for CPT code 34X06 based on the 
survey 25th percentile. CPT code 34X06 has nearly identical time values 
to CPT code 34X04, with 2 fewer minutes of intraservice time and total 
time, and the RUC-recommended work RVU was the same for both of these 
codes. The survey respondents also believe that these two codes had a 
comparable amount of work, as the survey 25th percentile work RVU is 
40.00 for both codes.
    We considered a work RVU of 30.00 for CPT code 34X08 based on the 
survey 25th percentile and seek comment on whether a work RVU of 30.00 
would improve relativity among the codes in this family. CPT code 34X08 
has identical intraservice and total times as CPT code 34X02. However, 
we note that the RUC-recommended work RVU of 36.50 for CPT code 34X08 
is higher than the RUC-recommended work RVU of 36.00 for CPT code 
34X02. This is the inverse of the relationship between CPT codes 34X07 
and 34X01, which describe the same procedures in a non-emergent state 
when a rupture does not take place. CPT code 34X07 has a RUC-
recommended work RVU of 22.28 while CPT code 34X01 has a RUC-
recommended work RVU of 23.71. We seek comment on whether the RUC-
recommended work RVUs would create a rank order anomaly within the 
family by reversing the relationship between these paired codes when 
performed in an emergent state. We note that if CPT codes 34X08 and 
34X02 were valued at the survey 25th percentile, this potential rank 
order anomaly disappears; in this scenario, we considered valuing CPT 
code 34X08 at a work RVU of 30.00 and CPT code 34X02 at a work RVU of 
32.00. We seek comment on whether these alternative work values would 
improve relativity with the RUC-recommended work RVUs for CPT code 
34X07 (22.28) and CPT code 34X01 (23.71), with an increment of

[[Page 33996]]

approximately 1.50 to 2.00 RVUs between the two code pairs.
    For the eight remaining codes that describe endovascular access 
procedures, we considered assignment of a 0-day global period, instead 
of the RUC-recommended add-on (ZZZ) global period and subsequently 
adding back the preservice and immediate postservice work time, and 
increasing the work RVU of each code accordingly using a building block 
methodology. We note that as add-on procedures, these eight codes would 
not be subject to the multiple procedure payment discount. We are 
concerned that the total payment for these services will be increasing 
in the aggregate based on changes in coding that alter MPPR 
adjustments, despite the information in the surveys that reflects a 
decrease in the intraservice time required to perform the procedures, 
and a decrease in their overall intensity as compared to the current 
values.
    We considered a work RVU of 3.95 for CPT code 34X13, based on the 
RUC-recommended work RVU of 2.50 plus an additional 1.45 work RVUs. 
This additional work results from the addition of 38 total minutes of 
preservice work time and 30 minutes of postservice work time based on a 
crosswalk to CPT code 37224 (Revascularization, endovascular, open or 
percutaneous, femoral, popliteal artery(s), unilateral; with 
transluminal angioplasty) as valued by using the building block 
methodology. Using the same method, we considered a work RVU of:
     6.48 for CPT code 34812 based on maintaining the current 
75 minutes of preservice work time and the current 30 minutes of 
postservice work time, with a total work RVU of 2.35, added to the RUC-
recommended work RVU of 4.13;
     7.53 for CPT code 34X15 with the addition of 75 minutes of 
preservice work time and 27 minutes of postservice work time to match 
CPT code 34833;
     9.46 for CPT code 34820 based on maintaining the current 
80 minutes of preservice work time and the current 30 minutes of 
postservice work time;
     10.44 for CPT code 34833 based on maintaining the current 
75 minutes of preservice work time and the current 27 minutes of 
postservice work time;
     5.00 for CPT code 34834 based on maintaining the current 
70 minutes of preservice work time and the current 35 minutes of 
postservice work time;
     8.35 for CPT code 34X19 with the addition of 70 minutes of 
preservice work time and 35 minutes of postservice work time to match 
CPT code 34834; and
     9.47 for CPT code 34X20 with the addition of 75 minutes of 
preservice work time and 27 minutes of postservice work time to match 
CPT code 34833.
(14) Selective Catheter Placement (CPT Codes 36215, 36216, 36217, and 
36218)
    CPT code 36215 was identified as potentially misvalued on a screen 
of Harvard-valued codes with utilization over 30,000 in CY 2014, as 
well as on a screen of high expenditure services across specialties 
with Medicare allowed charges of over $10 million. CPT codes 36216, 
36217, and 36218 were added to the family to be reviewed together with 
CPT code 36215.
    We are proposing the RUC-recommended work RVUs for each code in 
this family as follows: A work RVU of 4.17 for CPT code 36215, a work 
RVU of 5.27 for CPT code 36216, a work RVU of 6.29 for CPT code 36217, 
and a work RVU of 1.01 for CPT code 36218.
    We also considered refinements to the intraservice work time for 
CPT code 36217 from 60 minutes to 50 minutes, consistent with the RUC's 
usual use of the survey median intraservice work time. We have concerns 
that the use of the recommended survey 75th percentile intraservice 
work time will not be clinically appropriate for this code, as the 75th 
percentile time was identical for both CPT code 36216 and 36217, and 
therefore, the use of this value would not preserve the incremental, 
linear consistency between the work RVU and the intraservice time 
within the family.
    For the direct PE inputs, we are proposing to refine the clinical 
labor time for the ``Post-procedure doppler evaluation (extremity)'' 
activity from 3 minutes to 1 minute for CPT codes 36215, 36216, and 
36217. We believe that 1 minute would be more typical for this task, as 
the practitioner would be able to quickly evaluate if there was an 
issue with the extremity because there would be visual signs of 
arterial insufficiency resulting from the procedure.
    We are proposing to remove the equipment time for the mobile 
instrument table (EF027) from CPT codes 36215, 36216, and 36217. We 
believe that the mobile instrument table would be used for moderate 
sedation, which was removed from these procedures in CY 2017 (see CY 
2017 PFS final rule (81 FR 80339)). While we recognize that 180 minutes 
of post-procedure monitoring time remains in these codes during which 
the stretcher (EF018), IV infusion pump (EQ032), and 3-channel ECG 
(EQ011) would remain in use, we do not agree that the mobile instrument 
table would typically be in use during this period of monitoring. As a 
result, we are proposing to remove this equipment time from these three 
codes.
    While we remain concerned about the use of the survey 75th 
percentile intraservice work time for CPT code 36217, for CY 2018, we 
are proposing the RUC-recommended work RVUs for each code in this 
family and seek comment on whether our alternative values would be more 
appropriate.
(15) Treatment of Incompetent Veins (CPT Codes 36470, 36471, 364X3, 
364X4, 364X5, and 364X6)
    In September 2016, the CPT Editorial Panel created four new codes 
to describe the treatment of incompetent veins, and revised existing 
CPT codes 36470 and 36471. These six codes were reviewed together as 
part of the same family of procedures. For CY 2018, we are proposing 
the RUC-recommended work RVU for all six codes as follows: A work RVU 
of 0.75 for CPT code 36470, a work RVU of 1.50 for CPT code 36471, a 
work RVU of 3.50 for CPT code 364X3, and a work RVU of 1.75 for CPT 
code 364X4, a work RVU of 2.35 for CPT code 364X5, and a work RVU of 
3.00 for CPT code 364X6.
    We considered a work RVU of 4.38 for CPT code 364X3, which would 
have been based on the RUC-recommended work RVU of 3.50 plus half of 
the RUC-recommended work RVU of CPT code 364X4. We also considered 
assigning CPT code 364X4 a status indicator of ``bundled.'' The 
services that would be reported using CPT codes 364X3 and 364X4 in CY 
2018, are currently reported with unlisted CPT code 37799 (Unlisted 
procedure, vascular surgery). We have concerns about the frequency that 
the current services include treatment of an initial vein (CPT code 
364X3) as compared to the treatment of initial and subsequent veins 
(CPT codes 364X3 and 364X4 together). It may be more accurate to 
describe these services through the use of a single code, as in the 
rest of this code family, instead of a base code and add-on code pair. 
Under this potential scenario, we looked at the RUC-recommended 
crosswalk and noted that the add-on CPT code 364X4 was estimated to be 
billed 50 percent of the time together with CPT code 364X3. We 
therefore considered adding half of the RUC-recommended work RVU of CPT 
code 364X4 (0.88) to the RUC-recommended work RVU of CPT code 364X3 
(3.50), resulting in a work RVU of 4.38.
    We are proposing to remove the 2 minutes of clinical labor for the 
``Setup scope'' (CA015) activity and add the same 2 minutes of clinical 
labor for the ``Prepare room, equipment and

[[Page 33997]]

supplies'' (CA013) activity for CPT codes 364X3, 364X5, and 364X6. The 
RUC-recommended materials stated that these 2 minutes were a proxy for 
setting up the ultrasound machine, and we believe that this 2 minutes 
is more accurately described by the ``Prepare room, equipment and 
supplies'' (CA013) activity code, since there is no scope equipment 
utilized in these procedures. We are proposing to maintain the Vascular 
Tech (L054A) clinical labor type for these 2 minutes. We are also 
proposing to refine the clinical labor for the ``Check dressings, 
catheters, wounds'' (CA029) activity for CPT codes 36470, 36471, 364X3, 
364X5, and 364X6, consistent with the standard times for this clinical 
labor activity.
    We are proposing to remove the six individual 4x4 sterile gauze 
(SG055) supplies and replace them with a 4x4 sterile gauze pack of 10 
(SG056) for CPT codes 36470, 36471, 364X3, 364X5, and 364X6. The pack 
of 10 sterile gauze is cheaper than six individual pieces of sterile 
gauze, and we do not agree that it would be typical to pay a higher 
cost for fewer supplies. We are also proposing to create three new 
supply codes in response to the invoices submitted for this family of 
codes. We are proposing to establish a price of $1495 for the Venaseal 
glue (SD323) supply, a price of $3195 for the Varithena foam (SD324) 
supply, and a price of $40 for the Varithena admin pack (SA125) supply.
    We are proposing to adjust the equipment times for the surgical 
light (EF014), the power table (EF031), and the portable ultrasound 
unit (EQ250) for CPT codes 364X3, 364X5, and 364X6 consistent with the 
standards for non-highly technical equipment and to reflect the changes 
in the clinical labor described in this section of the proposed rule.
    While we remain concerned about the creation of a base code and 
add-on code pairing (CPT codes 364X3 and 364X4) out of services that 
are currently reported using an unlisted code, for CY 2018, we are 
proposing the RUC-recommended work RVUs for each code in this family 
and are seeking comment on whether our alternative values would be more 
appropriate.
(16) Therapeutic Apheresis (CPT Codes 36511, 36512, 36513, 36514, 
36516, and 36522)
    CPT code 36516 was nominated as potentially misvalued in the CY 
2016 PFS proposed rule. The CPT Editorial Panel deleted CPT code 36515 
and made revisions to CPT code 36516 to include immunoabsorption. CPT 
codes 36511, 36512, 36513, 36514, and 36522 were added to CPT code 
36516 to be reviewed together as part of the therapeutic apheresis 
family.
    For CY 2018, we are proposing the RUC-recommended work RVU for all 
six codes in the family as follows: A work RVU of 2.00 for CPT code 
36511, a work RVU of 2.00 for CPT 36512, a work RVU of 2.00 for CPT 
code 36513, a work RVU of 1.81 for CPT code 36514, a work RVU of 1.56 
for CPT code 36516, and a work RVU of 1.75 for CPT code 36522.
    We are proposing to use the RUC-recommended direct PE inputs for 
these codes without refinement. We considered refining the clinical 
labor time for the ``Prepare room, equipment, supplies'' activity from 
20 minutes to 10 minutes for CPT codes 36514 and 36522, and from 30 
minutes to 10 minutes for CPT code 36516. We also considered refining 
the clinical labor for the ``Prepare and position patient/monitor 
patient/set up IV'' activity from 15 minutes to 10 minutes for these 
same three codes. In both cases, we considered maintaining the current 
clinical labor time for CPT codes 36514 and 36516, and adjusting the 
clinical labor time for CPT code 36522 to match the other two codes in 
the family. We have concerns about the lack of a rationale provided for 
these changes in clinical labor time, and whether these clinical labor 
tasks would typically require this additional time.
    We are proposing the RUC-recommended work RVUs and to use the RUC-
recommended direct PE inputs for each code in this family and seeking 
comment on whether our alternative values would be more appropriate. We 
are also seeking comment on whether these procedures are creating a new 
point of venous access or utilizing a previously placed access.
(17) Insertion of Catheter (CPT Codes 36555, 36556, 36620, and 93503)
    CPT code 36556 was identified as part of a screen of high 
expenditure services with Medicare allowed charges of $10 million or 
more that had not been recently reviewed. CPT codes 36555, 36620, and 
93503 were added for review as part of the code family. We are 
proposing the RUC-recommended work RVUs for each code in this family as 
follows: A work RVU of 1.93 for CPT code 36555, a work RVU of 1.75 for 
CPT code 36556, a work RVU of 1.00 for CPT code 36620, and a work RVU 
of 2.00 for CPT code 93503.
    We are proposing to remove the clinical labor time for the 
``Monitor pt. following procedure'' activity and the equipment time for 
the 3-channel ECG (EQ011) for CPT code 36555. CPT code 36555 no longer 
includes moderate sedation as part of the procedure (see CY 2017 PFS 
final rule (81 FR 80339). We are proposing to remove the direct PE 
inputs related to moderate sedation from CPT code 36555 as they would 
now be included in the separately reported moderate sedation services. 
We are also proposing to refine the equipment times for the exam table 
(EF023) and the exam light (EQ168) to reflect changes in the clinical 
labor time.
(18) Insertion of PICC Catheter (CPT Code 36569)
    CPT code 36569 was identified as part of a screen of high 
expenditure services with Medicare allowed charges of $10 million or 
more that had not been recently reviewed. For CY 2018, we are proposing 
the RUC-recommended work RVU of 1.70 for CPT code 36569.
    We are proposing to remove the equipment time for the exam table 
(EF023), as this equipment item is a component part of the 
radiographic-fluoroscopic room (EL014) included in CPT code 77001 
(Fluoroscopic guidance for central venous access device placement, 
replacement (catheter only or complete), or removal). Because CPT code 
36569 is typically billed together with CPT code 77001, we believe that 
the additional equipment time for the exam table would be duplicative.
(19) Bone Marrow Aspiration (CPT Codes 38220, 38221, 382X3, and 2093X)
    CPT code 38221 was identified as part of a screen of high 
expenditure services with Medicare allowed charges of $10 million or 
more that had not been recently reviewed. The descriptors for CPT codes 
38220 and 38221 were revised to reflect changes in practice patterns, 
and two new CPT codes (382X3 and 2093X) were created to more accurately 
describe new services that are now available. For CY 2018, we are 
proposing the RUC-recommended work RVUs for each code in this family as 
follows: A work RVU of 1.20 for CPT code 38220, a work RVU of 1.28 for 
CPT code 38221, a work RVU of 1.44 for CPT code 382X3, and a work RVU 
of 1.16 for CPT code 2093X.
    We also received a recommendation from the RUC to change the global 
period for CPT codes 38220, 38221, and 382X3 from XXX global periods to 
0-day global periods, even though these codes were surveyed under the 
XXX global period. We agree with the recommendation that for these 
three particular codes, their services are more accurately described 
when assigned 0-day global periods as opposed to the XXX global status. 
Therefore, we propose to assign a 0-day global period

[[Page 33998]]

to all three codes in this family. We note, however, that we believe 
that global period changes must be addressed on an individual basis, 
especially when the routine survey methodologies rely on assumptions 
regarding global periods for particular codes. Subsequently, we are 
proposing to refine the preservice work time from 15 minutes of 
evaluation time to 9 minutes of evaluation time, 1 minute of 
positioning time, and 5 minutes of scrub, dress, and wait time. We are 
proposing these refinements to the work times for these three codes to 
more closely align with the preservice times of other recently reviewed 
0-day global procedures, such as CPT code 30903 (Control nasal 
hemorrhage, anterior, complex (extensive cautery and/or packing) any 
method). We also note that given our proposal to value CPT code 382X3, 
we are proposing to eliminate payment using HCPCS code G0364 for CY 
2018 since the changes to the set of CPT codes will now accurately 
describe the services currently reported by G0364. For CPT code 2093X, 
we considered a work RVU of 1.00 based on a direct crosswalk to CPT 
codes 64494 (Injection(s), diagnostic or therapeutic agent, 
paravertebral facet (zygapophyseal) joint (or nerves innervating that 
joint) with image guidance (fluoroscopy or CT), lumbar or sacral; 
second level) and 64495 (Injection(s), diagnostic or therapeutic agent, 
paravertebral facet (zygapophyseal) joint (or nerves innervating that 
joint) with image guidance (fluoroscopy or CT), lumbar or sacral; third 
and any additional level(s)). CPT code 2093X is a global ZZZ add-on 
code for CPT code 38220, and we are concerned with maintaining 
relativity among PFS services, considering that an add-on code 
typically has significantly less intraservice time and total time 
compared to the base code. We considered an alternative crosswalk to 
CPT codes 64494 and 64495, which share the same intraservice and total 
time with CPT code 2093X and have a work RVU of 1.00.
    We are also proposing to refine the clinical labor for ``Lab Tech 
activities'' from 12 minutes to 9 minutes for CPT code 38220, from 7.5 
minutes to 7 minutes for CPT code 38221, and from 12.5 minutes to 10 
minutes for CPT code 382X3. We are maintaining the current time value 
for the two existing codes, as we have no reason to believe that the 
typical duration has increased for these lab activities. We are 
assigning 10 minutes for CPT code 382X3 based on the statement in the 
RUC-recommended materials for the direct PE inputs that this activity 
takes 0.5 minutes longer than it does in the current version of CPT 
code 38220. We are also proposing to remove the breakout lines for the 
lab activities. We believe that the breakout of activities into 
numerous subactivities generally tends to inflate the total time 
assigned to clinical labor activities and results in values that are 
not consistent with the analogous times for other PFS services.
    We considered refining the clinical labor for ``Provide preservice 
education/obtain consent'' for CPT codes 38220, 38221, and 382X3 from 
12 minutes to 6 minutes. We have concerns regarding whether 12 minutes 
would be typical for education and consent prior to these procedures, 
as much of the patient education takes place following the procedure, 
in the clinical labor activity described under the ``Check dressings & 
wound/home care instructions'' heading.
    We are proposing the RUC-recommended work RVUs for each code in 
this family and are seeking comment on whether our alternative values 
would be more appropriate.
(20) Esophagectomy (CPT Codes 43107, 43112, 43117, 432X5, 432X6, and 
432X7)
    CPT codes 432X5, 432X6, and 432X7 were created by the CPT Editorial 
Panel to report esophagectomy via laparoscopic and thoracoscopic 
approaches. CPT codes 43107, 43112, and 43117 were also reviewed as 
part of the family with the three new codes. CPT code 43112 was revised 
to clarify the nature of the service being performed. We are proposing 
the RUC-recommended work RVUs and work times for all six codes in the 
family as follows: A work RVU of 52.05 for CPT code 43107, a work RVU 
of 62.00 for CPT code 43112, a work RVU of 57.50 for CPT code 43117, a 
work RVU of 55.00 for CPT code 432X5, a work RVU of 63.00 for CPT code 
432X6, and a work RVU of 66.42 for CPT code 432X7.
    We are also proposing the RUC-recommended work times for all six 
codes in this family. We considered removing 20 minutes from the 
preservice evaluation work time from all six of the codes in this 
family. We have concerns as to whether this additional evaluation time 
should be included for surgical procedures, due to the lack of evidence 
indicating that it takes longer to review outside imaging and lab 
reports for surgical services than for non-surgical services. We also 
considered refining the preservice positioning work time and the 
immediate postservice work time for all six of the codes in this family 
consistent with standard preservice and postservice work times 
allocated to other PFS services.
    We have concerns about the presence of two separate surveys 
conducted for the three new codes. We note that CPT codes 432X5, 432X6, 
and 432X7 were surveyed initially in January 2016, and then were 
surveyed again in October 2016 together with CPT codes 43107, 43112, 
and 43117 due to concerns about the description of the typical patient 
in the original vignette and a change in the codes on the reference 
service list (RSL). We note that CPT codes 432X5 and 432X6 had the same 
median intraservice time on both surveys, while CPT code 432X7 had a 
median intraservice time that was an hour longer on its second survey 
(420 minutes) as compared to its first survey (360 minutes). We also 
note that the total survey time for CPT code 432X5 decreased from 1058 
minutes in the first survey to 972 minutes in the second survey, while 
the median work RVU increased from 50.00 to 65.00. We do not understand 
how the survey median intraservice time could increase so significantly 
from the first survey to the second survey for CPT code 432X7, or how 
the surveyed times for CPT code 432X5 could be decreasing while the 
work RVU was simultaneously increasing by 15.00 work RVUs.
    Based on our analysis, it appears that the accompanying RSL is the 
main difference between the two surveys; the codes on the initial RSL 
had a median work RVU of 44.18, while the codes on the second RSL had a 
median work RVU of 59.64. This increase of 15.00 work RVUs between the 
two RSLs that accompanied the surveys appears to account for the 
increase in the work RVUs for the three new codes. We are concerned 
that the second survey may have overestimated the work required to 
perform these procedures, as the 25th percentile work RVU of the second 
survey is higher than the median work RVU of the initial survey for all 
three codes, despite no change in the median intraservice work time for 
CPT codes 432X5 and 432X6.
    Given these concerns, we considered a work RVU of 50.00 for CPT 
code 432X5, a work RVU of 60.00 for CPT code 432X6, and a work RVU of 
61.00 for CPT code 432X7, by using the survey median work RVU from the 
first survey for the three new codes. For CPT codes 43107 and 43117, we 
considered employing the intraservice time ratio between the 
laparoscopic version of the procedure represented by the new code and 
the open version of the same procedure represented by the existing 
code.

[[Page 33999]]

    We considered a work RVU of 45.00 for CPT code 43107 based on the 
intraservice time ratio with CPT code 432X5 and a work RVU of 55.00 for 
CPT code 43117 based on the intraservice time ratio with CPT code 
432X6. CPT code 43107 has 270 minutes of intraservice time as compared 
with 300 minutes of intraservice time for CPT code 432X5, which 
produces a ratio of 0.9, and when multiplied by a work RVU of 50.00 
(CPT code 432X5), results in the proposed work RVU of 45.00. We 
considered using the same methodology for CPT codes 43117 and 432X6.
    Finally, we considered a work RVU of 58.94 for CPT code 43112 based 
on a direct crosswalk to CPT code 46744 (Repair of cloacal anomaly by 
anorectovaginoplasty and urethroplasty, sacroperineal approach). We 
note that the intraservice time ratio when applied to CPT codes 43112 
and 432X7, the paired McKeown esophagectomy procedures, would have 
produced a potential work RVU of 52.29, creating a rank order anomaly 
within the family by establishing a higher work RVU for CPT code 43117 
than CPT code 43112, and are concerned with whether this is an 
appropriate valuation for the code. We are seeking comment on whether 
the alternative work RVUs that we considered may reflect the relative 
difference in work more accurately between the six codes in the family. 
We note, for example, that these valuations correct the rank order 
anomaly between CPT codes 43112 and 43121 as noted in the RUC 
recommendations.
    We are proposing the RUC-recommended direct PE inputs for all six 
codes in the family without refinement. We considered changing the 
preservice clinical labor type for all six codes from an RN (L051) to 
an RN/LPN/MTA blend (L037D). We have concerns about whether the use of 
RN clinical labor would be typical for filling out referral forms or 
for scheduling space and equipment in the facility. We also considered 
removing the additional clinical labor time for the ``Additional 
coordination between multiple specialties for complex procedures (eg, 
tests, meds, scheduling)'' activity, consistent with preservice 
standards for codes with 90-day global periods. We are concerned that 
this time would not typically be included in non-surgical procedures 
performed by other specialties even when additional coordination is 
required.
    We are seeking comment regarding the changes in the valuation 
between the two surveys, the preservice and immediate postservice work 
times, and the RN staffing type employed for routine preservice 
clinical labor.
(21) Transurethral Electrosurgical Resection of Prostate (CPT Code 
52601)
    CPT code 52601 appeared on a screen of potentially misvalued codes 
which indicated that it was performed less than 50 percent of the time 
in the inpatient setting, yet included inpatient hospital E/M services 
within the global period. For CY 2018, we are proposing the RUC-
recommended work RVU of 13.16 for CPT code 52601 and proposing to use 
the RUC-recommended direct PE inputs without refinements.
    We considered a work RVU of 12.29 for CPT code 52601 based on a 
direct crosswalk to CPT code 58541 (Laparoscopy, surgical, 
supracervical hysterectomy, for uterus 250 g or less), which is one of 
the reference codes. CPT code 58541 may potentially be a more accurate 
crosswalk for CPT code 52601 than the RUC-recommended direct crosswalk 
to CPT code 29828 (Arthroscopy, shoulder, surgical; biceps tenodesis). 
Although all three of these codes share the same intraservice time of 
75 minutes, CPT code 58541 is a closer match in terms of the total time 
at only 10 minutes difference. CPT code 58541 also shares the same 
postoperative office visits as CPT code 52601, a pair of CPT code 99213 
office visits, while CPT code 29828 also contains two CPT code 99212 
office visits that are not present in the reviewed code.
    We note that if we were to use a reverse building block methodology 
for CPT code 52601 and subtract out the value of the E/M visits being 
removed, the proposed work RVU would be 11.21. We are not proposing 
this work RVU, however, because as we noted in the CY 2017 PFS final 
rule (81 FR 80274), we agree that the per-minute intensity of work is 
not necessarily static over time or even necessarily during the course 
of a procedure. Instead, we utilize time ratios and building block 
methodologies to identify potential values that account for changes in 
time and compare these values to other PFS services for estimates of 
overall work. When the values we develop reflect a similar derived 
intensity, we agree that our values are the result of our assessment 
that the relative intensity of a given service has remained similar. 
For CPT code 52601, we are concerned as to how the RUC-recommended 
derived intensity of the procedure could be increasing by 30 percent 
over the current derived intensity, while at the same time the typical 
site of service is changing from inpatient to outpatient status. In 
other words, if it is now typical for CPT code 52601 to be performed on 
an outpatient basis, then we would generally expect the intensity of 
the procedure to be decreasing, not increasing. We considered a work 
RVU of 12.29 for CPT code 52601 based on a direct crosswalk to CPT code 
58541 (Lsh uterus 250 g or less), and seek comment on whether this 
alternative value might better reflect relativity.
(22) Peri-Prostatic Implantation of Biodegradable Material (CPT Code 
55X87)
    In October 2016, the CPT Editorial Panel deleted CPT Category III 
code 0438T and created a new CPT code 55X87 (Transperineal placement of 
biodegradable material, peri-prostatic, single or multiple 
injection(s), including image guidance, when performed). For CY 2018, 
we are proposing the RUC-recommended work RVU of 3.03 for CPT code 
55X87.
    In reviewing the RUC recommendations, we noted a decrease in 
preservice time (30 minutes) compared to the current value. In order to 
account for this change in time, we considered calculating the 
intraservice time ratio between the key reference code (CPT code 
49411), which has an intraservice time of 40 minutes, and the RUC-
recommended intraservice time (30 minutes) and multiplying that against 
the work RVU for CPT code 49411 (3.57), which would have resulted in a 
work RVU of 2.68. A work RVU of 2.68 would have been further supported 
by a bracket of two crosswalk codes, CPT code 65779 (Placement of 
amniotic membrane on the ocular surface; single layer, sutured) which 
has a work RVU of 2.50 and CPT code 43252 (Esophagogastroduodenoscopy, 
flexible, transoral; with optical endomicroscopy), which has a work RVU 
of 2.96. Compared with CPT code 55X87, these codes have identical 
intraservice and similar total times. We are seeking comment on whether 
these alternative values should be considered, especially given the 
changes in time reflected in the survey data.
    We received invoices with pricing information regarding two new 
supply items: ``endocavity balloon'' and ``biodegradeable material 
kit--periprostatic''. The invoice for endocavity balloon was $399.00 
and the input price on the PE spreadsheet for this supply item was 
noted as such. We believe the input price noted on the PE spreadsheet 
was an error, given that the invoice noted that the price of $399.00 
was for a box of ten and the specialty society requested a single unit 
of this supply item. Therefore, we are proposing to use this 
information to propose for supply item ``endocavity balloon'' a price 
of $39.90. The invoice

[[Page 34000]]

for the ``biodegradeable material kit--periprostatic'' totaled 
$2850.00. We are proposing to use this information to propose for the 
supply item ``biodegradeable material kit--periprostatic'' a price of 
$2850.00. We also received an invoice with pricing information 
regarding the new equipment item ``endocavitary US probe'' which 
totaled $16,146.00. We are proposing to use this information to propose 
for equipment item ``endocavitary US probe'', a per-minute price of 
$0.0639. We question, given an invoice price of $29,999.00 for this 
existing equipment item EQ250 (portable ultrasound unit), whether this 
equipment item includes probes. We are seeking public comments related 
to whether equipment item EQ250 (portable ultrasound) includes probes.
(23) Colporrhaphy With Cystourethroscopy (CPT Codes 57240, 57250, 57260 
and 57265)
    In October 2015, CPT code 57240 was identified by analysis of the 
Medicare data from 2011-2013 that indicated that services reported with 
CPT code 57240 were performed less than 50 percent of the time in the 
inpatient setting, yet include inpatient hospital E/M services within 
the global period. The RUC recommended that CPT codes 57240 (Anterior 
colporrhaphy, repair of cystocele with or without repair of 
urethrocele), 57250 (Posterior colporrhaphy, repair of rectocele with 
or without perineorrhaphy), 57260 (Combined anteroposterior 
colporrhaphy), and 57265 (Combined anteroposterior colporrhaphy; with 
enterocele repair) be referred to the CPT Editorial Panel. In September 
2016, the CPT Editorial Panel revised 57240, 57260 and 57265 to 
preclude separate reporting of follow up cystourethroscopy after 
colporrhaphy (CPT code 52000).
    For CY 2018, we are proposing the RUC-recommended work RVUs for CPT 
code 57240 (a work RVU of 10.08), CPT code 57250 (a work RVU of 10.08), 
CPT code 57260 (a work RVU of 13.25), and CPT code 57265 (a work RVU of 
15.00).
    We note that there were changes in service times reflected in the 
specialty surveys compared to the RUC-recommended work RVUs for CPT 
code 57240. Specifically, we note that the RUC recommended a 48 minute 
decrease in total time, compared to the specialty survey total time of 
259 minutes. The difference in total time reflected a decrease in 
preservice time (29 minutes) and inpatient visits (0.5 visits = 19 
minutes). We considered a work RVU of 9.77 for CPT code 57240, 
crosswalking to CPT code 50590 (Lithotripsy, extracorporeal shock 
wave), which has similar service times. We are seeking comment on 
whether CPT code 57250 would be a relevant comparator for CPT code 
57240, based on the described elements of each service and existing or 
surveyed service times, compared to CPT code 57240.
    We considered a work RVU of 11.47 for CPT code 57265, crosswalking 
to CPT code 47563 (Laparoscopy, surgical; cholecystectomy with 
cholangiography) with similar service times. We seek comment on how an 
alternative work RVU of 11.47 for CPT code 57265 would affect 
relativity among PFS services, and on whether CPT code 57260 is a 
relevant comparator for CPT code 57265, considering differences in the 
described procedures and service times.
    We are proposing the RUC-recommended direct PE inputs for CPT codes 
57240, 57250, 57260 and 57265 without refinements.
(24) Nerve Repair With Nerve Allograft (CPT Codes 64910, 64911, 64X91 
and 64X92)
    The CPT Editorial Panel created two new CPT Category I codes (64X91 
and 64X92) to report the repair of a nerve using a nerve allograft. CPT 
codes 64910 and 64911 were also reviewed as part of this code family. 
CPT codes 64X91 and 64X92 will be placed on the new technology list to 
be re-reviewed by the RUC in 3 years to ensure correct valuation and 
utilization assumptions.
    For CY 2018, we are proposing the RUC-recommended work RVUs for the 
following codes: A work RVU of 10.52 for CPT code 64910, a work RVU of 
14.00 for CPT code 64911, a work RVU of 12.00 for CPT code 64X91, and a 
work RVU of 3.00 for CPT code 64X92.
    We noted a decrease in preservice time (7 minutes) for CPT code 
64910 and considered an alternate work RVU of 10.15, crosswalking to 
CPT code 15120 (Split-thickness autograft, face, scalp, eyelids, mouth, 
neck, ears, orbits, genitalia, hands, feet, and/or multiple digits; 
first 100 sq cm or less, or 1 percent of body area of infants and 
children (except 15050)), which has similar service times. We seek 
comments on whether an alternative work RVU of 10.15 for CPT code 64910 
would better reflect relativity among PFS services with similar service 
times.
    For CPT code 64911 (Nerve repair; with autogenous vein graft 
(includes harvest of vein graft), each nerve)), we considered a work 
RVU of 13.50, crosswalking to CPT code 31591 (Laryngoplasty, 
medicalization, unilateral), which has similar service times. We seek 
comments on whether a work RVU of 13.50 for CPT code 64911 would better 
reflect relativity among other PFS services with similar service times.
    The new coding structure for these services increases granularity 
by including add-on codes that describe each strand of nerve repair. 
While we recognize that additional granularity may be important and 
useful for purposes of data collection, the advantages to Medicare for 
such granularity for purposes of payment are unclear, especially since 
we are unaware of a payment-related reason for such coding complexity. 
We considered proposing a bundled status to the new add-on codes and 
incorporating the relative resources in furnishing the add-on code (CPT 
code 64X92) into the base code (CPT code 64X91) based on the 
utilization assumptions that accompanied the RUC recommendations. The 
RUC estimated that CPT code 64X91 would have 750 Medicare allowed 
services in CY 2018, and that the corresponding add-on CPT code 64X92 
would have 150 Medicare allowed services in CY 2018. Therefore, the RUC 
estimates that CPT code 64X91 will be billed without add-on CPT code 
64X92 for 80 percent (750/900) of the Medicare allowed services, and 
that CPT code 64X91 will be billed with add-on CPT code time 64X92 for 
20 percent (150/900) of the Medicare allowed services in CY 2018. To 
account for the additional work involved in 20 percent of the allowed 
services, we added a work RVU of 0.60 (20 percent of a work RVU of 3.00 
for CPT code 64X92) to the work RVU of 12.00 for CPT code 64X91, to get 
to an alternate work RVU of 12.60 for CPT code 64X91 and increased the 
intraservice time by 6 minutes to account for the bundling of services 
from CPT code 64X92. The alternative work RVU of 12.60 would have been 
further supported by a crosswalk to CPT code 14301 (Adjacent tissue 
transfer or rearrangement, any area; defect 30.1 sq cm to 60.0 sq cm), 
which has similar intraservice and total times.
    We are proposing the RUC-recommended direct PE inputs for CPT codes 
64910, 64911, 64X91 and 64X92 without refinements.
(25) CT Soft Tissue Neck (CPT Codes 70490, 70491, and 70492)
    CPT codes 70490 and 70492 were identified through the high 
expenditure services across specialties with Medicare allowed charges 
of $10 million or more screen. CPT code 70491 was also included for 
review as part of this code family. For CY 2018, we are proposing the 
RUC-recommended work RVUs of 1.28 for CPT code 70490, 1.38

[[Page 34001]]

for CPT code 70491, and 1.62 for CPT code 70492.
    For CPT code 70490, we considered a work RVU of 1.07 based on a 
crosswalk to CPT code 72125 (Computed tomography, cervical spine; 
without contrast material). CPT code 72125 is a non-contrast CT service 
on a similar anatomical area and has identical intraservice and total 
times to those recommended by the RUC for CPT code 70490. We also 
considered work RVUs of 1.17 for CPT code 70491 and 1.41 for CPT code 
70492. We are seeking comment on how relativity among other CT services 
paid under the PFS would be affected by applying the alternative work 
RVUs described above for CPT codes in this family.
(26) Magnetic Resonance Angiography (MRA) Head (CPT Codes 70544, 70545, 
and 70546)
    CPT code 70544 was identified by a screen of services across 
specialties with Medicare allowed charges of $10 million or more. 
Subsequently, CPT codes 70545 and 70546 were also reviewed as part of 
this code family. We are proposing the RUC-recommended work RVUs of 
1.20 for CPT code 70544, 1.20 for CPT code 70545, and 1.48 for CPT code 
70546.
    We are also proposing the following refinements to the RUC-
recommended direct PE inputs. For the service period clinical labor 
activity ``Provide preservice education/obtain consent,'' we are 
proposing 5 minutes for CPT code 70544, 7 minutes for CPT code 70545, 
and 7 minutes for CPT code 70546 so that the times for this activity 
are consistent with other magnetic resonance (MR) services performed 
without-contrast materials, with-contrast materials, and without-and-
with contrast materials, respectively. For the clinical labor task 
``Acquire images,'' we are proposing to use the RUC-recommended 
clinical time of 26 minutes for CPT code 70544. We considered proposing 
20 minutes of clinical time to maintain the relativity among the three 
codes in this family and for consistency with other MRA and magnetic 
resonance imaging (MRI) codes, which do not typically assign more 
clinical labor time to this task for services without contrast material 
than for services with contrast material. We seek comments as to the 
appropriate time value for this clinical labor task.
(27) Magnetic Resonance Angiography (MRA) Neck (CPT Codes 70547, 70548, 
and 70549)
    CPT code 70549 was identified through a high expenditure screen. 
CPT codes 70547 and 70748 were also reviewed as part of this family of 
codes. We are proposing the RUC-recommended work RVUs of 1.20 for CPT 
code 70547, 1.50 for CPT code 70548, and 1.80 for CPT code 70549.
    We are also proposing several refinements to the RUC-recommended 
direct PE inputs for these services. For the service period clinical 
labor activity ``Provide preservice education/obtain consent'', we are 
proposing 5 minutes for CPT code 70547, 7 minutes for CPT code 70548, 
and 7 minutes for CPT code 70549 so that the times for this activity 
are consistent with other MR services performed without contrast 
material, with contrast material, and without-and-with contrast 
material, respectively.
    For the intraservice clinical labor task acquire images, for CPT 
code 70547, we are proposing to use the RUC-recommended 26 minutes. We 
considered applying 20 minutes to this clinical labor task, which would 
have maintained consistency with the 20 minutes recommended by the RUC 
for CPT code 70548 (the service that includes with-contrast material). 
We are concerned about the lack of evidence that a non-contrast MRA 
would require more clinical labor time than the with-contrast MRA 
service. We are seeking comment as to the appropriate time value for 
this clinical labor task.
(28) CT Chest (CPT Codes 71250, 71260, and 71270)
    CMS identified this code family through the high expenditures 
screen. We are proposing the RUC-recommended work RVUs of 1.16 for CPT 
code 71250, 1.24 for CPT code 71260, and 1.38 for CPT code 71270.
    For CPT code 71250, we considered maintaining the CY 2017 work RVU 
of 1.02. We are concerned with the lack of evidence that the physician 
time or intensity of furnishing this service has changed since it was 
last valued. In addition, a comparison to other CT codes indicates that 
the RUC-recommended work values could be overvalued relative to other 
CT services and compared to similar, non-contrast CT studies such as 
CPT codes 72131 (Computed tomography, lumbar spine; without contrast 
material) and 73700 (Computed tomography, lower extremity; without 
contrast material), both of which have work RVUs of 1.00.
    For CPT code 71260, we considered proposing a work RVU of 1.10 by 
applying the RUC-recommended increment between CPT code 71250 and 71260 
(0.08) to CPT code 71260. For CPT code 71270, we considered a work RVU 
of 1.24 by applying the RUC-recommended increment between CPT codes 
71260 and 71270 (0.22) to CPT code 71270. In addition to maintaining 
relatively among the codes in this family, we considered further 
supporting these alternative values based on a comparison to other CT 
studies, such as with-contrast material CT studies, and without-and-
with contrast CT studies.
    While we have concerns about the RUC-recommended work RVUs for 
these codes, for CY 2018, we are proposing the RUC recommended work 
RVUs for CPT code 71250, 71260, and 71270 and are seeking comment on 
whether our alternative values would improve relativity.
(29) MRI of Abdomen and Pelvis (CPT Codes 72195, 72196, 72197, 74181, 
74182, and 74183)
    CPT codes 74182 and 72196 were identified as part of the screen of 
high expenditure services across specialties with Medicare allowed 
charges of $10 million or more. CPT codes 74181, 74183, 72195, and 
72197 were also reviewed as part of this code family. We are proposing 
the RUC-recommended work RVUs of 1.46 for CPT code 72195, 1.73 for CPT 
code 72196, 2.20 for CPT code 72197, 1.46 for CPT code 74181, 1.73 for 
CPT code 74182, and 2.20 for CPT code 74183.
    While we are proposing the RUC-recommended direct PE inputs, we 
considered 30 minutes for clinical labor task ``Acquire images'' for 
CPT codes 74181 and 74182, which appears to be more consistent with the 
codes in this family and more consistent with other MR codes. We also 
note that for CPT codes 74181 and 74182, the clinical labor time for 
acquired images appears to have been developed through a consensus 
panel from the specialty society over 15 years ago. Given that these 
times are estimates based on expert panel consensus rather than survey 
data, we seek comments on whether using a structure that matches other 
MR code families would be more appropriate to value these clinical 
labor times.
(30) MRI Lower Extremity (CPT Codes 73718, 73719, and 73720)
    CPT codes 73718 and 73720 were identified as part of the screen of 
high expenditure services, and CPT code 73719 was included for review 
as part of the code family. We are proposing the RUC-recommended work 
RVUs of 1.35 for CPT code 73718, 1.62 for CPT code 73719, and 2.15 for 
CPT code 73720.
    We are also proposing the following refinements to the RUC-
recommended direct PE inputs. For the service period clinical labor 
activity ``Provide preservice education/obtain consent,''

[[Page 34002]]

we are proposing 5 minutes for CPT code 73718, 7 minutes for CPT code 
73719, and 7 minutes for CPT code 73720. Likewise, for the service 
period task ``Prepare room, equipment, supplies,'' we are proposing 3 
minutes for CPT code 73718, 5 minutes for CPT code 73719, and 5 minutes 
for CPT code 73720. We are proposing these changes to maintain 
consistency with other MR services without contrast materials, with 
contrast materials, and without-and-with contrast materials, 
respectively.
(31) Abdominal X-ray (CPT Codes 74022, 740X1, 740X2, and 740X3)
    CPT codes 74000 (Radiologic examination, abdomen; single 
anteroposterior view) and 74022 (Radiologic examination, abdomen; 
complete acute abdomen series, including supine, erect, and/or 
decubitus views, single view chest) were identified via a high 
expenditure screen. The CPT Editorial Panel created CPT codes 740X1, 
740X2, and 740X3 to replace CPT codes 74000, 74010, and 74020. For CY 
2018, we are proposing the RUC-recommended work values for these codes.
    As part of their recommendations, the RUC's utilization crosswalk 
suggests that 25 percent of services currently reported with CPT code 
74010 will be reported with CPT code 740X2 and 75 percent will be 
reported with CPT code 740X3; and 75 percent of services currently 
reported with CPT code 74020 will be reported with CPT code 740X2 and 
25 percent will be reported with CPT code 740X3. However, we did not 
identify evidence or a rationale for these assumptions. For purposes of 
calculating the proposed RVUs, we used an even distribution of services 
previously reported as CPT codes 74010 and 74020 to CPT codes 740X2 and 
740X3 instead of the RUC-recommended distribution because we think that 
the services previously reported with codes 74010 and 74020 will be 
reported in equal volume between the code representing two views and 
the code representing three views. We seek comment on information that 
would help us improve on this distribution for purposes of developing 
final RVUs, including rationale for the distribution reflected in the 
RUC's utilization crosswalk.
(32) Angiography of Extremities (CPT Codes 75710 and 75716)
    This code family was identified through the $10 million or more 
screen of high expenditure services. We are proposing the RUC-
recommended work RVUs of 1.75 for CPT code 75710 and 1.97 for CPT code 
75716. We are also proposing to use the RUC-recommended direct PE 
inputs for both CPT codes 75710 and 75716, with the following 
refinements. For the clinical labor task ``Technologist QC's images in 
PACS, checking for all images, reformats, and dose page,'' we are 
proposing refinements consistent with the standard clinical labor times 
for tasks associated with the PACS Workstation.
    We are also proposing to refine the clinical labor by removing the 
2 minutes associated with the task ``prepare room, equipment, and 
supplies.'' CPT codes 75710 and 75716, which represent radiological 
supervision and interpretation, are billed with codes that include 
activities such as needle placement and imaging, and the ``prepare 
room, equipment, supplies,'' activity will be accounted for with the 
codes that are billed with these interpretation codes.
(33) Ophthalmic Biometry (CPT Codes 76516, 76519, and 92136)
    In the CY 2016 PFS final rule with comment period, CMS identified 
CPT codes 76519 and 92136 as potentially misvalued on the high 
expenditure screen. For CY 2018, we are proposing the RUC-recommended 
work RVUs for each code in this family as follows: A work RVU of 0.40 
for CPT code 76516, a work RVU of 0.54 for CPT code 76519, and a work 
RVU of 0.54 for CPT code 92136.
    For both CPT codes 76519 and 92136, the RUC recommended adding an 
additional 8 minutes of immediate postservice time for dictating the 
report of the procedure for the medical record, review and sign report, 
communicate results to the patient, discussing lens implant options for 
desired post-operative refractive result, and entering an order for the 
intraocular lens implant. We considered time and work values that would 
not include the additional 8 minutes of immediate postservice time in 
either of these codes, due to the concern that the additional time may 
not reflect the typical case. Were we to not include those 8 minutes, 
each of these procedures would have a total time of 14 minutes. We 
considered applying the total time ratio (decrease from 17 minutes to 
14 minutes; ratio of 0.824) to the RUC-recommended work RVU of 0.54, 
which would have resulted in a work RVU of 0.44 for both CPT codes 
76519 and 92136. We are seeking comment on whether these alternative 
values would improve relativity.
(34) Ultrasound of Extremity (CPT Codes 76881 and 76882)
    The RUC identified CPT codes 76881 and 76882 for review of PE 
inputs. For CPT code 76881, we are proposing the recommended inputs 
with refinements. We are proposing to remove 1 minute from the clinical 
labor task ``Exam documents scanned into PACS. Exam completed in RIS 
system to generate billing process and to populate images into 
Radiologist work queue,'' because this code does not include any 
equipment time for the PACS workstation proxy or professional PACS 
workstation. We note that the RUC-recommended inputs shift the general 
ultrasound room from the PE inputs for CPT code 76881 to the PE inputs 
for CPT code 76882. We are proposing to make this change, consistent 
with the RUC recommendations. We are also seeking comment on whether a 
portable ultrasound unit would be a more accurate PE input for both 
codes, given that the dominant specialty for both of these services is 
podiatry based on available 2016 Medicare claims data. However, we are 
proposing that these codes would not be subject to the phase-in of 
significant RVU reductions given the significance of this shift of 
resource costs between codes in the same family. In the CY 2016 PFS 
final rule (80 FR 70927 through 70931), we finalized a policy to 
identify services that are not subject to the phase-in because they are 
new or revised codes. We excluded as new and revised codes those codes 
that describe a different set of services in the update year when 
compared to the current year by virtue of changes in other related 
codes or codes that are part of a family with significant coding 
revisions. Significant coding revisions within a family of codes can 
change the relationships among codes to the extent that it changes the 
way that all services in the group are reported, even if some 
individual codes retain the same number or, in some cases, the same 
descriptor. Moving the general ultrasound room input from CPT code 
76881 to CPT code 76882 as recommended by the RUC would represent a 
significant shift in direct PE due to the high cost nature of this 
equipment item. As a result, these codes describe different services in 
the update year than in the current year, producing a substantial 
revision in the valuation of the coding. We are seeking comment on this 
proposed application of the phase-in policy.
(35) Radiation Therapy Planning (CPT Codes 77261, 77262, and 77263)
    CPT code 77263 was identified through a screen of high expenditure 
services across specialties. CPT codes 77261 and 77262 were included 
for review. For CY 2018, we are proposing the RUC-recommended work RVUs 
of

[[Page 34003]]

1.30 for CPT code 77261, 2.00 for CPT code 77262, and 3.14 for CPT code 
77263.
    However, we have concerns regarding the RUC-recommended work RVUs 
given the decreases in service times as recommended by the RUC and 
reflected in the survey data compared to the current values. For CPT 
code 77263, we considered a work RVU of 2.60 based on a crosswalk to 
CPT code 96111 (Developmental testing, (includes assessment of motor, 
language, social, adaptive, and/or cognitive functioning by 
standardized developmental instruments) with interpretation and 
report), which has an identical intraservice time, and similar total 
time to the RUC-recommended time values for CPT code 77263. We are 
concerned that despite a 15 minute decrease in intraservice time, the 
RUC did not recommend a work RVU decrease.
    We note that the majority of the utilization among the codes in 
this family would be reported with CPT code 77263. Therefore, we 
considered using a work RVU of 2.60 for CPT code 77263 as a base for 
alternative valuations for CPT codes 77261 and 77262 by applying the 
ratio of the crosswalk work RVU of CPT code 96111 (Developmental test 
extend) to the RUC-recommended work RVU of CPT code 77263 (that is, 
2.60/3.14 = 0.83) to the RUC-recommended work RVU for CPT code 77261 
(that is, 0.83 x 1.30 = 1.08) and CPT code 77262 (that is, 0.83 x 2.0 = 
1.66), which would have resulted in work RVUs of 1.08 for CPT code 
77261 and 1.66 for CPT code 77262. We seek comments on whether the 
alternative valuation would be more appropriate for these codes.
(36) Pathology Consultation during Surgery (CPT Codes 88333 and 88334)
    CPT codes 88333 and 88334 were surveyed for both work and PE for 
the CY 2018 rule cycle. We are proposing the RUC-recommended work RVU 
of 1.20 for CPT code 88333 and the RUC-recommended work RVU of 0.73 for 
CPT code 88334. For the direct PE inputs, we are proposing to remove 
the clinical labor for the ``Prepare room. Filter and replenish stains 
and supplies (including setting up grossing station with colored 
stains)'' activity from CPT code 88333. This clinical labor is not 
currently included in the direct PE inputs for CPT code 88333, and we 
continue to believe that this is a form of indirect PE that is not 
individually allocable to a particular patient for a particular 
service. While we agree that replenishing stains and supplies is a 
necessary task, under the established methodology, it is more 
appropriately classified as indirect PE.
    We are proposing to refine the clinical labor time for ``Clean 
room/equipment following procedure'' activity for CPT code 88333, 
consistent with the standard clinical labor time assigned for room 
cleaning when used by laboratory services. We seek comments related to 
the equipment time assigned to the ``grossing station w-heavy duty 
disposal'' (EP015) for both CPT codes 88333 and 88334. Although the 
recommended equipment time of 10 minutes maintains the current 
equipment time assigned to the grossing station, and we have no reason 
to believe that this time is incorrect, it is unclear to us how this 
equipment time is derived.
(37) Tumor Immunohistochemistry (CPT Codes 88360 and 88361)
    CPT codes 88360 and 88361 appeared on a high expenditure services 
screen across specialties with Medicare allowed charges of over $10 
million. We are proposing the RUC-recommended work RVU of 0.85 for CPT 
code 88360 and the RUC-recommended work RVU of 0.95 for CPT code 88361. 
We are proposing to refine the clinical labor time for the ``Enter 
patient data, computational prep for antibody testing, generate and 
apply bar codes to slides, and enter data for automated slide stainer'' 
activity for both codes, consistent with the standard time for this 
clinical labor activity across different pathology services. For CPT 
code 88361, we are also proposing to remove the 1 minute of clinical 
labor time from the ``Performing instrument calibration, instrument qc 
and start up and shutdown'' and the ``Gate areas to be counted by the 
machine'' activities. These clinical labor activities do not appear in 
other recently reviewed computer-assisted pathology codes. We believe 
that these clinical labor activities would not be typical for CPT code 
88361 and are already included in the allocation of indirect PE 
consistent with our established methodology.
    We are proposing to remove the clinical labor time for ``Clean 
room/equipment following procedure'' for CPT codes 88360 and 88361, as 
we believe that this clinical labor is duplicative of the 4 minutes of 
clinical labor assigned to ``Clean equipment and work station in 
histology lab''. We are also proposing to remove the clinical labor 
time for the ``Verify results and complete work load recording logs'' 
and the ``Recycle xylene from tissue processor and stainer'' activities 
for CPT codes 88360 and 88361. As we have stated in previous rules, 
such as in the CY 2017 PFS final rule (81 FR 80319), we believe these 
clinical labor activities to be already included in the allocation of 
indirect PE consistent with our established methodology.
    We are proposing to refine the equipment time for the ``Benchmark 
ULTRA auto slide prep & E-Bar Label system'' (EP112) from 18 minutes to 
16 minutes for both codes. The RUC-recommended equipment time of 18 
minutes was an increase of 3 minutes from the current EP112 equipment 
time to incorporate the equipment time of the ``E-Bar II Barcode Slide 
Label System'' (EP113), which the recommended materials have clarified 
is part of the EP112 equipment item. We are proposing to add 1 minute 
over the current value of 15 minutes to the EP112 equipment time to 
reach the aforementioned 16 minutes, as we believe that this would be 
more typical for the slide labeling taking place.
    For CPT code 88361, we are proposing to maintain the current price 
of $195,000.00 for the DNA image analyzer (EP001) equipment, as the 
submitted invoice contains a series of unrelated items that have been 
crossed out, making it difficult to determine the cost of the 
equipment. We considered refining the equipment time for the DNA image 
analyzer from 30 minutes to 5 minutes. The equipment literature for the 
DNA image analyzer states that the machine can run 50 slides per hour, 
and CPT code 88361 only requires 3 slides per procedure. This works out 
to 3.6 minutes of equipment usage (3 slides divided by 50 slides per 
hour multiplied by 60 minutes in an hour), to which we considered 
adding 1 minute for preparing the slides. The resulting figure of 4.6 
minutes would then round up to 5 minutes, which we considered as the 
potential equipment time for EP001 assigned to CPT code 88361. We seek 
comments on additional pricing information for the EP001 DNA image 
analyzer equipment, specifically invoices solely for this equipment 
containing a rationale for each component part, as well as the 
appropriate equipment time typically required for use in CPT code 
88361.
(38) Cardiac Electrophysiology Device Monitoring Services (CPT Codes 
93279, 93281, 93282, 93283, 93284, 93285, 93286, 93287, 93288, 93289, 
93290, 93291, 93292, 93293, 93294, 93295, 93296, 93297, 93298, and 
93299)
    As part of the CY 2016 PFS final rule (80 FR 70914), several 
services in this family (reported with CPT codes 93288, 93293, 93294, 
93295, and 93296) were identified as potentially misvalued through the 
high expenditure by

[[Page 34004]]

specialty screen. Seven of the 21 services in this family involve 
remote monitoring of cardiovascular devices, and two of these services 
(reported with CPT codes 93296 and 93299) are valued for practice 
expense only. For CY 2018, we are proposing the RUC-recommended work 
RVUs for the 19 CPT codes in this family that are valued with physician 
work as follows: 0.65 for CPT code 93279, 0.77 for CPT code 93280, 0.85 
for CPT code 93281, 0.85 for CPT code 93282, 1.15 for CPT code 93283, 
1.25 for CPT code 93284, 0.52 for CPT code 93285, 0.30 for CPT code 
93286, 0.45 for CPT code 93287, 0.43 for CPT code 93288, 0.75 for CPT 
code 93289, 0.43 for CPT code 93290, 0.37 for CPT code 93291, 0.43 for 
CPT code 93292, 0.31 for CPT code 93293, 0.60 for CPT code 93294, 0.74 
for CPT code 93295, 0.52 for CPT code 93297, and 0.52 for CPT code 
93298.
    For CPT code 93293, we considered a work RVU of 0.91 (25th 
percentile survey result) and seek comment on whether this alternative 
work RVU for this service would better maintain relativity between 
single and dual lead pacemaker systems and cardioverter defibrillator 
services. We considered reducing the work RVU for CPT code 93282 by 
0.11 work RVUs and seek comments on whether this alternative value 
would better reflect relativity between the single and dual lead 
systems that exist within pacemaker services and within cardioverter 
defibrillator services. We also noted that there is a difference of 
0.10 work RVUs between the RUC-recommended values for CPT codes 93289 
and 93282. Therefore, we considered a proportionate reduction for CPT 
code 93289 to a work RVU of 0.69. For CPT code 93283, we considered a 
work RVU of 0.91, consistent with the 25th percentile from the survey 
results, and seek comment on whether this value would improve 
relativity.
    As noted in this section of the proposed rule, several of the CPT 
codes (99392, 99294, 99295, 99297, and 99298) reviewed by the RUC in 
January 2017 involve remote monitoring services for cardiac devices. We 
agree with the RUC that these services are difficult to value 
considering that the monitoring duration (number of days between 30 and 
90) and the average number of transmissions vary. We also note that 
these codes were surveyed twice, and in both cases the intraservice and 
total times were considered by the specialty societies to be 
inconsistent with existing times. The RUC explained that they 
extrapolated total and intraservice time data for these codes and 
warned against making comparisons. Without additional information about 
the methods and sources used for extrapolation, however, we have no 
basis for assuming the imputed values are of higher quality and/or 
accuracy than those from the survey. We do not agree, therefore, that 
survey results should not be used as a point of comparison in the 
context of other factors, particularly when they are used to support 
other considerations.
    Although we are proposing the RUC-recommended work RVUs for each of 
these CPT codes, we considered alternative values. The RUC recommended 
a work RVU of 0.31 for CPT code 93293, which is 0.01 work RVUs lower 
than the existing work RVU for this code. We have concerns that the 
amount of the reduction in the work RVU recommended by the RUC may not 
be consistent with the decrease in total time of 7 minutes. We 
considered an alternative crosswalk for CPT code 93293 (Pm phone r-
strip device eval) (5 minutes intraservice time and 13 minutes total 
time) to CPT code 94726 (Pulm funct tst plethysmograp), which has 5 
minutes intraservice time and 15 minutes total time and a work RVU of 
0.26. We seek comments our proposed and alternative valuations for this 
code.
    For CPT code 93294, we considered a work RVU of 0.55, crosswalking 
from CPT code 76706 (Us abdl aorta screen aaa), and we seek comments on 
whether it would better align with the RUC-recommended service times. 
We are concerned that a work RVU of 0.60 may not account for the 
difference between existing service times and the RUC-recommended 
service times. Similarly, the RUC recommended a work RVU for CPT code 
93294 of 0.60, which is 0.05 work RVUs less than the existing work RVU. 
The total time for furnishing services reported with CPT code 93294 
decreased by 10 minutes, however, and we believe this reduction in time 
may not be appropriately reflected by a decrease of 0.05 work RVUs. 
Compared to services with similar total and intraservice times, we 
identified CPT code 76706 (Us abdl aorta screen aaa) as potentially a 
more appropriate crosswalk. CPT code 76706 has identical intraservice 
and total service times as CPT code 93294, with a work RVU of 0.55. We 
seek comments on whether our alternative value would better reflect the 
time and intensity involved in furnishing this service.
    For CPT code 93295, we considered a work RVU of 0.69, crosswalking 
to CPT code 76586, which has identical intraservice and total times 
compared to CPT code 93295. We considered using a work RVU of 0.69 to 
maintain the differential between CPT code 93295 and the work RVU we 
considered for the previous code in this family (a work RVU of 0.11 for 
CPT code 93295). We are concerned about the decrease in service time 
compared to the work RVU. We note that the existing intraservice time 
is 22.5 minutes, compared to the RUC-recommended intraservice time of 
10 minutes. We seek comments on whether our alternative value would 
better reflect the time and intensity involved in furnishing this 
service.
    For CPT code 93298, the RUC recommended a work RVU of 0.52, which 
is unchanged from the current work RVU for this code. We are concerned 
about that recommendation given the reduction in both intraservice and 
total time for this service. The intraservice time decreased from 24 to 
7 minutes, while total time decreased from 44 to 17 minutes. We 
acknowledge that the current times for this CPT code and others in this 
family are extrapolations. However, without additional information 
about the extrapolation of data from survey results, we question 
whether the survey results should be excluded from consideration 
altogether. We considered a work RVU of 0.37 for CPT code 93297, 
crosswalking to CPT code 96446 (Chemotx admn prtl cavity). We also 
considered a work RVU of 0.37 for CPT code 93298 based on a crosswalk 
to CPT code 96446, since the RUC indicated that the work RVUs for CPT 
codes 93297 and 93298 should be the same. We are seeking comment on our 
proposed valuation and whether our alternative valuation would be more 
appropriate for this code.
    We propose the RUC-recommended direct PE inputs with the following 
refinements. We propose to remove 2 minutes for ``review charts'' from 
CPT codes 93279, 93281, 93282, 93283, 93284, 93285, 93286, 93287, 
93288, 93289, 93290, 93291, and 93292 to maintain relativity since it 
is not typically incorporated for similar PFS codes. We also propose 
removing 2 minutes for ``complete diagnostic forms, lab & X-ray 
requisitions'' for the labor category ``med tech/asst'' (L026A) for 
these services because we believe the same activity is being performed 
by labor category RN/LPN/MTA (L037D). We seek comments regarding 
whether this row was included in error. Also for the same group of CPT 
codes, we also propose standard refinements for the time for equipment 
items EF023 and EQ198.
    We propose to use the RUC-recommended direct practice expense 
inputs and times for all other CPT codes in this family (CPT codes 
93293, 93294,

[[Page 34005]]

93295, 93296, 93297, 93298, and 93299) without refinement.
(39) Transthoracic Echocardiography (TTE) (CPT Codes 93306, 93307, and 
93308)
    In the CY 2016 PFS final rule with comment period (80 FR 70914), 
CMS identified CPT code 93306 through the high expenditures screen. 
Subsequently, the RUC reviewed CPT codes 93307 and 93308, in addition 
to CPT code 93306 as part of this family of codes that describe 
transthoracic echocardiograms. For CY 2018, we are proposing the RUC-
recommended work RVUs for CPT codes 99306 (a work RVU of 1.50), 99307 
(a work RVU of 0.92), and 99308 (a work RVU of 0.53), and proposing the 
RUC-recommended direct PE inputs for CPT codes 93306, 93307, and 93308 
without refinement.
    For CPT code 93306 (Echocardiography, transthoracic, real-time with 
image documentation (2D), includes M-mode recording, when performed, 
complete, with spectral Doppler echocardiography, and with color flow 
Doppler echocardiography), we considered maintaining the CY 2017 work 
RVU of 1.30. The surveyed total time for this code dropped slightly due 
to changes in the immediate postservice time. The median preservice and 
intraservice time remained unchanged.
    For CPT code 93307 (Echocardiography, transthoracic, real-time with 
image documentation (2D), includes M-mode recording, when performed, 
complete, without spectral or color Doppler echocardiography), we 
considered a work RVU of 0.80, crosswalking to services with similar 
service times (CPT codes 93880 (Extracranial bilat study), 93925 (Lower 
extremity study), 93939, 93976 (Vascular study), and 93978 (Vascular 
study)). The surveyed total time dropped 3 minutes (from the 
intraservice time) compared to the existing service times for this 
code.
    For CPT code 93308 (Echocardiography, transthoracic, real-time with 
image documentation (2D), includes M-mode recording, when performed, 
follow-up or limited study), we considered a work RVU of 0.43, 
crosswalking to CPT code 93292 (Wcd device interrogate) based on 
similar service times. The surveyed total time dropped by 5 minutes 
(from the intraservice time) compared to the existing service times for 
this code.
    For CY 2018, we are proposing the RUC-recommended work RVUs for CPT 
codes 93306, 93307, and 93308 and seek comments on whether our 
alternative values would better reflect the time and intensity of these 
services.
(40) Stress Transthoracic Echocardiography (TTE) Complete (CPT Codes 
93350 and 93351)
    CPT code 93351 was identified as potentially misvalued and the RUC 
reviewed CPT code 93350 as part of the same code family. For CY 2018, 
we are proposing the RUC-recommended work RVUs for CPT codes 93350 (a 
work RVU of 1.46) and 93351 (a work RVU of 1.75).
    We are proposing the following refinements to the RUC-recommended 
direct PE inputs for CPT codes 93350 and 93351. For both codes, we 
applied the standard formula in developing the minutes for equipment 
item ED053 (professional PACS workstation), which results in 18 minutes 
for CPT code 93350 and 25 minutes for CPT code 93351. We are also 
proposing standard clinical labor times for providing preservice 
education/obtaining consent. We are not proposing to include clinical 
labor time for the task setup scope since there is no scope used in the 
procedure and we do not agree with the RUC's statement that this 
replicates 5 minutes in CPT code 93015 when the RN prepares patients 
for 10-lead ECG. We have found that there is no corresponding time of 5 
minutes for setup scope in the PE inputs for CPT code 93015. We are 
proposing refinements to the equipment time for ED050 (PACS workstation 
proxy) for CPT code 93351, consistent with our standard equipment times 
for PACS Workstation Proxy.
(41) Peripheral Artery Disease (PAD) Rehabilitation (CPT Code 93668)
    We have issued a national coverage determination (NCD) for Medicare 
coverage of supervised exercise therapy (SET) for the treatment of 
peripheral artery disease (PAD). Information regarding the NCD can be 
found on the CMS Web site at https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=287. For the remainder of 
CY 2017, we anticipate that CPT code 93668, currently assigned PROCSTAT 
N (noncovered service by Medicare), will be payable before the end of 
CY 2017, retroactive to the effective date of the NCD to implement 
payment under the NCD.
    For CY 2018, we are proposing to make payment for Medicare-covered 
SET for the treatment of PAD, consistent with the NCD, reported with 
CPT code 93668. For CPT code 93668, we are proposing to use the most 
recent RUC-recommended work and direct PE inputs. We are also seeking 
comment on the coding structure and valuation assumptions. Since the 
RUC has not reviewed CPT code 93668 since 2001, we seek comments on the 
direct PE inputs assigned to the code, which appear in the direct PE 
input database. We also note that CPT code 93668 is a PE only code and 
does not include physician work.
    CPT prefatory language states that CPT code 93668 may be separately 
reported with appropriate E/M services, including office and/or 
outpatient services (CPT codes 99201 through 99215), initial hospital 
care (CPT codes 99221 through 99223), subsequent hospital care (CPT 
codes 99231 through 99233), and critical care services (CPT codes 99291 
through 99292). Our understanding of CPT's prefatory language is that 
these E/M codes may only be billed when review or exam of the patient 
is medically indicated and must conform to all existing E/M 
documentation requirements. E/M visit codes should not be billed to 
account for supervision of SET for the treatment of PAD by a physician 
or other qualified healthcare practitioner. We seek comments on whether 
to develop professional coding to reflect the supervision of clinical 
staff, and on the potential overlap with CPT code 99211 (Office or 
other outpatient visit for the evaluation and management of an 
established patient, that may not require the presence of a physician 
or other qualified health care professional. Usually, the presenting 
problem(s) are minimal. Typically, 5 minutes are spent performing or 
supervising these services.) and any distinctions between time spent by 
clinical staff for CPT code 99211 and time spent by clinical staff for 
CPT code 93668.
(42) Pulmonary Diagnostic Tests (CPT Codes 94621, 946X2, and 946X3)
    CPT code 94620 was identified as part of a screen of high 
expenditure services with Medicare allowed charges of $10 million or 
more that had not been recently reviewed. CPT code 94621 was added to 
the family for review. The CPT Editorial Panel deleted CPT code 94620 
and split it into two new codes, CPT codes 946X2 and 946X3, to describe 
two different tests commonly performed for evaluation of dyspnea. We 
are proposing the RUC-recommended work RVUs of 1.42 for CPT code 94621, 
0.70 for CPT code 946X2, and 0.48 for CPT code 946X3.
    We are proposing to refine the clinical labor time for the 
``Provide preservice education/obtain consent'' activity from 10 
minutes to 5 minutes for CPT code 94621, which is the current time 
assigned for this task. While we agree that CPT code 94621 requires 
additional time above the standard for this clinical

[[Page 34006]]

labor activity, we do not believe that double the current time would be 
typical for this procedure. We are also proposing to refine the 
clinical labor time for the ``Prepare and position patient/monitor 
patient/set up IV'' activity from 5 minutes to 3 minutes for the same 
code. The standard time for this activity is 2 minutes, and we are 
proposing a value of 3 minutes to reflect 1 minute of additional 
preparation time above the standard. We believe that additional 
clinical labor time used for preparation would be included under the 10 
minutes assigned to the ``Prepare room, equipment, supplies'' activity 
for this code.
    We are proposing to refine the clinical labor time for the 
``Complete diagnostic forms, lab & X-ray requisitions'' activity, 
consistent with the standard clinical labor time for this activity. We 
also propose to refine the equipment times for CPT codes 94621 and 
946X2 to account for 1:4 patient monitoring time, and to refine the 
equipment times for CPT code 946X3 consistent with standards for non-
highly technical equipment.
    We considered refining the clinical labor time for the ``pre 
exercise ECG, VC, Min Vent. Calculation'' activity from 27 minutes to 
15 minutes for CPT code 94621. We considered proposing this value of 15 
minutes based on assigning 5 minutes apiece for the ECG, the MVV, and 
the spirometry. We believe that each of these three components of this 
clinical labor activity would typically take no longer than 5 minutes 
based on a comparison to the use of these tasks in other CPT codes. We 
also considered refining the clinical labor time for the ``Clinical 
staff performs procedure'' activity from 55 minutes to 35 minutes for 
CPT code 946X2 and from 14 minutes to 12 minutes for CPT code 94621. 
The RUC-recommended materials for the PE inputs state that this 
clinical labor task consists of performing 5 spirometries at 9 minutes 
each plus 10 minutes of exercise time for CPT code 946X2; we believe 
that the spirometries typically take 5 minutes each, which would reduce 
this activity from 55 minutes to 35 minutes. For CPT code 94621, we 
considered maintaining the current value of 12 minutes due to a lack of 
justification for increasing the time to 14 minutes.
    While we remain concerned about the intraservice period clinical 
labor times, for CY 2018, we are proposing the RUC-recommended work 
RVUs for each code in this family and seek comment on whether our 
alternative clinical labor times would better reflect the work and 
times for these services.
(43) Percutaneous Allergy Skin Tests (CPT Code 95004)
    In the CY 2016 PFS proposed rule (80 FR 41706), CPT code 95004 was 
identified through the high expenditures screen as potentially 
misvalued. The RUC suggested in its comments on the CY 2016 PFS 
proposed rule (80 FR 41706), that CPT code 95004 should be removed from 
the list of potentially misvalued codes because it has a work RVU of 
0.01 and that it would serve little purpose to survey physician work 
for this code. The RUC and CMS previously determined that there is 
physician work involved in providing this service since the physician 
must interpret the test and prepare a report. In the CY 2016 PFS final 
rule with comment period (80 FR 70913), CMS reiterated an interest in 
the review of work and PE for this service. We note that our interest 
in stakeholder review of a particular code should not be considered a 
directive for survey under the RUC process. We intend to more clearly 
state our interests in the future, so that under similar circumstances, 
such effort need not be undertaken based on a mistaken impression. To 
reiterate, we believe that whether or not a code should be surveyed in 
response to our interest in receiving recommendations regarding the 
work RVUs should be at the RUC and the specialties' discretion. In many 
cases, we have used recommendations developed through means other than 
surveys in developing RVUs. For example, for many PFS services, the 
direct PE inputs are the primary drivers of overall RVUs and Medicare 
payment. In most of these cases, the recommended inputs are not derived 
from survey data. In some cases, especially for resource-intensive and 
highly technical services, we have expressed some concern about the 
lack of survey or other broad-based data that we have relied on in 
developing rates across the PFS for many years.
    For CY 2018, we are proposing the RUC-recommended work RVU of 0.01 
for CPT code 95004.
    Regarding direct PE inputs, we are proposing to refine the 
equipment times for exam table (EF023) and mayo stand (EF015) to 79 
minutes each to account for clinical 1:4 patient monitoring time. We 
received invoices with new pricing information for two supplies: SH101 
``negative control, allergy test'' ($5.17) and SH102 ``positive 
control, allergy test'' ($26.12). Using this information, we are 
proposing a price of $0.03 per test for supply item SH101 and a price 
of $0.13 per test for supply item SH102.
(44) Continuous Glucose Monitoring (CPT Codes 95250 and 95251)
    CPT codes 95250 (Ambulatory continuous glucose monitoring of 
interstitial tissue fluid via a subcutaneous sensor for a minimum of 72 
hours; sensor placement, hook-up, calibration of monitor, patient 
training, removal of sensor, and printout of recording) and 95251 
(Ambulatory continuous glucose monitoring of interstitial tissue fluid 
via a subcutaneous sensor for a minimum of 72 hours; interpretation and 
report) are used to report the technical and professional component for 
continuous glucose monitoring. In April 2013, CPT code 95251 was 
identified through the high volume growth services screen and 
subsequently this code family was reviewed at the RUC's October 2016 
meeting.
    For CY 2018, we are proposing the RUC-recommended work RVU of 0.70 
for CPT code 95251. However, we are concerned and seek comments on 
whether the 2 minutes of physician preservice time is necessary. Since 
CPT code 95251 is typically billed with an E/M service on the same day, 
we believe the 2 minutes of preservice time may be duplicative. 
Furthermore, we seek comment on whether it would be typical for the 
physician to spend 2 minutes to obtain the CGM reports for review since 
we believe the report would typically be obtained by clinical staff on 
behalf of the physician.
    For the direct PE inputs, the RUC submitted 19 invoices to update 
the price of the medical supply item ``glucose monitoring 
(interstitial) sensor'' (SD114) for CPT code 95250. We are proposing to 
use these invoice prices for the glucose monitoring (interstitial) 
sensor (SD114), with an average cost of $53.08. Therefore, we are 
proposing to use the average price of $53.08 for this supply item.
    As part of our review of this service, we obtained publicly 
available pricing information for the CGM system (EQ125). We reviewed 
the information provided in a study titled, ``The cost-effectiveness of 
continuous glucose monitoring in type 1 diabetes,'' (Huang, SE., 
O'Grady, M., Basu, A. et al., Diabetes Care. June 2010), which 
indicated the price of CGM technology (without sensors) from 3 
different vendors, reflective of full retail prices with no insurer 
discounts, to be $600.00, $1119.00, and $1250.00, which equated to an 
average cost of $1016.00 for the CGM system. In addition, we obtained 
publicly available pricing information for two vendors. This 
information indicated the price of a

[[Page 34007]]

CGM system to be $1061.90 and $1279.17, which equated to an average 
cost of $1170.54. For CY 2018, we are proposing to price supply items 
SD114 at $53.08 and EQ125 at $1170.54. We seek comments on current 
pricing for equipment item ``continuous glucose monitoring system'' 
(EQ125).
(45) Parent, Caregiver-Focused Health Risk Assessment (CPT Codes 96160 
and 96161)
    In the CY 2017 PFS final rule (81 FR 80330), we discussed that in 
October 2015, the CPT Editorial Panel created two new PE-only codes, 
CPT code 96160 (Administration of patient focused health risk 
assessment instrument (e.g., health hazard appraisal) with scoring and 
documentation, per standardized instrument) and CPT code 96161 
(Administration of caregiver-focused health risk assessment instrument 
(e.g., depression inventory) for the benefit of the patient, with 
scoring and documentation, per standardized instrument). We assigned an 
active payment status to both codes for CY 2017 and finalized use of 
the RUC-recommended values for these codes. We also assigned an add-on 
code status to both of these services. As add-on codes, CPT codes 96160 
and 96161 describe additional resource components of a broader service 
furnished to the patient that are not accounted for in the valuation of 
the base code.
    The RUC submitted updated recommendations for the direct PE inputs 
for CPT codes 96160 and 96161 after reviewing new specialty society 
surveys. The RUC recommended 7 total minutes of clinical staff time, 
and we are proposing to adopt this number of minutes in valuing the 
services. The PE worksheet included several distinct tasks with minutes 
for each; however, in keeping with the standardization of clinical 
labor tasks, we are proposing to designate all 7 minutes under 
``administration, scoring, and documenting results of completed 
standardized instrument'' rather than dividing the minutes into the 
four categories as shown in the RUC recommendations.
(46) Chemotherapy Administration (CPT codes 96401, 96402, 96409, and 
96411)
    In the CY 2016 PFS proposed rule, CPT codes 96401 (Chemotherapy 
administration, subcutaneous or intramuscular; non-hormonal anti-
neoplastic), 96402 (Chemotherapy administration, subcutaneous or 
intramuscular; hormonal anti-neoplastic), 96409 (Chemotherapy 
administration; intravenous, push technique, single or initial 
substance/drug), and 96411 (Chemotherapy administration; intravenous, 
push technique, each additional substance/drug (List separately in 
addition to code for primary procedure)) were identified through the 
high expenditure services screen across specialties with Medicare 
allowed charges of over $10 million.
    For CY 2018, we are proposing the RUC-recommended work RVUs for CPT 
code 96401 (a work RVU of 0.21), CPT code 96402 (a work RVU of 0.19), 
CPT code 96409 (a work RVU of 0.24) and CPT code 96411 (a work RVU of 
0.20).
    For CPT code 96402, we are proposing the RUC-recommended equipment 
times with refinements for the biohazard hood (EP016) and exam table 
(EF023) from 31 minutes to 34 minutes to reflect the service period 
time associated with this code. We are proposing the RUC-recommended 
direct PE inputs for CPT codes 96401, 96409, and 96411 without 
refinements.
(47) Photochemotherapy (CPT Code 96910)
    CPT code 96910 appeared on a high expenditure services screen 
across specialties with Medicare allowed charges of over $10 million, 
which is a PE-only code that does not have work RVUs.We are proposing 
to refine the clinical labor time for the ``Provide preservice 
education/obtain consent'' from 3 minutes to 1 minute for CPT code 
96910. We believe that 1 minute would be typical for patient education, 
as CPT code 96910 is a repeat procedure where there would not be a need 
to obtain consent again. We are also proposing to remove the 2 minutes 
of clinical labor for the ``Complete diagnostic forms, lab & X-ray 
requisitions'' activity, as this item is considered indirect PE 
consistent with our established methodology. We are also proposing to 
create a new supply code (SB054) for the sauna suit, and proposing to 
price at $9.99 based on the submitted invoice. Finally, we are also 
proposing to adjust the equipment times to reflect changes in the 
clinical labor for CPT code 96910.
    We are proposing the RUC-recommended clinical labor time of 15 
minutes for the ``Prepare and position patient/monitor patient/set up 
IV'' activity, the RUC-recommended clinical labor time of 16 minutes 
for the ``Monitor patient during procedure'' activity, and the RUC-
recommended clinical labor time of 15 minutes for the ``Clean room/
equipment by physician staff'' activity, but seeking additional 
information regarding the rationale for these values. Given the lack of 
explanation, we considered using the current clinical labor time of 7 
minutes for the ``Prepare and position patient/monitor patient/set up 
IV'' activity, the current clinical labor time of 4 minutes for the 
``Monitor patient during procedure'' activity, and the current clinical 
labor time of 10 minutes for the ``Clean room/equipment by physician 
staff'' activity. We seek comment on whether maintaining the current 
values would improve relativity.
    We considered removing the ``Single Patient Discard Bag, 400 ml'' 
(SD236) supply and replacing it with the ``biohazard specimen transport 
bag'' (SM008). We are concerned about whether the single patient 
discard bag is the appropriate size for storing the sauna suit used in 
this procedure, and whether use of a biohazard specimen transport bag 
would be typical. We seek comments on our proposed and alternative 
values for these direct PE inputs.
(48) Photodynamic Therapy (CPT Codes 96567, 96X73, and 96X74)
    CPT code 96567 was identified as potentially misvalued through a 
CMS screen for codes with high expenditures. This code describes a 
service furnished by clinical staff and does not include physician 
work. For CY 2018, the CPT Editorial Panel created two new codes, CPT 
codes 96X73 and 96X74, to describe photodynamic therapy by external 
application of light to destroy premalignant skin lesions, including 
the physician work involved in furnishing the service. CPT codes 96567, 
96X73, and 96X74 were reviewed during the RUC's January 2017 meeting.
    For CY 2018, we are proposing the RUC-recommended work RVUs for CPT 
code 96X73 (a work RVU of 0.48) and CPT code 96X74 (a work RVU of 
1.01).
    We are proposing the RUC-recommended PE inputs with refinements due 
to inconsistencies between the stated description of clinical 
activities and the submitted spreadsheets. First, we propose to add 
assist physician clinical staff time to CPT codes 96X73 (10 minutes) 
and 96X74 (16 minutes), which is equivalent to the physician 
intraservice times for these services. For both CPT codes 96X73 and 
96X74, we propose a reduction from 35 minutes to 17 minutes for 
clinical activity in the postservice time, consistent with the 
description of clinical work in the summary of recommendations, which 
states that the patient receives activation of the affected area with 
the BLU-U Photodynamic Therapy Illuminator for approximately 17 
minutes. For CPT codes 96X73 and 96X74, we are

[[Page 34008]]

proposing to refine equipment formulas for two items: Power table 
(EF031) and LumaCare external light with probe set (EQ169), consistent 
with standards for nonhighly technical equipment. An explanation of the 
standards and formulas for equipment related to direct PE inputs is in 
the CY 2014 PFS final rule with comment period (79 FR 67557).
    We identified several vendors with publically available prices 
available for supply item LMX 4 percent cream (SH092) for significantly 
less than the existing $1.60 per gram. Based on our research of 
vendors, we are proposing to set the price of supply item SH092 to 
$0.78 per gram. Other CPT codes affected by the proposed change in the 
price of supply item LMX 4 percent cream (SH092) are: CPT code 46607 
(Anoscopy; with high-resolution magnification (HRA) (eg, colposcope, 
operating microscope) and chemical agent enhancement, with biopsy, 
single or multiple), CPT code 17000 (Destruction (eg, laser surgery, 
electrosurgery, cryosurgery, chemosurgery, surgical curettement), 
premalignant lesions (eg, actinic keratoses); first lesion), CPT code 
17003 (Destruction (eg, laser surgery, electrosurgery, cryosurgery, 
chemosurgery, surgical curettement), premalignant lesions (eg, actinic 
keratoses); second through 14 lesions, each (List separately in 
addition to code for first lesion)), and CPT code 17004 (Destruction 
(eg, laser surgery, electrosurgery, cryosurgery, chemosurgery, surgical 
curettement), premalignant lesions (eg, actinic keratoses), 15 or more 
lesions)).
    In addition, the RUC forwarded an invoice for a new supply item, 
safety goggles, at $6.00 and requested three goggles each for CPT codes 
96X73 and 96X74. Because we do not have a basis for distinguishing the 
requested new goggles from the existing UV-blocking goggles, we 
consider this invoice to be an additional price point for SJ027 rather 
than an entirely new item. We propose a price of $4.10 for supply item 
SJ027 (the average of the two prices for this supply item ($2.30 + 
$6.00)/2=$4.10)). Other CPT codes affected by the proposed change in 
the price of supply item UV-blocking goggles (SJ027) are: CPT code 
36522 (Photopheresis, extracorporeal), CPT code 96910 
(Photochemotherapy; tar and ultraviolet B (Goeckerman treatment) or 
petrolatum and ultraviolet B), CPT code 96912 (Photochemotherapy; 
psoralens and ultraviolet A (PUVA)), and CPT code 96913 
(Photochemotherapy (Goeckerman and/or PUVA) for severe photoresponsive 
dermatoses requiring at least 4-8 hours of care under direct 
supervision of the physician (includes application of medication and 
dressings)), CPT code 96920 (Laser treatment for inflammatory skin 
disease (psoriasis); total area less than 250 sq cm), CPT code 96921 
(Laser treatment for inflammatory skin disease (psoriasis); 250 sq cm 
to 500 sq cm), and CPT code 96922 (Laser treatment for inflammatory 
skin disease (psoriasis); over 500 sq cm). We seek comments on our 
proposed PE refinements, including our proposed supply item prices.
(49) Physical Medicine and Rehabilitation (PM&R) (CPT Codes 97012, 
97016, 97018, 97022, 97032, 97033, 97034, 97035, 97110, 97112, 97113, 
97116, 97140, 97530, 97533, 97535, 97537, 97542, and HCPCS code G0283)
    In our CY 2015 PFS final rule (79 FR 67576) and CY 2016 PFS final 
rule (80 FR 70917), we identified a total of ten codes through the high 
expenditure by specialty screen for services primarily furnished by 
physical and occupational therapists: CPT codes 97032, 97035, 97110, 
97112, 97113, 97116, 97140, 97530, 97535, and HCPCS code G0283. An 
additional nine codes in this PM&R family were identified for review by 
the physical therapy (PT) and occupational therapy (OT) specialty 
societies: CPT codes 97012, 97016, 97018, 97022, 97033, 97034, 97533, 
97537, and 97542. Many of these code values had not been reviewed since 
they were established in 1994, 1995 or 1998.
    After review during its January 2017 meeting, the HCPAC submitted 
recommendations for all 19 codes. While the HCPAC included 
recommendations for CPT code 97014, we note that this is a code we have 
not recognized for PFS payment since 2002 when we implemented our wound 
care electrical stimulation policies. For payment under the PFS, 
instead of CPT code 97014, we recognize HCPCS code G0281 for wound care 
electrical stimulation and HCPCS code G0283 for all other electrical 
stimulation scenarios, when covered. For CY 2018, we are proposing the 
HCPAC recommendations for CPT code 97014, HCPCS code G0283, and HCPCS 
code G0281.
    CMS considers all 19 codes as ``always therapy'' which means they 
are always considered to be furnished under a physical therapy (PT), 
occupational therapy (OT), or speech-language pathology (SLP) plan of 
care regardless of who furnishes them and the payment amounts are 
counted towards the appropriate statutory therapy cap--either the 
therapy cap for PT and SLP services combined, or the single therapy cap 
for OT services. These always therapy codes are also subject to the 
therapy MPPR.
    For CY 2018, we are proposing the HCPAC's recommended work RVUs for 
CPT codes 97012, 97016, 97018, 97022, 97032, 97033, 97533, 97034, 
97035, 97110, 97112, 97113, 97116, 97140, 97530, 97533, 97535, 97537, 
97542, and G0283 (97014).
    For supervised modality services reported with CPT codes 97012, 
97016, 97018, and 97022, and HCPCS code G0283 (97014), we considered 
maintaining the current values for these codes rather than the HCPAC 
recommendations. We note that the work times recommended by the HCPAC 
reflect use of the survey data even though the HCPAC explained in its 
recommendations that the survey results were not deemed credible 
because of a lack of evidence to support higher work RVUs of each 
survey's 25th percentile or median values. We note total time decreases 
among these codes ranging from 1 to 8 minutes.
    While we are proposing the HCPAC-recommended work RVUs and work 
times for each code in this family, we seek comments on whether 
maintaining the current times, given the HCPAC's lack of confidence in 
the survey data, would better reflect the work times for these 
services.
    We are proposing to maintain the existing CY 2017 PE inputs for all 
19 codes. We note that section 1848(b)(7) of the Act requires a 50 
percent therapy MPPR instead of the 25 percent therapy MPPR established 
during CY 201l PFS rulemaking. One of the primary rationales for the 
MPPR policy developed through the rulemaking process was that the 
direct PE inputs for these services did not fully recognize the 
redundant inputs when these services were furnished together, or in 
multiple units. After reviewing the recommended direct PE inputs, it is 
evident that they were developed based on an acknowledgement of the 
efficiencies of services typically furnished together as well as codes 
billed in multiple units. Given this assessment, we believe that were 
we to use the recommended inputs to develop the PE RVUs, the 50 percent 
MPPR on the PE for these services, as required by current law, would 
functionally duplicate the payment adjustments to account for 
efficiencies that had already been addressed through code-level 
valuation. Therefore, for CY 2018, we are proposing to retain the 
existing CY 2017 PE inputs for these services and seek comments on 
whether there is an

[[Page 34009]]

alternative approach that would avoid duplicative downward payment 
adjustments while still allowing for the direct PE inputs to be updated 
to better reflect current practice.
    We note that we believe that the always therapy codes subject to 
the therapy MPPR on PE are unique from other therapeutic and diagnostic 
procedure codes paid under the PFS and subject to MPPRs. For example, 
unlike most surgical services, these ``always therapy'' codes are 
typically billed either with other therapy codes or in multiple units, 
or both. Generally, MPPRs are used when codes are often, but not 
typically, furnished with other particular codes. When full sets of 
related codes are almost all typically billed with other codes, or 
billed in multiple units, coding and valuation have changed to reflect 
these practices. For example, new codes have been introduced to 
describe combined services or some related services are described by 
add-on codes. In other cases, the MPPR is considered in the valuation 
for individual services.
(50) Management and/or Training: Orthotics and Prosthetics (CPT Codes 
97760, 97761, and 977X1)
    For CY 2018, the CPT Editorial Panel revised the set of codes that 
comprise the CPT manual's PM&R subsection for orthotic management and 
prosthetic management at its September 2016 meeting. According to the 
CPT Editorial Panel, these revisions were made at the request of the 
specialty societies representing physical and occupational therapists 
to differentiate between the initial and subsequent encounters and to 
describe the ongoing management and/or training that is involved in 
subsequent encounters. These changes include:
     Revising the code descriptors by adding the term ``initial 
encounter'' to CPT code 97760 (Orthotic(s) management and training 
(including assessment and fitting when not otherwise reported), upper 
extremity(ies), lower extremity(ies) and/or trunk, initial orthotic(s) 
encounter, each 15 minutes), and CPT code 97761 (Prosthetic(s) 
training, upper and/or lower extremity(ies), initial prosthetic(s) 
encounter, each 15 minutes);
     Creating a new CPT code 977X1 (Orthotic(s)/prosthetic(s) 
management and/or training, upper extremity(ies), lower extremity(ies), 
and/or trunk, subsequent orthotic(s)/prosthetic(s) encounter, each 15 
minutes); and
     Deleting CPT code 97762 (checkout for orthotic/prosthetic 
use, established patient, each 15 minutes).
    Intended for the management and/or training of patients with 
orthotics and/or prosthetics, CPT codes 97760 and 97761 were previously 
used to report both the initial and subsequent encounters, that, when 
furnished under the Medicare outpatient therapy services benefit, 
included services occurring during the same PT or OT episode of care. 
CPT code 97762 was used to separately report the assessment and fitting 
(including any adjustments) of an orthotic or prosthetic for an 
established patient when these services were not bundled into another 
code or service. For CY 2018, CPT codes 97760 and 97761 are intended to 
be reported only for the initial encounter, and CPT code 977X1 is 
intended to be reported for all other orthotic and/or prosthetic 
services for an established patient that occur on a ``subsequent 
encounter'' or a different date of service from that of the initial 
encounter service.
    The HCPAC submitted work and PE recommendations for CPT codes 
97760, 97761, and 977X1 from their January 2017 meeting. For CY 2018, 
we propose the HCPAC recommended work RVU of 0.5 for CPT code 97760, a 
work RVU of 0.5 for CPT code 97761, and a work RVU of 0.48 for CPT code 
977X1. We note that for budget neutrality purposes, the HCPAC 
recommendations also included utilization crosswalks for each of the 
three codes that were each assigned a one-to-one crosswalk to the 
utilization of the prior codes: All the prior services of CPT codes 
97760 and 97761 were each crosswalked to the same newly revised codes; 
and, all the utilization from CPT code 97762 was crosswalked to the new 
CPT code 977X1.
    For CPT code 977X1, we considered a work RVU of 0.33, crosswalking 
to CPT code 92508 (Speech/hearing therapy), which has a similar total 
therapist time (22 minutes). We are concerned and seek comments on the 
HCPAC one-to-one utilization crosswalk recommendations for all three 
codes in this family since the utilization assumptions are potentially 
flawed when viewed in the context of the new CPT code descriptors. For 
instance, for CPT code 977X1, the new descriptor indicates that the 
services inherent to CPT code 97762 (over 14,000 in 2015), as well as 
the new services for subsequent encounters previously reported via CPT 
codes 97760 and 97761 will also be encompassed, although it is 
difficult to estimate the number of additional services the latter 
represents. We are concerned that the HCPAC's valuation is inconsistent 
with the submitted information regarding how services will be reported 
under the new coding. We seek comments on our proposed and alternative 
values for CPT code 977X1. We are also interested in receiving comments 
from stakeholders and clinicians with expertise in furnishing these 
orthotic management and/or prosthetics training services about the 
utilization and types of services that would be furnished under the new 
CPT coding structure, particularly those of the newly created CPT code 
977X1 and how these services differ from the services reported with the 
predecessor CPT code 97762.
    We propose to maintain the current PE inputs for CPT codes 97760, 
97761, and 977X1, as we discussed in our proposals for the PM&R codes 
discussed above; the same therapy MPPR applies. We are proposing the 
current direct PE inputs for CPT code 97762 and for new CPT code 977X1, 
though we are seeking comment as to whether or not a different 
crosswalk or other adjustment would be appropriate given the change in 
code descriptor.
    We also note that these codes are designated as always therapy, 
meaning that they always represent therapy services regardless of who 
furnishes them; and that a GO or GP therapy modifier is always required 
to indicate that the services are furnished under an OT or PT plan of 
care, respectively. As always therapy, these codes are subject to the 
therapy MPPR and the statutory therapy caps.
(51) Cognitive Function Intervention (CPT Code 97X11)
    We received HCPAC recommendations for new CPT code 97X11 that 
describes services currently reported under CPT code 97532 (Development 
of cognitive skills to improve attention, memory, problem solving 
(includes compensatory training), direct (one-on-one) patient contact, 
each 15 minutes). CPT code 97532 is scheduled to be deleted for CY 2018 
and replaced by CPT code 97X11.
    The existing code is reported per 15 minutes and the new code is 
reported once. Under current coding, Medicare utilization for these 
services is heterogeneous and indicates that practitioners of different 
disciplines incur significantly different resource costs (especially in 
time) when furnishing these services to Medicare beneficiaries. As 
described by both the existing and new code, the service might be 
appropriately furnished both by therapists under the outpatient therapy 
(OPT) services benefit (includes physical therapy (PT), occupational 
therapy (OT) or speech-language pathology (SLP)); and outside the 
therapy benefit by physicians, certain

[[Page 34010]]

NPPs, and psychologists. As an OPT service, it can (1) be billed by 
physicians, certain NPPs, or private practice therapists including 
physical therapists (PT-PPs), occupational therapists (OT-PPs) and 
speech-language pathologists (SLP-PPs) in private practice, or (2) be 
billed by institutional providers (for example, skilled nursing 
facilities, rehabilitation agencies, outpatient hospitals, etc.) when 
furnished by therapists working for the institutional providers.
    According to the HCPAC, professional claims data indicate that CPT 
code 97532 was most often billed in 4 units. The HCPAC recommended a 
work RVU of 1.50 for CPT code 97X11, which is only 3.4 times greater 
than the work RVU for the predecessor code (0.44). Assuming 
professional billing patterns remain the same, the recommended coding 
and valuation could result in a significant reduction in overall 
Medicare payment under the PFS.
    However, our analysis of the claims data indicates that the number 
of units typically reported for the current code suggests a significant 
difference in the amount of time spent with the patient, depending on 
which discipline (and implicitly under which benefit) bills Medicare 
for services described by this single code.
    Based on our review of claims data by specialty, SLP-PPs, OT-PPs 
and PT-PPs furnishing the same services under the OPT benefit would 
receive overall payment increases due simply to the change in coding 
because they typically bill for fewer than 4 units, while overall 
payment for clinical psychologists furnishing therapeutic interventions 
for cognitive function would decrease because they typically bill in 
units of four or more.
    We are seeking additional information regarding the potential 
impact of this coding and payment change prior to proposing its use 
under the PFS. For CY 2018, we are proposing to maintain the current 
coding and valuation for these cognitive function services. If the CPT 
Editorial Panel deletes the existing CPT code for CY 2018, we would 
effectuate this proposal through use of a new a G-code, GXXX1, which 
would maintain the descriptor and values from existing CPT code 97532. 
Under this proposal, new CPT code 97X11 would be given a procedure 
status of ``I'' (Invalid for Medicare).
    We also note that this change in coding and payment could have 
significant impact for payment to Medicare institutions for OPT 
services. Under section 1834(k) of the Act, when reported by Medicare 
institutional providers, OPT services are paid at PFS non-facility 
payment rates. Institutional claims data for CPT code 97532 when 
furnished by the three therapist disciplines show a much higher 
utilization overall than that for professional claims but significantly 
fewer 15 minute units reported. This suggests that professionals 
generally spend significantly less time with patients in the 
institutional setting. Use of the new CPT code could therefore result 
in significant additional expenditure to the Medicare program, as well 
as other payers, including Medicaid programs, based on the change in 
coding alone.
(52) INR Monitoring (CPT Codes 993X1 and 993X2)
    In October 2015, AMA staff assembled a list of all services with 
total Medicare utilization of 10,000 or more that have increased by at 
least 100 percent from 2008 through 2013 and these services were 
identified on that list. The RUC recommended that HCPCS codes G0248, 
G0249 and G0250, which describe related INR monitoring services, be 
referred to the CPT Editorial Panel to create Category I codes to 
describe these services. For CY 2018, the CPT Editorial Panel is 
deleting CPT codes 99363 and 99364 and creating new CPT codes 993X1 
(Patient/caregiver training for initiation of home INR monitoring under 
the direction of a physician or other qualified health care 
professional, including face-to-face, use and care of the INR monitor, 
obtaining blood sample, instructions for reporting home INR test 
results, and documentation of patient's/caregiver's ability to perform 
testing and report results) and 993X2 (Anticoagulant management for a 
patient taking warfarin, must include review and interpretation of a 
new home, office, or lab International Normalized Ratio (INR) test 
result, patient instructions, dosage adjustment (as needed), and 
scheduling of additional test(s) when performed). CPT code 993X1 is a 
technical component-only code. With the creation CPT codes 993X1 and 
993X2, the RUC recommended that CMS delete HCPCS codes G0248, G0249 and 
G0250.
    For CPT code 993X2, we are proposing the RUC-recommended work RVU 
of 0.18. Because HCPCS codes G0248, G0249 and G0250 are used to report 
related services under a national coverage determination, we do not 
intend to delete the G-codes.
    In reviewing the recommended PE inputs for these services, we 
obtained updated invoices for prices for particular items. We are 
proposing to use the invoices to update the price of the supply ``INR 
test strip'' (SJ055). We obtained publically available pricing 
information from two vendors. The pricing from one vendor indicated the 
price for a box of 24 of supply item SJ055 item (INR test strip) to be 
$150.00, which equated to a unit price of $6.25. Pricing from a second 
vendor indicated the price of a box of 48 of the supply item SJ055 to 
be $233.00, which equated to a unit price of $5.06. The average price 
of these two unit prices is $5.66.
    Therefore, we are proposing to re-price SJ055 from $21.86 to $5.66 
for CPT code 993X1. We are seeking public comments on current pricing 
for the INR test strip supply.
(53) Psychiatric Collaborative Care Management Services (CPT Codes 
994X1, 994X2, 994X3, and HCPCS Code G0507)
    In the CY 2017 PFS final rule (81 FR 80230), we established 
separate payment for three services (HCPCS codes G0502, G0503, and 
G0504) under the psychiatric collaborative care model that paralleled 
CPT codes that were being created to report these services as well as a 
G-code for general behavioral health integration (BHI) services (HCPCS 
code G0507).
    For CY 2018, the CPT Editorial Panel is creating CPT codes 994X1, 
994X2, 994X3, and 99XX5 to describe these services. We are proposing 
the RUC-recommended work RVUs for each of these services, which are 
identical to the current values for HCPCS codes G0502, G0503, G0504, 
and G0507.
    We are proposing the RUC-recommended PE inputs, with one 
refinement. The RUC-recommended values included clinical labor inputs 
in the facility setting, but we are not proposing to include these 
minutes in developing the facility PE RVUs.
    Were we to develop facility PE RVUs for these services that 
included clinical staff time, when a practitioner working in a 
provider-based department of a hospital was furnishing these services, 
both the professional and the hospital would be paid for the same 
clinical labor costs. We presume that this aspect of the RUC's 
recommendation reflects the circumstance where the patient receiving 
the services spends a significant period of time in a facility setting, 
but the billing practitioner is nonetheless incurring the cost 
associated with the non-face-to-face clinical staff time over the 
course of a month. We recognize that the binary site of service 
differential may not recognize the different models of this kind of 
care and may not be appropriate in some cases. We seek comments on how 
to best address this valuation issue for these and other monthly care

[[Page 34011]]

management services. We could consider a range of options for future 
rulemaking, including allowing separate billing for the professional, 
technical, and global components of these services to allow 
practitioners to bill the component of the service they furnish.
    We stated in the CY 2017 PFS final rule (81 FR 80236) that the 
general BHI code (CPT code 99XX5) may be used to report a range of 
models of BHI services and that we expected this code to be refined 
over time as we receive more information about other BHI models in use. 
We remain interested in how this code is being used and look forward to 
hearing from stakeholders regarding its use in reporting different 
models of BHI services. Additionally, we have received inquiries from 
stakeholders about whether or not professionals who cannot report E/M 
services to Medicare might nonetheless serve as a primary hub for BHI 
services. For example, stakeholders have suggested that a clinical 
psychologist might serve as the primary practitioner that integrates 
medical care and psychiatric expertise. For purposes of future 
rulemaking, we are seeking comment on the circumstances under which 
this model of care is happening and whether additional coding would be 
needed to accurately describe and value other models of care.
(54) Hyperbaric Oxygen Therapy (HCPCS Code G0277)
    In the CY 2016 PFS final rule (80 FR 71005), we discussed the CY 
2015 valuation of hyperbaric oxygen therapy services (79 FR 67677). 
Prior to CY 2015, CPT code 99183 was used to report both the 
professional attendance and supervision, and the costs associated with 
treatment delivery were included in the nonfacility direct PE inputs 
for the code. We created HCPCS code G0277 to be used to report the 
treatment delivery separately, consistent with the OPPS coding 
mechanism, to allow the use of the same coding structure across 
settings. In establishing interim final direct PE inputs for HCPCS code 
G0277, we used the RUC-recommended direct PE inputs for CPT code 99183, 
which assumed a 120-minute treatment interval and adjusted them to 
align with the 30-minute treatment interval of HCPCS code G0277. We 
observed that the quantity of oxygen increased significantly relative 
to the previous inputs for CPT code 99183.
    To better understand why the oxygen supply increased, we reviewed 
the instruction manual for the Sechrist Model 3600E Hyperbaric Chamber, 
which was the model noted on the invoice that was included with the RUC 
recommendations for use in pricing the capital equipment. The 
instruction manual for the Sechrist 3600E model provided guidance 
regarding the quantity of oxygen to be used in furnishing the service 
described by HCPCS code G0277. Based on our review at that time, we 
determined that 12,000 liters, rather than 47,000 liters, was the 
typical number of units for the oxygen gas. Therefore, in aligning the 
direct PE inputs as described in this section of the proposed rule, we 
first adjusted the units of oxygen to 12,000 liters for the recommended 
120 minute time, and subsequently adjusted it to align with the 30-
minute G-code by dividing by 4. We stated that we agreed that an 
initial high purge flow rate is needed to reach maximum pressure/
O2; however, we still had not seen data that demonstrated 
the need to continue the high purge flow rate throughout the entire 
session. According to the manufacturer's instruction manual for this 
model, ``once the nitrogen has been purged from the chamber and the 
internal oxygen concentration has exceeded 95 percent, high flows are 
no longer needed to maintain the patient's saturation level.'' The 
manual also stated that ``the plateau purge flow can be set to 80 
liters per minute (lpm).'' We calculated that 13 minutes at 400 lpm 
plus 120 minutes at 80 lpm equals 14,800 liters of oxygen. We stated 
that based on information in the manufacturer's manual that was 
publicly available at the time, we believed that this represented the 
typical usage for a 120-minute treatment. That amount represented an 
increase from the interim final amount of 12,000 liters. We aligned 
this total oxygen requirement to the 30-minute G-code by dividing 
14,800 liters of oxygen by 4 and stated we were updating the direct PE 
inputs to 3,700 liters of oxygen for HCPCS code G0277.
    For CY 2018, we received requests from stakeholders to update the 
direct PE inputs for HCPCS code G0277. In the CY 2016 PFS final rule 
(80 FR 71005), we explained that we had previously established values 
for this service based on information suggesting that the Sechrist 
Model 3600E Hyperbaric Chamber was typically used in furnishing the 
service in the non-facility setting. As we noted in that rule, we 
established the amount of oxygen used in furnishing the service based 
on use of the equipment item described as part of the RUC 
recommendation, instead of the RUC-recommended amount of oxygen, which 
appeared to be based on use of a different equipment product, the 
Sechrist Model 3200. Based on information received from stakeholders, 
we are proposing to update both the equipment item and the amount of 
oxygen so that the amount of oxygen conforms to the RUC-recommended 
value of 47,600 liters of oxygen, which we divided by 4 to conform to 
the 30-minute service period for HCPCS code G0277, and that the 
equipment item is consistent with that recommendation. The proposed 
direct PE inputs for HCPCS code G0277 are displayed in the proposed CY 
2018 direct PE input database, available on the CMS Web site under the 
downloads for the CY 2018 PFS proposed rule at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.
    We are also proposing to exclude this change in direct PE inputs 
from calculation of the misvalued code target since we view this 
proposed change as a refinement of a single recommendation over several 
years. Since the initial recommendation (79 FR 67677) was undertaken in 
a year without the misvalued code target, we believe it would be 
consistent with our previously established policy (80 FR 70923) to 
exclude this change from the calculation. We note that this change 
would represent an increase from the current PE RVUs for this service.
(55) Physician Coding for Insertion and Removal of Subdermal Drug 
Implants for the Treatment of Opioid Addiction (HCPCS Codes GDDD1, 
GDDD2, and GDDD3)
    We met with representatives from the American Society of Addiction 
Medicine (ASAM) in April 2016 to discuss the possibility of making 
separate payment for insertion and removal of buprenorphine 
hydrochloride, formulated as a 4-rod, 80 mg, long-acting subdermal drug 
implant for the treatment of opioid addiction. There are existing CPT 
codes that broadly describe the insertion and removal of non-
biodegradable drug delivery implants (CPT codes 11981 through 11983). 
However, ASAM contended that the resources associated with the 
administration of this particular drug are greater than that of other 
drug delivery implants, stating that the physician must insert four 
rods using a newly designed applicator and obturator and use a 
specially designed clamp to remove the four rods, which in some cases 
requires careful shaving of tissue that has attached to the rods during 
the 6-month period that the rods have been inserted. They noted that 
these procedures can have unique

[[Page 34012]]

challenges associated with treating patients with opioid addiction, who 
often have complications and/or co-morbidities. They also noted that 
the FDA has recognized the complexity of the technology and patient 
needs by establishing regulatory standards to adhere to the protocol 
and imposing special training requirements on physicians. ASAM 
indicated that they would pursue an application to the CPT Editorial 
Panel for new CPT codes.
    ASAM informed CMS that the CPT Editorial Panel did not approve 
their application; therefore, they repeated their request that CMS 
establish separate payment for the insertion, removal, and removal with 
reinsertion of the buprenorphine subdermal implants.
    To improve payment accuracy, for CY 2018, we are proposing to make 
separate payment for the insertion, removal, and removal with 
reinsertion of Buprenorphine subdermal implants using HCPCS G codes:
     HCPCS code GDDD1: Insertion, non-biodegradable drug 
delivery implants, 4 or more.
     HCPCS code GDDD2: Removal, non-biodegradable drug delivery 
implants, 4 or more.
     HCPCS code GDDD3: Removal with reinsertion, non-
biodegradable drug delivery implants, 4 or more.
    For HCPCS code GDDD1, ASAM states that performing the procedure 
according to the FDA-required Risk Evaluation and Mitigation Strategies 
(REMS) program takes approximately 23-25 minutes for the a physician 
who is not a trainer/proctor for this procedure. They state that in 
developing crosswalk recommendations for physician work values, they 
used a total time of 35-40 minutes, which is based on a preservice time 
of 10 minutes, an intraservice time of 20-25 minutes, and a postservice 
time of 5 minutes. Based on ASAM's recommendations, we are proposing a 
work RVU of 1.82 for HCPCS code GDDD1, which is supported by a direct 
crosswalk to CPT code 64644 (Chemodenervation of one extremity; 5 or 
more muscles).
    For HCPCS code GDDD2, ASAM states that data from physicians who 
perform this procedure indicated that it takes approximately 15-20 
additional minutes compared to the insertion procedure (HCPCS code 
GDDD1) based on the FDA-required REMS program for removal of the 
implant. They note that this procedure is of a higher intensity 
compared to CPT code 11982 as this service requires identification and 
removal of multiple subdermal implants. They state that in developing 
crosswalk recommendations for physician work values, they used a total 
time of 45-60 minutes, which is based on a preservice time of 10 
minutes, an intraservice time of 30-45 minutes, and a postservice time 
of 5 minutes. Based on ASAM's recommendations, we are proposing a work 
RVU of 2.10 for HCPCS code GDDD2, which is supported by a direct 
crosswalk to CPT code 96922 (Laser treatment for inflammatory skin 
disease (psoriasis); over 500 sq cm).
    For HCPCS code GDDD3, ASAM indicated that there is minimal 
consolidation of effort since the removal of the implants from one arm 
is followed by insertion of a new set of implants in the contralateral 
arm. Physician data from those who have performed this procedure 
indicated that it takes approximately 70 minutes of total intra-service 
time. They state that in developing crosswalk recommendations for 
physician work values, they assumed a preservice evaluation time of 10 
minutes (7 minutes for removal and 3 minutes for insertion), 
positioning of 4 minutes (2 minutes for each arm), and wait time of 2 
minutes (1 minute for each arm). They state that using the multiple 
surgical procedure rule, they calculated an intraservice time of 40-58 
minutes based on 100 percent of the intraservice time for HCPCS code 
GDDD2 (30-45 minutes) and 50 percent of the intraservice time for HCPCS 
code GDDD1 (0.5 x (20 - 25) = 10 - 13). They used a postservice time of 
8 minutes based on 100 percent of the postservice time for the removal 
arm and 50 percent of the postservice time for the insertion arm, 
equaling a total time of 58-76 minutes. Based on ASAM's 
recommendations, we are proposing a work RVU of 3.55 for HCPCS code 
GDDD3, which is supported by a direct crosswalk to CPT code 31628 
(Bronchoscopy, rigid or flexible, including fluoroscopic guidance, when 
performed; with transbronchial lung biopsy(s), single lobe).
    We are proposing to use the direct PE inputs requested by ASAM for 
HCPCS codes GDDD1, GDDD2, and GDDD3, which are reflected in the Direct 
PE Inputs public use files for clinical labor, supplies, and equipment, 
available on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html.
    In addition to seeking comment on the proposal to make separate 
payment for these services using HCPCS G codes, we are also seeking 
comment on the appropriateness and accuracy of our proposed work RVUs 
and direct PE inputs.
(56) Superficial Radiation Treatment Planning and Management (HCPCS 
Code GRRR1)
    In the CY 2015 PFS final rule with comment period (79 FR 67666 
through 67667), we noted that changes to the CPT prefatory language 
limited the codes that could be reported when describing services 
associated with superficial radiation treatment (SRT) delivery, 
described by CPT code 77401 (radiation treatment delivery, superficial 
and/or ortho voltage, per day). The changes effectively meant that many 
other related services were bundled with CPT code 77401, instead of 
being separately reported. For example, CPT guidance clarified that 
certain codes used to describe clinical treatment planning, treatment 
devices, isodose planning, physics consultation, and radiation 
treatment management cannot be reported when furnished in association 
with superficial radiation treatment. Stakeholders stated that these 
changes to the CPT prefatory language prohibited them from billing 
Medicare for codes that were previously frequently billed in addition 
to CPT code 77401. We solicited comments as to whether the coding for 
SRT allowed for accurate reporting of the associated services.
    In the CY 2016 PFS final rule with comment period (80 FR 70955), we 
noted that the RUC did not review the inputs for superficial radiation 
therapy procedures, and therefore, did not assess whether changes in 
its valuation were appropriate in light of the bundling of associated 
services. In addition, we solicited recommendations from stakeholders 
regarding whether or not it would be appropriate to add physician work 
for this service, even though physician work is not included in other 
radiation treatment services. As commenters were not in agreement as to 
whether the service should be valued with physician work, we introduced 
the possibility of creating a HCPCS G code to describe total work 
associated with the course of treatment for these services.
    The 2016 National Correct Coding Initiative (NCCI) Policy Manual 
for Medicare Services states that radiation oncology services may not 
be separately reported with E/M codes. While this edit is no longer 
active, stakeholders have stated that MACs have denied claims for E/M 
services associated with SRT based on the NCCI policy manual language. 
According to stakeholders, the bundling of services associated with 
SRT, as well as the confusion regarding the appropriate use of E/M 
coding to report associated physician work, means

[[Page 34013]]

that practitioners are not being accurately paid for planning and 
treatment management associated with furnishing SRT.
    In recognition of these concerns, we are proposing to make separate 
payment for the professional planning and management associated with 
SRT using HCPCS code GRRR1 (Superficial radiation treatment planning 
and management related services, including but not limited to, when 
performed, clinical treatment planning (for example, 77261, 77262, 
77263), therapeutic radiology simulation-aided field setting (for 
example, 77280, 77285, 77290, 77293), basic radiation dosimetry 
calculation (for example, 77300), treatment devices (for example, 
77332, 77333, 77334), isodose planning (for example, 77306, 77307, 
77316, 77317, 77318), radiation treatment management (for example, 
77427, 77431, 77432, 77435, 77469, 77470, 77499), and associated 
evaluation and management per course of treatment). We intend for this 
code to describe the range of professional services associated with a 
course of SRT, including services similar to those not otherwise 
separately reportable under CPT guidance and the NCCI manual.
    To value this code, we are including the physician work and work 
time associated with radiation management-related services that we 
think would be typical for a course of SRT treatment. These services 
include: CPT code 77261 (Therapeutic radiology treatment planning; 
simple), CPT code 77280 (Therapeutic radiology simulation-aided field 
setting; simple), CPT code 77300 (Basic radiation dosimetry 
calculation, central axis depth dose calculation, TDF, NSD, gap 
calculation, off axis factor, tissue inhomogeneity factors, calculation 
of non-ionizing radiation surface and depth dose, as required during 
course of treatment, only when prescribed by the treating physician), 
CPT code 77306 (Teletherapy isodose plan; simple (1 or 2 unmodified 
ports directed to a single area of interest), includes basic dosimetry 
calculation(s)), CPT code 77332 (Treatment devices, design and 
construction; simple (simple block, simple bolus)), and CPT code 77427 
(Radiation treatment management, 5 treatments). Therefore, for CY 2018, 
we are proposing a work RVU of 7.93 for HCPCS code GRRR1.
    To develop the proposed direct PE inputs for this code, we are 
proposing to use the RUC-recommended direct PE inputs from the 
aforementioned codes with several adjustments. We are proposing to 
apply the staff type ``RN/LPN/MTA'' for all of the clinical labor 
inputs for this code because we believe that the typical office 
performing SRT will be staffed with this labor type, rather than with 
another clinical labor type such as radiation therapists, and we seek 
comments as to the appropriateness of the staff type ``RN/LPN/MTA'' for 
this SRT-related service. Some stakeholders have suggested that many 
services related to SRT are personally performed by the billing 
practitioner rather than by clinical staff.
    We are proposing to remove the supply items ``gown, patient'' and 
``pillow case'' that are associated with CPT code 77280, as these items 
are included in the minimum multi-specialty visit pack that is 
associated with CPT code 77427. We are not proposing to include the 
equipment items ``radiation virtual simulation system,'' ``room, CT'' 
and ``PACS Workstation Proxy'' that are associated with CPT code 77280, 
as we do not believe that a typical office furnishing SRT uses this 
kind of equipment. Instead, we are including additional time for the 
capital equipment used in delivering SRT in the proposed direct PE 
inputs. For ``radiation dose therapy plan,'' we are proposing to apply 
the clinical labor time that is associated with CPT code 77300 to HCPCS 
code GRRR1 for purposes of developing a proposed value, but we seek 
comments as to whether the clinical staff would typically perform the 
radiation dose therapy planning for this service, or if the physician 
would perform this and/or other tasks, and, in the case of the latter, 
what the appropriate physician time would be. Likewise, we are 
soliciting comment as to whether the clinical labor associated with the 
teletherapy isodose plan would be performed by the physician. We are 
proposing to assign 14 minutes each to the equipment items ``radiation 
therapy dosimetry software (Argus QC)'', ``computer workstation'', and 
``3D teletherapy treatment planning'' as these are the times assigned 
to these equipment items for CPT code 77300.
    We are not proposing to include inputs related to radiation physics 
consultation, described by CPT code 77336, as we think that a typical 
course of SRT would not require this service, and the typical 
practitioner providing SRT would not be performing physics 
consultation, and we are seeking comment as to whether inputs 
associated with this code or other inputs used in furnishing analogous 
services should be included. We are not proposing to include the post-
operative office visits included in the valuation of CPT code 77427, as 
we do not believe that a typical course of SRT will require post-
operative visits; however, we are seeking comment regarding the amount 
of face-to-face time typically spent by the practitioner with the 
patient for radiation treatment management associated with SRT.
    As discussed in the CY 2016 PFS final rule (80 FR 70924 through 
70927), in the case of new codes that describe services that were 
previously included in the payment for other codes, we finalized the 
policy that these new codes are excluded from the misvalued code target 
when they were previously bundled into a set of broadly reported E/M 
codes and services that include E/M visits. We noted that we did not 
believe that the change to separate payment for these kinds of services 
should be counted as increases that are included in calculating ``net 
reductions'' in expenditure attributable to adjustments for misvalued 
codes. Therefore, we are proposing to exclude HCPCS code GRRR1 from the 
misvalued code target.
(57) Payment Accuracy for Prolonged Preventive Services (HCPCS Codes 
GYYY1 and GYYY2)
    Most services paid under the PFS are coded to reflect differential 
resource costs associated with different levels of care. However, this 
level of granularity is not applied evenly across the PFS. For example, 
there are far fewer Evaluation and Management (E/M) visit codes than 
there are codes that describe procedures. While not a comprehensive 
solution to address the differential resource costs of certain E/M 
visits, prolonged services codes can be used to report medically 
necessary E/M visits that require additional amounts of time. Like E/M 
visit codes, many of the Medicare-covered preventive services codes 
describe a service that has an atypically broad range of potential 
resource costs, including differential amounts of time required to 
furnish services. However, unlike for most E/M visit codes, there are 
not prolonged services codes that apply to Medicare-covered preventive 
services.
    Some stakeholders have expressed concerns to CMS that there is no 
coding mechanism for practitioners to report the additional time 
sometimes required to appropriately furnish care to a patient receiving 
a Medicare-covered preventive service. We note that Medicare covers a 
broad range of preventive services, such as a ``Welcome to Medicare 
Preventive Visit'', yearly wellness visits, cancer screenings, and many 
types of counseling. Medicare beneficiary coinsurance and deductible 
payments are not applicable for certain Medicare-covered preventive 
services. Additional information about preventive services

[[Page 34014]]

covered under Medicare, including whether beneficiary coinsurance or 
deductible apply, is available on the CMS Web site at https://www.cms.gov/Medicare/Prevention/PrevntionGenInfo/Downloads/MPS-QuickReferenceChart-1TextOnly.pdf. To more accurately reflect the 
differential resource costs when additional time is required to furnish 
a Medicare-covered preventive service, we are proposing to make payment 
for prolonged preventive services using two new HCPCS G codes that 
could be billed along with the Medicare-covered preventive service 
codes, when a clinician provides a prolonged Medicare-covered 
preventive service.
     GYYY1: Prolonged preventive service(s) (beyond the typical 
service time of the primary procedure) in the office or other 
outpatient setting requiring direct patient contact beyond the usual 
service; first 30 minutes (List separately in addition to code for 
preventive service)), and
     GYYY2: Prolonged preventive service(s) (beyond the typical 
service time of the primary procedure) in the office or other 
outpatient setting requiring direct patient contact beyond the usual 
service; each additional 30 minutes (List separately in addition to 
code for preventive service)). These proposed services (HCPCS codes 
GYYY1 and GYYY2) are only permitted to be billed with Medicare-covered 
preventive services. Beneficiary coinsurance and deductible would not 
be applicable for HCPCS codes GYYY1 and GYYY2 because the codes can 
only be reported to describe prolonged portions of services where 
beneficiary coinsurance and deductible are not applicable.
    We are proposing to use prolonged services codes in 30-minute 
increments instead of the 60-minute increments that apply for the 
parallel office/outpatient prolonged services codes, since some 
Medicare-covered preventive services have a shorter duration than E/M 
visits. For purposes of valuation for both initial and additional 30 
minute codes, we are proposing to use one half of the current work RVUs 
and direct PE inputs for CPT code 99354 (Prolonged evaluation and 
management or psychotherapy service(s) beyond the typical service time 
of the primary procedure) in the office or other outpatient setting 
requiring direct patient contact beyond the usual service; first hour 
(List separately in addition to code for office or other outpatient 
Evaluation and Management or psychotherapy service)). CPT code 99354 
has a total time of 60 minutes and a work RVU of 2.33. Therefore, we 
are proposing a work RVU of 1.17 and 30 minutes of total work time for 
HCPCS codes GYYY1 and GYYY2. We are proposing to use one half of the 
direct PE inputs for CPT code 99354, which results in a proposal of 7 
minutes of clinical labor type L037D (RN/LPN/MTA) and 15 minutes for 
equipment type EF031 (table, power) for HCPCS code GYYY1 and HCPCS code 
GYYY2 as the best reflection of typical direct PE costs. We understand 
that these specific clinical labor and equipment types may be 
functioning as proxy inputs for some Medicare-covered preventive 
services.
    As described in this section of the rule, we propose that HCPCS 
codes GYYY1 and GYYY2 be billed for prolonged preventive services 
beyond the typical service time of the primary procedure. For 
preventive services with both physician work and practice expense, we 
are considering the typical service time of the primary procedure to be 
the intraservice work time used for the purposes of ratesetting. For 
Medicare-covered preventive services with no face-to-face physician 
work, the typical time is the service period clinical staff time that 
best represents the face-to-face time with the patient. The counted 
time requirements (derived from the typical times assumed for 
ratesetting) for all eligible companion Medicare-covered preventive 
services are available in the file called ``CY 2018 Preventive Services 
Billed with Prolonged Preventives Code'' on the CMS Web site under 
downloads for the CY 2018 PFS proposed rule at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/PFS-Federal-Regulation-Notices.html.

              Table 10--Proposed CY 2018 Work RVUs for New, Revised and Potentially Misvalued Codes
----------------------------------------------------------------------------------------------------------------
                                                        Current    RUC work   CMS work
          HCPCS                    Descriptor           work RVU     RVU        RVU       CMS time  refinement
----------------------------------------------------------------------------------------------------------------
007X1....................  Anesthesia for upper              NEW       0.00       0.00  No.
                            gastrointestinal
                            endoscopic procedures,
                            endoscope introduced
                            proximal to duodenum; not
                            otherwise specified.
007X2....................  Anesthesia for upper              NEW       0.00       0.00  No.
                            gastrointestinal
                            endoscopic procedures,
                            endoscope introduced
                            proximal to duodenum;
                            endoscopic retrograde
                            cholangiopancreatography
                            (ERCP).
008X1....................  Anesthesia for lower              NEW       0.00       0.00  No.
                            intestinal endoscopic
                            procedures, endoscope
                            introduced distal to
                            duodenum; not otherwise
                            specified.
008X2....................  Anesthesia for lower              NEW       0.00       0.00  No.
                            intestinal endoscopic
                            procedures, endoscope
                            introduced distal to
                            duodenum; screening
                            colonoscopy.
008X3....................  Anesthesia for combined           NEW       0.00       0.00  No.
                            upper and lower
                            gastrointestinal
                            endoscopic procedures,
                            endoscope introduced both
                            proximal to and distal to
                            the duodenum.
10040....................  Acne surgery (e.g.,              1.21       0.91       0.91  No.
                            marsupialization, opening
                            or removal of multiple
                            milia, comedones, cysts,
                            pustules).
15734....................  Muscle, myocutaneous, or        19.86      23.00      23.00  No.
                            fasciocutaneous flap;
                            trunk.
15736....................  Muscle, myocutaneous, or        17.04      17.04      17.04  No.
                            fasciocutaneous flap;
                            upper extremity.
15738....................  Muscle, myocutaneous, or        19.04      19.04      19.04  No.
                            fasciocutaneous flap;
                            lower extremity.
157X1....................  Midface flap (i.e.,               NEW      13.50      13.50  No.
                            zygomaticofacial flap)
                            with preservation of
                            vascular pedicle(s).
157X2....................  Muscle, myocutaneous, or          NEW      15.68      15.68  No.
                            fasciocutaneous flap;
                            head and neck with named
                            vascular pedicle (i.e.,
                            buccinators,
                            genioglossus, temporalis,
                            masseter,
                            sternocleidomastoid,
                            levator scapulae).
192X1....................  Preparation of tumor              NEW       3.00       3.00  No.
                            cavity with placement of
                            a radiation therapy
                            applicator for
                            intraoperative radiation
                            therapy (IORT) concurrent
                            with partial mastectomy.
19303....................  Mastectomy, simple,             15.85      15.00      15.00  No.
                            complete.
2093X....................  Bone marrow aspiration for        NEW       1.16       1.16  No.
                            bone grafting, spine
                            surgery only, through
                            separate skin or fascial
                            incision.
29445....................  Application of rigid total       1.78       1.78       1.78  No.
                            contact leg cast.
29580....................  Strapping; Unna boot......       0.55       0.55       0.55  No.
29581....................  Application of multi-layer       0.25       0.60       0.60  No.
                            compression system; leg
                            (below knee), including
                            ankle and foot.
30140....................  Submucous resection              3.57       3.00       3.00  No.
                            inferior turbinate,
                            partial or complete, any
                            method.
30901....................  Control nasal hemorrhage,        1.10       1.10       1.10  No.
                            anterior, simple (limited
                            cautery and/or packing)
                            any method.
30903....................  Control nasal hemorrhage,        1.54       1.54       1.54  No.
                            anterior, complex
                            (extensive cautery and/or
                            packing) any method.
30905....................  Control nasal hemorrhage,        1.97       1.97       1.97  No.
                            posterior, with posterior
                            nasal packs and/or
                            cautery, any method;
                            initial.

[[Page 34015]]

 
30906....................  Control nasal hemorrhage,        2.45       2.45       2.45  No.
                            posterior, with posterior
                            nasal packs and/or
                            cautery, any method;
                            subsequent.
31XX1....................  Nasal/sinus endoscopy,            NEW       8.00       8.00  No.
                            surgical; with ligation
                            of sphenopalatine artery.
31XX2....................  Nasal/sinus endoscopy,            NEW       9.00       9.00  No.
                            surgical with
                            ethmoidectomy; total
                            (anterior and posterior),
                            including frontal sinus
                            exploration, with removal
                            of tissue from frontal
                            sinus, when performed.
31XX3....................  Nasal/sinus endoscopy,            NEW       8.00       8.00  No.
                            surgical with
                            ethmoidectomy; total
                            (anterior and posterior),
                            including sphenoidotomy.
31XX4....................  Nasal/sinus endoscopy,            NEW       8.48       8.48  No.
                            surgical with
                            ethmoidectomy; total
                            (anterior and posterior),
                            including sphenoidotomy,
                            with removal of tissue
                            from the sphenoid sinus.
31XX5....................  Nasal/sinus endoscopy,            NEW       4.50       4.50  No.
                            surgical; with dilation
                            of frontal and sphenoid
                            sinus ostia (e.g.,
                            balloon dilation).
31254....................  Nasal/sinus endoscopy,           4.64       4.27       4.27  No.
                            surgical with
                            ethmoidectomy; partial
                            (anterior).
31255....................  Nasal/sinus endoscopy,           6.95       5.75       5.75  No.
                            surgical with
                            ethmoidectomy; total
                            (anterior and posterior).
31256....................  Nasal/sinus endoscopy,           3.29       3.11       3.11  No.
                            surgical, with maxillary
                            antrostomy.
31267....................  Nasal/sinus endoscopy,           5.45       4.68       4.68  No.
                            surgical, with maxillary
                            antrostomy; with removal
                            of tissue from maxillary
                            sinus.
31276....................  Nasal/sinus endoscopy,           8.84       6.75       6.75  No.
                            surgical, with frontal
                            sinus exploration,
                            including removal of
                            tissue from frontal
                            sinus, when performed.
31287....................  Nasal/sinus endoscopy,           3.91       3.50       3.50  No.
                            surgical, with
                            sphenoidotomy.
31288....................  Nasal/sinus endoscopy,           4.57       4.10       4.10  No.
                            surgical, with
                            sphenoidotomy; with
                            removal of tissue from
                            the sphenoid sinus.
31295....................  Nasal/sinus endoscopy,           2.70       2.70       2.70  No.
                            surgical; with dilation
                            of maxillary sinus ostium
                            (e.g., balloon dilation),
                            transnasal or canine
                            fossa.
31296....................  Nasal/sinus endoscopy,           3.29       3.10       3.10  No.
                            surgical; with dilation
                            of frontal sinus ostium
                            (e.g., balloon dilation).
31297....................  Nasal/sinus endoscopy,           2.64       2.44       2.44  No.
                            surgical; with dilation
                            of sphenoid sinus ostium
                            (e.g., balloon dilation).
31600....................  Tracheostomy, planned            7.17       5.56       5.56  No.
                            (separate procedure).
31601....................  Tracheostomy, planned            4.44       8.00       8.00  No.
                            (separate procedure);
                            younger than 2 years.
31603....................  Tracheostomy, emergency          4.14       6.00       6.00  No.
                            procedure; transtracheal.
31605....................  Tracheostomy, emergency          3.57       6.45       6.45  No.
                            procedure; cricothyroid
                            membrane.
31610....................  Tracheostomy, fenestration       9.38      12.00      12.00  No.
                            procedure with skin flaps.
31645....................  Bronchoscopy, rigid or           2.91       2.88       2.88  No.
                            flexible, including
                            fluoroscopic guidance,
                            when performed with
                            therapeutic aspiration of
                            tracheobronchial tree,
                            initial.
31646....................  Bronchoscopy, rigid or           2.47       2.78       2.78  No.
                            flexible, including
                            fluoroscopic guidance,
                            when performed with
                            therapeutic aspiration of
                            tracheobronchial tree,
                            subsequent, same hospital
                            stay.
32998....................  Ablation therapy for             5.68       9.03       9.03  No.
                            reduction or eradication
                            of 1 or more pulmonary
                            tumor(s) including pleura
                            or chest wall when
                            involved by tumor
                            extension, percutaneous,
                            including imaging
                            guidance when performed,
                            unilateral;
                            radiofrequency.
32X99....................  Ablation therapy for              NEW       9.03       9.03  No.
                            reduction or eradication
                            of 1 or more pulmonary
                            tumor(s) including pleura
                            or chest wall when
                            involved by tumor
                            extension, percutaneous,
                            including imaging
                            guidance when performed,
                            unilateral; cryoablation.
339X1....................  Implantation of a total           NEW      49.00      49.00  No.
                            replacement heart system
                            (artificial heart) with
                            recipient cardiectomy.
339X2....................  Removal and replacement of        NEW          C          C  No.
                            total replacement heart
                            system (artificial heart).
339X3....................  Removal of a total                NEW          C          C  No.
                            replacement heart system
                            (artificial heart) for
                            heart transplantation.
34812....................  Open femoral artery              6.74       4.13       4.13  No.
                            exposure for delivery of
                            endovascular prosthesis
                            by groin incision,
                            unilateral.
34820....................  Open iliac artery exposure       9.74       7.00       7.00  No.
                            for delivery of
                            endovascular prosthesis
                            or iliac occlusion by
                            abdominal or
                            retroperitoneal incision,
                            unilateral.
34833....................  Open iliac artery exposure      11.98       8.16       8.16  No.
                            with creation of conduit
                            for delivery of
                            endovascular prosthesis
                            or for establishment of
                            cardiopulmonary bypass,
                            by abdominal or
                            retroperitoneal incision,
                            unilateral.
34834....................  Open brachial artery             5.34       2.65       2.65  No.
                            exposure for delivery of
                            endovascular prosthesis
                            unilateral.
34X01....................  Endovascular repair of            NEW      23.71      23.71  No.
                            infrarenal aorta by
                            deployment of an aorto-
                            aortic tube endograft
                            including pre-procedure
                            sizing and device
                            selection, all
                            nonselective
                            catheterization(s), all
                            associated radiological
                            supervision and
                            interpretation, all
                            endograft extension(s)
                            placed in the aorta from
                            the level of the renal
                            arteries to the aortic
                            bifurcation, and all
                            angioplasty/stenting
                            performed from the level
                            of the renal arteries to
                            the aortic bifurcation;
                            for other than rupture
                            (e.g., for aneurysm,
                            pseudoaneurysm,
                            dissection, penetrating
                            ulcer).
34X02....................  Endovascular repair of            NEW      36.00      36.00  No.
                            infrarenal aorta by
                            deployment of an aorto-
                            aortic tube endograft
                            including pre-procedure
                            sizing and device
                            selection, all
                            nonselective
                            catheterization(s), all
                            associated radiological
                            supervision and
                            interpretation, all
                            endograft extension(s)
                            placed in the aorta from
                            the level of the renal
                            arteries to the aortic
                            bifurcation, and all
                            angioplasty/stenting
                            performed from the level
                            of the renal arteries to
                            the aortic bifurcation;
                            for rupture including
                            temporary aortic and/or
                            iliac balloon occlusion
                            when performed (e.g., for
                            aneurysm, pseudoaneurysm,
                            dissection, penetrating
                            ulcer, traumatic
                            disruption).
34X03....................  Endovascular repair of            NEW      26.52      26.52  No.
                            infrarenal aorta and/or
                            iliac artery(ies) by
                            deployment of an aorto-
                            uniiliac endograft
                            including pre-procedure
                            sizing and device
                            selection, all
                            nonselective
                            catheterization(s), all
                            associated radiological
                            supervision and
                            interpretation, all
                            endograft extension(s)
                            placed in the aorta from
                            the level of the renal
                            arteries to the iliac
                            bifurcation, and all
                            angioplasty/stenting
                            performed from the level
                            of the renal arteries to
                            the iliac bifurcation;
                            for other than rupture
                            (e.g., for aneurysm,
                            pseudoaneurysm,
                            dissection, penetrating
                            ulcer).
34X04....................  Endovascular repair of            NEW      45.00      45.00  No.
                            infrarenal aorta and/or
                            iliac artery(ies) by
                            deployment of an aorto-
                            uniiliac endograft
                            including pre-procedure
                            sizing and device
                            selection, all
                            nonselective
                            catheterization(s), all
                            associated radiological
                            supervision and
                            interpretation, all
                            endograft extension(s)
                            placed in the aorta from
                            the level of the renal
                            arteries to the iliac
                            bifurcation, and all
                            angioplasty/stenting
                            performed from the level
                            of the renal arteries to
                            the iliac bifurcation;
                            for rupture including
                            temporary aortic and/or
                            iliac balloon occlusion
                            when performed (e.g., for
                            aneurysm, pseudoaneurysm,
                            dissection, penetrating
                            ulcer, traumatic
                            disruption).

[[Page 34016]]

 
34X05....................  Endovascular repair of            NEW      29.58      29.58  No.
                            infrarenal aorta and/or
                            iliac artery(ies) by
                            deployment of an aorto-
                            biiliac endograft
                            including pre-procedure
                            sizing and device
                            selection, all
                            nonselective
                            catheterization(s), all
                            associated radiological
                            supervision and
                            interpretation, all
                            endograft extension(s)
                            placed in the aorta from
                            the level of the renal
                            arteries to the iliac
                            bifurcation, and all
                            angioplasty/stenting
                            performed from the level
                            of the renal arteries to
                            the iliac bifurcation;
                            for other than rupture
                            (e.g., for aneurysm,
                            pseudoaneurysm,
                            dissection, penetrating
                            ulcer).
34X06....................  Endovascular repair of            NEW      45.00      45.00  No.
                            infrarenal aorta and/or
                            iliac artery(ies) by
                            deployment of an aorto-
                            biiliac endograft
                            including pre-procedure
                            sizing and device
                            selection, all
                            nonselective
                            catheterization(s), all
                            associated radiological
                            supervision and
                            interpretation, all
                            endograft extension(s)
                            placed in the aorta from
                            the level of the renal
                            arteries to the iliac
                            bifurcation, and all
                            angioplasty/stenting
                            performed from the level
                            of the renal arteries to
                            the iliac bifurcation;
                            for rupture including
                            temporary aortic and/or
                            iliac balloon occlusion
                            when performed (e.g., for
                            aneurysm, pseudoaneurysm,
                            dissection, penetrating
                            ulcer, traumatic
                            disruption).
34X07....................  Endovascular repair of            NEW      22.28      22.28  No.
                            iliac artery by
                            deployment of an ilio-
                            iliac tube endograft
                            including pre-procedure
                            sizing and device
                            selection, all
                            nonselective
                            catheterization(s), all
                            associated radiological
                            supervision and
                            interpretation, and all
                            endograft extension(s)
                            proximally to the aortic
                            bifurcation and distally
                            to the iliac bifurcation,
                            and treatment zone
                            angioplasty/stenting when
                            performed, unilateral;
                            for other than rupture
                            (e.g., for aneurysm,
                            pseudoaneurysm,
                            dissection, arteriovenous
                            malformation).
34X08....................  Endovascular repair of            NEW      36.50      36.50  No.
                            iliac artery by
                            deployment of an ilio-
                            iliac tube endograft
                            including pre-procedure
                            sizing and device
                            selection, all
                            nonselective
                            catheterization(s), all
                            associated radiological
                            supervision and
                            interpretation, and all
                            endograft extension(s)
                            proximally to the aortic
                            bifurcation and distally
                            to the iliac bifurcation,
                            and treatment zone
                            angioplasty/stenting when
                            performed, unilateral;
                            for rupture including
                            temporary aortic and/or
                            iliac balloon occlusion
                            when performed (e.g., for
                            aneurysm, pseudoaneurysm,
                            dissection, arteriovenous
                            malformation, traumatic
                            disruption).
34X09....................  Placement of extension            NEW       6.50       6.50  No.
                            prosthesis(es) distal to
                            the common iliac
                            artery(ies) or proximal
                            to the renal artery(ies)
                            for endovascular repair
                            of infrarenal abdominal
                            aortic or iliac aneurysm,
                            false aneurysm,
                            dissection, penetrating
                            ulcer, including pre-
                            procedure sizing and
                            device selection, all
                            nonselective
                            catheterization(s), all
                            associated radiological
                            supervision and
                            interpretation, and
                            treatment zone
                            angioplasty/stenting when
                            performed, per vessel
                            treated.
34X10....................  Delayed placement of              NEW      15.00      15.00  No.
                            distal or proximal
                            extension prosthesis for
                            endovascular repair of
                            infrarenal abdominal
                            aortic or iliac aneurysm,
                            false aneurysm,
                            dissection, endoleak, or
                            endograft migration,
                            including pre-procedure
                            sizing and device
                            selection, all
                            nonselective
                            catheterization(s), all
                            associated radiological
                            supervision and
                            interpretation, and
                            treatment zone
                            angioplasty/stenting when
                            performed; initial vessel
                            treated.
34X11....................  Delayed placement of              NEW       6.00       6.00  No.
                            distal or proximal
                            extension prosthesis for
                            endovascular repair of
                            infrarenal abdominal
                            aortic or iliac aneurysm,
                            false aneurysm,
                            dissection, endoleak, or
                            endograft migration,
                            including pre-procedure
                            sizing and device
                            selection, all
                            nonselective
                            catheterization(s), all
                            associated radiological
                            supervision and
                            interpretation, and
                            treatment zone
                            angioplasty/stenting when
                            performed; each
                            additional vessel treated.
34X12....................  Transcatheter delivery of         NEW      12.00      12.00  No.
                            enhanced fixation
                            device(s) to the
                            endograft (e.g., anchor,
                            screw, tack) and all
                            associated radiological
                            supervision and
                            interpretation.
34X13....................  Percutaneous access and           NEW       2.50       2.50  No.
                            closure of femoral artery
                            for delivery of endograft
                            through a large sheath
                            (12 French or larger),
                            including ultrasound
                            guidance, when performed,
                            unilateral.
34X15....................  Open femoral artery               NEW       5.25       5.25  No.
                            exposure with creation of
                            conduit for delivery of
                            endovascular prosthesis
                            or for establishment of
                            cardiopulmonary bypass,
                            by groin incision,
                            unilateral.
34X19....................  Open axillary/subclavian          NEW       6.00       6.00  No.
                            artery exposure for
                            delivery of endovascular
                            prosthesis by
                            infraclavicular or
                            supraclavicular incision,
                            unilateral.
34X20....................  Open axillary/subclavian          NEW       7.19       7.19  No.
                            artery exposure with
                            creation of conduit for
                            delivery of endovascular
                            prosthesis or for
                            establishment of
                            cardiopulmonary bypass,
                            by infraclavicular or
                            supraclavicular incision,
                            unilateral.
36215....................  Selective catheter               4.67       4.17       4.17  No.
                            placement, arterial
                            system; each first order
                            thoracic or
                            brachiocephalic branch,
                            within a vascular family.
36216....................  Selective catheter               5.27       5.27       5.27  No.
                            placement, arterial
                            system; initial second
                            order thoracic or
                            brachiocephalic branch,
                            within a vascular family.
36217....................  Selective catheter               6.29       6.29       6.29  No.
                            placement, arterial
                            system; initial third
                            order or more selective
                            thoracic or
                            brachiocephalic branch,
                            within a vascular family.
36218....................  Selective catheter               1.01       1.01       1.01  No.
                            placement, arterial
                            system; additional second
                            order, third order, and
                            beyond, thoracic or
                            brachiocephalic branch,
                            within a vascular family.
36470....................  Injection of sclerosant;         1.10       0.75       0.75  No.
                            single incompetent vein
                            (other than
                            telangiectasia).
36471....................  Injection of sclerosant;         1.65       1.50       1.50  No.
                            multiple incompetent
                            veins (other than
                            telangiectasia), same leg.
364X3....................  Endovenous ablation               NEW       3.50       3.50  No.
                            therapy of incompetent
                            vein, extremity, by
                            transcatheter delivery of
                            a chemical adhesive
                            (e.g., cyanoacrylate)
                            remote from the access
                            site, inclusive of all
                            imaging guidance and
                            monitoring, percutaneous;
                            first vein treated.
364X4....................  Endovenous ablation               NEW       1.75       1.75  No.
                            therapy of incompetent
                            vein, extremity, by
                            transcatheter delivery of
                            a chemical adhesive
                            (e.g., cyanoacrylate)
                            remote from the access
                            site, inclusive of all
                            imaging guidance and
                            monitoring, percutaneous;
                            subsequent vein(s)
                            treated in a single
                            extremity, each through
                            separate access sites.
364X5....................  Injection of non-                 NEW       2.35       2.35  No.
                            compounded foam
                            sclerosant with
                            ultrasound compression
                            maneuvers to guide
                            dispersion of the
                            injectate, inclusive of
                            all imaging guidance and
                            monitoring; single
                            incompetent extremity
                            truncal vein (e.g., great
                            saphenous vein, accessory
                            saphenous vein).
364X6....................  Injection of non-                 NEW       3.00       3.00  No.
                            compounded foam
                            sclerosant with
                            ultrasound compression
                            maneuvers to guide
                            dispersion of the
                            injectate, inclusive of
                            all imaging guidance and
                            monitoring; multiple
                            incompetent truncal veins
                            (e.g., great saphenous
                            vein, accessory saphenous
                            vein), same leg.
36511....................  Therapeutic apheresis; for       1.74       2.00       2.00  No.
                            white blood cells.
36512....................  Therapeutic apheresis; for       1.74       2.00       2.00  No.
                            red blood cells.
36513....................  Therapeutic apheresis; for       1.74       2.00       2.00  No.
                            platelets.
36514....................  Therapeutic apheresis; for       1.74       1.81       1.81  No.
                            plasma pheresis.

[[Page 34017]]

 
36516....................  Therapeutic apheresis;           1.22       1.56       1.56  No.
                            with extracorporeal
                            selective adsorption or
                            selective filtration and
                            plasma reinfusion.
36522....................  Photopheresis,                   1.67       1.75       1.75  No.
                            extracorporeal.
36555....................  Insertion of non-tunneled        2.43       1.93       1.93  No.
                            centrally inserted
                            central venous catheter;
                            younger than 5 years of
                            age.
36556....................  Insertion of non-tunneled        2.50       1.75       1.75  No.
                            centrally inserted
                            central venous catheter;
                            age 5 years or older.
36569....................  Insertion of peripherally        1.82       1.70       1.70  No.
                            inserted central venous
                            catheter (PICC), without
                            subcutaneous port or
                            pump; age 5 years or
                            older.
36620....................  Arterial catheterization         1.15       1.00       1.00  No.
                            or cannulation for
                            sampling, monitoring or
                            transfusion (separate
                            procedure); percutaneous.
38220....................  Diagnostic bone marrow;          1.08       1.20       1.20  Yes.
                            aspiration(s).
38221....................  Diagnostic bone marrow;          1.37       1.28       1.28  Yes.
                            biopsy(ies).
382X3....................  Diagnostic bone marrow;           NEW       1.44       1.44  Yes.
                            biopsy(ies) and
                            aspiration(s).
3857X....................  Laparoscopy, surgical;            NEW      20.00      20.00  No.
                            with bilateral total
                            pelvic lymphadenectomy
                            and peri-aortic lymph
                            node sampling peritoneal
                            washings, peritoneal
                            biopsy(s), omentectomy,
                            and diaphragmatic
                            washings, including
                            biopsy(s) when performed.
43107....................  Total or near total             44.18      52.05      52.05  No.
                            esophagectomy, without
                            thoracotomy; with
                            pharyngogastrostomy or
                            cervical
                            esophagogastrostomy, with
                            or without pyloroplasty
                            (transhiatal).
43112....................  Total or near total             47.48      62.00      62.00  No.
                            esophagectomy, with
                            thoracotomy; with
                            pharyngogastrostomy or
                            cervical
                            esophagogastrostomy, with
                            or without pyloroplasty
                            (i.e., McKeown
                            esophagectomy, or tri-
                            incisional esophagectomy).
43117....................  Partial esophagectomy,          43.65      57.50      57.50  No.
                            distal two-thirds, with
                            thoracotomy and separate
                            abdominal incision, with
                            or without proximal
                            gastrectomy; with
                            thoracic
                            esophagogastrostomy, with
                            or without pyloroplasty
                            (Ivor Lewis).
432X5....................  Esophagectomy, total or           NEW      55.00      55.00  No
                            near total, with
                            laparoscopic mobilization
                            of the abdominal and
                            mediastinal esophagus and
                            proximal gastrectomy,
                            with laparoscopic pyloric
                            drainage procedure if
                            performed, with open
                            cervical
                            pharyngogastrostomy or
                            esophagogastrostomy
                            (i.e., laparoscopic
                            transhiatal
                            esophagectomy).
432X6....................  Esophagectomy, distal two-        NEW      63.00      63.00  No.
                            thirds, with laparoscopic
                            mobilization of the
                            abdominal and lower
                            mediastinal esophagus and
                            proximal gastrectomy,
                            with laparoscopic pyloric
                            drainage procedure if
                            performed, with separate
                            thoracoscopic
                            mobilization of the
                            middle and upper
                            mediastinal esophagus and
                            thoracic
                            esophagogastrostomy
                            (i.e., laparoscopic
                            thoracoscopic
                            esophagectomy, Ivor Lewis
                            esophagectomy).
432X7....................  Esophagectomy, total or           NEW      66.42      66.42  No.
                            near total, with
                            thoracoscopic
                            mobilization of the
                            upper, middle, and lower
                            mediastinal esophagus,
                            with separate
                            laparoscopic proximal
                            gastrectomy, with
                            laparoscopic pyloric
                            drainage procedure if
                            performed, with open
                            cervical
                            pharyngogastrostomy or
                            esophagogastrostomy
                            (i.e., thoracoscopic,
                            laparoscopic and cervical
                            incision esophagectomy,
                            McKeown esophagectomy,
                            tri-incisional
                            esophagectomy).
51798....................  Measurement of post-             0.00       0.00       0.00  No.
                            voiding residual urine
                            and/or bladder capacity
                            by ultrasound, non-
                            imaging.
52601....................  Transurethral                   15.26      13.16      13.16  No.
                            electrosurgical resection
                            of prostate, including
                            control of postoperative
                            bleeding, complete
                            (vasectomy, meatotomy,
                            cystourethroscopy,
                            urethral calibration and/
                            or dilation, and internal
                            urethrotomy are included).
55X87....................  Transperineal placement of        NEW       3.03       3.03  No.
                            biodegradable material,
                            peri-prostatic, single or
                            multiple injection(s),
                            including image guidance,
                            when performed.
57240....................  Anterior colporrhaphy,          11.50      10.08      10.08  No.
                            repair of cystocele with
                            or without repair of
                            urethrocele, including
                            cystourethroscopy, when
                            performed.
57250....................  Posterior colporrhaphy,         11.50      10.08      10.08  No.
                            repair of rectocele with
                            or without perineorrhaphy.
57260....................  Combined anteroposterior        14.44      13.25      13.25  No.
                            colporrhaphy, including
                            cystourethroscopy, when
                            performed.
57265....................  Combined anteroposterior        15.94      15.00      15.00  No.
                            colporrhaphy, including
                            cystourethroscopy, when
                            performed; with
                            enterocele repair.
5857X....................  Laparoscopy, surgical,            NEW      32.60      32.60  No.
                            total hysterectomy; with
                            or without salpingo-
                            oophorectomy, unilateral
                            or bilateral, with
                            resection of malignancy
                            (tumor debulking), with
                            omentectomy.
64418....................  Injection, anesthetic            1.32       1.10       1.10  No.
                            agent; suprascapular
                            nerve.
64553....................  Percutaneous implantation        2.36       6.13       6.13  No
                            of neurostimulator
                            electrode array; cranial
                            nerve.
64555....................  Percutaneous implantation        2.32       5.76       5.76  No.
                            of neurostimulator
                            electrode array;
                            peripheral nerve
                            (excludes sacral nerve).
64910....................  Nerve repair; with              11.39      10.52      10.52  No.
                            synthetic conduit or vein
                            allograft (e.g., nerve
                            tube), each nerve.
64911....................  Nerve repair; with              14.39      14.00      14.00  No
                            autogenous vein graft
                            (includes harvest of vein
                            graft), each nerve.
64X91....................  Nerve repair; with nerve          NEW      12.00      12.00  No.
                            allograft, each nerve,
                            first strand (cable).
64X92....................  Nerve repair; with nerve          NEW       3.00       3.00  No.
                            allograft, each
                            additional strand.
67820....................  Correction of trichiasis;        0.71       0.32       0.32  No.
                            epilation, by forceps
                            only.
70490....................  Computed tomography, soft        1.28       1.28       1.28  No.
                            tissue neck; without
                            contrast material.
70491....................  Computed tomography, soft        1.38       1.38       1.38  No.
                            tissue neck; with
                            contrast material(s).
70492....................  Computed tomography, soft        1.45       1.62       1.62  No.
                            tissue neck; without
                            contrast material
                            followed by contrast
                            material(s) and further
                            sections.
70544....................  Magnetic resonance               1.20       1.20       1.20  No.
                            angiography, head;
                            without contrast
                            material(s).
70545....................  Magnetic resonance               1.20       1.20       1.20  No.
                            angiography, head; with
                            contrast material(s).
70546....................  Magnetic resonance               1.80       1.48       1.48  No.
                            angiography, head;
                            without contrast
                            material(s), followed by
                            contrast material(s) and
                            further sequences.
70547....................  Magnetic resonance               1.20       1.20       1.20  No.
                            angiography, neck;
                            without contrast
                            material(s).
70548....................  Magnetic resonance               1.20       1.50       1.50  No.
                            angiography, neck; with
                            contrast material(s).
70549....................  Magnetic resonance               1.80       1.80       1.80  No.
                            angiography, neck;
                            without contrast
                            material(s), followed by
                            contrast material(s) and
                            further sequences.
710X1....................  Radiologic examination,           NEW       0.18       0.18  No.
                            chest; single view.
710X2....................  Radiologic examination,           NEW       0.22       0.22  No.
                            chest; 2 views.
710X3....................  Radiologic examination,           NEW       0.27       0.27  No.
                            chest; 3 views.
710X4....................  Radiologic examination,           NEW       0.31       0.31  No.
                            chest; 4 or more views.
71100....................  Radiologic examination,          0.22       0.22       0.22  No.
                            ribs, unilateral; 2 views.
71101....................  Radiologic examination,          0.27       0.27       0.27  No.
                            ribs, unilateral;
                            including posteroanterior
                            chest, minimum of 3 views.
71110....................  Radiologic examination,          0.27       0.29       0.29  No.
                            ribs, bilateral; 3 views.
71111....................  Radiologic examination,          0.32       0.32       0.32  No.
                            ribs, bilateral;
                            including posteroanterior
                            chest, minimum of 4 views.

[[Page 34018]]

 
71250....................  Computed tomography,             1.02       1.16       1.16  No.
                            thorax; without contrast
                            material.
71260....................  Computed tomography,             1.24       1.24       1.24  No.
                            thorax; with contrast
                            material(s).
71270....................  Computed tomography,             1.38       1.38       1.38  No.
                            thorax; without contrast
                            material, followed by
                            contrast material(s) and
                            further sections.
72195....................  Magnetic resonance (e.g.,        1.46       1.46       1.46  No.
                            proton) imaging, pelvis;
                            without contrast
                            material(s).
72196....................  Magnetic resonance (e.g.,        1.73       1.73       1.73  No.
                            proton) imaging, pelvis;
                            with contrast material(s).
72197....................  Magnetic resonance (e.g.,        2.26       2.20       2.20  No.
                            proton) imaging, pelvis;
                            without contrast
                            material(s), followed by
                            contrast material(s) and
                            further sequences.
73100....................  Radiologic examination,          0.16       0.16       0.16  No.
                            wrist; 2 views.
73110....................  Radiologic examination,          0.17       0.17       0.17  No.
                            wrist; complete, minimum
                            of 3 views.
73120....................  Radiologic examination,          0.16       0.16       0.16  No.
                            hand; 2 views.
73130....................  Radiologic examination,          0.17       0.17       0.17  No.
                            hand; minimum of 3 views.
73140....................  Radiologic examination,          0.13       0.13       0.13  No.
                            finger(s), minimum of 2
                            views.
73718....................  Magnetic resonance (e.g.,        1.35       1.35       1.35  No.
                            proton) imaging, lower
                            extremity other than
                            joint; without contrast
                            material(s).
73719....................  Magnetic resonance (e.g.,        1.62       1.62       1.62  No.
                            proton) imaging, lower
                            extremity other than
                            joint; with contrast
                            material(s).
73720....................  Magnetic resonance (e.g.,        2.15       2.15       2.15  No.
                            proton) imaging, lower
                            extremity other than
                            joint; without contrast
                            material(s), followed by
                            contrast material(s) and
                            further sequences.
74022....................  Radiologic examination,          0.32       0.32       0.32  No.
                            abdomen; complete acute
                            abdomen series, including
                            supine, erect, and/or
                            decubitus views, single
                            view chest.
740X1....................  Radiologic examination,           NEW       0.18       0.18  No.
                            abdomen; 1 view.
740X2....................  Radiologic examination,           NEW       0.23       0.23  No.
                            abdomen; 2 views.
740X3....................  Radiologic examination,           NEW       0.27       0.27  No.
                            abdomen; 3 or more views.
74181....................  Magnetic resonance (e.g.,        1.46       1.46       1.46  No.
                            proton) imaging, abdomen;
                            without contrast
                            material(s).
74182....................  Magnetic resonance (e.g.,        1.73       1.73       1.73  No.
                            proton) imaging, abdomen;
                            with contrast material(s).
74183....................  Magnetic resonance (e.g.,        2.26       2.20       2.20  No.
                            proton) imaging, abdomen;
                            without contrast
                            material(s), followed by
                            with contrast material(s)
                            and further sequences.
75635....................  Computed tomographic             2.40       2.40       2.40  No.
                            angiography, abdominal
                            aorta and bilateral
                            iliofemoral lower
                            extremity runoff, with
                            contrast material(s),
                            including noncontrast
                            images, if performed, and
                            image postprocessing.
75710....................  Angiography, extremity,          1.14       1.75       1.75  No.
                            unilateral, radiological
                            supervision and
                            interpretation.
75716....................  Angiography, extremity,          1.31       1.97       1.97  No.
                            bilateral, radiological
                            supervision and
                            interpretation.
76510....................  Ophthalmic ultrasound,           1.55       0.70       0.70  No.
                            diagnostic; B-scan and
                            quantitative A-scan
                            performed during the same
                            patient encounter.
76511....................  Ophthalmic ultrasound,           0.94       0.64       0.64  No.
                            diagnostic; quantitative
                            A-scan only.
76512....................  Ophthalmic ultrasound,           0.94       0.56       0.56  No.
                            diagnostic; B-scan (with
                            or without superimposed
                            non-quantitative A-scan).
76516....................  Ophthalmic biometry by           0.54       0.40       0.40  No.
                            ultrasound echography, A-
                            scan.
76519....................  Ophthalmic biometry by           0.54       0.54       0.54  No.
                            ultrasound echography, A-
                            scan; with intraocular
                            lens power calculation.
76881....................  Ultrasound, extremity,           0.63       0.63       0.63  No.
                            nonvascular, real-time
                            with image documentation;
                            complete.
76882....................  Ultrasound, extremity,           0.49       0.49       0.49  No.
                            nonvascular, real-time
                            with image documentation;
                            limited, anatomic
                            specific.
77261....................  Therapeutic radiology            1.39       1.30       1.30  No.
                            treatment planning;
                            simple.
77262....................  Therapeutic radiology            2.11       2.00       2.00  No.
                            treatment planning;
                            intermediate.
77263....................  Therapeutic radiology            3.14       3.14       3.14  No.
                            treatment planning;
                            complex.
78300....................  Bone and/or joint imaging;       0.62       0.62       0.62  No.
                            limited area.
78305....................  Bone and/or joint imaging;       0.83       0.83       0.83  No.
                            multiple areas.
78306....................  Bone and/or joint imaging;       0.86       0.86       0.86  No.
                            whole body.
88333....................  Pathology consultation           1.20       1.20       1.20  No.
                            during surgery; cytologic
                            examination (e.g., touch
                            prep, squash prep),
                            initial site.
88334....................  Pathology consultation           0.73       0.73       0.73  No.
                            during surgery; cytologic
                            examination (e.g., touch
                            prep, squash prep), each
                            additional site.
88360....................  Morphometric analysis,           1.10       0.85       0.85  No.
                            tumor
                            immunohistochemistry
                            (e.g., Her-2/neu,
                            estrogen receptor/
                            progesterone receptor),
                            quantitative or
                            semiquantitative, per
                            specimen, each single
                            antibody stain procedure;
                            manual.
88361....................  Morphometric analysis,           1.18       0.95       0.95  No.
                            tumor
                            immunohistochemistry
                            (e.g., Her-2/neu,
                            estrogen receptor/
                            progesterone receptor),
                            quantitative or
                            semiquantitative, per
                            specimen, each single
                            antibody stain procedure;
                            using computer-assisted
                            technology.
92136....................  Ophthalmic biometry by           0.54       0.54       0.54  No.
                            partial coherence
                            interferometry with
                            intraocular lens power
                            calculation.
93279....................  Programming device               0.65       0.65       0.65  No.
                            evaluation (in person)
                            with iterative adjustment
                            of the implantable device
                            to test the function of
                            the device and select
                            optimal permanent
                            programmed values with
                            analysis, review and
                            report by a physician or
                            other qualified health
                            care professional; single
                            lead pacemaker system.
93280....................  Programming device               0.77       0.77       0.77  No.
                            evaluation (in person)
                            with iterative adjustment
                            of the implantable device
                            to test the function of
                            the device and select
                            optimal permanent
                            programmed values with
                            analysis, review and
                            report by a physician or
                            other qualified health
                            care professional; dual
                            lead pacemaker system.
93281....................  Programming device               0.90       0.85       0.85  No.
                            evaluation (in person)
                            with iterative adjustment
                            of the implantable device
                            to test the function of
                            the device and select
                            optimal permanent
                            programmed values with
                            analysis, review and
                            report by a physician or
                            other qualified health
                            care professional;
                            multiple lead pacemaker
                            system.
93282....................  Programming device               0.85       0.85       0.85  No.
                            evaluation (in person)
                            with iterative adjustment
                            of the implantable device
                            to test the function of
                            the device and select
                            optimal permanent
                            programmed values with
                            analysis, review and
                            report by a physician or
                            other qualified health
                            care professional; single
                            lead transvenous
                            implantable defibrillator
                            system.
93283....................  Programming device               1.15       1.15       1.15  No.
                            evaluation (in person)
                            with iterative adjustment
                            of the implantable device
                            to test the function of
                            the device and select
                            optimal permanent
                            programmed values with
                            analysis, review and
                            report by a physician or
                            other qualified health
                            care professional; dual
                            lead transvenous
                            implantable defibrillator
                            system.

[[Page 34019]]

 
93284....................  Programming device               1.25       1.25       1.25  No.
                            evaluation (in person)
                            with iterative adjustment
                            of the implantable device
                            to test the function of
                            the device and select
                            optimal permanent
                            programmed values with
                            analysis, review and
                            report by a physician or
                            other qualified health
                            care professional;
                            multiple lead transvenous
                            implantable defibrillator
                            system.
93285....................  Programming device               0.52       0.52       0.52  No.
                            evaluation (in person)
                            with iterative adjustment
                            of the implantable device
                            to test the function of
                            the device and select
                            optimal permanent
                            programmed values with
                            analysis, review and
                            report by a physician or
                            other qualified health
                            care professional;
                            implantable loop recorder
                            system.
93286....................  Peri-procedural device           0.30       0.30       0.30  No.
                            evaluation (in person)
                            and programming of device
                            system parameters before
                            or after a surgery,
                            procedure, or test with
                            analysis, review and
                            report by a physician or
                            other qualified health
                            care professional;
                            single, dual, or multiple
                            lead pacemaker system.
93287....................  Peri-procedural device           0.45       0.45       0.45  No.
                            evaluation (in person)
                            and programming of device
                            system parameters before
                            or after a surgery,
                            procedure, or test with
                            analysis, review and
                            report by a physician or
                            other qualified health
                            care professional;
                            single, dual, or multiple
                            lead implantable
                            defibrillator system.
93288....................  Interrogation device             0.43       0.43       0.43  No.
                            evaluation (in person)
                            with analysis, review and
                            report by a physician or
                            other qualified health
                            care professional,
                            includes connection,
                            recording and
                            disconnection per patient
                            encounter; single, dual,
                            or multiple lead
                            pacemaker system.
93289....................  Interrogation device             0.92       0.75       0.75  No.
                            evaluation (in person)
                            with analysis, review and
                            report by a physician or
                            other qualified health
                            care professional,
                            includes connection,
                            recording and
                            disconnection per patient
                            encounter; single, dual,
                            or multiple lead
                            transvenous implantable
                            defibrillator system,
                            including analysis of
                            heart rhythm derived data
                            elements.
93290....................  Interrogation device             0.43       0.43       0.43  No.
                            evaluation (in person)
                            with analysis, review and
                            report by a physician or
                            other qualified health
                            care professional,
                            includes connection,
                            recording and
                            disconnection per patient
                            encounter; implantable
                            cardiovascular monitor
                            system, including
                            analysis of 1 or more
                            recorded physiologic
                            cardiovascular data
                            elements from all
                            internal and external
                            sensors.
93291....................  Interrogation device             0.43       0.37       0.37  No.
                            evaluation (in person)
                            with analysis, review and
                            report by a physician or
                            other qualified health
                            care professional,
                            includes connection,
                            recording and
                            disconnection per patient
                            encounter; implantable
                            loop recorder system,
                            including heart rhythm
                            derived data analysis.
93292....................  Interrogation device             0.43       0.43       0.43  No.
                            evaluation (in person)
                            with analysis, review and
                            report by a physician or
                            other qualified health
                            care professional,
                            includes connection,
                            recording and
                            disconnection per patient
                            encounter; wearable
                            defibrillator system.
93293....................  Transtelephonic rhythm           0.32       0.31       0.31  No.
                            strip pacemaker
                            evaluation(s) single,
                            dual, or multiple lead
                            pacemaker system,
                            includes recording with
                            and without magnet
                            application with
                            analysis, review and
                            report(s) by a physician
                            or other qualified health
                            care professional, up to
                            90 days.
93294....................  Interrogation device             0.65       0.60       0.60  No.
                            evaluation(s) (remote),
                            up to 90 days; single,
                            dual, or multiple lead
                            pacemaker system with
                            interim analysis,
                            review(s) and report(s)
                            by a physician or other
                            qualified health care
                            professional.
93295....................  Interrogation device             1.29       0.74       0.74  No.
                            evaluation(s) (remote),
                            up to 90 days; single,
                            dual, or multiple lead
                            implantable defibrillator
                            system with interim
                            analysis, review(s) and
                            report(s) by a physician
                            or other qualified health
                            care professional.
93296....................  Interrogation device             0.00       0.00       0.00  No.
                            evaluation(s) (remote),
                            up to 90 days; single,
                            dual, or multiple lead
                            pacemaker system or
                            implantable defibrillator
                            system, remote data
                            acquisition(s), receipt
                            of transmissions and
                            technician review,
                            technical support and
                            distribution of results.
93297....................  Interrogation device             0.52       0.52       0.52  No.
                            evaluation(s), (remote)
                            up to 30 days;
                            implantable
                            cardiovascular monitor
                            system, including
                            analysis of 1 or more
                            recorded physiologic
                            cardiovascular data
                            elements from all
                            internal and external
                            sensors, analysis,
                            review(s) and report(s)
                            by a physician or other
                            qualified health care
                            professional.
93298....................  Interrogation device             0.52       0.52       0.52  No.
                            evaluation(s), (remote)
                            up to 30 days;
                            implantable loop recorder
                            system, including
                            analysis of recorded
                            heart rhythm data,
                            analysis, review(s) and
                            report(s) by a physician
                            or other qualified health
                            care professional.
93299....................  Interrogation device             0.00       0.00       0.00  No.
                            evaluation(s), (remote)
                            up to 30 days;
                            implantable
                            cardiovascular monitor
                            system or implantable
                            loop recorder system,
                            remote data
                            acquisition(s), receipt
                            of transmissions and
                            technician review,
                            technical support and
                            distribution of results.
93306....................  Echocardiography,                1.30       1.50       1.50  No.
                            transthoracic, real-time
                            with image documentation
                            (2D), includes M-mode
                            recording, when
                            performed, complete, with
                            spectral Doppler
                            echocardiography, and
                            with color flow Doppler
                            echocardiography.
93307....................  Echocardiography,                0.92       0.92       0.92  No.
                            transthoracic, real-time
                            with image documentation
                            (2D), includes M-mode
                            recording, when
                            performed, complete,
                            without spectral or color
                            Doppler echocardiography.
93308....................  Echocardiography,                0.53       0.53       0.53  No.
                            transthoracic, real-time
                            with image documentation
                            (2D), includes M-mode
                            recording, when
                            performed, follow-up or
                            limited study.
93350....................  Echocardiography,                1.46       1.46       1.46  No.
                            transthoracic, real-time
                            with image documentation
                            (2D), includes M-mode
                            recording, when
                            performed, during rest
                            and cardiovascular stress
                            test using treadmill,
                            bicycle exercise and/or
                            pharmacologically induced
                            stress, with
                            interpretation and report.
93351....................  Echocardiography,                1.75       1.75       1.75  No.
                            transthoracic, real-time
                            with image documentation
                            (2D), includes M-mode
                            recording, when
                            performed, during rest
                            and cardiovascular stress
                            test using treadmill,
                            bicycle exercise and/or
                            pharmacologically induced
                            stress, with
                            interpretation and
                            report; including
                            performance of continuous
                            electrocardiographic
                            monitoring, with
                            supervision by a
                            physician or other
                            qualified health care
                            professional.
93503....................  Insertion and placement of       2.91       2.00       2.00  No.
                            flow directed catheter
                            (e.g., Swan-Ganz) for
                            monitoring purposes.
93613....................  Intracardiac                     6.99       5.23       5.23  No.
                            electrophysiologic 3-
                            dimensional mapping.
93668....................  Peripheral arterial                 N       0.00       0.00  No.
                            disease (PAD)
                            rehabilitation, per
                            session.
94621....................  Cardiopulmonary exercise         1.42       1.42       1.42  No.
                            testing, including
                            measurements of minute
                            ventilation, CO2
                            production, O2 uptake,
                            and electrocardiographic
                            recordings.
946X2....................  Exercise test for                 NEW       0.70       0.70  No.
                            bronchospasm, including
                            pre- and post-spirometry
                            and pulse oximetry.
946X3....................  Pulmonary stress testing          NEW       0.48       0.48  No.
                            (e.g., 6-minute walk
                            test), including
                            measurement of heart
                            rate, oximetry, and
                            oxygen titration, when
                            performed.
95004....................  Percutaneous tests               0.01       0.01       0.01  No.
                            (scratch, puncture,
                            prick) with allergenic
                            extracts, immediate type
                            reaction, including test
                            interpretation and
                            report, specify number of
                            tests.

[[Page 34020]]

 
95250....................  Ambulatory continuous            0.00       0.00       0.00  No.
                            glucose monitoring of
                            interstitial tissue fluid
                            via a subcutaneous sensor
                            for a minimum of 72
                            hours; sensor placement,
                            hook-up, calibration of
                            monitor, patient
                            training, removal of
                            sensor, and printout of
                            recording.
95251....................  Ambulatory continuous            0.85       0.70       0.70  No.
                            glucose monitoring of
                            interstitial tissue fluid
                            via a subcutaneous sensor
                            for a minimum of 72
                            hours; interpretation and
                            report.
95930....................  Visual evoked potential          0.35       0.35       0.35  No.
                            (VEP) testing central
                            nervous system except
                            glaucoma, checkerboard or
                            flash, with
                            interpretation and report.
96160....................  Administration of patient-       0.00       0.00       0.00  No.
                            focused health risk
                            assessment instrument
                            (e.g., health hazard
                            appraisal) with scoring
                            and documentation, per
                            standardized instrument.
96161....................  Administration of                0.00       0.00       0.00  No.
                            caregiver-focused health
                            risk assessment
                            instrument (e.g.,
                            depression inventory) for
                            the benefit of the
                            patient, with scoring and
                            documentation, per
                            standardized instrument.
96360....................  Intravenous infusion,            0.17       0.17       0.17  No.
                            hydration; initial, 31
                            minutes to 1 hour.
96361....................  Intravenous infusion,            0.09       0.09       0.09  No.
                            hydration; each
                            additional hour.
96372....................  Therapeutic, prophylactic,       0.17       0.17       0.17  No.
                            or diagnostic injection
                            (specify substance or
                            drug); subcutaneous or
                            intramuscular.
96374....................  Therapeutic, prophylactic,       0.18       0.18       0.18  No.
                            or diagnostic injection
                            (specify substance or
                            drug); intravenous push,
                            single or initial
                            substance/drug.
96375....................  Therapeutic, prophylactic,       0.10       0.10       0.10  No.
                            or diagnostic injection
                            (specify substance or
                            drug); each additional
                            sequential intravenous
                            push of a new substance/
                            drug.
96377....................  Application of on-body           0.00       0.17       0.17  No.
                            injector (includes
                            cannula insertion) for
                            timed subcutaneous
                            injection.
96401....................  Chemotherapy                     0.21       0.21       0.21  No.
                            administration,
                            subcutaneous or
                            intramuscular; non-
                            hormonal anti-neoplastic.
96402....................  Chemotherapy                     0.19       0.19       0.19  No.
                            administration,
                            subcutaneous or
                            intramuscular; hormonal
                            anti-neoplastic.
96409....................  Chemotherapy                     0.24       0.24       0.24  No.
                            administration;
                            intravenous, push
                            technique, single or
                            initial substance/drug.
96411....................  Chemotherapy                     0.20       0.20       0.20  No.
                            administration;
                            intravenous, push
                            technique, each
                            additional substance/drug.
96910....................  Photochemotherapy; tar and       0.00       0.00       0.00  No.
                            ultraviolet B (Goeckerman
                            treatment) or petrolatum
                            and ultraviolet B.
96X73....................  Photodynamic therapy by           NEW       0.48       0.48  No.
                            external application of
                            light to destroy
                            premalignant lesions of
                            the skin and adjacent
                            mucosa with application
                            and illumination/
                            activation of
                            photosensitizing drug(s),
                            per day.
96X74....................  Debridement of                    NEW       1.01       1.01  No.
                            premalignant
                            hyperkeratotic lesion(s)
                            (i.e., targeted
                            curettage, abrasion)
                            followed with
                            photodynamic therapy by
                            external application of
                            light to destroy
                            premalignant lesions of
                            the skin and adjacent
                            mucosa with application
                            and illumination/
                            activation of
                            photosensitizing drug(s),
                            per day.
97012....................  Application of a modality        0.25       0.25       0.25  No.
                            to 1 or more areas;
                            traction, mechanical.
97014....................  Application of a modality        0.18       0.18       0.18  No.
                            to 1 or more areas;
                            electrical stimulation
                            (unattended).
97016....................  Application of a modality        0.18       0.18       0.18  No.
                            to 1 or more areas;
                            vasopneumatic devices.
97018....................  Application of a modality        0.06       0.06       0.06  No.
                            to 1 or more areas;
                            paraffin bath.
97022....................  Application of a modality        0.17       0.17       0.17  No.
                            to 1 or more areas;
                            whirlpool.
97032....................  Application of a modality        0.25       0.25       0.25  No.
                            to 1 or more areas;
                            electrical stimulation
                            (manual), each 15 minutes.
97033....................  Application of a modality        0.26       0.26       0.26  No.
                            to 1 or more areas;
                            iontophoresis, each 15
                            minutes.
97034....................  Application of a modality        0.21       0.21       0.21  No.
                            to 1 or more areas;
                            contrast baths, each 15
                            minutes.
97035....................  Application of a modality        0.21       0.21       0.21  No.
                            to 1 or more areas;
                            ultrasound, each 15
                            minutes.
97110....................  Therapeutic procedure, 1         0.45       0.45       0.45  No.
                            or more areas, each 15
                            minutes; therapeutic
                            exercises to develop
                            strength and endurance,
                            range of motion and
                            flexibility.
97112....................  Therapeutic procedure, 1         0.45       0.50       0.50  No.
                            or more areas, each 15
                            minutes; neuromuscular
                            reeducation of movement,
                            balance, coordination,
                            kinesthetic sense,
                            posture, and/or
                            proprioception for
                            sitting and/or standing
                            activities.
97113....................  Therapeutic procedure, 1         0.44       0.48       0.48  No.
                            or more areas, each 15
                            minutes; aquatic therapy
                            with therapeutic
                            exercises.
97116....................  Therapeutic procedure, 1         0.40       0.45       0.45  No.
                            or more areas, each 15
                            minutes; gait training
                            (includes stair climbing).
97140....................  Manual therapy techniques        0.43       0.43       0.43  No.
                            (e.g., mobilization/
                            manipulation, manual
                            lymphatic drainage,
                            manual traction), 1 or
                            more regions, each 15
                            minutes.
97530....................  Therapeutic activities,          0.44       0.44       0.44  No.
                            direct (one-on-one)
                            patient contact (use of
                            dynamic activities to
                            improve functional
                            performance), each 15
                            minutes.
97533....................  Sensory integrative              0.44       0.48       0.48  No.
                            techniques to enhance
                            sensory processing and
                            promote adaptive
                            responses to
                            environmental demands,
                            direct (one-on-one)
                            patient contact, each 15
                            minutes.
97535....................  Self-care/home management        0.45       0.45       0.45  No.
                            training (e.g.,
                            activities of daily
                            living (ADL) and
                            compensatory training,
                            meal preparation, safety
                            procedures, and
                            instructions in use of
                            assistive technology
                            devices/adaptive
                            equipment) direct one-on-
                            one contact, each 15
                            minutes.
97537....................  Community/work                   0.45       0.48       0.48  No.
                            reintegration training
                            (e.g., shopping,
                            transportation, money
                            management, avocational
                            activities and/or work
                            environment/modification
                            analysis, work task
                            analysis, use of
                            assistive technology
                            device/adaptive
                            equipment), direct one-on-
                            one contact, each 15
                            minutes.
97542....................  Wheelchair management            0.45       0.48       0.48  No.
                            (e.g., assessment,
                            fitting, training), each
                            15 minutes.
97760....................  Orthotic(s) management and       0.45       0.50       0.50  No.
                            training (including
                            assessment and fitting
                            when not otherwise
                            reported), upper
                            extremity(ies), lower
                            extremity(ies) and/or
                            trunk, initial
                            orthotic(s) encounter,
                            each 15 minutes.
97761....................  Prosthetic(s) training,          0.45       0.50       0.50  No.
                            upper and/or lower
                            extremity(ies), initial
                            prosthetic(s) encounter,
                            each 15 minutes.
977X1....................  Orthotic(s)/prosthetic(s)         NEW       0.48       0.48  No.
                            management and/or
                            training, upper
                            extremity(ies), lower
                            extremity(ies), and/or
                            trunk, subsequent
                            orthotic(s)/prosthetic(s)
                            encounter, each 15
                            minutes.
97X11....................  Therapeutic interventions         NEW       1.50          I  Yes.
                            that focus on cognitive
                            function (e.g.,
                            attention, memory,
                            reasoning, executive
                            function, problem
                            solving, and/or pragmatic
                            functioning) and
                            compensatory strategies
                            to manage the performance
                            of an activity (e.g.,
                            managing time or
                            schedules, initiating,
                            organizing and sequencing
                            tasks, direct (one-on-
                            one) patient contact (do
                            not report 97X11 in
                            conjunction with 0364T,
                            0365T, 0368T, 0369T)
                            (report 97X11 only once
                            per day).
993X1....................  Patient/caregiver training        NEW       0.00       0.00  No.
                            for initiation of home
                            INR monitoring under the
                            direction of a physician
                            or other qualified health
                            care professional,
                            including face-to-face,
                            use and care of the INR
                            monitor, obtaining blood
                            sample, instructions for
                            reporting home INR test
                            results, and
                            documentation of
                            patient's/caregiver's
                            ability to perform
                            testing and report
                            results.

[[Page 34021]]

 
993X2....................  Anticoagulant management          NEW       0.18       0.18  No.
                            for a patient taking
                            warfarin, must include
                            review and interpretation
                            of a new home, office, or
                            lab International
                            No.rmalized Ratio (INR)
                            test result, patient
                            instructions, dosage
                            adjustment (as needed),
                            and scheduling of
                            additional test(s) when
                            performed.
994X1....................  Initial psychiatric               NEW       1.70       1.70  No.
                            collaborative care
                            management, first 70
                            minutes in the first
                            calendar month of
                            behavioral health care
                            manager activities, in
                            consultation with a
                            psychiatric consultant,
                            and directed by the
                            treating physician or
                            other qualified health
                            care professional, with
                            the following required
                            elements: Outreach to and
                            engagement in treatment
                            of a patient directed by
                            the treating physician or
                            other qualified health
                            care professional;
                            initial assessment of the
                            patient, including
                            administration of
                            validated rating scales,
                            with the development of
                            an individualized
                            treatment plan; review by
                            the psychiatric
                            consultant with
                            modifications of the plan
                            if recommended; entering
                            patient in a registry and
                            tracking patient follow-
                            up and progress using the
                            registry, with
                            appropriate
                            documentation, and
                            participation in weekly
                            caseload consultation
                            with the psychiatric
                            consultant; and provision
                            of brief interventions
                            using evidence-based
                            techniques such as
                            behavioral activation,
                            motivational
                            interviewing, and other
                            focused treatment
                            strategies.
994X2....................  Subsequent psychiatric            NEW       1.53       1.53  No.
                            collaborative care
                            management, first 60
                            minutes in a subsequent
                            month of behavioral
                            health care manager
                            activities, in
                            consultation with a
                            psychiatric consultant,
                            and directed by the
                            treating physician or
                            other qualified health
                            care professional, with
                            the following required
                            elements: Tracking
                            patient follow-up and
                            progress using the
                            registry, with
                            appropriate
                            documentation;
                            participation in weekly
                            caseload consultation
                            with the psychiatric
                            consultant; ongoing
                            collaboration with and
                            coordination of the
                            patient's mental health
                            care with the treating
                            physician or other
                            qualified health care
                            professional and any
                            other treating mental
                            health providers;
                            additional review of
                            progress and
                            recommendations for
                            changes in treatment, as
                            indicated, including
                            medications, based on
                            recommendations provided
                            by the psychiatric
                            consultant; provision of
                            brief interventions using
                            evidence-based techniques
                            such as behavioral
                            activation, motivational
                            interviewing, and other
                            focused treatment
                            strategies; monitoring of
                            patient outcomes using
                            validated rating scales;
                            and relapse prevention
                            planning with patients as
                            they achieve remission of
                            symptoms and/or other
                            treatment goals and are
                            prepared for discharge
                            from active treatment.
994X3....................  Initial or subsequent             NEW       0.82       0.82  No.
                            psychiatric collaborative
                            care management, each
                            additional 30 minutes in
                            a calendar month of
                            behavioral health care
                            manager activities, in
                            consultation with a
                            psychiatric consultant,
                            and directed by the
                            treating physician or
                            other qualified health
                            care professional.
99XX3....................  Assessment of and care            NEW       3.44       3.44  No.
                            planning for a patient
                            with cognitive
                            impairment, requiring an
                            independent historian, in
                            the office or other
                            outpatient, home or
                            domiciliary or rest home,
                            with all of the following
                            required elements:
                            Cognition-focused
                            evaluation including a
                            pertinent history and
                            examination; Medical
                            decision making of
                            moderate or high
                            complexity; Functional
                            assessment (e.g., Basic
                            and Instrumental
                            Activities of Daily
                            Living), including
                            decision-making capacity;
                            Use of standardized
                            instruments for staging
                            of dementia (e.g.,
                            Functional Assessment
                            Staging Test [FAST],
                            Clinical Dementia Rating
                            [CDR]); Medication
                            reconciliation and review
                            for high-risk
                            medications; Evaluation
                            for neuropsychiatric and
                            behavioral symptoms,
                            including depression,
                            including use of
                            standardized screening
                            instrument(s); Evaluation
                            of safety (e.g., home),
                            including motor vehicle
                            operation; Identification
                            of caregiver(s),
                            caregiver knowledge,
                            caregiver needs, social
                            supports, and the
                            willingness of caregiver
                            to take on caregiving
                            tasks; Development,
                            updating or revision, or
                            review of an Advance Care
                            Plan; Creation of a
                            written care plan,
                            including initial plans
                            to address any
                            neuropsychiatric
                            symptoms, neuro-cognitive
                            symptoms, functional
                            limitations, and referral
                            to community resources as
                            needed (e.g.,
                            rehabilitation services,
                            adult day programs,
                            support groups) shared
                            with the patient and/or
                            caregiver with initial
                            education and support.
                            Typically, 50 minutes are
                            spent face-to-face with
                            the patient and/or family
                            or caregiver.
99XX5....................  Care management services          NEW       0.61       0.61  No.
                            for behavioral health
                            conditions, at least 20
                            minutes of clinical staff
                            time, directed by a
                            physician or other
                            qualified health care
                            professional, per
                            calendar month, with the
                            following required
                            elements: Initial
                            assessment or follow-up
                            monitoring, including the
                            use of applicable
                            validated rating scales;
                            Behavioral health care
                            planning in relation to
                            behavioral/psychiatric
                            health problems,
                            including revision for
                            patients who are not
                            progressing or whose
                            status changes;
                            Facilitating and
                            coordinating treatment
                            such as psychotherapy,
                            pharmacotherapy,
                            counseling and/or
                            psychiatric consultation;
                            and Continuity of care
                            with a designated member
                            of the care team.
G0283....................  Electrical stimulation           0.18       0.18       0.18  No.
                            (unattended), to one or
                            more areas for
                            indication(s) other than
                            wound care, as part of a
                            therapy plan of care.
GDDD1....................  Insertion, non-                   NEW  .........       1.82  No.
                            biodegradable drug
                            delivery implants, 4 or
                            more.
GDDD2....................  Removal, non-biodegradable        NEW  .........       2.10  No.
                            drug deliver implants, 4
                            or more.
GDDD3....................  Removal with reinsertion,         NEW  .........       3.55  No.
                            non-biodegradable drug
                            delivery implants, 4 or
                            more.
GRRR1....................  Superficial radiation             NEW  .........       7.93  No.
                            treatment planning and
                            management related
                            services, including but
                            not limited to, when
                            performed, clinical
                            treatment planning (e.g.,
                            77261, 77262, 77263),
                            therapeutic radiology
                            simulation-aided field
                            setting (e.g., 77280,
                            77285, 77290, 77293),
                            basic radiation dosimetry
                            calculation (e.g.,
                            77300), treatment devices
                            (e.g., 77332, 77333,
                            77334), isodose planning
                            (e.g., 77306, 77307,
                            77316, 77317, 77318),
                            radiation treatment
                            management (e.g., 77427,
                            77431, 77432, 77435,
                            77469, 77470, 77499), and
                            associated evaluation and
                            management per course of
                            treatment.
GXXX1....................  Therapeutic interventions         NEW  .........       0.44  No.
                            that focus on cognitive
                            function (e.g.,
                            attention, memory,
                            reasoning, executive
                            function, problem
                            solving, and/or pragmatic
                            functioning) and
                            compensatory strategies
                            to manage the performance
                            of an activity (e.g.,
                            managing time or
                            schedules, initiating,
                            organizing and sequencing
                            tasks, direct (one-on-
                            one) patient contact.
GYYY1....................  Prolonged preventive              NEW  .........       1.17  No.
                            service(s), initial 30
                            minutes.
GYYY2....................  Prolonged preventive              NEW  .........       1.17  No.
                            service(s), first 30
                            minutes.
----------------------------------------------------------------------------------------------------------------


[[Page 34022]]


                                                     Table 11--CY 2018 Proposed Codes With Direct PE Input Recommendations With Refinements
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                      RUC             CMS                               Direct
                          HCPCS code                                 Input code       Nonfacility (NF)/     Labor activity     recommendation or   refinement                           costs
    HCPCS code           description           Input code           description          Facility (F)     (where applicable)     current value      (min or           Comment         change (in
                                                                                                                                  (min or qty)        qty)                             dollars)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
157X1.............  Mdfc flap w/prsrv      ED050               Technologist PACS      NF                 ....................                115          117  E15: Refined                $0.04
                     vasc pedcl.                                workstation.                                                                                    equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
157X1.............  Mdfc flap w/prsrv      EF014               light, surgical......  NF                 ....................                115          117  E15: Refined                 0.02
                     vasc pedcl.                                                                                                                                equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
157X1.............  Mdfc flap w/prsrv      EF031               table, power.........  NF                 ....................                115          117  E15: Refined                 0.03
                     vasc pedcl.                                                                                                                                equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
157X1.............  Mdfc flap w/prsrv      EQ011               ECG, 3-channel (with   NF                 ....................                115          117  E15: Refined                 0.03
                     vasc pedcl.                                SpO2, NIBP, temp,                                                                               equipment time to
                                                                resp).                                                                                          conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
157X1.............  Mdfc flap w/prsrv      EQ110               electrocautery-        NF                 ....................                115          117  E15: Refined                 0.01
                     vasc pedcl.                                hyfrecator, up to 45                                                                            equipment time to
                                                                watts.                                                                                          conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
157X1.............  Mdfc flap w/prsrv      EQ138               instrument pack,       NF                 ....................                127          129  E15: Refined                 0.01
                     vasc pedcl.                                medium ($1500 and                                                                               equipment time to
                                                                up).                                                                                            conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
157X1.............  Mdfc flap w/prsrv      L038A               COMT/COT/RN/CST......  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.76
                     vasc pedcl.                                                                                                                                standard for this
                                                                                                                                                                clinical labor task.
29445.............  Apply rigid leg cast.  EF031               table, power.........  NF                 ....................                 69           67  E15: Refined                -0.03
                                                                                                                                                                equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
29445.............  Apply rigid leg cast.  EQ080               cast cart............  NF                 ....................                 69           67  E15: Refined                -0.02
                                                                                                                                                                equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
29445.............  Apply rigid leg cast.  EQ168               light, exam..........  NF                 ....................                 69           67  E15: Refined                -0.01
                                                                                                                                                                equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
29445.............  Apply rigid leg cast.  L037D               RN/LPN/MTA...........  NF                 Check dressings &                     5            3  L1: Refined time to         -0.74
                                                                                                          wound/home care                                       standard for this
                                                                                                          instructions/                                         clinical labor task.
                                                                                                          coordinate office
                                                                                                          visits/
                                                                                                          prescriptions.

[[Page 34023]]

 
29580.............  Application of paste   EF023               table, exam..........  NF                 ....................                 35           34  E15: Refined                 0.00
                     boot.                                                                                                                                      equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
29580.............  Application of paste   EQ168               light, exam..........  NF                 ....................                 35           34  E15: Refined                 0.00
                     boot.                                                                                                                                      equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
29580.............  Application of paste   L037D               RN/LPN/MTA...........  NF                 Provide pre-service                   3            2  L1: Refined time to         -0.37
                     boot.                                                                                education/obtain                                      standard for this
                                                                                                          consent.                                              clinical labor task.
29581.............  Apply multlay comprs   EF023               table, exam..........  NF                 ....................                 37           36  E15: Refined                 0.00
                     lwr leg.                                                                                                                                   equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
29581.............  Apply multlay comprs   EQ168               light, exam..........  NF                 ....................                 37           36  E15: Refined                 0.00
                     lwr leg.                                                                                                                                   equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
29581.............  Apply multlay comprs   L037D               RN/LPN/MTA...........  NF                 Provide pre-service                   3            2  L1: Refined time to         -0.37
                     lwr leg.                                                                             education/obtain                                      standard for this
                                                                                                          consent.                                              clinical labor task.
30140.............  Resect inferior        EF008               chair with headrest,   NF                 ....................                 98          100  E15: Refined                 0.02
                     turbinate.                                 exam, reclining.                                                                                equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
30140.............  Resect inferior        EQ137               instrument pack,       NF                 ....................                102          104  E15: Refined                 0.00
                     turbinate.                                 basic ($500-$1499).                                                                             equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
30140.............  Resect inferior        EQ170               light, fiberoptic      NF                 ....................                 98          100  E15: Refined                 0.02
                     turbinate.                                 headlight w-source.                                                                             equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
30140.............  Resect inferior        EQ234               suction and pressure   NF                 ....................                 98          100  E15: Refined                 0.02
                     turbinate.                                 cabinet, ENT (SMR).                                                                             equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
30140.............  Resect inferior        EQ383               reusable shaver        NF                 ....................                102          104  E15: Refined                 0.01
                     turbinate.                                 blade, 2mm.                                                                                     equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.

[[Page 34024]]

 
30140.............  Resect inferior        EQ384               Microdebrider          NF                 ....................                 98          100  E15: Refined                 0.03
                     turbinate.                                 handpiece.                                                                                      equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
30140.............  Resect inferior        EQ385               Microdebrider console  NF                 ....................                 98          100  E15: Refined                 0.06
                     turbinate.                                                                                                                                 equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
30140.............  Resect inferior        L037D               RN/LPN/MTA...........  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.74
                     turbinate.                                                                                                                                 standard for this
                                                                                                                                                                clinical labor task.
30901.............  Control of nosebleed.  EF008               chair with headrest,   NF                 ....................                 22           26  E1: Refined                  0.04
                                                                exam, reclining.                                                                                equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
30901.............  Control of nosebleed.  EQ137               instrument pack,       NF                 ....................                 29           33  E5: Refined                  0.01
                                                                basic ($500-$1499).                                                                             equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for
                                                                                                                                                                surgical instrument
                                                                                                                                                                packs.
30901.............  Control of nosebleed.  EQ170               light, fiberoptic      NF                 ....................                 22           26  E1: Refined                  0.03
                                                                headlight w-source.                                                                             equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
30901.............  Control of nosebleed.  EQ234               suction and pressure   NF                 ....................                 22           26  E1: Refined                  0.04
                                                                cabinet, ENT (SMR).                                                                             equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
30903.............  Control of nosebleed.  EF008               chair with headrest,   NF                 ....................                 27           31  E1: Refined                  0.04
                                                                exam, reclining.                                                                                equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
30903.............  Control of nosebleed.  EQ110               electrocautery-        NF                 ....................                 27           31  E1: Refined                  0.01
                                                                hyfrecator, up to 45                                                                            equipment time to
                                                                watts.                                                                                          conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
30903.............  Control of nosebleed.  EQ137               instrument pack,       NF                 ....................                 34           38  E5: Refined                  0.01
                                                                basic ($500-$1499).                                                                             equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for
                                                                                                                                                                surgical instrument
                                                                                                                                                                packs.

[[Page 34025]]

 
30903.............  Control of nosebleed.  EQ170               light, fiberoptic      NF                 ....................                 27           31  E1: Refined                  0.03
                                                                headlight w-source.                                                                             equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
30903.............  Control of nosebleed.  EQ234               suction and pressure   NF                 ....................                 27           31  E1: Refined                  0.04
                                                                cabinet, ENT (SMR).                                                                             equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
30905.............  Control of nosebleed.  EF008               chair with headrest,   NF                 ....................                 32           62  E1: Refined                  0.32
                                                                exam, reclining.                                                                                equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
30905.............  Control of nosebleed.  EQ110               electrocautery-        NF                 ....................                 32           62  E1: Refined                  0.08
                                                                hyfrecator, up to 45                                                                            equipment time to
                                                                watts.                                                                                          conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
30905.............  Control of nosebleed.  EQ137               instrument pack,       NF                 ....................                 39           69  E5: Refined                  0.07
                                                                basic ($500-1499).                                                                              equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for
                                                                                                                                                                surgical instrument
                                                                                                                                                                packs.
30905.............  Control of nosebleed.  EQ170               light, fiberoptic      NF                 ....................                 32           62  E1: Refined                  0.24
                                                                headlight w-source.                                                                             equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
30905.............  Control of nosebleed.  EQ234               suction and pressure   NF                 ....................                 32           62  E1: Refined                  0.28
                                                                cabinet, ENT (SMR).                                                                             equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
30906.............  Repeat control of      EF008               chair with headrest,   NF                 ....................                 42           72  E1: Refined                  0.32
                     nosebleed.                                 exam, reclining.                                                                                equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
30906.............  Repeat control of      EQ110               electrocautery-        NF                 ....................                 42           72  E1: Refined                  0.08
                     nosebleed.                                 hyfrecator, up to 45                                                                            equipment time to
                                                                watts.                                                                                          conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.

[[Page 34026]]

 
30906.............  Repeat control of      EQ137               instrument pack,       NF                 ....................                 49           79  E5: Refined                  0.07
                     nosebleed.                                 basic ($500-$1499).                                                                             equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for
                                                                                                                                                                surgical instrument
                                                                                                                                                                packs.
30906.............  Repeat control of      EQ170               light, fiberoptic      NF                 ....................                 42           72  E1: Refined                  0.24
                     nosebleed.                                 headlight w-source.                                                                             equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
30906.............  Repeat control of      EQ234               suction and pressure   NF                 ....................                 42           72  E1: Refined                  0.28
                     nosebleed.                                 cabinet, ENT (SMR).                                                                             equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31254.............  Nsl/sins ndsc w/prtl   EF008               chair with headrest,   NF                 ....................                 47           52  E1: Refined                  0.05
                     ethmdct.                                   exam, reclining.                                                                                equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31254.............  Nsl/sins ndsc w/prtl   EF015               mayo stand...........  NF                 ....................                 47           52  E1: Refined                  0.01
                     ethmdct.                                                                                                                                   equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31254.............  Nsl/sins ndsc w/prtl   EQ138               instrument pack,       NF                 ....................                 59           64  E5: Refined                  0.03
                     ethmdct.                                   medium ($1500 and                                                                               equipment time to
                                                                up).                                                                                            conform to
                                                                                                                                                                established
                                                                                                                                                                policies for
                                                                                                                                                                surgical instrument
                                                                                                                                                                packs.
31254.............  Nsl/sins ndsc w/prtl   EQ167               light source, xenon..  NF                 ....................                 47           52  E1: Refined                  0.14
                     ethmdct.                                                                                                                                   equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31254.............  Nsl/sins ndsc w/prtl   EQ170               light, fiberoptic      NF                 ....................                 47           52  E1: Refined                  0.04
                     ethmdct.                                   headlight w-source.                                                                             equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31254.............  Nsl/sins ndsc w/prtl   EQ234               suction and pressure   NF                 ....................                 47           52  E1: Refined                  0.05
                     ethmdct.                                   cabinet, ENT (SMR).                                                                             equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.

[[Page 34027]]

 
31254.............  Nsl/sins ndsc w/prtl   EQ383               reusable shaver        NF                 ....................                 47           52  E1: Refined                  0.02
                     ethmdct.                                   blade, 2mm.                                                                                     equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31254.............  Nsl/sins ndsc w/prtl   EQ384               Microdebrider          NF                 ....................                 47           52  E1: Refined                  0.06
                     ethmdct.                                   handpiece.                                                                                      equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31254.............  Nsl/sins ndsc w/prtl   EQ385               Microdebrider console  NF                 ....................                 47           52  E1: Refined                  0.15
                     ethmdct.                                                                                                                                   equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31254.............  Nsl/sins ndsc w/prtl   ES005               endoscope              NF                 ....................                 37           51  E4: Refined                  0.85
                     ethmdct.                                   disinfector, rigid                                                                              equipment time to
                                                                or fiberoptic, w-                                                                               conform to
                                                                cart.                                                                                           established
                                                                                                                                                                policies for scopes.
31254.............  Nsl/sins ndsc w/prtl   ES031               video system,          NF                 ....................                 47           44  E19: Refined                -0.39
                     ethmdct.                                   endoscopy                                                                                       equipment time to
                                                                (processor, digital                                                                             conform to
                                                                capture, monitor,                                                                               established
                                                                printer, cart).                                                                                 policies for scope
                                                                                                                                                                accessories.
31254.............  Nsl/sins ndsc w/prtl   ES040               PROXY endoscope,       NF                 ....................                 37           51  E4: Refined                  0.11
                     ethmdct.                                   rigid, sinoscopy (0                                                                             equipment time to
                                                                degrees).                                                                                       conform to
                                                                                                                                                                established
                                                                                                                                                                policies for scopes.
31254.............  Nsl/sins ndsc w/prtl   L037D               RN/LPN/MTA...........  NF                 Complete pre-service                  3            0  L1: Refined time to         -1.11
                     ethmdct.                                                                             diagnostic and                                        standard for this
                                                                                                          referral forms.                                       clinical labor task.
31254.............  Nsl/sins ndsc w/prtl   L037D               RN/LPN/MTA...........  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.74
                     ethmdct.                                                                                                                                   standard for this
                                                                                                                                                                clinical labor task.
31254.............  Nsl/sins ndsc w/prtl   L037D               RN/LPN/MTA...........  NF                 Provide pre-service                   3            0  L1: Refined time to         -1.11
                     ethmdct.                                                                             education/obtain                                      standard for this
                                                                                                          consent.                                              clinical labor task.
31254.............  Nsl/sins ndsc w/prtl   L037D               RN/LPN/MTA...........  NF                 Complete pre-                         3            0  L1: Refined time to         -1.11
                     ethmdct.                                                                             procedure phone                                       standard for this
                                                                                                          calls and                                             clinical labor task.
                                                                                                          prescription.
31295.............  Sinus endo w/balloon   EF008               chair with headrest,   NF                 ....................                 37           42  E1: Refined                  0.05
                     dil.                                       exam, reclining.                                                                                equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31295.............  Sinus endo w/balloon   EF015               mayo stand...........  NF                 ....................                 37           42  E1: Refined                  0.01
                     dil.                                                                                                                                       equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.

[[Page 34028]]

 
31295.............  Sinus endo w/balloon   EQ138               instrument pack,       NF                 ....................                 49           54  E5: Refined                  0.03
                     dil.                                       medium ($1500 and                                                                               equipment time to
                                                                up).                                                                                            conform to
                                                                                                                                                                established
                                                                                                                                                                policies for
                                                                                                                                                                surgical instrument
                                                                                                                                                                packs.
31295.............  Sinus endo w/balloon   EQ167               light source, xenon..  NF                 ....................                 37           42  E1: Refined                  0.14
                     dil.                                                                                                                                       equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31295.............  Sinus endo w/balloon   EQ170               light, fiberoptic      NF                 ....................                 37           42  E1: Refined                  0.04
                     dil.                                       headlight w-source.                                                                             equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31295.............  Sinus endo w/balloon   EQ234               suction and pressure   NF                 ....................                 37           42  E1: Refined                  0.05
                     dil.                                       cabinet, ENT (SMR).                                                                             equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31295.............  Sinus endo w/balloon   EQ383               reusable shaver        NF                 ....................                 37           42  E1: Refined                  0.02
                     dil.                                       blade, 2mm.                                                                                     equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31295.............  Sinus endo w/balloon   EQ384               Microdebrider          NF                 ....................                 37           42  E1: Refined                  0.06
                     dil.                                       handpiece.                                                                                      equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31295.............  Sinus endo w/balloon   EQ385               Microdebrider console  NF                 ....................                 37           42  E1: Refined                  0.15
                     dil.                                                                                                                                       equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31295.............  Sinus endo w/balloon   ES005               endoscope              NF                 ....................                 27           41  E4: Refined                  0.85
                     dil.                                       disinfector, rigid                                                                              equipment time to
                                                                or fiberoptic, w-                                                                               conform to
                                                                cart.                                                                                           established
                                                                                                                                                                policies for scopes.
31295.............  Sinus endo w/balloon   ES031               video system,          NF                 ....................                 37           34  E19: Refined                -0.39
                     dil.                                       endoscopy                                                                                       equipment time to
                                                                (processor, digital                                                                             conform to
                                                                capture, monitor,                                                                               established
                                                                printer, cart).                                                                                 policies for scope
                                                                                                                                                                accessories.
31295.............  Sinus endo w/balloon   ES040               PROXY endoscope,       NF                 ....................                 27           41  E4: Refined                  0.11
                     dil.                                       rigid, sinoscopy (0                                                                             equipment time to
                                                                degrees).                                                                                       conform to
                                                                                                                                                                established
                                                                                                                                                                policies for scopes.

[[Page 34029]]

 
31295.............  Sinus endo w/balloon   L037D               RN/LPN/MTA...........  NF                 Provide pre-service                   3            0  L1: Refined time to         -1.11
                     dil.                                                                                 education/obtain                                      standard for this
                                                                                                          consent.                                              clinical labor task.
31295.............  Sinus endo w/balloon   L037D               RN/LPN/MTA...........  NF                 Complete pre-                         3            0  L1: Refined time to         -1.11
                     dil.                                                                                 procedure phone                                       standard for this
                                                                                                          calls and                                             clinical labor task.
                                                                                                          prescription.
31295.............  Sinus endo w/balloon   L037D               RN/LPN/MTA...........  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.74
                     dil.                                                                                                                                       standard for this
                                                                                                                                                                clinical labor task.
31295.............  Sinus endo w/balloon   L037D               RN/LPN/MTA...........  NF                 Complete pre-service                  3            0  L1: Refined time to         -1.11
                     dil.                                                                                 diagnostic and                                        standard for this
                                                                                                          referral forms.                                       clinical labor task.
31296.............  Sinus endo w/balloon   EF008               chair with headrest,   NF                 ....................                 40           45  E1: Refined                  0.05
                     dil.                                       exam, reclining.                                                                                equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31296.............  Sinus endo w/balloon   EF015               mayo stand...........  NF                 ....................                 40           45  E1: Refined                  0.01
                     dil.                                                                                                                                       equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31296.............  Sinus endo w/balloon   EQ138               instrument pack,       NF                 ....................                 52           57  E5: Refined                  0.03
                     dil.                                       medium ($1500 and                                                                               equipment time to
                                                                up).                                                                                            conform to
                                                                                                                                                                established
                                                                                                                                                                policies for
                                                                                                                                                                surgical instrument
                                                                                                                                                                packs.
31296.............  Sinus endo w/balloon   EQ167               light source, xenon..  NF                 ....................                 40           45  E1: Refined                  0.14
                     dil.                                                                                                                                       equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31296.............  Sinus endo w/balloon   EQ170               light, fiberoptic      NF                 ....................                 40           45  E1: Refined                  0.04
                     dil.                                       headlight w-source.                                                                             equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31296.............  Sinus endo w/balloon   EQ234               suction and pressure   NF                 ....................                 40           45  E1: Refined                  0.05
                     dil.                                       cabinet, ENT (SMR).                                                                             equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31296.............  Sinus endo w/balloon   EQ383               reusable shaver        NF                 ....................                 40           45  E1: Refined                  0.02
                     dil.                                       blade, 2mm.                                                                                     equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.

[[Page 34030]]

 
31296.............  Sinus endo w/balloon   EQ384               Microdebrider          NF                 ....................                 40           45  E1: Refined                  0.06
                     dil.                                       handpiece.                                                                                      equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31296.............  Sinus endo w/balloon   EQ385               Microdebrider console  NF                 ....................                 40           45  E1: Refined                  0.15
                     dil.                                                                                                                                       equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31296.............  Sinus endo w/balloon   ES005               endoscope              NF                 ....................                 32           44  E4: Refined                  0.73
                     dil.                                       disinfector, rigid                                                                              equipment time to
                                                                or fiberoptic, w-                                                                               conform to
                                                                cart.                                                                                           established
                                                                                                                                                                policies for scopes.
31296.............  Sinus endo w/balloon   ES031               video system,          NF                 ....................                 40           37  E19: Refined                -0.39
                     dil.                                       endoscopy                                                                                       equipment time to
                                                                (processor, digital                                                                             conform to
                                                                capture, monitor,                                                                               established
                                                                printer, cart).                                                                                 policies for scope
                                                                                                                                                                accessories.
31296.............  Sinus endo w/balloon   ES040               PROXY endoscope,       NF                 ....................                 32           44  E4: Refined                  0.09
                     dil.                                       rigid, sinoscopy (0                                                                             equipment time to
                                                                degrees).                                                                                       conform to
                                                                                                                                                                established
                                                                                                                                                                policies for scopes.
31296.............  Sinus endo w/balloon   L037D               RN/LPN/MTA...........  NF                 Complete pre-service                  3            0  L1: Refined time to         -1.11
                     dil.                                                                                 diagnostic and                                        standard for this
                                                                                                          referral forms.                                       clinical labor task.
31296.............  Sinus endo w/balloon   L037D               RN/LPN/MTA...........  NF                 Provide pre-service                   3            0  L1: Refined time to         -1.11
                     dil.                                                                                 education/obtain                                      standard for this
                                                                                                          consent.                                              clinical labor task.
31296.............  Sinus endo w/balloon   L037D               RN/LPN/MTA...........  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.74
                     dil.                                                                                                                                       standard for this
                                                                                                                                                                clinical labor task.
31296.............  Sinus endo w/balloon   L037D               RN/LPN/MTA...........  NF                 Complete pre-                         3            0  L1: Refined time to         -1.11
                     dil.                                                                                 procedure phone                                       standard for this
                                                                                                          calls and                                             clinical labor task.
                                                                                                          prescription.
31297.............  Sinus endo w/balloon   EF008               chair with headrest,   NF                 ....................                 37           42  E1: Refined                  0.05
                     dil.                                       exam, reclining.                                                                                equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31297.............  Sinus endo w/balloon   EF015               mayo stand...........  NF                 ....................                 37           42  E1: Refined                  0.01
                     dil.                                                                                                                                       equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31297.............  Sinus endo w/balloon   EQ138               instrument pack,       NF                 ....................                 49           54  E5: Refined                  0.03
                     dil.                                       medium ($1500 and                                                                               equipment time to
                                                                up).                                                                                            conform to
                                                                                                                                                                established
                                                                                                                                                                policies for
                                                                                                                                                                surgical instrument
                                                                                                                                                                packs.

[[Page 34031]]

 
31297.............  Sinus endo w/balloon   EQ167               light source, xenon..  NF                 ....................                 37           42  E1: Refined                  0.14
                     dil.                                                                                                                                       equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31297.............  Sinus endo w/balloon   EQ170               light, fiberoptic      NF                 ....................                 37           42  E1: Refined                  0.04
                     dil.                                       headlight w-source.                                                                             equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31297.............  Sinus endo w/balloon   EQ234               suction and pressure   NF                 ....................                 37           42  E1: Refined                  0.05
                     dil.                                       cabinet, ENT (SMR).                                                                             equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31297.............  Sinus endo w/balloon   EQ383               reusable shaver        NF                 ....................                 37           42  E1: Refined                  0.02
                     dil.                                       blade, 2mm.                                                                                     equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31297.............  Sinus endo w/balloon   EQ384               Microdebrider          NF                 ....................                 37           42  E1: Refined                  0.06
                     dil.                                       handpiece.                                                                                      equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31297.............  Sinus endo w/balloon   EQ385               Microdebrider console  NF                 ....................                 37           42  E1: Refined                  0.15
                     dil.                                                                                                                                       equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31297.............  Sinus endo w/balloon   ES005               endoscope              NF                 ....................                 27           41  E4: Refined                  0.85
                     dil.                                       disinfector, rigid                                                                              equipment time to
                                                                or fiberoptic, w-                                                                               conform to
                                                                cart.                                                                                           established
                                                                                                                                                                policies for scopes.
31297.............  Sinus endo w/balloon   ES031               video system,          NF                 ....................                 37           34  E19: Refined                -0.39
                     dil.                                       endoscopy                                                                                       equipment time to
                                                                (processor, digital                                                                             conform to
                                                                capture, monitor,                                                                               established
                                                                printer, cart).                                                                                 policies for scope
                                                                                                                                                                accessories.
31297.............  Sinus endo w/balloon   ES040               PROXY endoscope,       NF                 ....................                 27           41  E4: Refined                  0.11
                     dil.                                       rigid, sinoscopy (0                                                                             equipment time to
                                                                degrees).                                                                                       conform to
                                                                                                                                                                established
                                                                                                                                                                policies for scopes.
31297.............  Sinus endo w/balloon   L037D               RN/LPN/MTA...........  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.74
                     dil.                                                                                                                                       standard for this
                                                                                                                                                                clinical labor task.
31297.............  Sinus endo w/balloon   L037D               RN/LPN/MTA...........  NF                 Complete pre-                         3            0  L1: Refined time to         -1.11
                     dil.                                                                                 procedure phone                                       standard for this
                                                                                                          calls and                                             clinical labor task.
                                                                                                          prescription.

[[Page 34032]]

 
31297.............  Sinus endo w/balloon   L037D               RN/LPN/MTA...........  NF                 Complete pre-service                  3            0  L1: Refined time to         -1.11
                     dil.                                                                                 diagnostic and                                        standard for this
                                                                                                          referral forms.                                       clinical labor task.
31297.............  Sinus endo w/balloon   L037D               RN/LPN/MTA...........  NF                 Provide pre-service                   3            0  L1: Refined time to         -1.11
                     dil.                                                                                 education/obtain                                      standard for this
                                                                                                          consent.                                              clinical labor task.
31645.............  Brnchsc w/ther aspir   EF027               table, instrument,     NF                 ....................                 57            0  G1: See preamble            -0.08
                     1st.                                       mobile.                                                                                         text.
31645.............  Brnchsc w/ther aspir   EF031               table, power.........  NF                 ....................                 57           58  E1: Refined                  0.02
                     1st.                                                                                                                                       equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31645.............  Brnchsc w/ther aspir   EQ004               CO2 respiratory        NF                 ....................                 57            0  G1: See preamble            -1.47
                     1st.                                       profile monitor.                                                                                text.
31645.............  Brnchsc w/ther aspir   EQ032               IV infusion pump.....  NF                 ....................                 57            0  G1: See preamble            -0.36
                     1st.                                                                                                                                       text.
31645.............  Brnchsc w/ther aspir   EQ235               suction machine        NF                 ....................                 57           58  E1: Refined                  0.00
                     1st.                                       (Gomco).                                                                                        equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31645.............  Brnchsc w/ther aspir   ES017               fiberscope, flexible,  NF                 ....................                 72           82  E4: Refined                  0.82
                     1st.                                       bronchoscopy.                                                                                   equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for scopes.
31645.............  Brnchsc w/ther aspir   ES031               video system,          NF                 ....................                 42           55  E19: Refined                 1.68
                     1st.                                       endoscopy                                                                                       equipment time to
                                                                (processor, digital                                                                             conform to
                                                                capture, monitor,                                                                               established
                                                                printer, cart).                                                                                 policies for scope
                                                                                                                                                                accessories.
31645.............  Brnchsc w/ther aspir   SD084               gas, oxygen..........  NF                 ....................                175            0  G1: See preamble            -0.53
                     1st.                                                                                                                                       text.
31XX5.............  Nsl/sins ndsc w/sins   EF008               chair with headrest,   NF                 ....................                 59           64  E1: Refined                  0.05
                     dilat.                                     exam, reclining.                                                                                equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31XX5.............  Nsl/sins ndsc w/sins   EF015               mayo stand...........  NF                 ....................                 59           64  E1: Refined                  0.01
                     dilat.                                                                                                                                     equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31XX5.............  Nsl/sins ndsc w/sins   EQ138               instrument pack,       NF                 ....................                 71           76  E5: Refined                  0.03
                     dilat.                                     medium ($1500 and                                                                               equipment time to
                                                                up).                                                                                            conform to
                                                                                                                                                                established
                                                                                                                                                                policies for
                                                                                                                                                                surgical instrument
                                                                                                                                                                packs.
31XX5.............  Nsl/sins ndsc w/sins   EQ167               light source, xenon..  NF                 ....................                 59           64  E1: Refined                  0.14
                     dilat.                                                                                                                                     equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.

[[Page 34033]]

 
31XX5.............  Nsl/sins ndsc w/sins   EQ170               light, fiberoptic      NF                 ....................                 59           64  E1: Refined                  0.04
                     dilat.                                     headlight w-source.                                                                             equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31XX5.............  Nsl/sins ndsc w/sins   EQ234               suction and pressure   NF                 ....................                 59           64  E1: Refined                  0.05
                     dilat.                                     cabinet, ENT (SMR).                                                                             equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31XX5.............  Nsl/sins ndsc w/sins   EQ383               reusable shaver        NF                 ....................                 59           64  E1: Refined                  0.02
                     dilat.                                     blade, 2mm.                                                                                     equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31XX5.............  Nsl/sins ndsc w/sins   EQ384               Microdebrider          NF                 ....................                 59           64  E1: Refined                  0.06
                     dilat.                                     handpiece.                                                                                      equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31XX5.............  Nsl/sins ndsc w/sins   EQ385               Microdebrider console  NF                 ....................                 59           64  E1: Refined                  0.15
                     dilat.                                                                                                                                     equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
31XX5.............  Nsl/sins ndsc w/sins   ES005               endoscope              NF                 ....................                 57           73  E4: Refined                  0.97
                     dilat.                                     disinfector, rigid                                                                              equipment time to
                                                                or fiberoptic, w-                                                                               conform to
                                                                cart.                                                                                           established
                                                                                                                                                                policies for scopes.
31XX5.............  Nsl/sins ndsc w/sins   ES031               video system,          NF                 ....................                 59           56  E19: Refined                -0.39
                     dilat.                                     endoscopy                                                                                       equipment time to
                                                                (processor, digital                                                                             conform to
                                                                capture, monitor,                                                                               established
                                                                printer, cart).                                                                                 policies for scope
                                                                                                                                                                accessories.
31XX5.............  Nsl/sins ndsc w/sins   ES040               PROXY endoscope,       NF                 ....................                 57           73  E4: Refined                  0.12
                     dilat.                                     rigid, sinoscopy (0                                                                             equipment time to
                                                                degrees).                                                                                       conform to
                                                                                                                                                                established
                                                                                                                                                                policies for scopes.
31XX5.............  Nsl/sins ndsc w/sins   L037D               RN/LPN/MTA...........  NF                 Complete pre-service                  3            0  L1: Refined time to         -1.11
                     dilat.                                                                               diagnostic and                                        standard for this
                                                                                                          referral forms.                                       clinical labor task.
31XX5.............  Nsl/sins ndsc w/sins   L037D               RN/LPN/MTA...........  NF                 Provide pre-service                   3            0  L1: Refined time to         -1.11
                     dilat.                                                                               education/obtain                                      standard for this
                                                                                                          consent.                                              clinical labor task.
31XX5.............  Nsl/sins ndsc w/sins   L037D               RN/LPN/MTA...........  NF                 Complete pre-                         3            0  L1: Refined time to         -1.11
                     dilat.                                                                               procedure phone                                       standard for this
                                                                                                          calls and                                             clinical labor task.
                                                                                                          prescription.
31XX5.............  Nsl/sins ndsc w/sins   L037D               RN/LPN/MTA...........  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.74
                     dilat.                                                                                                                                     standard for this
                                                                                                                                                                clinical labor task.

[[Page 34034]]

 
32998.............  Ablate pulm tumor      ED050               Technologist PACS      NF                 ....................                133          112  E18: Refined                -0.46
                     perq rf.                                   workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
32998.............  Ablate pulm tumor      EL007               room, CT.............  NF                 ....................                 98           96  E2: Refined                 -9.73
                     perq rf.                                                                                                                                   equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for highly
                                                                                                                                                                technical equipment.
32998.............  Ablate pulm tumor      EQ168               light, exam..........  NF                 ....................                 98          107  E1: Refined                  0.04
                     perq rf.                                                                                                                                   equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
32998.............  Ablate pulm tumor      EQ214               radiofrequency         NF                 ....................                 98           96  E2: Refined                 -0.25
                     perq rf.                                   generator (NEURO).                                                                              equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for highly
                                                                                                                                                                technical equipment.
32X99.............  Ablate pulm tumor      ED050               Technologist PACS      NF                 ....................                138          117  E18: Refined                -0.46
                     perq crybl.                                workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
32X99.............  Ablate pulm tumor      EL007               room, CT.............  NF                 ....................                103          101  E2: Refined                 -9.73
                     perq crybl.                                                                                                                                equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for highly
                                                                                                                                                                technical equipment.
32X99.............  Ablate pulm tumor      EQ168               light, exam..........  NF                 ....................                103          112  E1: Refined                  0.04
                     perq crybl.                                                                                                                                equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
32X99.............  Ablate pulm tumor      EQ302               cryosurgery system     NF                 ....................                103          101  E2: Refined                 -0.19
                     perq crybl.                                (for tumor ablation).                                                                           equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for highly
                                                                                                                                                                technical equipment.
36215.............  Place catheter in      ED050               Technologist PACS      NF                 ....................                 61           59  E15: Refined                -0.04
                     artery.                                    workstation.                                                                                    equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
36215.............  Place catheter in      EF027               table, instrument,     NF                 ....................                180            0  G1: See preamble            -0.25
                     artery.                                    mobile.                                                                                         text.

[[Page 34035]]

 
36215.............  Place catheter in      L037D               RN/LPN/MTA...........  NF                 Other Clinical                        3            1  G1: See preamble            -0.74
                     artery.                                                                              Activity--specify:                                    text.
                                                                                                          Post-procedure
                                                                                                          doppler evaluation
                                                                                                          (extremity).
36216.............  Place catheter in      ED050               Technologist PACS      NF                 ....................                 76           74  E15: Refined                -0.04
                     artery.                                    workstation.                                                                                    equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
36216.............  Place catheter in      EF027               table, instrument,     NF                 ....................                180            0  G1: See preamble            -0.25
                     artery.                                    mobile.                                                                                         text.
36216.............  Place catheter in      L037D               RN/LPN/MTA...........  NF                 Other Clinical                        3            1  G1: See preamble            -0.74
                     artery.                                                                              Activity--specify:                                    text.
                                                                                                          Post-procedure
                                                                                                          doppler evaluation
                                                                                                          (extremity).
36217.............  Place catheter in      ED050               Technologist PACS      NF                 ....................                 91           89  E15: Refined                -0.04
                     artery.                                    workstation.                                                                                    equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
36217.............  Place catheter in      EF027               table, instrument,     NF                 ....................                180            0  G1: See preamble            -0.25
                     artery.                                    mobile.                                                                                         text.
36217.............  Place catheter in      L037D               RN/LPN/MTA...........  NF                 Other Clinical                        3            1  G1: See preamble            -0.74
                     artery.                                                                              Activity--specify:                                    text.
                                                                                                          Post-procedure
                                                                                                          doppler evaluation
                                                                                                          (extremity).
36217.............  Place catheter in      L037D               RN/LPN/MTA...........  NF                 Circulator (25%)....                 12           15  G1: See preamble             1.11
                     artery.                                                                                                                                    text.
36470.............  Njx sclrsnt 1          L037D               RN/LPN/MTA...........  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.74
                     incmptnt vein.                                                                                                                             standard for this
                                                                                                                                                                clinical labor task.
36470.............  Njx sclrsnt 1          L037D               RN/LPN/MTA...........  NF                 Check dressings,                      5            3  L1: Refined time to         -0.74
                     incmptnt vein.                                                                       catheters, wounds.                                    standard for this
                                                                                                                                                                clinical labor task.
36470.............  Njx sclrsnt 1          SG055               gauze, sterile 4in x   NF                 ....................                  6            0  S7: Supply item             -0.95
                     incmptnt vein.                             4in.                                                                                            replaced by another
                                                                                                                                                                item; see preamble
                                                                                                                                                                SG056.
36470.............  Njx sclrsnt 1          SG056               gauze, sterile 4in x   NF                 ....................                  0            1  S8: Supply item              0.80
                     incmptnt vein.                             4in (10 pack uou).                                                                              replaces another
                                                                                                                                                                item; see preamble
                                                                                                                                                                SG055.
36471.............  Njx sclrsnt mlt        L037D               RN/LPN/MTA...........  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.74
                     incmptnt vn.                                                                                                                               standard for this
                                                                                                                                                                clinical labor task.
36471.............  Njx sclrsnt mlt        L037D               RN/LPN/MTA...........  NF                 Check dressings,                      5            3  L1: Refined time to         -0.74
                     incmptnt vn.                                                                         catheters, wounds.                                    standard for this
                                                                                                                                                                clinical labor task.
36471.............  Njx sclrsnt mlt        SG055               gauze, sterile 4in x   NF                 ....................                  6            0  S7: Supply item             -0.95
                     incmptnt vn.                               4in.                                                                                            replaced by another
                                                                                                                                                                item; see preamble
                                                                                                                                                                SG056.
36471.............  Njx sclrsnt mlt        SG056               gauze, sterile 4in x   NF                 ....................                  0            1  S8: Supply item              0.80
                     incmptnt vn.                               4in (10 pack uou).                                                                              replaces another
                                                                                                                                                                item; see preamble
                                                                                                                                                                SG055.

[[Page 34036]]

 
364X3.............  Endoven ther chem      EF014               light, surgical......  NF                 ....................                 58           53  E1: Refined                 -0.05
                     adhes 1st.                                                                                                                                 equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
364X3.............  Endoven ther chem      EF031               table, power.........  NF                 ....................                 58           53  E1: Refined                 -0.08
                     adhes 1st.                                                                                                                                 equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
364X3.............  Endoven ther chem      EQ250               ultrasound unit,       NF                 ....................                 58           53  E1: Refined                 -0.58
                     adhes 1st.                                 portable.                                                                                       equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
364X3.............  Endoven ther chem      L037D               RN/LPN/MTA...........  NF                 Check dressings,                      5            3  L1: Refined time to         -0.74
                     adhes 1st.                                                                           catheters, wounds.                                    standard for this
                                                                                                                                                                clinical labor task.
364X3.............  Endoven ther chem      L037D               RN/LPN/MTA...........  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.74
                     adhes 1st.                                                                                                                                 standard for this
                                                                                                                                                                clinical labor task.
364X3.............  Endoven ther chem      L054A               Vascular Technologist  NF                 Prepare room,                         0            2  G1: See preamble             1.08
                     adhes 1st.                                                                           equipment and                                         text.
                                                                                                          supplies.
364X3.............  Endoven ther chem      L054A               Vascular Technologist  NF                 Setup scope                           2            0  G1: See preamble            -1.08
                     adhes 1st.                                                                           (nonfacility                                          text.
                                                                                                          setting only).
364X3.............  Endoven ther chem      SG055               gauze, sterile 4in x   NF                 ....................                  6            0  S7: Supply item             -0.95
                     adhes 1st.                                 4in.                                                                                            replaced by another
                                                                                                                                                                item; see preamble
                                                                                                                                                                SG056.
364X3.............  Endoven ther chem      SG056               gauze, sterile 4in x   NF                 ....................                  0            1  S8: Supply item              0.80
                     adhes 1st.                                 4in (10 pack uou).                                                                              replaces another
                                                                                                                                                                item; see preamble
                                                                                                                                                                SG055.
364X5.............  Njx noncmpnd sclrsnt   EF014               light, surgical......  NF                 ....................                 48           43  E1: Refined                 -0.05
                     1 vein.                                                                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
364X5.............  Njx noncmpnd sclrsnt   EF031               table, power.........  NF                 ....................                 48           43  E1: Refined                 -0.08
                     1 vein.                                                                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
364X5.............  Njx noncmpnd sclrsnt   EQ250               ultrasound unit,       NF                 ....................                 48           43  E1: Refined                 -0.58
                     1 vein.                                    portable.                                                                                       equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
364X5.............  Njx noncmpnd sclrsnt   L037D               RN/LPN/MTA...........  NF                 Check dressings,                      5            3  L1: Refined time to         -0.74
                     1 vein.                                                                              catheters, wounds.                                    standard for this
                                                                                                                                                                clinical labor task.

[[Page 34037]]

 
364X5.............  Njx noncmpnd sclrsnt   L037D               RN/LPN/MTA...........  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.74
                     1 vein.                                                                                                                                    standard for this
                                                                                                                                                                clinical labor task.
364X5.............  Njx noncmpnd sclrsnt   L054A               Vascular Technologist  NF                 Setup scope                           2            0  G1: See preamble            -1.08
                     1 vein.                                                                              (nonfacility                                          text.
                                                                                                          setting only).
364X5.............  Njx noncmpnd sclrsnt   L054A               Vascular Technologist  NF                 Prepare room,                         0            2  G1: See preamble             1.08
                     1 vein.                                                                              equipment and                                         text.
                                                                                                          supplies.
364X5.............  Njx noncmpnd sclrsnt   SG055               gauze, sterile 4in x   NF                 ....................                  6            0  S7: Supply item             -0.95
                     1 vein.                                    4in.                                                                                            replaced by another
                                                                                                                                                                item; see preamble
                                                                                                                                                                SG056.
364X5.............  Njx noncmpnd sclrsnt   SG056               gauze, sterile 4in x   NF                 ....................                  0            1  S8: Supply item              0.80
                     1 vein.                                    4in (10 pack uou).                                                                              replaces another
                                                                                                                                                                item; see preamble
                                                                                                                                                                SG055.
364X6.............  Njx noncmpnd sclrsnt   EF014               light, surgical......  NF                 ....................                 58           53  E1: Refined                 -0.05
                     mlt vn.                                                                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
364X6.............  Njx noncmpnd sclrsnt   EF031               table, power.........  NF                 ....................                 58           53  E1: Refined                 -0.08
                     mlt vn.                                                                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
364X6.............  Njx noncmpnd sclrsnt   EQ250               ultrasound unit,       NF                 ....................                 58           53  E1: Refined                 -0.58
                     mlt vn.                                    portable.                                                                                       equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
364X6.............  Njx noncmpnd sclrsnt   L037D               RN/LPN/MTA...........  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.74
                     mlt vn.                                                                                                                                    standard for this
                                                                                                                                                                clinical labor task.
364X6.............  Njx noncmpnd sclrsnt   L037D               RN/LPN/MTA...........  NF                 Check dressings,                      5            3  L1: Refined time to         -0.74
                     mlt vn.                                                                              catheters, wounds.                                    standard for this
                                                                                                                                                                clinical labor task.
364X6.............  Njx noncmpnd sclrsnt   L054A               Vascular Technologist  NF                 Setup scope                           2            0  G1: See preamble            -1.08
                     mlt vn.                                                                              (nonfacility                                          text.
                                                                                                          setting only).
364X6.............  Njx noncmpnd sclrsnt   L054A               Vascular Technologist  NF                 Prepare room,                         0            2  G1: See preamble             1.08
                     mlt vn.                                                                              equipment and                                         text.
                                                                                                          supplies.
364X6.............  Njx noncmpnd sclrsnt   SG055               gauze, sterile 4in x   NF                 ....................                  6            0  S7: Supply item             -0.95
                     mlt vn.                                    4in.                                                                                            replaced by another
                                                                                                                                                                item; see preamble
                                                                                                                                                                SG056.
364X6.............  Njx noncmpnd sclrsnt   SG056               gauze, sterile 4in x   NF                 ....................                  0            1  S8: Supply item              0.80
                     mlt vn.                                    4in (10 pack uou).                                                                              replaces another
                                                                                                                                                                item; see preamble
                                                                                                                                                                SG055.
36555.............  Insert non-tunnel cv   EF023               table, exam..........  NF                 ....................                 68           38  E1: Refined                 -0.09
                     cath.                                                                                                                                      equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.

[[Page 34038]]

 
36555.............  Insert non-tunnel cv   EQ011               ECG, 3-channel (with   NF                 ....................                 68            0  G1: See preamble            -0.95
                     cath.                                      SpO2, NIBP, temp,                                                                               text.
                                                                resp).
36555.............  Insert non-tunnel cv   EQ168               light, exam..........  NF                 ....................                 68           38  E1: Refined                 -0.13
                     cath.                                                                                                                                      equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
36555.............  Insert non-tunnel cv   L037D               RN/LPN/MTA...........  NF                 Monitor pt.                         7.5            0  L11: Removed                -2.78
                     cath.                                                                                following procedure/                                  clinical labor
                                                                                                          check tubes,                                          associated with
                                                                                                          monitors, drains,                                     moderate sedation;
                                                                                                          multitasking 1:4.                                     moderate sedation
                                                                                                                                                                not typical for
                                                                                                                                                                this procedure.
36569.............  Insert picc cath.....  EF023               table, exam..........  NF                 ....................                 30            0  G1: See preamble            -0.09
                                                                                                                                                                text.
36569.............  Insert picc cath.....  EQ168               light, exam..........  NF                 ....................                 30           32  E15: Refined                 0.01
                                                                                                                                                                equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
36569.............  Insert picc cath.....  L037D               RN/LPN/MTA...........  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.74
                                                                                                                                                                standard for this
                                                                                                                                                                clinical labor task.
38220.............  Dx bone marrow         EF023               table, exam..........  NF                 ....................                 84           82  E1: Refined                 -0.01
                     aspirations.                                                                                                                               equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
38220.............  Dx bone marrow         L033A               Lab Technician.......  NF                 Other Clinical                       12            9  G1: See preamble            -0.99
                     aspirations.                                                                         Activity--specify:L                                   text.
                                                                                                          ab Tech activities.
38221.............  Dx bone marrow         EF023               table, exam..........  NF                 ....................                 83           82  E1: Refined                  0.00
                     biopsies.                                                                                                                                  equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
38221.............  Dx bone marrow         L033A               Lab Technician.......  NF                 Other Clinical                      7.5            7  G1: See preamble            -0.17
                     biopsies.                                                                            Activity--specify:L                                   text.
                                                                                                          ab Tech activities.
382X3.............  Dx bone marrow bx &    EF023               table, exam..........  NF                 ....................                 95           92  E1: Refined                 -0.01
                     aspir.                                                                                                                                     equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
382X3.............  Dx bone marrow bx &    L033A               Lab Technician.......  NF                 Other Clinical                     12.5           10  G1: See preamble            -0.83
                     aspir.                                                                               Activity--specify:L                                   text.
                                                                                                          ab Tech activities.
55X87.............  Tprnl plmt             EF031               table, power.........  NF                 ....................                 63           65  E15: Refined                 0.03
                     biodegrdabl matrl.                                                                                                                         equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.

[[Page 34039]]

 
55X87.............  Tprnl plmt             EQ250               ultrasound unit,       NF                 ....................                 48           50  E15: Refined                 0.23
                     biodegrdabl matrl.                         portable.                                                                                       equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
55X87.............  Tprnl plmt             EQ386               Endocavitary US probe  NF                 ....................                 48           50  E15: Refined                 0.13
                     biodegrdabl matrl.                                                                                                                         equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
55X87.............  Tprnl plmt             ER061               stepper, stabilizer,   NF                 ....................                 48           50  E15: Refined                 0.12
                     biodegrdabl matrl.                         template (for                                                                                   equipment time to
                                                                brachytherapy                                                                                   conform to changes
                                                                treatment).                                                                                     in clinical labor
                                                                                                                                                                time.
55X87.............  Tprnl plmt             ER062               stirrups (for          NF                 ....................                 48           50  E15: Refined                 0.02
                     biodegrdabl matrl.                         brachytherapy table).                                                                           equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
55X87.............  Tprnl plmt             L037D               RN/LPN/MTA...........  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.74
                     biodegrdabl matrl.                                                                                                                         standard for this
                                                                                                                                                                clinical labor task.
5857X.............  Laps tot hyst resj     EQ168               light, exam..........  F                  ....................                142          125  E7: Refined                 -0.07
                     mal.                                                                                                                                       equipment time to
                                                                                                                                                                conform to office
                                                                                                                                                                visit duration.
5857X.............  Laps tot hyst resj     SA051               pack, pelvic exam....  F                  ....................                  4            3  G1: See preamble            -1.17
                     mal.                                                                                                                                       text.
67820.............  Revise eyelashes.....  EL006               lane, screening (oph)  NF                 ....................                 11            5  G1: See preamble            -0.54
                                                                                                                                                                text.
67820.............  Revise eyelashes.....  L038A               COMT/COT/RN/CST......  F                  Coordinate pre-                       3            0  L1: Refined time to         -1.14
                                                                                                          surgery services.                                     standard for this
                                                                                                                                                                clinical labor task.
67820.............  Revise eyelashes.....  L038A               COMT/COT/RN/CST......  F                  Provide pre-service                   3            0  L1: Refined time to         -1.14
                                                                                                          education/obtain                                      standard for this
                                                                                                          consent.                                              clinical labor task.
67820.............  Revise eyelashes.....  L038A               COMT/COT/RN/CST......  F                  Schedule space and                    3            0  L1: Refined time to         -1.14
                                                                                                          equipment in                                          standard for this
                                                                                                          facility.                                             clinical labor task.
67820.............  Revise eyelashes.....  L038A               COMT/COT/RN/CST......  F                  Complete pre-service                  3            0  L1: Refined time to         -1.14
                                                                                                          diagnostic and                                        standard for this
                                                                                                          referral forms.                                       clinical labor task.
67820.............  Revise eyelashes.....  L038A               COMT/COT/RN/CST......  F                  Follow-up phone                       3            0  L1: Refined time to         -1.14
                                                                                                          calls and                                             standard for this
                                                                                                          prescriptions.                                        clinical labor task.
70544.............  Mr angiography head w/ ED050               Technologist PACS      NF                 ....................                 72           69  E15: Refined                -0.07
                     o dye.                                     workstation.                                                                                    equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
70544.............  Mr angiography head w/ ED053               Professional PACS      NF                 ....................                 17           15  E18: Refined                -0.12
                     o dye.                                     Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.

[[Page 34040]]

 
70544.............  Mr angiography head w/ EL008               room, MR.............  NF                 ....................                 39           38  E15: Refined                -3.38
                     o dye.                                                                                                                                     equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
70544.............  Mr angiography head w/ L047A               MRI Technologist.....  NF                 Technologist QCs                      4            3  L1: Refined time to         -0.47
                     o dye.                                                                               images in PACS,                                       standard for this
                                                                                                          checking all                                          clinical labor task.
                                                                                                          images, reformats,
                                                                                                          and dose page.
70544.............  Mr angiography head w/ L047A               MRI Technologist.....  NF                 Provide pre-service                   7            5  G1: See preamble            -0.94
                     o dye.                                                                               education/obtain                                      text.
                                                                                                          consent.
70545.............  Mr angiography head w/ ED050               Technologist PACS      NF                 ....................                 75           74  E15: Refined                -0.02
                     dye.                                       workstation.                                                                                    equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
70545.............  Mr angiography head w/ ED053               Professional PACS      NF                 ....................                 17           15  E18: Refined                -0.12
                     dye.                                       Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
70545.............  Mr angiography head w/ EL008               room, MR.............  NF                 ....................                 37           36  E15: Refined                -3.38
                     dye.                                                                                                                                       equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
70545.............  Mr angiography head w/ L047A               MRI Technologist.....  NF                 Technologist QCs                      4            3  L1: Refined time to         -0.47
                     dye.                                                                                 images in PACS,                                       standard for this
                                                                                                          checking all                                          clinical labor task.
                                                                                                          images, reformats,
                                                                                                          and dose page.
70545.............  Mr angiography head w/ L047A               MRI Technologist.....  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.94
                     dye.                                                                                                                                       standard for this
                                                                                                                                                                clinical labor task.
70545.............  Mr angiography head w/ L047A               MRI Technologist.....  NF                 Provide pre-service                   9            7  G1: See preamble            -0.94
                     dye.                                                                                 education/obtain                                      text.
                                                                                                          consent.
70546.............  Mr angiograph head w/  ED050               Technologist PACS      NF                 ....................                116          115  E15: Refined                -0.02
                     o&w/dye.                                   workstation.                                                                                    equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
70546.............  Mr angiograph head w/  ED053               Professional PACS      NF                 ....................                 20           18  E18: Refined                -0.12
                     o&w/dye.                                   Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
70546.............  Mr angiograph head w/  EL008               room, MR.............  NF                 ....................                 58           57  E15: Refined                -3.38
                     o&w/dye.                                                                                                                                   equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.

[[Page 34041]]

 
70546.............  Mr angiograph head w/  L047A               MRI Technologist.....  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.94
                     o&w/dye.                                                                                                                                   standard for this
                                                                                                                                                                clinical labor task.
70546.............  Mr angiograph head w/  L047A               MRI Technologist.....  NF                 Technologist QCs                      4            3  L1: Refined time to         -0.47
                     o&w/dye.                                                                             images in PACS,                                       standard for this
                                                                                                          checking all                                          clinical labor task.
                                                                                                          images, reformats,
                                                                                                          and dose page.
70546.............  Mr angiograph head w/  L047A               MRI Technologist.....  NF                 Provide pre-service                   9            7  G1: See preamble            -0.94
                     o&w/dye.                                                                             education/obtain                                      text.
                                                                                                          consent.
70547.............  Mr angiography neck w/ ED050               Technologist PACS      NF                 ....................                 72           69  E15: Refined                -0.07
                     o dye.                                     workstation.                                                                                    equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
70547.............  Mr angiography neck w/ ED053               Professional PACS      NF                 ....................                 17           15  E18: Refined                -0.12
                     o dye.                                     Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
70547.............  Mr angiography neck w/ EL008               room, MR.............  NF                 ....................                 39           38  E15: Refined                -3.38
                     o dye.                                                                                                                                     equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
70547.............  Mr angiography neck w/ L047A               MRI Technologist.....  NF                 Technologist QCs                      4            3  L1: Refined time to         -0.47
                     o dye.                                                                               images in PACS,                                       standard for this
                                                                                                          checking all                                          clinical labor task.
                                                                                                          images, reformats,
                                                                                                          and dose page.
70547.............  Mr angiography neck w/ L047A               MRI Technologist.....  NF                 Provide pre-service                   7            5  G1: See preamble            -0.94
                     o dye.                                                                               education/obtain                                      text.
                                                                                                          consent.
70548.............  Mr angiography neck w/ ED050               Technologist PACS      NF                 ....................                 75           74  E15: Refined                -0.02
                     dye.                                       workstation.                                                                                    equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
70548.............  Mr angiography neck w/ ED053               Professional PACS      NF                 ....................                 20           18  E18: Refined                -0.12
                     dye.                                       Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
70548.............  Mr angiography neck w/ EL008               room, MR.............  NF                 ....................                 37           36  E15: Refined                -3.38
                     dye.                                                                                                                                       equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
70548.............  Mr angiography neck w/ L047A               MRI Technologist.....  NF                 Technologist QCs                      4            3  L1: Refined time to         -0.47
                     dye.                                                                                 images in PACS,                                       standard for this
                                                                                                          checking all                                          clinical labor task.
                                                                                                          images, reformats,
                                                                                                          and dose page.

[[Page 34042]]

 
70548.............  Mr angiography neck w/ L047A               MRI Technologist.....  NF                 Provide pre-service                   9            7  G1: See preamble            -0.94
                     dye.                                                                                 education/obtain                                      text.
                                                                                                          consent.
70548.............  Mr angiography neck w/ L047A               MRI Technologist.....  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.94
                     dye.                                                                                                                                       standard for this
                                                                                                                                                                clinical labor task.
70549.............  Mr angiograph neck w/  ED050               Technologist PACS      NF                 ....................                116          115  E15: Refined                -0.02
                     o&w/dye.                                   workstation.                                                                                    equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
70549.............  Mr angiograph neck w/  ED053               Professional PACS      NF                 ....................                 25           23  E18: Refined                -0.12
                     o&w/dye.                                   Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
70549.............  Mr angiograph neck w/  EL008               room, MR.............  NF                 ....................                 58           57  E15: Refined                -3.38
                     o&w/dye.                                                                                                                                   equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
70549.............  Mr angiograph neck w/  L047A               MRI Technologist.....  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.94
                     o&w/dye.                                                                                                                                   standard for this
                                                                                                                                                                clinical labor task.
70549.............  Mr angiograph neck w/  L047A               MRI Technologist.....  NF                 Provide pre-service                   9            7  G1: See preamble            -0.94
                     o&w/dye.                                                                             education/obtain                                      text.
                                                                                                          consent.
70549.............  Mr angiograph neck w/  L047A               MRI Technologist.....  NF                 Technologist QCs                      4            3  L1: Refined time to         -0.47
                     o&w/dye.                                                                             images in PACS,                                       standard for this
                                                                                                          checking all                                          clinical labor task.
                                                                                                          images, reformats,
                                                                                                          and dose page.
71250.............  Ct thorax w/o dye....  ED053               Professional PACS      NF                 ....................                 20           18  E18: Refined                -0.12
                                                                Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
71260.............  Ct thorax w/dye......  ED053               Professional PACS      NF                 ....................                 21           19  E18: Refined                -0.12
                                                                Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
71270.............  Ct thorax w/o & w/dye  ED053               Professional PACS      NF                 ....................                 25           23  E18: Refined                -0.12
                                                                Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
72195.............  Mri pelvis w/o dye...  ED053               Professional PACS      NF                 ....................                 25           23  E18: Refined                -0.12
                                                                Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.

[[Page 34043]]

 
72196.............  Mri pelvis w/dye.....  ED050               Technologist PACS      NF                 ....................                 64           66  E15: Refined                 0.04
                                                                workstation.                                                                                    equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
72196.............  Mri pelvis w/dye.....  ED053               Professional PACS      NF                 ....................                 30           28  E18: Refined                -0.12
                                                                Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
72196.............  Mri pelvis w/dye.....  L047A               MRI Technologist.....  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.94
                                                                                                                                                                standard for this
                                                                                                                                                                clinical labor task.
72197.............  Mri pelvis w/o & w/    ED050               Technologist PACS      NF                 ....................                 79           81  E15: Refined                 0.04
                     dye.                                       workstation.                                                                                    equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
72197.............  Mri pelvis w/o & w/    ED053               Professional PACS      NF                 ....................                 32           30  E18: Refined                -0.12
                     dye.                                       Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
72197.............  Mri pelvis w/o & w/    L047A               MRI Technologist.....  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.94
                     dye.                                                                                                                                       standard for this
                                                                                                                                                                clinical labor task.
73718.............  Mri lower extremity w/ ED050               Technologist PACS      NF                 ....................                 55           53  E15: Refined                -0.04
                     o dye.                                     workstation.                                                                                    equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
73718.............  Mri lower extremity w/ ED053               Professional PACS      NF                 ....................                 20           18  E18: Refined                -0.12
                     o dye.                                     Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
73718.............  Mri lower extremity w/ EL008               room, MR.............  NF                 ....................                 44           42  E15: Refined                -6.76
                     o dye.                                                                                                                                     equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
73718.............  Mri lower extremity w/ L047A               MRI Technologist.....  NF                 Prepare room,                         5            3  G1: See preamble            -0.94
                     o dye.                                                                               equipment, supplies.                                  text.
73719.............  Mri lower extremity w/ ED050               Technologist PACS      NF                 ....................                 62           64  E15: Refined                 0.04
                     dye.                                       workstation.                                                                                    equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
73719.............  Mri lower extremity w/ ED053               Professional PACS      NF                 ....................                 25           23  E18: Refined                -0.12
                     dye.                                       Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.

[[Page 34044]]

 
73719.............  Mri lower extremity w/ EL008               room, MR.............  NF                 ....................                 48           46  E15: Refined                -6.76
                     dye.                                                                                                                                       equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
73719.............  Mri lower extremity w/ L047A               MRI Technologist.....  NF                 Provide pre-service                   5            7  G1: See preamble             0.94
                     dye.                                                                                 education/obtain                                      text.
                                                                                                          consent.
73719.............  Mri lower extremity w/ L047A               MRI Technologist.....  NF                 Prepare room,                         7            5  G1: See preamble            -0.94
                     dye.                                                                                 equipment, supplies.                                  text.
73719.............  Mri lower extremity w/ L047A               MRI Technologist.....  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.94
                     dye.                                                                                                                                       standard for this
                                                                                                                                                                clinical labor task.
73720.............  Mri lwr extremity w/   ED050               Technologist PACS      NF                 ....................                 77           79  E15: Refined                 0.04
                     o&w/dye.                                   workstation.                                                                                    equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
73720.............  Mri lwr extremity w/   ED053               Professional PACS      NF                 ....................                 29           27  E18: Refined                -0.12
                     o&w/dye.                                   Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
73720.............  Mri lwr extremity w/   EL008               room, MR.............  NF                 ....................                 63           61  E15: Refined                -6.76
                     o&w/dye.                                                                                                                                   equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
73720.............  Mri lwr extremity w/   L047A               MRI Technologist.....  NF                 Prepare room,                         7            5  G1: See preamble            -0.94
                     o&w/dye.                                                                             equipment, supplies.                                  text.
73720.............  Mri lwr extremity w/   L047A               MRI Technologist.....  NF                 Provide pre-service                   5            7  G1: See preamble             0.94
                     o&w/dye.                                                                             education/obtain                                      text.
                                                                                                          consent.
73720.............  Mri lwr extremity w/   L047A               MRI Technologist.....  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.94
                     o&w/dye.                                                                                                                                   standard for this
                                                                                                                                                                clinical labor task.
74181.............  Mri abdomen w/o dye..  ED053               Professional PACS      NF                 ....................                 25           23  E18: Refined                -0.12
                                                                Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
74182.............  Mri abdomen w/dye....  ED050               Technologist PACS      NF                 ....................                 74           76  E15: Refined                 0.04
                                                                workstation.                                                                                    equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
74182.............  Mri abdomen w/dye....  ED053               Professional PACS      NF                 ....................                 30           28  E18: Refined                -0.12
                                                                Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
74182.............  Mri abdomen w/dye....  L047A               MRI Technologist.....  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.94
                                                                                                                                                                standard for this
                                                                                                                                                                clinical labor task.

[[Page 34045]]

 
74183.............  Mri abdomen w/o & w/   ED050               Technologist PACS      NF                 ....................                 79           81  E15: Refined                 0.04
                     dye.                                       workstation.                                                                                    equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
74183.............  Mri abdomen w/o & w/   ED053               Professional PACS      NF                 ....................                 35           33  E18: Refined                -0.12
                     dye.                                       Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
74183.............  Mri abdomen w/o & w/   L047A               MRI Technologist.....  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.94
                     dye.                                                                                                                                       standard for this
                                                                                                                                                                clinical labor task.
75635.............  Ct angio abdominal     ED050               Technologist PACS      NF                 ....................                119          124  E18: Refined                 0.11
                     arteries.                                  workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
75635.............  Ct angio abdominal     ED053               Professional PACS      NF                 ....................                 49           44  E18: Refined                -0.29
                     arteries.                                  Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
75635.............  Ct angio abdominal     EL007               room, CT.............  NF                 ....................                 71           70  E15: Refined                -2.70
                     arteries.                                                                                                                                  equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
75635.............  Ct angio abdominal     L046A               CT Technologist......  NF                 Technologist QCs                      4            3  L1: Refined time to         -0.46
                     arteries.                                                                            images in PACS,                                       standard for this
                                                                                                          checking all                                          clinical labor task.
                                                                                                          images, reformats,
                                                                                                          and dose page.
75710.............  Artery x-rays arm/leg  ED050               Technologist PACS      NF                 ....................                 52           49  E15: Refined                -0.07
                                                                workstation.                                                                                    equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
75710.............  Artery x-rays arm/leg  ED053               Professional PACS      NF                 ....................                 55           48  E18: Refined                -0.41
                                                                Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
75710.............  Artery x-rays arm/leg  L041B               Radiologic             NF                 Technologist QCs                      4            3  L1: Refined time to         -0.41
                                                                Technologist.                             images in PACS,                                       standard for this
                                                                                                          checking all                                          clinical labor task.
                                                                                                          images, reformats,
                                                                                                          and dose page.
75710.............  Artery x-rays arm/leg  L041B               Radiologic             NF                 Prepare room,                         2            0  G1: See preamble            -0.82
                                                                Technologist.                             equipment, supplies.                                  text.
75716.............  Artery x-rays arms/    ED050               Technologist PACS      NF                 ....................                 62           59  E15: Refined                -0.07
                     legs.                                      workstation.                                                                                    equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.

[[Page 34046]]

 
75716.............  Artery x-rays arms/    ED053               Professional PACS      NF                 ....................                 65           58  E18: Refined                -0.41
                     legs.                                      Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
75716.............  Artery x-rays arms/    L041B               Radiologic             NF                 Prepare room,                         2            0  G1: See preamble            -0.82
                     legs.                                      Technologist.                             equipment, supplies.                                  text.
75716.............  Artery x-rays arms/    L041B               Radiologic             NF                 Technologist QCs                      4            3  L1: Refined time to         -0.41
                     legs.                                      Technologist.                             images in PACS,                                       standard for this
                                                                                                          checking all                                          clinical labor task.
                                                                                                          images, reformats,
                                                                                                          and dose page.
76881.............  Us xtr non-vasc        EF031               table, power.........  NF                 ....................                  8            7  E1: Refined                 -0.02
                     complete.                                                                                                                                  equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
76881.............  Us xtr non-vasc        EQ250               ultrasound unit,       NF                 ....................                  8            7  E1: Refined                 -0.12
                     complete.                                  portable.                                                                                       equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
76881.............  Us xtr non-vasc        L026A               Medical/Technical      NF                 Exam document                         1            0  G1: See preamble            -0.26
                     complete.                                  Assistant.                                scanned into PACS.                                    text.
                                                                                                          Exam completed in
                                                                                                          RIS system to
                                                                                                          generate billing
                                                                                                          process and to
                                                                                                          populate images
                                                                                                          into Radiologist
                                                                                                          work queue.
78300.............  Bone imaging limited   ED053               Professional PACS      NF                 ....................                 15           13  E18: Refined                -0.12
                     area.                                      Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
78305.............  Bone imaging multiple  ED053               Professional PACS      NF                 ....................                 15           13  E18: Refined                -0.12
                     areas.                                     Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
78306.............  Bone imaging whole     ED053               Professional PACS      NF                 ....................                 78           13  E18: Refined                -3.76
                     body.                                      Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
88333.............  Intraop cyto path      L033A               Lab Technician.......  NF                 Prepare room. Filter                 10            0  G6: Indirect                -3.30
                     consult 1.                                                                           and replenish                                         Practice Expense
                                                                                                          stains and                                            input and/or not
                                                                                                          supplies.                                             individually
                                                                                                          (including OCT                                        allocable to a
                                                                                                          blocks, set up                                        particular patient
                                                                                                          grossing station                                      for a particular
                                                                                                          with colored                                          service.
                                                                                                          stains).

[[Page 34047]]

 
88333.............  Intraop cyto path      L037B               Histotechnologist....  NF                 Clean room/equipment                  5            1  L1: Refined time to         -1.48
                     consult 1.                                                                           following procedure                                   standard for this
                                                                                                          (including any                                        clinical labor task.
                                                                                                          equipment
                                                                                                          maintenance that
                                                                                                          must be done after
                                                                                                          the procedure).
88360.............  Tumor immunohistochem/ EP112               Benchmark ULTRA        NF                 ....................                 18           16  G1: See preamble            -1.14
                     manual.                                    automated slide                                                                                 text.
                                                                preparation system.
88360.............  Tumor immunohistochem/ L033A               Lab Technician.......  NF                 Recycle xylene from                   1            0  G6: Indirect                -0.33
                     manual.                                                                              tissue processor                                      Practice Expense
                                                                                                          and stainer.                                          input and/or not
                                                                                                                                                                individually
                                                                                                                                                                allocable to a
                                                                                                                                                                particular patient
                                                                                                                                                                for a particular
                                                                                                                                                                service.
88360.............  Tumor immunohistochem/ L037B               Histotechnologist....  NF                 Clean room/equipment                  1            0  L2: Clinical labor          -0.37
                     manual.                                                                              following procedure                                   task redundant with
                                                                                                          (including any                                        clinical labor task
                                                                                                          equipment                                             Clean equipment and
                                                                                                          maintenance that                                      work station in
                                                                                                          must be done after                                    histology lab.
                                                                                                          the procedure).
88360.............  Tumor immunohistochem/ L037B               Histotechnologist....  NF                 Verify results and                    1            0  G6: Indirect                -0.37
                     manual.                                                                              complete work load                                    Practice Expense
                                                                                                          recording logs.                                       input and/or not
                                                                                                                                                                individually
                                                                                                                                                                allocable to a
                                                                                                                                                                particular patient
                                                                                                                                                                for a particular
                                                                                                                                                                service.
88360.............  Tumor immunohistochem/ L037B               Histotechnologist....  NF                 Enter patient data,                   5            1  L1: Refined time to         -1.48
                     manual.                                                                              computational prep                                    standard for this
                                                                                                          for antibody                                          clinical labor task.
                                                                                                          testing, generate
                                                                                                          and apply bar codes
                                                                                                          to slides, and
                                                                                                          enter data for
                                                                                                          automated slide
                                                                                                          stainer.
88361.............  Tumor immunohistochem/ EP112               Benchmark ULTRA        NF                 ....................                 18           16  G1: See preamble            -1.14
                     comput.                                    automated slide                                                                                 text.
                                                                preparation system.
88361.............  Tumor immunohistochem/ L033A               Lab Technician.......  NF                 Recycle xylene from                   1            0  G6: Indirect                -0.33
                     comput.                                                                              tissue processor                                      Practice Expense
                                                                                                          and stainer.                                          input and/or not
                                                                                                                                                                individually
                                                                                                                                                                allocable to a
                                                                                                                                                                particular patient
                                                                                                                                                                for a particular
                                                                                                                                                                service.

[[Page 34048]]

 
88361.............  Tumor immunohistochem/ L037B               Histotechnologist....  NF                 Verify results and                    1            0  G6: Indirect                -0.37
                     comput.                                                                              complete work load                                    Practice Expense
                                                                                                          recording logs.                                       input and/or not
                                                                                                                                                                individually
                                                                                                                                                                allocable to a
                                                                                                                                                                particular patient
                                                                                                                                                                for a particular
                                                                                                                                                                service.
88361.............  Tumor immunohistochem/ L037B               Histotechnologist....  NF                 Performing                            1            0  G1: See preamble            -0.37
                     comput.                                                                              instrument                                            text.
                                                                                                          calibration,
                                                                                                          instrument qc and
                                                                                                          start up and
                                                                                                          shutdown..
88361.............  Tumor immunohistochem/ L037B               Histotechnologist....  NF                 Gate areas to be                      1            0  G1: See preamble            -0.37
                     comput.                                                                              counted by the                                        text.
                                                                                                          machine.
88361.............  Tumor immunohistochem/ L037B               Histotechnologist....  NF                 Enter patient data,                   5            1  L1: Refined time to         -1.48
                     comput.                                                                              computational prep                                    standard for this
                                                                                                          for antibody                                          clinical labor task.
                                                                                                          testing, generate
                                                                                                          and apply bar codes
                                                                                                          to slides, and
                                                                                                          enter data for
                                                                                                          automated slide
                                                                                                          stainer.
88361.............  Tumor immunohistochem/ L037B               Histotechnologist....  NF                 Clean room/equipment                  1            0  L2: Clinical labor          -0.37
                     comput.                                                                              following procedure                                   task redundant with
                                                                                                          (including any                                        clinical labor task
                                                                                                          equipment                                             Clean equipment and
                                                                                                          maintenance that                                      work station in
                                                                                                          must be done after                                    histology lab.
                                                                                                          the procedure).
93279.............  Pm device progr eval   EF023               table, exam..........  NF                 ....................                 33           26  E1: Refined                 -0.02
                     sngl.                                                                                                                                      equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93279.............  Pm device progr eval   EQ198               pacemaker follow-up    NF                 ....................                 33           26  E1: Refined                 -0.53
                     sngl.                                      system (incl                                                                                    equipment time to
                                                                software and                                                                                    conform to
                                                                hardware) (Paceart).                                                                            established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93279.............  Pm device progr eval   L026A               Medical/Technical      NF                 Complete diagnostic                   2            0  L2: Clinical labor          -0.52
                     sngl.                                      Assistant.                                forms, lab, X-ray                                     task redundant with
                                                                                                          requisitions.                                         clinical labor task
                                                                                                                                                                L037D.
93279.............  Pm device progr eval   L037D               RN/LPN/MTA...........  NF                 Other Clinical                        2            0  L1: Refined time to         -0.74
                     sngl.                                                                                Activity--specify:                                    standard for this
                                                                                                          Review charts.                                        clinical labor task.
93280.............  Pm device progr eval   EF023               table, exam..........  NF                 ....................                 38           31  E1: Refined                 -0.02
                     dual.                                                                                                                                      equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.

[[Page 34049]]

 
93280.............  Pm device progr eval   EQ198               pacemaker follow-up    NF                 ....................                 38           31  E1: Refined                 -0.53
                     dual.                                      system (incl                                                                                    equipment time to
                                                                software and                                                                                    conform to
                                                                hardware) (Paceart).                                                                            established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93280.............  Pm device progr eval   L026A               Medical/Technical      NF                 Complete diagnostic                   2            0  L2: Clinical labor          -0.52
                     dual.                                      Assistant.                                forms, lab, X-ray                                     task redundant with
                                                                                                          requisitions.                                         clinical labor task
                                                                                                                                                                L037D.
93280.............  Pm device progr eval   L037D               RN/LPN/MTA...........  NF                 Other Clinical                        2            0  L1: Refined time to         -0.74
                     dual.                                                                                Activity--specify:                                    standard for this
                                                                                                          Review charts.                                        clinical labor task.
93281.............  Pm device progr eval   EF023               table, exam..........  NF                 ....................                 39           31  E1: Refined                 -0.02
                     multi.                                                                                                                                     equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93281.............  Pm device progr eval   EQ198               pacemaker follow-up    NF                 ....................                 39           31  E1: Refined                 -0.61
                     multi.                                     system (incl                                                                                    equipment time to
                                                                software and                                                                                    conform to
                                                                hardware) (Paceart).                                                                            established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93281.............  Pm device progr eval   L026A               Medical/Technical      NF                 Complete diagnostic                   2            0  L2: Clinical labor          -0.52
                     multi.                                     Assistant.                                forms, lab, X-ray                                     task redundant with
                                                                                                          requisitions.                                         clinical labor task
                                                                                                                                                                L037D.
93281.............  Pm device progr eval   L037D               RN/LPN/MTA...........  NF                 Other Clinical                        2            0  L1: Refined time to         -0.74
                     multi.                                                                               Activity--specify:                                    standard for this
                                                                                                          Review charts.                                        clinical labor task.
93281.............  Pm device progr eval   L037D               RN/LPN/MTA...........  NF                 Assist physician in                  16           15  L15: Refined                -0.37
                     multi.                                                                               performing                                            clinical labor time
                                                                                                          procedure.                                            to match
                                                                                                                                                                intraservice work
                                                                                                                                                                time.
93282.............  Prgrmg eval            EF023               table, exam..........  NF                 ....................                 35           28  E1: Refined                 -0.02
                     implantable dfb.                                                                                                                           equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93282.............  Prgrmg eval            EQ198               pacemaker follow-up    NF                 ....................                 35           28  E1: Refined                 -0.53
                     implantable dfb.                           system (incl                                                                                    equipment time to
                                                                software and                                                                                    conform to
                                                                hardware) (Paceart).                                                                            established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93282.............  Prgrmg eval            L026A               Medical/Technical      NF                 Complete diagnostic                   2            0  L2: Clinical labor          -0.52
                     implantable dfb.                           Assistant.                                forms, lab, X-ray                                     task redundant with
                                                                                                          requisitions.                                         clinical labor task
                                                                                                                                                                L037D.
93282.............  Prgrmg eval            L037D               RN/LPN/MTA...........  NF                 Other Clinical                        2            0  L1: Refined time to         -0.74
                     implantable dfb.                                                                     Activity--specify:                                    standard for this
                                                                                                          Review charts.                                        clinical labor task.

[[Page 34050]]

 
93283.............  Prgrmg eval            EF023               table, exam..........  NF                 ....................                 38           31  E1: Refined                 -0.02
                     implantable dfb.                                                                                                                           equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93283.............  Prgrmg eval            EQ198               pacemaker follow-up    NF                 ....................                 38           31  E1: Refined                 -0.53
                     implantable dfb.                           system (incl                                                                                    equipment time to
                                                                software and                                                                                    conform to
                                                                hardware) (Paceart).                                                                            established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93283.............  Prgrmg eval            L026A               Medical/Technical      NF                 Complete diagnostic                   2            0  L2: Clinical labor          -0.52
                     implantable dfb.                           Assistant.                                forms, lab, X-ray                                     task redundant with
                                                                                                          requisitions.                                         clinical labor task
                                                                                                                                                                L037D.
93283.............  Prgrmg eval            L037D               RN/LPN/MTA...........  NF                 Other Clinical                        2            0  L1: Refined time to         -0.74
                     implantable dfb.                                                                     Activity--specify:                                    standard for this
                                                                                                          Review charts.                                        clinical labor task.
93284.............  Prgrmg eval            EF023               table, exam..........  NF                 ....................               40.5         33.5  E1: Refined                 -0.02
                     implantable dfb.                                                                                                                           equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93284.............  Prgrmg eval            EQ198               pacemaker follow-up    NF                 ....................               40.5         33.5  E1: Refined                 -0.53
                     implantable dfb.                           system (incl                                                                                    equipment time to
                                                                software and                                                                                    conform to
                                                                hardware) (Paceart).                                                                            established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93284.............  Prgrmg eval            L026A               Medical/Technical      NF                 Complete diagnostic                   2            0  L2: Clinical labor          -0.52
                     implantable dfb.                           Assistant.                                forms, lab, X-ray                                     task redundant with
                                                                                                          requisitions.                                         clinical labor task
                                                                                                                                                                L037D.
93284.............  Prgrmg eval            L037D               RN/LPN/MTA...........  NF                 Other Clinical                        2            0  L1: Refined time to         -0.74
                     implantable dfb.                                                                     Activity--specify:                                    standard for this
                                                                                                          Review charts.                                        clinical labor task.
93285.............  Ilr device eval progr  EF023               table, exam..........  NF                 ....................                 30           25  E1: Refined                 -0.01
                                                                                                                                                                equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93285.............  Ilr device eval progr  EQ198               pacemaker follow-up    NF                 ....................                 30           25  E1: Refined                 -0.38
                                                                system (incl                                                                                    equipment time to
                                                                software and                                                                                    conform to
                                                                hardware) (Paceart).                                                                            established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93285.............  Ilr device eval progr  L026A               Medical/Technical      NF                 Complete diagnostic                   1            0  L2: Clinical labor          -0.26
                                                                Assistant.                                forms, lab, X-ray                                     task redundant with
                                                                                                          requisitions.                                         clinical labor task
                                                                                                                                                                L037D.
93285.............  Ilr device eval progr  L037D               RN/LPN/MTA...........  NF                 Other Clinical                        2            0  L1: Refined time to         -0.74
                                                                                                          Activity--specify:                                    standard for this
                                                                                                          Review charts.                                        clinical labor task.

[[Page 34051]]

 
93286.............  Peri-px pacemaker      EF023               table, exam..........  NF                 ....................                 27           20  E1: Refined                 -0.02
                     device evl.                                                                                                                                equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93286.............  Peri-px pacemaker      EQ198               pacemaker follow-up    NF                 ....................                 27           20  E1: Refined                 -0.53
                     device evl.                                system (incl                                                                                    equipment time to
                                                                software and                                                                                    conform to
                                                                hardware) (Paceart).                                                                            established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93286.............  Peri-px pacemaker      L026A               Medical/Technical      NF                 Complete diagnostic                   2            0  L2: Clinical labor          -0.52
                     device evl.                                Assistant.                                forms, lab, X-ray                                     task redundant with
                                                                                                          requisitions.                                         clinical labor task
                                                                                                                                                                L037D.
93286.............  Peri-px pacemaker      L037D               RN/LPN/MTA...........  NF                 Other Clinical                        2            0  L1: Refined time to         -0.74
                     device evl.                                                                          Activity--specify:                                    standard for this
                                                                                                          Review charts.                                        clinical labor task.
93287.............  Peri-px device eval &  EF023               table, exam..........  NF                 ....................                 27           20  E1: Refined                 -0.02
                     prgr.                                                                                                                                      equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93287.............  Peri-px device eval &  EQ198               pacemaker follow-up    NF                 ....................                 27           20  E1: Refined                 -0.53
                     prgr.                                      system (incl                                                                                    equipment time to
                                                                software and                                                                                    conform to
                                                                hardware) (Paceart).                                                                            established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93287.............  Peri-px device eval &  L026A               Medical/Technical      NF                 Complete diagnostic                   2            0  L2: Clinical labor          -0.52
                     prgr.                                      Assistant.                                forms, lab, X-ray                                     task redundant with
                                                                                                          requisitions.                                         clinical labor task
                                                                                                                                                                L037D.
93287.............  Peri-px device eval &  L037D               RN/LPN/MTA...........  NF                 Other Clinical                        2            0  L1: Refined time to         -0.74
                     prgr.                                                                                Activity--specify:                                    standard for this
                                                                                                          Review charts.                                        clinical labor task.
93288.............  Pm device eval in      EF023               table, exam..........  NF                 ....................                 33           26  E1: Refined                 -0.02
                     person.                                                                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93288.............  Pm device eval in      EQ198               pacemaker follow-up    NF                 ....................                 33           26  E1: Refined                 -0.53
                     person.                                    system (incl                                                                                    equipment time to
                                                                software and                                                                                    conform to
                                                                hardware) (Paceart).                                                                            established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93288.............  Pm device eval in      L026A               Medical/Technical      NF                 Complete diagnostic                   2            0  L2: Clinical labor          -0.52
                     person.                                    Assistant.                                forms, lab, X-ray                                     task redundant with
                                                                                                          requisitions.                                         clinical labor task
                                                                                                                                                                L037D.
93288.............  Pm device eval in      L037D               RN/LPN/MTA...........  NF                 Other Clinical                        2            0  L1: Refined time to         -0.74
                     person.                                                                              Activity--specify:                                    standard for this
                                                                                                          Review charts.                                        clinical labor task.

[[Page 34052]]

 
93289.............  Interrog device eval   EF023               table, exam..........  NF                 ....................                 33           26  E1: Refined                 -0.02
                     heart.                                                                                                                                     equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93289.............  Interrog device eval   EQ198               pacemaker follow-up    NF                 ....................                 33           26  E1: Refined                 -0.53
                     heart.                                     system (incl                                                                                    equipment time to
                                                                software and                                                                                    conform to
                                                                hardware) (Paceart).                                                                            established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93289.............  Interrog device eval   L026A               Medical/Technical      NF                 Complete diagnostic                   2            0  L2: Clinical labor          -0.52
                     heart.                                     Assistant.                                forms, lab, X-ray                                     task redundant with
                                                                                                          requisitions.                                         clinical labor task
                                                                                                                                                                L037D.
93289.............  Interrog device eval   L037D               RN/LPN/MTA...........  NF                 Other Clinical                        2            0  L1: Refined time to         -0.74
                     heart.                                                                               Activity--specify:                                    standard for this
                                                                                                          Review charts.                                        clinical labor task.
93290.............  Icm device eval......  EF023               table, exam..........  NF                 ....................                 28           24  E1: Refined                 -0.01
                                                                                                                                                                equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93290.............  Icm device eval......  EQ198               pacemaker follow-up    NF                 ....................                 28           24  E1: Refined                 -0.30
                                                                system (incl                                                                                    equipment time to
                                                                software and                                                                                    conform to
                                                                hardware) (Paceart).                                                                            established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93290.............  Icm device eval......  L026A               Medical/Technical      NF                 Complete diagnostic                   1            0  L2: Clinical labor          -0.26
                                                                Assistant.                                forms, lab, X-ray                                     task redundant with
                                                                                                          requisitions.                                         clinical labor task
                                                                                                                                                                L037D.
93290.............  Icm device eval......  L037D               RN/LPN/MTA...........  NF                 Other Clinical                        2            0  L1: Refined time to         -0.74
                                                                                                          Activity--specify:                                    standard for this
                                                                                                          Review charts.                                        clinical labor task.
93291.............  Ilr device             EF023               table, exam..........  NF                 ....................                 27           22  E1: Refined                 -0.01
                     interrogate.                                                                                                                               equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93291.............  Ilr device             EQ198               pacemaker follow-up    NF                 ....................                 27           22  E1: Refined                 -0.38
                     interrogate.                               system (incl                                                                                    equipment time to
                                                                software and                                                                                    conform to
                                                                hardware) (Paceart).                                                                            established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93291.............  Ilr device             L026A               Medical/Technical      NF                 Complete diagnostic                   1            0  L2: Clinical labor          -0.26
                     interrogate.                               Assistant.                                forms, lab, X-ray                                     task redundant with
                                                                                                          requisitions.                                         clinical labor task
                                                                                                                                                                L037D.
93291.............  Ilr device             L037D               RN/LPN/MTA...........  NF                 Other Clinical                        2            0  L1: Refined time to         -0.74
                     interrogate.                                                                         Activity--specify:                                    standard for this
                                                                                                          Review charts.                                        clinical labor task.

[[Page 34053]]

 
93292.............  Wcd device             EF023               table, exam..........  NF                 ....................                 30           25  E1: Refined                 -0.01
                     interrogate.                                                                                                                               equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93292.............  Wcd device             EQ198               pacemaker follow-up    NF                 ....................                 30           25  E1: Refined                 -0.38
                     interrogate.                               system (incl                                                                                    equipment time to
                                                                software and                                                                                    conform to
                                                                hardware) (Paceart).                                                                            established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93292.............  Wcd device             L026A               Medical/Technical      NF                 Complete diagnostic                   1            0  L2: Clinical labor          -0.26
                     interrogate.                               Assistant.                                forms, lab, X-ray                                     task redundant with
                                                                                                          requisitions.                                         clinical labor task
                                                                                                                                                                L037D.
93292.............  Wcd device             L037D               RN/LPN/MTA...........  NF                 Other Clinical                        2            0  L1: Refined time to         -0.74
                     interrogate.                                                                         Activity--specify:                                    standard for this
                                                                                                          Review charts.                                        clinical labor task.
93350.............  Stress tte only......  ED053               Professional PACS      NF                 ....................                 20           18  E18: Refined                -0.12
                                                                Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
93351.............  Stress tte complete..  ED050               Technologist PACS      NF                 ....................                104          114  E18: Refined                 0.22
                                                                workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
93351.............  Stress tte complete..  ED053               Professional PACS      NF                 ....................                 30           25  E18: Refined                -0.29
                                                                Workstation.                                                                                    equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for PACS
                                                                                                                                                                Workstations.
93351.............  Stress tte complete..  EQ078               cardiac monitor w-     NF                 ....................                104           91  E1: Refined                 -0.49
                                                                treadmill (12-lead                                                                              equipment time to
                                                                PC-based ECG).                                                                                  conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
93351.............  Stress tte complete..  L037D               RN/LPN/MTA...........  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.74
                                                                                                                                                                standard for this
                                                                                                                                                                clinical labor task.
93351.............  Stress tte complete..  L037D               RN/LPN/MTA...........  NF                 Provide pre-service                   3            2  L1: Refined time to         -0.37
                                                                                                          education/obtain                                      standard for this
                                                                                                          consent.                                              clinical labor task.
93351.............  Stress tte complete..  L051A               RN...................  NF                 Setup scope (non                      5            0  G1: See preamble            -2.55
                                                                                                          facility setting                                      text.
                                                                                                          only).
94621.............  Cardiopulm exercise    EQ042               Vmax 29c (cardio-pulm  NF                 ....................                127          115  E6: Refined                 -1.98
                     testing.                                   stress test equip,                                                                              equipment time to
                                                                treadmill, computer                                                                             conform to
                                                                system).                                                                                        established
                                                                                                                                                                policies for
                                                                                                                                                                equipment with 4x
                                                                                                                                                                monitoring time.

[[Page 34054]]

 
94621.............  Cardiopulm exercise    EQ211               pulse oximeter w-      NF                 ....................                127          115  E6: Refined                 -0.05
                     testing.                                   printer.                                                                                        equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for
                                                                                                                                                                equipment with 4x
                                                                                                                                                                monitoring time.
94621.............  Cardiopulm exercise    L047C               RN/Respiratory         NF                 Prepare and position                  5            3  G1: See preamble            -0.94
                     testing.                                   Therapist.                                pt/monitor pt/set                                     text.
                                                                                                          up IV.
94621.............  Cardiopulm exercise    L047C               RN/Respiratory         NF                 Provide pre-service                  10            5  G1: See preamble            -2.35
                     testing.                                   Therapist.                                education/obtain                                      text.
                                                                                                          consent.
94621.............  Cardiopulm exercise    L047C               RN/Respiratory         NF                 Complete diagnostic                   5            3  L1: Refined time to         -0.94
                     testing.                                   Therapist.                                forms, lab, X-ray                                     standard for this
                                                                                                          requisitions.                                         clinical labor task.
946X2.............  Exercise tst brncspsm  EQ043               Vmax 29s (spirometry   NF                 ....................                 87           83  E6: Refined                 -0.31
                                                                testing equip,                                                                                  equipment time to
                                                                computer system).                                                                               conform to
                                                                                                                                                                established
                                                                                                                                                                policies for
                                                                                                                                                                equipment with 4x
                                                                                                                                                                monitoring time.
946X2.............  Exercise tst brncspsm  EQ078               cardiac monitor w-     NF                 ....................                 87           83  E6: Refined                 -0.15
                                                                treadmill (12-lead                                                                              equipment time to
                                                                PC-based ECG).                                                                                  conform to
                                                                                                                                                                established
                                                                                                                                                                policies for
                                                                                                                                                                equipment with 4x
                                                                                                                                                                monitoring time.
946X2.............  Exercise tst brncspsm  EQ211               pulse oximeter w-      NF                 ....................                 87           83  E6: Refined                 -0.02
                                                                printer.                                                                                        equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for
                                                                                                                                                                equipment with 4x
                                                                                                                                                                monitoring time.
946X2.............  Exercise tst brncspsm  L047C               RN/Respiratory         NF                 Complete diagnostic                   4            3  L1: Refined time to         -0.47
                                                                Therapist.                                forms, lab, X-ray                                     standard for this
                                                                                                          requisitions.                                         clinical labor task.
946X3.............  Pulmonary stress       EQ211               pulse oximeter w-      NF                 ....................                 17           15  E1: Refined                 -0.01
                     testing.                                   printer.                                                                                        equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
946X3.............  Pulmonary stress       L047C               RN/Respiratory         NF                 Complete diagnostic                   2            3  L1: Refined time to          0.47
                     testing.                                   Therapist.                                forms, lab, X-ray                                     standard for this
                                                                                                          requisitions.                                         clinical labor task.
95004.............  Percut allergy skin    EF015               mayo stand...........  NF                 ....................               1.28         1.58  E6: Refined                  0.00
                     tests.                                                                                                                                     equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for
                                                                                                                                                                equipment with 4x
                                                                                                                                                                monitoring time.
95004.............  Percut allergy skin    EF023               table, exam..........  NF                 ....................               1.28         1.58  E6: Refined                  0.00
                     tests.                                                                                                                                     equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for
                                                                                                                                                                equipment with 4x
                                                                                                                                                                monitoring time.

[[Page 34055]]

 
96160.............  Pt-focused hlth risk   L026A               Medical/Technical      NF                 Explain purpose of                    2            0  G1: See preamble            -0.52
                     assmt.                                     Assistant.                                assessment to                                         text.
                                                                                                          patient/caregiver
                                                                                                          and answer
                                                                                                          questions.
96160.............  Pt-focused hlth risk   L026A               Medical/Technical      NF                 Remain in exam room                   2            0  G1: See preamble            -0.52
                     assmt.                                     Assistant.                                with patient/                                         text.
                                                                                                          caregiver exclusive
                                                                                                          to completion of
                                                                                                          assessment.
96160.............  Pt-focused hlth risk   L026A               Medical/Technical      NF                 Collate and score                     1            0  G1: See preamble            -0.26
                     assmt.                                     Assistant.                                data elements on                                      text.
                                                                                                          assessment in
                                                                                                          advance of
                                                                                                          physician exam.
96160.............  Pt-focused hlth risk   L026A               Medical/Technical      NF                 Scan assessment or                    2            0  G1: See preamble            -0.52
                     assmt.                                     Assistant.                                enter data elements                                   text.
                                                                                                          and total score
                                                                                                          into electronic
                                                                                                          health record.
96160.............  Pt-focused hlth risk   L026A               Medical/Technical      NF                 Administration,                       0            7  G1: See preamble             1.82
                     assmt.                                     Assistant.                                scoring, and                                          text.
                                                                                                          documenting results
                                                                                                          of completed
                                                                                                          standardized
                                                                                                          instrument.
96161.............  Caregiver health risk  L026A               Medical/Technical      NF                 Explain purpose of                    2            0  G1: See preamble            -0.52
                     assmt.                                     Assistant.                                assessment to                                         text.
                                                                                                          patient/caregiver
                                                                                                          and answer
                                                                                                          questions.
96161.............  Caregiver health risk  L026A               Medical/Technical      NF                 Remain in exam room                   2            0  G1: See preamble            -0.52
                     assmt.                                     Assistant.                                with patient/                                         text.
                                                                                                          caregiver exclusive
                                                                                                          to completion of
                                                                                                          assessment.
96161.............  Caregiver health risk  L026A               Medical/Technical      NF                 Collate and score                     1            0  G1: See preamble            -0.26
                     assmt.                                     Assistant.                                data elements on                                      text.
                                                                                                          assessment in
                                                                                                          advance of
                                                                                                          physician exam.
96161.............  Caregiver health risk  L026A               Medical/Technical      NF                 Scan assessment or                    2            0  G1: See preamble            -0.52
                     assmt.                                     Assistant.                                enter data elements                                   text.
                                                                                                          and total score
                                                                                                          into electronic
                                                                                                          health record.
96161.............  Caregiver health risk  L026A               Medical/Technical      NF                 Administration,                       0            7  G1: See preamble             1.82
                     assmt.                                     Assistant.                                scoring, and                                          text.
                                                                                                          documenting results
                                                                                                          of completed
                                                                                                          standardized
                                                                                                          instrument.
96360.............  Hydration iv infusion  EF023               table, exam..........  NF                 ....................                 16           24  E6: Refined                  0.02
                     init.                                                                                                                                      equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for
                                                                                                                                                                equipment with 4x
                                                                                                                                                                monitoring time.

[[Page 34056]]

 
96360.............  Hydration iv infusion  EQ032               IV infusion pump.....  NF                 ....................                 16           24  E6: Refined                  0.05
                     init.                                                                                                                                      equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for
                                                                                                                                                                equipment with 4x
                                                                                                                                                                monitoring time.
96360.............  Hydration iv infusion  L056A               RN/OCN...............  NF                 Obtain vital signs..                  3            5  L1: Refined time to          1.58
                     init.                                                                                                                                      standard for this
                                                                                                                                                                clinical labor task.
96361.............  Hydrate iv infusion    EF023               table, exam..........  NF                 ....................                  7            9  E15: Refined                 0.01
                     add-on.                                                                                                                                    equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
96361.............  Hydrate iv infusion    EQ032               IV infusion pump.....  NF                 ....................                  7            9  E15: Refined                 0.01
                     add-on.                                                                                                                                    equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
96361.............  Hydrate iv infusion    L056A               RN/OCN...............  NF                 Obtain vital signs..                  3            5  L1: Refined time to          1.58
                     add-on.                                                                                                                                    standard for this
                                                                                                                                                                clinical labor task.
96372.............  Ther/proph/diag inj    EF023               table, exam..........  NF                 ....................                 12            9  E15: Refined                -0.01
                     sc/im.                                                                                                                                     equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
96372.............  Ther/proph/diag inj    EQ189               otoscope-              NF                 ....................                 12            9  E15: Refined                -0.01
                     sc/im.                                     ophthalmoscope (wall                                                                            equipment time to
                                                                unit).                                                                                          conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
96372.............  Ther/proph/diag inj    L037D               RN/LPN/MTA...........  NF                 Complete medical                      1            0  G6: Indirect                -0.37
                     sc/im.                                                                               record                                                Practice Expense
                                                                                                          documentation.                                        input and/or not
                                                                                                                                                                individually
                                                                                                                                                                allocable to a
                                                                                                                                                                particular patient
                                                                                                                                                                for a particular
                                                                                                                                                                service.
96372.............  Ther/proph/diag inj    L037D               RN/LPN/MTA...........  NF                 Document lot number                   1            0  L3: Refined clinical        -0.37
                     sc/im.                                                                               and expiration date.                                  labor time to
                                                                                                                                                                conform with
                                                                                                                                                                identical labor
                                                                                                                                                                activity in other
                                                                                                                                                                codes in the family.
96372.............  Ther/proph/diag inj    L037D               RN/LPN/MTA...........  NF                 Clean room/equipment                  1            0  G8: Input removed;          -0.37
                     sc/im.                                                                               by physician staff.                                   code is typically
                                                                                                                                                                billed with an E/M
                                                                                                                                                                or other evaluation
                                                                                                                                                                service.
96374.............  Ther/proph/diag inj    EF023               table, exam..........  NF                 ....................                 23           31  E6: Refined                  0.02
                     iv push.                                                                                                                                   equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for
                                                                                                                                                                equipment with 4x
                                                                                                                                                                monitoring time.

[[Page 34057]]

 
96374.............  Ther/proph/diag inj    EQ189               otoscope-              NF                 ....................                 23           31  E6: Refined                  0.01
                     iv push.                                   ophthalmoscope (wall                                                                            equipment time to
                                                                unit).                                                                                          conform to
                                                                                                                                                                established
                                                                                                                                                                policies for
                                                                                                                                                                equipment with 4x
                                                                                                                                                                monitoring time.
96374.............  Ther/proph/diag inj    L056A               RN/OCN...............  NF                 Complete medical                      1            0  G6: Indirect                -0.79
                     iv push.                                                                             record                                                Practice Expense
                                                                                                          documentation.                                        input and/or not
                                                                                                                                                                individually
                                                                                                                                                                allocable to a
                                                                                                                                                                particular patient
                                                                                                                                                                for a particular
                                                                                                                                                                service.
96375.............  Tx/pro/dx inj new      EF023               table, exam..........  NF                 ....................                 12           17  E6: Refined                  0.01
                     drug addon.                                                                                                                                equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for
                                                                                                                                                                equipment with 4x
                                                                                                                                                                monitoring time.
96375.............  Tx/pro/dx inj new      EQ189               otoscope-              NF                 ....................                 12           17  E6: Refined                  0.01
                     drug addon.                                ophthalmoscope (wall                                                                            equipment time to
                                                                unit).                                                                                          conform to
                                                                                                                                                                established
                                                                                                                                                                policies for
                                                                                                                                                                equipment with 4x
                                                                                                                                                                monitoring time.
96375.............  Tx/pro/dx inj new      L056A               RN/OCN...............  NF                 Complete medical                      1            0  G6: Indirect                -0.79
                     drug addon.                                                                          record                                                Practice Expense
                                                                                                          documentation.                                        input and/or not
                                                                                                                                                                individually
                                                                                                                                                                allocable to a
                                                                                                                                                                particular patient
                                                                                                                                                                for a particular
                                                                                                                                                                service.
96377.............  Applicaton on-body     EF023               table, exam..........  NF                 ....................                 12           11  E15: Refined                 0.00
                     injector.                                                                                                                                  equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
96377.............  Applicaton on-body     EQ189               otoscope-              NF                 ....................                 12           11  E15: Refined                 0.00
                     injector.                                  ophthalmoscope (wall                                                                            equipment time to
                                                                unit).                                                                                          conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
96377.............  Applicaton on-body     L056A               RN/OCN...............  NF                 Complete medical                      1            0  G6: Indirect                -0.79
                     injector.                                                                            record                                                Practice Expense
                                                                                                          documentation.                                        input and/or not
                                                                                                                                                                individually
                                                                                                                                                                allocable to a
                                                                                                                                                                particular patient
                                                                                                                                                                for a particular
                                                                                                                                                                service.
96910.............  Photochemotherapy      EF023               table, exam..........  NF                 ....................                 67           65  E15: Refined                -0.01
                     with uv-b.                                                                                                                                 equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.

[[Page 34058]]

 
96910.............  Photochemotherapy      EQ168               light, exam..........  NF                 ....................                 67           65  E15: Refined                -0.01
                     with uv-b.                                                                                                                                 equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
96910.............  Photochemotherapy      EQ204               phototherapy unit,     NF                 ....................                 67           65  E15: Refined                -0.01
                     with uv-b.                                 hand-foot, UVA-UVB.                                                                             equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
96910.............  Photochemotherapy      EQ205               phototherapy unit,     NF                 ....................                 67           65  E15: Refined                -0.07
                     with uv-b.                                 whole body, UVA-UVB.                                                                            equipment time to
                                                                                                                                                                conform to changes
                                                                                                                                                                in clinical labor
                                                                                                                                                                time.
96910.............  Photochemotherapy      L037D               RN/LPN/MTA...........  NF                 Complete diagnostic                   2            0  G6: Indirect                -0.74
                     with uv-b.                                                                           forms, lab & X-ray                                    Practice Expense
                                                                                                          requisitions, and                                     input and/or not
                                                                                                          documentation.                                        individually
                                                                                                                                                                allocable to a
                                                                                                                                                                particular patient
                                                                                                                                                                for a particular
                                                                                                                                                                service.
96910.............  Photochemotherapy      L037D               RN/LPN/MTA...........  NF                 Provide pre-service                   3            1  G1: See preamble            -0.74
                     with uv-b.                                                                           education/obtain                                      text.
                                                                                                          consent.
96910.............  Photochemotherapy      L037D               RN/LPN/MTA...........  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.74
                     with uv-b.                                                                                                                                 standard for this
                                                                                                                                                                clinical labor task.
96X73.............  Pdt dstr prmlg les     EF031               table, power.........  NF                 ....................                230           52  E1: Refined                 -2.91
                     phys/qhp.                                                                                                                                  equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
96X73.............  Pdt dstr prmlg les     EQ169               light, external PDT,   NF                 ....................                 20           52  E1: Refined                  1.12
                     phys/qhp.                                  w-probe set                                                                                     equipment time to
                                                                (LumaCare).                                                                                     conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
96X73.............  Pdt dstr prmlg les     L037D               RN/LPN/MTA...........  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.74
                     phys/qhp.                                                                                                                                  standard for this
                                                                                                                                                                clinical labor task.
96X73.............  Pdt dstr prmlg les     SJ027               goggles, uv-blocking.  NF                 ....................                  0            3  S8: Supply item             12.30
                     phys/qhp.                                                                                                                                  replaces another
                                                                                                                                                                item; see preamble.
96X74.............  Dbrdmt prmlg les w/    EF031               table, power.........  NF                 ....................                232           54  E1: Refined                 -2.91
                     pdt.                                                                                                                                       equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.

[[Page 34059]]

 
96X74.............  Dbrdmt prmlg les w/    EQ168               light, exam..........  NF                 ....................                 52           54  E1: Refined                  0.01
                     pdt.                                                                                                                                       equipment time to
                                                                                                                                                                conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
96X74.............  Dbrdmt prmlg les w/    EQ169               light, external PDT,   NF                 ....................                 20           54  E1: Refined                  1.19
                     pdt.                                       w-probe set                                                                                     equipment time to
                                                                (LumaCare).                                                                                     conform to
                                                                                                                                                                established
                                                                                                                                                                policies for non-
                                                                                                                                                                highly technical
                                                                                                                                                                equipment.
96X74.............  Dbrdmt prmlg les w/    L037D               RN/LPN/MTA...........  NF                 Obtain vital signs..                  3            5  L1: Refined time to          0.74
                     pdt.                                                                                                                                       standard for this
                                                                                                                                                                clinical labor task.
96X74.............  Dbrdmt prmlg les w/    SJ027               goggles, uv-blocking.  NF                 ....................                  0            3  S8: Supply item             12.30
                     pdt.                                                                                                                                       replaces another
                                                                                                                                                                item; see preamble.
97012.............  Mechanical traction    EQ241               traction system (hi-   NF                 ....................                 13           15  G1: See preamble             0.03
                     therapy.                                   low table, digital                                                                              text.
                                                                unit, accessories).
97012.............  Mechanical traction    L023A               Physical Therapy Aide  NF                 Clean room/equipment                  1            2  G1: See preamble             0.23
                     therapy.                                                                             by physician staff.                                   text.
97012.............  Mechanical traction    L023A               Physical Therapy Aide  NF                 Assist therapist....                  2            0  G1: See preamble            -0.46
                     therapy.                                                                                                                                   text.
97012.............  Mechanical traction    L023A               Physical Therapy Aide  NF                 Other clinical                        0            1  G1: See preamble             0.23
                     therapy.                                                                             Activity--specify:                                    text.
                                                                                                          post-treatment
                                                                                                          assistance.
97012.............  Mechanical traction    L023A               Physical Therapy Aide  NF                 Prepare room,                         1            0  G1: See preamble            -0.23
                     therapy.                                                                             equipment, supplies.                                  text.
97012.............  Mechanical traction    L023A               Physical Therapy Aide  NF                 Prepare and position                  1            0  G1: See preamble            -0.23
                     therapy.                                                                             patient.                                              text.
97012.............  Mechanical traction    L039B               Physical Therapy       NF                 Check dressings &                     0            1  G1: See preamble             0.39
                     therapy.                                   Assistant.                                wound/home care                                       text.
                                                                                                          instructions/
                                                                                                          coordinate office
                                                                                                          visits/
                                                                                                          prescriptions.
97012.............  Mechanical traction    L039B               Physical Therapy       NF                 Assist therapist....                  0            5  G1: See preamble             1.95
                     therapy.                                   Assistant.                                                                                      text.
97012.............  Mechanical traction    SB022               gloves, non-sterile..  NF                 ....................                  1            0  G1: See preamble            -0.08
                     therapy.                                                                                                                                   text.
97012.............  Mechanical traction    SB026               gown, patient........  NF                 ....................                  1            0  G1: See preamble            -0.53
                     therapy.                                                                                                                                   text.
97012.............  Mechanical traction    SG039               dressing, 5in x 9in    NF                 ....................                  0            1  G1: See preamble             0.27
                     therapy.                                   (ABD-Combine).                                                                                  text.
97012.............  Mechanical traction    SK082               towel, paper (Bounty)  NF                 ....................                  2            0  G1: See preamble            -0.01
                     therapy.                                   (per sheet).                                                                                    text.
97012.............  Mechanical traction    SM012               disinfectant spray     NF                 ....................                  2            0  G1: See preamble            -0.06
                     therapy.                                   (Transeptic).                                                                                   text.
97014.............  Electric stimulation   EF028               table, mat, hi-lo, 6   NF                 ....................                 10           15  G1: See preamble             0.05
                     therapy.                                   x 8 platform.                                                                                   text.
97014.............  Electric stimulation   EQ116               electrotherapy         NF                 ....................                 10           15  G1: See preamble             0.03
                     therapy.                                   stimulator, high                                                                                text.
                                                                volt, 2 channel.
97014.............  Electric stimulation   L023A               Physical Therapy Aide  NF                 Prepare room,                         1            0  G1: See preamble            -0.23
                     therapy.                                                                             equipment, supplies.                                  text.
97014.............  Electric stimulation   L023A               Physical Therapy Aide  NF                 Assist therapist....                  2            0  G1: See preamble            -0.46
                     therapy.                                                                                                                                   text.

[[Page 34060]]

 
97014.............  Electric stimulation   L023A               Physical Therapy Aide  NF                 Clean room/equipment                  1            2  G1: See preamble             0.23
                     therapy.                                                                             by physician staff.                                   text.
97014.............  Electric stimulation   L023A               Physical Therapy Aide  NF                 Other clinical                        0            1  G1: See preamble             0.23
                     therapy.                                                                             Activity--specify:                                    text.
                                                                                                          post-treatment
                                                                                                          assistance.
97014.............  Electric stimulation   L023A               Physical Therapy Aide  NF                 Prepare and position                  1            0  G1: See preamble            -0.23
                     therapy.                                                                             patient.                                              text.
97014.............  Electric stimulation   L039B               Physical Therapy       NF                 Assist therapist....                  0            3  G1: See preamble             1.17
                     therapy.                                   Assistant.                                                                                      text.
97014.............  Electric stimulation   L039B               Physical Therapy       NF                 Check dressings &                     0            1  G1: See preamble             0.39
                     therapy.                                   Assistant.                                wound/home care                                       text.
                                                                                                          instructions/
                                                                                                          coordinate office
                                                                                                          visits/
                                                                                                          prescriptions.
97014.............  Electric stimulation   SB026               gown, patient........  NF                 ....................                  1            0  G1: See preamble            -0.53
                     therapy.                                                                                                                                   text.
97014.............  Electric stimulation   SJ024               electrolyte coupling   NF                 ....................                  0            1  G1: See preamble             0.02
                     therapy.                                   gel.                                                                                            text.
97014.............  Electric stimulation   SK068               razor................  NF                 ....................                  0            1  G1: See preamble             0.39
                     therapy.                                                                                                                                   text.
97014.............  Electric stimulation   SK082               towel, paper (Bounty)  NF                 ....................                  1            0  G1: See preamble            -0.01
                     therapy.                                   (per sheet).                                                                                    text.
97014.............  Electric stimulation   SM012               disinfectant spray     NF                 ....................                  1            0  G1: See preamble            -0.03
                     therapy.                                   (Transeptic).                                                                                   text.
97016.............  Vasopneumatic device   EF028               table, mat, hi-lo, 6   NF                 ....................                 11           20  G1: See preamble             0.09
                     therapy.                                   x 8 platform.                                                                                   text.
97016.............  Vasopneumatic device   EQ263               vasopneumatic          NF                 ....................                 11           20  G1: See preamble             0.02
                     therapy.                                   compression system.                                                                             text.
97016.............  Vasopneumatic device   L023A               Physical Therapy Aide  NF                 Other clinical                        0            2  G1: See preamble             0.46
                     therapy.                                                                             Activity--specify:                                    text.
                                                                                                          post-treatment
                                                                                                          assistance.
97016.............  Vasopneumatic device   L023A               Physical Therapy Aide  NF                 Prepare room,                         1            0  G1: See preamble            -0.23
                     therapy.                                                                             equipment, supplies.                                  text.
97016.............  Vasopneumatic device   L023A               Physical Therapy Aide  NF                 Clean room/equipment                  1            2  G1: See preamble             0.23
                     therapy.                                                                             by physician staff.                                   text.
97016.............  Vasopneumatic device   L023A               Physical Therapy Aide  NF                 Prepare and position                  1            0  G1: See preamble            -0.23
                     therapy.                                                                             patient.                                              text.
97016.............  Vasopneumatic device   L023A               Physical Therapy Aide  NF                 Assist therapist....                  2            0  G1: See preamble            -0.46
                     therapy.                                                                                                                                   text.
97016.............  Vasopneumatic device   L039B               Physical Therapy       NF                 Assist therapist....                  0           10  G1: See preamble             3.90
                     therapy.                                   Assistant.                                                                                      text.
97016.............  Vasopneumatic device   L039B               Physical Therapy       NF                 Check dressings &                     0            5  G1: See preamble             1.95
                     therapy.                                   Assistant.                                wound/home care                                       text.
                                                                                                          instructions/
                                                                                                          coordinate office
                                                                                                          visits/
                                                                                                          prescriptions.
97016.............  Vasopneumatic device   L039B               Physical Therapy       NF                 Obtain vital signs..                  0            2  G1: See preamble             0.78
                     therapy.                                   Assistant.                                                                                      text.
97016.............  Vasopneumatic device   SB026               gown, patient........  NF                 ....................                  1            0  G1: See preamble            -0.53
                     therapy.                                                                                                                                   text.
97018.............  Paraffin bath therapy  EQ200               paraffin bath, hand-   NF                 ....................                 11           15  G1: See preamble             0.03
                                                                foot (institutional).                                                                           text.

[[Page 34061]]

 
97018.............  Paraffin bath therapy  L023A               Physical Therapy Aide  NF                 Prepare room,                         1            3  G1: See preamble             0.46
                                                                                                          equipment, supplies.                                  text.
97018.............  Paraffin bath therapy  L023A               Physical Therapy Aide  NF                 Other clinical                        0            1  G1: See preamble             0.23
                                                                                                          Activity--specify:                                    text.
                                                                                                          post-treatment
                                                                                                          assistance.
97018.............  Paraffin bath therapy  L023A               Physical Therapy Aide  NF                 Clean room/equipment                  1            2  G1: See preamble             0.23
                                                                                                          by physician staff.                                   text.
97018.............  Paraffin bath therapy  L023A               Physical Therapy Aide  NF                 Assist therapist....                  2            0  G1: See preamble            -0.46
                                                                                                                                                                text.
97018.............  Paraffin bath therapy  L023A               Physical Therapy Aide  NF                 Prepare and position                  1            3  G1: See preamble             0.46
                                                                                                          patient.                                              text.
97018.............  Paraffin bath therapy  L039B               Physical Therapy       NF                 Check dressings &                     0            1  G1: See preamble             0.39
                                                                Assistant.                                wound/home care                                       text.
                                                                                                          instructions/
                                                                                                          coordinate office
                                                                                                          visits/
                                                                                                          prescriptions.
97018.............  Paraffin bath therapy  L039B               Physical Therapy       NF                 Assist therapist....                  0            5  G1: See preamble             1.95
                                                                Assistant.                                                                                      text.
97018.............  Paraffin bath therapy  SA048               pack, minimum multi-   NF                 ....................                  0          0.5  G1: See preamble             0.57
                                                                specialty visit.                                                                                text.
97022.............  Whirlpool therapy....  EF012               lift, hydraulic,       NF                 ....................                 26            4  G1: See preamble            -0.28
                                                                chair.                                                                                          text.
97022.............  Whirlpool therapy....  EF036               whirlpool, lo-boy      NF                 ....................                 26           24  G1: See preamble            -0.02
                                                                tank (whole body).                                                                              text.
97022.............  Whirlpool therapy....  L023A               Physical Therapy Aide  NF                 Prepare and position                  2            3  G1: See preamble             0.23
                                                                                                          patient.                                              text.
97022.............  Whirlpool therapy....  L023A               Physical Therapy Aide  NF                 Assist therapist....                  2            0  G1: See preamble            -0.46
                                                                                                                                                                text.
97022.............  Whirlpool therapy....  L023A               Physical Therapy Aide  NF                 Other clinical                        0            3  G1: See preamble             0.69
                                                                                                          Activity--specify:                                    text.
                                                                                                          post-treatment
                                                                                                          assistance.
97022.............  Whirlpool therapy....  L039B               Physical Therapy       NF                 Assist therapist....                  0            5  G1: See preamble             1.95
                                                                Assistant.                                                                                      text.
97022.............  Whirlpool therapy....  L039B               Physical Therapy       NF                 Check dressings &                     0            1  G1: See preamble             0.39
                                                                Assistant.                                wound/home care                                       text.
                                                                                                          instructions/
                                                                                                          coordinate office
                                                                                                          visits/
                                                                                                          prescriptions.
97022.............  Whirlpool therapy....  SB022               gloves, non-sterile..  NF                 ....................                  1            0  G1: See preamble            -0.08
                                                                                                                                                                text.
97022.............  Whirlpool therapy....  SB024               gloves, sterile......  NF                 ....................                  0            1  G1: See preamble             0.84
                                                                                                                                                                text.
97022.............  Whirlpool therapy....  SB033               mask, surgical.......  NF                 ....................                  0            1  G1: See preamble             0.20
                                                                                                                                                                text.
97022.............  Whirlpool therapy....  SG017               bandage, Kling, non-   NF                 ....................                  0            1  G1: See preamble             0.36
                                                                sterile 2in.                                                                                    text.
97022.............  Whirlpool therapy....  SG027               cast, stockinette 4in  NF                 ....................                  0            1  G1: See preamble             0.46
                                                                                                                                                                text.
97022.............  Whirlpool therapy....  SG055               gauze, sterile 4in x   NF                 ....................                  0            5  G1: See preamble             0.80
                                                                4in.                                                                                            text.
97022.............  Whirlpool therapy....  SG079               tape, surgical paper   NF                 ....................                  0           12  G1: See preamble             0.02
                                                                1in (Micropore).                                                                                text.
97022.............  Whirlpool therapy....  SJ046               silver nitrate         NF                 ....................                  0            1  G1: See preamble             0.07
                                                                applicator.                                                                                     text.
97032.............  Electrical             EF028               table, mat, hi-lo, 6   NF                 ....................                 18           15  G1: See preamble            -0.03
                     stimulation.                               x 8 platform.                                                                                   text.
97032.............  Electrical             EQ116               electrotherapy         NF                 ....................                 18           15  G1: See preamble            -0.02
                     stimulation.                               stimulator, high                                                                                text.
                                                                volt, 2 channel.

[[Page 34062]]

 
97032.............  Electrical             L023A               Physical Therapy Aide  NF                 Prepare room,                         1            0  G1: See preamble            -0.23
                     stimulation.                                                                         equipment, supplies.                                  text.
97032.............  Electrical             L023A               Physical Therapy Aide  NF                 Prepare and position                  1            0  G1: See preamble            -0.23
                     stimulation.                                                                         patient.                                              text.
97032.............  Electrical             L023A               Physical Therapy Aide  NF                 Other clinical                        0            1  G1: See preamble             0.23
                     stimulation.                                                                         Activity--specify:                                    text.
                                                                                                          post-treatment
                                                                                                          assistance.
97032.............  Electrical             L023A               Physical Therapy Aide  NF                 Clean room/equipment                  1            2  G1: See preamble             0.23
                     stimulation.                                                                         by physician staff.                                   text.
97032.............  Electrical             L039B               Physical Therapy       NF                 Assist therapist....                  0            3  G1: See preamble             1.17
                     stimulation.                               Assistant.                                                                                      text.
97032.............  Electrical             L039B               Physical Therapy       NF                 Check dressings &                     0            1  G1: See preamble             0.39
                     stimulation.                               Assistant.                                wound/home care                                       text.
                                                                                                          instructions/
                                                                                                          coordinate office
                                                                                                          visits/
                                                                                                          prescriptions.
97032.............  Electrical             SB022               gloves, non-sterile..  NF                 ....................                  1            0  G1: See preamble            -0.08
                     stimulation.                                                                                                                               text.
97032.............  Electrical             SB026               gown, patient........  NF                 ....................                  1            0  G1: See preamble            -0.53
                     stimulation.                                                                                                                               text.
97032.............  Electrical             SD055               electrode, electrical  NF                 ....................                  0            2  G1: See preamble             2.62
                     stimulation.                               stimulation.                                                                                    text.
97032.............  Electrical             SG079               tape, surgical paper   NF                 ....................                  0            6  G1: See preamble             0.01
                     stimulation.                               1in (Micropore).                                                                                text.
97032.............  Electrical             SJ020               electrode conductive   NF                 ....................                  0            5  G1: See preamble             0.08
                     stimulation.                               gel.                                                                                            text.
97032.............  Electrical             SJ053               swab-pad, alcohol....  NF                 ....................                  1            2  G1: See preamble             0.01
                     stimulation.                                                                                                                               text.
97032.............  Electrical             SK068               razor................  NF                 ....................                  0            1  G1: See preamble             0.39
                     stimulation.                                                                                                                               text.
97032.............  Electrical             SK082               towel, paper (Bounty)  NF                 ....................                  1            0  G1: See preamble            -0.01
                     stimulation.                               (per sheet).                                                                                    text.
97032.............  Electrical             SM012               disinfectant spray     NF                 ....................                  1            0  G1: See preamble            -0.03
                     stimulation.                               (Transeptic).                                                                                   text.
97033.............  Electric current       EF028               table, mat, hi-lo, 6   NF                 ....................                 20           15  G1: See preamble            -0.05
                     therapy.                                   x 8 platform.                                                                                   text.
97033.............  Electric current       EQ141               iontophoresis machine  NF                 ....................                 20           15  G1: See preamble            -0.01
                     therapy.                                                                                                                                   text.
97033.............  Electric current       L023A               Physical Therapy Aide  NF                 Other clinical                        0            1  G1: See preamble             0.23
                     therapy.                                                                             Activity--specify:                                    text.
                                                                                                          post-treatment
                                                                                                          assistance.
97033.............  Electric current       L023A               Physical Therapy Aide  NF                 Prepare room,                         2            3  G1: See preamble             0.23
                     therapy.                                                                             equipment, supplies.                                  text.
97033.............  Electric current       L023A               Physical Therapy Aide  NF                 Clean room/equipment                  1            3  G1: See preamble             0.46
                     therapy.                                                                             by physician staff.                                   text.
97033.............  Electric current       L039B               Physical Therapy       NF                 Other Clinical                        0            1  G1: See preamble             0.39
                     therapy.                                   Assistant.                                Activity--specify:                                    text.
                                                                                                          Obtain measurements.
97033.............  Electric current       SG055               gauze, sterile 4in x   NF                 ....................                  0            1  G1: See preamble             0.16
                     therapy.                                   4in.                                                                                            text.
97033.............  Electric current       SK068               razor................  NF                 ....................                  0            1  G1: See preamble             0.39
                     therapy.                                                                                                                                   text.
97034.............  Contrast bath therapy  L023A               Physical Therapy Aide  NF                 Clean room/equipment                  2            5  G1: See preamble             0.69
                                                                                                          by physician staff.                                   text.
97034.............  Contrast bath therapy  L023A               Physical Therapy Aide  NF                 Prepare room,                         2            3  G1: See preamble             0.23
                                                                                                          equipment, supplies.                                  text.
97034.............  Contrast bath therapy  L023A               Physical Therapy Aide  NF                 Prepare and position                  1            2  G1: See preamble             0.23
                                                                                                          patient.                                              text.

[[Page 34063]]

 
97034.............  Contrast bath therapy  L039B               Physical Therapy       NF                 Assist therapist....                  0            3  G1: See preamble             1.17
                                                                Assistant.                                                                                      text.
97034.............  Contrast bath therapy  L039B               Physical Therapy       NF                 Check dressings &                     0            3  G1: See preamble             1.17
                                                                Assistant.                                wound/home care                                       text.
                                                                                                          instructions/
                                                                                                          coordinate office
                                                                                                          visits/
                                                                                                          prescriptions.
97034.............  Contrast bath therapy  SB022               gloves, non-sterile..  NF                 ....................                  1            0  G1: See preamble            -0.08
                                                                                                                                                                text.
97034.............  Contrast bath therapy  SB026               gown, patient........  NF                 ....................                  1            0  G1: See preamble            -0.53
                                                                                                                                                                text.
97035.............  Ultrasound therapy...  EF028               table, mat, hi-lo, 6   NF                 ....................                 16           15  G1: See preamble            -0.01
                                                                x 8 platform.                                                                                   text.
97035.............  Ultrasound therapy...  EQ251               ultrasound unit,       NF                 ....................                 16            8  G1: See preamble            -0.03
                                                                therapeutic.                                                                                    text.
97035.............  Ultrasound therapy...  L023A               Physical Therapy Aide  NF                 Prepare and position                  1            0  G1: See preamble            -0.23
                                                                                                          patient.                                              text.
97035.............  Ultrasound therapy...  L023A               Physical Therapy Aide  NF                 Prepare room,                         1            0  G1: See preamble            -0.23
                                                                                                          equipment, supplies.                                  text.
97035.............  Ultrasound therapy...  L023A               Physical Therapy Aide  NF                 Other clinical                        0            1  G1: See preamble             0.23
                                                                                                          Activity--specify:                                    text.
                                                                                                          post-treatment
                                                                                                          assistance.
97035.............  Ultrasound therapy...  L039B               Physical Therapy       NF                 Assist therapist....                  0            3  G1: See preamble             1.17
                                                                Assistant.                                                                                      text.
97035.............  Ultrasound therapy...  SB022               gloves, non-sterile..  NF                 ....................                  1            0  G1: See preamble            -0.08
                                                                                                                                                                text.
97035.............  Ultrasound therapy...  SB026               gown, patient........  NF                 ....................                  1            0  G1: See preamble            -0.53
                                                                                                                                                                text.
97035.............  Ultrasound therapy...  SJ024               electrolyte coupling   NF                 ....................                  0            1  G1: See preamble             0.02
                                                                gel.                                                                                            text.
97035.............  Ultrasound therapy...  SJ062               ultrasound             NF                 ....................                 30            0  G1: See preamble            -0.39
                                                                transmission gel.                                                                               text.
97035.............  Ultrasound therapy...  SK082               towel, paper (Bounty)  NF                 ....................                  1            0  G1: See preamble            -0.01
                                                                (per sheet).                                                                                    text.
97035.............  Ultrasound therapy...  SM012               disinfectant spray     NF                 ....................                  1            0  G1: See preamble            -0.03
                                                                (Transeptic).                                                                                   text.
97110.............  Therapeutic exercises  EF028               table, mat, hi-lo, 6   NF                 ....................                 22           10  G1: See preamble            -0.12
                                                                x 8 platform.                                                                                   text.
97110.............  Therapeutic exercises  EQ118               exercise equipment     NF                 ....................                 22            8  G1: See preamble            -0.40
                                                                (treadmill, bike,                                                                               text.
                                                                stepper, UBE,
                                                                pulleys, balance
                                                                board).
97110.............  Therapeutic exercises  EQ129               hydrocollator, cold..  NF                 ....................                  0            4  G1: See preamble             0.02
                                                                                                                                                                text.
97110.............  Therapeutic exercises  EQ130               hydrocollator, hot...  NF                 ....................                  0            4  G1: See preamble             0.01
                                                                                                                                                                text.
97110.............  Therapeutic exercises  L023A               Physical Therapy Aide  NF                 Other clinical                        0            1  G1: See preamble             0.23
                                                                                                          Activity--specify:                                    text.
                                                                                                          post-treatment
                                                                                                          assistance.
97110.............  Therapeutic exercises  L023A               Physical Therapy Aide  NF                 Prepare room,                         1            0  G1: See preamble            -0.23
                                                                                                          equipment, supplies.                                  text.
97110.............  Therapeutic exercises  L023A               Physical Therapy Aide  NF                 Prepare and position                  1            0  G1: See preamble            -0.23
                                                                                                          patient.                                              text.
97110.............  Therapeutic exercises  L023A               Physical Therapy Aide  NF                 Assist therapist....                  5            0  G1: See preamble            -1.15
                                                                                                                                                                text.
97110.............  Therapeutic exercises  L023A               Physical Therapy Aide  NF                 Other Clinical                        0          1.5  G1: See preamble             0.35
                                                                                                          Activity--specify:                                    text.
                                                                                                          Verify/Coordinate
                                                                                                          availability of
                                                                                                          resources/equipment.

[[Page 34064]]

 
97110.............  Therapeutic exercises  L039B               Physical Therapy       NF                 Check dressings &                   1.5          2.5  G1: See preamble             0.39
                                                                Assistant.                                wound/home care                                       text.
                                                                                                          instructions/
                                                                                                          coordinate office
                                                                                                          visits/
                                                                                                          prescriptions.
97110.............  Therapeutic exercises  L039B               Physical Therapy       NF                 Other Clinical                        0          1.5  G1: See preamble             0.59
                                                                Assistant.                                Activity--specify:                                    text.
                                                                                                          Obtain measurements.
97110.............  Therapeutic exercises  L039B               Physical Therapy       NF                 Assist therapist....                2.5          7.5  G1: See preamble             1.95
                                                                Assistant.                                                                                      text.
97110.............  Therapeutic exercises  L039B               Physical Therapy       NF                 Other Clinical                        0            1  G1: See preamble             0.39
                                                                Assistant.                                Activity--specify:                                    text.
                                                                                                          Conduct phone calls/
                                                                                                          call in
                                                                                                          prescriptions.
97110.............  Therapeutic exercises  L039B               Physical Therapy       NF                 Other Clinical                        0          1.5  G1: See preamble             0.59
                                                                Assistant.                                Activity--specify:                                    text.
                                                                                                          Review/read
                                                                                                          documentation, plan
                                                                                                          of care, treatment
                                                                                                          goals.
97110.............  Therapeutic exercises  SA048               pack, minimum multi-   NF                 ....................                  0          0.5  G1: See preamble             0.57
                                                                specialty visit.                                                                                text.
97110.............  Therapeutic exercises  SB022               gloves, non-sterile..  NF                 ....................                  1            0  G1: See preamble            -0.08
                                                                                                                                                                text.
97110.............  Therapeutic exercises  SK082               towel, paper (Bounty)  NF                 ....................                  4            0  G1: See preamble            -0.03
                                                                (per sheet).                                                                                    text.
97110.............  Therapeutic exercises  SM012               disinfectant spray     NF                 ....................                  5            0  G1: See preamble            -0.14
                                                                (Transeptic).                                                                                   text.
97112.............  Neuromuscular          EF028               table, mat, hi-lo, 6   NF                 ....................                 22           10  G1: See preamble            -0.12
                     reeducation.                               x 8 platform.                                                                                   text.
97112.............  Neuromuscular          EQ068               balance assessment-    NF                 ....................                 22           15  G1: See preamble            -0.37
                     reeducation.                               retraining system                                                                               text.
                                                                (Balance Master).
97112.............  Neuromuscular          EQ118               exercise equipment     NF                 ....................                 22           15  G1: See preamble            -0.20
                     reeducation.                               (treadmill, bike,                                                                               text.
                                                                stepper, UBE,
                                                                pulleys, balance
                                                                board).
97112.............  Neuromuscular          EQ201               parallel bars,         NF                 ....................                 22            5  G1: See preamble            -0.06
                     reeducation.                               platform mounted.                                                                               text.
97112.............  Neuromuscular          L023A               Physical Therapy Aide  NF                 Prepare room,                         1            0  G1: See preamble            -0.23
                     reeducation.                                                                         equipment, supplies.                                  text.
97112.............  Neuromuscular          L023A               Physical Therapy Aide  NF                 Prepare and position                  1            0  G1: See preamble            -0.23
                     reeducation.                                                                         patient.                                              text.
97112.............  Neuromuscular          L023A               Physical Therapy Aide  NF                 Assist therapist....                  5            0  G1: See preamble            -1.15
                     reeducation.                                                                                                                               text.
97112.............  Neuromuscular          L023A               Physical Therapy Aide  NF                 Other clinical                        0            1  G1: See preamble             0.23
                     reeducation.                                                                         Activity--specify:                                    text.
                                                                                                          post-treatment
                                                                                                          assistance.
97112.............  Neuromuscular          L023A               Physical Therapy Aide  NF                 Other Clinical                        0          1.5  G1: See preamble             0.35
                     reeducation.                                                                         Activity--specify:                                    text.
                                                                                                          Verify/Coordinate
                                                                                                          availability of
                                                                                                          resources/equipment.

[[Page 34065]]

 
97112.............  Neuromuscular          L039B               Physical Therapy       NF                 Check dressings &                   1.5          2.5  G1: See preamble             0.39
                     reeducation.                               Assistant.                                wound/home care                                       text.
                                                                                                          instructions/
                                                                                                          coordinate office
                                                                                                          visits/
                                                                                                          prescriptions.
97112.............  Neuromuscular          L039B               Physical Therapy       NF                 Other Clinical                        0          1.5  G1: See preamble             0.59
                     reeducation.                               Assistant.                                Activity--specify:                                    text.
                                                                                                          Review/read
                                                                                                          documentation, plan
                                                                                                          of care, treatment
                                                                                                          goals.
97112.............  Neuromuscular          L039B               Physical Therapy       NF                 Assist therapist....                2.5          7.5  G1: See preamble             1.95
                     reeducation.                               Assistant.                                                                                      text.
97112.............  Neuromuscular          L039B               Physical Therapy       NF                 Other Clinical                        0            1  G1: See preamble             0.39
                     reeducation.                               Assistant.                                Activity--specify:                                    text.
                                                                                                          Conduct phone calls/
                                                                                                          call in
                                                                                                          prescriptions.
97112.............  Neuromuscular          L039B               Physical Therapy       NF                 Other Clinical                        0          1.5  G1: See preamble             0.59
                     reeducation.                               Assistant.                                Activity--specify:                                    text.
                                                                                                          Obtain measurements.
97112.............  Neuromuscular          SA048               pack, minimum multi-   NF                 ....................                  0          0.5  G1: See preamble             0.57
                     reeducation.                               specialty visit.                                                                                text.
97112.............  Neuromuscular          SB022               gloves, non-sterile..  NF                 ....................                  1            0  G1: See preamble            -0.08
                     reeducation.                                                                                                                               text.
97112.............  Neuromuscular          SK082               towel, paper (Bounty)  NF                 ....................                  4            0  G1: See preamble            -0.03
                     reeducation.                               (per sheet).                                                                                    text.
97112.............  Neuromuscular          SM012               disinfectant spray     NF                 ....................                  5            0  G1: See preamble            -0.14
                     reeducation.                               (Transeptic).                                                                                   text.
97113.............  Aquatic therapy/       EF012               lift, hydraulic,       NF                 ....................                  0            4  G1: See preamble             0.05
                     exercises.                                 chair.                                                                                          text.
97113.............  Aquatic therapy/       EQ050               aquatic therapy pool.  NF                 ....................                 30           15  G1: See preamble            -1.15
                     exercises.                                                                                                                                 text.
97113.............  Aquatic therapy/       EQ145               kit, aquatic exercise  NF                 ....................                 30           10  G1: See preamble            -0.03
                     exercises.                                                                                                                                 text.
97113.............  Aquatic therapy/       EQ207               pool cleaner.........  NF                 ....................                  0           15  G1: See preamble             0.05
                     exercises.                                                                                                                                 text.
97113.............  Aquatic therapy/       L023A               Physical Therapy Aide  NF                 Prepare room,                         2            0  G1: See preamble            -0.46
                     exercises.                                                                           equipment, supplies.                                  text.
97113.............  Aquatic therapy/       L023A               Physical Therapy Aide  NF                 Other Clinical                        0          1.5  G1: See preamble             0.35
                     exercises.                                                                           Activity--specify:                                    text.
                                                                                                          Verify/Coordinate
                                                                                                          availability of
                                                                                                          resources/equipment.
97113.............  Aquatic therapy/       L023A               Physical Therapy Aide  NF                 Other clinical                        2            3  G1: See preamble             0.23
                     exercises.                                                                           Activity--specify:                                    text.
                                                                                                          post-treatment
                                                                                                          assistance.
97113.............  Aquatic therapy/       L023A               Physical Therapy Aide  NF                 Greet patient,                        2          1.5  G1: See preamble            -0.12
                     exercises.                                                                           provide gowning,                                      text.
                                                                                                          ensure appropriate
                                                                                                          medical records are
                                                                                                          available.
97113.............  Aquatic therapy/       L023A               Physical Therapy Aide  NF                 Prepare and position                  3          1.5  G1: See preamble            -0.35
                     exercises.                                                                           patient.                                              text.
97113.............  Aquatic therapy/       L023A               Physical Therapy Aide  NF                 Clean room/equipment                  2            1  G1: See preamble            -0.23
                     exercises.                                                                           by physician staff.                                   text.

[[Page 34066]]

 
97113.............  Aquatic therapy/       L023A               Physical Therapy Aide  NF                 Assist therapist....                 15            0  G1: See preamble            -3.45
                     exercises.                                                                                                                                 text.
97113.............  Aquatic therapy/       L039B               Physical Therapy       NF                 Check dressings &                     2          2.5  G1: See preamble             0.20
                     exercises.                                 Assistant.                                wound/home care                                       text.
                                                                                                          instructions/
                                                                                                          coordinate office
                                                                                                          visits/
                                                                                                          prescriptions.
97113.............  Aquatic therapy/       L039B               Physical Therapy       NF                 Obtain vital signs..                  2            1  G1: See preamble            -0.39
                     exercises.                                 Assistant.                                                                                      text.
97113.............  Aquatic therapy/       L039B               Physical Therapy       NF                 Other Clinical                        0          1.5  G1: See preamble             0.59
                     exercises.                                 Assistant.                                Activity--specify:                                    text.
                                                                                                          Review/read
                                                                                                          documentation, plan
                                                                                                          of care, treatment
                                                                                                          goals.
97113.............  Aquatic therapy/       L039B               Physical Therapy       NF                 Other Clinical                        0          1.5  G1: See preamble             0.59
                     exercises.                                 Assistant.                                Activity--specify:                                    text.
                                                                                                          Obtain measurements.
97113.............  Aquatic therapy/       L039B               Physical Therapy       NF                 Other Clinical                        0            1  G1: See preamble             0.39
                     exercises.                                 Assistant.                                Activity--specify:                                    text.
                                                                                                          Conduct phone calls/
                                                                                                          call in
                                                                                                          prescriptions.
97113.............  Aquatic therapy/       L039B               Physical Therapy       NF                 Assist therapist....                  2          7.5  G1: See preamble             2.15
                     exercises.                                 Assistant.                                                                                      text.
97113.............  Aquatic therapy/       SA048               pack, minimum multi-   NF                 ....................                  0          0.5  G1: See preamble             0.57
                     exercises.                                 specialty visit.                                                                                text.
97113.............  Aquatic therapy/       SB022               gloves, non-sterile..  NF                 ....................                  1            0  G1: See preamble            -0.08
                     exercises.                                                                                                                                 text.
97113.............  Aquatic therapy/       SB041               swimsuit, female for   NF                 ....................                  0            1  G1: See preamble             6.87
                     exercises.                                 hydrotherapy.                                                                                   text.
97113.............  Aquatic therapy/       SK082               towel, paper (Bounty)  NF                 ....................                  4            0  G1: See preamble            -0.03
                     exercises.                                 (per sheet).                                                                                    text.
97113.............  Aquatic therapy/       SL032               culture media........  NF                 ....................                  0           10  G1: See preamble             0.13
                     exercises.                                                                                                                                 text.
97113.............  Aquatic therapy/       SL033               culture swab system    NF                 ....................                  0            1  G1: See preamble             0.87
                     exercises.                                 (Culturette).                                                                                   text.
97113.............  Aquatic therapy/       SM012               disinfectant spray     NF                 ....................                  5            0  G1: See preamble            -0.14
                     exercises.                                 (Transeptic).                                                                                   text.
97116.............  Gait training therapy  EF028               table, mat, hi-lo, 6   NF                 ....................                 22            0  G1: See preamble            -0.22
                                                                x 8 platform.                                                                                   text.
97116.............  Gait training therapy  EQ144               kit, ambulation......  NF                 ....................                  0           15  G1: See preamble             0.03
                                                                                                                                                                text.
97116.............  Gait training therapy  EQ201               parallel bars,         NF                 ....................                 22           10  G1: See preamble            -0.04
                                                                platform mounted.                                                                               text.
97116.............  Gait training therapy  EQ231               stairs, ambulation     NF                 ....................                 22            5  G1: See preamble            -0.03
                                                                training.                                                                                       text.
97116.............  Gait training therapy  EQ243               treadmill............  NF                 ....................                 22            0  G1: See preamble            -0.29
                                                                                                                                                                text.
97116.............  Gait training therapy  L023A               Physical Therapy Aide  NF                 Other clinical                        0            1  G1: See preamble             0.23
                                                                                                          Activity--specify:                                    text.
                                                                                                          post-treatment
                                                                                                          assistance.
97116.............  Gait training therapy  L023A               Physical Therapy Aide  NF                 Prepare room,                         1            0  G1: See preamble            -0.23
                                                                                                          equipment, supplies.                                  text.
97116.............  Gait training therapy  L023A               Physical Therapy Aide  NF                 Prepare and position                  1            0  G1: See preamble            -0.23
                                                                                                          patient.                                              text.
97116.............  Gait training therapy  L023A               Physical Therapy Aide  NF                 Assist therapist....                  5            0  G1: See preamble            -1.15
                                                                                                                                                                text.

[[Page 34067]]

 
97116.............  Gait training therapy  L023A               Physical Therapy Aide  NF                 Other Clinical                        0          1.5  G1: See preamble             0.35
                                                                                                          Activity--specify:                                    text.
                                                                                                          Verify/Coordinate
                                                                                                          availability of
                                                                                                          resources/equipment.
97116.............  Gait training therapy  L039B               Physical Therapy       NF                 Assist therapist....                2.5          7.5  G1: See preamble             1.95
                                                                Assistant.                                                                                      text.
97116.............  Gait training therapy  L039B               Physical Therapy       NF                 Check dressings &                   1.5          2.5  G1: See preamble             0.39
                                                                Assistant.                                wound/home care                                       text.
                                                                                                          instructions/
                                                                                                          coordinate office
                                                                                                          visits/
                                                                                                          prescriptions.
97116.............  Gait training therapy  L039B               Physical Therapy       NF                 Other Clinical                        0          1.5  G1: See preamble             0.59
                                                                Assistant.                                Activity--specify:                                    text.
                                                                                                          Review/read
                                                                                                          documentation, plan
                                                                                                          of care, treatment
                                                                                                          goals.
97116.............  Gait training therapy  L039B               Physical Therapy       NF                 Other Clinical                        0            1  G1: See preamble             0.39
                                                                Assistant.                                Activity--specify:                                    text.
                                                                                                          Conduct phone calls/
                                                                                                          call in
                                                                                                          prescriptions.
97116.............  Gait training therapy  L039B               Physical Therapy       NF                 Other Clinical                        0          1.5  G1: See preamble             0.59
                                                                Assistant.                                Activity--specify:                                    text.
                                                                                                          Obtain measurements.
97116.............  Gait training therapy  SA048               pack, minimum multi-   NF                 ....................                  0          0.5  G1: See preamble             0.57
                                                                specialty visit.                                                                                text.
97116.............  Gait training therapy  SB022               gloves, non-sterile..  NF                 ....................                  1            0  G1: See preamble            -0.08
                                                                                                                                                                text.
97116.............  Gait training therapy  SJ056               Thera-bands (6in       NF                 ....................                1.5            0  G1: See preamble            -0.90
                                                                width).                                                                                         text.
97116.............  Gait training therapy  SK082               towel, paper (Bounty)  NF                 ....................                  4            0  G1: See preamble            -0.03
                                                                (per sheet).                                                                                    text.
97116.............  Gait training therapy  SM012               disinfectant spray     NF                 ....................                  5            0  G1: See preamble            -0.14
                                                                (Transeptic).                                                                                   text.
97116.............  Gait training therapy  SM021               sanitizing cloth-wipe  NF                 ....................                  0            1  G1: See preamble             0.04
                                                                (patient).                                                                                      text.
97140.............  Manual therapy 1/>     EF029               table, mobolization-   NF                 ....................                 22           15  G1: See preamble            -0.13
                     regions.                                   manipulation                                                                                    text.
                                                                (Lloyd's).
97140.............  Manual therapy 1/>     L023A               Physical Therapy Aide  NF                 Prepare room,                         1            0  G1: See preamble            -0.23
                     regions.                                                                             equipment, supplies.                                  text.
97140.............  Manual therapy 1/>     L023A               Physical Therapy Aide  NF                 Other Clinical                        0          1.5  G1: See preamble             0.35
                     regions.                                                                             Activity--specify:                                    text.
                                                                                                          Verify/Coordinate
                                                                                                          availability of
                                                                                                          resources/equipment.
97140.............  Manual therapy 1/>     L023A               Physical Therapy Aide  NF                 Prepare and position                  1            0  G1: See preamble            -0.23
                     regions.                                                                             patient.                                              text.
97140.............  Manual therapy 1/>     L023A               Physical Therapy Aide  NF                 Other clinical                        0            1  G1: See preamble             0.23
                     regions.                                                                             Activity--specify:                                    text.
                                                                                                          post-treatment
                                                                                                          assistance.
97140.............  Manual therapy 1/>     L023A               Physical Therapy Aide  NF                 Assist therapist....                  5            0  G1: See preamble            -1.15
                     regions.                                                                                                                                   text.

[[Page 34068]]

 
97140.............  Manual therapy 1/>     L039B               Physical Therapy       NF                 Other Clinical                        0            1  G1: See preamble             0.39
                     regions.                                   Assistant.                                Activity--specify:                                    text.
                                                                                                          Conduct phone calls/
                                                                                                          call in
                                                                                                          prescriptions.
97140.............  Manual therapy 1/>     L039B               Physical Therapy       NF                 Other Clinical                        0          1.5  G1: See preamble             0.59
                     regions.                                   Assistant.                                Activity--specify:                                    text.
                                                                                                          Obtain measurements.
97140.............  Manual therapy 1/>     L039B               Physical Therapy       NF                 Other Clinical                        0          1.5  G1: See preamble             0.59
                     regions.                                   Assistant.                                Activity--specify:                                    text.
                                                                                                          Review/read
                                                                                                          documentation, plan
                                                                                                          of care, treatment
                                                                                                          goals.
97140.............  Manual therapy 1/>     L039B               Physical Therapy       NF                 Check dressings &                   1.5          2.5  G1: See preamble             0.39
                     regions.                                   Assistant.                                wound/home care                                       text.
                                                                                                          instructions/
                                                                                                          coordinate office
                                                                                                          visits/
                                                                                                          prescriptions.
97140.............  Manual therapy 1/>     L039B               Physical Therapy       NF                 Assist therapist....                2.5          7.5  G1: See preamble             1.95
                     regions.                                   Assistant.                                                                                      text.
97140.............  Manual therapy 1/>     SA048               pack, minimum multi-   NF                 ....................                  0          0.5  G1: See preamble             0.57
                     regions.                                   specialty visit.                                                                                text.
97140.............  Manual therapy 1/>     SB022               gloves, non-sterile..  NF                 ....................                  1            0  G1: See preamble            -0.08
                     regions.                                                                                                                                   text.
97140.............  Manual therapy 1/>     SK046               lotion, massage,       NF                 ....................                  2          0.5  G1: See preamble            -0.24
                     regions.                                   unscented.                                                                                      text.
97140.............  Manual therapy 1/>     SK082               towel, paper (Bounty)  NF                 ....................                  4            0  G1: See preamble            -0.03
                     regions.                                   (per sheet).                                                                                    text.
97140.............  Manual therapy 1/>     SM012               disinfectant spray     NF                 ....................                  5            0  G1: See preamble            -0.14
                     regions.                                   (Transeptic).                                                                                   text.
97530.............  Therapeutic            EL003               environmental module-- NF                 ....................                 22           12  G1: See preamble            -0.50
                     activities.                                the workshop.                                                                                   text.
97530.............  Therapeutic            EQ219               rehab and testing      NF                 ....................                 22            4  G1: See preamble            -3.20
                     activities.                                system (BTE primus).                                                                            text.
97530.............  Therapeutic            EQ267               work samples, small    NF                 ....................                 22           12  G1: See preamble            -0.06
                     activities.                                tools (Valpar 1).                                                                               text.
97530.............  Therapeutic            L023A               Physical Therapy Aide  NF                 Prepare and position                  1            0  G1: See preamble            -0.23
                     activities.                                                                          patient.                                              text.
97530.............  Therapeutic            L023A               Physical Therapy Aide  NF                 Assist therapist....               3.75            0  G1: See preamble            -0.86
                     activities.                                                                                                                                text.
97530.............  Therapeutic            L023A               Physical Therapy Aide  NF                 Other Clinical                        0          1.5  G1: See preamble             0.35
                     activities.                                                                          Activity--specify:                                    text.
                                                                                                          Verify/Coordinate
                                                                                                          availability of
                                                                                                          resources/equipment.
97530.............  Therapeutic            L023A               Physical Therapy Aide  NF                 Other clinical                        0            1  G1: See preamble             0.23
                     activities.                                                                          Activity--specify:                                    text.
                                                                                                          post-treatment
                                                                                                          assistance.
97530.............  Therapeutic            L023A               Physical Therapy Aide  NF                 Prepare room,                         1          1.5  G1: See preamble             0.12
                     activities.                                                                          equipment, supplies.                                  text.
97530.............  Therapeutic            L039B               Physical Therapy       NF                 Assist therapist....               3.75          7.5  G1: See preamble             1.46
                     activities.                                Assistant.                                                                                      text.

[[Page 34069]]

 
97530.............  Therapeutic            L039B               Physical Therapy       NF                 Other Clinical                        0          1.5  G1: See preamble             0.59
                     activities.                                Assistant.                                Activity--specify:                                    text.
                                                                                                          Review/read
                                                                                                          documentation, plan
                                                                                                          of care, treatment
                                                                                                          goals.
97530.............  Therapeutic            L039B               Physical Therapy       NF                 Check dressings &                   1.5          2.5  G1: See preamble             0.39
                     activities.                                Assistant.                                wound/home care                                       text.
                                                                                                          instructions/
                                                                                                          coordinate office
                                                                                                          visits/
                                                                                                          prescriptions.
97530.............  Therapeutic            SB022               gloves, non-sterile..  NF                 ....................                  1            0  G1: See preamble            -0.08
                     activities.                                                                                                                                text.
97530.............  Therapeutic            SK082               towel, paper (Bounty)  NF                 ....................                  4            0  G1: See preamble            -0.03
                     activities.                                (per sheet).                                                                                    text.
97530.............  Therapeutic            SM012               disinfectant spray     NF                 ....................                  5            0  G1: See preamble            -0.14
                     activities.                                (Transeptic).                                                                                   text.
97533.............  Sensory integration..  EQ224               sensory integration    NF                 ....................                 22           15  G1: See preamble            -0.06
                                                                equip (eg, ball pit,                                                                            text.
                                                                glider, trampoline,
                                                                ramp).
97533.............  Sensory integration..  EQ225               sensory integration    NF                 ....................                 22           15  G1: See preamble            -0.05
                                                                equipment,                                                                                      text.
                                                                suspension system.
97533.............  Sensory integration..  L023A               Physical Therapy Aide  NF                 Obtain vital signs..                  0            1  G1: See preamble             0.23
                                                                                                                                                                text.
97533.............  Sensory integration..  L023A               Physical Therapy Aide  NF                 Other Clinical                        0          1.5  G1: See preamble             0.35
                                                                                                          Activity--specify:                                    text.
                                                                                                          Verify/Coordinate
                                                                                                          availability of
                                                                                                          resources/equipment.
97533.............  Sensory integration..  L023A               Physical Therapy Aide  NF                 Assist therapist....                  0          7.5  G1: See preamble             1.73
                                                                                                                                                                text.
97533.............  Sensory integration..  L023A               Physical Therapy Aide  NF                 Prepare room,                         1          1.5  G1: See preamble             0.12
                                                                                                          equipment, supplies.                                  text.
97533.............  Sensory integration..  L023A               Physical Therapy Aide  NF                 Prepare and position                  1            0  G1: See preamble            -0.23
                                                                                                          patient.                                              text.
97533.............  Sensory integration..  L023A               Physical Therapy Aide  NF                 Other clinical                        0            1  G1: See preamble             0.23
                                                                                                          Activity--specify:                                    text.
                                                                                                          post-treatment
                                                                                                          assistance.
97533.............  Sensory integration..  L023A               Physical Therapy Aide  NF                 Check dressings &                     0          2.5  G1: See preamble             0.58
                                                                                                          wound/home care                                       text.
                                                                                                          instructions/
                                                                                                          coordinate office
                                                                                                          visits/
                                                                                                          prescriptions.
97533.............  Sensory integration..  L039B               Physical Therapy       NF                 Obtain vital signs..                  1            0  G1: See preamble            -0.39
                                                                Assistant.                                                                                      text.
97533.............  Sensory integration..  L039B               Physical Therapy       NF                 Assist therapist....                7.5            0  G1: See preamble            -2.93
                                                                Assistant.                                                                                      text.
97533.............  Sensory integration..  L039B               Physical Therapy       NF                 Check dressings &                   1.5            0  G1: See preamble            -0.59
                                                                Assistant.                                wound/home care                                       text.
                                                                                                          instructions/
                                                                                                          coordinate office
                                                                                                          visits/
                                                                                                          prescriptions.

[[Page 34070]]

 
97533.............  Sensory integration..  L039B               Physical Therapy       NF                 Other Clinical                        0          1.5  G1: See preamble             0.59
                                                                Assistant.                                Activity--specify:                                    text.
                                                                                                          Review/read
                                                                                                          documentation, plan
                                                                                                          of care, treatment
                                                                                                          goals.
97533.............  Sensory integration..  SJ053               swab-pad, alcohol....  NF                 ....................                  0            3  G1: See preamble             0.04
                                                                                                                                                                text.
97533.............  Sensory integration..  SK082               towel, paper (Bounty)  NF                 ....................                  4            0  G1: See preamble            -0.03
                                                                (per sheet).                                                                                    text.
97533.............  Sensory integration..  SM012               disinfectant spray     NF                 ....................                  5            0  G1: See preamble            -0.14
                                                                (Transeptic).                                                                                   text.
97535.............  Self care mngment      EL002               environmental module-- NF                 ....................                 22           12  G1: See preamble            -1.15
                     training.                                  kitchen.                                                                                        text.
97535.............  Self care mngment      EQ143               kit, ADL.............  NF                 ....................                 22           16  G1: See preamble            -0.01
                     training.                                                                                                                                  text.
97535.............  Self care mngment      L023A               Physical Therapy Aide  NF                 Other Clinical                        0          1.5  G1: See preamble             0.35
                     training.                                                                            Activity--specify:                                    text.
                                                                                                          Verify/Coordinate
                                                                                                          availability of
                                                                                                          resources/equipment.
97535.............  Self care mngment      L023A               Physical Therapy Aide  NF                 Prepare room,                         1          1.5  G1: See preamble             0.12
                     training.                                                                            equipment, supplies.                                  text.
97535.............  Self care mngment      L023A               Physical Therapy Aide  NF                 Prepare and position                  1            0  G1: See preamble            -0.23
                     training.                                                                            patient.                                              text.
97535.............  Self care mngment      L023A               Physical Therapy Aide  NF                 Other clinical                        0            1  G1: See preamble             0.23
                     training.                                                                            Activity--specify:                                    text.
                                                                                                          post-treatment
                                                                                                          assistance.
97535.............  Self care mngment      L039B               Physical Therapy       NF                 Check dressings &                   1.5          2.5  G1: See preamble             0.39
                     training.                                  Assistant.                                wound/home care                                       text.
                                                                                                          instructions/
                                                                                                          coordinate office
                                                                                                          visits/
                                                                                                          prescriptions.
97535.............  Self care mngment      L039B               Physical Therapy       NF                 Other Clinical                        0          1.5  G1: See preamble             0.59
                     training.                                  Assistant.                                Activity--specify:                                    text.
                                                                                                          Review/read
                                                                                                          documentation, plan
                                                                                                          of care, treatment
                                                                                                          goals.
97535.............  Self care mngment      SB022               gloves, non-sterile..  NF                 ....................                  1            0  G1: See preamble            -0.08
                     training.                                                                                                                                  text.
97535.............  Self care mngment      SK009               bath soap (one bar     NF                 ....................                  0          0.5  G1: See preamble             0.34
                     training.                                  uou).                                                                                           text.
97535.............  Self care mngment      SK080               toothbrush...........  NF                 ....................                  0            1  G1: See preamble             0.81
                     training.                                                                                                                                  text.
97535.............  Self care mngment      SK081               toothpaste...........  NF                 ....................                  0         0.25  G1: See preamble             0.12
                     training.                                                                                                                                  text.
97535.............  Self care mngment      SK082               towel, paper (Bounty)  NF                 ....................                  4            0  G1: See preamble            -0.03
                     training.                                  (per sheet).                                                                                    text.
97535.............  Self care mngment      SM012               disinfectant spray     NF                 ....................                  5            0  G1: See preamble            -0.14
                     training.                                  (Transeptic).                                                                                   text.

[[Page 34071]]

 
97535.............  Self care mngment      SM013               disinfectant, surface  NF                 ....................                  0            2  G1: See preamble             0.33
                     training.                                  (Envirocide,                                                                                    text.
                                                                Sanizide).
97537.............  Community/work         EL001               environmental module-- NF                 ....................                 22            8  G1: See preamble            -1.01
                     reintegration.                             car.                                                                                            text.
97537.............  Community/work         EQ147               kit, ergonomic         NF                 ....................                 22            8  G1: See preamble            -0.08
                     reintegration.                             (office).                                                                                       text.
97537.............  Community/work         L023A               Physical Therapy Aide  NF                 Prepare room,                         1          1.5  G1: See preamble             0.12
                     reintegration.                                                                       equipment, supplies.                                  text.
97537.............  Community/work         L023A               Physical Therapy Aide  NF                 Other clinical                        0            1  G1: See preamble             0.23
                     reintegration.                                                                       Activity--specify:                                    text.
                                                                                                          post-treatment
                                                                                                          assistance.
97537.............  Community/work         L023A               Physical Therapy Aide  NF                 Prepare and position                  1            0  G1: See preamble            -0.23
                     reintegration.                                                                       patient.                                              text.
97537.............  Community/work         L023A               Physical Therapy Aide  NF                 Other Clinical                        0          1.5  G1: See preamble             0.35
                     reintegration.                                                                       Activity--specify:                                    text.
                                                                                                          Verify/Coordinate
                                                                                                          availability of
                                                                                                          resources/equipment.
97537.............  Community/work         L039B               Physical Therapy       NF                 Check dressings &                   1.5          2.5  G1: See preamble             0.39
                     reintegration.                             Assistant.                                wound/home care                                       text.
                                                                                                          instructions/
                                                                                                          coordinate office
                                                                                                          visits/
                                                                                                          prescriptions.
97537.............  Community/work         L039B               Physical Therapy       NF                 Other Clinical                        0          1.5  G1: See preamble             0.59
                     reintegration.                             Assistant.                                Activity--specify:                                    text.
                                                                                                          Review/read
                                                                                                          documentation, plan
                                                                                                          of care, treatment
                                                                                                          goals.
97537.............  Community/work         SB022               gloves, non-sterile..  NF                 ....................                  1            0  G1: See preamble            -0.08
                     reintegration.                                                                                                                             text.
97537.............  Community/work         SK082               towel, paper (Bounty)  NF                 ....................                  4            0  G1: See preamble            -0.03
                     reintegration.                             (per sheet).                                                                                    text.
97537.............  Community/work         SM012               disinfectant spray     NF                 ....................                  5            0  G1: See preamble            -0.14
                     reintegration.                             (Transeptic).                                                                                   text.
97542.............  Wheelchair mngment     EL002               environmental module-- NF                 ....................                 22            8  G1: See preamble            -1.61
                     training.                                  kitchen.                                                                                        text.
97542.............  Wheelchair mngment     L023A               Physical Therapy Aide  NF                 Prepare room,                         1          1.5  G1: See preamble             0.12
                     training.                                                                            equipment, supplies.                                  text.
97542.............  Wheelchair mngment     L023A               Physical Therapy Aide  NF                 Other clinical                        0            1  G1: See preamble             0.23
                     training.                                                                            Activity--specify:                                    text.
                                                                                                          post-treatment
                                                                                                          assistance.
97542.............  Wheelchair mngment     L023A               Physical Therapy Aide  NF                 Prepare and position                  1            0  G1: See preamble            -0.23
                     training.                                                                            patient.                                              text.
97542.............  Wheelchair mngment     L023A               Physical Therapy Aide  NF                 Assist therapist....               3.75            0  G1: See preamble            -0.86
                     training.                                                                                                                                  text.

[[Page 34072]]

 
97542.............  Wheelchair mngment     L023A               Physical Therapy Aide  NF                 Other Clinical                        0          1.5  G1: See preamble             0.35
                     training.                                                                            Activity--specify:                                    text.
                                                                                                          Verify/Coordinate
                                                                                                          availability of
                                                                                                          resources/equipment.
97542.............  Wheelchair mngment     L039B               Physical Therapy       NF                 Check dressings &                   1.5          2.5  G1: See preamble             0.39
                     training.                                  Assistant.                                wound/home care                                       text.
                                                                                                          instructions/
                                                                                                          coordinate office
                                                                                                          visits/
                                                                                                          prescriptions.
97542.............  Wheelchair mngment     L039B               Physical Therapy       NF                 Other Clinical                        0          1.5  G1: See preamble             0.59
                     training.                                  Assistant.                                Activity--specify:                                    text.
                                                                                                          Review/read
                                                                                                          documentation, plan
                                                                                                          of care, treatment
                                                                                                          goals.
97542.............  Wheelchair mngment     L039B               Physical Therapy       NF                 Assist therapist....               3.75          7.5  G1: See preamble             1.46
                     training.                                  Assistant.                                                                                      text.
97542.............  Wheelchair mngment     SB022               gloves, non-sterile..  NF                 ....................                  1            0  G1: See preamble            -0.08
                     training.                                                                                                                                  text.
97542.............  Wheelchair mngment     SK082               towel, paper (Bounty)  NF                 ....................                  4            0  G1: See preamble            -0.03
                     training.                                  (per sheet).                                                                                    text.
97542.............  Wheelchair mngment     SM012               disinfectant spray     NF                 ....................                  5            0  G1: See preamble            -0.14
                     training.                                  (Transeptic).                                                                                   text.
97760.............  Orthotic mgmt&trainj   EF005               cart-workbench,        NF                 ....................                 27           10  G1: See preamble            -0.03
                     1st enc.                                   orthotic, mobile.                                                                               text.
97760.............  Orthotic mgmt&trainj   EF033               table, treatment, hi-  NF                 ....................                 27           10  G1: See preamble            -0.09
                     1st enc.                                   lo.                                                                                             text.
97760.............  Orthotic mgmt&trainj   EQ219               rehab and testing      NF                 ....................                 27            5  G1: See preamble            -3.91
                     1st enc.                                   system (BTE primus).                                                                            text.
97760.............  Orthotic mgmt&trainj   ER064               water bath,            NF                 ....................                 27           10  G1: See preamble            -0.04
                     1st enc.                                   thermoplastic                                                                                   text.
                                                                softener (20in x
                                                                12in).
97760.............  Orthotic mgmt&trainj   L023A               Physical Therapy Aide  NF                 Assist therapist....                  5            0  G1: See preamble            -1.15
                     1st enc.                                                                                                                                   text.
97760.............  Orthotic mgmt&trainj   L023A               Physical Therapy Aide  NF                 Other Clinical                        0          1.5  G1: See preamble             0.35
                     1st enc.                                                                             Activity--specify:                                    text.
                                                                                                          Verify/Coordinate
                                                                                                          availability of
                                                                                                          resources/equipment.
97760.............  Orthotic mgmt&trainj   L023A               Physical Therapy Aide  NF                 Other clinical                        0            1  G1: See preamble             0.23
                     1st enc.                                                                             Activity--specify:                                    text.
                                                                                                          post-treatment
                                                                                                          assistance.
97760.............  Orthotic mgmt&trainj   L023A               Physical Therapy Aide  NF                 Greet patient,                        2          1.5  G1: See preamble            -0.12
                     1st enc.                                                                             provide gowning,                                      text.
                                                                                                          ensure appropriate
                                                                                                          medical records are
                                                                                                          available.
97760.............  Orthotic mgmt&trainj   L023A               Physical Therapy Aide  NF                 Clean room/equipment                  2            1  G1: See preamble            -0.23
                     1st enc.                                                                             by physician staff.                                   text.

[[Page 34073]]

 
97760.............  Orthotic mgmt&trainj   L023A               Physical Therapy Aide  NF                 Prepare room,                         2          1.5  G1: See preamble            -0.12
                     1st enc.                                                                             equipment, supplies.                                  text.
97760.............  Orthotic mgmt&trainj   L023A               Physical Therapy Aide  NF                 Prepare and position                  2            0  G1: See preamble            -0.46
                     1st enc.                                                                             patient.                                              text.
97760.............  Orthotic mgmt&trainj   L039B               Physical Therapy       NF                 Assist therapist....                2.5          7.5  G1: See preamble             1.95
                     1st enc.                                   Assistant.                                                                                      text.
97760.............  Orthotic mgmt&trainj   L039B               Physical Therapy       NF                 Obtain vital signs..                  2            1  G1: See preamble            -0.39
                     1st enc.                                   Assistant.                                                                                      text.
97760.............  Orthotic mgmt&trainj   L039B               Physical Therapy       NF                 Other Clinical                        0          1.5  G1: See preamble             0.59
                     1st enc.                                   Assistant.                                Activity--specify:                                    text.
                                                                                                          Review/read
                                                                                                          documentation, plan
                                                                                                          of care, treatment
                                                                                                          goals.
97760.............  Orthotic mgmt&trainj   L039B               Physical Therapy       NF                 Check dressings &                     2          2.5  G1: See preamble             0.20
                     1st enc.                                   Assistant.                                wound/home care                                       text.
                                                                                                          instructions/
                                                                                                          coordinate office
                                                                                                          visits/
                                                                                                          prescriptions.
97760.............  Orthotic mgmt&trainj   L039B               Physical Therapy       NF                 Conduct phone calls/                  2            0  G1: See preamble            -0.78
                     1st enc.                                   Assistant.                                call in                                               text.
                                                                                                          prescriptions.
97760.............  Orthotic mgmt&trainj   SH035               fluori-methane (cold   NF                 ....................                  5          7.5  G1: See preamble             1.06
                     1st enc.                                   spray).                                                                                         text.
97760.............  Orthotic mgmt&trainj   SK082               towel, paper (Bounty)  NF                 ....................                  4            0  G1: See preamble            -0.03
                     1st enc.                                   (per sheet).                                                                                    text.
97760.............  Orthotic mgmt&trainj   SK087               water, distilled.....  NF                 ....................                 85          128  G1: See preamble             0.56
                     1st enc.                                                                                                                                   text.
97760.............  Orthotic mgmt&trainj   SM012               disinfectant spray     NF                 ....................                  5            0  G1: See preamble            -0.14
                     1st enc.                                   (Transeptic).                                                                                   text.
97761.............  Prosthetic trainj 1st  EF028               table, mat, hi-lo, 6   NF                 ....................                 27            5  G1: See preamble            -0.22
                     enc.                                       x 8 platform.                                                                                   text.
97761.............  Prosthetic trainj 1st  EQ069               balance board........  NF                 ....................                 27            4  G1: See preamble            -0.03
                     enc.                                                                                                                                       text.
97761.............  Prosthetic trainj 1st  EQ201               parallel bars,         NF                 ....................                 27            4  G1: See preamble            -0.09
                     enc.                                       platform mounted.                                                                               text.
97761.............  Prosthetic trainj 1st  EQ231               stairs, ambulation     NF                 ....................                 27            3  G1: See preamble            -0.04
                     enc.                                       training.                                                                                       text.
97761.............  Prosthetic trainj 1st  EQ243               treadmill............  NF                 ....................                 27            3  G1: See preamble            -0.32
                     enc.                                                                                                                                       text.
97761.............  Prosthetic trainj 1st  L023A               Physical Therapy Aide  NF                 Greet patient,                        2          1.5  G1: See preamble            -0.12
                     enc.                                                                                 provide gowning,                                      text.
                                                                                                          ensure appropriate
                                                                                                          medical records are
                                                                                                          available.
97761.............  Prosthetic trainj 1st  L023A               Physical Therapy Aide  NF                 Prepare room,                         2            0  G1: See preamble            -0.46
                     enc.                                                                                 equipment, supplies.                                  text.
97761.............  Prosthetic trainj 1st  L023A               Physical Therapy Aide  NF                 Prepare and position                  2            0  G1: See preamble            -0.46
                     enc.                                                                                 patient.                                              text.
97761.............  Prosthetic trainj 1st  L023A               Physical Therapy Aide  NF                 Other Clinical                        0          1.5  G1: See preamble             0.35
                     enc.                                                                                 Activity--specify:                                    text.
                                                                                                          Verify/Coordinate
                                                                                                          availability of
                                                                                                          resources/equipment.

[[Page 34074]]

 
97761.............  Prosthetic trainj 1st  L023A               Physical Therapy Aide  NF                 Other clinical                        0            1  G1: See preamble             0.23
                     enc.                                                                                 Activity--specify:                                    text.
                                                                                                          post-treatment
                                                                                                          assistance.
97761.............  Prosthetic trainj 1st  L023A               Physical Therapy Aide  NF                 Assist therapist....                 10            0  G1: See preamble            -2.30
                     enc.                                                                                                                                       text.
97761.............  Prosthetic trainj 1st  L023A               Physical Therapy Aide  NF                 Clean room/equipment                  2            1  G1: See preamble            -0.23
                     enc.                                                                                 by physician staff.                                   text.
97761.............  Prosthetic trainj 1st  L039B               Physical Therapy       NF                 Other Clinical                        0          1.5  G1: See preamble             0.59
                     enc.                                       Assistant.                                Activity--specify:                                    text.
                                                                                                          Obtain measurements.
97761.............  Prosthetic trainj 1st  L039B               Physical Therapy       NF                 Obtain vital signs..                  2            1  G1: See preamble            -0.39
                     enc.                                       Assistant.                                                                                      text.
97761.............  Prosthetic trainj 1st  L039B               Physical Therapy       NF                 Assist therapist....                  5          7.5  G1: See preamble             0.98
                     enc.                                       Assistant.                                                                                      text.
97761.............  Prosthetic trainj 1st  L039B               Physical Therapy       NF                 Other Clinical                        0          1.5  G1: See preamble             0.59
                     enc.                                       Assistant.                                Activity--specify:                                    text.
                                                                                                          Review/read
                                                                                                          documentation, plan
                                                                                                          of care, treatment
                                                                                                          goals.
97761.............  Prosthetic trainj 1st  L039B               Physical Therapy       NF                 Other Clinical                        0            1  G1: See preamble             0.39
                     enc.                                       Assistant.                                Activity--specify:                                    text.
                                                                                                          Conduct phone calls/
                                                                                                          call in
                                                                                                          prescriptions.
97761.............  Prosthetic trainj 1st  L039B               Physical Therapy       NF                 Conduct phone calls/                  2            0  G1: See preamble            -0.78
                     enc.                                       Assistant.                                call in                                               text.
                                                                                                          prescriptions.
97761.............  Prosthetic trainj 1st  L039B               Physical Therapy       NF                 Check dressings &                     2          2.5  G1: See preamble             0.20
                     enc.                                       Assistant.                                wound/home care                                       text.
                                                                                                          instructions/
                                                                                                          coordinate office
                                                                                                          visits/
                                                                                                          prescriptions.
97761.............  Prosthetic trainj 1st  SB026               gown, patient........  NF                 ....................               0.75            0  G1: See preamble            -0.40
                     enc.                                                                                                                                       text.
97761.............  Prosthetic trainj 1st  SG027               cast, stockinette 4in  NF                 ....................                0.3            1  G1: See preamble             0.32
                     enc.                                                                                                                                       text.
97761.............  Prosthetic trainj 1st  SG058               moleskin 9in width...  NF                 ....................                0.2         0.33  G1: See preamble             0.45
                     enc.                                                                                                                                       text.
97761.............  Prosthetic trainj 1st  SK082               towel, paper (Bounty)  NF                 ....................                  4            0  G1: See preamble            -0.03
                     enc.                                       (per sheet).                                                                                    text.
97761.............  Prosthetic trainj 1st  SM012               disinfectant spray     NF                 ....................                  5            0  G1: See preamble            -0.14
                     enc.                                       (Transeptic).                                                                                   text.
977X1.............  Orthc/prostc mgmt      EF005               cart-workbench,        NF                 ....................                 27           10  G1: See preamble            -0.03
                     sbsq enc.                                  orthotic, mobile.                                                                               text.
977X1.............  Orthc/prostc mgmt      EF033               table, treatment, hi-  NF                 ....................                 27           16  G1: See preamble            -0.06
                     sbsq enc.                                  lo.                                                                                             text.
977X1.............  Orthc/prostc mgmt      ER064               water bath,            NF                 ....................                 27           10  G1: See preamble            -0.04
                     sbsq enc.                                  thermoplastic                                                                                   text.
                                                                softener (20in x
                                                                12in).
977X1.............  Orthc/prostc mgmt      L023A               Physical Therapy Aide  NF                 Other clinical                        0            1  G1: See preamble             0.23
                     sbsq enc.                                                                            Activity--specify:                                    text.
                                                                                                          post-treatment
                                                                                                          assistance.

[[Page 34075]]

 
977X1.............  Orthc/prostc mgmt      L023A               Physical Therapy Aide  NF                 Greet patient,                        2          1.5  G1: See preamble            -0.12
                     sbsq enc.                                                                            provide gowning,                                      text.
                                                                                                          ensure appropriate
                                                                                                          medical records are
                                                                                                          available.
977X1.............  Orthc/prostc mgmt      L023A               Physical Therapy Aide  NF                 Clean room/equipment                  2            1  G1: See preamble            -0.23
                     sbsq enc.                                                                            by physician staff.                                   text.
977X1.............  Orthc/prostc mgmt      L023A               Physical Therapy Aide  NF                 Other Clinical                        0          1.5  G1: See preamble             0.35
                     sbsq enc.                                                                            Activity--specify:                                    text.
                                                                                                          Verify/Coordinate
                                                                                                          availability of
                                                                                                          resources/equipment.
977X1.............  Orthc/prostc mgmt      L023A               Physical Therapy Aide  NF                 Assist therapist....                  5            0  G1: See preamble            -1.15
                     sbsq enc.                                                                                                                                  text.
977X1.............  Orthc/prostc mgmt      L023A               Physical Therapy Aide  NF                 Prepare room,                         2          1.5  G1: See preamble            -0.12
                     sbsq enc.                                                                            equipment, supplies.                                  text.
977X1.............  Orthc/prostc mgmt      L023A               Physical Therapy Aide  NF                 Prepare and position                  2            0  G1: See preamble            -0.46
                     sbsq enc.                                                                            patient.                                              text.
977X1.............  Orthc/prostc mgmt      L039B               Physical Therapy       NF                 Other Clinical                        0          1.5  G1: See preamble             0.59
                     sbsq enc.                                  Assistant.                                Activity--specify:                                    text.
                                                                                                          Review/read
                                                                                                          documentation, plan
                                                                                                          of care, treatment
                                                                                                          goals.
977X1.............  Orthc/prostc mgmt      L039B               Physical Therapy       NF                 Obtain vital signs..                  2            1  G1: See preamble            -0.39
                     sbsq enc.                                  Assistant.                                                                                      text.
977X1.............  Orthc/prostc mgmt      L039B               Physical Therapy       NF                 Check dressings &                     2          2.5  G1: See preamble             0.20
                     sbsq enc.                                  Assistant.                                wound/home care                                       text.
                                                                                                          instructions/
                                                                                                          coordinate office
                                                                                                          visits/
                                                                                                          prescriptions.
977X1.............  Orthc/prostc mgmt      L039B               Physical Therapy       NF                 Assist therapist....                2.5          7.5  G1: See preamble             1.95
                     sbsq enc.                                  Assistant.                                                                                      text.
977X1.............  Orthc/prostc mgmt      SA048               pack, minimum multi-   NF                 ....................                0.5            1  G1: See preamble             0.57
                     sbsq enc.                                  specialty visit.                                                                                text.
977X1.............  Orthc/prostc mgmt      SG027               cast, stockinette 4in  NF                 ....................                0.4          0.5  G1: See preamble             0.05
                     sbsq enc.                                                                                                                                  text.
977X1.............  Orthc/prostc mgmt      SG058               moleskin 9in width...  NF                 ....................                0.7            1  G1: See preamble             1.04
                     sbsq enc.                                                                                                                                  text.
977X1.............  Orthc/prostc mgmt      SG060               outrigger line.......  NF                 ....................                  7           50  G1: See preamble             3.91
                     sbsq enc.                                                                                                                                  text.
977X1.............  Orthc/prostc mgmt      SG061               outrigger post.......  NF                 ....................                  3            4  G1: See preamble             0.40
                     sbsq enc.                                                                                                                                  text.
977X1.............  Orthc/prostc mgmt      SH035               fluori-methane (cold   NF                 ....................                  5          7.5  G1: See preamble             1.06
                     sbsq enc.                                  spray).                                                                                         text.
977X1.............  Orthc/prostc mgmt      SJ047               splint straps 1in....  NF                 ....................                0.7            1  G1: See preamble             0.39
                     sbsq enc.                                                                                                                                  text.
977X1.............  Orthc/prostc mgmt      SJ048               splint straps 2in....  NF                 ....................                1.3            2  G1: See preamble             1.07
                     sbsq enc.                                                                                                                                  text.
977X1.............  Orthc/prostc mgmt      SK071               rubber bands, non-     NF                 ....................                  4            6  G1: See preamble             0.04
                     sbsq enc.                                  sterile.                                                                                        text.

[[Page 34076]]

 
977X1.............  Orthc/prostc mgmt      SK082               towel, paper (Bounty)  NF                 ....................                  4            0  G1: See preamble            -0.03
                     sbsq enc.                                  (per sheet).                                                                                    text.
977X1.............  Orthc/prostc mgmt      SK087               water, distilled.....  NF                 ....................                 85          128  G1: See preamble             0.56
                     sbsq enc.                                                                                                                                  text.
977X1.............  Orthc/prostc mgmt      SM012               disinfectant spray     NF                 ....................                  5            0  G1: See preamble            -0.14
                     sbsq enc.                                  (Transeptic).                                                                                   text.
97X11.............  Ther ivntj w/focus     ED038               notebook (Dell         NF                 ....................                 60            0  G1: See preamble            -0.52
                     cog funcj.                                 Latitute D600).                                                                                 text.
97X11.............  Ther ivntj w/focus     EF027               table, instrument,     NF                 ....................                 60            5  G1: See preamble            -0.08
                     cog funcj.                                 mobile.                                                                                         text.
97X11.............  Ther ivntj w/focus     L023A               Physical Therapy Aide  NF                 Assist physician in                   0           12  G1: See preamble             2.76
                     cog funcj.                                                                           performing                                            text.
                                                                                                          procedure.
97X11.............  Ther ivntj w/focus     SK057               paper, laser printing  NF                 ....................                 10            0  G1: See preamble            -0.05
                     cog funcj.                                 (each sheet).                                                                                   text.
994X1.............  1st psyc collab care   EF042               One Couch and Two      F                  ....................                 38            0  G1: See preamble            -0.15
                     mgmt.                                      Chairs.                                                                                         text.
994X1.............  1st psyc collab care   L057B               Behavioral Health      F                  Other clinical                       85            0  G1: See preamble           -48.45
                     mgmt.                                      Care Manager.                             Activity--specify:                                    text.
                                                                                                          994X1 and 994X3.
994X2.............  Sbsq psyc collab care  EF042               One Couch and Two      F                  ....................                 27            0  G1: See preamble            -0.11
                     mgmt.                                      Chairs.                                                                                         text.
994X2.............  Sbsq psyc collab care  L057B               Behavioral Health      F                  Other clinical                       60            0  G1: See preamble           -34.20
                     mgmt.                                      Care Manager.                             Activity--specify:                                    text.
                                                                                                          994X2.
994X3.............  1st/sbsq psyc collab   EF042               One Couch and Two      F                  ....................               13.5            0  G1: See preamble            -0.05
                     care.                                      Chairs.                                                                                         text.
994X3.............  1st/sbsq psyc collab   L057B               Behavioral Health      F                  Other clinical                       30            0  G1: See preamble           -17.10
                     care.                                      Care Manager.                             Activity--specify:                                    text.
                                                                                                          994X1 and 994X3.
99XX5.............  Care mgmt svc bhvl     L057B               Behavioral Health      F                  Other clinical                       20            0  G1: See preamble           -11.40
                     hlth cond.                                 Care Manager.                             Activity--specify:                                    text.
                                                                                                          G0507.
G0507.............  Care manage serv       L057B               Behavioral Health      F                  Other clinical                       20            0  G1: See preamble           -11.40
                     minimum 20.                                Care Manager.                             Activity--specify:                                    text.
                                                                                                          G0507.
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


  Table 12--CY 2018 Proposed Codes With Direct PE Input Recommendations
                           Without Refinement
------------------------------------------------------------------------
            HCPCS code                           Description
------------------------------------------------------------------------
007X1.............................  Anes upr gi ndsc px nos.
007X2.............................  Anes upr gi ndsc px ercp.
008X1.............................  Anes lwr intst ndsc nos.
008X2.............................  Anes lwr intst scr colsc.
008X3.............................  Anes upr lwr gi hdsc px.
10040.............................  Acne surgery.
15734.............................  Muscle-skin graft trunk.
15736.............................  Muscle-skin graft arm.
15738.............................  Muscle-skin graft leg.
157X2.............................  Musc myoq/fscq flp h&n pedcl.
19303.............................  Mast simple complete.
31255.............................  Nsl/sins ndsc w/tot ethmdct.
31256.............................  Exploration maxillary sinus.
31267.............................  Endoscopy maxillary sinus.
31276.............................  Nsl/sins ndsc frnt tiss rmvl.
31287.............................  Nasal/sinus endoscopy surg.
31288.............................  Nasal/sinus endoscopy surg.
31600.............................  Incision of windpipe.
31601.............................  Incision of windpipe.
31603.............................  Incision of windpipe.
31610.............................  Incision of windpipe.
31646.............................  Brnchsc w/ther aspir sbsq.
31XX1.............................  Nsl/sins ndsc w/artery lig.
31XX2.............................  Nsl/sins ndsc total.
31XX3.............................  Nsl/sins ndsc tot w/sphendt.
31XX4.............................  Nsl/sins ndsc sphn tiss rmvl.
34812.............................  Opn fem art expos.
34820.............................  Opn ilac art expos.
34833.............................  Opn ilac art expos cndt crtj.
34834.............................  Opn brach art expos.
34X01.............................  Evasc rpr a-ao ndgft.
34X02.............................  Evasc rpr a-ao ndgft rpt.
34X03.............................  Evasc rpr a-unilac ndgft.
34X04.............................  Evasc rpr a-unilac ndgft rpt.
34X05.............................  Evac rpr a-biiliac ndgft.
34X06.............................  Evasc rpr a-biiliac rpt.
34X07.............................  Evasc rpr ilio-iliac ndgft.
34X08.............................  Evasc rpr ilio-iliac rpt.
34X09.............................  Plmt xtn prosth evasc rpr.
34X10.............................  Dlyd plmt xtn prosth 1st vsl.
34X11.............................  Dlyd plmt xtn prosth ea addl.
34X12.............................  Tcat dlvr enhncd fixj dev.

[[Page 34077]]

 
34X13.............................  Perq access & clsr fem art.
34X15.............................  Opn fem art expos cndt crtj.
34X19.............................  Opn ax/subcla art expos.
34X20.............................  Opn ax/subcla art expos cndt.
36218.............................  Place catheter in artery.
364X4.............................  Endoven ther chem adhes sbsq.
36514.............................  Apheresis plasma.
36516.............................  Apheresis immunoads slctv.
36522.............................  Photopheresis.
36556.............................  Insert non-tunnel cv cath.
3857X.............................  Laps pelvic lymphadec.
43107.............................  Removal of esophagus.
43112.............................  Esphg tot w/thrcm.
43117.............................  Partial removal of esophagus.
432X5.............................  Esphg tot w/laps moblj.
432X6.............................  Esphg dstl \2/3\ w/laps moblj.
432X7.............................  Esphg tot thrsc moblj.
51798.............................  Us urine capacity measure.
52601.............................  Prostatectomy (turp).
57240.............................  Anterior colporrhaphy.
57250.............................  Repair rectum & vagina.
57260.............................  Cmbn ant pst colprhy.
57265.............................  Cmbn ap colprhy w/ntrcl rpr.
64418.............................  N block inj suprascapular.
64553.............................  Implant neuroelectrodes.
64555.............................  Implant neuroelectrodes.
64910.............................  Nerve repair w/allograft.
64911.............................  Neurorraphy w/vein autograft.
64X91.............................  Nrv rpr w/nrv algrft 1st.
70490.............................  Ct soft tissue neck w/o dye.
70491.............................  Ct soft tissue neck w/dye.
70492.............................  Ct sft tsue nck w/o & w/dye.
710X1.............................  X-ray exam chest 1 view.
710X2.............................  X-ray exam chest 2 views.
710X3.............................  X-ray exam chest 3 views.
710X4.............................  X-ray exam chest 4+ views.
71100.............................  X-ray exam ribs uni 2 views.
71101.............................  X-ray exam unilat ribs/chest.
71110.............................  X-ray exam ribs bil 3 views.
71111.............................  X-ray exam ribs/chest4/> vws.
73100.............................  X-ray exam of wrist.
73110.............................  X-ray exam of wrist.
73120.............................  X-ray exam of hand.
73130.............................  X-ray exam of hand.
73140.............................  X-ray exam of finger(s).
74022.............................  X-ray exam series abdomen.
740X1.............................  X-ray exam abdomen 1 view.
740X2.............................  X-ray exam abdomen 2 views.
740X3.............................  X-ray exam abdomen 3+ views.
76510.............................  Ophth us b & quant a.
76511.............................  Ophth us quant a only.
76512.............................  Ophth us b w/non-quant a.
76516.............................  Echo exam of eye.
76519.............................  Echo exam of eye.
76882.............................  Us xtr non-vasc lmtd.
88334.............................  Intraop cyto path consult 2.
92136.............................  Ophthalmic biometry.
93293.............................  Pm phone r-strip device eval.
93296.............................  Pm/icd remote tech serv.
93299.............................  Icm/ilr remote tech serv.
93306.............................  Tte w/doppler complete.
93307.............................  Tte w/o doppler complete.
93308.............................  Tte f-up or lmtd.
95250.............................  Glucose monitoring cont.
95930.............................  Visual ep test cns w/i&r.
96401.............................  Chemo anti-neopl sq/im.
96402.............................  Chemo hormon antineopl sq/im.
96409.............................  Chemo iv push sngl drug.
96411.............................  Chemo iv push addl drug.
96567.............................  Pdt dstr prmlg les skn.
993X1.............................  Pt/caregiver trainj home inr.
993X2.............................  Anticoag mgmt pt warfarin.
99XX3.............................  Assmt & care pln pt cog imp.
GXXX1.............................  Cognitive skills development.
------------------------------------------------------------------------


                   Table 13--CY 2018 Proposed Rule--Invoices Received for New Direct PE Inputs
----------------------------------------------------------------------------------------------------------------
                                                                                                  Estimated non-
                                                                                                     facility
                                                                                                      allowed
                            CMS code                               Average price     Number of     services for
                                                                                     invoices       HCPCS codes
                                                                                                    using this
                                                                                                       item
----------------------------------------------------------------------------------------------------------------
EQ383...........................................................          790.00               1          39,006
SD322...........................................................           25.00               1           3,435
EQ384...........................................................        4,760.00               1          39,006
EQ385...........................................................        9,034.00               1          39,006
SD323...........................................................        1,495.00               1             387
SD324...........................................................        3,195.00               2            1550
SA125...........................................................           40.00               2            1550
SD328...........................................................          353.64               1              41
SD325...........................................................           39.90               1               4
SA126...........................................................        2,850.00               3               4
EQ386...........................................................       16,146.00               1               4
SA124...........................................................            2.35               2         421,539
SJ092...........................................................            8.44             209       9,931,981
SJ093...........................................................            0.19               5       9,931,981
SB054...........................................................            9.99               1         387,359
----------------------------------------------------------------------------------------------------------------


                                    Table 14--CY 2018 Proposed Rule--Invoices Received for Existing Direct PE Inputs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                          Estimated non-
                                                                                                                                             facility
                                                                                                                                              allowed
         CPT/HCPCS codes                Item name           CMS code       Current price   Updated price  Percent change     Number of     services for
                                                                                                                             invoices       HCPCS codes
                                                                                                                                            using this
                                                                                                                                               item
--------------------------------------------------------------------------------------------------------------------------------------------------------
17000, 17003, 17004, 46607,        LMX 4% anesthetic    SH092                       1.60            0.78             -51               1      23,584,412
 96567, 96X73, 96X74.               cream.
20982, 32998, 50592..............  probe,               SD109                     353.64         2233.00             531               1           2,972
                                    radiofrequency, 3
                                    array
                                    (StarBurstSDE).

[[Page 34078]]

 
30140, 30901, 30903, 30905,        Atomizer tips        SL464                       0.00            2.66  ..............               1         625,876
 30906, 31231, 31237, 31238,        (disposable).
 43197, 43198.
36514............................  tubing set, plasma   SC085                     173.33          273.66              58               1           1,237
                                    exchange.
36514, 36516.....................  ACD-A anticoagulant  SJ071                       6.58            7.10               8               1           2,517
none (formerly in deleted code     kit, apheresis       SA072                     140.00          243.33              74               1              22
 36515).                            treatment.
36522............................  kit, photopheresis   SA024                     858.00         1598.00              86               1              25
                                    procedure.
36522, 96567, 96910, 96912,        goggles, uv-         SJ027                       2.30             4.1              78               1         697,047
 96913, 96920, 96921, 96922,        blocking.
 96X73, 96X74.
88360, 88361.....................  Antibody Estrogen    SL493                      14.00           14.47               3               3         209,384
                                    Receptor
                                    monoclonal.
95004, 95017, 95018..............  negative control,    SH101                       5.08            5.17               2               2      10,036,050
                                    allergy test.
95004, 95017, 95018..............  positive control,    SH102                      17.28           26.12              51               6      10,036,050
                                    allergy test.
95250............................  sensor, glucose      SD114                      29.50           53.08              80              19          26,205
                                    monitoring
                                    (interstitial).
95250............................  glucose continuous   EQ125                    2465.00         1170.54             -53               5          26,205
                                    monitoring system.
993X1, G0249.....................  test strip, INR....  SJ055                      21.88            5.66             -74               2       1,265,540
--------------------------------------------------------------------------------------------------------------------------------------------------------

I. Evaluation & Management (E/M) Guidelines and Care Management 
Services

    In recent years, we have sought to recognize significant changes in 
health care practice, especially innovations in the active management 
and ongoing care of chronically ill patients. We have been engaged in 
an ongoing incremental effort to identify gaps in appropriate coding 
and payment for care management/coordination, cognitive services and 
primary care within the PFS. This has included working with the CPT 
Editorial Panel (CPT) to develop and value (or revalue) the following 
service codes:
     Transitional care management (TCM) services (2013).
     Chronic care management services (CCM) (2015, 2017).
     Behavioral health integration (BHI) services (2017).
     Assessment/care planning services for cognitive impairment 
(2017).
     Prolonged E/M services without direct patient contact 
(2017).
    In response to public feedback regarding the initial implementation 
of TCM and CCM, in the CY 2017 PFS final rule (81 FR 80225 through 
80256), we finalized significant administrative burden reduction for 
CCM and focused on limiting as much as possible the ways in which 
Medicare's rules differed from the CPT guidance that generally applies 
for all payers. We also worked with the CPT Editorial Panel and other 
stakeholders to develop coding and improve payment accuracy for BHI, 
cognitive impairment assessment/management, and prolonged services. In 
the CY 2017 PFS final rule (81 FR 80255), we also reiterated our 
commitment to addressing disparities for individuals with disabilities 
and advancing health equity, and noted that we will continue to explore 
improvements in payment accuracy for services furnished to individuals 
with disabilities. We look forward to continued work with stakeholders 
to ensure that the coding and valuation of these services accurately 
reflects the resource costs involved in furnishing these services. We 
are soliciting public comments on ways we might further reduce 
administrative burden for these and similar services under the PFS.
1. E/M Guidelines
a. Background
    Most physicians and other billing practitioners bill patient visits 
to the PFS under a relatively generic set of codes that distinguish 
level of complexity, site of care, and in some cases between new or 
established patients. These codes are called Evaluation and Management 
(E/M) visit codes. For example, there are generally three levels of 
hospital and nursing facility inpatient E/M visit codes, and five 
levels of office or hospital outpatient E/M visit codes, that vary 
based on complexity. The latter also distinguish whether or not the 
patient is new to the billing practitioner.
    Billing practitioners must maintain information in the medical 
record to document that they have reported the appropriate level of E/M 
visit code. CMS maintains guidelines that specify the kind of 
information that is required to support Medicare payment for each 
level. According to these documentation guidelines, there are three key 
components to selecting the appropriate level:
     History of Present Illness (HPI or History);
     Physical Examination (Exam); and
     Medical Decision Making (MDM).
    There are two versions of the documentation guidelines, commonly 
referenced based on the year of their

[[Page 34079]]

release (the ``1995'' and ``1997'' guidelines), available under 
downloads on the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html. The most 
substantial differences between the two sets of guidelines pertain to 
requirements for the physical exam. The two versions have a slight 
difference in requirements for documenting the history, and no 
difference in requirements for MDM. In documenting a given E/M service, 
practitioners must use one version of the guidelines or the other, with 
one exception related to extended histories (see the Evaluation and 
Management Services guide available on the CMS Web site at https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/eval-mgmt-serv-guide-ICN006764.pdf). These 
guidelines are very similar to guidelines within the CPT codebook for 
E/M visits. We provide an example of how the guidelines distinguish 
between level 2 and level 3 visits in Table 15.
    Stakeholders have long maintained that both the 1995 and 1997 
guidelines are administratively burdensome and outdated with respect to 
the practice of medicine, stating that they are too complex, ambiguous, 
and that they fail to distinguish meaningful differences among code 
levels. In general, we agree that there may be unnecessary burden with 
these guidelines and that they are potentially outdated, and believe 
this is especially true for the requirements for the history and the 
physical exam. The guidelines have not been updated to account for 
significant changes in technology, especially electronic health record 
(EHR) use, which presents challenges for data and program integrity and 
potential upcoding given the frequently automated selection of code 
level.
    While CMS conducts few audits on E/M visits relative to the volume 
of PFS services they comprise, we have repeatedly heard from 
practitioners that compliance with the guidelines is a source of 
significant audit vulnerability and administrative burden. Our prior 
attempts to revise the guidelines met with a lack of stakeholder 
consensus and support, which contributed to the current policy that 
allows practitioners to use either the 1995 guidelines or 1997 
guidelines, resulting in further complexity in determining or selecting 
the applicable requirements.
b. E/M Guidelines Public Comment Solicitation
    We continue to agree with stakeholders that the E/M documentation 
guidelines should be substantially revised. We believe that a 
comprehensive reform of E/M documentation guidelines would require a 
multi-year, collaborative effort among stakeholders. We believe that 
revised guidelines could both reduce clinical burden and improve 
documentation in a way that would be more effective in clinical 
workflows and care coordination. We also think updated E/M guidelines 
coupled with technological advancements in voice recognition, natural 
language processing and user-centered design of EHRs could improve 
documentation for patient care while also meeting requirements for 
billing and population health management. We recognize that achieving 
the goal of reduced clinician burden and improved, meaningful 
documentation for patient care will require both updated E/M 
guidelines, as well as changes in technology, clinician documentation 
practices and workflow. We are seeking input from a broad array of 
stakeholders, including patient advocates, on the specific changes we 
should undertake to reform the guidelines, reduce the associated 
burden, and better align E/M coding and documentation with the current 
practice of medicine. We are specifically seeking comment on how we 
might focus on initial changes to the guidelines for the history and 
physical exam because we believe documentation for these elements may 
be more significantly outdated, and that differences in MDM are likely 
the most important factors in distinctions between visits of different 
levels. We are also specifically seeking comment on whether it would be 
appropriate to remove our documentation requirements for the history 
and physical exam for all E/M visits at all levels. We believe medical 
decision-making and time are the more significant factors in 
distinguishing visit levels, and that the need for extended histories 
and exams is being replaced by population-based screening and 
intervention, at least for some specialties. In addition, an increase 
in the utilization of EHRs, and to some extent, shared health 
information via EHRs, may have changed the character of extended 
patient histories since the guidelines were established. As long as a 
history and physical exam are documented and generally consistent with 
complexity of MDM, there may no longer be a need for us to maintain 
such detailed specifications for what must be performed and documented 
for the history and physical exam (for example, which and how many body 
systems are involved). We are seeking comment on whether clinicians and 
other stakeholders believe removing the documentation requirements for 
the history and physical exam would be a good approach.
    While we believe MDM guidelines may also need to be updated, we 
believe in the nearer term it may be possible to eliminate the current 
focus on details of history and physical exam, and allow MDM and/or 
time to serve as the key determinant of E/M visit level. We are seeking 
public comment on this approach. We are also seeking comment on how 
such reforms may differentially affect physicians and practitioners of 
different specialties, including primary care clinicians, and how we 
could or should account for such effects as we examine this issue. We 
note, however, that there may still be clinical or legal reasons for 
individual practitioners to document an extended history or physical 
exam (for example, where there are negative findings for certain body 
systems in support of differential diagnosis). We are additionally 
seeking comment on whether CMS should leave it largely to the 
discretion of individual practitioners to what degree they should 
perform and document the history and physical exam. We also welcome 
comments on specific ideas that stakeholders may have on how to update 
MDM guidelines to foster appropriate documentation for patient care 
commensurate with the level of patient complexity, while avoiding 
burdensome documentation requirements and/or inappropriate upcoding.
    We note that through letters, meetings, public comment letters in 
past rulemaking cycles, and other avenues, we have heard from many 
stakeholders that the E/M code set itself is outdated and needs to be 
revised. For example, some stakeholders recommend an extensive research 
effort to revise and revalue E/M services, especially physician work 
inputs (see 81 FR 46200). In prior rulemaking cycles, we acknowledged 
the limitations of the current E/M code set and agree that the 
structure of the underlying code set and its valuation relative to 
other PFS services are also important issues that we expect to continue 
to explore, though we are immediately focused on revision of the 
current E/M guidelines in order to reduce unnecessary administrative 
burden.
2. Care Management Public Comment Solicitation
    We continue to be interested in the ongoing work of the medical 
community and other stakeholders to refine the set of codes used to 
describe care

[[Page 34080]]

management services. In section II.H., we are proposing to adopt CPT 
codes for CY 2018 to replace the G-codes we established for several of 
the care management services finalized last year. We are committed to 
continued work with stakeholders on necessary refinements to the code 
set, especially describing the professional work involved in caring for 
complex patients in other clinical contexts. We are seeking comment on 
ways we might further reduce burden on reporting practitioners for care 
management services, including through stronger alignment between CMS 
requirements and CPT guidance for existing and potential new codes.

     Table 15--Key Component Documentation Requirements for Level 2 vs 3 Evaluation & Management (E/M) Visit
----------------------------------------------------------------------------------------------------------------
     Key component [dagger]         Level 2 (1995)      Level 3 (1995)      Level 2 (1997)      Level 3 (1997)
----------------------------------------------------------------------------------------------------------------
History (History of Present       Review of Systems   Problem Pertinent   No change from      No change from
 Illness or HPI).                  (ROS) n/a.          ROS: inquires       1995.               1995.
                                                       about the system
                                                       directly related
                                                       to the problem(s)
                                                       identified in the
                                                       HPI.
Physical Examination (Exam).....  A limited           A limited           General multi-      General multi-
                                   examination of      examination of      system exam:        system exam:
                                   the affected body   the affected body   Performance and     Performance and
                                   area or organ       area or organ       documentation of    documentation of
                                   system.             system and other    one to five         at least six
                                                       symptomatic or      elements in one     elements in one
                                                       related organ       or more organ       or more organ
                                                       system(s).          system(s) or body   system(s) or body
                                                                           area(s).            area(s).
                                                                          Single organ        Single organ
                                                                           system exam:        system exam:
                                                                           Performance and     Performance and
                                                                           documentation of    documentation of
                                                                           one to five         at least six
                                                                           elements.           elements.
                                                                         ---------------------------------------
Medical Decision Making (MDM)     Straightforward:    Low complexity:              No change from 1995.
                                  1. Minimal........  1. Limited........
                                  2. Minimal or no    2. Limited data
                                   data review.        review.
                                  3. Minimal risk...  3. Low risk.......
                                                                         ---------------------------------------
Measured by: *
1. Problem--Number of diagnoses/
 treatment options
2. Data--Amount and/or
 complexity of data to be
 reviewed
3. Risk--Risk of complications
 and/or morbidity or mortality
----------------------------------------------------------------------------------------------------------------
* Two of three met or exceeded.
[dagger] For certain settings and patient types, each of these three key components must be met or exceeded (for
  example, new patients; initial hospital visits). For others, only two of the three key components must be met
  or exceeded (for example, established patients, subsequent hospital or other visits).

III. Other Provisions of the Proposed Rule

A. New Care Coordination Services and Payment for Rural Health Clinics 
(RHCs) and Federally-Qualified Health Centers (FQHCs)

1. Overview
    We have been engaged in a multi-year examination of coordinated and 
collaborative care services in professional settings, and as a result 
established codes and separate payment in the Physician Fee Schedule 
(PFS) to separately recognize and pay for these important services. As 
part of this initiative, the CY 2016 PFS proposed rule (80 FR 41708) 
solicited public comments on (1) improving payment for the professional 
work of care management services; (2) establishing separate payment for 
collaborative care, particularly inter-professional consultation 
between primary care physicians, psychiatrists, and other 
practitioners; and (3) assessing whether current PFS payment for 
Chronic Care Management (CCM) services is adequate and whether the 
administrative burden associated with furnishing and billing these 
services should be reduced.
    As a result of the comments we received in response to our request, 
we established in the PFS separate payment for complex CCM services, 
and temporary codes to make separate payment for general behavioral 
health integration (BHI) services and a psychiatric collaborative care 
model (CoCM). We established four G codes to describe BHI and 
psychiatric CoCM services and stated that we would consider whether to 
adopt and establish values for any associated new CPT codes being 
developed under our standard process once those codes are active. The 
separate payment for complex CCM services, general BHI, and psychiatric 
CoCM services were finalized in the CY 2017 PFS final rule (81 FR 
80225) beginning January 1, 2017, for practitioners billing under the 
PFS. Based on these payments and codes, we are proposing revisions to 
the CCM payment for RHCs and FQHCs, and proposing requirements and 
payment for general BHI and psychiatric CoCM services furnished in RHCs 
and FQHCs, beginning on January 1, 2018.

[[Page 34081]]

2. Background
a. RHC and FQHC Payment Methodologies
    RHC and FQHC visits are face-to-face encounters between a patient 
and one or more RHC or FQHC practitioners during which time one or more 
RHC or FQHC qualifying services are furnished. RHC and FQHC 
practitioners are physicians, nurse practitioners (NPs), physician 
assistants (PA), certified nurse midwives (CNMs), clinical 
psychologists, and clinical social workers, and under certain 
conditions, a registered nurse or licensed practical nurse furnishing 
care to a homebound RHC or FQHC patient. A Transitional Care Management 
(TCM) service can also be an RHC or FQHC visit, and a Diabetes Self-
Management Training (DSMT) service or a Medical Nutrition Therapy (MNT) 
service furnished by a certified DSMT or MNT provider may also be an 
FQHC visit. Only medically-necessary medical, mental health, or 
qualified preventive health services that require the skill level of an 
RHC or FQHC practitioner are RHC or FQHC billable visits. Services 
furnished by auxiliary personnel (for example, nurses, medical 
assistants, or other clinical personnel acting under the supervision of 
the RHC or FQHC practitioner) are considered incident to the visit and 
are included in the per-visit payment.
    RHCs are paid an all-inclusive rate (AIR) for medically necessary 
medical and mental health services and qualified preventive health 
services furnished on the same day (with some exceptions). In general, 
the A/B Medicare Administrative Contractor (MAC) calculates the AIR for 
each RHC by dividing total allowable costs by the total number of 
visits for all patients. Productivity, payment limits, and other 
factors are also considered in the calculation. Allowable costs must be 
reasonable and necessary and may include practitioner compensation, 
overhead, equipment, space, supplies, personnel, and other costs 
incident to the delivery of RHC services. The AIR is subject to a 
payment limit, except for certain provider-based RHCs that have an 
exception to the payment limit.
    FQHCs were paid under the same AIR methodology until October 1, 
2014, when, in accordance with section 1834(o) of the Act (as added by 
section 10501(i)(3) of the Affordable Care Act), they began to 
transition to an FQHC PPS system in which they are paid based on the 
lesser of the FQHC PPS rate or their actual charges. The FQHC PPS rate 
is adjusted for geographic differences in the cost of services by the 
FQHC PPS geographic adjustment factor (GAF). The rate is increased by 
34 percent when an FQHC furnishes care to a patient that is new to the 
FQHC, or to a beneficiary receiving an Initial Preventive Physical 
Examination (IPPE) or has an Annual Wellness Visit (AWV).
    Both the RHC AIR and FQHC PPS payment rates were designed to 
reflect the cost of all services and supplies that an RHC or FQHC 
furnishes to a patient in a single day. The rates are not adjusted for 
the complexity of the patient health care needs, the length of the 
visit, or the number or type of practitioners involved in the patient's 
care.
b. Current CCM Requirements and Payment for RHCs and FQHCs
    In the CY 2016 PFS final rule with comment period (80 FR 71080), we 
finalized policies for payment of CCM services in RHCs and FQHCs. 
Payment for CCM services in RHCs and FQHCs was effective beginning on 
January 1, 2016, for RHCs and FQHCs that furnish a minimum of 20 
minutes of qualifying CCM services during a calendar month to patients 
with multiple (two or more) chronic conditions that are expected to 
last at least 12 months or until the death of the patient, and that 
would place the patient at significant risk of death, acute 
exacerbation/decompensation, or functional decline. The requirement 
that RHC or FQHC services be furnished face-to-face was waived for CCM 
services.
    In the CY 2017 PFS final rule (81 FR 80256), we finalized revisions 
to the CCM requirements for RHCs and FQHCs. Specifically, we revised 
Sec.  405.2413(a)(5) and Sec.  405.2415(a)(5) to state that services 
and supplies furnished incident to CCM and TCM services can be 
furnished under general supervision of an RHC or FQHC practitioner, 
consistent with Sec.  410.26(b)(5), which allows CCM and TCM services 
and supplies to be furnished by clinical staff under general 
supervision when billed under the PFS. We also revised requirements 
pertaining to the provision of CCM services, consistent with the same 
revisions for practitioners billing under the PFS to reduce the burden 
of furnishing these services and promote beneficiary access to these 
services. These revisions were effective beginning on January 1, 2017, 
and included:
     Revising the requirement that CCM be initiated during a 
comprehensive evaluation and management (E/M), AWV, or IPPE visit, to 
require a separately billable initiating visit only for new patients or 
patients that have not had an E/M, AWV, or IPPE visit within the 
previous year;
     Revising the requirement that CCM services be available 
24/7 with an RHC or FQHC practitioner who has access to the patient's 
electronic care plan, to allow 24/7 access to auxiliary personnel with 
a means to make contact with an RHC or FQHC practitioner;
     Removing the restriction on faxing information, and no 
longer requiring that care plan information be available on a 24/7 
basis;
     Removing the requirement that clinical summaries must be 
formatted according to certified EHR technology, and instead requiring 
that the RHC or FQHC create, exchange, and transmit continuity of care 
document(s) in a timely manner with other practitioners and providers;
     Removing the description of the format of the care plan 
that is given to the patient or caregiver; and
     Revising the requirement that RHCs and FQHCs obtain a 
written agreement that the elements of CCM were discussed, to allowing 
this information to be documented in the medical record.
    In the CY 2017 PFS final rule, we stated that although CCM is 
typically associated with primary care conditions, patient eligibility 
is determined by the RHC or FQHC practitioner, and mental health 
conditions are not excluded. We invited comments on whether an 
additional code specifically for mental health conditions is necessary 
for RHCs and FQHCs that want to include beneficiaries with mental 
health conditions in their CCM services. We received a few comments 
regarding mental health services in RHCs and FQHCs and appreciate the 
information that was provided.
    The CCM payment rate for RHCs and FQHCs is set annually based on 
the PFS national non-facility payment rate, and is paid when CPT code 
99490 is billed alone or with other payable services on an RHC or FQHC 
claim. The 2017 rate for RHCs and FQHCs is $42.71 for 20 minutes or 
more of CCM services. This is the only RHC and FQHC service that is 
paid in this manner, and RHCs and FQHCs are not currently authorized to 
be paid for any other CCM or other care management codes. Also, RHCs 
and FQHCs cannot bill for CCM services for a beneficiary during the 
same service period as billing for TCM or any other program that 
provides additional payment for care management services (outside of 
the RHC AIR or FQHC PPS payment) for the same beneficiary.
    Additional information on CCM requirements is available on the CMS 
Care Management Web page at https://www.cms.gov/Medicare/Medicare-Fee-

[[Page 34082]]

for-Service-Payment/PhysicianFeeSched/Care-Management.html and on the 
CMS RHC and FQHC Web pages at https://www.cms.gov/Center/Provider-Type/Rural-Health-Clinics-Center.html and https://www.cms.gov/Center/Provider-Type/Federally-Qualified-Health-Centers-FQHC-Center.html.
c. Payment for Care Management Codes under the PFS
CCM Services (CPT Code 99487 and CPT Code 99489)
    As we stated in the CY 2017 PFS final rule (81 FR 80244), the 
initial claims data for CCM services billed under the PFS showed that 
although utilization was increasing steadily, use of CPT code 99490 was 
still relatively low, and interviews with practitioners indicated that 
many believed that they were exceeding the 20-minute time threshold for 
billing this code. To pay as accurately as possible and to encourage 
access to CCM services, the CY 2017 PFS final rule established separate 
payment for two additional CCM codes, CPT code 99487 and CPT code 
99489, effective beginning on January 1, 2017, for practitioners 
billing under the PFS. These codes are for complex CCM services that 
reflect additional clinical staff time, more extensive care planning, 
and higher complexity of the patient.
    CPT code 99487 is for complex CCM services. It requires multiple 
(two or more) chronic conditions expected to last at least 12 months, 
or until the death of the patient; chronic conditions that place the 
patient at significant risk of death, acute exacerbation/
decompensation, or functional decline; establishment or substantial 
revision of a comprehensive care plan; moderate or high complexity 
medical decision making; and 60 minutes of clinical staff time directed 
by a physician or other qualified health care professional, per 
calendar month.
    CPT code 99489 is for each additional 30 minutes of clinical staff 
time directed by a physician or other qualified health care 
professional, per calendar month.
    Practitioners paid under the PFS can bill either complex (CPT code 
99487 and CPT code 99489) or non-complex (CPT code 99490) CCM services 
during a given service period, and can submit only one professional 
claim for CCM services for that service period.
General BHI Services (HCPCS Code G0507)
    The types of chronic conditions that are eligible for CCM services 
are not specified and could include chronic mental health or behavioral 
health conditions or chronic cognitive disorders as long as the CCM 
requirements are met. However, because not all behavioral health issues 
fit into the CCM model, and Medicare beneficiaries with behavioral 
health conditions often require extensive care management discussions, 
information-sharing, and planning between a primary care practitioner 
and a behavioral health specialist, the CY 2017 PFS final rule 
established HCPCS code G0507 for 20 minutes or more of general BHI 
services. Payment for this code was effective beginning on January 1, 
2017, for practitioners billing under the PFS.
    BHI is a team-based, collaborative approach to care that focuses on 
integrative treatment of patients with primary care and mental or 
behavioral health conditions. As finalized in the CY 2017 PFS final 
rule, requirements for this code include an initial assessment or 
follow-up monitoring (including the use of applicable validated rating 
scales); behavioral health care planning in relation to behavioral/
psychiatric health problems (including revision for patients who are 
not progressing or whose status changes); facilitating and coordinating 
treatment such as psychotherapy, pharmacotherapy, counseling and/or 
psychiatric consultation; and continuity of care with a designated 
member of the care team.
Psychiatric CoCM Services (HCPCS codes G0502, G0503, and G0504)
    Psychiatric CoCM is a specific model of care provided by a primary 
care team consisting of a primary care provider and a health care 
manager who works in collaboration with a psychiatric consultant. As 
finalized in the CY 2017 PFS final rule, we provide Medicare payment 
for psychiatric CoCM services to practitioners billing under the PFS 
when these services are directed by a treating physician or other 
qualified health care professional. We also finalized that the treating 
physician or other qualified health care professional directs the 
behavioral health care manager, who must be an individual with formal 
education or specialized training in behavioral health, including 
social work, nursing, or psychology, working under the oversight and 
direction of the physician or qualified health care professional. We 
finalized that a psychiatric consultant must be a medical professional 
trained in psychiatry and qualified to prescribe the full range of 
medications. Finally, psychiatric CoCM services may be furnished to 
beneficiaries with any psychiatric or behavioral health condition(s) 
and may include substance use disorders. The three psychiatric CoCM 
codes established in the CY 2017 PFS final rule were G0502, G0503, and 
G0504.
    HCPCS code G0502 is for 70 minutes or more of initial psychiatric 
CoCM services in the first calendar month of behavioral health care 
manager activities, in consultation with a psychiatric consultant, and 
directed by the treating physician or other qualified health care 
professional. Required elements include: outreach to and treatment of a 
patient as directed by the treating physician or other qualified health 
care professional; initial assessment of the patient, including 
administration of validated rating scales, with the development of an 
individualized treatment plan; review by the psychiatric consultant 
with modifications of the plan, if recommended; entering of the patient 
into a registry and tracking patient follow-up and progress using the 
registry (with appropriate documentation), participation in weekly 
caseload consultation with the psychiatric consultant; and provision of 
brief interventions using evidence-based techniques such as behavioral 
activation, motivational interviewing, and other focused treatment 
strategies.
    HCPCS code G0503 is for 60 minutes of subsequent psychiatric CoCM 
services in a subsequent month and includes: tracking patient follow-up 
and progress using the registry (with appropriate documentation); 
participation in weekly caseload consultation with the psychiatric 
consultant; ongoing collaboration with and coordination of the 
patient's mental health care with the treating physician or other 
qualified health care professional and any other treating mental health 
providers; additional review of progress and recommendations for 
changes in treatment, as indicated, including medications, based on 
recommendations provided by the psychiatric consultant; provision of 
brief interventions using evidence-based techniques (such as behavioral 
activation, motivational interviewing, and other focused treatment 
strategies); monitoring of patient outcomes using validated rating 
scales; and relapse prevention planning with patients as they achieve 
remission of symptoms and/or other treatment goals and are prepared for 
discharge from active treatment.
    HCPCS code G0504 is for each additional 30 minutes of initial or 
subsequent psychiatric CoCM services in a calendar month.

[[Page 34083]]

3. Proposed Care Management Requirements and Payment for RHCs and FQHCs
    To ensure that RHC and FQHC patients have access to new care 
management services in a manner consistent with the RHC and FQHC per 
diem payment methodologies, we are proposing the establishment of two 
new G codes for use by RHCs and FQHCs. The first new G code, GCCC1, 
would be a General Care Management code for RHCs and FQHCs, with the 
payment amount set at the average of the national non-facility PFS 
payment rates for CCM codes 99490 and 99487 and general BHI code G0507. 
The second new G code for RHCs and FQHCs, GCCC2, would be a Psychiatric 
CoCM code,with the payment amount set at the average of the national 
non-facility PFS payment rates for psychiatric CoCM codes G0502 and 
G0503. The following is a detailed discussion of our proposal, as well 
as alternatives that we considered.
a. Proposed Establishment of a General Care Management Code for RHCs 
and FQHCs
    The RHC AIR and the FQHC PPS rate, which include all costs 
associated with an RHC or FQHC visit, are based on the RHC's and FQHC's 
costs. Although many RHCs and FQHCs have always provided some 
coordination of care within and outside their facilities, the type of 
structured care management services that are now billable under the PFS 
are generally not included in the RHC AIR or the FQHC PPS rate. Because 
CCM services are not required to be face-to-face encounters, and do not 
require the skill level of an RHC or FQHC practitioner, they do not 
meet the requirements for an RHC or FQHC billable visit. In addition, 
RHC and FQHC services cannot be separately billed to the PFS. 
Therefore, in the CY 2016 PFS final rule with comment period, we 
established payment for CCM services at the PFS national non-facility 
rate when CPT code 99490 is billed alone or with other payable services 
on an RHC or FQHC claim to pay for the costs of CCM services that are 
not already captured in the RHC AIR or the FQHC PPS payment.
    When CCM services were first established for RHCs and FQHCs, CPT 
code 99490 was the only CCM code that was billable under the PFS. Now 
that there are additional codes for more complex CCM services and for 
general BHI and psychiatric CoCM services, we believe it is necessary 
to revise our payment approach for payment of care management services.
    RHCs and FQHCs are paid per-visit rates that are not adjusted based 
on the complexity of a service or the time spent furnishing services, 
and the payment rate is not designed to be equal to the payment under 
the PFS for a specific service. We sought to develop a methodology for 
payment of care management services that is consistent with the RHC and 
FQHC payment principles of bundling services and not paying for 
services based on time increments. We also sought to develop a 
methodology that would support the provision of care management 
services without creating additional reporting burdens, while promoting 
beneficiary access to comprehensive CCM and BHI services furnished by 
RHCs and FQHCs.
    Therefore, effective for services furnished on or after January 1, 
2018, we are proposing to create General Care Management code GCCC1 for 
RHCs and FQHCs, with the payment amount set at the average of the 3 
national non-facility PFS payment rates for the CCM and general BHI 
codes and updated annually based on the PFS amounts. The 3 codes are:
     CPT 99490--20 minutes or more of CCM services
     CPT 99487--at least 60 minutes of complex CCM services
     HCPCS G0507--20 minutes or more of BHI services
    RHCs and FQHCs could bill the new General Care Management code when 
the requirements for any of these 3 codes (CPT codes 99490, 99487, or 
HCPCS code G0507) are met. The General Care Management code would be 
billed alone or in addition to other services furnished during the RHC 
or FQHC visit. This code could only be billed once per month per 
beneficiary, and could not be billed if other care management services 
(such as TCM or home health care supervision) are billed for the same 
time period. We note that CPT 99489 is an add-on code when CPT 99487 is 
furnished, and is therefore not included as RHCs and FQHCs are not paid 
for additional time once the minimum requirements have been met.
    As previously noted, the program requirements for RHCs and FQHCs 
furnishing CCM services were established in the CY 2016 PFS final rule 
with comment period (80 FR 71080) and revised in the CY 2017 PFS final 
rule (81 FR 80256). We are not proposing any changes to these 
requirements at this time.
    BHI refers to care management services that integrate behavioral 
health services with primary care and other clinical services. To bill 
for this service using the proposed General Care Management Code for 
RHCs and FQHCs, 20 minutes or more of clinical staff time, directed by 
an RHC or FQHC practitioner, must be furnished per calendar month. We 
are proposing the following requirements for RHCs and FQHCs furnishing 
BHI services:
     Initiating Visit: An E/M, AWV, or IPPE visit with an RHC 
or FQHC primary care practitioner (physician, NP, PA, or CNM) occurring 
no more than one-year prior to commencing BHI services. This could be 
the same initiating visit that is used for initiating CCM services, and 
would be billed separately as an RHC or FQHC visit (if the RHC or FQHC 
has not already billed for this visit).
     Beneficiary Consent: Documentation in the medical record 
that the beneficiary has consented to receive BHI services, given 
permission to consult with relevant specialists as needed, and been 
informed that there may be beneficiary cost-sharing, including 
deductible and coinsurance amounts as applicable, for both in-person 
and non-face-to-face services that are provided. The beneficiary 
consent process would also include informing the patient that only one 
practitioner/facility can furnish and be paid for these services during 
a calendar month, and that the patient can stop care coordination 
services at any time (effective at the end of the calendar month). This 
could be obtained at the same time that beneficiary consent is obtained 
for CCM services.
     Billing Requirements: At least 20 minutes of care 
management services per calendar month, furnished under the direction 
of the RHC or FQHC primary care physician, NP, PA, or CNM, and 
furnished by an RHC or FQHC practitioner, or by clinical personnel 
under general supervision. These are the same billing requirements as 
for CCM services. If both CCM and BHI services are furnished in the 
same month, the time would be combined and billed as one under the new 
care coordination code.
     Patient Eligibility: One or more new or pre-existing 
behavioral health or psychiatric conditions being treated by the RHC or 
FQHC primary care practitioner, including substance use disorders, 
that, in the clinical judgment of the RHC or FQHC primary care 
practitioner, warrants BHI services.
     Required Service Elements: An initial assessment or 
follow-up monitoring, including the use of applicable validated rating 
scales; behavioral health care planning in relation to behavioral/
psychiatric health problems, including revision for patients who are 
not progressing or whose status changes; facilitating and

[[Page 34084]]

coordinating treatment such as psychotherapy, pharmacotherapy, 
counseling and/or psychiatric consultation; and continuity of care with 
a designated member of the care team.
    Both CCM and general BHI services are intended to provide a 
structured and coordinated approach to care management that is not 
typically included in the RHC's AIR or the FQHC PPS payment 
methodology. Care management services are directed by the RHC or FQHC 
primary care practitioner, who remains involved through ongoing 
oversight, management, collaboration and reassessment, while care 
management services are typically furnished in a non-face-to-face 
setting primarily by a non-RHC or FQHC practitioner working under 
general supervision requirements. Time spent by administrative or 
clerical staff cannot be counted towards the time required to bill 
these services.
    Table 16 compares the requirements for CCM and general BHI 
services. We believe that even though there are some differences in the 
requirements of CCM and general BHI, bundling them together will help 
to promote integrated care management services for Medicare 
beneficiaries who have either or both primary care and behavioral 
health needs. It will also result in the least amount of reporting 
burden for RHCs and FQHCs because once the 20-minute threshold is met 
for either CCM or general BHI, reporting and tracking of additional 
time increments is not required.
    If this policy had been adopted for CY 2017, the payment amount for 
General Care Management for RHCs and FQHCs would have been 
approximately $61 (CPT 99490 at $42.71, + CPT 99487 at $93.67, + G0507 
at $47.73 = $184.11/3 = $61.37). This is more than is the CY 2017 PFS 
national non-facility rates for CPT code 99490 and HCPCS code G0507, 
and less than the PFS national non-facility rate for CPT code 99487. We 
believe that this bundling methodology is consistent with the RHC and 
FQHC payment methodology of averaging costs to determine a payment rate 
rather than paying for each individual service.

  Table 16--Comparison of Proposed CCM and General BHI Requirements For
                             RHCs and FQHCs
------------------------------------------------------------------------
                                                         General BHI
        Requirements          CCM (CPT codes 99490    (proposed) (HCPCS
                                   and 99487)            code G0507)
------------------------------------------------------------------------
Initiating Visit............  An E/M, AWV, or IPPE  Same.
                               visit occurring no
                               more than one-year
                               prior to commencing
                               care coordination
                               services.
                              Furnished by a        Same.
                               primary care
                               physician, NP, PA,
                               or CNM.
                              Billed as an RHC/     Same.
                               FQHC visit.
Beneficiary Consent.........  Obtained during or    Same.
                               after initiating
                               visit and before
                               provision of care
                               coordination
                               services by RHC or
                               FQHC practitioner
                               or clinical staff.
                              Written or verbal,    Same.
                               documented in the
                               medical record.
                              Includes              Same.
                               information:.
                               On the
                               availability of
                               care coordination
                               services and
                               applicable cost-
                               sharing;.
                               That only
                               one practitioner
                               can furnish and be
                               paid for care
                               coordination
                               services during a
                               calendar month;.
                               That the
                               patient has right
                               to stop care
                               coordination
                               services at any
                               time (effective at
                               the end of the
                               calendar month);
                               and.
                               That the
                               patient has given
                               permission to
                               consult with
                               relevant
                               specialists..
Billing Requirements........  At least 20 minutes   Same.
                               of care
                               coordination
                               services per
                               calendar month that
                               is:
                               Furnished
                               under the direction
                               of the RHC or FQHC
                               primary care
                               physician, NP, PA,
                               or CNM; and.
                               Furnished
                               by an RHC or FQHC
                               practitioner, or by
                               clinical personnel
                               under general
                               supervision.
Patient Eligibility.........  Multiple (two or      Any behavioral
                               more) chronic         health or
                               conditions expected   psychiatric
                               to last at least 12   condition being
                               months, or until      treated by the RHC
                               the death of the      or FQHC primary
                               patient, and place    care practitioner,
                               the patient at        including substance
                               significant risk of   use disorders,
                               death, acute          that, in the
                               exacerbation/         clinical judgment
                               decompensation, or    of the RHC or FQHC
                               functional decline.   practitioner,
                                                     warrants BHI
                                                     services.

[[Page 34085]]

 
Requirement Service Elements  Includes:             Includes:
                               Structured    Initial
                               recording of          assessment or
                               patient health        follow-up
                               information using     monitoring,
                               Certified EHR         including the use
                               Technology and        of applicable
                               includes              validated rating
                               demographics,         scales;
                               problems,             Behavioral
                               medications, and      health care
                               medication            planning in
                               allergies that        relation to
                               inform the care       behavioral/
                               plan, care            psychiatric health
                               coordination, and     problems, including
                               ongoing clinical      revision for
                               care;.                patients who are
                               24/7 access   not progressing or
                               to physicians or      whose status
                               other qualified       changes;
                               health care          
                               professionals or      Facilitating and
                               clinical staff        coordinating
                               including providing   treatment (such as
                               patients/caregivers   psychotherapy,
                               with a means to       pharmacotherapy,
                               make contact with     counseling and/or
                               health care           psychiatric
                               professionals in      consultation); and
                               the practice to       Continuity
                               address urgent        of care with a
                               needs regardless of   designated member
                               the time of day or    of the care team.
                               day of week, and
                               continuity of care
                               with a designated
                               member of the care
                               team with whom the
                               patient is able to
                               schedule successive
                               routine
                               appointments;.
                              
                               Comprehensive care
                               management
                               including
                               systematic
                               assessment of the
                               patient's medical,
                               functional, and
                               psychosocial needs;
                               system-based
                               approaches to
                               ensure timely
                               receipt of all
                               recommended
                               preventive care
                               services;
                               medication
                               reconciliation with
                               review of adherence
                               and potential
                               interactions; and
                               oversight of
                               patient self-
                               management of
                               medications;.
                              
                               Comprehensive care
                               plan including the
                               creation, revision,
                               and/or monitoring
                               of an electronic
                               care plan based on
                               a physical, mental,
                               cognitive,
                               psychosocial,
                               functional, and
                               environmental
                               (re)assessment and
                               an inventory of
                               resources and
                               supports; a
                               comprehensive care
                               plan for all health
                               issues with
                               particular focus on
                               the chronic
                               conditions being
                               managed;.
                               Care plan
                               information made
                               available
                               electronically
                               (including fax) in
                               a timely manner
                               within and outside
                               the RHC or FQHC as
                               appropriate and a
                               copy of the plan of
                               care given to the
                               patient and/or
                               caregiver;.
                               Management
                               of care transitions
                               between and among
                               health care
                               providers and
                               settings, including
                               referrals to other
                               clinicians; follow-
                               up after an
                               emergency
                               department visit;
                               and follow-up after
                               discharges from
                               hospitals, skilled
                               nursing facilities,
                               or other health
                               care facilities;
                               timely creation and
                               exchange/transmit
                               continuity of care
                               document(s) with
                               other practitioners
                               and providers;.
                              
                               Coordination with
                               home- and community-
                               based clinical
                               service providers,
                               and documentation
                               of communication to
                               and from home- and
                               community-based
                               providers regarding
                               the patient's
                               psychosocial needs
                               and functional
                               deficits in the
                               patient's medical
                               record; and.
                               Enhanced
                               opportunities for
                               the patient and any
                               caregiver to
                               communicate with
                               the practitioner
                               regarding the
                               patient's care
                               through not only
                               telephone access,
                               but also through
                               the use of secure
                               messaging,
                               Internet, or other
                               asynchronous non-
                               face-to-face
                               consultation
                               methods..
CY 2017 PFS Non-Facility      CPT 99490--$42.71...  G0507--$47.73.
 Payment.                     CPT 99487--$93.67...
RHC/FQHC Payment for new      Current: $42.71.....  Current: N/A
 General Care Management G    Proposed: Average of  Proposed: Average of
 code.                         CPT codes 99490,      CPT codes 99490,
                               99487 and G0507 (If   99487 and G0507 (If
                               using the 2017        using the 2017
                               payment amounts,      payment amounts,
                               this would be         this would be
                               $61.37).              $61.37).
------------------------------------------------------------------------

    We expect that utilization of care coordination services will 
continue to increase as more health care practices, including RHCs and 
FQHCs, implement these services. Because the separate payments for the 
complex CCM codes have only been implemented this year for 
practitioners billing under the PFS, we do not have adequate data to 
determine the frequency of billing for CCM codes CPT codes 99487 by 
practitioners billing under the PFS compared with CPT code 99490. 
Although billing practices may vary between physician offices and RHCs 
and FQHCs (and within and between RHCs and FQHCs), we believe that 
utilization patterns under the PFS can provide a reasonable proxy for 
utilization practices in RHCs and FQHCs of care coordination 
utilization. If the PFS data starts to show definitive trends in 
billing certain CCM and BHI codes, or if data becomes available that 
provides information on the extent of these services in RHCs and FQHCs, 
we may consider using a weighted average

[[Page 34086]]

in determining the payment rate in the future. Similarly, if the 
proposal to create a new care management code for RHCs and FQHCs is 
finalized, and any additional care management codes become available on 
the PFS, we would review the new codes to determine if they should also 
be factored into the RHC and FQHC General Care Management Code. Any 
changes would be undertaken through future rulemaking.
b. Proposed Establishment of a Psychiatric CoCM Code for RHCs and FQHCs
    Psychiatric CoCM is a defined model of care that integrates primary 
health care services with care management support for patients 
receiving behavioral health treatment, and includes regular psychiatric 
inter-specialty consultation with the primary care team, particularly 
regarding patients whose conditions are not improving. We recognize 
that the requirements of this model may be challenging for some RHCs 
and FQHCs, especially those who have difficulty maintaining adequate 
primary care and mental health staffing in rural and or underserved 
areas. For those RHCs and FQHCs that choose to offer these services, we 
believe this model may be particularly helpful, especially for patients 
with primary care and mental health conditions who have not benefited 
from standard treatment.
    Effective for services furnished on or after January 1, 2018, we 
are proposing to create a psychiatric CoCM code for RHCs and FQHCs, 
GCCC2, with the payment amount set at the average of the 2 national 
non-facility PFS payment rates for CoCM codes, to be updated annually 
based on the PFS amounts. The 2 codes are:
     G0502--70 minutes or more of initial psychiatric CoCM 
services
     G0503--60 minutes or more of subsequent psychiatric CoCM 
services
    RHCs and FQHCs could bill the new psychiatric CoCM code when the 
requirements for any of these 2 codes (G0502 or G0503) are met. The 
psychiatric CoCM code would be billed alone or in addition to other 
services furnished during the RHC or FQHC visit. To prevent duplication 
of payment, this code could only be billed once per month per 
beneficiary, and could not be billed if other care management services, 
including the proposed General Care Management code, are billed for the 
same time period. We note that G0504 is an add-on code when G0503 is 
furnished and is therefore not included as RHCs and FQHCs are not paid 
for additional time once the minimum requirements have been met.
    If this policy had been adopted for CY 2017, the payment amount for 
psychiatric CoCM for RHCs and FQHCs would have been approximately 
$134.58 (G0502 at $142.84 + G0503 at $126.33 = $269.17/2 = $134.58).
    All care management services, including psychiatric CoCM, require a 
separately billable initiating visit (E/M, AWV, or IPPE) for new 
patients or beneficiaries not seen within 1 year prior to commencement 
of care management services. Prior to commencement of psychiatric CoCM 
services, the beneficiary must provide consent for this service, 
including permission to consult with a psychiatric consultant and 
relevant specialists. Advance consent must also include information on 
cost sharing for both face-to-face and non-face-to-face services, and 
acceptance of these requirements must be documented in the medical 
record.
    Patients with mental health, behavioral health, or psychiatric 
conditions, including substance use disorders, who are being treated by 
an RHC or FQHC practitioner, may be eligible for psychiatric CoCM 
services, as determined by the RHC or FQHC practitioner. Psychiatric 
CoCM services, like CCM and general BHI services, are intended to 
provide a structured and coordinated approach to care management that 
is not typically included in the RHC's AIR or the FQHC PPS payment 
methodology.
    The psychiatric CoCM team must include the RHC or FQHC 
practitioner, a behavioral health manager, and a psychiatric 
consultant. Proposed specific requirements of the psychiatric CoCM team 
are as follows:
Psychiatric CoCM Team--RHC or FQHC Practitioner
    For psychiatric CoCM, the RHC or FQHC practitioner may be a primary 
care physician, NP, PA, or CNM. The psychiatric CoCM requirements of 
the RHC or FQHC practitioner are to:
     Direct the behavioral health care manager and any other 
clinical staff;
     Oversee the beneficiary's care, including prescribing 
medications, providing treatments for medical conditions, and making 
referrals to specialty care when needed; and
     Remain involved through ongoing oversight, management, 
collaboration and reassessment.
Psychiatric CoCM Team--Behavioral Health Care Manager
    For psychiatric CoCM, the behavioral health care manager is a 
designated individual with formal education or specialized training in 
behavioral health such as social work, nursing, or psychology. A 
behavioral health care manager in an RHC or FQHC would be expected to 
have a minimum of a bachelor's degree in a behavioral health field 
(such as in clinical social work or psychology), or be a clinician with 
behavioral health training, including RNs and LPNs. The behavioral 
health care manager furnishes both face-to-face and non-face-to-face 
services under the general supervision of the RHC or FQHC practitioner 
and may be employed by or working under contract to the RHC or FQHC. 
The psychiatric CoCM requirements of the behavioral health care manager 
are:
     Providing assessment and care management services, 
including the administration of validated rating scales; behavioral 
health care planning in relation to behavioral/psychiatric health 
problems, including revision for patients who are not progressing or 
whose status changes; provision of brief psychosocial interventions; 
ongoing collaboration with the RHC or FQHC practitioner; maintenance of 
the registry; acting in consultation with the psychiatric consultant;
     Being available to provide services face-to-face with the 
beneficiary; having a continuous relationship with the patient and a 
collaborative, integrated relationship with the rest of the care team; 
and
     Being available to contact the patient outside of regular 
RHC or FQHC hours as necessary to conduct the behavioral health care 
manager's duties.
Psychiatric CoCM Team--Psychiatric Consultant
    For CoCM, a psychiatric consultant is a medical professional 
trained in psychiatry and qualified to prescribe the full range of 
medications. The psychiatric consultant is not required to be on site 
or to have direct contact with the patient and does not prescribe 
medications or furnish treatment to the beneficiary directly. The CoCM 
requirements of the psychiatric consultant are:
     Participating in regular reviews of the clinical status of 
patients receiving psychiatric CoCM services;
     Advising the RHC or FQHC practitioner regarding diagnosis 
and options for resolving issues with beneficiary adherence and 
tolerance of behavioral health treatment; making adjustments to 
behavioral health treatment for beneficiaries who are not progressing; 
managing any negative interactions between beneficiaries'

[[Page 34087]]

behavioral health and medical treatments; and
     Facilitating referral for direct provision of psychiatric 
care when clinically indicated.
    RHCs and FQHCs could bill the new psychiatric CoCM code, GCCC2, 
when the requirements for HCPCS code G0502 or G0503 are met. This code 
could only be billed once per month per beneficiary, and could not be 
billed if other care management services, including the General Care 
Management code GCCC1, are billed for the same time period.
    As with the proposed General Care Management code GCCC1, we would 
monitor PFS data to determine if a weighted average would be more 
appropriate in determining the psychiatric CoCM payment rate for RHCs 
and FQHCs, and whether any additional codes that may be added to the 
PFS in the future should also be factored into the RHC and FQHC 
psychiatric CoCM code. Any changes would be done through future 
rulemaking.
    Table 17 compares the requirements for general BHI, which would be 
billed using the proposed General Care Management code GCCC1, and 
psychiatric CoCM services, which would be billed using the proposed 
psychiatric CoCM code, GCCC2.

    Table 17--Comparison of Proposed General BHI and Psychiatric CoCM
                     Requirements for RHCs and FQHCs
------------------------------------------------------------------------
                                                      Psychiatric CoCM
                                   General BHI        (proposed) (HCPCS
        Requirements            (proposed) (HCPCS      code G0502 and
                                   code G0507)             G0503)
------------------------------------------------------------------------
Initiating Visit............  An E/M, AWV, or IPPE  Same.
                               visit occurring no
                               more than one-year
                               prior to commencing
                               care coordination
                               services.
                              Furnished by a        Same.
                               primary care
                               physician, NP, PA,
                               or CNM.
                              Billed as an RHC or   Same.
                               FQHC visit.
Beneficiary Consent.........  Obtained during or    Same.
                               after initiating
                               visit and before
                               provision of care
                               coordination
                               services by RHC or
                               FQHC practitioner
                               or clinical staff.
                              Written or verbal,    Same.
                               documented in the
                               medical record.
                              Includes              Same.
                               information:
                               On the
                               availability of
                               care coordination
                               services and
                               applicable cost-
                               sharing;
                               That only
                               one entity can
                               furnish and be paid
                               for care
                               coordination
                               services during a
                               calendar month;
                               That the
                               patient has the
                               right to stop care
                               coordination
                               services at any
                               time (effective at
                               the end of the
                               calendar month);
                               and
                               That the
                               patient has given
                               permission to
                               consult with
                               relevant
                               specialists.
Billing Requirements........  At least 20 minutes   At least 70 minutes
                               of care management    in the first
                               services per          calendar month, and
                               calendar month that   at least 60 minutes
                               is:                   in subsequent
                               Furnished     calendar months of
                               under the direction   psychiatric CoCM
                               of the RHC or FQHC    services that is:
                               primary care          Furnished
                               physician, NP, PA,    under the direction
                               or CNM; and.          of the RHC or FQHC
                               Furnished     primary care
                               by an RHC or FQHC     practitioner; and
                               practitioner, or by   Furnished
                               clinical personnel    by an RHC or FQHC
                               under general         practitioner or
                               supervision..         behavioral health
                                                     care manager under
                                                     general
                                                     supervision.
Patient Eligibility.........  Any mental,           Same.
                               behavioral health,
                               or psychiatric
                               condition being
                               treated by the RHC
                               or FQHC primary
                               care practitioner,
                               including substance
                               use disorders,
                               that, in the
                               clinical judgment
                               of the RHC or FQHC
                               practitioner,
                               warrants BHI
                               services.
Requirement Elements........  Includes:             Includes:
                               Initial      RHC or FQHC primary
                               assessment or         care practitioner:
                               follow-up             Direct the
                               monitoring,           behavioral health
                               including the use     care manager or
                               of applicable         clinical staff;
                               validated rating      Oversee the
                               scales.               beneficiary's care,
                               Behavioral    including
                               health care           prescribing
                               planning in           medications,
                               relation to           providing
                               behavioral/           treatments for
                               psychiatric health    medical conditions,
                               problems, including   and making
                               revision for          referrals to
                               patients who are      specialty care when
                               not progressing or    needed; and
                               whose status          Remain
                               changes.              involved through
                                             ongoing oversight,
                               Facilitating and      management,
                               coordinating          collaboration and
                               treatment (such as    reassessment
                               psychotherapy,       Behavioral Health
                               pharmacotherapy,      Care Manager:
                               counseling and/or
                               psychiatric
                               consultation)
                               Continuity of care
                               with a designated
                               member of the care
                               team.
                                                     Provide
                                                     assessment and care
                                                     management
                                                     services, including
                                                     the administration
                                                     of validated rating
                                                     scales; behavioral
                                                     health care
                                                     planning in
                                                     relation to
                                                     behavioral/
                                                     psychiatric health
                                                     problems, including
                                                     revision for
                                                     patients who are
                                                     not progressing or
                                                     whose status
                                                     changes; provision
                                                     of brief
                                                     psychosocial
                                                     interventions;
                                                     ongoing
                                                     collaboration with
                                                     the RHC or FQHC
                                                     practitioner;
                                                     maintenance of the
                                                     registry; acting in
                                                     consultation with
                                                     the psychiatric
                                                     consultant;

[[Page 34088]]

 
                                                     Be
                                                     available to
                                                     provide services
                                                     face-to-face with
                                                     the beneficiary;
                                                     having a continuous
                                                     relationship with
                                                     the patient and a
                                                     collaborative,
                                                     integrated
                                                     relationship with
                                                     the rest of the
                                                     care team; and
                                                     Be
                                                     available to
                                                     contact the patient
                                                     outside of regular
                                                     RHC or FQHC hours
                                                     as necessary to
                                                     conduct the
                                                     behavioral health
                                                     care manager's
                                                     duties.
                                                    Psychiatric
                                                     Consultant:
                                                     Participate
                                                     in regular reviews
                                                     of the clinical
                                                     status of patients
                                                     receiving CoCM
                                                     services;
                                                     Advise the
                                                     RHC or FQHC
                                                     practitioner
                                                     regarding
                                                     diagnosis, options
                                                     for resolving
                                                     issues with
                                                     beneficiary
                                                     adherence and
                                                     tolerance of
                                                     behavioral health
                                                     treatment; making
                                                     adjustments to
                                                     behavioral health
                                                     treatment for
                                                     beneficiaries who
                                                     are not
                                                     progressing;
                                                     managing any
                                                     negative
                                                     interactions
                                                     between
                                                     beneficiaries'
                                                     behavioral health
                                                     and medical
                                                     treatments; and
                                                     Facilitate
                                                     referral for direct
                                                     provision of
                                                     psychiatric care
                                                     when clinically
                                                     indicated.
Cy 2017 PFS Non-Facility      G0507--$47.73.......  G0502--$142.84.
 Payment.                                           G0503--$126.33.
RHC/FQHC Payment for New      Current: N/A........  Current: N/A
 Psychiatric CoCM G Code.     Proposed: Average of  Proposed: Average of
                               CPT codes 99490,      HCPCS codes G0502
                               99487, and G0507.     and G0503. (If
                               (If using the 2017    using the 2017
                               payment amounts,      payment amounts,
                               this would be         this would be
                               $61.37).              $134.58).
------------------------------------------------------------------------

c. Other Options Considered
    We considered allowing RHCs and FQHCs to bill for the complex CCM 
codes, the BHI code, and the psychiatric CoCM codes by allowing the 
individual CPT or HCPCS codes to be added to an RHC or FQHC claim, in 
the same manner as we currently allow CPT code 99490 to be added to a 
claim. We do not believe this approach is in the best interest of RHCs 
and FQHCs. There are now 5 separate care management codes that are 
applicable to RHCs and FQHCs, and more codes could be added in the 
future as we learn more about the benefits of non-face-to-face care 
management services. Each of these codes has specific time increments 
that must be tracked and reported for payment under the PFS. We believe 
that bundling the CCM and BHI codes and the psychiatric CoCM codes into 
2 G codes is more consistent with the RHC and FQHC payment methodology 
of averaging actual costs to determine a payment rate and not paying 
for services based on time increments. It also requires less record 
keeping, monitoring, and coding expertise, while maintaining the same 
quality of care standards.
    We also considered bundling all 5 codes together into one G code, 
or developing 3 G codes--one for the CCM codes, one for the BHI code, 
and one for the psychiatric CoCM codes. We did not choose either of 
these approaches because CCM and BHI are similar services that 
complement each other, and bundling them together is consistent with an 
integrated approach to care with reduced reporting requirements. We 
also believe that psychiatric CoCM is different enough from both CCM 
and BHI in its requirements, particularly in staffing and required 
services, that it warrants a separate G code. We believe that our 
proposal of creating 2 new G codes to encompass the 5 care management 
codes is the best option for RHCs and FQHCs now and in the future if 
new care management codes are developed. We welcome comments on the 
proposal.
4. Implementation
    RHCs and FQHCs are familiar with billing G codes. If this proposal 
is finalized as proposed, RHCs and FQHCs would continue to receive 
payment for CCM when CPT code 99490 is billed alone or with other 
payable services on an RHC or FQHC claim until December 31, 2017. 
Beginning on January 1, 2018, we propose that RHCs and FQHCs would use 
the new General Care Management G code GCCC1 when billing for CCM or 
general BHI services, and the new psychiatric CoCM G code GCCC2 when 
billing for psychiatric CoCM services, either alone or with other 
payable services on an RHC or FQHC claim. Claims submitted using CPT 
99490 on January 1, 2018, or after, will not be paid.
    Both the current RHC and FQHC payment rate for CCM, and the 
proposed RHC and FQHC payment rates for General Care Management and 
Psychiatric CoCM codes, are based on the PFS national non-facility 
rates. The PFS rates are updated annually, and the new G codes for RHCs 
and FQHCs would be updated accordingly and finalized when the PFS rates 
are finalized for the year. No geographic adjustment would be applied 
to the General Care Management or Psychiatric CoCM G codes. RHCs and 
FQHCs are required to submit claims for RHC and FQHC services on an 
institutional claim (electronically per the HIPAA compliant ANSI X12 
837I or the Form CMS 1450, also known as the UB-04,) and are not 
authorized to bill RHC or FQHC services separately to the PFS. Specific 
information on billing and claims processing for the new G codes will 
be provided when the policy is finalized.
    We note that in section X of this proposed rule, G0502, G0503, and 
G0507 are proposed to be replaced by new CPT codes. Corresponding 
changes would be made for RHCs and FQHCs when the new CPT codes become 
available.
5. Regulatory Changes
    As previously noted, Sec.  405.2413(a)(5) and Sec.  405.2415(a)(5) 
was revised

[[Page 34089]]

effective January 1, 2017, to state that services and supplies 
furnished incident to CCM and TCM services can be furnished under 
general supervision of an RHC or FQHC practitioner, consistent with 
Sec.  410.26(b)(5), which allows CCM and TCM services and supplies to 
be furnished by clinical staff under general supervision when billed 
under the PFS. We propose to further revise Sec.  405.2413(a)(5) and 
Sec.  405.2415(a)(5) to state that services and supplies incident to 
the services of a physician, NP, PA, or CNM are furnished under the 
direct supervision of a physician, NP, PA, or CNM, except for TCM, 
General Care Management, and Psychiatric CoCM services, which can be 
furnished under general supervision of a physician, NP, PA, or CNM when 
these services or supplies are furnished by auxiliary personnel, as 
defined in Sec.  410.26(a)(1).

B. Part B Drug Payment: Infusion Drugs Furnished Through an Item of 
Durable Medical Equipment (DME)

    Section 303(c) of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (MMA) (Pub. L. 108-173, enacted on December 
8, 2003) revised the payment methodology for most Medicare-covered Part 
B drugs and biologicals by adding section 1847A to the Act, which 
established a new average sales price (ASP) drug payment methodology 
beginning January 1, 2005. However, section 303(b) of the MMA specified 
payments for certain drugs using methodologies other than the ASP 
pricing methodology. Specifically, section 303(b) of the MMA added 
section 1842(o)(1)(D)(i) of the Act that required that an infusion drug 
furnished through an item of DME covered under section 1861(n) of the 
Act be paid 95 percent of the average wholesale price (AWP) for that 
drug in effect on October 1, 2003.
    Section 5004(a) of the 21st Century Cures Act (Cures Act) (Pub. L. 
114-255, enacted on December 13, 2016) revised sections 1842(o)(1)(C) 
and (D) of the Act, changing the payment methodology for DME infusion 
drugs from being based on AWP to the methodologies in sections 1847, 
1847A, 1847B, or 1881(b)(13) of the Act, as the case may be for the 
drug or biological. To implement the pricing changes required by 
section 5004(a) of Cures Act, which modifies the payment for DME 
infusion drugs to the amount under section 1847A of the Act (ASP 
payment methodology), by the statutorily mandated effective date of 
January 1, 2017, we incorporated the ASP-based infusion drug payment 
amounts into the January 2017 quarterly ASP drug pricing files and 
instructed claims processing contractors to use the updated payment 
limits for DME infusion drugs.
    To conform regulations with the new payment requirements in section 
5004(a) of the Cures Act as they pertain to section 1847A of the Act, 
we propose revising Sec.  414.904(e)(2). Currently, this describes an 
exception to ASP-based payments and requires pricing DME infusion drugs 
at 95 percent of the 2003 AWP. Consistent with section 5004(a) of the 
Cures Act, the proposed revision limits the exception to infusion drugs 
furnished before January 1, 2017. In addition, we propose at Sec.  
414.904(e)(2) to delete the phrase ``and is not updated in 2006.'' We 
believe this language is not relevant since there was no update for 
pricing DME infusion drugs in 2006, and the proposed revision will 
serve to simplify the language. Effective January 1, 2017, payment 
limits for these drugs are determined under section 1847A of the Act.

C. Solicitation of Public Comments on Initial Data Collection and 
Reporting Periods for Clinical Laboratory Fee Schedule

1. Background on Medicare Clinical Diagnostic Laboratory Tests Payment 
System Final Rule
    In the final rule published in the June 23, 2016 Federal Register 
(81 FR 41036) entitled, ``Medicare Program; Medicare Clinical 
Diagnostic Laboratory Tests Payment System,'' we implemented the 
requirements of section 1834A of the Act, which requires extensive 
revisions to the Medicare payment, coding, and coverage for clinical 
diagnostic laboratory tests (CDLTs) paid under the Clinical Laboratory 
Fee Schedule (CLFS).
    Under the CLFS final rule, reporting entities are required to 
report to CMS certain applicable information for their component 
applicable laboratories. The applicable information includes, for each 
CDLT furnished during a data collection period, the specific HCPCS code 
associated with the test, each private payor rate for which final 
payment has been made, and the associated volume of tests performed 
corresponding to each private payor rate. In general, the payment 
amount for a test on the CLFS furnished on or after January 1, 2018, 
will be equal to the weighted median of private payor rates determined 
for the test, based on the applicable information that is collected 
during a data collection period and reported to us during a data 
reporting period.
    In the CLFS final rule, we established a data collection period 
that is the 6 months from January 1 through June 30 during which 
applicable information is collected and that precedes the data 
collection period. We established a data reporting period that is the 
3-month period, January 1 through March 31, during which a reporting 
entity reports applicable information to CMS and that follows the 
preceding data collection period. The first data collection period was 
January 1, 2016 through June 30, 2016. The first data reporting period 
was January 1, 2017 through March 31, 2017. This 6-month data 
collection period and 3-month data reporting period schedule will be 
repeated every 3 years for CDLTs that are not advanced diagnostic 
laboratory tests (ADLTs), and every year for ADLTS that are not new 
ADLTs.
    For the first data reporting period, industry feedback suggested 
that many reporting entities would not be able to submit a complete set 
of applicable information to us by the March 31, 2017 deadline, and 
that entities required additional time to review collected data, 
address any issues identified during such review, and compile the data 
into our required reporting format. As a result, on March 30, 2017, we 
announced that we would exercise enforcement discretion until May 30, 
2017, with respect to the data reporting period for reporting 
applicable information under the Medicare CLFS and the application of 
the Secretary's potential assessment of civil monetary penalties for 
failure to report applicable information.\1\ The enforcement discretion 
applied to entities that were subject to the data reporting 
requirements adopted in the CLFS final rule (81 FR 41036). We noted in 
the announcement that the 60-day enforcement discretion period was the 
maximum amount of time we could permit to still have sufficient time to 
calculate the CLFS payment rates scheduled to go into effect on January 
1, 2018.
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    The announcement stated that the enforcement discretion period 
would not prevent reporting entities prepared to report applicable 
information from doing so before May 30, 2017. We explained in the 
announcement that we were committed to the successful implementation of 
the new private payor rate-based CLFS and looked forward to working 
with the laboratory industry to ensure accurate payment rates. Over the 
coming months, we will be analyzing the applicable information we 
received, holding our Annual

[[Page 34090]]

Laboratory Public Meeting, meeting with the Advisory Panel for Clinical 
Diagnostic Laboratory tests, and posting preliminary payment rates.
2. Solicitation of Public Comments on Medicare Clinical Diagnostic 
Laboratory Tests Payment System Initial Data Collection and Reporting 
Periods
    To better understand the applicable laboratories' experiences with 
the data reporting, data collection, and other compliance requirements 
for the first data collection and reporting periods, we are interested 
in public comments from applicable laboratories and reporting entities 
on the following questions:
     Was the CMS data reporting system easy to use? Please 
describe your overall experience with navigating the CMS data reporting 
system. For example, describe the aspects of the CMS data reporting 
system that worked well for your reporting entity and/or any problems 
the reporting entity experienced with submitting applicable information 
to us.
     Did the applicable laboratory (or its reporting entity) 
request and receive assistance from our Help Desk regarding the CMS 
data reporting system? Please describe your experience with receiving 
assistance.
     Did the applicable laboratory (or its reporting entity) 
request and receive assistance from the CMS CLFS Inquiries Mailbox 
regarding policy questions? Please describe your experience with 
receiving assistance.
     Did the applicable laboratory (or its reporting entity) 
use the subregulatory guidance on data reporting provided on the CMS 
CLFS Web site? \2\ If so, was the information presented useful?
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     Was the information that the applicable laboratory was 
required to report readily available in the applicable laboratory's 
record systems?
     Did the reporting entity have a manual, automated, or 
semi-automated remittance process for data reporting?
     If the reporting entity used a manual or semi-automated 
remittance process for data reporting, what percentage of the process 
was manual?
     How much time (hours) was required to assemble and report 
applicable information to CMS?
     Is there any other information that will inform us 
regarding the reporting, recordkeeping, and other compliance 
requirements from the first data collection and reporting periods?
    We believe that industry feedback on these issues will help inform 
us regarding potential refinements to the private payor rate-based CLFS 
for future data collection and reporting periods. We welcome comments 
on these questions from the public.

D. Payment for Biosimilar Biological Products Under Section 1847A of 
the Act

    In the CY 2016 Physician Fee Schedule (PFS) final rule with comment 
period, we finalized a proposal to amend the regulation text at Sec.  
414.904(j) to make clear that the payment amount for a biosimilar 
biological product is based on the ASP of all NDCs assigned to the 
biosimilar biological products included within the same billing and 
payment code (80 FR 71096 through 71101, November 16, 2015 Federal 
Register). In general, this means that products that rely on a common 
reference product's biologics license application are grouped into the 
same payment calculation for determining a single ASP payment limit and 
that a single HCPCS code is used for such biosimilar products. The 
regulation went into effect on January 1, 2016.
    The comments received on the rule revealed that stakeholders had 
varying opinions about payment for biosimilar biological products under 
Part B. The commenters included individuals, pharmaceutical 
manufacturers, patient advocate groups, providers, insurers, and 
members of Congress. A number of commenters opposed a single payment 
amount for all biosimilars that rely on a common reference product. 
Most of these commenters believed that the proposed regulation would 
decrease incentives for biosimilar development and that grouping 
payment for biosimilar biological products is inconsistent with the 
statute. Some commenters also expressed concerns that prescribers' 
choices will be limited, that tracking or pharmacovigilance activities 
will be impaired, and that innovation and product development will be 
harmed, leading to market consolidation and increased costs for 
biosimilar biological products. Many commenters who opposed our 
proposal suggested that we determine a payment amount for each 
biosimilar biological product. These stakeholders have expressed 
concerns that the finalized policy restricts and threatens the 
viability of their business models and expressed support for a market-
based solution. Some of these stakeholders believe that determining a 
payment for each biosimilar product by using individual HCPCS codes, 
would drive and reward innovators producing potential cost savings, of 
at least 10-15 percent compared to the reference biologic ASP, 
necessary for biosimilar products to compete with the reference 
biological.
    However, some commenters supported our proposed regulation, stating 
that the potential marketplace for biosimilar biological products is 
large and it is less risky than the marketplace for reference 
biologicals. Commenters also expressed concern that separate payment 
for each biosimilar biological product would result in less competition 
among manufacturers, which in turn could lead to higher payment amounts 
for Medicare and beneficiaries. Some commenters stated that separate 
billing codes could be perceived as a type of price protection and 
could artificially increase prices for biosimilars. Commenters who 
supported the proposed regulation suggested that we remain mindful of 
our policy as the biosimilar biological product marketplace evolves. 
Several commenters requested that policy decisions be delayed while 
issues such as naming conventions and interchangeability standards are 
finalized by the FDA.
    As CMS expected, since the regulation was finalized, the biosimilar 
product marketplace has continued to grow, and several biosimilar 
biological products that are paid under Part B have been licensed, 
including one product that we expect will share a HCPCS code with 
another biosimilar biological product. Over the next year or so, we 
anticipate that several more biosimilar biological products will be 
licensed for use in the United States and that during the following 
years, the marketplace will continue to grow steadily. We also 
anticipate that biological products will continue to be heavily 
utilized in Part B. At the same time, we are aware of concerns that 
current policy may discourage development of new biosimilars and other 
innovation in this area potentially resulting in higher costs over time 
due to a lack of competition in the market place.
    In the 2016 PFS final rule, we stated that it is desirable to have 
fair reimbursement in a healthy marketplace that encourages product 
development (80 FR 71101). CMS seeks to promote innovation, to provide 
more options to patients and physicians, and competition to drive 
prices down, recognizing that even though these two goals may be 
difficult to achieve concurrently, to delink them would be 
counterproductive.
    Although we believe that the United States biosimilar biological 
product marketplace is still in an early phase (because only a few 
products are on the market), we are interested in assessing

[[Page 34091]]

the effects of Medicare payment policy on this important portion of the 
Part B drug marketplace at this time, particularly for fostering a 
robust, and competitive marketplace and encouraging the innovation that 
is necessary to bring these products to the marketplace. It is 
essential to take a measured approach that considers all options given 
the significant federal spending by Medicare on Part B drugs, the 
effect of payment policies on program sustainability for taxpayers, 
health care affordability and access for beneficiaries, and the 
considerable investment the biosimilar industry is making in the 
nascent market. Failure to do so could potentially restrict innovation 
in the marketplace, increase costs to the American taxpayer, and limit 
treatment options. With that in mind, it is CMS's goal to further 
investigate a solution that allows market forces to provide a robust 
and comprehensive selection of choices for patients at a fair price. 
Additionally, we are interested in better understanding if and how the 
innate differences in biological products and their current regulatory 
environment should be reflected in Medicare payment policy for 
biosimilars, particularly as it relates to biosimilars that are 
licensed for fewer than all indications for which the reference product 
is licensed or situations where different biosimilars may be licensed 
for different subsets of indications for which the reference product is 
licensed.
    Thus, we are requesting comments regarding our Medicare Part B 
biosimilar biological product payment policy. This comment solicitation 
is seeking new or updated information on the effects of the current 
biosimilar payment policy that is based on experience with the United 
States marketplace. We are particularly interested in obtaining 
material, such as market analyses or research articles that provide 
data and insight into the current economics of the biosimilar market 
place. This includes patient, plan, and manufacturer data both domestic 
and, where applicable, from European markets that may be more 
established than, and provide insight for, the current United States' 
market.
    We also seek data to demonstrate how individual HCPCS codes could 
impact the biosimilar market, including innovation, the number of 
biosimilar products introduced to the market, patient access, and drug 
spending. Finally, we also seek comment regarding other novel payment 
policies that would foster competition, increase access, and drive cost 
savings in the biological product marketplace. These solutions may 
include legislation, demonstrations, and administrative options. Please 
note that this is a solicitation for comments on this issue for future 
consideration. We are not making a proposal to change the existing 
payment policy in this proposed rule.

E. Appropriate Use Criteria for Advanced Diagnostic Imaging Services

    Section 218(b) of the Protecting Access to Medicare Act (PAMA) 
amended Title XVIII of the Act to add section 1834(q) of the Act 
directing us to establish a program to promote the use of appropriate 
use criteria (AUC) for advanced diagnostic imaging services. The CY 
2016 PFS final rule with comment period addressed the initial component 
of the new Medicare AUC program, specifying applicable AUC. In that 
rule (80 FR 70886), we established an evidence-based process and 
transparency requirements for the development of AUC, defined provider-
led entities (PLEs) and established the process by which PLEs may 
become qualified to develop, modify or endorse AUC. The first list of 
qualified PLEs was posted on the CMS Web site at the end of June 2016 
at which time their AUC libraries became specified applicable AUC for 
purposes of section 1834(q)(2)(A) of the Act. The CY 2017 PFS final 
rule addressed the second component of this program, specification of 
qualified clinical decision support mechanisms (CDSMs). In that rule 
(81 FR 80170), we defined CDSM, identified the requirements CDSMs must 
meet for qualification including an opportunity for preliminary 
qualification for mechanisms still working toward full adherence, and 
established a process by which CDSMs may become qualified. We also 
defined applicable payment systems under this program, specified the 
first list of priority clinical areas and identified exceptions to the 
requirements that ordering professionals consult specified applicable 
AUC when ordering applicable imaging services. The first list of 
qualified CDSMs will be posted on the CMS Web site in conjunction with 
this proposed rule.
    This rule proposes the start date of the Medicare AUC program for 
advanced diagnostic imaging services. It is on and after this date that 
ordering professionals must consult specified applicable AUC using a 
qualified CDSM when ordering applicable imaging services and furnishing 
professionals must report consultation information on the Medicare 
claim. This rule also proposes to modify the policy related to 
significant hardship exceptions and requests public feedback on details 
regarding how AUC consultation information must be included on the 
Medicare claim. To further this iterative process of implementation, we 
also discuss briefly the potential for alignment with other Medicare 
quality programs.
1. Background
    AUC present information in a manner that links: a specific clinical 
condition or presentation, one or more services and, an assessment of 
the appropriateness of the service(s). For purposes of this program AUC 
is a set or library of individual appropriate use criteria. Each 
individual criterion is an evidence-based guideline for a particular 
clinical scenario. Each scenario in turn starts with a patient's 
presenting symptoms or condition. Evidence-based AUC for imaging can 
assist clinicians in selecting the imaging study that is most likely to 
improve health outcomes for patients based on their individual clinical 
presentation.
    AUC need to be integrated as seamlessly as possible into the 
clinical workflow. CDSMs are the electronic portals through which 
clinicians access the AUC during the patient workup. While CDSMs can be 
standalone applications that require direct entry of patient 
information, they may be more effective when they automatically 
incorporate information such as specific patient characteristics, 
laboratory results, and lists of co-morbid diseases from Electronic 
Health Records (EHRs) and other sources. Ideally, practitioners would 
interact directly with the CDSM through their primary user interface, 
thus minimizing interruption to the clinical workflow.
    Consistent with descriptions of clinical decision support by the 
Agency for Healthcare Research and Quality (AHRQ) (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. Statutory Authority
    Section 218(b) of the PAMA added a new section 1834(q) of the Act 
entitled, ``Recognizing Appropriate Use Criteria for Certain Imaging 
Services,'' which

[[Page 34092]]

directs the Secretary to establish a new program to promote the use of 
AUC. Section 1834(q)(4) of the Act requires ordering professionals to 
consult with a qualified CDSM for applicable imaging services furnished 
in an applicable setting and paid for under an applicable payment 
system; and for the furnishing professional to include on the Medicare 
claim information about the ordering professional's consultation with a 
qualified CDSM.
3. Discussion of Statutory Requirements
    There are four major components of the AUC program under section 
1834(q) of the Act, and each component has its own implementation date: 
(1) Establishment of AUC by November 15, 2015 (section 1834(q)(2) of 
the Act); (2) identification of mechanisms for consultation with AUC by 
April 1, 2016 (section 1834(q)(3) of the Act); (3) AUC consultation by 
ordering professionals, and reporting on AUC consultation by furnishing 
professionals by January 1, 2017 (section 1834(q)(4) of the Act); and 
(4) annual identification of outlier ordering professionals for 
services furnished after January 1, 2017 (section 1834(q)(5) of the 
Act). As we will discuss later in this preamble and in prior PFS rules, 
we did not identify mechanisms for consultation by April 1, 2016. 
Therefore, we did not require ordering professionals to consult CDSMs 
or furnishing professionals to report information on the consultation 
by the January 1, 2017 date.
a. Establishment of AUC
    In the CY 2016 PFS final rule with comment period, we addressed the 
first component of the Medicare AUC program under section 1834(q)(2) of 
the Act--the requirements and process for establishment and 
specification of applicable AUC, along with relevant aspects of the 
definitions under section 1834(q)(1) of the Act. This included defining 
the term PLE and finalizing requirements for the rigorous, evidence-
based process by which a PLE would develop AUC, upon which 
qualification is based, as provided in section 1834(q)(2)(B) of the Act 
and in the CY 2016 PFS final rule with comment period. Using this 
process, once a PLE is qualified by CMS, the AUC that are developed, 
modified or endorsed by the qualified PLE are considered to be 
specified applicable AUC under section 1834(q)(2)(A) of the Act. We 
defined the term PLE to include national professional medical 
societies, health systems, hospitals, clinical practices and 
collaborations of such entities such as the High Value Healthcare 
Collaborative or the National Comprehensive Cancer Network. Qualified 
PLEs may collaborate with third parties that they believe add value to 
their development of AUC, provided such collaboration is transparent. 
We expect qualified PLEs to have sufficient infrastructure, resources, 
and the relevant experience to develop and maintain AUC according to 
the rigorous, transparent, and evidence-based processes detailed in the 
CY 2016 PFS final rule with comment period.
    In the same rule we established a timeline and process under Sec.  
414.94(c)(2) for PLEs to apply to become qualified. Consistent with 
this timeline the first list of qualified PLEs was published at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/PLE.html (OMB Control 
Number 0938-1288).
b. Mechanism for AUC Consultation
    In the CY 2017 PFS final rule, we addressed the second major 
component of the Medicare AUC program--the specification of qualified 
CDSMs for use by ordering professionals for consultation with specified 
applicable AUC under section 1834(q)(3) of the Act, along with relevant 
aspects of the definitions under section 1834(q)(1) of the Act. This 
included defining the term CDSM and finalizing functionality 
requirements of mechanisms, upon which qualification is based, as 
provided in section 1834(q)(3)(B) of the Act and in the CY 2017 PFS 
final rule. We included an opportunity for mechanisms still working 
toward full adherence to these requirements to receive preliminary 
qualification during the preliminary qualification period that begins 
June 30, 2017, and ends when the AUC consulting and reporting 
requirements become effective. The preliminarily qualified CDSMs must 
meet all requirements by that time. We defined CDSM as an interactive, 
electronic tool for use by clinicians that communicates AUC information 
to the user and assists them in making the most appropriate treatment 
decision for a patient's specific clinical condition. Tools may be 
modules within or available through certified EHR technology (as 
defined in section 1848(o)(4) of the Act) or private sector mechanisms 
independent from certified EHR technology or established by the 
Secretary.
    In the CY 2017 PFS final rule we established a timeline and process 
in Sec.  414.94(g)(2) for CDSM developers to apply to have their CDSMs 
qualified. Consistent with this timeline, the first list of qualified 
CDSMs will be posted on the CMS Web site https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Appropriate-Use-Criteria-Program/CDSM.html in conjunction with this proposed rule (OMB 
Control Number 0938-1315).
c. AUC Consultation and Reporting
    The third major component of the Medicare AUC program is in section 
1834(q)(4) of the Act, Consultation with Applicable Appropriate Use 
Criteria. This section establishes, beginning January 1, 2017, the 
requirement for an ordering professional to consult with a qualified 
CDSM when ordering an applicable imaging service that would be 
furnished in an applicable setting and paid for under an applicable 
payment system; and for the furnishing professional to include on the 
Medicare claim information about the ordering professional's 
consultation with a qualified CDSM. The statute distinguishes between 
the ordering and furnishing professional, recognizing that the 
professional who orders an applicable imaging service is usually not 
the same professional who bills Medicare for that service when 
furnished. Since a list of qualified CDSMs was not available by January 
1, 2017, we did not require ordering professionals to meet the 
consultation requirement by that date.
    Section 1834(q)(4)(C) of the Act provides for certain exceptions to 
the AUC consultation and reporting requirements including in the case 
of certain emergency services, inpatient services paid under Medicare 
Part A, and ordering professionals who obtain an exception due to a 
significant hardship. In the CY 2017 PFS final rule, we identified the 
circumstances specific to ordering professionals under which consulting 
and reporting requirements are not required. These include orders for 
applicable imaging services: (1) For emergency services when provided 
to individuals with emergency medical conditions as defined in section 
1867(e)(1) of the Act; (2) for an inpatient and for which payment is 
made under Medicare Part A; and (3) by ordering professionals who are 
granted a significant hardship exception to the Medicare EHR Incentive 
Program payment adjustment for that year under 42 CFR 495.102(d)(4), 
except for those granted such an exception under Sec.  
495.102(d)(4)(iv)(C). We propose changes to the significant hardship 
exception later in this preamble.
    Section 1834(q)(4)(D) of the Act specifies that the applicable 
payment systems for the AUC consultation and reporting requirements, 
and, in the CY 2017 PFS final rule we defined them as:

[[Page 34093]]

(1) The physician fee schedule established under section 1848(b) of the 
Act; (2) the prospective payment system for hospital outpatient 
department services under section 1833(t) of the Act; and (3) the 
ambulatory surgical center payment system under section 1833(i) of the 
Act.
d. Identification of Outliers
    The fourth component of the Medicare AUC program is in section 
1834(q)(5) of the Act, Identification of Outlier Ordering 
Professionals. The identification of outlier ordering professionals 
under this paragraph facilitates a prior authorization requirement for 
outlier professionals beginning January 1, 2020, as specified under 
section 1834(q)(6) of the Act. Given that we are proposing a program 
start date of January 1, 2019, we anticipate that implementation of the 
prior authorization component would be delayed. We expect to discuss 
details around outlier calculations and prior authorization in the CY 
2019 PFS proposed rule. However, we did finalize in the CY 2017 PFS 
final rule the first list of priority clinical areas to guide 
identification of outlier ordering professionals as follows:
     Coronary artery disease (suspected or diagnosed).
     Suspected pulmonary embolism.
     Headache (traumatic and non-traumatic).
     Hip pain.
     Low back pain.
     Shoulder pain (to include suspected rotator cuff injury).
     Cancer of the lung (primary or metastatic, suspected or 
diagnosed).
     Cervical or neck pain.
    As established in Sec.  414.94(e)(4) of our regulations, priority 
clinical areas may be used in the identification of outlier ordering 
professionals. By starting to identify these areas now, we believe 
ordering professionals will have the opportunity to become familiar 
with AUC within identified priority clinical areas prior to Medicare 
claims for those services being part of the input for calculating 
outlier ordering professionals.
    We are not including proposals to expand or modify the list of 
priority clinical areas in this rule.
4. Proposals for Continuing Implementation
    We propose to amend Sec.  414.94 of our regulations, ``Appropriate 
Use Criteria for Certain Imaging Services,'' to reflect the following 
proposals.
a. Consultation by Ordering Professional and Reporting by Furnishing 
Professional
    We are proposing that ordering professionals must consult specified 
applicable AUC through qualified CDSMs for applicable imaging services 
furnished in an applicable setting, paid for under an applicable 
payment system and ordered on or after January 1, 2019. This proposed 
effective date for the consulting and reporting requirements is 
necessary to allow time for ordering practitioners who are not already 
aligned with a qualified CDSM to research and evaluate the qualified 
CDSMs so they may make an informed decision. Although there will be 
another rulemaking cycle next year before the consulting and reporting 
requirement is effective as proposed on January 1, 2019, we are 
establishing this date through rulemaking this year because the agency 
expects practitioners and other stakeholders to begin preparing 
themselves to report on that date and, in response to public comment 
and stakeholder feedback, we want to ensure all impacted parties have 
sufficient time to prepare to meet the requirements of this program.
    After proposing the timeline and process for qualification of CDSMs 
in the CY 2017 PFS proposed rule (81 FR 46392), we anticipated that 
furnishing professionals may begin reporting as early as January 1, 
2018. However, we received comments that these timelines did not allow 
enough time to address the needs of different stakeholder groups. Some 
commenters requested that CMS delay the timeline and process to give 
practitioners sufficient time to obtain a qualified CDSM. Other 
commenters cited insufficient time for CDSMs to incorporate 
requirements between the release of the final CDSM requirements and 
January 1, 2018, and requested that CMS fully implement the program at 
a later date. Additionally, in the CY 2017 PFS final rule (81 FR 80411) 
we discussed commenters' recommendations that CMS develop and launch an 
educational campaign, including a Town Hall meeting. Some commenters 
requesting additional time suggested that, for purposes of both CDSM 
vendor readiness and practitioner readiness, consulting and reporting 
requirements should not go into effect for an additional 12-18 months 
after the initial list of CMS qualified CDSMs is posted.
    By proposing the consulting and reporting requirements begin on 
January 1, 2019 we believe that we are allowing needed time for 
education and outreach efforts, time for practitioners and stakeholders 
to prepare, and time for CDSMs to continue current strides in being 
more user-friendly and less burdensome. We note that the statute 
required publication of qualified CDSMs by April 1, 2016, and required 
AUC consultation and reporting by January 1, 2017; therefore, our 
proposal substantially lags the statutory requirements. As noted above 
and in previous rulemaking, a delay in the statutory timeline is 
necessary to maximize the opportunity for public comment and 
stakeholder engagement, also a statutory requirement, and allows for 
adequate advance notice to practitioners, beneficiaries, AUC 
developers, and CDSM developers.
    Consistent with section 1834(q)(4)(B) of the Act, we are also 
proposing that furnishing professionals report the following 
information on Medicare claims for applicable imaging services, 
furnished in an applicable setting, paid for under an applicable 
payment system as defined in Sec.  414.94(b), and ordered on or after 
January 1, 2019: (1) Which qualified CDSM was consulted by the ordering 
professional; (2) whether the service ordered would adhere to specified 
applicable AUC, would not adhere to specified applicable AUC, or 
whether specified applicable AUC were not applicable to the service 
ordered; and (3) the NPI of the ordering professional (if different 
from the furnishing professional).
    We believe that, unless a statutory exception applies, an AUC 
consultation must take place for every order for an applicable imaging 
service furnished in an applicable setting and under an applicable 
payment system. We further believe that section 1834(q)(4)(B) of the 
Act accounts for the possibility that AUC may not be available in a 
particular qualified CDSM to address every applicable imaging service 
that might be ordered; and thus, the furnishing professional can meet 
the requirement to report information on the ordering professional's 
AUC consultation by indicating that AUC is not applicable to the 
service ordered. We remind readers as required under Sec.  
414.94(g)(1)(iii) that qualified CDSMs must make available, at a 
minimum, AUC that reasonably address common and important clinical 
scenarios within all priority clinical areas. As discussed in the CY 
2017 PFS final rule (81 FR 80170), the current list of priority 
clinical areas represents about 40 percent of advanced diagnostic 
imaging services paid for by Medicare in 2014. We also remind readers 
that consistent with section 1834(q)(4)(A) of the Act, ordering 
professionals must consult AUC for every advanced diagnostic

[[Page 34094]]

imaging service ordered. While section 218(b) of the PAMA allows 
qualified CDSMs to return a response of ``not applicable'' if a 
qualified CDSM does not contain specified applicable AUC for the 
service ordered, we expect these situations to be limited in scope and 
number, and to decrease over time. The ``not applicable'' responses 
should decrease as qualified PLEs continue to build out their AUC 
libraries and qualified CDSMs update their content and potentially 
collaborate with more qualified PLEs so as to make available highly 
comprehensive tools.
    Section 1834(q)(4)(B) requires that payment may only be made if the 
claim for the service includes the specific information discussed in 
this proposed rule. This information, to the extent feasible, is 
required across claim types (including both the furnishing professional 
and facility claims) and across all three applicable payment systems 
(PFS, hospital outpatient prospective payment system and ambulatory 
surgical center payment system). In other words, we would expect this 
information to be included on the practitioner claim that includes the 
professional component of the imaging service and on the hospital 
outpatient claim for the technical component of the imaging service. 
Claims for services for which payment is not made under the three 
identified payment systems would not be required to include 
consultation related information.
    To implement this requirement we propose to establish a series of 
HCPCS level 3 codes. These G-codes would describe the specific CDSM 
that was used by the ordering professional. Ultimately there would be 
one G-code for every qualified CDSM with the code description including 
the name of the CDSM. However, because the claims processing system can 
only recognize new codes quarterly, we may not be able to update the G-
code descriptors simultaneously with the announcement of any new 
qualified CDSMs which is expected to occur in June of each year. To 
ensure that there is a code available to immediately describe newly 
qualified CDSMs, we propose to establish a generic G-code that would be 
used to report that a qualified CDSM was consulted, but would not 
identify a specific qualified CDSM; clinicians would only be permitted 
to use this code if a more specific named code did not yet exist for 
that clinician's CDSM. Furnishing professionals would report this code 
temporarily until a specific G-code describing the newly qualified CDSM 
by name becomes available. We also propose to establish a G-code to 
identify circumstances where there was no AUC consultation through a 
qualified CDSM. The description of this code would indicate that a 
qualified CDSM was not consulted by the ordering professional.
    G-codes would be a line-item on both practitioner claims and 
facility claims. We would expect that one AUC consulatation G-code 
would be reported for every advanced diagnostic imaging service on the 
claim. If there are two codes billed for advanced imaging services on 
the claim then we would expect two G-codes. Each G-code would be 
expected, on the same claim line, to contain at least one new HCPCS 
modifier. We propose to develop a series of modifiers to provide 
necessary information as to whether, when a CDSM is used to consult 
AUC: (1) The imaging service would adhere to the applicable appropriate 
use criteria; (2) the imaging service would not adhere to such 
criteria; or (3) such criteria were not applicable to the imaging 
service ordered. We propose to create additional modifiers to describe 
situations where an exception applies and a qualified CDSM was not used 
to consult AUC: (1) The imaging service was ordered for a patient with 
an emergency medical condition or (2) the ordering professional has a 
significant hardship exception. Based on this proposal we specifically 
seek comments on any additional HCPCS modifiers that might be needed to 
separately identify allowable scenarios for which a qualified CDSM was 
not consulted by the ordering professional.
    The proposed AUC consultation and reporting start date of January 
1, 2019 is expected to allow adequate time for us to operationalize the 
claims-based procedures and systems changes needed to accomplish the 
processing of Medicare claims with AUC consultation information.
    There are aspects of the AUC program that are novel and complex for 
the CMS claims processing system and for ordering and furnishing 
professionals. An AUC consultation by an ordering professional has 
never before been required by fee-for-service Medicare with such a 
broad application (all professionals ordering advanced diagnostic 
tests). Additional considerations for the complex communication of AUC 
consultation information from the ordering professional to the 
furnishing professional and facility that must include that information 
when billing for the service are warranted. Their billing systems will 
need to translate the AUC consultation information onto Medicare claims 
in the form of G-codes and HCPCS modifiers. These processes are new for 
many professionals, and there are many areas for potential error. For 
these reasons an educational and operations testing period is needed. 
During this period, ordering professionals would consult AUC and 
furnishing professionals would report AUC consultation information on 
the claim, but we would continue to pay claims whether or not they 
correctly include such information. This educational period allows 
professionals to actively participate in the program while avoiding 
claims denials during the learning curve. It also gives us an 
opportunity to make any needed claims processing adjustments before 
payments are impacted.
    We believe it is preferable to begin implementation using a single 
year educational and operations testing period, rather than possibly 
further delaying the start-date of the program. We do not expect to 
continue this educational and operations testing period beyond the 
first year of the AUC program.
    We look forward to receiving public comments on all aspects of our 
proposal, and specifically, comments related to whether the program 
should be delayed beyond the proposed start date of January 1, 2019. 
Although our proposal is based in part on comments received in prior 
rulemaking cycles, it is important to receive comments that help us 
understand the current readiness of stakeholders. In addition, we have 
proposed that the program begin with an educational and operations 
testing period and are interested in comments regarding how long, if 
longer than one year, such a period should be available.
    We expect a voluntary reporting period to be available ahead of 
January 1, 2019 and anticipate such a period will begin July 2018. The 
timing for this opportunity for voluntary reporting is dependent on the 
readiness of the Medicare claims system to accept and process claims 
that include AUC consultation information. When the voluntary period 
becomes available we will make announcements through our educational 
channels such as the CMS Web site and listservs. It is important to 
note that the proposed educational and operations testing period 
beginning January 1, 2019, is separate from the anticipated voluntary 
reporting period that we expect to allow before January 1, 2019. During 
the voluntary reporting period, AUC consultation and reporting are not 
required. However, for applicable imaging services ordered on and after 
January 1, 2019, consulting specified applicable AUC and reporting 
consultation information on the

[[Page 34095]]

Medicare claim would be required for all ordering and furnishing 
professionals, respectively.
b. Alignment With Other Medicare Quality Programs
    The CY 2017 Merit-based Incentive Payment System and Alternative 
Payment Model final rule with comment period (Quality Payment Program 
final rule) (81 FR 77008) finalized policies to improve physician and 
other clinician payments by changing the way Medicare incorporates 
quality measurement into payments and developing new policies to 
address and incentivize participation in Advanced Alternative Payment 
Models (APMs). We expect the Quality Payment Program to evolve over 
multiple years and to continue iterating on these policies. To this 
end, the AUC program has the potential to provide new opportunities to 
improve care delivery by supporting and rewarding clinicians as they 
find new ways to engage patients, families and caregivers as well as 
improving care coordination and patient health management.
    Therefore, we have proposed in the CY 2018 Quality Payment Program 
proposed rule to develop a direct tie between MIPS and the AUC program 
(See CY 2018 Quality Payment Program Proposed Rule (82 FR 30010) 
published in the June 30, 2017 Federal Register). In that rule, we 
proposed to give MIPS credit to ordering professionals for consulting 
AUC using a qualified CDSM as a high-weight improvement activity for 
the performance period beginning January 1, 2018 (82 FR 30484). We 
believe this will incentivize early use of qualified CDSMs to consult 
AUC by motivated eligible clinicians looking to improve patient care 
and to better prepare themselves for the AUC program. Although the AUC 
program would not officially begin until January 1, 2019, we are able 
to support this proposed improvement activity because the first 
qualified CDSMs will be announced in conjunction with this proposed 
rule; therefore, ordering professionals will be able to begin 
consulting AUC using those tools.
    We are also considering how the AUC program could serve to support 
a quality measure under the MIPS quality performance category and seek 
feedback from the public regarding feasibility and value of pursuing 
this idea further.
c. Significant Hardship Exceptions to Consulting and Reporting 
Requirements
    We are proposing to modify Sec.  414.94(i)(3) of our regulations to 
reflect the sunsetting of the payment adjustments under the Medicare 
EHR Incentive Program and to substitute an alignment with the advancing 
care information performance category of MIPS. The categories that we 
included in the CY 2017 PFS final rule for purposes of the AUC program 
significant hardship exceptions were the following from Sec.  
495.102(d)(4):
     Insufficient Internet Connectivity (as specified in Sec.  
495.102(d)(4)(i)).
     Practicing for less than 2 years (as specified in Sec.  
495.102(d)(4)(ii)).
     Extreme and Uncontrollable Circumstances (as specified in 
Sec.  495.102(d)(4)(iii)).
     Lack of Control over the Availability of CEHRT (as 
specified in Sec.  495.102(d)(4)(iv)(A)).
     Lack of Face-to-Face Patient Interaction (as specified in 
Sec.  495.102(d)(4)(iv)(B)).
    In addition, in the CY 2017 Quality Payment Program final rule, we 
finalized a policy (81 FR 77240-77243) to reweight the advancing care 
information performance category to zero in the MIPS final score for 
the year for MIPS eligible clinicians who meet the criteria in one of 
the above listed categories of Sec.  495.102(d)(4), with the exception 
of the category for clinicians practicing for less than 2 years. Under 
section 1848(q)(1)(C)(v) of the Act, eligible clinicians who first 
enroll in Medicare during the performance period for a year and have 
not previously submitted claims under Medicare are not considered MIPS 
eligible clinicians, and thus are excluded from MIPS. We believe it is 
likely that many clinicians who have been practicing for less than 2 
years would be excluded from MIPS on the basis that they are new 
Medicare-enrolled MIPS eligible clinicians as defined in Sec.  
414.1305. Because these clinicians are not MIPS eligible clinicians, 
they would never meet the criteria for re-weighting of their MIPS 
advancing care information performance category for the year. 
Therefore, to implement a hardship exception for purposes of the AUC 
program that is both operationally consistent and administratively 
efficient, we propose to remove as a criterion for a significant 
hardship exception for the AUC program the criterion specified in Sec.  
495.102(d)(4)(ii) of our regulations for those practicing for less than 
2 years. We propose to keep the remaining listed categories including 
insufficient internet connectivity, extreme and uncontrollable 
circumstances, lack of control over availability of CEHRT and lack of 
face-to-face patient interaction. We note that section 
1843(q)(4)(C)(iii) of the Act only allows the ordering professional to 
seek a significant hardship exception, not the furnishing professional.
    As such, we propose to amend the AUC significant hardship exception 
regulation to specify that ordering professionals who are granted re-
weighting of the advancing care information performance category to 
zero percent of the final score for the year under MIPS per Sec.  
414.1380(c)(2) due to circumstances that include the criteria listed in 
Sec.  495.102(d)(4)(i), (iii), (iv)(A) and (iv)(B) would be excepted 
from the AUC consultation requirement during the same year that the re-
weighting applies for purposes of the MIPS payment adjustment.
    There will be scenarios when a clinician's experience of a 
significant hardship or extraordinary circumstance does not align with 
the prospective identification of these ordering professionals with 
reference to MIPS criteria and processes. However, we believe the 
prospective identification process allows us to apply exceptions in 
real-time for claims submitted for advanced imaging services. There are 
timing differences between the MIPS and the AUC program (the MIPS 
payment adjustment year is based on performance in a prior year while 
the Medicare AUC program requires real-time AUC consultation and 
claims-based reporting). In addition to the timing, there will be 
instances when a clinician who is not a MIPS eligible clinician will 
need to seek a significant hardship exception to the Medicare AUC 
program. To accommodate these two separate scenarios, we propose to 
establish a process to identify ordering professionals in need of a 
significant hardship exception to the Medicare AUC program requirements 
that is outside the MIPS re-weighting process. For purposes of these 
scenarios, we propose to use the criteria for clinicians seeking an AUC 
significant hardship exception described under Sec.  495.102(d)(4) to 
include (i), (iii), (iv)(A) and (iv)(B) of our regulations. We propose 
these criteria to align with the criteria used under MIPS for re-
weighting under the advancing care information performance category, 
and to provide predictability and consistency to the determination of 
significant hardship. We further propose that a significant hardship 
exception from the Medicare AUC program requirements would be granted 
for no longer than 12 months, and that we could establish an exception 
for a shorter period where warranted by the circumstances.
    Therefore we propose that ordering professionals who have not 
received a re-weighting to zero for the MIPS

[[Page 34096]]

advancing care information performance category for the year, but 
experience one of the circumstances described in Sec.  495.102(d)(4) to 
include (i), (iii), (iv)(A) and (iv)(B), may be granted an AUC 
significant hardship exception for no longer than one year. We expect 
to provide further information on this execption process in future 
rulemaking.
    In addition to the proposals above, we invite the public to comment 
on additional circumstances for which it may be appropriate for an 
ordering professional to be granted a significant hardship exception 
under the AUC program.
5. Summary
    Section 1834(q) of the Act includes rapid timelines for 
establishing a Medicare AUC program for advanced diagnostic imaging 
services. The impact of this program is extensive as it will apply to 
every physician or other practitioner who orders or furnishes advanced 
diagnostic imaging services (for example, magnetic resonance imaging 
(MRI), computer tomography (CT) or positron emission tomography (PET)). 
This crosses almost every medical specialty and could have a particular 
impact on primary care physicians since their scope of practice can be 
quite broad. Stakeholders have expressed concern that program 
requirements may inadvertently encourage physicians to order imaging 
services that they do not believe are right for their patients. The 
goal of evidence-based AUC is to assist clinicians in ordering the most 
appropriate imaging service for their patients' specific clinical 
scenarios. However, to ensure we are implementing the program 
effectively, we are asking for public comment on such potential 
unintended consequences. Additionally, as we continue to develop the 
AUC program, we continue to engage a variety of stakeholders interested 
in participating in the development of AUC. We seek comment about how 
we can continue to engage interested participants, consistent with 
statutory requirements at section 1834(q) of the Act, in developing AUC 
in a transparent and scientifically robust manner. We are particularly 
interested in how qualified PLEs develop or modify AUC in collaboration 
with non-PLE entities and what additional challenges such entities 
might face.
    We continue to believe the best implementation approach is one that 
is diligent, maximizes the opportunity for public comment and 
stakeholder engagement, and allows for adequate advance notice to 
physicians and practitioners, beneficiaries, AUC developers, and CDSM 
developers. It is for these reasons we propose to continue a stepwise 
approach, adopted through notice and comment rulemaking. We propose 
policies to implement the third component of the AUC program--the 
consulting and reporting requirements and the effective date on which 
these requirements would begin. Under this proposal, ordering 
professionals must begin consulting specified applicable AUC through 
qualified CDSMs for applicable imaging services ordered on and after 
January 1, 2019, and furnishing professionals must begin reporting AUC 
consultation information on Medicare claims for advanced diagnostic 
imaging services for which payment is made under an applicable payment 
system as defined in Sec.  414.94(b) and ordered on or after January 1, 
2019.
    We also propose modifications to the significant hardship exception 
to better align these exceptions under the AUC program with those under 
existing quality programs.
    In summary, we are proposing requirements necessary to implement 
the third component of the AUC program. We invite the public to submit 
comments on these proposals.

F. Physician Quality Reporting System (PQRS) Criteria for Satisfactory 
Reporting for Individual EPs and Group Practices for the 2018 PQRS 
Payment Adjustment

1. Background
    Section 1848(a)(8) of the Act provides that for covered 
professional services furnished by an EP during each of 2015 through 
2018, if the EP does not satisfactorily report data on quality measures 
for covered professional services for the reporting period for the 
year, the PFS amount for services furnished by such professional during 
the year (including the PFS amount for purposes of determining a 
payment based on such amount) shall be equal to the applicable percent 
of the PFS amount that would otherwise apply to such services. For 2016 
through 2018, the applicable percent is 98.0 percent. Thus, individual 
EPs and group practices who did not satisfactorily report data on 
quality measures for the CY 2016 reporting period are subject to a 
downward payment adjustment of 2.0 percent to the PFS payment amount 
for covered professional services they furnish in 2018.
2. Previously Finalized Satisfactory Reporting Criteria for Individual 
EPs and Group Practices for the 2018 PQRS Payment Adjustment
    We previously finalized the satisfactory reporting criteria for 
individual EPs and group practices for the CY 2016 reporting period to 
avoid the 2018 PQRS payment adjustment in the CY 2016 PFS final rule 
(80 FR 71140 through 71250) at Sec.  414.90(j)(8) and (9) and Sec.  
414.90(k)(5).
    Table 18 summarizes the previously finalized satisfactory reporting 
criteria for individual EPs at Sec.  414.90(j)(8) and Sec.  
414.90(k)(5).

[[Page 34097]]



  Table 18--Summary of Requirements for the 2018 PQRS Payment Adjustment: Individual Reporting Criteria for the
  Satisfactory Reporting of Quality Measures Data via Claims, Qualified Registry, and Electronic Health Records
          (EHRs) and Satisfactory Participation Criteria in Qualified Clinical Data Registries (QCDRs)
----------------------------------------------------------------------------------------------------------------
                                                                                       Satisfactory reporting/
          Reporting period                Measure type         Reporting mechanism    satisfactory participation
                                                                                               criteria
----------------------------------------------------------------------------------------------------------------
12-month (Jan 1-Dec 31, 2016)......  Individual Measures...  Claims................  Report at least 9 measures,
                                                                                      covering at least 3 of the
                                                                                      National Quality Strategy
                                                                                      (NQS) domains AND report
                                                                                      each measure for at least
                                                                                      50 percent of the EP's
                                                                                      Medicare Part B Fee-for-
                                                                                      Service (FFS) patients
                                                                                      seen during the reporting
                                                                                      period to which the
                                                                                      measure applies. Of the
                                                                                      measures reported, if the
                                                                                      EP sees at least 1
                                                                                      Medicare patient in a face-
                                                                                      to-face encounter, the EP
                                                                                      will report on at least 1
                                                                                      measure contained in the
                                                                                      PQRS cross-cutting measure
                                                                                      set. If less than 9
                                                                                      measures apply to the EP,
                                                                                      the EP would report on
                                                                                      each measure that is
                                                                                      applicable), AND report
                                                                                      each measure for at least
                                                                                      50 percent of the Medicare
                                                                                      Part B FFS patients seen
                                                                                      during the reporting
                                                                                      period to which the
                                                                                      measure applies. Measures
                                                                                      with a 0 percent
                                                                                      performance rate would not
                                                                                      be counted.
12-month (Jan 1-Dec 31, 2016)......  Individual Measures...  Qualified Registry....  Report at least 9 measures,
                                                                                      covering at least 3 of the
                                                                                      NQS domains AND report
                                                                                      each measure for at least
                                                                                      50 percent of the EP's
                                                                                      Medicare Part B FFS
                                                                                      patients seen during the
                                                                                      reporting period to which
                                                                                      the measure applies. Of
                                                                                      the measures reported, if
                                                                                      the EP sees at least 1
                                                                                      Medicare patient in a face-
                                                                                      to-face encounter, the EP
                                                                                      will report on at least 1
                                                                                      measure contained in the
                                                                                      PQRS cross-cutting measure
                                                                                      set. If less than 9
                                                                                      measures apply to the EP,
                                                                                      the EP would report on
                                                                                      each measure that is
                                                                                      applicable, AND report
                                                                                      each measure for at least
                                                                                      50 percent of the Medicare
                                                                                      Part B FFS patients seen
                                                                                      during the reporting
                                                                                      period to which the
                                                                                      measure applies. Measures
                                                                                      with a 0 percent
                                                                                      performance rate would not
                                                                                      be counted.
12-month (Jan 1-Dec 31, 2016)......  Individual Measures...  Direct EHR Product or   Report 9 measures covering
                                                              EHR Data Submission     at least 3 of the NQS
                                                              Vendor Product.         domains. If an EP's direct
                                                                                      EHR product or EHR data
                                                                                      submission vendor product
                                                                                      does not contain patient
                                                                                      data for at least 9
                                                                                      measures covering at least
                                                                                      3 domains, then the EP
                                                                                      would be required to
                                                                                      report all of the measures
                                                                                      for which there is
                                                                                      Medicare patient data. An
                                                                                      EP would be required to
                                                                                      report on at least 1
                                                                                      measure for which there is
                                                                                      Medicare patient data.
12-month (Jan 1-Dec 31, 2016)......  Measures Groups.......  Qualified Registry....  Report at least 1 measures
                                                                                      group AND report each
                                                                                      measures group for at
                                                                                      least 20 patients, the
                                                                                      majority (11 patients) of
                                                                                      which are required to be
                                                                                      Medicare Part B FFS
                                                                                      patients. Measures groups
                                                                                      containing a measure with
                                                                                      a 0 percent performance
                                                                                      rate will not be counted.
12-month (Jan 1-Dec 31, 2016)......  Individual PQRS         QCDR..................  Report at least 9 measures
                                      measures and/or non-                            available for reporting
                                      PQRS measures                                   under a QCDR covering at
                                      reportable via a QCDR.                          least 3 of the NQS
                                                                                      domains, AND report each
                                                                                      measure for at least 50
                                                                                      percent of the EP's
                                                                                      patients. Of these
                                                                                      measures, the EP would
                                                                                      report on at least 2
                                                                                      outcome measures, OR, if 2
                                                                                      outcomes measures are not
                                                                                      available, report on at
                                                                                      least 1 outcome measures
                                                                                      and at least 1 of the
                                                                                      following types of
                                                                                      measures--resource use,
                                                                                      patient experience of
                                                                                      care, efficiency/
                                                                                      appropriate use, or
                                                                                      patient safety.
----------------------------------------------------------------------------------------------------------------

    Table 19 summarizes the previously finalized satisfactory reporting 
criteria for group practices via the group practice reporting option 
(GPRO) at Sec.  414.90(j)(9) and Sec.  414.90(k)(5).

[[Page 34098]]



  Table 19--Summary of Requirements for the 2018 PQRS Payment Adjustment: Group Practice Reporting Criteria for
                          Satisfactory Reporting of Quality Measures Data via the GPRO
----------------------------------------------------------------------------------------------------------------
                                   Group practice                          Reporting      Satisfactory reporting
        Reporting period                size           Measure type        mechanism             criteria
----------------------------------------------------------------------------------------------------------------
12-month (Jan 1-Dec 1, 2016)...  25-99 EPs; 100+    Individual GPRO    Web Interface....  Report on all measures
                                  EPs (if Consumer   Measures in the                       included in the web
                                  Assessment of      Web Interface.                        interface; AND
                                  Healthcare                                               populate data fields
                                  Providers and                                            for the first 248
                                  Systems (CAHPS)                                          consecutively ranked
                                  for PQRS does                                            and assigned
                                  not apply).                                              beneficiaries in the
                                                                                           order in which they
                                                                                           appear in the group's
                                                                                           sample for each
                                                                                           module or preventive
                                                                                           care measure. If the
                                                                                           pool of eligible
                                                                                           assigned
                                                                                           beneficiaries is less
                                                                                           than 248, then the
                                                                                           group practice must
                                                                                           report on 100 percent
                                                                                           of assigned
                                                                                           beneficiaries. In
                                                                                           other words, we
                                                                                           understand that, in
                                                                                           some instances, the
                                                                                           sampling methodology
                                                                                           we provide will not
                                                                                           be able to assign at
                                                                                           least 248 patients on
                                                                                           which a group
                                                                                           practice may report,
                                                                                           particularly those
                                                                                           group practices on
                                                                                           the smaller end of
                                                                                           the range of 25-99
                                                                                           EPs. If the group
                                                                                           practice is assigned
                                                                                           less than 248
                                                                                           Medicare
                                                                                           beneficiaries, then
                                                                                           the group practice
                                                                                           must report on 100
                                                                                           percent of its
                                                                                           assigned
                                                                                           beneficiaries. A
                                                                                           group practice must
                                                                                           report on at least 1
                                                                                           measure for which
                                                                                           there is Medicare
                                                                                           patient data.
12-month (Jan 1-Dec 31, 2016)..  25-99 EPs that     Individual GPRO    Web Interface +    The group practice
                                  elect CAHPS for    Measures in the    CMS-Certified      must have all CAHPS
                                  PQRS; 100+ EPs     Web Interface +    Survey Vendor.     for PQRS survey
                                  (if CAHPS for      CAHPS for PQRS.                       measures reported on
                                  PQRS applies).                                           its behalf via a CMS-
                                                                                           certified survey
                                                                                           vendor. In addition,
                                                                                           the group practice
                                                                                           must report on all
                                                                                           measures included in
                                                                                           the Web Interface;
                                                                                           AND populate data
                                                                                           fields for the first
                                                                                           248 consecutively
                                                                                           ranked and assigned
                                                                                           beneficiaries in the
                                                                                           order in which they
                                                                                           appear in the group's
                                                                                           sample for each
                                                                                           module or preventive
                                                                                           care measure. If the
                                                                                           pool of eligible
                                                                                           assigned
                                                                                           beneficiaries is less
                                                                                           than 248, then the
                                                                                           group practice must
                                                                                           report on 100 percent
                                                                                           of assigned
                                                                                           beneficiaries. A
                                                                                           group practice will
                                                                                           be required to report
                                                                                           on at least 1 measure
                                                                                           for which there is
                                                                                           Medicare patient
                                                                                           data.
                                                                                          Please note that, if
                                                                                           the CAHPS for PQRS
                                                                                           survey is applicable
                                                                                           to a group practice
                                                                                           who reports quality
                                                                                           measures via the Web
                                                                                           Interface, the group
                                                                                           practice must
                                                                                           administer the CAHPS
                                                                                           for PQRS survey in
                                                                                           addition to reporting
                                                                                           the Web Interface
                                                                                           measures.
12-month (Jan 1-Dec 31, 2016)..  2-99 EPs; 100+     Individual         Qualified          Report at least 9
                                  EPs (if CAHPS      Measures.          Registry.          measures, covering at
                                  for PQRS does                                            least 3 of the NQS
                                  not apply).                                              domains. Of these
                                                                                           measures, if a group
                                                                                           practice sees at
                                                                                           least 1 Medicare
                                                                                           patient in a face-to-
                                                                                           face encounter, the
                                                                                           group practice would
                                                                                           report on at least 1
                                                                                           measure in the PQRS
                                                                                           cross-cutting measure
                                                                                           set. If less than 9
                                                                                           measures covering at
                                                                                           least 3 NQS domains
                                                                                           apply to the group
                                                                                           practice, the group
                                                                                           practice would report
                                                                                           on each measure that
                                                                                           is applicable to the
                                                                                           group practice, AND
                                                                                           report each measure
                                                                                           for at least 50
                                                                                           percent of the
                                                                                           group's Medicare Part
                                                                                           B FFS patients seen
                                                                                           during the reporting
                                                                                           period to which the
                                                                                           measure applies.
                                                                                           Measures with a 0
                                                                                           percent performance
                                                                                           rate would not be
                                                                                           counted.
12-month (Jan 1-Dec 31, 2016)..  2-99 EPs that      Individual         Qualified          The group practice
                                  elect CAHPS for    Measures + CAHPS   Registry + CMS-    must have all CAHPS
                                  PQRS; 100+ EPs     for PQRS.          Certified Survey   for PQRS survey
                                  (if CAHPS for                         Vendor.            measures reported on
                                  PQRS applies).                                           its behalf via a CMS-
                                                                                           certified survey
                                                                                           vendor, and report at
                                                                                           least 6 additional
                                                                                           measures, outside of
                                                                                           the CAHPS for PQRS
                                                                                           survey, covering at
                                                                                           least 2 of the NQS
                                                                                           domains using the
                                                                                           qualified registry.
                                                                                           If less than 6
                                                                                           measures apply to the
                                                                                           group practice, the
                                                                                           group practice must
                                                                                           report on each
                                                                                           measure that is
                                                                                           applicable to the
                                                                                           group practice. Of
                                                                                           the additional
                                                                                           measures that must be
                                                                                           reported in
                                                                                           conjunction with
                                                                                           reporting the CAHPS
                                                                                           for PQRS survey
                                                                                           measures, if any EP
                                                                                           in the group practice
                                                                                           sees at least 1
                                                                                           Medicare patient in a
                                                                                           face-to-face
                                                                                           encounter, the group
                                                                                           practice must report
                                                                                           on at least 1 measure
                                                                                           in the PQRS cross-
                                                                                           cutting measure set.
12-month (Jan 1-Dec 31, 2016)..  2-99 EPs; 100+     Individual         Direct EHR         Report 9 measures
                                  EPs (if CAHPS      Measures.          Product or EHR     covering at least 3
                                  for PQRS does                         Data Submission    domains. If the group
                                  not apply).                           Vendor Product.    practice's direct EHR
                                                                                           product or EHR data
                                                                                           submission vendor
                                                                                           product does not
                                                                                           contain patient data
                                                                                           for at least 9
                                                                                           measures covering at
                                                                                           least 3 domains, then
                                                                                           the group practice
                                                                                           must report all of
                                                                                           the measures for
                                                                                           which there is
                                                                                           Medicare patient
                                                                                           data. A group
                                                                                           practice must report
                                                                                           on at least 1 measure
                                                                                           for which there is
                                                                                           Medicare patient
                                                                                           data.

[[Page 34099]]

 
12-month (Jan 1-Dec 31, 2016)..  2-99 EPs that      Individual         Direct EHR         The group practice
                                  elect CAHPS for    Measures + CAHPS   Product or EHR     must have all CAHPS
                                  PQRS; 100+ EPs     for PQRS.          Data Submission    for PQRS survey
                                  (if CAHPS for                         Vendor Product +   measures reported on
                                  PQRS applies).                        CMS-Certified      its behalf via a CMS-
                                                                        Survey Vendor.     certified survey
                                                                                           vendor, and report at
                                                                                           least 6 additional
                                                                                           measures, outside of
                                                                                           CAHPS for PQRS,
                                                                                           covering at least 2
                                                                                           of the NQS domains
                                                                                           using the direct EHR
                                                                                           product or EHR data
                                                                                           submission vendor
                                                                                           product. If less than
                                                                                           6 measures apply to
                                                                                           the group practice,
                                                                                           the group practice
                                                                                           must report all of
                                                                                           the measures for
                                                                                           which there is
                                                                                           Medicare patient
                                                                                           data. Of the
                                                                                           additional 6 measures
                                                                                           that must be reported
                                                                                           in conjunction with
                                                                                           reporting the CAHPS
                                                                                           for PQRS survey
                                                                                           measures, a group
                                                                                           practice would be
                                                                                           required to report on
                                                                                           at least 1 measure
                                                                                           for which there is
                                                                                           Medicare patient
                                                                                           data.
12-month (Jan 1-Dec 31, 2016)..  2+ EPs...........  Individual PQRS    QCDR.............  Report at least 9
                                                     measures and/or                       measures available
                                                     non-PQRS                              for reporting under a
                                                     measures                              QCDR covering at
                                                     reportable via a                      least 3 of the NQS
                                                     QCDR.                                 domains, AND report
                                                                                           each measure for at
                                                                                           least 50 percent of
                                                                                           the group practice's
                                                                                           patients. Of these
                                                                                           measures, the group
                                                                                           practice would report
                                                                                           on at least 2 outcome
                                                                                           measures, OR, if 2
                                                                                           outcomes measures are
                                                                                           not available, report
                                                                                           on at least 1 outcome
                                                                                           measures and at least
                                                                                           1 of the following
                                                                                           types of measures--
                                                                                           resource use, patient
                                                                                           experience of care,
                                                                                           efficiency/
                                                                                           appropriate use, or
                                                                                           patient safety.
----------------------------------------------------------------------------------------------------------------

3. Proposed Modifications to the Satisfactory Reporting Criteria for 
Individual EPs and Group Practices for the 2018 PQRS Payment Adjustment
    Since we finalized these requirements, we have heard from 
stakeholders that EPs have had difficulty with the previously finalized 
satisfactory reporting criteria for the CY 2016 reporting period, which 
is the final reporting period for the PQRS. Specifically, we have heard 
from stakeholders through written communications to CMS that EPs have 
found the requirements complex, and had difficulty in understanding the 
requirements to be a satisfactory reporter for PQRS. Stakeholders have 
also requested that the requirements for the CY 2016 reporting period 
be aligned with those of the Quality Payment Program, specifically the 
Merit-based Incentive Payment System (MIPS). In particular, we have 
heard requests to lower the previously finalized requirement from 9 
measures across 3 NQS domains, where applicable, to only 6 measures 
with no domain requirement associated with these measures. While the 
PQRS and the MIPS are separate programs, we understand that 
stakeholders would like to see greater continuity between the final 
year of the PQRS and the beginning of the MIPS.
    The final reporting period for the PQRS was CY 2016. The Quality 
Payment Program, authorized by the Medicare Access and CHIP 
Reauthorization Act of 2015 (MACRA), consolidates and replaces three 
existing programs (the Medicare EHR Incentive Program for EPs, the 
PQRS, and the Value-Based Payment Modifier (VM)). There are two ways 
eligible clinicians can participate in this program: (1) Through the 
MIPS; and (2) through Advanced Alternative Payment Models (APMs). The 
initial performance period for the MIPS began on January 1, 2017. Under 
MIPS, there are four connected pillars that affect how MIPS eligible 
clinicians will be paid by Medicare: Quality; Improvement Activities; 
Advancing Care Information; and Cost. For more information on the 
Quality Payment Program, see https://qpp.cms.gov/.
    While we understand that the data submission period for the CY 2016 
reporting period has already ended and that all data that has been 
submitted to CMS is based on the previously finalized satisfactory 
reporting criteria for the CY 2016 reporting period, we are revisiting 
our previously finalized policy because we want individual EPs and 
groups to be assessed for purposes of the 2018 PQRS payment adjustment 
based on satisfactory reporting criteria that are simpler, more 
understandable, and more consistent with the beginning of MIPS. We 
believe that such criteria will help clinicians more accurately gauge 
their readiness for the beginning of MIPS and transition into the 
Quality Payment Program successfully. Additionally, we want to be 
responsive to the concerns of the clinician community. Therefore, while 
we are not proposing to collect any additional data for the CY 2016 
reporting period, we are proposing to modify the criteria we would 
apply to the data already submitted for the CY 2016 reporting period to 
determine whether an individual EP or group practice has satisfactorily 
reported for purposes of avoiding the 2018 PQRS payment adjustment. 
Specifically, we are proposing to revise the previously finalized 
satisfactory reporting criteria for the CY 2016 reporting period to 
lower the requirement from 9 measures across 3 NQS domains, where 
applicable, to only 6 measures with no domain or cross-cutting measure 
requirement. For individual EPs, this would apply to the following 
reporting mechanisms: claims, qualified registry (except for measures 
groups), QCDR, direct EHR product and EHR data submissions vendor 
product. This proposal would not affect the criteria used to determine 
whether an individual EP or group practice has satisfactorily reported 
for purposes of avoiding the 2017 PQRS payment adjustment, with the 
exception of the criteria applicable to individual EPs and group 
practices reporting using the secondary reporting period established 
under Sec.  414.90(j)(1)(ii) for the 2017 PQRS payment adjustment 
(hereinafter referred to as the ``ACO Secondary Reporting Period''), as 
discussed in section III.F.4. of this proposed rule.
    Table 20 summarizes our proposed modifications to the previously 
finalized satisfactory reporting criteria for individual EPs to avoid 
the 2018

[[Page 34100]]

PQRS payment adjustment, based on data previously submitted for the CY 
2016 reporting period. We are not proposing to collect any additional 
data for the CY 2016 reporting period, as the data submission period 
for the CY 2016 reporting period has already ended. As summarized in 
Table 20, the NQS domain requirement would no longer apply. No changes 
are being proposed for the measures groups criteria.
    Additionally, we are also proposing that individual EPs and group 
practices reporting via claims or qualified registry, as applicable, 
would no longer be required to report a cross-cutting measure and that 
individual EPs and group practices reporting via QCDR would no longer 
be required to report an outcome or ``high priority'' measure (that is, 
for purposes of PQRS, a resource use, patient experience of care, 
efficiency/appropriate use, or patient safety measure). We note that 
what is considered to be a ``high-priority'' measure in PQRS is 
different from what is considered a ``high-priority'' measure in MIPS, 
and we are not proposing to align this requirement with MIPS for the 
last year of PQRS as this could cause confusion. While certain MIPS 
eligible clinicians are required to report at least one outcome or 
other high-priority measure (see Sec.  414.1335(a)(1)(i)), we are also 
not aligning with that requirement because, while we agree that outcome 
and high-priority measures are valuable for reporting, we want to 
revise the satisfactory reporting criteria for the last year of PQRS to 
be less complex for individual EPs and groups to understand.
    Lastly, where we are proposing to lower the requirement to only 6 
measures, if less than 6 measures apply to the individual EP or group 
practice, each measure that is applicable would need to have been 
reported. We define ``applicable'' to mean measures relevant to a 
particular individual EP's or group practice's services or care 
rendered. As previously finalized, individual EPs and group practices 
would continue to be subject to the measure application validity (MAV) 
process (80 FR 71140 through 71145). The MAV process seeks to identify 
clinically similar measures and creates clusters of measures that can 
be reported if one of the measures in the cluster is reported. We would 
maintain the requirement that each required measure be reported for at 
least 50 percent of the individual EP's or group practice's patients to 
which the measure applies.

Table 20--Summary of Proposed Modifications to the Requirements for the 2018 PQRS Payment Adjustment: Individual
 Reporting Criteria for the Satisfactory Reporting of Quality Measures Data via Claims, Qualified Registry, and
                             EHRs and Satisfactory Participation Criterion in QCDRs
----------------------------------------------------------------------------------------------------------------
                                                                                        Proposed satisfactory
          Reporting period                Measure type         Reporting mechanism        reporting criteria
----------------------------------------------------------------------------------------------------------------
12-month (Jan 1-...................  Individual Measures...  Claims................  Report at least 6 measures,
Dec 31, 2016)......................                                                   AND report each measure
                                                                                      for at least 50 percent of
                                                                                      the EP's Medicare Part B
                                                                                      FFS patients seen during
                                                                                      the reporting period to
                                                                                      which the measure applies.
                                                                                      If less than 6 measures
                                                                                      apply to the EP, the EP
                                                                                      must report on each
                                                                                      measure that is
                                                                                      applicable, AND report
                                                                                      each measure for at least
                                                                                      50 percent of the Medicare
                                                                                      Part B FFS patients seen
                                                                                      during the reporting
                                                                                      period to which the
                                                                                      measure applies. Measures
                                                                                      with a 0 percent
                                                                                      performance rate will not
                                                                                      be counted (unless they
                                                                                      are inverse measures where
                                                                                      a lower rate reflects
                                                                                      better performance).
12-month (Jan 1-...................  Individual Measures...  Qualified Registry....  Report at least 6 measures,
Dec 31, 2016)......................                                                   AND report each measure
                                                                                      for at least 50 percent of
                                                                                      the EP's Medicare Part B
                                                                                      FFS patients seen during
                                                                                      the reporting period to
                                                                                      which the measure applies.
                                                                                      If less than 6 measures
                                                                                      apply to the EP, the EP
                                                                                      must report on each
                                                                                      measure that is
                                                                                      applicable, AND report
                                                                                      each measure for at least
                                                                                      50 percent of the Medicare
                                                                                      Part B FFS patients seen
                                                                                      during the reporting
                                                                                      period to which the
                                                                                      measure applies. Measures
                                                                                      with a 0 percent
                                                                                      performance rate will not
                                                                                      be counted (unless they
                                                                                      are inverse measures where
                                                                                      a lower rate reflects
                                                                                      better performance).
12-month (Jan 1-...................  Individual Measures...  Direct EHR Product or   Report at least 6 measures.
Dec 31, 2016)......................                           EHR Data Submission     If an EP's direct EHR
                                                              Vendor Product.         product or EHR data
                                                                                      submission vendor product
                                                                                      does not contain patient
                                                                                      data for at least 6
                                                                                      measures, then the EP must
                                                                                      report all of the measures
                                                                                      for which there is
                                                                                      Medicare patient data. An
                                                                                      EP must report on at least
                                                                                      1 measure for which there
                                                                                      is Medicare patient data.
12-month (Jan 1-...................  Measures Groups.......  Qualified Registry....  No proposed changes.
Dec 31, 2016)......................
12-month (Jan 1-...................  Individual............  QCDR..................  Report at least 6 measures
Dec 31, 2016)......................  PQRS measures and/or                             available for reporting
                                      non-PQRS measures                               under a QCDR AND report
                                      reportable via a QCDR.                          each measure for at least
                                                                                      50 percent of the EP's
                                                                                      patients seen during the
                                                                                      reporting period to which
                                                                                      the measure applies. If
                                                                                      less than 6 measures apply
                                                                                      to the EP, the EP must
                                                                                      report on each measure
                                                                                      that is applicable, AND
                                                                                      report each measure for at
                                                                                      least 50 percent of the
                                                                                      EP's patients.
----------------------------------------------------------------------------------------------------------------


[[Page 34101]]

    Accordingly, we are proposing to revise Sec.  414.90(j)(8) and 
(k)(5) consistent with our proposals above. We believe these proposals 
will result in fewer individual EPs being subject to the 2018 PQRS 
payment adjustment, and will impose no additional burden on individual 
EPs because this data has already been submitted to CMS. We request 
comment on these proposals.
    As discussed above, while we are not proposing to collect any 
additional data for the CY 2016 reporting period, we are proposing to 
modify the satisfactory reporting criteria for the CY 2016 reporting 
period for purposes of the 2018 PQRS payment adjustment. Specifically, 
we are proposing to lower the requirement from 9 measures across 3 NQS 
domains, where applicable, to only 6 measures with no domain or cross-
cutting measure requirement. For group practices, this would apply to 
the following reporting mechanisms: Qualified registry; QCDR; direct 
EHR product; and EHR data submissions vendor product. This proposal 
would not affect the criteria used to determine whether an individual 
EP or group practice has satisfactorily reported for purposes of 
avoiding the 2017 PQRS payment adjustment, with the exception of the 
criteria applicable to individual EPs and group practices reporting 
using the ACO Secondary Reporting Period, as discussed in section 
III.F.4. of this proposed rule.
    Table 21 summarizes our proposed modifications to the previously 
finalized satisfactory reporting criteria for group practices to avoid 
the 2018 PQRS payment adjustment, based on data previously submitted 
for the CY 2016 reporting period. We are not proposing to collect any 
additional data for the CY 2016 reporting period, as the data 
submission period for the CY 2016 reporting period has already ended. 
As summarized in Table 21, the NQS domain requirement would no longer 
apply. No changes are being proposed for the Web Interface criteria.
    Additionally, as discussed above, we are proposing that individual 
EPs and group practices reporting via claims and qualified registry, as 
applicable, would no longer be required to report a cross-cutting 
measure and that individual EPs and group practices reporting via QCDR 
would no longer be required to report an outcome or high priority 
measure. We note that what is considered to be a ``high-priority'' 
measure in PQRS is different from what is considered a ``high-
priority'' measure in MIPS, and are not proposing to align this 
requirement with MIPS for the last year of PQRS as this could cause 
confusion. While certain MIPS eligible clinicians are required to 
report at least one outcome or other high-priority measure (see Sec.  
414.1335(a)(1)(i)), we are also not aligning with that requirement 
because, while we agree that outcome and high-priority measures are 
valuable for reporting, we want to revise the satisfactory reporting 
criteria for the last year of PQRS to be less complex for individual 
EPs and groups.
    Where we are proposing to lower the requirement to only 6 measures, 
if less than 6 measures apply to the individual EP or group practice, 
each measure that is applicable would need to have been reported. We 
define ``applicable'' to mean measures relevant to a particular 
individual EP's or group practice's services or care rendered. As 
previously finalized, individual EPs and group practices would continue 
to be subject to the MAV process (80 FR 71140 through 71145). The MAV 
process seeks to identify clinically similar measures and creates 
clusters of measures that can be reported if one of the measures in the 
cluster is reported. We would maintain the requirement that each 
required measure be reported for at least 50 percent of the individual 
EP's or group practice's patients to which the measure applies.
    Lastly, for purposes of the 2018 PQRS payment adjustment, Sec.  
414.90(j)(9)(viii) currently provides that if the CAHPS for PQRS survey 
is applicable to the practice, group practices comprised of 100 or more 
eligible professionals that register to participate in the GPRO must 
administer the CAHPS for PQRS survey, regardless of the GPRO reporting 
mechanism selected. For the reasons discussed above, we are proposing 
to revise Sec.  414.90(j)(9)(viii) to provide that such group practices 
may administer the CAHPS for PQRS survey, regardless of the GPRO 
reporting mechanism selected, but are not required to do so. This 
change would be consistent with the data submission criteria for the 
MIPS quality performance category, under which groups may voluntarily 
elect to participate in the CAHPS for MIPS survey (see Sec.  
414.1335(a)(3)(i)). As summarized in Table 21, the previously finalized 
satisfactory reporting criteria for group practices administering the 
CAHPS for PQRS survey would continue to apply to group practices that 
elected to administer the survey.

   Table 21--Summary of Proposed Modifications to the Requirements for the 2018 PQRS Payment Adjustment: Group
          Practice Reporting Criteria for Satisfactory Reporting of Quality Measures Data via the GPRO
----------------------------------------------------------------------------------------------------------------
                                   Group practice                          Reporting       Proposed satisfactory
        Reporting period              size \3\         Measure type        mechanism        reporting criteria
----------------------------------------------------------------------------------------------------------------
12-month (Jan 1-Dec 31,2016)...  25+ EPs..........  Individual GPRO    Web Interface....  No proposed changes.
                                                     Measures in the
                                                     Web Interface.
12-month (Jan 1-Dec 31,2016)...  25+ EPs that       Individual GPRO    Web Interface +    No proposed changes.
                                  elect CAHPS for    Measures in the    CMS-Certified
                                  PQRS.              Web Interface+     Survey Vendor..
                                                     CAHPS for PQRS.
12-month (Jan 1-Dec 31,2016)...  2+ EPs...........  Individual         Qualified          Report at least 6
                                                     Measures.          Registry.          measures AND report
                                                                                           each measure for at
                                                                                           least 50 percent of
                                                                                           the group's Medicare
                                                                                           Part B FFS patients
                                                                                           seen during the
                                                                                           reporting period to
                                                                                           which the measure
                                                                                           applies. If less than
                                                                                           6 measures apply to
                                                                                           the group, the group
                                                                                           practice must report
                                                                                           on each measure that
                                                                                           is applicable, AND
                                                                                           report each measure
                                                                                           for at least 50
                                                                                           percent of the
                                                                                           Medicare Part B FFS
                                                                                           patients seen during
                                                                                           the reporting period
                                                                                           to which the measure
                                                                                           applies. Measures
                                                                                           with a 0 percent
                                                                                           performance rate will
                                                                                           not be counted
                                                                                           (unless they are
                                                                                           inverse measures
                                                                                           where a lower rate
                                                                                           reflects better
                                                                                           performance).

[[Page 34102]]

 
12-month (Jan 1-Dec 31,2016)...  2+ EPs that elect  Individual         Qualified          The group practice
                                  CAHPS for PQRS.    Measures+CAHPS     Registry+CMS-      must have all CAHPS
                                                     for PQRS.          Certified Survey   for PQRS survey
                                                                        Vendor.            measures reported on
                                                                                           its behalf via a CMS-
                                                                                           certified survey
                                                                                           vendor. In addition,
                                                                                           the group practice
                                                                                           must report at least
                                                                                           3 additional measures
                                                                                           using the qualified
                                                                                           registry AND report
                                                                                           each measure for at
                                                                                           least 50 percent of
                                                                                           the group's Medicare
                                                                                           Part B FFS patients
                                                                                           seen during the
                                                                                           reporting period to
                                                                                           which the measure
                                                                                           applies. If less than
                                                                                           3 measures apply to
                                                                                           the group practice,
                                                                                           the group practice
                                                                                           must report on each
                                                                                           measure that is
                                                                                           applicable, AND
                                                                                           report each measure
                                                                                           for at least 50
                                                                                           percent of the
                                                                                           Medicare Part B FFS
                                                                                           patients seen during
                                                                                           the reporting period
                                                                                           to which the measure
                                                                                           applies. Measures
                                                                                           with a 0 percent
                                                                                           performance rate will
                                                                                           not be counted
                                                                                           (unless they are
                                                                                           inverse measures
                                                                                           where a lower rate
                                                                                           reflects better
                                                                                           performance).
12-month (Jan 1-Dec 31,2016)...  2+ EPs...........  Individual         Direct EHR         Report 6 measures. If
                                                     Measures.          Product or EHR     the group practice's
                                                                        Data Submission    direct EHR product or
                                                                        Vendor Product.    EHR data submission
                                                                                           vendor product does
                                                                                           not contain patient
                                                                                           data for at least 6
                                                                                           measures, then the
                                                                                           group practice must
                                                                                           report all of the
                                                                                           measures for which
                                                                                           there is Medicare
                                                                                           patient data. A group
                                                                                           practice must report
                                                                                           on at least 1 measure
                                                                                           for which there is
                                                                                           Medicare patient
                                                                                           data.
12-month (Jan 1-Dec 31,2016)...  2+ EPs that elect  Individual         Direct EHR         The group practice
                                  CAHPS for PQRS.    Measures+CAHPS     Productor EHR      must have all CAHPS
                                                     for PQRS.          Data Submission    for PQRS survey
                                                                        Vendor             measures reported on
                                                                        Product+CMS-       its behalf via a CMS-
                                                                        Certified Survey   certified survey
                                                                        Vendor.            vendor. In addition,
                                                                                           the group practice
                                                                                           must report at least
                                                                                           3 additional measures
                                                                                           using the direct EHR
                                                                                           product or EHR data
                                                                                           submission vendor
                                                                                           product. If less than
                                                                                           3 measures apply to
                                                                                           the group practice,
                                                                                           the group practice
                                                                                           must report all of
                                                                                           the measures for
                                                                                           which there is
                                                                                           patient data. Of the
                                                                                           additional 3 measures
                                                                                           that must be reported
                                                                                           in conjunction with
                                                                                           reporting the CAHPS
                                                                                           for PQRS survey
                                                                                           measures, a group
                                                                                           practice must report
                                                                                           on at least 1 measure
                                                                                           for which there is
                                                                                           Medicare patient
                                                                                           data.
12-month (Jan 1-Dec 31,2016)...  2+ EPs...........  Individual PQRS    QCDR.............  Report at least 6
                                                     measures and/or                       measures available
                                                     non-PQRS                              for reporting under a
                                                     measures                              QCDR AND report each
                                                     reportable via a                      measure for at least
                                                     QCDR.                                 50 percent of the
                                                                                           group practice's
                                                                                           patients seen during
                                                                                           the reporting period
                                                                                           to which the measure
                                                                                           applies. If less than
                                                                                           6 measures apply to
                                                                                           the group practice,
                                                                                           the group practice
                                                                                           must report on each
                                                                                           measure that is
                                                                                           applicable, AND
                                                                                           report each measure
                                                                                           for at least 50
                                                                                           percent of the group
                                                                                           practice's patients.
----------------------------------------------------------------------------------------------------------------
\3\ Please note that the group practice size descriptions have been revised for greater consistency with our
  proposal to make the CAHPS for PQRS survey voluntary.

    Accordingly, we are proposing to revise Sec.  414.90(j)(9) and 
(k)(5) consistent with our proposals above. We believe these proposals 
will result in fewer group practices being subject to the 2018 PQRS 
payment adjustment, and will impose no additional burden on group 
practices because this data has already been submitted to CMS. We 
request comment on these proposals.
4. Accountable Care Organization (ACO) Participants Who Report PQRS 
Quality Measures Separately During the Secondary Reporting Period
    As discussed in the CY 2017 PFS final rule (81 FR 80441 through 
80445), individual EPs and group practices who bill under the TIN of an 
ACO participant may report separately from the ACO, if the ACO failed 
to report on behalf of such individual EPs or group practices for the 
applicable reporting period, during the CY 2016 reporting period for 
purposes of the 2017 and 2018 PQRS payment adjustments, as applicable. 
Please note that, in accordance with our previously established 
policies for the ACO Secondary Reporting Period, our proposed 
modifications to the satisfactory reporting criteria for individual EPs 
and group practices for the CY 2016 reporting period would apply to 
such individual EPs and group practices for purposes of the 2017 PQRS 
payment adjustment. This proposal would not affect the 2017 PQRS 
payment adjustment for any other individual EP or group practice.

[[Page 34103]]

5. Physician Compare Downloadable Database--Addition of Value Modifier 
(VM) Data
    We previously finalized in the CY 2016 PFS final rule (80 FR 71129 
through 71130) a decision to publicly report three data points for the 
2018 VM based on 2016 data in the Physician Compare downloadable file 
in late 2017:
     2018 VM quality tiers for cost and quality, based on the 
2016 data, noting if the EP or group is high, low, or average on cost 
and quality per the VM.
     A notation of the payment adjustment received based on the 
cost and quality tiers--upward, downward, or neutral--for each EP or 
group.
     An indication if the EP or group was eligible to but did 
not report quality measures to CMS for CY 2016 under PQRS.
    In light of the proposals to change the 2016 reporting criteria to 
avoid the 2018 payment adjustment for PQRS (see section III.F. of this 
proposed rule) and subsequent VM proposed policies to hold all 
physician groups and solo practitioners who met minimum quality 
reporting requirements harmless from downward payment adjustments for 
performance under quality-tiering for the last year of the program (see 
section III.I. of this proposed rule), and because the proposed 
policies for PQRS and VM in this rule would change the nature of how 
the PQRS data will be used under the VM, we are now proposing not to 
report this data specific to the VM. Given the fact that VM data would 
be available for posting in the Physician Compare downloadable database 
for only one year and the VM data may not reflect an EP or group's 
actual performance or payment adjustment given they could have chosen 
to report fewer measures, we believe that proceeding with the posting 
of this data could be confusing for the public.
    Additionally, we have created other VM data files intended to 
promote transparency. For each VM performance year, we will publish a 
Public Use File (PUF) that contains VM performance results of de-
identified practices. Supporting documentation for each PUF that 
contains the field name, length, type, label, description, and notes 
for each variable included in the PUF. The Value Modifier program years 
2015 and 2016 (performance year 2013 and 2014) are currently available 
at https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/VMPUF/Value-Modifier-PUF.html. In addition, three 
Research Identifiable Files (RIFs) for Value Modifier program years 
2015 and 2016 (performance year 2013 and 2014) are available through 
the Research Data Assistance Center (ResDAC) and will be made available 
for each program year. These files include a practice-level, an NPI-
practice level, and a beneficiary-level file, as described at: https://www.resdac.org/news/cms-creates-set-rif-data-files-support-value-based-payment-modifier-program/2017/06.
    All other previously finalized policies related to 2016 PQRS data 
available for public reporting on Physician Compare in late 2017 remain 
unchanged (80 FR 71116 through 71132). Appreciating this, we believe 
the best course of action is to not move forward with publicly 
reporting this VM data for 2016. All data required to be reported by 
law will remain available for public reporting as previously finalized 
(80 FR 71116 through 71132). For more information on the public 
reporting policies previously finalized and proposed for MIPS, we refer 
readers to the Medicare Program; Merit-Based Incentive Payment System 
(MIPS) and Alternative Payment Model (APM) Incentive Under the 
Physician Fee Schedule, and Criteria for Physician-Focused Payment 
Models (81 FR 77390 through 77399) and Medicare Program; CY 2018 
Updates to the Quality Payment Program (82 FR 30163 through 30170), 
respectively. We request comment on this proposal and specifically, if 
we were to release this data, how it could be used by the public.

G. Clinical Quality Measurement for Eligible Professionals 
Participating in the Electronic Health Record (EHR) Incentive Program 
for 2016

1. Background
    Sections 1848(o), 1853(l) and (m), 1886(n), and 1814(l) of the Act 
provide the statutory basis for the Medicare incentive payments made to 
eligible professionals (EPs), Medicare Advantage (MA) organizations 
(for certain qualifying EPs and hospitals), subsection (d) hospitals, 
and critical access hospitals (CAHs) that demonstrate meaningful use of 
certified electronic health record (EHR) technology (CEHRT). Sections 
1848(a)(7), 1853(l) and (m), 1886(b)(3)(B), and 1814(l) of the Act also 
establish downward adjustments to Medicare payments, beginning with 
calendar or fiscal year (FY) 2015, for EPs, MA organizations, 
subsection (d) hospitals, and CAHs that are not meaningful users of 
CEHRT for certain associated reporting periods. Sections 1903(a)(3)(F) 
and 1903(t) of the Act provide the statutory basis for the Medicaid 
incentive payments made to EPs and eligible hospitals for the adoption, 
implementation, upgrade, and meaningful use of CEHRT. We have 
implemented these statutory provisions in prior rulemakings to 
establish the Medicare and Medicaid EHR Incentive Programs.
    Under these statutory provisions and the regulations at 42 CFR 
495.4, one of the requirements of being a meaningful EHR user is 
successfully reporting the clinical quality measures selected by CMS to 
CMS or the states, as applicable, in the form and manner specified by 
CMS or the states, as applicable. Section 1848(o)(2)(B)(iii) of the Act 
requires that in selecting clinical quality measures (CQMs) for EPs to 
report under the EHR Incentive Program, and in establishing the form 
and manner of reporting, the Secretary shall seek to avoid redundant or 
duplicative reporting otherwise required, including reporting under 
section 1848(k)(2)(C) of the Act (the Physician Quality Reporting 
System). As such, we have taken steps to establish alignments among 
various quality reporting and payment programs that include the 
submission of CQMs.
2. Clinical Quality Measure (CQM) Requirements for Meaningful Use in 
2016
    Under sections 1848(o)(2)(A)(iii) and 1903(t)(6)(C)(i)(II) of the 
Act and the definition of ``meaningful EHR user'' at Sec.  495.4, EPs 
must report on CQMs selected by CMS using CEHRT, as part of being a 
meaningful EHR user under the Medicare and Medicaid EHR Incentive 
Programs. In the final rule titled ``Medicare and Medicaid Programs; 
Electronic Health Record Incentive Program--Stage 3 and Modifications 
to Meaningful Use in 2015 Through 2017,'' we finalized the options for 
CQM submission for EPs in the Medicare EHR Incentive Program in 2016 as 
follows (80 FR 62888 through 62889):
     EP Options for Medicare EHR Incentive Program 
Participation (single program Participation--EHR Incentive Program 
only):
    ++ Option 1: Attest to CQMs through the EHR Registration & 
Attestation System.
    ++ Option 2: Electronically report CQMs through Physician Quality 
Reporting System (PQRS) Portal.
     EP Options for Electronic Reporting for Multiple Programs 
(for example: EHR Incentive Program plus PQRS participation):
    ++ Option 1: Report individual EP's CQMs through PQRS Portal.
    ++ Option 2: Report group's CQMs through PQRS Portal.
    (NOTE: Under option 2, this may include an EP reporting using the 
group

[[Page 34104]]

reporting option, either electronically using QRDA, or via the GPRO Web 
Interface.)
    For the Medicaid EHR Incentive Program, we specified (80 FR 62888) 
that states would continue to be responsible for determining whether 
and how electronic reporting of CQMs would occur, or if they wish to 
allow reporting through attestation. Any changes that states make to 
their CQM reporting methods must be submitted through the state 
Medicaid Health IT Plan (SMHP) process for our review and approval 
prior to being implemented.
    We maintained a requirement that EPs report 9 CQMs covering at 
least 3 NQS domains (80 FR 62888 through 62889). This requirement was 
established in the final rule titled ``Medicare and Medicaid Programs; 
Electronic Health Record Incentive Program--Stage 2'' (77 FR 54058).
    We also continued (80 FR 62888 through 62889) our existing policy 
that under Medicare, healthcare providers in any year of participation 
for the EHR Incentive Program for 2015 through 2017 may electronically 
report CQM data using the options previously outlined for electronic 
reporting either for single program participation in the Medicare EHR 
Incentive Program, or for participation in multiple programs if the 
requirements of the aligned quality program are also met.
    We noted that an EHR certified for CQMs under the 2014 Edition 
certification criteria does not need to be recertified each time it is 
updated to a more recent version of the eCQMs (80 FR 62889).
3. CQM Requirements for EPs and Groups Under the Medicare EHR Incentive 
Program in 2016
    As we discussed in section III.F. in this proposed rule, since we 
finalized these requirements, we have heard from stakeholders through 
written communications that EPs and groups have found the previously 
finalized reporting criteria for the CY 2016 reporting period to be 
complex and had difficulty in understanding the requirements to be a 
satisfactory reporter, and these same EPs and groups subsequently 
requested that the CQM reporting requirements for EPs and groups 
participating in the Medicare EHR Incentive Program in 2016 who chose 
to report CQMs electronically through the Physician Quality Reporting 
System (PQRS) Portal be aligned with those of the Quality Payment 
Program, specifically the Merit-based Incentive Payment System (MIPS).
    Therefore, while we are not proposing to collect any additional 
data for 2016, we are proposing to change the reporting criteria for 
EPs and groups who chose to electronically report CQMs through the PQRS 
Portal for purposes of the Medicare EHR Incentive Program. 
Specifically, we are proposing to change the reporting criteria from 9 
CQMs covering at least 3 NQS domains to 6 CQMs with no domain 
requirement. We are proposing this change so that the reporting 
criteria for the Medicare EHR Incentive Program would be in alignment 
with the modified requirement that we are proposing for the final PQRS 
reporting period (2016) in section III.F. of this proposed rule, as 
well as the transition year of the Quality Payment Program. We are 
proposing that an EP or group who satisfies the proposed reporting 
criteria may qualify for the 2016 incentive payment under section 
1848(o) of the Act and may avoid the downward payment adjustment in 
2017 and/or 2018 under section 1848(a)(7)(A) of the Act, depending on 
the EP or group's applicable EHR reporting period for the payment 
adjustment year. This proposed change would help maintain alignment 
with PQRS per the requirement under section 1848(o)(2)(B)(iii) of the 
Act for the Secretary to seek to avoid redundant or duplicative 
reporting otherwise required, including reporting under section 
1848(k)(2)(C) of the Act (the PQRS). We are not proposing to change the 
previously finalized requirements for CQM reporting in 2016 for 
eligible hospitals and CAHs; or the previously finalized requirements 
for EPs who chose to report CQMs through attestation in 2016 for the 
Medicare EHR Incentive Program (80 FR 62888). Our reasoning for not 
proposing to change the eligible hospital or CAH requirements for CQM 
reporting is because the changes proposed for PQRS in section III.F. of 
this proposed rule and the policies established for the transition year 
of the Quality Payment Program would only affect clinicians and groups, 
and therefore, there is no reason to propose changes to the established 
policy for eligible hospitals or CAHs. We are not proposing to change 
the requirements for EPs who reported CQMs through attestation because 
those who attested were successful, therefore we believe there is no 
need to change the requirement. Additionally, the Registration and 
Attestation portal is scheduled to sunset as of October 1, 2017 before 
this final rule is published.
    Lastly, we are also not proposing to change the previously 
finalized requirements for 2016 for EPs participating in the Medicaid 
EHR Incentive Program. We have already proposed in ``Medicare Program; 
Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals 
and the Long-Term Care Hospital Prospective Payment System and Proposed 
Policy Changes and Fiscal Year 2018 Rates; Quality Reporting 
Requirements for Specific Providers; Medicare and Medicaid Electronic 
Health Record (EHR) Incentive Program Requirements for Eligible 
Hospitals, Critical Access Hospitals, and Eligible Professionals; 
Provider-Based Status of Indian Health Service and Tribal Facilities 
and Organizations; Costs Reporting and Provider Requirements; Agreement 
Termination Notices'' that, for 2017, Medicaid EPs would be required to 
report on any six CQMs that are relevant to the EP's scope of practice 
(82 FR 20135). In proposing that change, we indicated that it is our 
intention to align CQM requirements for Medicaid EPs with requirements 
under the Medicare quality improvement programs, to the extent 
practicable. However, we believe that due to the timing of when any 
changes we might propose for 2016 through this rulemaking would take 
effect (if finalized), the benefits of proposing to extend the policy 
proposed for Medicare EPs for 2016 to Medicaid EPs for 2016 would not 
be realized, and the burden on states to implement such a policy would 
be significant. There is no negative payment adjustment for not 
participating in the Medicaid EHR Incentive Program, so it is likely 
that applying the proposed policy for Medicare EPs to Medicaid EPs for 
2016 would benefit Medicaid EPs only if they are able to submit new 
data to states for a Medicaid EHR incentive payment for 2016. Because 
we anticipate that most states will have completed processing and 
paying 2016 Medicaid EHR incentive payments by the time such a proposal 
(if finalized) would take effect, we believe that applying this change 
to the Medicaid EHR Incentive Program for 2016 would significantly 
burden states. We seek comment on our assessment of the difficulty 
states might face implementing this policy for 2016 for Medicaid EPs, 
and on the number of Medicaid EPs who might benefit if we instead 
decided to apply this policy in the Medicaid EHR Incentive Program for 
2016, to the extent that doing so would be legally permissible.

H. Medicare Shared Savings Program

    Under section 1899 of the Act, we established the Medicare Shared 
Savings Program (Shared Savings Program) to facilitate coordination and

[[Page 34105]]

cooperation among health care providers to improve the quality of care 
for Medicare Fee-For-Service (FFS) beneficiaries and reduce the rate of 
growth in expenditures under Medicare Parts A and B. Eligible groups of 
providers and suppliers, including physicians, hospitals, and other 
health care providers, may participate in the Shared Savings Program by 
forming or participating in an Accountable Care Organization (ACO). The 
final rule establishing the Shared Savings Program appeared in the 
November 2, 2011 Federal Register (Medicare Program; Medicare Shared 
Savings Program: Accountable Care Organizations; Final Rule (76 FR 
67802) (hereinafter referred to as the ``November 2011 final rule'')). 
A subsequent major update to the program rules appeared in the June 9, 
2015 Federal Register (Medicare Program; Medicare Shared Savings 
Program: Accountable Care Organizations; Final Rule (80 FR 32692) 
(hereinafter referred to as the ``June 2015 final rule'')). A final 
rule addressing changes related to the program's financial benchmark 
methodology appeared in the June 10, 2016 Federal Register (Medicare 
Program; Medicare Shared Savings Program; Accountable Care 
Organizations--Revised Benchmark Rebasing Methodology, Facilitating 
Transition to Performance-Based Risk, and Administrative Finality of 
Financial Calculations (81 FR 37950) (hereinafter referred to as the 
``June 2016 final rule'')). We have also made use of the annual 
calendar year (CY) Physician Fee Schedule (PFS) rules to address 
quality reporting and certain other issues. In addition, in the CY 2017 
Quality Payment Program final rule (81 FR 77255 through 77256), we 
finalized policies related to quality performance category scoring for 
Merit-Based Incentive Payment System (MIPS) eligible clinicians that 
participate in the Shared Savings Program. In that final rule, we 
adopted an APM scoring standard that reduces burden for eligible 
clinicians that participate in Shared Savings Program ACOs by using the 
same quality data reported by the ACO using the the CMS web interface 
for purposes of the Shared Savings Program to score the MIPS quality 
performance category for these eligible clinicians.
    In this CY 2018 PFS proposed rule, we propose further refinements 
to the Shared Savings Program rules. This rule includes two proposed 
modifications to the Shared Savings Program beneficiary assignment 
methodology: (1) Revisions to the assignment methodology under 42 CFR 
part 425, subpart E to reflect the requirement under section 17007 of 
the 21st Century Cures Act (Pub. L. 114-255, December 13, 2016), that 
for performance years beginning on or after January 1, 2019, the 
Secretary determine an appropriate method to assign Medicare FFS 
beneficiaries to an ACO based on their utilization of services 
furnished by rural health clinics (RHCs) or federally qualified health 
centers (FQHCs), and (2) addition of new chronic care management and 
BHI service codes to our definition of primary care services. In 
addition, we propose to revise the methodology used in our quality 
validation audits and the manner in which the results of these audits 
may be used to adjust an ACO's sharing rate. We also propose to reserve 
the discretion to redesignate a measure reported through the CMS web 
interface as pay-for-reporting when substantive changes are made to the 
measure under the Quality Payment Program.
    We also address proposals intended to reduce application burden for 
stakeholders by reducing certain documentation submission requirements 
included in the initial Shared Savings Program application and the 
application for use of the skilled nursing facility (SNF) 3-Day Rule 
Waiver. We also propose to establish specific procedures to address 
situations where a Taxpayer Identification Number (TIN) that is an ACO 
participant in more than one ACO begins to submit claims for services 
used in the beneficiary assignment process and becomes out of 
compliance with the ``exclusivity'' requirement in Sec.  425.306(b)(2). 
Finally, we propose that, for performance year 2018 and subsequent 
years, we would only include individually beneficiary identifiable 
payments made under a demonstration, pilot or time limited program that 
are final and not subject to further reconciliation in financial 
calculations related to establishing and updating benchmarks and 
determining performance year expenditures under the Shared Savings 
Program.
1. Modifications to the Shared Savings Program Beneficiary Assignment 
Methodology
a. Assignment of Beneficiaries to ACOs That Include RHCs and/or FQHCs
(1) Background
(a) General Shared Savings Program Assignment Methodology
    As originally enacted in the Affordable Care Act, section 1899(c) 
of the Act requires us to assign FFS beneficiaries to an ACO 
participating in the Shared Savings Program based on the beneficiary's 
utilization of primary care services rendered by physicians 
participating in the ACO. Medicare FFS beneficiaries do not enroll in 
the Shared Savings Program or with a particular ACO, and they retain 
the right to seek Medicare-covered services from any Medicare-enrolled 
provider or supplier of their choosing. Furthermore, no exclusions or 
restrictions based on health conditions or similar factors are applied 
in the assignment of Medicare FFS beneficiaries. Thus, a beneficiary's 
choice to receive primary care services during a prior 12 month period 
(the ``assignment window'') furnished by physicians and certain 
nonphysician practitioners that are ACO professionals in the ACO 
determines the beneficiary's assignment to an ACO under the Shared 
Savings Program.
    The regulations governing the assignment methodology under the 
Shared Savings Program are in part 425, subpart E. Consistent with the 
statutory requirement to base assignment on the utilization of primary 
care services furnished by physicians who are ACO professionals, a 
beneficiary is eligible for assignment to an ACO under Sec.  425.402 if 
the beneficiary had at least one primary care service during the 
applicable assignment window furnished by a physician who is an ACO 
professional in the ACO and who is a primary care physician as defined 
under Sec.  425.20 or has one of the primary specialty designations 
specified in Sec.  425.402(c). This initial process for determining 
whether a beneficiary is eligible for assignment is referred to as the 
assignment ``pre-step''. Under the first step of the assignment 
process, a beneficiary who is eligible for assignment to the ACO will 
be assigned to the ACO if the allowed charges for primary care services 
furnished to the beneficiary during the assignment window by all 
primary care physicians who are ACO professionals and non-physician ACO 
professionals in the ACO are greater than the allowed charges for such 
services provided during the assignment window by primary care 
physicians, nurse practitioners, physician assistants, and clinical 
nurse specialists who are ACO professionals in another ACO or not 
affiliated with any ACO and are identified by a Medicare-enrolled 
billing TIN. The second step of the assignment process considers the 
remainder of beneficiaries who have received at least one primary care 
service during the assignment window from an ACO physician who is a 
primary care physician as defined under Sec.  425.20 or who has one of 
the primary specialty designations specified in Sec.  425.402(c),

[[Page 34106]]

but have received no primary care services during the assignment window 
from a primary care physician, nurse practitioner, physician assistant, 
or clinical nurse specialist either inside or outside the ACO. These 
beneficiaries are assigned to the ACO if the allowed charges for 
primary care services furnished during the assignment window by 
physicians who are ACO professionals in the ACO with one of the 
specialty designations specified in Sec.  425.402(c) are greater than 
the allowed charges for primary care services furnished during the 
assignment window by physicians with such specialty designations who 
are ACO professionals in another ACO or who are not affiliated with any 
ACO and are identified by a Medicare-enrolled billing TIN. Thus, the 
assignment methodology simultaneously maintains the statutory 
requirement to focus on physician primary care services in beneficiary 
assignment, while recognizing the necessary and appropriate role of 
specialists and non-physician practitioners in providing primary care 
services, such as in areas with primary care physician shortages.
(b) Retrospective vs Prospective Assignment
    As discussed in detail in the November 2011 final rule we finalized 
a claims-based hybrid approach (called preliminary prospective 
assignment with retrospective reconciliation) for assigning 
beneficiaries to an ACO (76 FR 67851 through 67870), which is currently 
applicable to ACOs participating under Track 1 or Track 2 of the Shared 
Savings Program. Under this approach, beneficiaries are preliminarily 
assigned to an ACO at the beginning of a performance year and quarterly 
thereafter during the performance year, but the final beneficiary 
assignment is determined after each performance year based on where 
beneficiaries chose to receive a plurality of their primary care 
services during the performance year. We adopted this policy because we 
believe that the methodology balances beneficiary freedom to choose 
healthcare providers under FFS Medicare during the performance year 
with the ACO's desire to know in advance about beneficiaries who have 
chosen to receive such services from practitioners participating in the 
ACO in the past and who are likely to continue to choose to receive 
such services during the performance year. Knowing in advance which 
beneficiaries are likely to receive a plurality of their primary care 
from ACO practitioners during the performance year gives ACOs greater 
opportunities to proactively impact the quality and cost of care for 
beneficiaries who may be assigned to the ACO at the end of the 
performance year.
    In the June 2015 final rule, and in response to stakeholders' 
suggestions, we implemented an option for ACOs to participate in a new 
two-sided performance-based risk track, Track 3 (80 FR 32771 through 
32781). Under Track 3, beneficiaries are prospectively assigned to the 
ACO at the beginning of the performance year using the same two-step 
methodology described previously, based on where the beneficiaries have 
chosen to receive a plurality of their primary care services during a 
12-month assignment window offset from the calendar year that reflects 
the most recent 12 months for which data are available prior to the 
start of the performance year. The ACO is held accountable for 
beneficiaries who are prospectively assigned to it for the performance 
year. Under limited circumstances, a beneficiary may be excluded from 
the prospective assignment list during or after the performance year. 
For example, a beneficiary will be excluded from the prospective 
assignment list if the beneficiary enrolls in Medicare Advantage during 
the performance year or no longer lives in the United States or U.S. 
territories and possessions, based on the most recent available data 
regarding the beneficiary's residence at the end of the performance 
year. A beneficiary is not excluded from the ACO's prospective 
assignment list during the performance year or at the time of 
reconciliation for most other reasons, such as if the beneficiary chose 
to receive most or all of his or her primary care during the 
performance year from providers and suppliers outside the ACO. 
Additionally, no beneficiaries are added to the ACO's prospective 
assignment list during the performance year or at the time of 
reconciliation even if they chose to receive a plurality of their 
primary care during the performance year from ACO professionals 
participating in the ACO and were not previously identified on the 
prospective assignment list. Offering this alternative approach to 
beneficiary assignment responds to stakeholders who expressed a desire 
for a prospective assignment approach. These stakeholders believe 
prospective assignment will provide more certainty about the 
beneficiaries for whom the ACO will be held accountable during the 
performance year, thus enabling ACOs to redesign their patient care 
processes to more efficiently and effectively improve care for specific 
FFS beneficiaries rather than for all FFS beneficiaries. We note, 
however, that such certainty is limited because prospectively assigned 
beneficiaries who meet the exclusion criteria specified in Sec.  
425.401(b) during the performance year will not be assigned to the ACO 
at the end of the year; further, as noted, beneficiaries remain free 
under FFS Medicare to choose the healthcare providers from whom they 
receive services.
    Finally, in the CY 2017 Physician Fee Schedule final rule (81 FR 
80501 through 80510), we further enhanced the claims-based beneficiary 
assignment methodology by finalizing a policy to incorporate data 
gathered directly from beneficiaries who designate a ``main doctor'' 
they believe is responsible for coordinating their overall care. 
Beginning in performance year 2017, beneficiaries may designate a 
provider or supplier as responsible for coordinating their overall care 
using MyMedicare.gov, a secure, online, patient portal. Notwithstanding 
the assignment methodology in Sec.  425.402(b), beneficiaries who 
designate an ACO professional whose services are used in assignment as 
responsible for their overall care will be prospectively assigned to 
the ACO in which that ACO professional participates, provided the 
beneficiary meets the eligibility criteria established at Sec.  
425.401(a) and has had at least one primary care service during the 
assignment window with an ACO professional in the ACO who is a primary 
care physician or a physician with one of the primary specialty 
designations included in Sec.  425.402(c). Such beneficiaries will be 
added prospectively to the ACO's list of assigned beneficiaries for the 
subsequent performance year.
(c) Special Assignment Conditions for RHCs and FQHCs
    RHCs and FQHCs are facilities that furnish services that are 
typically furnished in an outpatient clinic setting. Prior to October 
1, 2014, FQHCs were paid an all-inclusive rate (AIR) per visit for 
qualified primary and preventive health services furnished to Medicare 
beneficiaries. On October 1, 2014, FQHCs began to transition to a new 
FQHC prospective payment system (PPS). FQHCs were required to use HCPCS 
coding on all their claims starting on January 1, 2011, to inform the 
development of the PPS and for limited other purposes, and are now 
required to use HCPCS coding for payment purposes under the FQHC PPS.

[[Page 34107]]

    RHCs are paid an AIR per visit for qualified primary and preventive 
health services furnished to Medicare beneficiaries. Prior to April 1, 
2016, RHCs were required to report HCPCS codes for a few services, such 
as certain preventive services eligible for a waiver of the deductible 
and/or coinsurance, services subject to frequency limits, and services 
eligible for payments in addition to the AIR. Effective April 1, 2016, 
all RHCs are required to report the appropriate HCPCS code for each 
service furnished during the visit, along with the appropriate revenue 
code (For additional background, please see the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/FQHCPPS/Downloads/RHC-Reporting-FAQs.pdf).
    As we noted in the November 2011 final rule, RHC and FQHC claims 
contain very limited information concerning the individual 
practitioner, or even the type of health professional (for example, 
physician, PA, or NP) who provided the service because this information 
is not necessary to determine payment rates for services in RHCs and 
FQHCs s (76 FR 67858 through 67861). Therefore, unlike physician fee 
schedule claims, there is no direct way for us to determine if a claim 
was for a service furnished by a physician at the RHC or FQHC.
    In spite of the difference in claims billing, based on detailed 
comments from some RHC and FQHC representatives, in the November 2011 
final rule, we established a process that allows primary care services 
furnished in RHCs and FQHCs to be considered in the assignment process 
for any ACO that includes an RHC or FQHC as an ACO participant. This 
process is set forth in Sec.  425.404. We assign beneficiaries to ACOs 
that include RHCs or FQHCs as ACO participants in a manner generally 
consistent with how we assign beneficiaries to other ACOs based on 
primary care services performed by certain physicians and non-physician 
practitioners who are ACO professionals in the ACO, as described 
previously. However, to address the requirement under section 1899(c) 
of the Act that beneficiaries be assigned to an ACO based on their use 
of primary care services furnished by physicians, we require ACOs that 
include RHCs or FQHCs to identify, through an attestation, the 
physicians that directly provide patient primary care services in their 
ACO participant RHCs or FQHCs (see Sec. Sec.  425.204(c)(5)(iii) and 
425.404(a)). We use the combination of the RHC or FQHC ACO participant 
TIN (and another unique identifier, such as a CCN, where appropriate) 
and the NPIs of the RHC or FQHC physicians provided to us through the 
attestation process to identify those beneficiaries who received a 
primary care service from a physician in the RHC or FQHC and who are 
therefore eligible to be assigned to the ACO as provided under Sec.  
425.402(b)(1), which we refer to as the assignment ``pre-step''. Then, 
we assign those beneficiaries to the ACO, using the step-wise 
assignment methodology under Sec.  425.402(b), if they received the 
plurality of their primary care services, as determined based on 
allowed charges for the HCPCS codes and revenue center codes included 
in the definition of primary care services at Sec.  425.20, from ACO 
professionals in the ACO.
    The special procedures that we have established for using RHC and 
FQHC services in the assignment methodology are discussed in detail in 
the June 2015 final rule (80 FR 32755 through 32756). RHC and FQHC 
services are billed on an institutional claim form and require special 
handling to incorporate them into the beneficiary assignment process. 
For RHCs and FQHCs that are ACO participants, we treat an RHC or FQHC 
service reported on an institutional claim as a primary care service 
performed by a primary care physician if the claim includes a HCPCS or 
revenue center code that is included in the definition of a primary 
care service at Sec.  425.20 and the service was furnished by a 
physician who was identified as directly providing primary care 
services on the attestation provided under Sec.  425.404(a). All such 
physicians are considered primary care physicians for purposes of the 
assignment methodology and no specialty code is required for these 
claims. If the claim is for a primary care service furnished by someone 
other than a physician listed on the attestation, we treat the service 
as a primary care service furnished by a non-physician ACO 
professional. As a result, all primary care services furnished by an 
ACO professional in an RHC or FQHC to a beneficiary eligible for 
assignment to the ACO are considered in step 1 of the assignment 
methodology. Finally, for RHCs and FQHCs that are not ACO participants, 
we assume a primary care physician performed all primary care services 
so that all primary care services furnished by non-ACO RHCs/FQHCs are 
considered in step 1 of the assignment methodology. We believe this 
approach helps to ensure that we do not disrupt established 
relationships between beneficiaries and their caregivers in non-ACO 
participant RHCs and FQHCs by inappropriately assigning beneficiaries 
to ACOs that are not primarily responsible for coordinating their 
overall care.
    We developed and implemented these regulatory and operational 
policies to facilitate full participation of rural providers, including 
RHCs and FQHCs, in the Shared Savings Program, within the statutory 
requirements for the program. In general, stakeholders have been 
appreciative of our policies to include rural providers and suppliers 
in the Shared Savings Program. However, some stakeholders have 
expressed concerns that the special conditions required for us to 
consider RHC and FQHC institutional claims in beneficiary assignment 
are burdensome and discourage ACOs from including RHCs and FQHCs as ACO 
participants in the Shared Savings Program. Stakeholders have commented 
that the requirement for ACOs that include an RHC or FQHC as an ACO 
participant to provide an attestation identifying ACO professionals who 
are physicians who directly furnish primary care services at the RHC or 
FQHC is particularly burdensome. In addition, due to the operational 
complexities of collecting identifying information about ACO 
participants, screening them for program integrity and other potential 
issues, and incorporating claims data for approved ACO participants 
into beneficiary assignment and financial calculations, we have 
implemented a policy that limits the addition of entities to the ACO 
participant list, absent unusual circumstances, to an annual basis. The 
limitation also applies to changes to the attestation to identify 
additional physicians who directly furnish primary care services at an 
ACO participant RHC or FQHC. In contrast, when a new ACO professional 
begins billing for primary care services under the TIN of an ACO 
participant that is not an RHC or FQHC, those services will be 
considered for purposes of assignment in the current performance year. 
As a result, there are a number of unique burdens and anomalies in the 
way in which RHC and FQHC institutional claims are used for purposes of 
assignment under the Shared Savings Program. First, as noted by 
stakeholders, the required attestation process for submitting physician 
identifiers requires more effort to ensure the accuracy of the ACO 
participant list (including the attestation that includes the physician 
identifiers) than the level of effort required for ACOs that do not 
include RHCs and FQHCs. Second, we have recognized that the required 
attestation process for submitting physician identifiers is also prone 
to error because some RHCs and FQHCs

[[Page 34108]]

(particularly rural FQHCs) have multiple locations with potentially 
hundreds of NPIs to report which, in turn, increases the likelihood 
that ACOs that include RHCs or FQHCs as ACO participants will make 
inadvertent clerical errors, such as transposing digits, in submitting 
the required information. Errors that are not identified and corrected 
by the specified deadline for additions to the ACO participant list may 
result in fewer claims being considered for purposes of assignment 
under the Shared Savings Program than would otherwise occur.
(2) Proposals
    Section 17007 of the 21st Century Cures Act, amended section 
1899(c) of the Act (42 U.S.C. 1395jjj(c)) to require the Secretary to 
assign beneficiaries to ACOs participating in the Shared Savings 
Program based not only on their utilization of primary care services 
furnished by physicians but also on their utilization of services 
furnished by RHCs and FQHCs, effective for performance years beginning 
on or after January 1, 2019. The statute provides the Secretary with 
broad discretion to determine how to incorporate services provided by 
RHCs and FQHCs into the Shared Savings Program beneficiary assignment 
methodology.
    We believe that the 21st Century Cures Act provides the Secretary 
with broad discretion to revise the assignment methodology to address 
the concerns expressed by certain stakeholders regarding the burdens 
placed on ACOs that include RHCs and FQHCs as ACO participants, as 
described above. Section 17007 of the 21st Century Cures Act provides 
that for performance years beginning on or after January 1, 2019, 
Medicare services furnished in an FQHC or RHC should be considered in 
beneficiary assignment for the Shared Savings Program, as may be 
determined by the Secretary. Accordingly, in implementing section 17007 
of the 21st Century Cures Act, we believe it would be appropriate to 
reduce operational burdens for ACOs that include RHCs or FQHCs as ACO 
participants and bring greater consistency to the operational method of 
using claims to assign beneficiaries to ACOs. In order to promote 
participation of RHCs and FQHCs under the Shared Savings Program, we 
propose to remove the burdensome attestation requirement and instead 
treat a service reported on an RHC or FQHC institutional claim as a 
primary care service furnished by a primary care physician. Consistent 
with the 21st Century Cures Act, under this proposal: (1) The 
requirement for an attestation identifying physicians who directly 
provide primary care services in each RHC or FQHC that is an ACO 
participant and/or ACO provider/supplier in the ACO would be removed; 
(2) all RHC and FQHC claims would be used to establish beneficiary 
eligibility to be assigned to the ACO (pre-step); and (3) all RHC and 
FQHC claims would be included in step 1. We would note that in 
considering all services billed under the TIN of the ACO participant 
RHC or FQHC, we would include services that do not meet the definition 
of primary care services, and such services would not be limited to 
those provided by a primary care physician, as defined under program 
rules. This means that under the proposal, a beneficiary could be 
furnished services in an RHC and FQHC only by a nurse practitioner, 
physician assistant, clinical nurse specialist, or any other 
practitioner in an RHC and FQHC and still be eligible for assignment to 
the ACO.
    More specifically, we are proposing the following changes to our 
regulations: (1) Remove Sec.  425.204(c)(5)(iii) in its entirety; (2) 
revise Sec.  425.404; and (3) make conforming changes to the definition 
of primary care physician found at Sec.  425.20. Under our proposal, 
for performance year 2019 and subsequent performance years, ACOs with 
ACO participants that are RHCs and FQHCs would no longer be required to 
submit NPIs or other identifying information for physicians who 
directly provide primary care services in the ACO participant RHCs and 
FQHCs as indicated in Sec.  425.204(c)(5)(iii)(A) and Sec.  425.404(a). 
Therefore we propose to remove Sec.  425.204(c)(5)(iii) in its 
entirety. Additionally, we propose revisions to Sec.  425.402 and Sec.  
425.404 to reflect that for performance year 2019 and subsequent 
performance years, we would assign beneficiaries to ACOs based on 
services furnished in RHCs or FQHCs consistent with the general 
assignment methodology in Sec.  425.402, by treating a service reported 
on an RHC or FQHC institutional claim in the same way as a primary care 
service performed by a primary care physician. We also propose to 
remove revenue center codes from the definition of primary care 
services (Sec.  425.20) for performance year 2019 and subsequent 
performance years because all RHC and FQHC services will be used for 
purposes of assignment for benchmark and performance years; therefore, 
we believe it is appropriate to modify our definition of primary care 
services for performance year 2019 and subsequent years to no longer 
include revenue center codes. Additionally, we note that the 
requirement for an attestation under Sec.  425.404 is also referenced 
in the definition of primary care physician at Sec.  425.20; 
accordingly, we propose to make a conforming revision to that 
definition to remove the reference to the attestation requirement for 
performance year 2019 and subsequent years.
    Consistent with how we have implemented other changes to the 
assignment methodology (see, for example, 80 FR 32757 through 32758), 
we propose to adjust all ACO benchmarks at the start of the first 
performance year in which the new assignment rules are applied so that 
the ACO benchmarks reflect the use of the same assignment rules as will 
apply in the performance year. Also consistent with how we have 
implemented previous changes to the Shared Savings Program assignment 
methodology, we would use the new methodology each time assignment is 
determined for purposes of performance year 2019, including using the 
new methodology in late CY 2018 to determine the eligibility of ACOs 
wishing to enter into or renew a participation agreement beginning 
January 1, 2019. Under the Shared Savings Program, ACOs must have and 
maintain at least 5,000 assigned beneficiaries.
    We believe this proposal would reduce administrative burden for 
ACOs that include RHCs or FQHCs as ACO participants and support our 
policy goal of assigning beneficiaries to the entity that is primarily 
responsible for the beneficiary's overall care. That is, including all 
services furnished by RHCs or FQHCs to establish beneficiary 
eligibility to be assigned to an ACO (pre-step) and in the stepwise 
assignment methodology should help to ensure that a beneficiary is 
assigned to an ACO when the ACO participants in that ACO are providing 
the plurality of care for that beneficiary and thus the ACO should be 
accountable for the patient's overall care.
    We welcome comments on our proposal to: (1) Remove Sec.  
425.204(c)(5)(iii) and modify Sec.  425.402 and Sec.  425.404, for 
performance year 2019 and subsequent performance years, to eliminate 
the requirement for ACOs that include an RHC or FQHC as an ACO 
participant to provide an attestation identifying physicians who 
directly provide primary care services in each RHC or FQHC that is an 
ACO participant and/or ACO provider/supplier in the ACO, and make 
conforming changes to the definition of primary care physician at Sec.  
425.20; and (2) for performance year 2019 and subsequent performance 
years, to: (a)

[[Page 34109]]

Use all claims submitted by RHCs and FQHCs in the ``pre-step'' of the 
assignment methodology under Sec.  425.402 to determine whether a 
beneficiary is eligible for assignment to an ACO participating in the 
Shared Savings Program, (b) treat a service reported on an RHC or FQHC 
claim as if it were a primary care service performed by a primary care 
physician, and (c) remove revenue center codes from the definition of 
primary care services.
    We recognize the unique needs and challenges of rural and 
underserved communities and the important role played by providers and 
suppliers serving these communities in assuring access to primary 
health care. RHCs, FQHCs, and other providers furnishing care in rural 
and underserved communities play an important role in the nation's 
health care delivery system by serving as safety net providers of 
primary care and other health care services, and we believe these 
proposed changes will enhance their ability to participate in the 
Shared Savings Program.
    We also invite suggestions on how we might further support 
participation of RHCs and FQHCs in the Shared Savings Program.
b. Revisions to the Definition of Primary Care Services
(1) Background
    Section 1899(c) of the Act requires the Secretary to assign 
beneficiaries to an ACO ``based on their utilization of primary care 
services'' provided by a physician. However, the statute does not 
specify which kinds of services may be considered primary care services 
for this purpose, nor the amount of those services that would be an 
appropriate basis for making assignments. In this section of this 
proposed rule, we summarize how we currently identify the appropriate 
primary care services on which we base assignment. In addition, we 
propose a revision to our current policies for defining primary care 
services for purposes of beneficiary assignment, consistent with our 
statement in the November 2011 final rule (76 FR 67853), that we 
intended to monitor this issue and would consider making changes to the 
definition of primary care services to add or delete HCPCS codes used 
to identify primary care services, if there were sufficient evidence 
that revisions were warranted.
    We currently define primary care services for purposes of the 
Shared Savings Program in Sec.  425.20 as the set of services 
identified by the following HCPCS/CPT codes: 99201 through 99215, 99304 
through 99318 (excluding claims including the POS 31 modifier), 99319 
through 99340, 99341 through 99350, 99495, 99496, 99490, the Welcome to 
Medicare visit (G0402), and the annual wellness visits (G0438 and 
G0439). In addition, we have established a cross-walk for these codes 
to certain revenue center codes used by FQHCs (for services furnished 
prior to January 1, 2011) and RHCs so that their services can be 
included in the beneficiary assignment process. Lastly, we include 
G0463 for services furnished in electing teaching amendment (ETA) 
hospitals.
    In the November 2011 final rule (76 FR 67853), we established the 
initial list of codes that we considered to constitute primary care 
services for several reasons. First, we believed the listed codes 
represented a reasonable approximation of the kinds of services that 
are described by the statutory language which refers to assignment of 
``Medicare fee-for-service beneficiaries to an ACO based on their 
utilization of primary care services'' furnished by physicians. In 
addition, we selected this list to be largely consistent with the 
definition of primary care services in section 5501 of the Affordable 
Care Act. That section establishes the Primary Care Incentive Payment 
Program to expand access to primary care services, and thus its 
definition of primary care services provides a compelling precedent for 
adopting a similar list of codes for purposes of the beneficiary 
assignment process under the Shared Savings Program. We slightly 
expanded the list of codes found in section 5501 of the Affordable Care 
Act to include the Welcome to Medicare visit (HCPCS code G0402) and the 
annual wellness visits (HCPCS codes G0438 and G0439) as primary care 
services for purposes of the Shared Savings Program. These codes 
clearly represent primary care services frequently received by Medicare 
beneficiaries, and in the absence of the special G codes the services 
provided during these visits would be described by one or more of the 
regular office visit codes that are included in the list under Section 
5501 of the Affordable Care Act.
    In the June 2015 final rule (80 FR 32746 through 32748), we 
expanded the definition of primary care services to include two 
transitional care management (TCM) codes (CPT codes 99495 and 99496), 
and one chronic care management (CCM) code, (CPT 99490). As discussed 
in the final rule, the TCM codes were established to pay a patient's 
physician or practitioner to coordinate the patient's care in the 30 
days following a hospital or skilled nursing facility (SNF) stay. 
Including these codes in the definition of primary care services 
reflects our belief that the work of community physicians and 
practitioners in managing a patient's care following discharge from a 
hospital or nursing facility to ensure better continuity of care for 
these patients and help reduce avoidable readmissions is a key aspect 
of primary care.
    In the CY 2017 PFS Final Rule, we finalized a separate payment for 
three additional CCM service codes, CPT codes 99487 and 99489 (see 81 
FR 80251), and an additional add-on code G0506 (see 81 FR 80245), to 
support care management for the most complex and time-consuming cases 
of beneficiaries with multiple chronic conditions. These codes are used 
to report complex CCM services furnished to patients with multiple (two 
or more) chronic conditions. CCM services generally include regular 
development and revision of a plan of care, communication with other 
treating health professionals, and medication management. We explained 
in the CY 2017 PFS final rule that we believe the addition of the 
complex CCM codes will retain elements of the CCM service that are 
characteristic of the changes in medical practice toward advanced 
primary care, while eliminating redundancy, simplifying provision of 
the services, and improving access to the services. Additional 
explanation of required elements for billing CCM services can be found 
in the CY 2017 PFS Final Rule (81 FR 80243 through 80251).
    Finally, in the 2017 PFS final rule (81 FR 80230 through 80243), we 
finalized a policy to make separate payments to physicians and non-
physician practitioners for behavioral health integration (BHI) 
services they furnish to beneficiaries over a calendar month service 
period using four new Medicare Part B billing codes. Three of these BHI 
codes (G0502, G0503, G0504) are used to bill for monthly services 
furnished using the Psychiatric Collaborative Care Model (CoCM), an 
approach to BHI shown to improve outcomes in multiple studies. CoCM is 
a model of BHI that enhances ``usual'' primary care by adding two key 
services: Care management support for patients receiving behavioral 
health treatment; and regular psychiatric inter-specialty consultation 
to the primary care team, particularly regarding patients whose 
conditions are not improving. The fourth BHI service code (G0507) is 
used to bill monthly services furnished using BHI models of care other 
than CoCM that similarly include ``core'' service elements such as 
systematic assessment and monitoring, care plan revision for

[[Page 34110]]

patients whose condition is not improving adequately, and a continuous 
relationship with a designated care team member. The BHI service codes 
may be billed by the treating practitioner. Physicians billing for 
these services would typically be primary care physicians, but may be 
of another specialty such as cardiology or oncology. Non-physician 
practitioners (PAs, NPs, CNSs, or CNMs), may also bill for these 
services.
(2) Proposals
    As discussed above, we previously finalized the inclusion of CCM 
code 99490 in the definition of primary care services for the Shared 
Savings Program. For the same reason that we included CCM code 99490, 
we believe that it would be also be appropriate to include the complex 
CCM service codes 99487, 99489, and G0506 in the definition of primary 
care services and to utilize these codes in the beneficiary assignment 
methodology under the Shared Savings Program beginning in 2018 for 
performance year 2019 and subsequent years. These three additional CCM 
codes reflect the changes in medical practice toward advanced primary 
care and differ from each other only in the amount of clinical staff 
service time provided; the complexity of medical decision-making as 
defined in the Evaluation and Management guidelines (determined by the 
problems addressed by the reporting practitioner during the month); and 
the nature of care planning that was performed (establishment or 
substantial revision of the care plan for complex CCM versus 
establishment, implementation, revision, or monitoring of the care plan 
for non-complex CCM).
    In addition, we believe that it would be also be appropriate to 
include the four BHI codes G0502, G0503, G0504 and G0507 in the 
definition of primary care services and to utilize these codes in the 
beneficiary assignment methodology under the Shared Savings Program 
beginning in 2018 for performance year 2019 and subsequent years. These 
BHI codes reflect important enhancements in primary care to support 
improvement and integration of care provided for patients receiving 
behavioral health treatment. As discussed above, the BHI service codes 
may be billed by the treating practitioner (a physician and/or non-
physician practitioner (PA, NP, CNS, CNM)). Physicians billing for 
these services would typically be primary care physicians, but may be 
of another specialty such as cardiology or oncology. (See fact sheet 
available on our Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/Downloads/Behavioral-Health-Integration-Fact-Sheet.pdf.)
    Therefore, we propose to revise the definition of primary care 
services currently located in Sec.  425.20 to include three additional 
CCM service codes 99487, 99489, and G0506, and four BHI service codes 
G0502, G0503, G0504 and G0507, beginning in 2018 for performance year 
2019 and subsequent performance years and to include these codes when 
performing beneficiary assignment under Sec.  425.402. In addition, we 
propose to move the list of service codes currently listed in the 
definition in Sec.  425.20 to Sec.  425.400(c). We believe Sec.  
425.400, which specifies general requirements related to the assignment 
methodology and currently contains a cross-reference at Sec.  
425.400(c) to the definition of primary care services under Sec.  
425.20, is the more appropriate place to specify the particular primary 
care codes that will be considered in the assignment methodology. We 
also propose to reorganize the list of service codes, grouping HCPCS 
codes, G codes, and revenue center codes together, respectively, by 
relevant performance year(s). We seek comments on this proposal. In 
addition, we seek comments as to whether there are any additional 
existing HCPCS/CPT codes, that we should consider adding to the 
definition of primary care services in future rulemaking for purposes 
of assignment of beneficiaries to ACOs under the Shared Savings 
Program.
    We also propose to remove paragraph (3) from the definition of 
primary care services. Paragraph (3) indicates that we will include 
additional codes designated by us as primary care services, including 
new HCPCS/CPT and revenue center codes and any subsequently modified or 
replacement codes for the HCPCS/CPT and revenue center codes identified 
in the definition. We finalized this policy in the June 2015 final rule 
(80 FR 32746), explaining that it was intended to promote flexibility 
for the Shared Savings Program and allow us to respond more quickly to 
HCPCS/CPT coding changes made in the annual PFS rulemaking process. We 
now believe this paragraph which directs CMS to respond to HCPCS/CPT 
coding changes though rulemaking is unnecessary because we always have 
the flexibility to propose, through the annual PFS rulemaking (or other 
rulemaking for the Shared Savings Program), to make changes to the 
definition of primary care services to reflect HCPCS/CPT coding changes 
made elsewhere in the same PFS rulemaking or in a previous PFS final 
rule. We therefore believe it would be reasonable to remove this 
paragraph rather than move it to subpart E under part 425 along with 
the other paragraphs making up the definition of primary care services.
2. ACO Quality Reporting
a. Changes to the Quality Measure Set Used in Establishing the Quality 
Performance Standard
(1) Background
    Section 1899(b)(3)(A) of the Act requires the Secretary to 
determine appropriate measures to assess the quality of care furnished 
by ACOs, such as measures of clinical processes and outcomes; patient 
and, wherever practicable, caregiver experience of care; and 
utilization, such as rates of hospital admission for ambulatory 
sensitive conditions. Section 1899(b)(3)(B) of the Act requires ACOs to 
submit data in a form and manner specified by the Secretary on measures 
that the Secretary determines necessary for ACOs to report to evaluate 
the quality of care furnished by ACOs. Section 1899(b)(3)(C) of the Act 
states that the Secretary shall establish quality performance standards 
to assess the quality of care furnished by ACOs and seek to improve the 
quality of care furnished by ACOs over time by specifying higher 
standards, new measures, or both. We designate the quality performance 
standard that will apply for each performance year. The quality 
performance standard is the overall standard the ACO must meet in order 
to be eligible for shared savings.
    In the November 2011 final rule (76 FR 67973), we initially 
established a quality performance standard consisting of 33 measures 
across 4 domains (see Sec.  425.502(d)), including patient experience 
of care, care coordination/patient safety, preventive health, and at-
risk population and a methodology for scoring the measures submitted by 
ACOs (see Sec.  425.502(e)). Quality measures are submitted by the ACO 
through the CMS web interface, calculated by us from administrative and 
claims data, and collected via a patient experience of care survey 
based on the Clinician and Group Consumer Assessment of Healthcare 
Providers and Systems (CG-CAHPS) survey. To qualify for shared savings 
(see Sec. Sec.  425.604(c), 425.606(c), and 425.610(c)), an ACO must 
meet or exceed its minimum savings rate, meet the minimum quality 
performance standards established under Sec.  425.502, and otherwise 
maintain its eligibility to participate in the Shared Savings Program. 
For example, under the

[[Page 34111]]

regulation at Sec.  425.604(d), an ACO participating in the Shared 
Savings Program under Track 1 that meets all the requirements for 
receiving shared savings payments will receive a shared savings payment 
of 50 percent of all savings under the updated benchmark (up to the 
performance payment limit).
    Since the November 2011 Shared Savings Program final rule, we have 
continued to review the quality measures used for the Shared Savings 
Program to ensure that they are up to date with current clinical 
practice and are aligned with the CMS web interface reporting for PQRS, 
and most recently, with reporting requirements under the Quality 
Payment Program. Through the annual rulemaking for the PFS we have 
reviewed and updated the quality measures reported by ACOs through the 
CMS web interface, including adding new measures and retiring measures 
that were redundant or no longer met the goals for group reporting, and 
ensuring that the ACO CMS web interface reported measures align with 
the measures reported through the CMS web interface by group practices 
in other CMS initiatives such as PQRS and the Quality Payment Program. 
The quality measure set currently includes 31 quality measures (see 
Tables 42 and 43 at 81 FR 80488 and 80489). To avoid confusion and 
duplication of rulemaking, and reduce provider burden, we also 
finalized a policy in the 2017 PFS final rule that future changes to 
the CMS web interface measure will be made through rulemaking for the 
Quality Payment Program and will be applicable to ACO quality reporting 
under the Shared Savings Program (81 FR 80499 and 80500). Under the APM 
scoring standard finalized in the CY 2017 Quality Payment Program final 
rule (81 FR 77255 through 77256), measures reported by Shared Savings 
Program ACOs through the CMS web interface will also be used to 
determine the Merit-Based Incentive Payment System (MIPS) quality 
performance category score for eligible clinicians participating in a 
Shared Savings Program ACO in 2017.
    When scoring ACO quality performance in the Shared Savings Program, 
we designate a performance benchmark and minimum attainment level for 
each measure. Performance below the minimum attainment level for a 
measure will receive zero points for that measure and performance equal 
to or greater than the minimum attainment level for the measure will 
receive points on a sliding scale based on the level of performance. We 
update the quality performance benchmarks every 2 years. For the first 
performance year of an ACO's first agreement period, we define the 
quality performance standard at the level of complete and accurate 
reporting for all quality measures. During subsequent performance years 
of the ACO's first agreement period, the quality performance standard 
is phased in such that the ACO must continue to report all measures but 
the ACO will be assessed on performance based on the quality 
performance benchmark and minimum attainment level for certain measures 
that are designated a pay for performance. The quality performance 
standard that applies to an ACO's final year in its first agreement 
period also applies for each performance year of an ACO's subsequent 
agreement period. A newly introduced measure is set at the level of 
complete and accurate reporting for the first 2 reporting periods the 
measure is required. For subsequent reporting periods, the quality 
performance standard for the measure will be assessed according to the 
phase-in schedule for the measure. Pay for reporting measures are worth 
2 points each for complete and accurate reporting, whereas pay for 
performance measures are worth 0-2 points based on ACO performance 
compared to the established benchmark. The EHR measure (ACO-11), 
however, is double-weighted and ACOs can earn up to 4 points based on 
their performance on this measure.
    Additionally, as discussed in the CY 2016 PFS final rule with 
comment period (see 80 FR 71269), occasionally issues arise with 
measures that cause us to reevaluate whether it is appropriate to hold 
an ACO accountable for performance on a measure. For instance, in the 
CY 2015 PFS final rule with comment period we retired measures that 
were no longer consistent with updated clinical guidelines for 
cholesterol targets, but we were unable to finalize retirement of the 
measures for the 2014 reporting year due to the timing of the guideline 
updates and rulemaking cycle. Because these measures did not align with 
updated clinicial guidance, in February 2015, we issued an update to 
the guidance document on the Medicare Shared Savings Program Quality 
Measure Benchmarks for the 2014 Reporting Year that maintained these 
measures, including the Diabetes Composite measure, as pay for 
reporting for the 2014 reporting year. In order to address such issues 
in the future, we finalized a policy in the CY 2016 PFS final rule with 
comment period (80 FR 71269) under which we reserve the right to 
maintain a measure as pay for reporting or revert a pay for performance 
measure to pay for reporting when the measure owner determines the 
measure no longer aligns with clinical practice or continued 
application of the measure may result in patient harm (see Sec.  
425.502(a)(5)).
(2) Proposals
    As previously noted in the background section, we finalized a 
policy that future changes to the CMS web interface measures will be 
adopted through rulemaking for the Quality Payment Program and will be 
applicable to ACO quality reporting under the Shared Savings Program 
(81 FR 80501). We also note that, as discussed in the CY 2017 Quality 
Payment Program final rule with comment period (81 FR 77136), section 
1848(q)(2)(D)(i)(II) of the Act requires the Secretary to update the 
final list of quality measures from the previous year (and publish an 
updated list in the Federal Register) annually. Updates may include the 
removal of quality measures the addition of new quality measures, and 
the exclusion of existing quality measures that the Secretary 
determines have gone through substantive changes. In the CY 2017 
Quality Payment Program final rule with comment period, we indicated 
that in the future we would use rulemaking for the MIPS program to 
address substantive changes to measures (81 FR 77143). On June 20, 
2017, HHS issued a proposed rule that includes a number of proposals to 
revise certain policies under the Quality Payment Program for CY 2018, 
including a proposal to make substantive changes to several measures 
reported through the CMS web interface. For example, substantive 
changes are proposed for the way ACO-17 Tobacco Use: Screening and 
Cessation Intervention measure rate is calculated via the CMS web 
interface (see Table E, 82 FR 30469). This measure was originally 
developed as a two-part measure: The first part of the measure assessed 
whether a patient had been screened for tobacco use within the past 24 
months; the second part of the measure assessed whether those who had 
been screened and identified as tobacco users in the first part of the 
measure also received tobacco cessation intervention (either counseling 
and/or pharmacotherapy). To date, the two parts of the measure have 
been combined into a single performance rate. We have identified two 
notable limitations with this approach, including (1) the performance 
rate does not show the difference in performance with respect to how 
well clinicians adhere to performing tobacco use screenings and how 
well clinicians follow the guidelines to provide tobacco

[[Page 34112]]

cessation interventions, and (2) the measure is topped out, meaning it 
continuously shows a high performance rate. The changes to the measure 
proposed in the CY 2018 Quality Payment Program proposed rule would not 
modify the sampling methodology or the data reported into the CMS web 
interface. The proposed changes would simply revise the measure 
specifications to measure the percent of tobacco users that received 
cessation counseling; instead of measuring a combined performance rate 
for beneficiaries that were screened for tobacco use and for the subset 
of beneficiaries that are tobacco users that received tobacco cessation 
counseling.
    Substantive changes to other CMS web interface measures are also 
proposed. A substantive change is proposed to the Influenza 
Immunization measure (ACO-14), however, the changes apply only to the 
Registry and EHR data submission methods and not the CMS web interface 
reporting method (82 FR 30472). Finally, a substantive change is 
proposed for the Body Mass Index Screening and Follow-Up Plan (ACO-16); 
specifically, the frequency of documenting BMI will change from 6 to 12 
months (82 FR 30471).
    Consistent with how we have addressed previous changes to measures, 
we reviewed the proposed substantive changes to the CMS web interface 
measures proposed in the CY 2018 Quality Payment Program proposed rule 
to assess whether the changes, if finalized, would warrant a change in 
how the measures are used to assess ACO performance under the Shared 
Savings Program. As part of this review, we considered whether the 
proposed substantive changes might raise sampling issues or require 
that we recalculate the measure benchmarks for purposes of the Shared 
Savings Program. Based on our preliminary review of the Quality Payment 
Program proposals, we believe the proposed ``substantive'' changes to 
the CMS web interface measures would not require that we revert these 
measures to pay for reporting for the 2018 performance year. The 
Quality Payment Program proposals do not appear to modify the current 
structure and reporting of the measures for which substantive changes 
are proposed; rather, in the case of the Tobacco Use: Screening and 
Cessation Intervention measure, the proposed change would only modify 
the way the data are manipulated and calculated after the data are 
submitted. Similarly, we do not believe that the proposed substantive 
change to the BMI measure to change the frequency of reporting would 
impact an ACO's ability to perform well compared to the established 
benchmark for this measure. Finally, the substantive change to the 
Influenza Immunization measure does not apply to the CMS web interface 
reporting method. Therefore, we believe that we will have the data 
necessary from past submission periods to calculate appropriate 
benchmarks that could be used to assess ACO performance for the CMS web 
interface measures under consideration for performance year 2018 and 
subsequent years. Additionally, the recalculation of the benchmark 
coincides with the biannual timing of the benchmark updates. Therefore, 
if the proposed changes to the measures are finalized under the Quality 
Payment Program, we do not believe it would be necessary or 
appropriate, to revert the measures to pay for reporting under the 
Shared Savings Program. Instead, we believe it would be appropriate 
under the Shared Savings Program to: (1) Update the measure 
specifications through subregulatory guidance in order to continue to 
align the measures with the measure specifications used under the 
Quality Payment Program and Million Hearts initiative, and (2) retain 
the current phase-in schedule for the measures rather than 
redesignating any of the measures as pay for reporting.
    Because the particular substantive changes that are proposed in the 
CY 2018 Quality Payment Program proposed rule do not appear to change 
the information that must be collected for these measures (which makes 
it possible for us to use data submitted previously to determine prior 
performance under the new measure rate, and therefore calculate an 
appropriate prospective quality benchmark), we do not believe any 
changes to the measures' phase-in schedules are necessary. However, the 
statutory directive under the Quality Payment Program to address 
substantive changes to measures in rulemaking and the proposals in the 
CY 2018 Quality Payment Program proposed rule to address substantive 
changes to certain web interface measures have caused us to evaluate 
what recourse we might have in the future under the Shared Savings 
Program rules to modify a measure's phase-in in instances where a 
substantive change to the measure makes it inappropriate to hold ACOs 
accountable for performance on a measure that has been substantively 
modified. We anticipate that there could be future substantive changes 
to the CMS web interface measures made under the Quality Payment 
Program that would give us reason to redesignate a measure as pay-for-
reporting under the Shared Savings Program. Currently, although the 
Shared Savings Program rules afford flexibility to redesignate a 
measure as pay for reporting whem the measure owner determines the 
measure no longer aligns with clinical practice or causes patient harm, 
there is no discretion to modify how we assess CMS web interface 
measures in the event substantive changes are made to those measures 
under the Quality Payment Program that make it inappropriate to hold 
ACOs accountable for performance on the measure. Given the timing of 
the Quality Payment Program proposals in relationship to the timing for 
when the quality performance benchmarks must be established under the 
Shared Savings Program, it may in some cases be necessary to have 
flexibility to designate a pay for performance measure as pay for 
reporting just before or following the start of a performance year 
outside of the formal rulemaking process, consistent with the way in 
which we have redesignated measures in the past when measure owners 
have made changes after the start of a performance year. Accordingly, 
we believe it would be appropriate to modify the Shared Savings Program 
regulations to provide additional flexibility to address substantive 
changes to CMS web interface measures that are made under the Quality 
Payment Program and to continue to facilitate alignment of measures 
with the Quality Payment Program and other CMS initiatives.
    We are therefore proposing to modify Sec.  425.502(a)(5) to include 
the right for CMS to redesignate a measure as pay-for-reporting when a 
substantive change to a CMS web interface measure is made under the 
Quality Payment Program. This proposed revision would supplement CMS's 
existing discretion to redesignate a measure as pay-for-reporting when 
the measure owner determines the measure no longer aligns with clinical 
practice or causes patient harm. Specifically, we are proposing to 
revise the regulation at Sec.  425.502(a)(5) to reserve CMS's right to 
redesignate CMS web interface measures that have undergone a 
substantive change as determined under the Quality Payment Program to 
pay-for-reporting status. Such measures would not necessarily be 
automatically redesignated as pay for reporting when a substantive 
change occurs (for example, as indicated previously, we do not believe 
the currently proposed substantive changes present an impediment to 
holding ACOs accountable for performance on these measures in 
performance year 2018 and

[[Page 34113]]

subsequent years); however, in the future, substantive changes made to 
CMS web interface measures under the Quality Payment Program (such as 
when the substantive change to a measure results in an issue with 
sampling, calculating performance, or the calculating the quality 
benchmark) may make it inappropriate to hold an ACO accountable for 
performance on the measure for the time needed for CMS to obtain the 
information necessary to calculate a quality benchmark for the 
substantively changed measure in advance of a performance year and/or 
until ACOs gain experience reporting the measure, as substantively 
changed. Although we expect to conduct at least a preliminary 
assessment of any substantive changes to the CMS web interface measures 
as part of the annual PFS rulemaking in order to determine whether any 
change to the phase in schedule for a measure is warranted, because we 
cannot always anticipate the types of substantive changes that may be 
finalized under the Quality Payment Program or the effect of those 
changes on our ability to calculate performance on the measure, this 
proposal would provide us with additional flexibility to redesignate 
existing measures undergoing a substantive change as pay-for-reporting 
on a measure by measure basis. We believe this additional flexibility 
would enable us to more appropriately assess ACO quality performance, 
by ensuring that ACOs are not held accountable for performance on a 
measure when substantive changes to that measure affect our ability to 
assess performance on that measure appropriately. Otherwise, ACOs could 
be inappropriately held accountable for performance on such measures 
until such time as we could undertake rulemaking to modify the phase-in 
schedule for the measure. As with redesignations that occur when the 
measure owner determines the measure no longer aligns with clinical 
practice or causes patient harm, redesignations that occur due to 
substantive changes to a measure would be communicated to ACOs as soon 
as possible through operational documents and other typical methods we 
use to communicate with ACOs. We invite comments on this proposal.
b. Further Refining the Process Used To Validate ACO Quality Data 
Reporting
(1) Background
    In the November 2011 final rule, we finalized a proposal to retain 
the right to validate the quality measure data ACOs enter into the web 
interface (76 FR 67893 through 67894). We believe that the data 
validation process implicitly incentivizes ACOs to keep organized and 
up-to-date medical records and is necessary to protect against gaming. 
This validation process, referred to as the Quality Measures Validation 
audit, was based on the process used in Phase I of the Physician Group 
Practice (PGP) demonstration. The policy was finalized at Sec.  
425.500(e) and involved a process under which we selected a subset of 
web interface measures and a random sample of 30 confirmed and 
completely reported beneficiaries for each measure in the subset. The 
ACO was required to provide medical records to support the data 
reported in the web interface for those beneficiaries. A measure-
specific audit performance rate was then calculated using a multi-
phased audit process. If at the conclusion of the third phase there was 
a discrepancy greater than 10 percent between the quality data reported 
and the medical records provided during the audit, the ACO was not 
given credit for meeting the quality target for any measure(s) for 
which the mismatch rate existed.
    In the CY 2017 PFS final rule (81 FR 80489 through 80492), we 
revisited the quality validation audit process and finalized several 
significant changes as a result of our experience in conducting audits 
and in an effort to increase the statistical rigor of the audit 
methodology while streamlining audit operations. We expressed our 
intent to align the quality measures validation audit used in the 
Shared Savings Program more closely with other CMS quality program 
audits, including those performed in the Physician Quality Reporting 
Program and the Hospital Inpatient and Outpatient Quality Reporting 
programs. We therefore finalized four improvements to our audit process 
that addressed the number of records to be reviewed per measure, the 
number of audit phases, the calculation of an audit match rate and the 
consequences if the audit match rate falls below 90 percent. 
Specifically, we finalized a policy under which we will audit enough 
medical records to achieve a 90 percent confidence interval; conduct 
the audit in a single phase; and calculate an overall audit performance 
rate. If at the conclusion of the audit process the overall match rate 
between the quality data reported and the medical records provided by 
the ACO is less than 90 percent, absent unusual circumstances, we will 
adjust the ACO's overall quality score proportional to the ACO's audit 
performance. The audit-adjusted quality score is calculated by 
multiplying the ACO's overall quality score by the ACO's overall audit 
match rate. For example, if an ACO's quality score is 75 percent and 
the ACO's audit match rate is 80 percent, the ACO's audit-adjusted 
quality score would be 60 percent. The audit-adjusted quality score is 
the quality score that will be used to determine the percentage of any 
earned savings that the ACO may share or the percentage of any losses 
for which the ACO is accountable. We note that under the revised audit 
methodology, our intent was to continue to audit a subset of ACOs, 
which we would identify by looking for data anomalies such as high skip 
rates, although we have flexibility to randomly select ACOs or specific 
measures for audit as we have done in the past.
    We also finalized a new requirement at Sec.  425.500(e)(3) that an 
ACO that has an audit match rate of less than 90 percent may be 
required to submit a corrective action plan (CAP) under Sec.  425.216 
for our approval. In the CAP, the ACO would be required to explain the 
reasons for the low audit match rate and how it plans to improve the 
accuracy of its quality reporting in the future. In addition, we noted 
that we maintain the right, as described in Sec.  425.500(f), to 
terminate or impose other sanctions on any ACO that does not report 
quality data accurately, completely, or timely. We indicated that we 
would begin applying these policies to the quality validation audits 
beginning in 2017 with the quality validation audits of quality 
reporting for the 2016 performance year.
(2) Proposals
    Since publication of the CY 2017 PFS final rule, we have gained 
additional experience with the quality validation audits, and have 
performed additional analyses related to these audits. Our analysis of 
the 2016 quality measure validation audit results for Shared Savings 
Program ACOs indicates that the average match rate of ACOs audited in 
calendar year 2016 was 72 percent and the median performance was 80 
percent. Typically, during the audit, we review medical record 
documentation and work with ACOs to better understand the mismatch 
between what was reported and what was documented and have determined 
through our analyses that ACOs continue to experience challenges in 
understanding certain aspects of the measure specifications, 
coordinating collection of information across many different providers 
and practices, and satisfying the requirements for supporting 
documentation. Many of these errors are not indicative of poor quality 
of care but rather reflect minor errors in process or

[[Page 34114]]

in understanding measure requirements. For instance, we have identified 
errors by individuals abstracting data from the medical record. In one 
case, a medical record abstractor incorrectly misinterpreted the less 
than symbol (<) in the quality measure specifications for the ACO-31 
Heart Failure: Beta Blocker Therapy for Left Ventricular Systolic 
Dysfunction and ACO-33 Angiotensin-Converting Enzyme (ACE) Inhibitor or 
Angiotensin Receptor Blocker (ARB) Therapy, and therefore, abstracted 
the data incorrectly for reporting.
    Under our newly finalized single-phase approach to quality 
validation audits, minor errors are more likely to affect the final 
audit results and impact the calculation of shared savings or shared 
losses when the overall match rate is below 90 percent. Additionally, 
we note that the match rate threshold under the Hospital Inpatient 
Quality Reporting (HIQR) Program is 75 percent. The HIQR validates data 
submitted by hospitals, which are entities that generally have more 
experience with quality reporting, greater health record accessibility 
and integration, and a longer history of validation of quality data 
submitted to CMS.
    In light of our analyses of the 2016 quality measure validation 
audit results, we believe it is appropriate to consider making 
additional modifications to our quality validation audit process. 
First, we are concerned that the 90 percent match rate adopted in CY 
2017 PFS final rule may be too high and could inappropriately penalize 
ACOs that make quality data reporting errors that are unrelated to care 
quality. In the early years of phasing in this new audit methodology, 
we believe that the match rate should instead be based on actual ACO 
experience in order to focus on holding ACOs accountable for clinically 
related mismatches in reporting quality measures as they continue to 
gain experience with how to measure, report and improve quality under 
the program. We believe that basing the audit match rate threshold on 
actual validation audit results would strike an appropriate balance 
between ensuring the accuracy of ACO quality reporting while not unduly 
penalizing ACOs for minor quality reporting errors that are not 
necessarily indicative of poor quality care. Accordingly, we believe it 
would be appropriate to set the audit match rate threshold based on the 
median match rate (80 percent) for ACOs audited in calendar year 2016 
rather than an alternative approach such as the mean match rate because 
the median match rate would be less affected by data outliers. 
Therefore, we are proposing to revise Sec.  425.500(e)(2) to indicate 
that if an ACO has a match rate below 80 percent, absent unusual 
circumstances, we would adjust the ACO's overall quality score 
proportional to the ACO's audit performance.
    Second, we propose to amend the method by which we adjust an ACO's 
overall quality score to reflect the ACO's audit performance. 
Specifically, we propose to revise the methodology described in the 
2017 PFS final rule (81 FR 80490) under which the audit-adjusted 
quality score is calculated by multiplying the ACO's overall quality 
score by the ACO's audit match rate. Instead, we propose that for each 
percentage point difference between the ACO's match rate and the match 
rate considered passing the audit, the ACO's overall quality score 
would be adjusted downward by 1 percent. That is, if we finalize the 
proposal to establish an 80 percent match rate as the threshold for 
passing the quality validation audit, and the ACO's match rate is 75 
percent, then under this proposal we would adjust the ACO's overall 
quality score downward by 5 percent. To illustrate, assuming a match 
rate threshold of 80 percent, an ACO with an overall quality score of 
90 percent would have an audit-adjusted quality score of 85.50 percent, 
that is, (90-[.05x90]) = 85.50.
    Finally, we propose a conforming change to Sec.  425.500(e)(3) to 
reflect the 80 percent threshold such that if at the conclusion of the 
audit process CMS determines there is an audit match rate of less than 
80 percent, the ACO may be required to submit a CAP.
    We believe that over time, as ACOs become more experienced with 
quality reporting requirements, improve their quality reporting 
processes and become better clinically integrated, quality validation 
audit results that show a significant mismatch between the information 
reported and the underlying medical records will more consistently 
reflect meaningful, clinically related quality reporting errors for 
which ACOs should be held accountable. In addition, because the audit 
process involves the exchange of information regarding medical record 
review and communication between ACOs and us, the audit process, 
itself, provides additional education on the quality measures and 
quality reporting. Accordingly, we will periodically review the audit 
match threshold and seek to increase the match rate over time. We may 
also consider requiring a higher match rate for ACOs that have been in 
the program longer. Therefore, we anticipate that we will continue to 
closely monitor quality validation audit results and the reasons for 
mismatches and, over time, seek to increase the audit match rate 
threshold.
    Although at this time we are proposing the change the audit match 
rate threshold to 80 percent, we also seek comment on an alternative 
approach we considered to address the quality validation audit match 
rate and the resulting impact on an ACO's overall quality score.
    Consistent with the approach used under the HIQR program, we 
considered revising Sec.  425.500(e)(2) to provide that we would adjust 
the ACO's overall quality score if an ACO has a match rate below 75 
percent. We did not propose this approach because the results of the 
Quality Measures Validation Audits conducted on Shared Savings Program 
ACOs in calendar year 2016 yielded a median match rate of 80 percent, 
suggesting that a match rate of 75 percent would be too low.
    We invite comment on the proposed refinements to the process used 
to validate ACO quality data reporting and to adjust an ACO's overall 
quality score to reflect the ACO's audit performance, and on the 
alternative that was considered, but not proposed.
3. Reducing Shared Savings Program Application Burden
a. SNF 3-Day Rule Waiver Application Requirement That ACOs Report Their 
Financial Relationships
(1) Background
    The Medicare SNF benefit is for beneficiaries who require a short-
term intensive stay in a SNF, requiring skilled nursing or skilled 
rehabilitation care, or both. Under section 1861(i) of the Act, 
beneficiaries must have a prior inpatient hospital stay of no fewer 
than 3 consecutive days in order to be eligible for Medicare coverage 
of inpatient SNF care. In the June 2015 final rule (80 FR 32804 through 
32806, 32808), we provided ACOs participating in Track 3 with 
additional flexibility to attempt to increase quality and decrease 
costs by allowing these ACOs to apply for a waiver of the SNF 3-day 
rule to permit their prospectively assigned beneficiaries to receive 
coverage for inpatient SNF care without a prior 3-day inpatient 
hospital stay when they are admitted to a ``SNF affiliate,'' that is, a 
SNF with which the ACO has executed a SNF affiliate agreement, and 
certain additional eligibility criteria are met (see Sec.  
425.612(a)(1)). Waivers are effective upon our notification to the ACO 
of approval for the waiver or the start date of the ACO's participation 
agreement, whichever is later (see Sec.  425.612(c)). We stated in the 
June 2015 final rule that the SNF 3-day rule waiver

[[Page 34115]]

would be effective for services furnished on or after January 1, 2017. 
Program requirements for this waiver are codified at Sec.  425.612. 
These requirements are primarily based on criteria previously developed 
under the Pioneer ACO Model. Specifically, under Sec.  425.612(a)(1), 
we waive the requirement in section 1861(i) of the Act for a 3-day 
inpatient hospital stay prior to a Medicare covered post-hospital 
extended care service for eligible beneficiaries prospectively assigned 
to ACOs participating in Track 3 (and as provided in Sec.  
425.612(a)(1)(iv) for certain other beneficiaries), who receive 
otherwise covered post-hospital extended care services furnished by an 
eligible SNF that has entered into a written agreement to partner with 
the ACO for purposes of this waiver. All other provisions of the 
statute and regulations regarding Medicare Part A post-hospital 
extended care services continue to apply.
    We believe that clarity regarding whether SNF services furnished to 
a particular beneficiary are eligible for payment under the SNF 3-day 
rule waiver is important to help ensure compliance with the conditions 
of the waiver and also improve our ability to monitor waivers for 
misuse. Therefore, in the June 2015 final rule, we limited the waiver 
to ACOs in Track 3 because under the prospective assignment methodology 
used in Track 3, beneficiaries are assigned in advance to the ACO for 
the entire performance year (unless they meet any of the exclusion 
criteria under Sec.  425.401(b)), so it will be clearer to a Track 3 
ACO and its SNF affiliates whether the waiver applies to SNF services 
furnished to a particular beneficiary than it would be to an ACO in 
Track 1 or 2, where beneficiaries are assigned using a preliminary 
prospective assignment methodology with retrospective reconciliation 
(80 FR 32804). An ACO's use of the SNF 3-day rule waiver will be 
associated with a distinct and easily identifiable event, specifically, 
admission of a prospectively assigned beneficiary to a previously 
identified SNF affiliate without prior inpatient hospitalization or 
after an inpatient hospitalization of fewer than 3 days.
    Based on our experiences under the Pioneer ACO Model, and in 
response to comments, we established certain requirements under Sec.  
425.612 that ACOs, ACO providers/suppliers, SNF affiliates, and 
beneficiaries must meet for SNF services to be covered under the SNF 3-
day rule waiver under the Shared Savings Program. All ACOs electing to 
participate in Track 3 are offered the opportunity to apply for a 
waiver of the SNF 3-day rule for their prospectively assigned 
beneficiaries at the time of their initial application to participate 
in Track 3 of the program and annually thereafter while participating 
in Track 3. The program rules for a waiver of the SNF 3-day rule are 
under Sec.  425.612 and are discussed in detail in the 2015 final rule 
(80 FR 32804 through 32806).
    To qualify to use the SNF 3-day rule waiver, ACOs must submit a SNF 
3-Day Rule Waiver application that includes supplemental information 
sufficient to demonstrate that the ACO has the capacity to identify and 
manage beneficiaries who would be either directly admitted to a SNF or 
admitted to a SNF after an inpatient hospitalization of fewer than 3 
days. Required application materials include but are not limited to the 
following:
     Narratives describing how the ACO plans to implement the 
waiver. Narratives must include a communication plan between the ACO 
and its SNF affiliates, a care management plan for beneficiaries 
admitted to a SNF affiliate, a beneficiary evaluation and admission 
plan approved by the ACO medical director and the health care 
professional responsible for the ACO's quality improvement and 
assurance processes, and a description of any financial relationships 
between the ACO, SNF, and acute care hospitals.
     A list of SNFs with which the ACO will partner along with 
executed written SNF affiliate agreements between the ACO and each 
listed SNF. The agreements must include elements determined by CMS 
including but not limited to the following:
    ++ Agreement to comply with the requirements and conditions of the 
Shared Savings Program.
    ++ The effective dates of the SNF affiliate agreement.
    ++ Agreement to implement and comply with the ACO's beneficiary 
evaluation and admission plan and care management plan.
    ++ Agreement to validate the eligibility of a beneficiary to 
receive covered SNF services in accordance with the waiver prior to 
admission.
    ++ Remedial processes and penalties that will apply for non-
compliance.
     Documentation demonstrating that each SNF included on the 
submitted list of SNF affiliates has an overall rating of 3 or higher 
under the CMS 5-star Quality Rating System as reported on CMS's Nursing 
Home Compare Web site.
    In addition, Sec.  425.612(b)(3) provides that we will evaluate the 
information submitted with the ACO's application for the SNF 3-day rule 
waiver and any supplemental information submitted in response to a CMS 
request for information to determine whether the ACO's waiver request 
satisfies the requirements of Sec.  425.612(a)(1). The effective date 
and termination date of the waiver are determined in accordance with 
Sec.  425.612(c). Section 425.612(d) provides for monitoring of the use 
of the waiver and termination of the waiver, and includes a requirement 
that ACOs that have been approved for the SNF 3-day rule waiver post 
their approval to use the waiver as part of public reporting under 
Sec.  425.308. If our monitoring of an ACO's use of the waiver reveals 
misuse of the waiver, we may revoke the ACO's approval to use the 
waiver. Additionally, we may revoke an ACO's approval to use a waiver 
if the ACO does not successfully meet the quality performance standard 
or we identify another program integrity issue affecting the ACO's use 
of the waiver.
    To be eligible to receive covered services under the SNF 3-day rule 
waiver, a beneficiary must be prospectively assigned to the ACO for the 
performance year in which he or she is admitted to the SNF affiliate, 
may not reside in a SNF or other long-term care setting, must be 
medically stable and have an identified skilled nursing or 
rehabilitation need that cannot be provided as an outpatient, and must 
meet the other requirements set forth in Sec.  425.612(a)(1)(ii).
    We noted in the 2015 final rule that we would continue to evaluate 
the waiver of the SNF 3-day rule including further lessons learned from 
Innovation Center models in which a waiver of the SNF 3-day rule is 
being tested (80 FR 32806). We indicated that in the event we 
determined that changes were necessary, we would propose these changes 
through future rulemaking. Subsequently, based on initial experiences 
with the SNF 3-day rule waiver under the Pioneer ACO Model and Next 
Generation ACO Model, we proposed and finalized additional SNF 3-day 
rule waiver beneficiary protections under Sec.  425.612(a)(1)(iv) and 
(v). (See the CY 2017 PFS final rule (81 FR 80510 through 80515)).
    We began accepting SNF 3-Day Rule Waiver applications in the summer 
of 2016 and approved 26 Track 3 ACOs to begin using the SNF 3-day rule 
waiver under the Shared Savings Program effective January 1, 2017.
(2) Proposal
    As discussed in this proposed rule, the SNF 3-day rule waiver 
requirements are primarily based on criteria previously developed under 
the Pioneer

[[Page 34116]]

ACO Model. As a result of our recent experience implementing the waiver 
in the Next Generation ACO Model and the Shared Savings Program, we 
believe that the rules governing use of the SNF 3-day rule waiver are 
generally reasonable. However, based on our initial experiences in 
reviewing SNF 3-Day Rule Waiver applications, we believe there are two 
requirements, in particular, that impose an unnecessary burden on 
applicants, without a sufficient benefit to the administration of the 
Shared Savings Program to justify the burden.
    First, the requirement under Sec.  425.612(a)(1)(i)(A)(4) that ACOs 
submit, as part of their application for the SNF 3-day rule waiver, a 
narrative describing any financial relationships that exist between the 
ACO, SNF affiliates, and acute care hospitals is burdensome for ACOs 
and CMS. As explained in the 2015 final rule (81 FR 32806), the SNF 3-
day rule waiver only provides for coverage of SNF services that meet 
all applicable requirements except the requirement for a prior 3-day 
inpatient stay. The waiver does not protect financial or other 
arrangements between or among ACOs, ACO participants, ACOs providers/
suppliers, or other individuals or entities providing services to 
Medicare beneficiaries from liability under the fraud and abuse laws or 
any other applicable laws (Sec.  425.612(e)(1)). The Shared Savings 
Program regulations do not prohibit ACOs or SNFs from having financial 
arrangements with acute care hospitals, nor do they require such 
arrangements. Therefore, we have found that the narratives are not 
useful to us for purposes of determining whether to approve a waiver 
request. Based on our experience with the implementation of SNF 3-day 
rule waivers, we are proposing to remove the requirement at Sec.  
425.612(a)(1)(i)(A)(4) under which ACOs applying for the SNF 3-day rule 
waiver must submit a narrative describing any financial relationships 
between the ACO, SNF affiliate, and acute care hospitals. Removing this 
requirement would not only reduce burden for ACOs applying for the 
waiver but would also enable us to devote our application review 
resources to a rigorous review of other, more relevant application 
elements. Focusing our resources on the review of the information that 
is most directly relevant to determining an ACO's capacity to manage 
beneficiaries who are admitted to a SNF without a prior 3-day inpatient 
hospital stay, along with ongoing oversight and program compliance 
monitoring of the use of the waiver by approved ACOs (as described in 
section III.G.3.a.(1) of this proposed rule), would also allow us to 
more efficiently use our resources to ensure that the SNF 3-day rule 
waiver is being used appropriately and to address any potential 
concerns about use of the waiver. Although we do not believe it is 
necessary for ACOs to submit separate narratives describing their 
financial relationships for purposes of the SNF 3-day rule waiver, we 
note that under the Shared Savings Program rules, ACOs, ACO 
participants, ACO providers/suppliers, and other individuals or 
entities performing functions or services related to ACO activities, 
including SNF affiliates, must maintain and give us access to certain 
documents and information related to items including financial 
arrangements related to ACO activities (Sec.  425.314(b)(1)). We 
continue to retain broad discretion under Sec.  425.316 to audit ACOs, 
ACO participants, and ACO providers/suppliers for compliance with 
program rules, and the program rules also make it clear that waivers 
under Sec.  425.612 do not protect financial or other arrangements 
between or among ACOs, ACO participants, ACO providers/suppliers, or 
other individuals or entities providing services to Medicare 
beneficiaries from liability under the fraud and abuse laws or any 
other applicable laws (Sec.  425.612(e)).
    Second, we believe that the requirement under Sec.  
425.612(a)(1)(i)(C) that ACOs submit documentation demonstrating that 
each SNF included on their list of SNF affiliates has an overall rating 
of 3 or higher under the CMS 5-star Quality Rating System is 
unnecessarily burdensome. In order to meet this requirement, ACOs 
typically submit a screen shot from the CMS Nursing Home Compare Web 
site or other Nursing Home Compare information that reflects the star 
rating for each listed SNF. The submission of this documentation by the 
ACO does not add value to our review and approval of SNFs included on 
the ACO's SNF affiliate list. Instead, we obtain the information 
directly from our Web site during the application review process. In 
this way, we insure that the most current information is used during 
the application review process. We also periodically monitor this 
information after an ACO has been approved to use the waiver because 
SNF affiliates are required to maintain an overall rating of 3 stars or 
higher, under Sec.  425.612(a)(1)(iii)(A). Because we are able to 
obtain the required information directly from the CMS Nursing Home 
Compare Web site, the additional documentation submitted by the ACO as 
part of its application does not add value to our ability to review and 
approve SNF affiliates. Accordingly, we are proposing to eliminate this 
documentation submission requirement by removing Sec.  
425.612(a)(1)(i)(C). We note that we are not proposing to remove or 
modify the requirement in Sec.  425.612(a)(1)(iii)(A) that SNF 
affiliates must have and maintain an overall rating of 3 or higher 
under the CMS 5-star Quality Rating System in order to remain eligible 
to partner with the ACO for purposes of the SNF 3-day rule waiver. The 
requirement for SNF affiliates to have and maintain a 3-star or higher 
rating is retained. Furthermore, as part of the application process, we 
intend to continue to verify that the ACO has met all requirements 
related to the SNF 3-day rule waiver, but we believe that the 
burdensome and duplicative submission of CMS 5-star Quality Rating 
System documentation is not necessary to ensure compliance with the 
requirement that the ACO's SNF affiliates have a star rating of 3 or 
more.
    We welcome comments on our proposal to remove Sec.  
425.612(a)(1)(i)(A)(4) which requires SNF 3-Day Rule Waiver applicants 
to submit a narrative describing any financial relationships that exist 
between the ACO, SNF affiliate, and acute care hospitals. We further 
welcome comments on our proposal to remove Sec.  425.612(a)(1)(i)(C) 
which requires waiver applicants to submit documentation demonstrating 
that each SNF affiliate on their SNF affiliate list has an overall 
rating of 3 or higher under the CMS 5-star Quality Rating System. We 
also welcome other suggestions on how we might further decrease the 
burden for ACOs requesting approval to use the SNF 3-day rule waiver, 
without compromising our ability to ensure that ACOs and their SNF 
affiliates have the capacity to identify and manage beneficiaries 
receiving covered SNF services pursuant to the waiver. We may consider 
any such suggestions in future rulemaking.
b. Modifications to the Shared Savings Program Initial Application
(1) Background
    In order to participate in the Shared Savings Program, 
organizations must meet certain eligibility requirements, including the 
statutory requirement to define processes to promote evidence-based 
medicine and patient engagement, report on quality and cost measures, 
and coordinate care. Additionally, the ACO

[[Page 34117]]

must demonstrate it meets patient-centeredness criteria specified by 
the Secretary, such as the use of patient and caregiver assessments or 
the use of individualized care plans. We discussed and finalized 
details for ACO eligibility criteria, including the four required 
processes and patient-centeredness criteria, in the November 2011 final 
rule (76 FR 67826 and 67827) and made updates to them in the June 2015 
final rule (80 FR 32722 through 32725).
    Section 425.204(c)(1) articulates the supporting documents and 
materials an ACO must submit to demonstrate that the ACO satisfies the 
eligibility requirements to participate in the Shared Savings Program.
    To obtain a determination regarding whether an ACO meets the 
requirements to participate in the Shared Savings Program, a 
prospective ACO must submit a complete application in the form and 
manner required by us by the deadline established by us (Sec.  
425.202(a)(1)). The content of the application is outlined at Sec.  
425.204. Section 425.204(c) states that as part of the application, and 
upon request thereafter, an ACO must submit to us certain supporting 
documentation to demonstrate that the ACO satisfies the requirements of 
the Shared Savings Program. Supporting documentation in this section 
includes:
     Documents (for example, ACO participant agreements, 
agreements with ACO providers/suppliers, employment contracts, and 
operating policies) sufficient to describe the ACO participants' and 
ACO providers'/suppliers' rights and obligations in and representation 
by the ACO, and how the opportunity to receive shared savings or other 
financial arrangements will encourage ACO participants and ACO 
providers/suppliers to adhere to the quality assurance and improvement 
program and evidence-based clinical guidelines.
     A description, or documents sufficient to describe, how 
the ACO will implement the required processes and patient-centeredness 
criteria under Sec.  425.112, including descriptions of the remedial 
processes and penalties (including the potential for expulsion) that 
will apply if an ACO participant or an ACO provider/supplier fails to 
comply with and implement these processes.
     Materials documenting the ACO's organization and 
management structure, including an organizational chart, a list of 
committees (including names of committee members) and their structures, 
and job descriptions for senior administrative and clinical leaders.
     Evidence that the ACO's governing body is an identifiable 
body, represents a mechanism for shared governance for ACO 
participants, is composed of representatives of its ACO participants; 
and is at least 75 percent controlled by its ACO participants.
     Evidence that the governing body includes a Medicare 
beneficiary representative(s) served by the ACO who does not have a 
conflict of interest with the ACO, and who has no immediate family 
member with a conflict of interest with the ACO.
     A copy of the ACO's compliance plan or documentation 
describing the plan that will be put in place at the time the 
participation agreement with CMS becomes effective. Additionally, Sec.  
425.204(d) states that as part of the application to participate in the 
Shared Savings Program, an ACO must describe the following:
    ++ How it plans to use shared savings payments, including the 
criteria it plans to employ for distributing shared savings among its 
ACO participants and ACO providers/suppliers.
    ++ How the proposed plan will achieve the specific goals of the 
Shared Savings Program.
    ++ How the proposed plan will achieve the general aims of better 
care for individuals, better health for populations, and lower growth 
in expenditures.
    Section 425.204(c)(1)(ii) includes a reference to the required 
processes and patient centeredness criteria under Sec.  425.112. Of 
note, Sec.  425.112(b)(4)(ii) requires that, as part of its 
application, an ACO must submit a description of its individualized 
care program, along with a sample individual care plan, that explains 
how the ACO's program is used to promote improved outcomes for, at a 
minimum, its high risk and multiple chronic condition patients (Sec.  
425.112(b)(4)(ii)(A)). The ACO must also, as part of its application, 
describe additional target populations that would benefit from 
individualized care plans (Sec.  425.112(b)(4)(ii)(B)) and describe how 
it will encourage and promote the use of enabling technologies for 
improving care coordination for beneficiaries (Sec.  
425.112(b)(4)(ii)(C)). Finally, as part of its application, the ACO 
must describe how it intends to partner with long-term and post-acute 
care providers, both inside and outside the ACO, to improve care 
coordination for its assigned beneficiaries (Sec.  
425.112(b)(4)(ii)(D)).
    Once an applicant has submitted the information required under 
Sec.  425.204, we evaluate it to determine whether the applicant 
satisfies the Shared Savings Program requirements. We notify ACO 
applicants during the application review process when information is 
missing or when supplemental documentation or other information is 
necessary to make a determination on the ACO's application and provide 
opportunities for the ACO to submit the requested additional 
information for review. At the end of the application review process, 
we approve or deny the application and notify the ACO of our 
determination.
(2) Proposals
    In conducting Shared Savings Program application reviews, we have 
found that many of the document submission requirements in Sec.  
425.204(c)(1) substantially increase application and review burden 
without lending significant value to our review of an organization's 
application to confirm that the ACO meets the eligibility requirements 
for participation in the Shared Savings Program. We believe it would 
meet program needs and reduce applicant burden if we were to revise 
Sec.  425.204(c)(1) to remove the requirement to submit supporting 
documents or narratives and instead provide that we may request these 
materials if additional information is needed in order to fully assess 
the ACO's application before making a decision to approve or deny the 
application.
    To illustrate, as discussed in this proposed rule, we require under 
Sec.  425.204(c)(1)(ii), as part of the application process, that the 
ACO submit documentation addressing the required processes and patient 
centeredness criteria under Sec.  425.112. This requirement is 
addressed in the Medicare Shared Savings Program Initial Application 
(see application on the CMS Web site at https://www.cms.gov/medicare/medicare-fee-for-service-payment/sharedsavingsprogram/application.html) 
through the requirement that an applicant ACO submit narratives 
describing how it will define, establish, implement, evaluate, and 
periodically update each process. In these narratives, the ACO must 
also describe certain additional details regarding the required 
processes:
     Process to promote evidence-based medicine. The ACO must 
describe how it will:
    ++ Encourage the use of protocols grounded in evidence-based 
medicine in the case of diagnoses with significant potential for the 
ACO to achieve quality improvements, while taking into account the 
circumstances of individual beneficiaries; and

[[Page 34118]]

    ++ Use the internal assessments of this process to continuously 
improve the ACO's care practices.
     Process to promote beneficiary engagement. The ACO must 
describe how it will:
    ++ Evaluate the health needs of its assigned beneficiary population 
(including consideration of diversity in its patient population) and 
develop a plan to address the needs of its population;
    ++ Communicate clinical knowledge/evidence-based medicine to 
beneficiaries in a way they can understand;
    ++ Engage beneficiaries in shared decision-making in ways that 
consider beneficiaries' unique needs, preferences, values and 
priorities;
    ++ Establish written standards for beneficiary access and 
communication as well as a process for beneficiaries to access their 
medical records; and
    ++ Use the internal assessments of this process to continuously 
improve the ACO's care practices.
     Process to internally report quality and cost metrics. The 
ACO must describe how:
    ++ The ACO will use these results to improve care and service over 
time; and
    ++ The ACO will use the internal assessments of this process to 
continuously improve the ACO's care practices.
     Process to promote coordination of care. The ACO must 
describe:
    ++ The ACO's methods and processes to coordinate care throughout an 
episode of care and during care transitions, such as discharge from a 
hospital or transfer of care from a primary care physician to a 
specialist (both inside and outside the ACO).
    ++ The ACO's individualized care program, along with a sample 
individual care plan, and explain how the ACO uses this program to 
promote improved outcomes for, at a minimum, high-risk and multiple 
chronic-condition patients.
    ++ How individual care plans take into account the community 
resources available to beneficiaries.
    ++ Additional target populations that would benefit from 
individualized care plans.
    ++ How the ACO will use the internal assessments of this process to 
continuously improve the ACO's care practices.
    ++ How the ACO will encourage and promote use of enabling 
technologies for improving care coordination for beneficiaries.
    ++ How the ACO intends to partner with long-term and post-acute 
care providers, both inside and outside of the ACO, to improve care 
coordination for their assigned beneficiaries.
    As a result of our experience in reviewing these narratives, we 
have determined that while they can be helpful to verify that the ACO 
has established the required processes and defined patient-centeredness 
criteria prior to its entry into the Shared Savings Program, the 
specific details of the processes the ACO has established are not 
particularly important or relevant for purposes of assessing whether 
the ACO is eligible to participate in the program. In fact, ACOs have 
indicated that their initial plans for the processes required under 
Sec.  425.112 as articulated in their program application often change 
as a result of obtaining additional information about their ACO 
participants' and ACO providers/suppliers' processes and gaining 
additional experience during implementation of the processes. We 
believe such improvements to ACO processes based on program experience 
are reasonable to expect and should be encouraged. First, under Sec.  
425.112(b), ACOs are required to evaluate and periodically update each 
process and as they do so, initially implemented processes will 
necessarily change to accommodate lessons learned. Moreover, once the 
ACO begins to request claims information and other CMS data and to 
incorporate this information into its operations, the ACO may discover 
that certain assumptions it made at the time of application should be 
adjusted to maximally improve the quality of care or cost efficiencies 
for the ACO's assigned population. In rare instances, particularly in 
the early days of the program before stakeholders fully understood the 
implications of program participation, we found review of such 
narratives useful to understand the level of an ACO's readiness for 
participation in the Shared Savings Program. However, such narratives 
have not been particularly useful in determining if the ACO meets the 
requirements for participation in the Shared Savings Program. In a vast 
majority of cases, we now believe it is sufficient that the ACO certify 
at the time of application that it has defined the required processes 
and patient centeredness criteria consistent with the requirements 
specified in section Sec.  425.112. Therefore, we believe it would 
reduce burden for ACOs, without compromising our ability to determine 
whether an ACO meets the criteria for participation in the Shared 
Savings Program, to require that the ACO certify that it meets the 
requirements in Sec.  425.112, and only submit a narrative or other 
documentation describing how the ACO will implement the required 
processes and patient-centeredness criteria upon our request. Further, 
we do not anticipate that this change would have a significant effect 
on beneficiaries receiving services from ACO providers/suppliers 
because as noted earlier, we anticipate that ACOs would update each 
process as they gain experience and, as they do so, initially 
implemented processes that might have been reflected in the narrative 
or other supporting documentation submitted with their application 
would necessarily change to accommodate lessons learned.
    Similarly, as part of the application process, the Shared Savings 
Program regulations require the ACO to submit materials documenting the 
ACO's organization and management structure, including an 
organizational chart, a list of committees (including names of 
committee members) and their structures, and job descriptions for 
senior administrative and clinical leaders (Sec.  425.204(c)(1)(iii)). 
While we have found the organizational chart useful for purposes of our 
review and approval of an ACO's application, and we anticipate 
continuing to request this chart from many applicants, we have found 
that further detail including lists of committees and job descriptions 
for senior administrative and clinical leaders have not added 
particular value to our review and approval of applications. Moreover, 
the receipt of such materials as part of the ACO's application has not 
significantly impacted our ability to determine whether the ACO meets 
the requirements regarding leadership and management in Sec.  425.108. 
We believe, on balance, that our need for such detailed information 
from all applicants is outweighed by our desire to reduce application 
burden. In particular circumstances where additional information would 
aid our review, we believe our need for such detailed information can 
be reasonably met by requiring applicants to submit such materials upon 
our request. As a result, we believe it would be less burdensome for us 
to require ACO applicants to certify that, for example, they meet the 
leadership and management requirements found at Sec.  425.108 rather 
than requiring all ACO applicants to submit detailed materials (such as 
job descriptions) or narratives about the ACO's committees and 
leadership.
    While we do not anticipate having to routinely request such 
materials to supplement our review and approval of ACO applications to 
participate in the Shared Savings Program, we believe it is important 
to retain the discretion to do

[[Page 34119]]

so in limited cases where such detail could be useful. Therefore, we 
propose to make revisions to our application requirements as discussed 
in this section. We would note that in cases where an ACO is requested 
to submit additional material for review in conjunction with its 
application, and we find that the material is inconsistent with program 
requirements, then we may deny the ACO's application. Similarly, if we 
discover the inconsistency after the ACO has already been approved to 
participate in the program, the ACO may be subject to the pre-
termination actions set forth in Sec.  425.216, termination under Sec.  
425.218, or both.
    Additionally, we do not believe it is necessary for ACO applicants 
to submit narratives describing how they would distribute shared 
savings payments or how the proposed plan would achieve the specific 
goals of the Shared Savings Program and the general aims of better care 
for individuals, better health for populations, and lower growth in 
expenditures, as required by Sec.  425.204(d). Based on our experience, 
such narratives have not been useful in determining if the ACO meets 
requirements for participation in the program or whether an ACO's 
application should be approved. We believe it would be more useful to 
us and less burdensome for ACOs if we were instead to require that, an 
ACO, as part of its application to participate in the Shared Savings 
Program, certify that it has a method and plan to receive shared 
savings payments and to distribute those payments to its ACO 
participants and ACO providers/suppliers, as required by the statute. 
We note, however, that we continue to believe it is useful to 
stakeholders to know how various ACOs have chosen to use or distribute 
the shared savings they earn. Therefore, in the interest of 
transparency, we will continue to require ACOs to publicly report 
information on their dedicated Web pages about their shared savings and 
shared losses, including information about the total proportion of 
shared savings invested in infrastructure, redesigned care processes, 
and other resources to support the three-part aim goals of better 
health for populations, better care for individuals, and lower growth 
in expenditures, including the proportion distributed among ACO 
participants, as required under Sec.  425.308(b)(4).
    In light of our experience with the review of the documentation 
submitted as part of the ACO's initial application, we are proposing 
several modifications to our requirements for document submission. 
Under this proposal, we would retain all requirements related to ACO 
eligibility criteria and public reporting, as currently specified under 
the Shared Savings Program regulations. However, in order to reduce 
application burden without compromising our ability to evaluate 
applications effectively for compliance with Shared Savings Program 
requirements, we propose to modify certain sections of our regulations 
that require ACOs to submit supporting materials and documentation at 
the time of application. Instead of requiring submission of certain 
materials, narratives, or supporting documentation, as discussed in 
this section, we propose to require ACOs to certify that they meet the 
applicable eligibility and documentation requirements as specified 
under our program rules. At the same time, while we are interested in 
reducing burden, we recognize that there have been instances when the 
review of supporting documentation and/or narratives has been helpful 
in making a determination about an ACO's eligibility for participation 
in the program. Therefore, although we are proposing to eliminate the 
general requirement that ACOs submit certain documentation as part of 
their initial application to participate in the Shared Savings Program, 
we propose to retain the right to request the submission of supporting 
materials and documentation in cases when such additional information 
would be useful in making a determination regarding the ACO's 
application. We believe that this proposed modification to the 
regulations governing ACO applications would introduce additional 
flexibility that would reduce the level of burden inherent in the 
Shared Savings Program application process while also ensuring we are 
still able to appropriately evaluate an ACO's eligibility for program 
participation.
    Accordingly, in order to reduce application burden while retaining 
flexibility to obtain additional documentation when necessary to 
determine ACO eligibility and compliance with program rules, we propose 
to remove the requirements in Sec. Sec.  425.204(c)(1) and (d), 
425.112(a)(3)(i) and (ii), and 425.112(b)(4)(ii) for the submission of 
certain specified documents and narratives as part of an ACO's 
application to participate in the Shared Savings Program. Specifically, 
we propose to revise paragraph Sec.  425.204(c)(1) to require an ACO, 
as part of its application, to certify that it satisfies the Shared 
Savings Program requirements and to submit, upon CMS request, 
supporting materials (including narratives) and documentation 
demonstrating that the ACO satisfies program requirements indicated in 
proposed revised Sec.  425.204(c). Additionally, we propose to revise 
Sec.  425.204(d) to indicate that the ACO must certify, as part of its 
application to participate in the Shared Savings Program, that it has a 
mechanism and plan to receive and use payments for shared savings, 
including criteria for distributing shared savings among its ACO 
participants and ACO providers/suppliers. We also propose to make a 
conforming change to remove paragraphs (d)(1) through (3) of Sec.  
425.204, which relate to the submission of narratives related to the 
ACO's use of shared savings payments. This proposal does not include a 
requirement that the ACO submit information regarding its mechanism and 
plan for receiving and using shared savings upon request. We do not 
intend to request this information as part of the application process 
because in our experience, how an ACO intends to use or distribute 
shared savings has not been a relevant consideration during any 
application cycle to determine whether the ACO has met the eligibility 
requirements to participate in the Shared Savings Program. However, we 
note that we continue to believe that information on how an ACO uses 
and distributes its shared savings is useful for the public, and 
therefore ACOs will continue to be required to publicly report this 
information under Sec.  425.308(b)(4)(ii).
    We also propose similar changes to the requirements in Sec.  
425.112(a)(3)(i), (a)(3)(ii), and (b)(4)(ii) to remove reference to the 
submission of narratives to explain or describe how the ACO will 
implement the required elements of the ACO's care processes and 
patient-centeredness criteria. ACOs must still implement these care 
processes and adopt a focus on patient-centeredness, however, they will 
no longer need to submit descriptions of how they will satisfy these 
requirements as part of their initial application. We note, however, 
that ACOs may still be required to submit upon request a description or 
documentation sufficient to describe how the ACO will implement the 
required processes and patient-centeredness criteria found at Sec.  
425.112 because under the proposed revisions to Sec.  
425.204(c)(1)(ii), CMS would retain the discretion to request such 
documentation from the ACO at any time.
    In summary, we believe these modifications to the application 
requirements will significantly reduce

[[Page 34120]]

the burden of applying to participate in the Shared Savings Program 
without reducing our ability to ensure that applicants meet the 
established eligibility requirements. Rather than requiring every 
applicant to submit detailed supporting documents or narratives for all 
of these requirements, we would instead request supporting documents or 
narratives only if additional information is needed in order to fully 
assess an ACO's application before making a decision to approve or deny 
the application. Further, we do not anticipate that the proposed 
modifications to our application requirements would have any effect on 
beneficiaries receiving care from providers and suppliers participating 
in the Shared Saving Program, nor do we believe that the proposed 
changes would affect our program integrity efforts, because we would 
retain discretion to request such information (and more targeted and 
appropriate information) as needed. We seek comment on these proposals 
and on additional ways to reduce burden in the application process.
4. Addressing Compliance With ACO Participant TIN Exclusivity 
Requirement
a. Background
    Under the Shared Savings Program, ACO participant TINs are not 
required to be exclusive to one Shared Savings Program ACO unless the 
TIN submits claims for primary care services used to determine the 
ACO's assigned population (Sec.  425.306(b)). The purpose behind this 
requirement is to ensure that we are able to assign a unique set of 
beneficiaries to each ACO participating in the Shared Savings Program. 
Therefore, as part of the Shared Savings Program application process 
and upon an ACO's request to add an ACO participant TIN, we check the 
TIN against all other Shared Savings Program ACO participant lists. If 
the TIN appears on the ACO participant list one or more other ACOs, the 
TIN is considered to be ``overlapping.'' We then determine whether the 
overlap is permissible under our program rules. If the overlap is not 
permissible (because the TIN has a history of billing for primary care 
services used in our assignment methodology) then we require the ACO 
that is seeking to add the TIN to its ACO participant list to rectify 
the overlap by the deadline we have established for making changes to 
the next performance year's ACO participant list. If the overlap is 
permissible (because the TIN does not have a history of billing for 
primary care services used in our assignment methodology) then the ACO 
participant TIN can be approved to be an ACO participant in more than 
one ACO for the performance year. Each time we run the assignment 
algorithm during the course of the performance year, we monitor 
overlaps to ensure that the overlaps continue to be in compliance with 
Sec.  425.306(b).
    In a few instances, as a result of our monitoring, we have 
discovered that ACO participant TINs that had been approved to 
participate in multiple ACOs subsequently began billing for primary 
care services used in assignment during a benchmark or performance 
year. For example, for performance year 2016, we identified four TINs 
that were initially permitted to overlap and participate in more than 
one ACO because they had not previously billed Medicare for primary 
care services used in our assignment methodology. At some point during 
the performance year, however, the TINs began billing Medicare for 
primary care services that are used to assign beneficiaries to the ACO 
(including claims for services furnished during the performance year, 
but submitted during the three-month claims runout for the performance 
year). This can occur, for example, if a single specialty practice made 
up of physician specialty types not used in assignment (for example, a 
practice of ophthalmologists) hires a nurse practitioner who then 
begins billing Medicare under the billing TIN of the ACO participant 
for primary care services as defined under the Shared Savings Program 
rules. Thus, the ACO participant TIN would be used to bill Medicare for 
primary care services furnished by a practitioner used in our 
assignment methodology (the nurse practitioner) and would therefore 
trigger our requirement under Sec.  425.306(b)(2) that the ACO 
participant TIN be exclusive to a single Shared Savings Program ACO. 
Although our program rules permit us to take compliance action against 
ACOs for violations of Shared Savings Program requirements, they do not 
specifically address what compliance actions we would impose on ACOs in 
instances where an ACO participant falls out of compliance with Sec.  
425.306(b)(2) during a benchmark or performance year or when non-
compliance with Sec.  425.306(b)(2) is discovered during the 3-month 
claims runout for a benchmark or performance year. Moreover, the 
program rules do not address what modifications to our assignment 
methodology could be made to account for this overlap. In the case of 
the four overlapping TINs discovered during the 2016 performance year, 
we notified the respective ACOs of the overlap and the ACO participant 
TINs were required to terminate their participation in the ACO of their 
choice. As a result, each ACO from which the TINs terminated was 
required to recertify its ACO participant list for the 2016 performance 
year. Depending on the timing of recertification, such changes to an 
ACO participant list may also require us to recalculate performance 
year beneficiary assignment and financial benchmarks. For example, if a 
TIN, that was previously allowed to appear on more than one ACO 
participant list, hires a nurse practitioner who begins billing primary 
care claims in the month of December for the ACO's third benchmark 
year, we would discover the now impermissible overlap when we begin 
creating the historical benchmark reports after the 3-month claims 
runout. We would contact the ACOs involved, each ACO would contact the 
TIN and ask the TIN to select the ACO it wishes to remain aligned with. 
The ACO not selected would be asked to remove the TIN from its ACO 
Participant List and recertify the list. As a result of the 
recertification of the list, the ACO's assigned population would need 
to be redetermined and calculation of its benchmark would be delayed. 
We are therefore concerned about the uncertainty the current process 
(which includes recertification of ACO participant lists, recalculation 
of assignment, and resulting delay of calculations for the benchmark or 
performance year) could introduce for ACOs that may have little 
influence over or knowledge of ACO participant TIN billing practices.
    We believe it is important for ACOs, ACO participants, and ACO 
providers/suppliers to have updated and accurate information regarding 
their participation status in the Shared Savings Program. For example, 
participation in a Shared Savings Program ACO has implications for ACO 
providers/suppliers under the new Quality Payment Program (see 81 FR 
80496 through 80501). The Quality Payment Program replaces a patchwork 
system of Medicare programs with a flexible system that allows eligible 
clinicians to choose from two paths that link payments to quality: The 
Merit-Based Incentive Payment System (MIPS) and participation in 
Advanced Alternative Payment Models (APMs). The Quality Payment 
Program, through MIPS and the APM incentive, will impact eligible 
clinicians' payments

[[Page 34121]]

beginning in payment year 2019 based on 2017 reporting.
    Under the CY 2017 Quality Payment Program final rule with comment 
period, eligible clinicians participating in Advanced APMs (including 
Tracks 2 and 3 under the Shared Savings Program) may become Qualifying 
APM Participants and receive a 5 percent APM Incentive Payment if they 
have a sufficient percentage of payments for Part B covered 
professional services, or a sufficient percentage of Medicare patients 
that are attributable to services furnished through an Advanced APM for 
a year. In addition to earning a 5 percent APM Incentive Payment, 
Qualifying APM Participants are not subject to the MIPS reporting 
requirements and payment adjustment for the year. As a result, 
revisions to ACO participant lists that occur mid-year or following the 
end of a benchmark or performance year could have widespread 
implications not only for the ACO but also for its ACO providers/
suppliers under the Quality Payment Program.
b. Proposals
    As participation in the Shared Savings Program grows and more ACOs 
and ACO participants join the program, we believe the overlap situation 
described previously is likely to become more common. We also believe 
that changes to our program rules regarding the claims that will be 
considered in assigning FFS beneficiaries to an ACO (specifically, the 
policy finalized in the June 2015 final rule to exclude services 
furnished by several physician specialty types from the assignment 
methodology) may result in a greater number of permissible ACO 
participant TIN overlaps (see 80 FR 32753 and 32754). As a result, we 
anticipate there could also be an increased number of cases where ACO 
participant TINs with initially permissible overlaps could become out 
of compliance with the requirement at Sec.  425.306(b)(2) that an ACO 
participant TIN be exclusive to a single Shared Savings Program ACO if 
the TIN bills for primary care services that are used to assign 
beneficiaries to the ACO. This could occur, for example, if a group 
practice that initially includes only physician specialty types whose 
services are excluded from the assignment methodology were to 
subsequently employ a non-physician practitioner who bills for primary 
care services. We believe these types of practice arrangements are 
becoming increasingly common.
    We therefore believe it is necessary to streamline our approach to 
handling such situations in order to reduce the burden and uncertainty 
for ACOs when changes in ACO participant billing practices result in an 
ACO participant falling out of compliance with the exclusivity 
requirement at Sec.  425.306(b)(2). Rather than the current policy 
under which an ACO may be required to remove an overlapping ACO 
participant and recertify its ACO participant list for the performance 
year (thus necessitating redetermination of beneficiary assignment and 
delays in or revisions to benchmark or performance year calculations), 
we believe it would be less disruptive for ACOs if we were to permit 
overlapping TINs that begin billing for services used in assignment 
during a benchmark or performance year (including claims for services 
furnished during the benchmark of performance year, but submitted 
during the 3-month claims runout) to remain on the ACO participant 
lists for all affected ACOs for the remainder of the performance year 
in which we determine that an overlap exists. For example, assume that, 
based on an analysis of claims for services furnished in performance 
year 2018, we were to identify an impermissibly overlapping TIN in 
January 2019 after the ACO participant lists for performance year 2019 
had already been certified. Under this proposal, the TIN would be able 
to remain on the ACO participant lists of all affected ACOs for the 
2018 performance year as well as the remainder of performance year 
2019. In order to ensure that the TIN overlap does not inadvertently 
result in assignment of the same beneficiaries to multiple ACOs, we 
would simply exclude any claims for services furnished by the 
overlapping TIN from the assignment methodology when conducting final 
beneficiary assignment for any benchmark or performance year in which 
the TIN bills Medicare for services used in our assignment methodology. 
The affected ACOs would be required to resolve the overlap prior to 
recertification of their ACO participant lists for the subsequent 
performance year. If the overlap remains unresolved when the ACOs 
certify their ACO participant lists for the next performance year, we 
would remove the TIN from the ACO participant lists of all ACOs seeking 
to include the TIN, in accordance with our current policy for resolving 
overlaps. For example, in the hypothetical case above, if the overlap 
were to remain unresolved when the ACOs certify their ACO participant 
lists for performance year 2020, we would remove the TIN from the ACO 
participant lists for all ACOs seeking to include the TIN as an ACO 
participant for performance year 2020.
    We therefore propose to modify our program rules in Sec.  425.306 
and subpart E of part 425 to address this issue. We propose to modify 
Sec.  425.306(b) to indicate that if, during a benchmark or performance 
year (including the 3-month claims run out period for such benchmark or 
performance year), an ACO participant that participates in more than 
one ACO begins billing for services that would be used in assignment, 
we would not consider any services billed through that TIN during the 
relevant performance year when performing beneficiary assignment for 
the applicable benchmark or performance year. As part of this proposed 
modification, we would also eliminate the references to ``primary 
care'' when describing the services used to determine the ACO's 
assigned beneficiary population in order to conform with our proposal 
to implement section 17007 of the 21st Century Cures Act under which we 
would consider all services furnished in FQHCs and RHCs in the 
assignment methodology as primary care services starting in the 2019 
performance year. In addition, the ACOs in which the overlapping TIN is 
an ACO participant may be subject to compliance action (as provided 
under Sec.  425.216) or termination under Sec.  425.218. Compliance 
actions may include requiring each ACO that includes the TIN as an ACO 
participant to submit a corrective action plan explaining how the ACO 
plans to work with the overlapping ACO participant to resolve the 
overlap for the next performance year. If the overlap remains 
unresolved by the date specified by us in our request for a corrective 
action plan, we would remove the overlapping ACO participant TIN from 
the ACO participant list of each ACO for the subsequent performance 
year.
    We also propose to revise our general assignment methodology at 
Sec.  425.400(a)(1) to add new paragraph (a)(1)(iii) to indicate that 
when we determine final assignment after the end of each benchmark or 
performance year, we will exclude claims for services furnished during 
the benchmark or performance year by an ACO participant that 
participates in more than one ACO. We believe that this policy will 
ensure a uniquely assigned beneficiary population for each ACO and 
prevent the same beneficiaries from being included in determining 
benchmark or performance year expenditures for more than one ACO.
    We believe that implementing this proposed process would improve 
ACO

[[Page 34122]]

and ACO participant understanding of our policies and requirements 
regarding ACO participant overlaps while also reducing burden for ACOs 
that currently must recertify ACO participant lists and may be subject 
to retrospective modifications or delays in assignment and other 
dependent benchmark or performance year calculations. We also note that 
this policy allows us to preserve the flexibility that is currently 
extended to ACO participants that do not bill for services used in 
assignment, while recognizing the possibility for mid-year changes in 
care and billing practices by these ACO participants. Additionally, ACO 
participant TINs and the eligible clinicians that bill through those 
TINs would be provided greater certainty regarding whether they qualify 
as participating in an APM or Advanced APM for a performance year. 
Under this proposed policy, an ACO participant would know for the 
entire performance year with certainty that it is participating in a 
particular APM entity.
5. Treatment of Individually Beneficiary Identifiable Payments Made 
Under a Demonstration, Pilot, or Time Limited Program
a. Background
    Under section 1899(d) of Act, ACOs participating in the Shared 
Savings Program are accountable for the total Parts A and B costs for 
the Medicare fee-for-service beneficiaries assigned to the ACO. 
Therefore, we include all payments made from the Medicare Trust Fund 
for Parts A and B services furnished to assigned Medicare FFS 
beneficiaries, including individually beneficiary identifiable non-
claims based payments made under a demonstration, pilot or time limited 
program, when computing average per capita Medicare expenditures for an 
ACO during both the benchmark period and performance years. We believe 
it is appropriate to take into account non-claims based payments from a 
demonstration, pilot, or time limited program in Medicare Shared 
Savings Program financial calculations to ensure that the final shared 
savings payments that are made to ACOs are accurate and reflect all 
Parts A and B expenditures for the ACO's assigned beneficiaries. We 
also review individually beneficiary identifiable payments made under a 
demonstration, pilot, or time-limited program as part of our efforts to 
ensure there is no duplication of payments for beneficiaries that may 
be assigned to both the Shared Savings Program and other Innovation 
Center models. This general policy of considering individually 
beneficiary identifiable non-claims based payments made under a 
demonstration, pilot or time limited program was initially established 
in the 2011 final rule implementing the Shared Savings Program (76 FR 
67915) for:
     Establishing, adjusting, and updating the benchmark for an 
ACO's first agreement period under Sec.  425.602(a)(1)(ii),
     Calculation of savings under the one-sided model (Track 1) 
at Sec.  425.604(a)(6)(ii), and
     Calculation of shared savings and losses under Track 2 at 
Sec.  425.606(a)(6)(ii).
    This policy has also been included in subsequent program 
modifications to the program for:
     Resetting, adjusting, and updating the benchmark for a 
subsequent agreement period under Sec. Sec.  425.603(c)(1)(ii) and 
425.603(e)(2)(ii), and
     Calculation of shared savings and losses under Track 3 at 
Sec.  425.610(a)(6)(ii).
    More specifically, in addition to Medicare Parts A and B claims, we 
include non-claims based individually beneficiary identifiable payments 
when performing financial calculations for the Shared Savings Program, 
including setting the preliminary and final benchmarks, updating the 
financial benchmark at the time of reconciliation and calculating 
performance year expenditures. We internally track non-claims based 
beneficiary identifiable payments (that is, payments made outside the 
Medicare fee-for-service claims system) through a separate CMS system 
that receives and stores these non-claims based payments made from the 
Medicare Trust Funds under a demonstration, pilot or time limited 
program. The non-claims based payments are loaded into the separate 
system at various points in time, depending on the terms of payment 
under each specific demonstration, pilot or time limited program. The 
amounts that are reflected in this separate system include interim 
payment amounts that are subject to final reconciliation and may not 
reflect the actual final payments to the provider or site. For example, 
the Bundled Payments for Care Improvement (BPCI) initiative is 
comprised of four broadly defined models of care, which link payments 
for the multiple services beneficiaries receive during an episode of 
care. (See the CMS Web site at https://innovation.cms.gov/initiatives/bundled-payments/). Under the retrospective BPCI payment models, 
Medicare continues to make fee-for-service (FFS) payments for the Part 
A and Part B services furnished to a beneficiary during an episode; 
but, the total Part A and Part B expenditures for the episode are later 
reconciled against a bundled payment amount (the target price) 
determined by CMS. A payment or recoupment amount is determined by 
comparing the aggregate expenditures to the target price. Interim 
payment and recoupment amounts are calculated quarterly but it is only 
after the BPCI claims run out period that the final reconciliation can 
be performed and the final expenditure amount is known. In contrast, 
under certain other demonstrations, pilots, or time limited programs 
only final non-claims based payment data are loaded into the system. 
For example, under the Community-based Care Transitions Program (CCTP), 
the participating community-based organizations were paid an all-
inclusive rate per eligible discharge. This final non-claims based 
payment was then loaded into the system and was not subject to 
subsequent reconciliations.
    To date, when we perform ACO benchmarking and financial 
calculations under the Shared Savings Program, we have included (in 
addition to all Medicare Parts A and B claims) all non-claims based 
beneficiary identifiable payments for the applicable benchmark or 
performance year that are included in the separate CMS system, 
including any payments made during the benchmark or performance year's 
3-months claims run-out period. This means that to date we have 
included some interim payments made under a demonstration, pilot or 
time limited program that will undergo subsequent reconciliation to 
determine the final payment amount in the calculation of historical 
benchmarks and performance year expenditures. However, because the 
various demonstrations, pilots or time limited programs may have 
different operational schedules to the Shared Savings Program, it is 
not possible for us to include all interim and final beneficiary 
identifiable payments made under these initiatives in benchmarking and 
financial reconciliation calculations for the Shared Savings Program; 
and, as a result, these calculations have excluded some interim and 
final non-claims based beneficiary identifiable payments made under 
certain demonstrations, pilots or time limited programs. For example, 
because of the timing and availability of BPCI non-claims based payment 
amounts, to date we have included only up to two quarters of interim 
payment data for BPCI in ACO benchmarking and financial reconciliation 
calculations for the

[[Page 34123]]

Shared Savings Program and no final payment amounts.
    To date, non-claims based individually beneficiary identifiable 
payments represent a relatively minor proportion of an ACO's total Part 
A and B beneficiary expenditure amounts as determined under the Shared 
Savings Program (mean of 0.09 percent overall impact of ACO non-claims 
based payments on total per capita expenditures and a mean of 137 
person-years in an ACO's assigned beneficiary population with a non-
claims based payment during the year; minimum -0.72 percent, 0 person-
years; maximum 1.24 percent, 1,865 person-years). For the 
demonstrations, pilots or time limited programs that include interim 
and final reconciliations, the impact of including the non-claims based 
payments could be positive or negative for an ACO for a given 
performance year. Additionally, a preliminary analysis suggests that 
interim payments made under select demonstrations, pilots or time-
limited program fluctuate on a quarterly basis. An examination of 
trends in total per capita non-claims based payments in 2016 quarterly 
program reports across 416 Track 1 and 2 ACOs found a mean decline of 
14 percent from Quarter 1 to Quarter 2, followed by a mean increase of 
144 percent from Quarter 2 to Quarter 3, and a mean increase of 742 
percent from Quarter 3 to Quarter 4. Quarterly trends for individual 
ACOs also tended to fluctuate. Per capita amounts in this analysis were 
based on those ACOs with at least one non-claims based payment in each 
quarterly report period. Almost half of the ACOs in the analysis (201 
out of 416) had at least one quarter in 2016 with a net negative per 
capita payment across all beneficiaries with at least one non-claims 
based payment and at least one quarter with a net positive per capita 
payment. A review of non-claims based payments incorporated in PY 2017 
preliminary historical benchmarks also found similar swings between 
negative and positive amounts, with roughly one third of ACOs receiving 
a benchmark (156 of 480) having at least one benchmark year with a net 
negative per capita payment across all beneficiaries with at least one 
non-claims based payment and at least one benchmark year with a net 
positive per capita payment.
    These fluctuations in the non-claims based payments for certain 
initiatives like BPCI have generated stakeholder concern. Further, 
stakeholders note that the impact of including interim payments in 
financial calculations may become greater in the future, given the 
increasingly widespread interest in participation in alternative 
payment models and the growing number of such models being tested 
through the CMS Innovation Center. Stakeholders have therefore 
suggested that we should revise our policies to clarify that only final 
non-claims based payments made within the 3 months claims run out 
period under a demonstration, pilot or time limited program will be 
included in the calculation of an ACO's benchmark and performance year 
expenditures.
b. Proposals
    Our preliminary analysis, as discussed in the background section, 
suggests that interim non-claims based payments (that is, payments that 
are subject to reconciliation at a later date) made under a 
demonstration, pilot, or time limited program can fluctuate 
significantly from quarter to quarter and may not reflect the actual 
final reconciled payment amount. Thus, we agree with the stakeholders 
who have suggested that only final non-claims based payments made under 
a demonstration, pilot or time limited program should be included in 
financial calculations related to benchmarks and performance year 
expenditures under the Shared Savings Program. We believe this would be 
a reasonable approach to determining Parts A and B expenditures for 
assigned beneficiaries for both benchmark and performance years given 
the uncertain impact on ACOs' financial calculations of including 
interim payments that will be subsequently revised to reflect the final 
reconciled payment amounts. We also agree that use of interim payments 
made under a demonstration, pilot or time limited program could have an 
increasingly large effect on ACO benchmarks and performance year 
expenditure calculations in the future given widespread stakeholder 
interest in participating in alternative payment models and CMS 
interest in testing and expanding additional payment models that may 
lead to higher quality and more coordinated care at a lower cost to 
Medicare.
    Therefore, we are proposing to revise the applicable regulations to 
make clear that we would include only final individually beneficiary 
identifiable payments made under a demonstration, pilot or time limited 
program in financial calculations related to establishing and updating 
benchmarks and determining performance year expenditures under the 
Shared Savings Program. We propose that this policy would be applied to 
calculations that are necessary to determine ACO performance for the 
2018 performance year and subsequent performance years. For ACOs that 
are in the middle of an agreement period when this revised policy takes 
effect, we would adjust the benchmarks for these ACOs at the start of 
the 2018 performance year and each subsequent performance year so that 
the benchmark for the ACO reflects the use of the same payment 
information that would apply in expenditure calculations for the 
performance year. More specifically, we propose to modify our 
regulations at Sec. Sec.  425.602(a)(1)(ii), 425.603(c)(1)(ii), and 
425.603(e)(2)(ii) to add new provisions to indicate that, (1) when 
establishing benchmarks for agreement periods before 2018, we will 
include all individually beneficiary identifiable payments, including 
interim payments, made under a demonstration, pilot, or time limited 
program, (2) for agreement periods beginning in 2018 and subsequent 
years, we would only include individually beneficiary identifiable 
payments made under a demonstration, pilot or time limited program that 
are final and not subject to further reconciliation, and (3) For the 
2018 performance year and subsequent performance years in agreement 
periods beginning in 2015, 2016 and 2017, the benchmark would be 
adjusted to reflect only individually beneficiary identifiable final 
payments made under a demonstration, pilot or time limited program. 
Additionally, we propose to add new Sec. Sec.  425.604(a)(6)(ii)(A), 
425.606(a)(6)(ii)(A) and 425.610(a)(6)(ii)(A) indicating that when 
calculating expenditures for performance years before 2018, we will 
include all individually beneficiary identifiable payments, including 
interim payments, made under a demonstration, pilot, or time limited 
program. We also propose to add new Sec. Sec.  425.604(a)(6)(ii)(B), 
425.606(a)(6)(ii)(B) and 425.610(a)(6)(ii)(B) indicating that when 
calculating expenditures for performance year 2018 and subsequent 
performance years, we would only include individually beneficiary 
identifiable payments made under a demonstration, pilot or time limited 
program that are final and not subject to further reconciliation. To be 
consistent with our treatment of claims-based payments, such final 
payments would have to be available in the separate CMS system by the 
end of the 3-month claims run out period.
    We invite comments on this proposal.

[[Page 34124]]

I. Value-Based Payment Modifier and Physician Feedback Program

1. Overview
    Section 1848(p) of the Act requires the establishment of a value-
based payment modifier (VM) that applies to specific physicians and 
groups of physicians the Secretary determines appropriate starting 
January 1, 2015, and to all physicians and groups of physicians by 
January 1, 2017. On or after January 1, 2017, section 1848(p)(7) of the 
Act provides the Secretary discretion to apply the VM to eligible 
professionals (EPs) as defined in section 1848(k)(3)(B) of the Act. 
Section 1848(p)(4)(C) of the Act requires the VM to be budget neutral. 
The VM and Physician Feedback programs continue our initiative to 
recognize and reward clinicians based on the quality and cost of care 
provided to their patients, increase the transparency of health care 
quality information and to assist clinicians and beneficiaries in 
improving medical decision-making and health care delivery. As stated 
in the CY 2016 PFS final rule with comment period (80 FR 71277), the 
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) (Pub. L. 
114-10) was enacted on April 16, 2015. Under section 1848(p)(4)(B)(iii) 
of the Act, as amended by section 101(b)(3) of MACRA, the VM shall not 
be applied to payments for items and services furnished on or after 
January 1, 2019. Section 1848(q) of the Act, as added by section 101(c) 
of MACRA, establishes the Merit-based Incentive Payment System (MIPS) 
that shall apply to payments for items and services furnished on or 
after January 1, 2019.
2. Overview of Existing Policies for the VM
    In the CY 2013 PFS final rule with comment period, we discussed the 
goals of the VM and also established that specific principles should 
govern the implementation of the VM (77 FR 69307). We refer readers to 
that rule for a detailed discussion. In the CY 2013 PFS final rule with 
comment period (77 FR 69310), we finalized policies to phase-in the VM 
by applying it beginning January 1, 2015, to Medicare PFS payments to 
physicians in groups of 100 or more EPs. A summary of the existing 
policies that we finalized for the CY 2015 VM can be found in the CY 
2014 PFS proposed rule (78 FR 43486 through 43488). Subsequently, in 
the CY 2014 PFS final rule with comment period (78 FR 74765 through 
74787), we finalized policies to continue the phase-in of the VM by 
applying it starting January 1, 2016, to payments under the Medicare 
PFS for physicians in groups of 10 or more EPs. Then, in the CY 2015 
PFS final rule with comment period (79 FR 67931 through 67966), we 
finalized policies to complete the phase-in of the VM by applying it 
starting January 1, 2017, to payments under the Medicare PFS for 
physicians in groups of 2 or more EPs and to physician solo 
practitioners. In the CY 2016 PFS final rule with comment period (80 FR 
71277 through 71279), we finalized that in the CY 2018 payment 
adjustment period, the VM will apply to non-physician EPs who are 
physician assistants (PAs), nurse practitioners (NPs), clinical nurse 
specialists (CNSs), and certified registered nurse anesthetists (CRNAs) 
in groups with 2 or more EPs and to PAs, NPs, CNSs, and CRNAs who are 
solo practitioners.
    In the CY 2016 PFS final rule with comment period (80 FR 71288 to 
71291), we finalized that we would apply the following adjustments to 
payments, for items and services furnished under the Medicare PFS in CY 
2018, to physicians, PAs, NPs, CNSs, and CRNAs in groups with 10 or 
more EPs and at least one physician:
     Negative 4 percent (-4.0 percent) for those that fall into 
Category 2, meaning that they did not meet the criteria to avoid the 
2018 PQRS payment adjustment.
     Negative 4 percent (-4.0 percent) under the quality-
tiering methodology for those classified as low quality/high cost and 
negative 2 percent (-2.0 percent) for those classified as either low 
quality/average cost or average quality/high cost.
     An upward adjustment of four times an adjustment factor 
(+4.0x) under the quality-tiering methodology for those classified as 
high quality/low cost and two times an adjustment factor (+2.0x) for 
those classified as either average quality/low cost or high quality/
average cost.
    We finalized that we would apply the following adjustments to 
payments, for items and services furnished under the Medicare PFS in CY 
2018, to physician solo practitioners and physicians, PAs, NPs, CNSs, 
and CRNAs in groups with 2 to 9 EPs and at least one physician:
     Negative 2 percent (-2.0 percent) to those that fall into 
Category 2, meaning that they did not meet the criteria to avoid the 
2018 PQRS payment adjustment.
     Negative 2 percent (-2.0 percent) under the quality 
tiering methodology for those classified as low quality/high cost and 
negative 1 percent (-1.0 percent) for those classified as either low 
quality/average cost or average quality/high cost.
     An upward adjustment of two times an adjustment factor 
(+2.0x) under the quality-tiering methodology for those classified as 
high quality/low cost and one times an adjustment factor (+1.0x), for 
those classified as either average quality/low cost or high quality/
average cost.
    We finalized that we would apply the following adjustments to 
payments, for items and services furnished under the Medicare PFS in CY 
2018, to non-physician solo practitioners who are PAs, NPs, CNSs, and 
CRNAs and to PAs, NPs, CNSs, and CRNAs in groups comprised solely of 
non-physician EPs:
     Negative 2 percent (-2.0 percent) for those who fall in 
Category 2, meaning that they did not meet the criteria to avoid the 
2018 PQRS payment adjustment.
     No downward adjustments under the quality-tiering 
methodology in CY 2018.
     An upward adjustment of two times an adjustment factor 
(+2x) under the quality-tiering methodology, for those classified as 
high quality/low cost and one times an adjustment factor (+1.0x) for 
those classified as either average quality/low cost or high quality/
average cost.
    In the CY 2017 PFS final rule with comment period (81 FR 80520-
80524), we finalized the following, with regard to Medicare Shared 
Savings Program ACO participant TINs whose ACO did not successfully 
report quality data on behalf of its EPs for purposes of PQRS as 
required by the Shared Savings Program under Sec.  425.504 for the CY 
2017 and CY 2018 PQRS payment adjustments:
     For the CY 2017 VM payment adjustment period, we will use 
the data reported to the PQRS by the EPs under the ACO participant TIN 
(as a group or as individuals) outside of the ACO during the secondary 
PQRS reporting period in 2016 to determine whether the TIN would fall 
in Category 1 or Category 2 under the VM.
     We will apply the two-category approach finalized for the 
CY 2017 VM based on participation in the PQRS by groups and solo 
practitioners to determine whether groups and solo practitioners that 
participate in a Shared Savings Program ACO, but report to the PQRS 
outside of the ACO, would fall in Category 1 or Category 2 under the 
VM.
     We will assess the individual EP or group's 2016 data 
submitted outside the ACO and during the secondary PQRS reporting 
period against the reporting requirements for the CY 2018 PQRS payment 
adjustment. Therefore, groups that meet the criteria to avoid the PQRS 
payment adjustment for CY 2018 as a

[[Page 34125]]

group or by having at least 50 percent of the group's EPs meet the 
criteria to avoid the PQRS payment adjustment for CY 2018 as 
individuals, based on data submitted outside the ACO and during the 
secondary PQRS reporting period in 2016, will be included in Category 1 
for the CY 2017 VM. In addition, solo practitioners that meet the 
criteria to avoid the PQRS payment adjustment for CY 2018 as 
individuals, based on data submitted outside the ACO and during the 
secondary PQRS reporting period in 2016, will be included in Category 1 
for the CY 2017 VM. For these groups and solo practitioners in Category 
1, we will classify their quality composite as ``average quality,'' and 
as established in the CY 2015 PFS final rule with comment period (79 FR 
67943), we will classify their cost composite as ``average cost.'' 
Category 2 will include those groups and solo practitioners subject to 
the CY 2017 VM that participate in a Shared Savings Program ACO and do 
not fall within Category 1. We note that we would need to update the 
group or solo practitioner's status so that they will stop receiving an 
automatic downward adjustment under the VM for items and services 
furnished in CY 2017 and reprocess all claims that were previously 
paid.
    For the CY 2018 payment adjustment period, if groups that 
participate in a Shared Savings Program ACO in 2016 report quality data 
to the PQRS outside of the ACO and meet the criteria to avoid PQRS 
payment adjustment for CY 2018 as a group or by having at least 50 
percent of the group's EPs meet the criteria to avoid the PQRS payment 
adjustment for CY 2018 as individuals by reporting quality data to PQRS 
outside of the ACO, then they will be included in Category 1 for the CY 
2018 VM. If solo practitioners that participate in a Shared Savings 
Program ACO in 2016 report quality data to the PQRS outside of the ACO 
and meet the criteria to avoid the PQRS payment adjustment for CY 2018 
as individuals, then they will also be included in Category 1. We will 
classify their quality composite for the VM for the CY 2018 payment 
adjustment period as ``average quality.'' As finalized in the CY 2015 
PFS final rule with comment period (79 FR 67943), the cost composite 
for groups and solo practitioners that participate in a Shared Savings 
Program ACO is classified as ``average cost.''
3. Provisions of This Proposed Rule
    As a general summary, we are proposing the following modifications 
to the VM policies for the CY 2018 payment adjustment period:
     Reduce the automatic downward adjustment for groups and 
solo practitioners in Category 2 (those who do not meet the criteria to 
avoid the 2018 PQRS payment adjustment as individual solo 
practitioners, as a group practice, or groups that have at least 50 
percent of the group's EPs meet the criteria as individuals) to 
negative 2 percent (-2.0 percent) for groups with 10 or more EPs and at 
least one physician, and negative 1 percent (-1.0 percent) for groups 
with between 2 to 9 EPs, physician solo practitioners, and for groups 
and solo practitioners that consist only of non-physician EPs.
     Hold all groups and solo practitioners who are in Category 
1 (those who meet the criteria to avoid the 2018 PQRS payment 
adjustment as individual solo practitioners, as a group practice, or 
groups that have at least 50 percent of the group's EPs meet the 
criteria as individuals) harmless from downward payment adjustments 
under quality tiering for the last year of the program.
     To provide a smoother transition to the MIPS and to align 
incentives across all groups and solo practitioners, reduce the maximum 
upward adjustment under the quality-tiering methodology to two times an 
adjustment factor (+2.0x) for groups with 10 or more EPs. This is the 
same maximum upward adjustment under the quality-tiering methodology 
that we finalized and will maintain for groups with between 2 to 9 EPs, 
physician solo practitioners, and for groups and solo practitioners 
that consist only of non-physician EPs.
a. Approach to Setting the VM Adjustment Based on PQRS Participation
    Section 1848(p)(4)(B)(iii)(II) of the Act requires the Secretary to 
apply the VM to items and services furnished under the PFS beginning 
not later than January 1, 2017, for all physicians and groups of 
physicians. Therefore, as mentioned in this proposed rule, in the CY 
2016 PFS final rule with comment period (80 FR 71277 through 71279), we 
established that for the CY 2018 payment adjustment period, the VM will 
apply to non-physician EPs who are PAs, NPs, CNSs, and CRNAs in groups 
with 2 or more EPs and to PAs, NPs, CNSs, and CRNAs who are solo 
practitioners.
    In the CY 2016 PFS final rule with comment period (80 FR 71280), we 
adopted a two-category approach for the CY 2018 VM based on 
participation in the PQRS by groups and solo practitioners. For the 
purposes of the CY 2018 VM, Category 1 includes the following groups 
and solo practitioners:
    (1) Groups that meet the criteria to avoid the CY 2018 PQRS payment 
adjustment as a group practice participating in the PQRS GPRO;
    (2) Groups that have at least 50 percent of the group's EPs meet 
the criteria to avoid the PQRS payment adjustment for CY 2018 as 
individuals;
    (3) Solo practitioners that meet the criteria to avoid the CY 2018 
PQRS payment adjustment as individuals; and
    (4) Groups and solo practitioners that meet the criteria to avoid 
the CY 2018 PQRS payment adjustment through participation in a Shared 
Savings Program ACO, if the ACO in which they participate successfully 
reports quality data as required by the Shared Savings Program.
    Category 2 includes those groups and solo practitioners that are 
subject to the CY 2018 VM payment adjustment and do not fall within 
Category 1. Groups in Category 1 have been eligible to receive upward, 
neutral, or downward adjustments under our quality tiering methodology, 
and groups and solo practitioners in Category 2 receive an automatic 
downward adjustment under the VM.
    As noted in this proposed rule, under section 1848(p)(4)(B)(iii) of 
the Act, as amended by section 101(b)(3) of MACRA, the VM shall not be 
applied to payments for items and services furnished on or after 
January 1, 2019. Section 1848(q) of the Act, as added by section 101(c) 
of MACRA, establishes the MIPS that shall apply to payments for items 
and services furnished on or after January 1, 2019. In the interest of 
program alignment and providing a smooth transition between the VM and 
MIPS, as well as aligning with the proposed changes to the policies for 
satisfactory reporting under the final year of PQRS, modifications to 
the CY 2018 VM payment adjustments are proposed and described in 
section III.F. of this proposed rule. We are not proposing any change 
to our existing policy that TINs that avoid the downward payment 
adjustment under PQRS (either as a group practice participating in the 
PQRS GPRO or through the individual participation of at least 50 
percent of the group's EPs, or as a solo practitioner) will be 
considered Category 1 under the VM. These TINs therefore will avoid an 
automatic downward adjustment under the VM.
b. Payment Adjustment Amount
    In this section, we are proposing modifications to the VM policies 
for the CY 2018 payment adjustment period. As discussed in greater 
detail below, we are proposing these modifications based on our general 
policy goals of better

[[Page 34126]]

alignment and ensuring a smooth transition from the final year of the 
VM (2018) to the first year of MIPS (2019) as well as continuing to 
align the VM with the policies established for the PQRS.
    To maintain stability in the payment adjustment amounts applicable 
under the VM as we transition to the MIPS in 2019, we maintained 
generally the same VM payment adjustment amounts from the CY 2017 
payment adjustment period to the CY 2018 payment adjustment period (80 
FR 71288 through 71291). Under our existing policy (80 FR 71290), the 
estimated funds derived from the application of the downward 
adjustments to groups and solo practitioners in Category 1 and Category 
2 are available to all groups and solo practitioners eligible for 
upward adjustments under the VM. The upward payment adjustment factor 
(the ``x'' factor) is determined after the performance period has ended 
based on the aggregate amount of downward payment adjustments. Despite 
our efforts to ensure a smooth transition from the VM to the MIPS, the 
2017 VM adjustment factor has resulted in payment adjustments for some 
groups and solo practitioners that are significantly higher than the 
maximum upward adjustment under the MIPS, which will apply to payments 
starting in 2019, after the sunset of the VM in 2018. The magnitude of 
the 2017 VM adjustment factor is due in large part to the number of 
physician practices failing to satisfy the criteria to avoid the PQRS 
payment adjustment (Category 2). Furthermore, we believe it is likely 
that many physician practices that fail to meet these criteria and as a 
result are in Category 2 and are subject to automatic downward 
adjustments under the 2018 VM will be excluded from MIPS in 2019, due 
to the low-volume threshold. For example, as noted in the 2015 PQRS 
Experience Report, CMS foundthat, based on historical data, the 
participation rate for practices falling below the low volume threshold 
``low volume'' (< $30k charges OR <100 beneficiaries) would be 
approximately 60 percent. Based on historical data, the participation 
rate among practices falling above the low volume threshold (>= $30k 
charges AND >=100 beneficiaries) would be approximately 80 percent.
    The 2017 VM adjustment factor is 15.48 percent, which is similar to 
the 2016 VM adjustment factor of 15.92 percent. We would expect, absent 
any policy change, that the 2018 VM adjustment factor would be similar 
or higher. The 2018 VM adjustment factor could potentially be higher 
than the 2017 VM adjustment factor, because non-physician EPs who will 
be subject to the 2018 VM may be less familiar with quality reporting 
and may fail to meet the criteria to avoid the CY 2018 PQRS payment 
adjustment, which would result in a greater number of groups and solo 
practitioners in Category 2. In addition, groups with 2-9 EPs and solo 
practitioner physicians will no longer be held harmless from downward 
adjustments under the quality-tiering methodology in the CY 2018 
payment adjustment period.
    In section III.F. of this proposed rule, we are proposing to change 
certain policies for the 2018 PQRS payment adjustment. We discuss the 
implications of these proposed changes for PQRS with regard to the VM 
in greater detail below.
     Quality-Tiering for groups and solo practitioners in 
Category 1: As noted in section III.F. of this proposed rule, we are 
proposing to change the reporting criteria for the 2018 PQRS payment 
adjustment. We are proposing to lower the number of measures required 
and to eliminate the requirement for reporting across a number of 
domains. We recognize that some groups and solo practitioners may have 
reported differently under PQRS if the PQRS reporting criteria had been 
established prior to the reporting period. For example, it is possible 
that groups and solo practitioners may have selected fewer or different 
PQRS measures to report or may have chosen to report through a 
different PQRS reporting mechanism, which could have resulted in a 
higher quality composite score under the VM. Based on these 
implications for the VM, we are proposing to hold all groups and solo 
practitioners in Category 1 harmless from downward adjustments under 
the quality-tiering methodology in the CY 2018 payment adjustment 
period. This proposal would apply to groups and solo practitioners who 
would have otherwise received downward adjustments based on their 
quality composite score and/or cost composite score. A group or solo 
practitioner that is classified as ``high cost'' based on their cost 
composite score potentially could have reported differently under the 
PQRS and received a quality composite score that would be classified as 
``high quality,'' if the PQRS reporting criteria proposed in section 
III.F. of this proposed rule had been established prior to the 
reporting period. A high quality/high cost classification would have 
resulted in a neutral adjustment under the VM in 2018.
    In contrast to the existing policy for 2018 where only non-
physician solo practitioners and groups comprised solely of non-
physician EPs would be held harmless from downward adjustments under 
quality-tiering, this proposed policy would mean that all groups and 
solo practitioners that meet the criteria to avoid the 2018 PQRS 
payment adjustment would receive either a neutral or upward adjustment 
based on performance.
    We also propose to reduce the maximum upward adjustment under the 
quality-tiering methodology in CY 2018 from four times an adjustment 
factor (+4.0x) to two times an adjustment factor (+2.0x) for those 
classified as high quality/low cost and from two times an adjustment 
factor (+2.0x) to one times an adjustment factor (+1.0x), for those 
classified as either average quality/low cost or high quality/average 
cost. This proposal would align the upward adjustments for groups with 
ten or more eligible professionals with the existing policy for smaller 
groups and solo practitioners, as well as groups comprised solely of 
non-physician EPs (80 FR 71290). We are proposing this change based on 
our concern that the 2018 VM adjustment factor (the ``x'' factor used 
to determine upward adjustments) could potentially be higher than the 
2017 VM adjustment factor, as discussed above. Lowering the maximum 
upward adjustment in 2018 would mitigate the effect of a high 
adjustment factor and ensure a smoother transition from the VM 
adjustment in 2018 to the MIPS adjustment in 2019. We welcome public 
comment on this proposal.
    We are not proposing any change to the existing policy (80 FR 
71291) that groups and solo practitioners that are eligible for upward 
adjustments under the quality-tiering methodology and have average 
beneficiary risk score that is in the top 25 percent of all beneficiary 
risk scores will earn an additional upward adjustment of one times an 
adjustment factor (+1x). We are also not proposing any change to the 
existing policy (81 FR 80520 through 80524) (a) for the CY 2017 payment 
adjustment period for groups and solo practitioners that would be in 
Category 1 as a result of meeting the proposed reduced PQRS reporting 
criteria (see section III.F. of this proposed rule) outside of their 
Shared Savings Program ACO during the secondary PQRS reporting period 
in 2016 or (b) for the CY 2018 payment adjustment period for groups and 
solo practitioners that would be Category 1 as a result of reporting 
outside of their Shared Savings Program ACO because their ACO failed to 
successfully report on their behalf to avoid the PQRS payment 
adjustment. As stated

[[Page 34127]]

previously, under the existing policy, these groups and solo 
practitioners in Category 1 would be classified as ``average quality'' 
and ``average cost'' for purposes of the CY 2017 VM.
    Tables 22 through 24 illustrate how the proposed policies differ 
from the existing policies for each group size and composition.

  Table 22--Current and Proposed CY 2018 VM Amounts Under the Quality-Tiering Approach for Physicians, NPs, PAs, CNSs, & CRNAs in Groups of Physicians
                                                                      With 10+ EPs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                      Cost/quality                                  Low quality                   Average quality                  High quality
--------------------------------------------------------------------------------------------------------------------------------------------------------
                  VM Payment adjustment                     Current (%)    Proposed (%)       Current        Proposed         Current        Proposed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Low Cost................................................            +0.0            +0.0          +2.0x*          +1.0x*          +4.0x*          +2.0x*
Average Cost............................................            -2.0            +0.0           +0.0%           +0.0%          +2.0x*          +1.0x*
High Cost...............................................            -4.0            +0.0           -2.0%           +0.0%           +0.0%           +0.0%
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Under existing policy, these groups are eligible for an additional +1.0x if their average beneficiary risk score is in the top 25 percent of all
  beneficiary risk scores, where `x' represents the upward payment adjustment factor.


  Table 23--Current and Proposed CY 2018 VM Amounts Under the Quality-Tiering Approach for Physicians, PAs, NPs, CNSs, & CRNAs in Groups of Physicians
                                                      With 2-9 EPs and Physician Solo Practitioners
--------------------------------------------------------------------------------------------------------------------------------------------------------
                      Cost/quality                                  Low quality                   Average quality                  High quality
--------------------------------------------------------------------------------------------------------------------------------------------------------
                  VM Payment adjustment                     Current (%)    Proposed (%)       Current        Proposed         Current        Proposed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Low Cost................................................            +0.0            +0.0          +1.0x*          +1.0x*          +2.0x*          +2.0x*
Average Cost............................................            -1.0            +0.0           +0.0%           +0.0%          +1.0x*          +1.0x*
High Cost...............................................            -2.0            +0.0           -1.0%           +0.0%           +0.0%           +0.0%
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Under existing policy, these groups and solo practitioners are eligible for an additional +1.0x if their average beneficiary risk score is in the top
  25 percent of all beneficiary risk scores, where `x' represents the upward payment adjustment factor.


Table 24--Current and Proposed CY 2018 VM Amounts Under the Quality-Tiering Approach for PAs, NPs, CNSs, & CRNAs who are Solo Practitioners or in Groups
                                                          Consisting of Non-Physician EPs Only
--------------------------------------------------------------------------------------------------------------------------------------------------------
                      Cost/quality                                  Low quality                   Average quality                  High quality
--------------------------------------------------------------------------------------------------------------------------------------------------------
                  VM Payment adjustment                     Current (%)    Proposed (%)       Current        Proposed         Current        Proposed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Low Cost................................................            +0.0            +0.0          +1.0x*          +1.0x*          +2.0x*          +2.0x*
Average Cost............................................            +0.0            +0.0           +0.0%           +0.0%          +1.0x*          +1.0x*
High Cost...............................................            +0.0            +0.0           +0.0%           +0.0%           +0.0%           +0.0%
--------------------------------------------------------------------------------------------------------------------------------------------------------
* Under existing policy, these groups and solo practitioners are eligible for an additional +1.0x if their average beneficiary risk score is in the top
  25 percent of all beneficiary risk scores, where `x' represents the upward payment adjustment factor.

    Table 25 displays the proposed 2018 VM adjustments under the 
quality-tiering methodology, for groups and solo practitioners in 
Category 1. Under the proposed policies, groups of any size and 
composition would be subject to the same upward adjustments under 
quality tiering and would be held harmless from any downward 
adjustments based on performance.

  Table 25--Proposed CY 2018 VM Amounts Under the Quality-Tiering Approach for Physicians, PAs, NPs, CNSs, and
                        CRNAs Who Are Solo Practitioners and Those in Groups of Any Size
----------------------------------------------------------------------------------------------------------------
                                                                    Low quality       Average
                          Cost/quality                                  (%)           quality      High quality
----------------------------------------------------------------------------------------------------------------
Low cost........................................................            +0.0          +1.0x*          +2.0x*
Average cost....................................................            +0.0           +0.0%          +1.0x*
High cost.......................................................            +0.0           +0.0%           +0.0%
----------------------------------------------------------------------------------------------------------------
* Under existing policy, these groups and solo practitioners are eligible for an additional +1.0x if their
  average beneficiary risk score is in the top 25 percent of all beneficiary risk scores, where `x' represents
  the upward payment adjustment factor.

     Automatic Downward Adjustments for groups and solo 
practitioners in Category 2. Under existing policy, the total maximum 
downward adjustment in 2018 under the PQRS and VM programs combined is 
negative 6 percent (-6.0 percent), while the maximum downward 
adjustment under MIPS in 2019 is negative 4 percent (-4.0 percent). In 
order to ensure a smoother transition to the downward payment 
adjustments under MIPS, we are proposing to reduce the amount of the 
automatic downward adjustments applied to payments for TINs

[[Page 34128]]

categorized as Category 2 (those that do not avoid the PQRS payment 
adjustment as individual solo practitioners, as a group practice, or as 
a group that has at least 50 percent of the group's EPs meet the 
criteria to avoid the payment adjustment as individuals).
    For physicians, PAs, NPs, CNSs, and CRNAs in groups with 10 or more 
EPs and at least one physician, we propose to reduce the automatic 
downward VM adjustment from negative 4 percent (-4.0 percent) to 
negative 2 percent (-2.0 percent) for those that fall in Category 2, 
meaning they did not meet the criteria to avoid the 2018 PQRS payment 
adjustment. We welcome public comment on this proposal.
    For physician, PA, NP, CNS, and CRNA solo practitioners; 
physicians, PAs, NPs, CNSs, and CRNAs in groups with 2 to 9 EPs; and 
for PAs, NPs, CNSs, and CRNAs who are in groups comprised solely of 
non-physician EPs, we propose to reduce the automatic downward VM 
adjustment from negative 2 percent (-2.0 percent) to negative 1 percent 
(-1.0 percent) for those that fall in Category 2. We welcome public 
comment on this proposal.
    Section 1848(p) of the Act does not specify the amount of payment 
that should be subject to the adjustment for the VM; however, section 
1848(p)(4)(C) of the Act requires the VM be implemented in a budget 
neutral manner. In the past, under the VM, we have achieved budget 
neutrality by increasing payments for some groups and solo 
practitioners based on high performance and decreasing them for others 
based on low performance or failing to meet the criteria to avoid the 
PQRS payment adjustment as a group or as individuals. Under the 
proposals discussed above for the CY 2018 payment adjustment period, we 
would not decrease payments to groups and solo practitioners based on 
performance under the quality-tiering methodology, provided that they 
are classified as Category 1 under the VM (meaning that they meet the 
criteria to avoid the CY 2018 PQRS payment adjustment as individual 
solo practitioners, as a group practice, or as a group that has at 
least 50 percent of the group's EPs meet the criteria). We would 
continue to decrease payments to groups and solo practitioners in 
Category 2 (meaning that they did not meet the criteria to avoid the CY 
2018 PQRS payment adjustment as individual solo practitioners, as a 
group practice, or as a group that has at least 50 percent of the 
group's EPs meet the criteria). Regardless of the proposals discussed 
above for the CY 2018 payment adjustment period, the aggregate expected 
amount of Medicare spending in any given year for physician and non-
physician EP services paid under the Medicare PFS will not change as a 
result of the application of the VM. As discussed above, because the VM 
must be implemented in a budget neutral manner, the amount available 
for upward adjustments for high performers would decrease under our 
proposals. In other words, groups and solo practitioners that performed 
well on cost and quality would receive a smaller increase in payment. 
For this reason, we seek comment on whether we have appropriately 
balanced the interests of high and low-performing groups and solo 
practitioners through this proposed change to the policy.
    We propose to make conforming revisions to Sec. Sec.  414.1270, and 
414.1275(c)(4) and (d)(3) to reflect the proposals described in this 
section. We seek public comment on these proposed changes to the 
regulation text.

J. MACRA Patient Relationship Categories and Codes

1. Development of Patient Relationship Categories and Codes To Improve 
Identification of Physician-Patient Relationship
a. Overview
    The Quality Payment Program (QPP) aims to improve health outcomes, 
promote smarter spending, minimize burden of participation, and provide 
fairness and transparency in operations. These aims are centered on 
improving beneficiary outcomes and engaging patients through patient-
centered policies, and enhancing clinician experience through flexible 
and transparent program design and interactions with easy-to-use 
program tools.
    The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) 
(Pub. L. 114-10) was enacted on April 16, 2015. Section 101(f) of MACRA 
amended section 1848 of the Act to create a new subsection (r) entitled 
Collaborating with the Physician, Practitioner, and Other Stakeholder 
Communities to Improve Resource Use Measurement. Section 1848(r)(2) of 
the Act requires the development of care episode and patient condition 
groups, and classification codes for such groups. To facilitate the 
attribution of patients and episodes to one or more clinicians, section 
1848(r)(3) of the Act requires the development of patient relationship 
categories and codes that define and distinguish the relationship and 
responsibility of a physician or applicable practitioner with a patient 
at the time of furnishing an item or service. The categories shall 
include different relationships of the clinician to the patient and 
reflect various types of responsibility for and frequency of furnishing 
care. Pursuant to section 1848(r)(3)(C) of the Act, we posted a draft 
list of patient relationship categories in April 2016 and solicited 
public comment on the categories and the policy principles that were 
used in developing them.\4\ In December 2016, we solicited additional 
comment on potential modifications to these categories based on 
comments received previously, as well as a method to operationalize the 
coding of these categories on the Medicare claim.\5\
---------------------------------------------------------------------------

    \4\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Patient-Relationship-Categories-and-Codes.pdf (assessed 04/26/2017).
    \5\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Patient-Relationship-Categories-and-Codes-Posting-FINAL.pdf.
---------------------------------------------------------------------------

2. Operational List of Patient Relationship Categories
    Based on the public comments received and consultation with 
stakeholders and experts regarding the draft list of patient 
relationship categories posted in April 2016 and the list of modified 
patient relationship categories posted in December 2016, we posted the 
operational list of patient relationship categories on May 17, 2017, 
pursuant to section 1848(r)(3)(E) of the Act, which is available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/CMS-Patient-Relationship-Categories-and-Codes.pdf. The patient relationship 
categories on the operational list are the following:
     Continuous/Broad Services.
     Continuous/Focused Services.
     Episodic/Broad services.
     Episodic/Focused Services.
     Only as Ordered by Another Clinician.
3. Subsequent Revisions
    Section 1848(r)(3)(F) of the Act requires that after the posting of 
the operational list of patient relationship categories and codes, not 
later than November 1st of each year (beginning with 2018), the 
Secretary shall, through rulemaking, make revisions to the operational 
list of patient relationship categories and codes as the Secretary 
determines appropriate. The revisions may be based on experience, new 
information and input from stakeholders. In preparation for

[[Page 34129]]

potential subsequent revisions by November 1, 2018, we seek comment on 
the operational list of patient relationship categories available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/CMS-Patient-Relationship-Categories-and-Codes.pdf.
4. Reporting of Patient Relationship Codes Using Modifiers
    Section 1848(r)(4) of the Act requires that claims submitted for 
items and services furnished by a physician or applicable practitioner 
on or after January 1, 2018, shall, as determined appropriate by the 
Secretary, include the applicable codes established for care episode 
groups, patient condition groups, and patient relationship categories 
under sections 1848(r)(2) and (3) of the Act, as well as the NPI of the 
ordering physician or applicable practitioner (if different from the 
billing physician or applicable practitioner). Applicable practitioners 
are defined in section 1848(r)(9)(B) of the Act as a physician 
assistant, nurse practitioner, and clinical nurse specialist (as such 
terms are defined in section 1861(aa)(5)), and a certified registered 
nurse anesthetist (as defined in section 1861(bb)(2)), and beginning 
January 1, 2019, such other eligible professionals (as defined in 
subsection (k)(3)(B)) as specified by the Secretary.
    We have been planning for the use of procedure code modifiers for 
the reporting of patient relationships codes on Medicare claims. In 
December 2016, as described above, when we solicited comments on the 
potential modifications to the patient relationship categories, we also 
sought comment on the use of Level II Healthcare Common Procedure 
Coding System (HCPCS) Modifiers for the patient relationship codes. 
Public comments indicated that Current Procedural Terminology (CPT) 
Modifiers would be the best way to operationalize the reporting of 
patient relationship codes.\6\
---------------------------------------------------------------------------

    \6\ The CMS Level II HCPCS Coding Workgroup meets regularly 
(generally monthly) to consider requests for new HCPCS codes and 
modifiers. Information on the code request and approval process is 
available at https://www.cms.gov/Medicare/Coding/MedHCPCSGenInfo/index.html (assessed 04/26/2017).
---------------------------------------------------------------------------

    We worked with the American Medical Association's (AMA) CPT 
Editorial Panel, which is responsible for maintaining the CPT code set. 
We submitted an application for the CPT modifiers for reporting of the 
patient relationship codes. The CPT Editorial Panel, at their June 2017 
meeting determined that AMA would not include the modifiers in the CPT 
code set, pending future finalization of the modifiers by CMS, whereby 
CMS publishes the modifiers as Level II HCPCS Modifiers. Therefore, we 
are proposing the Level II HCPCS Modifiers in Table 26 as the patient 
relationship codes, which we would add to the operational list if we 
adopt them in the final rule.

 Table 26--Proposed Patient Relationship HCPCS Modifiers and Categories
------------------------------------------------------------------------
                                 Proposed HCPCS    Patient relationship
              No.                   modifier            categories
------------------------------------------------------------------------
1x.............................              X1  Continuous/broad
                                                  services
2x.............................              X2  Continuous/focused
                                                  services
3x.............................              X3  Episodic/broad services
4x.............................              X4  Episodic/focused
                                                  services
5x.............................              X5  Only as ordered by
                                                  another clinician
------------------------------------------------------------------------

    We are proposing that Medicare claims submitted for items and 
services furnished by a physician or applicable practitioner on or 
after January 1, 2018, should include the applicable HCPCS modifiers in 
Table 26, as well as the NPI of the ordering physician or applicable 
practitioner (if different from the billing physician or applicable 
practitioner). We anticipate there will be a learning curve with the 
use of the modifiers to report patient relationships, and believe that 
time would be needed to work with clinicians to ensure they gain 
experience in using these modifiers. Therefore, for at least an initial 
period while clinicians gain familiarity, we are proposing that the 
HCPCS modifiers may be voluntarily reported on Medicare claims, and the 
use and selection of the modifiers would not be a condition of payment. 
Claims would be paid regardless of whether and how the modifiers are 
included. We would work with clinicians to educate them about the 
proper use of the modifiers.
    The use of modifiers to report patient relationships would not 
change the meaning of the procedure codes used to report items and 
services and guidelines associated with use of such procedure codes. 
The modifiers would also not be tied or related to intensity of 
services (evaluation and management services). Finally, we note that, 
while we may work with clinicians to explore incorporating these codes 
into the QPP in future years, the measures we have proposed and 
finalized to date, those we have proposed for 2018, and those we are 
currently developing for future rulemaking for the MIPS performance 
categories do not require patient relationship codes to properly 
measure clinicians' quality and resource use in the Medicare program.
    We solicit comment on our proposal for voluntary reporting of the 
proposed HCPCS modifiers on claims submitted for items and services 
furnished by a physician or applicable practitioner on or after January 
1, 2018 and on the proposed list of HCPCS modifiers in Table 26. We 
seek comments on our intention to resubmit these patient relationship 
modifiers to AMA for future consideration into the CPT modifier code 
set.

K. Proposed Changes to the Medicare Diabetes Prevention Program (MDPP) 
Expanded Model

1. Background
a. Authority for and Establishment of the MDPP Expanded Model
    In the November 15, 2016 Federal Register, we issued a final rule 
to implement aspects of the Medicare Diabetes Prevention Program (MDPP) 
expanded model (81 FR 80459 through 80475 and 80552 through 80558) as 
part of the CY 2017 PFS final rule.
    Section 1115A(c) of the Act provides the Secretary with the 
authority to expand, through rulemaking (including implementation on a 
nationwide basis), the duration and scope of a model that is being 
tested under section 1115A(b) of the Act if certain determinations 
specified in the Act are made, taking into account the evaluation of 
the model under section 1115A(b)(4) of the Act. The MDPP expanded model 
is an

[[Page 34130]]

expansion of CMS' Center for Medicare and Medicaid Innovation's 
(Innovation Center) Diabetes Prevention Program (DPP) model test under 
the authority of section 1115A of the Act. The Secretary expanded the 
DPP model test in duration and scope under the authority of section 
1115A(c) of the Act. For further information on the DPP model test, and 
the associated National DPP administered by the Centers for Disease 
Control and Prevention (CDC), we refer readers to the CY 2017 PFS final 
rule and the following Web sites: https://Innovation.cms.gov/initiatives/Health-Care-Innovation-Awards/ and https://www.cdc.gov/diabetes/prevention/index.html .
    The aim of the MDPP expanded model is to continue to test a method 
of prevention of the onset of type 2 diabetes among Medicare 
beneficiaries with an indication of prediabetes as defined by the MDPP 
beneficiary eligibility criteria (finalized at Sec.  410.79(c)(1)). 
Services available through the MDPP expanded model are MDPP services 
furnished in community and health care settings by coaches, such as 
trained community health workers or health professionals. We have 
designated services under the MDPP expanded model to be covered as 
additional preventive services under Medicare, as defined in section 
1861(ddd) of the Act.
    For a detailed discussion of the DPP model test and the development 
of aspects of the MDPP expanded model, we refer readers to the July 15, 
2016 MDPP proposed rule (``Proposed Expansion of the Diabetes 
Prevention Program (DPP) Model'') (81 FR 46413 through 46418), and the 
CY 2017 PFS final rule (81 FR 80459 through 80475).
    In the CY 2017 PFS final rule, we responded to and incorporated 
certain suggestions from the public comments we received that were 
within the scope of the MDPP proposals presented in the July 15, 2016 
MDPP proposed rule. We indicated in that final rule (81 FR 80459) that 
the MDPP expanded model would be implemented through at least two 
rounds of rulemaking. In the CY 2017 PFS final rule, we finalized MDPP 
policies that will enable CDC-recognized organizations to prepare for 
enrollment, including finalizing the framework for the MDPP expanded 
model, details of the MDPP expanded model (codified at Sec.  410.79(a) 
and (b)), beneficiary eligibility criteria (codified at Sec.  410.79(c) 
and (d)), supplier eligibility criteria and supplier enrollment 
requirements (codified at Sec.  424.59, proposed in this rule to be 
redesignated as Sec.  424.205). We also identified several issues, 
including some issues raised by commenters that we deferred to future 
rulemaking. The proposals in this proposed rule address a number of 
issues raised by the public in response to the July 15, 2016 MDPP 
proposed rule. We also are making additional proposals to implement the 
MDPP expanded model.
b. Summary of Provisions Finalized 2017 PFS Final Rule
    In the CY 2017 PFS final rule (81 FR 80465 through 80468), we 
finalized the structure of MDPP services. We provided that the MDPP 
core benefit consists of at least 16 weekly core sessions over months 1 
through 6 and at least 6 monthly core maintenance sessions over months 
7 through 12, furnished regardless of weight loss (Sec.  410.79(b) and 
(c)(2)). We also finalized that Medicare will cover ongoing maintenance 
sessions after the 12-month core set of MDPP services if beneficiaries 
achieve and maintain the required minimum weight loss of 5 percent. In 
section III.K.2.b. of this proposed rule, we are proposing to further 
revise the structure of MDPP services as a 3-year service period, 
generally contingent upon a beneficiary's attainment of two performance 
goals: achievement and maintenance of weight loss and attendance at a 
certain number of MDPP sessions.
    As used in this proposed rule, the term ``MDPP services period'' 
refers to the time period in which MDPP services are furnished under 
the MDPP expanded model over a minimum of 12 consecutive months and a 
maximum of 36 consecutive months from the date of the first core 
session the beneficiary attends. We use the term ``set of MDPP 
services'' to include the entirety of MDPP services available under the 
MDPP expanded model, including core sessions, core maintenance 
sessions, and, subject to paragraph Sec.  410.79(c)(3), ongoing 
maintenance sessions offered over the course of the MDPP services 
period. For purposes of this proposed rule and the expanded model, MDPP 
services would be covered under the ``additional preventive services'' 
benefit category under section 1861(ddd)(1) of the Act and paid through 
the Medicare Part B Trust Fund. As indicated in the CY 2017 PFS, we 
intended to begin supplier enrollment before MDPP services became 
available, and we finalized an expanded model start date of January 1, 
2018.
    In this proposed rule, we propose a new start date for the 
furnishing of MDPP services within the expanded model of April 1, 2018. 
That is, MDPP suppliers will not be able to furnish MDPP services, or 
to receive payment for these services, prior to April 1, 2018. We note 
that if finalized as part of the CY 2018 PFS, the supplier enrollment 
and compliance policies will become effective on January 1, 2018. This 
change to delay the furnishing of MDPP services would allow time for 
organizations to enroll in Medicare before they begin furnishing and 
billing for MDPP services.
    In the CY 2017 PFS final rule (81 FR 80459), we described a 
possible payment structure for MDPP services, but deferred full 
development of the payment structure to future rulemaking. In section 
III.K.2.d. of this proposed rule, we discuss our proposed payment 
structure for MDPP services. This proposal takes into consideration the 
significant number of public comments we received in response to the 
possible payment structure we described in the July 15, 2016 MDPP 
proposed rule. We also are proposing payment policies for instances in 
which an MDPP beneficiary switches MDPP suppliers.
    In the CY 2017 PFS final rule (81 FR 80471 through 80474), we 
required CDC-recognized organizations that will bill Medicare for MDPP 
services to enroll in Medicare as MDPP suppliers. We also finalized the 
requirements for coaches furnishing MDPP services. We finalized 
policies regarding CDC Diabetes Prevention Recognition Program (DPRP) 
full recognition for MDPP suppliers and we indicated an intention to 
propose policies in future rulemaking regarding whether a DPP 
organization without full CDC recognition could enroll as an MDPP 
supplier. We are proposing an interim MDPP preliminary recognition 
standard in section III.K.2.e. of this proposed rule. Also, in this 
section of this proposed rule, we are proposing revisions to the 
supplier eligibility and enrollment requirements, including 
establishment of standards and implementation of appropriate program 
integrity safeguards. In section III.K.2.f. of this proposed rule, we 
are proposing policies related to MDPP beneficiary engagement 
incentives furnished by MDPP suppliers.
    In the CY 2017 PFS final rule (81 FR 80459), we deferred 
establishing policies related to organizations delivering ``virtual'' 
DPP services, where services are not furnished in person. In section 
III.K.3. of this proposed rule, we explain that the MDPP expanded model 
covers in-person MDPP services (other than ad hoc virtual make-up 
sessions discussed in section III.K.2.c.iv.(3) of this proposed rule), 
and thus, explain why we are not currently making any proposals related 
to MDPP services

[[Page 34131]]

furnished 100 percent virtual and state that we are considering a 
separate model under CMS's Innovation Center authority to test and 
evaluate virtual DPP services.
2. Proposed Policy Changes
a. Proposed Changes to Effective Date of MDPP Services
    In the CY 2017 PFS final rule, we established at Sec.  410.79(a) 
that MDPP services would be available on January 1, 2018. We are 
proposing to change Sec.  410.79(a) to state that MDPP services would 
be available on April 1, 2018. We are proposing this change because we 
want to ensure that MDPP suppliers have sufficient time to enroll in 
Medicare after the effective date of the CY 2018 PFS final rule.
    Therefore, beneficiaries will not be able to receive MDPP services 
immediately on January 1, 2018 due to the time needed for supplier 
enrollment. For this reason, we are proposing April 1, 2018 as the 
expanded model start date, which we believe allows a sufficient amount 
of time (90 days) for eligible suppliers to enroll in Medicare before 
furnishing and billing for MDPP services. Subject to this proposed 
change, the following regulatory provisions, if finalized, would be 
effective April 1, 2018: Sec.  414.84 related to payment for MDPP 
services; and Sec.  424.210 related to beneficiary engagement 
incentives. All other sections, if finalized, will be effective on 
January 1, 2018, including the policies proposed in section III.K.2.e. 
related to supplier enrollment and compliance. We seek comment on this 
new expanded model start date and whether 90 days is a sufficient 
amount of time for organizations to enroll in Medicare and prepare to 
furnish and bill for MDPP services.
b. Proposed Changes to the Set of MDPP Services
    In the CY 2017 PFS final rule, we established the parameters of 
MDPP services. The policies and terms proposed in this proposed rule 
seek to clarify, build on, and at times change these previously 
finalized policies. In particular, we propose to refine and add terms 
related to the different aspects of ``MDPP services.'' In this proposed 
rule, we propose to slightly refine the term ``MDPP services'' to refer 
to structured health behavior change sessions that are furnished under 
the MDPP expanded model with the goal of preventing diabetes among 
Medicare beneficiaries with prediabetes, and that follow a CDC-approved 
curriculum (proposed Sec.  410.79(b)). The sessions provide practical 
training in long-term dietary change, increased physical activity, and 
problem-solving strategies for overcoming challenges to maintaining 
weight loss and a healthy lifestyle.
    In the preamble to the CY 2017 PFS final rule, we referenced the 
set of MDPP services covered under the expanded model as the ``MDPP 
benefit.'' In this proposed rule, we propose to update this 
terminology. In cases where we would have previously referred to the 
term ``benefit'' to describe the entire set of MDPP sessions covered 
under the MDPP model, we propose to use the phrase ``set of MDPP 
services.'' ``Set of MDPP services'' means the series of MDPP sessions, 
composed of core sessions, core maintenance sessions, and ongoing 
maintenance sessions, offered over the course of the MDPP services 
period (proposed Sec.  410.79(b)).
    In cases where we would have previously used the term ``benefit'' 
to describe a period of time, we propose to refer to the ``MDPP 
services period.'' The MDPP services period means the time period, 
beginning on the date an MDPP beneficiary attends his or her first core 
session, over which the set of MDPP services is furnished to the MDPP 
beneficiary, to include the core services period described in paragraph 
Sec.  410.79(c)(2)(i) and, subject to paragraph Sec.  410.79(c)(3), one 
or more ongoing maintenance session intervals during the ongoing 
services period described in paragraph Sec.  410.79(c)(2)(ii) (proposed 
Sec.  410.79(b)). The duration of the MDPP services period is discussed 
further in section III.K.2.c.iv. of this proposed rule. As noted 
throughout this section, the term ``benefit'' would no longer be used. 
We propose to remove the term ``MDPP core benefit'' from the list of 
definitions.
    In the CY 2017 PFS final rule, we included a definition for ``core 
sessions'' that referred to the set of core sessions covered under the 
MDPP expanded model. We propose to revise the definition for ``core 
sessions,'' and instead define the singular ``core session'' as an MDPP 
service that is furnished by an MDPP supplier to an MDPP beneficiary 
during months 1 through 6 of the MDPP services period, is approximately 
1 hour in length, and adheres to a CDC-approved DPP curriculum for core 
sessions (proposed Sec.  410.79(b)). We believe that having a 
definition for the individual core session would be more uniform with 
other MDPP definitions, which are defined in the singular form. We 
propose to revise the definition of ``core maintenance session'' as an 
MDPP service that is furnished by an MDPP supplier to an MDPP 
beneficiary during a core maintenance session interval, is 
approximately 1 hour in length, and adheres to a CDC-approved DPP 
curriculum for maintenance sessions (under proposed revised Sec.  
410.79(b)).
    We propose to revise the definition of an ``ongoing maintenance 
session'' as an MDPP service that is furnished by an MDPP supplier to 
an MDPP beneficiary during an ongoing maintenance session interval; is 
approximately 1 hour in length and adheres to a CDC-approved DPP 
curriculum for maintenance sessions (proposed revised Sec.  410.79(b)). 
The proposed time period over which MDPP suppliers offer ongoing 
maintenance sessions, which differs from our previously finalized 
policy, is discussed in section III.K.2.b.i. of this proposed rule.
    We propose to add a definition for ``MDPP session,'' which means a 
core session, a core maintenance session, or an ongoing maintenance 
session (proposed Sec.  410.79(b)).
    We invite public comments on these proposals.
i. Ongoing Maintenance Session Time Limit
    In the CY 2017 PFS final rule, we finalized that ``MDPP eligible 
beneficiaries,'' a term we now propose to remove and replace with 
``MDPP beneficiary,'' as described further in section III.K.2.c. of 
this proposed rule, would have Medicare coverage for ongoing 
maintenance sessions for an unspecified length of time, provided that 
they maintained the required minimum weight loss, which is 5 percent 
weight loss from baseline. Based on public comments indicating the 
limited administrative and operational capability of many MDPP 
suppliers to provide ongoing maintenance sessions for an individual 
indefinitely (81 FR 80468), we stated our intent to propose a limit on 
the number or duration of ongoing maintenance sessions to be covered in 
the set of MDPP services, although we did not finalize a policy that 
would do so.
    In this rule, we propose a 2-year limit on Medicare coverage for 
ongoing maintenance sessions (proposed Sec.  410.79(c)(2)(ii)). The CMS 
Chief Actuary noted in the certification of the expansion of the DPP 
model test that continued participation in a type 2 diabetes DPP after 
3 years has generally been untested. In addition, a DPP clinical trial 
conducted by the National Institutes of Health from 1996 to 2001 
followed participants in a DPP for 3 years and found that, at the end 
of the study, diabetes incidence was reduced by 58 percent in the group 
that received a DPP lifestyle intervention when

[[Page 34132]]

compared to the placebo group.\7\ Based on the lack of evidence about 
DPP services beyond 3 years and evidence of positive effects from DPP 
participation for 3 years, in this proposed rule, we propose a total 
MDPP services period of up to 3 years (consisting of 1 year of core 
sessions and core maintenance sessions, followed by up to 2 years of 
ongoing maintenance sessions, (proposed Sec.  410.79(b)).
---------------------------------------------------------------------------

    \7\ Available at http://www.nejm.org/doi/full/10.1056/NEJMoa012512.
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    We considered alternatives to this proposal, such as limiting 
Medicare coverage for ongoing maintenance sessions to 1 year, which 
would limit the total MDPP services period to 2 years. Because the CDC 
DPRP does not require organizations to offer ongoing maintenance 
sessions, we also considered not covering ongoing maintenance sessions 
altogether, which would limit the total MDPP services period to 1 year. 
However, we believe that beneficiaries can benefit from maintenance 
sessions beyond the 6 months of core maintenance sessions because 
weight loss is difficult to achieve and can be even more difficult to 
sustain. We believe that the behavior changes necessary to sustain 
weight loss will be more deeply ingrained through beneficiary 
participation in ongoing maintenance sessions. Existing evidence also 
supports the effectiveness of participation in a DPP through 3 years.
    We did not consider alternatives that would extend Medicare 
coverage for ongoing maintenance sessions beyond 2 years, and 
therefore, create an MDPP services period that would last longer than 3 
years. Therefore, we propose to continue to include ongoing maintenance 
sessions, but with a limit of up to 2 years. As stated earlier, we 
believe there is not enough evidence available to support the 
effectiveness of participation in a DPP beyond 3 years. We also 
believe, based on public comments received in response to the July 15, 
2016 MDPP proposed rule, that many suppliers have limited 
administrative and operational capacity to offer MDPP ongoing 
maintenance sessions indefinitely to all MDPP beneficiaries who 
maintain eligibility. As noted in section III.K.2.e.iv.4 of this 
proposed rule, an example of a capacity limit could include a situation 
where an MDPP supplier has met its class size maximum and therefore 
could not accept additional beneficiaries. We are inviting public 
comments on our proposal and the alternatives we considered.
ii. MDPP Services Period Clarifications
    At Sec.  410.79(b), we propose to remove the existing definition of 
``maintenance session bundle,'' and to establish new definitions for 
``core maintenance session interval,'' and ``ongoing maintenance 
session interval,'' which we believe will more directly reflect the 
structure of the set of MDPP services, as well as support the proposed 
policies in this proposed rule. Through these proposed definition 
changes, we are seeking to clarify the differences between the two 
types of intervals. We propose to define ``core maintenance session 
interval'' as one of the two consecutive 3-month time periods during 
months 7 through 12 of the MDPP services period, during which an MDPP 
supplier offers an MDPP beneficiary at least one core maintenance 
session per month. We propose to define ``ongoing maintenance session 
interval'' as one of the up to eight consecutive 3-month time periods 
during the ongoing services period described in paragraph Sec.  
410.79(c)(2)(ii), during which an MDPP supplier offers at least one 
ongoing maintenance session to an MDPP beneficiary per month.
    We are making the proposal to use the term ``interval'' instead of 
``bundle'' because the proposed performance payments are tied to 
attendance and weight loss performance goals and, in aggregate, 
constitute the payment to MDPP suppliers for furnishing MDPP services 
during the MDPP services period, but they do not provide specific 
payments for a particular subset of sessions. Therefore, we believe 
that the term ``bundle'' is not appropriate for describing performance 
payments for these time intervals. The proposed new terms allow us to 
more appropriately describe the relationship of the performance 
payments to the specific time periods where performance is measured. 
Furthermore, we propose to define ``make-up session'' as a core 
session, a core maintenance session, or an ongoing maintenance session 
furnished to an MDPP beneficiary when the MDPP beneficiary misses a 
regularly scheduled core session, core maintenance session, or ongoing 
maintenance session (proposed at Sec.  410.79(b)). We propose to define 
``virtual make-up session'' as a make-up session that is not furnished 
in person and that is furnished in a manner consistent with the DPRP 
standards for virtual sessions (proposed Sec.  410.79(b)). Policies 
describing the parameters of make-up sessions and virtual make-up 
sessions are described further in section III.K.2.c.iv.(3).
    We propose an additional term that helps describe key aspects of 
the MDPP expanded model: ``Performance goal.'' This term refers to an 
attendance or weight loss goal that an MDPP beneficiary must achieve 
during the MDPP services period for an MDPP supplier to be paid a 
performance payment (proposed Sec.  414.84(a)). Because we propose this 
term that more broadly speaks to the performance goals of this expanded 
model, we propose to remove the definition of ``maintenance of weight 
loss.'' We also propose to move the definition of ``coach'' from Sec.  
410.79(b) to Sec.  424.205(a) (we propose in section III.K.2.e to 
redesignate Sec.  424.59, Requirements for Medicare Diabetes Prevention 
Program suppliers to Sec.  424.205). We propose to revise the 
definition of ``MDPP supplier'' to mean an entity that is enrolled in 
Medicare to furnish MDPP services as provided in Sec.  424.59 (proposed 
to be redesignated as Sec.  424.205).
    We invite public comments on these proposals.
c. Proposed Changes Related to Beneficiary Eligibility
    In the CY 2017 PFS final rule, we established the eligibility 
criteria for Medicare beneficiaries to have coverage of the set of MDPP 
services, codified at Sec. Sec.  410.79(c)(1) and 410.79(d), 
respectively. We previously finalized that an individual who met these 
criteria would be referred as an ``MDPP eligible beneficiary.'' 
However, in this proposed rule, we propose to remove this term, and 
instead, add the definition of ``MDPP beneficiary'' to mean a Medicare 
beneficiary who meets the criteria specified in paragraph Sec.  
410.79(c)(1)(i), who has initiated the MDPP services period by 
attending the first core session, and for whom the MDPP services period 
has not ended as specified in paragraph Sec.  410.79(c)(3) (proposed 
Sec.  410.79(b)). We believe that this revised definition will provide 
more clarity about when a beneficiary qualifies to receive MDPP 
services. We propose to remove the definition of ``MDPP eligible 
beneficiary'' to avoid confusion between the two definitions, and we 
propose conforming changes to Sec.  410.79 to remove the term ``MDPP 
eligible beneficiary'' and use the term ``MDPP beneficiary'' in its 
place, where appropriate.
    In the CY 2017 PFS final rule (81 FR 80470), we specified at Sec.  
410.79(c)(1) that Medicare beneficiaries are eligible for MDPP services 
if they meet all of the following criteria:
     Are enrolled in Medicare Part B.
     Have, as of the date of attendance at the first core 
session, a body mass

[[Page 34133]]

index (BMI) of at least 25 if not self-identified as Asian or a BMI of 
at least 23 if self-identified as Asian (please see our discussion of 
BMI parameters in the CY 2017 PFS final rule at 81 FR 80468).
     Have, within the 12 months prior to attending the first 
core session, a hemoglobin A1c test with a value between 5.7 and 6.4 
percent, a fasting plasma glucose of 110-125 mg/dL, or a 2-hour plasma 
glucose of 140-199 mg/dL (oral glucose tolerance test).
     Have no previous diagnosis of type 1 or type 2 diabetes 
(other than gestational diabetes).
     Do not have end-stage renal disease (ESRD).
    In this proposed rule, we propose changes to these eligibility 
criteria at Sec.  410.79(c)(1) to clarify the eligibility limitations 
related to previous type 1 or type 2 diabetes diagnosis (described 
further in section III.K.2.c.ii. of this proposed rule), move and edit 
the regulation text that specifies that each beneficiary can only 
receive the set of MDPP services once in their lifetime (described 
further in section III.K.2.c.iii. of this proposed rule), and make 
editorial changes so that the provisions are specific to an individual 
beneficiary. We also are taking this opportunity to clarify some of 
these eligibility criteria.
i. Clarifying MDPP Eligibility Criteria Related to Gestational Diabetes 
and End-Stage Renal Disease (ESRD)
    We note that we are not excluding beneficiaries with a prior 
history of gestational diabetes from eligibility for MDPP services, 
while beneficiaries with a prior history of a diagnosis of type 1 or 
type 2 diabetes are ineligible. The eligibility criteria are intended 
to identify a beneficiary at high risk for the development of type 2 
diabetes in an individual that has not been diagnosed with type 1 or 
type 2 diabetes. Gestational diabetes is a condition that develops 
during pregnancy and typically resolves after delivery, although an 
individual with a history of gestational diabetes is at increased risk 
of subsequent type 2 diabetes development and may benefit from the set 
of MDPP services. Because of the clinical differences between 
gestational diabetes and type 1 or type 2 diabetes, we determined that 
it was appropriate not to exclude a beneficiary with a prior history of 
gestational diabetes from eligibility for MDPP services.
    We also are clarifying that a beneficiary who is diagnosed with 
ESRD after having begun receiving MDPP services would lose eligibility. 
We do not believe MDPP services are appropriate for beneficiaries with 
ESRD because beneficiaries with ESRD require dialysis, and the 
nutrition requirements for individuals on dialysis are very specific 
and therefore MDPP curriculum will not apply.\8\ We believe that a 
beneficiary receiving MDPP services who develops ESRD will be best 
suited by ceasing to receive MDPP services and receiving attention by 
other health care professionals specifically suited to address his or 
her condition. Additionally, individuals with ESRD were not included in 
the DPP model test. Suppliers can use the online HIPAA Eligibility 
Transaction System (HETS) to verify if a beneficiary has ESRD by 
checking his or her eligibility status as a Part B or ESRD Medicare 
beneficiary. Suppliers can find more information on this system at 
https://www.cms.gov/hetshelp/. We recognize that some Medicare 
beneficiaries may have other serious conditions, such as heart disease 
or cancer, and therefore may also have specific dietary requirements. 
We recommend that beneficiaries with complex dietary needs consult 
their health care provider as to whether they should participate in 
MDPP.
---------------------------------------------------------------------------

    \8\ WE Mitch, ``Beneficial responses to modified diets in 
treating patients with chronic kidney disease,'' Kidney 
International Supplements April, 94 (2005): S133-5, https://www.ncbi.nlm.nih.gov/pubmed/15752230. J Rysz et al., ``The Effect of 
Diet on the Survival of Patients with Chronic Kidney Disease,'' 
Nutrients 9, no. 5 (2017): E495, https://www.ncbi.nlm.nih.gov/pubmed/28505087. ME Chen et al., ``Correlations of dietary energy 
and protein intakes with renal function impairment in chronic kidney 
disease patients with or without diabetes,'' The Kaohsiung Journal 
of Medical Sciences 33, no. 5 (2017):252-259, https://www.ncbi.nlm.nih.gov/pubmed/28433072.
---------------------------------------------------------------------------

    In summary, a beneficiary must maintain Medicare Part B coverage 
and not have ESRD throughout the duration of the MDPP services period 
to remain eligible to receive coverage for MDPP services. In 
conjunction with our proposal in this proposed rule related to diabetes 
diagnosis (explained further in section III.K.2.c.ii. of this proposed 
rule), a beneficiary must meet the eligibility requirements related to 
prediabetes and diabetes (including BMI, blood test results, and no 
diagnosis of diabetes other than gestational diabetes) as of the date 
of attendance at the first core session.
    We invite public comments on these proposals.
ii. Diabetes Diagnosis During the MDPP Services Period
    In the CY 2017 PFS final rule, we finalized that to be eligible for 
coverage for the set of MDPP services, a Medicare beneficiary must have 
prediabetes, as shown through a qualifying BMI and blood test results, 
and must have no previous diagnosis of type 1 or type 2 diabetes (other 
than gestational diabetes). We received public comments in response to 
the July 15, 2016 MDPP proposed rule that asked whether a beneficiary 
would remain eligible for the set of MDPP services if the beneficiary 
developed diabetes during the MDPP services period. In the CY 2017 PFS 
final rule, we deferred action in response to these public comments and 
are now addressing them in this proposed rule.
    We propose that the diabetes diagnosis exclusion applies only at 
the time of the first core session (that is, if a beneficiary develops 
diabetes during the MDPP services period, it would not affect the 
beneficiary's eligibility to continue receiving MDPP services). 
Specifically, we propose to revise the eligibility requirements for 
MDPP services to state that a beneficiary has, as of the date of 
attendance at the first core session, no previous diagnosis of 
diabetes, other than gestational diabetes (proposed Sec.  
410.79(c)(1)(i)(E)). This proposed policy is based in part on the fact 
that the DPP model test, which demonstrated cost savings, did not 
exclude from the model individuals who developed diabetes. 
Additionally, whereas suppliers can check HETS to verify a 
beneficiary's ESRD status fairly easily, we believe requiring a 
supplier to reassess other beneficiary eligibility criteria such as 
diabetes status and blood test results, and subsequently removing those 
who no longer meet the eligibility criteria is impractical and unduly 
burdensome.
    Alternatively, we considered deeming any beneficiary who develops 
diabetes during the MDPP services period to be ineligible to continue 
to receive coverage for MDPP services because these services are 
intended to be preventive. If a beneficiary progresses to type 2 
diabetes, other treatment options, such as Diabetes Self-Management 
Training (DSMT), may be more appropriate than services that seek to 
prevent a condition the beneficiary already has. However, it is 
important to note that the receipt of MDPP services does not preclude a 
beneficiary from accessing other treatments for diabetes during the 
time period that the beneficiary is covered for MDPP services. An MDPP 
beneficiary who ultimately also receives DSMT at some time during the 
MDPP services period because he or she develops diabetes after 
beginning the set of MDPP services will receive different types of 
information and training. For example, a beneficiary receiving DSMT 
furnished by certified diabetes educators acquires knowledge for self-
care and life style

[[Page 34134]]

changes including blood sugar monitoring, insulin usage, medication 
management, and crisis management. In contrast, MDPP services are 
furnished by trained coaches who teach patients with prediabetes how to 
lower their risk of progressing to type 2 diabetes with methods that do 
not include medication or other interventions for patients diagnosed 
with diabetes. Despite some common elements, the interventions for the 
MDPP expanded model and the DSMT benefit target different populations 
and furnish different services.
    We are seeking public comments on our proposal and whether 
individuals who develop diabetes during the MDPP services period should 
continue to be eligible for coverage of MDPP services for the full 
duration of the MDPP services period.
iii. Once-Per-Lifetime Set of Services
    In the CY 2017 PFS final rule, we specified that coverage for the 
set of core MDPP services is available only once per lifetime for each 
MDPP beneficiary (codified at Sec.  410.79(d)(1)). In this rule, we 
propose to delete Sec.  410.79(d)(1) and move this provision to 
proposed Sec.  410.79(c)(1)(i)(B) to place it with other MDPP 
beneficiary eligibility criteria. We also propose to edit this 
provision to specify that coverage for the full set of MDPP services, 
inclusive of ongoing maintenance sessions as opposed to only core MDPP 
services, is available only once per lifetime per MDPP beneficiary. Now 
that we propose to limit the ongoing services period to 2 years, we 
believe that this proposed revision is necessary to clarify that 
coverage for the entire set of MDPP services is subject to this 
limitation--otherwise, the once-per-lifetime limitation has no 
practical effect because an MDPP beneficiary could continue to attend 
ongoing maintenance sessions long after the MDPP beneficiary has 
completed the core services period. In addition, for the reasons stated 
previously, we do not have evidence to support coverage of MDPP 
services for more than 3 years. We also are clarifying that the once-
per-lifetime coverage limit applies to a beneficiary who receives a set 
of MDPP services under the MDPP model expansion. This limitation would 
not apply to beneficiaries who participated in a DPP as part of the DPP 
model test unless they receive the set of MDPP services under the MDPP 
expanded model. We invite public comments on our proposal.
    In the CY 2017 PFS final rule, we stated that beneficiaries could 
self-report to MDPP suppliers that they had not previously received 
MDPP services. We recognize that self-reported information may not be 
the most reliable source for MDPP suppliers to use before submitting 
claims for MDPP beneficiaries, and there is a risk that information 
that is inaccurately self-reported could result in the denial of 
payments for MDPP services. We are considering ways MDPP suppliers 
would be able to reliably verify if a beneficiary has received coverage 
of MDPP services from another supplier, such as through a standardized 
tracker described in section III.K.2.d.v of this proposed rule, and we 
are seeking public comments on any additional ways MDPP suppliers could 
access this information. We intend to provide administrative guidance 
on any resources to assist MDPP suppliers in identifying beneficiaries' 
previous receipt of covered MDPP sessions, as appropriate.
iv. Eligibility Throughout the MDPP Services Period
    In the CY 2017 PFS final rule, we specified the minimum number and 
frequency of sessions that MDPP suppliers must offer to MDPP 
beneficiaries (codified at Sec. Sec.  410.79(c)(2)(i) and 
410.79(c)(2)(ii)). We finalized that MDPP suppliers must furnish 
ongoing maintenance session intervals to MDPP eligible beneficiaries 
who have maintained 5 percent weight loss from their baseline weight as 
measured during the previous maintenance session interval. As defined 
at Sec.  410.79(b), ``baseline weight'' is the MDPP beneficiary's body 
weight recorded during that beneficiary's first core session.
    However, because in this proposed rule we propose to tie payment 
for MDPP services to the beneficiary's achievement of performance 
goals, we propose additional changes to tie the beneficiary's 
eligibility for continued coverage of ongoing maintenance session 
intervals to his or her achievement of performance goals, namely 
requiring a minimum level of attendance. Because our proposed policies 
for payment and coverage differ somewhat, we are addressing them 
separately below.
(1) MDPP Services Period
    As discussed in section III.K.2.b. of this proposed rule, we 
propose to revise Sec.  410.79(c)(2), which describes MDPP services 
periods, to specify that the MDPP services period means the time 
period, beginning on the date an MDPP beneficiary attends his or her 
first core session, over which the set of MDPP services is furnished to 
the MDPP beneficiary, to include the core services period described in 
paragraph Sec.  410.79(c)(2)(i) and, subject to paragraph Sec.  
410.79(c)(3), one or more ongoing maintenance session intervals during 
the ongoing services period described in paragraph Sec.  
410.79(c)(2)(ii).
    We propose to revise Sec.  410.79(c)(2) to specify that there are 
two service periods in which Medicare will cover MDPP services for a 
beneficiary: The core services period; and the ongoing services period. 
Together these would make up the MDPP services period. The core 
services period is the first 12 months of the MDPP services period, and 
consists of core sessions and core maintenance sessions. There are 16 
core sessions that are offered at least a week apart in months 1 
through 6, beginning on the date of attendance at the first core 
session. Core maintenance sessions are offered at least once per month 
in months 7 through 12 of the core services period. We propose to move 
the requirements for MDPP suppliers to offer these services to Sec.  
424.205(d)(9) because they are more appropriately included among other 
requirements for MDPP suppliers. Consistent with our policies finalized 
in the CY 2017 PFS final rule, we do not condition coverage for the 
core services period upon weight loss or attendance. Medicare will pay 
for the set of core MDPP services, regardless of how many sessions the 
beneficiary attends and regardless of his or her weight loss. However, 
we note that an MDPP beneficiary must attend at least one core session 
to initiate the MDPP services period.
    These proposals would align with CDC's 1-year curriculum, divided 
into two 6-month periods. We recognize that framing the MDPP services 
period in terms of months may cause some confusion because the CDC 
terminology uses weeks. However, we believe that framing the MDPP 
services period in months would better align with our proposed payment 
structure. We did not make eligibility for the core maintenance 
sessions contingent upon an attendance-based performance goal; because 
the CDC DPP curriculum covers 12 months of sessions, we believe that 
coverage for the 12 months of the core services period should be 
available to all MDPP beneficiaries, regardless of attendance. The 12-
month CDC DPP curriculum is based on evidence from the original DPP 
randomized clinical trial, and the curriculum used in that trial, which 
achieved a 58 percent reduction in type 2 diabetes risk (with

[[Page 34135]]

71 percent reduction in those over age 60).\9\
---------------------------------------------------------------------------

    \9\ WC Knowler et al., ``Reduction in the incidence of type 2 
diabetes with lifestyle intervention or metformin,'' New England 
Journal of Medicine 346, 6 (2002): 393-403, https://www.ncbi.nlm.nih.gov/pubmed/11832527. The Diabetes Prevention 
Program (DPP) Research Group, ``The Diabetes Prevention Program,'' 
Diabetes Care 25, 12 (2002): 2165-2171, http://care.diabetesjournals.org/content/25/12/2165.long.
---------------------------------------------------------------------------

    As discussed in section III.K.2.e.iv.4 of this proposed rule, MDPP 
suppliers must offer a minimum of 16 core sessions, no more frequently 
than once each week, in months 1 through 6, and at least 1 core 
maintenance session each month in months 7 through 12 of the core 
services period. However, some MDPP suppliers may choose to furnish 
more than the minimum number of sessions, and these proposed coverage 
parameters would allow beneficiaries to receive more than the minimum 
number of sessions if the MDPP supplier elects to furnish them.
    We invite public comments on our proposals.
(2) Ongoing Services Period
    As discussed in section III.K.2.b.i. of this proposed rule, we 
propose to revise Sec.  410.79(c)(2)(ii) to clarify that the ongoing 
services period consists of up to eight 3-month ongoing maintenance 
session intervals offered during months 13 through 36 of the MDPP 
services period. Medicare's coverage of the ongoing services period is 
subject to limitations proposed subsequently in this section.
(a) Eligibility for the Ongoing Services Period
    Our existing regulations at Sec.  410.79(b) affirm that Medicare 
will cover MDPP services in the first 12 months of the MDPP services 
period, without regards to a beneficiary's achievement of performance 
goals, whereas Sec.  410.79(d)(2) specifies that, for coverage of 
ongoing maintenance sessions, the beneficiary must have achieved weight 
loss of 5 percent from his or her baseline weight. In this proposed 
rule, we propose to delete Sec.  410.79(d)(2) and move this provision 
to Sec.  410.79(c)(1) with other MDPP beneficiary eligibility criteria. 
We also propose to add paragraph (c)(1)(ii) to Sec.  410.79 to specify 
that beneficiaries must also attend at least one in-person core 
maintenance session in months 10 through 12 of the MDPP services period 
and achieve or maintain required minimum weight loss at a minimum of 
one in-person session during the final core maintenance session 
interval to be eligible for coverage of the first ongoing maintenance 
session interval. We propose to establish that a beneficiary must 
attend at least one in-person core maintenance session in months 10 
through 12 of the MDPP services period because, as stated in the CY 
2017 PFS final rule, an MDPP beneficiary must achieve at least 5 
percent weight loss from baseline at least once during the previous 
maintenance session interval to have coverage of an ongoing maintenance 
session.
    Because we propose that weight measurements used for determining 
beneficiary eligibility for coverage or supplier payment must be taken 
in person by an MDPP supplier at an MDPP core maintenance or ongoing 
maintenance session (proposed Sec.  410.79(c)(1)(iv)), a beneficiary 
must attend at least one in-person core maintenance session during 
months 10 through 12 to have his or her weight measured to determine 
whether he or she qualifies for coverage of the first ongoing 
maintenance session interval. We believe that in-person measurements 
are the most feasible method for weight ascertainment at this time for 
services where the beneficiary would have regular in-person sessions 
with the MDPP supplier. We believe that self-reported weight loss is 
not reliable for the purposes of determining continued coverage of MDPP 
services for a beneficiary. We invite public comments on these 
proposals.
(b) Eligibility for Ongoing Maintenance Session Intervals 2 Through 8
    In addition to achieving weight loss performance goals, as 
previously finalized in the CY 2017 PFS final rule, we propose that 
beneficiaries must also meet an attendance-related performance goal in 
order for Medicare to cover ongoing maintenance session intervals. We 
propose to add paragraph (c)(1)(iii) to Sec.  410.79 to specify that 
for coverage of ongoing maintenance session intervals 2 through 8, an 
MDPP beneficiary must attend at least 3 ongoing maintenance sessions 
during the previous ongoing maintenance session interval, in addition 
to maintaining 5 percent weight loss from baseline at least once during 
the previous ongoing maintenance session interval.
    We believe that adding an attendance-related performance goal 
during the ongoing services period is important because it will provide 
an incentive to keep MDPP beneficiaries engaged after the core services 
period. MDPP beneficiaries who meet the specified attendance and weight 
loss goals will have Medicare coverage of ongoing maintenance sessions, 
which are a part of the set of MDPP services, but not a part of the CDC 
DPP curriculum. We believe that the subsequent attendance goal 
requirements during ongoing maintenance session intervals will motivate 
beneficiaries to take on more individual responsibility for their 
behavior changes over time because coverage of these services is 
dependent upon their attendance and achievement and maintenance of 
weight loss.
    In addition, this proposed policy closely aligns with our proposed 
policy for supplier payment for ongoing maintenance session intervals. 
As described further in section III.K.2.d.iii.5. of this proposed rule, 
we propose that a supplier would be paid for furnishing an ongoing 
maintenance session interval only if the MDPP beneficiary both attended 
three sessions, as well as maintained a 5 percent weight loss from 
baseline measured at least once in that interval. However, in light of 
our proposal to pay MDPP suppliers upon the beneficiary's attendance of 
three ongoing maintenance sessions (in addition to maintaining at least 
a 5 percent weight loss), we believe that we similarly need to have 
attendance goals for beneficiaries to continue to have coverage of 
ongoing maintenance sessions. Without requiring attendance, an MDPP 
beneficiary who maintained 5 percent weight loss but only attended two 
ongoing maintenance sessions in an ongoing maintenance session interval 
would be eligible for coverage of ongoing maintenance sessions, but the 
supplier would not receive payment for furnishing that ongoing 
maintenance session interval. In effect, the MDPP supplier could be 
required to furnish up to 24 months of MDPP services without payment. 
For this reason, we propose to require beneficiaries to attend all 
three sessions within an ongoing maintenance session interval to have 
coverage of the subsequent interval.
    We considered an alternative where a beneficiary would have 
continued coverage of ongoing maintenance session intervals if he or 
she attends at least one in-person ongoing maintenance session during 
an ongoing maintenance session interval, as long as that beneficiary 
maintained at least 5 percent weight loss from baseline at least once 
during that interval. However, we do not believe that this alternative 
would align with our proposed supplier payment requirements for ongoing 
maintenance sessions discussed in section III.K.2.d.iii.5 of this 
proposed rule, which would require suppliers to furnish, and the 
beneficiary to attend, all three sessions of the ongoing maintenance 
session interval for the supplier to receive payment for that

[[Page 34136]]

interval. We are inviting public comments on our proposal and the 
alternative we considered.
(c) Limitations on the Set of MDPP Services
    In this proposed rule, we propose to add Sec.  410.79(c)(3) to 
specify that coverage of the MDPP services period would end upon 
completion of the core services period for a beneficiary that is not 
eligible for the first ongoing maintenance session interval as proposed 
under Sec.  410.79(c)(1)(ii); that is, if the beneficiary does not 
attend at least one in-person core maintenance session during the 
second core maintenance session interval and/or does not achieve the 
required minimum weight loss during this interval. For any beneficiary 
who is eligible for at least one ongoing maintenance sessions interval, 
but who does not meet the requirements for coverage of a subsequent 
interval based on failure to meet attendance or weight loss goals 
proposed at Sec.  410.79(c)(1)(iii), the beneficiary's coverage of the 
set of MDPP services would end upon completion of his or her current 
ongoing maintenance session interval. It is important to note that 
proposed performance payments, discussed in section III.K.2.d.iii.5. of 
this proposed rule, would be tied to the achievement of the same 
performance goals a beneficiary must meet to have coverage for the 
ongoing maintenance session intervals. Therefore, if an MDPP 
beneficiary does not meet weight loss or attendance goals to access the 
subsequent ongoing maintenance session interval, the supplier will not 
receive payment for that ongoing maintenance session interval or any 
subsequent performance payments related to that beneficiary.
    We are inviting public comments on these proposed policies.
(d) Beneficiaries Who Change MDPP Suppliers During the MDPP Services 
Period
    In the CY 2017 PFS final rule, we indicated that a beneficiary may 
change MDPP suppliers at any time. However, we deferred to future 
rulemaking specific policies to address coverage of and payment for 
MDPP services when beneficiaries change MDPP suppliers. In this 
proposed rule, we are clarifying that a beneficiary may change MDPP 
suppliers at any time during his or her MDPP services period, subject 
to beneficiary eligibility requirements. Based on evidence from the CDC 
DPRP, we believe that the instances of beneficiaries changing MDPP 
suppliers will be relatively infrequent. However, we intend to monitor 
how often beneficiaries change MDPP suppliers, as well as MDPP 
suppliers' billing patterns to detect any aberrant billing patterns 
suggestive of fraudulent or discriminatory practices. Payment policies 
related to when a beneficiary changes MDPP suppliers are discussed in 
section III.K.2.d.v.
(3) Make-Up Sessions
(a) General Requirements
    In this proposed rule, we propose at Sec.  410.79(d)(1) that 
suppliers may offer make-up sessions to an MDPP beneficiary who missed 
a regularly scheduled session. As defined at proposed Sec.  410.79(b), 
``make-up session'' means a core session, core maintenance session, or 
ongoing maintenance session furnished to an MDPP beneficiary when the 
MDPP beneficiary misses a regularly scheduled core session, core 
maintenance session, or ongoing maintenance session. Make-up sessions 
may be delivered in person or virtually, although virtual make-up 
sessions are subject to additional requirements proposed in this rule 
(and the term ``virtual make-up session'' is separately defined). We 
propose the availability of make-up sessions to be consistent with 
CDC's DPRP standards and to ensure that MDPP beneficiaries have the 
opportunity to receive the full DPRP curriculum, even if they are 
unable to attend a particular regularly scheduled MDPP session.
    We propose that the curriculum delivered during a make-up session 
must address the same CDC-approved DPP curriculum topic as the session 
that the beneficiary missed (proposed Sec.  410.79(d)(1)(i)). To be 
consistent with CDC's proposed 2018 DPRP standards, we propose that the 
MDPP supplier may furnish to the beneficiary a maximum of one make-up 
session on the same day as a regularly scheduled session (proposed 
Sec.  410.79(d)(1)(ii)) and the MDPP supplier may furnish to the 
beneficiary a maximum of one make-up session per week (proposed Sec.  
410.79(d)(1)(iii)).
(b) Virtual Make-Up Sessions
    There is a growing area of research examining the effectiveness of 
DPP delivered virtually. CDC began recognizing Virtual DPP 
organizations in 2015 and emerging evidence suggests that virtual 
delivery of DPP services can show similarly successful participant 
weight loss and health benefits to DPP delivered in other settings, 
including among Medicare-age participants.\10\ Since CDC's DPRP 
standards permit virtual make-up sessions, and we recognize that MDPP 
beneficiaries may encounter situations where they are unable to attend 
in-person make-up sessions, we propose to allow MDPP suppliers to offer 
a limited number of virtual make-up sessions (proposed Sec.  
410.79(d)(2)). As proposed in Sec.  410.79(b), ``virtual make-up 
session'' means a make-up session that is not furnished in person and 
that is furnished in a manner consistent with the DPRP standards for 
virtual sessions. All requirements proposed in Sec.  410.79(d)(1) apply 
to virtual make-up sessions. In addition, we propose that virtual make-
up sessions are subject to additional requirements.
---------------------------------------------------------------------------

    \10\ See, for example: F Chen et al., ``Clinical and Economic 
Impact of a Digital, Remotely-Delivered Intensive Behavioral 
Counseling Program on Medicare Beneficiaries at Risk for Diabetes 
and Cardiovascular Disease.'' PLoS ONE 11, 10 (2016), https://doi.org/10.1371/journal.pone.0163627. W Su et al., ``Return on 
Investment for Digital Behavioral Counseling in Patients With 
Prediabetes and Cardiovascular Disease.'' Preventing Chronic Disease 
13 (2016), http://dx.doi.org/10.5888/pcd13.150357. J Ma et al., 
``Translating the Diabetes Prevention Program lifestyle intervention 
for weight loss into primary care: A randomized trial.'' JAMA Intern 
Med. 173, 2 (2013): 113-21, https://www.ncbi.nlm.nih.gov/pubmed/23229846. CS Sepah et al., ``Translating the diabetes prevention 
program into an online social network: Validation against CDC 
standards.'' The Diabetes Educator 40, 4 (2014): 435-443, https://www.ncbi.nlm.nih.gov/pubmed/24723130.
---------------------------------------------------------------------------

    First, as indicated by the applicable definition, virtual make-up 
sessions must be furnished in a manner consistent with CDC's DPRP 
standards for virtual sessions (proposed Sec.  410.79(d)(2)(i)). To 
align with CDC's DPRP standards, virtual make-up sessions refer to any 
modality, or method of furnishing MDPP services, that is not in person. 
This includes, but is not limited to:
    (1) Furnishing services online where the behavior change program is 
furnished 100 percent online, with participants accessing course 
resources and a coach via a computer, laptop, tablet, smart phone, or 
other device with Internet access. This modality requires that the MDPP 
beneficiary have an Internet connection to participate in all aspects 
of the virtual make-up session;
    (2) Furnishing services online with other means of support by a 
coach (for example, telecommunications, video conferencing). This 
modality requires that the MDPP beneficiary have an Internet connection 
for some aspects of the virtual make-up session, but not all; and
    (3) Distance learning, where a coach is present in one location and 
participants are calling, video-conferencing, or otherwise using 
telecommunications technology to access the coach from another 
location.

[[Page 34137]]

This modality does not require that the MDPP beneficiary have an 
Internet connection for any of the aspects of the virtual make-up 
session.
    By defining MDPP virtual make-up sessions as being consistent with 
CDC's DPRP standards for virtual sessions, we allow our definition to 
change over time as such standards are updated.
    Second, a supplier may only offer virtual make-up sessions based on 
an individual MDPP beneficiary's request (proposed Sec.  
410.79(d)(2)(ii)). A supplier may not cancel a regularly scheduled MDPP 
session and offer the session to all MDPP beneficiaries virtually. 
However, the supplier may cancel a regularly scheduled MDPP session and 
offer the session to all MDPP beneficiaries in person. We believe that 
this is necessary to ensure that the MDPP expanded model remains a 
model predominantly delivered in person. Individual beneficiary needs 
may be accommodated, but suppliers should not use virtual make-up 
sessions as a means to move toward virtually-delivered MDPP sessions 
more generally.
    Third, to further ensure that MDPP services are largely provided 
in-person, we propose at Sec.  410.79(d)(2)(iii) that a supplier may 
offer: (a) No more than 4 virtual make-up sessions within the core 
services period to an MDPP beneficiary, of which no more than 2 virtual 
make-up sessions may be core maintenance sessions; and (b) no more than 
3 virtual make-up sessions that are ongoing maintenance sessions to an 
MDPP beneficiary during any rolling 12-month time period. At Sec.  
410.79(d)(3), we propose that these same limitations on the number of 
virtual make-up sessions also apply for the purposes of determining 
whether a beneficiary has attended a sufficient number of MDPP sessions 
in order to be eligible for ongoing maintenance sessions (proposed 
Sec.  410.79(c)(1)) and for assessing whether a beneficiary has met the 
attendance-related performance goals used to determine whether an MDPP 
supplier is eligible to receive a performance payment (proposed Sec.  
414.84(b)). The limitation on the number of make-up sessions is not 
applicable to in-person make-up sessions.
    We assume not all suppliers will have the ability to offer virtual 
make-up sessions, and we are not requiring suppliers to offer virtual 
make-up sessions. Conversely, an MDPP supplier could offer only virtual 
make-up sessions and no in-person make up sessions if the supplier 
chooses as long as the proposed limits for these sessions are not 
exceeded. We believe that allowing fewer than these proposed number of 
virtual make-up sessions will make it difficult for suppliers to meet 
DPRP standards, and therefore remain enrolled as an eligible MDPP 
supplier. However, the DPP model test only offered in-person sessions 
(no virtual sessions) and therefore the MDPP expanded model is intended 
to predominantly offer services in person. Allowing more than the 
proposed number of virtual make-up sessions would not support an 
evaluation of an in-person MDPP curriculum. We seek comment on our 
proposals and specifically on the proposed limitations on virtual make-
up sessions.
    We considered the following alternatives to this proposal. We 
considered not allowing any make-up sessions to be furnished virtually. 
However, we believe that this would place undue restrictions on MDPP 
suppliers who are willing and would like to offer virtual make-up 
sessions to MDPP beneficiaries, particularly if these are offered to 
other DPP participants who are not Medicare beneficiaries.
    We also considered allowing an MDPP supplier to furnish between one 
and three sessions within the core services period and either one or 
two ongoing maintenance sessions each year as virtual make-up sessions 
per MDPP beneficiary. However, we believe that allowing fewer sessions 
to be furnished as virtual make-up sessions than proposed would not 
provide sufficient flexibility for MDPP suppliers to meet CDC's DPRP 
standards, which require organizations to meet attendance requirements 
for their panel of participants. Organizations may struggle to meet 
DPRP attendance requirements without the flexibility to provide virtual 
make-up sessions.
    We also considered permitting suppliers to offer any number of 
virtual make-up sessions, and for attendance at any number of virtual 
make-up sessions to count toward attendance goals. However, as stated 
previously, since the DPP model test only offered DPP services in 
person, the MDPP expanded model is intended to predominantly offer MDPP 
sessions in person as well. Therefore we believe that it is important 
to limit the number of virtual make-up sessions so that MDPP 
beneficiaries are predominantly receiving MDPP sessions in person.
    We propose that the payment policies detailed in section III.K.2.d. 
of this proposed rule apply to virtual make-up sessions. Specifically, 
as indicated in sections III.K.2.c.1.iv. and III.K.2.d.iii.10.b. of 
this proposed rule, weight measurements used for the purposes of 
determining the achievement or maintenance of weight loss for weight 
loss performance payments, or for determining eligibility for coverage 
of ongoing maintenance sessions, would be required to be taken at an 
in-person session, not during a virtual make-up session. We are seeking 
public comments on these proposals and the alternatives considered.
d. Payment for MDPP Services
i. MDPP Payment Discussion in Prior Rulemaking
    In the July 15, 2016 MDPP proposed rule (81 FR 46415 through 
46416), we discussed a potential MDPP payment structure and the 
associated payment amounts and sought information from the public to 
inform future MDPP proposals. We received a number of public comments 
on these topics and have considered this information in the development 
of our proposals for the MDPP payment structure, payment amounts, and 
related issues discussed in this section.
ii. Conceptual Framework for Payment for MDPP Services
    In this proposed rule, we are proposing to pay for the set of MDPP 
services through a performance-based payment methodology that makes 
periodic performance payments to MDPP suppliers during the MDPP 
services period. The aggregate of all performance payments constitutes 
the total performance-based payment amount for the set of MDPP 
services. As discussed in detail throughout this section, we are 
proposing a maximum total performance payment amount per beneficiary 
for the set of MDPP services of $810. Performance payments would be 
made to MDPP suppliers periodically during the course of a 
beneficiary's MDPP services period based upon a number of factors, 
including the beneficiary's completion of a specified number of MDPP 
sessions and the achievement of the required minimum weight loss that 
is associated with a reduced incidence of type 2 diabetes, rather than 
individual payments being made upon the furnishing of any service as is 
typical of payment in the traditional Medicare program.
    The aggregate amount of the performance payments proposed in this 
section would equal the total performance-based payment amount for the 
set of MDPP services during the MDPP services period, including core 
sessions, core maintenance sessions, and ongoing maintenance sessions. 
Even though these performance payments would be made periodically and 
in amounts that would not be

[[Page 34138]]

evenly distributed across the course of sessions furnished during the 
MDPP services period, payment for each session would be included in the 
total performance-based payment amount. For example, the proposed 
performance payment of $25 that would be paid to MDPP suppliers upon 
furnishing the first MDPP core session is relatively large on a per-
session basis compared to other attendance-based performance payments 
(as calculated on a per-session basis) ranging from approximately $3 to 
$20 made during the MDPP services period. However, the performance 
payment for the first core session would make payment for some of the 
MDPP supplier resources used in furnishing the first session, as well 
as make a partial prospective payment attributable to the MDPP supplier 
furnishing subsequent sessions.
    Once the required minimum weight loss is achieved and the 12-month 
core services period, described at proposed Sec.  410.79(c)(2)(i), 
concludes, we would make additional 3-month interval performance 
payments for ongoing maintenance sessions when the required minimum 
weight loss is maintained, whereas no additional interval performance 
payments would be made for ongoing maintenance sessions if the required 
minimum weight loss is not maintained. Finally, when a beneficiary 
achieves a significant percentage of weight loss, specifically a level 
of 5 percent (the required minimum weight loss) or 9 percent, we are 
proposing to make additional performance payments to the MDPP supplier. 
This proposal would provide performance payments in addition to the 
performance payments we may have already made for the previous MDPP 
sessions furnished to the beneficiary because those sessions resulted 
in the beneficiary achieving the weight loss performance goal.
    In total, based on our consultation with DPP providers holding 
commercial contracts, review of information related to DPP providers 
that currently hold or are in the process of obtaining CDC recognition, 
and comments received on the discussion of the payment structure and 
payment amounts for the set of MDPP services included in the July 15, 
2016 MDPP proposed rule (81 FR 46415 through 46416), we believe the 
proposed performance-based payment methodology would pay MDPP suppliers 
appropriately for the resources used in furnishing MDPP services 
throughout the MDPP services period. We note that we sought public 
comment on the payment structure and payment amounts for the set of 
MDPP services in the July 15, 2016 MDPP proposed rule, and we have used 
the information provided by commenters in developing the proposed 
performance-based payments included in this proposed rule.
    In this performance-based payment structure, it is important to 
note that a beneficiary's performance goals are not considered in the 
same way for beneficiary coverage and supplier payment during each 
specific period within the MDPP services period. During the core 
services period, a beneficiary would not be required to achieve 
attendance and/or weight loss performance goals for coverage of MDPP 
services, although a beneficiary would be required to achieve specified 
performance goals for an MDPP supplier to receive performance payments 
during this period. In contrast, achieving performance goals would be 
required for both coverage of MDPP services and performance payments 
during the ongoing services period.
    For example, a supplier is required to offer a minimum of 16 core 
sessions during the core services period according to Sec.  
410.79(c)(2)(i) but a beneficiary would not need to achieve an 
attendance or weight loss performance goal to be eligible for coverage 
of core maintenance sessions. However, MDPP supplier performance 
payments during the core services period would be based on the 
beneficiary's achievement of attendance and/or weight loss performance 
goals. During the ongoing services period, achievement of performance 
goals would affect both coverage and supplier payment. We note that a 
beneficiary would need to attend at least 1 core session to initiate 
the core services period, and attend at least 1 core maintenance 
session during the final core maintenance session interval to determine 
whether he or she has achieved the required minimum weight loss to have 
coverage of ongoing maintenance sessions. Because we are proposing in 
section III.K.2.d.iii.4 of this proposed rule to make a performance 
payment for core maintenance sessions only when the beneficiary attends 
at least 3 sessions within a 3-month interval, it is possible that an 
MDPP supplier would not be paid a separate performance payment for the 
second core maintenance session interval, but the beneficiary would 
still have coverage of the first ongoing maintenance session interval. 
This would occur if the beneficiary attended only 1 or 2 core 
maintenance sessions during the second core maintenance session 
interval and achieved or maintained the required minimum weight loss as 
measured at 1 of those 2 sessions.
iii. Performance Payments for MDPP Services
(1) Overview of Public Comments on Discussion of Payment for MDPP 
Services in Prior Rulemaking
    In addition to requests for clarification on certain details of the 
payment structure, such as the timing of beneficiary achievement of 
weight loss, which are addressed subsequently in this section, 
commenters on the discussion of payment for MDPP services in the July 
15, 2016 MDPP proposed rule (81 FR 46415 through 46416) expressed a 
variety of perspectives on the performance-based payment methodology 
presented in that proposed rule. In general, commenters urged us to set 
payment amounts that are sufficient to ensure MDPP supplier 
participation.
    Several commenters recommended that a sustainable payment rate 
structure should mirror performance-based payment models in the 
existing employer marketplace. A number of commenters requested that we 
not tie Medicare payment to weight loss or that we make separate weight 
loss and attendance payments; that we tie payment to aggregate, rather 
than individual, beneficiary weight loss; or that we tie payment to 
other factors besides or in addition to weight loss. Other commenters 
urged us to provide payment based on sessions furnished by MDPP 
suppliers rather than basing payment on an individual beneficiary's 
success, arguing that the payment structure presented would not be a 
sustainable model for MDPP suppliers that would expend resources 
furnishing sessions but would have little influence over beneficiaries' 
achievement of attendance and/or weight loss performance goals.
    Several commenters requested that we provide information on how the 
payment rates included in the discussion were determined. Some 
commenters expressed concern that the magnitude of MDPP payments was 
not consistent with payments for other similar services.
    A number of commenters urged that higher payments be made at the 
beginning of the MDPP services period to cover program start-up costs, 
that we decrease supplier financial risk by providing sufficient 
payment for beneficiaries who do not achieve weight loss performance 
goals, and that we implement risk-stratification of payments to reduce 
the risk of MDPP suppliers preferentially seeking to

[[Page 34139]]

furnish MDPP services to low-risk beneficiaries most likely to achieve 
weight loss and avoiding high-risk beneficiaries. In addition, several 
commenters requested that we update the payment rates annually for 
inflation and the increasing costs experienced by MDPP suppliers.
    As discussed in this section, the proposed MDPP payment structure 
is generally similar to that which was discussed in the July 15, 2016 
MDPP proposed rule (81 FR 46415 through 46416). However, the proposed 
performance payment amounts for core sessions, core maintenance session 
3-month intervals, and ongoing maintenance session 3-month intervals 
differ somewhat based on our consideration of the comments received in 
response to the July 15, 2016 MDPP proposed rule in the context of our 
policy goal to prioritize the achievement and maintenance of the 
required minimum weight loss that is associated with a reduction in the 
incidence of type 2 diabetes. In this proposed rule, we are proposing a 
payment structure for MDPP services that is performance-based in 
relation to two meaningful performance goals.
    First, the proposed payment structure values beneficiary weight 
loss most significantly. Weight loss is a key indicator of success 
among individuals enrolled in a DPP due to the strong association 
between weight loss and reduction in the risk of type 2 diabetes.\11\ 
Second, the proposed payment structure values beneficiary attendance 
because, in the DPP model test, session attendance was associated with 
greater weight loss. According to the second year independent 
evaluation of the DPP model test, those beneficiaries who attended at 
least 1 core session lost an average of 7.6 pounds, while beneficiaries 
who attended at least 4 core sessions lost an average of 9 pounds. Body 
mass index was reduced from 32.9 to 31.5 among Medicare beneficiaries 
who attended at least 4 core sessions.\12\
---------------------------------------------------------------------------

    \11\ RF Hamman et al., ``Effects of Weight Loss with Lifestyle 
Intervention on Risk of Diabetes,'' Diabetes Care 29, no. 9 (2006): 
2102-2107.
    \12\ Hinnant L, Razi S, Lewis R, Sun A, Alva M, Hoerger T, 
Jacobs S, Halpern M. Evaluation of the Health Care Innovation 
Awards: Community Resource Planning, Prevention, and Monitoring, 
Annual Report 2015. Awardee-Level Findings: YMCA of the USA; 2016. 
Table 17. Average/Frequencies Health Outcomes of all Participants 
through Q11, p. 36. RTI Project Number 0212790.010.001.004, Contract 
HHSM-500-2010-00021I. Sponsored by the Centers for Medicare & 
Medicaid Services.
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    In addition to weight loss, we considered linking other criteria 
such as hemoglobin A1c level to MDPP performance payments, or using 
aggregate instead of individual weight loss for MDPP payments. However, 
the MDPP expanded model was determined to meet the statutory 
requirements for expansion based on the DPP model test, which 
demonstrated that weight loss was associated with reductions in 
Medicare expenditures. Although elevated hemoglobin A1c levels were 
included as part of the beneficiary eligibility criteria in the DPP 
model test, hemoglobin A1c levels were not evaluated post-intervention 
in that model. Therefore, we are not proposing to use hemoglobin A1c 
blood values in the performance-based payment methodology for MDPP 
services. The use of hemoglobin A1c blood values in the MDPP payment 
methodology would have incorporated changes in values for which there 
was no evidence that could be used to support the determination that 
the MDPP expanded model meets the statutory requirements for expansion. 
We further note that the CDC does not require post-MDPP services 
hemoglobin A1c blood values to be determined as part of its 2015 DPRP 
standards, and we aim to align with the CDC DPRP standards as much as 
possible. While 5 percent weight loss is considered a performance 
measure for DPRP recognition, the CDC does not examine pre-post DPP 
differences in hemoglobin A1c as part of its DPRP standards.
    The proposed MDPP payment structure incentivizes MDPP suppliers to 
prioritize the achievement and maintenance of beneficiary weight loss 
by furnishing MDPP services, and provides a balance between 
performance-based payments related to weight loss and session 
attendance. We do not believe that it would be appropriate for payment 
to be tied to attendance alone because weight loss is more directly 
associated with a reduction in the incidence of type 2 diabetes than 
attendance at MDPP sessions. We further believe that the proposed 
performance-based payment structure based on individual beneficiary 
success, rather than average weight loss across all MDPP beneficiaries 
who receive MDPP services from an MDPP supplier, maximizes the focus of 
MDPP suppliers on the achievement of the performance goals for all 
beneficiaries, including those beneficiaries who experience challenges 
with achieving attendance and/or weight loss performance goals. 
Therefore, we do not believe it would be appropriate to use aggregate 
beneficiary information (that is, average weight loss) in the proposed 
performance-based payment methodology.
(2) Overall Approach To Setting Performance Payment Amounts
    We are proposing to establish the rules governing payment for MDPP 
services at new Sec.  414.84. We note that as discussed in section 
III.K.2.a. of this proposed rule, we are proposing that MDPP services 
may be furnished and payment made under the MDPP expanded model 
starting April 1, 2018. Therefore, we are proposing that the effective 
date of Sec.  414.84 would be April 1, 2018. Only MDPP services 
furnished on or after April 1, 2018, would be eligible for payment when 
all requirements for billing for performance payments for those 
services are met.
    At proposed Sec.  414.84(a)(1), we are proposing to define 
``performance goal'' as an attendance or weight loss goal that an MDPP 
beneficiary must achieve for an MDPP supplier to be paid a performance 
payment. We are proposing to define ``performance payment'' as a 
payment to an MDPP supplier for furnishing certain MDPP services when 
an MDPP beneficiary achieves the applicable performance goal. These 
definitions are used in our proposals for payment of MDPP services.
    To align with the once-per-lifetime policy, we are proposing at 
Sec.  414.84(b) that each performance payment made based on attendance 
of a specified number of core sessions, for a specific 3-month core 
maintenance or ongoing maintenance interval during the MDPP services 
period, or for achieving a weight loss performance goal, is made only 
once per MDPP beneficiary.
(a) Total Amount and Distribution of Performance Payments Across the 
Set of MDPP Services
    As displayed in Table 27, we are proposing a maximum total 
performance payment amount per beneficiary for the set of MDPP services 
of $810. This amount is the aggregate of the maximum performance 
payments for core sessions, core maintenance sessions, and ongoing 
maintenance sessions furnished to MDPP beneficiaries who achieve weight 
loss of at least 9 percent over the 36 months of the MDPP services 
period. This performance payment amount would be made for a minimum of 
46 MDPP sessions required to be offered to the beneficiary in the set 
of MDPP services. Although CMS would make performance payments to MDPP 
suppliers at intervals throughout the MDPP services period in varying 
amounts, payment for each session furnished would be included in the 
total

[[Page 34140]]

performance payment amount a supplier was paid for the set of MDPP 
services.
    While we are not proposing that payment for MDPP services utilize a 
fee-for-service payment methodology, we note that, estimated on a per-
session basis, the maximum MDPP payment amount for achievement of all 
the performance goals would equate to approximately $18 per session. 
For comparison, Medicare pays under the PFS approximately $10 
(excluding physician work and malpractice) for CPT code 98962 
(Education and training for patient self-management by a qualified, 
nonphysician health care professional using a standardized curriculum, 
face-to-face with the patient (could include caregiver/family) each 30 
minutes; 5-8 patients), a service that may bear some resemblance to an 
MDPP session furnished by an MDPP supplier, although an MDPP session 
would be furnished by a coach (not necessarily a health care 
professional), has a duration of 1 hour, and has no explicit limitation 
on group size.
    However, this estimated per-session MDPP payment amount would 
result only from the furnishing of MDPP services to those beneficiaries 
who achieve the highest attendance and weight loss performance goals 
under the proposed performance-based payment methodology for MDPP 
services. For beneficiaries who do not achieve the highest performance 
goals, the estimated per-session MDPP payment amount would generally be 
significantly lower, with the amount based upon the actual attendance 
and weight loss performance of the beneficiary. The differences between 
the estimated MDPP per-session payment amounts and between the MDPP and 
PFS payment amounts result from the proposed performance-based 
methodology for MDPP services. We note that under the PFS payments are 
based on suppliers' relative resources used to furnish services. On the 
other hand, we believe that that the estimated per-session MDPP payment 
amounts under our proposal for beneficiaries who achieve specified 
attendance and weight loss performance goals are appropriate in the 
context of a performance-based payment methodology for the set of MDPP 
services that differs from the methodology used under the PFS.
    Finally, we note that there are also some administrative costs that 
MDPP suppliers would bear to enroll in Medicare and ensure compliance 
with the requirements for furnishing MDPP services. The total MDPP 
performance payment across all Medicare beneficiaries would provide 
some payment for the resources that would be used by MDPP suppliers to 
meet the administrative requirements for furnishing MDPP services.
    In terms of the proposed distribution of the maximum total 
performance payment amount for MDPP services across the types of 
performance payments, as discussed in detail in sections 
III.K.2.d.iii.(3) and (4) of this proposed rule and displayed in Table 
27, we are proposing that, for those beneficiaries achieving the 
highest core services period performance goals, approximately 13 
percent of the maximum of $810 would be paid for attendance at core 
sessions during the initial 6 months of the core services period, while 
approximately 15 percent would be paid for core maintenance sessions 
during months 7 to 12 of the core services period. We believe that 
payment of a similar percentage of the maximum total performance 
payment amount during the initial 6 months of the core services period 
for beneficiaries who meet attendance performance goals and during 
months 7 to 12 for beneficiaries who meet both weight loss and 
attendance performance goals is appropriate to balance performance 
payment for attendance and weight loss throughout the core services 
period.
    In addition, as discussed in detail in section III.K.2.d.iii.(5) of 
this proposed rule, we are proposing that approximately 49 percent of 
the maximum of $810 would be paid for ongoing maintenance sessions over 
a 24-month period, or 24.5 percent per each 12-month period, for those 
beneficiaries who maintain the required minimum weight loss. The focus 
of ongoing maintenance sessions is on maintenance of weight loss that 
has already been achieved, and there would typically be an established 
relationship between the MDPP supplier and the MDPP beneficiary during 
the ongoing services period. Therefore, the totality of MDPP sessions 
furnished during this 24-month period would result in a slightly lower 
performance payment per 12-month period than the totality of those 
sessions furnished when the required minimum weight loss is achieved 
during the 12 months of the core services period, when 28 percent of 
the maximum total performance payment amount would be paid.
    Finally, due to the importance of weight loss as a meaningful 
outcome of MDPP services because of its association with a reduction in 
the incidence of type 2 diabetes, as discussed in detail in section 
III.K.2.d.iii.(6) of this proposed rule, we are proposing that 23 
percent of the maximum total performance payment amount would be paid 
for weight loss performance payments to provide additional payments for 
MDPP sessions that are effective (that is, lead to specified 
percentages of weight loss). We note that, in the DPP model test, 44.7 
percent of participants achieved 5 percent weight loss, which under our 
proposal would result in a weight loss performance payment of 
approximately 20 percent of the maximum total performance payment 
amount.\13\ Moreover, according to estimates from CDC's DPRP, 
approximately 12 percent of program participants attending at least 2 
sessions achieved 9 percent or greater weight loss.\14\
---------------------------------------------------------------------------

    \13\ National Council of Young Men's Christian Associations, 
Measurement and Monitoring Report. CMS Health Care Innovation 
Awards, Round One, Sixteenth Quarterly Reporting Period (16QR), 
April, May, and June 2016.
    \14\ CDC's Diabetes Prevention Recognition Program dataset as of 
March 1, 2017.
---------------------------------------------------------------------------

    Table 27 summarizes the proposed maximum total amount and 
distribution of performance payments for the set of MDPP services.

  Table 27--Proposed Maximum Total Amount and Distribution of Performance Payments for the Set of MDPP Services
----------------------------------------------------------------------------------------------------------------
                                                      Maximum performance  payment
                                                        for achieving  attendance    Percentage of maximum total
             Type of performance payment                   and/or weight-loss            performance payment
                                                          performance goals ($)
----------------------------------------------------------------------------------------------------------------
Core sessions.......................................                           105                            13
Core maintenance session intervals..................                           120                            15
Ongoing maintenance session intervals...............                           400                            49

[[Page 34141]]

 
Weight loss.........................................                           185                            23
                                                     -----------------------------------------------------------
    Total performance payment.......................                           810                           100
----------------------------------------------------------------------------------------------------------------

    We are inviting public comments on our proposals for the maximum 
total performance payment amount and the distribution of performance 
payments for MDPP services across the set of MDPP services.
(b) Payment Considerations Related to Coverage of MDPP Services for 
Beneficiaries With Social Risk Factors
    We understand that social risk factors such as income, education, 
race and ethnicity, employment, disability, community resources, and 
social support play a major role in health. The Office of the Assistant 
Secretary for Planning and Evaluation (ASPE) and the National Academies 
of Sciences, Engineering, and Medicine recently released reports on the 
issue of accounting for social risk factors in CMS 
programs.15 16 We have previously sought public comment on 
accounting for social risk factors in CMS programs, primarily on the 
topics of quality measurement and reporting, such as in the Request for 
Information Regarding Implementation of the Merit-Based Incentive 
Payment System, Promotion of Alternative Payment Models, and Incentive 
Payments for Participation in Eligible Alternative Payment Models 
published in the October 1, 2015 Federal Register (80 FR 59105, 59109, 
59110, and 59113).
---------------------------------------------------------------------------

    \15\ Available at https://aspe.hhs.gov/sites/default/files/pdf/253971/ASPESESRTCfull.pdf.
    \16\ Available at http://nationalacademies.org/hmd/Reports.aspx?filters=inmeta:activity=Committee+on+Accounting+for+SES+in+Medicare+Payment+Programs.
---------------------------------------------------------------------------

    In the CY 2017 PFS final rule (81 FR 80466), we acknowledged 
commenters' concerns regarding the potential unintended consequences if 
the MDPP expanded model were to result in low-income or other 
disadvantaged populations having less access to ongoing maintenance 
sessions due to their failure to achieve or maintain the weight loss 
performance goal required for coverage of these sessions. In addition, 
through listening sessions, stakeholders have provided us with 
anecdotal information suggesting that racial and ethnic minorities and 
low socioeconomic status populations lose about 1 percent less weight, 
on average, than higher socioeconomic groups and non-Hispanic whites.
    We are proposing an MDPP payment structure for the set of MDPP 
services that is similar to the structure presented in the July 15, 
2016 MDPP proposed rule (81 FR 46416), where performance payments are 
tied to attendance at MDPP sessions and/or weight loss. Based on 
information provided to us by stakeholders, we acknowledge that tying 
performance payment to a specific threshold of weight loss and/or 
attendance may make achieving the performance goals required for the 
highest performance payments and beneficiary eligibility for coverage 
of ongoing maintenance sessions more challenging for MDPP suppliers 
furnishing services to individuals with social risk factors. We note 
that our proposal for beneficiary engagement incentives as discussed in 
section III.K.2.f. of this proposed rule would provide MDPP suppliers 
with the flexibility under certain conditions to furnish in-kind 
patient engagement incentives, such as transportation, to support 
beneficiaries in achieving the MDPP expanded model performance goals, 
including session attendance and weight loss. We expect these 
beneficiary engagement incentives may be helpful to MDPP suppliers 
furnishing services to beneficiaries, including those with social risk 
factors that could increase their risk of not achieving the MDPP 
performance goals.
    We are not proposing to risk-adjust MDPP payments for social risk 
factors or to adopt additional special payment policies to specifically 
encourage MDPP suppliers to furnish sessions to beneficiaries with 
social risk factors because, for the MDPP expanded model, we do not 
believe that such approaches are necessary to ensure access to MDPP 
services for all beneficiaries. This is because we believe that the 
proposed performance goals upon which the performance payments for the 
set of MDPP services would be based, as well as the payment policies 
that recognize that weight loss is a gradual process that may occur 
slowly over the 12 months of the core services period, should allow 
MDPP suppliers sufficient time to work with all eligible beneficiaries, 
including beneficiaries with social risk factors, toward achieving the 
attendance and weight loss performance goals of the MDPP expanded 
model. However, we may consider proposing additional payment policies 
for the MDPP expanded model in the future.
    We are requesting comments about social risk factors in the context 
of the set of MDPP services that could inform any future considerations 
of additional payment policies for the MDPP expanded model. We also are 
inviting public comments on other types of strategies that we could 
utilize throughout the testing of the MDPP expanded model to assist 
MDPP suppliers in providing robust access to MDPP services for 
beneficiaries with social risk factors, such as learning activities to 
share best practices among MDPP suppliers in providing the set of MDPP 
services.
(3) Performance Payments for Core Sessions
    The payment structure presented in the July 15, 2016 MDPP proposed 
rule (81 FR 46415 through 46416) would have made attendance-based 
payments of $25 for the first core session, $50 for 4 total core 
sessions, and $100 for 9 total core sessions. Based on our 
consideration of information provided in the public comments on that 
proposed rule and our increased emphasis in the performance payments on 
the achievement and maintenance of the required minimum weight loss as 
the outcome of MDPP services, our proposal for the attendance-based 
performance payments for 4 and 9 core sessions differs from these 
payment amounts.
    We are proposing that an MDPP supplier would be paid a $25 
performance payment the first time it furnishes an MDPP session to an 
MDPP beneficiary as displayed in Table 28. This performance payment 
would be

[[Page 34142]]

available once per beneficiary for the beneficiary's first core 
session.
    We are proposing that an MDPP supplier would be paid the 
performance payment upon furnishing the first core session to a 
beneficiary who initiates the MDPP services period, regardless of 
whether the MDPP supplier qualifies for any of the additional 
performance payments for that beneficiary. As we are proposing in the 
sections that follow, additional performance payments would depend upon 
the beneficiary's achievement of the performance goals for attendance 
and/or weight loss. We believe that making the first performance 
payment based on beneficiary attendance at the first core session is 
appropriate because the MDPP supplier would use significant resources 
to furnish the first session, including collecting administrative 
information on the beneficiary who is not already known to the 
supplier, regardless of whether the beneficiary goes on to receive 
further MDPP services from that supplier.
    On a per-session basis, the performance payment for the first MDPP 
core session would be the highest performance payment amount for any 
core session during the core services period. Of note, the first core 
session performance payment also provides some payment for MDPP 
supplier activities to encourage the beneficiary's attendance at 
additional core sessions following the first session. Such supplier 
activities could include sending electronic messages or making reminder 
phone calls about upcoming sessions or providing transportation to the 
next session under the beneficiary engagement incentives policy 
proposed in section III.K.2.f. of this proposed rule. It is only 
through attendance at the first core session with an MDPP supplier that 
a beneficiary initiates the MDPP services period and has the potential 
to achieve weight loss through receiving MDPP services.
    Further, we are proposing that suppliers would be paid a 
performance payment for the interval (which we are referring to in this 
proposed rule as an ``interval performance payment'' to distinguish it 
from other performance payments, such as the performance payment upon 
an MDPP beneficiary's achievement of the required minimum weight loss, 
that do not require attendance at multiple sessions) upon a 
beneficiary's attendance at 4 total core sessions, and again upon a 
beneficiary's attendance at 9 total core sessions--that is, attendance 
of 5 more core sessions after having attended his or her first 4. We 
are proposing an interval performance payment of $30 upon a beneficiary 
attending 4 core sessions and an interval performance payment of $50 
upon a beneficiary attending 9 core sessions as displayed in Table 28. 
Although an MDPP supplier must offer at least 16 core sessions to a 
beneficiary during the initial 6 month of the MDPP core services 
period, we are not proposing any other interval performance payment for 
the core sessions after the performance payment for attendance at 9 
core sessions. We note that while these proposed payment amounts are 
somewhat lower than the payment amounts for these milestones presented 
in the July 15, 2016 MDPP proposed rule (81 FR 46415 through 46416), 
they follow a similar pattern of a higher payment amount associated 
with attendance at a larger cumulative number of core sessions to 
provide a significant financial incentive for MDPP suppliers to 
encourage MDPP beneficiary attendance at core sessions in the first 6 
months of the core services period.
    On a per-session basis, the payments for attendance at 4 total core 
sessions and 9 total core sessions would be approximately $10 and $4 to 
$10, respectively, depending upon the number of sessions attended by 
the beneficiary beyond the 9 required for the second interval 
performance payment up to the maximum of 16 core sessions that must be 
offered to the beneficiary by the MDPP supplier during the initial 6 
months of the MDPP core services period. Because the performance 
payments for core sessions would be based solely on the achievement of 
attendance performance goals, we believe these per-session performance 
payment amounts that are lower than the proposed performance payment 
amount for the first core session are still appropriate because we 
expect that fewer MDPP supplier resources would be used to furnish 
sessions to beneficiaries with whom the MDPP supplier has an 
established relationship. The per-session payment amounts for core 
sessions are set based on attendance at these sessions, which is 
associated with ultimate achievement of the required minimum weight 
loss.
    We are proposing to make the first interval performance payment for 
core sessions when the beneficiary has attended 4 core sessions for the 
following reasons. First, beneficiary attendance at 4 core sessions was 
a significant attendance milestone in the evaluation of the DPP model 
test, which provided evidence that meeting this milestone is tied to 
weight loss outcomes.\17\ According to the second year independent 
evaluation of the DPP model test, those beneficiaries who attended at 
least 1 core session lost an average of 7.6 pounds while beneficiaries 
who attended at least 4 core sessions lost an average of 9 pounds. BMI 
was reduced from 32.9 to 31.5 among Medicare beneficiaries who attended 
at least 4 core sessions. Second, in examining CDC's DPRP participant 
trend data, we found that a higher percentage of participants drop out 
after 3 core sessions as compared to those who drop out after 4 core 
sessions, meaning that if a beneficiary completes the 4th core session, 
he or she is more likely to remain in the DPP for the 12-month 
program.\18\ Therefore, we believe making the first interval 
performance payment after beneficiary attendance at 4 core sessions 
would be appropriate.
---------------------------------------------------------------------------

    \17\ Hinnant L, Razi S, Lewis R, Sun A, Alva M, Hoerger T, 
Jacobs S, Halpern M. Evaluation of the Health Care Innovation 
Awards: Community Resource Planning, Prevention, and Monitoring, 
Annual Report 2015. Awardee-Level Findings: YMCA of the USA; 2016. 
Table 17. Average/Frequencies Health Outcomes of all Participants 
through Q11, p. 36. RTI Project Number 0212790.010.001.004, Contract 
HHSM-500-2010-00021I. Sponsored by the Centers for Medicare & 
Medicaid Services.
    \18\ CDC's Diabetes Prevention Recognition Program dataset as of 
March 1, 2017.
---------------------------------------------------------------------------

    We are proposing to make the second interval performance payment 
when the beneficiary has attended 9 core sessions because attending a 
higher amount of sessions in the initial 6 months of the MDPP core 
services period, beginning at session 9, has been shown to greatly 
improve weight loss outcomes. Specifically, according to CDC data, 
there is a 125 percent increase in weight loss comparing beneficiaries 
who attend 4 to 8 sessions (1.6 percent weight loss on average) and 
beneficiaries who attend 9 to 16 sessions (3.6 percent weight loss on 
average).\19\ Therefore, we believe that attendance at 9 sessions 
reflects clinically meaningful attendance at core sessions and would 
provide an incentive to MDPP suppliers to encourage beneficiaries to 
continue into the second 6 months of the MDPP core services period, 
which is when the 5 percent weight loss from baseline is usually 
achieved or exceeded. Additionally, 9 is the number of core sessions, 
on average, that a participant must attend in CDC's National DPP in the 
first 6 months for a CDC-recognized organization to achieve full CDC 
recognition.
---------------------------------------------------------------------------

    \19\ CDC's Diabetes Prevention Recognition Program dataset as of 
February 28, 2017.
---------------------------------------------------------------------------

    MDPP suppliers would be paid these performance payments when 
beneficiaries achieve these core session

[[Page 34143]]

attendance performance goals, regardless of weight loss. Although we 
are proposing to base performance payments during the MDPP services 
period substantially on weight loss, which is directly associated with 
a significant decrease in the incidence of type 2 diabetes, we 
recognize that weight loss is a gradual process and that MDPP suppliers 
utilize resources to furnish MDPP services during the period of time 
when the beneficiary is losing weight. Therefore, we are proposing that 
performance payments for beneficiary attendance at core sessions during 
the first 6 months of the core services period be based on attendance 
only. The maximum total performance payment to MDPP suppliers for 
furnishing MDPP core sessions would be $105 per beneficiary, as 
displayed in Table 28.

 Table 28--Proposed Attendance-Based Performance Payments for MDPP Core
                                Sessions
------------------------------------------------------------------------
                                                            Attendance-
                                                               based
                                                            performance
                    Performance goal                        payment per
                                                            beneficiary
                                                                ($)
------------------------------------------------------------------------
1st core session attended (performance payment).........              25
4 total core sessions attended (interval performance                  30
 payment)...............................................
9 total core sessions attended (interval performance                  50
 payment)...............................................
Maximum total performance payment for core sessions.....             105
------------------------------------------------------------------------

    We considered alternatives to this proposed payment structure for 
core sessions, such as making higher payments for attendance at the 
earlier sessions to provide MDPP suppliers with additional funds for 
the resources necessary for start-up of the MDPP expanded model. 
Although we understand that there are some up-front supplier costs 
associated with implementing the MDPP expanded model, we believe these 
costs would disproportionately be related to start-up and not generally 
be ongoing costs borne by the MDPP supplier. In addition, because we 
expect that many MDPP suppliers are currently offering DPPs through 
contracts with commercial payers, MDPP suppliers may be able to 
minimize start-up costs by relying on their relevant experience with 
offering other DPPs. Finally, we believe that our proposal for payment 
of MDPP core sessions already includes substantial payment for session 
attendance early in a beneficiary's participation with the MDPP 
supplier, considering that MDPP suppliers would be paid an initial $25 
performance payment for the first core session attended by the 
beneficiary and would then be paid performance payments for beneficiary 
attendance of up to 9 core sessions, regardless of weight loss. We 
believe that increasing the initial payments for attendance at MDPP 
sessions would shift the nature of the payment for the set of MDPP 
services from a performance-based structure based on a balance of 
attendance and weight loss considerations toward a payment structure 
that is based on attendance at each session furnished.
    The proposed attendance-based performance payments for MDPP core 
sessions are included at proposed Sec.  414.84(b)(1), (2), and (3). We 
are inviting public comments on these proposals. We also are inviting 
public comments on the alternative considered.
(4) Performance Payments for Core Maintenance Session Intervals
    We are proposing that performance payments for core maintenance 
sessions would be tied to the beneficiary's achievement of attendance 
and weight loss performance goals during a core maintenance session 
interval. A core maintenance session interval, as we are proposing to 
define it at Sec.  410.79(b), means one of the two consecutive 3-month 
time periods during months 7 through 12 of the MDPP services period, 
during which an MDPP supplier offers at least one core maintenance 
session per month to an MDPP beneficiary.
    The payment structure presented in the July 15, 2016 MDPP proposed 
rule (81 FR 46415 through 46416) would have required the MDPP 
beneficiary to attend 3 core maintenance sessions and achieve or 
maintain a minimum 5 percent weight loss for a $45 payment to be made 
to an MDPP supplier for the core maintenance session interval. If 5 
percent weight loss was not achieved or maintained during the core 
maintenance session interval, no separate performance payment would be 
made. MDPP suppliers would still have been required to offer (and 
furnish if the beneficiary attended) MDPP services during core 
maintenance intervals to beneficiaries regardless of weight loss. Based 
on our consideration of information provided in the public comments on 
that proposed rule and our increased emphasis in the performance 
payments on the achievement and maintenance of the required minimum 
weight loss as the outcome of MDPP services, our proposal for the 
performance payments for core maintenance sessions differs from the 
payment amounts included in the July 15, 2016 MDPP proposed rule (81 FR 
46415 through 46416).
    For the MDPP expanded model, we are proposing performance payments 
amounts for core maintenance session intervals that value achievement 
of both session attendance and the required minimum weight loss, with 
an emphasis on achieving the weight loss performance goal. We are 
proposing that an MDPP supplier would be paid a performance payment for 
a core maintenance session interval if a beneficiary achieves the 
performance goal of attending at least 3 core maintenance sessions 
during the interval. The specific performance payment amount would be 
determined by whether the beneficiary has also achieved or maintained 
the required minimum weight loss within the interval. The achievement 
or maintenance of the required minimum weight loss within the 3-month 
core maintenance session interval would be determined based on a 
measurement taken in-person during any 1 session within that 3-month 
interval. We are proposing that MDPP suppliers would be paid a 
performance payment for no more than two core maintenance session 
intervals for each MDPP beneficiary.
    As discussed previously, we recognize that weight loss is a process 
that may still be ongoing for some beneficiaries during the final 
months of the core services period. According to an analysis of 
participant data from CDC's DPRP, the longer a participant remains in 
the lifestyle change program, the greater his or her average weight 
loss achieved.\20\ Findings indicate that it takes an average of 17 DPP 
sessions attended to exceed the required minimum weight loss, and the 9 
percent or greater weight loss goal is more likely to be achieved upon 
attending 19 sessions on average. This average number of sessions 
exceeds the 16 core sessions that must be offered to the MDPP 
beneficiary during the first 6 months of the MDPP services period and 
emphasizes the importance of core maintenance sessions to achievement 
of meaningful weight loss goals.
---------------------------------------------------------------------------

    \20\ CDC's Diabetes Prevention Recognition Program dataset as of 
March 1, 2017.
---------------------------------------------------------------------------

    Of further note, the National DPP's core maintenance sessions were 
developed based on results from the original 2002 DPP Randomized 
Control Trial and CDC's DPRP standards were developed with this science 
in mind.\21\

[[Page 34144]]

Core maintenance sessions are integral for the expected reduction in 
the incidence of type 2 diabetes to be experienced by MDPP 
beneficiaries. These findings were recently confirmed in a literature 
review on combined diet and physical activity programs to prevent type 
2 diabetes conducted by the Community Preventive Services Task Force 
that reiterated the year-long intensity and duration of the National 
DPP.\22\
---------------------------------------------------------------------------

    \21\ Available at https://www.niddk.nih.gov/about-niddk/research-areas/diabetes/diabetes-prevention-program-dpp/Documents/DPP_508.pdf.
    \22\ Available at http://www.thecommunityguide.org/diabetes/combineddietandpa.html.
---------------------------------------------------------------------------

    Therefore, we believe that providing no performance payment to MDPP 
suppliers for furnishing core maintenance sessions to beneficiaries who 
have not achieved the required minimum weight loss prior to or during 
months 7 to 12 of the core services period could reduce the opportunity 
for MDPP beneficiaries to achieve the weight loss performance goal. 
Such a payment methodology could reduce the likelihood that MDPP 
suppliers would continue to work to engage beneficiaries in the weight 
loss process if those beneficiaries had not achieved the required 
minimum weight loss after completion of the initial 6 months of the 
MDPP core services period. We note that, as finalized in the CY 2017 
PFS final rule (81 FR 80459), suppliers must offer a minimum of 1 core 
maintenance session per month in months 7 to 12 of the core services 
period to eligible beneficiaries, regardless of the beneficiary's 
weight loss. We believe that it is possible for some beneficiaries to 
have achieved the required minimum weight loss performance goal by the 
time the core sessions have been completed, and we want to incentivize 
MDPP suppliers to work toward the weight loss performance goal in that 
timeframe. However, we believe that it is also appropriate to place 
some value on achieving attendance performance goals alone through 
performance payments for core maintenance session intervals so that 
MDPP suppliers continue to work to engage all beneficiaries in striving 
to achieve the required minimum weight loss performance goal.
    As discussed in section III.K.2.d.iii.(2)(a) of this proposed rule, 
we are proposing that the maximum total performance payment for MDPP 
core maintenance sessions would be $120 for beneficiaries who achieve 
both the attendance and weight loss performance goals during months 7 
to 12 of the core services period. Specifically, we are proposing to 
pay MDPP suppliers $60 for a core maintenance session interval if a 
beneficiary attends 3 sessions and achieves or maintains the required 
minimum weight loss during that interval, and to pay MDPP suppliers $10 
for a core maintenance session interval if the beneficiary attends 3 
sessions but does not achieve or maintain the required minimum weight 
loss during that core maintenance session interval.
    As compared to the payment amounts with and without achievement or 
maintenance of the required minimum weight loss that were presented for 
core maintenance session intervals in the July 15, 2016 MDPP proposed 
rule (81 FR 46415 through 46416), these payment amounts are both 
higher. As discussed previously in this section, we believe it is 
appropriate in months 7 to 12 of the core services period to provide 
some performance payment for achievement of attendance performance 
goals even if the required minimum weight loss is not achieved, in 
order to provide the greatest opportunity for beneficiaries to achieve 
the required minimum weight loss over the full core services period. In 
addition, we are proposing a higher payment amount for core maintenance 
session intervals with achievement or maintenance of the required 
minimum weight loss to recognize that achievement and maintenance of 
the required minimum weight loss are necessary for the reduced 
incidence of type 2 diabetes and to encourage MDPP suppliers to work to 
engage beneficiaries in achieving weight loss and sustaining their 
weight loss over time.
    Proposed performance payments for the core maintenance session 
intervals are displayed in Table 29. On a per-session basis, these 
payments would be approximately $20 and $3, respectively. While both of 
these payment amounts provide payment to MDPP suppliers for the 
resources involved with furnishing core maintenance sessions, we 
believe the relatively high per-session performance payment of $20 in 
comparison to the per-session performance payment amounts for core 
sessions is appropriate due to the achievement or maintenance of both 
the required minimum weight loss and beneficiary attendance at core 
maintenance sessions, as compared to core sessions where the 
performance payment is based solely on attendance. On the other hand, 
we believe that the relatively low per-session payment amount in our 
core maintenance session interval performance payment proposal for core 
maintenance sessions for those beneficiaries who do not achieve the 
weight loss performance goal, while providing some performance payment 
for attendance at core maintenance sessions by beneficiaries still 
working to achieve the required minimum weight loss, is appropriate 
because these sessions have not yet resulted in those beneficiaries 
achieving the weight loss performance goal.

                 Table 29--Proposed Performance Payments for Core Maintenance Session Intervals
----------------------------------------------------------------------------------------------------------------
                                                         Performance payment per       Performance Payment per
                                                           beneficiary  (with           beneficiary  (without
                  Performance goal                     achievement or  maintenance   achievement or  maintenance
                                                       of required  minimum weight   of required  minimum weight
                                                                  loss)                         loss)
----------------------------------------------------------------------------------------------------------------
3 sessions attended in first core maintenance                                  $60                           $10
 session interval (months 7-9 of the MDPP core
 services period)...................................
3 sessions attended in second core maintenance                                  60                            10
 session interval (months 10-12 of the MDPP core
 services period)...................................
Maximum total performance payment for core                                     120                            20
 maintenance session intervals (two consecutive 3-
 month intervals over months 7-12 of the MDPP core
 services period)...................................
----------------------------------------------------------------------------------------------------------------


[[Page 34145]]

    The proposed core maintenance session interval performance payments 
for core maintenance sessions are included at proposed Sec.  
414.84(b)(4). We are inviting public comments on these proposals.
(5) Performance Payments for Ongoing Maintenance Session Intervals
    Similar to our proposal for the payment of core maintenance session 
intervals described previously, we are proposing to make performance 
payments to MDPP suppliers for 3-month ongoing maintenance session 
intervals. This payment would be made when suppliers furnish ongoing 
maintenance sessions during the 24 months of the ongoing services 
period after the 12-month MDPP core services period ends. We are 
proposing that an MDPP supplier would be paid a performance payment for 
an ongoing maintenance session interval if an MDPP beneficiary achieves 
the performance goals of attending at least 3 ongoing maintenance 
sessions and maintaining the required minimum weight loss from baseline 
measured in person during a session at least once within that interval. 
Under this proposal, an MDPP supplier would not be paid a performance 
payment unless the beneficiary has achieved these both of these 
performance goals within that 3-month interval. An ongoing maintenance 
session interval, as we are proposing to define it at Sec.  410.79(b), 
means one of the up to eight consecutive 3-month time periods during 
the ongoing services period, during which an MDPP supplier offers at 
least one ongoing maintenance session to an MDPP beneficiary per month.
    The payment structure presented in the July 15, 2016 MDPP proposed 
rule (81 FR 46415 through 46416) would have required the MDPP 
beneficiary to attend 3 ongoing maintenance sessions and maintain the 
required minimum weight loss for a $45 payment to be made to an MDPP 
supplier for the ongoing maintenance session interval. Based on our 
consideration of information provided in the public comments on that 
proposed rule and our increased emphasis in the performance payments on 
the achievement and maintenance of weight loss as the outcome of MDPP 
services, our proposal for the performance payment for ongoing 
maintenance session intervals differs from that payment amount.
    We are proposing that MDPP suppliers could be paid up to 8 
performance payments of $50 each for ongoing maintenance session 
intervals. Just like the other proposals for performance payments, we 
are proposing this payment in CY 2018 dollars to ensure consistency in 
calendar year dollars among performance payments for a given calendar 
year. However, we note that no ongoing maintenance session interval 
payments, available only for intervals in the ongoing services period 
during months 13 through 36 of an MDPP beneficiary's MDPP services 
period, would be made in CY 2018 based on our proposal in section 
III.K.2.a. of this proposed rule that MDPP services be available on 
April 1, 2018. Under this proposal, MDPP services would only be 
available for 9 months of CY 2018 so no MDPP beneficiaries would attend 
ongoing maintenance sessions in CY 2018. The first ongoing maintenance 
session interval performance payments would be made in CY 2019 and 
would equal $50 adjusted by the percent change in the Consumer Price 
Index for All Urban Consumers (CPI-U) (U.S. city average) for the 12-
month period ending June 30th, 2018, as discussed in section 
III.K.2.d.iii.(9) of this proposed rule.
    This proposed payment amount is somewhat higher than the potential 
payment discussed in the July 15, 2016 MDPP proposed rule (81 FR 46415 
through 46416) to recognize that maintenance of the required minimum 
weight loss is necessary for the reduced incidence of type 2 diabetes 
and to encourage MDPP suppliers to work to engage beneficiaries in 
sustaining their weight loss over time. The maximum total performance 
payment for MDPP ongoing maintenance sessions would be $400, as 
displayed in Table 30. On a per-session basis, this payment would be 
approximately $17, which we believe is appropriate for MDPP suppliers 
that furnish ongoing maintenance sessions to beneficiaries who maintain 
the required minimum weight loss during ongoing maintenance session 
interval. We note that this per-session payment amount would be 
somewhat lower than the $20 per-session payment amount included in the 
core maintenance session interval performance payment for beneficiaries 
who achieve attendance and weight loss performance goals during the 3-
month intervals in months 7 to 12 of the MDPP core services period. 
Like the proposed performance payment for core maintenance session 
intervals, the proposed performance payment for ongoing maintenance 
session intervals values both attendance and weight loss. However, 
during core maintenance session intervals it is likely that the 
required minimum weight loss would first be achieved, and we believe 
that a somewhat higher per-session payment amount is appropriate under 
these circumstances. In contrast, we believe that a somewhat lower per-
session payment amount for ongoing maintenance sessions during 
intervals where the required minimum weight loss is maintained, rather 
achieved, is appropriate.
    We considered an alternative policy in which an MDPP supplier would 
receive a payment for an ongoing maintenance session interval so long 
as the beneficiary attended at least 1 ongoing maintenance session 
during the interval and maintained the required minimum loss. In this 
scenario, we considered that the MDPP supplier would still be required 
to offer at least 2 additional ongoing maintenance sessions (at least 
one per month) to the beneficiary over the 3-month interval. However, 
we believe that the goal of ongoing maintenance sessions is to promote 
both sustained beneficiary engagement and weight loss and, therefore, 
we believe that ongoing maintenance session interval performance 
payments should be tied to achieving both attendance and weight loss 
performance goals.
    The proposed payment policy also would align with the service 
limitations for ongoing maintenance sessions at Sec.  410.79(c)(1)(iii) 
in that beneficiaries also would be required to attend all 3 sessions 
within a given ongoing maintenance session 3-month interval to be 
covered for the subsequent 3-month interval. We note that the proposed 
coverage and payment policies are aligned for ongoing maintenance 
session intervals, where attendance at 3 sessions within an interval is 
required for a performance payment as well as for coverage of ongoing 
maintenance sessions in the next interval. In contrast, MDPP suppliers 
are required to offer core maintenance sessions in both core 
maintenance session intervals for all beneficiaries, regardless of a 
beneficiary's attendance at core maintenance sessions, although 
attendance is required for a performance payment to be made for the 
core maintenance session interval.

[[Page 34146]]



 Table 30--Proposed Performance Payments for Ongoing Maintenance Session
                                Intervals
------------------------------------------------------------------------
                                            Performance     Performance
                                            payment per     payment per
                                            beneficiary     beneficiary
                                               (with         (without
            Performance goal              maintenance of  maintenance of
                                           the required    the required
                                          minimum weight  minimum weight
                                               loss)           loss)
------------------------------------------------------------------------
3 sessions attended in 1 ongoing                     $50              $0
 maintenance session interval...........
Maximum total performance payment for                400         * 0-350
 ongoing maintenance session intervals
 (8 consecutive 3-month intervals over
 months 13-36 of the MDPP ongoing
 services period).......................
------------------------------------------------------------------------
* = The specific payment amount depends on whether the beneficiary has
  coverage of 1 to 7 ongoing maintenance session intervals, as well as
  whether the beneficiary meets the performance goals for the
  performance payment for that ongoing maintenance session interval.

    The proposed ongoing maintenance session interval performance 
payments for ongoing maintenance sessions are included at proposed 
Sec.  414.84(b)(5). We are inviting public comments on these proposals. 
We also are inviting public comments on the alternative considered.
(6) Weight Loss Performance Payments
    We are proposing that if a beneficiary achieves the required 
minimum weight loss measured at any session attended during the core 
services period, an MDPP supplier would be paid the weight loss 
performance payment of $160 displayed in Table 31. As discussed in 
section III.K.2.d.iii.(2)(a) of this proposed rule, we are proposing 
that 23 percent of the maximum total performance payment amount for the 
set of MDPP services would be paid for the achievement of weight loss, 
regardless of session attendance, because weight loss is the most 
important outcome for the MDPP expanded model. The proposed performance 
payment of $160 for the required minimum weight loss, which constitutes 
approximately 90 percent of the maximum total weight loss performance 
payment, was set to be the large majority of the available weight loss 
performance payment based on the strong evidence for the association of 
the required minimum weight loss with a reduction in the incidence of 
type 2 diabetes.
    We note that this association is evidenced by the CDC's National 
DPP, which is based on the 2002 DPP Randomized Control Trial and 
follow-up efficacy trials.\23\ All of the trials found that the greater 
the intensity and duration of the diabetes prevention program--with 1 
year being the most effective program ``dose''--the greater the 
reduction in the incidence of type 2 diabetes. Specially, persons at 
high-risk for type 2 diabetes who participated in a year-long lifestyle 
change program, focused on modest weight loss (5-7 percent), 
experienced a 58 percent lower incidence of type 2 diabetes than those 
who did not receive the lifestyle intervention. The DPP Randomized 
Control Trial, as well as the DPP model test, involved the provision of 
16 weekly core sessions and 6 monthly core maintenance sessions (all 
approximately 1 hour in length), similar to the set of core services in 
the MDPP expanded model. We recognize that not all beneficiaries would 
be able to achieve the required minimum weight loss within the first 6 
months, which is the period when core sessions are furnished. 
Therefore, we believe that our proposed policy for payment of the 
performance payment upon achievement of the required minimum weight 
loss any time during the 12 months of the MDPP core services period 
would allow MDPP suppliers the greatest flexibility to work throughout 
the full MDPP core services period with beneficiaries who face 
difficulty in achieving this weight loss performance goal.
---------------------------------------------------------------------------

    \23\ Available at https://www.niddk.nih.gov/about-niddk/research-areas/diabetes/diabetes-prevention-program-dpp/Documents/DPP_508.pdf.
---------------------------------------------------------------------------

    We also are proposing that, in addition to the weight loss 
performance payment for the required minimum weight loss, an MDPP 
supplier would be paid an additional weight loss performance payment of 
$25 if the beneficiary achieves at least 9 percent weight loss from his 
or her baseline weight at any time during the MDPP services period as 
displayed in Table 31. We are proposing this additional weight loss 
performance payment based on information from stakeholders that 
commercial payers paying for DPPs frequently include an incentive 
payment for 9 percent weight loss as an incentive to try to encourage 
greater and/or continued weight loss and behavior change. We believe 
that making an additional weight loss performance payment for 9 percent 
weight loss at any time during the MDPP services period would provide 
an additional incentive for MDPP suppliers to continue weight loss 
efforts with beneficiaries, especially during the ongoing services 
period, which may extend for a period of up to 24 months.
    We are proposing that MDPP suppliers may submit claims for these 
weigh loss performance payments on the date when the beneficiary first 
reaches the required minimum or 9 percent weight loss, as measured in 
person during a session, respectively, and each weight loss performance 
payment would be paid to only one supplier and only once per 
beneficiary. In the unusual circumstance where the beneficiary achieved 
9 percent weight loss as the first weight loss change measured from 
baseline, the MDPP supplier could bill and be paid both the 5 percent 
and 9 percent weight loss performance payments.

           Table 31--Proposed Weight Loss Performance Payments
------------------------------------------------------------------------
                                                            Performance
                    Performance goal                        payment per
                                                            beneficiary
------------------------------------------------------------------------
5 percent weight loss (required minimum weight loss)....            $160
9 percent weight loss...................................              25
Maximum total performance payment for weight loss.......             185
------------------------------------------------------------------------

    The proposed weight loss performance payments are included at 
proposed Sec.  414.84(b)(6) and (7). We are inviting public comments on 
these proposals.
(7) Summary Table of Performance Payments for the Set of MDPP Services
    In summary, for furnishing MDPP services during the MDPP services 
period, we are proposing that MDPP suppliers could be paid a minimum of 
$25 per beneficiary (if the beneficiary attends the first core session) 
and a maximum total of $810 per beneficiary (if the beneficiary 
achieves all performance goals, maintains eligibility for 36 months, 
and does not change

[[Page 34147]]

MDPP suppliers). Table 32 summarizes all of the proposed performance 
payments for the set of MDPP services that are discussed in sections 
III.K.2.d.iii.(3) through (6) of this proposed rule.

  Table 32--Proposed Performance Payments for the Set of MDPP Services
------------------------------------------------------------------------
                                            Performance     Performance
                                            payment per     payment per
                                            beneficiary     beneficiary
            Performance goal                 (with the     (without the
                                             required        required
                                          minimum weight  minimum weight
                                               loss)           loss)
------------------------------------------------------------------------
1st core session attended...............                $25
4 total core sessions attended..........                30
9 total core sessions attended..........                50
                                         -------------------------------
3 sessions attended in first core                   * 60              10
 maintenance session interval (months 7-
 9 of the MDPP core services period)....
3 sessions attended in second core                  * 60              10
 maintenance session interval (months 10-
 12 of the MDPP core services period)...
5 percent weight loss achieved..........             160               0
9 percent weight loss achieved..........              25               0
3 sessions attended in ongoing                      * 50            ** 0
 maintenance session interval (eight
 consecutive 3[dash]month intervals over
 months 13-36 of the MDPP ongoing
 services period).......................
                                         -------------------------------
    Total performance payment...........             810             125
------------------------------------------------------------------------
* The required minimum weight loss from baseline must be achieved or
  maintained during the core maintenance session 3-month interval or
  maintained during the ongoing maintenance session 3-month interval.
** A beneficiary attends at least 1 core session during the core
  services period to initiate the MDPP services period; must attend at
  least 1 session during the final core maintenance session 3-month
  interval; and must achieve or maintain the required minimum weight
  loss at least once during the final core maintenance session 3-month
  interval to have coverage of the first ongoing maintenance session
  interval. Then, a beneficiary must attend at least 3 sessions and
  maintain the required minimum weight loss at least once during an
  ongoing maintenance session 3-month interval to have coverage of the
  next ongoing maintenance session interval.

(8) Considerations Related to Potential Future Geographic Adjustment of 
MDPP Payments
    Although Medicare is a national program, it frequently adjusts fee-
for-service payments to hospitals, physicians, and other providers and 
suppliers according to the geographic locations in which they furnish 
services. These adjustments generally account for differences in the 
relative costs of doing business in different geographic areas compared 
to the national average. For example, section 1886(d)(3)(E) of the Act 
requires that, as part of the methodology for determining prospective 
payments to hospitals, the Secretary must adjust the standardized 
amounts for area differences in hospital wage levels by a factor 
(established by the Secretary) reflecting the relative hospital wage 
level in the geographic area of the hospital compared to the national 
average hospital wage level. This adjustment factor for hospitals is 
the wage index, and we currently define hospital geographic areas 
(labor market areas) based on the definitions of Core-Based Statistical 
Areas (CBSAs) established by the Office of Management and Budget. 
Similarly, a geographic adjustment is also made for services paid under 
the PFS, and a geographic practice cost index (GPCI) has been 
established for every Medicare PFS payment locality, many of which are 
statewide, for each of the three components of a service's relative 
value units (that is, the relative value units for work, practice 
expense, and malpractice).
    We are proposing to make performance-based payments to MDPP 
suppliers in intervals based on achievement of performance goals, 
rather than fee-for-service payments for individual services furnished. 
While we intend for those performance payments to make payment to MDPP 
suppliers for MDPP services that involve the use of supplier resources, 
we are unsure if there is notable variation in the relative costs of 
furnishing MDPP services among geographic areas. Because the DPP model 
test was carried out in only eight States, we do not have the data to 
determine whether there are geographic differences nationwide. In 
addition, because a substantial portion of the proposed MDPP 
performance payments are based on the beneficiary's achievement of 
weight loss performance goals, we are uncertain about the 
appropriateness of geographically adjusting such performance-based 
payments.
    Therefore, we are not proposing geographic adjustment of 
performance payments for MDPP services. However, we are inviting public 
comments on issues related to geographic adjustment of payment for MDPP 
services in the context of the MDPP performance-based payment 
methodology, including appropriate sources of information for 
determining any geographic cost differences. We may consider proposing 
additional payment policies for the MDPP expanded model in the future. 
We request that commenters submitting information on these issues 
provide justification, including any relevant analysis, to support any 
suggestions regarding potential future geographic adjustment of 
performance-based payments for MDPP services.
(9) Updating MDPP Payment Amounts
    To account for inflation, we are proposing to update MDPP payment 
amounts annually based on the CPI-U. The CPI-U is a measure of the 
average change over time in prices paid for a market basket of consumer 
goods and services, and is a measure of economy-wide inflation. There 
are no statutory requirements for the update factor for payments for 
MDPP services so there is no requirement that a productivity adjustment 
be applied to the MDPP services update factor as there are for certain 
other Medicare-covered items and services where prices are updated by 
the CPI-U, such as the Clinical Laboratory Fee Schedule; Durable 
Medical Equipment, Prosthetics/Orthotics, and Supplies Fee Schedule; 
Ambulance Fee Schedule; and Ambulatory Surgical Center payment system.

[[Page 34148]]

    We considered using other indices such as the Medicare Economic 
Index (MEI) to update the MDPP payment amounts. The MEI measures price 
changes in the inputs required to operate a self-employed physician 
practice. We do not believe that the MEI would be appropriate to update 
MDPP payment amounts because MDPP suppliers are not similar to self-
employed physician practices. We note that the CPI-U by definition is 
an economy-wide measure of inflation and, therefore, in the absence of 
an appropriate specific index for MDPP services, we believe the CPI-U 
to be the most technically appropriate index available to update 
payments for MDPP services. We further note that the CPI-U is used to 
update Medicare payments for other Medicare-covered items and services, 
such as ambulance, clinical laboratory, and ambulatory surgical center 
services.
    We are proposing to update MDPP performance payments and the bridge 
payment (a proposed one-time payment to an MDPP supplier for furnishing 
its first session to an MDPP beneficiary who has previously received 
MDPP services from a different MDPP supplier as discussed in detail in 
section III.K.2.d.v. of this proposed rule) that may be paid to MDPP 
suppliers in the following manner:
     Beginning in CY 2019 and each year forward, the 
performance payment and bridge payment amounts will be adjusted by the 
12-month percent change in the CPI-U (U.S. city average) for the period 
ending June 30th of the year preceding the update year. The percent 
change update will be calculated based on the level of precision of the 
index as published by the Bureau of Labor Statistics and applied based 
on one decimal place of precision. The annual MDPP services payment 
update will be published by CMS transmittal.
    The proposed methodology to update MDPP performance payments and 
the bridge payment is included at proposed Sec.  414.84(d). We are 
inviting public comments on this proposal.
(10) MDPP Supplier Billing and Payment for MDPP Services
(a) Payment for MDPP Services on an Assignment-Related Basis
    We are proposing that performance payments and bridge payments to 
MDPP suppliers for MDPP services would be made only on an assignment-
related basis in accordance with Sec.  424.55. As described in Chapter 
1, Section 30.3 of the Medicare Claims Processing Manual,\24\ CMS 
identifies a number of supplier and practitioner types who furnish 
services under the Medicare program and who are required to accept 
assignment for all Medicare claims for their services. This means that 
they must accept the Medicare allowed amount as payment in full for 
their services, regardless of whether the supplier is a participating 
or non-participating provider in the Medicare program. In these 
circumstances, the beneficiary's liability is limited to any applicable 
deductible plus the 20 percent coinsurance if coinsurance applies to 
the service. CMS currently mandates assignment for claims from multiple 
types of suppliers and practitioners, including clinical diagnostic 
laboratory services and physician lab services; physician services to 
individuals dually entitled to Medicare and Medicaid; and services of 
physician assistants, nurse practitioners, clinical nurse specialists, 
nurse midwives, certified registered nurse anesthetists, clinical 
psychologists, clinical social workers, registered dietitians/
nutritionists, anesthesiologist assistants, and mass immunization 
roster billers. The beneficiary (or the person authorized to request 
payment on the beneficiary's behalf) is not required to assign the 
claim to the supplier in order for an assignment to be effective, and 
when these claims are inadvertently submitted as unassigned, Medicare 
Administrative Contractors (MACs) process them as assigned.
---------------------------------------------------------------------------

    \24\ Available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/clm104c01.pdf.
---------------------------------------------------------------------------

    Consistent with our established requirements for these other types 
of suppliers, some of whom are similar to MDPP suppliers in that they 
furnish a limited breadth of Medicare-covered services, we believe it 
would be appropriate to require all MDPP suppliers, whether they are 
participating or not participating in Medicare, to accept assignment. 
We also believe that making performance payments for MDPP services 
solely on an assignment-related basis is the most appropriate 
methodology, given the performance-based MDPP payment methodology which 
is based on the achievement of weight loss and/or attendance 
performance goals and not based on the MDPP supplier resource expended 
to furnish individual MDPP services. We further note that as finalized 
in the CY 2017 PFS final rule (81 FR 80464), MDPP services are 
additional preventive services under section 1861(ddd) of the Act and, 
therefore, consistent with section 1833(a)(1)(W) of the Act, are not 
subject to the Medicare Part B coinsurance or deductible. Under our 
proposal Medicare would pay 100 percent of the Medicare allowed charge 
for MDPP services furnished to MDPP beneficiaries, and a beneficiary 
would have no liability for covered MDPP services. MDPP suppliers would 
be required to accept the Medicare allowed charge as payment in full 
and would not be able to bill or collect from the beneficiary any 
amount.
    Finally, to minimize the potential administrative burden on 
beneficiaries related to payment for MDPP services on an assignment-
related basis, we are proposing that for purposes of claims for 
services submitted by an MDDP supplier, Medicare would deem such claims 
to have been assigned by the beneficiary (or the person authorized to 
request payment on the beneficiary's behalf) and the assignment 
accepted by the MDDP supplier. This proposed treatment of claims from 
MDPP suppliers in new Sec.  424.55(d) is consistent with the current 
exception in Sec.  424.55(c) regarding payment to a supplier which 
specifies that when payment under the Act can only be made on an 
assignment-related basis or when payment is for services furnished by a 
participating physician or supplier, the beneficiary (or the person 
authorized to request payment on the beneficiary's behalf) is not 
required to assign the claim to the supplier in order for an assignment 
to be effective.
    The proposed assignment-related basis for performance payments and 
bridge payments MDPP suppliers is included at proposed Sec.  414.84(b) 
and (c). The proposal to not require the beneficiary to assign the 
claim for MDPP services to the MDPP supplier in order for assignment to 
be effective is included at proposed Sec.  424.55(d). We are inviting 
comments on these proposals.
(b) Requirements for Payment of Bridge Payments and Performance 
Payments
    MDPP suppliers may only submit claims for a performance payment or 
bridge payment for MDPP services when all of the proposed requirements 
for the payment are met. Claims for services that do not meet these 
requirements will not be paid. In accordance with Sec.  424.80, MDPP 
suppliers are reminded that there are exceptions to the prohibition of 
reassignment of claims by suppliers for certain arrangements provided 
the applicable requirements are met. Of specific note, Medicare may pay 
an agent who furnishes billing and collection services to the supplier 
if the conditions of Sec.  424.80(b)(5) are met.

[[Page 34149]]

    Proposed requirements for performance payments and the bridge 
payment include that the MDPP services were furnished to a beneficiary 
eligible for MDPP services as specified at Sec.  410.79(c) and that the 
MDPP supplier complies with all applicable enrollment and program 
requirements. In addition, the MDPP services must be furnished by an 
eligible coach on or after his or her coach eligibility start date and, 
if applicable, before his or her coach eligibility end date, and the 
MDPP supplier must submit the National Provider Identifier (NPI) of the 
coach on MDPP claims. We describe additional details on how eligible 
coach information would be processed in section III.K.2.d.iii.(10)(d) 
of this proposed rule. All specific additional proposed requirements 
for the performance payment or bridge payment, as discussed in sections 
III.K.2.d.iii.(3) through (6) and III.K.2.d.v. of this proposed rule, 
must also be met.
    In order to submit a claim for a performance payment under the MDPP 
expanded model, the billing supplier must have documentation in the 
beneficiary's MDPP record, as specified in proposed Sec.  424.205(g), 
that all requirements for the payment, including the achievement of the 
performance goal(s) applicable to the performance payment, have been 
met. We note that the billing supplier's MDPP record for the 
beneficiary may include a copy of the beneficiary's MDPP record from a 
previous MDPP supplier that has been provided to the billing supplier 
at the request of the MDPP beneficiary. For purposes of an MDPP 
supplier submitting a claim for an interval performance payment based 
on attendance at more than one session, this copy of the MDPP record 
from the previously MDPP supplier may be used as part of the billing 
supplier's documentation demonstrating that the attendance and weight 
loss, if applicable, performance goal(s) for the performance payment 
were achieved. We note that as we finalized at Sec.  424.59(b) in the 
CY 2017 PFS final rule (proposed to be redesignated and amended at 
Sec.  424.205(g)), MDPP suppliers are required to maintain and handle 
any personally identifiable information (PII) and protected health 
information (PHI) in compliance with HIPAA, other applicable state and 
federal privacy laws, and CMS standards. Therefore, MDPP suppliers must 
follow these rules when providing any copies of information from a 
beneficiary's MDPP records to another MDPP supplier.
    We are proposing that any weight loss measurement taken and 
recorded by an MDPP supplier for the purposes of performance payments 
must be taken in person during an MDPP core session, core maintenance 
session, or ongoing maintenance session by the MDPP supplier during the 
MDPP services period. We believe that in-person measurements are the 
most feasible method for weight ascertainment at this time for services 
because the beneficiary would attend regular in-person sessions with 
the MDPP supplier. Moreover, we believe that self-reported weight loss 
is not reliable for the purposes of performance payment in the MDPP 
expanded model. This proposal also would apply to our proposed policy 
regarding virtual make-up sessions, described in detail in section 
III.K.2.c.iv.(3) of this proposed rule, meaning that weight loss could 
not be measured or reported during a virtual make-up session for the 
purpose of the MDPP supplier submitting a claim for a performance 
payment. We also are proposing to require that weight loss be measured 
in person at an MDPP session to align with CDC's DPRP standards, which 
require for in-person sessions that weight be measured in person at the 
session.
    In addition, we note that the achievement or maintenance of the 
required minimum weight loss that determines the performance payment 
amount for a core maintenance session interval and the maintenance of 
the required minimum weight loss that determines whether a performance 
payment for an ongoing maintenance session interval is made must be 
determined by an in-person weight measurement at a session furnished 
during the applicable interval. Thus, for these interval performance 
payments, achievement of the performance goal for minimum weight loss 
does not need to be determined based on attendance at a session 
furnished by the MDPP supplier billing for that performance payment. 
However, as discussed previously, if achievement of the performance 
goal for minimum weight loss was measured at a session furnished by a 
previous MDPP supplier in the interval, the subsequent supplier must 
have documentation through a copy of the beneficiary's MDPP record from 
that previous supplier that the weight loss performance goal was met in 
the interval to bill for the interval performance payment. Finally, the 
performance payments for the required minimum and 9 percent weight loss 
would only be billed by the MDPP supplier furnishing the session at 
which the weight loss performance goal is met during an in-person 
session.
    Furthermore, we are proposing that the beneficiary must achieve the 
applicable attendance performance goal for core session, core 
maintenance session interval, or ongoing maintenance session interval 
performance payments upon attendance at a session furnished by the MDPP 
supplier billing for that specific performance payment. An MDPP 
supplier can only bill for a performance payment on the date the 
beneficiary has achieved all performance goals associated with that 
performance payment. We note that in order to bill for an interval 
performance payment that is based on attendance, the MDPP supplier that 
furnished the session where the attendance goal is met would bill for 
the performance payment, even if that supplier did not itself furnish 
all sessions attended by the MDPP beneficiary during that interval. In 
these circumstances, as discussed previously, if attendance at a 
session furnished by a previous MDPP supplier occurred in the interval, 
the subsequent supplier must have documentation through a copy of the 
beneficiary's MDPP record from that previous supplier of the session 
attendance in order to bill for the interval performance payment based 
on attendance at that session. An MDPP supplier may not bill for an 
interval performance payment when the MDPP supplier does not furnish 
the session where the attendance goal is met.
    For all interval performance payments, we are proposing that the 
performance payment would be based on the date the MDPP supplier 
furnished the session where the interval attendance performance goal is 
met. Thus, for those intervals where the performance payment is based 
on MDPP beneficiary session attendance that spans two calendar years, 
the interval performance payment would be the amount applicable to the 
later calendar year, reflecting the annual update from the prior year 
as discussed in section III.K.2.d.iii.(9) of this proposed rule. The 
proposed conditions for payment by CMS of performance payments and 
bridge payments to MDPP suppliers are included at proposed Sec.  
414.84(b) and (c), as well as at the other provisions in these 
sections. We are inviting public comments on these proposals.
(c) Reporting HCPCS G-Codes on Claims for MDPP Services
    We are proposing to establish 19 unique Healthcare Common Procedure 
Coding System (HCPCS) G-codes so that MDPP suppliers may submit claims 
for payment when all the requirements for

[[Page 34150]]

billing the codes have been met. Our proposal for the HCPCS G-codes is 
displayed in Table 33.
    We note that each MDPP supplier would be able to bill one of the 18 
payable HCPCS G-codes on the date when all the requirements for billing 
the code have been met, including the session attendance for specific 
core and ongoing maintenance session intervals and achievement and/or 
maintenance of weight loss, as applicable to the specific HCPCS G-code. 
One of the proposed HCPCS G-codes would be nonpayable and assigned a 
payment amount of $0 because it would only be reported on a claim that 
also includes a payable HCPCS G-code for MDPP services as described 
subsequently in this section.
    HCPCS G-codes GXXX1 through GXXX3 and GXXX8 through GXX17 may each 
be paid only once in a beneficiary's lifetime, and the Medicare claims 
processing system would ensure that no more than one of each specific 
performance payment per beneficiary reported with these HCPCS G-codes 
is made. In addition, because only one performance payment may be made 
for each core maintenance session interval per beneficiary, the claims 
processing system would also ensure that no more than one unit of HCPCS 
code GXXX4 or GXXX6 and no more than one unit of HCPCS code GXXX5 or 
GXXX7 was paid in a beneficiary's lifetime.
    Due to these lifetime limitations on payment for certain HCPCS 
codes for each beneficiary, in the circumstances where two MDPP 
suppliers furnished sessions during the MDPP services period and both 
MDPP suppliers met all requirements for billing the same HCPCS G-code, 
based on our operational processes, we would pay the first valid claim 
received and deny the second claim. The first valid claim received for 
a beneficiary for a given HCPCS G-code with a lifetime limitation would 
be determined through the CMS' Common Working File (CWF), which 
processes claims for all MACs.
    Based on information from the CDC's national DPP, we expect that 
circumstances where a beneficiary changes MDPP suppliers during the 
MDPP services period will be uncommon. In addition, in view of the 
typical structure of DPPs where core sessions are offered weekly for 
the first 6 months of the core services period, and then offered 
monthly, we believe it would be rare for more than one MDPP supplier to 
meet the requirements for billing for the same once-per-lifetime 
performance payment. However, as an example an MDPP beneficiary could 
maintain the required minimum weight loss throughout the first core 
maintenance session interval and attend 3 sessions furnished by one 
MDPP supplier in the first 1\1/2\ months of the first core maintenance 
interval, and then change to another supplier and attend 3 more core 
maintenance sessions furnished by a subsequent MDPP supplier before the 
end of that interval. While both MDPP suppliers would meet the 
requirements for billing HCPCS code GXXX6, we would only pay the first 
claim for the HCPCS G-code that was submitted. The second claim for 
HCPCS code GXXX6 received by us would be denied. We expect that our 
operational processes will result in MDPP suppliers submitting claims 
for HCPCS G-codes as soon as the sessions are furnished that meet all 
of the requirements for billing for the particular performance payment, 
and that this practice will generally result in the performance payment 
being made to the MDPP supplier that furnished the first session where 
the performance goals were met.
    Finally, as discussed in section III.K.2.d.v. of this proposed 
rule, we are not proposing to limit the number of bridge payments, 
which would be reported with HCPCS code GXX18, that may be paid for an 
MDPP beneficiary who changes MDPP suppliers during the MDPP services 
period.

           Table 33--Proposed HCPCS G-Codes for MDPP Services
------------------------------------------------------------------------
      Proposed HCPCS
   G[dash]code for MDPP       Proposed      Description of MDPP service
        services *         payment amount
------------------------------------------------------------------------
GXXX1....................             $25  1st core session attended.
GXXX2....................              30  4 total core sessions
                                            attended.
GXXX3....................              50  9 total core sessions
                                            attended.
GXXX4....................              10  3 core maintenance sessions
                                            attended in months 7-9
                                            (weight- loss goal not
                                            achieved or maintained).
GXXX5....................              10  3 core maintenance sessions
                                            attended in months 10-12
                                            (weight loss goal not
                                            achieved or maintained).
GXXX6....................              60  3 core maintenance sessions
                                            attended in months 7-9 and
                                            weight loss goal achieved or
                                            maintained.
GXXX7....................              60  3 core maintenance sessions
                                            attended in months 10-12 and
                                            weight loss goal achieved or
                                            maintained.
GXXX8....................             160  5 percent weight loss from
                                            baseline achieved.
GXXX9....................              25  9 percent weight loss from
                                            baseline achieved.
GXX10....................              50  3 ongoing maintenance
                                            sessions attended in months
                                            13-15 and weight loss goal
                                            maintained.
GXX11....................              50  3 ongoing maintenance
                                            sessions attended in months
                                            16-18 and weight loss goal
                                            maintained.
GXX12....................              50  3 ongoing maintenance
                                            sessions attended in months
                                            19-21 and weight loss goal
                                            maintained.
GXX13....................              50  3 ongoing maintenance
                                            sessions attended in months
                                            22-24 and weight loss goal
                                            maintained.
GXX14....................              50  3 ongoing maintenance
                                            sessions attended in months
                                            25-27 and weight loss goal
                                            maintained.
GXX15....................              50  3 ongoing maintenance
                                            sessions attended in months
                                            28-30 and weight loss goal
                                            maintained.
GXX16....................              50  3 ongoing maintenance
                                            sessions attended in months
                                            31-33 and weight loss goal
                                            maintained.
GXX17....................              50  3 ongoing maintenance
                                            sessions attended in months
                                            34-36 and weight loss goal
                                            maintained.
GXX18....................              25  Bridge payment--first session
                                            furnished by MDPP supplier
                                            to an MDPP beneficiary who
                                            has previously received MDPP
                                            services from a different
                                            MDPP supplier.
GXX19....................               0  MDPP session reported as a
                                            line-item on a claim for a
                                            payable MDPP services HCPCS
                                            G-code for a session
                                            furnished by the billing
                                            supplier that counts toward
                                            achievement of the
                                            attendance performance goal
                                            for the payable MDPP
                                            services HCPCS G-code.
------------------------------------------------------------------------
* Illustrative HCPCS G-code numbers are placeholders to allow for
  comment on this proposed rule. Final HCPCS codes for MDPP services
  under the MDPP expanded model will be included in the CY 2018 PFS
  final rule.

    We also plan to issue specific billing instructions to MDPP 
suppliers for those 14 proposed HCPCS G-codes (excluding GXXX1, GXXX8, 
GXXX9, GXX18, and GXX19) that represent an interval performance payment 
where attendance

[[Page 34151]]

at more than 1 session is required for the performance payment to be 
made. Suppliers would report the applicable HCPCS G-code as a line-item 
on the claim on the date the session was furnished where the interval 
attendance goal was met. On the same claim, suppliers would also report 
1 line-item of HCPCS code GXXX19 for each other session furnished by 
the supplier during the interval that was not previously reported on a 
claim but that counts toward achievement of the attendance performance 
goal for the applicable HCPCS G-code.
    For example, while beneficiary attendance at the 2nd and 3rd of the 
4 core sessions would not result in a separate performance payment, we 
would instruct MDPP suppliers that the 2nd and 3rd core sessions 
furnished by the supplier submitting the claim for HCPCS code GXXX2 (4 
total core sessions attended) be reported as 2 separate line-items of 
HCPCS code GXX19 on the claim for the performance payment for 4 core 
sessions attended. The 4th core session furnished by the billing 
supplier where the interval attendance goal was met would be 
represented on the claim line reporting HCPCS code GXXX2. Each of these 
line-items (one line-item of GXXX2 and 2 line-items of GXX19) would 
include the date of service and the NPI of the coach associated with 
that MDPP supplier who furnished the specific session reported as the 
line-item.
    When billing for a HCPCS G-code that represents a cumulative number 
of MDPP sessions where some sessions already have been reported on a 
previous claim, only the sessions not previously reported on a claim 
would be reported by the MDPP supplier. For example, HCPCS code GXXX3 
(9 total core sessions attended) would be used to bill for 9 core 
sessions attended, and the line-item of HCPCS code GXXX3 would 
represent the 9th core session furnished. Separate line-items of HCPCS 
code GXX19 would be reported on the same claim only for the 5th through 
8th core sessions furnished by the MDPP supplier. Claims for HCPCS 
codes GXXX1 (1st core session attended) and GXXX2 (4 core sessions 
attended) would already have been submitted, and those claims would 
have included line-items for the 1st core session, and for the 2nd, 
3rd, and 4th core sessions.
    We believe that instructing MDPP suppliers to report a line-item 
for each session on a single claim submitted for an interval 
performance payment would simplify the tracking and administrative 
activities of MDPP suppliers and the reporting of the coach NPI on 
claims for MDPP services furnished to beneficiaries as discussed in 
section III.K.2.d.iii.(10)(d) of this proposed rule. We further believe 
that there should be no significant administrative burden for MDPP 
suppliers to include information on all sessions they furnished on 
interval performance payment claims for two reasons. First, the 
documentation requirements for MDPP sessions at Sec.  424.205(g), 
including the beneficiary's eligibility, specific session topics 
attended, the NPI of the coach who furnished the session attended, the 
date and place of service of sessions attended, and weight, would 
require the MDPP supplier to document and retain this information.
    Therefore, MDPP suppliers would have documentation of the date of 
each session and the NPI of the furnishing coach for reporting on each 
line-item on the claim for the interval performance payment. Second, 
MDPP suppliers would be instructed not to submit separate claims for 
each session represented in an interval performance payment. All 
sessions would be reported on the single claim that would be submitted 
for the interval performance payment.
    In the case of an MDPP supplier submitting a claim for an interval 
performance payment where the billing supplier did not furnish all the 
sessions attributable to the interval because another supplier had 
furnished some of the first sessions in the interval, the billing 
supplier would report on the claim only the sessions it furnished. 
However, the supplier would need to maintain MDPP records documenting 
that all requirements, including session attendance and achievement or 
maintenance of weight loss, if applicable, for billing the HCPCS G-code 
for the interval for the beneficiary were met. Any sessions covered by 
the interval performance payment HCPCS G-code but not furnished by the 
supplier submitting the claim for that interval would not be reported 
as separate line-items on the claim. However, the billing supplier 
would need to maintain in the beneficiary's MDPP record a copy of his 
or her MDPP record from the previous supplier in order to consider 
sessions furnished by the previous supplier in determining that the 
performance goal(s) for the interval performance payment were met.
    Although the NPIs of the coaches who furnished such sessions that 
would not be reported as separate line-items would also not be recorded 
on the claim, the billing supplier would still be required to maintain 
documentation in the beneficiary's MDPP record of the NPI of each coach 
who furnished each session through a copy of the beneficiary's MDPP 
record about those sessions from the previous supplier. Therefore, upon 
medical review, CMS and its contractors would be able to review and 
assess the remaining coaches who furnished sessions to Medicare 
beneficiaries associated with a claim submitted for a given interval 
performance payment HCPCS G-code, but who do not have an NPI reported 
on the claim. Because we expect it to be uncommon for suppliers not to 
furnish all sessions attributable to an interval and due to the 
administrative burden that could result from a requirement that an MDPP 
supplier report specific information on sessions on a claim that the 
particular supplier did not itself furnish, we believe the program 
integrity risk associated with the limitation in the completeness of 
information from administrative claims data under this scenario is low. 
However, we will monitor the completeness of reporting line-items on 
claims for interval performance payments and may consider revising our 
billing instructions in the future if we determine that we lack 
information from administrative claims on a significant number of 
sessions furnished to MDPP beneficiaries.
    We are inviting public comments on the proposal to create 19 HCPCS 
G-codes for billing for the performance payments and bridge payment and 
reporting additional session line-items on claims for MDPP services. We 
also are inviting public comment on matters related to billing 
instructions for MDPP suppliers that we plan to issue so that 
information on the date and furnishing coach NPI for all sessions 
furnished by the billing supplier would be submitted on claims. 
However, we note that we intend to provide additional claims submission 
instructions in guidance.
(d) Reporting the Coach National Provider Identifier (NPI) on Claims
    In the CY 2017 PFS final rule, we established the policy that 
coaches will not enroll in Medicare for purposes of furnishing MDPP 
services, but that they will be required to obtain NPIs. Further 
details on these policies are described in section III.K.2.e.iii. of 
this proposed rule.
    According to Chapter 26, Section 10.4 of the Medicare Claims 
Processing Manual,\25\ the NPI of the rendering provider is to be 
reported as Item 24J on the line-item for each service reported on the 
CMS-1500 claim form. Our proposal in section III.K.2.d.iii.(10)(c) of

[[Page 34152]]

this proposed rule would require that, in the circumstances of a claim 
for an interval performance payment for MDPP services, each session 
furnished by the billing supplier be reported as a separate line-item 
on the claim. In addition, we are proposing to require MDPP suppliers 
to report the NPI of the coach who furnished the session as Item 24J on 
the line-item for each session reported on claims for performance 
payments for MDPP services. Under our proposal, the coach who furnished 
the session would be the rendering provider for purposes of reporting 
on the CMS-1500 claim form.
---------------------------------------------------------------------------

    \25\ Available at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c26.pdf.
---------------------------------------------------------------------------

    While only MDPP suppliers, not coaches, would be subject to 
potential Medicare administrative actions related to payments the 
suppliers may receive, we believe that our proposal to require the NPI 
of the coach who furnished the session to be reported as the rendering 
provider for each line-item HCPCS G-code on a claim for MDPP services 
would provide us with a number of program integrity protections, 
including the ability to monitor MDPP coach activity to identify 
suspected fraud or other improper payments and to determine the need 
for medical review or investigation as appropriate. We would only 
process claims for payment of MDPP services when all of the coach NPIs 
reported on the claim are associated with eligible coaches who have 
been submitted on the coach roster in the MDPP supplier's enrollment 
application, and when all of the coaches have successfully completed 
Medicare's screening processes. We would also only process claims for 
payment of MDPP services furnished by a coach on or after his or her 
coach eligibility start date, and, if applicable, prior to his or her 
coach eligibility end date, as the definitions of these terms are 
included in proposed Sec.  424.205(a).
    Without such program integrity protections, we would lack a 
sufficient method to verify that payment is being made for services 
furnished by a coach who has met the requirements outlined in section 
III.K.2.e.iii. of this proposed rule. This verification will help 
protect both Medicare beneficiaries and the Medicare Trust Funds. 
Including coach NPIs on claims may also encourage accuracy in reporting 
on the achievement of beneficiary attendance and/or weight loss 
performance goals because both CMS and MDPP suppliers would be able to 
identify on the claim in question which coaches furnished the sessions 
attributable to the performance payment. In addition, because the 
accuracy of information reported on the claim is ultimately the MDPP 
supplier's responsibility, and the MDPP supplier attests to the 
accuracy of each claim submitted, including the relevant coach NPIs on 
the claim may assist the MDPP supplier when conducting internal 
monitoring of claim accuracy.
    These proposed requirements for reporting the coach NPI as the 
rendering provider on session line-items included on claims for 
performance payments and bridge payments to MDPP suppliers are included 
at proposed Sec.  414.84(b) and (c). We are inviting public comments on 
these proposals.
iv. Comparison of Supplier Requirements for Furnishing the Set of MDPP 
Services and Supplier Payment
    As in the DPP model test under section 1115A(b) of the Act, MDPP 
services are based on a CDC-approved DPP curriculum and, therefore, 
MDPP suppliers must offer sessions in accordance with that curriculum. 
We are proposing to apply a performance-based payment methodology to 
MDPP services, which ties most payments to outcomes--in this case, 
weight loss and session attendance--to help incentivize suppliers to be 
engaged in their beneficiaries' weight loss efforts. Given this 
proposed methodology, we recognize that there would be an inherent 
amount of supplier financial risk, and that coverage of sessions and 
supplier requirements and payment would not always align. This section 
aims to clarify how we are proposing that these elements would fit 
together in the MDPP expanded model, as displayed in Table 34.

                                   Table 34--Set of MDPP Services and Payment
----------------------------------------------------------------------------------------------------------------
                                         MDPP beneficiary         MDPP supplier must
           MDPP services             eligibility for coverage           offer            MDPP supplier payment
----------------------------------------------------------------------------------------------------------------
Core sessions (months 1 to 6 of     An eligible beneficiary     At least 16 core        $25 performance
 the MDPP services period).          has Medicare coverage of    sessions, furnished    payment for beneficiary
                                     core sessions in the        no more frequently     attendance at the first
                                     first 6 months of the       than once per week,    core session.
                                     MDPP core services          over the first 6       $30 interval
                                     period, regardless of       months of the          performance payment
                                     attendance or weight loss.  beneficiary's MDPP     after the beneficiary
                                    * Note: To start the MDPP    services period.       has attended a total of
                                     services period, the                               4 core sessions.
                                     beneficiary attends his                            $50 interval
                                     or her first core                                  performance payment
                                     session, which begins the                          after the beneficiary
                                     beneficiary's MDPP                                 has attended a total of
                                     services period timeline                           9 core sessions.
                                     of a maximum of 36                                * Note: All payments for
                                     months..                                           core sessions are
                                                                                        independent of
                                                                                        beneficiary weight loss.
Core maintenance sessions (months   Beneficiary has coverage    At least 1 core         $10 payment if a
 7 to 12 of the MDPP services        of core maintenance         maintenance session    beneficiary attends 3
 period).                            sessions in months 7 to     per month in months    sessions within a 3-
                                     12 of the MDPP services     7 to 12 of the MDPP    month core maintenance
                                     period, regardless of       services period.       session interval but
                                     attendance or weight loss.                         does not achieve or
                                                                                        maintain the required
                                                                                        minimum weight loss at
                                                                                        least once within that 3-
                                                                                        month core maintenance
                                                                                        session interval; or
                                                                                        $60 if a
                                                                                        beneficiary attends 3
                                                                                        sessions and achieves or
                                                                                        maintains the required
                                                                                        minimum weight loss at
                                                                                        least once within that 3-
                                                                                        month core maintenance
                                                                                        session interval.
                                                                                       * Note: There are two
                                                                                        consecutive core
                                                                                        maintenance session
                                                                                        intervals.

[[Page 34153]]

 
Ongoing maintenance sessions        Beneficiary has coverage    At least 1 ongoing      $50 payment if a
 (months 13 to 36 of the MDPP        of ongoing maintenance      maintenance session    beneficiary attends 3
 services period).                   sessions in the first       per month for up to    sessions and maintains
                                     ongoing maintenance         24 months, if the      the required minimum
                                     session interval (months    beneficiary            weight loss from
                                     13 to 15 of the MDPP        maintains              baseline at least once
                                     services period) if:        eligibility to have    within a 3-month ongoing
                                     He or she           coverage of ongoing    maintenance session
                                     attended at least 1         maintenance sessions.  interval.
                                     session during the final                          * Note: There are up to
                                     core maintenance session                           eight consecutive
                                     interval (months 9 to 12                           ongoing maintenance
                                     of the MDPP services                               session intervals.
                                     period) and had weight
                                     measured..
                                     He or she
                                     achieved or maintained
                                     the required minimum
                                     weight loss at least once
                                     during the final core
                                     maintenance session
                                     interval (months 10 to 12
                                     of the MDPP services
                                     period)..
                                    A beneficiary has coverage
                                     of a subsequent ongoing
                                     maintenance session
                                     interval (for up to 21
                                     months after the end of
                                     the first ongoing
                                     maintenance session
                                     interval), if he or she
                                     attended at least 3
                                     sessions and maintained
                                     the required minimum
                                     weight loss from baseline
                                     at least once during the
                                     previous ongoing
                                     maintenance session
                                     interval.
----------------------------------------------------------------------------------------------------------------

    Once an MDPP supplier enrolls in Medicare to furnish MDPP services, 
it must offer the set of MDPP services in accordance with the MDPP 
supplier standards (noted in section III.K.2.e.iv.(4) of this proposed 
rule and at Sec.  424.205(d), including that it must offer at least 16 
core sessions, furnished no more frequently than once per week, over 
the first 6 months of the MDPP core services period; at least 1 core 
maintenance session per month over months 7 to 12 of the MDPP core 
services period; and at least 1 ongoing maintenance session per month 
for up to 24 additional months (months 13 through 36 of the MDPP 
services period), if the beneficiary maintains eligibility for coverage 
of ongoing maintenance sessions. We recognize that beneficiaries might 
not attend these sessions. However, they must be made available, in 
accordance with CDC's DPRP standards, to beneficiaries as long as they 
are eligible for coverage of MDPP sessions. We further note that the 
set of MDPP services must be furnished in compliance with all 
applicable federal laws and regulations.
    Although a beneficiary is not required to use MDPP services at all, 
the MDPP services period is initiated by the beneficiary attending his 
or her first core session, which begins the MDPP services period 
timeline. To qualify for coverage of ongoing maintenance sessions, a 
beneficiary would also need to attend at least 1 session during the 
final core maintenance session interval where in-person weight 
measurement is performed that demonstrates the achievement or 
maintenance of the required minimum weight loss.
    All of the proposed performance payments except for the weight loss 
performance payments require the achievement of an attendance 
performance goal, and if a beneficiary does not achieve attendance 
performance goals, an MDPP supplier would not be paid a performance 
payment that relies on achieving those goals. For example, if a 
beneficiary does not attend 3 sessions in the first core maintenance 
session interval, a supplier would not be paid a performance payment 
for the interval that spans months 7 to 9 of the MDPP core services 
period. However, a supplier must offer at least 1 core maintenance 
session per month to the beneficiary to ensure that the beneficiary has 
the opportunity to attend. Furthermore, while the proposed weight loss 
performance payments are based solely on the achievement of the 
required minimum or 9 percent weight loss, we note that all weight loss 
measurements must be obtained in person at a session so that if a 
beneficiary does not attend a session where weight loss can be measured 
and compared to baseline, the MDPP supplier would not be paid a 
performance payment that relies on achieving a weight loss performance 
goal.
v. Payment Policies When a Beneficiary Changes MDPP Suppliers
    In the CY 2017 PFS final rule (81 FR 80470), we confirmed that a 
beneficiary may change MDPP suppliers at any time. However, we deferred 
specific policies regarding attribution of beneficiaries who change 
MDPP suppliers as related to payment to future rulemaking. We are 
making proposals for payment policies when a beneficiary changes MDPP 
suppliers during the MDPP services period in this section.
    At proposed Sec.  414.84(a)(1), we are proposing to define ``bridge 
payment'' as a one-time payment to an MDPP supplier for furnishing its 
first MDPP services session to an MDPP beneficiary who has previously 
received one or more MDPP services from a different MDPP supplier. We 
use this definition in the proposed MDPP payment policies for the 
circumstances when a beneficiary changes MDPP suppliers for any reason 
during the MDPP services period after the beneficiary has attended at 
least the first core session.
    In cases where the beneficiary changes MDPP suppliers, there is a 
shift in accountability for offering the set of MDPP services for which 
the beneficiary is eligible for coverage from one MDPP supplier to a 
subsequent MDPP supplier. Similar to our proposal for a performance 
payment to an MDPP supplier that furnishes the first core session to an 
MDPP beneficiary who initiates the MDPP services period as discussed in 
section III.K.2.d.iii.(3) of this proposed rule, we are proposing that 
an MDPP supplier would be paid a bridge payment of $25 for furnishing 
its first session to an MDPP beneficiary who has previously received 
MDPP services from a different MDPP supplier, regardless of whether the 
MDPP

[[Page 34154]]

supplier is paid any performance payments for that beneficiary. A 
subsequent MDPP supplier would be paid this bridge payment after 
furnishing the first session to a beneficiary and billing the 
appropriate HCPCS G-code only if the supplier did not furnish the first 
core session to the MDPP beneficiary.
    We believe that making a bridge payment that is the same amount as 
the proposed performance payment for the first core session discussed 
in section III.K.2.d.iii.(3) of this proposed rule is appropriate 
because we expect the MDPP supplier's resources used to be similar 
under both of these circumstances. The subsequent supplier would expend 
resources for furnishing a first session to a beneficiary, including 
collecting administrative information on the beneficiary who is not 
already known to the supplier, regardless of whether the beneficiary 
goes on to receive further MDPP sessions from that supplier.
    We are proposing that the bridge payment would be paid to the 
subsequent MDPP supplier any time a beneficiary changes suppliers 
during the MDPP services period, regardless of when during the core 
services period or ongoing services period the beneficiary changes MDPP 
suppliers. The bridge payment is not intended to be a performance 
payment, which could be paid to the subsequent MDPP supplier in 
addition to the bridge payment if a beneficiary achieves a performance 
goal while receiving MDPP services from that the subsequent supplier. 
Rather, the bridge payment accounts for the financial risk a subsequent 
MDPP supplier takes on by furnishing services to a beneficiary changing 
MDPP suppliers during the MDPP services period.
    We believe that when suppliers furnish MDPP services to MDPP 
beneficiaries in these circumstances, they generally do not have the 
same opportunity for performance payments that they would have if the 
beneficiary had been receiving MDPP services from the supplier from the 
beginning of the MDPP services period because certain performance 
goals, such as the required minimum weight loss, might already have 
been achieved by the beneficiary. The proposed bridge payment policy 
would play an important role in ensuring access to MDPP services and 
freedom of choice of MDPP suppliers for those beneficiaries who either 
choose to or must change suppliers during the MDPP services period.
    If we were to only make performance payments for MDPP services as 
proposed in sections III.K.2.d.iii.(3) through (6) of this proposed 
rule and not make a bridge payment to a subsequent supplier when an 
MDPP beneficiary changes suppliers during the MDPP services period, 
access problems could result due to the number of scenarios where 
subsequent MDPP suppliers offering and furnishing MDPP services would 
be paid no performance payment for the sessions furnished. The 
following examples illustrate such scenarios.
     A beneficiary changes from MDPP supplier A to MDPP 
supplier B after attending core session 4; attends core sessions 5 to 8 
with supplier B; and then decides not to attend any more MDPP sessions. 
Supplier B does not meet the requirements for billing for the 
performance payment for the 9th core session because only 8 core 
sessions were attended, despite supplier B offering and furnishing core 
sessions 5 to 8.
     A beneficiary who has not met the required minimum weight 
loss performance goal changes from MDPP supplier A to MDPP supplier B 
after completing the first 3-month core maintenance session interval; 
attends 2 core maintenance sessions in months 9-12 with supplier B; and 
then fails to attend the 3rd core maintenance session in this interval. 
Supplier B does not meet the requirements for billing for the 
performance payment for the second core maintenance session interval 
despite offering and furnishing core maintenance sessions and the 
beneficiary eligibility for coverage of MDPP services then ends after 
month 12, the end of the core services period.
    We believe that circumstances like these examples where subsequent 
MDPP suppliers would receive no payment for sessions furnished to MDPP 
beneficiaries who change suppliers during the MDPP services period in 
the absence of the bridge payment policy could lead to those MDPP 
suppliers preferentially seeking to furnish the remaining MDPP services 
during the MDPP services period to beneficiaries who have either 
already achieved the required minimum weight loss, or whom they believe 
will attend sessions and achieve weight loss, because the required 
minimum weight loss is tied to eligibility for ongoing maintenance 
sessions and higher performance payment for core maintenance session 
intervals.
    We note that we are proposing in section III.K.2.e.iv.(4) of this 
proposed rule that MDPP suppliers may not deny access to MDPP services 
to eligible beneficiaries based on any reason other than the supplier's 
own capacity limits to furnish MDPP services to additional 
beneficiaries and on a discretionary basis if a beneficiary 
significantly disrupts the session for other participants or becomes 
abusive. However, MDPP suppliers could comply with this access 
requirement, while still preferentially seeking to furnish the 
remaining MDPP services in the MDPP services period to MDPP 
beneficiaries they believe are most likely to achieve the performance 
goals. To ensure beneficiary freedom of choice of MDPP supplier, 
including the choice to change suppliers, we believe the proposal to 
make a bridge payment helps mitigate the likelihood of MDPP suppliers 
acting on such preferences. The subsequent supplier would be paid a 
bridge payment for a beneficiary who changes suppliers, even if the 
beneficiary does not achieve performance goals that result in a 
performance payment being made to the subsequent supplier.
    We considered an alternative policy in which the bridge payment 
would only be made in circumstances where the subsequent supplier would 
not be paid a performance payment that is based on attendance at the 
first session furnished by that supplier. For example, under this 
alternative if a beneficiary attends the 1st session during the ongoing 
maintenance session interval for months 13 through 15 at one MDPP 
supplier and then changes to a subsequent MDPP supplier that furnishes 
two additional ongoing maintenance sessions within that same interval 
and the beneficiary maintains the required minimum weight loss, the 
subsequent supplier would not be paid the $25 bridge payment but would 
be paid the ongoing maintenance session interval performance payment 
for months 13 through 15. The subsequent supplier would only be paid 
the $25 bridge payment if the beneficiary did not maintain the required 
minimum weight loss for the performance payment for that ongoing 
maintenance session interval. We are not proposing this alternative 
because we believe it is appropriate to make a bridge payment for the 
first session furnished by the subsequent supplier that expends 
resources for furnishing a session to a beneficiary not previously 
known to that supplier, unrelated to whether or not the beneficiary 
achieves a performance goal that results in a performance payment being 
paid to the subsequent supplier.
    We are proposing that an MDPP supplier can be paid either one 
performance payment for furnishing the first core session or one bridge 
payment per beneficiary, but not both. We are proposing this policy 
because we

[[Page 34155]]

believe that the potential to be paid both a performance payment for 
the first core session and a bridge payment, or multiple bridge 
payments, for the same beneficiary, could increase the risk of MDPP 
suppliers encouraging discontinuous care patterns. Such patterns could 
hinder the achievement of the required minimum weight loss that leads 
to a reduction in the incidence of type 2 diabetes and could lead to 
increased Medicare expenditures for MDPP services. Financial incentives 
resulting from the potential for multiple bridge payments to a single 
supplier for one beneficiary could lead MDPP suppliers to encourage 
beneficiaries to repeatedly change among them between sessions during 
the MDPP services period so that the suppliers may repeatedly bill for 
bridge payments. We believe that limiting the bridge payment to one per 
beneficiary per supplier and making it available for payment only if 
the performance payment for the first core session was not paid to that 
same supplier helps mitigate this risk. However, we are not proposing 
to limit the number of MDPP suppliers that may be paid a bridge payment 
for a particular beneficiary because we are not proposing to limit 
beneficiary freedom of choice for MDPP suppliers. We are proposing only 
to limit the bridge payments that a particular MDPP supplier may be 
paid for each MDPP beneficiary to one.
    While this proposed limit is intended to provide some protection 
against MDPP suppliers encouraging certain care patterns for the 
purposes of their financial gain alone, we understand there may be 
organizations enrolled in Medicare as the same supplier type but under 
separate MDPP supplier enrollment records that are part of a larger 
franchise or umbrella organization with shared financial interests. 
There is some program integrity risk that these organizations could 
coordinate to bill multiple bridge payments that would ultimately 
increase total MDPP payments to separately enrolled MDPP suppliers to 
serve the financial interests of the umbrella organization. This 
scenario could occur if MDPP suppliers systematically encourage 
beneficiaries to change suppliers for the purpose of being paid the 
bridge payment.
    Although we believe that organizations under a larger umbrella 
organization may have a greater financial incentive and opportunity to 
engage in this behavior, we understand that any two or more MDPP 
suppliers could coordinate in this way, potentially affecting large 
numbers of MDPP beneficiaries. To mitigate this risk, we are proposing 
to prohibit MDPP suppliers and other individuals or entities performing 
functions or services related to MDPP services on an MDPP supplier's 
behalf from unduly coercing an MDPP beneficiary's decision to change or 
not to change to a different MDPP supplier, including through the use 
of pressure, intimidation, or bribery as described further in section 
III.K.2.e.iv.(4). of this proposed rule. We will monitor MDPP supplier 
billing patterns to detect how frequently bridge payments are paid and 
to determine whether patterns exists that may suggest fraudulent 
activity regarding bridge payment claim submissions across suppliers, 
conducting audits, medical reviews, and investigations as appropriate.
    In the CY 2017 PFS final rule, we finalized at Sec.  410.79(b) that 
a beneficiary's baseline weight refers to the MDPP beneficiary's body 
weight recorded during that beneficiary's first core session. This 
definition applies to determine weight loss throughout the MDPP 
services period. Additionally, the once-per-lifetime policy finalized 
at Sec.  410.79(d)(1) applies if a beneficiary changes MDPP suppliers, 
and the services furnished by the subsequent supplier would begin where 
the beneficiary left off with the previous supplier. We recognize these 
policies may require the beneficiary to request that a copy of his or 
her MDPP record be provided by the previous supplier to the subsequent 
supplier so that subsequent supplier can determine whether the 
beneficiary achieves or maintains the required minimum weight loss and 
has information about the MDPP services already furnished. We also 
finalized at Sec.  424.59(b) (proposed to be redesignated and amended 
as Sec.  424.205(g)) that an MDPP supplier shall maintain documentation 
that includes services furnished and body weight measurements. Finally, 
we finalized at Sec.  424.59(b) (proposed to be redesignated and 
amended as Sec.  424.205(g)) that MDPP suppliers are required to 
maintain and handle any beneficiary PII and PHI in compliance with 
HIPAA, other applicable privacy laws and CMS standards. Any sharing of 
information from a beneficiary's MDPP record between MDPP suppliers 
must follow these rules.
    We are considering ways to streamline the sharing of this 
information between suppliers, such as through the development of a 
model tracker that logs the contact information of a beneficiary's 
previous supplier and/or coach, and the beneficiary's attendance and 
weight loss. Beneficiaries could take the tracker with them if they 
change suppliers during the MDPP services period. Such a tracker would 
not supplant the previous supplier's beneficiary MDPP record which the 
subsequent supplier would need to have a copy of in order to consider 
sessions furnished by the previous supplier in determining whether the 
subsequent supplier could bill for a performance payment that was based 
in part on those prior sessions as discussed in section 
III.K.2.d.iii.(10)(b) of this proposed rule. If the subsequent supplier 
does not have the beneficiary's MDPP record from the previous supplier, 
the subsequent supplier cannot use information from the sessions 
furnished by the previous supplier, such as weight or session 
attendance, to determine that the performance goals for a performance 
payment were met so that the subsequent supplier can bill for the 
performance payment. However, it may help facilitate the process for 
subsequent suppliers to enroll beneficiaries partway through the MDPP 
services period while the subsequent supplier is coordinating with the 
previous supplier to obtain a copy of the beneficiary's MDPP record 
from that supplier. We are inviting public comments on additional ways 
this data sharing could be streamlined between suppliers.
    The proposed bridge payment is included at proposed Sec.  
414.84(c). We are inviting public comments on this proposal and the 
alternative considered.
e. Supplier Enrollment and Compliance
    In the CY 2017 PFS final rule, we established MDPP supplier 
enrollment eligibility and revocation policies at Sec.  424.59. We 
propose to add subpart I, which includes Sec. Sec.  424.200, 424.205, 
and 424.210. This subpart specifies the requirements for Medicare 
Diabetes Prevention Program suppliers and beneficiary engagement 
incentives under the Medicare Diabetes Prevention Program expanded 
model. We propose to redesignate all requirements under Sec.  424.59 to 
Sec.  424.205. These requirements previously finalized in the CY 2017 
PFS final rule created MDPP suppliers as a new Medicare supplier type, 
and require that any organization seeking to furnish and receive 
payment for MDPP services must enroll as this supplier type. Given that 
the set of MDPP services utilizes CDC's DPRP curriculum, in the CY 2017 
PFS final rule we established supplier eligibility criteria that 
closely match CDC's DPRP standards. The CY 2017 PFS final rule provides 
that any organization that meets full CDC DPRP recognition will be 
eligible to enroll as an MDPP

[[Page 34156]]

supplier. In this proposed rule, we are proposing to build on these 
eligibility criteria for enrollment, as well as make some changes, as 
described in further detail later in this section.
    The CY 2017 PFS final rule also established other requirements 
related to MDPP suppliers. For example, we assigned MDPP suppliers to 
the high-risk screening category under Sec.  424.518. We also 
established the policy that coaches will not enroll in Medicare for 
purposes of furnishing MDPP services, but that they would be required 
to obtain NPIs. We established that MDPP suppliers must submit the 
active and valid NPIs of all affiliated coaches and provide updates of 
this information to us within 30 days of a coach beginning or ceasing 
to furnish MDPP services. We provided that this roster of coach 
information must include the first and last name, social security 
number (SSN), and NPI. The proposals outlined in this section seek to 
build on these requirements.
    In the CY 2017 PFS final rule, we acknowledged that many DPP 
organizations have not yet achieved full CDC DPRP recognition, and that 
it might take 36 months to meet CDC's performance standards for full 
recognition. We believe allowing only organizations with full 
recognition to enroll as an MDPP supplier would limit the number of 
organizations with demonstrated capacity to furnish MDPP services, and 
therefore, constrain beneficiary access to these services. However, we 
deferred to future rulemaking addressing the issue of allowing certain 
DPP organizations with less than full CDC recognition to enroll in 
Medicare.
    We are proposing an MDPP interim preliminary recognition standard 
under CMS authority (proposed at Sec.  424.205(c)). We also are 
proposing that organizations that meet this standard would be eligible 
to enroll in Medicare as an MDPP supplier.
i. Preliminary Recognition
    The current CDC 2015 Diabetes Prevention Recognition Program (DPRP) 
Standards do not have standards for preliminary recognition. In the CY 
2017 PFS final rule, we indicated that we would align the CDC's DPRP 
and the set of MDPP services, to the extent possible. It will not be 
possible for CMS to permit DPP organizations to enroll as MDPP 
suppliers based on achievement of any new CDC standard through this 
rulemaking because any updates to the CDC Standards are not expected to 
go into effect until 2018.
    However, our intent is to allow organizations that do not yet have 
full recognition, but have demonstrated a capacity to furnish DPP 
services, to enroll in Medicare as of the effective date of the 
enrollment policies proposed in this rule. We believe this will 
increase access to MDPP services. For this reason, we are proposing, at 
Sec.  424.205(c), to establish an MDPP interim preliminary recognition 
standard to permit DPP organizations who meet this standard to enroll 
in Medicare even if they do not have full CDC recognition. This MDPP 
interim preliminary recognition standard will be hereafter referred to 
as ``interim preliminary recognition.'' As we stated in CY 2017 PFS 
final rule, our intent with this policy is to bridge the gap until such 
time as any CDC preliminary recognition standards are established. Once 
we have established the transition process with CDC, we would expect 
DPP organizations that seek to enroll into Medicare to obtain CDC 
preliminary recognition, but MDPP suppliers who have enrolled in 
Medicare with interim preliminary recognition would maintain their 
enrollment eligibility as an MDPP supplier.
(1) MDPP Interim Preliminary Recognition Standard
    We are proposing, at Sec.  424.205(c)(2)(ii), that DPP 
organizations with pending CDC recognition that meet the following 
additional criteria would meet the interim preliminary recognition 
standard:
     The organization must continue to follow the current 2015 
CDC DPRP Standards for data submission and submit a full 12 months of 
performance data to CDC on at least one completed cohort (see Appendix 
D, 2015 CDC DPRP Standards, https://www.cdc.gov/diabetes/prevention/pdf/dprp-standards.pdf). For this purpose, a completed cohort is a set 
of at least five participants that entered into a lifestyle change 
program that has a fixed first and last session and runs for 12 months. 
An organization can have multiple cohorts running at the same time:
     The 12-month data submission to CDC includes at least 5 
participants who attended at least 3 sessions in the first 6 months, 
and whose time from first session attended to last session of the 
lifestyle change program was at least 9 months; and
     Of the participants eligible for evaluation in the first 
criterion, at least 60 percent attended at least 9 sessions in months 1 
through 6 and at least 60 percent attended at least 3 sessions in 
months 7 through 12.
    All proposed data requirements reflect current reporting 
requirements to progress from pending recognition to full recognition 
through CDC's DPRP; no new data collection would be required. To 
implement the proposed interim preliminary recognition standard, DPP 
organizations with pending recognition would submit data following 
CDC's typical recognition process. For the current standards, this 
includes data submission every 12 months, during the month of the 
anniversary of the effective date. The organization's data submission 
should include: (1) Data for all sessions attended by participants from 
the approval date to the day before the first anniversary of the 
effective date, (if the organization has a 2016 effective date; this 
should include at least 6 months of participant data) or data for all 
sessions attended by participants from the last anniversary of the 
effective date to the day before the next anniversary of the effective 
date (if an organization's effective date is before 2016); and (2) one 
record for each session attended by each participant during the 
preceding year. CDC would perform a new assessment, interim preliminary 
recognition, on our behalf. Our interim preliminary recognition will be 
evaluated by CDC based on those data submissions that use the 
timetables and submission deadlines that currently apply for CDC 
recognition. For interim preliminary recognition governed under this 
regulation, CDC would provide us with its recommendation as to which 
organizations have met the recognition standards for interim 
preliminary recognition, but we, using our authority, would make the 
final decision. CMS would not make any determination for recognition 
status governed under current or future CDC DPRP recognition processes. 
We believe that such an approach would minimize burden for DPP 
organizations, promote consistency in the application of the standards, 
and allow for a smooth transition if and when CDC adopts preliminary 
recognition standards. We intend to release additional guidance on the 
details of this process once the CDC 2018 Standards are released.
(2) MDPP Supplier Enrollment Under the MDPP Interim Preliminary 
Recognition Standard
    Our regulations at Sec.  424.59 (proposed to be redesignated and 
amended at Sec.  424.205 in this proposed rule) specify that a DPP 
organization with full CDC recognition is eligible for enrollment as an 
MDPP supplier if it also meets all of the other conditions for 
enrollment in Sec.  424.59(a) (proposed to be redesignated and amended 
at Sec.  424.205(b) in this

[[Page 34157]]

proposed rule). We are proposing that organizations that meet the MDPP 
interim preliminary recognition standard, as proposed in section 
III.K.2.e.i.(1) of this proposed rule, and meet all other enrollment 
conditions would also be eligible to enroll as an MDPP supplier.
    We also are proposing that DPP organizations would be eligible to 
enroll as an MDPP supplier if they meet CDC DPRP Standards for 
preliminary recognition, once any such standards go into effect 
(proposed Sec.  424.205(c)(2)(i)). We anticipate that CDC's preliminary 
recognition standards will be established on or after January 1, 2018. 
After the effective date of any updated CDC standards, we are proposing 
that MDPP suppliers who have enrolled in Medicare with MDPP interim 
preliminary recognition would continue to be eligible for MDPP 
enrollment (assuming they continue to meet all other requirements for 
enrollment, described in proposed Sec.  424.205(b)).
    We intend to ensure that any transition an MDPP supplier may make 
from interim preliminary recognition to CDC preliminary recognition 
does not disrupt its status as an MDPP supplier. We will address 
possible transition issues in future rulemaking or guidance, as 
appropriate.
    We considered an alternative to wait until new CDC DPRP standards 
are effective to allow organizations other than those with full 
recognition to enroll as MDPP suppliers. However, as indicated in the 
CY 2017 PFS final rule, based on CDC data we believe that waiting until 
the new DPRP standards are effective would limit the number of 
organizations with demonstrated capacity to furnish the set of MDPP 
services from enrolling in Medicare when enrollment starts and offering 
MDPP services once they become effective. We are inviting public 
comments on this proposed MDPP interim preliminary recognition 
standard, including performance standards, and the use of this standard 
as a condition for enrollment in Medicare, and the alternative 
considered.
ii. Enrollment and Billing Effective Dates
(1) Date MDPP Suppliers May Begin Enrollment
    As described in section III.K.2.a. of this proposed rule, we are 
proposing to change the start date of the MDPP expanded model to April 
1, 2018. All other policies not related to the furnishing or billing of 
MDPP services would, if finalized, be effective January 1, 2018. Thus, 
although MDPP suppliers would not be able to begin furnishing MDPP 
services on January 1, 2018, MDPP supplier enrollment would begin on 
January 1, 2018, if these proposals are finalized. In the CY 2017 PFS 
final rule, we established that any organization wishing to furnish 
MDPP services must enroll as an MDPP supplier, regardless of any 
existing enrollment in Medicare. As indicated in section J.4. of the CY 
2017 PFS final rule, we believe that including an effective date for 
enrollment that precedes the implementation date for MDPP services is 
necessary to allow organizations sufficient time to enroll as MDPP 
suppliers. Thus, MDPP services would only become available after there 
is sufficient time to enroll MDPP suppliers that will furnish those 
services.
(2) Effective Date of MDPP Suppliers' Billing Privileges
    Under Sec.  424.502, the definition of enroll/enrollment means 
``the process that Medicare uses to establish eligibility to submit 
claims for Medicare-covered items and services, and the process that 
Medicare uses to establish eligibility to order or certify Medicare-
covered items and services.'' Thus, the purpose of enrollment is to 
establish billing privileges in Medicare. In accordance with our 
proposal that MDPP services will be available beginning on April 1, 
2018, we propose that MDPP suppliers may not have an effective date of 
billing privileges that precedes the date that MDPP services become 
available (proposed at Sec.  424.205(e)(2). Given that it typically 
takes an enrollment application 45-60 days to process, if an MDPP 
supplier submitted its application in January, the application may be 
approved prior to when MDPP services become available. For this reason, 
we are specifying a proposal that, under no circumstances would an MDPP 
suppliers have an effective date for billing privileges for MDPP 
services prior to April 1, 2018.
    We propose that for MDPP supplier enrollment applications that are 
submitted and subsequently approved, the effective date for billing 
privileges would be the date the application was submitted. However for 
applications submitted and subsequently approved prior to April 1, 
2018, we propose that the effective date for billing privileges would 
be April 1, 2018. This proposal is consistent with other suppliers like 
physicians, non-physician practitioner organizations, ambulance 
suppliers, and independent diagnostic testing facilities (IDTFs). 
However, unlike physicians, non-physician practitioner organizations, 
and ambulance suppliers, MDPP suppliers would not be permitted to 
retrospectively bill for services rendered prior to their effective 
date for billing privileges. Given that MDPP suppliers do not furnish 
services with immediate impacts on health like the aforementioned Part 
B suppliers, we chose to utilize the approach of IDTFs. We have 
established MDPP supplier standards as a condition of enrollment, as 
described in section III.K.2.e.iv of this proposed rule (proposed at 
Sec.  424.205(d)), and MDPP suppliers are required to certify in their 
enrollment application that they are in compliance and will continue to 
remain in compliance with all MDPP supplier standards. Therefore, 
generally, an MDPP supplier could begin furnishing services on the date 
the application was submitted, with the goal of having their 
application subsequently approved. However, payment for those services 
would depend upon whether the enrollment application is subsequently 
approved.
    We propose that for any enrollment application that is denied under 
Sec.  424.530(a)(1) for non-compliance, but then subsequently approved 
due to the submission of a corrective action plan (CAP), the effective 
date of enrollment would be the date of the CAP submission. This 
proposal is also consistent with practices for existing suppliers, and 
institutes an appropriate safeguard for Medicare beneficiaries and the 
program at-large by prohibiting services from being furnished from 
suppliers who are not compliant. We acknowledge, however, that if a 
supplier began furnishing services the date it submitted its 
application, but was then denied enrollment, it would not be paid for 
any services it furnished prior to the date it submitted the CAP, if 
approved. However, as described in section III.K.2.e.iv of this 
proposed rule (proposed at Sec.  424.205(d)), upon submitting its 
enrollment application, an MDPP supplier certifies that--to its 
knowledge--it meets and agrees to continue to meet the following MDPP 
supplier standards, and all other applicable Medicare requirements. 
Thus, at the time the MDPP supplier applicant submits its application, 
it should believe that its enrollment application will be approved. 
Examples of actions the MDPP supplier could take to improve its 
certainty and increase the probability that the application will be 
approved may include reviewing any MDPP supplier supporting 
documentation to fully understand MDPP supplier enrollment requirements 
and accompanying CMS guidance or

[[Page 34158]]

supplier support materials, confirming compliance with the MDPP 
supplier standards in this rule (including conducting background checks 
for those who would be screened by CMS during the enrollment process as 
required under Sec.  424.518(c) and proposed Sec.  424.205(d)(3)), and 
conducting a thorough review of the enrollment application to ensure no 
mistakes exist in the submitted application.
    We also propose that if an MDPP supplier adds a new administrative 
location (defined and discussed further section III.K.2.e.iii.(2) of 
this section of the proposed rule) that resulted in a new enrollment 
record or Provider Transaction Access Number (PTAN), the effective date 
for billing privileges would be the date the MDPP supplier began its 
MDPP operations at that location. We believe that this proposal is 
appropriate given that it follows a similar approach for an effective 
date that applies to when physician organizations, non-physician 
practitioner organizations, ambulance suppliers, and Independent 
Diagnostic Testing Facilities (IDTFs) add a new practice location to an 
existing enrollment record. Though the definition of administrative 
location differs from that of practice location, it provides a similar 
function. We seek comments on these proposals.
iii. Enrollment Application
(1) Enrollment Application Type Applicable to MDPP Suppliers
    We are proposing to require the use of a new, CMS-approved 
enrollment application specific to MDPP suppliers. We believe that the 
creation of a new application will be more easily navigated by and 
reduce the burden on new, non-traditional suppliers because the new 
enrollment application will only solicit information relevant to the 
MDPP supplier type. As this new enrollment application is being created 
specifically for the MDPP expanded model, we have determined that this 
new enrollment application is exempt from the Paperwork Reduction Act 
in accordance with section 1115A(d)(3) of the Act. Further, this 
enrollment application would be considered an ``enrollment 
application'' for purposes of part 424 subpart P, and therefore, all 
existing regulations and administrative guidance that govern the CMS-
855 enrollment applications would apply to this new form, unless 
otherwise specified. We also considered an alternative option to amend 
the current CMS-855B Medicare Enrollment Application for Clinics/Group 
Practices and Certain Other Suppliers (CMS-855B) for MDPP supplier 
enrollment, but we determined that the existing length and complexity 
of the CMS-855B enrollment application and its applicability to other 
non-MDPP suppliers may add burdens or unnecessary confusion to MDPP 
suppliers given that many sections of the current CMS-855B enrollment 
application would not apply to MDPP suppliers. In addition, we would 
need to add new sections to solicit information specific to MDPP 
suppliers, which would only further increase the length of the CMS-855B 
enrollment application. We invite public comments on this proposal.
(2) Information on MDPP Enrollment Application
    On the new MDPP enrollment application, we intend to solicit 
information specific to MDPP suppliers, as well as information 
consistent with existing reporting requirements applicable to all 
suppliers who enroll through the CMS-855B enrollment application, while 
excluding all reporting requirements that do not apply to MDPP 
suppliers. As a Medicare supplier enrolling under part 424 subpart P, 
MDPP suppliers are required to provide complete and accurate 
information on the MDPP enrollment application, or be subject to 
enrollment denial under Sec.  424.530(a)(4) or revocation under Sec.  
424.535(a)(4). This requirement would include all information solicited 
on the MDPP-specific enrollment application. The MDPP-specific 
enrollment application is under development and will be available prior 
to its use, if this proposal is finalized. While the application is 
being developed, we wish to indicate some of the information we intend 
to include on the MDPP enrollment application, as further described in 
this section.
    As finalized in the CY 2017 PFS final rule, Sec.  424.59(a)(5) 
requires that MDPP suppliers submit the active and valid NPIs of all 
coaches who will furnish services on the supplier's behalf, as well as 
their first name, last name, and SSN (in this proposed rule, Sec.  
424.59(a)(5) is proposed to be redesignated and amended at Sec.  
424.205(b)(4)). We are proposing, at Sec.  424.205(b)(4), to require 
that MDPP suppliers provide this identifying information of the coaches 
directly through the enrollment application. This information will be 
used to complete background checks of the coaches. To accompany the 
coach identifying information, we propose to require MDPP suppliers to 
provide an eligibility start and end date, if applicable, for each 
coach on the supplier's roster. Coach eligibility start and end dates 
are described at length in section III.K.2.e.iv.(2). As described in 
more detail in section III.K.2.e.iv., the background checks would be 
used to prevent MDPP suppliers from allowing coaches to furnish MDPP 
services when certain adverse histories may indicate potential to harm 
Medicare beneficiaries or undermine program integrity. We outline 
further details on our proposed enforcement of this provision in 
section III.K.2.e.iv. of this proposed rule.
    To enable us to conduct background checks of coaches, we are 
proposing that MDPP suppliers also submit to CMS the date of birth of 
all coaches who will furnish MDPP services (proposed Sec.  
424.205(b)(4)). Combined with other identifying information, date of 
birth plays a critical role in validating an individual's identity. By 
collecting date of birth, we would be able to more accurately screen 
coaches, including accurately conducting a background check, and 
distinguishing them in the Provider Enrollment, Chain and Ownership 
System (PECOS). In addition, we want to ensure that we have the 
capability to most accurately identify individuals reported on the 
form. To mitigate potential confusion or error found when individuals 
have common names, we are proposing to collect coach's middle initial 
(if applicable) on the enrollment application (proposed Sec.  
424.205(b)(4)). We believe that this proposal will help to lessen the 
possibility that CMS or its contractors misattribute the background of 
one individual for another.
    We are proposing, at Sec.  424.205(d)(4), that MDPP suppliers would 
identify their administrative location(s) by reporting these 
location(s) on their enrollment application. We are proposing, at Sec.  
424.205 (a), to define administrative location as the physical location 
associated with the supplier's operations, from where coaches are 
dispatched or based, and where MDPP services may or may not be 
furnished. We are proposing that an MDPP supplier must have at least 
one such administrative location, and report any additional 
administrative locations of the supplier, if MDPP services are either 
furnished at these locations and/or if the location reflects from where 
coaches are dispatched or based. For example, if an MDPP supplier 
operated 2 locations, but only 1 of the 2 locations associated with the 
entity offered MDPP, only the location offering MDPP would be 
considered an administrative location. If coaches began offering MDPP 
in community settings (described in the subsequent paragraph and 
proposed to be defined at Sec.  424.205(a), but were

[[Page 34159]]

dispatched and/or based out of the other non-administrative location, 
then this location would then be considered under the definition of an 
administrative location, and would need to be reported on the MDPP 
enrollment application within 90 days of the change. Given that MDPP 
suppliers are categorized as high risk under Sec.  424.518, these 
administrative locations may be subject to site visits prior to 
approval of an enrollment application. Collecting information on the 
MDPP supplier's administrative location (regardless whether they 
furnish services in this location) is important because we may utilize 
this information to verify that the organization is operational per 
requirements under proposed Sec.  424.205(d)(4) and (6), discussed in 
detail in section III.K.2.e.iii.(3) of this proposed rule.
    While we recognize that many suppliers furnish MDPP services 
outside of their administrative locations in community settings, we are 
proposing to only require enrollment of the administrative locations. 
In proposed Sec.  424.205(a), we define ``community setting'' as a 
location where the MDPP supplier furnishes MDPP services outside of 
their administrative locations. A community setting is a location open 
to the public, not primarily associated with the supplier. Community 
settings may include, for example, church basements or multipurpose 
rooms in recreation centers. When determining whether a location is 
considered an administrative location or a community setting, MDPP 
suppliers should consider whether their organizational entity is the 
primary user of that space and whether coaches are based or dispatched 
from this location. If so, the location would be considered an 
administrative location, even if this location dually serves as a 
community setting. In comparison, community settings are locations not 
primarily associated with the supplier where many activities occur, 
including MDPP services.
    We seek public comments on these proposals.
(3) Updating Information on MDPP Enrollment Application
    We are proposing, at Sec.  424.205(d)(5), that MDPP suppliers must 
update their enrollment application within 30 days of any changes of 
ownership, changes to the coach roster, or new final adverse action 
history of any individual or entity required to report such information 
on the enrollment application. We are proposing that MDPP suppliers 
report all other changes to information required on the enrollment 
application within 90 days of the reportable event. Timely reporting 
and updating of information plays a critical role in our ability to 
protect Medicare beneficiaries and protect the integrity of the 
Medicare program and Trust Funds. We believe that these requirements 
are fair and consistent with existing reporting requirements for other 
Medicare suppliers.
    All suppliers are required to report changes of ownership and new 
adverse action history within 30 days. Adding the requirement that any 
changes to the coach roster be reported within 30 days is consistent 
with IDTFs requirements at Sec.  410.33(g)(2). Although IDTFs differ 
from MDPP suppliers in many ways, IDTFs must report a roster of 
supervising physicians who serve functions on the supplier's behalf and 
must also report changes to this roster within 30 days. Given this 
similarity with IDTFs, we modeled our approach after this process. 
However, we note that while MDPP suppliers would be required to submit 
changes to the coach roster within 30 days, we would encourage them to 
submit such changes as soon as possible, due to reasoning explained 
further in section III.K.2.e.iv.(2) of this proposed rule.
    We invite public comments on these proposals.
(4) Enrollment Application Fee
    In the CY 2017 PFS final rule, we finalized that MDPP suppliers 
would enroll in Medicare. We solicited comments on, but did not propose 
or finalize, an applicable application fee associated with the MDPP 
supplier's enrollment. In this proposed rule, we propose to amend the 
definition of ``institutional provider'' as defined under Sec.  
424.502, to include MDPP suppliers such that, Sec.  424.514, which 
governs the application fee, would similarly apply to MDPP suppliers. 
``Institutional providers'' that are initially enrolling in Medicare, 
revalidating their enrollment, or adding a new Medicare practice 
location are required to submit a fee with their enrollment 
application. We would like to highlight that while we are proposing to 
include MDPP suppliers as an institutional provider, MDPP suppliers 
utilize administrative locations, not practice locations, and therefore 
the fee would not apply when adding a new administrative location to an 
existing enrollment record. The application fee is adjusted annually, 
and additional information about how the adjustment is calculated may 
be found in the November 7, 2016 Federal Register notice establishing 
the calendar year 2017 application fee (81 FR 78159). For calendar year 
2017, the application fee is $560. Section 6401(a) of the Patient 
Protection and Affordable Care Act (as amended by section 10603 of the 
Affordable Care Act, amended section 1866(j)(2)(C) of the Act to 
require the Secretary to impose a fee on each institutional provider of 
medical or other items or services or supplier. This fee would be used 
for program integrity efforts including to cover the cost of screening 
and to carry out the provisions of sections 1866(j) and 1128J of the 
Act. Given that section 10603 of the Affordable Care Act excludes 
individual practitioners, such as physicians and nurse practitioners, 
from paying an enrollment application fee, we have previously 
determined that an ``institutional provider'' to include any provider 
or supplier that submits a paper Medicare enrollment application using 
the CMS-855A, CMS-855B (not including physician and non-physician 
practitioner organizations), CMS-855S or associated Internet-based 
PECOS enrollment application.\26\ MDPP suppliers are entities, and not 
individual practitioners. We believe that they would similarly qualify 
as a ``provider of medical or other items or services'' used to define 
institutional providers. Taken together, we believe that the definition 
of institutional provider would also apply to MDPP suppliers. Given 
that the CY 2017 PFS final rule established that MDPP suppliers would 
be screened under high categorical risk (codified at Sec.  
424.59(a)(3), proposed to be redesignated as Sec.  424.205(b)(3)(i)), 
the application fee would play an important role in executing 
particular aspects of the high-risk screening. As we noted in the CY 
2017 PFS final rule, any organization that faces financial difficulty 
related to the application fee may apply for a hardship exception. For 
more information on the hardship exemption, see https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/downloads/MM7350.pdf. We are soliciting comments on 
this proposal.
---------------------------------------------------------------------------

    \26\ See CMS-6028-FC for further discussion, 76 FR 5862 and 5907 
through 5908 (Feb. 2, 2011).
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iv. MDPP Supplier Standards
    We are proposing to establish standards that MDPP suppliers must 
meet and remain in compliance with to be eligible to receive payment 
for an MDPP service (proposed Sec.  424.205(d)). These supplier 
standards would build on the conditions for enrollment established 
under existing Sec.  424.59(a) (which in this proposed rule is

[[Page 34160]]

proposed to be redesignated and amended at paragraph Sec.  424.205(b)), 
as well as any existing Medicare requirements that apply to all 
suppliers. We are proposing that an MDPP supplier wishing to 
participate in MDPP must adhere to current Medicare MDPP supplier 
requirements as outlined in Sec.  424.59 (proposed to be redesignated 
as Sec.  424.205), as well as all other requirements that apply to 
Medicare providers and suppliers. MDPP suppliers may choose to utilize 
a third party administrator, billing agent, or other entity to comply 
with the requirements of Sec.  424.59 (proposed to be redesignated as 
Sec.  424.205). Regardless of any use of such entities, any failure to 
comply with the standards of Sec.  424.205(d) or other relevant 
Medicare requirements, may result in an enrollment denial under Sec.  
424.530(a)(1), revocation of the MDPP supplier for non-compliance under 
Sec.  424.535(a)(1) or other revocation authority, as appropriate (as 
proposed in Sec.  424.205(g)). Consistent with existing regulations, we 
are proposing that MDPP suppliers would have appeal rights under part 
498.
    We believe that the standards outlined in this section are 
generally consistent with standards established for other Medicare 
suppliers while adding safeguards to help ensure compliance with MDPP 
rules and regulations specific to this expanded model. Because this 
expanded model would pay MDPP suppliers based on a beneficiary's 
achievement of performance goals, we believe that it is prudent to 
include additional requirements consistent with the Office of the 
Inspector's General's compliance guidance,\27\ to promote adherence to 
applicable statutes, regulations, and program requirements and help 
reduce fraud, waste, and abuse. In addition to the proposed standards, 
the MDPP expanded model will be routinely monitored for compliance with 
supplier standards, consistent with section 1893 of the Act (42 U.S.C. 
1395ddd). Although we recognize that these standards may be new for 
MDPP suppliers and would, if finalized, impose additional requirements 
on these organizations that they may not otherwise face, both 
individually and collectively, these standards play an important role 
in ensuring the integrity of the Medicare program and the safety of our 
beneficiaries. Therefore, given the goals of these proposed standards 
to mitigate fraud, waste, or abuse to the Medicare program and its 
beneficiaries, we believe that they are appropriate for governing MDPP 
suppliers and do not place an undue burden on suppliers. We are 
inviting public comments on our proposed approach, as well as any 
unintended consequences or burdens that we may have not considered.
---------------------------------------------------------------------------

    \27\ https://oig.hhs.gov/compliance/compliance-guidance/.
---------------------------------------------------------------------------

(1) Medicaid Terminations
    In addition to establishing standards for MDPP suppliers with 
respect to their delivery of MDPP services, we also are proposing 
standards for MDPP suppliers' general eligibility to furnish services 
to Medicare beneficiaries. These standards would establish program 
integrity safeguards that would protect both Medicare beneficiaries and 
the Medicare program. We are proposing that MDPP suppliers must not 
currently have their billing privileges terminated for-cause from any 
State Medicaid program or be excluded from any State Medicaid program 
(proposed Sec.  424.205(d)(2)). If a supplier's Medicaid billing 
privileges are currently terminated from or the supplier is excluded 
from any State Medicaid program, we do not believe that supplier should 
be able to furnish Medicare services. We believe that this proposal is 
warranted given that a supplier's improper behavior in another Federal 
health care program may be duplicated in Medicare. We believe that this 
proposed requirement would mitigate the MDPP expanded model's 
susceptibility to fraud, waste, and abuse. Consistent with all 
standards in this section, any MDPP supplier who does not meet this 
requirement would be subject to a Medicare enrollment denial or 
revocation. We believe that this proposed standard would serve to 
ensure continuity of safeguards across Federal health care programs, 
and will help preserve the integrity of the Medicare program and 
protect beneficiaries by prohibiting suppliers found to be noncompliant 
in one Federal health care program from enrolling in and furnishing 
services in another.
    We seek comments on this proposal.
(2) Ineligible Coaches: Individuals Prohibited From Furnishing MDPP 
Services to Medicare Beneficiaries
    We are proposing, at Sec.  424.205(d)(3), that the MDPP supplier 
must report coach information on its enrollment application and the 
MDPP supplier must only permit MDPP services to be furnished by 
individual coaches who meet the eligibility criteria. We propose, at 
Sec.  424.205(e)(1) that MDPP coach eligibility criteria require that a 
coach must not:
     Currently have his or her Medicare billing privileges 
revoked and whose reenrollment bar has not yet expired. We believe that 
this proposed supplier standard would protect beneficiaries from 
receiving MDPP services from individuals already prohibited from 
furnishing other Medicare services. If an individual is precluded from 
maintaining enrollment in Medicare for a non-MDPP service, we believe 
that it is prudent that they similarly not furnish MDPP services.
     Currently have his or her Medicaid billing privileges 
terminated for-cause or is excluded from any State Medicaid Agency 
(proposed at Sec.  424.205(e)(1)(ii)). We believe that this proposed 
supplier standard is warranted given that an individual's improper 
behavior in another Federal health care program may be duplicated in 
Medicare. We do not believe that we should permit MDPP suppliers to 
allow coaches with current for-cause terminations or exclusions in 
Medicaid to furnish MDPP services to Medicare beneficiaries.
     Currently be excluded from any other Federal health care 
program, as defined in Sec.  1001.2 of this chapter, in accordance with 
section 1128, 1128A, 1156, 1842, 1862, 1867 or 1892 of the Act. This 
includes, but is not limited to, the Office of Inspector General 
(OIG)'s List of Excluded Individuals and Entities (LEIE). We are 
proposing this supplier standard for similar reasons we are proposing 
not to permit coaches with revocations from Medicare or current 
exclusions from Medicaid to furnish MDPP services.
     Currently be debarred, suspended, or otherwise excluded 
from participating in any other Federal procurement or non-procurement 
program or activity in accordance with the Federal Acquisition 
Streamlining Act implementing regulations and the Department of Health 
and Human Services non-procurement common rule at 45 CFR part 76. We 
note that this includes individuals who have an active status on the 
General Service Administration's System for Award Management list. We 
may also utilize the Bureau of the Fiscal Service, U.S. Department of 
the Treasury's Do Not Pay (DNP) List as a resource for determining 
which individuals fall under this category. The Improper Payments 
Elimination and Recovery Improvement Act (IPERIA) of 2012 established 
the DNP to support Federal agencies with their efforts to prevent and 
detect improper payments by aggregating various data sources for pre-
award, pre-payment eligibility verification. Data sources included in 
this list include Credit Alert System,

[[Page 34161]]

Death Master File, LEIE, Office of Foreign Assets Control (OFAC), 
System for Award Management (SAM) Entity Registration Records, and SAM 
Exclusion Records. We believe that we may utilize the DNP as a method 
of determining whether a coach is excluded from participating in any 
other federal procurement or nonprocurement programs. Although coaches 
will not directly be receiving payment from us for furnishing MDPP 
services, we do not believe that payment should be made to MDPP 
suppliers for services furnished by individuals excluded from federal 
procurement or nonprocurement programs, particularly given that MDPP 
payments rely on beneficiary's achievement of performance goals that 
the coaches will document. Although the MDPP supplier is ultimately 
responsible for attesting to all claims submitted for MDPP services, we 
do not believe that it would be prudent to permit MDPP suppliers to 
allow coaches excluded from other federal procurement programs to 
furnish MDPP services.
     Have, in the previous 10 years, one of the following state 
or federal felony convictions:
    ++ Crimes against persons, such as murder, rape, assault, and other 
similar crimes for which the individual was convicted, as defined under 
42 CFR 1001.2, had a guilty plea or adjudicated pretrial diversion.
    ++ Financial crimes, such as extortion, embezzlement, income tax 
evasion, insurance fraud and other similar crimes for which the 
individual was convicted, as defined under 42 CFR 1001.2, had a guilty 
plea or adjudicated pretrial diversion.
    ++ Any felony that placed the Medicare program or its beneficiaries 
at immediate risk, such as a malpractice suit that results in the 
individual being convicted, as defined under 42 CFR 1001.2, having a 
guilty plea or having adjudicated pretrial diversion of criminal 
neglect or misconduct.
    ++ Any felonies that for which the individual was convicted, as 
defined under 42 CFR 1001.2, had a guilty plea or adjudicated pretrial 
diversion that would result in mandatory exclusion under section 
1128(a) of the Act.
    We propose that CMS will screen each individual identified on the 
roster of coaches included with the supplier's enrollment application 
to verify that the individual coach does not meet any of these 
conditions and that the coach can provide MDPP services on behalf of an 
MDPP supplier (proposed at Sec.  424.205(e)(2)). We are proposing these 
requirements as a means to ensure the integrity and safety of the 
Medicare program and the beneficiaries whom we serve. We have selected 
these types of felony convictions based on the risk we believe they 
could pose to the Medicare program and our beneficiaries. Additionally, 
it is consistent with existing criteria that we use to determine 
felonies that are detrimental to the best interest of the program and 
its beneficiaries as described in Sec.  424.535(a)(3)(ii). While we 
selected these criteria to be consistent with how we evaluate other 
individuals, we also sought to create a more definite list such that 
MDPP suppliers would have the ability to conduct background checks on 
coaches prior to, as well as potentially after enrolling in Medicare, 
to avoid receiving an enrollment denial or revocation due to failure to 
meet this standard. While coaches are not directly enrolled, and 
therefore, not directly receiving payment, we believe that it is 
prudent to prohibit MDPP suppliers from utilizing individuals convicted 
of certain felonies to furnish services to Medicare beneficiaries. 
Because coaches will be directly interacting with beneficiaries, 
recording their attendance and weight loss, we believe that a coach's 
trustworthiness is vital. Consequentially, we do not believe that such 
coaches should have a criminal history such as those described in Sec.  
424.535(a)(3)(ii).
    Coaches that meet any of these criteria would be considered 
ineligible to furnish MDPP services, and therefore, could not be on an 
MDPP supplier's roster. Coaches whose information was submitted in an 
MDPP supplier's enrollment application, screened, and determined as not 
meeting any of these criteria would be considered eligible coaches. 
Although the MDPP supplier is the entity that is enrolled in Medicare 
and submits claims, coaches furnish MDPP services, directly interacting 
with the beneficiary and documenting attendance and weight loss. 
Therefore, we believe that precluding individual coaches who meet any 
of the ineligibility criteria from directly furnishing MDPP services to 
Medicare beneficiaries would both help reduce fraud, waste, and abuse 
that could occur in the MDPP expanded model, as well as protect 
beneficiaries from harm.
    If after screening, CMS or its contractors determine that a coach 
is eligible to furnish MDPP services, the coach would be assigned an 
eligibility start date, similar to a supplier's enrollment effective 
date. We are proposing to define coach eligibility start date as 
follows: The start date indicated by the MDPP supplier when submitting 
an eligible coach's information on the MDPP enrollment application 
(proposed at 424.205(a)). On the enrollment application, the MDPP 
supplier will include a date indicating when the coach began furnishing 
MDPP services. Consistent with proposals at Sec.  424.205(d)(5), the 
MDPP supplier must report changes to the coach roster on its enrollment 
application, including any new coaches added, within 30 days of such a 
change. Thus, the start date associated with any new coach information 
must be within 30 days of the date the MDPP supplier actually reports 
the change on its application. If the coach has not yet begun 
furnishing MDPP services, the MDPP supplier should indicate the date 
the supplier is reporting the information. Though the date reflects 
either when the coach began furnishing services or when the coach could 
ultimately be determined as eligible to begin furnishing services, 
after the enrollment application was submitted, CMS must still 
determine whether the coach is eligible (proposed at Sec.  
424.205(e)(2)). If we determine the coach to be eligible, then his or 
her eligibility start date would be the date the MDPP supplier 
indicated on its enrollment application. As described in 
III.K.2.d.(10)(d), payment can be made for services furnished by this 
coach on or after his or her eligibility start date.
    However, if a coach was determined to be ineligible at the onset, 
the coach would have its eligibility start and end date on the same 
date, effectively never being eligible to furnish MDPP services. If the 
coach later became ineligible, he or she would be assigned an 
eligibility end date. Consistent with proposals at 414.84, payment for 
MDPP services is made only if such services are furnished by an 
eligible coach, on or after his or her coach eligibility start date 
and, if applicable, before his or her coach eligibility end date, to an 
MDPP beneficiary. This could pose a situation in which an MDPP supplier 
could submit an updated coach roster that includes a new coach, and 
allow him or her to begin furnishing services based on the belief that 
he or she is eligible. Should, after screening, CMS or its contractors 
determine that the coach is ineligible, the MDPP supplier could be 
revoked for non-compliance. Though the MDPP supplier would have an 
opportunity to submit a corrective action plan that removes the 
ineligible coach from their enrollment application, any claims for 
services furnished by the ineligible coach would be denied, and the 
MDPP supplier would not be paid for such services. For this reason, we 
encourage suppliers to report changes to the coach roster as soon as 
possible. If the MDPP supplier submits a claim that

[[Page 34162]]

includes a coach NPI for a coach we have not yet determined to be an 
eligible coach for furnishing MDPP services as of the date of service, 
the claim will be rejected, and the supplier will need to refile the 
claim with the same information once CMS has made the eligibility 
determination. If at that time, CMS determined the coach to be 
ineligible, the claim for the service provided by the coach will be 
denied, as described in section III.K.2.d.iii.(10)(d).
    We believe that the majority of the coach ineligibility criteria 
described in this section is crafted in such a way that the MDPP 
supplier could, with reasonable certainty, conduct an independent 
background check on the coach, to determine whether he or she meets the 
ineligibility criteria. If the MDPP supplier has any uncertainty about 
whether the coach meets the ineligibility criteria, they may wish to 
preclude the coach from furnishing services to Medicare beneficiaries 
until CMS determines that the coach is eligible. This would avoid a 
potential situation of a coach furnishing services for which the MDPP 
supplier could not get paid. If the MDPP supplier believes the coach is 
eligible and wishes to allow the coach to furnish services prior CMS 
determining his or her eligibility, then the MDPP supplier would assume 
the risk not receiving payment for claims for serviced rendered by the 
ineligible coach.
    If a coach no longer provides MDPP services for an MDPP supplier, 
the supplier must remove that coach from its roster and indicate the 
date of such event to designate an eligibility end date for that coach. 
If the MDPP supplier voluntarily terminates its Medicare enrollment or 
is revoked, CMS will automatically reflect the date of this action as 
the coach's eligibility end date for that MDPP supplier. We are 
proposing to define coach ineligibility end date as follows, the end 
date indicated by the MDPP supplier in submitting a change to the 
supplier's MDPP enrollment application that removed the coach's 
information, or the date the supplier itself was revoked from or 
withdrew its Medicare enrollment as an MDPP supplier.
    We are proposing that CMS or its contractors would determine 
whether coaches submitted on MDPP rosters satisfy the previously stated 
criteria by using the identifying information MDPP suppliers submit on 
their enrollment applications (including any changes that MDPP 
suppliers would be required to report). This information would be 
checked against internal and publicly available data sources. We are 
proposing that, upon identification of evidence that a coach met any 
ineligibility criteria, we may take administrative action to deny or 
revoke the MDPP supplier's enrollment as appropriate under Sec. Sec.  
424.530(a)(1) and 424.535(a)(1) (proposed at Sec.  424.205(g)(1)(ii)). 
Consistent with existing enrollment denial and revocation actions, we 
would notify the prospective or enrolled MDPP supplier via an 
enrollment denial or revocation notification and include the specific 
reason for the administrative action. The enrollment denial or 
revocation notification detailing the findings and the reasoning for 
the determination would follow requirements under Sec.  488.18. 
Consistent with similar processes at Sec. Sec.  424.530(c) and 
424.535(e), we are proposing that an MDPP supplier could respond to the 
enrollment denial or revocation by submitting a corrective action plan 
(CAP) that would include the removal of the coach from its roster 
within 30 days of receiving the enrollment denial or revocation 
notification, and therefore, come into compliance and enroll or 
maintain its enrollment status. If MDPP suppliers believe that the 
decision was made in error, they could exercise existing appeal rights 
under part 498.
    We also are proposing that if we determine that an MDPP supplier 
has continued to allow an ineligible coach to furnish MDPP services 
after having submitted a CAP removing the coach from its roster to 
enroll or maintain enrollment in Medicare, we would revoke the MDPP 
supplier without the opportunity for additional corrective action. This 
authority, outlined in proposed Sec.  424.205(h)(1)(v), would allow us 
to revoke an MDPP supplier for knowingly using an ``ineligible coach'' 
to furnish MDPP services. ``Knowingly,'' in this context, means that 
the supplier received an enrollment denial or revocation notice based 
on failing to meet supplier standards at Sec.  424.205(d)(3) (related 
to ineligible coaches), was provided notice by CMS or contractors 
working on its behalf of this action including the reason(s) for the 
administrative action, submitted a CAP to remove the coach, but 
continued to allow the coach to provide MDPP services in violation of 
the CAP. We are proposing to define an ``ineligible coach'' in Sec.  
424.205(a) as an individual whom CMS has screened and has determined 
ineligible to furnish MDPP services on behalf of an MDPP supplier based 
on the standard specified in Sec.  424.205(e), and we are proposing in 
the same paragraph to define ``eligible coach'' in Sec.  424.205(a) as 
an individual who CMS has screened and has determined can furnish MDPP 
services on behalf of an MDPP supplier based on the standard specified 
in proposed Sec.  424.205(e).
    While any individual may be eligible to become a DPP coach, 
provided that they meet requirements and trainings as dictated by the 
CDC's DPRP Standards, an individual can only become an eligible coach 
for purposes of furnishing MDPP services after having their required 
identifying information submitted on an MDPP supplier's enrollment 
application, being screened by CMS or its contractors, and as a result, 
being determined to be eligible to furnish MDPP services on behalf of 
an MDPP supplier. If CMS or its contractors deem a coach ineligible, 
this would apply only to the furnishing of MDPP services and would not 
preclude the DPP organization from continuing to allow this individual 
to furnish administrative services or DPP sessions to non-Medicare 
beneficiaries. However, serving as a coach for Medicare beneficiaries 
would be prohibited and would be subject the MDPP supplier to this 
revocation authority.
    We are proposing this new revocation authority due to the novel 
program integrity risks that would be posed by MDPP suppliers who 
knowingly continue to permit ineligible coaches to furnish MDPP 
services to Medicare beneficiaries. We believe that this new basis for 
revocation is necessary because coaches are not enrolled in Medicare, 
even though they will undergo background checks by CMS or its 
contractors and must meet specified criteria. While we considered using 
existing revocation authorities under Sec.  424.535(a)(1) (related to 
noncompliance), Sec.  424.535(a)(4) (related to false or misleading 
information), and Sec.  424.535(a)(9) (related to failure to report), 
we determined that these authorities were too general for purposes of 
specifically addressing MDPP coaches who become ineligible to furnish 
MDPP services. We are proposing that this revocation authority would 
follow similar requirements under Sec.  424.535(c), (g), and (h). We do 
not believe that Sec.  424.535(e) (related to reversal of the 
revocation) should apply in this case, given that the MDPP supplier 
already had an opportunity to remove the coach from their roster by 
submitting a CAP, but continued to allow the ineligible coach to 
furnish MDPP services. The proposals that we would apply from the 
provisions of Sec.  424.535 stated in this section are as follows:
     The revocation becomes effective 30 days after CMS or the 
CMS contractor

[[Page 34163]]

mails notice of its determination to the MDPP supplier;
     For the revocation authority, MDPP suppliers are barred 
from participating in the Medicare program from the date of the 
revocation until the end of the re-enrollment bar, which begins 30 days 
after CMS or its contractor mails notice of the revocation and lasts a 
minimum of 1 year, but not greater than 3 years, depending on the 
severity of the basis for revocation; and
     A revoked MDPP supplier must, within 60 calendar days 
after the effective date of revocation, submit all claims for items and 
services furnished before the date of the revocation letter.
    We believe that these proposals would appropriately govern this 
proposed new revocation authority, given the consistency with existing 
revocation authorities. Given these consistencies, we do not believe 
that this proposal places an undue burden on MDPP suppliers, and any 
burden established would be warranted given the violation of the 
supplier standards that jeopardize both the integrity of the Medicare 
program and the safety of its beneficiaries.
    We are inviting public comments on these proposals.
(3) Ensuring MDPP Suppliers Are Legitimate, Operational Organizations
    We are proposing a number of requirements that would help ensure 
that MDPP suppliers are operational, have the resources necessary to 
furnish MDPP services, and are in compliance with MDPP supplier 
standards. At Sec.  424.205(d)(4), we are proposing that, regardless of 
whether the MDPP supplier furnishes services solely in community 
settings, it must maintain at least one administrative location. All 
administrative locations maintained by the MDPP supplier must be on an 
appropriate site available to the public and must be reported on the 
CMS-approved enrollment application. We are proposing that this 
administration location may not be a private residence. We are 
proposing that an appropriate site must have signage posted on the 
exterior of the building, as well as be open for business and have 
employees, staff, or volunteers present during operational hours. For 
the purposes of this requirement, such signage may include, for 
example, the MDPP supplier's legal business name or its ``doing 
business as'' (DBA) name, as well as hours of operation. This proposal 
seeks to utilize measurable objective indicators to determine that 
organizations are legitimately operating and able to furnish MDPP 
services to Medicare beneficiaries. We believe that, regardless of 
whether the MDPP supplier furnishes services at its administrative 
location, establishing a physical location is necessary for associated 
requirements for furnishing MDPP services, including recordkeeping 
requirements, training facilities, and storage for any educational 
materials distributed during sessions.
    We are proposing, at Sec.  424.205(d)(6), that a MDPP supplier must 
maintain a primary business telephone number listed under the name of 
the organization in public view. Public view could signify, for 
example, that the phone number is listed on a Web site, on flyers and 
materials. This proposed policy would require that calls must not 
automatically go to the answering machine or utilize an answering 
service during posted business hours. The purpose of this proposed 
requirement is to help verify that the organization is a legitimate 
organization and not simply posing as an organization and seeking to 
bill Medicare fraudulently.
    We are further proposing, at Sec.  424.205(d)(7), that an MDPP 
supplier must not knowingly sell to or allow another individual or 
entity to use its billing number, consistent with Sec.  424.535(a)(7). 
We are including this proposal to avoid a situation in which another 
entity uses an existing MDPP supplier's billing number. We believe that 
this proposal plays an important role in ensuring that payments are 
only being made to the intended recipient who has met all of the 
supplier and compliance standards and that we continue to hold entities 
responsible for maintaining compliance. Otherwise, we risk making 
payments to suppliers potentially engaging in fraudulent or potentially 
harmful behavior.
    We believe that the proposed requirements in this section would not 
pose an undue burden on MDPP suppliers as they are minimum requirements 
for any functional, operational organization. By establishing these 
requirements, we believe that we would ensure that MDPP suppliers that 
do not meet the baseline requirements for an operational organization 
would not be permitted to furnish MDPP services to or receive payment 
for such services. We are proposing, at Sec.  424.205(d)(15), that an 
MDPP supplier must permit CMS or its agents to conduct onsite 
inspections to ascertain the supplier's compliance with these 
standards. While we believe that any operational business that truly 
furnishes MDPP services would be able to meet these requirements, we 
are inviting public comments on any aspects of these proposed 
standards.
(4) Beneficiary Access
    We are proposing, at Sec.  424.205(d)(8), that MDPP suppliers may 
not deny access to MDPP services to eligible beneficiaries based on any 
reason other than the supplier's own self-determined and published 
capacity limits to furnish MDPP services to additional people and, on a 
discretionary basis, if a beneficiary significantly disrupts the 
session for other participants or becomes abusive. Given that we do not 
yet currently have data on optimal class size for MDPP services, we are 
currently allowing MDPP suppliers to self-determine any upper 
limitation on class size. Should they establish such a limit and intent 
to turn beneficiaries away once the capacity limit is reached, the MDPP 
supplier must have previously made this limit publicly available; for 
example, denoting the limit in any brochures, Web sites, or other 
materials that outline their MDPP services. We are proposing that MDPP 
suppliers must maintain a record of the number of eligible Medicare 
beneficiaries turned away for each of these reasons, as well as the 
date the beneficiary was informed. We are further proposing that if an 
MDPP supplier denies a Medicare beneficiary access citing disruptive or 
abusive behavior, details of the occurrence(s), including date(s) of 
the behavior, any remediation efforts taken by the supplier, and final 
action (for example, dismissal from an MDPP session or denial from 
future sessions) must be documented in the beneficiary's MDPP records 
and adhere to documentation requirements outlined in Sec.  424.205(g). 
We note that one supplier's decision to dismiss a beneficiary for this 
purpose would not limit that beneficiary from switching to another MDPP 
supplier.
    We will seek to monitor compliance with this requirement, and 
investigate further if necessary, based on beneficiary complaints, 
rates of access denials citing capacity limits in comparison to 
estimated capacity based on claims submitted, as well as monitoring 
claims for success rates for achieving performance goals that are 
higher than what would be expected for a typical Medicare population. 
Illustrative examples of capacity limits could include that the MDPP 
supplier has met its self-determined and published class size maximum, 
or that the supplier is providing MDPP sessions in cohorts and does not 
have a new or upcoming cohort at the time the beneficiary is seeking 
MDPP services. Furnishing MDPP services in a cohort means that the DPP 
curriculum is delivered among a single group, or

[[Page 34164]]

cohort, from start to finish with sessions furnished in a specific 
order, therefore, not allowing any new individuals to join once the 
cohort has begun.
    Given that our proposed payment structure for MDPP services relies 
on the achievement of weight loss and attendance goals, there may be 
incentives for MDPP suppliers to seek to serve only those beneficiaries 
for which they are more likely to earn performance payments. This, in 
turn, could result in discriminatory treatment of beneficiaries. 
Through this proposed supplier standard, we would expressly prohibit 
MDPP suppliers from conditioning access to MDPP services on the basis 
of a beneficiary's weight or health status (except as provided in our 
proposed regulations). We also would prohibit MDPP suppliers from 
conditioning access to MDPP services on the basis of a beneficiary's 
achievement of performance goals, except where the beneficiary becomes 
ineligible for additional sessions as a result of not meeting those 
goals, as proposed elsewhere in this proposed rule. We believe that it 
is appropriate to prohibit suppliers from denying access to MDPP 
services except in certain limited circumstances. If a supplier were to 
deny access to a beneficiary citing lack of capacity, but then furnish 
MDPP services to a different beneficiary, this may signal a violation 
of such standards. In addition, and for the same reasons, we are 
proposing to prohibit MDPP suppliers, which includes any coaches or 
entities performing functions or furnishing services related to MDPP 
services on their behalf, from unduly coercing a beneficiary's decision 
to change or not change to a different or specific MDPP supplier, 
including through the use of pressure, intimidation, or bribery in 
proposed Sec.  424.205(d)(9). Information that may result in a 
beneficiary changing to a different MDPP supplier provided in response 
to a beneficiary's request for information would not violate this 
provision.
    At Sec.  424.79, the CY 2017 PFS final rule established the set of 
services included in the expanded model, but did not stipulate that 
once a supplier began furnishing such services to a beneficiary, that 
it must continue to offer them to the beneficiary as a part of the MDPP 
expanded model. We are proposing, at Sec.  424.205(d)(10), that MDPP 
suppliers must offer and provide beneficiary access to the entire set 
of MDPP services for which beneficiaries are eligible. This includes 
the requirement that suppliers offer at least 16 in-person core 
sessions, no more frequently than once per week, over the first 6 
months of the core services period and offer at least 6 core 
maintenance sessions, at least once per month, over months 7 through 12 
of the core services period (proposed at Sec.  410.79(c)(2)(i)). For 
beneficiaries to whom the supplier has begun furnishing MDPP services, 
and who meet the eligibility requirements for ongoing maintenance 
sessions described in proposed Sec.  410.79(c)(1)(ii) and (iii), MDPP 
suppliers are required to offer 24 ongoing maintenance sessions, 
furnished at least once per month over the course of months 13 through 
36 of the MDPP services period, in 3-month consecutive increments. 
These requirements would also apply to any MDPP supplier who gains a 
beneficiary at some point during their receipt of MDPP services. Should 
this MDPP supplier begin furnishing services to a beneficiary at any 
point during the 3-year MDPP services period, it must continue to offer 
the services for which the beneficiary is eligible but has not yet 
received. For example, if a beneficiary changed suppliers after the 
core sessions in month 6, the subsequent supplier would be required to 
offer core maintenance sessions for months 7 through 12, and ongoing 
maintenance sessions should the beneficiary remain eligible for these 
services.
    We also are soliciting public comments on a potential future policy 
to require a specific class size limit for MDPP sessions. While we 
acknowledge that MDPP services may be successfully furnished in group 
settings, we believe that it is important to ensure that the group's 
size is appropriately set such that each beneficiary gains the 
necessary interaction with the coach furnishing the session to properly 
learn the curriculum. We considered different mechanisms to ensure this 
program objective, and are requesting public comments on considerations 
to date. The mechanism that currently seems most viable would require a 
limitation on the number of total attendees in a given session taught 
by an individual coach. Based on CDC's experience with the DPP program 
and review of the literature on appropriate class sizes for educational 
settings, we considered including a class size limitation of 30 
participants per coach in a given session (including Medicare 
beneficiaries). Given that limited data currently exist on this type of 
requirement among DPP sessions, we are soliciting public comments on 
what an appropriate class size limitation would be, including any 
evidence to support such a proposal.
    Furthermore, we are soliciting public comments on how MDPP 
suppliers who furnish sessions in no specific sequential order and 
allow drop ins would balance the requirement of providing beneficiary 
access with a class size requirement for a given session. For example, 
if a supplier offers classes multiple times a week and gives 
beneficiaries flexibility regarding when to participate, we questioned 
whether a certain class size limitation could force a supplier to turn 
away a beneficiary seeking to attend a session at a time when 
attendance is high, and in so doing potentially discourage continued 
use of the set of MDPP services. In addition, we are unsure of any 
implications that would result from establishing a class size 
restriction for MDPP services while acknowledging that MDPP 
beneficiaries may participate in DPP sessions with non-Medicare 
beneficiaries who may not face the same class size limitation. Given 
these considerations, we are soliciting public comments on how we could 
structure this proposal in the future that would achieve the 
programmatic goals of effectively furnishing the DPP curriculum to 
Medicare beneficiaries in a manner and setting that contributes to 
positive behavioral changes and ultimately less progression to type 2 
diabetes. In providing comments on this approach, we encourage the 
submission of data and evidence to justify what specific class size 
would be appropriate for MDPP suppliers.
(5) Disclosure
    We are proposing, at Sec.  424.205(d)(11), that MDPP suppliers must 
provide information about the MDPP expanded model to each beneficiary 
to whom it furnishes MDPP services as specified by CMS. This includes 
detailed information on coverage for the set of MDPP services, the 
once-per-lifetime limit, on eligibility requirements, and the MDPP 
supplier standards. We recognize that many aspects of the MDPP expanded 
model are novel for both beneficiaries and suppliers, and we desire 
that both parties are well informed. Therefore, we believe that 
requiring the supplier to fully disclose information about the MDPP 
expanded model, coverage, and the MDPP supplier standards will help 
inform all parties. We intend to provide a specific template for the 
MDPP supplier to use to disclose this information to the beneficiaries. 
For this reason, we do not believe that requiring this type of 
disclosure places a significant burden on the supplier. While we 
believe that this approach will help to address the policy goals of the 
MDPP expanded model, we are inviting public comments on this approach, 
particularly upon the provision of a standard CMS disclosure

[[Page 34165]]

notification as compared to CMS providing MDPP suppliers with 
information they could use to their own disclosure notification 
materials. Along these lines, we would like to highlight that we also 
intent to publish information on MDPP in the 2019 Medicare & You 
Handbook.
    We invite public comments on these proposals.
(6) Beneficiary Complaints
    We are proposing that MDPP suppliers must answer Medicare 
beneficiaries' questions about MDPP services and respond to MDPP 
related complaints within a reasonable timeframe in proposed Sec.  
424.205(d)(12). We also are proposing that MDPP suppliers implement a 
complaint resolution protocol and maintain documentation of all 
beneficiary contact regarding such complaints, including the name and 
Medicare Beneficiary Identifier of the beneficiary, a summary of the 
complaint, related correspondences, notes of actions taken, and the 
names and/or NPIs of individuals who took such action on behalf of the 
MDPP supplier. We are proposing that this information must be kept at a 
supplier's administrative location and made available to CMS or its 
contractors upon request. These records would adhere to the same 
recordkeeping requirements in Sec.  424.205(g), and therefore, would 
need to be maintained for 10 years. While other records are typically 
required to be held only for 7 years (per Sec.  424.516(f)), given that 
the MDPP expanded model includes beneficiary engagement incentive 
(described further in section III.K.2.f.v.) which typically requires an 
extended documentation requirement, we considered it important to align 
all recordkeeping requirements for the MDPP expanded model. As noted 
earlier in this section, we are proposing at Sec.  424.205(d)(15) that 
an MDPP supplier must allow CMS or its agents to conduct recordkeeping 
reviews to ascertain the supplier's compliance with these standards, as 
well as documentation requirements as outlined in Sec.  424.205(g).
    We believe our proposal that MDPP suppliers must answer, respond 
to, and document beneficiary complaints and resolutions establishes a 
tracking mechanism to determine whether or not suppliers are adequately 
addressing beneficiary concerns. We find this requirement particularly 
important given that complaint procedures provide a good way to ensure 
best practices by suppliers. Moreover, DMEPOS supplier standards 
contain a requirement regarding maintaining complaint procedures. 
Although we acknowledge that this method requires the MDPP suppliers to 
self-attest to complaints, requiring such documentation as a required 
Medicare standard can help to build accountability to following through 
with complaint resolution. Additionally, mandating that suppliers take 
and maintain records of complaints may help to address situations where 
beneficiaries raise issues directly to us after failing to receive 
resolution from the supplier directly.
    We believe that requiring this documentation would provide an 
additional mechanism for us to ensure that the supplier is fully 
disclosing information pertinent to the supplier standards, 
specifically those regarding beneficiary access, and other concerns. As 
an additional benefit of this policy, if a beneficiary is denied 
access, the MDPP supplier would be required to demonstrate the 
reasoning behind this approach, and we could have an opportunity to 
review if this reasoning complied with the proposed standard under 
Sec.  424.205(d)(8).
    This approach is consistent with supplier standards for other 
Medicare suppliers, including those for Durable Medical Equipment 
Prosthetics, Orthotics, and Supplies (DMEPOS) suppliers. Given that CMS 
has imposed similar standards regarding supplier responsibility for 
addressing beneficiaries' complaints among other supplier types, we do 
not believe that requiring a similar such requirement poses an undue 
burden on MDPP suppliers. Rather, we believe that this approach can 
facilitate beneficiary satisfaction with the services suppliers furnish 
by requiring that beneficiary complaints are acknowledged, resolved, 
and tracked appropriately. We believe that this approach will help 
ensure that the supplier is meeting beneficiaries' needs as they relate 
to the MDPP expanded model. In addition, we believe that this will help 
ensure the integrity of the MDPP expanded model.
    We invite public comments on these proposals.
(7) MDPP Expanded Model Evaluation Compliance
    In the CY 2017 PFS final rule, we finalized a requirement for MDPP 
suppliers to maintain and submit to CMS a crosswalk file that 
documented how the beneficiary identifiers submitted to CMS for billing 
and the beneficiary identifiers submitted to CDC for session-level 
performance data linked to the same beneficiary as a documentation 
retention and provision requirement (existing Sec.  424.59(b), proposed 
to be redesignated and amended as Sec.  424.205(e) in this proposed 
rule). CMS will use this crosswalk for evaluation purposes so CMS can 
review session level data that MDPP suppliers provide to CDC to 
supplement the claims data we receive directly from MDPP suppliers. We 
indicated that we would provide additional information on format and 
frequency of this reporting requirement in future rulemaking or 
administrative guidance as appropriate. We are proposing the 
maintenance and submission of the crosswalk as an MDPP supplier 
standard and are providing additional details regarding the format and 
frequency. We are proposing that the crosswalk file would contain 
Medicare Health Insurance Claims Numbers or Medicare Beneficiary 
Identifiers and the unique participant identifier assigned by the 
organization, for the purposes of CDC performance data reporting, for 
each beneficiary receiving MDPP services (proposed Sec.  
424.205(d)(13)). Beneficiaries for whom at least one Medicare claim was 
submitted by an MDPP supplier would be required to be included in the 
crosswalk. We are proposing that the crosswalk be supplied to CMS, or 
our contractor, beginning 6 months after the organization begins 
furnishing MDPP services, and quarterly thereafter. The crosswalk would 
be maintained in a spreadsheet (for example, an Excel file or a CSV 
file), in a form and manner as specified by CMS. We are inviting public 
comments on this approach.
    Additionally, to enable evaluation of MDPP services for a 
beneficiary's entire MDPP services period (that is, up to 3 years), we 
are proposing that MDPP suppliers must submit performance data for any 
beneficiaries who attend ongoing maintenance sessions in a manner and 
form as specified by CMS (proposed Sec.  424.205(d)(14)). This proposal 
serves to ensure that MDPP suppliers provide session-level data for 
ongoing maintenance sessions that are consistent with the data they are 
already providing to CDC for the core MDPP services period. This 
requirement is necessary given that session-level performance data 
plays a critical role in the Innovation Center's evaluation of the 
entirety of the MDPP expanded model. Without such data, the Innovation 
Center would lack any streamlined method of obtaining session-level 
data for ongoing maintenance sessions furnished to MDPP beneficiaries. 
We are proposing that this performance data must align with the 
performance date elements as

[[Page 34166]]

required by CDC for the DPRP standards. We are soliciting public 
comments on this approach.
v. MDPP Supplier Revalidation
    In the CY 2017 PFS final rule, we specified that newly enrolling 
MDPP suppliers as high categorical risk in accordance with Sec.  
424.518(c), but we did not address the risk level of MDPP suppliers 
upon revalidation. Section 6401(a) of the Affordable Care Act 
established that all Medicare suppliers must revalidate their 
enrollments as a program integrity measure. Upon revalidation, 
suppliers are screened for their continued enrollment in Medicare. 
While MDPP suppliers enroll at the high risk level, we are proposing, 
at Sec.  424.205(b)(3)(ii), that MDPP suppliers would revalidate under 
a moderate risk level in accordance with Sec.  424.518(b). We believe 
that this approach is appropriate, given that fingerprint-based 
criminal history record checks through the Federal Bureau of 
Investigation's Integrated Automated Fingerprint Identification System 
requirement for ``high'' categorical risk and will have already been 
completed upon initial enrollment. In addition, we believe that this 
approach is appropriate, given its consistency with other providers and 
suppliers who initially enroll under ``high'' categorical risk, but 
revalidate under ``moderate'' categorical risk, such as DMEPOS 
suppliers and Home Health Agencies. We also are proposing, at Sec.  
424.205(b)(6), as a condition of enrollment, that MDPP suppliers must 
agree to revalidate their enrollment every 3 years, consistent with 
DMEPOS suppliers who are initially screened under ``high'' categorical 
risk screening level. While we believe that this approach is 
appropriate for MDPP suppliers, we welcome public comments on these 
proposals. Interested parties can learn more information on 
revalidation available on the CMS Web site at https://www.cms.gov/medicare/provider-enrollment-and-certification/medicareprovidersupenroll/revalidations.html.
    We invite comment on the proposed risk level upon revalidation, as 
well as the frequency with which MDPP suppliers must revalidate their 
enrollment.
vi. Documentation Retention and Provisions Requirements
    We are proposing that the following requirements would apply to 
records related to a MDPP supplier's compliance with the MDPP expanded 
model (codified at Sec.  424.59(b), redesignated as amended at Sec.  
424.205(g)). We believe that these proposals will increase supplier 
recordkeeping accuracy, and clarify documentation retention 
requirements. Specifically, we are proposing that an MDPP supplier 
must:
     Provide to CMS or its contractors, the OIG, and the 
Comptroller General or their designee(s) scheduled and unscheduled 
access to all books, contracts, records, documents, and other evidence 
sufficient to enable the audit, evaluation, inspection, or 
investigation of the supplier's compliance with MDPP requirements, 
including the MDPP expanded model requirements for in-kind beneficiary 
incentive engagements found in Sec.  424.210 in the event that the MDPP 
supplier chooses to offer such incentives to any MDPP beneficiary.
     Maintain all such books, contracts, records, documents, 
and other evidence for a period of 10 years from the last day of the 
MDPP beneficiary's receipt of MDPP services furnished by the MDPP 
supplier or from the date of completion of any audit, evaluation, 
inspection, or investigation, whichever is later, unless--
    ++ CMS determines that there is a special need to retain a 
particular record or group of records for a longer period and notifies 
the MDPP supplier at least 30 calendar days before the normal 
disposition rate; or
    ++ There has been a dispute or allegation of fraud or similar 
fault, as defined at Sec.  405.902, against the MDPP supplier, in which 
case the records must be maintained for an additional 6 years from the 
date of any resulting final resolution of the dispute or allegation of 
fraud or similar fault.
    We believe these modifications increase the likelihood of 
operationalizing MDPP program integrity strategies that include audits, 
evaluations, inspections, or investigations, and that they provide 
additional clarity on documentation retention for ongoing program 
integrity. In addition, in the CY 2017 PFS established supplier 
requirements for documentation and recordkeeping (codified at Sec.  
424.59(b), proposed to be redesignated and amended at Sec.  424.205(g). 
In this proposed rule, we are modifying these requirements to improve 
clarity. We are proposing at Sec.  424.205(g)(1) and (g)(2) to require 
that documentation must be established contemporaneous to the furnished 
MDPP services, which we believe is important for accuracy. We are also 
proposing that for the initial core session, these records must include 
the following organizational information:
     The organizational name, CDC DPRP organization number, and 
organizational NPI;
     Basic beneficiary information including but not limited to 
beneficiary name, HICN, and age; and
     Evidence that each such beneficiary satisfied the 
eligibility requirements under Sec.  410.79(c) at the time of service.
    For each additional session, we propose that these records must 
include:
     Documentation of the type of session, whether a core 
session, a core maintenance session, an ongoing maintenance session, an 
in-person make-up session, or a virtual make-up session.
     Identification of which CDC-approved DPRP curriculum was 
associated with each session.
     The NPI of the coach who furnished the session.
     The date and place of service of the session.
     Each MDPP's beneficiary's weight and date weight taken, in 
a form and manner as specified by CMS.
    We believe that this information will play an important role in 
documenting the provision of MDPP services and fidelity to the 
requirements established for the expanded model. Finally, at Sec.  
424.205(g)(3), we are proposing that MDPP suppliers must maintain and 
handle any beneficiary Personally Identifiable Information (PII) and 
Personal Health Information (PHI) in compliance with HIPAA, other state 
and federal privacy laws, and CMS standards. We believe these proposals 
will improve supplier recordkeeping accuracy and lessen the possibility 
of incomplete records and supplier recordkeeping variations.
    We are inviting public comments on our proposed documentation and 
maintenance of records requirements, including whether additional or 
different requirements may provide better program integrity safeguards.
f. Beneficiary Engagement Incentives Under the MDPP Expanded Model
    We believe that the MDPP expanded model would encourage MDPP 
suppliers to furnish high quality and engaging health behavior change 
services to MDPP beneficiaries that lead to improved beneficiary health 
and reductions in Medicare spending. We further believe that one 
mechanism that may be useful to the MDPP suppliers in achieving these 
goals would be allowing MDPP suppliers to furnish certain in-kind items 
and services to their MDPP beneficiaries during the core services 
period and ongoing services period (described at proposed Sec.  
410.79(c)(2)). Under such an approach, the costs of these beneficiary 
engagement incentives would be borne by the MDPP supplier. However, we 
believe that certain

[[Page 34167]]

conditions on these incentives are necessary to ensure that they would 
be furnished solely for the purpose of achieving the MDPP goal of 
engaging beneficiaries in making sustainable, healthy behavior changes 
to reduce their risk of type 2 diabetes.
    We are proposing to establish the rules governing the furnishing of 
beneficiary engagement incentives to MDPP beneficiaries under the MDPP 
expanded model at new Sec.  424.210. As discussed in section III.K.2.a. 
of this proposed rule, we are proposing that MDPP services would be 
available beginning on April 1, 2018. Therefore, because there would be 
no MDPP beneficiaries who could receive beneficiary engagement 
incentives from MDPP suppliers until on or after April 1, 2018, we are 
proposing that the effective date of Sec.  424.210 would be April 1, 
2018.
i. Definitions Specific to Beneficiary Engagement Incentives
    We are proposing that if an MDPP supplier offers an in-kind 
beneficiary engagement incentive, the item or service offered as an 
incentive must be furnished by an MDPP supplier to a MDPP beneficiary 
during the engagement incentive period. An engagement incentive period 
would begin when an MDPP supplier furnishes any MDPP service to an MDPP 
beneficiary. As proposed at Sec.  424.210(a), the term ``engagement 
incentive period'' means the period of time during which an MDPP 
supplier may furnish in-kind beneficiary engagement incentives to a 
given MDPP beneficiary to whom the MDPP supplier is furnishing MDPP 
services. The engagement incentive period would end upon the earliest 
of the following: The beneficiary's MDPP services period ends (as 
specified in proposed Sec.  410.79(c)(3)) for any reason; the MDPP 
supplier knows the MDPP beneficiary will no longer be receiving MDPP 
services from the MDPP supplier; or the MDPP supplier has not had 
direct contact, either in person, by telephone, or via other 
telecommunications technology, with the MDPP beneficiary for more than 
90 consecutive calendar days during the MDPP services period.
    We are proposing that items and services may only be furnished as 
in-kind beneficiary engagement incentives during the engagement 
incentive period. This is to ensure that the flexibilities that MDPP 
suppliers would be afforded under these proposed regulations to furnish 
free items and services to Medicare beneficiaries only apply while the 
beneficiary is an MDPP beneficiary being offered MDPP services by that 
MDPP supplier. Once the MDPP beneficiary's engagement incentive period 
ends with an MDPP supplier, all existing laws and regulations would 
apply to the furnishing of free items and services to a Medicare 
beneficiary by the entity that is an MDPP supplier. Limiting the 
furnishing of beneficiary engagement incentives under the MDPP expanded 
model to the engagement incentive period with a particular MDPP 
supplier serves as a safeguard against the furnishing of free items and 
services to Medicare beneficiaries to steer them toward particular 
providers, suppliers, or other services, rather than to engage MDPP 
beneficiaries in healthy behavior changes that reduce their incidence 
of type 2 diabetes.
    During the course of the MDPP services period, an MDPP beneficiary 
may begin and end multiple engagement incentive periods, and, to the 
extent feasible, the MDPP beneficiary would not be in more than one 
engagement incentive period at the same time. For example, where, after 
receiving MDPP services from MDPP supplier A, an MDPP beneficiary 
notifies MDPP supplier A that he or she has chosen to receive MDPP 
services from MDPP supplier B and subsequently receives MDPP services 
from MDPP supplier B, the first engagement incentive period ends when 
MDPP supplier A is told by the MDPP beneficiary that he or she will no 
longer attend MDPP services with MDPP supplier A. A new engagement 
incentive period begins when the MDPP beneficiary receives his or her 
first MDPP service from MDPP supplier B. Additionally, where an MDPP 
beneficiary begins an engagement incentive period with an MDPP supplier 
and the engagement incentive period has ended because the MDPP supplier 
has not had direct contact, either in person, by telephone, or via 
other telecommunications technology, with the MDPP beneficiary for 90 
consecutive days during the MDPP services period, should that MDPP 
beneficiary receive MDPP services from that MDPP supplier on day 100, a 
new engagement incentive period would begin.
    These proposals for the definitions specific to beneficiary 
engagement incentives are included at proposed Sec.  424.210(a). We are 
inviting public comments on these proposed definitions specific to 
furnishing in-kind beneficiary engagement incentives.
ii. General Conditions for Beneficiary Engagement Incentives
    We are proposing, at Sec.  424.210(b), that an MDPP supplier may 
choose to furnish items or services as in-kind beneficiary engagement 
incentives to an MDPP beneficiary only during the engagement incentive 
period, subject to a number of additional conditions as program 
safeguards. Under this proposal, the in-kind items and services 
furnished as beneficiary engagement incentives under the MDPP expanded 
model would not be Medicare-covered items or services.
    We are proposing that the engagement incentive must be furnished 
directly by an MDPP supplier or by an agent of the MDPP supplier under 
the MDPP supplier's direction and control, such as a coach, to an MDPP 
beneficiary. As established in the Sec.  410.79(b) in the CY 2017 PFS 
final rule, coach refers to an individual who furnishes MDPP services 
on behalf of an MDPP supplier as an employee, contractor, or volunteer. 
We considered whether this policy on beneficiary engagement incentives 
should extend to entities other than MDPP suppliers and their agents 
that may refer to or furnish MDPP services during an engagement 
incentive period.
    However, given that MDPP suppliers maintain the responsibility to 
ensure the integrity of MDPP programs and would be best positioned to 
comply with beneficiary engagement incentive documentation and 
technology retrieval requirements proposed at Sec.  424.210(e) and (c), 
respectively, we believe that they are best suited to furnished 
beneficiary engagement incentives. We are proposing that the item or 
service furnished as a beneficiary engagement incentive must be 
reasonably connected to the CDC-approved curriculum taught by an MDPP 
supplier to an MDPP beneficiary during a core session, a core 
maintenance session, or an ongoing maintenance session. For example, 
under this proposal, an MDPP supplier could furnish beneficiary 
engagement incentives such as gym memberships to reduce barriers 
associated with beneficiary achievement of physical activity 
recommended as part of the CDC-approved curriculum, but they could not 
furnish theater tickets, which would bear no reasonable connection to 
the CDC-approved curriculum. Similarly, MDPP suppliers may offer 
incentives such as onsite child care when the MDPP beneficiary attends 
MDPP services or transportation vouchers to the site of MDPP services 
that may reduce barriers to beneficiary attendance at MDPP services, 
but they could not furnish attendance awards such as movie tickets or 
retail gift cards, which would have no reasonable connection to the 
CDC-approved curriculum. Likewise, this proposal would allow MDPP 
suppliers to furnish equipment that is reasonably necessary for the 
curriculum being taught to the

[[Page 34168]]

beneficiary, such as digital scales to track and document patient 
weight or pedometers to track physical activity, but not broadly used 
technology that is more valuable to the beneficiary, such as a 
smartphone. If an MDPP supplier were to furnish a smartphone at no cost 
to an MDPP beneficiary, a reasonable inference arises that the 
technology would not be reasonably connected to the curriculum being 
taught to the beneficiary. Among other things, this safeguard precludes 
incentives that might serve to induce beneficiaries inappropriately to 
receive other services than MDPP services from the MDPP supplier.
    We also are proposing that the beneficiary engagement incentive 
must be a preventive care item or service, or an item or service that 
advances a clinical goal for an MDPP beneficiary as described in 
section III.K.2.f.iv. of this proposed rule by engaging him or her in 
better managing his or her own health. This ensures that a relationship 
between the incentive and the goals of the MDPP expanded model exists 
so that the beneficiary engagement incentive is necessary for testing 
the expanded MDPP model. Under this proposed condition, we note that 
beneficiary engagement incentives may not be offered to an MDPP 
beneficiary as a reward for achievement of a specified outcome, such as 
losing weight or attending a certain number of sessions, unless the 
beneficiary engagement incentive meets all the proposed conditions, 
including that it is reasonably connected to the CDC-approved DPP 
curriculum furnished to the MDPP beneficiary during a core session, a 
core maintenance session, or an ongoing maintenance session by the MDPP 
supplier and that it is a preventive care item or service or it 
advances a clinical goal for an MDPP beneficiary by engaging him or her 
in better managing his or her own health. Furnishing in-kind patient 
engagement incentives upon achievement of an outcome may not advance a 
clinical goal for an MDPP beneficiary by engaging him or her in better 
managing his or her own health unless there are clinical goals that the 
incentive itself can continue to advance. We are further proposing that 
the item or service furnished as a beneficiary engagement incentive 
must not be tied to the receipt of items or services outside the MDPP 
services, and that the item or service must not be tied to the receipt 
of items or services from a particular provider, supplier, or coach. 
These provisions provide safeguards against the furnishing of in-kind 
beneficiary engagement incentives to steer beneficiaries toward certain 
providers, suppliers, or coaches for services outside MDPP services.
    We note that in some circumstances, an item or service may be 
linked to an MDPP supplier and be offered to the MDPP supplier's MDPP 
beneficiaries as part of the CDC-approved curriculum that must be 
furnished during the MDPP services period, rather than being offered to 
steer the MDPP beneficiary to a particular provider, supplier, or 
coach. In these situations, we believe the item or service may be 
furnished as a beneficiary engagement incentive without violating the 
requirement that the item or service not be tied to the receipt of the 
items or services from a particular provider, supplier, or coach. For 
instance, where an MDPP supplier offers a gym membership as a 
beneficiary engagement incentive, we understand that the gym membership 
must be tied to a particular supplier of services so that the 
beneficiary can use the membership. However, in this case, the gym 
membership would be linked to the MDPP supplier that, in compliance 
with the curriculum that must be furnished during the MDPP services 
period, is teaching MDPP beneficiaries how to utilize a physical 
fitness regime to meet the MDPP goal of reducing an MDPP beneficiary's 
risk of developing diabetes, rather than being furnished to steer the 
MDPP beneficiary to a particular supplier. Therefore, we believe that 
gym memberships may be furnished as a beneficiary engagement incentive 
without violating the requirement that the item or service not be tied 
to the receipt of items or services from a particular provider, 
supplier, or coach as long as the gym membership is reasonably 
connected to the CDC-approved curriculum and not being furnished to 
steer the MDPP beneficiary to a particular supplier.
    We are proposing that, in general, the availability of the items or 
services furnished as beneficiary engagement incentives must not be 
advertised or promoted as in-kind beneficiary engagement incentives 
available to an MDPP beneficiary receiving MDPP services from the MDPP 
supplier. However, an MDPP beneficiary may be made aware of the 
availability of the items or services at the time the MDPP beneficiary 
could reasonably benefit from them during the engagement incentive 
period. This condition provides a safeguard against the advertisement 
of in-kind patient engagement incentives to beneficiaries based on 
their perceived ability to meet the performance goals of attendance and 
weight loss as described at proposed Sec.  414.84(a) and associated 
with the MDPP performance payments proposed at Sec.  414.84(b). The 
proposed payment structure for MDPP services largely relies on the 
achievement of these performance goals. Therefore, advertising patient 
engagement incentives to encourage participation of MDPP-eligible 
beneficiaries most likely to meet the attendance and weight loss 
performance goals could produce financial gain for MDPP suppliers that 
is not related to the quality and efficacy of the MDPP supplier's MDPP 
services.
    In addition, prohibiting the advertisement or promotion of in-kind 
beneficiary engagement incentives available to an MDPP beneficiary 
receiving MDPP services from the MDPP supplier except that an MDPP 
beneficiary may be made aware of the availability of the items or 
services at the time the MDPP beneficiary could reasonably benefit from 
them during the engagement incentive period provides a safeguard 
against using the incentive to steer a beneficiary toward a particular 
MDPP supplier. Beneficiaries would not be made aware of the 
availability of beneficiary engagement incentives until the MDPP 
beneficiary was in an engagement incentive period, which would begin 
when an MDPP supplier furnished its first MDPP service to the 
beneficiary. At that point in time, the beneficiary would have already 
selected that MDPP supplier to furnish his or her MDPP services so the 
incentive could not be used to steer the beneficiary to that MDPP 
supplier. We note that we do not intend for beneficiary engagement 
incentives proposed for the MDPP expanded model to alter an MDPP 
supplier's market share for an MDPP or non-MDPP item or service.
    Finally, we are proposing that the cost of the items or services 
offered as in-kind beneficiary engagement incentives must not be 
shifted to another Federal health care program, as defined at section 
1128B(f) of the Act. This requirement affirms that the cost of any 
beneficiary engagement incentive offered by an MDPP supplier is the 
sole responsibility of the MDPP supplier, and the furnishing of a 
beneficiary engagement incentive, for instance, must not result in 
increased payments to the MDPP supplier by Federal health care programs 
for other items or services.
    These proposals for the general conditions for in-kind beneficiary 
engagement incentives are included at proposed Sec.  424.210(b). We are 
inviting public comments on these proposed general conditions for 
furnishing beneficiary engagement incentives. In addition, we are 
inviting public

[[Page 34169]]

comments on additional or alternative program integrity safeguards.
iii. Technology Furnished to a MDPP Beneficiary
    In some cases, items or services involving technology may be useful 
as beneficiary engagement incentives because they can advance a 
clinical goal of the MDPP expanded model by engaging an MDPP 
beneficiary in managing his or her health. However, we believe specific 
enhanced safeguards are necessary for these items and services to 
prevent abuse.
    First, we are proposing that items or services involving technology 
furnished by an MDPP supplier to its MDPP beneficiary may not, in the 
aggregate, exceed $1,000 in retail value for any one MDPP beneficiary. 
We believe that this proposed limit is appropriate, in conjunction with 
our proposed enhanced requirements for items of technology with a 
retail value greater than $100 as discussed subsequently in this 
section. The proposed $1,000 limitation would allow sufficient MDPP 
supplier flexibility to furnish items or services involving technology 
as beneficiary engagement incentives to improve the likelihood of the 
beneficiary's achievement and maintenance of the required minimum weigh 
loss. The proposed limitation would not allow the furnishing of items 
of technology that in the aggregate constitute an excessively high 
value to the beneficiary that could increase the risk that the items of 
technology would not be in compliance with all of the proposed 
requirements for beneficiary engagement incentives.
    For example, under this proposal, an MDPP beneficiary who begins 
receiving MDPP services from an MDPP supplier and who, after receiving 
MDPP services from that MDPP supplier, is furnished items or services 
of technology with a total retail value of $1,000 may not receive 
additional items or services of technology from that MDPP supplier. 
Therefore, an MDPP beneficiary may receive from a MDPP supplier a 
tablet valued at $700 that is preloaded with weight loss and fitness 
tracking apps that would support the beneficiary's weight loss goals 
under the MDPP expanded model and also receive from the same MDPP 
supplier a fitness tracking watch valued at $200 that uploads and 
monitors fitness data to the tablet, but he or she could not then 
receive additional items of technology from the MDPP supplier with an 
aggregate retail value greater than $100 as this would exceed the 
$1,000 limit.
    In addition, if the same MDPP beneficiary chooses to receive MDPP 
services from another MDPP supplier, the subsequent supplier is under 
no obligation to determine the value of any items or services of 
technology furnished to the MDPP beneficiary by other MDPP suppliers, 
and may furnish items or services of technology to the MDPP beneficiary 
so long as those items or services furnished by the subsequent supplier 
are the minimum necessary to advance a clinical goal for the MDPP 
beneficiary, are furnished during the engagement incentive period, and 
do not, in aggregate, exceed $1,000 in retail value. We note that, 
while items of technology must be furnished to the MDPP beneficiary 
during an engagement incentive period, the $1,000 limit for items of 
technology that may be furnished to any one MDPP beneficiary by any one 
MDPP supplier is not otherwise affected by the engagement incentive 
period. For example, if an MDPP beneficiary begins and ends multiple 
engagement incentive periods with the same MDPP supplier as described 
in section III.K.2.f.i. of this proposed rule, the $1,000 limit for 
items of technology would not ``reset'' at the beginning of a new 
engagement incentive period with that MDPP supplier.
    We are further proposing that items or services involving 
technology furnished to an MDPP beneficiary must be the minimum 
necessary to advance a clinical goal for MDPP beneficiaries as 
discussed in section III.K.2.f.iv. of this proposed rule.
    We are proposing enhanced requirements for items of technology 
exceeding $100 in retail value as an additional safeguard against 
misuse of these items as beneficiary engagement incentives. We believe 
it would be inappropriate for MDPP suppliers to furnish items of 
technology with a retail value of over $100 for beneficiaries' 
permanent use because the high value of these items could unduly 
influence the beneficiary to continue to receive MDPP services from 
that supplier, or to receive items or services from the supplier other 
than MDPP services. Therefore, we are proposing that items of 
technology with a retail value of over $100 would remain the property 
of the MDPP supplier and be retrieved from the MDPP beneficiary at the 
end of the engagement incentive period. We do not believe that this 
requirement would substantially increase the administrative burden on 
MDPP suppliers because a central facilitator of the success of an MDPP 
beneficiary in meeting MDPP performance goals is the MDPP supplier's 
ability to maintain contact with the MDPP beneficiary and engage him or 
her in MDPP services. We note that items of technology with a retail 
value of $100 or less could be furnished as beneficiary engagement 
incentives and would remain the property of the beneficiary. In the 
case of these items of a technology with a lower retail value, we 
believe the administrative burden of retrieving these items would 
outweigh the program integrity benefits of retrieval.
    We are further proposing that the MDPP supplier must document all 
technology retrieval attempts, including the ultimate date of 
retrieval. However, because we understand that MDPP suppliers may not 
always be able to retrieve these items, such as when a beneficiary dies 
or moves to another geographic area, documented, diligent, good faith 
attempts to retrieve items of technology would be deemed to meet the 
retrieval requirement.
    Our proposals for enhanced requirements for technology furnished to 
MDPP beneficiaries as beneficiary engagement incentives under the MDPP 
expanded model are included at proposed Sec.  424.210(c). We are 
inviting public comments on our proposed requirements for beneficiary 
engagement incentives that involve technology and welcome comments on 
additional or alternative program integrity safeguards for this type of 
beneficiary engagement incentive, including whether the financial 
thresholds proposed in this section are reasonable, necessary, and 
appropriate.
iv. Clinical Goals of the MDPP Expanded Model
    As established at Sec.  410.79(b) in the CY 2017 PFS final rule, 
MDPP services furnished to MDPP beneficiaries must follow a CDC-
approved curriculum, which outlines required and recommended topics for 
structured health behavior change sessions offered as MDPP services 
with the goal of preventing diabetes through long-lasting health 
behavior change. MDPP suppliers seeking recognition under the CDC's 
DPRP must furnish either the CDC-preferred curriculum, based on the 
current evidence base, or may develop their own curriculum. MDPP 
suppliers who wish to develop their own curriculum must submit it to 
the CDC for approval. This requirement ensures that all curricula 
furnished to MDPP beneficiaries meet the DPRP's curriculum content 
requirements and are based on evidence from efficacy and effectiveness 
trials consistent with the current evidence base. To be consistent with 
the current evidence base, all curricula offered by MDPP suppliers must 
furnish MDPP services focused on the overarching goal of preventing 
type

[[Page 34170]]

2 diabetes in persons at high risk for diabetes because they have 
prediabetes. This requires MDPP suppliers to emphasize the need to make 
lasting health behavior changes, rather than simply completing a one-
time set of MDPP services that result in the required minimum weight 
loss during the MDPP services period. MDPP services must also emphasize 
long-term improvements in nutrition and physical activity that 
contribute to beneficiaries sustaining weight loss. Therefore, we 
believe that in-kind patient engagement incentives may appropriately be 
furnished to support and motivate MDPP beneficiaries in achieving 
dietary and health behavior change and to teach MDPP beneficiaries to 
problem-solve strategies to overcome challenges to maintaining weight 
loss and healthy behaviors, as well as to assist MDPP beneficiaries in 
meeting the attendance and weight loss performance goals of the MDPP 
expanded model.
    Therefore, we are proposing that the following would be the 
clinical goals of the MDPP expanded model, which may be advanced 
through beneficiary engagement incentives:
     Beneficiary attendance at MDPP core sessions, core 
maintenance sessions, or ongoing maintenance sessions during the MDPP 
services period.
     Beneficiary weight loss.
     Long-term dietary change for the beneficiary.
     Beneficiary adherence to long-term health behavior 
changes.
    We note that under this proposal, the MDPP supplier may not furnish 
multiple free meals or meal replacement services to an MDPP beneficiary 
over a substantial portion of the engagement incentive period because 
such a practice would not advance a clinical goal for an MDPP 
beneficiary by engaging him or her in better managing his or her own 
health.
    When a beneficiary engagement incentive does not qualify as a 
preventive care item or service, our proposals for the clinical goals 
of the MDPP expanded model that a beneficiary engagement incentive must 
be intended to advance are included at proposed Sec.  424.210(d). We 
are inviting public comments on our proposed clinical goals of the 
MDPP, as well as whether the advancement of additional or different 
clinical goals through beneficiary engagement incentives may better 
advance the overarching goals of the MDPP expanded model, while 
maintaining appropriate program integrity safeguards.
v. Documentation of Beneficiary Engagement Incentives
    As a program safeguard against misuse of beneficiary engagement 
incentives under the MDPP expanded model, we are proposing that, in 
addition to the documentation requirements for MDPP suppliers at 
proposed Sec.  424.205(g), MDPP suppliers must maintain documentation 
of items and services furnished as beneficiary engagement incentives 
that individually exceed $25 in retail value. We recognize that an MDPP 
beneficiary could receive many incentives that are each of low dollar 
value but in the aggregate constitute an excessively high value to the 
beneficiary. Therefore, we believe it is important to incorporate a 
documentation threshold at a modest level for all beneficiary 
incentives in order to monitor compliance with the proposed conditions 
for furnishing these items and services. Moreover, we believe the 
proposed $25 retail value threshold strikes an appropriate balance 
between beneficiary and program protections and MDPP supplier 
administrative burden.
    In addition, we are proposing to require that the documentation 
must be established contemporaneously with the furnishing of the items 
and services and must include at least the date the incentive was 
furnished; the identity of the beneficiary to whom the item or service 
was furnished; the agent of the supplier who furnished the item or 
service if applicable; a description of the item or service; the retail 
value of the beneficiary engagement incentive; and documentation 
establishing that the item or service was furnished to the MDPP 
beneficiary during the engagement incentive period.
    In addition to the proposed requirements in the previous paragraph, 
we are further proposing that the documentation regarding items or 
services furnished to the MDPP beneficiary for use on an ongoing basis 
during the engagement incentive period, including items of technology 
exceeding $100 in retail value, must also include contemporaneous 
documentation establishing that the MDPP beneficiary is in the 
engagement incentive period throughout the time period that the MDPP 
beneficiary possesses or has access to the item or service furnished by 
the MDPP supplier. For example, if an MDPP supplier furnishes a gym 
membership to an MDPP beneficiary, the MDPP supplier must maintain 
contemporaneous documentation establishing that the MDPP beneficiary is 
in the engagement incentive period throughout the time period that the 
MDPP beneficiary has access to the gym via the membership furnished by 
the MDPP supplier.
    In addition to the above requirements, we are further proposing 
that the documentation regarding items of technology exceeding $100 in 
retail value that MSPP suppliers are required to retrieve from the MDPP 
beneficiary must also include contemporaneous documentation of any 
attempts to retrieve the item of technology furnished by the MDPP 
supplier from the MDPP beneficiary as required at proposed Sec.  
424.210(c)(3)(ii). We reiterate that under our proposal documented, 
diligent, good faith attempts to retrieve items of technology would be 
deemed to meet the retrieval requirement.
    Finally, we are proposing that the MDPP supplier must retain and 
provide access to the required documentation in accordance with 
proposed Sec.  424.205(g).
    Table 35 summarizes the proposed documentation requirements for 
beneficiary engagement incentives under the MDPP expanded model.

[[Page 34171]]



    Table 35--Proposed Beneficiary Engagement Incentive Documentation
                              Requirements
------------------------------------------------------------------------
    Beneficiary Engagement Incentive        Documentation requirement
------------------------------------------------------------------------
Item or service with retail value         Contemporaneous
 greater than $25.                        documentation that includes at
                                          least:
                                         [ssquf] The date the incentive
                                          was furnished.
                                         [ssquf] The identity of the
                                          MDPP beneficiary to whom the
                                          item or service was furnished.
                                         [ssquf] Documentation
                                          establishing that the item or
                                          service was furnished to the
                                          MDPP beneficiary during the
                                          engagement incentive period.
                                         [ssquf] The agent of the
                                          supplier who furnished the
                                          item or service, if
                                          applicable.
                                         [ssquf] A description of the
                                          item or service.
                                         [ssquf] The retail value of the
                                          item or service.
                                          Documentation
                                          regarding items or services
                                          that are furnished to the MDPP
                                          beneficiary for use on an
                                          ongoing basis during the
                                          engagement incentive period,
                                          including items of technology
                                          exceeding $100 in retail
                                          value, must also include
                                          contemporaneous documentation
                                          establishing that the MDPP
                                          beneficiary is in the
                                          engagement incentive period
                                          throughout the time period
                                          that the MDPP beneficiary
                                          possesses or has access to the
                                          item or service furnished by
                                          the MDPP supplier.
                                          The documentation
                                          regarding items of technology
                                          exceeding $100 in retail value
                                          must also include
                                          contemporaneous documentation
                                          of any attempt to retrieve the
                                          technology.*
                                          The MDPP supplier must
                                          retain and provide access to
                                          the documentation.
------------------------------------------------------------------------
* = Items of technology with a retail value greater than $100 remain the
  property of the MDPP supplier and must be retrieved from the MDPP
  beneficiary at the end of the engagement incentive period.

    Our proposals for the documentation requirements for beneficiary 
engagement incentives under the MDPP expanded model are included at 
proposed Sec.  424.210(e). We are inviting public comments on our 
proposed documentation requirements, including whether additional or 
different documentation requirements may provide better program 
integrity safeguards.
vi. Compliance With Fraud and Abuse Laws
    Certain arrangements between MDPP suppliers and beneficiaries may 
implicate the civil monetary penalty (CMP) law (sections 1128A(a)(5), 
(b)(1) and (b)(2) of the Act), or the Federal Anti-kickback statute 
(section 1128B(b)(1) and (2) of the Act). In many cases, arrangements 
that implicate these laws can be structured to comply with them by 
using existing safe harbors and exceptions. Section 1115A(d)(1) of the 
Act authorizes the Secretary to waive certain specified fraud and abuse 
laws as may be necessary solely for purposes of testing of models under 
section 1115A(b) of the Act. A waiver is not needed for an arrangement 
that does not implicate the fraud and abuse laws or that implicates the 
fraud and abuse laws, but either fits within an existing exception or 
safe harbor, as applicable, or does not otherwise violate the law. 
Accordingly, pursuant to section 1115A(d)(1) of the Act, the Secretary 
will consider whether waivers of certain fraud and abuse laws are 
necessary for the MDPP expanded model. Such waivers, if any, would be 
promulgated separately from this proposed regulation by OIG (as to 
sections 1128A and 1128B of the Act), to which the respective 
authorities have been delegated.
    The requirements in the final rule for the MDPP expanded model will 
bear on the need for and scope of any fraud and abuse waivers that 
might be granted for the model. Because of the close nexus between the 
final regulations governing the structure and operations of the MDPP 
expanded model and the development of any fraud and abuse waivers 
necessary to carry out the provisions of the model, CMS and OIG may, 
when considering the need for or scope of any waivers, consider 
comments submitted in response to this proposed rule and the provisions 
of the final rule.
3. Virtual DPP and the MDPP Expanded Model
    The CDC's DPRP standards allow evidence-based DPP curricula to be 
furnished through a variety of modes, including through remote 
technologies. Similar to the description noted in section 
III.K.2.c.iv.3 with respect to virtual make-up sessions, virtual DPP 
refers to any modality, or method of furnishing MDPP services, that is 
not in person. This includes, but is not limited to:
    (1) Furnishing services online where the behavior change program is 
furnished 100 percent online, with participants accessing course 
resources and lifestyle coach via a computer, laptop, tablet, smart 
phone, or other device with internet access. This modality requires an 
internet connection to participate in all aspects of the DPP;
    (2) Furnishing services online with other means of support by a 
coach (for example, telecommunications, video conferencing). This 
modality requires an internet connection for some aspects of the DPP, 
but not all; and
    (3) Distance learning, where a coach is present in one location and 
participants are calling, video-conferencing, or otherwise using 
telecommunications technology to access the coach from another 
location. This modality does not require any internet connection for 
any of the aspects of the DPP.
    These types of delivery modes are hereafter referred to as 
``virtual,'' and DPP furnished exclusively through these modes with no 
in-person delivery is hereafter referred to as ``virtual DPP.''
    We acknowledge that the public comments in response to the MDPP 
expanded model in the CY 2017 PFS proposed rule supported the inclusion 
of virtual DPP in the MDPP expanded model. Many commenters stated that 
this proposal would increase access to MDPP services, referenced 
emerging evidence that suggests virtual DPP may be as effective as DPP 
furnished in a community setting, and stated that virtual delivery may 
be preferable to some beneficiaries. In the CY 2017 PFS final rule, we 
deferred policies pertinent

[[Page 34172]]

to virtual DPP to future rulemaking. While we propose to allow a 
limited number of virtual make-up sessions in the MDPP expanded model 
(discussed in section III.K.2.c.iv.3), we do not propose to include 
virtual DPP services (that is, DPP furnished exclusively through remote 
technologies with no in-person delivery) . We considered including 
virtual DPP services in the MDPP expanded model, however, the DPP model 
test that was used to make the statutorily required determination for 
expansion did not include virtual DPP services. Instead, we are 
considering a separate model under CMS's Innovation Center authority to 
test and evaluate virtual DPP services. Our intention is that any 
separate model test of virtual DPP services would run in parallel with 
the MDPP Expanded Model. Consistent with our regular practice for 
Innovation Center models, we would release details on the model test 
for virtual DPP services separately.
    We note that some DPP suppliers currently offer DPP services 
through a combination of in-person and virtual delivery. We only 
propose to allow this combination of delivery subject to the 
requirements on virtual make-up sessions discussed in section 
III.K.2.c.iv.3. The combined-delivery DPP services that are currently 
offered are intended to offer a participant DPP services through both 
online and in-person methods. The MDPP expanded model, in contrast, is 
intended to offer participants in-person DPP services primarily, but 
allows a limited number of virtual make-up sessions on an individual 
basis. As discussed in section III.K.2.c.iv.3., there is substantial 
research on the effectiveness of DPP furnished virtually, and emerging 
evidence on DPP delivered virtually suggests that virtual delivery can 
show similarly successful participant weight loss and health benefits 
to DPP delivered in other settings, including among Medicare-age 
participants. However, since the DPP model test only included in-person 
delivery, we propose to limit the number of virtually-delivered make-up 
sessions to the limits discussed in section III.K.2.c.iv.3.
    An organization may furnish separate DPPs where some participants 
receive only in-person DPP services, others receive only virtual DPP 
services, and others receive a combination program where some sessions 
are offered in person and others virtually. If an organization that 
offers multiple distinct DPPs through different delivery modes enrolls 
as an MDPP supplier, we propose that only DPP services furnished in 
person will be paid in the MDPP expanded model, with the exception of 
virtual make-up sessions as discussed in section III.K.2.c.iv.3 of this 
proposed rule.
    We invite public comments on these policies.
4. Evaluation
    We intend to evaluate the MDPP expanded model using a combination 
of encounter and claims data to analyze the long-term utilization of 
services by beneficiaries who have received the MDPP benefit. As 
discussed in the CY 2017 PFS final rule, we will continue to assess 
whether the MDPP expanded model is expected to improve the quality of 
care without increasing spending, reduce spending without reducing the 
quality of care, or improve the quality of care and reduce spending, 
and we will terminate or modify the MDPP expanded model if the expanded 
model is not expected to meet these criteria.
    Among other possible questions we might explore, our analysis will 
specifically look at long-term utilization and expenditures that might 
suggest subsequent treatment of diabetes. We intend to use beneficiary-
level encounter data and program data furnished by CDC and will match 
these data to Medicare claims using the crosswalk finalized at Sec.  
424.59(b)(3) of the CY 2017 PFS final rule (proposed to be redesignated 
and amended at Sec.  424.205(d)(13)). As with other Innovation Center 
model evaluation reports (which are currently published online at 
https://innovation.cms.gov/Data-and-Reports/index.html), we intend to 
publish the MDPP evaluation annual reports publicly on a CMS Web site. 
We refer readers to the supplier requirements discussed under section 
III.K.2.e.iv.(7) of this proposed rule for the proposal regarding 
supplier compliance with this requirement, as well as specifications on 
the timing and format of the crosswalk.

L. Request for Information on CMS Flexibilities and Efficiencies

    CMS is committed to transforming the health care delivery system--
and the Medicare program--by putting an additional focus on patient-
centered care and working with providers, physicians, and patients to 
improve outcomes. We seek to reduce burdens for hospitals, physicians, 
and patients, improve the quality of care, decrease costs, and ensure 
that patients and their providers and physicians are making the best 
health care choices possible. These are the reasons we are including 
this Request for Information in this proposed rule.
    As we work to maintain flexibility and efficiency throughout the 
Medicare program, we would like to start a national conversation about 
improvements that can be made to the health care delivery system that 
reduce unnecessary burdens for clinicians, other providers, and 
patients and their families. We aim to increase quality of care, lower 
costs improve program integrity, and make the health care system more 
effective, simple and accessible.
    We would like to take this opportunity to invite the public to 
submit their ideas for regulatory, subregulatory, policy, practice, and 
procedural changes to better accomplish these goals. Ideas could 
include payment system redesign, elimination or streamlining of 
reporting, monitoring and documentation requirements, aligning Medicare 
requirements and processes with those from Medicaid and other payers, 
operational flexibility, feedback mechanisms and data sharing that 
would enhance patient care, support of the physician-patient 
relationship in care delivery, and facilitation of individual 
preferences. Responses to this Request for Information could also 
include recommendations regarding when and how CMS issues regulations 
and policies and how CMS can simplify rules and policies for 
beneficiaries, clinicians, physicians, providers, and suppliers. Where 
practicable, data and specific examples would be helpful. If the 
proposals involve novel legal questions, analysis regarding CMS' 
authority is welcome for CMS' consideration. We are particularly 
interested in ideas for incentivizing organizations and the full range 
of relevant professionals and paraprofessionals to provide screening, 
assessment and evidence-based treatment for individuals with opioid use 
disorder and other substance use disorders, including reimbursement 
methodologies, care coordination, systems and services integration, use 
of paraprofessionals including community paramedics and other 
strategies. We are requesting commenters to provide clear and concise 
proposals that include data and specific examples that could be 
implemented within the law.
    We note that this is a Request for Information only. Respondents 
are encouraged to provide complete but concise responses. This Request 
for Information is issued solely for information and planning purposes; 
it does not constitute a Request for Proposal (RFP), applications, 
proposal abstracts, or quotations. This Request for Information does 
not commit the U.S.

[[Page 34173]]

Government to contract for any supplies or services or make a grant 
award. Further, CMS is not seeking proposals through this Request for 
Information and will not accept unsolicited proposals. Responders are 
advised that the U.S. Government will not pay for any information or 
administrative costs incurred in response to this Request for 
Information; all costs associated with responding to this Request for 
Information will be solely at the interested party's expense. We note 
that not responding to this Request for Information does not preclude 
participation in any future procurement, if conducted. It is the 
responsibility of the potential responders to monitor this Request for 
Information announcement for additional information pertaining to this 
request. In addition, we note that CMS will not respond to questions 
about the policy issues raised in this Request for Information. CMS 
will not respond to comment submissions in response to this Request for 
Information in the FY 2018 PFS final rule. Rather, CMS will actively 
consider all input as we develop future regulatory proposals or future 
subregulatory policy guidance. CMS may or may not choose to contact 
individual responders. Such communications would be for the sole 
purpose of clarifying statements in the responders' written responses. 
Contractor support personnel may be used to review responses to this 
Request for Information. Responses to this notice are not offers and 
cannot be accepted by the Government to form a binding contract or 
issue a grant. Information obtained as a result of this Request for 
Information may be used by the Government for program planning on a 
nonattribution basis. Respondents should not include any information 
that might be considered proprietary or confidential. This Request for 
Information should not be construed as a commitment or authorization to 
incur cost for which reimbursement would be required or sought. All 
submissions become U.S. Government property and will not be returned. 
CMS may publically post the public comments received, or a summary of 
those public comments.

IV. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. chapter 
35), we are required to publish a 60-day notice in the Federal Register 
and solicit public comment before a collection of information 
requirement is submitted to the Office of Management and Budget (OMB) 
for review and approval.
    To fairly evaluate whether an information collection should be 
approved by OMB, section 3506(c)(2)(A) of the PRA requires that we 
solicit comment on the following issues:
     The need for the information collection and its usefulness 
in carrying out the proper functions of our agency.
     The accuracy of our burden estimates.
     The quality, utility, and clarity of the information to be 
collected.
     Our effort to minimize the information collection burden 
on the affected public, including the use of automated collection 
techniques.
    We are soliciting public comment on each of the required issues 
under section 3506(c)(2)(A) of the PRA for the following information 
collection requirements (ICRs): (1) The Medicare Diabetes Prevention 
Program (MDPP) Expanded Model, (2) the Physician Quality Reporting 
System (PQRS), (3) appropriate use criteria for advanced diagnostic 
imaging services, and (4) the Medicare Shared Savings Program.

A. Wage Estimates

    To derive average costs, we used data from the U.S. Bureau of Labor 
Statistics' May 2016 National Occupational Employment and Wage 
Estimates for all salary estimates (http://www.bls.gov/oes/current/oes_nat.htm). In this regard, Table 36 presents the mean hourly wage, 
the cost of fringe benefits and overhead (calculated at 100 percent of 
salary), and the adjusted hourly wage.

                          Table 36--National Occupational Employment and Wage Estimates
----------------------------------------------------------------------------------------------------------------
                                                                                Fringe benefits
              Occupation title                Occupation code    Mean hourly      and overhead   Adjusted hourly
                                                                 wage ($/hr)      costs ($/hr)     wage ($/hr)
----------------------------------------------------------------------------------------------------------------
Family and General Practitioner.............         29-1062            96.54            96.54           193.08
----------------------------------------------------------------------------------------------------------------

    As indicated, we are adjusting our employee hourly wage estimates 
by a factor of 100 percent. This is necessarily a rough adjustment, 
both because fringe benefits and overhead costs vary significantly from 
employer to employer, and because methods of estimating these costs 
vary widely from study to study. Nonetheless, there is no practical 
alternative and we believe that doubling the hourly wage to estimate 
total cost is a reasonably accurate estimation method.

B. Proposed Information Collection Requirements (ICRs)

1. ICRs Regarding the Medicare Diabetes Prevention Program (MDPP) 
Expanded Model
    In Sec. Sec.  410.79, 414.84, 424.200, 424.205, 424.210, 424.502, 
424.516, 424.518 and 424.55 of this proposed rule, we discuss our 
proposals to further implement the Medicare Diabetes Prevention Program 
(MDPP) Expanded Model, which is aimed at preventing the onset of type 2 
diabetes among Medicare beneficiaries with prediabetes. Section 
1115A(d)(3) of the Act exempts Innovation Center model tests and 
expansions, which include the MDPP expanded model, from the provisions 
of the PRA. Specifically, this section provides that the provisions of 
the PRA shall not apply to the testing and evaluation of Innovation 
Center models or expansions of such models.
2. ICRs Regarding the Physician Quality Reporting System (PQRS) (Sec.  
414.90)
    While this rule proposes to revise our PQRS reporting criteria for 
the 2016 reporting period to avoid the 2018 payment adjustment, we are 
not proposing to accept any additional data for the 2016 reporting 
period. In this regard this rule does not set out any new or revised 
burden or requirements that would trigger the requirements of the PRA.
3. ICRs Regarding Appropriate Use Criteria for Advanced Diagnostic 
Imaging Services (Sec.  414.94)
    This rule proposes to revise Sec.  414.94(i)(3) by reiterating the 
availability of a significant hardship exception for ordering 
professionals who demonstrate a significant hardship consistent with 
the criteria listed under Sec.  495.102(d)(4)(i), (d)(4)(iii), 
(d)(4)(iv)(A) or (d)(4)(iv)(B). Consistent with a final rule that 
published on November 14,

[[Page 34174]]

2016 (81 FR 79865 through 79866) the hardship exception process 
involves the completion of an application which imposes no burden 
beyond the provision of identifying information and attesting to the 
applicable information. In this regard, the application is not 
``information'' as defined under 5 CFR 1320.3(h), and therefore, is 
exempt from requirements of the PRA.
    Consistent with section 1834(q)(4)(A) of the Act (as amended by 
section 218(b) of the PAMA), Sec.  414.94(j) proposes to require that 
ordering professionals consult specified applicable AUC through a 
qualified clinical decision support mechanism (CDSM) for applicable 
imaging services ordered on or after January 1, 2019. We propose a one-
time burden associated with a possible 6-month voluntary consulting 
period beginning sometime in 2018, as well as a mandatory annual burden 
beginning January 1, 2019. Because general practitioners are the 
largest group of practitioners who order applicable imaging services 
and would be required to consult AUC under this program we use ``family 
and general practitioner'' for our estimates below.
    During the 6-month voluntary participation period, we estimate 
3,410,000 responses in the form of consultations based on market 
research from current applicants for the qualification of their CDSMs 
for advanced diagnostic imaging services. Based on feedback from CDSMs 
with experience in AUC consultation as well as standards recommended by 
the Office of the National Coordinator (ONC) and the Healthcare 
Information Management Systems Society (HIMSS), we estimate it would 
take 2 minutes at $193.08/hr for a family and general practitioner to 
use a qualified CDSM to consult specified applicable AUC. Per 
consultation, we estimate 2 minutes (0.033 hr) at a cost of $6.37 
(0.033 hr x $193.08/hr). In aggregate, we estimate a one-time burden of 
112,530 hours (0.033 hr x 3,410,000 consultations) at a cost of 
$21,727,292.40 (112,530 hr x $193.08/hr).
    Annually, we estimate 37,510 hours (112,530 hr/3 yr) at a cost of 
$7,242,430.80 ($21,727,292.40/3 yr). We are annualizing the one-time 
burden (by dividing our estimates by OMB's 3-year approval period) 
since we do not anticipate any additional burden after the 6-month 
voluntary participation period ends.
    Beginning January 1, 2019, we anticipate 43,181,818 responses in 
the form of consultations based on the aforementioned market research, 
as well as Medicare claims data for advanced diagnostic imaging 
services. As noted above, we estimate it would take 2 minutes (0.033 
hr) at $193.08/hr for a family and general practitioner to use a 
qualified CDSM to consult specified applicable AUC. In this regard, we 
estimate 0.033 hours per consultation at a cost of $6.37 (0.033 hr x 
$193.08/hr). In aggregate, we estimate an annual burden of 1,425,000 
hours (0.033 hr x 43,181,818 consultations) at a cost of $275,139,000 
(1,425,000 hr x $193.08/hr).
    The consultation requirements and burden will be submitted to OMB 
for approval under control number 0938-New (CMS-10654).
    Consistent with section 1834(q)(4)(B) of the Act, we are also 
proposing to implement a one-time 6-month voluntary reporting period 
beginning sometime in 2018, as well as a mandatory annual reporting 
requirement beginning January 1, 2019. Specifically, Sec.  414.94(k) 
proposes to require that furnishing professionals report on the 
Medicare claims for advanced diagnostic imaging services, paid for 
under an applicable payment system (as defined in Sec.  414.94(b)) and 
ordered on or after January 1, 2019, the following information: (1) 
Identify which qualified CDSM was consulted by the ordering 
professional; (2) identify whether the service ordered would adhere to 
specified applicable AUC, would not adhere to specified applicable AUC, 
or whether specified applicable AUC was not applicable to the service 
ordered; and (3) identify the NPI of the ordering professional (if 
different from the furnishing professional). The proposed reporting 
requirement would not have any impact on any Medicare claim forms 
because the forms' currently approved data fields, instructions, and 
burden are not expected to change. Consequently, there is no need for 
review by OMB under the authority of the PRA.
    The timing and implementation of the voluntary consultation and 
reporting period is dependent on the readiness of the Medicare claims 
systems to accept and process claims including AUC consultation 
information. Currently, 99 percent of all Medicare claims are submitted 
electronically as a result of The Administrative Simplification 
Compliance Act amendment to section 1862(a) of the Act, which 
prescribes that no payment may be made under Part B of the Medicare 
Program for any expenses incurred for items or services for which a 
claim is received in a non-electronic form. Consequently, absent an 
applicable exception, paper claims received by Medicare will not be 
paid. Continued developments in the deployment of CDSMs has produced 
research \28\ and best practices 29 30 31 supporting our 
position that any such changes made to respondent IT systems would be a 
usual and customary business practice whose burden is exempt from the 
requirements of the PRA under 5 CFR 1320.3(b).
---------------------------------------------------------------------------

    \28\ CDC Health Information Innovation Consortium, May 17 2016, 
available at https://www.cdc.gov/ophss/chiic/forums/2016-05-17_index.html.
    \29\ ONC eCQI resource for process improvement: bit.ly/
oncecqicds.
    \30\ CMS CDS tipsheet: bit.ly/cmscdstips.
    \31\ HIMSS CDS Guidebook Series: www.himss.org/cdsguide.
---------------------------------------------------------------------------

4. ICRs Regarding the Medicare Shared Savings Program (Part 425)
    Section 1899(e) of the Act provides that chapter 35 of title 44 of 
the U.S. Code, which includes such provisions as the PRA, shall not 
apply to the Shared Savings Program.

C. Summary of Annual Burden Estimates for Proposed Requirements

                                                    Table 37--Proposed Annual Requirements and Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                            Burden per                     Labor cost of
          Regulation section(s)             OMB control     Respondents      Responses       response      Total annual    reporting ($/  Total cost ($)
                                              number                                          (hours)     burden (hours)        hr)              *
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   414.94(j) (voluntary                     0938-New       3,410,000    1,136,666.67           0.033          37,510          193.08       7,242,431
 consultations).........................                                   (3,410,000/3)
Sec.   414.94(j) (mandatory               ..............      43,181,818      43,181,818           0.033       1,425,000          193.08     275,139,000
 consultations).........................

[[Page 34175]]

 
        Total...........................  ..............      46,591,818      44,318,485           0.033       1,462,510          193.08     282,381,431
--------------------------------------------------------------------------------------------------------------------------------------------------------
* With respect to the PRA, this rule would not impose any non-labor costs.

D. Submission of PRA-Related Comments

    We have submitted a copy of this proposed rule to OMB for its 
review of the rule's information collection and recordkeeping 
requirements. These requirements are not effective until they have been 
approved by the OMB.
    To obtain copies of the supporting statement and any related forms 
for the proposed collections discussed above, please visit CMS' Web 
site at Web site address at https://www.cms.gov/Regulations-andGuidance/Legislation/PaperworkReductionActof1995/PRAListing.html, or 
call the Reports Clearance Office at 410-786-1326.
    We invite public comments on these potential information collection 
requirements. If you wish to comment, please submit your comments 
electronically as specified in the ADDRESSES section of this proposed 
rule and identify the rule (CMS-1676-P) and where applicable the ICR's 
CFR citation, CMS ID number, and OMB control number.
    See the DATES and ADDRESSES sections of this proposed rule for 
further information.

V. Response to Comments

    Because of the large number of public comments we normally receive 
on Federal Register documents, we are not able to acknowledge or 
respond to them individually. We will consider all comments we receive 
by the date and time specified in the DATES section of this preamble, 
and, when we proceed with a subsequent document, we will respond to the 
comments in the preamble to that document.

VI. Regulatory Impact Analysis

A. Statement of Need

    This proposed rule makes payment and policy changes under the 
Medicare PFS and makes required statutory changes under the MACRA, 
ABLE, PAMA, and the Consolidated Appropriations Act of 2016. This final 
rule also makes changes to payment policy and other related policies 
for Medicare Part B, Part D, and Medicare Advantage.

B. Overall Impact

    We examined the impact of this rule as required by Executive Order 
12866 on Regulatory Planning and Review (September 30, 1993), Executive 
Order 13563 on Improving Regulation and Regulatory Review (February 2, 
2013), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. 
L. 96-354), section 1102(b) of the Social Security Act, section 202 of 
the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-
4), Executive Order 13132 on Federalism (August 4, 1999), the 
Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 
on Reducing Regulation and Controlling Regulatory Costs (January 30, 
2017).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). A 
regulatory impact analysis (RIA) must be prepared for major rules with 
economically significant effects ($100 million or more in any 1 year). 
We estimate, as discussed in this section, that the PFS provisions 
included in this final rule would redistribute more than $100 million 
in 1 year. Therefore, we estimate that this rulemaking is 
``economically significant'' as measured by the $100 million threshold, 
and hence also a major rule under the Congressional Review Act. 
Accordingly, we prepared an RIA that, to the best of our ability, 
presents the costs and benefits of the rulemaking. The RFA requires 
agencies to analyze options for regulatory relief of small entities. 
For purposes of the RFA, small entities include small businesses, 
nonprofit organizations, and small governmental jurisdictions. Most 
hospitals, practitioners and most other providers and suppliers are 
small entities, either by nonprofit status or by having annual revenues 
that qualify for small business status under the Small Business 
Administration standards. (For details see the SBA's Web site at http://www.sba.gov/content/table-small-business-size-standards (refer to the 
620000 series)). Individuals and states are not included in the 
definition of a small entity.
    The RFA requires that we analyze regulatory options for small 
businesses and other entities. We prepare a regulatory flexibility 
analysis unless we certify that a rule would not have a significant 
economic impact on a substantial number of small entities. The analysis 
must include a justification concerning the reason action is being 
taken, the kinds and number of small entities the rule affects, and an 
explanation of any meaningful options that achieve the objectives with 
less significant adverse economic impact on the small entities.
    Approximately 95 percent of practitioners, other providers, and 
suppliers are considered to be small entities, based upon the SBA 
standards. There are over 1 million physicians, other practitioners, 
and medical suppliers that receive Medicare payment under the PFS. 
Because many of the affected entities are small entities, the analysis 
and discussion provided in this section, as well as elsewhere in this 
final rule is intended to comply with the RFA requirements regarding 
significant impact on a substantial number of small entities.
    For example, the effects of changes to payment rates for 
practitioners, other providers, and suppliers are discussed in VI.C. of 
this proposed rule. Alternative options considered to the proposed 
payment rates are discussed generally in section VI.F of this proposed 
rule, while specific alternatives for individual codes are discussed 
throughout this rule, especially in section II.H.
    In addition, section 1102(b) of the Act requires us to prepare an 
RIA if a rule may have a significant impact on the operations of a 
substantial number of small rural hospitals. This analysis must conform 
to the provisions of section 603 of the RFA. For purposes of section 
1102(b) of the Act, we define a small rural hospital as a hospital that 
is located outside of a Metropolitan Statistical Area for Medicare 
payment regulations and has fewer than 100 beds. We did not prepare an 
analysis for section 1102(b) of the Act because we

[[Page 34176]]

determined, and the Secretary certified, that this final rule would not 
have a significant impact on the operations of a substantial number of 
small rural hospitals.
    Section 202 of the Unfunded Mandates Reform Act of 1995 also 
requires that agencies assess anticipated costs and benefits on state, 
local, or tribal governments or on the private sector before issuing 
any rule whose mandates require spending in any 1 year of $100 million 
in 1995 dollars, updated annually for inflation. In 2017, that 
threshold is approximately $148 million. This proposed rule will impose 
no mandates on state, local, or tribal governments or on the private 
sector.
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it issues a proposed rule (and subsequent final 
rule) that imposes substantial direct requirement costs on state and 
local governments, preempts state law, or otherwise has Federalism 
implications. Since this regulation does not impose any costs on state 
or local governments, the requirements of Executive Order 13132 are not 
applicable.
    Executive Order 13771, entitled Reducing Regulation and Controlling 
Regulatory Costs (82 FR 9339), was issued on January 30, 2017. This 
proposed rule is subject to the requirements of E.O. 13771 because, if 
finalized as proposed, it is expected to result in regulatory costs.
    We prepared the following analysis, which together with the 
information provided in the rest of this preamble, meets all assessment 
requirements. The analysis explains the rationale for and purposes of 
this proposed rule; details the costs and benefits of the rule; 
analyzes alternatives; and presents the measures we would use to 
minimize the burden on small entities. As indicated elsewhere in this 
proposed rule, we are implementing a variety of changes to our 
regulations, payments, or payment policies to ensure that our payment 
systems reflect changes in medical practice and the relative value of 
services, and implementing statutory provisions. We provide information 
for each of the policy changes in the relevant sections of this 
proposed rule. We are unaware of any relevant federal rules that 
duplicate, overlap, or conflict with this proposed rule. The relevant 
sections of this proposed rule contain a description of significant 
alternatives if applicable.

C. Changes in Relative Value Unit (RVU) Impacts

1. Resource-Based Work, PE, and MP RVUs
    Section 1848(c)(2)(B)(ii)(II) of the Act requires that increases or 
decreases in RVUs may not cause the amount of expenditures for the year 
to differ by more than $20 million from what expenditures would have 
been in the absence of these changes. If this threshold is exceeded, we 
make adjustments to preserve budget neutrality.
    Our estimates of changes in Medicare expenditures for PFS services 
compare payment rates for CY 2017 with proposed payment rates for CY 
2018 using CY 2016 Medicare utilization. The payment impacts in this 
proposed rule reflect averages by specialty based on Medicare 
utilization. The payment impact for an individual practitioner could 
vary from the average and would depend on the mix of services he or she 
furnishes. The average percentage change in total revenues would be 
less than the impact displayed here because practitioners and other 
entities generally furnish services to both Medicare and non-Medicare 
patients. In addition, practitioners and other entities may receive 
substantial Medicare revenues for services under other Medicare payment 
systems. For instance, independent laboratories receive approximately 
83 percent of their Medicare revenues from clinical laboratory services 
that are paid under the Clinical Laboratory Fee Schedule.
    The annual update to the PFS conversion factor (CF) was previously 
calculated based on a statutory formula; for details about this 
formula, we refer readers to the CY 2015 PFS final rule with comment 
period (79 FR 67741 through 67742). Section 101(a) of the MACRA 
repealed the previous statutory update formula and amended section 
1848(d) of the Act to specify the update adjustment factors for 
calendar years 2015 and beyond. For CY 2018, the specified update is 
0.5 percent before applying other adjustments.
    Section 220(d) of the PAMA added a new paragraph at section 
1848(c)(2)(O) of the Act to establish an annual target for reductions 
in PFS expenditures resulting from adjustments to relative values of 
misvalued codes. Under section 1848(c)(2)(O)(ii) of the Act, if the net 
reduction in expenditures for the year is equal to or greater than the 
target for the year, reduced expenditures attributable to such 
adjustments shall be redistributed in a budget-neutral manner within 
the PFS in accordance with the existing budget neutrality requirement 
under section 1848(c)(2)(B)(ii)(II) of the Act. Section 
1848(c)(2)(O)(iii) of the Act specifies that, if the estimated net 
reduction in PFS expenditures for the year is less than the target for 
the year, an amount equal to the target recapture amount shall not be 
taken into account when applying the budget neutrality requirements 
specified in section 1848(c)(2)(B)(ii)(II) of the Act. We estimate the 
CY 2018 net reduction in expenditures resulting from adjustments to 
relative values of misvalued codes to be 0.31 percent. Since this 
amount does not meet the 0.5 percent target established by the 
Achieving a Better Life Experience Act of 2014 (ABLE) (Division B of 
Pub. L. 113-295, enacted December 19, 2014), payments under the fee 
schedule must be reduced by the difference between the target for the 
year and the estimated net reduction in expenditures, known as the 
target recapture amount. As a result, we estimate that the CY 2018 
target recapture amount will produce a reduction to the conversion 
factor of -0.19 percent.
    To calculate the proposed conversion factor for this year, we 
multiplied the product of the current year conversion factor and the 
update adjustment factor by the target recapture amount and the budget 
neutrality adjustment described in the preceding paragraphs. We 
estimate the CY 2018 PFS conversion factor to be 35.9903, which 
reflects the budget neutrality adjustment, the 0.5 percent update 
adjustment factor specified under section 1848(d)(18) of the Act, and 
the -0.31 percent target recapture amount required under section 
1848(c)(2)(O)(iv) of the Act and described above. We estimate the CY 
2018 anesthesia conversion factor to be 22.0353, which reflects the 
same overall PFS adjustments, as well as an additional adjustment due 
to an update to the malpractice risk factor for the anesthesia 
specialty.

   Table 38--Calculation of the Proposed CY 2018 PFS Conversion Factor
------------------------------------------------------------------------
 Conversion factor in effect in CY
               2017                                           35.8887
------------------------------------------------------------------------
Update Factor.....................  0.50 percent          ..............
                                     (1.0050).
CY 2018 RVU Budget Neutrality       -0.03 percent         ..............
 Adjustment.                         (0.9997).

[[Page 34177]]

 
CY 2018 Target Recapture Amount...  -0.19 percent         ..............
                                     (0.9981).
CY 2018 Conversion Factor.........  ....................         35.9903
------------------------------------------------------------------------


   Table 39--Calculation of the Proposed CY 2018 Anesthesia Conversion
                                 Factor
------------------------------------------------------------------------
     CY 2017 national average
   anesthesia  conversion factor                              22.0454
------------------------------------------------------------------------
Update Factor.....................  0.50 percent          ..............
                                     (1.0050).
CY 2018 RVU Budget Neutrality       -0.03 percent         ..............
 Adjustment.                         (0.9997).
CY 2018 Target Recapture Amount...  -0.19 percent         ..............
                                     (0.9981).
CY 2018 Anesthesia Fee Schedule     -0.33 percent         ..............
 Practice Expense and Malpractice    (0.9967).
 Adjustment.
CY 2018 Conversion Factor.........  ....................         22.0353
------------------------------------------------------------------------

    Table 40 shows the payment impact on PFS services of the proposals 
contained in this proposed rule. To the extent that there are year-to-
year changes in the volume and mix of services provided by 
practitioners, the actual impact on total Medicare revenues would be 
different from those shown in Table 40 (CY 2018 PFS Estimated Impact on 
Total Allowed Charges by Specialty). The following is an explanation of 
the information represented in Table 40.
     Column A (Specialty): Identifies the specialty for which 
data are shown.
     Column B (Allowed Charges): The aggregate estimated PFS 
allowed charges for the specialty based on CY 2016 utilization and CY 
2017 rates. That is, allowed charges are the PFS amounts for covered 
services and include coinsurance and deductibles (which are the 
financial responsibility of the beneficiary). These amounts have been 
summed across all services furnished by physicians, practitioners, and 
suppliers within a specialty to arrive at the total allowed charges for 
the specialty.
     Column C (Impact of Work RVU Changes): This column shows 
the estimated CY 2018 impact on total allowed charges of the changes in 
the work RVUs, including the impact of changes due to potentially 
misvalued codes.
     Column D (Impact of PE RVU Changes): This column shows the 
estimated CY 2018 impact on total allowed charges of the changes in the 
PE RVUs.
     Column E (Impact of MP RVU Changes): This column shows the 
estimated CY 2018 impact on total allowed charges of the changes in the 
MP RVUs, which are primarily driven by the required five-year review 
and update of MP RVUs.
     Column F (Combined Impact): This column shows the 
estimated CY 2018 combined impact on total allowed charges of all the 
changes in the previous columns. Column F may not equal the sum of 
columns C, D, and E due to rounding.

                 Table 40--CY 2018 PFS Estimated Impact on Total Allowed Charges by Specialty *
----------------------------------------------------------------------------------------------------------------
                                                  (C)  Impact of  (D)  Impact of  (E)  Impact of
                                   (B)  Allowed       work RVU         PE RVU          MP RVU      (F)  Combined
         (A)  Specialty           charges  (mil)      changes         changes         changes        impact **
                                                     (percent)       (percent)       (percent)       (percent)
----------------------------------------------------------------------------------------------------------------
    TOTAL.......................         $92,628               0               0               0               0
ALLERGY/IMMUNOLOGY..............             245               0              -3               0              -3
ANESTHESIOLOGY..................           2,009              -1               0               0               0
AUDIOLOGIST.....................              66               0               0              -1              -1
CARDIAC SURGERY.................             311               0               0              -1              -2
CARDIOLOGY......................           6,671               0              -1              -1              -2
CHIROPRACTOR....................             772               0               1               0               1
CLINICAL PSYCHOLOGIST...........             756               0               2               0               2
CLINICAL SOCIAL WORKER..........             664               0               3               0               3
COLON AND RECTAL SURGERY........             166               0               0              -1              -1
CRITICAL CARE...................             332               0               0               0               0
DERMATOLOGY.....................           3,475               0               0              -1              -1
DIAGNOSTIC TESTING FACILITY.....             765               0              -6               0              -6
EMERGENCY MEDICINE..............           3,176               0               0              -1              -1
ENDOCRINOLOGY...................             477               0               0               0               0
FAMILY PRACTICE.................           6,307               0               0               0               0
GASTROENTEROLOGY................           1,792               0               0              -1              -1
GENERAL PRACTICE................             452               0               0               0               0
GENERAL SURGERY.................           2,154               0               0               0              -1
GERIATRICS......................             211               0               0               0               1
HAND SURGERY....................             200               0               0               0               1
HEMATOLOGY/ONCOLOGY.............           1,802               0               0               0               0
INDEPENDENT LABORATORY..........             684               0              -1               0              -2
INFECTIOUS DISEASE..............             651               0               0               1               1
INTERNAL MEDICINE...............          11,022               0               0               0               0
INTERVENTIONAL PAIN MGMT........             830               0               0               0               0

[[Page 34178]]

 
INTERVENTIONAL RADIOLOGY........             357               0              -1               0              -1
MULTISPECIALTY CLINIC/OTHER PHYS             139               0               0               0               0
NEPHROLOGY......................           2,257               0               0               0               0
NEUROLOGY.......................           1,545               0               0               0               0
NEUROSURGERY....................             805               0               0              -1              -1
NUCLEAR MEDICINE................              50               0               0               0               0
NURSE ANES/ANES ASST............           1,238              -1               0               1              -1
NURSE PRACTITIONER..............           3,541               0               0               0               0
OBSTETRICS/GYNECOLOGY...........             658               0               0              -1              -1
OPHTHALMOLOGY...................           5,480               0               0               0               0
OPTOMETRY.......................           1,259               0               0               0               0
ORAL/MAXILLOFACIAL SURGERY......              57               0              -2               0              -2
ORTHOPEDIC SURGERY..............           3,784               0               0               0               0
OTHER...........................              28               0               0               0               0
OTOLARNGOLOGY...................           1,232               0              -1               0              -2
PATHOLOGY.......................           1,147               0               0               0              -1
PEDIATRICS......................              63               0               0               0               0
PHYSICAL MEDICINE...............           1,105               0               0               0               1
PHYSICAL/OCCUPATIONAL THERAPY...           3,780               1               1               0               1
PHYSICIAN ASSISTANT.............           2,232               0               0               0               0
PLASTIC SURGERY.................             379               0               0               0               0
PODIATRY........................           1,973               0               1               1               1
PORTABLE X-RAY SUPPLIER.........             100               0              -1               0              -1
PSYCHIATRY......................           1,233               0               1               0               1
PULMONARY DISEASE...............           1,753               0               0               0               0
RADIATION ONCOLOGY AND RADIATION           1,784               0               1               1               1
 THERAPY CENTERS................
RADIOLOGY.......................           4,863               0              -1               0              -1
RHEUMATOLOGY....................             553               0               0               0               0
THORACIC SURGERY................             356               0               0              -1              -1
UROLOGY.........................           1,772               0              -1               0              -1
VASCULAR SURGERY................           1,115               0              -1               0              -2
----------------------------------------------------------------------------------------------------------------
** Column F may not equal the sum of columns C, D, and E due to rounding.

2. CY 2018 PFS Impact Discussion
a. Changes in RVUs
    The most widespread specialty impacts of the final RVU changes are 
generally related to the changes to RVUs for specific services 
resulting from the Misvalued Code Initiative, including finalized RVUs 
for new and revised codes. The estimated impacts for some specialties, 
including behavioral health specialists, physical and occupational 
therapists, and radiation oncology, reflect increases relative to other 
physician specialties. These increases can largely be attributed to 
proposed increases in value for particular services following the 
American Medical Association Relative Value Update Committee and CMS 
review, the proposed change in allocation of indirect practice expense 
RVUs for office-based, face-to-face behavioral health services, and 
proposed changes based on updated professional liability premium data.
    The estimated impacts for several specialties, including diagnostic 
testing facilities, allergy/immunology, otolaryngology, oral/
maxillofacial surgery, and independent laboratories, reflect decreases 
in payments relative to payment to other physician specialties as a 
result of proposed revaluation of individual procedures reviewed by the 
American Medical Association Relative Value Update Committee and CMS, 
proposed changes based on updated professional liability premium data, 
proposed decreases in relative payment as a result of proposed updates 
to prices for particular medical supplies, and continued implementation 
of previously finalized code-level reductions that are being phased-in 
over several years. For independent laboratories, it is important to 
note that these entities receive approximately 83 percent of their 
Medicare revenues from services that are paid under the Clinical 
Laboratory Fee Schedule. As a result, the estimated 2 percent reduction 
for CY 2018 is only applicable to approximately 17 percent of the 
Medicare payment to these entities.
    We often receive comments regarding the changes in RVUs displayed 
on the specialty impact table, including comments received in response 
to the proposed rates. We remind stakeholders that although the 
estimated impacts are displayed at the specialty level, typically the 
changes are driven by the valuation of a relatively small number of new 
and/or potentially misvalued codes. The percentages in the table are 
based upon aggregate estimated PFS allowed charges summed across all 
services furnished by physicians, practitioners, and suppliers within a 
specialty to arrive at the total allowed charges for the specialty, and 
compared to the same summed total from the previous calendar year. They 
are therefore averages, and may not necessarily be representative of 
what is happening to the particular services furnished by a single 
practitioner within any given specialty.
b. Impact
    Column F of Table 40 displays the estimated CY 2018 impact on total 
allowed charges, by specialty, of all the RVU changes. A table shows 
the estimated impact on total payments for selected high volume 
procedures of all

[[Page 34179]]

of the changes is available under ``downloads'' on the CY 2018 PFS 
proposed rule Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/. We selected these procedures for 
sake of illustration from among the most commonly furnished by a broad 
spectrum of specialties. The change in both facility rates and the 
nonfacility rates are shown. For an explanation of facility and 
nonfacility PE, we refer readers to Addendum A on the CMS Web site at 
http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/.
D. Effect of Changes in Telehealth List
    As discussed in section II.D. of this proposed rule, we are 
proposing to add several new codes to the list of Medicare telehealth 
services. Although we expect these changes to have the potential to 
increase access to care in rural areas, based on recent telehealth 
utilization of services already on the list, including services similar 
to the proposed additions, we estimate no significant impact on PFS 
expenditures from the proposed additions. For example, for services 
already on the list, they are furnished via telehealth, on average, 
less than 0.1 percent of the time they are reported overall.
E. Effect of Changes to Payment to Provider-Based Departments (PBDs) of 
Hospitals Paid Under the PFS
    As discussed in section II.G of this proposed rule, for CY 2018, we 
are proposing a PFS Relativity Adjuster of 25 percent, meaning that 
nonexcepted items and services furnished by nonexcepted PBDs would be 
paid under the PFS at a rate that is 25 percent of the OPPS rate. We 
estimate that this change will result in total Medicare Part B savings 
of $25 million for CY 2018 relative to maintaining the CY 2017 PFS 
Relativity Adjuster for CY 2018.
F. Other Provisions of the Proposed Regulation
1. New Care Coordination Services and Payment for RHCs and FQHCs
    As discussed in section III.A of this proposed rule, we are 
proposing the establishment of two new G codes for use by RHCs and 
FQHCs. The first new G code would be a General Care Management code for 
RHCs and FQHCs with the payment amount set at the average of the 3 
national non-facility PFS payment rates for the CCM and general BHI 
codes. The second new G code for RHCs and FQHCs would be a Psychiatric 
CoCM code with the payment amount set at the average of the 2 national 
non-facility PFS payment rates for psychiatric CoCM services. The 
payment rate for each code would be updated annually, based on the 
national non-facility PFS payment rates for each code contained in the 
G code.
    The proposed methodology for payment of care coordination services 
is consistent with the RHC and FQHC payment principles of not paying 
for services based on time increments. It does not create additional 
reporting burden and is expected to promote beneficiary access to 
comprehensive care management services furnished by RHCs and FQHCs.
    Establishment of the RHC and FQHC General Care Management code, 
which includes all levels of CCM and general BHI services, is projected 
to increase Medicare spending by $600,000 in CY 2018 and by $7.4 
million over 10 years. This estimate is based on the proposed per 
service allowed charge increase (from approximately $42.71 to $61.37) 
applied to historical 2016 CCM and BHI volume in RHCs and FQHCs. This 
volume was adjusted with an assumed 10 percent behavioral volume 
increase to reflect the increase in allowed charges per service.
    Establishment of the RHC and FQHC Psychiatric CoCM code, which 
includes all levels of psychiatric CoCM services, is projected to 
increase Medicare spending by approximately $100,000 in CY2018 and $3.7 
million over 10 years. Because psychiatric CoCM is not billable 
currently by RHCs or FQHCs and is also new to practitioners billing 
under the PFS, this estimate is based on first quarter 2017 PFS 
psychiatric CoCM claims of 0.03 percent of psychiatric E/M visits, 
adjusted to an ultimate average rate of 0.16 percent based on the 
pattern of increase in CCM services in the PFS found in the first two 
years of implementation. This rate was then applied to the number of 
2016 RHC and FQHC mental health visits to get an estimate of CoCM 
volume, and then projected forward on a per-capita basis. PFS price 
updates were applied to the initial approximate $135 psychiatric CoCM 
payment amount to project future costs.
    The combined increase in Medicare spending for both new G codes is 
estimated to be approximately $600,000 in 2018, and approximately $11.1 
million over 10 years. While these services are expected to increase 
quality and improve efficiency over time, the programs are still new 
and the data is not available yet to demonstrate any cost savings. 
Therefore, no healthcare cost reductions were assumed as a result of 
increased care management.

[[Page 34180]]



                    Table 42--Calendar Years 2018-2027 Projected Spending Impact of New General Care Management and Psychiatric CoCM Codes for RHCs and FQHCs (millions) \32\
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                        CY                             2018         2019         2020         2021         2022         2023         2024         2025         2026         2027      2018-2027
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
General Care Management..........................          0.6          0.7          0.7          0.7          0.7          0.8          0.8          0.8          0.8          0.8          7.4
Psychiatric CoCM.................................          0.1          0.4          0.4          0.4          0.4          0.4          0.4          0.4          0.4          0.4          3.7
                                                  ----------------------------------------------------------------------------------------------------------------------------------------------
    Total........................................          0.8          1.0          1.1          1.1          1.1          1.1          1.2          1.2          1.2          1.3         11.1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\32\ Figures may not sum to totals due to rounding.


[[Page 34181]]

    As discussed in section III.A. of this proposed rule, we considered 
3 other options (for example, allowing any of the 7 codes to be 
separately added to a claim, bundling all 7 codes into one G code, and 
developing 3 separate G codes--one each for CCM, BHI, and CoCM 
services). We estimate that there would be no significant difference in 
the costs among the options because all of the options considered 
include the same services paid at the same rate and no data is 
available to estimate a different rate of billing for each code.
2. Payment for DME Infusion Drugs
    As discussed in section III.B. of this proposed rule, we proposed 
to conform the regulation text at Sec.  414.904(e)(2) to section 5004 
of the Cures Act, which transitioned payment for DME infusion drugs 
from AWP-based pricing to the ASP-pricing methodology on January 1, 
2017. Table 43 shows the effect of changes in drug payments to DME 
suppliers. We estimate adoption of the ASP+6 pricing methodology will 
result in total Medicare Part B savings ranging over the 10-year period 
from $40 million in FY 2017 to $110 million in FY 2026 with a 10-year 
total Medicare Part B savings of $960 million.

[[Page 34182]]



                                       Table 43--Impact of Cures Section 5004 on Payment for Infusion Drugs Furnished Through an Item of DMS (in millions)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                                            5-yr        10-yr
                 FY                       2017         2018         2019         2020         2021         2022         2023         2024         2025         2026        impact    impact 2017-
                                                                                                                                                                         2017- 2021      2026
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits............................         (50)        (110)        (130)        (130)        (130)        (130)        (150)        (150)        (150)        (150)        (550)      (1,280)
Premium Offset......................           10           30           30           30           30           30           40           40           40           40          130          320
                                     -----------------------------------------------------------------------------------------------------------------------------------------------------------
    Total Part B....................         (40)         (80)        (100)        (100)        (100)        (100)        (110)        (110)        (110)        (110)        (420)        (960)
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 34183]]

3. Appropriate Use Criteria for Advanced Diagnostic Imaging Services
    We are proposing and requesting public comment on the appropriate 
use criteria (AUC) consulting and reporting requirements and the 
effective date on which these requirements will begin. We are also 
proposing modifications to the significant hardship exception to better 
align these exceptions under the AUC program with those under existing 
quality programs. In the COI section of this document, we have 
estimated the proposed consulting requirement to result in an annual 
burden of 1,425,000 hours at a cost of $275,139,000. Under these 
proposals, claims for advanced diagnostic imaging services would not be 
denied in CY 2018, and thus, these proposals would not impact CY 2018 
physician payments under the PFS. The Congressional Budget Office 
estimates that section 218 of the PAMA would save approximately 200 
million dollars over 10 years from FY 2014 through 2024, which could be 
the result of identification of outlier ordering professionals. Because 
we have not yet proposed a mechanism or calculation for outlier 
ordering professional identification and prior authorization, we are 
unable to quantify that impact at this time. We will provide an impact 
statement when applicable in future rulemaking.
4. Physician Quality Reporting System Criteria for Satisfactory 
Reporting for Individual EPs
a. Burden Estimate for PQRS Reporting
    We previously discussed the burden estimate for PQRS regarding the 
program year 2016 reporting criteria, which applies to the 2018 payment 
adjustment in the CY 2016 PFS final rule (see 80 FR 71362 through 
71367). The burden estimates for reporting that data have not changed 
since these data for program year 2016 PQRS have already been reported; 
therefore, there are no added burden estimates for the proposed policy 
change in this rule in section III.F.
b. Burden Savings Estimated Based on PQRS Measures Reduction Proposed 
Policy
    Amending the policy to reduce the amount of measures needed to 
satisfactorily report to avoid the 2018 payment adjustment from 9 
measures across 3 NQS domains to 6 measures (see section III.F. of this 
proposed rule) would increase the amount of satisfactory reporters for 
the 2016 reporting period, which would decrease those subject to the 
2018 payment adjustment. Using data from the 2015 reporting period as 
the basis for our estimates, there were roughly 525,000 eligible 
professionals who failed the PQRS reporting requirements for the 2015 
reporting period and received a downward payment adjustment in 2017 
(see https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/PQRS/Downloads/2015_PQRS_Experience_Report.pdf). 
We estimate that, based on 2015 results, approximately 4.5 percent of 
EPs that received a downward payment adjustment would be found 
successful and therefore would avoid the payment penalty. This equates 
to an estimated 23,625 EPs that would no longer be subject to the 2018 
payment adjustment based on PQRS data for the 2015 reporting period.
    Based on the estimated average payment adjustment of $937.02 in 
program year 2015, which was negative 2 percent based on 2015 PFS 
charges, an estimated ($937.02 x 23,625 = $22,137,097.50) would be the 
amount EPs would receive as a result of not being subject to the 2018 
payment adjustment due to the proposed measure reduction policy in this 
rule for PQRS program year 2016, which applies to the 2018 payment 
adjustment.
5. Medicare Shared Savings Program
    We are proposing certain modifications to our rules regarding ACO 
assignment and financial calculations, quality measures and quality 
validation audits, TIN overlaps, and application requirements. 
Specifically we are proposing: (1) Modifications to how services 
furnished by FQHCs and RHCs are used for purposes of beneficiary 
assignment to an ACO as a result of the 21st Century Cures Act, 
including reducing reporting burden for ACOs that include FQHCs and 
RHCs; (2) modifications to the assignment methodology to include new 
chronic care management and behavioral health integration codes in our 
definition of primary care services; (3) a policy to improve the 
quality validation audit process and, absent unusual circumstances, to 
use the results to proportionally modify an ACO's overall quality 
score; (4) a policy to address substantive changes to quality measures 
made under the Quality Payment Program; (5) revisions to our 
application requirements to reduce burden for ACO applicants seeking to 
participate in the Shared Savings Program and for ACOs applying to use 
the SNF 3-Day Rule Waiver; (6) changes to our program rules to address 
compliance with our ACO participant TIN overlap policies, specifically, 
to address situations in which overlapping ACO participant TINs begin 
billing for services that are used in beneficiary assignment during a 
benchmark or performance year; and (7) a policy to use final 
beneficiary identifiable non-claims based payments in establishing 
benchmarks and performing financial reconciliation.
    Each of these proposed policies is generally expected to have a 
minimal impact on affected ACOs. We do not anticipate any overall 
impact for these proposed policies because potential individual ACO 
impacts are more likely to offset one another rather than build to a 
substantial total in terms of costs or savings.
6. Value-Based Payment Modifier and the Physician Feedback Program
    Section 1848(p) of the Act requires that we establish a value-based 
payment modifier (VM) and apply it to specific physicians and groups of 
physicians the Secretary determines appropriate starting January 1, 
2015, and to all physicians and groups of physicians by January 1, 
2017. Section 1848(p)(4)(C) of the Act requires the VM to be budget 
neutral. Budget-neutrality means that, in aggregate, the increased 
payments to high performing physicians and groups equal the reduced 
payments to low performing physicians and groups, as well as those 
physicians and groups that failed to meet the criteria to avoid the 
PQRS payment adjustment as a group or as individuals.
    In the CY 2016 PFS final rule with comment period (80 FR 71277 and 
71279), we established that, beginning with the CY 2018 payment 
adjustment period, the VM will apply to nonphysician EPs who are 
physician assistants (PAs), nurse practitioners (NPs), clinical nurse 
specialists (CNSs), and certified registered nurse anesthetists (CRNAs) 
in groups with 2 or more EPs and to PAs, NPs, CNSs, and CRNAs who are 
solo practitioners.
    In CY 2018, the VM will be waived for groups and solo 
practitioners, as identified by their TIN, if at least one EP who 
billed for Medicare PFS items and services under the TIN during 2016 
participated in the Pioneer ACO Model, the Comprehensive Primary Care 
initiative, Next Generation ACO Model, the Oncology Care Model, and the 
Comprehensive ESRD Care Initiative in 2016 (80 FR 71286 through 71288).
    In the CY 2016 PFS final rule with comment period (80 FR 71280), we 
adopted a two-category approach for the CY 2018 VM based on 
participation in the PQRS by groups and solo practitioners. For the 
purposes of the CY 2018 VM, Category 1 represents those groups and solo 
practitioners subject to

[[Page 34184]]

the VM who met the criteria to avoid the 2018 PQRS payment adjustment 
(a) as a group practice participating in the PQRS GPRO, (b) groups that 
have at least 50 percent of the group's EPs meet the criteria to avoid 
the 2018 PQRS payment adjustment for CY 2018 as individuals, (c) solo 
practitioners that meet the criteria to avoid the CY 2018 PQRS payment 
adjustment as individuals, and (d) groups and solo practitioners that 
participated in a Shared Savings Program ACO, if the ACO in which they 
participate successfully reports quality data as required by the Shared 
Savings Program. Category 2 represents those groups and solo 
practitioners that are subject to the CY 2018 VM payment adjustment and 
do not fall within Category 1.
    In section III.I. of this proposed rule, we are proposing to reduce 
the CY 2018 VM payment adjustment amount for groups and solo 
practitioners in Category 2. We proposed to reduce the automatic 
payment adjustment from -4.0 percent to -2.0 percent for Physicians, 
PAs, NPs, CNSs, and CRNAs in groups with 10 or more EPs and at least 
one physician and from -2.0 percent to -1.0 percent for Physicians, 
PAs, NPs, CNSs, and CRNAs in groups of 2 or more EPs, PAs, NPs, CNSs, 
and CRNAs in groups comprised solely of non-physician EPs and physician 
and non-physician solo practitioners.
    Additionally, in section III.I. in this proposed rule, we are 
proposing that, under quality-tiering, which is the methodology for 
evaluating performance on quality and cost measures for the VM, there 
will be no downward adjustments for groups or solo practitioners in 
Category 1 for the VM for CY 2018. We are also proposing to reduce the 
maximum upward adjustment under the quality-tiering methodology in CY 
2018 for physicians, PAs, NPs, CNSs, and CRNAs in groups with 10 or 
more EPs and at least one physician that are Category 1 from four times 
an adjustment factor (+4.0x) to two times an adjustment factor (+2.0x) 
for those classified as high quality/low cost and from two times an 
adjustment factor (+2.0x) to one times an adjustment factor (+1.0x) for 
those classified as either average quality/low cost or high quality/
average cost. This proposal aligns the upward adjustment for groups of 
10 or more EPs with those previously finalized for smaller groups and 
solo practitioners, as well as groups comprised solely of non-physician 
EPs and provides a smoother transition to MIPS by bringing the 
incentives in line with those in the first year of the MIPS.
    Under the quality-tiering methodology, each group and solo 
practitioner's quality and cost composites will continue to be 
classified into high, average, and low categories depending upon 
whether the composites are at least one standard deviation above or 
below the mean and statistically different from the mean. We will 
compare their quality of care composite classification with the cost 
composite classification to determine their VM adjustment for the CY 
2018 payment adjustment period according to the amounts in Table 44.

  Table 44--Proposed CY 2018 VM Amounts Under the Quality-Tiering Approach for Physicians, PAs, NPs, CNSs, and
                                  CRNAs Who Are in Groups or Solo Practitioners
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                          Cost/Quality                              Low quality       quality      High quality
----------------------------------------------------------------------------------------------------------------
Low cost........................................................           +0.0%         +1.0x *         +2.0x *
Average cost....................................................            +0.0           +0.0%         +1.0x *
High cost.......................................................            +0.0            +0.0           +0.0%
----------------------------------------------------------------------------------------------------------------
* Groups and solo practitioners eligible for an additional +1.0x if reporting measures and average beneficiary
  risk score is in the top 25 percent of all beneficiary risk scores, where `x' represents the upward payment
  adjustment factor.

    Under the quality-tiering methodology, for groups and solo 
practitioners that participated in a Shared Savings ACO that 
successfully reports quality data for CY 2016, the cost composite will 
be classified as ``Average'' and the quality of care composite will 
continue to be based on ACO-level quality measures. We will compare 
their quality of care composite classification with the ``Average'' 
cost composite classification to determine their VM adjustment for the 
CY 2018 payment adjustment period. For groups and solo practitioners 
that participate in a Shared Savings Program ACO that did not 
successfully report quality data for CY 2016 and are Category 1 as a 
result of quality data reported to the PQRS outside of the ACO, the 
quality and cost composites will continue to be classified as 
``Average''.
    To ensure budget neutrality, we first aggregate the automatic 
downward payment adjustments of -1.0 percent or -2.0 percent for groups 
and solo practitioners subject to the VM that fall within Category 2. 
Using the aggregate downward payment adjustment amount, we then 
calculate the upward payment adjustment factor (x). Additionally, as we 
have done when calculating the upward payment adjustment factor for the 
2017 VM, we will also incorporate adjustments made for estimated 
changes in physician behavior (that is, changes in the volume and/or 
intensity of services delivered and shifting of services to TINs that 
receive higher VM adjustments) and estimated impact of pending PQRS and 
VM informal reviews. These calculations will be done after the 
performance period has ended and announced around the start of the 
payment adjustment year after the informal review period ends.
    At the time of this proposed rule, we have not completed the 
analysis of the impact of the VM in CY 2018 on physicians and non-
physicians in groups of 2 or more EPs and physician and non-physician 
solo practitioners based on performance in 2016. However, preliminary 
estimates indicate that the implementation of the proposed policies 
discussed above, would reduce the adjustment factor to below 10 
percent. In the CY 2018 PFS final rule, we will present the number of 
groups and solo practitioners that will be subject to the VM in CY 
2018.
7. MACRA Patient Relationship Categories and Codes
    We are soliciting comments on these HCPCS codes. Our intention is 
to collect the codes beginning January 2018, and our plan not to tie 
the collection of the codes with payment until we are sure clinicians 
have gained ample experience and education in using these modifiers. 
Therefore, there is no impact to CY 2018 physician payments under the 
PFS. There may be a burden associated with clinicians and their 
administrative staff having to learn which codes to use and how to 
submit them properly.

[[Page 34185]]

8. Effects of Proposals Relating to the Medicare Diabetes Prevention 
Program Expanded Model
    In section III.K of the preamble of this proposed rule, we discuss 
our proposals to further implement the MDPP expanded model under the 
authority of section 1115A of the Act, which authorizes the Innovation 
Center to test innovative payment and service delivery models to reduce 
program expenditures while preserving or enhancing the quality of care 
furnished to Medicare, Medicaid and CHIP beneficiaries. The MDPP 
expanded model was established in the November 15, 2016 MDPP final rule 
as an additional preventive service with a model effective date of 
January 1, 2018. Many of the policies for the MDPP expanded model were 
deferred to future rulemaking and, therefore, are being proposed in 
this rule. On March 14, 2016, the Office of the Actuary (OACT) 
published a certification memorandum setting out the conditions for 
expansion of the Medicare Diabetes Prevention Program (MDPP). Prior to 
its implementation, OACT is required to review the parameters of the 
MDPP expansion and provide an updated certification. This regulatory 
impact assessment is not an updated certification; rather, it is based 
on estimates of the proposed rule.
    Diabetes affects more than 25 percent of Americans aged 65 or older 
and its prevalence is projected to increase approximately two-fold for 
all U.S. adults (ages 18-79) by 2050 if current trends continue.\33\ 
Furthermore, the risk of progression to type 2 diabetes in an 
individual with pre-diabetes is 5-10 percent per year, or 5-20 times 
higher than in individuals with normal blood glucose.\34\ We estimate 
that Medicare spent $42 billion more in the single year of 2016 on fee-
for-service, non-dual eligible, over age 65 beneficiaries with diabetes 
and related comorbidities than it would have spent if those 
beneficiaries did not have diabetes, including $20 billion more for 
Part A, $17 billion more for Part B, and $5 billion more for Part 
D.\35\ The goal of the MDPP expanded model is to reduce the incidence 
rate of type 2 diabetes among Medicare beneficiaries with prediabetes 
through a structured behavioral change program where the primary 
outcome is weight loss. Weight loss is a key indicator of success among 
persons enrolled in a Diabetes Prevention Program due to the strong 
association between weight loss and reduction in the risk of type 2 
diabetes. In reducing the incidence rate of type 2 diabetes we expect 
to reduce Medicare spending while improving quality of care for 
eligible beneficiaries. In this proposed rule, we are proposing a 
value-based payment structure for the MDPP Expanded Model. Instead of 
traditional fee-for-service payment, our proposed payment structure 
shifts risk from Medicare to the rendering supplier by making payments 
for MDPP services to MDPP suppliers based on the achievement of 
performance goals.
---------------------------------------------------------------------------

    \33\ Centers for Medicare & Medicaid Services, ``Chronic 
Conditions Among Medicare Beneficiaries, Chartbook: 2012 Edition,'' 
Centers for Medicare & Medicaid Services, 2012, https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-reports/chronic-conditions/downloads/2012chartbook.pdf. James Boyle, et al., 
``Projection of the Year 2050 Burden of Diabetes in the US Adult 
Population: Dynamic Modeling of Incidence, Mortality, and Pre-
Diabetes Prevalence,'' Population Health Metrics 8, no. 29 (2010): 
1-12.
    \34\ X Zhang et al., ``A1C Level and Future Risk of Diabetes: A 
Systematic Review,'' Diabetes Care 33, no. 7 (2010): 1665-1673.
    \35\ Erkan Erdem and Holly Korda, ``Medicare Fee- For-Service 
Spending for Diabetes: Examining Aging and Comorbidities,'' Diabetes 
& Metabolism 5, no. 3 (2014); The Boards of Trustees: Federal 
Hospital Insurance and Federal Supplementary Medical Insurance Trust 
Funds, ``2016 Annual Report of the Boards of Trustees of the Federal 
Hospital Insurance and Federal Supplementary Medical Insurance Trust 
Funds,'' Centers for Medicare & Medicaid Services, 2016, https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/ReportsTrustFu2016.pdf.; and CMS estimates.
---------------------------------------------------------------------------

a. Anticipated Effects
(1) Effects on Beneficiaries
    The MDPP expanded model is expected to have a positive impact on 
beneficiaries' health that will generally lead to reduced beneficiary 
spending on Part A, Part B, and Part D health care services over time 
due to a reduced need for Part A, Part B, and Part D services. As a new 
preventive service, the MDPP services are available to eligible 
Medicare beneficiaries without cost-sharing. The CDC estimates that 
approximately 50 percent of adults aged 65 and over living in the 
United States have prediabetes \36\ and that awareness of the condition 
among those who have it is relatively low--approximately 30 percent for 
the general population. Therefore, we anticipate that up to 7 million 
Medicare beneficiaries who are aware of their prediabetes would be 
eligible for the MDPP services at the start of the MDPP expanded model. 
This estimate does not take into account any increased beneficiary 
awareness of their prediabetes due to the availability of MDPP 
services. We also expect there to be pent-up demand, with the number of 
beneficiaries utilizing the MDPP services greater in the initial few 
years (roughly 65,000 to 110,000 per year) but then leveling off 
afterwards (to a base demand of roughly 50,000 participants per year).
---------------------------------------------------------------------------

    \36\ https://www.cdc.gov/diabetes/pubs/statsreport14national-diabetes-report-web.pdf.
---------------------------------------------------------------------------

    To arrive at our participation estimate we developed projections 
for pent-up demand and ongoing demand. To develop the projection for 
pent-up demand we first analyzed data from the CDC National Diabetes 
Prevention Recognition Program (DPRP). Specifically, we analyzed State-
by-State DPRP in-person utilization for ages 65 or older in 2015. 
Because the Health Care Innovation Award (HCIA) MDPP model test was 
still serving beneficiaries during this period, and the HCIA DPP 
suppliers are also part of the DPRP, we used its enrollment data to 
inform what Medicare beneficiary participation may look like when 
Medicare pays for MDPP. Given that HCIA participation seemed to drive 
most of the DPRP participation in an HCIA supplier's region, we 
determined that a well-defined HCIA region would be a reasonable proxy 
for the rest of the nation. We found the state with the highest HCIA 
saturation, and calculated the percentage of fee for service 
beneficiaries that received services from a DPRP DPP. This percentage 
was applied to all fee for service beneficiaries nationwide in order to 
get a national pent-up demand estimate. We added this pent-up demand to 
a stable level of demand based on the number of new beneficiaries 
utilizing the obesity management benefit each year. Given the limited 
nationwide Medicare DPP participation data, there is a great amount of 
uncertainty in these estimates.
    We believe that the eligibility criteria for continued 
participation in the set of MDPP services incentivizes beneficiaries to 
lose 5-percent body weight from baseline. Beneficiaries are 
incentivized to lose weight because continued eligibility for the 
services benefit after the first 12 months is contingent upon achieving 
5-percent weight loss and the set of MDPP services is a once per 
lifetime set of services. In addition to prevention of type 2 diabetes, 
we believe participating beneficiaries would likely receive other 
possible health benefits including prevention of obesity for those who 
are overweight upon receiving MDPP services, prevention of sleep 
apnoea, and reduced risk for heart disease, coronary artery disease and 
stroke.\37\

[[Page 34186]]

Furthermore, we believe the MDPP expanded model could improve mental 
health and wellbeing by affording beneficiaries social interaction with 
their peers during sessions and could lead to reduced social 
isolation.\38\ The prevention of type 2 diabetes and these other 
potential health benefits of MDPP services may result in reduced 
beneficiary expenditures for health care services over time as services 
will not be needed to treat health conditions that are avoided.
---------------------------------------------------------------------------

    \37\ Orchard, T. J., et al. (2005). ``The effect of metformin 
and intensive lifestyle intervention on the metabolic syndrome: the 
Diabetes Prevention Program randomized trial.'' Ann Intern Med 
142(8): 611-619; Orchard, T. J., et al. (2013). ``Long-term effects 
of the Diabetes Prevention Program interventions on cardiovascular 
risk factors: a report from the DPP Outcomes Study.'' Diabet Med 
30(1): 46-55; Li, G., et al. (2014). ``Cardiovascular mortality, 
all-cause mortality, and diabetes incidence after lifestyle 
intervention for people with impaired glucose tolerance in the Da 
Qing Diabetes Prevention Study: a 23-year follow-up study.'' Lancet 
Diabetes Endocrinol 2(6): 474-480; Mudaliar, U., et al. (2016). 
``Cardiometabolic Risk Factor Changes Observed in Diabetes 
Prevention Programs in US Settings: A Systematic Review and Meta-
analysis.'' PLoS Med 13(7): e1002095; Kuna, S. T., et al. (2013). 
``Long-term effect of weight loss on obstructive sleep apnea 
severity in obese patients with type 2 diabetes.'' Sleep 36(5): 641-
649a; Mitchell, L. J., et al. (2014). ``Weight loss from lifestyle 
interventions and severity of sleep apnoea: a systematic review and 
meta-analysis.'' Sleep Med 15(10): 1173-1183; Thomasouli, M. A., et 
al. (2013). ``The impact of diet and lifestyle management strategies 
for obstructive sleep apnoea in adults: a systematic review and 
meta-analysis of randomised controlled trials.'' Sleep Breath 17(3): 
925-935; U.S. Department of Health and Human Services. 2008 Physical 
Activity Guidelines for Americans. Washington (DC): U.S. Department 
of Health and Human Services; 2008. ODPHP Publication No. U0036. 
Available at: http://www.health.gov/paguidelines; U.S. Department of 
Health and Human Services and U.S. Department of Agriculture. 2015--
2020 Dietary Guidelines for Americans. 8th Edition. December 2015. 
Available at http://health.gov/dietaryguidelines/2015/guidelines/.
    \38\ Florez, H., et al. (2012). ``Impact of lifestyle 
intervention and metformin on health-related quality of life: the 
diabetes prevention program randomized trial.'' J Gen Intern Med 
27(12): 1594-1601; Ackermann, R. T., et al. (2009). ``Changes in 
health state utilities with changes in body mass in the Diabetes 
Prevention Program.'' Obesity (Silver Spring) 17(12): 2176-2181; 
Weinhold, K. R., et al. (2015). ``A Randomized Controlled Trial 
Translating the Diabetes Prevention Program to a University 
Worksite, Ohio, 2012-2014.'' Preventing Chronic Disease 12: E210.
---------------------------------------------------------------------------

(2) Effects on the Market
    Currently, more than 1,200 organizations nationally are providing 
DPP services with some level of recognition through the CDC. Service 
delivery is primarily to individuals with private or employer-sponsored 
insurance, as well as some Medicare Advantage plans. The majority of 
existing DPP organizations are not enrolled in the Medicare program. We 
anticipate that the addition of MDPP services as new preventive 
services in Medicare would result in growth in the market, including 
growth in the number of individuals served per year by existing DPP 
suppliers, as well as the introduction of new suppliers into the 
market. There are burdens associated with obtaining CDC recognition and 
enrolling into Medicare as an MDPP supplier. There is also burden 
associated with submitting claims to Medicare for payment. Below we 
have provided an estimate of the financial burden to suppliers.
(3) Burden Related to Information Collection Requirements
(a) Wage Estimates
    To derive average costs for use throughout the subsequent sections, 
we used data from the U.S. Bureau of Labor Statistics' May 2015 
National Occupational Employment and Wage Estimates for all salary 
estimates (https://www.bls.gov/oes/current/oes_nat.htm). Table 45 
presents the mean hourly wage, the cost of fringe benefits and overhead 
(calculated at 100 percent of salary), and the adjusted hourly wage.

                          Table 45--National Occupational Employment and Wage Estimates
----------------------------------------------------------------------------------------------------------------
                                                                                      Fringe
                                                    Occupation      Mean hourly    benefits and      Adjusted
                Occupation title                       code        wage  ($/hr)    overhead  ($/    hourly wage
                                                                                        hr)           ($/hr)
----------------------------------------------------------------------------------------------------------------
Medical records and health information                   29-2071           19.93           19.93           39.84
 technician.....................................
Office and administrative support worker........         43-9000           16.31           16.31           32.62
Billing and posting Clerk.......................         43-3011          $18.09          $18.09          $36.18
----------------------------------------------------------------------------------------------------------------

(b) Interim Preliminary Recognition
    Our proposals under proposed Sec.  424.205 would provide that an 
entity is eligible to enroll in Medicare as an MDPP supplier if it has 
MDPP interim preliminary recognition, as determined by CMS. In order to 
receive MDPP interim preliminary recognition, we are proposing that the 
entity must have pending CDC recognition and must submit a full 12 
months of data on at least one completed cohort of participants to CDC. 
In order to receive pending recognition from CDC, organizations are 
required to submit an application for recognition to CDC and agree to 
CDC's curriculum, duration and intensity requirements. CMMI plans to 
engage CDC's services to assist CMMI in administering its interim 
preliminary recognition standard, if finalized. CMMI would make the 
final determination of which entities qualify to receive interim 
preliminary recognition.
    The burden associated with the preceding requirements is the time 
for MDPP staff to: submit an application for pending recognition to CDC 
and then collect and submit a full 12 months of data (including session 
attendance, body weight documentation, physical activity minutes 
documentation, and weight loss achieved) on at least one completed 
cohort of participants to CDC for the purposes of being evaluated for 
interim preliminary recognition.
    We estimate that it will take a medical records and health 
information technician 12 hours, at $38.88/hour to collect and report 
these data for one cohort of participants, and an office or 
administrative worker 1 hour, at $31.54/hour, to complete the CDC 
application for pending recognition. The estimated cost per supplier to 
achieve interim preliminary recognition is $498.10.
(c) Supplier Standards
    Our proposals under proposed revised Sec.  424.59 (proposed in this 
rule to be redesignated at Sec.  424.205) would require that an MDPP 
supplier must certify in its enrollment application, which is a new 
Medicare enrollment application that we are creating specific to MDPP 
suppliers, and that it meets a set of standards. As this new enrollment 
application is being created specifically for the MDPP expanded model, 
we have determined that it is exempt from the Paperwork Reduction Act 
in accordance with section 1115A(d)(3) of the Act. We estimate that it 
will take an office or administrative support worker 3 hours, at 
$31.54/hour, to complete the MDPP supplier enrollment application using 
the internet-based Provider Enrollment,

[[Page 34187]]

Chain and Ownership System (PECOS). In general, provider enrollment 
fees for Medicare are $560 in 2017. We also note that CMS provides 
hardship exceptions to the application fee with a written request that 
describes the need for the hardship exception. CMS determines such 
exceptions on a case-by-case basis. The estimated cost to complete the 
MDPP supplier enrollment application, without a hardship exception, is 
$843.86. If a provider is granted a hardship exception from the 
enrollment fee, then the estimated cost to complete the enrollment 
process is $283.86.
    We also note that access to the HIPAA Eligibility Transaction 
System (HETS), which a supplier could use to check factors of 
eligibility for the MDPP services, including the beneficiary's Part B 
eligibility and whether the beneficiary has received coverage for end-
stage renal disease (ESRD) is free to suppliers, as long as they are 
active Medicare fee-for-service providers or suppliers in PECOS.
    Suppliers also would be required to maintain documentation of all 
beneficiary contact regarding complaints or questions, as specified in 
proposed Sec.  424.205(d)(11), and maintain and submit to CMS a 
crosswalk file which indicates how participant identifications for the 
purposes of CDC performance data correspond to Medicare Beneficiary 
Identifiers (that is, beneficiary health insurance claims numbers) for 
each beneficiary receiving MDPP services. We estimate that creating and 
maintaining documentation of beneficiary contact regarding complaints 
or questions will take an office or administrative support worker 1 
hour, at $31.54/hour, per complaint or question request to create and 
maintain documentation of the request. We have no way to estimate how 
many complaints or questions MDPP suppliers will receive from 
beneficiaries, and we expect that may differ based on many factors, so 
have not included an overall cost in this burden estimate. Further, we 
estimate that it will take an office and administrative support worker 
approximately 4 hours, at $31.54/hour, to create and submit the 
crosswalk file for a cohort of 100 beneficiaries participating in the 
MDPP services, for a total cost of $126.16 per cohort of 100 
beneficiaries. The crosswalk is proposed to be submitted quarterly. 
Therefore, for a year of delivering the set of MDPP services the 
estimated total cost to create and submit the crosswalk file would be 
$504.64 per cohort of 100 beneficiaries. We believe the incremental 
costs to meet this requirement would decrease with the addition of 
beneficiaries to a cohort, because the work and time to establish the 
file and submit it would be the same for a cohort of 100 and a cohort 
of 1000. What would be different is the collection of the information 
from the beneficiaries, and the addition of these data points to the 
file. We estimate that, for every additional 100 beneficiaries added to 
the file, the office and administrative support worker would add 1 
hour, at $31.54/hour. We estimate the total incremental cost over 1 
year for each additional 100 beneficiaries above the cohort of 100 
beneficiaries is $126.16.
    Our proposals under proposed Sec.  424.205 also would require that 
suppliers meet a set of standards that includes maintaining a physical 
facility on an appropriate site and maintain a primary business 
telephone that is operating at the appropriate site. Because we have no 
way to estimate how many beneficiaries each MDPP supplier may provide 
the set of MDPP services to, and we expect this will differ based on 
many factors, including but not limited to the size of the supplier, 
the number of coaches the supplier employs, the physical space the 
supplier uses to furnish MDPP services, and the supplier's geographic 
location, we have not included an overall cost for these requirements 
in this burden estimate.
(d) Payment for MDPP Services
    Our proposals under proposed Sec.  414.84 specify the proposed 
payments MDPP suppliers may be eligible to receive for furnishing MDPP 
services and meeting performance targets related to beneficiary weight 
loss and/or attendance. MDPP suppliers would be paid by CMS by 
submitting claims for MDPP beneficiaries using claim form CMS-1500 
(https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS1500.pdf), and as a condition for payment, claims submitted by MDPP 
suppliers must be for services furnished to eligible beneficiaries in 
accordance with Sec.  414.84(b) and (c). Our proposal under proposed 
Sec.  424.205 would require MDPP suppliers to include an attestation 
that the MDPP beneficiary for which it is submitting a claim has met 
the performance goals laid out in proposed Sec.  424.205. Section 
424.205 also proposes to require MDPP suppliers to report the NPI of 
the coach on MDPP claims as a program integrity safeguard. To meet 
these requirements for submitting claims, we estimate that it would 
take a billing and posting clerk 10 minutes per beneficiary to fill out 
the claim form and submit it to CMS at $33.70/hour. Based on this time 
and wage, we estimate the total cost per beneficiary per claim to be 
$5.62. As mentioned previously, we have no way to estimate how many 
beneficiaries to whom each MDPP supplier may furnish MDPP services. 
Therefore, we have not included an estimate of the overall cost of 
submitting claims in the burden estimate.
(4) Effects on the Medicare Program
(a) Estimated 10-Year Impact of MDPP
    The set of MDPP services is an optional set of services for 
beneficiaries who meet the eligibility requirements described elsewhere 
in the proposed rule. MDPP services will be furnished by a new provider 
type in Medicare. The CDC recognizes DPPs nationwide; these programs 
effectively deliver lifestyle-changing services that reduce the 
incidence of type 2 diabetes. The number of CDC-recognized DPPs is 
growing rapidly, increasing by nearly 90 percent from September 2015 to 
March 2017. The historical participation rate suggests that the vast 
majority of these providers are not serving a significant volume of new 
participants, aside from those served in the DPP model test.
    This estimate is based on the initial methodology used for the 
estimate of the MDPP expanded model as set out in the certification 
memorandum, but with differences in several program features including 
the payment parameters. It also includes the impact of improved 
longevity among those who participate in the MDPP expanded model. This 
cost of improved longevity was ignored for certification purposes, as 
noted in that memorandum.
    The model is dependent on the number of eligible participants, the 
annual take-up rate, and the savings per participant, all of which are 
uncertain. The methodology determines gross savings as the result of an 
assumed reduction in the number of beneficiaries transitioning from 
prediabetes to diabetes and a marginal cost difference between the 
individuals with diabetes and those that are prediabetic. The Office of 
the Actuary assumed that the initial savings per beneficiary for 
avoiding diabetes is $3,000 per year. The progression rate from 
prediabetes to diabetes absent the intervention is expected to be 
roughly 5 percent per year. Based on observed results, we assume that 
the set of MDPP services will reduce the progression rate among those 
receiving the services by 50 percent in the first year and that the 
reduction will be 5 percent less in each subsequent year until leveling 
off at a rate of 10 percent. The program costs in

[[Page 34188]]

this estimate include payments to MDPP suppliers in the initial year of 
the MDPP services period and in the 2 maintenance years. Based on the 
results of the DPP model test regarding the number of sessions attended 
and the weight loss achieved, we estimate the average expected Medicare 
payment per participant to be approximately $320 in the first year and 
$75 in each of the following 2 years. Overall, the payments under the 
expanded model would occur in the first 3 years following the 
beneficiary's first MDPP services, but the expected reduction in 
medical costs would occur over a long period following the 
intervention. For the leading cohort of 2018, we would expect savings 
in excess of costs by 2019 (the second year), with cumulative savings 
by 2022 (after 4 years). Yearly net savings reduce slightly each 
subsequent year but do not result in a cost to Medicare during the 10-
year projection window.
    Table 46 shows the 10-year impact of the MDPP expanded model, net 
of payments to MDPP providers but gross of any other model costs, based 
on our expected enrollment per year. The 10-year impact is a savings to 
Medicare of $186 million. The estimate is expected to cross into a 
cumulative savings to Medicare in the sixth year of the MDPP expanded 
model.

            Table 46--Estimated 10-Year Impact of MDPP on Net Claims Costs, Payments to Providers, and Net Savings for CYs 2018 Through 2027
                                                     [In millions, negative values indicate savings]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                         Year                            2018     2019     2020     2021     2022     2023     2024     2025     2026     2027    Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Net Claim Costs......................................      -$5     -$16     -$29     -$41     -$52     -$60     -$66     -$70     -$72     -$72    -$484
Provider Payments....................................       21       41       40       31       28       26       27       28       28       29      298
Net Savings..........................................       16       25       11      -10      -25      -34      -40      -43      -44      -43     -186
Cumulative Net Savings...............................       16       41       52       42       17      -17      -56      -99     -143     -186  .......
--------------------------------------------------------------------------------------------------------------------------------------------------------

(b) Sensitivity Testing
    MDPP is a new Medicare expanded model that was tested in the DPP 
model test using a small percentage of the population. As a result, the 
estimated impact from the expanded MDPP model is very uncertain. In 
particular, it is unknown how many beneficiaries will be interested in 
participating in MDPP and how quickly MDPP suppliers available will be 
able to serve those individuals. To understand how various 
participation scenarios would affect the financial results, we have 
prepared the estimates under two other participation scenarios. The 
first shows the results if half of the beneficiaries shown in the best 
estimate participate, and the second uses twice as many beneficiaries. 
The details are shown in Tables 47 and 48.

  Table 47--Scenario Test of MDPP 10-Year Impact of Half the Expected Participants on Net Claims Costs, Payments to Providers, and Net Savings for CYs
                                                                    2018 Through 2027
--------------------------------------------------------------------------------------------------------------------------------------------------------
                         Year                            2018     2019     2020     2021     2022     2023     2024     2025     2026     2027    Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Net Claim Costs......................................      -$2      -$8     -$15     -$21     -$26     -$30     -$33     -$35     -$36     -$36    -$242
Provider Payments....................................       10       20       20       16       14       13       13       14       14       14      149
Net Savings..........................................        8       13        5       -5      -12      -17      -20      -21      -22      -22      -93
--------------------------------------------------------------------------------------------------------------------------------------------------------


 Table 48--Scenario Test of MDPP 10-Year Impact of Double the Expected Participants on Net Claims Costs, Payments to Providers, and Net Savings for CYs
                                                                    2018 Through 2027
--------------------------------------------------------------------------------------------------------------------------------------------------------
                         Year                            2018     2019     2020     2021     2022     2023     2024     2025     2026     2027    Total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Net Claim Costs......................................      -$9     -$31     -$58     -$83    -$104    -$121    -$133    -$140    -$144    -$145    -$969
Provider Payments....................................       41       82       80       63       55       52       54       55       56       58      596
Net Savings..........................................       32       50       22      -20      -49      -68      -79      -85      -88      -87     -372
--------------------------------------------------------------------------------------------------------------------------------------------------------

b. Alternatives Considered for MDPP
    Section III.K. of the preamble of this proposed rule includes a 
range of proposed policies necessary to implement the MDPP expanded 
model, including benefit structure, payment, supplier enrollment, and 
supplier standards. Throughout section III.K., we present descriptions 
of the relevant statutory provisions; identify those policies when 
discretion has been exercised in our proposals, present rationale for 
our proposed policies; and discuss alternative to our proposals that 
where considered.
    We considered alternatives to the MDPP services period that would 
significantly impact the potential payment. Specifically, we considered 
limiting the MDPP to a 12-month MDPP services period without any 
ongoing maintenance sessions available in months 13 through 36. It is 
estimated that the average payment to suppliers for the maintenance 
years is $75 per year per beneficiary. We also considered limiting the 
ongoing maintenance sessions to 12 months, culminating in a total MDPP 
service period of up to 2 years as opposed to up to 3 years. Either of 
these alternatives would reduce the total potential payment to MDPP 
suppliers by 52 percent or 28 percent, respectively, from a maximum of 
$810 for meeting all attendance and weight loss achievement goals under 
our proposals. We did not propose these alternatives because weight 
loss is difficult to achieve and can be more difficult to sustain. Our 
proposal to allow for up to 2 years of ongoing maintenance sessions for 
those beneficiaries who have achieved a minimum 5 percent weight loss 
from baseline during months 1 to 12 of the MDPP services period will 
allow for reinforcement of the lifestyle changes

[[Page 34189]]

needed to maintain weight loss. Finally, a 3-year diabetes prevention 
program is supported by evidence from the NIH DPP clinical trial.
    In this proposed rule, we also considered linking additional 
outcomes beyond attendance and weight loss to payment in the value-
based payment methodology. Specifically, we considered linking 
hemoglobin A1c level to MDPP payments. However, we did not adopt this 
alternative because the MDPP expanded model is certified based on the 
DPP model test, which demonstrated that weight loss was associated with 
reductions in Medicare expenditures. Although elevated hemoglobin A1c 
levels were included as part of the beneficiary eligibility criteria in 
the DPP model test, hemoglobin A1c levels were not evaluated post-
intervention in the DPP model test. Therefore, the proposed MDPP 
payment structure would incentivize MDPP suppliers to prioritize the 
achievement of beneficiary weight loss by furnishing MDPP services, 
providing a balance between value-based payments related to weight loss 
and session attendance.
    In conclusion, we estimate that the 10-year impact of the MDPP 
expanded model, net of payments to MDPP providers but gross of any 
other program costs, based on our expected enrollment per year would be 
a savings to Medicare of $186 million. The estimate is expected to 
cross into a cumulative savings to Medicare in the sixth year of the 
MDPP expanded model.

F. Alternatives Considered

    This proposed rule contains a range of policies, including some 
provisions related to specific statutory provisions. The preceding 
preamble provides descriptions of the statutory provisions that are 
addressed, identifies those policies when discretion has been 
exercised, presents rationale for our final policies and, where 
relevant, alternatives that were considered. For purposes of the 
payment impact on PFS services of the policies contained in this 
proposed rule, we presented the estimated impact on total allowed 
charges by specialty. The alternatives we considered, as discussed in 
the preceding preamble sections, will result in different proposed 
payment rates, and therefore, result in different estimates than those 
shown in Table 40 (CY 2018 PFS Estimated Impact on Total Allowed 
Charges by Specialty).

G. Impact on Beneficiaries

    There are a number of changes in this proposed rule that would have 
an effect on beneficiaries. In general, we believe that many of these 
changes, including those intended to improve accuracy in payment 
through revisions to the inputs used to calculate payments under the 
PFS, would have a positive impact and improve the quality and value of 
care provided to Medicare beneficiaries.
    Most of the aforementioned proposed policy changes could result in 
a change in beneficiary liability as relates to coinsurance (which is 
20 percent of the fee schedule amount, if applicable for the particular 
provision after the beneficiary has met the deductible). To illustrate 
this point, as shown in our public use file Impact on Payment for 
Selected Procedures available on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/, the CY 2017 national payment amount in the 
nonfacility setting for CPT code 99203 (Office/outpatient visit, new) 
was $109.46, which means that in CY 2017, a beneficiary would be 
responsible for 20 percent of this amount, or $21.89. Based on this 
proposed rule, using the CY 2018 CF, the CY 2018 national payment 
amount in the nonfacility setting for CPT code 99203, as shown in the 
Impact on Payment for Selected Procedures table, is $109.77, which 
means that, in CY 2018, the final beneficiary coinsurance for this 
service would be $21.95.

H. Estimating Regulatory Familiarization Costs

    If regulations impose administrative costs on private entities, 
such as the time needed to read and interpret this proposed rule, we 
should estimate the cost associated with regulatory review. Due to the 
uncertainty involved with accurately quantifying the number of entities 
that will review the rule, we assume that the total number of unique 
commenters on last year's proposed rule will be the number of reviewers 
of this proposed rule. We acknowledge that this assumption may 
understate or overstate the costs of reviewing this rule. It is 
possible that not all commenters reviewed last year's rule in detail, 
and it is also possible that some reviewers chose not to comment on the 
proposed rule. For these reasons we thought that the number of past 
commenters would be a fair estimate of the number of reviewers of this 
rule. We welcome any comments on the approach in estimating the number 
of entities which will review this proposed rule.
    We also recognize that different types of entities are in many 
cases affected by mutually exclusive sections of this proposed rule, 
and therefore for the purposes of our estimate we assume that each 
reviewer reads approximately 50 percent of the rule. We seek comments 
on this assumption.
    Using the wage information from the BLS for medical and health 
service managers (Code 11-9111), we estimate that the cost of reviewing 
this rule is $105.16 per hour, including overhead and fringe benefits 
https://www.bls.gov/oes/current/oes_nat.htm. Assuming an average 
reading speed, we estimate that it would take approximately 8.0 hours 
for the staff to review half of this proposed rule. For each facility 
that reviews the rule, the estimated cost is $841 (8.0 hours x 
$105.16). Therefore, we estimate that the total cost of reviewing this 
regulation is $4,981,243 ($841 x 5,943 reviewers).

I. Accounting Statement

    As required by OMB Circular A-4 (available at http://www.whitehouse.gov/omb/circulars/a004/a-4.pdf), in Tables 49 and 50 
(Accounting Statements), we have prepared an accounting statement. This 
estimate includes growth in incurred benefits from CY 2017 to CY 2018 
based on the FY 2018 President's Budget baseline.

Table 49--Accounting Statement: Classification of Estimated Expenditures
------------------------------------------------------------------------
                Category                            Transfers
------------------------------------------------------------------------
CY 2018 Annualized Monetized Transfers.  Estimated increase in
                                          expenditures of $0.3 billion
                                          for PFS CF update.
From Whom To Whom?.....................  Federal Government to
                                          physicians, other
                                          practitioners and providers
                                          and suppliers who receive
                                          payment under Medicare.
------------------------------------------------------------------------


[[Page 34190]]


   Table 50--Accounting Statement: Classification of Estimated Costs,
                          Transfer, and Savings
------------------------------------------------------------------------
                Category                             Transfer
------------------------------------------------------------------------
CY 2018 Annualized Monetized Transfers   $0.1 billion.
 of beneficiary cost coinsurance.
From Whom to Whom?.....................  Federal Government to
                                          Beneficiaries.
------------------------------------------------------------------------


               Table 51--Estimated Costs and Cost Savings
------------------------------------------------------------------------
            Category                     Costs           Cost savings
------------------------------------------------------------------------
ICR Burden......................  $282 million......  ..................
MDPP............................  ..................  $186 million.
Regulatory Familiarization......  $5 million........  ..................
------------------------------------------------------------------------

J. Conclusion

    The analysis in the previous sections, together with the remainder 
of this preamble, provided an initial Regulatory Flexibility Analysis. 
The previous analysis, together with the preceding portion of this 
preamble, provides a Regulatory Impact Analysis. In accordance with the 
provisions of Executive Order 12866, this regulation was reviewed by 
the Office of Management and Budget.

List of Subjects

42 CFR Part 405

    Administrative practice and procedure, Health facilities, Health 
professions, Kidney diseases, Medical devices, Medicare, Reporting and 
recordkeeping requirements, Rural areas, X-rays.

42 CFR Part 410

    Health facilities, Health professions, Kidney diseases, 
Laboratories, Medicare, Reporting and recordkeeping requirements, Rural 
areas, X-rays.

42 CFR Part 414

    Administrative practice and procedure, Biologics, Drugs, Health 
facilities, Health professions, Kidney diseases, Medicare, Reporting 
and recordkeeping requirements.

42 CFR Part 424

    Emergency medical services, Health facilities, Health professions, 
Medicare, Reporting and recordkeeping requirements.

42 CFR Part 425

    Administrative practice and procedure, Health facilities, Health 
professions, Medicare, Reporting and recordkeeping requirements.
    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services proposes to amend 42 CFR chapter IV as set forth 
below:

PART 405--FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED

0
1. The authority citation for part 405 continues to read as follows:

    Authority: Secs. 205(a), 1102, 1861, 1862(a), 1869, 1871, 1874, 
1881, and 1886(k) of the Social Security Act (42 U.S.C. 405(a), 
1302, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr and 
1395ww(k)), and sec. 353 of the Public Health Service Act (42 U.S.C. 
263a).

0
2. Section 405.2413 is amended by revising paragraph (a)(5) to read as 
follows:


Sec.  405.2413  Services and supplies incident to a physician's 
services.

    (a) * * *
    (5) Furnished under the direct supervision of a physician, except 
that services and supplies furnished incident to Transitional Care 
Management, General Care Management, and the Psychiatric Collaborative 
Care model, can be furnished under general supervision of a physician 
when these services or supplies are furnished by auxiliary personnel, 
as defined in Sec.  410.26(a)(1) of this chapter.
* * * * *
0
3. Section 405.2415 is amended by revising paragraph (a)(5) to read as 
follows:


Sec.  405.2415  Incident to services and direct supervision.

    (a) * * *
    (5) Furnished under the direct supervision of a nurse practitioner, 
physician assistant, or certified nurse-midwife, except that services 
and supplies furnished incident to Transitional Care Management, 
General Care Management, and the Psychiatric Collaborative Care model, 
can be furnished under general supervision of a nurse practitioner, 
physician assistant, or certified nurse-midwife, when these services or 
supplies are furnished by auxiliary personnel, as defined in Sec.  
410.26(a)(1) of this chapter.
* * * * *

PART 410--SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS

0
4. The authority citation for part 410 is revised to read as follows:

    Authority:  Secs. 1102, 1834, 1871, 1881, and 1893 of the Social 
Security Act (42 U.S.C. 1302, 1395m, 1395hh, 1395rr, and 1395ddd).

0
5. Section 410.79 is amended by--
0
a. Revising the section heading and paragraph (a);
0
b. Under paragraph (b):
0
i. Revising the definition of ``Baseline weight'';
0
ii. Removing the definition ``Coach'';
0
iii. Revising the definition of ``Core maintenance session'';
0
iv. Adding in alphabetical order a definition for ``Core maintenance 
session interval;''
0
v. Revising the definition of ``Core session'';
0
vi. Removing the definitions of ``Maintenance of weight loss'' and 
``Maintenance session bundle'';
0
vii. Adding in alphabetical order definitions for ``Make-up session'' 
and ``MDPP beneficiary'';
0
viii. Removing the definitions of ``MDPP core benefit'' and ``MDPP 
eligible beneficiary'';
0
ix. Revising the definition of ``MDPP services'';
0
x. Adding in alphabetical order definitions for ``MDPP services 
period'' and ``MDPP session'';
0
xi. Revising the definitions of ``MDPP supplier'' and ``Medicare 
Diabetes Prevention Program (MDPP)'';
0
xii. Adding in alphabetical order a definition for ``Ongoing 
maintenance session interval'';
0
xiii. Revising the definition of ``Ongoing maintenance sessions''; and
0
xiv. Adding in alphabetical order definitions for ``Set of MDPP 
services'' and ``Virtual make-up session''; and

[[Page 34191]]

0
c. Revising paragraphs (c) and (d).
    The revisions and additions read as follows:


Sec.  410.79   Medicare Diabetes Prevention Program expanded model: 
Conditions of coverage.

    (a) Medicare Diabetes Prevention Program (MDPP) services will be 
available beginning on April 1, 2018.
    (b) * * *
    Baseline weight means the MDPP beneficiary's body weight recorded 
during that beneficiary's first core session.
* * * * *
    Core maintenance session means an MDPP service that--
    (i) Is furnished by an MDPP supplier to an MDPP beneficiary during 
a core maintenance session interval;
    (ii) Is approximately 1 hour in length; and
    (iii) Adheres to a CDC-approved DPP curriculum for maintenance 
sessions.
    Core maintenance session interval means one of the two consecutive 
3-month time periods during months 7 through 12 of the MDPP services 
period, during which an MDPP supplier offers an MDPP beneficiary at 
least one core maintenance session per month.
    Core session means an MDPP service that--
    (i) Is furnished by an MDPP supplier to an MDPP beneficiary during 
months 1 through 6 of the MDPP services period;
    (ii) Is approximately 1 hour in length; and
    (iii) Adheres to a CDC-approved DPP curriculum for core sessions.
* * * * *
    Make-up session means a core session, a core maintenance session, 
or an ongoing maintenance session furnished to an MDPP beneficiary when 
the MDPP beneficiary misses a regularly scheduled core session, core 
maintenance session, or ongoing maintenance session.
    MDPP beneficiary means a Medicare beneficiary who meets the 
criteria specified in paragraph (c)(1)(i) of this section, who has 
initiated the MDPP services period by attending the first core session, 
and for whom the MDPP services period has not ended as specified in 
paragraph (c)(3) of this section.
    MDPP services means structured health behavior change sessions that 
are furnished under the MDPP expanded model with the goal of preventing 
diabetes among Medicare beneficiaries with prediabetes, and that follow 
a CDC-approved curriculum. The sessions provide practical training in 
long-term dietary change, increased physical activity, and problem-
solving strategies for overcoming challenges to maintaining weight loss 
and a healthy lifestyle.
    MDPP services period means the time period, beginning on the date 
an MDPP beneficiary attends his or her first core session, over which 
the set of MDPP services is furnished to the MDPP beneficiary, to 
include the core services period described in paragraph (c)(2)(i) and, 
subject to paragraph (c)(3) of this section, one or more ongoing 
maintenance session intervals during the ongoing services period 
described in paragraph (c)(2)(ii) of this section.
    MDPP session means a core session, a core maintenance session, or 
an ongoing maintenance session.
    MDPP supplier means an entity that is enrolled in Medicare to 
furnish MDPP services as provided in Sec.  424.205 of this chapter.
    Medicare Diabetes Prevention Program (MDPP) refers to a model test 
expanded under section 1115A(c) of the Act that makes MDPP services 
available to MDPP beneficiaries.
* * * * *
    Ongoing maintenance session means an MDPP service that--
    (i) Is furnished by an MDPP supplier to an MDPP beneficiary during 
an ongoing maintenance session interval;
    (ii) Is approximately 1 hour in length; and
    (iii) Adheres to a CDC-approved DPP curriculum for maintenance 
sessions.
    Ongoing maintenance session interval means one of the up to eight 
consecutive 3-month time periods during the ongoing services period 
described in paragraph (c)(2)(ii) of this section, during which an MDPP 
supplier offers at least one ongoing maintenance session to an MDPP 
beneficiary per month.
* * * * *
    Set of MDPP services means the series of MDPP sessions, composed of 
core sessions, core maintenance sessions, and subject to paragraph 
(c)(3) of this section, ongoing maintenance sessions, offered over the 
course of the MDPP services period.
    Virtual make-up session means a make-up session that is not 
furnished in person and that is furnished in a manner consistent with 
the DPRP standards for virtual sessions.
    (c) Coverage for MDPP services.--
    (1) Beneficiary eligibility. (i) A Medicare beneficiary is eligible 
for MDPP services offered during the core services period described in 
paragraph (c)(2)(i) of this section if the beneficiary meets all of the 
following criteria:
    (A) Is enrolled under Medicare Part B;
    (B) Attended the first core session within the most recent 12-month 
time period and, prior to attending this first core session, had not 
previously received the set of MDPP services in his or her lifetime;
    (C) Has, on the date of attendance at the first core session, a 
body mass index (BMI) of at least 25 if not self-identified as Asian or 
a BMI of at least 23 if self-identified as Asian;
    (D) Has received, within the 12-month time period prior to the date 
of attendance at the first core session, a hemoglobin A1c test with a 
value of between 5.7 and 6.4 percent, a fasting plasma glucose test 
with a value of between 110 and 125 mg/dL, or a 2-hour plasma glucose 
test (oral glucose tolerance test) with a value of between 140 and 199 
mg/dL;
    (E) Has, as of the date of attendance at the first core session, no 
previous diagnosis of diabetes, other than gestational diabetes; and
    (F) Does not have end-stage renal disease (ESRD).
    (ii) An MDPP beneficiary is eligible for the first ongoing 
maintenance session interval only if the beneficiary:
    (A) Attends at least one in-person core maintenance session during 
the final core maintenance session interval; and
    (B) Achieves or maintains the required minimum weight loss at a 
minimum of one in-person core maintenance session during the final core 
maintenance session interval.
    (iii) An MDPP beneficiary is eligible for a subsequent ongoing 
maintenance session interval only if the beneficiary:
    (A) Attends at least three ongoing maintenance sessions during the 
previous ongoing maintenance session interval, including at least one 
in-person ongoing maintenance session; and
    (B) Maintains the required minimum weight loss at a minimum of one 
in-person ongoing maintenance session furnished during the previous 
ongoing maintenance session interval.
    (iv) Weight measurements used to determine the achievement or 
maintenance of the required minimum weight loss must be taken in person 
by an MDPP supplier during an MDPP session.
    (2) MDPP services period. An MDPP beneficiary's MDPP services 
period is composed of the following periods and intervals:
    (i) The core services period, which is the first 12 months of the 
MDPP services period, and consists of:
    (A) At least 16 core sessions offered at least one week apart 
during months 1 through 6 of the MDPP services period; and

[[Page 34192]]

    (B) Two 3-month core maintenance session intervals offered during 
months 7 through 12 of the MDPP services period.
    (ii) Subject to paragraph (c)(3) of this section, the ongoing 
services period, which consists of up to eight 3-month ongoing 
maintenance session intervals offered during months 13 through 36 of 
the MDPP services period.
    (3) Limitations on the MDPP services period. (i) The MDPP services 
period ends upon completion of the core services period described in 
paragraph (c)(2)(i) of this section, unless the MDPP beneficiary 
qualifies for the first ongoing maintenance session interval, in 
accordance with paragraph (c)(1)(ii) of this section.
    (ii) If the MDPP beneficiary qualifies for the first ongoing 
maintenance session interval as described in paragraph (c)(3)(i) of 
this section, the MDPP services period ends upon completion of this 
first ongoing maintenance session interval or any subsequent ongoing 
maintenance session interval, unless the beneficiary meets the 
eligibility requirements under paragraph (c)(1)(iii) of this section.
    (iii) Unless sooner ended in accordance with this paragraph (c)(3), 
the MDPP services period ends automatically upon the completion of the 
eighth ongoing maintenance session interval.
    (d) Make-up sessions. (1) An MDPP supplier may offer a make-up 
session to an MDPP beneficiary who missed a regularly scheduled 
session. If an MDPP supplier offers one or more make-up sessions to an 
MDPP beneficiary, each such session must be furnished in accordance 
with the following requirements:
    (i) The curriculum furnished during the make-up session must 
address the same CDC-approved DPP curriculum topic as the regularly 
scheduled session that the beneficiary missed;
    (ii) The MDPP supplier may furnish to the beneficiary a maximum of 
one make-up session on the same day as a regularly scheduled session; 
and
    (iii) The MDPP supplier may furnish to the beneficiary a maximum of 
one make-up session per week.
    (2) An MDPP supplier may offer virtual make-up sessions only if 
consistent with the requirements in paragraph (d)(1) of this section. 
Virtual make-up sessions are also subject to the following 
requirements:
    (i) Virtual make-up sessions must be furnished in a manner 
consistent with the DPRP standards for virtual sessions;
    (ii) An MDPP supplier may only offer virtual make-up sessions based 
on an individual MDPP beneficiary's request; and
    (iii) An MDPP supplier may offer to an MDPP beneficiary:
    (A) No more than 4 virtual make-up sessions within the core 
services period described in paragraph (c)(2)(i) of this section, of 
which no more than 2 virtual make-up sessions are core maintenance 
sessions; and
    (B) No more than 3 virtual make-up sessions that are ongoing 
maintenance sessions during any rolling 12-month time period.
    (3) Make-up sessions furnished in accordance with paragraph (d)(1) 
of this section that an MDPP beneficiary attends in person are counted 
toward meeting the attendance requirements described in paragraph 
(c)(1) of this section and toward achieving the performance goals 
described in Sec.  414.84(b) of this chapter as if the MDPP beneficiary 
attended a regularly scheduled session. Virtual make-up sessions 
furnished in accordance with paragraph (d)(2) of this section are also 
counted toward such attendance requirements and performance goals, 
subject to the following limitations:
    (i) The MDPP beneficiary receives no more than 4 virtual make-up 
sessions within the core services period described in paragraph 
(c)(2)(i) of this section, of which no more than 2 virtual make-up 
sessions may be core maintenance sessions; and
    (ii) The MDPP beneficiary receives no more than 3 virtual make-up 
sessions that are ongoing maintenance sessions during any rolling 12-
month period.

PART 414--PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES

0
6. The authority citation for part 414 continues to read as follows:

    Authority: Secs. 1102, 1871, and 1881(b)(l) of the Social 
Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(l)).

0
7. Section 414.84 is added to read as follows:


Sec.  414.84   Payment for MDPP services.

    (a) Definitions. In addition to the definitions specified at 
Sec. Sec.  410.79(b) and 424.205(a) of this chapter, the following 
definitions apply to this section.
    Bridge payment means a one-time payment to an MDPP supplier for 
furnishing its first MDDP session to an MDPP beneficiary who has 
previously received one or more MDPP services from a different MDPP 
supplier.
    Performance goal means an attendance or weight-loss goal that an 
MDPP beneficiary must achieve during the MDPP services period for an 
MDPP supplier to be paid a performance payment.
    Performance payment means a payment made to an MDPP supplier for 
furnishing certain MDPP services to an MDPP beneficiary when the MDPP 
beneficiary achieves the applicable performance goal.
    (b) Performance payment. CMS makes one or more types of performance 
payments to an MDPP supplier as specified in this paragraph. Each type 
of performance payment is made only if the beneficiary achieves the 
applicable performance goal and only once per MDPP beneficiary. A 
performance payment is made only on an assignment-related basis in 
accordance with Sec.  424.55 of this chapter, and MDPP suppliers must 
accept the Medicare allowed charge as payment in full and may not bill 
or collect from the beneficiary any amount. CMS will make a performance 
payment only to an MDPP supplier that complies with all applicable 
enrollment and program requirements and only for MDPP services that are 
furnished by an eligible coach, on or after his or her coach 
eligibility start date and, if applicable, before his or her coach 
eligibility end date. As a condition of payment, the MDPP supplier must 
report the NPI of the coach who furnished each session on the claim for 
the MDPP session. The seven types of performance payments are as 
follows:
    (1) Performance Goal 1: Attends the first core session that 
initiates the MDPP services period. CMS makes a performance payment to 
an MDPP supplier if an MDPP beneficiary attends the first core session, 
which initiates the MDPP services period, and that first core session 
was furnished by that supplier. An MDPP supplier who has been paid this 
performance payment for an MDPP beneficiary is not eligible to be paid 
a bridge payment described in paragraph (c) of this section for that 
MDPP beneficiary. The amount of this performance payment is determined 
as follows:
    (i) For a first core session furnished April 1 through December 31, 
2018, the amount of the performance payment is $25.
    (ii) For a first core session furnished during a calendar year 
subsequent to CY 2018. The performance payment amount specified in this 
paragraph for the prior year, adjusted as specified in paragraph (d) of 
this section.
    (2) Performance Goal 2: Attends four core sessions. CMS makes a 
performance payment to an MDPP supplier if an MDPP beneficiary achieves 
attendance at the beneficiary's fourth core session upon attendance at

[[Page 34193]]

a core session furnished by that supplier. The amount of this 
performance payment is determined as follows:
    (i) For a fourth core session furnished April 1 through December 
31, 2018, the amount of the performance payment is $30.
    (ii) For a fourth core session furnished during a calendar year 
subsequent to CY 2018, the performance payment amount specified in this 
paragraph for the prior year, adjusted as specified in paragraph (d) of 
this section.
    (3) Performance Goal 3: Attends nine core sessions. CMS makes a 
performance payment to an MDPP supplier if an MDPP beneficiary achieves 
attendance at the ninth core session upon the beneficiary's attendance 
at a core session furnished by that supplier. The amount of this 
performance payment is determined as follows:
    (i) For a ninth core session furnished April 1 through December 31, 
2018, the amount of the performance payment is $50.
    (ii) For a ninth core session furnished during a calendar year 
subsequent to CY 2018, the performance payment amount specified in this 
paragraph for the prior year, adjusted as specified in paragraph (d) of 
this section.
    (4) Performance Goal 4: Attends three core maintenance sessions 
during a core maintenance session interval. CMS makes a performance 
payment to an MDPP supplier if an MDPP beneficiary attends three core 
maintenance sessions in a core maintenance session interval and 
achieves attendance at that third core maintenance session upon 
attendance at a core maintenance session furnished by that supplier. 
CMS makes this performance payment to an MDPP supplier only once per 
MDPP beneficiary per core maintenance session interval. The amount of 
this performance payment is determined as follows:
    (i) If the beneficiary also achieves or maintains the required 
minimum weight loss as measured in-person during a core maintenance 
session furnished during the applicable core maintenance session 
interval:
    (A) For a third core maintenance session furnished April 1 through 
December 31, 2018, the amount of the performance payment is $60.
    (B) For a third core maintenance session furnished during a 
calendar year subsequent to CY 2018., the performance payment amount 
specified in this paragraph for the prior year, adjusted as specified 
in paragraph (d) of this section.
    (ii) If the beneficiary does not achieve or maintain the required 
minimum weight loss as measured in-person during a core maintenance 
session furnished during the applicable core maintenance session 
interval:
    (A) For a third core maintenance session furnished April 1 through 
December 31, 2018, the amount of the performance payment is $10.
    (B) For a third core maintenance session furnished during a 
calendar year subsequent to CY 2018, the performance payment amount 
specified in this paragraph for the prior year, adjusted as specified 
in paragraph (d) of this section.
    (5) Performance Goal 5: Attends three ongoing maintenance sessions 
and maintains the required minimum weight loss within an ongoing 
maintenance session interval. CMS makes a payment to an MDPP supplier 
if an MDPP beneficiary attends three ongoing maintenance sessions 
during an ongoing maintenance session interval, achieves attendance at 
that third ongoing maintenance session upon attendance at an ongoing 
maintenance session furnished by that supplier, and achieves or 
maintains the required minimum weight loss as measured in-person during 
an ongoing maintenance session furnished during the applicable ongoing 
maintenance session interval. CMS makes this performance payment to an 
MDPP supplier only once per MDPP beneficiary per ongoing maintenance 
session interval. The amount of this performance payment is determined 
as follows:
    (i) For a third ongoing maintenance session furnished April 1 
through December 31, 2018, the amount of the performance payment is 
$50.
    (ii) For a third ongoing maintenance session furnished during a 
calendar year subsequent to CY 2018, the performance payment amount 
specified in this paragraph for the prior year, adjusted as specified 
in paragraph (d) of this section.
    (6) Performance Goal 6: Achieves the required minimum weight loss. 
CMS makes a performance payment to an MDPP supplier for an MDPP 
beneficiary who achieves the required minimum weight loss as measured 
in-person during a core session or core maintenance session furnished 
by that supplier. The amount of this performance payment is determined 
as follows:
    (i) For a core session or core maintenance session, as applicable, 
furnished April 1 through December 31, 2018, the amount of the 
performance payment is $160.
    (ii) For a core session or core maintenance session, as applicable, 
furnished during a calendar year subsequent to CY 2018, the performance 
payment amount specified in this paragraph for the prior year, adjusted 
as specified in paragraph (d) of this section.
    (7) Performance Goal 7: Achieves 9-percent weight loss. CMS makes a 
performance payment to an MDPP supplier for an MDPP beneficiary who 
achieves at least a 9-percent weight loss as measured in-person during 
a core session, core maintenance session, or ongoing maintenance 
session furnished by that supplier. The amount of this performance 
payment is determined as follows:
    (i) For a core session, core maintenance session, or ongoing 
maintenance session, as applicable, furnished April 1 through December 
31, 2018, the amount of the performance payment is $25.
    (ii) For a core session, core maintenance session, or ongoing 
maintenance session, as applicable, furnished during a calendar year 
subsequent to CY 2018, the performance payment amount specified in this 
paragraph for the prior year, adjusted as specified in paragraph (d) of 
this section.
    (c) Bridge payment. CMS makes a bridge payment to an MDPP supplier 
only for a core session, core maintenance session, or ongoing 
maintenance session furnished to an MDPP beneficiary who has previously 
received MDPP services from a different MDPP supplier. An MDPP supplier 
who has previously been paid either a bridge payment or a performance 
payment for an MDPP beneficiary is not eligible to be paid a bridge 
payment for that beneficiary. A bridge payment is made only on an 
assignment-related basis in accordance with Sec.  424.55 of this 
chapter, and MDPP suppliers must accept the Medicare allowed charge as 
payment in full and may not bill or collect from the beneficiary any 
amount. CMS will make a bridge payment only to an MDPP supplier that 
complies with all applicable enrollment and program requirements, and 
only for MDPP services furnished by an eligible coach, on or after his 
or her coach eligibility start date and, if applicable, before his or 
her coach eligibility end date. As a condition of payment, the MDPP 
supplier must report the NPI of the coach who furnished the session on 
the claim for the MDPP session. The amount of the bridge payment is 
determined as follows:
    (1) For a core session, core maintenance session, or ongoing

[[Page 34194]]

maintenance session furnished April 1 through December 31, 2018, the 
amount of the bridge payment is $25.
    (2) For a core session, core maintenance session, or ongoing 
maintenance session furnished during a calendar year subsequent to CY 
2018, the bridge payment amount specified in this paragraph for the 
prior year, adjusted as specified in paragraph (d) of this section.
    (d) Updating performance payments and the bridge payment. The 
performance payments and bridge payment will be adjusted each calendar 
year by the percent change in the Consumer Price Index for All Urban 
Consumers (CPI-U) (U.S. city average) for the 12-month period ending 
June 30th of the year preceding the update year. The percent change 
update will be calculated based on the level of precision of the index 
as published by the Bureau of Labor Statistics and applied based on one 
decimal place of precision. The annual MDPP services payment update 
will be published by CMS transmittal.
0
8. Section 414.90 is amended by revising paragraphs (j)(8)(i)(A)(1)(i), 
(j)(8)(ii)(A)(1)(i), (j)(8)(ii)(A)(2), (j)(8)(iii) and (iv), (j)(9)(ii) 
through (vi) and (viii), (k)(3) introductory text subject heading, and 
(k)(5)(i) and by adding (k)(5)(ii) to read as follows:


Sec.  414.90   Physician Quality Reporting System (PQRS).

* * * * *
    (j) * * *
    (8) * * *
    (i) * * *
    (A) * * *
    (1)(i) Report at least 6 measures AND report each measure for at 
least 50 percent of the eligible professional's Medicare Part B Fee-
for-Service patients seen during the reporting period to which the 
measure applies. If less than 6 measures apply to the eligible 
professional, the eligible professional must report on each measure 
that is applicable, AND report each measure for at least 50 percent of 
the Medicare Part B Fee-for-Service patients seen during the reporting 
period to which the measure applies. Measures with a 0 percent 
performance rate will not be counted (unless they are inverse measures 
where a lower rate reflects better performance).
* * * * *
    (ii) * * *
    (A) * * *
    (1)(i) Report at least 6 measures AND report each measure for at 
least 50 percent of the eligible professional's Medicare Part B Fee-
for-Service patients seen during the reporting period to which the 
measure applies. If less than 6 measures apply to the eligible 
professional, the eligible professional must report on each measure 
that is applicable, AND report each measure for at least 50 percent of 
the Medicare Part B Fee-for-Service patients seen during the reporting 
period to which the measure applies.
* * * * *
    (2) Measures with a 0 percent performance rate or measures groups 
containing a measure with a 0 percent performance rate will not be 
counted (unless they are inverse measures where a lower rate reflects 
better performance).
* * * * *
    (iii) Via EHR direct product. For the 12-month 2018 PQRS payment 
adjustment reporting period, report 6 measures. If an eligible 
professional's direct EHR product or EHR data submission vendor product 
does not contain patient data for at least 6 measures, then the 
eligible professional must report all of the measures for which there 
is Medicare patient data. An eligible professional must report on at 
least 1 measure for which there is Medicare patient data.
    (iv) Via EHR data submission vendor. For the 12-month 2018 PQRS 
payment adjustment reporting period, report at least 6 measures. If an 
eligible professional's direct EHR product or EHR data submission 
vendor product does not contain patient data for at least 6 measures, 
then the eligible professional must report all of the measures for 
which there is Medicare patient data. An eligible professional must 
report on at least 1 measure for which there is Medicare patient data.
    (9) * * *
    (ii) Via qualified registry. For a group practice of 2 or more 
eligible professionals, for the 12-month 2018 PQRS payment adjustment 
reporting period, report at least 6 measures AND report each measure 
for at least 50 percent of the group practice's Medicare Part B Fee-
for-Service patients seen during the reporting period to which the 
measure applies. If less than 6 measures apply to the group practice, 
the group practice must report on each measure that is applicable, AND 
report each measure for at least 50 percent of the Medicare Part B Fee-
for-Service patients seen during the reporting period to which the 
measure applies. Measures with a 0 percent performance rate would not 
be counted (unless they are inverse measures where a lower rate 
reflects better performance).
    (iii) Via EHR direct product. For a group practice of 2 or more 
eligible professionals, for the 12-month 2018 PQRS payment adjustment 
reporting period, report 6 measures. If the group practice's direct EHR 
product or EHR data submission vendor product does not contain patient 
data for at least 6 measures, then the group practice must report all 
of the measures for which there is Medicare patient data. A group 
practice must report on at least 1 measure for which there is Medicare 
patient data.
    (iv) Via EHR data submission vendor. For a group practice of 2 or 
more eligible professionals, for the 12-month 2018 PQRS payment 
adjustment reporting period, report 6 measures. If the group practice's 
direct EHR product or EHR data submission vendor product does not 
contain patient data for at least 6 measures, then the group practice 
must report all of the measures for which there is Medicare patient 
data. A group practice must report on at least 1 measure for which 
there is Medicare patient data.
    (v) Via a certified survey vendor in addition to a qualified 
registry. For a group practice of 2 or more eligible professionals that 
elects to report via a certified survey vendor in addition to a 
qualified registry for the 12-month 2018 PQRS payment adjustment 
reporting period, the group practice must have all CAHPS for PQRS 
survey measures reported on its behalf via a CMS-certified survey 
vendor. In addition, the group practice must report at least 3 
additional measures using the qualified registry AND report each 
measure for at least 50 percent of the group practice's Medicare Part B 
Fee-for-Service patients seen during the reporting period to which the 
measure applies. If less than 3 measures apply to the group practice, 
the group practice must report on each measure that is applicable, AND 
report each measure for at least 50 percent of the Medicare Part B Fee-
for-Service patients seen during the reporting period to which the 
measure applies. Measures with a 0 percent performance rate would not 
be counted (unless they are inverse measures where a lower rate 
reflects better performance).
    (vi) Via a certified survey vendor in addition to a direct EHR 
product or EHR data submission vendor. For a group practice of 2 or 
more eligible professionals that elects to report via a certified 
survey vendor in addition to a direct EHR product or EHR data 
submission vendor for the 12-month 2018 PQRS payment adjustment 
reporting period, the group practice must have all CAHPS for PQRS 
survey measures reported on its behalf via a CMS-certified survey 
vendor. In addition, the group practice must report at least 3 
additional measures using the

[[Page 34195]]

direct EHR product or EHR data submission vendor product. If less than 
3 measures apply to the group practice, the group practice must report 
all of the measures for which there is patient data. Of the additional 
3 measures that must be reported in conjunction with reporting the 
CAHPS for PQRS survey measures, a group practice must report on at 
least 1 measure for which there is Medicare patient data.
* * * * *
    (viii) If the CAHPS for PQRS survey is applicable to the practice, 
group practices comprised of 100 or more eligible professionals that 
register to participate in the GPRO may administer the CAHPS for PQRS 
survey, regardless of the GPRO reporting mechanism selected.
    (k) * * *
    (3) Satisfactory participation criteria for individual eligible 
professionals for the 2016 PQRS payment adjustment. * * *
* * * * *
    (5) * * *
    (i) Individual eligible professional. For the applicable 12-month 
reporting period, report at least 6 measures available for reporting 
under a QCDR AND report each measure for at least 50 percent of the 
eligible professional's patients seen during the reporting period to 
which the measure applies. If less than 6 measures apply to the 
eligible professional, the eligible professional must report on each 
measure that is applicable, AND report each measure for at least 50 
percent of the eligible professional's patients.
    (ii) Group practices. For the applicable 12-month reporting period, 
report at least 6 measures available for reporting under a QCDR AND 
report each measure for at least 50 percent of the group practice's 
patients seen during the reporting period to which the measure applies. 
If less than 6 measures apply to the group practice, the group practice 
must report on each measure that is applicable, AND report each measure 
for at least 50 percent of the group practice's patients. If a group 
practice reports the CAHPS for PQRS survey measures, apply reduced 
criteria as follows: 3 measures, as applicable.
* * * * *
0
9. Section 414.94 is amended by revising paragraph (i)(3) and adding 
paragraphs (j) and (k) to read as follows:


Sec.  414.94   Appropriate use criteria for advanced diagnostic imaging 
services.

* * * * *
    (i) * * *
    (3) The significant hardship exception applies to ordering 
professionals who:
    (i) Are granted re-weighting of the advancing care information 
performance category to zero percent of the final score for the year 
under MIPS pursuant to Sec.  414.1380(c)(2) due to circumstances that 
include the criteria listed in Sec.  495.102(d)(4)(i) and (iii) and 
(d)(4)(iv)(A) and (B) of this chapter. The AUC significant hardship 
exception is available for the same period the re-weight is applied for 
purposes of the MIPS payment adjustments, or
    (ii) Demonstrate a significant hardship consistent with the 
criteria listed in Sec.  495.102(d)(4)(i) and (iii) and (d)(4)(iv)(A) 
or (B) of this chapter. The AUC significant hardship exception may be 
available for a period no longer than 12 months.
    (j) Consulting. Ordering Professionals must consult specified 
applicable AUC through qualified CDSMs for applicable imaging services 
furnished in an applicable setting, paid for under an applicable 
payment system and ordered on or after January 1, 2019.
    (k) Reporting. Furnishing Professionals must report the following 
information on Medicare claims for advanced diagnostic imaging services 
furnished in an applicable setting, paid for under an applicable 
payment system defined in Sec.  414.94(b), and ordered on or after 
January 1, 2019:
    (1) The qualified CDSM consulted by the ordering professional.
    (2) Information indicating:
    (i) Whether the service ordered would adhere to specified 
applicable AUC;
    (ii) Whether the service ordered would not adhere to specified 
applicable AUC, or
    (iii) Whether the specified applicable AUC consulted was not 
applicable to the service ordered.
    (3) The NPI of the ordering professional who consulted specified 
applicable AUC as required in paragraph (j) of this section, if 
different from the furnishing professional.
0
10. Section 414.904 is amended by revising paragraph (e)(2) to read as 
follows:


Sec.  414.904  Average sales price as the basis for payment.

* * * * *
    (e) * * *
    (2) Infusion drugs furnished through a covered item of durable 
medical equipment. The payment limit for an infusion drug furnished 
before January 1, 2017, through a covered item of durable medical 
equipment is calculated using 95 percent of the average wholesale price 
in effect on October 1, 2003.
* * * * *
0
11. Section 414.1270 is amended by revising paragraph (d)(1) to read as 
follows:


Sec.  414.1270  Determination and calculation of the Value-Based 
Payment Modifier adjustments.

* * * * *
    (d) * * *
    (1) A downward payment adjustment of -1.0 percent will be applied 
to a solo practitioner, a group with two to nine eligible 
professionals, and a group consisting only of nonphysician eligible 
professionals subject to the value-based payment modifier and no 
physicians; and a downward payment adjustment of -2.0 percent will be 
applied to a group with 10 or more eligible professionals and at least 
one physician if, during the applicable performance period as defined 
in Sec.  414.1215, the following apply:
    (i) For groups:
    (A) Such group does not meet the criteria as a group to avoid the 
PQRS payment adjustment for CY 2018 as specified by CMS; and
    (B) Fifty percent of the eligible professionals in such group do 
not meet the criteria as individuals to avoid the PQRS payment 
adjustment for CY 2018 as specified by CMS.
    (ii) For solo practitioners, such solo practitioner does not meet 
the criteria as an individual to avoid the PQRS payment adjustment for 
CY 2018 as specified by CMS.
* * * * *
0
12. Section 414.1275 is amended by revising paragraphs (c)(4) and 
(d)(3)(i) and (ii) to read as follows:


Sec.  414.1275   Value-based payment modifier quality-tiering scoring 
methodology.

* * * * *
    (c) * * *
    (4) The following value-based payment modifier percentages apply to 
the CY 2018 payment adjustment period, for physicians, physician 
assistants, nurse practitioners, clinical nurse specialists, and 
certified registered nurse anesthetists who are solo practitioners or 
who are in groups of any size:

[[Page 34196]]



    CY 2018--Value-Based Payment Modifier Amounts for the Quality-Tiering Approach for Physicians, Physician
    Assistants, Nurse Practitioners, Clinical Nurse Specialists, and Certified Registered Nurse Anesthetists
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                          Cost/quality                              Low quality       quality      High quality
----------------------------------------------------------------------------------------------------------------
Low Cost........................................................           +0.0%          +*1.0x          +*2.0x
Average Cost....................................................           +0.0%           +0.0%          +*1.0x
High Cost.......................................................           +0.0%           +0.0%           +0.0%
----------------------------------------------------------------------------------------------------------------
* Eligible for an additional +1.0x if reporting Physician Quality Reporting System quality measures and average
  beneficiary risk score is in the top 25 percent of all beneficiary risk scores, where `x' represents the
  upward payment adjustment factor.

    (d) * * *
    (3) * * *
    (i) Classified as high quality/low cost receive an upward 
adjustment of +3x (rather than +2x); and
    (ii) Classified as either high quality/average cost or average 
quality/low cost receive an upward adjustment of +2x (rather than +1x).

PART 424--CONDITIONS FOR MEDICARE PAYMENT

0
13. The authority citation for part 424 continues to read as follows:

    Authority:  Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh).
0
14. Section 424.55 is amended by adding paragraph (d) to read as 
follows:


Sec.  424.55   Payment to the supplier.

* * * * *
    (d) For purposes of claims for services submitted by an MDDP 
supplier (as defined at Sec.  410.79(b)), Medicare deems such claims to 
have been assigned by the beneficiary (or the person authorized to 
request payment on the beneficiary's behalf) and the assignment 
accepted by the MDDP supplier.


Sec.  424,59   [Removed]

0
 15. Remove Sec.  424.59.
0
 16. Subpart I, consisting of Sec. Sec.  424.200 through 424.210, is 
added to read as follows:

Subpart I--Requirements for Medicare Diabetes Prevention Program 
Suppliers and Beneficiary Engagement Incentives Under the Medicare 
Diabetes Prevention Program Expanded Model

Sec.
424.200 Scope.
424.205 Requirements for Medicare Diabetes Prevention Program 
suppliers.
424.210 Beneficiary engagement incentives under the Medicare 
Diabetes Prevention Program expanded model.

Subpart I--Requirements for Medicare Diabetes Prevention Program 
Suppliers and Beneficiary Engagement Incentives Under the Medicare 
Diabetes Prevention Program Expanded Model


Sec.  424.200  Scope.

    This subpart specifies the requirements for Medicare Diabetes 
Prevention Program suppliers and beneficiary engagement incentives 
under the Medicare Diabetes Prevention Program expanded model.


Sec.  424.205   Requirements for Medicare Diabetes Prevention Program 
suppliers.

    (a) Definitions. In addition to the definitions specified at 
Sec. Sec.  410.79(b) and 414.84(a) of this subchapter, the following 
definitions apply to this section:
    Administrative location means a physical location associated with 
the MDPP supplier's operations, from where coaches are dispatched or 
based, and where MDPP services may or may not be furnished.
    Coach means an individual who furnishes MDPP services on behalf of 
an MDPP supplier as an employee, contractor, or volunteer.
    Coach eligibility end date means the end date indicated by the MDPP 
supplier in submitting a change to the supplier's MDPP enrollment 
application in accordance with paragraph (d)(5) of this section that 
removed the coach's information, or the date the supplier itself was 
revoked from or withdrew its Medicare enrollment as an MDPP supplier.
    Coach eligibility start date, means the start date indicated by the 
MDPP supplier when submitting an eligible the coach's information on 
the MDPP enrollment application.
    Community setting means a location where the MDPP supplier 
furnishes MDPP services outside of their administrative locations. A 
community setting is a location open to the public not primarily 
associated with the supplier. Community settings may include, for 
example, church basements or multipurpose rooms in recreation centers.
    Eligible coach means an individual who CMS has screened and has 
determined can provide MDPP services on behalf of an MDPP supplier in 
accordance with paragraph (e) of this section.
    Ineligible coach means an individual whom CMS has screened and has 
determined cannot provide MDPP services on behalf of an MDPP supplier 
in accordance with paragraph (e) of this section.
    MDPP interim preliminary recognition means a status that CMS has 
granted to an entity in accordance with paragraph (c) of this section.
    (b) Conditions for MDPP supplier enrollment. An entity may enroll 
as an MDPP supplier only if it satisfies the following requirements and 
all other applicable Medicare enrollment requirements:
    (1) Has either an MDPP preliminary recognition, as defined in 
paragraph (c)(1) of this section or a full CDC DPRP recognition.
    (2) Maintains an active and valid TIN and NPI at the organizational 
level.
    (3) Has passed screening requirements as follows:
    (i) Upon initial enrollment, at a ``high'' categorical risk in 
accordance with Sec.  424.518(c)(2); and
    (ii) Upon revalidation, at a ``moderate'' categorical risk in 
accordance with Sec.  424.518(b)(2).
    (4) Maintains, and submits to CMS through the CMS-approved 
enrollment application, a roster of all coaches who will be furnishing 
MDPP services on the entity's behalf that includes each coach's first 
and last names, middle initial (if applicable), date of birth, Social 
Security Number (SSN), active and valid NPI, coach eligibility start 
date, and coach eligibility end date (if applicable). This roster must 
be updated in accordance with paragraph (d)(5) of this section.
    (5) Meets and certifies in its CMS-approved enrollment application 
that it meets and will continue to meet the

[[Page 34197]]

supplier enrollment standards described in paragraph (d) of this 
section.
    (6) Revalidates its Medicare enrollment every 3 years after the 
effective date of enrollment.
    (c) MDPP preliminary recognition. (1) For the purposes of this 
section, an MDPP preliminary recognition may include either:
    (i) Any preliminary recognition established by CDC for the purposes 
of the DPRP; or
    (ii) An MDPP interim preliminary recognition.
    (A) MDPP interim preliminary recognition application period. 
Entities may apply to CDC for CMS' MDPP interim preliminary by 
submitting information at the time and in the form and manner specified 
by CMS.
    (B) MDPP Interim preliminary recognition requirements. An entity 
may qualify for MDPP interim preliminary recognition if--
    (1) The entity has pending CDC recognition.
    (2) The entity submits a full 12 months of performance data to CDC 
on at least one completed cohort. The 12 month data submission includes 
at least 5 participants who attended at least 3 sessions in the first 6 
months and whose time from first session attended to last session of 
the lifestyle change program was at least 9 months, at least 60 percent 
of whom attended at least 9 sessions in months 1 through 6, and at 
least 60 percent of whom attended at least 3 sessions in months 7 
through 12.
    (2) [Reserved]
    (d) Medicare Diabetes Prevention Program supplier standards. An 
MDPP supplier must meet and must certify in its CMS-approved enrollment 
application that it meets and will continue to meet the following 
standards.
    (1) The MDPP supplier must have and maintain MDPP preliminary 
recognition, as defined under paragraph (c)(1) of this section, or a 
full CDC DPRP recognition.
    (2) The MDPP supplier must not currently have its billing 
privileges terminated for-cause or be excluded by a State Medicaid 
agency.
    (3) The MDPP supplier must not include on the roster of coaches, 
described in paragraph (b)(4) of this section and updated in accordance 
with paragraph (d)(5) of this section, nor permit MDPP services to be 
furnished by any individual coach who meets any of ineligibility 
criteria outlined in paragraph (e)(1) of this section.
    (4) The MDPP supplier must maintain at least one administrative 
location. All administrative locations maintained by the MDPP supplier 
must be located at an appropriate site and be reported on the CMS-
approved enrollment application. An appropriate site for such an 
administrative location would include all of the following 
characteristics:
    (i) Signage posted on the exterior of the building. Such signage 
may include, for example, the MDPP supplier's legal business name or 
DBA, as well as hours of operation.
    (ii) Open for business during stated operational hours.
    (iii) Employees, staff, or volunteers present during operational 
hours; and
    (iv) Not a private residence.
    (5) The MDPP supplier must update its enrollment application within 
30 days of any changes of ownership, changes to the coach roster 
(including due to coach ineligibility or because the coach is no longer 
an employee, contractor, or volunteer of the MDPP supplier), and final 
adverse action history, and report all other changes, including but not 
limited to changes in the MDPP supplier's administrative location(s), 
to CMS within 90 days of the reportable event.
    (6) The MDPP supplier must maintain a primary business telephone 
that operates either at administrative locations described in paragraph 
(d)(4) of this section or directly where services are furnished, if 
services are furnished in community settings. The associated telephone 
number must be listed with the either the legal or doing business as 
name of the supplier in public view, including on Web sites, flyers, 
and materials.
    (7) The MDPP supplier must not knowingly sell to or allow another 
individual or entity to use its supplier billing number.
    (8) Subject to paragraph (d)(8)(i) of this section, the MDPP 
supplier must not deny an MDPP beneficiary access to MDPP services 
during the MDPP services period described in Sec.  410.79(c)(2) of this 
chapter, including on the basis of the beneficiary's weight, health 
status, or achievement of performance goals.
    (i) Suppliers may deny an MDPP beneficiary access to MDPP services 
during the MDPP services period only under one of the following 
conditions:
    (A) The MDPP beneficiary no longer meets the eligibility criteria 
for MDPP services under Sec.  410.79(c)(1) of this chapter.
    (B) The MDPP supplier lacks the self-determined capacity to furnish 
MDPP services to additional MDPP beneficiaries.
    (C) The MDPP supplier determines that the MDPP beneficiary 
significantly disrupts the session for other MDPP beneficiaries or 
becomes abusive.
    (ii) MDPP suppliers must maintain a record of the number of MDPP 
beneficiaries turned away for the reasons outlined in paragraphs 
(d)(8)(i)(B) and (C) of this section, to include the date each such 
beneficiary was turned away. For beneficiaries turned away for reasons 
described in paragraph (d)(8)(i)(C) of this section, the MDPP supplier 
must document details of the occurrence(s), including date(s) of the 
behavior, any remediation efforts taken by the MDPP supplier, and final 
action (for example, dismissal from an MDPP session or denial from 
future sessions) in the beneficiary's MDPP records.
    (9) The MDPP supplier and other individuals or entities performing 
functions or services related to MDPP services on the MDPP supplier's 
behalf must not unduly coerce an MDPP beneficiary's decision to change 
or not to change to a different MDPP supplier, including through the 
use of pressure, intimidation, or bribery.
    (10) Except as allowed under paragraph (d)(8) of this section, the 
MDPP supplier must offer an MDPP beneficiary no fewer than all of the 
following:
    (i) Sixteen in-person core sessions no more frequently than weekly 
for the first 6 months of the MDPP services period, which begins on the 
date of attendance at the first such core session.
    (ii) One in-person core maintenance session each month during 
months 7 through 12 (6 months total) of the MDPP services period.
    (iii) One in-person ongoing maintenance session each month for 
months 13 through 36 of the MDPP services period, as long as the 
beneficiary maintains eligibility to receive such services in 
accordance with Sec.  410.79(c)(1)(ii) and (iii) of this chapter.
    (11) Before the initial core session is furnished, the MDPP 
supplier must disclose detailed information about the set of MDPP 
services to each MDPP beneficiary to whom it wishes to begin furnishing 
MDPP services. Such information must include all of the following:
    (i) Eligibility requirements under Sec.  410.79(c)(1) of this 
chapter, including the once-per-lifetime nature of MDPP services.
    (ii) The MDPP supplier standards as outlined in this section.
    (12) The MDPP supplier must answer MDPP beneficiaries' questions 
about MDPP services and respond to MDPP-related complaints within a 
reasonable timeframe. An MDPP supplier must

[[Page 34198]]

implement a complaint resolution protocol and maintain documentation of 
all beneficiary contact regarding such complaints, including the name 
and Medicare Beneficiary Identifier of the beneficiary, a summary of 
the complaint, related correspondences, notes of actions taken, and the 
names and/or NPIs of individuals who took such actions on behalf of the 
MDPP supplier. Failure to maintain a complaint resolution protocol or 
to retain information regarding MDPP related complaints in accordance 
with paragraph (g) of this section may be considered evidence that the 
MPPP supplier standards have not been met. This information must be 
kept at each administrative location and made available to CMS or its 
contractors upon request.
    (13) The MDPP supplier must maintain a crosswalk file which 
indicates how beneficiary identifications for the purposes of CDC 
performance data requirements correspond to corresponding beneficiary 
health insurance claims numbers or Medicare Beneficiary Identifiers for 
each MDPP beneficiary receiving MDPP services from the MDPP supplier. 
The MDPP supplier must submit the crosswalk file to CMS or its 
contractor.
    (14) The MDPP supplier must submit performance data for MDPP 
beneficiaries who attend ongoing maintenance sessions with data 
elements consistent with the CDC's DPRP standards for data elements 
required for the core services period.
    (15) The MDPP supplier must allow CMS or its agents to conduct 
onsite inspections or recordkeeping reviews in order to ascertain the 
MDPP supplier's compliance with these standards, and must adhere to the 
documentation requirements as outlined in paragraph (g) of this 
section.
    (e) Coach eligibility--(1) Criteria. To furnish MDPP services to a 
beneficiary, an MDPP coach must not:
    (i) Currently have Medicare billing privileges revoked and be 
currently subject to the reenrollment bar.
    (ii) Currently have its Medicaid billing privileges terminated for-
cause or be excluded by a State Medicaid agency.
    (iii) Currently be excluded from any other Federal health care 
program, as defined in 42 CFR 1001.2, in accordance with section 1128, 
1128A, 1156, 1842, 1862, 1867 or 1892 of the Act.
    (iv) Currently be debarred, suspended, or otherwise excluded from 
participating in any other Federal procurement or nonprocurement 
program or activity in accordance with the Federal Acquisition 
Streamlining Act implementing regulations and the Department of Health 
and Human Services nonprocurement common rule at 45 CFR part 76.
    (v) Have, in the previous 10 years, one of the following State or 
Federal felony convictions:
    (A) Crimes against persons, such as murder, rape, assault, and 
other similar crimes for which the individual was convicted, as defined 
under 42 CFR 1001.2, had a guilty plea or adjudicated pretrial 
diversion.
    (B) Financial crimes, such as extortion, embezzlement, income tax 
evasion, insurance fraud and other similar crimes for which the 
individual was convicted, as defined under 42 CFR 1001.2, had a guilty 
plea or adjudicated pretrial diversion.
    (C) Any felony that placed the Medicare or its beneficiaries at 
immediate risk, such as a malpractice suit that results in the 
individual being convicted, as defined under 42 CFR 1001.2, had a 
guilty plea or adjudicated pretrial diversion of criminal neglect or 
misconduct.
    (D) Any felonies for which the individual was convicted, as defined 
under 42 CFR 1001.2, had a guilty plea or adjudicated pretrial 
diversion that would result in mandatory exclusion under section 
1128(a) of the Act.
    (2) CMS determination of coach eligibility. CMS will screen each 
individual identified on the roster of coaches included with the 
supplier's enrollment application described in paragraph (b)(4) of this 
section and updated in accordance with paragraph (d)(5) of this section 
to verify that the individual coach does not meet any of the conditions 
specified in paragraph (e)(1) of this section and that the coach can 
provide MDPP services on behalf of an MDPP supplier. For each 
individual coach successfully screened by CMS, his or her eligibility 
start date becomes effective and remains effective until an MDPP 
supplier or CMS takes action that results in an eligibility end date.
    (f) Effective date for billing privileges. (1) For MDPP suppliers 
initially enrolling and for newly established administrative locations 
that result in a new enrollment record or Provider Transaction Access 
Number, the effective date for Medicare billing privileges for MDPP 
suppliers is--
    (i) The later of--
    (A) The date of filing of a Medicare enrollment application that 
was subsequently approved by a Medicare contractor;
    (B) The date of filing of a corrective action plan that was 
subsequently approved by a Medicare contractor; or
    (C) The date that the supplier first began furnishing services at a 
new administrative location that resulted in a new enrollment record or 
Provider Transaction Access Number
    (ii) Under no circumstances should the effective date of billing 
privileges for any MDPP supplier be prior to April 1, 2018
    (2) For any newly established administrative locations that do not 
result in a new enrollment record or Provider Transaction Access 
Number, the existing billing privilege effective date for their 
Provider Transaction Access Number will apply, but not earlier than 
April 1, 2018.
    (g) Documentation retention and provision requirements. An MDPP 
supplier must maintain all documentation related to participation in 
the MDPP in accordance with all applicable Federal and State laws. The 
MDPP supplier must provide to CMS, a contractor acting on CMS' behalf, 
the Office of the Inspector General, and the Comptroller General or 
their designee(s) scheduled and unscheduled access to the MDPP 
supplier's records, including, but not limited to, all books, 
contracts, records, documents, and other evidence sufficient to enable 
the audit, evaluation, inspection, or investigation of the MDPP 
supplier's compliance with the MDPP expanded model's requirements, 
including the MDPP expanded model requirements for in-kind beneficiary 
incentive engagements in Sec.  424.210 of this chapter in the event 
that the MDPP supplier chooses to offer such incentives to any MDPP 
beneficiary.
    (1) The documentation for the first core session must be 
established contemporaneous with the furnishing of MDPP services and 
must include at least all of the following:
    (i) Organizational information, including MDPP supplier name, CDC 
DPRP number, and NPI.
    (ii) Basic beneficiary information for each MDPP beneficiary in 
attendance, including but not limited to beneficiary name, HICN, age.
    (iii) Evidence that each such beneficiary satisfied the eligibility 
requirements under Sec.  410.79(c) at the time of service.
    (2) The documentation for each MDPP session attended must be 
established contemporaneous with the furnishing of MDPP services and 
must include at least all of the following:
    (i) Documentation of the type of session, whether a core session, a 
core maintenance session, an ongoing maintenance session, an in-person 
make-up session, or a virtual make-up session.

[[Page 34199]]

    (ii) Identification of which CDC-approved DPRP curriculum was 
associated with the session.
    (iii) The NPI of the coach who furnished the session.
    (iv) The date and place of service of the session.
    (v) Each MDPP's beneficiary's weight and date weight taken, in a 
form and manner as specified by CMS.
    (3) If an MDPP supplier chooses to offer in-kind beneficiary 
engagement incentives to MDPP beneficiaries as permitted under Sec.  
424.210, the records maintained by the MDPP supplier in accordance with 
this section must also include the information required by Sec.  
424.210(e).
    (4) An MDPP supplier is required to maintain and handle any 
beneficiary Personally Identifiable Information (PII) and Protected 
Health Information (PHI) in compliance with HIPAA, other applicable 
state and federal privacy laws, and CMS standards.
    (5) The MDPP supplier's records must include an attestation from 
the MDPP supplier that, as applicable, the MDPP beneficiary for which 
it is submitting a claim--
    (i) Has attended their first, fourth or ninth core session, as 
applicable, if the claim submitted is for a performance payment under 
Sec.  414.84(b)(1), (2), or (3) of this chapter.
    (ii) Has attended at least three core maintenance sessions, 
achieved required minimum weight loss, or both, as applicable, if the 
claim submitted is for a performance payment under Sec.  414.84(b)(4) 
of this chapter.
    (iii) Has achieved the required minimum weight loss and attended at 
least three ongoing maintenance sessions within an ongoing maintenance 
session interval, if the claim submitted is for a performance payment 
under Sec.  414.84(b)(5) of this chapter, if the claim submitted is for 
a performance payment under Sec.  414.84(b)(6) of this chapter.
    (iv) Has achieved required minimum weight loss as measured in-
person during a core session or core maintenance session furnished by 
that supplier, if the claim submitted is for a performance payment 
under Sec.  414.84(b)(6) of this chapter.
    (v) Has achieved at least a 9-percent weight loss percentage as 
measured in-person during a core session, core maintenance session, or 
ongoing maintenance session furnished by that supplier, if the claim 
submitted is for a performance payment under Sec.  414.84(b)(7) of this 
chapter.
    (6) The MDPP supplier must maintain all records required under this 
section for a period of 10 years from the last day of the MDPP 
beneficiary's receipt of MDPP services provided by the MDPP supplier or 
from the date of completion of any audit, evaluation, inspection, or 
investigation, whichever is later, unless either of the following 
apply:
    (i) CMS determines that there is a special need to retain a 
particular record or group of records for a longer period and notifies 
the MDPP supplier at least 30 calendar days before the normal 
disposition rate; or
    (ii) There has been a dispute or allegation of fraud or similar 
fault against the MDPP supplier, in which case the records must be 
maintained for an additional 6 years from the date of any resulting 
final resolution of the dispute or allegation of fraud or similar 
fault, as defined at Sec.  405.902 of this chapter.
    (h) Denial or revocation of MDPP supplier enrollment. (1) An MDPP 
supplier is subject to enrollment denial or revocation of its MDPP 
supplier enrollment for one or more of the following reasons:
    (i) Failure to meet enrollment requirements. The MDPP supplier does 
not satisfy the conditions specified in paragraph (b) of this section.
    (A) An enrollment denial under this paragraph (h)(1)(i) is 
considered an enrollment denial under Sec.  424.530(a)(1) of this 
chapter.
    (B) A revocation under this paragraph (h)(1)(i) is considered a 
revocation under Sec.  424.535(a)(1) of this chapter.
    (C) An MDPP supplier that does not satisfy the requirements in 
paragraph (b)(1) of this section may become eligible to bill for MDPP 
services again if it successfully achieves MDPP preliminary recognition 
or full CDC DPRP recognition, and successfully enrolls again in 
Medicare as an MDPP supplier after any applicable reenrollment bar has 
expired.
    (ii) Failure to meet MDPP supplier standards. The MDPP supplier 
fails to meet the standards specified in paragraph (d) of this section.
    (A) An enrollment denial under this paragraph (h)(1)(ii) is 
considered an enrollment denial under Sec.  424.530(a)(1) of this part.
    (B) A revocation under this paragraph (h)(1)(ii) is considered a 
revocation under Sec.  424.535(a)(1) of this part.
    (iii) Application of existing enrollment denial reasons. One of the 
enrollment denial reasons specified in Sec.  424.530(a) of this part 
applies.
    (iv) Application of existing revocation reasons. One of the 
revocation reasons specified in Sec.  424.535(a) of this chapter 
applies.
    (v) Use of an ineligible coach. (A) The MDPP supplier knowingly 
allows an ineligible coach to furnish MDPP services to Medicare 
beneficiaries. Knowingly means that the MDPP supplier received an 
enrollment denial or revocation notice based on failing to meet the 
standard specified in Sec.  424.205(d)(3), was provided notice by CMS 
or contractors working on its behalf of this coach's ineligibility 
including the reason(s) for ineligibility, submitted a corrective 
action plan (CAP) to remove the coach and become compliant therefore 
maintaining its enrollment, but continued to allow the coach to provide 
MDPP services in violation of the CAP.
    (B) Revocation under this paragraph (h)(1)(v) is subject to the 
following requirements:
    (1) The revocation becomes effective 30 days after CMS or the CMS 
contractor mails notice of its determination to the MDPP supplier.
    (2) For the revocation authority under this paragraph, MDPP 
suppliers are barred from participating in the Medicare program from 
the date of the revocation, which begins 30 days after CMS or its 
contractor mails notice of the revocation, until the end of the 
reenrollment bar, which lasts a minimum of 1 year, but not greater than 
3 years, depending on the severity of the basis for revocation.
    (3) A revoked MDPP supplier must, within 60 calendar days after the 
effective date of revocation, submit all claims for items and services 
furnished before the date of the revocation letter.
    (2) An MDPP supplier may appeal an enrollment denial or revocation 
decision in accordance with the procedures specified in part 498 of 
this chapter. References to suppliers in that section apply to MDPP 
suppliers.


Sec.  424.210   Beneficiary engagement incentives under the Medicare 
Diabetes Prevention Program expanded model.

    (a) Definitions. In addition to the definitions specified at Sec.  
410.79(b) and Sec.  424.205(a) of this chapter, the following 
definition applies to this section:
    Engagement incentive period means the period of time during which 
an MDPP supplier may furnish in-kind beneficiary engagement incentives 
to a given MDPP beneficiary to whom the MDPP supplier is furnishing 
MDPP services. This period begins when an MDPP supplier furnishes any 
MDPP service to an MDPP eligible beneficiary and ends when one of the 
following occurs, whichever occurs first:
    (i) The MDPP beneficiary's MDPP services period ends as described 
in Sec.  410.79(c)(3) of this chapter.

[[Page 34200]]

    (ii) The MDPP supplier knows the MDPP beneficiary will no longer be 
receiving MDPP services from the MDPP supplier.
    (iii) The MDPP supplier has not had direct contact, either in-
person, by telephone, or via other telecommunications technology, with 
the MDPP beneficiary for more than 90 consecutive calendar days during 
the MDPP services period.
    (b) General. An MDPP supplier may choose to furnish an item or 
service as an in-kind beneficiary engagement incentive to an MDPP 
beneficiary only during the engagement incentive period, subject to the 
following conditions:
    (1) The item or service must be furnished directly to an MDPP 
beneficiary by an MDPP supplier or by an agent of the MDPP supplier, 
such as a coach, under the MDPP supplier's direction and control.
    (2) The item or service must be reasonably connected to the CDC-
approved DPP curriculum furnished to the MDPP beneficiary during a core 
session, a core maintenance session, or ongoing maintenance session 
furnished by the MDPP supplier.
    (3) The item or service must be a preventive care item or service 
or an item or service that advances a clinical goal, as specified in 
paragraph (d) of this section, for an MDPP beneficiary by engaging him 
or her in better managing his or her own health.
    (4) The item or service must not be tied to the receipt of services 
outside of the MDPP services
    (5) The item or service must not be tied to the receipt of services 
from a particular provider, supplier, or coach.
    (6) The availability of the item or service must not be advertised 
or promoted as an in-kind beneficiary engagement incentive available to 
an MDPP beneficiary receiving MDPP services from the MDPP supplier 
except that an MDPP beneficiary may be made aware of the availability 
of the item or service at the time the MDPP beneficiary could 
reasonably benefit from it during the engagement incentive period.
    (7) The cost of the item or service must not be shifted to another 
Federal health care program, as defined at section 1128B(f) of the Act.
    (c) Technology furnished to an MDPP beneficiary. In-kind 
beneficiary engagement incentives involving technology furnished by an 
MDPP supplier to an MDPP beneficiary are subject to the following 
conditions:
    (1) Items or services involving technology may not, in the 
aggregate, exceed $1,000 in retail value for any one MDPP beneficiary.
    (2) Items or services involving technology must be the minimum 
necessary to advance a clinical goal, as listed in paragraph (d) of 
this section, for an MDPP beneficiary.
    (3) Items involving technology exceeding $100 in retail value 
must--
    (i) Remain the property of the MDPP supplier; and
    (ii) Be retrieved from the MDPP beneficiary at the end of the 
engagement incentive period. The MDPP supplier must document all 
retrieval attempts, including the ultimate date of retrieval in 
accordance with paragraph (e)(3) of this section. Documented diligent, 
good faith attempts to retrieve items of technology will be deemed to 
meet the retrieval requirement.
    (d) Clinical goals of the MDPP expanded model. The following are 
the clinical goals for MDPP beneficiaries, that may be advanced through 
in-kind beneficiary engagement incentives:
    (1) Attendance at core sessions, core maintenance sessions, or 
ongoing maintenance sessions.
    (2) Weight loss.
    (3) Long-term dietary change.
    (4) Adherence to long-term health behavior changes.
    (e) Documentation of beneficiary engagement incentives. In addition 
to the documentation requirements at Sec.  424.205(g), an MDPP supplier 
must maintain documentation of items and services furnished as in-kind 
beneficiary engagement incentives that exceed $25 in retail value.
    (1) The documentation must be established contemporaneous with the 
furnishing of the in-kind items and services and must include at least 
the following:
    (i) The date the item or service is furnished.
    (ii) The identity of the MDPP beneficiary to whom the item or 
service is furnished.
    (iii) The agent of the MDPP supplier who furnished the item or 
service, if applicable.
    (iv) A description of the item or service.
    (v) The retail value of the item or service.
    (vi) Documentation establishing that the item or service was 
furnished to the MDPP beneficiary during the engagement incentive 
period.
    (2) Documentation regarding items or services that are furnished to 
the MDPP beneficiary for use on an ongoing basis during the engagement 
incentive period, including items of technology exceeding $100 in 
retail value, must also include contemporaneous documentation 
establishing that the MDPP beneficiary is in the engagement incentive 
period throughout the time period that the MDPP beneficiary possesses 
or has access to the item or service furnished by the MDPP supplier.
    (3) The documentation regarding items of technology exceeding $100 
in retail value must also include contemporaneous documentation of any 
attempt to retrieve technology as required by paragraph (c)(3)(ii) of 
this section.
    (4) The MDPP supplier must retain and provide access to the 
documentation required in this section in accordance with Sec.  
424.205(g).
0
17. Section 424.502 is amended by revising the definition for 
``Institutional provider'' to read as follows.


Sec.  424.502  Definitions.

* * * * *
    Institutional provider means any provider or supplier that submits 
a paper Medicare enrollment application using the CMS-855A, CMS-855B 
(not including physician and nonphysician practitioner organizations), 
CMS-855S, any enrollment application designated for MDPP suppliers, or 
an associated Internet-based PECOS enrollment application.
* * * * *
0
18. Section 424.516 is amended by revising paragraph (e) introductory 
text to read as follows.


Sec.  424.516  Additional provider and supplier requirements for 
enrolling and maintaining active enrollment status in the Medicare 
program.

* * * * *
    (e) Reporting requirements for all other providers and suppliers. 
Reporting requirements for all other providers and suppliers not 
identified in paragraphs (a) through (d) of this section, with the 
exception of MDPP suppliers whose reporting requirements are 
established in Sec.  424.205(d), must report to CMS the following 
information within the specified timeframes:
* * * * *

PART 425--MEDICARE SHARED SAVINGS PROGRAM

0
19. The authority citation for part 425 continues to read as follows:

    Authority:  Secs. 1102, 1106, 1871, and 1899 of the Social 
Security Act (42 U.S.C. 1302, 1306 1395hh, and 1395jjjj).

0
20. Section 425.20 is amended by revising the definitions of ``Primary 
care physician'' and ``Primary care services'' to read as follows:


Sec.  425.20  Definitions.

* * * * *
    Primary care physician means:

[[Page 34201]]

    (1) For performance years 2012 through 2015, a physician included 
in an attestation by the ACO as provided under Sec.  425.404 for 
services furnished in an FQHC or RHC, or a physician who has a primary 
care specialty designation of internal medicine, general practice, 
family practice, or geriatric medicine;
    (2) For performance years 2016 through 2018, a physician included 
in an attestation by the ACO as provided under Sec.  425.404 for 
services furnished in an FQHC or RHC, or a physician who has a primary 
care specialty designation of internal medicine, general practice, 
family practice, geriatric medicine, or pediatric medicine; and
    (3) For performance year 2019 and subsequent years, a physician who 
has a primary care specialty designation of internal medicine, general 
practice, family practice, geriatric medicine, or pediatric medicine.
    Primary care services means the set of services identified by the 
HCPCS and revenue center codes designated under Sec.  425.400(c).
* * * * *
0
22. Section 425.112 is amended--
0
a. In paragraph (a)(3)(i) by removing the phrase ``Explain how it will 
require ACO participants'' and adding in its place the phrase ``Require 
ACO participants'';
0
b. In paragraph (a)(3)(ii) by removing the phrase ``Explain how it will 
employ its internal assessments'' and adding in its place the phrase 
``Employ its internal assessments''; and
0
c. By revising paragraph (b)(4)(ii).
    The revision reads as follows:


Sec.  425.112  Required processes and patient-centeredness criteria.

* * * * *
    (b) * * *
    (4) * * *
    (ii) Have a written plan to:
    (A) Implement an individualized care program that promotes improved 
outcomes for, at a minimum, the ACO's high-risk and multiple chronic 
condition patients.
    (B) Identify additional target populations that would benefit from 
individualized care plans. Individualized care plans must take into 
account the community resources available to the individual.
    (C) Encourage and promote use of enabling technologies for 
improving care coordination for beneficiaries. Enabling technologies 
may include one or more of the following:
    (1) Electronic health records and other health IT tools.
    (2) Telehealth services, including remote patient monitoring.
    (3) Electronic exchange of health information.
    (4) Other electronic tools to engage beneficiaries in their care.
    (D) Partner with long-term and post-acute care providers, both 
inside and outside the ACO, to improve care coordination for its 
assigned beneficiaries.
0
 23. Section 425.204 is amended by--
0
a. Revising paragraph (c)(1) introductory text;
0
b. Removing paragraph (c)(5)(iii);
0
c. Redesignating paragraph (c)(5)(iv) as paragraph (c)(5)(iii); and
0
d. Revising paragraph (d).
    The revisions read as follows:


Sec.  425.204   Content of the application.

* * * * *
    (c) * * *
    (1) As part of its application, an ACO must certify that the ACO 
satisfies the requirements set forth in this part. Upon request, the 
ACO must submit the following supporting materials to demonstrate that 
it satisfies the requirements set forth in this part:
* * * * *
    (d) Distribution of savings. As part of its application to 
participate in the Shared Savings Program, an ACO must certify it has a 
mechanism and plan to receive and use payments for shared savings, 
including criteria for distributing shared savings among its ACO 
participants and ACO providers/suppliers.
* * * * *
0
24. Section 425.306 is amended by revising paragraph (b)(2) to read as 
follows:


Sec.  425.306   Participant agreement and exclusivity of ACO 
participants.

* * * * *
    (b) * * *
    (2) Each ACO participant that submits claims for services used to 
determine the ACO's assigned population under subpart E of this part 
must be exclusive to one Shared Savings Program ACO. If, during a 
benchmark or performance year (including the 3-month claims runout for 
such benchmark or performance year), an ACO participant that 
participates in more than one ACO submits claims for services used in 
assignment under subpart E of this part, then:
    (i) CMS will not consider any services billed through the TIN of 
the ACO participant when performing assignment under subpart E of this 
part for the benchmark or performance year.
    (ii) The ACO may be subject to the pre-termination actions set 
forth in Sec.  425.216, termination under Sec.  425.218, or both.
0
 25. Section 425.400 is amended by adding paragraph (a)(1)(iii) and 
revising paragraph (c) to read as follows:


Sec.  425.400   General.

    (a) * * *
    (1) * * *
    (iii) In determining final assignment for a benchmark or 
performance year, CMS will exclude any services furnished during the 
benchmark or performance year that are billed through the TIN of an ACO 
participant that is an ACO participant in more than one ACO.
* * * * *
    (c) Primary care services for purposes of assigning beneficiaries 
are identified by selected HCPCS/CPT codes, or revenue center codes.
    (1) Primary care service codes are as follows:
    (i) For performance years 2012 through 2015:
    (A) CPT codes:
    (1) 99201 through 99215.
    (2) 99304 through 99340.
    (3) 99341 through 99350.
    (B) HCPCS codes G0402 (the code for the Welcome to Medicare visit) 
and G0438 and G0439 (codes for the annual wellness visits).
    (C) Revenue center codes 0521, 0522, 0524, and 0525 submitted by 
FQHCs (for services furnished prior to January 1, 2011), or by RHCs.
    (ii) For performance year 2016 as follows:
    (A) CPT codes:
    (1) 99201 through 99215.
    (2) 99304 through 99340.
    (3) 99341 through 99350.
    (4) 99495, 99496, and 99490.
    (B) HCPCS codes:
    (1) G0402 (the code for the Welcome to Medicare visit) and
    (2) G0438 and G0439 (codes for the annual wellness visits).
    (3) G0463 for services furnished in ETA hospitals.
    (C) Revenue center codes 0521, 0522, 0524, and 0525 submitted by 
FQHCs (for services furnished prior to January 1, 2011), or by RHCs.
    (iii) For performance year 2017 and 2018 as follows:
    (A) CPT codes:
    (1) 99201 through 99215.
    (2) 99304 through 99318 (excluding claims including the POS 31 
modifier).
    (3) 99319 through 99340.
    (4) 99341 through 99350.
    (5) 99495, 99496, and 99490.
    (B) HCPCS Codes:
    (1) G0402 (the code for the Welcome to Medicare visit) and
    (2) G0438 and G0439 (codes for the annual wellness visits).
    (3) G0463 for services furnished in ETA hospitals.
    (C) Revenue center codes 0521, 0522, 0524, and 0525 submitted by 
FQHCs (for services furnished prior to January 1, 2011), or by RHCs.

[[Page 34202]]

    (iv) For performance year 2019 as follows:
    (A) CPT codes:
    (1) 99201 through 99215.
    (2) 99304 through 99318 (excluding claims including the POS 31 
modifier).
    (3) 99319 through 99340.
    (4) 99341 through 99350.
    (5) 99487 and 99489.
    (6) 99495, 99496, and 99490.
    (B) HCPCS Codes:
    (1) G0402 (the code for the Welcome to Medicare visit) and
    (2) G0438 and G0439 (codes for the annual wellness visits).
    (3) G0463 for services furnished in ETA hospitals.
    (4) G0506 (code for chronic care management).
    (5) G0502, G0503, G0504 and G0507 (codes for behavioral health 
integration).
0
26. Section 425.404 is amended--
0
a. In the introductory text by removing the phrase ``with two special 
conditions:'' and adding in its place the phrase ``with special 
conditions:''; and
0
b. By revising paragraphs (a) and (b).
    The revisions read as follows:


Sec.  425.404   Special assignment conditions for ACOs including FQHCs 
and RHCs.

* * * * *
    (a) For performance years 2012 through 2018--
    (1) Such ACOs are required to identify, through an attestation, 
physicians who directly provide primary care services in each FQHC or 
RHC that is an ACO participant and/or ACO provider/supplier in the ACO.
    (2) Under the assignment methodology in Sec.  425.402, CMS treats a 
service reported on an FQHC/RHC claim as a primary care service--
    (i) If the claim includes a HCPCS or revenue center code that meets 
the definition of primary care services under Sec.  425.20;
    (ii) Performed by a primary care physician if the NPI of a 
physician identified in the attestation provided under paragraph (a)(1) 
of this section is reported on the claim for a primary care service (as 
described in paragraph (a)(2)(i) of this section) as the attending 
provider; and
    (iii) Performed by a non-physician ACO professional if the NPI 
reported on the claim for a primary care service (as described in 
paragraph (a)(2)(i) of this section) as the attending provider is an 
ACO professional but is not identified in the attestation provided 
under paragraph (a)(1) of this section.
    (b) For performance year 2019 and subsequent performance years, 
under the assignment methodology in Sec.  425.402, CMS treats a service 
reported on an FQHC/RHC claim as a primary care service performed by a 
primary care physician.


Sec.  425.500  [Amended]

0
27. Section 425.500 is amended--
0
a. In paragraph (e)(2) by removing the phrase ``of this section is less 
than 90 percent, absent unusual circumstances,'' and adding in its 
place the phrase ``of this section is less than 80 percent, absent 
unusual circumstances,''; and
0
b. In paragraph (e)(3) by removing the phrase ``determines there is a 
match rate of less than 90 percent, the ACO'' and adding in its place 
the phrase ``determines there is a match rate of less than 80 percent, 
the ACO''.


Sec.  425.502  [Amended]

0
28. Section 425.502 is amended in paragraph (a)(5) by removing the 
phrase ``or causes patient harm.'' and adding in its place the phrase 
``or causes patient harm, or when there is a determination under the 
Quality Payment Program that the measure has undergone a substantive 
change.''
0
29. Section Sec.  425.602 is amended by adding paragraphs (a)(1)(ii)(A) 
through (C) to read as follows:


Sec.  425.602   Establishing, adjusting, and updating the benchmark for 
an ACO's first agreement period.

    (a) * * *
    (1) * * *
    (ii) * * *
    (A) For agreement periods beginning before 2018, this calculation 
considers all individually beneficiary identifiable payments, including 
interim payments, made under a demonstration, pilot or time limited 
program.
    (B) For agreement periods beginning in 2018 and subsequent years, 
this calculation considers individually beneficiary identifiable final 
payments made under a demonstration, pilot or time limited program.
    (C) For the 2018 performance year and subsequent performance years 
in agreement periods beginning in 2015, 2016 and 2017, the benchmark is 
adjusted to reflect only individually beneficiary identifiable final 
payments made under a demonstration, pilot or time limited program.
* * * * *
0
30. Section Sec.  425.603 is amended by adding paragraphs (c)(1)(ii)(A) 
through (C) and (e)(2)(ii)(A) through (C) to read as follows:


Sec.  425.603   Resetting, adjusting, and updating the benchmark for a 
subsequent agreement period.

* * * * *
    (c) * * *
    (1) * * *
    (ii) * * *
    (A) For agreement periods beginning before 2018, considers all 
individually beneficiary identifiable payments, including interim 
payments, made under a demonstration, pilot or time limited program.
    (B) For agreement periods beginning in 2018 and subsequent years, 
considers individually beneficiary identifiable final payments made 
under a demonstration, pilot or time limited program.
    (C) For the 2018 and 2019 performance years in agreement periods 
beginning in 2017, the benchmark is adjusted to reflect only 
individually beneficiary identifiable final payments made under a 
demonstration, pilot or time limited program.
* * * * *
    (e) * * *
    (2) * * *
    (ii) * * *
    (A) For agreement periods beginning before 2018, considers all 
individually beneficiary identifiable payments, including interim 
payments, made under a demonstration, pilot or time limited program.
    (B) For agreement periods beginning in 2018 and subsequent years, 
considers individually beneficiary identifiable final payments made 
under a demonstration, pilot or time limited program.
    (C) For the 2018 and 2019 performance years in agreement periods 
beginning in 2017, risk adjusted county fee-for-service expenditures 
are adjusted to reflect only individually beneficiary identifiable 
final payments made under a demonstration, pilot or time limited 
program.
* * * * *
0
31. Section Sec.  425.604 is amended by adding paragraphs (a)(6)(ii)(A) 
and (B) to read as follows:


Sec.  425.604   Calculation of savings under the one-sided model.

    (a) * * *
    (6) * * *
    (ii) * * *
    (A) For performance years beginning before 2018, these calculations 
will take into consideration all individually beneficiary identifiable 
payments, including interim payments, made under a demonstration, pilot 
or time limited program.
    (B) For performance year 2018 and subsequent performance years, 
these calculations will take into consideration individually 
beneficiary identifiable final payments made under a demonstration, 
pilot or time limited program.
* * * * *

[[Page 34203]]

0
32. Section Sec.  425.606 is amended by adding paragraphs (a)(6)(ii)(A) 
and (B) to read as follows:


Sec.  425.606   Calculation of shared savings and losses under Track 2.

    (a) * * *
    (6) * * *
    (ii) * * *
    (A) For performance years beginning before 2018, these calculations 
will take into consideration all individually beneficiary identifiable 
payments, including interim payments, made under a demonstration, pilot 
or time limited program.
    (B) For performance year 2018 and subsequent performance years, 
these calculations will take into consideration individually 
beneficiary identifiable final payments made under a demonstration, 
pilot or time limited program.
* * * * *
0
33. Section Sec.  425.610 is amended by adding paragraphs (a)(6)(ii)(A) 
and (B) to read as follows:


Sec.  425.610   Calculation of shared savings and losses under Track 3.

    (a) * * *
    (6) * * *
    (ii) * * *
    (A) For performance years beginning before 2018, these calculations 
will take into consideration all individually beneficiary identifiable 
payments, including interim payments, made under a demonstration, pilot 
or time limited program.
    (B) For performance year 2018 and subsequent performance years, 
these calculations will take into consideration individually 
beneficiary identifiable final payments made under a demonstration, 
pilot or time limited program.
* * * * *


Sec.  425.612  [Amended]

0
34. Section 425.612 is amended by removing paragraphs (a)(1)(i)(A)(4) 
and (a)(1)(i)(C).

    Dated: June 28, 2017.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: June 28, 2017.
Thomas E. Price,
Secretary, Department of Health and Human Services.
[FR Doc. 2017-14639 Filed 7-13-17; 4:15 pm]
 BILLING CODE 4120-01-P