[Federal Register Volume 82, Number 84 (Wednesday, May 3, 2017)]
[Proposed Rules]
[Pages 20690-20747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-08428]



[[Page 20689]]

Vol. 82

Wednesday,

No. 84

May 3, 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 412





Medicare Program; Inpatient Rehabilitation Facility Prospective Payment 
System for Federal Fiscal Year 2018; Proposed Rule

  Federal Register / Vol. 82 , No. 84 / Wednesday, May 3, 2017 / 
Proposed Rules  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 412

[CMS-1671-P]
RIN 0938-AS99


Medicare Program; Inpatient Rehabilitation Facility Prospective 
Payment System for Federal Fiscal Year 2018

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

ACTION: Proposed rule.

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SUMMARY: This proposed rule would update the prospective payment rates 
for inpatient rehabilitation facilities (IRFs) for federal fiscal year 
(FY) 2018 as required by the statute. As required by section 1886(j)(5) 
of the Act, this rule includes the classification and weighting factors 
for the IRF prospective payment system's (IRF PPS) case-mix groups and 
a description of the methodologies and data used in computing the 
prospective payment rates for FY 2018. We are also proposing to remove 
the 25 percent payment penalty for inpatient rehabilitation facility 
patient assessment instrument (IRF-PAI) late transmissions, remove the 
voluntary swallowing status item (Item 27) from the IRF-PAI, revise the 
International Classification of Diseases, 10th Revision, Clinical 
Modification (ICD-10-CM) diagnosis codes that are used to determine 
presumptive compliance under the ``60 percent rule,'' solicit comments 
regarding the criteria used to classify facilities for payment under 
the IRF PPS, provide for automatic annual updates to presumptive 
methodology diagnosis code lists, use height/weight items on the IRF-
PAI to determine patient body mass index (BMI) greater than 50 for 
cases of single-joint replacement under the presumptive methodology, 
and revise and update quality measures and reporting requirements under 
the IRF quality reporting program (QRP).

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, not later than 5 p.m. on June 26, 2017.

ADDRESSES: In commenting, please refer to file code CMS-1671-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 http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    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-1671-P, P.O. Box 8016, 
Baltimore, MD 21244-8016.
    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-1671-P, Mail 
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
    4. By hand or courier. Alternatively, you may deliver (by hand or 
courier) your written comments ONLY to the following addresses prior to 
the close of the comment period:
    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 erroneously mailed to the addresses indicated as 
appropriate for hand or courier delivery may be delayed and received 
after the comment period.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: 
    Gwendolyn Johnson, (410) 786-6954, for general information.
    Catie Kraemer, (410) 786-0179, for information about the wage 
index.
    Christine Grose, (410) 786-1362, for information about the quality 
reporting program.
    Kadie Derby, (410) 786-0468, or Susanne Seagrave, (410) 786-0044, 
for information about the payment policies and payment rates.

SUPPLEMENTARY INFORMATION: The IRF PPS Addenda along with other 
supporting documents and tables referenced in this proposed rule are 
available through the Internet on the CMS Web site at http://www.cms.hhs.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/.
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. We post all comments 
received before the close of the comment period as soon as possible 
after they have been received at http://www.regulations.gov. Follow the 
search instructions on that Web site to view public comments.
    Comments received timely will also be available for public 
inspection as they are received, generally beginning approximately 3 
weeks after publication of a document, at the headquarters of the 
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, 
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 
a.m. to 4 p.m. To schedule an appointment to view public comments, 
phone 1-800-743-3951.

Executive Summary

A. Purpose

    This proposed rule would update the prospective payment rates for 
IRFs for FY 2018 (that is, for discharges occurring on or after October 
1, 2017, and on or before September 30, 2018) as required under section 
1886(j)(3)(C) of the Social Security Act (the Act). As required by 
section 1886(j)(5) of the Act, this rule includes the classification 
and weighting factors for the IRF PPS's case-mix groups and a 
description of the methodologies and data used in computing the 
prospective payment rates for FY 2018. This proposed rule would also 
remove the 25 percent payment penalty for IRF-PAI late transmissions, 
remove the voluntary swallowing status item (Item 27) from the IRF-PAI, 
revise the ICD-10-CM diagnosis codes that are used to determine 
presumptive compliance under the 60 percent rule, provide for automatic 
annual updates to the presumptive methodology diagnosis

[[Page 20691]]

code lists, solicit comments regarding the criteria used to classify 
facilities for payment under the IRF PPS, use height/weight items from 
the IRF-PAI to determine patient BMI greater than 50 for cases of lower 
extremity single joint replacement under the presumptive methodology, 
and revise and update the quality measures and reporting requirements 
under the IRF QRP.

B. Summary of Major Provisions

    In this proposed rule, we use the methods described in the FY 2017 
IRF PPS final rule (81 FR 52056) to propose updates to the prospective 
payment rates for FY 2018 using updated FY 2016 IRF claims and the most 
recent available IRF cost report data, which is FY 2015 IRF cost report 
data. (Note: In the interest of brevity, the rates previously referred 
to as the ``Federal prospective payment rates'' are now referred to as 
the ``prospective payment rates''. No change in meaning is intended.) 
We are also proposing to revise and update quality measures and 
reporting requirements under the IRF QRP.

C. Summary of Impacts

------------------------------------------------------------------------
       Provision description                      Transfers
------------------------------------------------------------------------
FY 2018 IRF PPS payment rate        The overall economic impact of this
 update.                             proposed rule is an estimated $80
                                     million in increased payments from
                                     the Federal government to IRFs
                                     during FY 2018.
                                   -------------------------------------
                                                    Costs
                                   -------------------------------------
New quality reporting program       The total costs in FY 2018 for IRFs
 requirements.                       as a result of the new quality
                                     reporting requirements are
                                     estimated to be $3.4 million.
------------------------------------------------------------------------

    To assist readers in referencing sections contained in this 
document, we are providing the following Table of Contents.

Table of Contents

I. Background
    A. Historical Overview of the IRF PPS
    B. Provisions of the Affordable Care Act Affecting the IRF PPS 
in FY 2012 and Beyond
    C. Operational Overview of the Current IRF PPS
    D. Advancing Health Information Exchange
II. Summary of Provisions of the Proposed Rule
III. Proposed Update to the Case-Mix Group (CMG) Relative Weights 
and Average Length of Stay Values for FY 2018
IV. Facility-Level Adjustment Factors
V. Proposed FY 2018 IRF PPS Payment Update
    A. Background
    B. Proposed FY 2018 Market Basket Update and Productivity 
Adjustment
    C. Proposed Labor-Related Share for FY 2018
    D. Proposed Wage Adjustment
    E. Description of the Proposed IRF Standard Payment Conversion 
Factor and Payment Rates for FY 2018
    F. Example of the Methodology for Adjusting the Proposed 
Prospective Payment Rates
VI. Proposed Update to Payments for High-Cost Outliers Under the IRF 
PPS
    A. Proposed Update to the Outlier Threshold Amount for FY 2018
    B. Proposed Update to the IRF Cost-to-Charge Ratio Ceiling and 
Urban/Rural Averages
VII. Proposed Removal of the 25 Percent Payment Penalty for IRF-PAI 
Late Submissions
VIII. Proposed Revision to the IRF-PAI to Remove the Voluntary Item 
27 (Swallowing Status)
IX. Proposed Refinements to the Presumptive Compliance Methodology 
ICD-10-CM Diagnosis Codes
    A. Background on the IRF 60 Percent Rule
    B. Enforcement of the IRF 60 Percent Rule
    C. Background on the Use of ICD-10-CM Diagnosis Codes in the 
Presumptive Compliance Method
    D. Proposed Changes to the Presumptive Methodology Diagnosis 
Code List
    E. Proposed Revisions Involving Traumatic Brain Injury and Hip 
Fracture Codes
    F. Proposed Revisions Regarding Major Multiple Trauma Codes
    G. Proposed Removal of Unspecified Codes and Arthritis Codes
    H. Proposed Removal of ICD-10-CM Code G72.89--Other Specified 
Myopathies
    I. Solicitation of Comments Regarding the Criteria Used To 
Classify Facilities for Payment Under the IRF PPS
X. Proposed Subregulatory Process for Certain Updates to Presumptive 
Methodology Diagnosis Code Lists
XI. Proposed Use of IRF-PAI Data to Determine Patient Body Mass 
Index (BMI) Greater Than 50 for Cases of Lower Extremity Single 
Joint Replacement
XII. Proposed Revisions and Updates to the IRF Quality Reporting 
Program (QRP)
    A. Background and Statutory Authority
    B. General Considerations Used for Selection of Quality Measures 
for the IRF QRP
    C. Proposed Collection of Standardized Patient Assessment Data 
Under the IRF QRP
    D. Policy for Retaining IRF QRP Measures and Proposal To Apply 
That Policy to Standardized Patient Assessment Data
    E. Policy for Adopting Changes to IRF QRP Measures and Proposal 
To Apply that Policy to Standardized Patient Assessment Data
    F. Quality Measures Currently Adopted for the IRF QRP
    G. IRF QRP Quality Measures Proposed Beginning with the FY 2020 
IRF QRP
    H. Proposed Removal of the All-Cause Unplanned Readmission 
Measure for 30 Days Post-Discharge from IRFs From the IRF QRP
    I. IRF QRP Quality Measures under Consideration for Future Years
    J. Proposed Standardized Patient Assessment Data Reporting for 
the IRF QRP
    K. Proposals Relating to the Form, Manner, and Timing of Data 
Submission Under the IRF QRP
    L. Proposal to Apply the IRF QRP Exception and Extension 
Requirements to the Submission of Standardized Patient Assessment 
Data Beginning With the FY 2019 IRF QRP
    M. Proposal To Apply the IRF QRP Data Completion Thresholds to 
the Submission of Standardized Patient Assessment Data Beginning 
With the FY 2019 IRF QRP
    N. Proposal To Apply the IRF QRP Data Completion Thresholds to 
the Submission of Standardized Patient Assessment Data Beginning 
With the FY 2019 IRF QRP
    O. Proposals and Policies Regarding Public Display of Measure 
Data for the IRF QRP
    P. Mechanism for Providing Feedback Reports to IRFs
    Q. Proposed Method for Applying the Reduction to the FY 2018 IRF 
Increase Factor for IRFs That Fail To Meet the Quality Reporting 
Requirements
XIII. Request for Information on CMS Flexibilities and Efficiencies
XIV. Collection of Information Requirements
    A. Statutory Requirement for Solicitation of Comments
    B. Collection of Information Requirements for Updates Related to 
the IRF QRP
XV. Response to Public Comments
XVI. Regulatory Impact Statement
    Regulation Text

Acronyms, Abbreviations, and Short Forms

    Because of the many terms to which we refer by acronym, 
abbreviation, or short form in this final rule, we are listing the 
acronyms, abbreviation, and short forms used and their corresponding 
terms in alphabetical order.

The Act The Social Security Act
The Affordable Care Act Patient Protection and Affordable Care Act 
(Pub. L. 111-148, enacted on March 23, 2010)

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AHRQ Agency for Healthcare Research and Quality
ASAP Assessment Submission and Processing
ASCA The Administrative Simplification Compliance Act of 2002 (Pub. L. 
107-105, enacted on December 27, 2002)
ASPE Office of the Assistant Secretary for Planning and Evaluation
BIMS Brief Interview for Mental Status
BiPAP Bilevel Positive Airway Pressure
BLS U.S. Bureau of Labor Statistics
BMI Body Mass Index
CAM Confusion Assessment Method
CARE Continuity Assessment Record and Evaluation
CAUTI Catheter-Associated Urinary Tract Infection
CBSA Core-Based Statistical Area
CCR Cost-to-Charge Ratio
CDI Clostridium difficile Infection
CMG Case-Mix Group
CMS Centers for Medicare & Medicaid Services
CPAP Continuous Positive Airway Pressure
CY Calendar year
DRA Deficit Reduction Act of 2005 (Pub. L. 109-171, enacted on February 
8, 2006)
DSH Disproportionate Share Hospital
DTI Deep Tissue Injury
FFS Fee-for-Service
FISS Fiscal Intermediary Shared System
FR Federal Register
FY Federal Fiscal Year
GAO Government Accountability Office
GEMS General Equivalence Mapping
HHA Home Health Agency
HHS U.S. Department of Health & Human Services
HIPAA Health Insurance Portability and Accountability Act of 1996 (Pub. 
L. 104-191, enacted on August 21, 1996)
ICD-9-CM International Classification of Diseases, 9th Revision, 
Clinical Modification
ICD-10-CM International Classification of Diseases, 10th Revision, 
Clinical Modification
IGC Impairment Group Code
IGI IHS Global Insight
IMPACT Act Improving Medicare Post-Acute Care Transformation Act of 
2014 (Pub. L. 113-185, enacted on October 6, 2014)
IPPS Inpatient prospective payment system
IRF Inpatient Rehabilitation Facility
IRF-PAI Inpatient Rehabilitation Facility-Patient Assessment Instrument
IRF PPS Inpatient Rehabilitation Facility Prospective Payment System
IRF QRP Inpatient Rehabilitation Facility Quality Reporting Program
IRVEN Inpatient Rehabilitation Validation and Entry
IV Intravenous
LIP Low-Income Percentage
LTCH Long-Term Care Hospital
MA Medicare Advantage (formerly known as Medicare Part C)
MAC Medicare Administrative Contractor
MACRA Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L. 
114-10, enacted on April 16, 2015)
MAP Measures Application Partnership
MedPAC Medicare Payment Advisory Commission
MFP Multifactor Productivity
MMSEA Medicare, Medicaid, and SCHIP Extension Act of 2007 (Pub. L. 110-
173, enacted on December 29, 2007)
MRSA Methicillin-Resistant Staphylococcus aureus
MSPB Medicare Spending Per Beneficiary
NCHS National Center for Health Statistics
NHSN National Healthcare Safety Network
NPUAP National Pressure Ulcer Advisory Panel
NQF National Quality Forum
OMB Office of Management and Budget
ONC Office of the National Coordinator for Health Information 
Technology
OPPS/ASC Outpatient Prospective Payment System/Ambulatory Surgical 
Center
PAC Post-Acute Care
PAC/LTC Post-Acute Care/Long-Term Care
PAI Patient Assessment Instrument
PHQ Patient Health Questionnaire
PPR Potentially Preventable Readmissions
PPS Prospective Payment System
PRA Paperwork Reduction Act of 1995 (Pub. L. 104-13, enacted on May 22, 
1995)
QIES Quality Improvement Evaluation System
QRP Quality Reporting Program
RIA Regulatory Impact Analysis
RIC Rehabilitation Impairment Category
RFA Regulatory Flexibility Act (Pub. L. 96-354, enacted on September 
19, 1980)
RN Registered Nurse
RPL Rehabilitation, Psychiatric, and Long-Term Care
RTI Research Triangle Institute International
SME Subject Matter Experts
SNF Skilled Nursing Facility
SODF Special Open Door Forum
SSI Supplemental Security Income
TEP Technical Expert Panel
TPN Total Parenteral Nutrition

I. Background

A. Historical Overview of the IRF PPS

    Section 1886(j) of the Act provides for the implementation of a 
per-discharge prospective payment system (PPS) for inpatient 
rehabilitation hospitals and inpatient rehabilitation units of a 
hospital (collectively, hereinafter referred to as IRFs). Payments 
under the IRF PPS encompass inpatient operating and capital costs of 
furnishing covered rehabilitation services (that is, routine, 
ancillary, and capital costs), but not direct graduate medical 
education costs, costs of approved nursing and allied health education 
activities, bad debts, and other services or items outside the scope of 
the IRF PPS. Although a complete discussion of the IRF PPS provisions 
appears in the original FY 2002 IRF PPS final rule (66 FR 41316) and 
the FY 2006 IRF PPS final rule (70 FR 47880), we are providing a 
general description of the IRF PPS for FYs 2002 through 2017.
    Under the IRF PPS from FY 2002 through FY 2005, the prospective 
payment rates were computed across 100 distinct case-mix groups (CMGs), 
as described in the FY 2002 IRF PPS final rule (66 FR 41316). We 
constructed 95 CMGs using rehabilitation impairment categories (RICs), 
functional status (both motor and cognitive), and age (in some cases, 
cognitive status and age may not be a factor in defining a CMG). In 
addition, we constructed five special CMGs to account for very short 
stays and for patients who expire in the IRF.
    For each of the CMGs, we developed relative weighting factors to 
account for a patient's clinical characteristics and expected resource 
needs. Thus, the weighting factors accounted for the relative 
difference in resource use across all CMGs. Within each CMG, we created 
tiers based on the estimated effects that certain comorbidities would 
have on resource use.
    We established the federal PPS rates using a standardized payment 
conversion factor (formerly referred to as the budget-neutral 
conversion factor). For a detailed discussion of the budget-neutral 
conversion factor, please refer to our FY 2004 IRF PPS final rule (68 
FR 45684 through 45685). In the FY 2006 IRF PPS final rule (70 FR 
47880), we discussed in detail the methodology for determining the 
standard payment conversion factor.
    We applied the relative weighting factors to the standard payment

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conversion factor to compute the unadjusted prospective payment rates 
under the IRF PPS from FYs 2002 through 2005. Within the structure of 
the payment system, we then made adjustments to account for interrupted 
stays, transfers, short stays, and deaths. Finally, we applied the 
applicable adjustments to account for geographic variations in wages 
(wage index), the percentage of low-income patients, location in a 
rural area (if applicable), and outlier payments (if applicable) to the 
IRFs' unadjusted prospective payment rates.
    For cost reporting periods that began on or after January 1, 2002, 
and before October 1, 2002, we determined the final prospective payment 
amounts using the transition methodology prescribed in section 
1886(j)(1) of the Act. Under this provision, IRFs transitioning into 
the PPS were paid a blend of the federal IRF PPS rate and the payment 
that the IRFs would have received had the IRF PPS not been implemented. 
This provision also allowed IRFs to elect to bypass this blended 
payment and immediately be paid 100 percent of the federal IRF PPS 
rate. The transition methodology expired as of cost reporting periods 
beginning on or after October 1, 2002 (FY 2003), and payments for all 
IRFs now consist of 100 percent of the federal IRF PPS rate.
    We established a CMS Web site as a primary information resource for 
the IRF PPS which is available at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/index.html. The Web site 
may be accessed to download or view publications, software, data 
specifications, educational materials, and other information pertinent 
to the IRF PPS.
    Section 1886(j) of the Act confers broad statutory authority upon 
the Secretary to propose refinements to the IRF PPS. In the FY 2006 IRF 
PPS final rule (70 FR 47880) and in correcting amendments to the FY 
2006 IRF PPS final rule (70 FR 57166) that we published on September 
30, 2005, we finalized a number of refinements to the IRF PPS case-mix 
classification system (the CMGs and the corresponding relative weights) 
and the case-level and facility-level adjustments. These refinements 
included the adoption of the Office of Management and Budget's (OMB) 
Core-Based Statistical Area (CBSA) market definitions, modifications to 
the CMGs, tier comorbidities, and CMG relative weights, implementation 
of a new teaching status adjustment for IRFs, revision and rebasing of 
the market basket index used to update IRF payments, and updates to the 
rural, low-income percentage (LIP), and high-cost outlier adjustments. 
Beginning with the FY 2006 IRF PPS final rule (70 FR 47908 through 
47917), the market basket index used to update IRF payments was a 
market basket reflecting the operating and capital cost structures for 
freestanding IRFs, freestanding inpatient psychiatric facilities, and 
long-term care hospitals (LTCHs) (hereinafter referred to as the 
rehabilitation, psychiatric, and long-term care (RPL) market basket). 
Any reference to the FY 2006 IRF PPS final rule in this final rule also 
includes the provisions effective in the correcting amendments. For a 
detailed discussion of the final key policy changes for FY 2006, please 
refer to the FY 2006 IRF PPS final rule (70 FR 47880 and 70 FR 57166).
    In the FY 2007 IRF PPS final rule (71 FR 48354), we further refined 
the IRF PPS case-mix classification system (the CMG relative weights) 
and the case-level adjustments, to ensure that IRF PPS payments would 
continue to reflect as accurately as possible the costs of care. For a 
detailed discussion of the FY 2007 policy revisions, please refer to 
the FY 2007 IRF PPS final rule (71 FR 48354).
    In the FY 2008 IRF PPS final rule (72 FR 44284), we updated the 
prospective payment rates and the outlier threshold, revised the IRF 
wage index policy, and clarified how we determine high-cost outlier 
payments for transfer cases. For more information on the policy changes 
implemented for FY 2008, please refer to the FY 2008 IRF PPS final rule 
(72 FR 44284), in which we published the final FY 2008 IRF prospective 
payment rates.
    After publication of the FY 2008 IRF PPS final rule (72 FR 44284), 
section 115 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 
(Pub. L. 110-173, enacted on December 29, 2007) (MMSEA), amended 
section 1886(j)(3)(C) of the Act to apply a zero percent increase 
factor for FYs 2008 and 2009, effective for IRF discharges occurring on 
or after April 1, 2008. Section 1886(j)(3)(C) of the Act required the 
Secretary to develop an increase factor to update the IRF prospective 
payment rates for each FY. Based on the legislative change to the 
increase factor, we revised the FY 2008 prospective payment rates for 
IRF discharges occurring on or after April 1, 2008. Thus, the final FY 
2008 IRF prospective payment rates that were published in the FY 2008 
IRF PPS final rule (72 FR 44284) were effective for discharges 
occurring on or after October 1, 2007, and on or before March 31, 2008; 
and the revised FY 2008 IRF prospective payment rates were effective 
for discharges occurring on or after April 1, 2008, and on or before 
September 30, 2008. The revised FY 2008 prospective payment rates are 
available on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Data-Files.html.
    In the FY 2009 IRF PPS final rule (73 FR 46370), we updated the CMG 
relative weights, the average length of stay values, and the outlier 
threshold; clarified IRF wage index policies regarding the treatment of 
``New England deemed'' counties and multi-campus hospitals; and revised 
the regulation text in response to section 115 of the MMSEA to set the 
IRF compliance percentage at 60 percent (the ``60 percent rule'') and 
continue the practice of including comorbidities in the calculation of 
compliance percentages. We also applied a zero percent market basket 
increase factor for FY 2009 in accordance with section 115 of the 
MMSEA. For more information on the policy changes implemented for FY 
2009, please refer to the FY 2009 IRF PPS final rule (73 FR 46370), in 
which we published the final FY 2009 IRF prospective payment rates.
    In the FY 2010 IRF PPS final rule (74 FR 39762) and in correcting 
amendments to the FY 2010 IRF PPS final rule (74 FR 50712) that we 
published on October 1, 2009, we updated the prospective payment rates, 
the CMG relative weights, the average length of stay values, the rural, 
LIP, teaching status adjustment factors, and the outlier threshold; 
implemented new IRF coverage requirements for determining whether an 
IRF claim is reasonable and necessary; and revised the regulation text 
to require IRFs to submit patient assessments on Medicare Advantage 
(MA) (formerly called Medicare Part C) patients for use in the 60 
percent rule calculations. Any reference to the FY 2010 IRF PPS final 
rule in this final rule also includes the provisions effective in the 
correcting amendments. For more information on the policy changes 
implemented for FY 2010, please refer to the FY 2010 IRF PPS final rule 
(74 FR 39762 and 74 FR 50712), in which we published the final FY 2010 
IRF prospective payment rates.
    After publication of the FY 2010 IRF PPS final rule (74 FR 39762), 
section 3401(d) of the Patient Protection and Affordable Care Act (Pub. 
L. 111-148, enacted on March 23, 2010), as amended by section 10319 of 
the same Act and by section 1105 of the Health Care and Education 
Reconciliation Act of 2010 (Pub. L. 111-152, enacted on March 30, 2010) 
(collectively,

[[Page 20694]]

hereinafter referred to as ``The Affordable Care Act''), amended 
section 1886(j)(3)(C) of the Act and added section 1886(j)(3)(D) of the 
Act. Section 1886(j)(3)(C) of the Act requires the Secretary to 
estimate a multifactor productivity (MFP) adjustment to the market 
basket increase factor, and to apply other adjustments as defined by 
the Act. The productivity adjustment applies to FYs from 2012 forward. 
The other adjustments apply to FYs 2010 to 2019.
    Sections 1886(j)(3)(C)(ii)(II) and 1886(j)(3)(D)(i) of the Act 
defined the adjustments that were to be applied to the market basket 
increase factors in FYs 2010 and 2011. Under these provisions, the 
Secretary was required to reduce the market basket increase factor in 
FY 2010 by a 0.25 percentage point adjustment. Notwithstanding this 
provision, in accordance with section 3401(p) of the Affordable Care 
Act, the adjusted FY 2010 rate was only to be applied to discharges 
occurring on or after April 1, 2010. Based on the self-implementing 
legislative changes to section 1886(j)(3) of the Act, we adjusted the 
FY 2010 federal prospective payment rates as required, and applied 
these rates to IRF discharges occurring on or after April 1, 2010, and 
on or before September 30, 2010. Thus, the final FY 2010 IRF 
prospective payment rates that were published in the FY 2010 IRF PPS 
final rule (74 FR 39762) were used for discharges occurring on or after 
October 1, 2009, and on or before March 31, 2010, and the adjusted FY 
2010 IRF prospective payment rates applied to discharges occurring on 
or after April 1, 2010, and on or before September 30, 2010. The 
adjusted FY 2010 prospective payment rates are available on the CMS Web 
site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Data-Files.html.
    In addition, sections 1886(j)(3)(C) and (D) of the Act also 
affected the FY 2010 IRF outlier threshold amount because they required 
an adjustment to the FY 2010 RPL market basket increase factor, which 
changed the standard payment conversion factor for FY 2010. 
Specifically, the original FY 2010 IRF outlier threshold amount was 
determined based on the original estimated FY 2010 RPL market basket 
increase factor of 2.5 percent and the standard payment conversion 
factor of $13,661. However, as adjusted, the IRF prospective payments 
are based on the adjusted RPL market basket increase factor of 2.25 
percent and the revised standard payment conversion factor of $13,627. 
To maintain estimated outlier payments for FY 2010 equal to the 
established standard of 3 percent of total estimated IRF PPS payments 
for FY 2010, we revised the IRF outlier threshold amount for FY 2010 
for discharges occurring on or after April 1, 2010, and on or before 
September 30, 2010. The revised IRF outlier threshold amount for FY 
2010 was $10,721.
    Sections 1886(j)(3)(C)(ii)(II) and 1886(j)(3)(D)(i) of the Act also 
required the Secretary to reduce the market basket increase factor in 
FY 2011 by a 0.25 percentage point adjustment. The FY 2011 IRF PPS 
notice (75 FR 42836) and the correcting amendments to the FY 2011 IRF 
PPS notice (75 FR 70013) described the required adjustments to the FY 
2011 and FY 2010 IRF PPS prospective payment rates and outlier 
threshold amount for IRF discharges occurring on or after April 1, 
2010, and on or before September 30, 2011. It also updated the FY 2011 
prospective payment rates, the CMG relative weights, and the average 
length of stay values. Any reference to the FY 2011 IRF PPS notice in 
this final rule also includes the provisions effective in the 
correcting amendments. For more information on the FY 2010 and FY 2011 
adjustments or the updates for FY 2011, please refer to the FY 2011 IRF 
PPS notice (75 FR 42836 and 75 FR 70013).
    In the FY 2012 IRF PPS final rule (76 FR 47836), we updated the IRF 
prospective payment rates, rebased and revised the RPL market basket, 
and established a new QRP for IRFs in accordance with section 
1886(j)(7) of the Act. We also revised regulation text for the purpose 
of updating and providing greater clarity. For more information on the 
policy changes implemented for FY 2012, please refer to the FY 2012 IRF 
PPS final rule (76 FR 47836), in which we published the final FY 2012 
IRF prospective payment rates.
    The FY 2013 IRF PPS notice (77 FR 44618) described the required 
adjustments to the FY 2013 prospective payment rates and outlier 
threshold amount for IRF discharges occurring on or after October 1, 
2012, and on or before September 30, 2013. It also updated the FY 2013 
prospective payment rates, the CMG relative weights, and the average 
length of stay values. For more information on the updates for FY 2013, 
please refer to the FY 2013 IRF PPS notice (77 FR 44618).
    In the FY 2014 IRF PPS final rule (78 FR 47860), we updated the 
prospective payment rates, the CMG relative weights, and the outlier 
threshold amount. We also updated the facility-level adjustment factors 
using an enhanced estimation methodology, revised the list of diagnosis 
codes that count toward an IRF's 60 percent rule compliance calculation 
to determine ``presumptive compliance,'' revised sections of the IRF-
PAI, revised requirements for acute care hospitals that have IRF units, 
clarified the IRF regulation text regarding limitation of review, 
updated references to previously changed sections in the regulations 
text, and revised and updated quality measures and reporting 
requirements under the IRF QRP. For more information on the policy 
changes implemented for FY 2014, please refer to the FY 2014 IRF PPS 
final rule (78 FR 47860), in which we published the final FY 2014 IRF 
prospective payment rates.
    In the FY 2015 IRF PPS final rule (79 FR 45872), we updated the 
prospective payment rates, the CMG relative weights, and the outlier 
threshold amount. We also further revised the list of diagnosis codes 
that count toward an IRF's 60 percent rule compliance calculation to 
determine ``presumptive compliance,'' revised sections of the IRF-PAI, 
and revised and updated quality measures and reporting requirements 
under the IRF QRP. For more information on the policy changes 
implemented for FY 2015, please refer to the FY 2015 IRF PPS final rule 
(79 FR 45872) and the FY 2015 IRF PPS correction notice (79 FR 59121).
    In the FY 2016 IRF PPS final rule (80 FR 47036), we updated the 
prospective payment rates, the CMG relative weights, and the outlier 
threshold amount. We also adopted an IRF-specific market basket that 
reflects the cost structures of only IRF providers, a blended one-year 
transition wage index based on the adoption of new OMB area 
delineations, a 3-year phase-out of the rural adjustment for certain 
IRFs due to the new OMB area delineations, and revisions and updates to 
the IRF QRP. For more information on the policy changes implemented for 
FY 2016, please refer to the FY 2016 IRF PPS final rule (80 FR 47036).
    In the FY 2017 IRF PPS final rule (81 FR 52056), we updated the 
prospective payment rates, the CMG relative weights, and the outlier 
threshold amount. We also revised and updated quality measures and 
reporting requirements under the IRF QRP. For more information on the 
policy changes implemented for FY 2017, please refer to the FY 2017 IRF 
PPS final rule (81 FR 52056) and the FY 2017 IRF PPS correction notice 
(81 FR 59901).

[[Page 20695]]

B. Provisions of the Affordable Care Act Affecting the IRF PPS in FY 
2012 and Beyond

    The Affordable Care Act included several provisions that affect the 
IRF PPS in FYs 2012 and beyond. In addition to what was previously 
discussed, section 3401(d) of the Affordable Care Act also added 
section 1886(j)(3)(C)(ii)(I) (providing for a ``productivity 
adjustment'' for fiscal year 2012 and each subsequent fiscal year). The 
productivity adjustment for FY 2018 is discussed in section V.B. of 
this proposed rule. Section 3401(d) of the Affordable Care Act requires 
an additional 0.75 percentage point adjustment to the IRF increase 
factor for each of FYs 2017, 2018, and 2019. The applicable adjustment 
for FY 2018 is discussed in section V.B. of this proposed rule. Section 
1886(j)(3)(C)(ii)(II) of the Act notes that the application of these 
adjustments to the market basket update may result in an update that is 
less than 0.0 for a fiscal year and in payment rates for a fiscal year 
being less than such payment rates for the preceding fiscal year.
    Section 3004(b) of the Affordable Care Act also addressed the IRF 
PPS. It reassigned the previously designated section 1886(j)(7) of the 
Act to section 1886(j)(8) and inserted a new section 1886(j)(7), which 
contains requirements for the Secretary to establish a QRP for IRFs. 
Under that program, data must be submitted in a form and manner and at 
a time specified by the Secretary. Beginning in FY 2014, section 
1886(j)(7)(A)(i) of the Act requires the application of a 2 percentage 
point reduction of the applicable market basket increase factor for 
IRFs that fail to comply with the quality data submission requirements. 
Application of the 2 percentage point reduction may result in an update 
that is less than 0.0 for a fiscal year and in payment rates for a 
fiscal year being less than such payment rates for the preceding fiscal 
year. Reporting-based reductions to the market basket increase factor 
will not be cumulative; they will only apply for the FY involved.
    Under section 1886(j)(7)(D)(i) and (ii) of the Act, the Secretary 
is generally required to select quality measures for the IRF QRP from 
those that have been endorsed by the consensus-based entity which holds 
a performance measurement contract under section 1890(a) of the Act. 
This contract is currently held by the National Quality Forum (NQF). So 
long as due consideration is given to measures that have been endorsed 
or adopted by a consensus-based organization, section 1886(j)(7)(D)(ii) 
of the Act authorizes the Secretary to select non-endorsed measures for 
specified areas or medical topics when there are no feasible or 
practical endorsed measure(s).
    Section 1886(j)(7)(E) of the Act requires the Secretary to 
establish procedures for making the IRF PPS quality reporting data 
available to the public. In so doing, the Secretary must ensure that 
IRFs have the opportunity to review any such data prior to its release 
to the public.

C. Operational Overview of the Current IRF PPS

    As described in the FY 2002 IRF PPS final rule, upon the admission 
and discharge of a Medicare Part A Fee-for-Service (FFS) patient, the 
IRF is required to complete the appropriate sections of a patient 
assessment instrument (PAI), designated as the IRF-PAI. In addition, 
beginning with IRF discharges occurring on or after October 1, 2009, 
the IRF is also required to complete the appropriate sections of the 
IRF-PAI upon the admission and discharge of each MA patient, as 
described in the FY 2010 IRF PPS final rule. All required data must be 
electronically encoded into the IRF-PAI software product. Generally, 
the software product includes patient classification programming called 
the Grouper software. The Grouper software uses specific IRF-PAI data 
elements to classify (or group) patients into distinct CMGs and account 
for the existence of any relevant comorbidities.
    The Grouper software produces a 5-character CMG number. The first 
character is an alphabetic character that indicates the comorbidity 
tier. The last 4 characters are numeric characters that represent the 
distinct CMG number. Free downloads of the Inpatient Rehabilitation 
Validation and Entry (IRVEN) software product, including the Grouper 
software, are available on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Software.html.
    Once a Medicare FFS Part A patient is discharged, the IRF submits a 
Medicare claim as a Health Insurance Portability and Accountability Act 
of 1996 (Pub. L. 104-191, enacted on August 21, 1996) (HIPAA) compliant 
electronic claim or, if the Administrative Simplification Compliance 
Act of 2002 (Pub. L. 107-105, enacted on December 27, 2002) (ASCA) 
permits, a paper claim (a UB-04 or a CMS-1450 as appropriate) using the 
five-character CMG number and sends it to the appropriate Medicare 
Administrative Contractor (MAC). In addition, once a MA patient is 
discharged, in accordance with the Medicare Claims Processing Manual, 
chapter 3, section 20.3 (Pub. 100-04), hospitals (including IRFs) must 
submit an informational-only bill (Type of Bill (TOB) 111), which 
includes Condition Code 04 to their MAC. This will ensure that the MA 
days are included in the hospital's Supplemental Security Income (SSI) 
ratio (used in calculating the IRF LIP adjustment) for fiscal year 2007 
and beyond. Claims submitted to Medicare must comply with both ASCA and 
HIPAA.
    Section 3 of the ASCA amends section 1862(a) of the Act by adding 
paragraph (22), which requires the Medicare program, subject to section 
1862(h) of the Act, to deny payment under Part A or Part B for any 
expenses for items or services for which a claim is submitted other 
than in an electronic form specified by the Secretary. Section 1862(h) 
of the Act, in turn, provides that the Secretary shall waive such 
denial in situations in which there is no method available for the 
submission of claims in an electronic form or the entity submitting the 
claim is a small provider. In addition, the Secretary also has the 
authority to waive such denial in such unusual cases as the Secretary 
finds appropriate. For more information, see the ``Medicare Program; 
Electronic Submission of Medicare Claims'' final rule (70 FR 71008). 
Our instructions for the limited number of Medicare claims submitted on 
paper are available at http://www.cms.gov/manuals/downloads/clm104c25.pdf.
    Section 3 of the ASCA operates in the context of the administrative 
simplification provisions of HIPAA, which include, among others, the 
requirements for transaction standards and code sets codified in 45 
CFR, parts 160 and 162, subparts A and I through R (generally known as 
the Transactions Rule). The Transactions Rule requires covered 
entities, including covered health care providers, to conduct covered 
electronic transactions according to the applicable transaction 
standards. (See the CMS program claim memoranda at http://www.cms.gov/ElectronicBillingEDITrans/ and listed in the addenda to the Medicare 
Intermediary Manual, Part 3, section 3600).
    The MAC processes the claim through its software system. This 
software system includes pricing programming called the ``Pricer'' 
software. The Pricer software uses the CMG number, along with other 
specific claim data elements and provider-specific data, to adjust the 
IRF's prospective payment for interrupted stays, transfers, short 
stays,

[[Page 20696]]

and deaths, and then applies the applicable adjustments to account for 
the IRF's wage index, percentage of low-income patients, rural 
location, and outlier payments. For discharges occurring on or after 
October 1, 2005, the IRF PPS payment also reflects the teaching status 
adjustment that became effective as of FY 2006, as discussed in the FY 
2006 IRF PPS final rule (70 FR 47880).

D. Advancing Health Information Exchange

    The Department of Health & Human Services (HHS) has a number of 
initiatives designed to encourage and support the adoption of health 
information technology and to promote nationwide health information 
exchange to improve health care. As discussed in the August 2013 
Statement ``Principles and Strategies for Accelerating Health 
Information Exchange'' (available at http://www.healthit.gov/sites/default/files/acceleratinghieprinciples_strategy.pdf), we believe that 
all individuals, their families, their healthcare and social service 
providers, and payers should have consistent and timely access to 
health information in a standardized format that can be securely 
exchanged between the patient, providers, and others involved in the 
individual's care. Health information technology (health IT) that 
facilitates the secure, efficient, and effective sharing and use of 
health-related information when and where it is needed is an important 
tool for settings across the continuum of care, including inpatient 
rehabilitation facilities. The effective adoption and use of health 
information exchange and health IT tools will be essential as IRFs seek 
to improve quality and lower costs through value-based care.
    The Office of the National Coordinator for Health Information 
Technology (ONC) has released a document entitled ``Connecting Health 
and Care for the Nation: A Shared Nationwide Interoperability Roadmap'' 
(Roadmap) (available at https://www.healthit.gov/sites/default/files/hie-interoperability/nationwide-interoperability-roadmap-final-version-1.0.pdf). In the near term, the Roadmap focuses on actions that will 
enable individuals and providers across the care continuum to send, 
receive, find, and use a common set of electronic clinical information 
at the nationwide level by the end of 2017. The Roadmap's goals also 
align with the Improving Medicare Post-Acute Care Transformation Act of 
2014 (Pub. L. 113-185, enacted on October 6, 2014) (IMPACT Act), which 
requires assessment data to be standardized and interoperable to allow 
for exchange of the data.
    The Roadmap identifies four critical pathways that health IT 
stakeholders should focus on now to create a foundation for long-term 
success: (1) Improve technical standards and implementation guidance 
for priority data domains and associated elements; (2) rapidly shift 
and align federal, state, and commercial payment policies from FFS to 
value-based models to stimulate the demand for interoperability; (3) 
clarify and align federal and state privacy and security requirements 
that enable interoperability; and (4) align and promote the use of 
consistent policies and business practices that support 
interoperability, in coordination with stakeholders. In addition, ONC 
has released the final version of the 2017 Interoperability Standards 
Advisory (available at https://www.healthit.gov/standards-advisory), a 
coordinated catalog of standards and implementation specifications to 
enable priority health information exchange functions. Providers, 
payers, and vendors are encouraged to take these health IT standards 
into account as they implement interoperable health information 
exchange across the continuum of care, including care settings such as 
inpatient rehabilitation facilities.
    We encourage stakeholders to utilize health information exchange 
and certified health IT to effectively and efficiently help providers 
improve internal care delivery practices, engage patients in their 
care, support management of care across the continuum, enable the 
reporting of electronically specified clinical quality measures, and 
improve efficiencies and reduce unnecessary costs. As adoption of 
certified health IT increases and interoperability standards continue 
to mature, HHS will seek to reinforce standards through relevant 
policies and programs.

II. Summary of Provisions of the Proposed Rule

    In this rule, we propose to update the IRF prospective payment 
rates for FY 2018, remove the 25 percent penalty for IRF-PAI late 
transmissions, remove the voluntary swallowing status item (Item 27) 
from the IRF-PAI, revise the lists of ICD-10-CM diagnosis codes that 
are used to determine presumptive compliance under the 60 percent rule, 
provide for automatic annual updates to presumptive methodology 
diagnosis code lists, solicit comments regarding the criteria used to 
classify facilities for payment under the IRF PPS, use height/weight 
items from the IRF-PAI to determine patient BMI greater than 50 for 
cases of lower extremity single-joint replacement under the presumptive 
methodology, and revise and update quality measures and reporting 
requirements under the IRF QRP.
    The proposed updates to the IRF prospective payment rates for FY 
2018 are as follows:
     Update the FY 2018 IRF PPS relative weights and average 
length of stay values using the most current and complete Medicare 
claims and cost report data in a budget-neutral manner, as discussed in 
section III. of this proposed rule.
     Describe the continued use of FY 2014 facility-level 
adjustment factors as discussed in section IV. of this proposed rule.
     Update the FY 2018 IRF PPS payment rates by the proposed 
market basket increase factor, as required by sections 
1886(j)(3)(C)(iii) of the Act, as described in section V. of this 
proposed rule.
     Update the FY 2018 IRF PPS payment rates by the FY 2018 
wage index and the labor-related share in a budget-neutral manner, as 
discussed in section V. of this proposed rule.
     Describe the calculation of the IRF standard payment 
conversion factor for FY 2018, as discussed in section V. of this 
proposed rule.
     Update the outlier threshold amount for FY 2018, as 
discussed in section VI. of this proposed rule.
     Update the cost-to-charge ratio (CCR) ceiling and urban/
rural average CCRs for FY 2018, as discussed in section VI. of this 
proposed rule.
     Describe the proposed removal of the 25 percent payment 
penalty for IRF-PAI late transmissions in section VII. of this proposed 
rule.
     Describe proposed revisions to the IRF-PAI to remove the 
voluntary swallowing status item in section VIII. of this proposed 
rule.
     Describe proposed refinements to the presumptive 
compliance methodology ICD-10-CM diagnosis codes in section IX. of this 
proposed rule.
     Solicit comments regarding the criteria used to classify 
facilities for payment under the IRF PPS in section IX. of this 
proposed rule.
     Describe proposed automatic annual updates to the 
presumptive methodology diagnosis code lists in section X. of this 
proposed rule.
     Describe the proposed use of height/weight items on the 
IRF-PAI to determine patient BMI greater than 50 for cases of lower 
extremity single joint replacement under the presumptive

[[Page 20697]]

methodology in section XI. of this proposed rule.
     Describe proposed revisions and updates to quality 
measures and reporting requirements under the QRP for IRFs in 
accordance with sections 1886(j)(7) and 1899B of the Act, as discussed 
in section XII. of this proposed rule.

III. Proposed Update to the Case-Mix Group (CMG) Relative Weights and 
Average Length of Stay Values for FY 2018

    As specified in Sec.  412.620(b)(1), we calculate a relative weight 
for each CMG that is proportional to the resources needed by an average 
inpatient rehabilitation case in that CMG. For example, cases in a CMG 
with a relative weight of 2, on average, will cost twice as much as 
cases in a CMG with a relative weight of 1. Relative weights account 
for the variance in cost per discharge due to the variance in resource 
utilization among the payment groups, and their use helps to ensure 
that IRF PPS payments support beneficiary access to care, as well as 
provider efficiency.
    In this proposed rule, we propose to update the CMG relative 
weights and average length of stay values for FY 2018. As required by 
statute, we always use the most recent available data to update the CMG 
relative weights and average lengths of stay. For FY 2018, we propose 
to use the FY 2016 IRF claims and FY 2015 IRF cost report data. These 
data are the most current and complete data available at this time. 
Currently, only a small portion of the FY 2016 IRF cost report data are 
available for analysis, but the majority of the FY 2016 IRF claims data 
are available for analysis.
    In this rule, we propose to apply these data using the same 
methodologies that we have used to update the CMG relative weights and 
average length of stay values each fiscal year since we implemented an 
update to the methodology to use the more detailed CCR data from the 
cost reports of IRF subprovider units of primary acute care hospitals, 
instead of CCR data from the associated primary care hospitals, to 
calculate IRFs' average costs per case, as discussed in the FY 2009 IRF 
PPS final rule (73 FR 46372). In calculating the CMG relative weights, 
we use a hospital-specific relative value method to estimate operating 
(routine and ancillary services) and capital costs of IRFs. The process 
used to calculate the CMG relative weights for this final rule is as 
follows:
    Step 1. We estimate the effects that comorbidities have on costs.
    Step 2. We adjust the cost of each Medicare discharge (case) to 
reflect the effects found in the first step.
    Step 3. We use the adjusted costs from the second step to calculate 
CMG relative weights, using the hospital-specific relative value 
method.
    Step 4. We normalize the FY 2018 CMG relative weights to the same 
average CMG relative weight from the CMG relative weights implemented 
in the FY 2017 IRF PPS final rule (81 FR 52056).
    Consistent with the methodology that we have used to update the IRF 
classification system in each instance in the past, we propose to 
update the CMG relative weights for FY 2018 in such a way that total 
estimated aggregate payments to IRFs for FY 2018 are the same with or 
without the changes (that is, in a budget-neutral manner) by applying a 
budget neutrality factor to the standard payment amount. To calculate 
the appropriate budget neutrality factor for use in updating the FY 
2018 CMG relative weights, we use the following steps:
    Step 1. Calculate the estimated total amount of IRF PPS payments 
for FY 2018 (with no changes to the CMG relative weights).
    Step 2. Calculate the estimated total amount of IRF PPS payments 
for FY 2018 by applying the proposed changes to the CMG relative 
weights (as discussed in this proposed rule).
    Step 3. Divide the amount calculated in step 1 by the amount 
calculated in step 2 to determine the budget neutrality factor (0.9974) 
that would maintain the same total estimated aggregate payments in FY 
2018 with and without the proposed changes to the CMG relative weights.
    Step 4. Apply the budget neutrality factor (0.9974) to the FY 2017 
IRF PPS standard payment amount after the application of the budget-
neutral wage adjustment factor.
    In section V. E. of this proposed rule, we discuss the proposed use 
of the existing methodology to calculate the proposed standard payment 
conversion factor for FY 2018.
    In Table 1, ``Proposed Relative Weights and Average Length of Stay 
Values for Case-Mix Groups,'' we present the proposed CMGs, the 
comorbidity tiers, the corresponding relative weights, and the average 
length of stay values for each CMG and tier for FY 2018. The average 
length of stay for each CMG is used to determine when an IRF discharge 
meets the definition of a short-stay transfer, which results in a per 
diem case level adjustment.

                                Table 1--Proposed Relative Weights and Average Length of Stay Values for Case-Mix Groups
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                          Relative weight                             Average length of stay
                                                         -----------------------------------------------------------------------------------------------
           CMG             CMG Description (M = motor, C                                         No                                              No
                               = cognitive, A = age)        Tier 1     Tier 2     Tier 3   comorbidities    Tier 1     Tier 2     Tier 3   comorbidities
                                                                                                tier                                            tier
--------------------------------------------------------------------------------------------------------------------------------------------------------
0101.....................  Stroke, M>51.05..............     0.8483     0.7280     0.6724        0.6423           9          9          9             8
0102.....................  Stroke, M>44.45 and M<51.05       1.0670     0.9157     0.8458        0.8079          11         12         10            10
                            and C>18.5.
0103.....................  Stroke, M>44.45 and M<51.05       1.2069     1.0357     0.9567        0.9138          13         13         12            11
                            and C<18.5.
0104.....................  Stroke, M>38.85 and M<44.45..     1.2945     1.1109     1.0261        0.9802          13         13         12            12
0105.....................  Stroke, M>34.25 and M<38.85..     1.5055     1.2920     1.1934        1.1399          14         14         14            13
0106.....................  Stroke, M>30.05 and M<34.25..     1.6678     1.4313     1.3220        1.2628          16         16         15            15
0107.....................  Stroke, M>26.15 and M<30.05..     1.8621     1.5980     1.4760        1.4099          17         17         16            16
0108.....................  Stroke, M<26.15 and A>84.5...     2.3684     2.0324     1.8773        1.7932          21         23         21            20
0109.....................  Stroke, M>22.35 and M<26.15       2.1330     1.8304     1.6907        1.6150          19         19         19            19
                            and A<84.5.
0110.....................  Stroke, M<22.35 and A<84.5...     2.7845     2.3896     2.2072        2.1083          27         26         23            24
0201.....................  Traumatic brain injury,           0.8414     0.6780     0.6173        0.5671           9          9          8             7
                            M>53.35 and C>23.5.
0202.....................  Traumatic brain injury,           1.0873     0.8762     0.7977        0.7329          11         11         10             9
                            M>44.25 and M<53.35 and
                            C>23.5.
0203.....................  Traumatic brain injury,           1.2583     1.0140     0.9231        0.8481          12         12         11            11
                            M>44.25 and C<23.5.
0204.....................  Traumatic brain injury,           1.3877     1.1182     1.0180        0.9353          11         12         12            12
                            M>40.65 and M<44.25.
0205.....................  Traumatic brain injury,           1.6314     1.3146     1.1968        1.0996          15         15         14            13
                            M>28.75 and M<40.65.
0206.....................  Traumatic brain injury,           1.9703     1.5877     1.4454        1.3280          18         18         16            15
                            M>22.05 and M<28.75.
0207.....................  Traumatic brain injury,           2.5103     2.0229     1.8416        1.6920          28         23         19            18
                            M<22.05.
0301.....................  Non-traumatic brain injury,       1.1649     0.9439     0.8581        0.8107          10         11         10            10
                            M>41.05.

[[Page 20698]]

 
0302.....................  Non-traumatic brain injury,       1.4142     1.1460     1.0418        0.9842          13         13         12            12
                            M>35.05 and M<41.05.
0303.....................  Non-traumatic brain injury,       1.6626     1.3472     1.2248        1.1571          15         15         13            13
                            M>26.15 and M<35.05.
0304.....................  Non-traumatic brain injury,       2.1547     1.7459     1.5872        1.4995          21         19         17            16
                            M<26.15.
0401.....................  Traumatic spinal cord injury,     0.8971     0.8369     0.7456        0.6728          11         11         10             9
                            M>48.45.
0402.....................  Traumatic spinal cord injury,     1.3102     1.2223     1.0888        0.9825          13         14         13            12
                            M>30.35 and M<48.45.
0403.....................  Traumatic spinal cord injury,     2.1239     1.9813     1.7650        1.5927          22         22         20            18
                            M>16.05 and M<30.35.
0404.....................  Traumatic spinal cord injury,     3.7200     3.4704     3.0915        2.7897          42         36         31            33
                            M<16.05 and A>63.5.
0405.....................  Traumatic spinal cord injury,     3.4257     3.1958     2.8469        2.5690          33         35         31            27
                            M<16.05 and A<63.5.
0501.....................  Non-traumatic spinal cord         0.9396     0.7059     0.6687        0.6136           9          9          9             7
                            injury, M>51.35.
0502.....................  Non-traumatic spinal cord         1.2215     0.9178     0.8693        0.7978          12         11         10            10
                            injury, M>40.15 and M<51.35.
0503.....................  Non-traumatic spinal cord         1.5300     1.1496     1.0889        0.9992          16         13         12            12
                            injury, M>31.25 and M<40.15.
0504.....................  Non-traumatic spinal cord         1.7373     1.3053     1.2364        1.1346          17         15         14            13
                            injury, M>29.25 and M<31.25.
0505.....................  Non-traumatic spinal cord         1.9970     1.5004     1.4212        1.3042          18         17         16            15
                            injury, M>23.75 and M<29.25.
0506.....................  Non-traumatic spinal cord         2.7578     2.0721     1.9627        1.8011          26         23         21            20
                            injury, M<23.75.
0601.....................  Neurological, M>47.75........     1.0678     0.8160     0.7570        0.6888          10          9          9             8
0602.....................  Neurological, M>37.35 and         1.3930     1.0646     0.9876        0.8986          12         12         11            11
                            M<47.75.
0603.....................  Neurological, M>25.85 and         1.7085     1.3056     1.2112        1.1021          14         14         13            13
                            M<37.35.
0604.....................  Neurological, M<25.85........     2.2217     1.6978     1.5750        1.4331          19         18         16            16
0701.....................  Fracture of lower extremity,      1.0395     0.8307     0.7888        0.7185          12         11         10             9
                            M>42.15.
0702.....................  Fracture of lower extremity,      1.3168     1.0523     0.9993        0.9102          12         12         11            11
                            M>34.15 and M<42.15.
0703.....................  Fracture of lower extremity,      1.5920     1.2722     1.2082        1.1004          15         14         14            13
                            M>28.15 and M<34.15.
0704.....................  Fracture of lower extremity,      2.0178     1.6125     1.5313        1.3947          18         18         17            16
                            M<28.15.
0801.....................  Replacement of lower              0.8775     0.6453     0.6128        0.5656           8          8          7             7
                            extremity joint, M>49.55.
0802.....................  Replacement of lower              1.1266     0.8285     0.7868        0.7262          11         10          9             9
                            extremity joint, M>37.05 and
                            M<49.55.
0803.....................  Replacement of lower              1.4578     1.0721     1.0181        0.9396          13         13         12            11
                            extremity joint, M>28.65 and
                            M<37.05 and A>83.5.
0804.....................  Replacement of lower              1.3414     0.9865     0.9368        0.8646          12         11         11            10
                            extremity joint, M>28.65 and
                            M<37.05 and A<83.5.
0805.....................  Replacement of lower              1.5913     1.1703     1.1114        1.0257          14         13         12            12
                            extremity joint, M>22.05 and
                            M<28.65.
0806.....................  Replacement of lower              1.9238     1.4148     1.3436        1.2400          16         16         14            14
                            extremity joint, M<22.05.
0901.....................  Other orthopedic, M>44.75....     1.0100     0.8084     0.7245        0.6736          10         10          9             8
0902.....................  Other orthopedic, M>34.35 and     1.3277     1.0627     0.9524        0.8856          12         12         11            10
                            M<44.75.
0903.....................  Other orthopedic, M>24.15 and     1.6291     1.3040     1.1686        1.0866          15         14         13            13
                            M<34.35.
0904.....................  Other orthopedic, M<24.15....     2.0410     1.6337     1.4641        1.3613          18         18         16            15
1001.....................  Amputation, lower extremity,      1.0450     0.9001     0.7939        0.7247          10         11         10             9
                            M>47.65.
1002.....................  Amputation, lower extremity,      1.3755     1.1847     1.0450        0.9538          13         13         12            11
                            M>36.25 and M<47.65.
1003.....................  Amputation, lower extremity,      2.0095     1.7308     1.5266        1.3935          18         18         17            16
                            M<36.25.
1101.....................  Amputation, non-lower             1.3101     1.1733     1.0154        0.8784          12         15         12            10
                            extremity, M>36.35.
1102.....................  Amputation, non-lower             1.8980     1.6999     1.4711        1.2727          16         23         15            14
                            extremity, M<36.35.
1201.....................  Osteoarthritis, M>37.65......     1.2205     0.9178     0.8571        0.7889           9         11         10            10
1202.....................  Osteoarthritis, M>30.75 and       1.5786     1.1871     1.1086        1.0203          11         13         13            12
                            M<37.65.
1203.....................  Osteoarthritis, M<30.75......     1.9315     1.4525     1.3564        1.2485          12         15         15            14
1301.....................  Rheumatoid, other arthritis,      1.2280     0.9277     0.8333        0.7974          10         10         10             9
                            M>36.35.
1302.....................  Rheumatoid, other arthritis,      1.6884     1.2755     1.1457        1.0964          16         14         12            12
                            M>26.15 and M<36.35.
1303.....................  Rheumatoid, other arthritis,      2.1985     1.6609     1.4919        1.4276          18         18         16            16
                            M<26.15.
1401.....................  Cardiac, M>48.85.............     0.9282     0.7469     0.6826        0.6196          10          8          8             8
1402.....................  Cardiac, M>38.55 and M<48.85.     1.2233     0.9844     0.8997        0.8165          12         11         10            10
1403.....................  Cardiac, M>31.15 and M<38.55.     1.4648     1.1787     1.0773        0.9777          13         13         12            11
1404.....................  Cardiac, M<31.15.............     1.8551     1.4927     1.3643        1.2382          17         16         14            14
1501.....................  Pulmonary, M>49.25...........     1.0146     0.8485     0.7738        0.7413          10          9          9             8
1502.....................  Pulmonary, M>39.05 and            1.3154     1.1001     1.0032        0.9612          11         12         11            10
                            M<49.25.
1503.....................  Pulmonary, M>29.15 and            1.5983     1.3367     1.2190        1.1679          14         14         12            12
                            M<39.05.
1504.....................  Pulmonary, M<29.15...........     1.9815     1.6572     1.5112        1.4478          20         16         15            14
1601.....................  Pain syndrome, M>37.15.......     1.1541     0.9076     0.8273        0.7600          10         11         10             9
1602.....................  Pain syndrome, M>26.75 and        1.5368     1.2085     1.1016        1.0120          12         14         13            12
                            M<37.15.
1603.....................  Pain syndrome, M<26.75.......     1.9181     1.5084     1.3749        1.2631          14         16         15            14
1701.....................  Major multiple trauma without     1.1984     0.9331     0.8430        0.7737          10         11         10             9
                            brain or spinal cord injury,
                            M>39.25.
1702.....................  Major multiple trauma without     1.5242     1.1867     1.0722        0.9840          14         14         12            12
                            brain or spinal cord injury,
                            M>31.05 and M<39.25.
1703.....................  Major multiple trauma without     1.8018     1.4029     1.2675        1.1633          17         15         14            14
                            brain or spinal cord injury,
                            M>25.55 and M<31.05.

[[Page 20699]]

 
1704.....................  Major multiple trauma without     2.2806     1.7756     1.6043        1.4724          21         19         17            17
                            brain or spinal cord injury,
                            M<25.55.
1801.....................  Major multiple trauma with        1.3059     1.0064     0.8850        0.8157          13         11         10            10
                            brain or spinal cord injury,
                            M>40.85.
1802.....................  Major multiple trauma with        1.8718     1.4425     1.2685        1.1692          17         16         14            14
                            brain or spinal cord injury,
                            M>23.05 and M<40.85.
1803.....................  Major multiple trauma with        2.9245     2.2538     1.9819        1.8267          32         26         21            20
                            brain or spinal cord injury,
                            M<23.05.
1901.....................  Guillian Barre, M>35.95......     1.2961     1.0778     0.9935        0.9522          13         12         12            11
1902.....................  Guillian Barre, M>18.05 and       2.2324     1.8563     1.7112        1.6400          23         20         21            18
                            M<35.95.
1903.....................  Guillian Barre, M<18.05......     3.6781     3.0585     2.8194        2.7020          39         32         28            30
2001.....................  Miscellaneous, M>49.15.......     0.9421     0.7634     0.6971        0.6329           9          9          8             8
2002.....................  Miscellaneous, M>38.75 and        1.2399     1.0047     0.9174        0.8330          11         11         10            10
                            M<49.15.
2003.....................  Miscellaneous, M>27.85 and        1.5409     1.2486     1.1401        1.0351          14         14         12            12
                            M<38.75.
2004.....................  Miscellaneous, M<27.85.......     1.9681     1.5948     1.4562        1.3222          18         17         15            15
2101.....................  Burns, M>0...................     1.8414     1.8221     1.3846        1.2977          29         17         14            14
5001.....................  Short-stay cases, length of    .........  .........  .........        0.1567   .........  .........  .........             2
                            stay is 3 days or fewer.
5101.....................  Expired, orthopedic, length    .........  .........  .........        0.6583   .........  .........  .........             7
                            of stay is 13 days or fewer.
5102.....................  Expired, orthopedic, length    .........  .........  .........        1.6390   .........  .........  .........            18
                            of stay is 14 days or more.
5103.....................  Expired, not orthopedic,       .........  .........  .........        0.8111   .........  .........  .........             8
                            length of stay is 15 days or
                            fewer.
5104.....................  Expired, not orthopedic,       .........  .........  .........        2.0333   .........  .........  .........            21
                            length of stay is 16 days or
                            more.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Generally, updates to the CMG relative weights result in some 
increases and some decreases to the CMG relative weight values. Table 2 
shows how we estimate that the application of the proposed revisions 
for FY 2018 would affect particular CMG relative weight values, which 
would affect the overall distribution of payments within CMGs and 
tiers. Note that, because we propose to implement the CMG relative 
weight revisions in a budget-neutral manner (as previously described), 
total estimated aggregate payments to IRFs for FY 2018 would not be 
affected as a result of the proposed CMG relative weight revisions. 
However, the proposed revisions would affect the distribution of 
payments within CMGs and tiers.

   Table 2--Distributional Effects of the Proposed Changes to the CMG
                            Relative Weights
              [FY 2017 Values Compared with FY 2018 values]
------------------------------------------------------------------------
    Percentage change in CMG relative        Number of     Percentage of
                 weights                  cases affected  cases affected
------------------------------------------------------------------------
Increased by 15% or more................              51             0.0
Increased by between 5% and 15%.........           1,720             0.4
Changed by less than 5%.................         394,048            99.3
Decreased by between 5% and 15%.........             850             0.2
Decreased by 15% or more................               0             0.0
------------------------------------------------------------------------

    As Table 2 shows, 99.3 percent of all IRF cases are in CMGs and 
tiers that would experience less than a 5 percent change (either 
increase or decrease) in the CMG relative weight value as a result of 
the proposed revisions for FY 2018. The largest estimated increase in 
the proposed CMG relative weight values that affects the largest number 
of IRF discharges would be a 4.1 percent change in the CMG relative 
weight value for CMG 0603--Neurological, with a motor score greater 
than 25.85 and less than 37.35--in tier 1. In the FY 2016 claims data, 
1,322 IRF discharges (0.3 percent of all IRF discharges) were 
classified into this CMG and tier.
    The largest decrease in a CMG relative weight value affecting the 
largest number of IRF cases would be a 3.6 percent decrease in the CMG 
relative weight for CMG 0506--Non-traumatic spinal cord injury, with a 
motor score less than 23.75--in tier 3. In the FY 2016 IRF claims data, 
this change would have affected 2,395 cases (0.6 percent of all IRF 
cases).
    The proposed changes in the average length of stay values for FY 
2018, compared with the FY 2017 average length of stay values, are 
small and do not show any particular trends in IRF length of stay 
patterns.
    We invite public comment on our proposed updates to the CMG 
relative weights and average length of stay values for FY 2018.

IV. Facility-Level Adjustment Factors

    Section 1886(j)(3)(A)(v) of the Act confers broad authority upon 
the Secretary to adjust the per unit payment rate by such factors as 
the Secretary determines are necessary to properly reflect variations 
in necessary costs of treatment among rehabilitation facilities. Under 
this authority, we currently adjust the prospective payment amount 
associated with a CMG to account for facility-level characteristics 
such as an IRF's LIP, teaching status, and location in a rural

[[Page 20700]]

area, if applicable, as described in Sec.  412.624(e).
    Based on the substantive changes to the facility-level adjustment 
factors that were adopted in the FY IRF PPS 2014 final rule (78 FR 
47860, 47868 through 47872), in the FY 2015 IRF PPS final rule (79 FR 
45872, 45882 through 45883), we froze the facility-level adjustment 
factors at the FY 2014 levels for FY 2015 and all subsequent years 
(unless and until we propose to update them again through future 
notice-and-comment rulemaking). For FY 2018, we will continue to hold 
the adjustment factors at the FY 2014 levels as we continue to monitor 
the most current IRF claims data available and continue to evaluate and 
monitor the effects of the FY 2014 changes.

V. Proposed FY 2018 IRF PPS Payment Update

A. Background

    Section 1886(j)(3)(C) of the Act requires the Secretary to 
establish an increase factor that reflects changes over time in the 
prices of an appropriate mix of goods and services included in the IRF 
PPS payment, which is referred to as a market basket index. According 
to section 1886(j)(3)(A)(i) of the Act, the increase factor shall be 
used to update the IRF prospective payment rates for each FY. Section 
1886(j)(3)(C)(ii)(I) of the Act requires the application of a 
productivity adjustment, as described in this section. In addition, 
sections 1886(j)(3)(C)(ii)(II) and 1886(j)(3)(D)(v) of the Act require 
the application of a 0.75 percentage point reduction to the market 
basket increase factor for FY 2018. However, section 411(b) of the 
Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) amended 
section 1886(j)(3)(C) of the Act by adding clause (iii), which provides 
that the increase factor for fiscal year 2018, after the application of 
the productivity adjustment and other adjustment, must be 1.0 percent. 
In accordance with section 1886(j)(3)(C)(iii) of the Act, we are 
applying an increase factor of 1.0 percent to update the proposed IRF 
prospective payment rates for FY 2018 in this proposed rule.
    For FY 2015, IRF PPS payments were updated using the 2008-based RPL 
market basket. Beginning with the FY 2016 IRF PPS, we created and 
adopted a stand-alone IRF market basket, which was referred to as the 
2012-based IRF market basket, reflecting the operating and capital cost 
structures for freestanding IRFs and hospital-based IRFs. The general 
structure of the 2012-based IRF market basket is similar to the 2008-
based RPL market basket; however, we made several notable changes. In 
developing the 2012-based IRF market basket, we derived cost weights 
from Medicare cost report data for both freestanding and hospital-based 
IRFs (the 2008-based RPL market basket was based on freestanding data 
only), incorporated the 2007 Input-Output data from the Bureau of 
Economic Analysis (the 2008-based RPL market basket was based on the 
2002 Input-Output data); used new price proxy blends for two cost 
categories (Fuel, Oil, and Gasoline and Medical Instruments); added one 
additional cost category (Installation, Maintenance, and Repair), which 
was previously included in the residual All Other Services: Labor-
Related cost category of the 2008-based RPL market basket; and 
eliminated three cost categories (Apparel, Machinery & Equipment, and 
Postage). The FY 2016 IRF PPS final rule (80 FR 47046 through 47068) 
contains a complete discussion of the development of the 2012-based IRF 
market basket.

B. Proposed FY 2018 Market Basket Update and Productivity Adjustment

    As noted above, in accordance with section 1886(j)(3)(C)(iii) of 
the Act, as added by section 411(b) of MACRA, we are applying an 
increase factor of 1.0 percent to update the proposed IRF prospective 
payment rates for FY 2018 in this proposed rule. For comparison 
purposes, we are providing an estimate of what the proposed IRF 
increase factor would have been for FY 2018 prior to the enactment of 
section 411(b) of MACRA. This estimate is based on the same methodology 
described in the FY 2017 IRF PPS final rule (81 FR 52071) and IHS 
Global Insight Inc.'s first quarter 2017 forecast of the market basket 
update and MFP adjustment with historical data through the fourth 
quarter 2016. IHS Global Insight Inc. is a nationally recognized 
economic and financial forecasting firm with which CMS contracts to 
forecast the components of the market baskets and MFP. Using this 
methodology, the proposed FY 2018 payment increase factor would be 1.55 
percent (based on IHS Global Insight, Inc.'s first quarter 2017 
forecast with historical data through the fourth quarter of 2016), 
reflecting a FY 2018 estimated market basket update of 2.7 percent as 
required by section 1886(j)(3)(C) of the Act, with an estimated 
productivity adjustment of 0.4 percentage point as required by section 
1886(j)(3)(C)(ii)(I) of the Act, and a 0.75 percentage point reduction 
as required by sections 1886(j)(3)(C)(ii)(II) and 1886(j)(3)(D)(v) of 
the Act. However, section 411(b) of MACRA amended section 1886(j)(3)(C) 
of the Act by adding clause (iii), which provides that the increase 
factor for fiscal year 2018, after the application of the productivity 
adjustment and other adjustment, must be 1.0 percent.
    For FY 2018, the Medicare Payment Advisory Commission (MedPAC) 
recommends that we reduce IRF PPS payment rates by 5 percent. As 
discussed, and in accordance with sections 1886(j)(3)(C) and 
1886(j)(3)(D) of the Act, as amended by MACRA, the Secretary will 
update the IRF PPS payment rates for FY 2018 by 1.0 percent, as section 
1886(j)(3)(C) of the Act does not provide the Secretary with the 
authority to apply a different update factor to IRF PPS payment rates 
for FY 2018.
    We invite public comment on this proposal.

C. Proposed Labor-Related Share for FY 2018

    Section 1886(j)(6) of the Act specifies that the Secretary is to 
adjust the proportion (as estimated by the Secretary from time to time) 
of rehabilitation facilities' costs which are attributable to wages and 
wage-related costs of the prospective payment rates computed under 
section 1886(j)(3) for area differences in wage levels by a factor 
(established by the Secretary) reflecting the relative hospital wage 
level in the geographic area of the rehabilitation facility compared to 
the national average wage level for such facilities. The labor-related 
share is determined by identifying the national average proportion of 
total costs that are related to, influenced by, or vary with the local 
labor market. We continue to classify a cost category as labor-related 
if the costs are labor-intensive and vary with the local labor market.
    Based on our definition of the labor-related share and the cost 
categories in the 2012-based IRF market basket, we propose to include 
in the labor-related share for FY 2018 the sum of the FY 2018 relative 
importance of Wages and Salaries, Employee Benefits, Professional Fees: 
Labor-Related, Administrative and Facilities Support Services, 
Installation, Maintenance, and Repair Services, All Other: Labor-
related Services, and a portion of the Capital-Related cost weight from 
the 2012-based IRF market basket. For more details regarding the 
methodology for determining specific cost categories for inclusion in 
the 2012-based IRF labor-related share, see the FY 2016 IRF final rule 
(80 FR 47066 through 47068).
    Using this method and the IHS Global Insight, Inc. first quarter 
2017 forecast for the 2012-based IRF market basket,

[[Page 20701]]

the sum of the relative importance for FY 2018 operating costs (Wages 
and Salaries, Employee Benefits, Professional Fees: Labor-related, 
Administrative and Facilities Support Services, Installation 
Maintenance & Repair Services, and All Other: Labor-related Services) 
using the 2012-based IRF market basket is 66.9 percent. We propose that 
the portion of Capital-Related Costs that is influenced by the local 
labor market is estimated to be 46 percent. Incorporating the estimate 
of the FY 2018 relative importance of Capital-Related costs from the 
2012-based IRF market basket based on IHS Global Insight's (IGI) first 
quarter 2017 forecast, which is 8.3 percent, we take 46 percent of 8.3 
percent to determine the labor-related share of Capital for FY 2018. We 
propose to then add this amount (3.8 percent) to the sum of the 
relative importance for FY 2018 operating costs (66.9 percent) to 
determine the total proposed labor-related share for FY 2018 of 70.7 
percent. We also propose that if more recent data are subsequently 
available, we would use such data to determine the FY 2018 IRF labor-
related share in the final rule.
    We invite public comment on this proposal.

                    Table 3--IRF Labor-Related Share
------------------------------------------------------------------------
                                              FY 2018
                                          Proposed labor-  FY 2017 Final
                                           related share   labor related
                                                \1\          share \2\
------------------------------------------------------------------------
Wages and Salaries......................            47.7            47.7
Employee Benefits.......................            11.3            11.3
Professional Fees: Labor-related........             3.4             3.5
Administrative and Facilities Support                0.8             0.8
 Services...............................
Installation, Maintenance, and Repair                1.9             1.9
 Services...............................
All Other: Labor-related Services.......             1.8             1.8
                                         -------------------------------
    Subtotal............................            66.9            67.0
Labor-related portion of capital (46%)..             3.8             3.9
                                         -------------------------------
        Total Labor-Related Share.......            70.7            70.9
------------------------------------------------------------------------
\1\ Based on the 2012-based IRF Market Basket, IHS Global Insight, Inc.
  1st quarter 2017 forecast.
\2\ Federal Register (81 FR 52073).

D. Proposed Wage Adjustment

1. Background
    Section 1886(j)(6) of the Act requires the Secretary to adjust the 
proportion of rehabilitation facilities' costs attributable to wages 
and wage-related costs (as estimated by the Secretary from time to 
time) by a factor (established by the Secretary) reflecting the 
relative hospital wage level in the geographic area of the 
rehabilitation facility compared to the national average wage level for 
those facilities. The Secretary is required to update the IRF PPS wage 
index on the basis of information available to the Secretary on the 
wages and wage-related costs to furnish rehabilitation services. Any 
adjustment or updates made under section 1886(j)(6) of the Act for a FY 
are made in a budget-neutral manner.
    For FY 2018, we propose to maintain the policies and methodologies 
described in the FY 2017 IRF PPS final rule (81 FR 52055, 52073 through 
52074) related to the labor market area definitions and the wage index 
methodology for areas with wage data. Thus, we propose to use the CBSA 
labor market area definitions and the FY 2017 pre-reclassification and 
pre-floor hospital wage index data. In accordance with section 
1886(d)(3)(E) of the Act, the FY 2017 pre-reclassification and pre-
floor hospital wage index is based on data submitted for hospital cost 
reporting periods beginning on or after October 1, 2012, and before 
October 1, 2013 (that is, FY 2013 cost report data).
    The labor market designations made by the OMB include some 
geographic areas where there are no hospitals and, thus, no hospital 
wage index data on which to base the calculation of the IRF PPS wage 
index. We propose to continue to use the same methodology discussed in 
the FY 2008 IRF PPS final rule (72 FR 44299) to address those 
geographic areas where there are no hospitals and, thus, no hospital 
wage index data on which to base the calculation for the FY 2018 IRF 
PPS wage index.
    We invite public comment on this proposal.
2. Update
    The wage index used for the IRF PPS is calculated using the pre-
reclassification and pre-floor acute care hospital wage index data and 
is assigned to the IRF on the basis of the labor market area in which 
the IRF is geographically located. IRF labor market areas are 
delineated based on the CBSAs established by the OMB. In the FY 2016 
IRF PPS final rule (80 FR 47036, 47068), we established an IRF wage 
index based on FY 2011 acute care hospital wage data to adjust the FY 
2016 IRF payment rates. We also adopted the revised CBSAs set forth by 
OMB. The current CBSA delineations (which were implemented for the IRF 
PPS beginning with FY 2016) are based on revised OMB delineations 
issued on February 28, 2013, in OMB Bulletin No. 13-01. OMB Bulletin 
No. 13-01 established revised delineations for Metropolitan Statistical 
Areas, Micropolitan Statistical Areas, and Combined Statistical Areas 
in the United States and Puerto Rico, and provided guidance on the use 
of the delineations of these statistical areas based on new standards 
published on June 28, 2010, in the Federal Register (75 FR 37246 
through 37252). A copy of this bulletin may be obtained at https://obamawhitehouse.archives.gov/sites/default/files/omb/bulletins/2013/b13-01.pdf.
    Generally, OMB issues major revisions to statistical areas every 10 
years, based on the results of the decennial census. However, OMB 
occasionally issues minor updates and revisions to statistical areas in 
the years between the decennial censuses. On July 15, 2015, OMB issued 
OMB Bulletin No. 15-01, which provides minor updates to and supersedes 
OMB Bulletin No. 13-01 that was issued on February 28, 2013. The 
attachment to OMB Bulletin No. 15-01 provides detailed information on 
the update to statistical areas since February 28, 2013. The updates 
provided in OMB Bulletin No. 15-01 are based on the application

[[Page 20702]]

of the 2010 Standards for Delineating Metropolitan and Micropolitan 
Statistical Areas to Census Bureau population estimates for July 1, 
2012 and July 1, 2013. The complete list of statistical areas 
incorporating these changes is provided in OMB Bulletin No. 15-01. A 
copy of this bulletin may be obtained at https://obamawhitehouse.archives.gov/sites/default/files/omb/bulletins/2015/15-01.pdf.
    According to OMB, the bulletin establishes revised delineations for 
the Nation's Metropolitan Statistical Areas, Micropolitan Statistical 
Areas, and Combined Statistical Areas. The bulletin also provides 
delineations of Metropolitan Divisions as well as delineations of New 
England City and Town Areas. OMB Bulletin No. 15-01 made the following 
changes that are relevant to the IRF wage index:
     Garfield County, OK, with principal city Enid, OK, which 
was a Micropolitan (geographically rural) area, now qualifies as an 
urban new CBSA 21420 called Enid, OK.
     The county of Bedford City, VA, a component of the 
Lynchburg, VA CBSA 31340, changed to town status and is added to 
Bedford County. Therefore, the county of Bedford City (SSA State county 
code 49088, FIPS State County Code 51515) is now part of the county of 
Bedford, VA (SSA State county code 49090, FIPS State County Code 
51019). However, the CBSA remains Lynchburg, VA, 31340.
     The name of Macon, GA, CBSA 31420, as well as a principal 
city of the Macon-Warner Robins, GA combined statistical area, is now 
Macon-Bibb County, GA. The CBSA code remains as 31420.
    We believe that it is important for the IRF PPS to use the latest 
labor market area delineations available as soon as is reasonably 
possible to maintain a more accurate and up-to-date payment system that 
reflects the reality of population shifts and labor market conditions. 
As discussed in the FY 2017 Inpatient prospective payment system (IPPS) 
and Long-Term Care Hospital (LTCH) PPS final rule (81 FR 56913), these 
updated labor market area definitions were implemented under the IPPS 
beginning on October 1, 2016. Therefore, we are proposing to implement 
these revisions for the IRF PPS beginning October 1, 2017, consistent 
with our historical practice of modeling IRF PPS adoption of the labor 
market area delineations after IPPS adoption of these delineations. We 
invite public comments on this proposal.
3. Transition Period
    In FY 2016, we applied a transition period when implementing the 
OMB delineations as described in the February 28, 2013 OMB Bulletin No. 
13-01, as this bulletin contained a number of significant changes that 
resulted in substantial payment implications for some IRF providers. We 
are proposing to incorporate the CBSA changes published in the most 
recent OMB bulletin without a transition period as we anticipate that 
these changes will have minor effects for a single IRF provider. One 
provider, located in Garfield County, OK and designated as rural in FY 
2017, will be designated as urban in FY 2018. While this provider will 
lose the 14.9 percent rural adjustment in FY 2018, this provider will 
experience an increase of 13 percent in their proposed wage index 
value. As this provider is not expected to experience as steep of a 
reduction in payments as the majority of facilities for which a phase 
out of the rural adjustment was implemented, we do not believe it is 
appropriate or necessary to adopt a transition policy. As the changes 
made in OMB Bulletin No 15-01 are minor and do not have a large effect 
on a substantial number of providers, we are not proposing a transition 
period to adopt these updates.
    In FY 2016, we applied a 1-year blended wage index for all IRF 
providers to mitigate the impact of the wage index change due to the 
implementation of the revised CBSA delineations. In FY 2016, all IRF 
providers received a blended wage index using 50 percent of their FY 
2016 wage index based on the revised OMB CBSA delineations and 50 
percent of their FY 2016 wage index based on the OMB delineations used 
in FY 2015. This 1-year blended wage index became effective on October 
1, 2015 and expired on September 30, 2016.
    For FY 2016, in addition to the blended wage index, we also adopted 
a three-year budget neutral phase out of the rural adjustment for FY 
2015 rural IRFs that became urban in FY 2016 under the revised CBSA 
delineations. In FY 2016, IRFs that were designated as rural in FY 2015 
and became designated as urban in FY 2016 received two-thirds of the 
2015 rural adjustment of 14.9 percent. In FY 2017, the second year of 
the 3-year phase out, these IRFs received one-third of the 2015 rural 
adjustment of 14.9 percent, as finalized in the FY 2017 IRF PPS final 
rule (81 FR 52055, 52074 through 52076). FY 2018 represents the third 
and final year of the three-year phase out of the rural adjustment. We 
will no longer apply any portion of the rural adjustment for IRFs that 
became urban in FY 2016 under the revised CBSA delineations, as 
finalized in the FY 2016 IRF PPS final rule (80 FR 47036, 47073 through 
47074). We are not proposing any additional wage index transition 
adjustments for IRF providers due to the adoption of the new OMB 
delineations in FY 2016. We refer readers to the FY 2016 IRF PPS final 
rule (80 FR 47036, 47068 through 47076) for a full discussion of our 
implementation of the new OMB labor market area delineations for the FY 
2016 wage index. The proposed wage index applicable to FY 2018 is 
available on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Data-Files.html. Table A 
is for urban areas, and Table B is for rural areas.
    To calculate the wage-adjusted facility payment for the payment 
rates set forth in this proposed rule, we multiply the unadjusted 
federal payment rate for IRFs by the FY 2018 labor-related share based 
on the 2012-based IRF market basket (70.7 percent) to determine the 
labor-related portion of the standard payment amount. A full discussion 
of the calculation of the labor-related share is located in section V.C 
of this proposed rule. We then multiply the labor-related portion by 
the applicable IRF wage index from the tables in the addendum to this 
proposed rule. These tables are available through the Internet on the 
CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Data-Files.html.
    Adjustments or updates to the IRF wage index made under section 
1886(j)(6) of the Act must be made in a budget-neutral manner. We 
propose to calculate a budget-neutral wage adjustment factor as 
established in the FY 2004 IRF PPS final rule (68 FR 45689), codified 
at Sec.  412.624(e)(1), as described in the steps below. We propose to 
use the listed steps to ensure that the FY 2018 IRF standard payment 
conversion factor reflects the proposed update to the wage indexes 
(based on the FY 2013 hospital cost report data) and the labor-related 
share in a budget-neutral manner:
    Step 1. Determine the total amount of the estimated FY 2017 IRF PPS 
payments, using the FY 2017 standard payment conversion factor and the 
labor-related share and the wage indexes from FY 2017 (as published in 
the FY 2017 IRF PPS final rule (81 FR 52056)).
    Step 2. Calculate the total amount of estimated IRF PPS payments 
using the proposed FY 2018 standard payment

[[Page 20703]]

conversion factor and the proposed FY 2018 labor-related share and CBSA 
urban and rural wage indexes.
    Step 3. Divide the amount calculated in step 1 by the amount 
calculated in step 2. The resulting quotient is the proposed FY 2018 
budget-neutral wage adjustment factor of 1.0007.
    Step 4. Apply the proposed FY 2018 budget-neutral wage adjustment 
factor from step 3 to the FY 2017 IRF PPS standard payment conversion 
factor after the application of the increase factor to determine the 
proposed FY 2018 standard payment conversion factor.
    We discuss the calculation of the proposed standard payment 
conversion factor for FY 2018 in section V.E of this proposed rule.
    We invite public comment on the proposed IRF wage adjustment for FY 
2018.

E. Description of the Proposed IRF Standard Payment Conversion Factor 
and Payment Rates for FY 2018

    To calculate the proposed standard payment conversion factor for FY 
2018, as illustrated in Table 4, we begin by applying the proposed 
increase factor for FY 2018, as adjusted in accordance with sections 
1886(j)(3)(C)(iii) of the Act, as added by MACRA, to the standard 
payment conversion factor for FY 2017 ($15,708). Applying the proposed 
1.0 percent increase factor for FY 2018 to the standard payment 
conversion factor for FY 2017 of $15,708 yields a standard payment 
amount of $15,865. Then, we apply the budget neutrality factor for the 
FY 2018 wage index and labor-related share of 1.0007, which results in 
a proposed standard payment amount of $15,876. We next apply the 
proposed budget neutrality factor for the revised CMG relative weights 
of 0.9974, which results in the proposed standard payment conversion 
factor of $15,835 for FY 2018.

Table 4--Calculations To Determine the Proposed FY 2018 Standard Payment
                            Conversion Factor
------------------------------------------------------------------------
              Explanation for adjustment                  Calculations
------------------------------------------------------------------------
Standard Payment Conversion Factor for FY 2017.......            $15,708
Market Basket Increase Factor for FY 2018 (1.0                  x 1.0100
 percent), as required by section 1886(j)(3)(C)(iii)
 of the Act..........................................
Budget Neutrality Factor for the Wage Index and Labor-          x 1.0007
 Related Share.......................................
Budget Neutrality Factor for the Revisions to the CMG           x 0.9974
 Relative Weights....................................
Proposed FY 2018 Standard Payment Conversion Factor..          = $15,835
------------------------------------------------------------------------

    We invite public comment on the proposed FY 2018 standard payment 
conversion factor.
    After the application of the proposed CMG relative weights 
described in section III of this proposed rule to the proposed FY 2018 
standard payment conversion factor ($15,835), the resulting unadjusted 
IRF prospective payment rates for FY 2018 are shown in Table 5.

                                     Table 5--Proposed FY 2018 Payment Rates
----------------------------------------------------------------------------------------------------------------
                                                                                                   Payment rate
                       CMG                         Payment rate    Payment rate    Payment rate         no
                                                      tier 1          tier 2          tier 3        comorbidity
----------------------------------------------------------------------------------------------------------------
0101............................................     $ 13,432.83     $ 11,527.88     $ 10,647.45     $ 10,170.82
0102............................................       16,895.95       14,500.11       13,393.24       12,793.10
0103............................................       19,111.26       16,400.31       15,149.34       14,470.02
0104............................................       20,498.41       17,591.10       16,248.29       15,521.47
0105............................................       23,839.59       20,458.82       18,897.49       18,050.32
0106............................................       26,409.61       22,664.64       20,933.87       19,996.44
0107............................................       29,486.35       25,304.33       23,372.46       22,325.77
0108............................................       37,503.61       32,183.05       29,727.05       28,395.32
0109............................................       33,776.06       28,984.38       26,772.23       25,573.53
0110............................................       44,092.56       37,839.32       34,951.01       33,384.93
0201............................................       13,323.57       10,736.13        9,774.95        8,980.03
0202............................................       17,217.40       13,874.63       12,631.58       11,605.47
0203............................................       19,925.18       16,056.69       14,617.29       13,429.66
0204............................................       21,974.23       17,706.70       16,120.03       14,810.48
0205............................................       25,833.22       20,816.69       18,951.33       17,412.17
0206............................................       31,199.70       25,141.23       22,887.91       21,028.88
0207............................................       39,750.60       32,032.62       29,161.74       26,792.82
0301............................................       18,446.19       14,946.66       13,588.01       12,837.43
0302............................................       22,393.86       18,146.91       16,496.90       15,584.81
0303............................................       26,327.27       21,332.91       19,394.71       18,322.68
0304............................................       34,119.67       27,646.33       25,133.31       23,744.58
0401............................................       14,205.58       13,252.31       11,806.58       10,653.79
0402............................................       20,747.02       19,355.12       17,241.15       15,557.89
0403............................................       33,631.96       31,373.89       27,948.78       25,220.40
0404............................................       58,906.20       54,953.78       48,953.90       44,174.90
0405............................................       54,245.96       50,605.49       45,080.66       40,680.12
0501............................................       14,878.57       11,177.93       10,588.86        9,716.36
0502............................................       19,342.45       14,533.36       13,765.37       12,633.16
0503............................................       24,227.55       18,203.92       17,242.73       15,822.33
0504............................................       27,510.15       20,669.43       19,578.39       17,966.39
0505............................................       31,622.50       23,758.83       22,504.70       20,652.01
0506............................................       43,669.76       32,811.70       31,079.35       28,520.42
0601............................................       16,908.61       12,921.36       11,987.10       10,907.15

[[Page 20704]]

 
0602............................................       22,058.16       16,857.94       15,638.65       14,229.33
0603............................................       27,054.10       20,674.18       19,179.35       17,451.75
0604............................................       35,180.62       26,884.66       24,940.13       22,693.14
0701............................................       16,460.48       13,154.13       12,490.65       11,377.45
0702............................................       20,851.53       16,663.17       15,823.92       14,413.02
0703............................................       25,209.32       20,145.29       19,131.85       17,424.83
0704............................................       31,951.86       25,533.94       24,248.14       22,085.07
0801............................................       13,895.21       10,218.33        9,703.69        8,956.28
0802............................................       17,839.71       13,119.30       12,458.98       11,499.38
0803............................................       23,084.26       16,976.70       16,121.61       14,878.57
0804............................................       21,241.07       15,621.23       14,834.23       13,690.94
0805............................................       25,198.24       18,531.70       17,599.02       16,241.96
0806............................................       30,463.37       22,403.36       21,275.91       19,635.40
0901............................................       15,993.35       12,801.01       11,472.46       10,666.46
0902............................................       21,024.13       16,827.85       15,081.25       14,023.48
0903............................................       25,796.80       20,648.84       18,504.78       17,206.31
0904............................................       32,319.24       25,869.64       23,184.02       21,556.19
1001............................................       16,547.58       14,253.08       12,571.41       11,475.62
1002............................................       21,781.04       18,759.72       16,547.58       15,103.42
1003............................................       31,820.43       27,407.22       24,173.71       22,066.07
1101............................................       20,745.43       18,579.21       16,078.86       13,909.46
1102............................................       30,054.83       26,917.92       23,294.87       20,153.20
1201............................................       19,326.62       14,533.36       13,572.18       12,492.23
1202............................................       24,997.13       18,797.73       17,554.68       16,156.45
1203............................................       30,585.30       23,000.34       21,478.59       19,770.00
1301............................................       19,445.38       14,690.13       13,195.31       12,626.83
1302............................................       26,735.81       20,197.54       18,142.16       17,361.49
1303............................................       34,813.25       26,300.35       23,624.24       22,606.05
1401............................................       14,698.05       11,827.16       10,808.97        9,811.37
1402............................................       19,370.96       15,587.97       14,246.75       12,929.28
1403............................................       23,195.11       18,664.71       17,059.05       15,481.88
1404............................................       29,375.51       23,636.90       21,603.69       19,606.90
1501............................................       16,066.19       13,436.00       12,253.12       11,738.49
1502............................................       20,829.36       17,420.08       15,885.67       15,220.60
1503............................................       25,309.08       21,166.64       19,302.87       18,493.70
1504............................................       31,377.05       26,241.76       23,929.85       22,925.91
1601............................................       18,275.17       14,371.85       13,100.30       12,034.60
1602............................................       24,335.23       19,136.60       17,443.84       16,025.02
1603............................................       30,373.11       23,885.51       21,771.54       20,001.19
1701............................................       18,976.66       14,775.64       13,348.91       12,251.54
1702............................................       24,135.71       18,791.39       16,978.29       15,581.64
1703............................................       28,531.50       22,214.92       20,070.86       18,420.86
1704............................................       36,113.30       28,116.63       25,404.09       23,315.45
1801............................................       20,678.93       15,936.34       14,013.98       12,916.61
1802............................................       29,639.95       22,841.99       20,086.70       18,514.28
1803............................................       46,309.46       35,688.92       31,383.39       28,925.79
1901............................................       20,523.74       17,066.96       15,732.07       15,078.09
1902............................................       35,350.05       29,394.51       27,096.85       25,969.40
1903............................................       58,242.71       48,431.35       44,645.20       42,786.17
2001............................................       14,918.15       12,088.44       11,038.58       10,021.97
2002............................................       19,633.82       15,909.42       14,527.03       13,190.56
2003............................................       24,400.15       19,771.58       18,053.48       16,390.81
2004............................................       31,164.86       25,253.66       23,058.93       20,937.04
2101............................................       29,158.57       28,852.95       21,925.14       20,549.08
5001............................................  ..............  ..............  ..............        2,481.34
5101............................................  ..............  ..............  ..............       10,424.18
5102............................................  ..............  ..............  ..............       25,953.57
5103............................................  ..............  ..............  ..............       12,843.77
5104............................................  ..............  ..............  ..............       32,197.31
----------------------------------------------------------------------------------------------------------------

F. Example of the Methodology for Adjusting the Proposed Prospective 
Payment Rates

    Table 6 illustrates the methodology for adjusting the proposed 
federal prospective payments (as described in sections V.A. through 
V.F. of this proposed rule). The following examples are based on two 
hypothetical Medicare beneficiaries, both classified into CMG 0110 
(without comorbidities). The proposed unadjusted prospective payment 
rate for CMG 0110 (without comorbidities) appears in Table 5.
    Example: One beneficiary is in Facility A, an IRF located in rural 
Spencer County, Indiana, and another beneficiary is in Facility B, an 
IRF located in urban Harrison County, Indiana. Facility A, a rural non-
teaching hospital has a Disproportionate Share

[[Page 20705]]

Hospital (DSH) percentage of 5 percent (which would result in a LIP 
adjustment of 1.0156), a wage index of 0.8167, and a rural adjustment 
of 14.9 percent. Facility B, an urban teaching hospital, has a DSH 
percentage of 15 percent (which would result in a LIP adjustment of 
1.0454 percent), a wage index of 0.8859, and a teaching status 
adjustment of 0.0784.
    To calculate each IRF's labor and non-labor portion of the 
prospective payment, we begin by taking the unadjusted prospective 
payment rate for CMG 0110 (without comorbidities) from Table 5. Then, 
we multiply the labor-related share for FY 2018 (70.7 percent) 
described in section V.C. of this proposed rule by the proposed 
unadjusted prospective payment rate. To determine the non-labor portion 
of the proposed prospective payment rate, we subtract the labor portion 
of the proposed federal payment from the proposed unadjusted 
prospective payment.
    To compute the proposed wage-adjusted prospective payment, we 
multiply the labor portion of the proposed federal payment by the 
appropriate proposed wage index located in tables A and B. These tables 
are available on the CMS Web site at http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Data-Files.html. 
The resulting figure is the wage-adjusted labor amount. Next, we 
compute the proposed wage-adjusted federal payment by adding the wage-
adjusted labor amount to the non-labor portion.
    Adjusting the proposed wage-adjusted federal payment by the 
facility-level adjustments involves several steps. First, we take the 
wage-adjusted prospective payment and multiply it by the appropriate 
rural and LIP adjustments (if applicable). Second, to determine the 
appropriate amount of additional payment for the teaching status 
adjustment (if applicable), we multiply the teaching status adjustment 
(0.0784, in this example) by the wage-adjusted and rural-adjusted 
amount (if applicable). Finally, we add the additional teaching status 
payments (if applicable) to the wage, rural, and LIP-adjusted 
prospective payment rates. Table 6 illustrates the components of the 
adjusted payment calculation.

                        Table 6--Example of Computing the FY 2018 IRF Prospective Payment
----------------------------------------------------------------------------------------------------------------
                                                                                                           Urban
                                                                                                          facility
                             Steps                                                    Rural facility A       B
                                                                                      (Spencer Co., IN)  (Harrison
                                                                                                          Co., IN)
------------------------------------------------------------------------------------------------------- -----------
1. Unadjusted Payment..........................................          $33,384.93          $33,384.93
2. Labor Share.................................................             x 0.707             x 0.707
3. Labor Portion of Payment....................................        = $23,603.15        = $23,603.15
4. CBSA-Based Wage Index (shown in the Addendum, Tables A and              x 0.8167            x 0.8859
 B)............................................................
5. Wage-Adjusted Amount........................................        = $19,276.69        = $20,910.03
6. Non-Labor Amount............................................         + $9,781.78         + $9,781.78
7. Wage-Adjusted Payment.......................................        = $29,058.47        = $30,691.81
8. Rural Adjustment............................................             x 1.149             x 1.000
9. Wage- and Rural-Adjusted Payment............................        = $33,388.19        = $30,691.81
10. LIP Adjustment.............................................            x 1.0156            x 1.0454
11. Wage-, Rural- and LIP-Adjusted Payment.....................        = $33,909.04        = $32,085.22
12. Wage- and Rural-Adjusted Payment...........................          $33,388.19          $30,691.81
13. Teaching Status Adjustment.................................                 x 0            x 0.0784
14. Teaching Status Adjustment Amount..........................             = $0.00         = $2,406.24
15. Wage-, Rural-, and LIP-Adjusted Payment....................        + $33,909.04        + $32,085.22
16. Total Adjusted Payment.....................................        = $33,909.04        = $34,491.46
----------------------------------------------------------------------------------------------------------------

    Thus, the proposed adjusted payment for Facility A would be 
$33,909.04, and the proposed adjusted payment for Facility B would be 
$34,491.46.

VI. Proposed Update to Payments for High-Cost Outliers Under the IRF 
PPS

A. Proposed Update to the Outlier Threshold Amount for FY 2018

    Section 1886(j)(4) of the Act provides the Secretary with the 
authority to make payments in addition to the basic IRF prospective 
payments for cases incurring extraordinarily high costs. A case 
qualifies for an outlier payment if the estimated cost of the case 
exceeds the adjusted outlier threshold. We calculate the adjusted 
outlier threshold by adding the IRF PPS payment for the case (that is, 
the CMG payment adjusted by all of the relevant facility-level 
adjustments) and the adjusted threshold amount (also adjusted by all of 
the relevant facility-level adjustments). Then, we calculate the 
estimated cost of a case by multiplying the IRF's overall CCR by the 
Medicare allowable covered charge. If the estimated cost of the case is 
higher than the adjusted outlier threshold, we make an outlier payment 
for the case equal to 80 percent of the difference between the 
estimated cost of the case and the outlier threshold.
    In the FY 2002 IRF PPS final rule (66 FR 41362 through 41363), we 
discussed our rationale for setting the outlier threshold amount for 
the IRF PPS so that estimated outlier payments would equal 3 percent of 
total estimated payments. For the 2002 IRF PPS final rule, we analyzed 
various outlier policies using 3, 4, and 5 percent of the total 
estimated payments, and we concluded that an outlier policy set at 3 
percent of total estimated payments would optimize the extent to which 
we could reduce the financial risk to IRFs of caring for high-cost 
patients, while still providing for adequate payments for all other 
(non-high cost outlier) cases.
    Subsequently, we updated the IRF outlier threshold amount in the 
FYs 2006 through 2017 IRF PPS final rules and the FY 2011 and FY 2013 
notices (70 FR 47880, 71 FR 48354, 72 FR 44284, 73 FR 46370, 74 FR 
39762, 75 FR 42836, 76 FR 47836, 76 FR 59256, and 77 FR 44618, 78 FR 
47860, 79 FR 45872, 80 FR 47036, 81 FR 52056, respectively) to maintain 
estimated outlier payments at 3 percent of total estimated payments. We 
also stated in the FY 2009 final rule (73 FR 46370 at 46385) that we 
would continue to analyze the estimated outlier payments for subsequent 
years and adjust the outlier threshold amount as appropriate to 
maintain the 3 percent target.
    To update the IRF outlier threshold amount for FY 2018, we propose 
to use FY 2016 claims data and the same methodology that we used to set 
the initial outlier threshold amount in the

[[Page 20706]]

FY 2002 IRF PPS final rule (66 FR 41316 and 41362 through 41363), which 
is also the same methodology that we used to update the outlier 
threshold amounts for FYs 2006 through 2017. Based on an analysis of 
the preliminary data used for the proposed rule, we estimated that IRF 
outlier payments as a percentage of total estimated payments would be 
approximately 3.0 percent in FY 2017. Therefore, we propose to update 
the outlier threshold amount from $7,984 for FY 2017 to $8,656 for FY 
2018 to maintain estimated outlier payments at approximately 3 percent 
of total estimated aggregate IRF payments for FY 2018.
    Although our analysis shows that we achieved our goal to have 
estimated outlier payments equal 3.0 percent of total IRF payments for 
FY 2017, we still need to adjust the IRF outlier threshold to reflect 
changes in estimated costs and payments for IRFs in FY 2018. That is, 
as discussed previously in this proposed rule, we are proposing to 
increase IRF PPS payment rates by 1.0 percent, in accordance with 
section 1886(j)(3)(C)(iii) of the Act. Similarly, IRF estimated costs 
for FY 2018 are expected to increase. Therefore, we propose to update 
the outlier threshold amount from $7,984 for FY 2017 to $8,656 for FY 
2018 to account for the increases in IRF PPS payments and estimated 
costs, to maintain estimated outlier payments at approximately 3 
percent of total estimated aggregate IRF payments for FY 2018.
    We invite public comment on the proposed update to the FY 2018 
outlier threshold amount to maintain estimated outlier payments at 
approximately 3 percent of total estimated IRF payments.

B. Proposed Update to the IRF Cost-to-Charge Ratio Ceiling and Urban/
Rural Averages

    Cost-to-charge ratios are used to adjust charges from Medicare 
claims to costs and are computed annually from facility-specific data 
obtained from Medicare cost reports. IRF specific cost-to-charge ratios 
are used in the development of the CMG relative weights and the 
calculation of outlier payments under the IRF prospective payment 
system. In accordance with the methodology stated in the FY 2004 IRF 
PPS final rule (68 FR 45674, 45692 through 45694), we propose to apply 
a ceiling to IRFs' CCRs. Using the methodology described in that final 
rule, we propose to update the national urban and rural CCRs for IRFs, 
as well as the national CCR ceiling for FY 2017, based on analysis of 
the most recent data that is available. We apply the national urban and 
rural CCRs in the following situations:
     New IRFs that have not yet submitted their first Medicare 
cost report.
     IRFs whose overall CCR is in excess of the national CCR 
ceiling for FY 2018, as discussed below in this section.
     Other IRFs for which accurate data to calculate an overall 
CCR are not available.
    Specifically, for FY 2018, we propose to estimate a national 
average CCR of 0.516 for rural IRFs, which we calculated by taking an 
average of the CCRs for all rural IRFs using their most recently 
submitted cost report data. Similarly, we propose to estimate a 
national average CCR of 0.416 for urban IRFs, which we calculated by 
taking an average of the CCRs for all urban IRFs using their most 
recently submitted cost report data. We apply weights to both of these 
averages using the IRFs' estimated costs, meaning that the CCRs of IRFs 
with higher total costs factor more heavily into the averages than the 
CCRs of IRFs with lower total costs. For this proposed rule, we have 
used the most recent available cost report data (FY 2015). This 
includes all IRFs whose cost reporting periods begin on or after 
October 1, 2014, and before October 1, 2015. If, for any IRF, the FY 
2015 cost report was missing or had an ``as submitted'' status, we used 
data from a previous fiscal year's (that is, FY 2004 through FY 2014) 
settled cost report for that IRF. We do not use cost report data from 
before FY 2004 for any IRF because changes in IRF utilization since FY 
2004 resulting from the 60 percent rule and IRF medical review 
activities suggest that these older data do not adequately reflect the 
current cost of care.
    In accordance with past practice, we propose to set the national 
CCR ceiling at 3 standard deviations above the mean CCR. Using this 
method, the proposed national CCR ceiling would be 1.28 for FY 2018. 
This means that, if an individual IRF's CCR were to exceed this 
proposed ceiling of 1.28 for FY 2018, we would replace the IRF's CCR 
with the appropriate proposed national average CCR (either rural or 
urban, depending on the geographic location of the IRF). We calculated 
the proposed national CCR ceiling by:
    Step 1. Taking the national average CCR (weighted by each IRF's 
total costs, as previously discussed) of all IRFs for which we have 
sufficient cost report data (both rural and urban IRFs combined).
    Step 2. Estimating the standard deviation of the national average 
CCR computed in step 1.
    Step 3. Multiplying the standard deviation of the national average 
CCR computed in step 2 by a factor of 3 to compute a statistically 
significant reliable ceiling.
    Step 4. Adding the result from step 3 to the national average CCR 
of all IRFs for which we have sufficient cost report data, from step 1.
    The proposed national average rural and urban CCRs and the proposed 
national CCR ceiling in this section will be updated in the final rule 
if more recent data becomes available to use in these analyses.
    We invite public comment on the proposed update to the IRF CCR 
ceiling and the urban/rural averages for FY 2018.

VII. Proposed Removal of the 25 Percent Payment Penalty for IRF-PAI 
Late Submissions

    Under section 1886(j)(2)(D) of the Act, the Secretary is authorized 
to require rehabilitation facilities that provide inpatient hospital 
services to submit such data as the Secretary deems necessary to 
establish and administer the IRF PPS. The timely collection of patient 
data is indispensable for the successful operation of the IRF PPS. A 
comprehensive, reliable system for collecting standardized patient 
assessment data is necessary to assign beneficiaries to the appropriate 
CMGs, to monitor the effects of the IRF PPS on patient care and 
outcomes, and to determine whether adjustments to the CMGs are 
warranted.
    In the FY 2002 IRF PPS final rule (66 FR 41316), we implemented the 
IRF-PAI data collection instrument, through which IRFs are required to 
collect and electronically submit patient data for all Medicare Part A 
FFS patients. IRFs are required to submit their IRF-PAI to CMS through 
its contractor, currently the CMS National Assessment Collection 
Database, in accordance with the requirements in Sec. Sec.  
412.610(c)(2)(i)(B), 412.610(d), and 412.614(c). To encourage timely 
filling, the requirement at Sec.  412.614(d)(1)(ii) provides that 
failure to submit the IRF-PAI on Medicare Part A FFS patients within 
the required deadline would result in the imposition of a 25 percent 
payment penalty.
    The FY 2010 IRF PPS final rule (74 FR 39798 through 39800) expanded 
collection of IRF-PAI data to Medicare Part C (Medicare Advantage) IRF 
patients. IRFs that failed to timely submit IRF-PAIs on their Part C 
patients would forfeit their ability to have any of their Part C data 
used in the calculations for determining their eligibility for 
exclusion under Sec.  412.23(b). We are not

[[Page 20707]]

proposing any changes to the Medicare Part C IRF-PAI submission 
requirements or the consequences of failure to submit complete and 
timely IRF-PAI data for Medicare Part C (Medicare Advantage) patients 
in this proposed rule.
    Effective October 1, 2012, we issued a change request (CR 7760) 
that created a new edit within the Fiscal Intermediary Shared System 
(FISS) for IRF PPS claim submissions. In the event that an IRF attempts 
to submit a Medicare Part-A FFS claim for a patient, and there is not a 
corresponding IRF-PAI for the patient on file to match the claim with, 
the FISS edit will return an error to the IRF provider advising that an 
IRF-PAI needs to be submitted. Since IRFs can now only receive payment 
from Medicare for a Medicare Part-A FFS patient when both an IRF claim 
and an IRF-PAI are submitted and matched accordingly, we believe that 
they will be financially motivated to file a patient's claim and the 
patient's corresponding IRF-PAI in a timely manner. Therefore, we 
believe that the 25 percent payment penalty for late transmission of 
the IRF-PAI is no longer needed to encourage providers to submit data 
to CMS.
    Furthermore, we believe that the 25 percent payment penalty is no 
longer necessary, and we also believe it is placing an unnecessary 
burden on IRFs when they need to apply for a waiver from the penalty. 
Section 412.614(e) enables CMS to waive the 25 percent payment penalty 
in extraordinary situations that are beyond the control of the IRF. 
These include, but are not limited to, fires, floods, earthquakes, or 
similar unusual events that inflect extensive damage to an inpatient 
facility as well as situations in which data transmission issues beyond 
the control of the IRF have made it impossible for the IRF to submit 
IRF-PAIs in the required timeframe. In such instances, IRFs have 
generally filed waiver requests under the waiver provision. We review 
each waiver request on a case-by-case basis and have found that the 
vast majority of the requests that we received since October 2012 met 
the waiver criteria. In such cases, the penalty is waived per Sec.  
412.614(e), the claim is reprocessed, and the IRF is paid for the claim 
in full. Of the approximately 10,000 fee-for-service IRF-PAIs that we 
estimate (based on FY 2015 data) are transmitted late each year, 
amounting to a total payment penalty of approximately $37.6 million per 
year, the vast majority qualify for a waiver under Sec.  412.614(e). 
Thus, based on our review of our records, we have found that the vast 
majority of these cases incurred the expenses of the IRF requesting a 
waiver, CMS reviewing the waiver request, and CMS reprocessing the 
applicable claims. Without the 25 percent payment penalty, this 
process, where the vast majority of cases ultimately meet the waiver 
criteria, would also no longer by necessary.
    We are not proposing any changes to the timely filing requirements 
at Sec.  412.614(c). However, we are proposing to remove the payment 
penalty by revising the following regulations that pertain to the 
application of the 25 percent payment penalty for late transmission of 
the IRF-PAI. These changes would become effective for all discharges 
beginning on or after October 1, 2017.
     Revise Sec.  412.614(d) Consequences of failure to submit 
complete and timely IRF-PAI data.
     Revise Sec.  412.614(d)(1).
     Revise Sec.  412.614(d)(1)(i).
     Reserve Sec.  412.614(d)(1)(ii).
     Revise Sec.  412.614(e) Exemption to the consequences for 
transmitting the IRF-PAI data late. We invite public comment on our 
proposal to remove and revise the regulations pertaining to the 25 
percent payment penalty for late transmission of the IRF-PAI.

VIII. Proposed Revision to the IRF-PAI To Remove the Voluntary Item 27 
(Swallowing Status)

    In the FY 2014 IRF PPS final rule (78 FR 47896 through 47897), we 
removed the voluntary items 25, 26, and 28 from the IRF-PAI as we 
believed that the information should be well documented in the 
patient's medical record at the IRF. We chose not to remove the 
voluntary item 27: Swallowing status, from the IRF-PAI at the time 
because we believed that it was an integral part of the patient's IRF 
care and should continue to be evaluated and monitored.
    In the FY 2016 IRF PPS final rule (80 FR 47113 through 47117), we 
revised the IRF-PAI to include new items that assess functional status 
and the risk factor items. Section K-Swallowing/Nutritional Status, was 
added to the IRF-PAI as a risk adjustor for the functional outcome 
measures. We believe that continuing to collect data for voluntary item 
27: Swallowing status, on the IRF-PAI would be duplicative since the 
new quality item captures very similar data. Furthermore, to the extent 
that such information would be relevant to the provision of patient 
care, this information should be captured in either the transfer 
documentation from the referring physician, or the patient's initial 
assessment documentation. At this time, we no longer believe that 
voluntary item 27 is necessary, and in the interest of reducing burden 
on providers, we are proposing to remove this item from the IRF-PAI for 
all IRF discharges beginning on or after October 1, 2017.
    We invite public comment on our proposal to remove the swallowing 
status item from the IRF-PAI.

IX. Proposed Refinements to the Presumptive Compliance Methodology ICD-
10-CM Diagnosis Codes

A. Background on the IRF 60 Percent Rule

    The compliance percentage has been part of the criteria for 
defining IRFs since implementation of the Inpatient Prospective Payment 
System (IPPS) in 1983. In the FY 2015 IRF PPS final rule (79 FR 45872, 
45891 through 45892), we discussed the development of the compliance 
percentage or the ``60 percent rule.'' We refer readers to that 
discussion for background on the 60 percent rule and the IRF PPS.

B. Enforcement of the IRF 60 Percent Rule

    As described in detail in Chapter 3, section 140.1.3 of the 
Medicare Claims Processing Manual (Pub. 100-04), which is located on 
the Web site at https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-Only-Manuals-IOMs.html, the MACs evaluate IRFs' 
compliance with the 60 percent rule policies annually, using two 
different methods. One of these methods is called the presumptive 
compliance method, and the other method is called the medical review 
method.
1. Presumptive Compliance Method
    The presumptive compliance method is typically the first method 
MACs use to evaluate an IRF's compliance with the 60 percent rule. To 
use the presumptive compliance method, an IRF must first demonstrate 
that it treats a patient population that consists of at least 50 
percent Medicare FFS or MA patients. If it cannot meet this 
requirement, then the MAC is required to evaluate the IRF's compliance 
using the medical review method (described below in this section).
    The presumptive compliance method relies on a computerized 
algorithm that compares lists of diagnosis codes with the diagnosis 
codes that IRFs report on patients' IRF-PAIs. First, the computer 
algorithm compares the impairment group codes (IGCs), which represent 
the primary reason the patient is being treated in the IRF, with the 
list of IGCs that presumptively meets the 60 percent rule requirements 
(which can be

[[Page 20708]]

downloaded from the IRF PPS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Criteria.html). 
If the computer algorithm finds a match, then the computer algorithm 
examines further to determine whether there are any etiologic diagnosis 
exclusions on the list that match with any etiologic diagnosis codes 
(ICD-10-CM codes in item #22 of the IRF-PAI). If the IGC on the IRF-PAI 
matches an IGC that presumptively meets the 60 percent rule 
requirements, and there are no etiologic diagnosis exclusions (or there 
are no matches with the etiologic diagnoses on the IRF-PAI), then the 
case is counted as meeting the requirements. If the IGC on the IRF-PAI 
matches one of the presumptive IGCs, but there is an etiologic 
diagnosis exclusion that matches one of the etiologic diagnoses on the 
IRF-PAI, then the case is not counted as meeting the requirements. If 
the IGC on the IRF-PAI does not match one of the presumptive IGCs, then 
the computer algorithm goes a further step to examine the comorbid 
conditions listed in item #24 on the IRF-PAI. If, in this second step, 
one or more comorbid conditions listed in item #24 match one of the 
ICD-10-CM diagnosis codes (or code combinations) listed on the 
presumptive compliance list (which can also be downloaded from the IRF 
PPS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Criteria.html), then the case is counted 
as presumptively meeting the 60 percent rule requirements. Otherwise, 
the case is not counted as meeting the requirements.
2. Medical Review Method
    The medical review method of determining an IRF's compliance with 
the 60 percent rule requirements must be used if the IRF's Medicare FFS 
and MA population makes up less than 50 percent of its total patient 
population, or for some reason the MAC is unable to generate a valid 
compliance percentage for the IRF using the presumptive compliance 
method, or the IRF fails to meet the 60 percent rule requirements using 
the presumptive compliance method. However, the MAC is always permitted 
to use the medical review method for an IRF if the MAC determines that 
this method will result in the most accurate portrayal of the IRF's 
compliance with the 60 percent rule requirements.
    Under the medical review method, the MAC takes a statistically 
valid random sample of an IRF's claims for the 12-month compliance 
review period, and requests the complete medical records for this 
sample of claims from the IRF. The MAC then reviews this sample of 
medical records to determine whether the IRF is in compliance with the 
60 percent rule requirements.
    Thus, if an IRF fails to meet the requirements according to the 
presumptive compliance method, the MAC must always perform the medical 
review method to determine whether the IRF has met the requirements. An 
IRF cannot fail to meet the requirements based solely on the outcome of 
the presumptive compliance method.

C. Background on the Use of ICD-10-CM Diagnosis Codes in the 
Presumptive Compliance Method

    We developed the presumptive compliance method to simplify the 
process of determining whether an IRF meets the 60 percent rule 
requirements. By using a computerized algorithm that looks for 
diagnosis codes on the IRF-PAI and attempts to match them to diagnosis 
codes on the lists of codes that presumptively meet the requirements, 
the presumptive compliance method can be performed quickly and 
efficiently. However, in order to accurately reflect whether an IRF 
meets the 60 percent rule requirements using the presumptive compliance 
method, we must ensure that the lists of diagnosis codes (IGCs, 
etiologic diagnosis exclusions, and comorbid condition codes) that are 
used in the presumptive compliance method are accurate and updated. 
That is, we must ensure that each code used in the presumptive 
compliance method, if applicable to a given patient, would more than 
likely mean that the patient required intensive rehabilitation services 
in an IRF for treatment of one or more of the conditions specified at 
Sec.  412.29(b)(2) or that they had a comorbidity that caused 
significant decline in functional ability such that, even in the 
absence of the admitting condition, the patient would require the 
intensive rehabilitation treatment.
    To ensure that the diagnosis codes used in the presumptive 
compliance method were accurately reflecting this, in the FY 2014 IRF 
PPS final rule (78 FR 47860, 47879 through 47895), we implemented the 
first updates and revisions in nearly a decade to the list of 
International Classification of Diseases, 9th Revision, Clinical 
Modification (ICD-9-CM) codes then used in determining presumptive 
compliance with the 60 percent rule when we revised the Presumptive 
Methodology list (then, ``ICD-9-CM Codes That Meet Presumptive 
Compliance Criteria''). At the time, our examination found that changes 
over time (including changes in the use of the individual codes, 
changes in clinical practice, changes in the frequency of various types 
of illness and disability, and changes to the application of 60 percent 
rule itself) supported our updating the diagnosis codes that are deemed 
appropriate to count toward a facility's 60 percent rule compliance 
calculation. Such updates ensured that the codes better reflected the 
regulations at Sec.  412.29(b). We performed a clinical analysis of the 
ICD-9-CM Presumptive Methodology code list to determine the clinical 
appropriateness of each individual ICD-9-CM code's inclusion on the 
list, and a statistical analysis of the ICD-9-CM diagnoses code list to 
enhance our understanding of how individual ICD-9-CM codes were being 
used by IRFs. For example, one revision we made was to remove non-
specific codes where we believed more specific codes were available for 
coding. These changes were in line with our overall goal to encourage 
more specific coding on the IRF-PAI.
    As a follow up to the revisions we implemented in the FY 2014 IRF 
PPS final rule, in the FY 2015 IRF PPS final rule (79 FR 45872, 45896 
through 45900), we revised the ICD-9-CM diagnosis codes on the ``IGCs 
That Meet Presumptive Compliance Criteria'' list. An ``impairment group 
code'' is not an ICD diagnosis code, but part of a separate unique set 
of codes specifically developed for the IRF PPS for assigning the 
primary reason for admission to an IRF. Our objective in revising the 
list was to make conforming changes to the IGC list that we had made to 
the Presumptive Methodology list in the FY 2014 IRF PPS final rule. We 
also revised the diagnosis codes listed as exclusions on the ``IGCs 
That Meet Presumptive Compliance Criteria'' list. In the IRF PPS, we 
exclude these diagnosis codes from counting if they are the patient's 
Etiologic Diagnosis (that is, the etiologic problem that led to the 
condition for which the patient is receiving rehabilitation). That is, 
a given IGC that would otherwise meet the presumptive compliance 
criteria will not meet such criteria if the patient has one of the 
``excluded'' Etiologic Diagnoses for that IGC.
    In the FY 2015 IRF PPS final rule (79 FR 45872, 45905 through 
45908), we also finalized our translation of the diagnosis code lists 
from ICD-9-CM to ICD-10-CM, effective for use when ICD-10 would become 
the required medical code data set for use on Medicare claims and IRF-
PAI submissions (which occurred on October 1, 2015). As discussed in 
that

[[Page 20709]]

rule, we translated the ICD-9-CM code lists used in the IRF PPS 
presumptive compliance methodology into ICD-10-CM using the General 
Equivalence Mappings (GEMs) tool. Our intension was to perform a 
straightforward translation of these codes from ICD-9-CM to ICD-10-CM 
using the GEMs tool. That is, we made no policy or clinical analysis of 
the codes under their ICD-10-CM code definition or label, but merely 
registered the ICD-10 diagnosis codes generated through the GEMS tool. 
Our intention in converting the ICD-9-CM diagnosis codes to ICD-10-CM 
diagnosis codes was for the converted codes to reflect the same 
``meaning'' as the original codes. That is, we did not intend to add 
conditions to, or delete conditions from, the ICD-9-CM codes used in 
the IRF PPS at that time.
    To ensure a smooth transition from the use of ICD-9-CM diagnosis 
codes to ICD-10-CM codes for the IRF PPS and to allow for public 
comment on these lists, we proposed and posted to the CMS Web site the 
resulting ICD-10-CM lists. After carefully considering the comments 
that we received on our proposed translation of the ICD-9-CM code lists 
into ICD-10-CM using the GEMs tool, we finalized the ICD-10-CM lists in 
the FY 2015 IRF PPS final rule. The current ICD-10-CM lists are 
available for download from the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Downloads/ICD-10-CM-DataFiles.zip.
    We stated in the FY 2014 and FY 2015 final rules that, after the 
adoption of the ICD-10 medical code set, we would review the lists in 
ICD-10 (once we had enough ICD-10 data available) and make any 
necessary changes to the lists.

D. Proposed Changes to the Presumptive Methodology Diagnosis Code List

    Over the past year, we have performed a comprehensive analysis of 
the presumptive methodology diagnosis code lists in ICD-10-CM. Overall, 
our analysis shows that the process we implemented for updating, 
revising, and converting the ICD-9-CM diagnosis codes to ICD-10-CM (in 
the FY 2014 and FY 2015 final rules) worked as intended. However, our 
analysis indicates that there are areas for improvement. Though we did 
not propose any specific proposals for changes to ICD-10-CM or the 
presumptive compliance criteria in the FY 2017 IRF PPS proposed rule 
(81 FR 24178), we received several miscellaneous public comments on the 
ICD-10-CM diagnosis codes some of which we summarized in the FY 2017 
IRF PPS final rule (81 FR 52132). Our analysis and the public comments 
show the following areas for improvement:
     Issues with ICD-10-CM diagnosis codes that were added to 
the list of IGC exclusions through the ICD-9-CM to ICD-10-CM conversion 
process for patients with traumatic brain injury conditions and hip 
fracture conditions.
     Issues with identification of major multiple trauma codes 
that did not translate exactly from ICD-9-CM to ICD-10-CM.
     Issues with certain non-specific and arthritis diagnosis 
codes that were re-introduced back onto the lists through the ICD-10-CM 
conversion process.
     One ICD-10-CM code, G72.89--Other specified myopathies, 
that we believe is being inappropriately applied.
    Thus, to ensure that the ICD-10-CM diagnosis code lists reflect as 
accurately as possible the relevant conditions that we believe should 
count presumptively toward the 60 percent rule, we are proposing to 
revise the codes on the list. The complete revised lists are posted on 
the IRF PPS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Downloads/ICD-10-CM-DataFiles.zip. 
The proposed revisions discussed below are designed to maximize the 
extent to which the presumptive methodology is in alignment with the 60 
percent rule in Sec.  412.29(b), the policies that we finalized in the 
FY 2014 and FY 2015 IRF PPS final rules (78 FR 47860 and 79 FR 45872, 
respectively), and the ICD-10-CM coding guidelines, ``ICD-10-CM 
Official Guidelines for Coding and Reporting.'' CMS and the National 
Center for Health Statistics (NCHS), provide the guidelines for coding 
and reporting using ICD-10-CM. The current ICD-10-CM coding guidelines 
are located on the CMS Web site at https://www.cms.gov/medicare/coding/icd10/2017-icd-10-cm-and-gems.html.

E. Proposed Revisions Involving Traumatic Brain Injury and Hip Fracture 
Codes

    Our comprehensive review of the ICD-10-CM code lists for the 
presumptive methodology showed that excluded diagnosis codes listed in 
two IGC categories were affected by the ICD-10-CM translation: 
Traumatic brain injury (TBI) and hip fracture(s).
    The excluded diagnosis codes on the IGC list fall into the 
following IGC categories:

 Brain Dysfunction--0002.21 Traumatic, Open Injury
 Brain Dysfunction--0002.22 Traumatic, Closed Injury
 Orthopedic Disorders--0008.11 Status Post Unilateral Hip 
Fracture
 Orthopedic Disorders--0008.12 Status Post Bilateral Hip 
Fractures
1. Traumatic Brain Injury Code Exclusions on the IGC List
    We used the GEMs tool, purely to translate the ICD-9-CM diagnosis 
codes used in the presumptive compliance methodology lists to ICD-10-CM 
diagnosis code lists. We intended the breadth of conditions covered in 
the former would be equivalent to the latter. However, under ICD-10-CM, 
the code labels for certain etiologic diagnoses for traumatic brain 
injuries changed from the meaning of the diagnosis codes for traumatic 
brain injuries under ICD-9-CM. Thus, for this proposed rule, we 
analyzed the ICD-10-CM traumatic brain injury diagnosis codes listed as 
exclusions on the IGC list based on the ICD-10-CM code labels 
(diagnosis descriptions). Based on this analysis, we propose to remove 
some of the traumatic brain injury codes listed as exclusions on the 
IGC list (that is, if listed as an Etiologic Diagnosis on the IRF-PAI, 
these diagnosis codes would count toward the presumptive compliance 
criteria). However, we propose to retain exclusion of ``IGC Brain 
Dysfunction--0002.22 Traumatic, Closed Injury we have retained 
S06.9X9A--Unspecified intracranial injury with loss of consciousness of 
unspecified duration, initial encounter,'' as part of an excluded 
combination diagnosis code (meaning that one code contains more than 
one diagnosis) because we believe other, more specific codes are 
available on the presumptive compliance list that would be more 
appropriate for coding conditions suitable for inclusion in the 
presumptive compliance count for a facility.
2. Hip Fracture(s) Code Exclusions on the IGC List
    In the FY 2014 IRF PPS final rule (78 FR 47860, 47894), we removed 
ICD-9-CM diagnosis codes 820.8--Closed fracture of unspecified part of 
neck of femur, and 820.9--Open fracture of unspecified part of neck of 
femur, from the ICD-9-CM Codes That Meet Presumptive Compliance 
Criteria list. In the FY 2015 IRF PPS final rule (79 FR 45872, 45897), 
we excluded these diagnosis codes from counting if they are the 
patient's Etiologic Diagnosis (that is, the etiologic problem that led 
to the condition for which the patient is receiving rehabilitation) 
under IGC 0008.11--Orthopedic Disorders-Status Post Unilateral Hip 
Fracture, and IGC 0008.12--Orthopedic Disorders-Status Post Bilateral 
Hip Fractures. Also, in the FY 2015 IRF PPS final rule (79 FR

[[Page 20710]]

45872, 458905 through 45908), we adopted the ICD-10 medical code set 
for the IRF PPS, in which we translated these ICD-9-CM diagnosis codes 
to ICD-10-CM diagnosis codes.
    For this proposed rule, we reviewed the IGC ICD-10-CM diagnosis 
code exclusions under IGC 0008.11 and IGC 0008.12. After a thorough 
review of the codes listed as exclusions under these IGCs, we are 
proposing to remove some of the exclusion codes for these two IGCs, to 
allow them to count under the presumptive compliance methodology. In 
the FY 2014 IRF PPS final rule (78 FR 47860, 47885), we agreed with 
commenters that treatment for a femoral neck fracture is the same 
regardless of the level of the fracture line within the capsule of the 
hip or the trochanteric region. During the ICD-10-CM conversion, some 
hip fracture codes were inadvertently added as exclusions to IGC 
0008.11--Orthopedic Disorders-Status Post Unilateral Hip Fracture, and 
IGC 0008.12--Orthopedic Disorders-Status Post Bilateral Hip Fractures. 
Consistent with our decision described in the FY 2014 IRF PPS final 
rule, we are proposing to remove the diagnosis code exclusions for a 
fracture of ``unspecified part of neck of femur.'' However, we are 
proposing to retain the diagnosis code exclusions with the code label, 
``fracture of unspecified part of neck of femur of unspecified femur.'' 
That is, we believe that documentation should support which femur 
(left/right or bilateral) is injured.
    We invite public comment on our proposed revisions involving TBI 
and hip fracture codes.

F. Proposed Revisions Regarding Major Multiple Trauma Codes

    Under ICD-9-CM, diagnosis codes 828.0--Closed multiple fractures 
involving both lower limbs, lower with upper limb, and lower limb(s) 
with rib(s) and sternum, and 828.1--Open multiple fractures involving 
both lower limbs, lower with upper limb, and lower limb(s) with rib(s) 
and sternum, would count a case as meeting the 60 percent rule 
requirements under the presumptive compliance method. However, similar 
codes do not exist in ICD-10-CM. The GEMs tool translates these ICD-9-
CM codes to the ICD-10-CM code of T07--Unspecified multiple injuries. 
IRF providers have communicated to CMS their understanding that they 
would be violating ICD-10-CM Official Guidelines for Coding and 
Reporting if they were to use code T07 for patients with multiple 
fractures, unless they truly do not know where any of the patient's 
fractures are located. The IRFs stated that ICD-10-CM Official 
Guidelines for Coding and Reporting indicates that codes for specific 
bones fractured should be reported. As such, providers state that they 
no longer are able to code for these patients in a manner that allows 
them to count under presumptive compliance. The ICD-10-CM Official 
Guidelines for Coding and Reporting is located on the CMS Web site at 
https://www.cms.gov/medicare/coding/icd10/2017-icd-10-cm-and-gems.html.
    Under the IRF PPS, the GEMs translation provides the following ICD-
10-CM combination codes as eligible codes for multiple trauma cases:

S42.90XA A Fracture of unspecified shoulder girdle, part 
unspecified, initial encounter for closed fracture
S52.90XA A Unspecified fracture of unspecified forearm, initial 
encounter for closed fracture
S22.20XA B Unspecified fracture of sternum, initial encounter for 
closed fracture
S22.49XA C Multiple fractures of ribs, unspecified side, initial 
encounter for closed fracture
S42.91XA A Fracture of right shoulder girdle, part unspecified, 
initial encounter for closed fracture
S52.91XA A Unspecified fracture of right forearm, initial encounter 
for closed fracture
S42.92XA B Fracture of left shoulder girdle, part unspecified, 
initial encounter for closed fracture
S52.92XA B Unspecified fracture of left forearm, initial encounter 
for closed fracture

    However, it is noted that unlike ICD-9-CM codes 828.0--Closed 
multiple fractures involving both lower limbs, lower with upper limb, 
and lower limb(s) with rib(s) and sternum, and 828.1--Open multiple 
fractures involving both lower limbs, lower with upper limb, and lower 
limb(s) with rib(s) and sternum, the IRF PPS ICD-10-CM translation 
provided no codes for the lower extremities as part of multiple 
fractures.
    So that IRFs may appropriately count patients with multiple 
fractures that include lower extremity fractures under the presumptive 
methodology, we propose to count IRF-PAIs that contain 2 or more of the 
ICD-10-CM codes from the three major multiple trauma lists (in the 
specified code combinations) that are located on the CMS Web site at 
https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Downloads/ICD-10-CM-DataFiles.zip. These codes 
would need to be specifically combined so that (a) at least one lower 
extremity fracture is combined with an upper extremity fracture and/or 
a rib/sternum fracture or (b) fractures are present in both lower 
extremities.
    In order for patients with multiple fractures to qualify as meeting 
the 60 percent rule requirement for IRFs under the presumptive 
methodology, the following codes could be used if combined as described 
above:

 List A: Major Multiple Trauma--Lower Extremity Fracture
 List B: Major Multiple Trauma--Upper Extremity Fracture
 List C: Major Multiple Trauma--Ribs and Sternum Fracture

    We also propose to remove ICD-10-CM diagnosis code T07--Unspecified 
multiple injuries from the presumptive methodology list and replace it 
with codes from the three major multiple trauma lists (in the specified 
code combinations), as described above. We believe that any patient who 
suffered multiple trauma and subsequently required admission into an 
IRF would have experienced an extensive medical examination to identify 
the scope of his or her injuries in the acute care setting. After a 
review of the acute care medical record, these injuries would be known 
to both the IRF pre-admission personnel and the admitting IRF 
physician, and would be able to be coded from the medical record in the 
most specific manner possible in the IRF setting.
    We invite public comment on our proposed revisions to the 
presumptive methodology list for major multiple trauma.

G. Proposed Removal of Unspecified Codes and Arthritis Codes

1. Unspecified Codes
    In the FY 2014 IRF PPS final rule (78 FR 47860, 47884 through 
47885), we stated that we believe that highly descriptive coding 
provides the best and clearest way to document the appropriateness of a 
given patient's admission and would improve the accuracy of the 
presumptive compliance method of calculating a facility's 60 percent 
rule compliance percentage. Thus, whenever possible, we believe that 
the most specific code that describes a medical disease, condition, or 
injury should be used to document diagnoses on the IRF-PAI. As we 
stated in that final rule, generally, ``unspecified'' codes are used 
when there is a lack of information about location or severity of 
medical conditions in the medical record. We believe that specific 
diagnosis codes that narrowly identify anatomical sites where disease, 
injury, or condition exist should be used when coding patients' 
conditions on the IRF-PAI whenever such codes are available. Moreover, 
we

[[Page 20711]]

believe that imprecise codes would inappropriately categorize an overly 
broad segment of the patient population as having the conditions 
required for inclusion in a facility's presumptive compliance 
calculation, which would result in an inflated compliance percentage. 
If the IRF does not have enough information about the patient's 
condition to code the more specific codes on the IRF-PAI, we would 
expect the IRF to seek out and document additional information from the 
patient's acute care hospital to determine and submit the appropriate, 
more specific code(s) to use.
    In this proposed rule, we used the same approach in analyzing the 
ICD-10-CM diagnosis codes that we used in our analysis of ICD-9-CM 
diagnosis codes in the FY 2014 IRF PPS final rule. That is, we went 
through each ICD-10-CM code currently on the presumptive compliance 
methodology lists individually to determine whether the ICD-10-CM code 
is sufficiently specific to reliably identify a subset of conditions 
suitable for inclusion in the presumptive methodology compliance 
calculation. If we determined that a given ICD-10-CM code was not 
sufficiently specific, we ascertained whether more specific codes were 
available for use (that could count for the presumptive compliance 
methodology) to identify those members of the patient population with 
conditions that we believe it would be appropriate to include in the 
presumptive methodology compliance calculation. For example, we would 
likely determine that an injury to an unspecified part of the body 
would not be sufficiently specific, but we sought to identify where 
there were codes available (that could count for the presumptive 
compliance methodology) to code that injury for specific locations on 
the body. Now, in light of our findings and consistent with our 
rationale for removing codes in the FY 2014 IRF PPS final rule (78 FR 
47860, 47884 through 47885), we propose to remove certain unspecified 
diagnosis codes that, on review, we believe are inappropriate to 
include in the Presumptive Compliance list. These codes are listed on 
the CMS IRF PPS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Downloads/ICD-10-CM-DataFiles.zip.
    If finalized, we believe that ICD-10-CM codes that provide more 
specific information to describe medical disease, condition, or injury 
would remain available on the presumptive compliance list that 
facilities could use to code cases that should be included in their 
facility's presumptive compliance percentage compliance count. For 
example, we propose to remove the diagnosis code T22.559S--Corrosion of 
first degree of unspecified shoulder, sequela. However, we propose that 
T22.551S--Corrosion of the first degree of right shoulder, sequela and 
T22.552S--Corrosion of first degree of left shoulder, sequela remain on 
the Presumptive List. We believe documentation of anatomic location of 
injury should be readily available in the medical record and that this 
information should be used to appropriately code claims in the 
facility's presumptive methodology percentage using the IRF-PAI.
2. Arthritis Codes
    In the FY 2014 IRF PPS final rule (78 FR 47887 through 47895), we 
finalized the removal of ICD-9-CM diagnosis codes for arthritis 
conditions from the from the ICD-9-CM Codes That Meet Presumptive 
Compliance Criteria list because the inclusion of patients with these 
medical conditions in the presumptive compliance calculation of the 
IRF's compliance percentage is conditioned on those patients meeting 
the described severity and prior treatment requirements. The ICD-9-CM 
diagnosis codes that reflected these arthritis and arthropathy 
conditions did not provide any information about the severity of the 
condition or whether the prior treatment requirements were met. 
Therefore, we stated in the FY 2014 IRF PPS final rule (78 FR 47888) 
that we believe that additional information beyond the presence of the 
code is necessary to determine if the medical record would support 
inclusion of individuals with the arthritis and arthropathy conditions 
outlined in our regulations under Sec.  412.29(b)(2)(x) through (xii) 
in the presumptive compliance calculation of the facility's compliance 
percentage. For this reason, we finalized the removal of the ICD-9-CM 
diagnosis codes associated with the medical conditions outlined under 
Sec.  412.29(b)(2)(x) through (xii) from the list of ICD-9-CM Codes 
That Meet Presumptive Compliance Criteria list.
    Though we removed arthritis diagnosis codes from the ICD-9-CM Codes 
That Meet Presumptive Compliance Criteria list prior to the ICD-9-CM to 
ICD-10-CM conversion process, some ICD-10-CM arthritis codes are listed 
due to the straight translation. However, in analyzing the ICD-10-CM 
diagnosis codes for this proposed rule and consistent with our FY 2014 
IRF PPS final rule rationale for removing ICD-9-CM arthritis diagnosis 
codes from the ICD-9-CM Codes That Meet Presumptive Compliance Criteria 
list, we propose to remove 15 ICD-10-CM diagnosis codes related to 
``rheumatoid polyneuropathy with rheumatoid arthritis.''
    We welcome public comments on our proposed removal of the 
unspecified codes and arthritis codes that were re-introduced back onto 
the lists through the ICD-10-CM conversion process.

H. Proposed Removal of ICD-10-CM Code G72.89--Other Specified 
Myopathies

    Through our monitoring of IRFs' use of the ICD-10-CM codes that 
currently count toward a facility's compliance percentage under the 
presumptive compliance method, we have discovered what we believe to be 
inconsistent use of one ICD-10-CM code (G72.89--Other Specified 
Myopathies) among IRFs. We included this ICD-10-CM code on the 
presumptive compliance code list based on our understanding that it is 
intended to represent a relatively narrow set of specified myopathies 
that are confirmed by the results of specific medical testing and 
identified as such in the patients' medical records. However, having 
reviewed certain IRFs' disproportionately higher use of the code, we 
have found that some IRFs are using this code more broadly, including 
to represent patients with generalized weakness who do not meet the 
requirements in the 60 percent rule under Sec.  412.29(b)(2).
    Therefore, to avoid the improper inclusion of cases that do not 
meet the requirements in the 60 percent rule under Sec.  412.29(b) in 
IRFs' presumptive compliance, we are proposing to remove G72.89--Other 
Specified Myopathies from the presumptive compliance list. If 
finalized, IRFs would not be able to use this code to meet the 60 
percent rule requirements using the presumptive compliance methodology, 
but patients with other specified myopathies that can be verified 
through a review of the patient's medical record would continue to 
count toward an IRF's compliance percentage using the medical review 
method.
    We welcome public comment on our proposal to remove ICD-10-CM code 
G72.89--Other specified myopathies from the presumptive compliance 
list.
    Again, the proposed revised ICD-10-CM Presumptive List and the 
proposed revised IGCs That Meet Presumptive Compliance Criteria list 
are available for download from the CMS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Downloads/ICD-10-CM-DataFiles.zip.

[[Page 20712]]

I. Solicitation of Comments Regarding the Criteria Used To Classify 
Facilities for Payment Under the IRF PPS

    Sections 1886(d)(1)(B) and 1886(d)(1)(B)(ii) of the Act give the 
Secretary discretion in defining a ``rehabilitation unit'' and a 
``rehabilitation hospital'' for payment under the IRF PPS. In 1983, 
when Congress first authorized the Secretary to define IRFs for 
purposes of excluding them from the inpatient prospective payment 
system (IPPS), we used some of the accreditation requirements that were 
used by the Joint Commission on Accreditation of Hospitals (which is 
now known as the Joint Commission) and other accrediting organizations 
to develop our definition of a rehabilitation hospital. We also used 
other criteria that we believed distinguished rehabilitation hospitals 
from other types of hospitals, including the requirement that the 
hospital must be primarily engaged in furnishing intensive 
rehabilitation services as demonstrated by patient medical records 
showing that, during the hospital's most recently completed 12-month 
cost reporting period, at least 75 percent of the hospital's inpatients 
were treated for one or more conditions specified in these regulations 
that typically require intensive inpatient rehabilitation. (48 FR 
39756). We included this requirement, commonly referred to as the 75 
percent rule, as a defining feature of a rehabilitation hospital 
because we believed that examining the types of conditions for which 
the hospital's inpatients are treated, and the proportion of patients 
treated for conditions that typically require intensive inpatient 
rehabilitation, will help distinguish those hospitals in which the 
provisions of rehabilitation services is a primary, rather than a 
secondary, goal. (48 FR 39756).
    The original list of medical conditions used in evaluating this 
requirement were stroke, spinal cord injury, congenital deformity, 
amputation, major multiple trauma, fracture of femur (hip fracture), 
brain injury, and polyarthritis, including rheumatoid arthritis. This 
list of 8 medical conditions was partly based on the information 
contained in a document entitled, ``Sample Screening Criteria for 
Review of Admissions to Comprehensive Medical Rehabilitation Hospitals/
Units,'' produced by the American Academy of Physical Medicine and 
Rehabilitation and the American Congress of Rehabilitation Medicine. On 
January 3, 1984, we published a final rule entitled ``Medicare Program: 
Prospective Payment for Medicare Inpatient Hospital Services'' (49 FR 
234), that expanded the initial list of conditions to include 
neurological disorders (including multiple sclerosis, motor neuron 
diseases, polyneuropathy, muscular dystrophy, and Parkinson's disease) 
and burns, in response to public comment.
    In the FY 2004 IRF PPS proposed rule, we provided additional 
background on how the definition of an IRF developed and evolved over 
time. In that proposed rule, we also discussed the need to use these 
requirements in distinguishing IRFs from other types of inpatient 
facilities and thereby maintaining compliance with sections 
1886(d)(1)(B) and 1886(d)(1)(B)(ii) of the Act. In addition, we stated 
that making this distinction is also critical to fulfilling the 
requirements of section 1886(j)(1)(A), which requires Medicare to make 
payments to IRFs under a PPS specifically designed for the services 
they furnish.
    In the May 7, 2004 final rule, we updated the list of conditions 
used to evaluate compliance with the ``75 percent rule'' from 10 
conditions to 13, and implemented a new presumptive compliance 
methodology, as discussed previously in this proposed rule, to simplify 
the rule and to promote more consistent enforcement. The list of 13 
conditions that were developed in the May 7, 2004 final rule, which is 
still the list that we use to evaluate compliance with the rule, can be 
found in Sec.  412.29(b)(2):
     Stroke.
     Spinal cord injury.
     Congenital deformity.
     Amputation.
     Major multiple trauma.
     Fracture of femur (hip fracture).
     Brain injury.
     Neurological disorders, including multiple sclerosis, 
motor neuron diseases, polyneuropathy, muscular dystrophy, and 
Parkinson's disease.
     Burns.
     Active, polyarticular rheumatoid arthritis, psoriatic 
arthritis, and seronegative arthropathies, under specified conditions 
(see Sec.  412.29(b)(2)(x)).
     Systemic vasculidities with joint inflammation, under 
specified conditions (see Sec.  412.29(b)(2)(xi)).
     Severe or advanced osteoarthritis (osteoarthritis or 
degenerative joint disease), under specified conditions (see Sec.  
412.29(b)(2)(xii)).
     Knee or hip joint replacement, or both, if the 
replacements are bilateral, if the patient is age 85 or older, or if 
the patient have a body mass index (BMI) of at least 50.
    Subsequent to the May 7, 2004 final rule, on June 16, 2005, the 
Government Accountability Office (GAO) issued a report entitled, ``More 
Specific Criteria Needed to Classify Inpatient Rehabilitation 
Facilities,'' which recommended that CMS describe more thoroughly the 
subgroups of patients within a condition that require IRF services, 
possibly using functional status or other factors in addition to 
condition. In this report, the GAO did not recommend that more 
conditions be added to the list of conditions in Sec.  412.29(b)(2), in 
part because the experts convened for this study could not agree on 
conditions to add and in part because the GAO said that it believed 
that the rule should instead be ``refined to clarify which types of 
patients should be in IRFs as opposed to another setting.''
    In addition, in September 2009, we issued a Report to Congress 
entitled ``Analysis of the Classification Criteria for Inpatient 
Rehabilitation Facilities.'' This report was required by section 115 of 
MMSEA, which also required the IRF compliance rate to be set no higher 
than 60 percent and required comorbidities to continue to be included 
in the compliance rate calculation. In conducting the analysis for this 
report, the contractor (Research Triangle Institute International 
(RTI)) solicited public comments and held a technical expert panel 
(TEP) to analyze the effects of, and potential refinements to, the 60 
percent rule and the list of conditions that are used to evaluate 
compliance with the 60 percent rule. The report generally concluded the 
following:
     In considering changes to the 60 percent rule, CMS should 
establish policies that ensure the availability of IRF services to 
beneficiaries whose intensive rehabilitation needs cannot be adequately 
served in other settings.
     CMS should ensure that criteria for IRF classification 
focus on the intensity of service needs that justify the higher IRF 
payment rate.
     An IRF stay is not needed for all patients having a 
rehabilitation-type diagnosis.
     Patient characteristics, such as medical comorbidities, 
prognosis for improvement and cognitive deficits, are important to 
consider when identifying appropriate IRF patients.
    Thus, to assist us in generating ideas and information for 
analyzing refinements and updates to the criteria used to classify 
facilities for payment under the IRF PPS, we are specifically 
soliciting public comments from stakeholders on the 60 percent rule, 
including but not limited to, the list of conditions in Sec.  
412.29(b)(2).

[[Page 20713]]

X. Proposed Subregulatory Process for Certain Updates to Presumptive 
Methodology Diagnosis Code Lists

    We have not established a formal process for updating the code 
lists used for the presumptive compliance methodology to account for 
changes to the ICD-10 medical code data set or to alert providers to 
the effects of these changes on the presumptive methodology code lists. 
In this proposed rule, we propose to establish such a formal process, 
to distinguish between non-substantive updates to the ICD-10-CM codes 
on the lists that would be applied through a sub-regulatory process and 
substantive revisions to the ICD-10-CM codes on the lists that would 
only be proposed and finalized through notice and comment rulemaking.
    In this proposed rule, we are proposing to establish a formal 
process of updating the lists of ICD-10-CM codes used in the 
presumptive compliance methodology using a subregulatory process to 
apply non-substantive changes to the lists of ICD-10-CM codes used in 
the presumptive compliance methodology in accordance with changes to 
the ICD-10 medical data codes set that are implemented annually by the 
ICD-10 Coordination and Maintenance Committee (information about the 
ICD-10 Coordination and Maintenance Committee can be found at https://www.cdc.gov/nchs/icd/icd10_maintenance.htm). We would continue our 
practice of using notice-and-comment rulemaking to propose and finalize 
substantive changes to the lists of ICD-10-CM codes used in the 
presumptive methodology.
    The ICD-10 Coordination and Maintenance Committee is a federal 
interdepartmental committee that is chaired by representatives from the 
NCHS and by representatives from CMS. The committee typically meets bi-
annually, and publishes updates to the ICD-10 medical code data sets in 
June of each year, which become effective October 1 of each year. Note 
that the ICD-10 Coordination and Maintenance Committee has the ability 
to make changes to the ICD-10 medical code data sets effective on April 
1, but has not yet done so. In accordance with 45 CFR part 162, subpart 
J, we require Medicare providers to use the most current ICD-10 medical 
code data set in coding Medicare claims and IRF-PAIs.
    To ensure that the lists of ICD-10-CM codes used in the presumptive 
compliance methodology are updated in accordance with changes to the 
ICD-10 medical code data set, we propose to obtain the list of changes 
to the ICD-10 medical code data set from the ICD-10 Coordination and 
Maintenance Committee (at https://www.cdc.gov/nchs/icd/icd10_maintenance.htm) and, through a subregulatory process, apply all 
relevant changes to the lists of codes used in the presumptive 
compliance methodology. Any such changes would be limited to those 
specific changes that are necessary to maintain consistency with the 
most current ICD-10 medical code data set, which Medicare providers are 
generally required to use in accordance with 45 CFR part 162, subpart 
J. Our intent in applying these changes through the proposed 
subregulatory process would be to keep the same conditions on the 
presumptive methodology lists, but ensure that the codes used to 
identify those conditions are synchronized with the most current ICD-10 
medical code data set.
    We propose to publish the updated lists of codes on the IRF PPS Web 
site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Criteria.html before the effective date for these 
changes so that IRFs will be able to use the most current ICD-10 
medical code data set to appropriately count cases toward meeting the 
60 percent rule requirements under the presumptive compliance 
methodology.
    For example, ICD-10-CM code M50.02--Cervical disc disorder with 
myelopathy, mid-cervical region--is one of the ICD-10-CM codes on the 
presumptive compliance methodology list that ``counts'' a patient as 
meeting the 60 percent rule requirements if the patient is coded with 
this diagnosis code. However, effective October 1, 2016, the ICD-10 
Coordination and Maintenance Committee made M50.02 an ``invalid'' code, 
meaning that this code is no longer available for use within the ICD-10 
medical code data set. In place of this code, the ICD-10 Coordination 
and Maintenance Committee added:

 M50.020--Cervical disc disorder with myelopathy, mid-cervical 
region, unspecified level (new code),
 M50.021--Cervical disc disorder at C4-C5 level with myelopathy 
(new code)
 M50.022--Cervical disc disorder at C5-C6 level with myelopathy 
(new code)
 M50.023--Cervical disc disorder at C6-C7 level with myelopathy 
(new code)

As we did not have a process for updating the ICD-10-CM codes in the 
presumptive compliance methodology prior to October 1, 2016, we were 
unable to reflect this change in the presumptive compliance methodology 
and therefore only counted patients that had M50.02 on their IRF-PAI 
submission and were not able to recognize codes M50.020, M50.021, 
M50.022, or M50.023 in the presumptive compliance methodology. Thus, an 
IRF that adopted the changes to the ICD-10 medical code data set on 
October 1, 2016, as required, and coded a patient with, for example, 
M5.023, would not have that patient counted as meeting the 60 percent 
rule requirements under the presumptive compliance methodology (unless 
the patient happened to have another ICD-10-CM code that would have 
counted under the presumptive compliance methodology). The update 
process that we are proposing in this proposed rule would enable us to 
remove the invalid code M50.02 and add the new codes M50.020, M50.021, 
M50.022, and M50.023 to the lists of codes used in the presumptive 
compliance methodology prior to the effective date of the change 
(October 1, 2016) so that an IRF's appropriate use of the newly added 
code M50.023 would allow the patient to count as meeting the 60 percent 
rule requirements.
    We note that, in the example above, we would not make any policy 
judgments in adopting the changes to the ICD-10 medical code data set 
through subregulatory means. Whether or not we believed, for example, 
that M50.020 might be too non-specific to include in the presumptive 
compliance methodology, we would nevertheless add it through this 
subregulatory process because we would treat M50.020, M50.021, M50.022, 
and M50.023 exactly the same as the M50.02 code that they replaced. We 
would simply replace the invalid code with the four new valid codes. 
If, hypothetically speaking, we were to decide at a later date that 
M50.020 is too non-specific and would therefore want to remove it from 
the presumptive compliance lists, we would consider that to be a 
substantive change that would necessitate notice and comment 
rulemaking. Any substantive changes to the lists of codes used in the 
presumptive compliance methodology would be promulgated through notice 
and comment rulemaking.
    In the FY 2007 IRF PPS final rule (71 FR 48354 at 48360 through 
48361), we implemented the same subregulatory updating process for the 
IRF tier comorbidities list (also a list of ICD-10-CM codes) that we 
are proposing to implement for the lists of ICD-10-CM codes used in the 
presumptive compliance methodology. As we

[[Page 20714]]

discussed in that final rule, we believe that the best way for us to 
convey information about changes to the ICD-10 medical code data set 
that affect the presumptive compliance lists and alert providers to 
non-substantive program changes that result is to update the lists 
using a subregulatory process and make the documents containing the 
program's lists of ICD-10-CM codes web-based, rather than publishing 
each non-substantive change to the ICD-10-CM codes in regulation. We 
believe that this would ensure providers have the most up-to-date 
information possible for their 60 percent compliance purposes. 
Therefore, we are proposing that each year's updated lists of ICD-10-CM 
codes for presumptive compliance methodology will be available on the 
IRF PPS Web site (located at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Data-Files.html) prior to the 
effective date of the changes to the ICD-10 medical code data set.
    The current proposed presumptive compliance lists are available for 
download from the IRF PPS Web site https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Data-Files.html) 
prior to the effective date of the changes to the ICD-10 medical code 
data set.
    The current proposed presumptive compliance lists are available for 
download from the IRF PPS Web site at https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Downloads/ICD-10-CM-DataFiles.zip. These lists reflect the proposed substantive 
revisions outlined in this proposed rule, as well as adoption of the 
ICD-10 Coordination and Maintenance Committee's draft changes to the 
ICD-10 medical code data sets, effective October 1, 2017. The version 
of these lists that is finalized in conjunction with the FY 2018 IRF 
PPS final rule will constitute the baseline for any future updates to 
the presumptive methodology lists.
    We invite public comment on the proposed subregulatory process for 
certain updates to the presumptive methodology ICD-10-CM code lists.

XI. Proposed Use of IRF-PAI Data To Determine Patient Body Mass Index 
(BMI) Greater Than 50 for Cases of Lower Extremity Single Joint 
Replacement

    Previously, we had no information from the IRF-PAI that we could 
use to calculate the BMI for patients. Thus, we were not able to count 
lower-extremity joint replacement patients with BMI greater than 50 as 
meeting the 60 percent rule requirements using the presumptive 
compliance methodology. We could only identify these specific patients 
using the medical review methodology.
    In the FY 2014 IRF PPS final rule (78 FR 47860, 47896 and 47899), 
we added Item 25A--Height and Item 26A--Weight to the IRF-PAI. This 
information can be used to calculate BMI and thereby provides the data 
necessary to presumptively identify and count lower extremity single 
joint replacement cases with a BMI greater than 50 in an IRF's 60 
percent rule compliance percentage. In this proposed rule, we propose 
to use the information recorded for Item 25A--Height and Item 26A--
Weight on the IRF-PAI in the calculation of a patient BMI greater than 
50 and to use that data to determine and presumptively count lower 
extremity single joint replacement cases toward an IRF's compliance 
percentage.
    We invite public comment on the proposed plan to calculate BMI 
greater than 50 for cases of lower extremity single joint replacement.

XII. Proposed Revisions and Updates to the IRF Quality Reporting 
Program (QRP)

A. Background and Statutory Authority

    Section 3004(b) of the Affordable Care Act amended section 1886(j) 
of the Act by adding paragraph (7), requiring the Secretary to 
establish the IRF QRP. This program applies to freestanding IRFs, as 
well as IRF units affiliated with either acute care facilities or 
critical access hospitals. Beginning with the FY 2014 IRF QRP, the 
Secretary is required to reduce any annual update to the standard 
federal rate for discharges occurring during such fiscal year by 2 
percentage points for any IRF that does not comply with the 
requirements established by the Secretary. Section 1886(j)(7) of the 
Act requires that for the FY 2014 IRF QRP, each IRF submit data on 
quality measures specified by the Secretary in a form and manner, and 
at a time, specified by the Secretary. For more information on the 
statutory history of the IRF QRP, please refer to the FY 2015 IRF PPS 
final rule (79 FR 45908).
    Please note that term ``FY [year] IRF QRP'' refers to the fiscal 
year for which the IRF QRP requirements applicable to that fiscal year 
must be met for a IRF to receive the full annual update when 
calculating the payment rates applicable to it for that fiscal year.
    The Improving Medicare Post-Acute Care Transformation Act of 2014 
(IMPACT Act) amended Title XVIII of the Act, in part, by adding a new 
section 1899B, entitled ``Standardized Post-Acute Care (PAC) Assessment 
Data for Quality, Payment and Discharge Planning,'' that enacts new 
data reporting requirements for certain post-acute care (PAC) 
providers, including IRFs. Specifically, sections 1899B(a)(1)(A)(ii) 
and (iii) of the Act require IRFs, long-term care hospitals (LTCHs), 
skilled nursing facilities (SNFs) and home health agencies (HHAs), 
under their respective quality reporting program (which, for IRFs, is 
found at section 1886(m)(7)), to report data on quality measures 
specified under section 1899B(c)(1), which in turn requires that the 
measures cover at least five domains, and data on resource use and 
other measures specified under section 1899B(d)(1), which in turn 
requires that the measures cover at least three domains. Section 
1899B(a)(1)(A)(i) further requires each of these PAC providers to 
report under their respective quality reporting program standardized 
patient assessment data in accordance with section (b), which requires 
that the data be for at least the quality measures specified under 
section (c)(1) and that is for five specific categories: Functional 
status; cognitive function and mental status; special services, 
treatments, and interventions; medical conditions and co-morbidities; 
and impairments. All of the data that must be reported in accordance 
with section 1899B(a)(1)(A) must be standardized and interoperable so 
as to allow for the exchange of the information among PAC providers and 
other providers and the use of such data in order to enable access to 
longitudinal information and to facilitate coordinated care. For 
information on the IMPACT Act, please refer to the FY 2016 IRF PPS 
final rule (80 FR 47080 through 47083).

B. General Considerations Used for Selection of Quality Measures for 
the IRF QRP

    For a detailed discussion of the considerations we use for the 
selection of IRF QRP quality measures, such as alignment with the CMS 
Quality Strategy,\1\ which incorporates the three broad aims of the 
National Quality Strategy,\2\ please refer to the FY 2015 IRF PPS final 
rule (79 FR 45911) and the FY 2016 IRF PPS final rule (80 FR 47083 
through 47084).
---------------------------------------------------------------------------

    \1\ http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/CMS-Quality-Strategy.html.
    \2\ http://www.ahrq.gov/workingforquality/nqs/nqs2011annlrpt.htm.
---------------------------------------------------------------------------

    As part of our consideration for measures for use in the IRF QRP, 
we review and evaluate measures that have been implemented in other 
programs

[[Page 20715]]

and take into account measures that have been endorsed by NQF for 
provider settings other than the IRF setting. We have previously 
adopted measures with the term ``Application of'' in the names of those 
measures. We have received questions pertaining to the term 
``application'' and want to clarify that when we refer to a measure as 
an ``application of'' the measure, it means that the measure will be 
used in the IRF setting, rather than the setting for which it was 
endorsed by the NQF. For example, in the FY 2016 IRF PPS final rule (80 
FR 47096 through 47100), we adopted an Application of Percent of 
Residents Experiencing One or More Falls With Major Injury (Long Stay) 
(NQF #0674), which is endorsed for the nursing home setting, but not 
for the IRF setting. For such measures, we intend to seek NQF 
endorsement for the IRF setting, and if the NQF endorses one or more of 
them, we will update the title of the measure to remove the reference 
to ``application.''
1. Accounting for Social Risk Factors in the IRF QRP
    We consider related factors that may affect measures in the IRF 
QRP. We understand that social risk factors such as income, education, 
race and ethnicity, employment, disability, community resources, and 
social support (certain factors of which are also sometimes referred to 
as socioeconomic status (SES) factors or socio-demographic status (SDS) 
factors) play a major role in health. One of our core objectives is to 
improve beneficiary outcomes, including reducing health disparities, 
and we want to ensure that all beneficiaries, including those with 
social risk factors, receive high quality care. In addition, we seek to 
ensure that the quality of care furnished by providers and suppliers is 
assessed as fairly as possible under our programs while ensuring that 
beneficiaries have adequate access to excellent care.
    We have been reviewing reports prepared by the Office of the 
Assistant Secretary for Planning and Evaluation (ASPE \3\) and the 
National Academies of Sciences, Engineering, and Medicine on the issue 
of measuring and accounting for social risk factors in CMS' value-based 
purchasing and quality reporting programs, and considering options on 
how to address the issue in these programs. On December 21, 2016, ASPE 
submitted a Report to Congress on a study it was required to conduct 
under section 2(d) of the Improving Medicare Post-Acute Care 
Transformation (IMPACT) Act of 2014. The study analyzed the effects of 
certain social risk factors of Medicare beneficiaries on quality 
measures and measures of resource use used in one or more of nine 
Medicare value-based purchasing programs.\4\ The report also included 
considerations for strategies to account for social risk factors in 
these programs. In a January 10, 2017 report released by The National 
Academies of Sciences, Engineering, and Medicine, that body provided 
various potential methods for measuring and accounting for social risk 
factors, including stratified public reporting.\5\
---------------------------------------------------------------------------

    \3\ https://aspe.hhs.gov/pdf-report/report-congress-social-risk-factors-and-performance-under-medicares-value-based-purchasing-programs.
    \4\ https://aspe.hhs.gov/pdf-report/report-congress-social-risk-factors-and-performance-under-medicares-value-based-purchasing-programs.
    \5\ National Academies of Sciences, Engineering, and Medicine. 
2017. Accounting for social risk factors in Medicare payment. 
Washington, DC: The National Academies Press.
---------------------------------------------------------------------------

    As discussed in the FY 2017 IRF PPS final rule, the NQF has 
undertaken a 2-year trial period in which new measures, measures 
undergoing maintenance review and measures endorsed with the condition 
that they enter the trial period can be assessed to determine whether 
risk adjustment for selected social risk factors is appropriate for 
these measures. Measures from the IRF QRP are being addressed in this 
trial. This trial entails temporarily allowing inclusion of social risk 
factors in the risk-adjustment approach for these measures. At the 
conclusion of the trial, NQF will issue recommendations on the future 
inclusion of social risk factors in risk adjustment for quality 
measures.
    As we continue to consider the analyses and recommendations from 
these reports and await the results of the NQF trial on risk adjustment 
for quality measures, we are continuing to work with stakeholders in 
this process. As we previously communicated, we are concerned about 
holding providers to different standards for the outcomes of their 
patients with social risk factors because we do not want to mask 
potential disparities or minimize incentives to improve the outcomes 
for disadvantaged populations. Keeping this concern in mind, while we 
sought input on this topic previously, we continue to seek public 
comment on whether we should account for social risk factors in 
measures in the IRF QRP, and if so, what method or combination of 
methods would be most appropriate for accounting for social risk 
factors. Examples of methods include: Confidential reporting to 
providers of measure rates stratified by social risk factors, public 
reporting of stratified measure rates, and potential risk adjustment of 
a particular measure as appropriate based on data and evidence.
    In addition, we are also seeking public comment on which social 
risk factors might be most appropriate for reporting stratified measure 
scores and/or potential risk adjustment of a particular measure. 
Examples of social risk factors include, but are not limited to, dual 
eligibility/low-income subsidy, race and ethnicity, and geographic area 
of residence. We are seeking comments on which of these factors, 
including current data sources where this information would be 
available, could be used alone or in combination, and whether other 
data should be collected to better capture the effects of social risk. 
We will take commenters' input into consideration as we continue to 
assess the appropriateness and feasibility of accounting for social 
risk factors in the IRF QRP. We note that any such changes would be 
proposed through future notice and comment rulemaking.
    We look forward to working with stakeholders as we consider the 
issue of accounting for social risk factors and reducing health 
disparities in CMS programs. Of note, implementing any of the above 
methods would be taken into consideration in the context of how this 
and other CMS programs operate (for example, data submission methods, 
availability of data, statistical considerations relating to 
reliability of data calculations, among others), so we also welcome 
comment on operational considerations. We are committed to ensuring 
that beneficiaries have access to and receive excellent care, and that 
the quality of care furnished by providers and suppliers is assessed 
fairly in CMS programs.

C. Proposed Collection of Standardized Patient Assessment Data Under 
the IRF QRP

1. Proposed Definition of Standardized Patient Assessment Data
    Section 1886(j)(7)(F)(ii) of the Act requires that for fiscal year 
2019 and each subsequent year, IRFs report standardized patient 
assessment data required under section 1899B(b)(1) of the Act. For 
purposes of meeting this requirement, section 1886(j)(7)(F)(iii) of the 
Act requires an IRF to submit the standardized patient assessment data 
required under section 1899B(b)(1) of the Act using the standard 
instrument in a time, form, and manner specified by the Secretary.
    Section 1899B(b)(1)(B) of the Act describes standardized patient 
assessment data as data required for at

[[Page 20716]]

least the quality measures described in section 1899B(c)(1) of the Act 
and that is for the following categories:
     Functional status, such as mobility and self-care at 
admission to a PAC provider and before discharge from a PAC provider;
     Cognitive function, such as ability to express ideas and 
to understand and mental status, such as depression and dementia;
     Special services, treatments and interventions such as the 
need for ventilator use, dialysis, chemotherapy, central line placement 
and total parenteral nutrition (TPN);
     Medical conditions and co-morbidities such as diabetes, 
congestive heart failure and pressure ulcers;
     Impairments, such as incontinence and an impaired ability 
to hear, see or swallow; and
     Other categories deemed necessary and appropriate.

As required under section 1899B(b)(1)(A) of the Act, the standardized 
patient assessment data must be reported at least for IRF admissions 
and discharges, but the Secretary may require the data to be reported 
more frequently.
    In this rule, we are proposing to define the standardized patient 
assessment data that IRFs must report to comply with section 
1886(j)(7)(F)(ii) of the Act, as well as the requirements for the 
reporting of these data. The collection of standardized patient 
assessment data is critical to our efforts to drive improvement in 
healthcare quality across the four post-acute care (PAC) settings to 
which the IMPACT Act applies. We intend to use these data for a number 
of purposes, including facilitating their exchange and longitudinal use 
among healthcare providers to enable high quality care and outcomes 
through care coordination, as well as for quality measure calculations, 
and identifying comorbidities that might increase the medical 
complexity of a particular admission.
    IRFs are currently required to report patient assessment data 
through the IRF-PAI by responding to an identical set of assessment 
questions using an identical set of response options (we refer to each 
solitary question/response option as a data element and we refer to a 
group of questions/responses as data elements), both of which 
incorporate an identical set of definitions and standards. The primary 
purpose of the identical questions and response options is to ensure 
that we collect a set of standardized data elements across IRFs which 
can then be used for a number of purposes, including IRF payment and 
measure calculation for the IRF QRP.
    LTCHs, skilled nursing facilities (SNFs), and home health 
associations (HHAs) are also required to report patient assessment data 
through their applicable PAC assessment instruments, and they do so by 
responding to identical assessment questions developed for their 
respective settings using an identical set of response options (which 
incorporate an identical set of definitions and standards). Like the 
IRF-PAI, the questions and response options for each of these other PAC 
assessment instruments are standardized across the PAC provider type to 
which the PAC assessment instrument applies. However, the assessment 
questions and response options in the four PAC assessment instruments 
are not currently standardized with each other. As a result, questions 
and response options that appear on the IRF-PAI cannot be readily 
compared with questions and response options that appear, for example, 
on the MDS, the PAC assessment instrument used by SNFs. This is true 
even when the questions and response options are similar. This lack of 
standardization across the four PAC providers has limited our ability 
to compare one PAC provider type with another for purposes such as care 
coordination and quality improvement.
    To achieve a level of standardization across SNFs, LTCHs, IRFs, and 
HHAs that enables us to make comparisons between them, we are proposing 
to define ``standardized patient assessment data'' as patient 
assessment questions and response options that are identical in all 
four PAC assessment instruments, and to which identical standards and 
definitions apply. Standardizing the questions and response options 
across the four PAC assessment instruments will also enable the data to 
be interoperable, allowing it to be shared electronically, or 
otherwise, between PAC provider types. It will enable the data to be 
comparable for various purposes, including the development of cross-
setting quality measures and to inform payment models that take into 
account patient characteristics rather than setting, as described in 
the IMPACT Act.
    We are inviting public comment on this proposed definition.
2. General Considerations Used for the Selection of Proposed 
Standardized Patient Assessment Data
    As part of our effort to identify appropriate standardized patient 
assessment data for purposes of collecting under the IRF QRP, we sought 
input from the general public, stakeholder community, and subject 
matter experts on items that would enable person-centered, high quality 
health care, as well as access to longitudinal information to 
facilitate coordinated care and improved beneficiary outcomes.
    To identify optimal data elements for standardization, our data 
element contractor organized teams of researchers for each category, 
and each team worked with a group of advisors made up of clinicians and 
academic researchers with expertise in PAC. Information-gathering 
activities were used to identify data elements, as well as key themes 
related to the categories described in section 1899B(b)(1)(B) of the 
Act. In January and February 2016, our data element contractor also 
conducted provider focus groups for each of the four PAC provider 
types, and a focus group for consumers that included current or former 
PAC patients and residents, caregivers, ombudsmen, and patient advocacy 
group representatives. The Development and Maintenance of Post-Acute 
Care Cross-Setting Standardized Patient Assessment Data Focus Group 
Summary Report is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Our data element contractor also assembled a 16-member TEP that met 
on April 7 and 8, 2016, and January 5 and 6, 2017, in Baltimore, 
Maryland, to provide expert input on data elements that are currently 
in each PAC assessment instrument, as well as data elements that could 
be standardized. The Development and Maintenance of Post-Acute Care 
Cross-Setting Standardized Patient Assessment Data TEP Summary Reports 
are available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    As part of the environmental scan, data elements currently in the 
four existing PAC assessment instruments were examined to see if any 
could be considered for proposal as standardized patient assessment 
data. Specifically, this evaluation included consideration of data 
elements in OASIS-C2 (effective January 2017); IRF-PAI, v1.4 (effective 
October 2016); LCDS, v3.00 (effective April 2016); and MDS 3.0, v1.14 
(effective October 2016). Data elements

[[Page 20717]]

in the standardized assessment instrument that we tested in the Post-
Acute Care Payment Reform Demonstration (PAC PRD)--the Continuity 
Assessment Record and Evaluation (CARE) were also considered. A 
literature search was also conducted to determine whether additional 
data elements to propose as standardized patient assessment data could 
be identified.
    We additionally held four Special Open Door Forums (SODFs) on 
October 27, 2015; May 12, 2016; September 15, 2016; and December 8, 
2016, to present data elements we were considering and to solicit 
input. At each SODF, some stakeholders provided immediate input, and 
all were invited to submit additional comments via the CMS IMPACT 
Mailbox at [email protected].
    We also convened a meeting with federal agency subject matter 
experts (SMEs) on May 13, 2016. In addition, a public comment period 
was open from August 12, to September 12, 2016, to solicit comments on 
detailed candidate data element descriptions, data collection methods, 
and coding methods. The IMPACT Act Public Comment Summary Report 
containing the public comments (summarized and verbatim) and our 
responses is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We specifically sought to identify standardized patient assessment 
data that we could feasibly incorporate into the LTCH, IRF, SNF, and 
HHA assessment instruments and that have the following attributes: (1) 
Being supported by current science; (2) testing well in terms of their 
reliability and validity, consistent with findings from the Post-Acute 
Care Payment Reform Demonstration (PAC PRD); (3) the potential to be 
shared (for example, through interoperable means) among PAC and other 
provider types to facilitate efficient care coordination and improved 
beneficiary outcomes; (4) the potential to inform the development of 
quality, resource use and other measures, as well as future payment 
methodologies that could more directly take into account individual 
beneficiary health characteristics; and (5) the ability to be used by 
practitioners to inform their clinical decision and care planning 
activities. We also applied the same considerations that we apply with 
quality measures, including the CMS Quality Strategy which is framed 
using the three broad aims of the National Quality Strategy.

D. Policy for Retaining IRF QRP Measures and Proposal To Apply That 
Policy to Standardized Patient Assessment Data

    In the CY 2013 Hospital Outpatient Prospective Payment System/
Ambulatory Surgical Center (OPPS/ASC) Payment Systems and Quality 
Reporting Programs final rule (77 FR 68500 through 68507), we adopted a 
policy that allows any quality measure adopted for use in the IRF QRP 
to remain in effect until the measure is removed, suspended, or 
replaced. For further information on how measures are considered for 
removal, suspension, or replacement, please refer to the CY 2013 OPPS/
ASC final rule (77 FR 68500). We propose to apply this policy to the 
standardized patient assessment data that we adopt for the IRF QRP.
    We are inviting public comment on our proposal.

E. Policy for Adopting Changes to IRF QRP Measures and Proposal To 
Apply That Policy to Standardized Patient Assessment Data

    In the CY 2013 OPPS/ASC final rule (77 FR 68500 through 68507), we 
adopted a subregulatory process to incorporate updates to IRF quality 
measure specifications that do not substantively change the nature of 
the measure. Substantive changes will be proposed and finalized through 
rulemaking. For further information on what constitutes a substantive 
versus a non-substantive change and the subregulatory process for non-
substantive changes, please refer to the CY 2013 OPPS/ASC final rule 
(77 FR 68500). We propose to apply this policy to the standardized 
patient assessment data that we adopt for the IRF QRP.
    We are inviting public comment on our proposal.

F. Quality Measures Currently Adopted for the IRF QRP

    The IRF QRP currently has 18 currently adopted measures, as 
outlined in Table 7.

       Table 7--Quality Measures Currently Adopted for the IRF QRP
------------------------------------------------------------------------
            Short name                  Measure name and data source
------------------------------------------------------------------------
                                 IRF-PAI
------------------------------------------------------------------------
Pressure Ulcers...................  Percent of Residents or Patients
                                     with Pressure Ulcers That Are New
                                     or Worsened (Short Stay) (NQF
                                     #0678).
Patient Influenza Vaccine.........  Percent of Residents or Patients Who
                                     Were Assessed and Appropriately
                                     Given the Seasonal Influenza
                                     Vaccine (Short Stay) (NQF #0680).
Application of Falls..............  Application of Percent of Residents
                                     Experiencing One or More Falls with
                                     Major Injury (Long Stay) (NQF
                                     #0674).*
Application of Functional           Application of Percent of LTCH
 Assessment.                         Patients with an Admission and
                                     Discharge Functional Assessment and
                                     a Care Plan That Addresses Function
                                     (NQF #2631).*
Change in Self-Care...............  IRF Functional Outcome Measure:
                                     Change in Self-Care Score for
                                     Medical Rehabilitation Patients
                                     (NQF #2633).**
Change in Mobility................  IRF Functional Outcome Measure:
                                     Change in Mobility Score for
                                     Medical Rehabilitation Patients
                                     (NQF #2634).**
Discharge Self-Care Score.........  IRF Functional Outcome Measure:
                                     Discharge Self-Care Score for
                                     Medical Rehabilitation Patients
                                     (NQF #2635).**
Discharge Mobility Score..........  IRF Functional Outcome Measure:
                                     Discharge Mobility Score for
                                     Medical Rehabilitation Patients
                                     (NQF #2636).**
DRR...............................  Drug Regimen Review Conducted with
                                     Follow-Up for Identified Issues--
                                     PAC IRF QRP.*
------------------------------------------------------------------------
                                  NHSN
------------------------------------------------------------------------
CAUTI.............................  National Healthcare Safety Network
                                     (NHSN) Catheter-Associated Urinary
                                     Tract Infection (CAUTI) Outcome
                                     Measure (NQF #0138).

[[Page 20718]]

 
MRSA..............................  NHSN Facility-Wide Inpatient
                                     Hospital-Onset Methicillin-
                                     Resistant Staphylococcus aureus
                                     (MRSA) Bacteremia Outcome Measure
                                     (NQF #1716).
CDI...............................  NHSN Facility-wide Inpatient
                                     Hospital-Onset Clostridium
                                     difficile Infection (CDI) Outcome
                                     Measure (NQF #1717).
HCP Influenza Vaccine.............  Influenza Vaccination Coverage among
                                     Healthcare Personnel (NQF #0431).
------------------------------------------------------------------------
                              Claims-based
------------------------------------------------------------------------
All-Cause Readmissions............  All-Cause Unplanned Readmission
                                     Measure for 30 Days Post Discharge
                                     from IRFs (NQF #2502).
MSPB..............................  Medicare Spending per Beneficiary
                                     (MSPB)--PAC IRF QRP.*
DTC...............................  Discharge to Community--PAC IRF
                                     QRP.*
Potentially Preventable             Potentially Preventable 30-Day Post-
 Readmissions (PPR) 30 day.          Discharge Readmission Measure for
                                     IRF QRP.*
PPR Within Stay...................  Potentially Preventable Within Stay
                                     Readmission Measure for IRFs.*
------------------------------------------------------------------------
* Not currently NQF-endorsed for the IRF setting.
** In satisfaction of section 1899B(c)(1) of the Act quality measure
  domain: Functional status, cognitive function, and changes in function
  and cognitive function domain.

G. IRF QRP Quality Measures Proposed Beginning With the FY 2020 IRF QRP

    Beginning with the FY 2020 IRF QRP, in addition to the quality 
measures we are retaining under our policy described in section XII.F. 
of this proposed rule, we are proposing to remove the current pressure 
ulcer measure entitled Percent of Residents or Patients with Pressure 
Ulcers That Are New or Worsened (Short Stay) (NQF #0678) and to replace 
it with a modified version of the measure entitled Changes in Skin 
Integrity Post-Acute Care: Pressure Ulcer/Injury. We are also proposing 
to characterize the data elements described below as standardized 
patient assessment data under section 1899B(b)(1)(B) of the Act that 
must be reported by IRFs under the IRF QRP through the IRF-PAI.
1. Proposal To Replace the Current Pressure Ulcer Quality Measure, 
Percent of Residents or Patients With Pressure Ulcers That Are New or 
Worsened (Short Stay) (NQF #0678), With a Modified Pressure Ulcer 
Measure, Changes in Skin Integrity Post-Acute Care: Pressure Ulcer/
Injury
a. Measure Background
    In this proposed rule, we are proposing to remove the current 
pressure ulcer measure, Percent of Residents or Patients with Pressure 
Ulcers That Are New or Worsened (Short Stay) (NQF #0678), from the IRF 
QRP measure set and to replace it with a modified version of that 
measure, Changes in Skin Integrity Post-Acute Care: Pressure Ulcer/
Injury, beginning with the FY 2020 IRF QRP. The change in the measure 
name is to reduce confusion about the new modified measure. The 
modified version differs from the current version of the measure 
because it includes new or worsened unstageable pressure ulcers, 
including deep tissue injuries (DTIs), in the measure numerator. The 
proposed modified version of the measure also contains updated 
specifications intended to eliminate redundancies in the assessment 
items needed for its calculation and to reduce the potential for 
underestimating the frequency of pressure ulcers. The modified version 
of the measure would satisfy the IMPACT Act domain of skin integrity 
and changes in skin integrity.
b. Measure Importance
    As described in the FY 2012 IRF PPS final rule (76 FR 47876 through 
47878), pressure ulcers are high-cost adverse events and are an 
important measure of quality. For information on the history and 
rationale for the relevance, importance, and applicability of having a 
pressure ulcer measure in the IRF QRP, we refer readers to the FY 2012 
IRF PPS final rule (76 FR 47876 through 47878) and the FY 2014 IRF PPS 
final rule (78 FR 47911 through 47912).
    We are proposing to adopt a modified version of the current 
pressure ulcer measure because unstageable pressure ulcers, including 
DTIs, are similar to Stage 2, Stage 3, and Stage 4 pressure ulcers in 
that they represent poor outcomes, are a serious medical condition that 
can result in death and disability, are debilitating and painful, and 
are often an avoidable outcome of medical care.6 7 8 9 10 11 
Studies show that most pressure ulcers can be avoided and can also be 
healed in acute, post-acute, and long-term care settings with 
appropriate medical care.\12\ Furthermore, some studies indicate that 
DTIs, if managed using appropriate care, can be resolved without 
deteriorating into a worsened pressure ulcer.13 14
---------------------------------------------------------------------------

    \6\ Casey, G. (2013). ``Pressure ulcers reflect quality of 
nursing care.'' Nurs N Z 19(10): 20-24.
    \7\ Gorzoni, M.L. and S.L. Pires (2011). ``Deaths in nursing 
homes.'' Rev Assoc Med Bras 57(3): 327-331.
    \8\ Thomas, J.M., et al. (2013). ``Systematic review: health-
related characteristics of elderly hospitalized adults and nursing 
home residents associated with short-term mortality.'' J Am Geriatr 
Soc 61(6): 902-911.
    \9\ White-Chu, E.F., et al. (2011). ``Pressure ulcers in long-
term care.'' Clin Geriatr Med 27(2): 241-258.
    \10\ Bates-Jensen BM. Quality indicators for prevention and 
management of pressure ulcers in vulnerable elders. Ann Int Med. 
2001;135 (8 Part 2), 744-51.
    \11\ Bennet, G, Dealy, C Posnett, J (2004). The cost of pressure 
ulcers in the UK, Age and Aging, 33(3):230-235.
    \12\ Black, Joyce M., et al. ``Pressure ulcers: avoidable or 
unavoidable? Results of the national pressure ulcer advisory panel 
consensus conference.'' Ostomy-Wound Management 57.2 (2011): 24.
    \13\ Sullivan, R. (2013). A Two-year Retrospective Review of 
Suspected Deep Tissue Injury Evolution in Adult Acute Care Patients. 
Ostomy Wound Management 59(9).
    \14\ Posthauer, ME, Zulkowski, K. (2005). Special to OWM: The 
NPUAP Dual Mission Conference: Reaching Consensus on Staging and 
Deep Tissue Injury. Ostomy Wound Management 51(4) http://www.o-wm.com/content/the-npuap-dual-mission-conference-reaching-consensus-staging-and-deep-tissue-injury.
---------------------------------------------------------------------------

    While there are few studies that provide information regarding the 
incidence of unstageable pressure ulcers in PAC settings, an analysis 
conducted by a contractor suggests the incidence of unstageable 
pressure ulcers varies according to the type of unstageable pressure 
ulcer and setting. This analysis examined the national incidence of new 
unstageable pressure ulcers in IRFs at discharge compared with 
admission using IRF discharges from January through December 2015. The 
contractor found a national incidence of 0.14 percent of new 
unstageable pressure ulcers due to slough and/or eschar, 0.02

[[Page 20719]]

percent of new unstageable pressure ulcers due to non-removable 
dressing/device, and 0.26 percent of new DTIs. In addition, an 
international study spanning the time period 2006 to 2009 provides some 
evidence to suggest that the proportion of pressure ulcers identified 
as DTI has increased over time. The study found DTIs increased by three 
fold, to 9 percent of all observed ulcers in 2009, and that DTIs were 
more prevalent than either Stage 3 or 4 ulcers. During the same time 
period, the proportion of Stage 1 and 2 ulcers decreased, and the 
proportion of Stage 3 and 4 ulcers remained constant.\15\
---------------------------------------------------------------------------

    \15\ VanGilder, C, MacFarlane, GD, Harrison, P, Lachenbruch, C, 
Meyer, S (2010). The Demographics of Suspected Deep Tissue Injury in 
the United States: An Analysis of the International Pressure Ulcer 
Prevalence Survey 2006-2009. Advances in Skin & Wound Care. 23(6): 
254-261.
---------------------------------------------------------------------------

    The inclusion of unstageable pressure ulcers, including DTIs, in 
the numerator of this measure is expected to increase measure scores 
and variability in measure scores, thereby improving the ability to 
discriminate among poor- and high-performing IRFs. In the currently 
implemented pressure ulcer measure, Percent of Residents or Patients 
with Pressure Ulcers That Are New or Worsened (Short Stay) (NQF #0678), 
analysis using data from Quarter 4 2016 reveals that the IRF mean score 
is 0.64 percent and the 25th and 75th percentiles are 0 percent and 
0.95 percent, respectively. In the proposed measure, Changes in Skin 
Integrity Post-Acute Care: Pressure Ulcer/Injury, during the same 
timeframe, the IRF mean score is 1.46 percent and the 25th and 75th 
percentiles are 0 percent and 2.27 percent, respectively.
c. Stakeholder Feedback
    Our measure development contractor sought input from subject matter 
experts, including Technical Expert Panels (TEPs), over the course of 
several years on various skin integrity topics and specifically those 
associated with the inclusion of unstageable pressure ulcers, including 
DTIs. Most recently, on July 18, 2016, a TEP convened by our measure 
development contractor provided input on the technical specifications 
of this proposed quality measure, including the feasibility of 
implementing the proposed measure's updates across PAC settings. The 
TEP supported the updates to the measure across PAC settings, including 
the inclusion in the numerator of unstageable pressure ulcers due to 
slough and/or eschar that are new or worsened, new unstageable pressure 
ulcers due to a non-removable dressing or device, and new DTIs. The TEP 
also supported the use of different data elements for measure 
calculation. The TEP recommended supplying additional guidance to 
providers regarding each type of unstageable pressure ulcer. This 
support was in agreement with earlier TEP meetings, held on June 13 and 
November 15, 2013, which had recommended that we update the 
specifications for the pressure ulcer measure to include unstageable 
pressure ulcers in the numerator.\16\ \17\ Exploratory data analysis 
conducted by our measure development contractor suggests that the 
addition of unstageable pressure ulcers, including DTIs, will increase 
the observed incidence and variation in the rate of new or worsened 
pressure ulcers at the facility level, which may improve the ability of 
the proposed quality measure to discriminate between poor- and high-
performing facilities.
---------------------------------------------------------------------------

    \16\ Schwartz, M., Nguyen, K.H., Swinson Evans, T.M., Ignaczak, 
M.K., Thaker, S., and Bernard, S.L.: Development of a Cross-Setting 
Quality Measure for Pressure Ulcers: OY2 Information Gathering, 
Final Report. Centers for Medicare & Medicaid Services, November 
2013. Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Development-of-a-Cross-Setting-Quality-Measure-for-Pressure-Ulcers-Information-Gathering-Final-Report.pdf.
    \17\ Schwartz, M., Ignaczak, M.K., Swinson Evans, T.M., Thaker, 
S., and Smith, L.: The Development of a Cross-Setting Pressure Ulcer 
Quality Measure: Summary Report on November 15, 2013, Technical 
Expert Panel Follow-Up Webinar. Centers for Medicare & Medicaid 
Services, January 2014. Available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/Downloads/Development-of-a-Cross-Setting-Pressure-Ulcer-Quality-Measure-Summary-Report-on-November-15-2013-Technical-Expert-Pa.pdf.
---------------------------------------------------------------------------

    We solicited stakeholder feedback on this proposed measure by means 
of a public comment period held from October 17 through November 17, 
2016. In general, we received considerable support for the proposed 
measure. A few commenters supported all of the changes to the current 
pressure ulcer measure that resulted in the proposed measure, with one 
commenter noting the significance of the work to align the pressure 
ulcer quality measure specifications across the PAC settings.
    Many commenters supported the inclusion of unstageable pressure 
ulcers due to slough/eschar, due to non-removable dressing/device, and 
DTIs in the proposed quality measure. Other commenters did not support 
the inclusion of DTIs in the proposed quality measure because they 
stated that there is no universally accepted definition for this type 
of skin injury.
    Some commenters provided feedback on the data elements used to 
calculate the proposed quality measure. We believe that these data 
elements will promote facilitation of cross-setting quality comparison 
as mandated by the IMPACT Act, alignment between quality measures and 
payment, reduction in redundancies in assessment items, and prevention 
of inappropriate underestimation of pressure ulcers. The currently 
implemented pressure ulcer measure is calculated using retrospective 
data elements that assess the number of new or worsened pressure ulcers 
at each stage, while the proposed measure is calculated using the 
number of unhealed pressure ulcers at each stage after subtracting the 
number that were present upon admission. Some commenters did not 
support the data elements that would be used to calculate the proposed 
measure and requested further testing of these data elements. Other 
commenters supported the use of these data elements, stating that these 
data elements simplified the measure calculation process.
    The public comment summary report for the proposed measure is 
available on the CMS Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html. 
This summary includes further detail about our responses to various 
concerns and ideas stakeholders raised.
    The NQF-convened Measures Application Partnership (MAP) Post-Acute 
Care/Long-Term Care (PAC/LTC) Workgroup met on December 14 and 15, 
2016, and the MAP Coordinating Committee met on January 24 and 25, 
2017, and provided input to CMS about this proposed measure. The MAP 
provided a recommendation of ``conditional support for rulemaking'' for 
use of the proposed measure in the IRF QRP. The MAP's conditions of 
support include that, as a part of measure implementation, we provide 
guidance on the correct collection and calculation of the measure 
result, as well as guidance on public reporting Web sites explaining 
the impact of the specification changes on the measure result. The 
MAP's conditions also specify that we continue analyzing the proposed 
measure in order to investigate unexpected results reported in public 
comment. We intend to fulfill these conditions by offering additional 
training opportunities and educational materials in advance of public 
reporting, and by continuing to monitor and analyze the proposed 
measure. More information about the MAP's recommendations for this 
measure is

[[Page 20720]]

available at http://www.qualityforum.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=84452.
    We reviewed the NQF's consensus endorsed measures and were unable 
to identify any NQF-endorsed pressure ulcer quality measures for PAC 
settings that are inclusive of unstageable pressure ulcers. There are 
related measures, but after careful review, we determined these 
measures are not applicable for use in IRFs based on the populations 
addressed or other aspects of the specifications. We are unaware of any 
other such quality measures that have been endorsed or adopted by 
another consensus organization for the IRF setting. Therefore, based on 
the evidence discussed above, we are proposing to adopt the quality 
measure entitled, Changes in Skin Integrity Post-Acute Care: Pressure 
Ulcer/Injury, for the IRF QRP beginning with the FY 2020 IRF QRP. We 
plan to submit the proposed measure to the NQF for endorsement 
consideration as soon as feasible.
d. Data Collection
    The data for this quality measure would be collected using the IRF-
PAI, which is currently submitted by IRFs through the Quality 
Improvement and Evaluation System (QIES) Assessment Submission and 
Processing (ASAP) System. The proposed standardized patient assessment 
admission and discharge data applicable to this measure that must be 
reported by IRFs for patients discharged on or after October 1, 2018 is 
described in section XII.K of this proposed rule. While the inclusion 
of unstageable wounds in the proposed measure results in a measure 
calculation methodology that is different from the methodology used to 
calculate the current pressure ulcer measure, the data elements needed 
to calculate the proposed measure are already included on the IRF-PAI. 
In addition, our proposal to eliminate duplicative data elements that 
were used in calculation of the current pressure ulcer measure will 
result in an overall reduced reporting burden for IRFs for the proposed 
measure. To view the updated IRF-PAI, with the changes, we refer the 
reader to https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-PAI-and-IRF-QRP-Manual.html. For more information on IRF-PAI submission using the QIES 
ASAP System, we refer readers to https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/IRFPAI.html and http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/index.html.
    For technical information about this proposed measure, including 
information about the measure calculation and the standardized patient 
assessment data elements used to calculate this measure, we refer 
readers to the document titled, Proposed Specifications for IRF QRP 
Quality Measures and Standardized Data Elements, available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Program-Measures-Information-.html.
    We are proposing that IRFs would begin reporting the proposed 
pressure ulcer measure Changes in Skin Integrity Post-Acute Care: 
Pressure Ulcer/Injury, which will replace the current pressure ulcer 
measure, with data collection beginning October 1, 2018.
    We are inviting public comment on our proposal to replace the 
current pressure ulcer measure, Percent of Residents or Patients with 
Pressure Ulcers That Are New or Worsened (Short Stay) (NQF #0678), with 
a modified version of that measure, entitled Changes in Skin Integrity 
Post-Acute Care: Pressure Ulcer/Injury, for the IRF QRP beginning with 
the FY 2020 IRF QRP.

H. Proposed Removal of the All-Cause Unplanned Readmission Measure for 
30 Days Post-Discharge From IRFs From the IRF QRP

    We are proposing to remove the All-Cause Unplanned Readmission 
Measure for 30 Days Post-Discharge from IRFs (NQF #2502) from the IRF 
QRP.
    In the FY 2016 IRF PPS final rule (80 FR 47087 through 47089), we 
adopted the All-Cause Unplanned Readmission Measure for 30 Days Post-
Discharge from IRFs (NQF #2502) for the IRF QRP. This measure assesses 
all-cause unplanned hospital readmissions from IRFs. In the FY 2017 IRF 
PPS final rule (81 FR 52103 through 52108), we adopted the Potentially 
Preventable 30-Day Post-Discharge Readmission Measure for IRF QRP to 
fulfill IMPACT Act requirements. We also adopted the Potentially 
Preventable Within Stay Readmission Measure for IRFs (81 FR 52108 
through 52111) for the IRF QRP. In response to the FY 2017 IRF PPS 
proposed rule, we received public comments expressing concern over the 
multiplicity of readmission measures and the overlap between the All-
Cause Readmission and Potentially Preventable Readmission (PPR) 30-Day 
Post-Discharge measures (see 81 FR 52106; 81 FR 52109 through 52111). 
Commenters also commented that multiple readmission measures would 
create confusion and require additional effort by providers to track 
and improve performance.
    We retained the All-Cause Readmission measure because it would 
allow us to monitor trends in both all-cause and PPR rates. In 
particular, we could compare facility performance on the All-Cause 
Readmission and PPR 30-Day Post-Discharge measures. However, upon 
further consideration of the public comments, we believe that removing 
the All-Cause Readmission measure and retaining the PPR 30-Day Post-
Discharge measure in the IRF QRP would prevent duplication, because 
potentially preventable readmissions are a subset of all-cause 
readmissions. Although there is no data collection burden associated 
with these claims-based measures, we recognize that having 3 hospital 
readmission measures in the IRF QRP may create confusion. We also agree 
with commenters who preferred the PPR measures, which identify a subset 
of all-cause readmissions, because we believe the PPR measures will be 
more actionable for quality improvement.
    We are proposing to remove the All-Cause Readmission measure 
beginning with the FY 2019 IRF QRP. We are proposing that public 
reporting of this measure would end by October 2018 when public 
reporting of the PPR 30-Day Post-Discharge and PPR Within Stay measures 
begins by October 2018. We refer readers to section XII.N of this 
proposed rule for more information regarding our proposal to publicly 
report the PPR 30-Day Post Discharge and PPR Within Stay measures. We 
refer readers to the PPR 30-Day Post-Discharge and PPR Within Stay 
measure specifications available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/Downloads/Measure-Specifications-for-FY17-IRF-QRP-Final-Rule.pdf.
    We are inviting public comment on our proposal to remove the All-
Cause Unplanned Readmission Measure for 30 Days Post-Discharge from 
IRFs (NQF #2502) from the IRF QRP, beginning with the FY 2019 IRF QRP.

I. IRF QRP Quality Measures Under Consideration for Future Years

    We are inviting public comment on the importance, relevance, 
appropriateness, and applicability of each of the quality measures 
listed in Table 8 for future years in the IRF QRP.
    In this proposed rule, we are soliciting public comments on the use 
of survey-based experience of care

[[Page 20721]]

measures for the IRF QRP. We are currently developing an experience of 
care survey for IRFs, and survey-based measures will be developed from 
this survey. These survey-based measures may be considered for 
inclusion in the IRF QRP through future notice-and-comment rulemaking. 
This survey was developed using a rigorous survey development 
methodology that included a public request for measures (refer to 
Request for Information To Aid in the Design and Development of a 
Survey Regarding Patient and Family Member Experiences With Care 
Received in Inpatient Rehabilitation Facilities, at 80 FR 72726 through 
72727); focus groups and interviews with patients, family members, and 
caregivers; input from a TEP of IRF providers, researchers, and patient 
advocates; and cognitive interviewing. The survey has also been field 
tested. The survey explores experience of care across five main areas: 
(1) Beginning stay at the rehabilitation hospital/unit; (2) 
interactions with staff; (3) experience during the rehabilitation 
hospital/unit stay; (4) preparing for leaving the rehabilitation 
hospital/unit; and (5) overall rehabilitation hospital/unit rating. We 
are specifically interested in comments regarding survey implementation 
and logistics, use of the survey-based measures in the IRF QRP, and 
general feedback. We are also considering a measure focused on pain 
that relies on the collection of patient-reported pain data. We are 
inviting public comment on the possible inclusion of such a measure in 
future years of the IRF QRP.
1. IMPACT Act Measure--Possible Future Update To Measure Specifications
    In the FY 2017 IRF PPS final rule (81 FR 52095 through 52103), we 
finalized the Discharge to Community-PAC IRF QRP measure, which 
assesses successful discharge to the community from an IRF setting, 
with successful discharge to the community including no unplanned 
rehospitalizations and no death in the 31 days following discharge from 
the IRF. We received public comments (see 81 FR 52098 through 52099), 
recommending exclusion of baseline nursing facility residents from the 
measure, as these residents did not live in the community prior to 
their IRF stay. At that time, we highlighted that using Medicare FFS 
claims alone, we were unable to accurately identify baseline nursing 
facility residents. We stated that potential future modifications of 
the measure could include assessment of the feasibility and impact of 
excluding baseline nursing facility residents from the measure through 
the addition of patient assessment-based data. In response to these 
public comments, we are considering a future modification of the 
Discharge to Community-PAC IRF QRP measure, which would exclude 
baseline nursing facility residents from the measure. We are inviting 
public comment on the possible exclusion of baseline nursing facility 
residents from the Discharge to Community-PAC IRF QRP measure in future 
years of the IRF QRP.
2. IMPACT Act Implementation Update
    As a result of the input and suggestions provided by technical 
experts at the TEPs held by our measure developer, and through public 
comment, we are engaging in additional development work, including 
performing additional testing, for two measures that would satisfy the 
domain of accurately communicating the existence of and providing for 
the transfer of health information and care preferences in section 
1899B(c)(1)(E) of the Act. The measures under development are (1) 
Transfer of Information at Post-Acute Care Admission, Start or 
Resumption of Care from other Providers/Settings, and (2) Transfer of 
Information at Post-Acute Care Discharge, and End of Care to other 
Providers/Settings. We intend to specify these measures under section 
1899B(c)(1)(E) of the Act no later than October 1, 2018, and we intend 
to propose to adopt them for the FY 2021 IRF QRP, with data collection 
beginning on or about October 1, 2019.

 Table 8--IRF QRP Quality Measures Under Consideration for Future Years
------------------------------------------------------------------------
           NQS priority             Patient- and caregiver-centered care
------------------------------------------------------------------------
Measures..........................   Experience of Care.
                                     Application of Percent of
                                     Residents Who Self-Report Moderate
                                     to Severe Pain (Short Stay) (NQF
                                     #0676).
                                   -------------------------------------
                                     Communication and care coordination
                                   -------------------------------------
Measure...........................   Modification of the
                                     Discharge to Community-Post Acute
                                     Care Inpatient Rehabilitation
                                     Facility Quality Reporting Program
                                     measure.
------------------------------------------------------------------------

J. Proposed Standardized Patient Assessment Data Reporting for the IRF 
QRP

1. Proposed Standardized Patient Assessment Data Reporting for the FY 
2019 IRF QRP
    Section 1886(j)(7)(F)(ii) of the Act requires that for fiscal year 
2019 and each subsequent year, IRFs report standardized patient 
assessment data required under section 1899B(b)(1) of the Act. As we 
describe in more detail above, we are proposing that the current 
pressure ulcer measure, Percent of Residents or Patients with Pressure 
Ulcers That Are New or Worsened (Short Stay) (NQF #0678), be removed 
and replaced with the proposed pressure ulcer measure, Changes in Skin 
Integrity Post-Acute Care: Pressure Ulcer/Injury, beginning with the FY 
2020 IRF QRP. The current pressure ulcer measure will remain in the IRF 
QRP until that time. Accordingly, for the requirement that IRFs report 
standardized patient assessment data for the FY 2019 IRF QRP, we are 
proposing that the data elements used to calculate the current pressure 
ulcer measure, Percent of Residents or Patients with Pressure Ulcers 
That Are New or Worsened (Short Stay) (NQF #0678) meet the definition 
of standardized patient assessment data for medical conditions and co-
morbidities under section 1899B(b)(1)(B)(iv) of the Act, and that the 
successful reporting of that data under section 1886(j)(7)(F)(i) of the 
Act for admissions as well as discharges occurring during fourth 
quarter CY 2017 would also satisfy the requirement to report 
standardized patient assessment data for the FY 2019 IRF QRP.
    The collection of assessment data pertaining to skin integrity, 
specifically pressure related wounds, is important for multiple 
reasons. Clinical decision support, care planning, and quality 
improvement all depend on reliable assessment data collection. Pressure

[[Page 20722]]

related wounds represent poor outcomes, are a serious medical condition 
that can result in death and disability, are debilitating, painful and 
are often an avoidable outcome of medical 
care.18 19 20 21 22 23 Pressure related wounds are 
considered healthcare acquired conditions.
---------------------------------------------------------------------------

    \18\ Casey, G. (2013). ``Pressure ulcers reflect quality of 
nursing care.'' Nurs N Z 19(10): 20-24.
    \19\ Gorzoni, M.L. and S.L. Pires (2011). ``Deaths in nursing 
homes.'' Rev Assoc Med Bras 57(3): 327-331.
    \20\ Thomas, J.M., et al. (2013). ``Systematic review: health-
related characteristics of elderly hospitalized adults and nursing 
home residents associated with short-term mortality.'' J Am Geriatr 
Soc 61(6): 902-911.
    \21\ White-Chu, E.F., et al. (2011). ``Pressure ulcers in long-
term care.'' Clin Geriatr Med 27(2): 241-258.
    \22\ Bates-Jensen BM. Quality indicators for prevention and 
management of pressure ulcers in vulnerable elders. Ann Int Med. 
2001;135 (8 Part 2), 744-51.
    \23\ Bennet, G, Dealy, C Posnett, J (2004). The cost of pressure 
ulcers in the UK, Age and Aging, 33(3):230-235.
---------------------------------------------------------------------------

    As we note above, the data elements needed to calculate the current 
pressure ulcer measure are already included on the IRF-PAI and reported 
for IRFs, and exhibit validity and reliability for use across PAC 
providers. Item reliability for these data elements was also tested for 
the nursing home setting during implementation of MDS 3.0. Testing 
results are from the RAND Development and Validation of MDS 3.0 
project.\24\ The RAND pilot test of the MDS 3.0 data elements showed 
good reliability and is also applicable to both the IRF-PAI and the 
LTCH CARE Data Set because the data elements tested are the same. 
Across the pressure ulcer data elements, the average gold-standard 
nurse to gold-standard nurse kappa statistic was 0.905. The average 
gold-standard nurse to facility-nurse kappa statistic was 0.937. Data 
elements used to risk adjust this quality measure were also tested 
under this same pilot test, and the gold-standard to gold-standard 
kappa statistic, or percent agreement (where kappa statistic not 
available), ranged from 0.91 to 0.99 for these data elements. These 
kappa scores indicate ``almost perfect'' agreement using the Landis and 
Koch standard for strength of agreement.\25\
---------------------------------------------------------------------------

    \24\ Saliba, D., & Buchanan, J. (2008, April). Development and 
validation of a revised nursing home assessment tool: MDS 3.0. 
Contract No. 500-00-0027/Task Order #2. Santa Monica, CA: Rand 
Corporation. Retrieved from http://www.cms.hhs.gov/NursingHomeQualityInits/Downloads/MDS30FinalReport.pdf.
    \25\ Landis, R., & Koch, G. (1977, March). The measurement of 
observer agreement for categorical data. Biometrics 33(1), 159-174.
---------------------------------------------------------------------------

    The data elements used to calculate the current pressure ulcer 
measure received public comment on several occasions, including when 
that measure was proposed in the FY 2012 IRF PPS (76 FR 47876) and 
IPPS/LTCH PPS proposed rules (76 FR 51754). Further, they were 
discussed in the past by TEPs held by our measure development 
contractor on June 13 and November 15, 2013, and recently by a TEP on 
July 18, 2016. TEP members supported the measure and its cross-setting 
use in PAC. The report, Technical Expert Panel Summary Report: 
Refinement of the Percent of Patients or Residents with Pressure Ulcers 
that are New or Worsened (Short-Stay) (NQF #0678) Quality Measure for 
Skilled Nursing Facilities (SNFs), Inpatient Rehabilitation Facilities 
(IRFs), Long-Term Care Hospitals (LTCHs), and Home Health Agencies 
(HHAs)'' is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We are inviting public comment on this proposal.
2. Proposed Standardized Patient Assessment Data Reporting Beginning 
With the FY 2020 IRF QRP
    We describe below in this section our proposals for the reporting 
of standardized patient assessment data by IRFs beginning with the FY 
2020 IRF QRP. For FY 2020, this would apply to all Medicare Part A and 
MA patients discharged between October 1, 2018 and December 31, 2018. 
IRFs would be required to report these data on admission and discharge, 
with the exception of three data elements (Brief Interview of Mental 
Status (BIMS), Hearing, and Vision) that would be collected on 
admission only. The BIMS, Hearing, and Vision data elements would be 
assessed at admission only due to the relatively stable nature of the 
types of cognitive function, hearing impairment, and vision impairment, 
making it unlikely that these assessments would change between the 
start and end of the IRF stay. Assessment of the BIMS, Hearing, and 
Vision data elements at discharge would introduce additional burden 
without improving the quality or usefulness of the data, and is 
unnecessary. Following the initial reporting year for the FY 2020 IRF 
QRP, subsequent years for the IRF QRP would be based on a full calendar 
year of such data reporting.
    In selecting the data elements described below in this section, we 
carefully weighed the balance of burden in assessment-based data 
collection and aimed to minimize additional burden through the 
utilization of existing data in the assessment instruments. We also 
note that the patient and resident assessment instruments are 
considered part of the medical record and sought the inclusion of data 
elements relevant to patient care.
    We also took into consideration the following factors for each data 
element: Overall clinical relevance; ability to support clinical 
decisions, care planning, and interoperable exchange to facilitate care 
coordination during transitions in care; and the ability to capture 
medical complexity and risk factors that can inform both payment and 
quality. Additionally the data elements had to have strong scientific 
reliability and validity; be meaningful enough to inform longitudinal 
analysis by providers; had to have received general consensus agreement 
for its usability; and had to have the ability to collect such data 
once but support multiple uses. Further, to inform the final set of 
data elements for proposal, we took into account technical and clinical 
subject matter expert review, public comment, and consensus input in 
which such principles were applied. We also took into account the 
consensus work and empirical findings from the Post-Acute Care Payment 
Reform Demonstration. We acknowledge that during the development 
process that led to these proposals, some providers expressed concern 
that changes to the IRF-PAI to accommodate standardized patient 
assessment data reporting would lead to an overall increased reporting 
burden. However, we note that there is no additional data collection 
burden for standardized data already collected and submitted on the 
quality measures.
a. Proposed Standardized Patient Assessment Data by Category
(1) Functional Status Data
    We are proposing that the data elements currently reported by IRFs 
to calculate the proposed measure, Application of Percent of Long-Term 
Care Hospital Patients with an Admission and Discharge Functional 
Assessment and a Care Plan That Addresses Function (NQF #2631), would 
also meet the definition of standardized patient assessment data for 
functional status under section 1899B(b)(1)(B)(i) of the Act, and that 
the successful reporting of that data under section 1886(j)(7)(F)(i) of 
the Act would also satisfy the requirement to report standardized 
patient assessment data under section 1886(j)(7)(F)(ii) of the Act.
    These patient assessment data for functional status are from the 
CARE Item Set. The development of the CARE Item Set and a description 
and rationale for each item is described in a report

[[Page 20723]]

entitled ``The Development and Testing of the Continuity Assessment 
Record and Evaluation (CARE) Item Set: Final Report on the Development 
of the CARE Item Set: Volume 1 of 3.'' \26\ Reliability and validity 
testing were conducted as part of CMS' Post-Acute Care Payment Reform 
Demonstration, and we concluded that the functional status items have 
acceptable reliability and validity. A description of the testing 
methodology and results are available in several reports, including the 
report entitled ``The Development and Testing of the Continuity 
Assessment Record And Evaluation (CARE) Item Set: Final Report On 
Reliability Testing: Volume 2 of 3'' \27\ and the report entitled ``The 
Development and Testing of The Continuity Assessment Record And 
Evaluation (CARE) Item Set: Final Report on Care Item Set and Current 
Assessment Comparisons: Volume 3 of 3.'' \28\ The reports are available 
on CMS' Post-Acute Care Quality Initiatives Web page at http://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/CARE-Item-Set-and-B-CARE.html. For more information about this quality measure, we refer 
readers to the FY 2016 IRF PPS final rule (80 FR 47100 through 47111).
---------------------------------------------------------------------------

    \26\ Barbara Gage et al., ``The Development and Testing of the 
Continuity Assessment Record and Evaluation (CARE) Item Set: Final 
Report on the Development of the CARE Item Set '' (RTI 
International, 2012).
    \27\ Ibid.
    \28\ Ibid.
---------------------------------------------------------------------------

    We are inviting public comment on this proposal.
(2) Cognitive Function and Mental Status Data
    Cognitive function and mental status in PAC patient and resident 
populations can be affected by a number of underlying conditions, 
including dementia, stroke, traumatic brain injury, side effects of 
medication, metabolic and/or endocrine imbalances, delirium, and 
depression.\29\ The assessment of cognitive function and mental status 
by PAC providers is important because of the high percentage of 
patients and residents with these conditions,\30\ and the opportunity 
for improving the quality of care. Symptoms of dementia may improve 
with pharmacotherapy, occupational therapy, or physical 
activity,\31\ 32 33 and promising treatments for severe 
traumatic brain injury are currently being tested.\34\ For older 
patients and residents diagnosed with depression, treatment options to 
reduce symptoms and improve quality of life include antidepressant 
medication and psychotherapy,\35\ 36 37 38 and targeted 
services, such as therapeutic recreation, exercise, and restorative 
nursing, to increase opportunities for psychosocial interaction.\39\
---------------------------------------------------------------------------

    \29\ National Institute on Aging. (2014). Assessing Cognitive 
Impairment in Older Patients. A Quick Guide for Primary Care 
Physicians. Retrieved from https://www.nia.nih.gov/alzheimers/publication/assessing-cognitive-impairment-older-patients.
    \30\ Gage B., Morley M., Smith L., et al. (2012). Post-Acute 
Care Payment Reform Demonstration (Final report, Volume 4 of 4). 
Research Triangle Park, NC: RTI International.
    \31\ Casey D.A., Antimisiaris D., O'Brien J. (2010). Drugs for 
Alzheimer's Disease: Are They Effective? Pharmacology & 
Therapeutics, 35, 208-11.
    \32\ Graff M.J., Vernooij-Dassen M.J., Thijssen M., Dekker J., 
Hoefnagels W.H., Rikkert M.G.O. (2006). Community Based Occupational 
Therapy for Patients with Dementia and their Care Givers: Randomised 
Controlled Trial. BMJ, 333(7580): 1196.
    \33\ Bherer L., Erickson K.I., Liu-Ambrose T. (2013). A Review 
of the Effects of Physical Activity and Exercise on Cognitive and 
Brain Functions in Older Adults. Journal of Aging Research, 657508.
    \34\ Giacino J.T., Whyte J., Bagiella E., et al. (2012). 
Placebo-controlled trial of amantadine for severe traumatic brain 
injury. New England Journal of Medicine, 366(9), 819-826.
    \35\ Alexopoulos G.S., Katz I.R., Reynolds C.F. 3rd, Carpenter 
D., Docherty J.P., Ross R.W. (2001). Pharmacotherapy of depression 
in older patients: a summary of the expert consensus guidelines. 
Journal of Psychiatric Practice, 7(6), 361-376.
    \36\ Arean P.A., Cook B.L. (2002). Psychotherapy and combined 
psychotherapy/pharmacotherapy for late life depression. Biological 
Psychiatry, 52(3), 293-303.
    \37\ Hollon S.D., Jarrett R.B., Nierenberg A.A., Thase M.E., 
Trivedi M., Rush A.J. (2005). Psychotherapy and medication in the 
treatment of adult and geriatric depression: which monotherapy or 
combined treatment? Journal of Clinical Psychiatry, 66(4), 455-468.
    \38\ Wagenaar D, Colenda CC, Kreft M, Sawade J, Gardiner J, 
Poverejan E. (2003). Treating depression in nursing homes: practice 
guidelines in the real world. J Am Osteopath Assoc. 103(10), 465-
469.
    \39\ Crespy SD, Van Haitsma K, Kleban M, Hann CJ. Reducing 
Depressive Symptoms in Nursing Home Residents: Evaluation of the 
Pennsylvania Depression Collaborative Quality Improvement Program. J 
Healthc Qual. 2016. Vol. 38, No. 6, pp. e76-e88.
---------------------------------------------------------------------------

    Accurate assessment of cognitive function and mental status of 
patients and residents in PAC would be expected to have a positive 
impact on the National Quality Strategy's domains of patient and family 
engagement, patient safety, care coordination, clinical process/
effectiveness, and efficient use of healthcare resources. For example, 
standardized assessment of cognitive function and mental status of 
patients and residents in PAC will support establishing a baseline for 
identifying changes in cognitive function and mental status (for 
example, delirium), anticipating the patient or resident's ability to 
understand and participate in treatments during a PAC stay, ensuring 
patient and resident safety (for example, risk of falls), and 
identifying appropriate support needs at the time of discharge or 
transfer. Standardized assessment data elements will enable or support 
clinical decision-making and early clinical intervention; person-
centered, high quality care through: Facilitating better care 
continuity and coordination; better data exchange and interoperability 
between settings; and longitudinal outcome analysis. Hence, reliable 
data elements assessing cognitive impairment and mental status are 
needed in order to initiate a management program that can optimize a 
patient or resident's prognosis and reduce the possibility of adverse 
events.
(i) Brief Interview for Mental Status (BIMS)
    We are proposing that the data elements that comprise the Brief 
Interview for Mental Status meet the definition of standardized patient 
assessment data for cognitive function and mental status under section 
1899B(b)(1)(B)(ii) of the Act. The proposed data elements consist of 
seven BIMS questions that result in a cognitive function score. For 
more information on the BIMS, we refer readers to the document titled, 
Proposed Specifications for IRF QRP Quality Measures and Standardized 
Data Elements, available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Program-Measures-Information-.html.
    The BIMS is a performance-based cognitive assessment that assesses 
repetition, recall with and without prompting, and temporal 
orientation. It was developed to be a brief screener to assess 
cognition, with a focus on learning and memory. Dementia and cognitive 
impairment are associated with long-term functional dependence and, 
consequently, poor quality of life and increased health care costs and 
mortality.\40\ This makes assessment of mental status and early 
detection of cognitive decline or impairment critical in the PAC 
setting. The burden of cognitive impairment in PAC is high. The 
intensity of routine nursing care is higher for patients and residents 
with cognitive impairment than those without, and dementia is a 
significant variable in predicting readmission after discharge to the 
community from PAC

[[Page 20724]]

providers.\41\ The BIMS data elements are currently in use in two of 
the PAC assessments: The MDS 3.0 in SNFs and the IRF-PAI in IRFs. The 
BIMS was tested in the PAC PRD where it was found to have substantial 
to almost perfect agreement for inter-rater reliability (kappa range of 
0.71 to 0.91) when tested in all four PAC settings.\42\ Clinical and 
subject matter expert advisors working with our data element contractor 
agreed that the BIMS is a feasible data element for use by PAC 
providers. Additionally, discussions during a TEP convened on April 6 
and 7, 2016, demonstrated support for the BIMS. The Development and 
Maintenance of Post-Acute Care Cross-Setting Standardized Patient 
Assessment Data Technical Expert Panel Summary Report is available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
---------------------------------------------------------------------------

    \40\ Ag[uuml]ero-Torres, H., Fratiglioni, L., Guo, Z., Viitanen, 
M., von Strauss, E., & Winblad, B. (1998). ``Dementia is the major 
cause of functional dependence in the elderly: 3-year follow-up data 
from a population-based study.'' Am J of Public Health 88(10): 1452-
1456.
    \41\ RTI International. Proposed Measure Specifications for 
Measures Proposed in the FY 2017 LTCH QRP Proposed Rule. Research 
Triangle Park, NC. 2016.
    \42\ Gage B., Morley M., Smith L., et al. (2012). Post-Acute 
Care Payment Reform Demonstration (Final report, Volume 2 of 4). 
Research Triangle Park, NC: RTI International.
---------------------------------------------------------------------------

    To solicit additional feedback on the BIMS, we requested public 
comment from August 12 to September 12, 2016. Many commenters expressed 
support for use of the BIMS, noting that it is reliable, feasible to 
use across settings, and will provide useful information about patients 
and residents. These comments noted that the data collected through the 
BIMS will provide a clearer picture of patient or resident complexity, 
help with the care planning process, and be useful during care 
transitions and when coordinating across providers. A full report of 
the comments is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Therefore, we are proposing to adopt the BIMS for use in the IRF 
QRP. As noted above in this section, the BIMS is already included on 
the IRF-PAI. For purposes of reporting for the FY 2020 IRF QRP, IRFs 
would be required to report these data on admission for all Medicare 
Part A and MA patients discharged between October 1, 2018 and December 
31, 2018. Following the initial reporting year for the FY 2020 IRF QRP, 
subsequent years for the IRF QRP would be based on a full calendar year 
of such data reporting. The BIMS data element would be assessed at 
admission only due to the relatively stable nature of the types of 
cognitive function assessed by the BIMS, making it unlikely that a 
patient's score on this assessment would change between the start and 
end of the PAC stay. Assessment at discharge would introduce additional 
burden without improving the quality or usefulness of the data, and we 
believe that it is unnecessary.
    We are inviting public comment on these proposals.
(ii) Confusion Assessment Method (CAM)
    We are proposing that the data elements that comprise the Confusion 
Assessment Method (CAM) meet the definition of standardized patient 
assessment data for cognitive function and mental status under section 
1899B(b)(1)(B)(ii) of the Act. The CAM is a six-question instrument 
that screens for overall cognitive impairment, as well as distinguishes 
delirium or reversible confusion from other types of cognitive 
impairment. For more information on the CAM, we refer readers to the 
document titled, Proposed Specifications for IRF QRP Quality Measures 
and Standardized Data Elements, available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Program-Measures-Information-.html.
    The CAM was developed to identify the signs and symptoms of 
delirium. It results in a score that suggests whether the patient or 
resident should be assigned a diagnosis of delirium. Because patients 
and residents with multiple comorbidities receive services from PAC 
providers, it is important to assess delirium, which is associated with 
a high mortality rate and prolonged duration of stay in hospitalized 
older adults.\43\ Assessing these signs and symptoms of delirium is 
clinically relevant for care planning by PAC providers.
---------------------------------------------------------------------------

    \43\ Fick, D. M., Steis, M. R., Waller, J. L., & Inouye, S. K. 
(2013). ``Delirium superimposed on dementia is associated with 
prolonged length of stay and poor outcomes in hospitalized older 
adults.'' J of Hospital Med 8(9): 500-505.
---------------------------------------------------------------------------

    The CAM is currently in use in two of the PAC assessments: The MDS 
3.0 in SNFs and the LCDS in LTCHs. The CAM was tested in the PAC PRD 
where it was found to have substantial agreement for inter-rater 
reliability for the ``Inattention and Disorganized Thinking'' questions 
(kappa range of 0.70 to 0.73); and moderate agreement for the ``Altered 
Level of Consciousness'' question (kappa of 0.58).\44\
---------------------------------------------------------------------------

    \44\ Gage B., Morley M., Smith L., et al. (2012). Post-Acute 
Care Payment Reform Demonstration (Final report, Volume 2 of 4). 
Research Triangle Park, NC: RTI International.
---------------------------------------------------------------------------

    Clinical and subject matter expert advisors working with our data 
element contractor agreed that the CAM is feasible for use by PAC 
providers, that it assesses key aspects of cognition, and that this 
information about patient or resident cognition would be clinically 
useful both within and across PAC provider types. The CAM was also 
supported by a TEP that discussed and rated candidate data elements 
during a meeting on April 6 and 7, 2016. The Development and 
Maintenance of Post-Acute Care Cross-Setting Standardized Patient 
Assessment Data Technical Expert Panel Summary Report is available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html. We requested public comment on 
the CAM from August 12 to September 12, 2016. Many commenters expressed 
support for use of the CAM, noting that it would provide important 
information for care planning and care coordination, and therefore, 
contribute to quality improvement. The commenters noted it is 
particularly helpful in distinguishing delirium and reversible 
confusion from other types of cognitive impairment. A full report of 
the comments is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Therefore, we are proposing to add the CAM data elements to the 
IRF-PAI, and that IRFs would be required to report these data for the 
FY 2020 IRF QRP on admission and discharge for all Medicare Part A and 
MA patients discharged between October 1, 2018 and December 31, 2018. 
Following the initial reporting year for the FY 2020 IRF QRP, 
subsequent years for the IRF QRP would be based on a full calendar year 
of such data reporting.
    We are inviting public comment on these proposals.
(iii) Behavioral Signs and Symptoms
    We are proposing that the Behavioral Signs and Symptoms data 
elements meet the definition of standardized patient assessment data 
for cognitive

[[Page 20725]]

function and mental status under section 1899B(b)(1)(B)(ii) of the Act. 
The proposed data elements consist of three Behavioral Signs and 
Symptoms questions and result in three scores that categorize 
respondents as having or not having certain types of behavioral signs 
and symptoms. For more information on the Behavioral Signs and Symptoms 
data elements, we refer readers to the document titled, Proposed 
Specifications for IRF QRP Quality Measures and Standardized Data 
Elements, available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Program-Measures-Information-.html.
    The questions included in the Behavioral Signs and Symptoms group 
assess whether the patient or resident has exhibited any behavioral 
symptoms that may indicate cognitive impairment or other mental health 
issues during the assessment period, including physical, verbal, and 
other disruptive or dangerous behavioral symptoms, but excluding 
patient wandering. Such behavioral disturbances can indicate 
unrecognized needs and care preferences and are associated most 
commonly with dementia and other cognitive impairment, and less 
commonly with adverse drug events, mood disorders, and other 
conditions. Assessing behavioral disturbances can lead to early 
intervention, patient- and resident-centered care planning, clinical 
decision support, and improved staff and patient or resident safety 
through early detection. Assessment and documentation of these 
disturbances can help inform care planning and patient transitions and 
provide important information about resource use.
    Data elements that capture behavioral symptoms are currently 
included in two of the PAC assessments: The MDS 3.0 in SNFs and the 
OASIS-C2 in HHAs. In the MDS, each question includes four response 
options ranging from ``behavior not exhibited'' (0) to behavior 
``occurred daily'' (3). The OASIS-C2 includes some similar data 
elements which record the frequency of disruptive behaviors on a 6-
point scale ranging from ``never'' (0) to ``at least daily'' (5). Data 
elements that mirror those used in the MDS and serve the same 
assessment purpose were tested in post-acute providers in the PAC PRD 
and found to be clinically relevant, meaningful for care planning, and 
feasible for use in each of the four PAC settings.\45\
---------------------------------------------------------------------------

    \45\ Gage B., Morley M., Smith L., et al. (2012). Post-Acute 
Care Payment Reform Demonstration (Final report, Volume 2 of 4). 
Research Triangle Park, NC: RTI International.
---------------------------------------------------------------------------

    The proposed data elements were supported by comments from the 
Standardized Patient Assessment Data TEP held by our data element 
contractor. The TEP identified patient and resident behaviors as an 
important consideration for resource intensity and care planning, and 
affirmed the importance of the standardized assessment of patient 
behaviors through data elements such as those in use in the MDS. The 
Development and Maintenance of Post-Acute Care Cross-Setting 
Standardized Patient Assessment Data Technical Expert Panel Summary 
Report is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Because the PAC PRD version of the Behavioral Signs and Symptoms 
data elements were previously tested across PAC providers, we solicited 
additional feedback on this version of the data elements by including 
these data elements in a call for public comment that was open from 
August 12 to September 12, 2016. Consistent with the TEP discussion on 
the importance of patient and resident behaviors, many commenters 
expressed support for use of the Behavioral Signs and Symptoms data 
elements, noting that they would provide useful information about 
patient and resident behavior at both admission and discharge and 
contribute to care planning related to what treatment is appropriate 
for the patient or resident and what resources are needed. Public 
comment also supported the use of highly similar MDS version of the 
data element in order to provide continuity with existing assessment 
processes in SNFs. A full report of the comments is available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Therefore, we are proposing the MDS version of the Behavioral Signs 
and Symptoms data elements because they focus more closely on 
behavioral symptoms than the OASIS data elements, and include more 
detailed response categories than those used in the PAC PRD version, 
capturing more information about the frequency of behaviors. We are 
proposing to add the Behavioral Signs and Symptoms data elements to the 
IRF-PAI, and that IRFs would be required to report these data for the 
FY 2020 IRF QRP on admission and discharge for all Medicare Part A and 
MA patients discharged between October 1, 2018 and December 31, 2018. 
Following the initial reporting year for the FY 2020 IRF QRP, 
subsequent years for the IRF QRP would be based on a full calendar year 
of such data reporting.
    We are inviting public comment on these proposals.
(iv) Patient Health Questionnaire-2 (PHQ-2)
    We are proposing that the PHQ-2 data elements meet the definition 
of standardized patient assessment data for cognitive function and 
mental status under section 1899B(b)(1)(B)(ii) of the Act. The proposed 
data elements consist of the PHQ-2 two-item questionnaire that assesses 
the cardinal criteria for depression: Depressed mood and anhedonia 
(inability to feel pleasure). For more information on the PHQ-2, we 
refer readers to the document titled, Proposed Specifications for IRF 
QRP Quality Measures and Standardized Data Elements, available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Program-Measures-Information-.html.
    Depression is a common mental health condition often missed and 
under-recognized. Assessments of depression help PAC providers better 
understand the needs of their patients and residents by: Prompting 
further evaluation (that is, to establish a diagnosis of depression); 
elucidating the patient's or resident's ability to participate in 
therapies for conditions other than depression during their stay; and 
identifying appropriate ongoing treatment and support needs at the time 
of discharge. A PHQ-2 score beyond a predetermined threshold signals 
the need for additional clinical assessment in order to determine a 
depression diagnosis.
    The proposed data elements that comprise the PHQ-2 are currently 
used in the OASIS-C2 for HHAs and the MDS 3.0 for SNFs (as part of the 
PHQ-9). The PHQ-2 data elements were tested in the PAC PRD, where they 
were found to have almost perfect agreement for inter-rater reliability 
(kappa range of

[[Page 20726]]

0.84 to 0.91) when tested by all four PAC providers.\46\
---------------------------------------------------------------------------

    \46\ Gage B., Smith L., Ross J. et al. (2012). The Development 
and Testing of the Continuity Assessment Record and Evaluation 
(CARE) Item Set (Final Report on Reliability Testing, Volume 2 of 
3). Research Triangle Park, NC: RTI International.
---------------------------------------------------------------------------

    Clinical and subject matter expert advisors working with our data 
element contractor agreed that the PHQ-2 is feasible for use in PAC, 
that it assesses key aspects of mental status, and that this 
information about patient or resident mood would be clinically useful 
both within and across PAC provider types. We note that both the PHQ-9 
and the PHQ-2 were supported by TEP members who discussed and rated 
candidate data elements during a meeting on April 6 and 7, 2016. They 
particularly noted that the brevity of the PHQ-2 made it feasible with 
low burden for both assessors and PAC patients or residents. The 
Development and Maintenance of Post-Acute Care Cross-Setting 
Standardized Patient Assessment Data Technical Expert Panel Summary 
Report is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    To solicit additional feedback on the PHQ-2, we requested public 
comment from August 12 to September 12, 2016. Many commenters provided 
feedback on using the PHQ-2 for the assessment of mood. Overall, 
commenters believed that collecting these data elements across PAC 
provider types was appropriate, given the role that depression plays in 
well-being. Several commenters expressed support for an approach that 
would use PHQ-2 as a gateway to the longer PHQ-9 and would maintain the 
reduced burden on most patients and residents, as well as test 
administrators, which is a benefit of the PHQ-2, while ensuring that 
the PHQ-9, which exhibits higher specificity,\47\ would be administered 
for patients and residents who showed signs and symptoms of depression 
on the PHQ-2. Specific comments are described in a full report 
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
---------------------------------------------------------------------------

    \47\ Arroll B, Goodyear-Smith F, Crengle S, Gunn J, Kerse N, 
Fishman T, et al. Validation of PHQ-2 and PHQ-9 to screen for major 
depression in the primary care population. Annals of family 
medicine. 2010;8(4):348-53. doi: 10.1370/afm.1139 pmid:20644190; 
PubMed Central PMCID: PMC2906530.
---------------------------------------------------------------------------

    Therefore, we are proposing to add the PHQ-2 data elements to the 
IRF-PAI, and that IRFs would be required to report these data for the 
FY 2020 IRF QRP on admission and discharge for all Medicare Part A and 
MA patients discharged between October 1, 2018 and December 31, 2018. 
Following the initial reporting year for the FY 2020 IRF QRP, 
subsequent years for the IRF QRP would be based on a full calendar year 
of such data reporting.
    We are inviting public comment on these proposals.
(3) Special Services, Treatments, and Interventions Data
    Special services, treatments, and interventions performed in PAC 
can have a major effect on an individual's health status, self-image, 
and quality of life. The assessment of these special services, 
treatments, and interventions in PAC is important to ensure the 
continuing appropriateness of care for the patients and residents 
receiving them, and to support care transitions from one PAC provider 
to another, an acute care hospital, or discharge. Accurate assessment 
of special services, treatments, and interventions of patients and 
residents served by PAC providers are expected to have a positive 
impact on the National Quality Strategy's domains of patient and family 
engagement, patient safety, care coordination, clinical process/
effectiveness, and efficient use of healthcare resources.
    For example, standardized assessment of special services, 
treatments, and interventions used in PAC can promote patient and 
resident safety through appropriate care planning (for example, 
mitigating risks such as infection or pulmonary embolism associated 
with central intravenous access), and identifying life-sustaining 
treatments that must be continued, such as mechanical ventilation, 
dialysis, suctioning, and chemotherapy, at the time of discharge or 
transfer. Standardized assessment of these data elements will enable or 
support: Clinical decision-making and early clinical intervention; 
person-centered, high quality care through, for example, facilitating 
better care continuity and coordination; better data exchange and 
interoperability between settings; and longitudinal outcome analysis. 
Hence, reliable data elements assessing special services, treatments, 
and interventions are needed to initiate a management program that can 
optimize a patient or resident's prognosis and reduce the possibility 
of adverse events.
    We are proposing 15 special services, treatments, and interventions 
as presented below in this section grouped by cancer treatments, 
respiratory treatments, other treatments, and nutritional approaches. A 
TEP convened by our data element contractor provided input on the 15 
data elements for Special Services, Treatments, and Interventions. This 
TEP, held on January 5 and 6, 2017, opined that these data elements are 
appropriate for standardization because they would provide useful 
clinical information to inform care planning and care coordination. The 
TEP affirmed that assessment of these services and interventions is 
standard clinical practice, and that the collection of these data by 
means of a list and checkbox format would conform to common workflow 
for PAC providers. A full report of the TEP discussion is available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
(i) Cancer Treatment: Chemotherapy (IV, Oral, Other)
    We are proposing that the Chemotherapy (IV, Oral, Other) data 
elements meet the definition of standardized patient assessment data 
for special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act. The proposed data elements consist of 
the principal Chemotherapy data element and three sub-elements: IV 
Chemotherapy, Oral Chemotherapy, and Other. For more information on the 
Chemotherapy data element, we refer readers to the document titled, 
Proposed Specifications for IRF QRP Quality Measures and Standardized 
Data Elements, available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Program-Measures-Information-.html.
    Chemotherapy is a type of cancer treatment that uses drugs to 
destroy cancer cells. It is sometimes used when a patient has a 
malignancy (cancer), which is a serious, often life-threatening or 
life-limiting condition. Both intravenous (IV) and oral chemotherapy 
have serious side effects, including nausea/vomiting, extreme fatigue, 
risk of infection due to a suppressed immune system, anemia, and an 
increased risk of bleeding due to low platelet counts. Oral 
chemotherapy can be as potent as chemotherapy given by IV, but can be 
significantly more

[[Page 20727]]

convenient and less resource-intensive to administer. Because of the 
toxicity of these agents, special care must be exercised in handling 
and transporting chemotherapy drugs. IV chemotherapy may be given by 
peripheral IV, but is more commonly given via an indwelling central 
line, which raises the risk of bloodstream infections. Given the 
significant burden of malignancy, the resource intensity of 
administering chemotherapy, and the side effects and potential 
complications of these highly-toxic medications, assessing the receipt 
of chemotherapy is important in the PAC setting for care planning and 
determining resource use.
    The need for chemotherapy predicts resource intensity, both because 
of the complexity of administering these potent, toxic drug 
combinations under specific protocols, and because of what the need for 
chemotherapy signals about the patient's underlying medical condition. 
Furthermore, the resource intensity of IV chemotherapy is higher than 
for oral chemotherapy, as the protocols for administration and the care 
of the central line (if present) require significant resources.
    The Chemotherapy (IV, Oral, Other) data elements consist of a 
principal data element and three sub-elements: IV chemotherapy, which 
is generally resource-intensive; oral chemotherapy, which is less 
invasive and generally less intensive with regard to administration 
protocols; and a third category provided to enable the capture of other 
less common chemotherapeutic approaches. This third category is 
potentially associated with higher risks and is more resource intensive 
due to delivery by other routes (for example, intraventricular or 
intrathecal).
    The principal Chemotherapy data element is currently in use in the 
MDS 3.0. One proposed sub-element, IV Chemotherapy, was tested in the 
PAC PRD and found feasible for use in each of the four PAC settings. We 
solicited public comment on IV Chemotherapy from August 12 to September 
12, 2016. Several commenters provided support for the data element and 
suggested it be included as standardized patient assessment data. 
Commenters stated that assessing the use of chemotherapy services is 
relevant to share across the care continuum to facilitate care 
coordination and care transitions and noted the validity of the data 
element. Commenters also noted the importance of capturing all types of 
chemotherapy, regardless of route, and stated that collecting data only 
on patients and residents who received chemotherapy by IV would limit 
the usefulness of this standardized data element. A full report of the 
comments is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    As a result of the comments and input received from clinical and 
subject matter experts, we are proposing a principal Chemotherapy data 
element with three sub-elements, including Oral and Other for 
standardization. Our data element contractor then presented the 
proposed data elements to the Standardized Patient Assessment Data TEP 
on January 5 and 6, 2017, who supported these data elements for 
standardization. A full report of the TEP discussion is available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Therefore, we are proposing that the Chemotherapy (IV, Oral, Other) 
data elements with a principal data element and three sub-elements meet 
the definition of standardized patient assessment data for special 
services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act. We are proposing to add the 
Chemotherapy (IV, Oral, Other) data elements to the IRF-PAI, and that 
IRFs would be required to report these data for the FY 2020 IRF QRP on 
admission and discharge for all Medicare Part A and MA patients 
discharged between October 1, 2018 and December 31, 2018. Following the 
initial reporting year for the FY 2020 IRF QRP, subsequent years for 
the IRF QRP would be based on a full calendar year of such data 
reporting.
    We are inviting public comment on these proposals.
(ii) Cancer Treatment: Radiation
    We are proposing that the Radiation data element meets the 
definition of standardized patient assessment data for special 
services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act. The proposed data element consists of 
the single Radiation data element. For more information on the 
Radiation data element, we refer readers to the document titled, 
Proposed Specifications for IRF QRP Quality Measures and Standardized 
Data Elements, available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Program-Measures-Information-.html.
    Radiation is a type of cancer treatment that uses high-energy 
radioactivity to stop cancer by damaging cancer cell DNA, but it can 
also damage normal cells. Radiation is an important therapy for 
particular types of cancer, and the resource utilization is high, with 
frequent radiation sessions required, often daily for a period of 
several weeks. Assessing whether a patient or resident is receiving 
radiation therapy is important to determine resource utilization 
because PAC patients and residents will need to be transported to and 
from radiation treatments, and monitored and treated for side effects 
after receiving this intervention. Therefore, assessing the receipt of 
radiation therapy, which would compete with other care processes given 
the time burden, would be important for care planning and care 
coordination by PAC providers.
    The Radiation data element is currently in use in the MDS 3.0. This 
data element was not tested in the PAC PRD. However, public comment and 
other expert input on the Radiation data element supported its 
importance and clinical usefulness for patients in PAC settings, due to 
the side effects and consequences of radiation treatment on patients 
that need to be considered in care planning and care transitions. To 
solicit additional feedback on the Radiation data element we are 
proposing, we requested public comment from August 12 to September 12, 
2016. Several commenters provided support for the data element, noting 
the relevance of this data element to facilitating care coordination 
and supporting care transitions, the feasibility of the item, and the 
potential for it to improve quality. A full report of the comments is 
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The proposed data element was presented to and supported by the TEP 
held by our data element contractor on January 5 and 6, 2017, which 
opined that Radiation was important corollary information about cancer 
treatment to collect alongside Chemotherapy (IV, Oral, Other), and 
that, because capturing this information is a customary part of 
clinical practice, the proposed data element would be feasible, 
reliable, and easily incorporated into existing workflow.
    Therefore, we are proposing that the Radiation data element meets 
the definition of standardized patient assessment data for special 
services,

[[Page 20728]]

treatments, and interventions under section 1899B(b)(1)(B)(iii) of the 
Act. We are proposing to add the Radiation data element to the IRF-PAI, 
and that IRFs would be required to report these data for the FY 2020 
IRF QRP on admission and discharge for all Medicare Part A and MA 
patients discharged between October 1, 2018 and December 31, 2018. 
Following the initial reporting year for the FY 2020 IRF QRP, 
subsequent years for the IRF QRP would be based on a full calendar year 
of such data reporting.
    We are inviting public comment on these proposals.
(iii) Respiratory Treatment: Oxygen Therapy (Continuous, Intermittent)
    We are proposing that the Oxygen Therapy (Continuous, Intermittent) 
data elements meet the definition of standardized patient assessment 
data for special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act. The proposed data elements consist of 
the principal Oxygen data element and two sub-elements, ``Continuous'' 
(whether the oxygen was delivered continuously, typically defined as 
[gE]14 hours per day), or ``Intermittent.'' For more information on the 
Oxygen Therapy (Continuous, Intermittent) data elements, we refer 
readers to the document titled, Proposed Specifications for IRF QRP 
Quality Measures and Standardized Data Elements, available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Program-Measures-Information-.html.
    Oxygen therapy provides a patient or resident with extra oxygen 
when medical conditions such as chronic obstructive pulmonary disease, 
pneumonia, or severe asthma prevent the patient or resident from 
getting enough oxygen from breathing. Oxygen administration is a 
resource-intensive intervention, as it requires specialized equipment 
such as a source of oxygen, delivery systems (for example, oxygen 
concentrator, liquid oxygen containers, and high-pressure systems), the 
patient interface (for example, nasal cannula or mask), and other 
accessories (for example, regulators, filters, tubing). These data 
elements capture patient or resident use of two types of oxygen therapy 
(continuous and intermittent) which are reflective of intensity of care 
needs, including the level of monitoring and bedside care required. 
Assessing the receipt of this service is important for care planning 
and resource use for PAC providers.
    The proposed data elements were developed based on similar data 
elements that assess oxygen therapy, currently in use in the MDS 3.0 
(``Oxygen Therapy'') and OASIS-C2 (``Oxygen (intermittent or 
continuous)''), and a data element tested in the PAC PRD that focused 
on intensive oxygen therapy (``High O2 Concentration Delivery System 
with FiO2 > 40%'').
    As a result of input from expert advisors, we solicited public 
comment on the single data element, Oxygen (inclusive of intermittent 
and continuous oxygen use), from August 12 to September 12, 2016. 
Several commenters supported the importance of the Oxygen data element, 
noting feasibility of this item in PAC, and the relevance of it to 
facilitating care coordination and supporting care transitions, but 
suggesting that the extent of oxygen use be documented. A full report 
of the comments is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    As a result of public comment and input from expert advisors about 
the importance and clinical usefulness of documenting the extent of 
oxygen use, we expanded the single data element to include two sub-
elements, intermittent and continuous.
    Therefore, we are proposing that the Oxygen Therapy (Continuous, 
Intermittent) data elements with a principal data element and two sub-
elements meet the definition of standardized patient assessment data 
for special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act. We are proposing to add the Oxygen 
Therapy (Continuous, Intermittent) data elements to the IRF-PAI, and 
that IRFs would be required to report these data for the FY 2020 IRF 
QRP on admission and discharge for all Medicare Part A and MA patients 
discharged between October 1, 2018 and December 31, 2018. Following the 
initial reporting year for the FY 2020 IRF QRP, subsequent years for 
the IRF QRP would be based on a full calendar year of such data 
reporting.
    We are inviting public comment on these proposals.
(iv) Respiratory Treatment: Suctioning (Scheduled, as Needed)
    We are proposing that the Suctioning (Scheduled, As needed) data 
elements meet the definition of standardized patient assessment data 
element for special services, treatments, and interventions under 
section 1899B(b)(1)(B)(iii) of the Act. The proposed data elements 
consist of the principal Suctioning data element, and two sub-elements, 
``Scheduled'' and ``As needed.'' These sub-elements capture two types 
of suctioning. ``Scheduled'' indicates suctioning based on a specific 
frequency, such as every hour; ``As needed'' means suctioning only when 
indicated. For more information on the Suctioning (Scheduled, As 
needed) data elements, we refer readers to the document titled, 
Proposed Specifications for IRF QRP Quality Measures and Standardized 
Data Elements, available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Program-Measures-Information-.html.
    Suctioning is a process used to clear secretions from the airway 
when a person cannot clear those secretions on his or her own. It is 
done by aspirating secretions through a catheter connected to a suction 
source. Types of suctioning include oropharyngeal and nasopharyngeal 
suctioning, nasotracheal suctioning, and suctioning through an 
artificial airway such as a tracheostomy tube. Oropharyngeal and 
nasopharyngeal suctioning are a key part of many patients' care plans, 
both to prevent the accumulation of secretions than can lead to 
aspiration pneumonias (a common condition in patients with inadequate 
gag reflexes), and to relieve obstructions from mucus plugging during 
an acute or chronic respiratory infection, which often lead to 
desaturations and increased respiratory effort. Suctioning can be done 
on a scheduled basis if the patient is judged to clinically benefit 
from regular interventions; or can be done as needed, such as when 
secretions become so prominent that gurgling or choking is noted, or a 
sudden desaturation occurs from a mucus plug. As suctioning is 
generally performed by a care provider rather than independently, this 
intervention can be quite resource-intensive if it occurs every hour, 
for example, rather than once a shift. It also signifies an underlying 
medical condition that prevents the patient from clearing his/her 
secretions effectively (such as after a stroke, or during an acute 
respiratory infection). Generally, suctioning is necessary to ensure 
that the airway is clear of secretions which can inhibit successful 
oxygenation of the individual. The intent of suctioning is to maintain 
a patent airway, the loss of which can lead to death, or complications 
associated with hypoxia.

[[Page 20729]]

    The proposed data elements are based on an item currently in use in 
the MDS 3.0 (``Suctioning'' without the two sub-elements), and data 
elements tested in the PAC PRD that focused on the frequency of 
suctioning required for patients with tracheostomies (``Trach Tube with 
Suctioning: Specify most intensive frequency of suctioning during stay 
[Every __hours]'').
    Clinical and subject matter expert advisors working with our data 
element contractor agreed that the proposed Suctioning (Scheduled, As 
needed) data elements are feasible for use in PAC, and that they 
indicate important treatment that would be clinically useful to capture 
both within and across PAC providers. We solicited public comment on 
the suctioning data element currently included in the MDS 3.0 between 
August 12 and September 12, 2016. Several commenters wrote in support 
of this data element, noting feasibility of this item in PAC, and the 
relevance of this data element to facilitating care coordination and 
supporting care transitions. We also received comments suggesting that 
we examine the frequency of suctioning in order to better understand 
the use of staff time, the impact on a patient or resident's capacity 
to speak and swallow, and intensity of care required. Based on these 
comments, we decided to add two sub-elements (scheduled and as needed) 
to the suctioning element. The proposed data elements, Suctioning 
(Scheduled, As needed) includes both the principal suctioning data 
element that is included on the MDS 3.0 and two sub-elements, 
``scheduled'' and ``as needed.'' A full report of the comments is 
available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    A TEP convened by the data element contractor provided input on the 
proposed data elements. This TEP, held on January 5 and 6, 2017, opined 
that these data elements are appropriate for standardization because 
they would provide useful clinical information to inform care planning 
and care coordination. The TEP affirmed that assessment of these 
services and interventions is standard clinical practice. A full report 
of the TEP discussion is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Therefore, we are proposing that the Suctioning (Scheduled, As 
needed) data elements with a principal data element and two sub-
elements meet the definition of standardized patient assessment data 
for special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act. We are proposing to add the Suctioning 
(Scheduled, As needed) data elements to the IRF-PAI, and that IRFs 
would be required to report these data for the FY 2020 IRF QRP on 
admission and discharge for all Medicare Part A and MA patients 
discharged between October 1, 2018 and December 31, 2018. Following the 
initial reporting year for the FY 2020 IRF QRP, subsequent years for 
the IRF QRP would be based on a full calendar year of such data 
reporting.
    We are inviting public comment on these proposals.
(v) Respiratory Treatment: Tracheostomy Care
    We are proposing that the Tracheostomy Care data element meets the 
definition of standardized patient assessment data for special 
services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act. The proposed data element consists of 
the single Tracheostomy Care data element. For more information on the 
Tracheostomy Care data element, we refer readers to the document 
titled, Proposed Specifications for IRF QRP Quality Measures and 
Standardized Data Elements, available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Program-Measures-Information-.html.
    A tracheostomy provides an air passage to help a patient or 
resident breathe when the usual route for breathing is obstructed or 
impaired. Generally, in all of these cases, suctioning is necessary to 
ensure that the tracheostomy is clear of secretions which can inhibit 
successful oxygenation of the individual. Often, individuals with 
tracheostomies are also receiving supplemental oxygenation. The 
presence of a tracheostomy, albeit permanent or temporary, warrants 
careful monitoring and immediate intervention if the tracheostomy 
becomes occluded or in the case of a temporary tracheostomy, the device 
used becomes dislodged. While in rare cases the presence of a 
tracheostomy is not associated with increased care demands (and in some 
of those instances, the care of the ostomy is performed by the patient) 
in general the presence of such as device is associated with increased 
patient risk, and clinical care services will necessarily include close 
monitoring to ensure that no life-threatening events occur as a result 
of the tracheostomy, often considered part of the patient's life line. 
In addition, tracheostomy care, which primarily consists of cleansing, 
dressing changes, and replacement of the tracheostomy cannula (tube), 
is also a critical part of the care plan. Regular cleansing is 
important to prevent infection such as pneumonia and to prevent any 
occlusions with which there are risks for inadequate oxygenation.
    The proposed data element is currently in use in the MDS 3.0 
(``Tracheostomy care''). Data elements (``Trach Tube with Suctioning'') 
that were tested in the PAC PRD included an equivalent principal data 
element on the presence of a tracheostomy. This data element was found 
feasible for use in each of the four PAC settings as the data 
collection aligned with usual work flow.
    Clinical and subject matter expert advisors working with our data 
element contractor agreed that the Tracheostomy Care data element is 
feasible for use in PAC and that it assesses an important treatment 
that would be clinically useful both within and across PAC provider 
types.
    We solicited public comment on this data element from August 12 to 
September 12, 2016. Several commenters wrote in support of this data 
element, noting the feasibility of this item in PAC, and the relevance 
of this data element to facilitating care coordination and supporting 
care transitions. A full report of the comments is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    A TEP convened by the data element contractor provided input on the 
proposed data elements. This TEP, held on January 5 and 6, 2017, opined 
that these data elements are appropriate for standardization because 
they would provide useful clinical information to inform care planning 
and care coordination. The TEP affirmed that assessment of these 
services and interventions is standard clinical practice. A full report 
of the TEP discussion is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Therefore, we are proposing that the Tracheostomy Care data element 
meets

[[Page 20730]]

the definition of standardized patient assessment data for special 
services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act. We are proposing to add the 
Tracheostomy Care data element to the IRF-PAI, and that IRFs would be 
required to report these data for the FY 2020 IRF QRP on admission and 
discharge for all Medicare Part A and MA patients discharged between 
October 1, 2018 and December 31, 2018. Following the initial reporting 
year for the FY 2020 IRF QRP, subsequent years for the IRF QRP would be 
based on a full calendar year of such data reporting.
    We are inviting public comment on these proposals.
(vi) Respiratory Treatment: Non-Invasive Mechanical Ventilator (BiPAP, 
CPAP)
    We are proposing that the Non-invasive Mechanical Ventilator 
(Bilevel Positive Airway Pressure [BiPAP], Continuous Positive Airway 
Pressure [CPAP]) data elements meet the definition of standardized 
patient assessment data for special services, treatments, and 
interventions under section 1899B(b)(1)(B)(iii) of the Act. The 
proposed data elements consist of the principal Non-invasive Mechanical 
Ventilator data element and two sub-elements, BiPAP and CPAP. For more 
information on the Non-invasive Mechanical Ventilator (BiPAP, CPAP) 
data element, we refer readers to the document titled, Proposed 
Specifications for IRF QRP Quality Measures and Standardized Data 
Elements, available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Program-Measures-Information-.html.
    BiPAP and CPAP are respiratory support devices that prevent the 
airways from closing by delivering slightly pressurized air via 
electronic cycling throughout the breathing cycle (Bilevel PAP, 
referred to as BiPAP) or through a mask continuously (Continuous PAP, 
referred to as CPAP). Assessment of non-invasive mechanical ventilation 
is important in care planning, as both CPAP and BiPAP are resource-
intensive (although less so than invasive mechanical ventilation) and 
signify underlying medical conditions about the patient or resident who 
requires the use of this intervention. Particularly when used in 
settings of acute illness or progressive respiratory decline, 
additional staff (for example, respiratory therapists) are required to 
monitor and adjust the CPAP and BiPAP settings and the patient or 
resident may require more nursing resources.
    Data elements that assess BiPAP and CPAP are currently included on 
the OASIS-C2 for HHAs (``Continuous/Bi-level positive airway 
pressure''), LCDS for the LTCH setting (``Non-invasive Ventilator 
(BIPAP, CPAP)''), and the MDS 3.0 for the SNF setting (``BiPAP/CPAP''). 
A data element that focused on CPAP was tested across the four PAC 
providers in the PAC-PRD study and found to be feasible for 
standardization. All of these data elements assess BiPAP or CPAP with a 
single check box, not separately.
    Clinical and subject matter expert advisors working with our data 
element contractor agreed that the standardized assessment of Non-
invasive Mechanical Ventilator (BiPAP, CPAP) data elements would be 
feasible for use in PAC, and assess an important treatment that would 
be clinically useful both within and across PAC provider types.
    To solicit additional feedback on the form of the Non-invasive 
Mechanical Ventilator (BiPAP, CPAP) data elements best suited for 
standardization, we requested public comment on a single data element, 
BiPAP/CPAP, equivalent (but for labeling) to what is currently in use 
on the MDS, OASIS, and LCDS, from August 12 to September 12, 2016. 
Several commenters wrote in support of this data element, noting the 
feasibility of these items in PAC, and the relevance of these data 
elements for facilitating care coordination and supporting care 
transitions. In addition, there was support in the public comment 
responses for separating out BiPAP and CPAP as distinct sub-elements, 
as they are therapies used for different types of patients and 
residents. A full report of the comments is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    A TEP convened by the data element contractor provided input on the 
proposed data elements. This TEP, held on January 5 and 6, 2017, opined 
that these data elements are appropriate for standardization because 
they would provide useful clinical information to inform care planning 
and care coordination. The TEP affirmed that assessment of these 
services and interventions is standard clinical practice. A full report 
of the TEP discussion is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Therefore, we are proposing that the Non-invasive Mechanical 
Ventilator (BiPAP, CPAP) data elements with a principal data element 
and two sub-elements meet the definition of standardized patient 
assessment data for special services, treatments, and interventions 
under section 1899B(b)(1)(B)(iii) of the Act. We are proposing that the 
Non-invasive Mechanical Ventilator (BiPAP, CPAP) data elements would be 
added to the IRF-PAI, and that IRFs would be required to report these 
data for the FY 2020 IRF QRP on admission and discharge for all 
Medicare Part A and MA patients discharged between October 1, 2018 and 
December 31, 2018. Following the initial reporting year for the FY 2020 
IRF QRP, subsequent years for the IRF QRP would be based on a full 
calendar year of such data reporting.
    We are inviting public comment on these proposals.
(vii) Respiratory Treatment: Invasive Mechanical Ventilator
    We are proposing that the Invasive Mechanical Ventilator data 
element meets the definition of standardized patient assessment data 
for special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act. The proposed data element consists of a 
single Invasive Mechanical Ventilator data element. For more 
information on the Invasive Mechanical Ventilator data element, we 
refer readers to the document titled, Proposed Specifications for IRF 
QRP Quality Measures and Standardized Data Elements, available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Program-Measures-Information-.html.
    Invasive mechanical ventilation includes ventilators and 
respirators that ventilate the patient through a tube that extends via 
the oral airway into the pulmonary region or through a surgical opening 
directly into the trachea. Thus, assessment of invasive mechanical 
ventilation is important in care planning and risk mitigation. 
Ventilation in this manner is a resource-intensive therapy associated 
with life-threatening conditions without which the patient or resident 
would not survive. However, ventilator use has inherent risks requiring 
close monitoring. Failure to adequately care for the patient or 
resident who is ventilator dependent can lead to iatrogenic events such 
as death, pneumonia and sepsis. Mechanical ventilation further 
signifies

[[Page 20731]]

the complexity of the patient's underlying medical and or surgical 
condition. Of note, invasive mechanical ventilation is associated with 
high daily and aggregate costs.\48\
---------------------------------------------------------------------------

    \48\ Wunsch, H., Linde-Zwirble, W. T., Angus, D. C., Hartman, M. 
E., Milbrandt, E. B., & Kahn, J. M. (2010). ``The epidemiology of 
mechanical ventilation use in the United States.'' Critical Care Med 
38(10): 1947-1953.
---------------------------------------------------------------------------

    Data elements that capture invasive mechanical ventilation, but 
vary in their level of specificity, are currently in use in the MDS 3.0 
(``Ventilator or respirator'') and LCDS (``Invasive Mechanical 
Ventilator: Weaning'' and ``Invasive Mechanical Ventilator: Non-
weaning''), and related data elements that assess invasive ventilator 
use and weaning status were tested in the PAC PRD (``Ventilator--
Weaning'' and ``Ventilator--Non-Weaning'') and found feasible for use 
in each of the four PAC settings.
    Clinical and subject matter expert advisors working with our data 
element contractor agreed that assessing Invasive Mechanical Ventilator 
use is feasible in PAC, and would be clinically useful both within and 
across PAC providers.
    To solicit additional feedback on the form of a data element on 
this topic that would be appropriate for standardization, data element 
that assess invasive ventilator use and weaning status that were tested 
in the PAC PRD (``Ventilator--Weaning'' and ``Ventilator--Non-
Weaning'') were included in a call for public comment that was open 
from August 12 to September 12, 2016 because they were being considered 
for standardization. Several commenters wrote in support of these data 
elements, highlighting the importance of this information in supporting 
care coordination and care transitions. Some commenters expressed 
concern about the appropriateness for standardization, given the 
prevalence of ventilator weaning across PAC providers; the timing of 
administration; how weaning is defined; and how weaning status in 
particular relates to quality of care. These comments guided the 
decision to propose a single data element focused on current use of 
invasive mechanical ventilation only, and does not attempt to capture 
weaning status. A full report of the comments is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    A TEP convened by the data element contractor provided input on the 
proposed data elements. This TEP, held on January 5 and 6, 2017, opined 
that these data elements are appropriate for standardization because 
they would provide useful clinical information to inform care planning 
and care coordination. The TEP affirmed that assessment of these 
services and interventions is standard clinical practice. A full report 
of the TEP discussion is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Therefore, we are proposing that the Invasive Mechanical Ventilator 
data element that assesses the use of an invasive mechanical 
ventilator, but does not assess weaning status, meets the definition of 
standardized patient assessment data for special services, treatments, 
and interventions under section 1899B(b)(1)(B)(iii) of the Act. We are 
proposing to add the Invasive Mechanical Ventilator data element to the 
IRF-PAI, and that IRFs would be required to report these data for the 
FY 2020 IRF QRP on admission and discharge for all Medicare Part A and 
MA patients discharged between October 1, 2018 and December 31, 2018. 
Following the initial reporting year for the FY 2020 IRF QRP, 
subsequent years for the IRF QRP would be based on a full calendar year 
of such data reporting.
    We are inviting public comment on these proposals.
(viii) Other Treatment: Intravenous (IV) Medications (Antibiotics, 
Anticoagulation, Other)
    We are proposing that the IV Medications (Antibiotics, 
Anticoagulation, Other) data elements meet the definition of 
standardized patient assessment data for special services, treatments, 
and interventions under section 1899B(b)(1)(B)(iii) of the Act. The 
proposed data elements consist of the principal IV Medications data 
element and three sub-elements, Antibiotics, Anticoagulation, and 
Other. For more information on the IV Medications (Antibiotics, 
Anticoagulation, Other) data element, we refer readers to the document 
titled, Proposed Specifications for IRF QRP Quality Measures and 
Standardized Data Elements, available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Program-Measures-Information-.html.
    IV medications are solutions of a specific medication (for example, 
antibiotics, anticoagulants) administered directly into the venous 
circulation via a syringe or intravenous catheter (tube). IV 
medications are administered via intravenous push (bolus), single, 
intermittent, or continuous infusion through a tube placed into the 
vein (for example, commonly referred to as central, midline, or 
peripheral ports). Further, IV medications are more resource intensive 
to administer than oral medications, and signify a higher patient 
complexity (and often higher severity of illness).
    The clinical indications for each of the sub-elements of the IV 
Medication data element (Antibiotics, Anticoagulants, and Other) are 
very different. IV antibiotics are used for severe infections when: (1) 
The bioavailability of the oral form of the medication would be 
inadequate to kill the pathogen; (2) an oral form of the medication 
does not exist; or (3) the patient is unable to take the medication by 
mouth. IV anticoagulants refer to anti-clotting medications (that is, 
``blood thinners''), often used for the prevention and treatment of 
deep vein thrombosis and other thromboembolic complications. IV 
anticoagulants are commonly used in patients with limited mobility 
(either chronically or acutely, in the post-operative setting), who are 
at risk of deep vein thrombosis, or patients with certain cardiac 
arrhythmias such as atrial fibrillation. The indications, risks, and 
benefits of each of these classes of IV medications are distinct, 
making it important to assess each separately in PAC. Knowing whether 
or not patients are receiving IV medication and the type of medication 
provided by each PAC provider will improve quality of care.
    The principal IV Medication data element is currently in use on the 
MDS 3.0 and there is a related data element in OASIS-C2 that collects 
information on Intravenous and Infusion Therapies. One sub-element of 
the proposed data elements, IV Anti-coagulants, and two other data 
elements related to IV therapy (IV Vasoactive Medications and IV 
Chemotherapy), were tested in the PAC PRD and found feasible for use in 
that the data collection aligned with usual work flow in each of the 
four PAC settings, demonstrating the feasibility of collecting IV 
medication information, including type of IV medication, through 
similar data elements in these settings.
    Clinical and subject matter expert advisors working with our data 
element contractor agreed that standardized collection of information 
on medications, including IV medications, would be feasible in PAC, and 
assess an important treatment that would be

[[Page 20732]]

clinically useful both within and across PAC provider types.
    We solicited public comment on a related data element, Vasoactive 
Medications, from August 12 to September 12, 2016. While commenters 
supported this data element with one noting the importance of this data 
element in supporting care transitions, others criticized the need for 
collecting specifically on Vasoactive Medications, giving feedback that 
the data element was too narrowly focused. Additionally, comment 
received indicated that the clinical significance of vasoactive 
medications administration alone was not high enough in PAC to merit 
mandated assessment, noting that related and more useful information 
could be captured in an item that assessed all IV medication use.
    Overall, public comment indicated the importance of including the 
additional check box data elements to distinguish particular classes of 
medications. A full report of the comments is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    A TEP convened by the data element contractor provided input on the 
proposed data elements. This TEP, held on January 5 and 6, 2017, opined 
that these data elements are appropriate for standardization because 
they would provide useful clinical information to inform care planning 
and care coordination. The TEP affirmed that assessment of these 
services and interventions is standard clinical practice. A full report 
of the TEP discussion is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Therefore, we are proposing that the IV Medications (Antibiotics, 
Anticoagulation, Other) data elements with a principal data element and 
three sub-elements meet the definition of standardized patient 
assessment data for special services, treatments, and interventions 
under section 1899B(b)(1)(B)(iii) of the Act. We are proposing to add 
the IV Medications (Antibiotics, Anticoagulation, Other) data elements 
to the IRF-PAI, and that IRFs would be required to report these data 
for the FY 2020 IRF QRP on admission and discharge for all Medicare 
Part A and MA patients discharged between October 1, 2018 and December 
31, 2018. Following the initial reporting year for the FY 2020 IRF QRP, 
subsequent years for the IRF QRP would be based on a full calendar year 
of such data reporting.
    We are inviting public comment on these proposals.
(ix) Other Treatment: Transfusions
    We are proposing that the Transfusions data element meets the 
definition of standardized patient assessment data element for special 
services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act. The proposed data element consists of 
the single Transfusions data element. For more information on the 
Transfusions data element, we refer readers to the document titled, 
Proposed Specifications for IRF QRP Quality Measures and Standardized 
Data Elements, available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Program-Measures-Information-.html.
    Transfusion refers to introducing blood, blood products, or other 
fluid into the circulatory system of a person. Blood transfusions are 
based on specific protocols, with multiple safety checks and monitoring 
required during and after the infusion in case of adverse events. 
Coordination with the provider's blood bank is necessary, as well as 
documentation by clinical staff to ensure compliance with regulatory 
requirements. In addition, the need for transfusions signifies 
underlying patient complexity that is likely to require care 
coordination and patient monitoring, and impacts planning for 
transitions of care, as transfusions are not performed by all PAC 
providers.
    The proposed data element was selected from three existing 
assessment items on transfusions and related services, currently in use 
in the MDS 3.0 (``Transfusions'') and OASIS-C2 (``Intravenous or 
Infusion Therapy''), and a data element tested in the PAC PRD (``Blood 
Transfusions''), that was found feasible for use in each of the four 
PAC settings. We chose to propose the MDS version because of its 
greater level of specificity over the OASIS-C2 data element. This 
selection was informed by expert advisors and reviewed and supported in 
the proposed form by the Standardized Patient Assessment Data TEP held 
by our data element contractor on January 5 and 6, 2017. A full report 
of the TEP discussion is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Therefore, we are proposing that the Transfusions data element that 
is currently in use in the MDS meets the definition of standardized 
patient assessment data for special services, treatments, and 
interventions under section 1899B(b)(1)(B)(iii) of the Act. We are 
proposing to add the Transfusions data element to the IRF-PAI, and that 
IRFs would be required to report these data for the FY 2020 IRF QRP on 
admission and discharge for all Medicare Part A and MA patients 
discharged between October 1, 2018 and December 31, 2018. Following the 
initial reporting year for the FY 2020 IRF QRP, subsequent years for 
the IRF QRP would be based on a full calendar year of such data 
reporting.
    We are inviting public comment on these proposals.
(x) Other Treatment: Dialysis (Hemodialysis, Peritoneal Dialysis)
    We are proposing that the Dialysis (Hemodialysis, Peritoneal 
dialysis) data elements meet the definition of standardized patient 
assessment data for special services, treatments, and interventions 
under section 1899B(b)(1)(B)(iii) of the Act. The proposed data 
elements consist of the principal Dialysis data element and two sub-
elements, Hemodialysis and Peritoneal dialysis. For more information on 
the Dialysis (Hemodialysis, Peritoneal dialysis) data elements, we 
refer readers to the document titled, Proposed Specifications for IRF 
QRP Quality Measures and Standardized Data Elements, available at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Program-Measures-Information-.html.
    Dialysis is a treatment primarily used to provide replacement for 
lost kidney function. Both forms of dialysis (hemodialysis and 
peritoneal dialysis) are resource intensive, not only during the actual 
dialysis process but before, during and following. Patients and 
residents who need and undergo dialysis procedures are at high risk for 
physiologic and hemodynamic instability from fluid shifts and 
electrolyte disturbances as well as infections that can lead to sepsis. 
Further, patients or residents receiving hemodialysis are often 
transported to a different facility, or at a minimum, to a different 
location in the same facility. Close monitoring for fluid shifts, blood 
pressure abnormalities, and other adverse effects is required prior to,

[[Page 20733]]

during and following each dialysis session. Nursing staff typically 
perform peritoneal dialysis at the bedside, and as with hemodialysis, 
close monitoring is required.
    The principal Dialysis data element is currently included on the 
MDS 3.0 and the LCDS v3.0 and assesses the overall use of dialysis. The 
sub-elements for Hemodialysis and Peritoneal dialysis were tested 
across the four PAC providers in the PAC PRD study, and found to be 
feasible for standardization. Clinical and subject matter expert 
advisors working with our data element contractor opined that the 
standardized assessment of dialysis is feasible in PAC, and that it 
assesses an important treatment that would be clinically useful both 
within and across PAC providers. As the results of expert and public 
feedback, described below, we decided to propose a data element that 
includes both the principal Dialysis data element and the two sub-
elements (hemodialysis and peritoneal dialysis).
    The Hemodialysis data element, which was tested in the PAC PRD, was 
included in a call for public comment that was open from August 12 to 
September 12, 2016. Commenters supported the assessment of hemodialysis 
and recommended that the data element be expanded to include peritoneal 
dialysis. Several commenters supported the Hemodialysis data element, 
noting the relevance of this information for sharing across the care 
continuum to facilitate care coordination and care transitions, the 
potential for this data element to be used to improve quality, and the 
feasibility for use in PAC. In addition, we received comment that the 
item would be useful in improving patient and resident transitions of 
care. Several commenters also stated that peritoneal dialysis should be 
included in a standardized data element on dialysis and recommended 
collecting information on peritoneal dialysis in addition to 
hemodialysis. The rationale for including peritoneal dialysis from 
commenters included the fact that patients and residents receiving 
peritoneal dialysis will have different needs at post-acute discharge 
compared to those receiving hemodialysis or not having any dialysis. 
Based on these comments, the Hemodialysis data element was expanded to 
include a principal Dialysis data element and two sub-elements, 
hemodialysis and peritoneal dialysis; these are the same two data 
elements that were tested in the PAC PRD. This expanded version, 
Dialysis (Hemodialysis, Peritoneal dialysis), are the data elements 
being proposed. A full report of the comments is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We note that the Dialysis (Hemodialysis, Peritoneal dialysis) data 
elements were also supported by the TEP that discussed candidate data 
elements for Special Services, Treatments, and Interventions during a 
meeting on January 5 and 6, 2017. A full report of the TEP discussion 
is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Therefore, we are proposing that the Dialysis (Hemodialysis, 
Peritoneal dialysis) data elements with a principal data element and 
two sub-elements meet the definition of standardized patient assessment 
data for special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act. We are proposing that the Dialysis 
(Hemodialysis, Peritoneal dialysis) data elements would be added to the 
IRF-PAI, and that IRFs would be required to report these data for the 
FY 2020 IRF QRP on admission and discharge for all Medicare Part A and 
MA patients discharged between October 1, 2018 and December 31, 2018. 
Following the initial reporting year for the FY 2020 IRF QRP, 
subsequent years for the IRF QRP would be based on a full calendar year 
of such data reporting.
    We are inviting public comment on these proposals.
(xi) Other Treatment: Intravenous (IV) Access (Peripheral IV, Midline, 
Central Line, Other)
    We are proposing that the IV Access (Peripheral IV, Midline, 
Central line, Other) data elements meet the definition of standardized 
patient assessment data element for special services, treatments, and 
interventions under section 1899B(b)(1)(B)(iii) of the Act. The 
proposed data elements consist of the principal IV Access data element 
and four sub-elements, Peripheral IV, Midline, Central line, and Other. 
For more information on the IV Access data element, we refer readers to 
the document titled, Proposed Specifications for IRF QRP Quality 
Measures and Standardized Data Elements, available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Program-Measures-Information-.html.
    Patients or residents with central lines, including those 
peripherally inserted or who have subcutaneous central line ``port'' 
access, always require vigilant nursing care to keep patency of the 
lines and ensure that such invasive lines remain free from any 
potentially life-threatening events such as infection, air embolism, or 
bleeding from an open lumen. Clinically complex patients and residents 
are likely to be receiving medications or nutrition intravenously. The 
sub-elements included in the IV Access data elements distinguish 
between peripheral access and different types of central access. The 
rationale for distinguishing between a peripheral IV and central IV 
access is that central lines confer higher risks associated with life-
threatening events such as pulmonary embolism, infection, and bleeding.
    The proposed IV Access (Peripheral IV, Midline, Central line, 
Other) data elements are not currently included on any of the mandated 
PAC assessment instruments. However, related data elements (for 
example, IV Medication in MDS 3.0 for SNF, Intravenous or infusion 
therapy in OASIS-C2 for HHAs) currently assess types of IV access. 
Several related data elements that describe types of IV access (for 
example, Central Line Management, IV Vasoactive Medications) were 
tested across the four PAC providers in the PAC PRD study, and found to 
be feasible for standardization.
    Clinical and subject matter expert advisors working with our data 
element contractor agreed that assessing type of IV access would be 
feasible for use in PAC and that it assesses an important treatment 
that would be clinically useful both within and across PAC provider 
types. We requested public comment on one of the PAC PRD data elements, 
Central Line Management, from August 12 to September 12, 2016. A 
central line is one type of IV access. Commenters supported the 
assessment of central line management and recommended that the data 
element be broadened to also include other types of IV access. Several 
commenters supported the data element, noting feasibility and 
importance for facilitating care coordination and care transitions. 
However, a few commenters recommended that the definition of this data 
element be broadened to include peripherally inserted central catheters 
(``PICC lines'') and midline IVs. Based on public comment feedback and 
in consultation with clinical and subject matters experts, we expanded 
the Central Line Management data element to include more types of IV 
access (Peripheral IV, Midline, Central line,

[[Page 20734]]

Other). This expanded version, IV Access (Peripheral IV, Midline, 
Central line, Other), are the data elements being proposed. A full 
report of the comments is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We note that the IV Access (Peripheral IV, Midline, Central line, 
Other) data elements were supported by the TEP that discussed candidate 
data elements for Special Services, Treatments, and Interventions 
during a meeting on January 5 and 6, 2017. A full report of the TEP 
discussion is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Therefore, we are proposing that the IV access (Peripheral IV, 
Midline, Central line, Other) data elements with a principal data 
element and four sub-elements meet the definition of standardized 
patient assessment data for special services, treatments, and 
interventions under section 1899B(b)(1)(B)(iii) of the Act. We are 
proposing to add the IV Access (Peripheral IV, Midline, Central line, 
Other) data elements to the IRF-PAI and that IRFs would be required to 
report these data for the FY 2020 IRF QRP on admission and discharge 
for all Medicare Part A and MA patients discharged between October 1, 
2018 and December 31, 2018. Following the initial reporting year for 
the FY 2020 IRF QRP, subsequent years for the IRF QRP would be based on 
a full calendar year of such data reporting.
    We are inviting public comment on these proposals.
(xii) Nutritional Approach: Parenteral/IV Feeding
    We are proposing that the Parenteral/IV Feeding data element meets 
the definition of standardized patient assessment data for special 
services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act. The proposed data element consists of 
the single Parenteral/IV Feeding data element. For more information on 
the Parenteral/IV Feeding data element, we refer readers to the 
document titled, Proposed Specifications for IRF QRP Quality Measures 
and Standardized Data Elements, available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Program-Measures-Information-.html.
    Parenteral/IV Feeding refers to a patient or resident being fed 
intravenously using an infusion pump, bypassing the usual process of 
eating and digestion. The need for IV/parenteral feeding indicates a 
clinical complexity that prevents the patient or resident from meeting 
his/her nutritional needs enterally, and is more resource intensive 
than other forms of nutrition, as it often requires monitoring of blood 
chemistries, and maintenance of a central line. Therefore, assessing a 
patient or resident's need for parenteral feeding is important for care 
planning and resource use. In addition to the risks associated with 
central and peripheral intravenous access, total parenteral nutrition 
is associated with significant risks such as embolism and sepsis.
    The Parenteral/IV Feeding data element is currently in use in the 
MDS 3.0, and equivalent or related data elements are in use in the 
LCDS, IRF-PAI, and the OASIS-C2. An equivalent data element was tested 
in the PAC PRD (``Total Parenteral Nutrition'') and found feasible for 
use in each of the four PAC settings, demonstrating the feasibility of 
collecting information about this nutritional service in these 
settings.
    Total Parenteral Nutrition (an item with the same meaning as the 
proposed data element, but with the label used in the PAC PRD) was 
included in a call for public comment that was open from August 12 to 
September 12, 2016. Several commenters supported this data element, 
noting its relevance to facilitating care coordination and supporting 
care transitions. After the public comment period, the Total Parenteral 
Nutrition data element was re-named Parenteral/IV Feeding, to be 
consistent with how this data element is referred to in the MDS. A full 
report of the comments is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    A TEP convened by the data element contractor provided input on the 
proposed data elements. This TEP, held on January 5 and 6, 2017, opined 
that these data elements are appropriate for standardization because 
they would provide useful clinical information to inform care planning 
and care coordination. The TEP affirmed that assessment of these 
services and interventions is standard clinical practice. A full report 
of the TEP discussion is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Therefore, we are proposing that the Parenteral/IV Feeding data 
element meets the definition of standardized patient assessment data 
for special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act. We are proposing to modify the existing 
Tube/Parenteral feeding item in the IRF-PAI to the Parenteral/IV 
Feeding data element, and that IRFs would be required to report these 
data for the FY 2020 IRF QRP on admission and discharge for all 
Medicare Part A and MA patients discharged between October 1, 2018 and 
December 31, 2018. Following the initial reporting year for the FY 2020 
IRF QRP, subsequent years for the IRF QRP would be based on a full 
calendar year of such data reporting.
    We are inviting public comment on these proposals.
(xiii) Nutritional Approach: Feeding Tube
    We are proposing that the Feeding Tube data element meets the 
definition of standardized patient assessment data for special 
services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act. The proposed data element consists of 
the single Feeding Tube data element. For more information on the 
Feeding Tube data element, we refer readers to the document titled, 
Proposed Specifications for IRF QRP Quality Measures and Standardized 
Data Elements, available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Program-Measures-Information-.html.
    The majority of patients admitted to acute care hospitals 
experience deterioration of their nutritional status during their 
hospital stay, making assessment of nutritional status and method of 
feeding if unable to eat orally very important in PAC. A feeding tube 
can be inserted through the nose or the skin on the abdomen to deliver 
liquid nutrition into the stomach or small intestine. Feeding tubes are 
resource intensive and are therefore important to assess for care 
planning and resource use. Patients with severe malnutrition are at 
higher risk for a variety of complications.\49\ In PAC settings, there

[[Page 20735]]

are a variety of reasons that patients and residents may not be able to 
eat orally (including clinical or cognitive status).
---------------------------------------------------------------------------

    \49\ Dempsey, D.T., Mullen, J.L., & Buzby, G.P. (1988). ``The 
link between nutritional status and clinical outcome: can 
nutritional intervention modify it?'' Am J of Clinical Nutrition 
47(2): 352-356.
---------------------------------------------------------------------------

    The Feeding Tube data element is currently included in the MDS 3.0 
for SNFs, and in the OASIS-C2 for HHAs, where it is labeled Enteral 
Nutrition. A related data element is collected in the IRF-PAI for IRFs 
(Tube/Parenteral Feeding). The testing of similar nutrition-focused 
data elements in the PAC PRD, and the current assessment of feeding 
tubes and related nutritional services and devices, demonstrates the 
feasibility of collecting information about this nutritional service in 
these settings.
    Clinical and subject matter expert advisors working with our data 
element contractor opined that the Feeding Tube data element is 
feasible for use in PAC, and supported its importance and clinical 
usefulness for patients in PAC settings, due to the increased level of 
nursing care and patient monitoring required for patients who received 
enteral nutrition with this device.
    We solicited additional feedback on an Enteral Nutrition data 
element (an item with the same meaning as the proposed data element, 
but with the label used in the OASIS) in a call for public comment that 
was open from August 12 to September 12, 2016. Several commenters 
supported the data element, noting the importance of assessing enteral 
nutrition status for facilitating care coordination and care 
transitions. After the public comment period, the Enteral Nutrition 
data element used in public comment was re-named Feeding Tube, 
indicating the presence of an assistive device. A full report of the 
comments is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    We note that the Feeding Tube data element was also supported by 
the TEP that discussed candidate data elements for Special Services, 
Treatments, and Interventions during a meeting on January 5 and 6, 
2017. A full report of the TEP discussion is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Therefore, we are proposing that the Feeding Tube data element 
meets the definition of standardized patient assessment data for 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act. We are proposing to modify the existing 
Tube/Parenteral feeding item in the IRF-PAI to the Feeding Tube data 
element and that IRFs would be required to report these data for the FY 
2020 IRF QRP on admission and discharge for all Medicare Part A and MA 
patients discharged between October 1, 2018 and December 31, 2018. 
Following the initial reporting year for the FY 2020 IRF QRP, 
subsequent years for the IRF QRP would be based on a full calendar year 
of such data reporting.
    We are inviting public comment on these proposals.
(xiv) Nutritional Approach: Mechanically Altered Diet
    We are proposing that the Mechanically Altered Diet data element 
meets the definition of standardized patient assessment data for 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act. The proposed data element consists of 
the single Mechanically Altered Diet data element. For more information 
on the Mechanically Altered Diet data element, we refer readers to the 
document titled, Proposed Specifications for IRF QRP Quality Measures 
and Standardized Data Elements, available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Program-Measures-Information-.html.
    The Mechanically Altered Diet data element refers to food that has 
been altered to make it easier for the patient or resident to chew and 
swallow, and this type of diet is used for patients and residents who 
have difficulty performing these functions. Patients with severe 
malnutrition are at higher risk for a variety of complications.\50\ In 
PAC settings, there are a variety of reasons that patients and 
residents may have impairments related to oral feedings, including 
clinical or cognitive status. The provision of a mechanically altered 
diet may be resource intensive, and can signal difficulties associated 
with swallowing/eating safety, including dysphagia. In other cases, it 
signifies the type of altered food source, such as ground or puree that 
will enable the safe and thorough ingestion of nutritional substances 
and ensure safe and adequate delivery of nourishment to the patient. 
Often, patients on mechanically altered diets also require additional 
nursing supports such as individual feeding, or direct observation, to 
ensure the safe consumption of the food product. Assessing whether a 
patient or resident requires a mechanically altered diet is therefore 
important for care planning and resource identification.
---------------------------------------------------------------------------

    \50\ Dempsey, D.T., Mullen, J.L., & Buzby, G.P. (1988). ``The 
link between nutritional status and clinical outcome: can 
nutritional intervention modify it?'' Am J of Clinical Nutrition 
47(2): 352-356.
---------------------------------------------------------------------------

    The proposed data element for a mechanically altered diet is 
currently included on the MDS 3.0 for SNFs. A related data element for 
modified food consistency/supervision is currently included on the IRF-
PAI for IRFs. A related data element is included in the OASIS-C2 for 
HHAs that collects information about independent eating that requires 
``a liquid, pureed or ground meat diet.'' The testing of similar 
nutrition-focused data elements in the PAC PRD, and the current 
assessment of various nutritional services across the four PAC 
settings, demonstrates the feasibility of collecting information about 
this nutritional service in these settings.
    Clinical and subject matter expert advisors working with our data 
element contractor agreed that the proposed Mechanically Altered Diet 
data element is feasible for use in PAC, and it assesses an important 
treatment that would be clinically useful both within and across PAC 
settings. Expert input on the Mechanically Altered Diet data element 
highlighted its importance and clinical usefulness for patients in PAC 
settings, due to the increased monitoring and resource use required for 
patients on special diets. We note that the Mechanically Altered Diet 
data element was also supported by the TEP that discussed candidate 
data elements for Special Services, Treatments, and Interventions 
during a meeting on January 5 and 6, 2017. A full report of the TEP 
discussion is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Therefore, we are proposing that the Mechanically Altered Diet data 
element meets the definition of standardized patient assessment data 
for special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act. We are proposing to modify the existing 
Modified food consistency/supervision data element in the IRF-PAI to 
the Mechanically Altered Diet data element and that IRFs would be 
required to report these data for the FY 2020 IRF QRP on admission and 
discharge for all Medicare Part A and

[[Page 20736]]

MA patients discharged between October 1, 2018 and December 31, 2018. 
Following the initial reporting year for the FY 2020 IRF QRP, 
subsequent years for the IRF QRP would be based on a full calendar year 
of such data reporting.
    We are inviting public comment on these proposals.
(xv) Nutritional Approach: Therapeutic Diet
    We are proposing that the Therapeutic Diet data element meets the 
definition of standardized patient assessment data for special 
services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act. The proposed data element consists of 
the single Therapeutic Diet data element. For more information on the 
Therapeutic Diet data element, we refer readers to the document titled, 
Proposed Specifications for IRF QRP Quality Measures and Standardized 
Data Elements, available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Program-Measures-Information-.html.
    Therapeutic Diet refers to meals planned to increase, decrease, or 
eliminate specific foods or nutrients in a patient or resident's diet, 
such as a low-salt diet, for the purpose of treating a medical 
condition. The use of therapeutic diets among patients in PAC provides 
insight on the clinical complexity of these patients and their multiple 
comorbidities. Therapeutic diets are less resource intensive from the 
bedside nursing perspective, but do signify one or more underlying 
clinical conditions that preclude the patient from eating a regular 
diet. The communication among PAC providers about whether a patient is 
receiving a particular therapeutic diet is critical to ensure safe 
transitions of care.
    The Therapeutic Diet data element is currently in use in the MDS 
3.0. The testing of similar nutrition-focused data elements in the PAC 
PRD, and the current assessment of various nutritional services across 
the four PAC settings, demonstrates the feasibility of collecting 
information about this nutritional service in these settings.
    Clinical and subject matter expert advisors working with our data 
element contractor supported the importance and clinical usefulness of 
the proposed Therapeutic Diet data element for patients in PAC 
settings, due to the increased monitoring and resource use required for 
patients on special diets, and agreed that it is feasible for use in 
PAC and that it assesses an important treatment that would be 
clinically useful both within and across PAC settings. We note that the 
Therapeutic Diet data element was also supported by the TEP that 
discussed candidate data elements for Special Services, Treatments, and 
Interventions during a meeting on January 5 and 6, 2017.
    Therefore, we are proposing that the Therapeutic Diet data element 
meets the definition of standardized patient assessment data for 
special services, treatments, and interventions under section 
1899B(b)(1)(B)(iii) of the Act. We are proposing to add the Therapeutic 
Diet data element to the IRF-PAI, and that IRFs would be required to 
report these data for the FY 2020 IRF QRP on admission and discharge 
for all Medicare Part A and MA patients discharged between October 1, 
2018 and December 31, 2018. Following the initial reporting year for 
the FY 2020 IRF QRP, subsequent years for the IRF QRP would be based on 
a full calendar year of such data reporting.
    We are inviting public comment on these proposals.
(4) Medical Condition and Comorbidity Data
    We are proposing that the data elements needed to calculate the 
current measure, Percent of Residents or Patients with Pressure Ulcers 
That Are New or Worsened (Short Stay) (NQF #0678), and the proposed 
measure, Changes in Skin Integrity Post-Acute Care: Pressure Ulcer/
Injury, meet the definition of standardized patient assessment data for 
medical conditions and co-morbidities under section 1899B(b)(1)(B)(iv) 
of the Act, and that the successful reporting of that data under 
section 1886(j)(7)(F)(i) of the Act would also satisfy the requirement 
to report standardized patient assessment data under section 
1886(j)(7)(F)(ii) of the Act.
    ``Medical conditions and comorbidities'' and the conditions 
addressed in the standardized data elements used in the calculation and 
risk adjustment of these measures, that is, the presence of pressure 
ulcers, diabetes, incontinence, peripheral vascular disease or 
peripheral arterial disease, mobility, as well as low body mass index, 
are all health-related conditions that indicate medical complexity that 
can be indicative of underlying disease severity and other 
comorbidities.
    Specifically, the data elements used in the measure are important 
for care planning and provide information pertaining to medical 
complexity. Pressure ulcers are serious wounds representing poor 
outcomes, and can result in sepsis and death. Assessing skin condition, 
care planning for pressure ulcer prevention and healing, and informing 
providers about their presence in patient transitions of care is a 
customary and best practice. Venous and arterial disease and diabetes 
are associated with low blood flow which may increase the risk of 
tissue damage. These diseases are indicators of factors that may place 
individuals at risk for pressure ulcer development and are therefore 
important for care planning. Low BMI, which may be an indicator of 
underlying disease severity, may be associated with loss of fat and 
muscle, resulting in potential risk for pressure ulcers. Bowel 
incontinence, and the possible maceration to the skin associated, can 
lead to higher risk for pressure ulcers. In addition, the bacteria 
associated with bowel incontinence can complicate current wounds and 
cause local infection. Mobility is an indicator of impairment or 
reduction in mobility and movement which is a major risk factor for the 
development of pressure ulcers. Taken separately and together, these 
data elements are important for care planning, transitions in services 
and identifying medical complexities.
    In sections XII.G.1 and XII.J.1 of this proposed rule, we discuss 
our rationale for proposing that the data elements used in the measures 
meet the definition of standardized patient assessment data. In 
summary, we believe that the collection of such assessment data is 
important for multiple reasons, including clinical decision support, 
care planning, and quality improvement, and that the data elements 
assessing pressure ulcers and the data elements used to risk adjust 
showed good reliability. We solicited stakeholder feedback on the 
quality measure, and the data elements from which it is derived, by 
means of a public comment period and TEPs, as described in section 
XII.G.1 of this proposed rule.
    We are inviting public comment on this proposal.
(5) Impairment Data
    Hearing and vision impairments are conditions that, if unaddressed, 
affect activities of daily living, communication, physical functioning, 
rehabilitation outcomes, and overall quality of life. Sensory 
limitations can lead to confusion in new settings, increase isolation, 
contribute to mood disorders, and impede accurate assessment of other 
medical conditions. Failure to appropriately assess, accommodate, and 
treat these conditions increases the likelihood that patients will 
require more intensive and prolonged treatment. Onset of these

[[Page 20737]]

conditions can be gradual, so individualized assessment with accurate 
screening tools and follow-up evaluations are essential to determining 
which patients need hearing- or vision-specific medical attention or 
assistive devices, and accommodations, including auxiliary aids and/or 
services, and to ensure that person-directed care plans are developed 
to accommodate a patient's needs. Accurate diagnosis and management of 
hearing or vision impairment would likely improve rehabilitation 
outcomes and care transitions, including transition from institutional-
based care to the community. Accurate assessment of hearing and vision 
impairment would be expected to lead to appropriate treatment, 
accommodations, including the provision of auxiliary aids and services 
during the stay, and ensure that patients continue to have their vision 
and hearing needs met when they leave the facility.
    Accurate individualized assessment, treatment, and accommodation of 
hearing and vision impairments of patients and residents in PAC would 
be expected to have a positive impact on the National Quality 
Strategy's domains of patient and family engagement, patient safety, 
care coordination, clinical process/effectiveness, and efficient use of 
healthcare resources. For example, standardized assessment of hearing 
and vision impairments used in PAC will support ensuring patient safety 
(for example, risk of falls) identifying accommodations needed during 
the stay, and appropriate support needs at the time of discharge or 
transfer. Standardized assessment of these data elements will enable or 
support clinical decision-making and early clinical intervention; 
person-centered, high quality care (for example, facilitating better 
care continuity and coordination); better data exchange and 
interoperability between settings; and longitudinal outcome analysis. 
Hence, reliable data elements assessing hearing and vision impairments 
are needed to initiate a management program that can optimize a patient 
or resident's prognosis and reduce the possibility of adverse events.
(i) Hearing
    We are proposing that the Hearing data element meets the definition 
of standardized patient assessment data for impairments under section 
1899B(b)(1)(B)(v) of the Act. The proposed data element consists of the 
single Hearing data element. This data element assesses level of 
hearing impairment, and consists of one question. For more information 
on the Hearing data element, we refer readers to the document titled, 
Proposed Specifications for IRF QRP Quality Measures and Standardized 
Data Elements, available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Program-Measures-Information-.html.
    Accurate assessment of hearing impairment is important in the PAC 
setting for care planning and resource use. Hearing impairment has been 
associated with lower quality of life, including poorer physical, 
mental, and social functioning, and emotional health.51 52 
Treatment and accommodation of hearing impairment led to improved 
health outcomes, including but not limited to quality of life.\53\ For 
example, hearing loss in elderly individuals has been associated with 
depression and cognitive impairment,54 55 56 higher rates of 
incident cognitive impairment and cognitive decline,\57\ and less time 
in occupational therapy.\58\ Accurate assessment of hearing impairment 
is important in the PAC setting for care planning and defining resource 
use.
---------------------------------------------------------------------------

    \51\ Dalton DS, Cruickshanks KJ, Klein BE, Klein R, Wiley TL, 
Nondahl DM. The impact of hearing loss on quality of life in older 
adults. Gerontologist. 2003;43(5):661-668.
    \52\ Hawkins K, Bottone FG, Jr., Ozminkowski RJ, et al. The 
prevalence of hearing impairment and its burden on the quality of 
life among adults with Medicare Supplement Insurance. Qual Life Res. 
2012;21(7):1135-1147.
    \53\ Horn KL, McMahon NB, McMahon DC, Lewis JS, Barker M, 
Gherini S. Functional use of the Nucleus 22-channel cochlear implant 
in the elderly. The Laryngoscope. 1991;101(3):284-288.
    \54\ Sprinzl GM, Riechelmann H. Current trends in treating 
hearing loss in elderly people: A review of the technology and 
treatment options--a mini-review. Gerontology. 2010;56(3):351-358.
    \55\ Lin FR, Thorpe R, Gordon-Salant S, Ferrucci L. Hearing Loss 
Prevalence and Risk Factors Among Older Adults in the United States. 
The Journals of Gerontology Series A: Biological Sciences and 
Medical Sciences. 2011;66A(5):582-590.
    \56\ Hawkins K, Bottone FG, Jr., Ozminkowski RJ, et al. The 
prevalence of hearing impairment and its burden on the quality of 
life among adults with Medicare Supplement Insurance. Qual Life Res. 
2012;21(7):1135-1147.
    \57\ Lin FR, Metter EJ, O'Brien RJ, Resnick SM, Zonderman AB, 
Ferrucci L. Hearing Loss and Incident Dementia. Arch Neurol. 
2011;68(2):214-220.
    \58\ Cimarolli VR, Jung S. Intensity of Occupational Therapy 
Utilization in Nursing Home Residents: The Role of Sensory 
Impairments. J Am Med Dir Assoc. 2016;17(10):939-942.
---------------------------------------------------------------------------

    The proposed data element was selected from two forms of the 
Hearing data element based on expert and stakeholder feedback. We 
considered the two forms of the Hearing data element, one of which is 
currently in use in the MDS 3.0 (Hearing) and another data element with 
different wording and fewer response option categories that is 
currently in use in the OASIS-C2 (Ability to Hear). Ability to Hear was 
also tested in the PAC PRD and found to have substantial agreement for 
inter-rater reliability across PAC settings (kappa of 0.78).\59\
---------------------------------------------------------------------------

    \59\ Gage B., Smith L., Ross J. et al. (2012). The Development 
and Testing of the Continuity Assessment Record and Evaluation 
(CARE) Item Set (Final Report on Reliability Testing, Volume 2 of 
3). Research Triangle Park, NC: RTI International.
---------------------------------------------------------------------------

    Several data elements that assess hearing impairment were presented 
to the Standardized Patient Assessment Data TEP held by our data 
element contractor. The TEP did not reach consensus on the ideal number 
of response categories or phrasing of response options, which are the 
primary differences between the current MDS (Hearing) and OASIS 
(Ability to Hear) items. The Development and Maintenance of Post-Acute 
Care Cross-Setting Standardized Patient Assessment Data Technical 
Expert Panel Summary Report is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    The PAC PRD form of the data element (Ability to Hear) was included 
in a call for public comment that was open from August 12 to September 
12, 2016. This data element includes three response choices, in 
contrast to the Hearing data element (in use in the MDS 3.0 and being 
proposed for standardization), which includes four response choices. 
Several commenters supported the use of the Ability to Hear data 
element, although some commenters raised concerns that the three-level 
response choice was not compatible with the current, four-level 
response used in the MDS, and favored the use of the MDS version of the 
Hearing data element. In addition, we received comments stating that 
standardized assessment related to hearing impairment has the ability 
to improve quality of care if information on hearing is included in 
medical records of patients and residents, which would improve care 
coordination and facilitate the development of patient- and resident-
centered treatment plans. Based on comments that the three-level 
response choice (Ability to Hear) was not congruent with the current, 
four-level response used in the MDS (Hearing), and support for the use 
of the MDS version of the Hearing data element received in the public 
comment, we are proposing the Hearing data element. A full report of 
the

[[Page 20738]]

comments is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Therefore, we are proposing the Hearing data element currently in 
use in the MDS. We are proposing to add the Hearing data element to the 
IRF-PAI, and that IRFs would be required to report these data for the 
FY 2020 IRF QRP on admission for all Medicare Part A and MA patients 
discharged between October 1, 2018 and December 31, 2018. Following the 
initial reporting year for the FY 2020 IRF QRP, subsequent years for 
the IRF QRP would be based on a full calendar year of such data 
reporting. The Hearing data element would be assessed at admission only 
due to the relatively stable nature of hearing impairment, making it 
unlikely that this assessment would change between the start and end of 
the PAC stay. Assessment at discharge would introduce additional burden 
without improving the quality or usefulness of the data, and we believe 
it is unnecessary.
    We are inviting public comment on these proposals.
(ii) Vision
    We are proposing that the Vision data element meets the definition 
of standardized patient assessment data element for impairments under 
section 1899B(b)(1)(B)(v) of the Act. The proposed data element 
consists of the single Vision (Ability To See in Adequate Light) data 
element that consists of one question with five response categories. 
For more information on the Vision data element, we refer readers to 
the document titled, Proposed Specifications for IRF QRP Quality 
Measures and Standardized Data Elements, available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Program-Measures-Information-.html.
    Evaluation of an individual's ability to see is important for 
assessing for risks such as falls and provides opportunities for 
improvement through treatment and the provision of accommodations, 
including auxiliary aids and services, which can safeguard patients and 
improve their overall quality of life. Further, vision impairment is 
often a treatable risk factor associated with adverse events and poor 
quality of life. For example, individuals with visual impairment are 
more likely to experience falls and hip fracture, have less mobility, 
and report depressive symptoms.60 61 62 63 64 65 66
---------------------------------------------------------------------------

    \60\ Colon-Emeric CS, Biggs DP, Schenck AP, Lyles KW. Risk 
factors for hip fracture in skilled nursing facilities: Who should 
be evaluated? Osteoporos Int. 2003;14(6):484-489.
    \61\ Freeman EE, Munoz B, Rubin G, West SK. Visual field loss 
increases the risk of falls in older adults: The Salisbury eye 
evaluation. Invest Ophthalmol Vis Sci. 2007;48(10):4445-4450.
    \62\ Keepnews D, Capitman JA, Rosati RJ. Measuring patient-level 
clinical outcomes of home health care. J Nurs Scholarsh. 
2004;36(1):79-85.
    \63\ Nguyen HT, Black SA, Ray LA, Espino DV, Markides KS. 
Predictors of decline in MMSE scores among older Mexican Americans. 
J Gerontol A Biol Sci Med Sci. 2002;57(3):M181-185.
    \64\ Prager AJ, Liebmann JM, Cioffi GA, Blumberg DM. Self-
reported Function, Health Resource Use, and Total Health Care Costs 
Among Medicare Beneficiaries With Glaucoma. JAMA ophthalmology. 
2016;134(4):357-365.
    \65\ Rovner BW, Ganguli M. Depression and disability associated 
with impaired vision: The MoVies Project. J Am Geriatr Soc. 
1998;46(5):617-619.
    \66\ Tinetti ME, Ginter SF. The nursing home life-space 
diameter. A measure of extent and frequency of mobility among 
nursing home residents. J Am Geriatr Soc. 1990;38(12):1311-1315.
---------------------------------------------------------------------------

    Individualized initial screening can lead to life-improving 
interventions such as accommodations, including the provision of 
auxiliary aids and services, during the stay and/or treatments that can 
improve vision and prevent or slow further vision loss. For patients 
with some types of visual impairment, use of glasses and contact lenses 
can be effective in restoring vision.\67\ Other conditions, including 
glaucoma \68\ and age-related macular degeneration,69 70 
have responded well to treatment. In addition, vision impairment is 
often a treatable risk factor associated with adverse events which can 
be prevented and accommodated during the stay. Accurate assessment of 
vision impairment is important in the PAC setting for care planning and 
defining resource use.
---------------------------------------------------------------------------

    \67\ Rein DB, Wittenborn JS, Zhang X, et al. The Cost-
effectiveness of Welcome to Medicare Visual Acuity Screening and a 
Possible Alternative Welcome to Medicare Eye Evaluation Among 
Persons Without Diagnosed Diabetes Mellitus. Archives of 
ophthalmology. 2012;130(5):607-614.
    \68\ Leske M, Heijl A, Hussein M, et al. Factors for glaucoma 
progression and the effect of treatment: The early manifest glaucoma 
trial. Archives of Ophthalmology. 2003;121(1):48-56.
    \69\ Age-Related Eye Disease Study Research G. A randomized, 
placebo-controlled, clinical trial of high-dose supplementation with 
vitamins c and e, beta carotene, and zinc for age-related macular 
degeneration and vision loss: AREDS report no. 8. Archives of 
Ophthalmology. 2001;119(10):1417-1436.
    \70\ Takeda AL, Colquitt J, Clegg AJ, Jones J. Pegaptanib and 
ranibizumab for neovascular age-related macular degeneration: A 
systematic review. The British Journal of Ophthalmology. 
2007;91(9):1177-1182.
---------------------------------------------------------------------------

    The Vision data element that we are proposing for standardization 
was tested as part of the development of the MDS 3.0 and is currently 
in use in that assessment. Similar data elements, but with different 
wording and fewer response option categories, are in use in the OASIS-
C2 and were tested in post-acute providers in the PAC PRD and found to 
be clinically relevant, meaningful for care planning, reliable (kappa 
of 0.74),\71\ and feasible for use in each of the four PAC settings.
---------------------------------------------------------------------------

    \71\ Gage B., Smith L., Ross J. et al. (2012). The Development 
and Testing of the Continuity Assessment Record and Evaluation 
(CARE) Item Set (Final Report on Reliability Testing, Volume 2 of 
3). Research Triangle Park, NC: RTI International.
---------------------------------------------------------------------------

    Several data elements that assess vision were presented to the TEP 
held by our data element contractor. The TEP did not reach consensus on 
the ideal number of response categories or phrasing of response 
options, which are the primary differences between the current MDS and 
OASIS items; some members preferring more granular response options 
(for example, mild impairment and moderate impairment) while others 
were comfortable with collapsed response options (that is, mild/
moderate impairment). The Development and Maintenance of Post-Acute 
Care Cross-Setting Standardized Patient Assessment Data Technical 
Expert Panel Summary Report is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html. We solicited public comment from August 12 to September 
12, 2016, on the Ability to See in Adequate Light data element (version 
tested in the PAC PRD with three response categories). The data element 
in public comment differed from the proposed data element, but the 
comments supported the assessment of vision in PAC settings and the 
useful information a vision data element would provide. The commenters 
stated that the Ability to See item would provide important information 
that would facilitate care coordination and care planning, and 
consequently improve the quality of care. Other commenters suggested it 
would be helpful as an indicator of resource use and noted that the 
item would provide useful information about the abilities of patients 
and residents to care for themselves. Additional commenters noted that 
the item could feasibly be implemented across PAC providers and that 
its kappa scores from the PAC PRD support its validity. Some commenters 
noted a preference for MDS version of the Vision data element over the 
form put forward in public comment, citing the widespread use of this 
data element.

[[Page 20739]]

A full report of the comments is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Post-Acute-Care-Quality-Initiatives/IMPACT-Act-of-2014/IMPACT-Act-Downloads-and-Videos.html.
    Therefore, we are proposing the Vision data element from the MDS. 
We are proposing to add the Vision data element to the IRF-PAI and that 
IRFs would be required to report these data for the FY 2020 IRF QRP on 
admission for all Medicare Part A and MA patients discharged between 
October 1, 2018 and December 31, 2018. Following the initial reporting 
year for the FY 2020 IRF QRP, subsequent years for the IRF QRP would be 
based on a full calendar year of such data reporting. The Vision data 
element would be assessed at admission only due to the relatively 
stable nature of vision impairment, making it unlikely that this 
assessment would change between the start and end of the PAC stay. 
Assessment at discharge would introduce additional burden without 
improving the quality or usefulness of the data, and we believe that it 
is unnecessary.
    We are inviting public comment on these proposals.

K. Proposals Relating to the Form, Manner, and Timing of Data 
Submission Under the IRF QRP

1. Proposed Start Date for Standardized Patient Assessment Data 
Reporting by New IRFs
    In the IRF PPS FY 2016 final rule (80 FR 47123 through 47124), we 
adopted timing for new IRFs to begin reporting quality data under the 
IRF QRP beginning with the FY 2017 IRF QRP. We are proposing in this 
proposed rule that new IRFs will be required to begin reporting 
standardized patient assessment data on the same schedule. We are 
inviting public comment on this proposal.
2. Proposed Mechanism for Reporting Standardized Patient Assessment 
Data Beginning With the FY 2019 IRF QRP
    Under our current policy, IRFs report data by completing applicable 
sections of the IRF-PAI, and submitting the IRF-PAI to CMS through the 
QIES, ASAP system. For more information on IRF QRP reporting through 
the QIES ASAP system, refer to the ``Related Links'' section at the 
bottom of https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/Software.html. The proposed standardized 
patient assessment data elements are either already included on, or 
would be added to, the IRF-PAI. Details regarding the IRF-PAI to the 
proposed standardized assessment data are available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-PAI-and-IRF-QRP-Manual.html.
    We are inviting public comments on this proposal.
3. Proposed Schedule for Reporting Standardized Patient Assessment Data 
Beginning With the FY 2019 IRF QRP
    Starting with the FY 2019 IRF QRP, we are proposing to apply our 
current schedule for the reporting of measure data to the reporting of 
standardized patient assessment data. Under that policy, except for the 
first program year for which a measure is adopted, IRFs must report 
data on measures for IRF Medicare patients who are discharged during 
the 12-month calendar year (CY) period that apply to the program year. 
For the first program year for which a measure is adopted, IRFs are 
only required to report data on IRF Medicare patients who are 
discharged on or after October 1 of the last quarter of the calendar 
year that applies to that program year. For example, for the FY 2018 
IRF QRP, data on measures adopted for earlier program years must be 
reported for all IRF Medicare patients who are discharged during CY 
2016. However, data on new measures adopted for the first time for the 
FY 2018 IRF QRP must only be reported for IRF Medicare patients who are 
discharged during the last calendar quarter of 2016.
    Tables 9 and 10 illustrate this policy using the FY 2019 and FY 
2020 IRF QRP as examples.

   Table 9--Summary Illustration of Initial Reporting Cycle for Newly
Adopted Measure and Standardized Patient Assessment Data Reporting Using
                         CY Q4 Data *[supcaret]
------------------------------------------------------------------------
     Proposed data collection/       Proposed data submission quarterly
  submission quarterly reporting      deadlines *[supcaret] for the FY
             period *                          2019 IRF QRP **
------------------------------------------------------------------------
Q4: CY 2017 10/1/2017-12/31/2017..  CY 2017 Q4 Deadline: May 15, 2018.
------------------------------------------------------------------------
* We note that the submission of IRF-PAI data must also adhere to the
  IRF PPS deadlines.
** The term ``FY 2019 IRF QRP'' means the fiscal year for which the IRF
  QRP requirements applicable to that fiscal year must be met in order
  for an IRF to receive the full annual update when calculating the
  payment rates applicable to it for that fiscal year.
[supcaret] Applies to data reporting using the IRF PAI and data
  reporting using the National Health Safety Network.


   Table 10--Summary Illustration of Calendar Year Quarterly Reporting
  Cycles for Measure and Standardized Patient Assessment Data Reporting
                               *[supcaret]
------------------------------------------------------------------------
     Proposed data collection/       Proposed data submission quarterly
  submission quarterly reporting      deadlines *[supcaret] for the FY
             period *                          2020 IRF QRP **
------------------------------------------------------------------------
Q1: CY 2018 1/1/2018-3/31/2018....  CY 2018 Q1 Deadline: August 15,
                                     2018.
Q2: CY 2018 4/1/2018-6/30/2018....  CY 2018 Q2 Deadline: November 15,
                                     2018.
Q3: CY 2018 7/1/2018-9/30/2018....  CY 2018 Q3 Deadline: February 15,
                                     2019.
Q4: CY 2018 10/1/2018-12/31/2018..  CY 2018 Q4 Deadline: May 15, 2019.
------------------------------------------------------------------------
* We note that the submission of IRF-PAI data must also adhere to the
  IRF PPS deadlines.
** The term ``FY 2020 IRF QRP'' means the fiscal year for which the IRF
  QRP requirements applicable to that fiscal year must be met in order
  for an IRF to receive the full annual update when calculating the
  payment rates applicable to it for that fiscal year.
[supcaret] Applies to data reporting using the IRF PAI and data
  reporting using the National Health Safety Network.


[[Page 20740]]

    We are inviting public comment on our proposal to extend our 
current policy governing the schedule for reporting quality measure 
data to the reporting of standardized patient assessment data beginning 
with the FY 2019 IRF QRP.
4. Proposed Schedule for Reporting the Proposed Changes in Skin 
Integrity Post-Acute Care: Pressure Ulcer/Injury Measure Beginning With 
the FY 2020 IRF QRP
    As discussed in section XII.G. of this proposed rule, we are 
proposing to adopt the Changes in Skin Integrity Post-Acute Care: 
Pressure Ulcer/Injury measure beginning with the FY 2020 IRF QRP. We 
are proposing that IRFs would report data on that measure using the 
IRF-PAI that is submitted through the QIES ASAP system. IRFs would be 
required to report these data on admission and discharge for all 
Medicare Part A and MA patients discharged between October 1, 2018 and 
December 31, 2018. More information on IRF reporting using the QIES 
ASAP system is located at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/Technical-Information.html.
    Under our current policy, IRFs would only be required to submit 
data on the proposed measure for the fourth quarter of CY 2018 for 
purposes of the FY 2020 IRF QRP. Starting in CY 2019, IRFs would be 
required to submit data for the entire calendar year beginning with the 
FY 2021 IRF QRP.
5. Input Sought for Data Reporting Related to Assessment Based Measures
    Through various means of public input, including that through 
previous rules, public comment on measures and the Measures Application 
Partnership, we received input suggesting that we expand the quality 
measures to include all patients regardless of payer status so as to 
ensure representation of the quality of the services provided on the 
population as a whole, rather than a subset limited to Medicare. For 
IRFs, the Medicare population comprises approximately 60 percent of the 
IRF population served. We agree that collecting quality data on all 
patients in the IRF setting supports CMS' mission to ensure quality 
care for all individuals, including Medicare beneficiaries. We also 
appreciate that collecting quality data on all patients regardless of 
payer source may create additional burden. However, we also note that 
the effort to separate out Medicare beneficiaries from other patients 
has clinical and work flow implications with an associated burden, and 
we further appreciate that it is common practice for IRFs to collect 
IRF-PAI data on all patients, regardless of payer source. Accurate 
representation of quality provided in IRFs is best conveyed using data 
on all IRF patients, regardless of payer. Thus, we are seeking input on 
whether we should require quality data reporting on all IRF patients, 
regardless of payer, where feasible--noting that Part A claims data are 
limited to only Medicare beneficiaries.
    We are seeking comments on this topic.

L. Proposal To Apply the IRF QRP Submission Requirements and Payment 
Impact to the Standardized Patient Assessment Data Beginning With the 
FY 2019 IRF QRP

    We are proposing to revise Sec.  412.634(b) to require IRFs to 
report both data on measures and standardized patient assessment data 
under the IRF QRP, in a form and manner, and at a time specified by 
CMS.
    We are inviting public comment on this proposal.

M. Proposal To Apply the IRF QRP Exception and Extension Requirements 
to the Submission of Standardized Patient Assessment Data Beginning 
With the FY 2019 IRF QRP

    In the FY 2017 IRF PPS final rule (81 FR 52124), we codified the 
requirements pertaining to data submission exception and extension for 
the IRF QRP at Sec.  412.634(c). We are proposing to revise Sec.  
412.634(c) to extend these policies to the submission of standardized 
patient assessment data beginning with the FY 2019 IRF QRP. We are 
inviting public comment on this proposal.

N. Proposal To Apply the IRF QRP Data Completion Thresholds to the 
Submission of Standardized Patient Assessment Data Beginning With the 
FY 2019 IRF QRP

    In the FY 2015 IRF PPS final rule (79 FR 45921 through 45923), we 
finalized IRF QRP thresholds for completeness of IRF data submissions. 
To ensure that IRFs are meeting an acceptable standard for completeness 
of submitted data, we finalized the policy that, beginning with the FY 
2016 IRF QRP, IRFs must meet or exceed two separate data completeness 
thresholds: One threshold set at 95 percent for completion of measures 
data collected using the IRF-PAI submitted through the QIES and a 
second threshold set at 100 percent for measures data collected and 
submitted using the Centers for Disease Control and Prevention (CDC) 
National Healthcare Safety Network (NHSN).
    For a detailed discussion of the finalized IRF QRP data completion 
requirements, please refer to the FY 2015 IRF PPS final rule (79 FR 
45921 through 45923). In the FY 2017 IRF PPS final rule, (81 FR 52124), 
we codified the IRF QRP Data Completion Thresholds at Sec.  412.634. We 
note that Sec.  412.634(f)(1) requires that IRFs meet or exceed the 
reporting threshold set at 95 percent for completion of measure data 
collected using the IRF-PAI. However, some assessment data will not 
invoke a response and in those circumstances are not ``missing'' nor is 
the data incomplete. For example, in the case of a patient who does not 
have any of the medical conditions in a check-all-that-apply listing, 
the absence of a response indicates that the condition is not present, 
and it would be incorrect to consider the absence of such data as 
missing in a threshold determination. We are proposing to extend our 
current IRF QRP data completion requirements to the reporting of 
standardized patient assessment data.
    We are also proposing to revise Sec.  412.634(f)(1) and (2) to 
include the submission of standardized patient assessment data that is 
collected using the IRF-PAI.
    As we noted in the FY 2015 IRF PPS final rule (79 FR 45921 through 
45923), the threshold of 95 percent is based on the need for complete 
records, which allows appropriate analysis of measure data for the 
purposes of updating measure specifications as they undergo measure 
maintenance reviews with the NQF. Additionally, complete data is needed 
to understand the validity and reliability of data items, including 
risk-adjustment models. Our data suggests that the majority of current 
IRF providers are in compliance with, or exceed this threshold related 
to the measure data, and we believe it is feasible for the standardized 
patient assessment data as well.
    We invite public comment on our proposal to revise Sec.  
412.634(f)(1) and (2) to add standardized patient assessment data for 
the 95 percent completeness threshold for data collected via IRF-PAI.

O. Proposals and Policies Regarding Public Display of Measure Data for 
the IRF QRP

    Section 1886(j)(7)(E) of the Act requires the Secretary to 
establish procedures for making the IRF QRP data available to the 
public after ensuring that an IRF has the opportunity to review its 
data prior to public display. Measure data is currently displayed on

[[Page 20741]]

the Inpatient Rehabilitation Facility Compare Web site, which is an 
interactive web tool that assists individuals by providing information 
on IRF quality of care, including those who need to select an IRF. For 
more information on IRF Compare, we refer readers to https://www.medicare.gov/inpatientrehabilitationfacilitycompare/. Additionally, 
for a more detailed discussion about the provider's confidential review 
process prior to public display of quality measures, we refer readers 
to the FY 2017 IRF PPS final rule (81 FR 52128 through 52131).
    We also finalized the process we use to publish a list of IRFs that 
successfully meet the reporting requirements for the applicable IRF QRP 
year on the IRF QRP Web site in the FY 2017 IRF PPS final rule (81 FR 
52125). The list of compliant IRFs is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Reporting-Data-Submission-Deadlines.html.
    In the FY 2017 IRF PPS final rule (81 FR 52055 through 52141), we 
finalized the public display of measure data on the IRF Compare Web 
site in CY 2017 for the following four quality measures pending the 
availability of data: (1) NHSN Facility-wide Inpatient Hospital-onset 
MRSA Bacteremia Outcome Measure (NQF #1716); (2) NHSN Facility-wide 
Inpatient Hospital-onset CDI Outcome Measure (NQF #1717); (3) Influenza 
Vaccination Coverage Among Healthcare Personnel (NQF #0431); and (4) 
Percent of Residents or Patients Who Were Assessed and Appropriately 
Given the Seasonal Influenza Vaccine (NQF #0680).
    The public display of NHSN Facility-wide Inpatient Hospital-onset 
MRSA Bacteremia Outcome Measure (NQF #1716) and NHSN Facility-wide 
Inpatient Hospital-onset CDI Outcome Measure (NQF #1717) will initially 
be based on data collected from January 1, 2015, through December 31, 
2015 and will be displayed based on four rolling quarters. The 
Influenza Vaccination Coverage Among Healthcare Personnel (NQF #0431) 
and Percent of Residents or Patients Who Were Assessed and 
Appropriately Given the Seasonal Influenza Vaccine (NQF #0680) will be 
based on the influenza vaccination season from October 1, 2015, through 
March 31, 2016 and will be updated annually. We refer readers to the FY 
2017 IRF PPS final rule (81 FR 52126 through 52128) for details on the 
calculations and display of these quality measures. In this FY 2018 IRF 
PPS proposed rule, pending the availability of data, we are proposing 
to publicly report data in CY 2018 for the following two assessment-
based measures: (1) Application of Percent of Long-Term Care Hospital 
(LTCH) Patients With an Admission and Discharge Functional Assessment 
and a Care Plan That Addresses Function (NQF #2631); and (2) 
Application of Percent of Residents Experiencing One or More Falls with 
Major Injury (NQF #0674). Data collection for these two assessment-
based measures began on October 1, 2016. We are proposing to display 
data for the assessment-based measures based on four rolling quarters 
of data and would initially use discharges from January 1, 2017, 
through December 31, 2017. In addition, we are proposing to publicly 
report four claims-based measures: (1) Medicare Spending Per 
Beneficiary-PAC IRF QRP; (2) Discharge to Community-PAC IRF QRP; (3) 
Potentially Preventable 30-Day Post-Discharge Readmission Measure for 
IRF QRP; and (4) Potentially Preventable Within Stay Readmission 
Measure for IRFs.
    These measures were adopted for the IRF QRP in the FY 2017 IRF PPS 
final rule (81 FR 52130 through 52131) to be based on data from 2 
consecutive calendar years. As previously adopted, confidential 
feedback reports for these four claims-based measures will be based on 
calendar years 2015 and 2016 and data collected for discharges 
beginning January 1, 2015, through December 31, 2016. However, our 
current proposal revises the dates for public reporting and we are 
proposing to transition from calendar year to fiscal year to make these 
measure data publicly available by October 2018. Thus, we are proposing 
for public reporting beginning in CY 2018 for four claims-based 
measures based on fiscal years 2016 and 2017 and data collected from 
discharges beginning October 1, 2015, through September 30, 2017.
    We are proposing to remove the following claims-based measure 
``All-Cause Unplanned Readmission Measure for 30 Days Post Discharge 
from Inpatient Rehabilitation Facilities'' from the IRF QRP and public 
reporting by October 2018. We refer readers to section XII.H. of this 
proposed rule for additional information regarding the proposed removal 
of this measure from quality reporting and public display. We also 
propose to remove the following assessment-based measure ``Percent of 
Residents or Patients with Pressure Ulcers That Are New or Worsened 
(Short Stay) (NQF #0678)'' and to replace it with a modified version of 
the measure entitled ``Changes in Skin Integrity Post-Acute Care: 
Pressure Ulcer/Injury'' from the IRF QRP and public reporting by 
October 2020. We refer readers to section XII.G. of this proposed rule 
for additional information regarding the proposed replacement of this 
measure from quality reporting and public display.
    For the assessment-based measures, Application of Percent of LTCH 
Patients With an Admission and Discharge Functional Assessment and a 
Care Plan That Addresses Function (NQF #2631); and Application of 
Percent of Residents Experiencing One or More Falls with Major Injury 
(NQF #0674), to ensure the statistical reliability of the measures, we 
are proposing to assign IRFs with fewer than 20 eligible cases during a 
performance period to a separate category: ``The number of cases/
patient stays is too small to report.'' If an IRF had fewer than 20 
eligible cases, the IRF's performance would not be publicly reported 
for the measure for that performance period.
    For the claims-based measures, Discharge to Community-PAC IRF QRP; 
Potentially Preventable 30-Day Post-Discharge Readmission Measure for 
IRF QRP; and Potentially Preventable Within Stay Readmission Measure 
for IRFs, to ensure the statistical reliability of the measures, we are 
proposing to assign IRFs with fewer than 25 eligible cases during a 
performance period to a separate category: ``The number of cases/
patient stays is too small to report.'' If an IRF had fewer than 25 
eligible cases, the IRF's performance would not be publicly reported 
for the measure for that performance period. For Medicare Spending Per 
Beneficiary-PAC IRF QRP, to ensure the statistical reliability of the 
measure, we are proposing to assign IRFs with fewer than 20 eligible 
cases during a performance period to a separate category: ``The number 
of cases/patient stays is too small to report.'' If an IRF had fewer 
than 20 eligible cases, the IRF's performance would not be publicly 
reported for the measure for that performance period.

[[Page 20742]]



 Table 11--Previously Finalized and Proposed Measures for CY 2018 Public
                Display and Confidential Feedback Reports
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Previously Finalized Measures:
    Percent of Residents or Patients with Pressure Ulcers That Are New
     or Worsened (Short Stay) (NQF #678)
    National Healthcare Safety Network Catheter-Associated Urinary Tract
     Infection (CAUTI) Outcome Measure (NQF #0138)
    NHSN Facility-wide Inpatient Hospital-onset Methicillin-resistant
     Staphylococcus aureus Bacteremia Outcome Measure (NQF #1716)
    NHSN Facility-wide Inpatient Hospital-onset Clostridium difficile
     Infection Outcome Measure (NQF #1717)
    Influenza Vaccination Coverage Among Healthcare Personnel (NQF
     #0431)
    Percent of Residents or Patients Who Were Assessed and Appropriately
     Given the Seasonal Influenza Vaccine (NQF #0680)
Proposed Measures:
    Application of Percent of Long-Term Care Hospital (LTCH) Patients
     With an Admission and Discharge Functional Assessment and a Care
     Plan That Addresses Function (NQF #2631)
    Application of Percent of Residents Experiencing One or More Falls
     with Major Injury (NQF# 0674)
    Medicare Spending Per Beneficiary-PAC IRF QRP
    Discharge to Community-PAC IRF QRP
    Potentially Preventable 30-Day Post-Discharge Readmission Measure
     for IRF QRP
    Potentially Preventable Within Stay Readmission Measure for IRFs
------------------------------------------------------------------------

    We are inviting public comment on the proposal for the public 
display of the two assessment-based measures and four claims-based 
measures, the removal of the All-Cause Unplanned Readmission Measure 
for 30 Days Post Discharge from IRFs from the IRF QRP and from public 
display, and the replacement of ``Percent of Residents or Patients with 
Pressure Ulcers That Are New or Worsened (Short Stay) (NQF #0678)'' 
with a modified version of the measure entitled ``Changes in Skin 
Integrity Post-Acute Care: Pressure Ulcer/Injury'' as described above.

P. Mechanism for Providing Feedback Reports to IRFs

    Section 1899B(f) of the Act requires the Secretary to provide 
confidential feedback reports to PAC providers on their performance on 
the measures specified under sections 1899B(c)(1) and (d)(1) of the 
Act, beginning one year after the specified application date that 
applies to such measures and PAC providers. In the FY 2017 IRF PPS 
final rule (81 FR 52131), we finalized processes to provide IRFs the 
opportunity to review their data and information using confidential 
feedback reports that will enable IRFs to review their performance on 
the measures required under the IRF QRP. Information on how to obtain 
these and other reports available to the IRF can be found at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/IRF-Quality-Public-Reporting.html. We 
are not proposing any changes to this policy.

Q. Proposed Method for Applying the Reduction to the FY 2018 IRF 
Increase Factor for IRFs That Fail To Meet the Quality Reporting 
Requirements

    As previously noted, section 1886(j)(7)(A)(i) of the Act requires 
the application of a 2-percentage point reduction of the applicable 
market basket increase factor for IRFs that fail to comply with the 
quality data submission requirements. In compliance with section 
1886(j)(7)(A)(i) of the Act, we propose to apply a 2-percentage point 
reduction to the applicable FY 2018 market basket increase factor in 
calculating a proposed adjusted FY 2018 standard payment conversion 
factor to apply to payments for only those IRFs that failed to comply 
with the data submission requirements. As previously noted, application 
of the 2-percentage point reduction may result in an update that is 
less than 0.0 for a fiscal year and in payment rates for a fiscal year 
being less than such payment rates for the preceding fiscal year. Also, 
reporting-based reductions to the market basket increase factor will 
not be cumulative; they will only apply for the FY involved.
    We invite public comment on the proposed method for applying the 
reduction to the FY 2018 IRF increase factor for IRFs that fail to meet 
the quality reporting requirements.
    Table 12 shows the calculation of the proposed adjusted FY 2018 
standard payment conversion factor that will be used to compute IRF PPS 
payment rates for any IRF that failed to meet the quality reporting 
requirements for the applicable reporting period(s).

    Table 12--Calculations To Determine the Proposed Adjusted FY 2018
   Standard Payment Conversion Factor for IRFs That Failed To Meet the
                      Quality Reporting Requirement
------------------------------------------------------------------------
              Explanation for adjustment                  Calculations
------------------------------------------------------------------------
Standard Payment Conversion Factor for FY 2017.......           $ 15,708
Increase Factor for FY 2018 (1.0 percent), as                   x 0.9900
 required by section 1886(j)(3)(C)(iii) of the Act,
 and further reduced by 2 percentage points for IRFs
 that failed to meet the quality reporting
 requirement.........................................
Budget Neutrality Factor for the Wage Index and Labor-          x 1.0007
 Related Share.......................................
Budget Neutrality Factor for the Revisions to the CMG           x 0.9974
 Relative Weights....................................
                                                      ------------------
Adjusted FY 2018 Standard Payment Conversion Factor..         = $ 15,521
------------------------------------------------------------------------

XIII. 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.

[[Page 20743]]

    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. 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 IRF PPS 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.

XIV. Collection of Information Requirements

A. Statutory Requirement for Solicitation of Comments

    Under the Paperwork Reduction Act of 1995 (PRA), we are required to 
provide 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the 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 estimate of the information collection 
burden.
     The quality, utility, and clarity of the information to be 
collected.
     Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    This proposed rule makes reference to associated information 
collections that are not discussed in the regulation text contained in 
this document.

B. Collection of Information Requirements for Updates Related to the 
IRF QRP

    Failure to submit data required under section 1886(j)(7)(C) and (F) 
of the Act will result in the reduction of the annual update to the 
standard federal rate for discharges occurring during such fiscal year 
by 2 percentage points for any IRF that does not comply with the 
requirements established by the Secretary. At the time that this 
analysis was prepared, 80, or approximately 7 percent, of the 1137 
active Medicare-certified IRFs did not receive the full annual 
percentage increase for the FY 2017 annual payment update 
determination. Information is not available to determine the precise 
number of IRFs that will not meet the requirements to receive the full 
annual percentage increase for the FY 2018 payment determination.
    We believe that the burden associated with the IRF QRP is the time 
and effort associated with data collection and reporting. As of 
February 1, 2017, there are approximately 1137 IRFs currently reporting 
quality data to CMS. For the purposes of calculating the costs 
associated with the collection of information requirements, we obtained 
mean hourly wages for these staff from the U.S. Bureau of Labor 
Statistics' May 2016 National Occupational Employment and Wage 
Estimates (http://www.bls.gov/oes/current/oes_nat.htm). To account for 
overhead and fringe benefits, we have doubled the hourly wage. These 
amounts are detailed in Table 13.

[[Page 20744]]



     Table 13--U.S. Bureau of Labor Statistics' May 2016 National Occupational Employment and Wage Estimates
----------------------------------------------------------------------------------------------------------------
                                                                                                     Adjusted
                Occupation title                    Occupation      Mean hourly   Fringe benefit    hourly wage
                                                       code        wage  ($/hr)        ($/hr)         ($/hr)
----------------------------------------------------------------------------------------------------------------
Registered Nurse (RN)...........................         29-1141           34.70           34.70           69.40
Licensed Practical and Licensed Vocational               29-2061           21.56           21.56           43.12
 Nurses (LVN)...................................
Respiratory Therapists (RT).....................         29-1126           29.15           29.15           58.30
Speech-Language Pathologists (SLP)..............         29-1127           37.60           37.60           75.20
Occupational Therapists (OT)....................         29-1122           40.25           40.25           80.50
Psychologist....................................         19-3030           38.77           38.77           77.54
----------------------------------------------------------------------------------------------------------------

    As discussed elsewhere, this rule proposes to: (1) Adopt one new 
pressure ulcer measure that has been specified under section 
1899B(c)(1)(C) of the Act, beginning with the FY 2020 IRF QRP (see 
section XII.G.1 of this proposed rule). The measure would be calculated 
using data elements that are currently included in the IRF-PAI. The 
data elements are discrete questions and response codes that collect 
information on an IRF patient's health status, preferences, goals and 
general administrative information.
    We are also proposing to require IRFs to report certain 
standardized patient assessment data beginning with the FY 2019 IRF QRP 
(see section XII.J of this proposed rule). We are proposing to define 
the term ``standardized patient assessment data'' as patient assessment 
questions and response options that are identical in all four PAC 
assessment instruments, and to which identical standards and 
definitions apply. The standardized patient assessment data is intended 
to be shared electronically among PAC providers and will otherwise 
enable the data to be comparable for various purposes, including the 
development of cross-setting quality measures and to inform payment 
models that take into account patient characteristics rather than 
setting.
    Pursuant to 1899B(m) of the Act, the Paperwork Reduction Act does 
not apply to the specific changes in the collections of information 
described in this proposed rule.
    These changes to the collections of information arise from Section 
2(a) of the IMPACT Act, which added new section 1899B to the Act. That 
section requires IRFs to report standardized patient assessment data, 
data on quality measures, and data on resource use and other measures. 
All of this data must, under section 1899B(a)(1)(B) of the Act, be 
standardized and interoperable to allow for its exchange among PAC 
providers and other providers and the use by such providers in order to 
provide access to longitudinal information to facilitate coordinated 
care and improved Medicare beneficiary outcomes. Section 1899B(a)(1)(C) 
of the Act requires us to modify the IRF-PAI to allow for the 
submission of quality measure data and standardized patient assessment 
data to enable its comparison across IRFs and other providers.
    As noted in section VIII, we are also proposing to remove item 27 
(Swallowing Status) from the IRF-PAI, on admission and discharge.
    We are also proposing to remove the All-Cause Unplanned Readmission 
Measure for 30 Days Post-Discharge from IRFs (NQF #2502). This is a 
claims-based measure, and IRFs will still be required to submit the 
claims on which this measure is calculated. Therefore, we believe the 
IRF QRP burden estimate is unaffected by the proposed removal of this 
measure.
    Adoption of the Changes in Skin Integrity Post-Acute Care: Pressure 
Ulcer/Injury measure would result in the removal of some data items 
related to pressure ulcer assessment that we believe are duplicative or 
no longer necessary. As a result, the estimated burden and cost for 
IRFs to report the updated version of the measure would be reduced from 
the burden and cost to report the current version of the measure. 
Specifically, we believe that there will be a 5 minute reduction in 
clinical staff time to report data, and we believe the items being 
removed would be completed by RNs. In addition, the removal of item 27 
(Swallowing Status) on both admission and discharge will result in a 
0.5 minute reduction in clinical staff time to report data. We believe 
that these swallowing items would be completed by RNs (approximately 75 
percent of the time) and SLPs (approximately 25 percent of the time). 
We estimate 402,311 discharges from 1,137 IRFs annually. This equates 
to 36,878.51 hours (0.0917 hours x 402,311 discharges) decrease in 
burden for all IRFs. Given 5.4 minutes of RN time and 0.1 minutes of 
SLP time, completing an average of 354 IRF-PAIs per provider per year, 
and the wages listed in Table 13, we estimated the total cost would be 
reduced by $2,255.26 per IRF annually, or $2,564,229.74 for all IRFs 
annually. This decrease in burden will be accounted for in the 
information collection under OMB control number (0938-0842) which 
expires July 31, 2017. We will send the revised information collection 
request to OMB for review and approval.
    In section XII.J. of this proposed rule, we are proposing 
requirements related to the reporting of standardized patient 
assessment data beginning with the FY 2019 IRF QRP. Some of these data 
elements are already included on the IRF-PAI assessment and are already 
included in current burden estimates. We are proposing, however, to 
require IRFs to report 24 new standardized patient assessment data 
elements on IRF admissions and 24 new standardized patient assessment 
data elements on IRF discharges. We estimate that it will take an IRF's 
clinical staff 7.2 minutes to report the data elements required on 
admission and 7.2 minutes to report the data elements required on 
discharge, for a total of 14.4 additional minutes. This equates to 
96,554.64 additional burden hours per year (0.24 hours x 402,311 
discharges).
    We believe that the additional IRF-PAI items we are proposing would 
be completed by the following clinicians: RN (approximately 50 percent 
of the time), LVN (approximately 30 percent of the time), RT 
(approximately 7 percent of the time), SLP (approximately 6 percent of 
the time), and other therapists, including OT and psychologist 
(approximately 7 percent of the time). We estimate 402,311 discharges 
from 1,137 IRFs annually based on the numbers obtained February 1, 
2017. To estimate the mean hourly wage for ``other therapists,'' we 
averaged the mean hourly wage of OTs and psychologists for a mean 
hourly rate of $39.51, doubled to $79.02 to account for overhead and 
fringe benefits. Individual providers determine the staffing resources 
necessary. Given the

[[Page 20745]]

clinician times and wages in Table 13, completing an average of 354 
IRF-PAIs per provider per year, the total cost related to the 
additional standardized patient assessment data elements is estimated 
at $5,244.73 per IRF annually, or $5,963,253.19 for all IRFs annually. 
This increase in burden will be accounted for in the information 
collection under OMB control number (0938-0842). We will send the 
revised information collection request to OMB for review and approval.
    In summary, given the 5.5-minute reduction in burden for items 
being removed from the IRF-PAI), and the 14.4 additional minutes of 
burden for the proposed standardized patient assessment data elements, 
the overall cost associated with proposed changes to the IRF QRP is 
estimated at an additional $2,989.47 per IRF annually, or $3,399,023.45 
for all IRFs annually.
    Under section 1899B(m) of the Act, the Paperwork Reduction Act does 
not apply to the specific changes to the collections of information 
described in this proposed rule. We are, however, setting out the 
burden as a courtesy to advise interested parties of the proposed 
actions' time and costs and for reference refer to section XVI of this 
proposed rule of the regulatory impact analysis (RIA). The requirement 
and burden will be submitted to OMB for review and approval when the 
modifications to the IRF-PAI have achieved standardization and are no 
longer exempt from the requirements under section 1899B(m) of the Act.

XV. Response to Public 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.

XVI. Regulatory Impact Statement

    We have 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 
(January 18, 2011), 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). 
This rule does not reach the economic threshold and thus is not 
considered a major rule.
    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 and most other providers and suppliers 
are small entities, either by nonprofit status or by having revenues of 
less than $7.5 million to $38.5 million in any 1 year depending on 
industry classification, or by being nonprofit organizations that are 
not dominant in their markets. (For details, see the Small Business 
Administration's final rule that set forth size standards for health 
care industries (65 FR 69432) at http://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf, effective March 26, 2012 and 
updated on February 26, 2016.) Because we lack data on individual 
hospital receipts, we cannot determine the number of small proprietary 
IRFs or the proportion of IRFs' revenue that is derived from Medicare 
payments. Therefore, we assume that all IRFs (an approximate total of 
1,100 IRFs, of which approximately 60 percent are nonprofit facilities) 
are considered small entities and that Medicare payment constitutes the 
majority of their revenues. The HHS generally uses a revenue impact of 
3 to 5 percent as a significance threshold under the RFA. We estimate 
that the net revenue impact of this final rule on all IRFs is to 
increase estimated payments by approximately 1.0 percent. The rates and 
policies set forth in this final rule will not have a significant 
impact (not greater than 3 percent) on a substantial number of small 
entities. Medicare Administrative Contractors are not considered to be 
small entities. Individuals and States are not included in the 
definition of a small entity. We are not preparing an analysis for the 
RFA because we have determined, and the Secretary certifies, that this 
proposed rule would not have a significant economic impact on a 
substantial number of small entities.
    In addition, section 1102(b) of the Act requires us to prepare a 
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 are not preparing 
an analysis for section 1102(b) of the Act because we have determined, 
and the Secretary certifies, that this proposed 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 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, titled Reducing Regulation and Controlling 
Regulatory Costs, was issued on January 30, 2017. Section 2(a) of 
Executive Order 13771 requires an agency, unless prohibited by law, to 
identify at least two existing regulations to be repealed when the 
agency publicly proposes for notice and comment, or otherwise 
promulgates, a new regulation. In furtherance of this requirement, 
section 2(c) of Executive Order 13771 requires that the new incremental 
costs associated with new regulations shall, to the extent permitted by 
law, be offset by the elimination of existing costs associated with at 
least two prior regulations. OMB's implementation guidance, issued on 
April 5, 2017, explains that ``Federal spending regulatory actions that 
cause only income transfers between taxpayers and program beneficiaries 
(e.g., regulations

[[Page 20746]]

associated with . . . Medicare spending) are considered `transfer 
rules' and are not covered by EO 13771. . . . However . . . such 
regulatory actions may impose requirements apart from transfers . . . 
In those cases, the actions would need to be offset to the extent they 
impose more than de minimis costs. Examples of ancillary requirements 
that may require offsets include new reporting or recordkeeping 
requirements . . . . ''

Regulatory Review 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 $90.16 per hour, including overhead and fringe benefits 
https://www.bls.gov/oes/2015/may/naics4_621100.htm. Assuming an average 
reading speed, we estimate that it would take approximately 2 hours for 
the staff to review half of this proposed rule. For each IRF that 
reviews the rule, the estimated cost is $180.32 (2 hours x $90.16). 
Therefore, we estimate that the total cost of reviewing this regulation 
is $12,262 ($180.32 x 68 reviewers).

Accounting Statement

    As required by OMB Circular A-4 (available at http://www.whitehouse.gov/sites/default/files/omb/assets/omb/circulars/a004/a-4.pdf), in Table 14, we have prepared an accounting statement showing 
the classification of the expenditures associated with the provisions 
of this proposed rule. Table 14 provides our best estimate of the 
increase in Medicare payments under the IRF PPS as a result of the 
updates presented in this proposed rule based on the data for 1,137 
IRFs in our database. In addition, Table 14 presents the costs 
associated with the proposed new IRF QRP requirements for FY 2018.

                    Table 14--Accounting Statement: Classification of Estimated Expenditures
----------------------------------------------------------------------------------------------------------------
                Category                                                Transfers
----------------------------------------------------------------------------------------------------------------
                      Change in Estimated Transfers from FY 2017 IRF PPS to FY 2018 IRF PPS
----------------------------------------------------------------------------------------------------------------
Annualized Monetized Transfers.........  $80 million.
From Whom to Whom?.....................  Federal Government to IRF Medicare Providers.
----------------------------------------------------------------------------------------------------------------
                Category                                                  Costs
----------------------------------------------------------------------------------------------------------------
                             FY 2018 Cost to Updating the Quality Reporting Program
----------------------------------------------------------------------------------------------------------------
Cost for IRFs to Submit Data for the     $3.4 million.
 Quality Reporting Program.
----------------------------------------------------------------------------------------------------------------

    In accordance with the provisions of Executive Order 12866, this 
regulation was reviewed by the Office of Management and Budget.

List of Subjects in 42 CFR Part 412

    Administrative practice and procedure, Health facilities, Medicare, 
Puerto Rico, Reporting and recordkeeping requirements.

    For the reasons set forth in the preamble, the Department of Health 
and Human Services proposes to amend 42 CFR chapter IV as set forth 
below:

PART 412--PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL 
SERVICES

0
1. The authority citation for part 412 continues to read as follows:

    Authority: Secs. 1102 and 1871 of the Social Security Act (42 
U.S.C. 1302 and 1395hh), sec. 124 of Pub. L. 106-113 (113 Stat. 
1501A-332), sec. 1206 of Pub. L. 113-67, sec. 112 of Pub. L. 113-93, 
and sec. 231 of Pub. L. 114-113.

0
2. Section 412.614 is amended by revising paragraphs (d) heading, 
(d)(1), and (e) to read as follows:


Sec.  412.614  Transmission of patient assessment data.

* * * * *
    (d) Failure to submit complete and timely IRF-PAI data, as required 
under paragraph (c) of this section--(1) Medicare Part-A fee-for-
service. (i) A given Medicare Part-A fee-for-service IRF claim will not 
be accepted and processed for payment until a corresponding IRF-PAI has 
been received and accepted by CMS.
    (ii) [Reserved]
* * * * *
    (e) Exemption to the consequences for transmitting the IRF-PAI data 
late for Medicare Part C (Medicare Advantage) patients. CMS may waive 
the consequences of failure to submit complete and timely IRF-PAI data 
specified in paragraph (d) of this section when, due to an 
extraordinary situation that is beyond the control of an inpatient 
rehabilitation facility, the inpatient rehabilitation facility is 
unable to transmit the patient assessment data in accordance with 
paragraph (c) of this section. Only CMS can determine if a situation 
encountered by an inpatient rehabilitation facility is extraordinary 
and qualifies as a situation for waiver of the forfeiture specified in 
paragraph (d)(2) of this section. An extraordinary situation may be due 
to, but is not limited to, fires, floods, earthquakes, or similar 
unusual events that inflect extensive damage to an inpatient facility. 
An extraordinary situation may be one that produces a data transmission 
problem that is beyond the control of the inpatient rehabilitation 
facility, as well as other situations determined by CMS to be beyond 
the control of the inpatient rehabilitation

[[Page 20747]]

facility. An extraordinary situation must be fully documented by the 
inpatient rehabilitation facility.


Sec.  412.624  [Amended]

0
3. In Sec.  412.624--
0
a. Amend paragraph (d)(4) by removing the reference ``paragraph (e)(2), 
(e)(3), (e)(4) and (e)(7), of this section,'' and adding in its place 
the reference ``paragraph (e)(2), (3), (4) and (6), of this section,'';
0
b. Remove paragraph (e)(6);
0
c. Redesignate paragraph (e)(7) as paragraph (e)(6);
0
d. Amend newly redesignated paragraph (e)(6)(ii) by removing the 
reference ``paragraph (e)(7)(i)(A) and (e)(7)(i)(B) of this section'' 
and adding in its place the reference ``paragraph (e)(6)(i)(A) and (B) 
of this section''; and
0
e. Amend paragraph (f)(2)(v) by removing the reference ``paragraphs 
(e)(1), (e)(2), (e)(3), (e)(4), and (e)(7) of this section'' and adding 
in its place the reference ``paragraphs (e)(1), (2), (3), (4), and (6) 
of this section''.
0
4. Section 412.634 is amended by revising paragraphs (b)(1), (c)(1), 
(f)(1) and (2) to read as follows:


Sec.  412.634   Requirements under the Inpatient Rehabilitation 
Facility (IRF) Quality Reporting Program (QRP).

* * * * *
    (b) * * *
    (1) IRFs must submit to CMS data on measures specified under 
section 1886(j)(7)(D), 1899B(c)(1), and 1899B(d)(1) of the Act, as 
applicable. Such data must be submitted in the form and manner, and at 
a time, specified by CMS.
* * * * *
    (c) * * *
    (1) An IRF may request and CMS may grant exceptions or extensions 
to the measures data or standardized patient assessment data reporting 
requirements, for one or more quarters, when there are certain 
extraordinary circumstances beyond the control of the IRF.
* * * * *
    (f) * * *
    (1) IRFs must meet or exceed two separate data completeness 
thresholds: One threshold set at 95 percent for completion of measures 
data and standardized patient assessment data collected using the IRF-
PAI submitted through the QIES and a second threshold set at 100 
percent for measures data collected and submitted using the CDC NHSN.
    (2) These thresholds (95 percent for completion of measures data 
and standardized patient assessment data on the IRF-PAI; 100 percent 
for CDC NHSN data) will apply to all measures and standardized patient 
assessment data requirements adopted into the IRF QRP.
* * * * *

    Dated: April 12, 2017.
Seema Verma,
 Administrator, Centers for Medicare & Medicaid Services.

    Approved: April 17, 2017.
Thomas E. Price,
Secretary, Department of Health and Human Services.
[FR Doc. 2017-08428 Filed 4-27-17; 4:15 pm]
BILLING CODE 4120-01-P