Medicare Program; Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2018, 20690-20747 [2017-08428]
Download as PDF
20690
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Proposed rule.
AGENCY:
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):
nlaroche on DSK30NT082PROD with PROPOSALS2
SUMMARY:
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
1. Electronically. You may submit
electronic comments on this regulation
to https://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.
PO 00000
Frm 00002
Fmt 4701
Sfmt 4702
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 https://
www.cms.hhs.gov/Medicare/MedicareFee-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 https://
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 casemix 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
E:\FR\FM\03MYP2.SGM
03MYP2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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
20691
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 update.
The overall economic impact of this proposed rule is an estimated $80 million in increased payments from
the Federal government to IRFs during FY 2018.
Costs
New quality reporting program requirements.
The total costs in FY 2018 for IRFs 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.
nlaroche on DSK30NT082PROD with PROPOSALS2
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 HighCost Outliers Under the IRF PPS
A. Proposed Update to the Outlier
Threshold Amount for FY 2018
B. Proposed Update to the IRF Cost-toCharge 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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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
PO 00000
Frm 00003
Fmt 4701
Sfmt 4702
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)
E:\FR\FM\03MYP2.SGM
03MYP2
nlaroche on DSK30NT082PROD with PROPOSALS2
20692
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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
PO 00000
Frm 00004
Fmt 4701
Sfmt 4702
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 budgetneutral 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
E:\FR\FM\03MYP2.SGM
03MYP2
nlaroche on DSK30NT082PROD with PROPOSALS2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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 https://
www.cms.gov/Medicare/Medicare-Feefor-Service-Payment/
InpatientRehabFacPPS/. 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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
basket index used to update IRF
payments, and updates to the rural, lowincome 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 caselevel 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
PO 00000
Frm 00005
Fmt 4701
Sfmt 4702
20693
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 https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/InpatientRehabFacPPS/DataFiles.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 multicampus 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,
E:\FR\FM\03MYP2.SGM
03MYP2
nlaroche on DSK30NT082PROD with PROPOSALS2
20694
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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 selfimplementing 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 https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/InpatientRehabFacPPS/DataFiles.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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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 facilitylevel adjustment factors using an
enhanced estimation methodology,
PO 00000
Frm 00006
Fmt 4701
Sfmt 4702
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 IRFspecific 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).
E:\FR\FM\03MYP2.SGM
03MYP2
nlaroche on DSK30NT082PROD with PROPOSALS2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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-forService (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 5character 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 https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/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
PO 00000
Frm 00007
Fmt 4701
Sfmt 4702
20695
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
https://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 https://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,
E:\FR\FM\03MYP2.SGM
03MYP2
20696
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
nlaroche on DSK30NT082PROD with PROPOSALS2
and deaths, and then applies the
applicable adjustments to account for
the IRF’s wage index, percentage of lowincome 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
https://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/hieinteroperability/nationwideinteroperability-roadmap-final-version1.0.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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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/
PO 00000
Frm 00008
Fmt 4701
Sfmt 4702
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
E:\FR\FM\03MYP2.SGM
03MYP2
20697
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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 § 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 hospitalspecific 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
CMG Description
(M = motor, C = cognitive, A = age)
nlaroche on DSK30NT082PROD with PROPOSALS2
CMG
0101
0102
0103
0104
0105
0106
0107
0108
0109
0110
0201
0202
......
......
......
......
......
......
......
......
......
......
......
......
0203
0204
0205
0206
0207
0301
......
......
......
......
......
......
Stroke, M>51.05 ..................................................
Stroke, M>44.45 and M<51.05 and C>18.5 .......
Stroke, M>44.45 and M<51.05 and C<18.5 .......
Stroke, M>38.85 and M<44.45 ...........................
Stroke, M>34.25 and M<38.85 ...........................
Stroke, M>30.05 and M<34.25 ...........................
Stroke, M>26.15 and M<30.05 ...........................
Stroke, M<26.15 and A>84.5 ..............................
Stroke, M>22.35 and M<26.15 and A<84.5 .......
Stroke, M<22.35 and A<84.5 ..............................
Traumatic brain injury, M>53.35 and C>23.5 .....
Traumatic brain injury, M>44.25 and M<53.35
and C>23.5.
Traumatic brain injury, M>44.25 and C<23.5 .....
Traumatic brain injury, M>40.65 and M<44.25 ...
Traumatic brain injury, M>28.75 and M<40.65 ...
Traumatic brain injury, M>22.05 and M<28.75 ...
Traumatic brain injury, M<22.05 .........................
Non-traumatic brain injury, M>41.05 ...................
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
PO 00000
Tier 1
Tier 2
Average length of stay
No
comorbidities
tier
Tier 3
Tier 1
Tier 2
Tier 3
No
comorbidities
tier
0.8483
1.0670
1.2069
1.2945
1.5055
1.6678
1.8621
2.3684
2.1330
2.7845
0.8414
1.0873
0.7280
0.9157
1.0357
1.1109
1.2920
1.4313
1.5980
2.0324
1.8304
2.3896
0.6780
0.8762
0.6724
0.8458
0.9567
1.0261
1.1934
1.3220
1.4760
1.8773
1.6907
2.2072
0.6173
0.7977
0.6423
0.8079
0.9138
0.9802
1.1399
1.2628
1.4099
1.7932
1.6150
2.1083
0.5671
0.7329
9
11
13
13
14
16
17
21
19
27
9
11
9
12
13
13
14
16
17
23
19
26
9
11
9
10
12
12
14
15
16
21
19
23
8
10
8
10
11
12
13
15
16
20
19
24
7
9
1.2583
1.3877
1.6314
1.9703
2.5103
1.1649
1.0140
1.1182
1.3146
1.5877
2.0229
0.9439
0.9231
1.0180
1.1968
1.4454
1.8416
0.8581
0.8481
0.9353
1.0996
1.3280
1.6920
0.8107
12
11
15
18
28
10
12
12
15
18
23
11
11
12
14
16
19
10
11
12
13
15
18
10
Frm 00009
Fmt 4701
Sfmt 4702
E:\FR\FM\03MYP2.SGM
03MYP2
20698
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
TABLE 1—PROPOSED RELATIVE WEIGHTS AND AVERAGE LENGTH OF STAY VALUES FOR CASE-MIX GROUPS—Continued
Relative weight
CMG Description
(M = motor, C = cognitive, A = age)
CMG
0302 ......
0303 ......
0304 ......
0401 ......
0402 ......
0403 ......
0404 ......
0405 ......
0501 ......
0502 ......
0503 ......
0504 ......
0505 ......
0506
0601
0602
0603
0604
0701
0702
......
......
......
......
......
......
......
0703 ......
0704 ......
0801 ......
0802 ......
0803 ......
0804 ......
0805 ......
......
......
......
......
......
......
......
1003
1101
1102
1201
1202
1203
1301
1302
nlaroche on DSK30NT082PROD with PROPOSALS2
0806
0901
0902
0903
0904
1001
1002
......
......
......
......
......
......
......
......
1303
1401
1402
1403
1404
1501
1502
1503
1504
1601
1602
1603
1701
......
......
......
......
......
......
......
......
......
......
......
......
......
1702 ......
1703 ......
Non-traumatic brain injury, M>35.05 and
M<41.05.
Non-traumatic brain injury, M>26.15 and
M<35.05.
Non-traumatic brain injury, M<26.15 ...................
Traumatic spinal cord injury, M>48.45 ................
Traumatic spinal cord injury, M>30.35 and
M<48.45.
Traumatic spinal cord injury, M>16.05 and
M<30.35.
Traumatic spinal cord injury, M<16.05 and
A>63.5.
Traumatic spinal cord injury, M<16.05 and
A<63.5.
Non-traumatic spinal cord injury, M>51.35 .........
Non-traumatic spinal cord injury, M>40.15 and
M<51.35.
Non-traumatic spinal cord injury, M>31.25 and
M<40.15.
Non-traumatic spinal cord injury, M>29.25 and
M<31.25.
Non-traumatic spinal cord injury, M>23.75 and
M<29.25.
Non-traumatic spinal cord injury, M<23.75 .........
Neurological, M>47.75 ........................................
Neurological, M>37.35 and M<47.75 ..................
Neurological, M>25.85 and M<37.35 ..................
Neurological, M<25.85 ........................................
Fracture of lower extremity, M>42.15 .................
Fracture of lower extremity, M>34.15 and
M<42.15.
Fracture of lower extremity, M>28.15 and
M<34.15.
Fracture of lower extremity, M<28.15 .................
Replacement of lower extremity joint, M>49.55
Replacement of lower extremity joint, M>37.05
and M<49.55.
Replacement of lower extremity joint, M>28.65
and M<37.05 and A>83.5.
Replacement of lower extremity joint, M>28.65
and M<37.05 and A<83.5.
Replacement of lower extremity joint, M>22.05
and M<28.65.
Replacement of lower extremity joint, M<22.05
Other orthopedic, M>44.75 .................................
Other orthopedic, M>34.35 and M<44.75 ...........
Other orthopedic, M>24.15 and M<34.35 ...........
Other orthopedic, M<24.15 .................................
Amputation, lower extremity, M>47.65 ...............
Amputation, lower extremity, M>36.25 and
M<47.65.
Amputation, lower extremity, M<36.25 ...............
Amputation, non-lower extremity, M>36.35 ........
Amputation, non-lower extremity, M<36.35 ........
Osteoarthritis, M>37.65 .......................................
Osteoarthritis, M>30.75 and M<37.65 ................
Osteoarthritis, M<30.75 .......................................
Rheumatoid, other arthritis, M>36.35 .................
Rheumatoid, other arthritis, M>26.15 and
M<36.35.
Rheumatoid, other arthritis, M<26.15 .................
Cardiac, M>48.85 ................................................
Cardiac, M>38.55 and M<48.85 .........................
Cardiac, M>31.15 and M<38.55 .........................
Cardiac, M<31.15 ................................................
Pulmonary, M>49.25 ...........................................
Pulmonary, M>39.05 and M<49.25 ....................
Pulmonary, M>29.15 and M<39.05 ....................
Pulmonary, M<29.15 ...........................................
Pain syndrome, M>37.15 ....................................
Pain syndrome, M>26.75 and M<37.15 .............
Pain syndrome, M<26.75 ....................................
Major multiple trauma without brain or spinal
cord injury, M>39.25.
Major multiple trauma without brain or spinal
cord injury, M>31.05 and M<39.25.
Major multiple trauma without brain or spinal
cord injury, M>25.55 and M<31.05.
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
PO 00000
Tier 1
Tier 2
Average length of stay
No
comorbidities
tier
Tier 3
Tier 1
Tier 2
Tier 3
No
comorbidities
tier
1.4142
1.1460
1.0418
0.9842
13
13
12
12
1.6626
1.3472
1.2248
1.1571
15
15
13
13
2.1547
0.8971
1.3102
1.7459
0.8369
1.2223
1.5872
0.7456
1.0888
1.4995
0.6728
0.9825
21
11
13
19
11
14
17
10
13
16
9
12
2.1239
1.9813
1.7650
1.5927
22
22
20
18
3.7200
3.4704
3.0915
2.7897
42
36
31
33
3.4257
3.1958
2.8469
2.5690
33
35
31
27
0.9396
1.2215
0.7059
0.9178
0.6687
0.8693
0.6136
0.7978
9
12
9
11
9
10
7
10
1.5300
1.1496
1.0889
0.9992
16
13
12
12
1.7373
1.3053
1.2364
1.1346
17
15
14
13
1.9970
1.5004
1.4212
1.3042
18
17
16
15
2.7578
1.0678
1.3930
1.7085
2.2217
1.0395
1.3168
2.0721
0.8160
1.0646
1.3056
1.6978
0.8307
1.0523
1.9627
0.7570
0.9876
1.2112
1.5750
0.7888
0.9993
1.8011
0.6888
0.8986
1.1021
1.4331
0.7185
0.9102
26
10
12
14
19
12
12
23
9
12
14
18
11
12
21
9
11
13
16
10
11
20
8
11
13
16
9
11
1.5920
1.2722
1.2082
1.1004
15
14
14
13
2.0178
0.8775
1.1266
1.6125
0.6453
0.8285
1.5313
0.6128
0.7868
1.3947
0.5656
0.7262
18
8
11
18
8
10
17
7
9
16
7
9
1.4578
1.0721
1.0181
0.9396
13
13
12
11
1.3414
0.9865
0.9368
0.8646
12
11
11
10
1.5913
1.1703
1.1114
1.0257
14
13
12
12
1.9238
1.0100
1.3277
1.6291
2.0410
1.0450
1.3755
1.4148
0.8084
1.0627
1.3040
1.6337
0.9001
1.1847
1.3436
0.7245
0.9524
1.1686
1.4641
0.7939
1.0450
1.2400
0.6736
0.8856
1.0866
1.3613
0.7247
0.9538
16
10
12
15
18
10
13
16
10
12
14
18
11
13
14
9
11
13
16
10
12
14
8
10
13
15
9
11
2.0095
1.3101
1.8980
1.2205
1.5786
1.9315
1.2280
1.6884
1.7308
1.1733
1.6999
0.9178
1.1871
1.4525
0.9277
1.2755
1.5266
1.0154
1.4711
0.8571
1.1086
1.3564
0.8333
1.1457
1.3935
0.8784
1.2727
0.7889
1.0203
1.2485
0.7974
1.0964
18
12
16
9
11
12
10
16
18
15
23
11
13
15
10
14
17
12
15
10
13
15
10
12
16
10
14
10
12
14
9
12
2.1985
0.9282
1.2233
1.4648
1.8551
1.0146
1.3154
1.5983
1.9815
1.1541
1.5368
1.9181
1.1984
1.6609
0.7469
0.9844
1.1787
1.4927
0.8485
1.1001
1.3367
1.6572
0.9076
1.2085
1.5084
0.9331
1.4919
0.6826
0.8997
1.0773
1.3643
0.7738
1.0032
1.2190
1.5112
0.8273
1.1016
1.3749
0.8430
1.4276
0.6196
0.8165
0.9777
1.2382
0.7413
0.9612
1.1679
1.4478
0.7600
1.0120
1.2631
0.7737
18
10
12
13
17
10
11
14
20
10
12
14
10
18
8
11
13
16
9
12
14
16
11
14
16
11
16
8
10
12
14
9
11
12
15
10
13
15
10
16
8
10
11
14
8
10
12
14
9
12
14
9
1.5242
1.1867
1.0722
0.9840
14
14
12
12
1.8018
1.4029
1.2675
1.1633
17
15
14
14
Frm 00010
Fmt 4701
Sfmt 4702
E:\FR\FM\03MYP2.SGM
03MYP2
20699
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
TABLE 1—PROPOSED RELATIVE WEIGHTS AND AVERAGE LENGTH OF STAY VALUES FOR CASE-MIX GROUPS—Continued
Relative weight
CMG Description
(M = motor, C = cognitive, A = age)
CMG
1704 ......
1801 ......
1802 ......
1803 ......
1901
1902
1903
2001
2002
2003
2004
2101
5001
......
......
......
......
......
......
......
......
......
5101 ......
5102 ......
5103 ......
5104 ......
Tier 1
Major multiple trauma without brain or spinal
cord injury, M<25.55.
Major multiple trauma with brain or spinal cord
injury, M>40.85.
Major multiple trauma with brain or spinal cord
injury, M>23.05 and M<40.85.
Major multiple trauma with brain or spinal cord
injury, M<23.05.
Guillian Barre, M>35.95 ......................................
Guillian Barre, M>18.05 and M<35.95 ................
Guillian Barre, M<18.05 ......................................
Miscellaneous, M>49.15 .....................................
Miscellaneous, M>38.75 and M<49.15 ...............
Miscellaneous, M>27.85 and M<38.75 ...............
Miscellaneous, M<27.85 .....................................
Burns, M>0 ..........................................................
Short-stay cases, length of stay is 3 days or
fewer.
Expired, orthopedic, length of stay is 13 days or
fewer.
Expired, orthopedic, length of stay is 14 days or
more.
Expired, not orthopedic, length of stay is 15
days or fewer.
Expired, not orthopedic, 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
Tier 2
Average length of stay
No
comorbidities
tier
Tier 3
Tier 1
Tier 2
No
comorbidities
tier
Tier 3
2.2806
1.7756
1.6043
1.4724
21
19
17
17
1.3059
1.0064
0.8850
0.8157
13
11
10
10
1.8718
1.4425
1.2685
1.1692
17
16
14
14
2.9245
2.2538
1.9819
1.8267
32
26
21
20
1.2961
2.2324
3.6781
0.9421
1.2399
1.5409
1.9681
1.8414
................
1.0778
1.8563
3.0585
0.7634
1.0047
1.2486
1.5948
1.8221
................
0.9935
1.7112
2.8194
0.6971
0.9174
1.1401
1.4562
1.3846
................
0.9522
1.6400
2.7020
0.6329
0.8330
1.0351
1.3222
1.2977
0.1567
13
23
39
9
11
14
18
29
................
12
20
32
9
11
14
17
17
................
12
21
28
8
10
12
15
14
................
11
18
30
8
10
12
15
14
2
................
................
................
0.6583
................
................
................
7
................
................
................
1.6390
................
................
................
18
................
................
................
0.8111
................
................
................
8
................
................
................
2.0333
................
................
................
21
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]
Number
of cases
affected
Percentage change in CMG relative weights
nlaroche on DSK30NT082PROD with PROPOSALS2
Increased by 15% or more ......................................................................................................................................
Increased by between 5% and 15% .......................................................................................................................
Changed by less than 5% .......................................................................................................................................
Decreased by between 5% and 15% ......................................................................................................................
Decreased by 15% or more ....................................................................................................................................
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.
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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
PO 00000
Frm 00011
Fmt 4701
Sfmt 4702
Percentage
of cases
affected
51
1,720
394,048
850
0
0.0
0.4
99.3
0.2
0.0
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
E:\FR\FM\03MYP2.SGM
03MYP2
20700
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
area, if applicable, as described in
§ 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-andcomment 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.
nlaroche on DSK30NT082PROD with PROPOSALS2
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 2012based IRF market basket is similar to the
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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 InputOutput 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: LaborRelated 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
PO 00000
Frm 00012
Fmt 4701
Sfmt 4702
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 laborrelated 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 CapitalRelated 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 laborrelated 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,
E:\FR\FM\03MYP2.SGM
03MYP2
20701
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
local labor market is estimated to be 46
percent. Incorporating the estimate of
the FY 2018 relative importance of
Capital-Related costs from the 2012based 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
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: Laborrelated Services) using the 2012-based
IRF market basket is 66.9 percent. We
propose that the portion of CapitalRelated Costs that is influenced by the
relative importance for FY 2018
operating costs (66.9 percent) to
determine the total proposed laborrelated 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-related
share 1
FY 2017
Final labor
related share 2
Wages and Salaries ................................................................................................................................................
Employee Benefits ...................................................................................................................................................
Professional Fees: Labor-related ............................................................................................................................
Administrative and Facilities Support Services .......................................................................................................
Installation, Maintenance, and Repair Services ......................................................................................................
All Other: Labor-related Services ............................................................................................................................
47.7
11.3
3.4
0.8
1.9
1.8
47.7
11.3
3.5
0.8
1.9
1.8
Subtotal .............................................................................................................................................................
Labor-related portion of capital (46%) .....................................................................................................................
66.9
3.8
67.0
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.
Register (81 FR 52073).
2 Federal
nlaroche on DSK30NT082PROD with PROPOSALS2
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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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 prereclassification 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
PO 00000
Frm 00013
Fmt 4701
Sfmt 4702
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/b1301.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
E:\FR\FM\03MYP2.SGM
03MYP2
nlaroche on DSK30NT082PROD with PROPOSALS2
20702
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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/2015/1501.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.
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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
PO 00000
Frm 00014
Fmt 4701
Sfmt 4702
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 https://www.cms.gov/
Medicare/Medicare-Fee-for-ServicePayment/InpatientRehabFacPPS/DataFiles.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 https://
www.cms.gov/Medicare/Medicare-Feefor-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 § 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 budgetneutral 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
E:\FR\FM\03MYP2.SGM
03MYP2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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
20703
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 ......................................................................................................................
Market Basket Increase Factor for FY 2018 (1.0 percent), as required by section 1886(j)(3)(C)(iii) of the Act ..........................
Budget Neutrality Factor for the Wage Index and Labor-Related Share ......................................................................................
Budget Neutrality Factor for the Revisions to the CMG Relative Weights ...................................................................................
Proposed FY 2018 Standard Payment Conversion Factor ...........................................................................................................
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
$15,708
× 1.0100
× 1.0007
× 0.9974
= $15,835
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
tier 1
nlaroche on DSK30NT082PROD with PROPOSALS2
CMG
0101
0102
0103
0104
0105
0106
0107
0108
0109
0110
0201
0202
0203
0204
0205
0206
0207
0301
0302
0303
0304
0401
0402
0403
0404
0405
0501
0502
0503
0504
0505
0506
0601
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
PO 00000
Frm 00015
Fmt 4701
$ 13,432.83
16,895.95
19,111.26
20,498.41
23,839.59
26,409.61
29,486.35
37,503.61
33,776.06
44,092.56
13,323.57
17,217.40
19,925.18
21,974.23
25,833.22
31,199.70
39,750.60
18,446.19
22,393.86
26,327.27
34,119.67
14,205.58
20,747.02
33,631.96
58,906.20
54,245.96
14,878.57
19,342.45
24,227.55
27,510.15
31,622.50
43,669.76
16,908.61
Sfmt 4702
Payment rate
tier 2
$ 11,527.88
14,500.11
16,400.31
17,591.10
20,458.82
22,664.64
25,304.33
32,183.05
28,984.38
37,839.32
10,736.13
13,874.63
16,056.69
17,706.70
20,816.69
25,141.23
32,032.62
14,946.66
18,146.91
21,332.91
27,646.33
13,252.31
19,355.12
31,373.89
54,953.78
50,605.49
11,177.93
14,533.36
18,203.92
20,669.43
23,758.83
32,811.70
12,921.36
E:\FR\FM\03MYP2.SGM
03MYP2
Payment rate
tier 3
$ 10,647.45
13,393.24
15,149.34
16,248.29
18,897.49
20,933.87
23,372.46
29,727.05
26,772.23
34,951.01
9,774.95
12,631.58
14,617.29
16,120.03
18,951.33
22,887.91
29,161.74
13,588.01
16,496.90
19,394.71
25,133.31
11,806.58
17,241.15
27,948.78
48,953.90
45,080.66
10,588.86
13,765.37
17,242.73
19,578.39
22,504.70
31,079.35
11,987.10
Payment rate
no
comorbidity
$ 10,170.82
12,793.10
14,470.02
15,521.47
18,050.32
19,996.44
22,325.77
28,395.32
25,573.53
33,384.93
8,980.03
11,605.47
13,429.66
14,810.48
17,412.17
21,028.88
26,792.82
12,837.43
15,584.81
18,322.68
23,744.58
10,653.79
15,557.89
25,220.40
44,174.90
40,680.12
9,716.36
12,633.16
15,822.33
17,966.39
20,652.01
28,520.42
10,907.15
20704
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
TABLE 5—PROPOSED FY 2018 PAYMENT RATES—Continued
Payment rate
tier 1
CMG
nlaroche on DSK30NT082PROD with PROPOSALS2
0602
0603
0604
0701
0702
0703
0704
0801
0802
0803
0804
0805
0806
0901
0902
0903
0904
1001
1002
1003
1101
1102
1201
1202
1203
1301
1302
1303
1401
1402
1403
1404
1501
1502
1503
1504
1601
1602
1603
1701
1702
1703
1704
1801
1802
1803
1901
1902
1903
2001
2002
2003
2004
2101
5001
5101
5102
5103
5104
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
.................................................................................................................
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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
Payment rate
tier 2
Payment rate
tier 3
22,058.16
27,054.10
35,180.62
16,460.48
20,851.53
25,209.32
31,951.86
13,895.21
17,839.71
23,084.26
21,241.07
25,198.24
30,463.37
15,993.35
21,024.13
25,796.80
32,319.24
16,547.58
21,781.04
31,820.43
20,745.43
30,054.83
19,326.62
24,997.13
30,585.30
19,445.38
26,735.81
34,813.25
14,698.05
19,370.96
23,195.11
29,375.51
16,066.19
20,829.36
25,309.08
31,377.05
18,275.17
24,335.23
30,373.11
18,976.66
24,135.71
28,531.50
36,113.30
20,678.93
29,639.95
46,309.46
20,523.74
35,350.05
58,242.71
14,918.15
19,633.82
24,400.15
31,164.86
29,158.57
........................
........................
........................
........................
........................
16,857.94
20,674.18
26,884.66
13,154.13
16,663.17
20,145.29
25,533.94
10,218.33
13,119.30
16,976.70
15,621.23
18,531.70
22,403.36
12,801.01
16,827.85
20,648.84
25,869.64
14,253.08
18,759.72
27,407.22
18,579.21
26,917.92
14,533.36
18,797.73
23,000.34
14,690.13
20,197.54
26,300.35
11,827.16
15,587.97
18,664.71
23,636.90
13,436.00
17,420.08
21,166.64
26,241.76
14,371.85
19,136.60
23,885.51
14,775.64
18,791.39
22,214.92
28,116.63
15,936.34
22,841.99
35,688.92
17,066.96
29,394.51
48,431.35
12,088.44
15,909.42
19,771.58
25,253.66
28,852.95
........................
........................
........................
........................
........................
15,638.65
19,179.35
24,940.13
12,490.65
15,823.92
19,131.85
24,248.14
9,703.69
12,458.98
16,121.61
14,834.23
17,599.02
21,275.91
11,472.46
15,081.25
18,504.78
23,184.02
12,571.41
16,547.58
24,173.71
16,078.86
23,294.87
13,572.18
17,554.68
21,478.59
13,195.31
18,142.16
23,624.24
10,808.97
14,246.75
17,059.05
21,603.69
12,253.12
15,885.67
19,302.87
23,929.85
13,100.30
17,443.84
21,771.54
13,348.91
16,978.29
20,070.86
25,404.09
14,013.98
20,086.70
31,383.39
15,732.07
27,096.85
44,645.20
11,038.58
14,527.03
18,053.48
23,058.93
21,925.14
........................
........................
........................
........................
........................
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.
PO 00000
Frm 00016
Fmt 4701
Sfmt 4702
Payment rate
no
comorbidity
14,229.33
17,451.75
22,693.14
11,377.45
14,413.02
17,424.83
22,085.07
8,956.28
11,499.38
14,878.57
13,690.94
16,241.96
19,635.40
10,666.46
14,023.48
17,206.31
21,556.19
11,475.62
15,103.42
22,066.07
13,909.46
20,153.20
12,492.23
16,156.45
19,770.00
12,626.83
17,361.49
22,606.05
9,811.37
12,929.28
15,481.88
19,606.90
11,738.49
15,220.60
18,493.70
22,925.91
12,034.60
16,025.02
20,001.19
12,251.54
15,581.64
18,420.86
23,315.45
12,916.61
18,514.28
28,925.79
15,078.09
25,969.40
42,786.17
10,021.97
13,190.56
16,390.81
20,937.04
20,549.08
2,481.34
10,424.18
25,953.57
12,843.77
32,197.31
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
E:\FR\FM\03MYP2.SGM
03MYP2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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 nonlabor 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 laborrelated 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 wageadjusted 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
https://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.
20705
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 wageadjusted and rural-adjusted amount (if
applicable). Finally, we add the
additional teaching status payments (if
applicable) to the wage, rural, and LIPadjusted prospective payment rates.
Table 6 illustrates the components of
the adjusted payment calculation.
TABLE 6—EXAMPLE OF COMPUTING THE FY 2018 IRF PROSPECTIVE PAYMENT
Rural facility A
(Spencer Co., IN)
Steps
1. Unadjusted Payment ...........................................................................................................................
2. Labor Share .........................................................................................................................................
3. Labor Portion of Payment ...................................................................................................................
4. CBSA-Based Wage Index (shown in the Addendum, Tables A and B) .............................................
5. Wage-Adjusted Amount .......................................................................................................................
6. Non-Labor Amount ..............................................................................................................................
7. Wage-Adjusted Payment .....................................................................................................................
8. Rural Adjustment .................................................................................................................................
9. Wage- and Rural-Adjusted Payment ...................................................................................................
10. LIP Adjustment ..................................................................................................................................
11. Wage-, Rural- and LIP-Adjusted Payment ........................................................................................
12. Wage- and Rural-Adjusted Payment .................................................................................................
13. Teaching Status Adjustment .............................................................................................................
14. Teaching Status Adjustment Amount ................................................................................................
15. Wage-, Rural-, and LIP-Adjusted Payment .......................................................................................
16. Total Adjusted Payment ....................................................................................................................
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
nlaroche on DSK30NT082PROD with PROPOSALS2
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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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
PO 00000
Frm 00017
Fmt 4701
Sfmt 4702
$33,384.93
× 0.707
= $23,603.15
× 0.8167
= $19,276.69
+ $9,781.78
= $29,058.47
× 1.149
= $33,388.19
× 1.0156
= $33,909.04
$33,388.19
×0
= $0.00
+ $33,909.04
= $33,909.04
$33,384.93
× 0.707
= $23,603.15
× 0.8859
= $20,910.03
+ $9,781.78
= $30,691.81
× 1.000
= $30,691.81
× 1.0454
= $32,085.22
$30,691.81
× 0.0784
= $2,406.24
+ $32,085.22
= $34,491.46
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
E:\FR\FM\03MYP2.SGM
03MYP2
20706
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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.
nlaroche on DSK30NT082PROD with PROPOSALS2
B. Proposed Update to the IRF Cost-toCharge 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 costto-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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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.
PO 00000
Frm 00018
Fmt 4701
Sfmt 4702
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
§§ 412.610(c)(2)(i)(B), 412.610(d), and
412.614(c). To encourage timely filling,
the requirement at § 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 § 412.23(b). We are not
E:\FR\FM\03MYP2.SGM
03MYP2
nlaroche on DSK30NT082PROD with PROPOSALS2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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 caseby-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 § 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 § 412.614(e). Thus, based
on our review of our records, we have
found that the vast majority of these
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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
§ 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 § 412.614(d) Consequences
of failure to submit complete and timely
IRF–PAI data.
• Revise § 412.614(d)(1).
• Revise § 412.614(d)(1)(i).
• Reserve § 412.614(d)(1)(ii).
• Revise § 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
PO 00000
Frm 00019
Fmt 4701
Sfmt 4702
20707
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-andGuidance/Guidance/Manuals/InternetOnly-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
E:\FR\FM\03MYP2.SGM
03MYP2
20708
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
nlaroche on DSK30NT082PROD with PROPOSALS2
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-ServicePayment/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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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
§ 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
PO 00000
Frm 00020
Fmt 4701
Sfmt 4702
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 § 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
E:\FR\FM\03MYP2.SGM
03MYP2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
nlaroche on DSK30NT082PROD with PROPOSALS2
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-ServicePayment/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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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 reintroduced 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-Feefor-Service-Payment/
InpatientRehabFacPPS/Downloads/ICD10-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
§ 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
PO 00000
Frm 00021
Fmt 4701
Sfmt 4702
20709
• 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
E:\FR\FM\03MYP2.SGM
03MYP2
20710
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
nlaroche on DSK30NT082PROD with PROPOSALS2
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 DisordersStatus Post Unilateral Hip Fracture, and
IGC 0008.12—Orthopedic DisordersStatus 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–
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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/ICD10-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
PO 00000
Frm 00022
Fmt 4701
Sfmt 4702
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
E:\FR\FM\03MYP2.SGM
03MYP2
nlaroche on DSK30NT082PROD with PROPOSALS2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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-ServicePayment/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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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 § 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
§ 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
PO 00000
Frm 00023
Fmt 4701
Sfmt 4702
20711
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 reintroduced 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 § 412.29(b)(2).
Therefore, to avoid the improper
inclusion of cases that do not meet the
requirements in the 60 percent rule
under § 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/ICD10-CM-DataFiles.zip.
E:\FR\FM\03MYP2.SGM
03MYP2
nlaroche on DSK30NT082PROD with PROPOSALS2
20712
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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 12month 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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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
§ 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
§ 412.29(b)(2)(x)).
• Systemic vasculidities with joint
inflammation, under specified
conditions (see § 412.29(b)(2)(xi)).
• Severe or advanced osteoarthritis
(osteoarthritis or degenerative joint
disease), under specified conditions (see
§ 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.
PO 00000
Frm 00024
Fmt 4701
Sfmt 4702
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
§ 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 § 412.29(b)(2).
E:\FR\FM\03MYP2.SGM
03MYP2
nlaroche on DSK30NT082PROD with PROPOSALS2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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 nonsubstantive 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-andcomment 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 biannually, 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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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
PO 00000
Frm 00025
Fmt 4701
Sfmt 4702
20713
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
E:\FR\FM\03MYP2.SGM
03MYP2
20714
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
nlaroche on DSK30NT082PROD with PROPOSALS2
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 nonsubstantive 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-Feefor-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/ICD10-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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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-
PO 00000
Frm 00026
Fmt 4701
Sfmt 4702
Acute Care (PAC) Assessment Data for
Quality, Payment and Discharge
Planning,’’ that enacts new data
reporting requirements for certain postacute 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).
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
1 https://www.cms.gov/Medicare/QualityInitiatives-Patient-Assessment-Instruments/
QualityInitiativesGenInfo/CMS-QualityStrategy.html.
2 https://www.ahrq.gov/workingforquality/nqs/
nqs2011annlrpt.htm.
E:\FR\FM\03MYP2.SGM
03MYP2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
nlaroche on DSK30NT082PROD with PROPOSALS2
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’ valuebased 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
3 https://aspe.hhs.gov/pdf-report/report-congresssocial-risk-factors-and-performance-undermedicares-value-based-purchasing-programs.
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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
As discussed in the FY 2017 IRF PPS
final rule, the NQF has undertaken a 2year 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
4 https://aspe.hhs.gov/pdf-report/report-congresssocial-risk-factors-and-performance-undermedicares-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.
PO 00000
Frm 00027
Fmt 4701
Sfmt 4702
20715
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
E:\FR\FM\03MYP2.SGM
03MYP2
nlaroche on DSK30NT082PROD with PROPOSALS2
20716
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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 comorbidities 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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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
PO 00000
Frm 00028
Fmt 4701
Sfmt 4702
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 CrossSetting Standardized Patient
Assessment Data Focus Group Summary
Report is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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
E:\FR\FM\03MYP2.SGM
03MYP2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
in the standardized assessment
instrument that we tested in the PostAcute 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
PACQualityInitiative@cms.hhs.gov.
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-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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
20717
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 nonsubstantive 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 ..............................
Patient Influenza Vaccine ...............
Application of Falls ..........................
Application of Functional Assessment.
Change in Self-Care .......................
nlaroche on DSK30NT082PROD with PROPOSALS2
Change in Mobility ..........................
Discharge Self-Care Score .............
Discharge Mobility Score ................
DRR ................................................
Percent of Residents or Patients with Pressure Ulcers That Are New or Worsened (Short Stay) (NQF
#0678).
Percent of Residents or Patients Who Were Assessed and Appropriately Given the Seasonal Influenza
Vaccine (Short Stay) (NQF #0680).
Application of Percent of Residents Experiencing One or More Falls with Major Injury (Long Stay) (NQF
#0674).*
Application of Percent of LTCH Patients with an Admission and Discharge Functional Assessment and a
Care Plan That Addresses Function (NQF #2631).*
IRF Functional Outcome Measure: Change in Self-Care Score for Medical Rehabilitation Patients (NQF
#2633).**
IRF Functional Outcome Measure: Change in Mobility Score for Medical Rehabilitation Patients (NQF
#2634).**
IRF Functional Outcome Measure: Discharge Self-Care Score for Medical Rehabilitation Patients (NQF
#2635).**
IRF Functional Outcome Measure: Discharge Mobility Score for Medical Rehabilitation Patients (NQF
#2636).**
Drug Regimen Review Conducted with Follow-Up for Identified Issues—PAC IRF QRP.*
NHSN
CAUTI .............................................
VerDate Sep<11>2014
14:32 May 02, 2017
National Healthcare Safety Network (NHSN) Catheter-Associated Urinary Tract Infection (CAUTI) Outcome
Measure (NQF #0138).
Jkt 241001
PO 00000
Frm 00029
Fmt 4701
Sfmt 4702
E:\FR\FM\03MYP2.SGM
03MYP2
20718
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
TABLE 7—QUALITY MEASURES CURRENTLY ADOPTED FOR THE IRF QRP—Continued
Short name
Measure name and data source
MRSA ..............................................
NHSN Facility-Wide Inpatient Hospital-Onset Methicillin-Resistant Staphylococcus aureus (MRSA)
Bacteremia Outcome Measure (NQF #1716).
NHSN Facility-wide Inpatient Hospital-Onset Clostridium difficile Infection (CDI) Outcome Measure (NQF
#1717).
Influenza Vaccination Coverage among Healthcare Personnel (NQF #0431).
CDI ..................................................
HCP Influenza Vaccine ...................
Claims-based
All-Cause Readmissions .................
MSPB ..............................................
DTC .................................................
Potentially Preventable Readmissions (PPR) 30 day.
PPR Within Stay .............................
All-Cause Unplanned Readmission Measure for 30 Days Post Discharge from IRFs (NQF #2502).
Medicare Spending per Beneficiary (MSPB)—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.*
* 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
nlaroche on DSK30NT082PROD with PROPOSALS2
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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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
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
PO 00000
Frm 00030
Fmt 4701
Sfmt 4702
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
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
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) https://
www.o-wm.com/content/the-npuap-dual-missionconference-reaching-consensus-staging-and-deeptissue-injury.
E:\FR\FM\03MYP2.SGM
03MYP2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
nlaroche on DSK30NT082PROD with PROPOSALS2
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
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 PostAcute 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
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.
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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 poorand high-performing facilities.
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 nonremovable 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
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-AssessmentInstruments/Post-Acute-Care-Quality-Initiatives/
Downloads/Development-of-a-Cross-SettingQuality-Measure-for-Pressure-Ulcers-InformationGathering-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-UlcerQuality-Measure-Summary-Report-on-November15-2013-Technical-Expert-Pa.pdf.
PO 00000
Frm 00031
Fmt 4701
Sfmt 4702
20719
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/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html. This summary includes
further detail about our responses to
various concerns and ideas stakeholders
raised.
The NQF-convened Measures
Application Partnership (MAP) PostAcute 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
E:\FR\FM\03MYP2.SGM
03MYP2
20720
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
nlaroche on DSK30NT082PROD with PROPOSALS2
available at https://www.quality
forum.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 PostAcute 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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFPAI-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-Feefor-Service-Payment/
InpatientRehabFacPPS/IRFPAI.html
and https://www.cms.gov/Medicare/
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
Quality-Initiatives-Patient-AssessmentInstruments/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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFQuality-Reporting-Program-MeasuresInformation-.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 PostAcute 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 AllCause 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 30Day 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
PO 00000
Frm 00032
Fmt 4701
Sfmt 4702
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 allcause and PPR rates. In particular, we
could compare facility performance on
the All-Cause Readmission and PPR 30Day 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 allcause readmissions, because we believe
the PPR measures will be more
actionable for quality improvement.
We are proposing to remove the AllCause 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 30Day 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 PostDischarge and PPR Within Stay measure
specifications available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/
Downloads/Measure-Specifications-forFY17-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
E:\FR\FM\03MYP2.SGM
03MYP2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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-andcomment 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 patientreported 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
20721
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
nlaroche on DSK30NT082PROD with PROPOSALS2
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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
(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
PO 00000
Frm 00033
Fmt 4701
Sfmt 4702
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
E:\FR\FM\03MYP2.SGM
03MYP2
20722
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
nlaroche on DSK30NT082PROD with PROPOSALS2
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.
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 goldstandard 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 goldstandard 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
The data elements used to calculate
the current pressure ulcer measure
received public comment on several
occasions, including when that measure
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.
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 https://
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.
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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), LongTerm Care Hospitals (LTCHs), and
Home Health Agencies (HHAs)’’ is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.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
PO 00000
Frm 00034
Fmt 4701
Sfmt 4702
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
E:\FR\FM\03MYP2.SGM
03MYP2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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 https://www.cms.gov/Medicare/
Quality-Initiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/CARE-Item-Set-and-BCARE.html. For more information about
this quality measure, we refer readers to
the FY 2016 IRF PPS final rule (80 FR
47100 through 47111).
We are inviting public comment on
this proposal.
(2) Cognitive Function and Mental
Status Data
nlaroche on DSK30NT082PROD with PROPOSALS2
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
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.
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.
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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
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
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.
PO 00000
Frm 00035
Fmt 4701
Sfmt 4702
20723
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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFQuality-Reporting-Program-MeasuresInformation-.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
40 Aguero-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.
E:\FR\FM\03MYP2.SGM
03MYP2
nlaroche on DSK30NT082PROD with PROPOSALS2
20724
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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 CrossSetting Standardized Patient
Assessment Data Technical Expert Panel
Summary Report is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
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/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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
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.
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFQuality-Reporting-Program-MeasuresInformation-.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.
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
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.
PO 00000
Frm 00036
Fmt 4701
Sfmt 4702
0.70 to 0.73); and moderate agreement
for the ‘‘Altered Level of
Consciousness’’ question (kappa of
0.58).44
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 PostAcute Care Cross-Setting Standardized
Patient Assessment Data Technical
Expert Panel Summary Report is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.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-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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
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.
E:\FR\FM\03MYP2.SGM
03MYP2
nlaroche on DSK30NT082PROD with PROPOSALS2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFQuality-Reporting-Program-MeasuresInformation-.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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
feasible for use in each of the four PAC
settings.45
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 CrossSetting Standardized Patient
Assessment Data Technical Expert Panel
Summary Report is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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
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.
PO 00000
Frm 00037
Fmt 4701
Sfmt 4702
20725
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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFQuality-Reporting-Program-MeasuresInformation-.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
E:\FR\FM\03MYP2.SGM
03MYP2
20726
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
nlaroche on DSK30NT082PROD with PROPOSALS2
0.84 to 0.91) when tested by all four
PAC providers.46
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/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
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.
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.
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
IMPACT-Act-Downloads-andVideos.html.
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.
PO 00000
Frm 00038
Fmt 4701
Sfmt 4702
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-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFQuality-Reporting-Program-MeasuresInformation-.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
E:\FR\FM\03MYP2.SGM
03MYP2
nlaroche on DSK30NT082PROD with PROPOSALS2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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 highlytoxic 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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
of the comments is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFQuality-Reporting-Program-MeasuresInformation-.html.
PO 00000
Frm 00039
Fmt 4701
Sfmt 4702
20727
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/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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,
E:\FR\FM\03MYP2.SGM
03MYP2
20728
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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.
nlaroche on DSK30NT082PROD with PROPOSALS2
(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 ´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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFQuality-Reporting-Program-MeasuresInformation-.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.
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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 subelements 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
PO 00000
Frm 00040
Fmt 4701
Sfmt 4702
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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFQuality-Reporting-Program-MeasuresInformation-.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.
E:\FR\FM\03MYP2.SGM
03MYP2
nlaroche on DSK30NT082PROD with PROPOSALS2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
The proposed data elements are based
on an item currently in use in the MDS
3.0 (‘‘Suctioning’’ without the two subelements), 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-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.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/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFQuality-Reporting-Program-MeasuresInformation-.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
PO 00000
Frm 00041
Fmt 4701
Sfmt 4702
20729
care services will necessarily include
close monitoring to ensure that no lifethreatening 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/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Therefore, we are proposing that the
Tracheostomy Care data element meets
E:\FR\FM\03MYP2.SGM
03MYP2
20730
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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.
nlaroche on DSK30NT082PROD with PROPOSALS2
(vi) Respiratory Treatment: NonInvasive Mechanical Ventilator (BiPAP,
CPAP)
We are proposing that the Noninvasive 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 subelements, 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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFQuality-Reporting-Program-MeasuresInformation-.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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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/Bilevel 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/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
PO 00000
Frm 00042
Fmt 4701
Sfmt 4702
IMPACT-Act-Downloads-andVideos.html.
Therefore, we are proposing that the
Non-invasive Mechanical Ventilator
(BiPAP, CPAP) data elements with a
principal data element and two subelements 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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFQuality-Reporting-Program-MeasuresInformation-.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
E:\FR\FM\03MYP2.SGM
03MYP2
nlaroche on DSK30NT082PROD with PROPOSALS2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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
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: Nonweaning’’), 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/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
A TEP convened by the data element
contractor provided input on the
proposed data elements. This TEP, held
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.
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFQuality-Reporting-Program-MeasuresInformation-.html.
IV medications are solutions of a
specific medication (for example,
antibiotics, anticoagulants)
PO 00000
Frm 00043
Fmt 4701
Sfmt 4702
20731
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
E:\FR\FM\03MYP2.SGM
03MYP2
nlaroche on DSK30NT082PROD with PROPOSALS2
20732
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFQuality-Reporting-Program-MeasuresInformation-.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/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
PO 00000
Frm 00044
Fmt 4701
Sfmt 4702
IMPACT-Act-Downloads-andVideos.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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFQuality-Reporting-Program-MeasuresInformation-.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,
E:\FR\FM\03MYP2.SGM
03MYP2
nlaroche on DSK30NT082PROD with PROPOSALS2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
is available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.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-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFQuality-Reporting-Program-MeasuresInformation-.html.
PO 00000
Frm 00045
Fmt 4701
Sfmt 4702
20733
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,
E:\FR\FM\03MYP2.SGM
03MYP2
20734
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.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-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Therefore, we are proposing that the
IV access (Peripheral IV, Midline,
Central line, Other) data elements with
a principal data element and four subelements 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.
nlaroche on DSK30NT082PROD with PROPOSALS2
(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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRF-
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
Quality-Reporting-Program-MeasuresInformation-.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/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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://
PO 00000
Frm 00046
Fmt 4701
Sfmt 4702
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFQuality-Reporting-Program-MeasuresInformation-.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
49 Dempsey, D.T., Mullen, J.L., & Buzby, G.P.
(1988). ‘‘The link between nutritional status and
clinical outcome: can nutritional intervention
E:\FR\FM\03MYP2.SGM
03MYP2
nlaroche on DSK30NT082PROD with PROPOSALS2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
are a variety of reasons that patients and
residents may not be able to eat orally
(including clinical or cognitive status).
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 renamed Feeding Tube, indicating the
presence of an assistive device. A full
report of the comments is available at
https://www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.html.
Therefore, we are proposing that the
Feeding Tube data element meets the
definition of standardized patient
modify it?’’ Am J of Clinical Nutrition 47(2): 352–
356.
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFQuality-Reporting-Program-MeasuresInformation-.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
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.
PO 00000
Frm 00047
Fmt 4701
Sfmt 4702
20735
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.
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/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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
E:\FR\FM\03MYP2.SGM
03MYP2
20736
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
nlaroche on DSK30NT082PROD with PROPOSALS2
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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFQuality-Reporting-Program-MeasuresInformation-.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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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
PO 00000
Frm 00048
Fmt 4701
Sfmt 4702
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
E:\FR\FM\03MYP2.SGM
03MYP2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
nlaroche on DSK30NT082PROD with PROPOSALS2
conditions can be gradual, so
individualized assessment with accurate
screening tools and follow-up
evaluations are essential to determining
which patients need hearing- or visionspecific 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; personcentered, 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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFQuality-Reporting-Program-MeasuresInformation-.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.
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
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 minireview. 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.
PO 00000
Frm 00049
Fmt 4701
Sfmt 4702
20737
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
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 CrossSetting Standardized Patient
Assessment Data Technical Expert Panel
Summary Report is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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 patientand resident-centered treatment plans.
Based on comments that the three-level
response choice (Ability to Hear) was
not congruent with the current, fourlevel 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
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.
E:\FR\FM\03MYP2.SGM
03MYP2
20738
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
nlaroche on DSK30NT082PROD with PROPOSALS2
comments is available at https://
www.cms.gov/Medicare/QualityInitiatives-Patient-AssessmentInstruments/Post-Acute-Care-QualityInitiatives/IMPACT-Act-of-2014/
IMPACT-Act-Downloads-andVideos.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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFQuality-Reporting-Program-MeasuresInformation-.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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
less mobility, and report depressive
symptoms.60 61 62 63 64 65 66
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.
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
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 lifespace diameter. A measure of extent and frequency
of mobility among nursing home residents. J Am
Geriatr Soc. 1990;38(12):1311–1315.
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 agerelated macular degeneration: A systematic review.
The British Journal of Ophthalmology.
2007;91(9):1177–1182.
PO 00000
Frm 00050
Fmt 4701
Sfmt 4702
assessment. Similar data elements, but
with different wording and fewer
response option categories, are in use in
the OASIS–C2 and were tested in postacute 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.
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 PostAcute Care Cross-Setting Standardized
Patient Assessment Data Technical
Expert Panel Summary Report is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.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.
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.
E:\FR\FM\03MYP2.SGM
03MYP2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
A full report of the comments is
available at https://www.cms.gov/
Medicare/Quality-Initiatives-PatientAssessment-Instruments/Post-AcuteCare-Quality-Initiatives/IMPACT-Act-of2014/IMPACT-Act-Downloads-andVideos.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-Feefor-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-
20739
Initiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFPAI-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 *∧
Proposed data collection/submission
quarterly reporting period *
Proposed data submission quarterly deadlines *∧ for the FY 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.
∧ 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 *∧
nlaroche on DSK30NT082PROD with PROPOSALS2
Proposed data collection/submission
quarterly reporting period *
Q1:
Q2:
Q3:
Q4:
CY
CY
CY
CY
2018
2018
2018
2018
Proposed data submission quarterly deadlines *∧ for the FY 2020 IRF QRP **
1/1/2018–3/31/2018 ......................
4/1/2018–6/30/2018 ......................
7/1/2018–9/30/2018 ......................
10/1/2018–12/31/2018 ..................
CY
CY
CY
CY
2018
2018
2018
2018
Q1
Q2
Q3
Q4
Deadline:
Deadline:
Deadline:
Deadline:
August 15, 2018.
November 15, 2018.
February 15, 2019.
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.
∧ Applies to data reporting using the IRF PAI and data reporting using the National Health Safety Network.
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
PO 00000
Frm 00051
Fmt 4701
Sfmt 4702
E:\FR\FM\03MYP2.SGM
03MYP2
20740
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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.
nlaroche on DSK30NT082PROD with PROPOSALS2
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/QualityInitiatives-Patient-AssessmentInstruments/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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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
§ 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
§ 412.634(c). We are proposing to revise
§ 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
PO 00000
Frm 00052
Fmt 4701
Sfmt 4702
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 § 412.634. We note that
§ 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-thatapply 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
§ 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 riskadjustment 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 § 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
E:\FR\FM\03MYP2.SGM
03MYP2
nlaroche on DSK30NT082PROD with PROPOSALS2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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/QualityInitiatives-Patient-AssessmentInstruments/IRF-Quality-Reporting/IRFQuality-Reporting-Data-SubmissionDeadlines.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 Hospitalonset 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 Facilitywide 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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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 assessmentbased 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 PostDischarge 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 ‘‘AllCause 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
PO 00000
Frm 00053
Fmt 4701
Sfmt 4702
20741
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 PostDischarge 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 BeneficiaryPAC 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.
E:\FR\FM\03MYP2.SGM
03MYP2
20742
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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-PatientAssessment-Instruments/IRF-QualityReporting/IRF-Quality-PublicReporting.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, reportingbased 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
$ 15,708
Adjusted FY 2018 Standard Payment Conversion Factor ............................................................................................................
nlaroche on DSK30NT082PROD with PROPOSALS2
Standard Payment Conversion Factor for FY 2017 ......................................................................................................................
Increase Factor for FY 2018 (1.0 percent), as 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-Related Share ......................................................................................
Budget Neutrality Factor for the Revisions to the CMG Relative Weights ...................................................................................
= $ 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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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
PO 00000
Frm 00054
Fmt 4701
Sfmt 4702
× 0.9900
× 1.0007
× 0.9974
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.
E:\FR\FM\03MYP2.SGM
03MYP2
nlaroche on DSK30NT082PROD with PROPOSALS2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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
PO 00000
Frm 00055
Fmt 4701
Sfmt 4702
20743
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 Medicarecertified 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
(https://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.
E:\FR\FM\03MYP2.SGM
03MYP2
20744
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
TABLE 13—U.S. BUREAU OF LABOR STATISTICS’ MAY 2016 NATIONAL OCCUPATIONAL EMPLOYMENT AND WAGE
ESTIMATES
Occupation
code
Occupation title
nlaroche on DSK30NT082PROD with PROPOSALS2
Registered Nurse (RN) ....................................................................................
Licensed Practical and Licensed Vocational Nurses (LVN) ............................
Respiratory Therapists (RT) ............................................................................
Speech-Language Pathologists (SLP) ............................................................
Occupational Therapists (OT) .........................................................................
Psychologist .....................................................................................................
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 crosssetting 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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
29–1141
29–2061
29–1126
29–1127
29–1122
19–3030
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 × 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
PO 00000
Frm 00056
Fmt 4701
Sfmt 4702
Mean hourly
wage
($/hr)
34.70
21.56
29.15
37.60
40.25
38.77
Fringe benefit
($/hr)
34.70
21.56
29.15
37.60
40.25
38.77
Adjusted
hourly wage
($/hr)
69.40
43.12
58.30
75.20
80.50
77.54
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 × 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
E:\FR\FM\03MYP2.SGM
03MYP2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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.
nlaroche on DSK30NT082PROD with PROPOSALS2
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
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
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
https://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
PO 00000
Frm 00057
Fmt 4701
Sfmt 4702
20745
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
E:\FR\FM\03MYP2.SGM
03MYP2
20746
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
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 ×
$90.16). Therefore, we estimate that the
total cost of reviewing this regulation is
$12,262 ($180.32 × 68 reviewers).
Accounting Statement
As required by OMB Circular A–4
(available at https://
www.whitehouse.gov/sites/default/files/
omb/assets/omb/circulars/a004/a4.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 ................................................................................................
From Whom to Whom? ..............................................................................................................
$80 million.
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 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
nlaroche on DSK30NT082PROD with PROPOSALS2
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
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–
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
$3.4 million.
67, sec. 112 of Pub. L. 113–93, and sec. 231
of Pub. L. 114–113.
2. Section 412.614 is amended by
revising paragraphs (d) heading, (d)(1),
and (e) to read as follows:
■
§ 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
PO 00000
Frm 00058
Fmt 4701
Sfmt 4702
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
E:\FR\FM\03MYP2.SGM
03MYP2
Federal Register / Vol. 82, No. 84 / Wednesday, May 3, 2017 / Proposed Rules
facility. An extraordinary situation must
be fully documented by the inpatient
rehabilitation facility.
■
§ 412.624
§ 412.634 Requirements under the
Inpatient Rehabilitation Facility (IRF) Quality
Reporting Program (QRP).
[Amended]
3. In § 412.624—
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,’’;
■ b. Remove paragraph (e)(6);
■ c. Redesignate paragraph (e)(7) as
paragraph (e)(6);
■ 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
■ 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’’.
■
nlaroche on DSK30NT082PROD with PROPOSALS2
■
VerDate Sep<11>2014
14:32 May 02, 2017
Jkt 241001
4. Section 412.634 is amended by
revising paragraphs (b)(1), (c)(1), (f)(1)
and (2) to read as follows:
*
*
*
*
*
(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:
PO 00000
Frm 00059
Fmt 4701
Sfmt 9990
20747
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
E:\FR\FM\03MYP2.SGM
03MYP2
Agencies
[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
-----------------------------------------------------------------------
Centers for Medicare & Medicaid Services
-----------------------------------------------------------------------
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
[[Page 20690]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://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 https://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)
[[Page 20692]]
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
[[Page 20693]]
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 https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/InpatientRehabFacPPS/. 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 https://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 https://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 https://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 https://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 https://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 https://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 https://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 https://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 https://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\ https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/CMS-Quality-Strategy.html.
\2\ https://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 PACQualityInitiative@cms.hhs.gov.
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) https://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 https://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 https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/IRF-Quality-Reporting/.
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 https://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 https://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 (https://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 https://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 https://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